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`Daily Activi§_v_
`
`Table of Contents
`
`(Dates and starting pages for yearly citations and selected events)
`
`2_K2- 1
`
`0-18-2005
`
`1 1-Month Dog Toxicity Study (study No. P000 12-05-05) — dosing begins _
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`Z_-- 1
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`1-Month Dog Toxicity Study (Study No. P000l2-05-05) — dosing ends
`
`nJ 1
`n I
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`
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`06-25-2007
`07-28-2007
`
`09-MS-301 Phase ]I[ Human Study — dosing begins ‘
`2-Year Mouse Carcinogenicity Study (Study No. P00012-05-03) — dosing ends ‘
`109-MS-302 Phase 111 Human Study — dosing begins _
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`Page 1 01 111
`
`Biogen Exhibit 2051
`Coalition v. Biogen
`IPR2015-01993
`
`

`

`Key of Letter Symbols for Study Activities
`the following abbreviations are used throughout the daily diligence chart
`
`further advance clinical develo ment toward Phase III clinical trials are collective] desi an ted below with the abbreviation “CD Ph3."
`
`Clinical Development toward Phase III
`Once the Phase Ilb clinical trial was underway. Biogen worked continuously on numerous tasks required to further advance its clinical
`development of BG-12 toward Phase III. such as preparing and filing IND 73.061 (BG-12 MS treatment), preparing Phase 111 designs and
`protocols, corresponding with the FDA and other regulatory agencies. and performing Phase III start-up activities. These activities to
`
`Dosing Animals
`From at least as early as Sept. 2004 until June 2007. Biogen conducted five overlapping. nonclinical (animal) studies as part of its BG-12
`program. Completion of these nonclinical (animal) studies necessitated a variety of activities. including the daily administration of a
`con u o sition containin DNIF to stud animals. which is desi -4| ted in the chart below with the abbreviation “DA."
`
`Recruiting and Enrolling Patients and Sites
`Successful initiation and completion of Biogen’s Phase Hb clinical trial and subsequent Phase III clinical trials required significant
`recruitment and enrollment of MS patients and trial study sites to carry out Biogen’s clinical trial protocols. These recruitment and
`enrollment eflbrts are designated in the chart below with the abbreviation “R/E."
`
`Page 2 of 111
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`

`

`Summary of Nonclinical Study Dosing Dates
`Biogen conducted eettain nonclinical (animal) studies in developing BG—l2, each study involving a range ofdaily
`dosingdates. Thedailydiligencechartbelowusescolor-codedcohmmsto showthosedameranges duringwhichstudy
`subjectsreceivedastudydosewithinarespectivetrial. Thiscondensedrepresentationofthosedosingdateranges
`illustrates the overlapping nature ofthese studies.
`
`P000l2-05-03
`
`2-Year Mouse Carcinggenicig Stu(_l1
`0
`Ex. 2375 at 26; Ex. 2377 at 1, 10, 18-
`19.
`
`P000l2—0S—05
`ll-Month
`
`R at Dose Toxic’
`
`E:
`0
`Ex. 2085 at 77; Ex. 2275 at 1, 9, 14-16.
`
`
`1-Year Monkey Remat Dose Toxicity
`Sfilx
`o
`Ex. zoss at 68; Ex. 2276 at 1, 9-11.
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`Page 3 of 111
`
`6/28/05
`to
`6/25/07
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`1,1,,“
`to
`1/15/o7
`
`iii
`
`

`

`Daily Diligence Chart
`
`All Supporting Evidence
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`05/1/2006 DA
`
`(Mon)
`
`DA: 13:17-15:6
`
`CD Ph3: 15:9-16:8;
`17:1-8; 17:16-18:18:
`22:2-4
`
`05/2/2006 DA
`
`(Tues)
`
`DA: 13:17-15:6
`
`CD Ph3: 15:9-16:8;
`17:1-8: 17:16-18:18;
`22:2-4
`
`Ex. 2076 1|1[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9. 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21: Ex. 2377 at 19);
`Ex. 2079 1]1[40-43 (Ex. 2255: Ex. 2252 at 1; Ex. 2122 at 2: Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`2124 at 2);
`Ex. 2078 1[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11):
`Ex. 2080 1|1[ 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54: Ex.
`2283: Ex. 2375 at 18, 25, 26: Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`Ex. 2076 1|1[ 25. 26. 45. 47. 49-53 (Ex. 2262 at 1: Ex. 2375: Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11: Ex. 2381; Ex. 2343: Ex. 2350 at 1; Ex. 2122 at 2: Ex. 2252 at 1; Ex. 2131 at 1: Ex. 2115 at
`1: Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2079 1|1[40-43 (Ex. 2255: Ex. 2252 at 1: Ex. 2122 at 2: Ex. 2131 at 1; Ex. 2115 at 1: Ex.
`2124 at 2);
`Ex. 2078 fi[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15: Ex. 2276 at 9-11):
`Ex. 2080 fi|1[ 25-35 (Ex. 2274; Ex. 2330 at 6-8. 28. 35, 37: Ex. 2281 at 34, 37-39. 50-54: Ex.
`2283: Ex. 2375 at 18, 25. 26: Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284: Ex. 2226: Ex.
`2275: Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`dosinganimals
`
`DA =
`
`RIE =
`
`sites/patients
`
`CDl’II3=PhaseIlIclinicaldcvelopmcnt
`‘Gray rows = weekends and/or holidays
`
`Page 4 of 111
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`

`

`All Supporting Evidence
`
`.
`
`.
`
`D ‘
`
`Date
`
`All
`
`(Day)
`
`Activity
`
`05/3/2006 DA
`(Wed)
`CD Ph3
`
`05/4/2006 DA
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`Ex. 2076 1|1[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1: Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19):
`Ex. 2079 fi|1[40-43 (Ex. 2255; Ex. 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8; 2124 at 2);
`17:1-8; 17:16-18:18; Ex. 2078 1[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`22:2-4
`Ex. 2080 1|1[ 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`Ex. 2076 1|1[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2079 1|1[40-43 (Ex. 2255; Ex 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8; 2124 at-7-)1:
`17:1-8; 17:16-18:18; Ex. 2078 1[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`2222-4
`Ex. 2080 1|1[ 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`DA=dosinganimals
`RIE =
`
`sites/patients
`
`CDPII3=PhaseI[Ic1inica1de've1opment
`‘Gray tows = vwekcnck and/or holidays
`
`Page 5 of 111
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`

`

`Date
`
`All
`
`(Day)
`
`Activity
`
`Motion
`Citations
`
`(page:linc)
`
`All Supporting Evidence
`
`Exhibit Citations for All Activities
`
`Declaration Ex. 0:"-.xhibits cited therein)
`
`05/5/2006 DA
`
`(Fri)
`
`CD Ph3
`
`DA: 13:17-15:6
`
`CD Ph3: 15:9-16:8‘.
`17:1-8: 17:16-18:18:
`22:2-4
`
`DA: 13:17-15:6
`
`DA: 13:17-15:6
`
`Ex. 2076 111 25. 26. 45. 47. 49-53 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2079 111140-43 (Ex. 2255; Ex. 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`2124 at 2):
`Ex. 2078 fi[ 7 (Ex. 2375 at 18. 26; Ex. 2275 at 9. 14. 15; Ex. 2276 at 9-11):
`Ex. 2080 M 25-35 (Ex. 2274: Ex. 2330 at 6-8. 28. 35, 37: Ex. 2281 at 34. 37-39. 50-54: Ex.
`2283: Ex. 2375 at 18. 25. 26: Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284: Ex. 2226: Ex.
`2275: Ex. 2285: Ex. 2326: Ex. 2276: Ex. 2286)
`
`2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-11;
`Ex. 2076 1fl25, 26, 45, 52, 53
`Ex. 2381; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2078 1] 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; E. 2276 at 9-11);
`Ex. 2080 1fl 25-35
`2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; E.
`2283; E. 2375 at 18, 25, 26; E. 2085 at 68-74, 128-52; Ex. 2377; E. 2284; E. 2226; E.
`2275; E. 2285; E. 2326; E. 2276; Ex. 2286)
`
`2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-11;
`Ex. 2076 1fl25, 26, 45, 52, 53
`Ex. 2381; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2078 1] 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; E. 2276 at 9-11);
`Ex. 2080 1fl 25-35
`2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; E. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; E. 2284; E. 2226; Ex.
`2275; E. 2285; E. 2326; E. 2276; Ex. 2286)
`
`DA =
`
`dosing animals
`RIE = reuniting/enrolling sites/patients
`
`CD P113 = Phase I[[ clinical development
`‘Gray tows = weekends and/or holidays
`
`Page 6 of 111
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`

`

`Date
`
`All
`
`(Day)
`
`Activity
`
`05/8/2006 DA
`CD Ph3
`(Mon)
`
`05/9/2006 DA
`
`All Supporting Evidence
`
`1;::17:
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`Ex. 2076 1|1[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1: Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19):
`Ex. 2079 fi|1[40-43 (Ex. 2255; Ex. 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8; 2124 at 2);
`17:1-8; 17:16-18:18; Ex. 2078 1[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`22:2-4
`Ex. 2080 11 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`Ex. 2076 1|1[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`1l;Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2079 1|1[40-43 (Ex. 2255; Ex 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8; 2124 at 2);
`17:1-8; 17:16-18:18; Ex. 2078 1[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`2222-4
`Ex. 2080 1|1[ 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`DA=dosinganimals
`RIE =
`
`sites/patients
`
`CDPII3=PhaseI[Ic1inica1de've1opment
`‘Gray tows = vwekcnck and/or holidays
`
`4
`
`Page 7 of 111
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`

`

`Date
`
`All
`
`(Day)
`
`Activity
`
`05/10/2006 DA
`CD Ph3
`(Wed)
`
`05/1 1/2006 DA
`(Thur)
`CD Ph3
`
`All Supporting Evidence
`
`1;:2112':
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`Ex. 2076 1|1[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1: Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19):
`Ex. 2079 fi|1[40-43 (Ex. 2255; Ex. 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8; 2124 312);
`17:1-8; 17:16-18:18; Ex. 2078 1[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`22:2-4
`Ex. 2080 111 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25,26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`Ex. 2076 1|'|[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2079 1|1[40-43 (Ex. 2255; Ex 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8; 2124 at 2);
`17:1-8; 17:16-18:18; Ex. 2078 1[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`22:2-4
`Ex. 2080 1|1[ 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`05/12/2006 DA
`
`(Fri)
`
`Ph3
`
`CD
`
`DA: 13:17-15:6
`
`CD P113: 15:9-16:8;
`17:1-8; 17:16-18:18;
`22:2-4
`
`Ex. 2076 fi|1[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1: Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2078 fi[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`Ex. 2079 1n[4o-43 (Ex. 2255; Ex. 2252 at 1; Ex. 2122 at2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`2124 at 2);
`Ex. 2080 111 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28,35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`DA=dosinganimals
`RIE =
`
`sites/patients
`
`CDPI13=P11aseI[Ic1inica1dc've1opmcm
`‘Gray rows = vwekcnck and/or holidays
`
`Page 8 of 111
`
`

`

`Date
`(Day)
`
`All
`Activity
`
`Motion
`Citations
`(pagclinc)
`
`°5’13’2°°5 DA
`(S39
`
`DA: 13:17-15:6
`
`05/14/2006
`
`(sun)
`
`DA
`
`DA: 13:17-15:6
`
`All Supporting Evidence
`
`_
`_
`_
`_
`_
`_
`_
`Exhibit Citations for All Activities
`Declaration Ex. 0:"-.xhibits cited therein)
`
`Ex. 2076 111 25, 26, 45, 52, 5303:. 2262 at 1; Br. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-1 1;
`Ex. 2381; Ex. 2274 at20, 21; Ex. 2377 at 19);
`Ex. 2078 1| 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`Ex. 2080 1|-[25-35 (Br. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; m.
`2283; E1. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; m. 2226; Ex.
`2275; Er. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`Ex. 2076 1fl25, 26, 45, 52, 53 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-11;
`Ex. 2381; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2078 1] 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`Ex. 2080 1|] 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`05/15/2006 DA
`
`Ex. 2076 M 25, 26, 45, 47, 49-53 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16: Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2: Ex. 2252 at 1; Ex. 2131 at 1: Ex. 2115 at
`1; Ex. 2274 at 20, 21: Ex. 2377 at 19):
`Ex. 2079 1|1[40-43 (Ex. 2255: Ex. 2252 at 1; EX. 2122 at 2: Ex. 2131 at 1; Ex. 2115 at 1: Ex.
`DA: 13:17-15:6
`CD P113: l5:9—16:8: 2124 312);
`1721-8: 17:16-18:18: Ex. 2078 fi[ 7 (Ex. 2375 at 18. 26; Ex. 2275 at 9, 14, 15: Ex. 2276 at 9-11):
`22:2-4
`Ex. 2080 M 25-35 (Ex. 2274: Ex. 2330 at 6-8, 28. 35, 37: Ex. 2281 at 34, 37-39. 50-54: Ex.
`2283: Ex. 2375 at 18, 25. 26: Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226: Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276: Ex. 2286)
`
`1::Ziillfg
`3
`
`“"16
`
`:- ZYMo'-
`
`DA=dosinganimals
`RIE = tetmiiting/enrolling sites/patients
`
`CDl’I|3=PhascI[[c1inicaldc'velopmcnt
`‘Gray tows = weekends and/or holidays
`
`Page 9 of 111
`
`

`

`Date
`
`All
`
`(Day)
`
`Activity
`
`05/16/2006 DA
`CD Ph3
`(Tues)
`
`05/17/2006 DA
`
`All Supporting Evidence
`
`1;::17:
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`Ex. 2076 1|1[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1: Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19):
`Ex. 2079 fi|1[40-43 (Ex. 2255; Ex. 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8; 2124 at 2);
`17:1-8; 17:16-18:18; Ex. 2078 1[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`22:2-4
`Ex. 2080 11 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`Ex. 2076 1|1[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2079 1|1[40-43 (Ex. 2255; Ex 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8; 2124 at 2);
`17:1-8; 17:16-18:18; Ex. 2078 1[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`2222-4
`Ex. 2080 1|1[ 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`DA=dosinganimals
`RIE =
`
`sites/patients
`
`CDPII3=PhaseI[Ic1inica1de've1opment
`‘Gray tows = vwekcnck and/or holidays
`
`Page 10 of 111
`
`

`

`All Supporting Evidence
`
`.
`
`.
`
`Date
`
`All
`
`(Day)
`
`Activity
`
`05/18/2006 DA
`
`(Thur)
`
`CD Ph3
`
`DA: 13:17-15:6
`
`CD P113: 15:9-16:8;
`17:1-8:17:16-18:18;
`22:2-4
`
`05/19/2006 DA
`
`(Fri)
`
`CD Ph3
`
`DA: 13:17-15:6
`
`CD P113: 15:9-16:8;
`17:1-8; 17:16-18:18;
`2222-4
`
`05/20/2006
`
`DA
`
`DA: 13:17-15:6
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`Ex. 2076 1]1[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1: Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343: Ex. 2350 at 1; Ex. 2122 at 2: Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19):
`Ex. 2079 1]1[40-43 (Ex. 2255; Ex. 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`2124 at 2);
`Ex. 2078 fi[ 7 (Ex. 2375 at 18. 26; Ex. 2275 at 9, 14. 15; Ex. 2276 at 9-11):
`Ex. 2080 1fi[ 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39. 50-54: Ex.
`2283; Ex. 2375 at 18, 25, 26: Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284: Ex. 2226: Ex.
`2275: Ex. 2285: Ex. 2326: Ex. 2276: Ex. 2286)
`
`Ex. 2076 1]'|[ 25, 26, 45. 47, 49-53 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19):
`Ex. 2079 1|1[ 40-43 (Ex. 2255; Ex. 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`2124 at 2);
`Ex. 2078 1[ 7 (Ex. 2375 at 18. 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`Ex. 2080 1]1[ 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39. 50-54: Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284: Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-11;
`Ex. 2076 fi25, 26, 45, 52, 53
`Ex. 2381; Ex. 2274 at20, 21; Ex. 2377 at 19);
`Ex. 2078 17 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-1 1);
`Ex. 2080 fl 25-35
`2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Fx. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Fx. 2276; Ex. 2286)
`
`DA =
`
`dosinganimals
`RIE = reuniting/enrolling sites/patients
`
`CDl’I|3=PhascI[Iclinicaldcve1opmcnt
`‘Gray tows = weekends and/or holidays
`
`Page 11 of 111
`
`Daily
`
`0
`
`Ii:-
`
`n:-
`
`

`

`Date
`
`All
`
`(Day)
`
`Activity
`
`All Supporting Evidence
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`°5’2”2°°° DA
`(S‘'“)
`
`DA: 13:17-15:6
`
`Ex. 2076 1125, 26, 45, 52, 53 (E1. 2262 at 1; Ex. 2375; FJ. 2275 at 9, 14-16; E1. 2276 at 9-11;
`Ex. 2381; Ex. 2274 atzo, 21; Ex. 2377 at 19);
`Ex. 2078 17 (E; 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`Ex. 2080 1125-35 (E1. 2274; E1. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; E1. 2377; Ex. 2284; m. 2226; Ex.
`2275; Er. 2285; Br. 2326; Br. 2276; Ex. 2286)
`
`05/22/2006 DA
`CD Ph3
`(Mon)
`
`05/23/2006 DA
`CD Ph3
`(Tues)
`
`Ex. 2076 111 25. 26. 45. 47. 49-53 (Ex. 2262 at 1: Ex. 2375: Ex. 2275 at 9, 14-16: Ex. 2276 at 9-
`11: Ex. 2381: Ex. 2343: Ex. 2350 at 1: Ex. 2122 at 2: Ex. 2252 at 1: Ex. 2131 at 1: Ex. 2115 at
`
`1: Ex. 2274 at 20, 21: Ex. 2377 at 19);
`Ex. 2079 11140-43 (Ex. 2255: Ex. 2252 at 1: Ex. 2122 at 2: Ex. 2131 at 1: Ex. 2115 at 1: Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8: 2124 at 2):
`17:1-8; 17:16-18:18; Ex. 2078 1 7 (Ex. 2375 at 18. 26: Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11):
`22:2-4
`Ex. 2080 11 25-35 (Ex. 2274; Ex. 2330 at 6-8. 28, 35. 37; Ex. 2281 at 34. 37-39, 50-54: Ex.
`2283: Ex. 2375 at 18, 25, 26: Ex. 2085 at 68-74. 128-52: Ex. 2377; Ex. 2284: Ex. 2226: Ex.
`2275: Ex. 2285: Ex. 2326; Ex. 2276: Ex. 2286)
`
`Ex. 2076 111 25, 26. 45, 47. 49-53 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11: Ex. 2381; Ex. 2343: Ex. 2350 at 1; Ex. 2122 at 2: Ex. 2252 at 1; Ex. 2131 at 1: Ex. 2115 at
`1: Ex. 2274 at 20, 21; Ex. 2377 at 19):
`Ex. 2079 1140-43 (Ex. 2255; Ex. 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8; 2124 at 2):
`17:1-8: 17:16-18:18; Ex. 2078 1 7 (Ex. 2375 at 18. 26: Ex. 2275 at 9, 14. 15; Ex. 2276 at 9-11);
`22:2-4
`Ex. 2080 1fi[ 25-35 (Ex. 2274; Ex. 2330 at 6-8. 28. 35, 37: Ex. 2281 at 34. 37-39. 50-54: Ex.
`2283: Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284: Ex. 2226: Ex.
`2275: Ex. 2285: Ex. 2326: Ex. 2276: Ex. 2286)
`
`DA=dosinganimals
`RIE = reuniting/enrolling sites/patients
`
`CDl’I|3=PhascI[Iclinicaldcvelopmcnt
`‘Gray tows = weekends and/or holidays
`
`Page 12 of 111
`
`

`

`Date
`
`All
`
`(Day)
`
`Activity
`
`05/24/2006 DA
`CD Ph3
`(Wed)
`
`05/25/2006 DA
`
`All Supporting Evidence
`
`1;::17:
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`Ex. 2076 1|1[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1: Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19):
`Ex. 2079 fi|1[40-43 (Ex. 2255; Ex. 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8; 2124 at 2);
`17:1-8; 17:16-18:18; Ex. 2078 1[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`22:2-4
`Ex. 2080 11 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`Ex. 2076 1|1[ 25, 26, 45, 47, 49-53 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2343; Ex. 2350 at 1; Ex. 2122 at 2; Ex. 2252 at 1; Ex. 2131 at 1; Ex. 2115 at
`1; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2079 1|1[40-43 (Ex. 2255; Ex 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8; 2124 at 2);
`17:1-8; 17:16-18:18; Ex. 2078 1[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`2222-4
`Ex. 2080 1|1[ 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`DA=dosinganimals
`RIE =
`
`sites/patients
`
`CDPII3=PhaseI[Ic1inica1de've1opment
`‘Gray tows = vwekcnck and/or holidays
`
`10
`
`Page 13 of 111
`
`

`

`Date
`
`All
`
`(Day)
`
`Activity
`
`Motion
`Citations
`
`(page:line)
`
`All Supporting Evidence
`
`Exhibit Citations for All Activities
`
`Declaration Ex. Oixhibits cited therein)
`
`05/26/2006
`
`(Fri)
`
`DA
`CD Ph3
`
`DA: 13:17-15:6
`
`CD P113: 15:9—l6:8'.
`17:1-8: 17:16-18:18:
`22:2-4
`
`DA: 13:17-15:6
`
`DA: 13:17-15:6
`
`Ex. 2076 M 25. 26. 45. 47. 49-53 (Ex. 2262 at 1: Ex. 2375‘. Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11: Ex. 2381; Ex. 2343; Ex. 2350 at 1: Ex. 2122 at 2: Ex. 2252 at 1: Ex. 2131 at 1; Ex. 2115 at
`1: Ex. 2274 at 20, 21: Ex. 2377 at 19):
`Ex. 2079 1|1[40-43 (Ex. 2255: Ex. 2252 at 1: Ex. 2122 at 2: Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`2124 at 2):
`Ex. 2078 fi[ 7 (Ex. 2375 at 18. 26: Ex. 2275 at 9. 14. 15; Ex. 2276 at 9-11):
`Ex. 2080 M 25-35 (Ex. 2274: Ex. 2330 at 6-8. 28. 35, 37: Ex. 2281 at 34. 37-39. 50-54: Ex.
`2283: Ex. 2375 at 18. 25. 26: Ex. 2085 at 68-74, 128-52: Ex. 2377; Ex. 2284: Ex. 2226: Ex.
`2275: Ex. 2285: Ex. 2326: Ex. 2276: Ex. 2286)
`
`2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; E. 2276 at 9-1 1;
`Ex. 2076 1fl25, 26, 45, 52, 53
`Ex. 2381; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2078 1| 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; E. 2276 at 9-1 1);
`Ex. 2080 1fl 25-35
`2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; E.
`2283; E. 2375 at 18, 25, 26; E. 2085 at 68-74, 128-52; Ex. 2377; E. 2284; E. 2226; E.
`2275; E. 2285; E. 2326; E. 2276; Ex. 2286)
`
`Ex. 2076 1|] 25, 26, 45, 52, 53 (E. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; E. 2276 at 9-1 1;
`Ex. 2381; Ex. 2274 at20, 21; Ex. 2377 at 19);
`Ex. 2078 1| 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, l4, 15; E. 2276 at 9-1 1);
`Ex. 2080 1|] 25-35 (E. 2274; Ex. 2330 at 6-8, 28, 35, 37; E. 2281 at 34, 37-39, 50-54; E.
`2283; E. 2375 at 18, 25, 26; E. 2085 at 68-74, 128-52; Ex. 2377; E. 2284; E. 2226; E.
`2275; E. 2285; E. 2326; E. 2276; Ex. 2286)
`
`DA =
`
`dosing animals
`RIE = tetmniting/enrolling sites/patients
`
`CD P113 = Phase I[[ clinical development
`‘Gray tows = weekends and/or holidays
`
`11
`
`Page 14 of 111
`
`

`

`Date
`
`All
`
`(Day)
`
`Activity
`
`All Supporting Evidence
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`°5’29’2°°° DA
`(MW)
`
`DA: 13:17-15:6
`
`Ex. 2076 1125, 26, 45, 52, 53 (E1. 2262 at 1; Ex. 2375; FJ. 2275 at 9, 14-16; E1. 2276 at 9-11;
`Ex. 2381; Ex. 2274 atzo, 21; Ex. 2377 at 19);
`Ex. 2078 17 (E; 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`Ex. 2080 11 25-35 (E1. 2274; E1. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; E1. 2377; Ex. 2284; m. 2226; Ex.
`2275; Er. 2285; Br. 2326; Br. 2276; Ex. 2286)
`
`05/30/2006 DA
`CD Ph3
`(Tues)
`
`05/31/2006 DA
`CD Ph3
`(wed)
`
`Ex. 2076 111 25. 26. 45. 47. 49-53 (Ex. 2262 at 1: Ex. 2375: Ex. 2275 at 9, 14-16: Ex. 2276 at 9-
`11: Ex. 2381: Ex. 2343: Ex. 2350 at 1: Ex. 2122 at 2: Ex. 2252 at 1: Ex. 2131 at 1: Ex. 2115 at
`
`1: Ex. 2274 at 20, 21: Ex. 2377 at 19);
`Ex. 2079 11140-43 (Ex. 2255: Ex. 2252 at 1: Ex. 2122 at 2: Ex. 2131 at 1: Ex. 2115 at 1: Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8: 2124 at 2):
`17:1-8; 17:16-18:18; Ex. 2078 1 7 (Ex. 2375 at 18. 26: Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11):
`22:2-4
`Ex. 2080 11 25-35 (Ex. 2274; Ex. 2330 at 6-8. 28, 35. 37; Ex. 2281 at 34. 37-39, 50-54: Ex.
`2283: Ex. 2375 at 18, 25, 26: Ex. 2085 at 68-74. 128-52: Ex. 2377; Ex. 2284: Ex. 2226: Ex.
`2275: Ex. 2285: Ex. 2326; Ex. 2276: Ex. 2286)
`
`Ex. 2076 111 25, 26. 45, 47. 49-53 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11: Ex. 2381; Ex. 2343: Ex. 2350 at 1; Ex. 2122 at 2: Ex. 2252 at 1; Ex. 2131 at 1: Ex. 2115 at
`1: Ex. 2274 at 20, 21; Ex. 2377 at 19):
`Ex. 2079 1140-43 (Ex. 2255; Ex. 2252 at 1; Ex. 2122 at 2; Ex. 2131 at 1; Ex. 2115 at 1; Ex.
`DA: 13:17-15:6
`CD P113: 15:9-16:8; 2124 at 2):
`17:1-8: 17:16-18:18; Ex. 2078 1 7 (Ex. 2375 at 18. 26: Ex. 2275 at 9, 14. 15; Ex. 2276 at 9-11);
`22:2-4
`Ex. 2080 1fi[ 25-35 (Ex. 2274; Ex. 2330 at 6-8. 28. 35, 37: Ex. 2281 at 34. 37-39. 50-54: Ex.
`2283: Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284: Ex. 2226: Ex.
`2275: Ex. 2285: Ex. 2326: Ex. 2276: Ex. 2286)
`
`DA=dosinganimals
`RIE = reuniting/enrolling sites/patients
`
`CDl’I|3=PhascI[Iclinicaldcvelopmcnt
`‘Gray tows = weekends and/or holidays
`
`12
`
`Page 15 of 111
`
`

`

`All Supporting Evidence
`
`.
`
`.
`
`D i]
`
`Date
`
`All
`
`(Day)
`
`Activity
`
`06/1/2006 DA
`(Thur)
`CD Ph3
`
`°6’_2’2°°6 DA
`(F11)
`CD Ph3
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`Ex. 2076 111 25, 26, 45, 47, 54-58 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2345 at 1; Ex. 2125; Ex. 2126 at 3; Ex. 2316 at 1, 2; Ex. 2352; Ex. 2321 at 1,
`2; Ex. 2351 at 1, 2; Ex. 2346; Ex. 2341; Ex. 2105; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2077 111 9, 15-25, 33, 34 (Ex. 2316 at 5; Ex. 2087 at 1; Ex. 2085 at 68-74, 77-95, 128-179;
`Ex. 2275 at 9, 14-16; Ex. 2375 at 18, 26; Ex. 2377 at 10, 18, 19; Ex. 2274 at 10, 20, 21; Ex.
`2276 at 1, 9, 10; Ex. 2297 at 3-6; Ex. 2128 at 1; Ex. 2352);
`DA‘ ‘3“7'15‘6
`Ex. 2079 1|1[ 44-47 (Ex. 2277; Ex. 2105; Ex. 2116; Ex. 2125; Ex. 2126 at 3; Ex. 2316 at 1,2,6;
`CD H3‘ 15‘9‘124
`EL 2279 at 1),
`1628-14: 1728-13;
`18‘15‘19‘177'22’4'7 Ex. 20781[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`Ex. 2080 111 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284: Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`Ex. 2076 111 25, 26, 45, 47, 54-58 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2345 at 1; Ex. 2125; Ex. 2126 at 3; Ex. 2316 at 1, 2; Ex. 2352; Ex. 2321 at 1,
`2; Ex. 2351 at 1, 2; Ex. 2346; Ex. 2341; Ex. 2105; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2077 111 9, 15-25, 33, 34 (Ex. 2316 at 5; Ex. 2087 at 1; Ex. 2085 at 68-74, 77-95, 128-179;
`Ex. 2275 at 9, 14-16; Ex. 2375 at 18, 26; Ex. 2377 at 10, 18, 19; Ex. 2274 at 10, 20, 21; Ex.
`2276 at 1, 9, 10; Ex. 2297 at 3-6; Ex. 2128 at 1; Ex. 2352);
`DA‘ ‘3‘17‘15‘6
`Ex. 2079 111 44-47 (Ex. 2277; Ex. 2105; Ex. 2116; Ex. 2125; Ex. 2126 at 3; Ex. 2316 at 1,2,6;
`CD ”'3‘ 15‘9'129
`Ex 2279 at 1);
`1628-14; 1728-13;
`l8'l5’19‘17’22'4'7 Ex. 20781[ 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`Ex. 2080 111 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`DA=dosinganimals
`RIE =
`
`sites/patients
`
`CDPII3=PhaseI[Ic1inicaldc've1opmcnt
`‘Gray rows = vwekcnck and/or holidays
`
`13
`
`Page 16 of 111
`
`

`

`All Supporting Evidence
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`DA=dos'nganimals
`R/E =tecruiting/enrolling sites/patiuns
`
`CDPh3=Phasel]Iclinicaldevelopma1t
`‘Gray rows= we&endsand/orholidays
`
`14
`
`Page 17 of 111
`
`

`

`Date
`
`All
`
`(Day)
`
`Activity
`
`All Supporting Evidence
`
`1;:Ziillfg
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`06/5/2006
`
`(Mon)
`
`DA
`CD Ph3
`
`DA‘ ‘3“7'15‘6
`CD Ph3: 15:9-12;
`1628-14: 1728-13;
`18:15-19:17; 22:4-7
`
`06/6/2006
`
`(Tues)
`
`DA
`CD Ph3
`
`DA‘ ‘3‘17‘15‘6
`CD "'3' 15-942-
`1628-14; 1728-13;
`18-15 19-17- 22-4 7
`'
`‘
`'
`’
`' ’
`
`Ex. 2076 1|1[ 25, 26,45, 47, 54-58 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2345 at 1; Ex. 2125; Ex. 2126 at 3; Ex. 2316 at 1, 2; Ex. 2352; Ex. 2321 at 1,
`2; Ex. 2351 at 1, 2; Ex. 2346; Ex. 2341; Ex. 2105; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2077 1|1[ 9, 15-25, 33, 34 (Ex. 2316 at 5; Ex. 2087 at 1; Ex. 2085 at 68-74, 77-95, 128-179;
`Ex. 2275 at 9, 14-16; Ex. 2375 at 18, 26; Ex. 2377 at 10, 18, 19; Ex. 2274 at 10, 20, 21; Ex.
`2276 at 1, 9, 10; Ex. 2297 at 3-6; Ex. 2128 at 1; Ex. 2352);
`Ex. 2079 fi|1[ 44-47 (Ex. 2277; Ex. 2105; Ex. 2116; Ex. 2125; Ex. 2126 at 3: Ex. 2316 at 1, 2, 6;
`Ex. 2279 at 1);
`2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`Ex. 20781 7
`Ex. 2080 fi|1[ 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284: Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`Ex. 2076 1|1[ 25, 26, 45, 47, 54-58 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2345 at 1; Ex. 2125; Ex. 2126 at 3; Ex. 2316 at 1, 2; Ex. 2352; Ex. 2321 at 1,
`2; Ex. 2351 at 1, 2; Ex. 2346; Ex. 2341; Ex. 2105; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2077 1|1[ 9, 15-25, 33, 34 (Ex. 2316 at 5; Ex. 2087 at 1; Ex. 2085 at 68-74, 77-95, 128-179;
`Ex. 2275 at 9, 14-16; Ex. 2375 at 18, 26; Ex. 2377 at 10, 18, 19; Ex. 2274 at 10, 20, 21; Ex.
`2276 at 1, 9, 10; Ex. 2297 at 3-6; Ex. 2128 at 1; Ex. 2352);
`Ex. 2079 111 44-47 (Ex. 2277; Ex. 2105; Ex. 2116; Ex. 2125; Ex. 2126 at 3; Ex. 2316 at 1,2,6;
`_
`EX‘ 2279 at 1)’
`Ex. 207311 7 (Ex. 2375 at 18, 26; Ex. 2275 at 9, 14, 15; Ex. 2276 at 9-11);
`Ex. 2080 1n] 25-35 (Ex. 2274; Ex. 2330 at 6-8, 28, 35, 37; Ex. 2281 at 34, 37-39, 50-54; Ex.
`2283; Ex. 2375 at 18, 25, 26; Ex. 2085 at 68-74, 128-52; Ex. 2377; Ex. 2284; Ex. 2226; Ex.
`2275; Ex. 2285; Ex. 2326; Ex. 2276; Ex. 2286)
`
`DA=dosinganimals
`RIE =
`
`sites/patients
`
`CDPII3=PhaseI[Iclinicaldc've1opmcm
`‘Gray rows = vwekcnck and/or holidays
`
`15
`
`Page 18 of 111
`
`

`

`All Supporting Evidence
`
`.
`
`.
`
`D i]
`
`Date
`
`All
`
`(Day)
`
`Activity
`
`06/7/2006 DA
`(Wed)
`CD Ph3
`
`°6’8’2°°6 DA
`(Thur)
`CD Ph3
`
`Exhibit Citations for All Activities
`
`Declaration Ex. (Exhibits cited therein)
`
`Ex. 2076 111 25, 26, 45, 47, 54-58 (Ex. 2262 at 1; Ex. 2375; Ex. 2275 at 9, 14-16; Ex. 2276 at 9-
`11; Ex. 2381; Ex. 2345 at 1; Ex. 2125; Ex. 2126 at 3; Ex. 2316 at 1, 2; Ex. 2352; Ex. 2321 at 1,
`2; Ex. 2351 at 1, 2; Ex. 2346; Ex. 2341; Ex. 2105; Ex. 2274 at 20, 21; Ex. 2377 at 19);
`Ex. 2077 111 9, 15-25, 33, 34 (Ex. 2316 at 5; Ex. 2087 at 1; Ex. 2085 at 68-74, 77-95, 128-179;
`Ex. 2275 at 9, 14-16; Ex. 2375 at 18, 26; Ex. 2377 at 10, 18, 19; Ex. 2274 at 10, 20, 21; Ex.
`2276 at 1, 9, 10; Ex. 2297 at 3-6; Ex. 2128 at 1; Ex. 2352);
`DA‘ ‘3“7'15‘6
`Ex. 2079 1|1[ 44-47 (Ex. 2277; Ex. 2105; Ex. 2116; Ex. 2125; Ex. 2126 at 3; Ex. 231