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`

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`(
`
`(
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`(
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`Novartis
`IND Table of Contents
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`Confidential
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`Page 12
`RAD001
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`[30] Pfister T. SDZ RAD 666: Acute oral toxicity study in mice. Research &
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`[31] Pfister T. SDZ RAD 666: Acute oral toxicity study in rats. Research &
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`[32] Pfister T. SDZ Rf'.D 666: Acute intravenous toxicity study in mice.
`Research & Consulting Company Ltd., ltingen, Switzerland. RCC
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`[33] Pfister T. SDZ RAD 666: Acute Intravenous toxicity study in rats.
`Research & Consulting Company Ltd., ltingen, Switzerland. RCC
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`(34] Noakes JP. SDZ RAD: Range finding toxicity study by oral gavage
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`[36] Schmid H, Allard G, Keller B, Weber K, Amstrom J. SDZ RAD: A
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`· [37J Chase KR. SDZ RAD: Toxicity study by oral gavage administration to
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`Chase KR Additional pathology investigations to a.toxicity study by oral
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`Report No. SPM 090/960876, 21-Aug-1996.
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`
`x-reference
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`52,003
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`2-12
`
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`

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`Novartis
`IND Table of Contents
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`Confidential
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`Page 13
`RAD001
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`Vol
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`[39] Nicholls IM. SDZ RAD: Toxicity study by oral gavage administration to
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`[40) Makin A. SDZ RAD: Dose range finding study (intravenous infusion
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`[46) MakinA. SDZ RAD: Dose escalating study (oral administration) in
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`[47] Makin A. SDZ RAD: 14-day dose range finding study (oral roule) in
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`
`L
`
`x-refetenca
`to IND 52,003.
`01/26/98
`
`-x-
`reference to
`I.ND 52,003
`11/15/96
`
`x-reference
`to IND
`52,003
`01/26/98
`8-1463
`
`8-1565
`
`x-reference
`to IND
`52,003
`01/26/98
`
`x-reference
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`2-13
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`

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`Novartis.
`IND Table of Contents
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`confidential
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`Page 14
`RAD001
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`[50] Noakes JP. SDZ RAD: Toxicity study by oral gavage administration to
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`21-Aug-1995~
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`(58] Schmid .H. Allard G, Keller B. Weber K, Chevalier HJ. SDZ RAD Solid
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`[59] Webley LJ. SDZ RAD: Oncogenicity study by oral gavage administration
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`x-reference
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`
`11
`
`8-3124
`
`x-reference
`to IND
`52,003
`01/26198
`
`12-16
`
`8-3502
`
`2-14
`
`(
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`
`

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`(
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`Novartis
`IND Table of Contents
`
`Confidential
`
`Page 15
`RAD001
`
`[60) Thomas H. SDZ RAD (SDZ 222-666): An oral 13-week investigative
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`1060R (203-057). 18-Sep-1996.
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`[64] Thomas H. SDZ RAD (SDZ 222-666): An oral fertility and embryo-fetal
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`
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`[65] Bartmann K. SDZ RAD 666 (SDZ 222-666): An oral embryo-fetal
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`placental transfer. Sandoz Pharma Ltd, Basel, Switzerland. Sandoz
`Study 2059K (203-056), 18-Sep-1996.
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`[66] Thomas H. SDZ RAD (SDZ 222-666): An oral embryo-fetal
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`Novartis Report No. 4070K (203-074), 02-Sep-1997.
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`(67] Youreneff M. RAD001: An oral pre- and postnatal development study in
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`[68) Suter W. SDZ RAD 666: Mutagenicily test using Salmonella
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`No. Mut.Bakt.27/95 (203-016), 19-Sep-1995.
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`(69) Suter W. SDZ RAD 666 (SDZ 222-666): Mutagenicily lest using
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`[70) Suter W. SDZ RAD 666 (SDZ 222-666): Mutagenicity test using
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`
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`
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`
`17
`
`Page No.
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`8-6011
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`18-24 .
`
`8-6586
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`11/15/96
`
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`to IND
`52,003
`01/26/98
`
`x-reference
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`52,003
`01/26198
`
`25
`
`8-9120
`
`-x(cid:173)
`
`reference to
`IND 52,003
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`
`2-15
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`

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`
`Novartis
`IND Table of Contents
`
`Confidential
`
`Page 16
`RA0001
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`[71] Suter W. SDZ RAD (Solid dispersion): Mutagenicity test using
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`[74) Locher F. SDZ RAD 666: Chromosomal aberration test withV79
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`
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`[76) Ptltter F. RAD001: Chromosome aberration test with V79 Chinese
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`[77) Suter W. SDZ RAD 666 (SDZ 222-666): Mouse bone marrow
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`[80) Van Huygevoort AHBM. Primary skin irritation/corrosion study with
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`[81) Van Huygevoort AHBM. Assessment of contact hypersensitivity to
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`
`Vol
`
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`x-reference
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`8-9486
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`IND 52,003
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`01/26/98
`
`26
`
`s;.9513
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`x-reference
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`26
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`8•9568
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`26
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`8-9577
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`IND Table of Contents
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`Confidential
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`Page 17
`RAD001
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`(82] Figueiredo J, BrOggen J, Muller M, Vaxelaire J, Hattenberger M, Lane H,
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