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Page 1: FTC v. Watson Pharmaceuticals - Joint Appendix (Volume 2 ... · No. 03-cv-2501 (N.D. Ga.), and Unimed Pharmaceuticals, Inc ... Mitchell, Brian; Janco, Jay Tulip updates Tulip-042606-v3.ppt
Page 2: FTC v. Watson Pharmaceuticals - Joint Appendix (Volume 2 ... · No. 03-cv-2501 (N.D. Ga.), and Unimed Pharmaceuticals, Inc ... Mitchell, Brian; Janco, Jay Tulip updates Tulip-042606-v3.ppt

TABLE OF CONTENTS

Page

Volume 1

Court of appeals docket entries ................................................. 1

District court docket entries ...................................................... 7

Second amended complaint (Docket entry No. 114) .......... 27

Docket entries in Unimed Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., No. 03-cv-2501 (N.D. Ga.) (Docket entry No. 44, Attachment 15) (Excerpts) ............................................................................. 65

Docket Entries in Unimed Pharmaceuticals, Inc. v. Paddock Laboratories, No. 03-cv-2503 (N.D. Ga.) (Docket entry No. 44, Attachment 16) (Excerpts) ........ 79

Transcript of Proceedings Held February 26, 2004, in Unimed Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., No. 03-cv-2501 (N.D. Ga.), and Unimed Pharmaceuticals, Inc. v. Paddock Laboratories, No. 03-cv-2503 (N.D. Ga.) (Docket entry No. 64) (Excerpts) ........... ~ ........................ 94

Consent Judgment and Order of Permanent Injunction, Unimed Pharmaceuticals, Inc. v. Paddock Laboratories, No. 03-cv-2503 (N.D. Ga. Sept. 15,2006) (Docket entry No. 131, Attachment 2) ..................................................................... 97

Volume 2

Second Amended Complaint Exhibit A (Docket entry No. 114, Attachment 1) .......................... 103

,; (1)

H

The following opinions and orders have been omitted in printing this joint appendi~ because they appear on the following pages in the appendix to the petition for a writ of certiorari:

Appendix A: Court of appeals opinion (Apr. 12,2012) .................................................. la

Appendix B: District court order (Feb. 22, 2010) ................ 37a

Appendix C: Order denying rehearing (July 18, 2012) ............................... , ................. 62a

Page 3: FTC v. Watson Pharmaceuticals - Joint Appendix (Volume 2 ... · No. 03-cv-2501 (N.D. Ga.), and Unimed Pharmaceuticals, Inc ... Mitchell, Brian; Janco, Jay Tulip updates Tulip-042606-v3.ppt

From: Sent: To: Subject:

Attachments:

.m-. . ~.... .. . :- . ....

Tulip·042606-v3.ppt (654 KB}

ElainE! '{<"my

Yang, Elaine Wednesday, April 26, 20062:29 PM Kay, Murray; Hynd, Jim; Mitchell, Brian; Janco, Jay Tulip updates

Tulip-042606-v3.ppt

Strategic and Business Analysis Solvay Pharmaceuticals, Inc. Phone: 770-578-5619 Email: [email protected]

SLV585072 CONFIDENTIAL

Page 4: FTC v. Watson Pharmaceuticals - Joint Appendix (Volume 2 ... · No. 03-cv-2501 (N.D. Ga.), and Unimed Pharmaceuticals, Inc ... Mitchell, Brian; Janco, Jay Tulip updates Tulip-042606-v3.ppt

104

BUlsiness Outlook withoUlt Se;ttle'm!en,t -------"_._. __ ._-----_. ------------_._-------------_ ... _--._-----_. __ ..... ---_._ ..... __ ._._ ...• _--_ .... ----""--_. __ .....

Solvay wins patent litigation

Solvay loses patent litigation

Mid Point

1,241

359

800

-DRAFT ..

o 152

76

o 131

66

'/

Privileged and Confidential For purposes of settlement negotiations only Subject to Fed. R. Evid. 408 and all other applicable privileges

o o o

1,241

642

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105

Business uti k .. Settlement (no addit.ional features such as commerci_!~~r; manufacturing alliance)

2011 2012 2013 2014 2015

2011 2012 2013 2014 2015

786 900 959

1,021 1,060

(14) 100 159 221 260

Splits of newly created value are NOT aUra ..

-DRAFT .. ..... /

Privileged and Confidential For purposes of settlem~f;! Subject to Fed. R. Evid. 408 and all other aDDlicri'l

92 75 62 50 41

92 .. 75 62 50 41

1,062 1,125

. 1,145 1,171 1,183

121 184 204 230 242

Page 6: FTC v. Watson Pharmaceuticals - Joint Appendix (Volume 2 ... · No. 03-cv-2501 (N.D. Ga.), and Unimed Pharmaceuticals, Inc ... Mitchell, Brian; Janco, Jay Tulip updates Tulip-042606-v3.ppt

106

Distribution

OTHER 9.80/0

HIV 11.8%

II rescrl

.. DRAFT .. Privileged and Confidential For purposes of settlemAnl

Subject to Fed. R. Evid. 408 and all other ap

";". ;',

URO 15.6,%

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iii

107

Potential artnershi O.ptions: PAR

.. Par Co-promotes Androgel in HIV .

.. Potential Compensation Alternatives to Par:

.. Pay 500/0 to Par for sales above $26 MUSD

• Pay $30/detail for 10,000 details and 50% of sales above $32 MUSD

• Carve-out Marinol HIV business and share profits

• Offer right to manufacture a portion of Androgel

• Offer right to Marinol Authorized Generic.

• In-license Par's technology related to Marinolmanufacturing/formulation, and pay royalty on existing Marinol business.

-DRAFT .. Privileged and Confidential For purposes of settlement negotiations only

Subject to Fed. R. Evid. 408 and all other applicable privileges

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108

otential Partnership

• Solvay will. provide marketing sup

(I Solvay will train Par sales force

(I Solvay will book sales

(I Par pays sales force incentive com n '

(I Par participates in launch of low v

.. DRAFT· Privileged and Confidential For purposes of settlement

. '. Subject to Fed. R. Evid. 408 and all other applicable' .;r .

:ns: PAR

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109

t' t,,· I': o ri,en c:18J artnerSihli WA,TSON

el i locy

• Watson will receive profit sharing for its deta;l according to following scale:

Watson Profit Share (0/0) 20071 50.0%

2008 52.50/0

2009 55.0%

2010 57.5%

2011 60.00/0

2012 62.5%

2013 65.0%

2014 67.50/0

2015 70.0%

.. DRAFT .. . r Privileged and Confidential For purposes of settlement negotiations only

Subject to Fed. R. Evid. 408 and all other applicable privileges

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110

P t· t'-" IJ P rt h' III O' t·-" i § ....• . ' '.. ••.•. .i' ~;,., _ I '" • /' I, .. ....... .' ',. .... ...:' ." r I I' ....; ." : :' :. 1& ,"0 en ,18,: a';,ners "lp./·p,lo;ns,. W· '. i.A ..... T .... ·S··"'O······N' ,j'r .. ...... ! .......... 1 ji ..... l

------------------------------------------------------------------------------------------------.--------------------------

\I Watson P . I in Urology

• Solvay will provide marketing support

\I Solvay will train Watson sales force

it Solvay will book sales

• Solvay will phase out detailing support in urology universe over 18 months

\I Watson pays sales force incentive comp

\I Watson participates in launch of low volume

it Option for Watson to launch diabetes indication

ndroGer .. "~! ttellOlterooe c.elll't (ii, ./ .

.. DRAFT· Privileged and Confidential For purposes of settlement negotiations only

Subject to Fed. R. Evid. 408 and all other applicable privileges

Page 11: FTC v. Watson Pharmaceuticals - Joint Appendix (Volume 2 ... · No. 03-cv-2501 (N.D. Ga.), and Unimed Pharmaceuticals, Inc ... Mitchell, Brian; Janco, Jay Tulip updates Tulip-042606-v3.ppt

111

Business Logic on rofit Sharin

Urology Based Androgel Business ( all in Million USD)

Androgel Total Brand Sales 0/0 Business in Urology Androgel Urology Dollar Sales

2007

$330

15%

$50

80% $40 _ . Androgel Gross Margin Marketing Expense in Urology 15% of Androgel marketing budget ($3) Other commercial support for Urology space Net Profit

10% of Androgel Urology Sales ($5)

Watson Share Watson Net Profit Sharing

./

·DRAFT .. Privileged and Confidential For purposes of settlement negotiations only

Subject to Fed. R. Evid. 408 and all other applicable privileges

$32

50%

2014

$450

15%

$68

$54

($3)

($7)

$44

70%

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112

B. II

:us"lness utlook with Settlement (with urology carve-out for Watson and Pay per detait + baseline structure for Par)

Assume 3-player generic market Solvay NPV Watson Par Generic Carve-out Total Generic Carve-out !.2.ml

2011 711 82 59 141 82 24 106 2012 779 67 71 138 67 28 95 2013 827 56 82 138 56 31 87 2014 865 46 91 137 46 33 79 2015 888 39 99 138 39 35 74

Delta .to Mid-poinfAndrogelNPV Solvay Watson Par Other Total 2011 2012 2013 16% 370/0 13% 2014 35% 33% 70/0 2015 450/0 31% 40/0

.. DRAFT· Privileged and Confidential For purposes of settlement negotiations only

Subject to Fed. R. Evid. 408 and all other applicable privileges

0 0 0 0

34% 100% 250/0 1000/0 200/0 100%

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113

Wa' ar ancial II lew

2007 I 20081~D09 2010 I 2011 I 2012 I 2013 I 2014 I 2015 I 2016

14 14 14 20 18 20 6 4 6

2007 2008 .. 't~009 2010 2011 2012 Par Income if launching generic Androgel( $ MUSD) 15 30 :20 14 . 14 14 Par Income with settlement( $ MUSD) 6 7 :.7 9 6 4 Delta ----------- _."-

(9) (23) .:(13) (5) (8) ...... _(1°1

.. DRAFT .. Privileged and Confidential For purpo.es of settlement negotiations only

Subject to Fed. R. Evid. 408 and lUI other applicable privilege$

'/

14 14 14 14 19 17 55 45 5 3 41 31

2013 2014 2015 2016

14 14 14 14 4 3 55 45

(10) (11 ) 41 31

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114

Solva Financial Impact

Androgel

Sales - Five Year Plan 311 312

Androgel Income- Five Year Plan 149 143 Impact of Settlement

Watson Urology Co-Promotion (19) (20)

Par Co-Promotion/Manufacturing Back-LIP (6) (7)

TotalWatson/Par ~~ ..

(25) (27)

Redeployment of Reps 10 10

Besins Contribution 6 6

Net Impact

Androgel Income after Settlement 140 132

Androgel Income-Generic Competition 24 15 Delta 116 117

f ~ .. DRAFT .. Privileged and Confidential For purposes of settlement negotiations only

Subject to Fed. R. Evid. 408 and all other applicable privileges

310 317

139 138

(22) (23)

(7) (9)

(29) (32)

11 11

6 6

(12) (15) -«'<:Ct'i-:'.:.""'";.{f._"( c p: .. "'

127 123

11 10 116 114

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115

Watson

Solvay Offer On 4/24/2006

atson Counter 4/26/2006

Delta

Feature #1

Exclusivity through Jan, 2015

Exclusivity through Jan, 2015

ter

Feature #3 Profit Sharing: 50% and grow by 2.5%/year with cap of 70%

Profit Sharing: 65% and grow by 1 %/year with cap of 70%

2010

Watson ($ MUSD)

99

122

23

2011

&1 §I ;z rrrr pn? m

ndroGel" 'l;j lreslosierooe gel) 1\ ~:;

,Y: "e

.. DRAft .. Privileged and Confidential For purpo~es of settlement negotiations only

Subject to Fed. R. Evid. 408 and ~llother applicable privileges

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116

AndroGel Coverag is VI

AndroGel Decile I MDs I All Targets I % Reach I Cum. Reach

Decile 10 450 443 98% 98%

Decile 9 972 955 98% 98%

Decile 8 1,457 1413 97% 98%

Decile 7 2,014 1942 96% 97%

Decile 6 2,705 2614 97% 97%

Decile 5 3,631 3434 95% 96%

Decile 4 4,991 4593 92% 95%

Decile 3 7,193 6148 85% 92%

Decile 1 38,861 16259 42% 63%

Decile 0 23,918

Total 74,000 70,268

.. ORAFtr-

Prescriber Univ'erse trong

URO MDs URO Targets I % Reach I Cum. Reach

74 74 100% 100%

221 217 98% 99%

339 335 99% 99%

425 413 97% 98%

486 463 95% 97%

572 543 95% 97%

634 566 89% 95%

706 548 78% 91%

1,699 591 35% 71%

5,682

11,674 4,254

.. t Privileged and Confidential For purposes of settlement negotiations only Subject to Fed. R. Evid. 408 and all other applicable privileges