Amerigen Pharmaceuticals Limited vs Shire, LLC et al.

Termination Decision Document

Joint Notice of Settlement, Request to Terminate and Request to Keep Separate Under 37 C.F.R. 42.74 (c)

Request to File Settlement Agreement as Business Confidential Information Pursuant to 35 U.S.C. 317 and 37 C.F.R. 42.74(c)

Settlement Agreement

Patent Owner Power of Attorney under 37 C.F.R. 42.10(b)

Patent Owner Mandatory Notices under 37 C.F.R. 42.8(a)(2)

Notice of Accord Filing Date

Original application 11/383,066 (the '066 application)

The '066 application, first preliminary amendment, 10-24-06

The '066 application, second preliminary amendment, 10-26-06

The '066 application, first Office Action, 10-2-09

The '066 application, first Response, 1-29-10

The '066 application, second Office Action, 4-30-10

The '066 application, second Response, 7-28-10

The '066 application, third Office Action, 10-12-10

The '066 application, third Response, 1-12-2011

The '066 application, fourth Response, 1-24-2014

The '066 application, fifth Response, 6-3-2014

The '066 application, fourth Office Action, 10-07-13

The '066 application, fifth Office Action, 4-30-2014

The '066 application, Notice of Allowance and Allowability, 7-7-2014

C. Bradley, The Behavior of Young Children Receiving Benzedrine, AM. J. PSYCHIATRY, vol. 94, 154-162 (1937)

"Adderall," Drugs@FDA (http://www.accessdata.fda.gov/)

"Adderall XR," Drugs@FDA (http://www.accessdata.fda.gov/)

U.S. Patent No. 6,913,768

U.S. Patent No. 2,738,303

U.S. Patent No. 5,407,686

U.S. Patent Application Publication No. 2004/0197405

U.S. Patent No. 5,837,284

U.S. Patent No. 5,326,570

U.S. Patent No. 8,313,776

U.S. Patent No. 8,906,413

U.S. Patent No. 6,555,136

U.S. Patent No. 4,728,512

U.S. Patent No. 5,474,786

U.S. Patent No. RE42,096

Adderall XR Medication Guide

August 2005 Package Insert for Adderall Immediate Release ("IR")

U.S. Patent No. 4,794,001

U.S. Patent No. 4,904,476

SURERELEASE Product Brochure

The '066 application, Patent Publication No. 2007/0264323

OPADRY Manufacturer Poster

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Patent and Exclusivity for: N021303

Ansel, Popovich & Allen, Pharmaceutical Dosage Forms and Drug Delivery Systems (6th ed., 1995)

Simon J. Tulloch, et al., SLI381 (Adderall XR), a Two-Component, Extended-Release Formulation of Mixed Amphetamine Salts: Bioavailability of Three Test Formulations ..., PHARMACOTHERAPY vol. 22 (2002)

1993 Physicians' Desk Reference (47th ed., 1992)

1997 Physicians' Desk Reference (51st ed., 1997)

Patricia K. Sonsalia, Remington: The Science and Practice of Pharmacy (19th ed., 1995)

Charles S.L. Chiao & Joseph R. Robinson, Remington: The Science and Practice of Pharmacy (19th ed., 1995)

Handbook of Pharmaceutical Excipients (Ainley Wade & Paul J. Weller, ed., 2d ed., 1994)

U.S. Patent No. 1,921,424

July 2005 Package Insert for Adderall Extended Release ("XR")

The Merck Index, (Susan Budavari, ed., 11th ed., 1996)

Susan B. Clausen, Single- and multiple-dose pharmacokinetics of an oral mixed amphetamine salts extended-release formulation in adults, CNS SPECTRUMS vol. 10 (Dec. 2005)

Adderall Immediate Release ("IR") Medication Guide

1974: Physicians' Desk Reference (28th ed., 1974)

1995 Physicians' Desk Reference (49th ed., 1994)

Brian B. Hoffman & Robert J. Lefkowitz, Goodman & Gilman's The Pharmacological Basis of Therapeutics (9th ed., 1996)

Stuart C. Porter, Remington: The Science and Practice of Pharmacy (19th ed., 1995)

1995 United States Pharmacopeia and National Formulary, USP 23-NF (1994)

W. H. Hartung & J. C. Munch, Amino Alcohols, VI. The Preparation and Pharmacodynamic Activity of Four Isomeric Phenylpropylamines, 53 J. AM. CHEM. SOC. (1931)

James R. McCowan, Dispensing of Medication (Eric W. Martin ed., 7th ed., 1971)

Edward Stempel, Dispensing of Medication (Eric W. Martin ed., 7th ed., 1971)

U.S. Patent No. 1,879,003

Approval Letter from Robert Temple, M.D., Director, Office of Drug Eval., to William A. Nuerge, Chief Oper. Officer, Richwood Pharm. Co., Inc. (Feb. 13, 1996)(on file at http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/11522S010_Adderall.pdf)

Charles W. Popper, M.D., The Story of Four Salts, JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY vol. 4, n. 4 (1994)

Approval Letter from Russell Katz, M.D., Director, Div. of Neuropharm. Drug Products, Office of Drug Eval., to Tami Martin, Vice Pres. of Reg. Affairs, Shire Labs., Inc. (Oct. 11, 2001)(on file at http://www.accessdata.fda.gov/drugsatfda_docs/....pdf)

April 21, 2003 Resp. to Office Action dated March 4, 2003, App. No. 09/807,462

U.S. Patent No. 8,846,100 (the '100 patent)

U.S. Patent No. 6,322,819 (the '819 patent)

U.S. Patent No. 6,605,300 (the '300 patent)

Christopher J. Kratochvil, ADHD: Treatment and Outcome, MANAGING ADHD, vol. 4 (3A) (2004)

Declaration of Edmund J. Elder, Jr., Ph.D., R.Ph.

Petitioner's Power of Attorney for Inter Partes Review of U.S. Patent No. 8,846,100

Petition for Inter Partes Review of U.S. Patent No. 8,846,100 Under 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.100 et. seq.