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APPENDIX II
`
`Materials Considered By Mansoor M. Amiji, Ph.D., RPH
`
`U.S. Patent No. 8,679,544
`
`File History of U.S. Patent No. 8,679,544
`
`U.S. Patent No. 8,99,387
`
`File History of U.S. Patent No. 8,99,387
`
`U.S. Patent No. 9,017,721
`
`File History of U.S. Patent No. 9,017,721
`
`PCT Publication No. WO2008/000042, published January 3, 2008 (Meiser)
`
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`May 2000
`
`United States Pharmacopeia 30, Section <711> (2007)
`
`United States Pharmacopeia 30, Section <1092> (2007)
`
`Chuasuwan et al., “Biowaiver Monographs for Immediate Release Solid
`Oral Dosage Forms Diclofenac Sodium and Diclofenac Potassium,”
`98(4):1206-1219 (2009)
`
`PCT Publication No. WO2006/133954, published December 21, 2006 (Reiner)
`
`PCT Publication No. WO2006/069419, published July 6, 2006 (Payne)
`
`1.
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`2.
`
`3.
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`4.
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`5.
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`6.
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`7.
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`8.
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`9.
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`
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`
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`
`1
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`LUPIN EX. 1004
`Lupin v. iCeutica
`US Patent No. 9,017,721
`
`

`
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`Cogrinding and Spray-drying: Comparison with Commercial Preparations,”
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`
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`
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`
`Iroko F-1 Prospectus filed with the Securities and Exchange Commission on
`June 18, 2013
`
`Khazaeinia et al., “A Comparison of Gastrointestinal Permeability Induced by
`Diclofenac-phospholipid complex with Diclofenac Acid and its Sodium Salt,”
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`
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`Particle Technology Platform” (Sept. 24, 2014)
`
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`
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`
`iCeutica Press Release dated April 28, 2011: iCeutica Announces Sale to
`Partner Iroko; 10X uplift on original value
`
`FDA Orangebook listing for Zorvolex; available at:
`http://www.accessdata.fda.gov/scripts/cder/ob/docs
`/obdetail.cfm?Appl_No=204592&TABLE1=OB_Rx; and
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/
`/patexclnew.cfm?Appl_No=204592&Product_No=001&table1=OB_Rx
`(accessed November 2, 2015)
`
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`

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`42.
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`43.
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`44.
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`45.
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`46.
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`47.
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`
`Countdown to the 10th Anniversary Scrip Awards, available at:
`https://ibiawards.com/scrip-awards/wp-
`content/uploads/sites/41/2014/11/script_shottlist_ad6_141125_16.pdf (accessed
`November 2, 2015)
`
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`
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`and Diclofenac sodium, ¶ 1921 (2007)
`
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`
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`
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`
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`
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`
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`Compounds,” Dissolution Technologies (Aug. 2001)
`
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`Dodd Re: Lab mill for API and excipient (ICT0085082-085)
`
`November 3, 2014 email from Bill Bosch to Seamus Mulligan Re: Introduction
`to iCeutica (ICT0006103-104)
`
`iCeutica Pty Ltd and Iroko Pharmaceuticals, LLC’s Opening Claim
`Construction Brief (D.I. 67)
`
`Declaration of Elizabeth M. Flanagan in Support of iCeutica Pty Ltd and Iroko
`Pharmaceuticals, LLC’s Opening Claim Construction Brief, and all exhibits
`attached thereto (D.I. 68)
`
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`Delayed Release Tablets USP Opadry® Enteric (94 Series),” Colorcon
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`
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`pharmacosomes of diclofenac,” Acta Pharm. 59:335-344 (2009)
`
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`Dosage Forms: Efavirenz,” J. of Pharm. Scis., Vol. 102, No. 2 (February 2013)
`
`Gowthamarajan, et al., “Dissolution Testing for Poorly Soluble Drugs: A
`Continuing Perspective,” Dissolution Technologies (Aug. 2010)
`
`3
`
`

`
`50.
`
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`http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm (accessed
`Sept, 18, 2015)
`
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`
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`
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`“Measuring the Size of Nanoparticles in Aqueous Media Using Batch-Mode
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`2007, rev. Feb. 2010)
`
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`
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`
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`
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`
`Singla, et al., “A Discriminatory and Biorelevant Dissolution Test Method for
`Simvastatin Drug Products,” Dissolution Technologies (Nov. 2009)
`
`Noory, et al., “Steps for Development of a Dissolution Test for Sparingly
`Water-Soluble Drug Products,” Dissolution Technologies, Article 3 (Feb. 2000)
`
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`(Jan. 2004)
`
`Jamzad, et al., “Role of Surfactant and pH on Dissolution Properties of
`Fenofibrate and Glipizide—A Technical Note,” AAPS PharmSciTech 2006; 7
`(2) Article 33
`
`4

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