Paper No. _
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`Filed:
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`AKORN, INC.
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`Petitioner
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`SENIU PHARMACEUTICAL C0,, LTD.
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`MITSUBISHI CHEMICAL CORPORATION
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`Patent Owner
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`Case IPR2015-01205
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`Patent 6,114,319
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`DECLARATION OF DIANE PANG REGARDING AUTHENTICATION OF
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`REFRESH OPTIVE ADVANCED® LABEL
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`SENJU-MITSUBISHI 2086
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`IPR2015-01205
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`U.S. Patent No. 6,114,319
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`Declaration of Diane Pang
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`Exhibits Referenced In This Declaration
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`Printout of Refresh Optive Advanced® label
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`(NDC Codes: 0023-4307-03, 0023-4307-10,
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`0023—4307—20
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`Printout of Refresh Optive Advanced® label
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`NDC Codes: 0023-4491-05, 0023-4491-30
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`lPR2015-01205
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`U.S. Patent No. 6,114,319
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`Declaration of Diane Pang
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`1.
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`2.
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`I, Diane Pang, am an attorney at O’Melveny & Myers LLP.
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`Exhibits A and B are true and correct copies of Refresh Optive
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`Advanced® labels that I obtained from the DAILYMED database
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`(httpsfldailymed.nlm.nih.gov[dailymed[) on July 14, 2016.
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`3.
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`I declare under penalty of perjury under the laws of the United States
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`that the foregoing is true and correct. This declaration is executed this 22"“ day of
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`June, 2016, at Newmrt Beach, California.
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` Diane Pang
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`Exhibit A
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`REFRESH OPTIVE ADVANCED- carbnxymethylcellulose sodium, glycerin, and polysorbate 80 solution] drops
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`Allergan, Inc.
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`Disclaimer.‘ Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they compb’ with applicable regulations and
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`policies. FDA has not evaluated whether this product complies.
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`Active ingredients
`Carboxymethylcellulose sodium 0.5%
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`Glycerin 1%
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`Polysorbate 80 0.5%
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`Purpose
`Eye lubricant
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`Eye lubricant
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`Eye lubricant
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`Uses
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`- For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
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`in May be used as a protectant against further irritation.
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`Warnings
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`n For external use only.
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`I To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
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`I If solution changes color, do not use.
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`Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or
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`persists for more than 72 hours.
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`Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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`Directions
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`instill 1 or 2 drops in the affected eye(s) as needed.
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`Other information
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`Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
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`Use before expiration date marked on container.
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`Discard 90 days after opening.
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`Store at 59°—86°F (15"-30°C).
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`RETAIN THIS CARTON FOR FUTURE REFERENCE.
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`Inactive ingredients
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`Boric acid; castor oil; erythritol; levoeamitine; carbomer copolymer type A; purified water; and PURITEQ (stabilized oxychloro complex). May also
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`contain sodium hydroxide to adjust pH.
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`htrpszildaiIymed.rtlrn.nih.govfdailymedt‘t‘da.'fd:DrugXsl.ct'm?selid-ua943e4-'i'cJB-41:5:-b7c0—5a656dBcafe0&type=displ:y|6l1M2016 1:52:l4 PM]
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`

`
`Questions or comments?
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`':rl.800.433.887l
`
`refreshbrand.com
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`REFRESH AMERICA
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`SENDING EYE DROPS TO OUR FIRST RESPONDERS
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`Refresh
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`Lubricant Eye Drops
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`TRIPLE-ACTION RELIEF
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`Clirricaliy proven to lubricate,
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`hydrate, and protect
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`0.33 fl oz (10 mL) Sterile
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`h1tps:.v'ldniIymed.nlm.nih.gov/dailymcdlfdalfdaDrugxsl.cfm?se1idzaaa943:4-7c.'5B-4c5a-b7c0-5a656dBI:al'c{l&1ype=displIy[6a'14.0016 1:52:14 PM]
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`HUMAN 0'rc DRUG
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`mm Code (Source)
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`NDC:0023-4307
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`REFRESH OPTIVE ADVANCED
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`carboxymethylcellulose sodium, glyeuin, and polysorbate 80 solution] drops
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`
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`Exhibit B
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`

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`REFRESH OPTIVE ADVANCED- carboxymethylcellnlose sodium, glycerin, polysorbnte 80 solution.’ drops
`
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`Allergen, Inc.
`
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`Disclaimer.‘ Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has
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`not evaluated whether this product complies.
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`Drug Facts
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`Active ingredients
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`Carboxymelhylcellulose sodium 0.5%
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`
`
`Glycerin 1%
`
`
`Polysorbate 80 0.5%
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`
`
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`Purpose
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`Eye lubricant
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`Eye lubricant
`
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`Eye lubricant
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`Uses
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`I For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
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`I May be used as a protectant against further irritation.
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`Warnings
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`I For external use only.
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`I To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.
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`I Do not touch unit-dose tip to eye.
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`I ll‘ solution changes color, do not use.
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`Stop use and ask a doctor if you experience eye pain, changes in vision. continued redness or irritation of the eye, or if the condition worsens or persists for more than
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`72 hours.
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`Keep out of reach of children. If swallowed, get medical help or Contact a Poison Control Center right away.
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`Directions
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`To open, TWIST AND PULL TAB TO REMOVE. instill 1 or 2 drops in the affected eye(s) as needed and discard container.
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`Other information
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`I Use only if single-use container is intact.
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`I Use before expiration date marked on container.
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`I Store at 59°-86°F (15°-30°C).
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`I RETAIN THIS CARTON FOR FUTURE REFERENCE.
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`Inactive ingredients
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`Boric acid; carbomer copolymer type A; castor oil; erythritol; levocarnitine; purified water; and sodium hydroxide.
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`refreshbrand.com
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`NDC 0023-4491-30
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`Single-Use
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`httpsilldlilymcd.n1m.nih.gov:'dnilymcdlidlflduI)rugXs1.clm?seIid=cl'KIJ839e-2c1d-4c0e-9R6c- 191'] L5c7635il¢ltIype=display'[f\I'lI8f2£ll 6 1:56:10 PM]
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`Containers
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`|flFI ?fl.&#@9o-hlflfl-Wfl-lm Bc16358l.lypo-dqiaflfllflwlfi 1:56:10 PM]