U.S. DEPARTMENT OF COMMERCE- PATENT & TRADEMARK OFFICE
`PACE DATA ENTRY CODING SHEET
`faviMi)
`APPLICATION NUMBER
`TYPE
`RUNG DATE
`APPL
`MONTH
`DAY
`YEAR
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`noti-m
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`11/883398
`
`SPECIAL
`HANOUNQ
`
`1ST EXAMINER
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`S7CC>&7
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`2ND EXAMINER
`GROUP
`ART UNIT
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`CLASS
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`PATE 6 -2- rz-
`DATE
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`SHEETS OF
`DRAWING
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`LICENSE
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`CONTINUITY DATA
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`PARENT
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`TIPTx
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`PCT/FOREIQN APPLICATION DATA
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`MONTH
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`

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`OBLON
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`ATTORNEYS AT LAW
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`STEPHENG. BAXTER
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`COMMISSIONER FOR PATENTS
`ALEXANDRIA, VIRGINIA 22313
`
`MAIL STOP: PATENT TERM EXTENSION
`
`RECEIVED
`SEP 3 0 2009
`PATENT EXTENSION
`OPLA
`
`07/883,398
`RE: Application Serial No.:
`Applicants: Yoshihiro FUJIKAWA et al
`Filing Dale: May 15,1992
`For: QUINOLINE TYPE MEVALONOLACTONES
`Group Art Unit: 1613
`Examiner:
`L. L. STOCKTON
`Patent No.:
`5,856,336
`Issued:
`January 5, 1999
`
`SIR:
`
`Attached hereto for filing are the following papers:
`APPLICATION FOR EXTENSION OF PATENT TERM UNDER 35 U.S.C. § 156 AND 37 C.F.R.
`§§ 1.710,1.720,1.730,1.740,1.741,1.750,1.775 AND 1.785 (b) WITH EXHIBITS A THRU E (ONE
`ORIGINAL SIGNATURE PLUS FOUR COPIES)
`Credit card payment is being made online (if electronically filed), or is attached hereto (if paper
`filed), in the amount of $1.120.00 to cover any required fees. In the event any variance exists between the
`amount enclosed and the Patent Office charges for filing the above-noted documents, including any fees
`required under 37 C.F.R 1.136 for any necessary Extension of Time to make the filing of the attached
`documents timely, please charge or credit the difference to our Deposit Account No. 15-0030. Further, if
`these papers are not considered timely filed, then a petition is hereby made under 37 C.F.R. 1.136 for the
`necessary extension of time.
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`Respectfully submitted,
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`OBLON, SPIVAK, McCLELLAND,
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`Page 155 of 266
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`DOCKET NO: 342163US68 SD
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`RECEIVED
`
`SEP 3 0 2009
`
`
`PATENT EXTENSION
`
`
`OPLA
`IN THE UNITED STATES PATENT & TRADEMARK OFFICE
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`
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`IN RE PATENT OF
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`YOSHIHIRO FUJIKAWA ET AL
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`: GROUP ART UNIT: 1613
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`SERIAL NO: 07/883,398
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`
`
`: EXAMINER: STOCKTON, L. L.
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`
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`
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`FILED: MAY 15, 1992
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`
`
`
`: PATENT NO. 5,856,336
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`
`
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`
`: ISSUED: JANUARY 5, 1999
`
`
`
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`
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`FOR: QUINOLINE TYPE
`
`
`MEVALONOLACTONES
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`
`
`APPLICATION FOR EXTENSION OF PATENT TERM
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`UNDER 35 U.S.C. 8 156 AND 37 C.F.R. SS 1.710, 1.720.
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`1.730. 1.740.1.741.1.750.1.775 AND 1.785 (b)
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`MAIL STOP: PATENT TERM EXTENSION
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`
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`
`
`
`COMMISSIONER FOR PATENTS
`
`
`
`ALEXANDRIA, VIRGINIA 22313
`
`
`
`
`SIR:
`
`
`This is an application for extension of patent term under 35 U.S.C. § 156 and 37 C.F.R.
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`
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`§§ 1.710, 1.720, 1.730, 1.740, 1.741, 1.750, 1.775 and 1.785 (b) for U.S. Patent No. 5,856,336
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`("the '336 patent").
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`Two additional copies of this application (for a total of three copies) are being submitted
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`herewith (37 C.F.R. § 1.740(b)).
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`Sawai Ex 1002
`Page 156 of 266
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`

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`U.S. Patent No. 5,856,336
`Application for Extension of Patent Term
`
`Complete Identification of Approved Product (37 C.F.R. S 1.740(a)(1)).
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`The approved product is Livalo®, which is the registered name for film-coated tablets of
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`pitavastatin calcium. The chemical name for pitavastatin calcium is (+)monocalcium bis{(3R,
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`5S, 6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate}. The
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`empirical formula for pitavastatin calcium is C5oH46CaF2N208 and the molecular weight is
`
`880.98. The structural formula is:
`
`F
`
`N
`
`OH OH O
`
`O
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`2* Ca
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`Each film-coated tablet of Livalo® contains 1.045 mg, 2.09 mg, or 4.18 mg of
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`pitavastatin calcium, which is equivalent to 1 mg, 2 mg, or 4 mg, respectively of the free base.
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`The following inactive ingredients are included: lactose monohydrate, low substituted
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`hydroxypropylcellulose, hypromellose, magnesium aluminometasilicate, magnesium stearate.
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`The film-coating contains the following inactive ingredients: hypromellose, titanium dioxide.
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`triethyl citrate, and colloidal anhydrous silica.
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`&•'
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`2
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`

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`U.S. Patent No. 5,856,336
`
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`Application for Extension of Patent Term
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`II.
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`Complete Identification of Federal Statute under which Regulatory Review
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`Occurred (37 C.F.R. S 1.740(a)(2»
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`Regulatory permission to sell Livalo® was granted under 21 U.S.C. § 355 (section 505 of
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`the Federal Food, Drug, and Cosmetic Act).
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`III.
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`Identification of Date on which Product Received Permission for Commercial
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`Marketing or Use (37 C.F.R. § 1.740(a)(3)).
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`Regulatory approval for Livalo® was granted on August 3, 2009, and a copy of the
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`approval letter is attached hereto as Exhibit A.
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`IV.
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`Identification of Each Active Ingredient in Product and Statement That Each Active
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`Ingredient Has Not Been Previously Approved for Commercial Marketing or Use
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`(37 C.F.R. § 1.740(a)(4)).
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`The sole active ingredient in the approved product is pitavastatin calcium. Pitavastatin
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`calcium has not been previously approved for commercial marketing or use under the Federal
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`Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Virus-Serum-Toxin Act.
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`V.
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`Statement that Application Is Being Submitted within Sixty Day Period and
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`Identification of Date of Last Day on which Application Could Be Submitted (37
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`C.F.R. S 1.740(a)(5)).
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`This application is being submitted within the sixty day period specified by 35 U.S.C. §
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`156(1) and 37 C.F.R. § 1.720(f). The last day on which this application could be submitted is
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`October 1, 2009.
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`u <
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`3
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`Sawai Ex 1002
`Page 158 of 266
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`

`
`U.S. Patent No. 5,856,336
`Application for Extension of Patent Term
`
`VI. Complete Identification of Patent for which Extension Is Being Sought by Name of
`Inventor, Patent number. Date of Issue, and Date of Expiration (37 C.F.R. S
`1.740(a)(6)).
`
`The patent for which extension of patent term is sought is U.S. Patent No. 5,856,336
`
`("the '336 patent"), which names Yoshihiro Fujikawa, Mikio Suzuki, Hiroshi Iwasaki, Mitsuaki
`
`Sakashita and Masaki Kitahara as inventors, and which issued on January 5, 1999, from U.S.
`
`Patent Application Serial No. 07/883,398, and is currently set to expire on January 5, 2016.
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`VII. Copy of Patent for which Extension Is Being Sought (37 C.F.R. § 1.740(a)(7)).
`
`A copy of the '336 patent is attached hereto as Exhibit B.
`
`VIII. Copy of Any Disclaimer, Certificate of Correction, Receipt of Maintenance Fee
`Payment or Reexamination Certificate Issued in Patent (37 C.F.R. S 1.740(a)(8)).
`
`Applicant states on the record that no disclaimers have been filed in the *336 patent, no
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`certificates of correction have been requested or issued in the *336 patent, and no reexamination
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`certificate has been issued in the *336 patent.
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`A copy of the receipts of maintenance fee payments for the first and second maintenance
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`fees in the *336 patent arc attached hereto as Exhibit C.
`
`IX.
`
`Statement that Patent Claims Approved Product and Showing which Lists Each
`Applicable Patent Claim and Demonstrates Manner in which at least One Such
`Patent Claim Reads On Approved Product (37 C.F.R. § 1.740(a)(9)).
`
`The approved product, Livalo®, film-coated tablets of pitavastatin calcium, is claimed in
`
`the *336 patent.
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`The relationship between the claims of the *336 patent and the approved product is set
`
`I
`
`4
`
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`Page 159 of 266
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`

`
`U.S. Patent No. 5,856336
`Application for Extension of Patent Term
`
`forth in TABLE I below.
`
`Claims of the '336 Patent
`1. A compound of the formula,
`F
`
`Z
`
`TABLE 1
`
`Livalo®
`Livalo® contains pitavastatin calcium, which
`is given by the formula
`F
`
`OH OH Q
`O" Ca2+
`
`N
`
`—2
`l_
`which is equivalent to the formula set forth in
`claim 1 of the 4336 Patent.
`
`Livalo® is approved for administration to
`patients with primary hyperlipidemia.
`
`N
`
`A
`
`[A]
`Z= -CH(OH)-CH2-CH(OH)-CH2-COO-,/2
`Ca.
`2. A method for reducing hyperlipidemia,
`hyperlipoproteinemia or atherosclerosis,
`which comprises administering an effective
`amount of the compound of formula A as
`defined in claim 1.
`
`It
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`5
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`U.S. Patent No. 5,856,336
`
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`Application for Extension of Patent Term
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`X.
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`Statement Beginning on New Page of Relevant Dates and Information to Enable the
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`Secretary of Health and Human Services to Determine Applicable Regulatory
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`Review Period (37 C.F.R. S 1.740(a)(10HiVh
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`(A)
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`Effective Date of Investigational New Drug (IND) Application and IND
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`Number (37 C.F.R. § 1.740(a)(10)(i)(A)).
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`The effective date for the IND for the approved product is June 9, 2000, and the IND
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`number for the approved product is IND 60,492.
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`(B) Date on which New Drug Application (NDA) was Initially Submitted and
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`NDA Number (37 C.F.R. § 1.740(a)(10)(B)).
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`The NDA for the approved product was initially submitted on October 1, 2008, and the
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`NDA number for the approved product is NDA 022363.
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`(C) Date on which NDA Was Approved (37 C.F.R. § 1.740(a)(10)(C)).
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`NDA 022363 was approved on August 3, 2009.
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`6
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`U.S. Patent No. 5,856,336
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`Application for Extension of Patent Term
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`XI.
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`Brief Description Beginning on New Page of Significant Activities Undertaken bv
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`Marketing Applicant during Applicable Regulatory Review Period with respect to
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`Approved Product and Significant Dates Applicable to Such Activities (37 C.F.R. 8
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`1,740(11)).
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`A.
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`The IND.
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`A list of significant activities undertaken by the marketing applicant during the IND and
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`the significant dates applicable thereto is provided in TABLE 2 below.
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`TABLE 2
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`DATE
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`TYPE
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`6/9/00
`
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`Initial IND
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`
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`DESCRIPTION
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`22 Toxicology Reports, 1 Clinical Study
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`Protocol (Study NK-104-101) to be
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`
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`Conducted in France
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`6/13/00
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`Correspondence
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`IND Acknowledgment Letter
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`6/14/00
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`Information Amendments
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`6/15/00
`
`
`Other
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`6/21/00
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`
`Other
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`6/30/00
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`Correspondence
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`7/11/00
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`Teleconference
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`7/19/00
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`Teleconference
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`8/28/00
`
`
`Correspondence
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`Form FDA 1572 and Revised
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`
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`Investigators' CV for Study NK-104-101
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`Additional Copy of Volume 1.1 from the
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`Initial IND Submission SN 0000
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`Electronic Media for Original IND (2
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`
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`Floppy Disks, 1 CD-ROM)
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`
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`Copies of Pharmacology Publications
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`IND Comments Before the End of the 30-
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`
`
`
`
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`day Waiting Period
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`Follow-Up to Teleconference with Drs.
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`Orloff and Lubas on 7/11/00
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`Meeting Minutes of the FDA Center for
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`Drug Evaluation and Research, Executive
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`Carcinogenesis Assessment Committee
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`
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`(FAX)
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`
`7
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`U.S. Patent No. 5,856,336
`Application for Extension of Patent Term
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`DATE
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`TYPE
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`8/29/00
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`Correspondence
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`9/15/00
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`General Correspondence
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`9/28/00
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`Other
`
`10/5/00
`
`Correspondence
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`10/10/00
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`Correspondence
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`10/11/00
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`Teleconference
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`10/27/00
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`Correspondence
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`10/27/00
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`Other
`
`12/4/00
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`Other
`
`12/12/00
`
`Correspondence
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`12/14/00
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`Correspondence
`
`4/3/01
`
`Protocol Amendments
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`4/9/01
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`Teleconference
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`4/23/01
`
`Protocol Amendments
`
`4/25/01
`
`Information Amendments
`
`5/15/01
`
`Correspondence
`
`DESCRIPTION
`Meeting Minutes of the FDA Center for
`Drug Evaluation and Research, Executive
`Carcinogenesis Assessment Committee
`(official letter & minutes)
`Questions Regarding Carcinogenicity
`Studies
`Request for a Meeting with the Executive
`Carcinogenicity Assessment Committee
`Telephone Conference with Pharm/Tox
`Team Confirmation
`List of participants for teleconference on
`Oct. 11, 2000 for Carcinogenicity Studies
`Carcinogenicity Issues
`Minutes of the Telephone Conference on
`10/11/00
`Sponsor Response to FDA Comments
`Regarding Slit Lamp Examinations in
`Multiple-Dose Clinical Studies
`Questions Regarding Survival Analysis of
`the 92-Week Mouse Study
`Comments from Clinical Team Meeting
`Information on Survival-Adjusted
`Analyses of Tumor Data
`Study Protocol for Study NK-104-209,
`Study NK-104-209 Investigator
`Information, Updated Investigators'
`Brochure (Feb 2001)
`Comments about 4/3/01 Submission for
`104-209 Protocol
`Study NK-104-209 Protocol Amendment
`(addition of Slit Lamp Examinations)
`information Amendment: Clinical Data
`from Study NK-104-101 to Support 64
`mg Dose Group in Study NK-104-209
`Comments from the Clinical and
`Pharm/Tox Teams Regarding IND 60,492
`
`h'u
`
`iLw
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`8
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`U.S. Patent No. 5,856,336
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`Application for Extension of Patent Term
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`
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`
`DATE
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`
`TYPE
`
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`5/31/01
`
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`Correspondence
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`6/1/01
`
`
`Correspondence
`
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`6/4/01
`
`
`Protocol Amendments
`
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`6/8/01
`
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`Information Amendments
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`6/15/01
`
`
`Other
`
`
`6/28/01
`
`
`Information Amendments
`
`
`
`6/29/01
`
`
`Other
`
`
`6/17/01
`
`
`IND Safety Reports
`
`
`
`
`7/11/01
`
`
`Teleconference
`
`
`7/12/01
`
`
`Teleconference
`
`
`7/20/01
`
`
`IND Safety Reports
`
`
`
`
`7/24/01
`
`
`IND Safety Reports
`
`
`
`
`7/30/01
`
`
`IND Safety Reports
`
`
`
`
`8/1/01
`
`
`IND Safety Reports
`
`
`
`
`8/23/01
`
`
`Protocol Amendments
`
`
`
`L -
`
`9
`
`
`
`
`
`
`DESCRIPTION
`
`Pharmacokinetic Data for Chronic
`
`
`
`
`Toxicity Studies
`
`
`Pharmacokinetic Data for Chronic
`
`
`
`
`Toxicity Studies
`
`
`Study NK-104-209 Investigator
`
`
`
`Information
`
`Copies of a Monkey and a Rat
`
`
`
`
`
`
`Toxicokinetic Report (originally
`
`
`
`submitted as part of SN0000) requested
`
`
`
`
`
`
`by FDA
`
`
`NDA Questions
`
`
`Peer Review of Rat Carcinogencity Study
`
`
`
`
`
`Requested by FDA
`
`
`
`New Sponsor Liaison Person
`
`
`
`
`Study NK-104-209:Serious, Unexpected
`
`
`
`
`Adverse Event Report - 15-Day
`
`
`
`
`Expedited Report (Initial)
`
`
`
`Termination of Randomization of Patients
`
`
`
`
`
`to 32 mg and 64 mg NK-104 and NK-
`
`
`
`
`
`
`
`
`
`104-209
`
`Termination of Randomization of Patients
`
`
`
`
`to 32 mg and 64 mg NK-104 and NK-
`
`
`
`
`
`
`
`104-209 follow up with FDA
`
`
`
`
`
`Study NK-104-209: Serious, Unexpected
`
`
`
`
`
`Adverse Event Report - 15-Day
`
`
`
`
`Expedited Report (Initial)
`
`
`
`Study NK-104-209: Serious, Unexpected
`
`
`
`Adverse Event Report - 15-Day
`
`
`
`
`Expedited Report (Initial)
`
`
`
`Study NK-104-209: Serious, Unexpected
`
`
`
`
`
`Adverse Event Report - 15-Day
`
`
`
`
`Expedited Report (Initial)
`
`
`
`Study NK-104-209: Serious, Unexpected
`
`
`
`
`Adverse Event Report - 15-Day
`
`
`
`
`Expedited Report (Initial)
`
`
`
`Study NK-104-209 Amendment #2
`
`
`
`
`
`
`
`
`Sawai Ex 1002
`Page 164 of 266
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`

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`U.S. Patent No. 5,856,336
`
`
`
`
`Application for Extension of Patent Term
`
`
`
`
`
`
`
`DATE
`
`
`TYPE
`
`
`8/24/01
`
`
`Protocol Amendments
`
`
`
`9/6/01
`
`
`Other
`
`
`9/10/01
`
`
`Annual Report
`
`
`
`9/28/01
`
`
`IND Safety Reports
`
`
`
`
`10/30/01
`
`
`IND Safety Reports
`
`
`
`
`10/31/01
`
`
`IND Safety Reports
`
`
`
`
`12/14/01
`
`
`IND Safety Reports
`
`
`
`
`1/9/02
`
`
`IND Safety Reports
`
`
`
`
`2/11/02
`
`
`IND Safety Reports
`
`
`
`
`7/1/02
`
`
`Protocol Amendments
`
`
`
`7/5/02
`
`
`Protocol Amendments
`
`
`
`9/17/02
`
`
`Annual Report
`
`
`
`10/4/02
`
`
`Correspondence
`
`
`11/8/02
`
`
`Protocol Amendments
`
`
`
`DESCRIPTION
`
`Study NK-104-209 Investigator
`
`
`
`
`Information
`
`Termination of Clinical Study NK-104-
`
`
`
`
`209
`
`Annual Report IND 60,492 (7/12/00 -
`
`
`
`
`
`7/11/01); CD-ROM
`
`
`Study NK-104-209: Serious, Unexpected
`
`
`
`
`
`Adverse Event Report - 15-Day
`
`
`
`
`Expedited Report (Follow-Up #1; 2
`
`
`
`
`
`patients)
`
`Study NK-104-209: Serious, Unexpected
`
`
`
`
`
`Adverse Event Report - 15-Day
`
`
`
`
`Expedited Report (Follow-Up #2)
`
`
`
`
`Study NK-104-209: Serious, Unexpected
`
`
`
`
`
`Adverse Event Report - 15-Day
`
`
`
`
`Expedited Report (Follow-Up #1)
`
`
`
`
`Study NK-104-209: Serious, Unexpected
`
`
`
`
`
`Adverse Event Report - 15-Day
`
`
`
`
`Expedited Report (Follow-Up #1; 2
`
`
`
`
`
`patients)
`
`Study NK-104-209: Serious, Unexpected
`
`
`
`
`
`Adverse Event Report - 15-Day
`
`
`
`
`Expedited Report (Follow-Up #1)
`
`
`
`
`Study NK-104-209: Serious, Unexpected
`
`
`
`
`
`Adverse Event Report - 15-Day
`
`
`
`
`Expedited Report (Follow-Up #2)
`
`
`
`
`Study NK-104-109 Protocol (Protocol
`
`
`
`
`
`
`Amendment #2), Study NK-104-109
`
`
`
`
`
`
`Investigator Information
`
`
`Study NK-104-210 Protocol (Protocol
`
`
`
`
`
`Amendment #2), Investigator Information
`
`
`
`
`Annual Report IND 60,492 (7/12/01 -
`
`
`
`
`
`7/11/02)
`
`Clinical Trials Data Bank
`
`
`
`
`Study NK-104-211 Protocol, Investigator
`
`
`
`
`
`Information
`
`
`10
`
`
`Sawai Ex 1002
`Page 165 of 266
`
`

`
`U.S. Patent No. 5,856,336
`
`
`
`
`Application for Extension of Patent Term
`
`
`
`
`
`
`
`DATE
`
`
`TYPE
`
`
`12/20/02
`
`
`Other
`
`
`2/25/03
`
`
`Protocol Amendments
`
`
`
`9/16/03
`
`
`Information .^Vmendments
`
`
`
`9/16/03
`
`
`Annual Report
`
`
`
`1/27/04
`
`
`Teleconference
`
`
`2/3/04
`
`
`IND Safety Reports
`
`
`
`
`4/2/04
`
`
`IND Safety Reports
`
`
`
`
`4/19/04
`
`
`Information Amendments
`
`
`
`6/1/04
`
`
`IND Safety Reports
`
`
`
`
`6/22/04
`
`
`IND Safety Reports
`
`
`
`
`7/29/04
`
`
`IND Safety Reports
`
`
`
`
`9/10/04
`
`
`Annual Report
`
`
`
`
`9/23/04
`
`
`IND Safety Reports
`
`
`
`
`
`
`DESCRIPTION
`
`Termination of Patients on 8 mg NK-104
`
`
`
`
`
`
`
`
`in Study NK-104-210
`
`
`
`
`Study NK-104-210 Protocol Amendment
`
`
`
`
`#3 and #4)
`
`
`
`Study NK-104-109 Clinical Study Report,
`
`
`
`
`
`Study SNY 419/013926 Clinical Study
`
`
`
`
`
`Report
`
`Annual Report (July 12, 2002 to July 11,
`
`
`
`
`
`
`
`
`2003)
`
`FDA suggested that Sankyo re-analyze
`
`
`
`
`
`the Phase I data in the NK-104-109 study
`
`
`
`
`
`
`
`
`
`and begin to think about an EOP2a
`
`
`
`
`
`
`
`meeting.
`
`Japan, Post-Marketing: Serious,
`
`
`
`Unexpected Adverse Event Report - IND
`
`
`
`
`
`Safety Report - Initial
`
`
`
`Japan, Post-Marketing: Serious,
`
`
`
`Unexpected Adverse Event Reports - 15-
`
`
`
`
`day expedited report - Initial
`
`
`
`
`Study NK-104-GJ Clinical Study Report,
`
`
`
`
`
`Study NKS104A2204 Clinical Study
`
`
`
`
`
`Report
`
`Japan, Post-Marketing: Serious,
`
`
`
`Unexpected Adverse Event Reports - IND
`
`
`
`
`
`Safety Report - Initial (2 patients)
`
`
`
`
`
`Japan, Post-Marketing: Serious, Adverse
`
`
`
`
`Event Report - IND Safety Report -
`
`
`
`
`
`Follow-up No. 1
`
`
`
`Japan, Post-Marketing: Serious,
`
`
`
`Unexpected Adverse Event Reports - IND
`
`
`
`
`
`Safety Report - Initial
`
`
`
`Annual Report (July 12, 2003 to July 11,
`
`
`
`
`
`
`
`
`2004)
`
`Japan, Post-Marketing: Serious,
`
`
`
`Unexpected Adverse Event Reports - IND
`
`
`
`
`
`Safety Report - Initial
`
`
`
`
`11
`
`
`Sawai Ex 1002
`Page 166 of 266
`
`

`
`U.S. Patent No. 5,856,336
`
`
`
`
`Application for Extension of Patent Term
`
`
`
`
`
`
`
`TYPE
`
`
`IND Safety Reports
`
`
`
`
`IND Safety Reports
`
`
`
`
`DESCRIPTION
`
`Japan, Post-Marketing: Serious,
`
`
`
`Unexpected Adverse Event Reports - IND
`
`
`
`
`
`Safety Report - Initial
`
`
`
`Japan, Post-Marketing: Serious,
`
`
`
`Unexpected Adverse Event Report - IND
`
`
`
`
`
`Safety Report - Initial
`
`
`
`Study NK104-210/211 Clinical Study
`
`
`
`Report, Study NK104-101 Clinical Study
`
`
`
`
`
`
`Report
`
`Information Amendments Drug Product Stability Update
`
`
`
`
`
`
`Information Amendments
`Study NK-104-209 Clinical Study Report
`
`
`
`
`
`
`
`
`Japan, Post-Marketing: Serious,
`
`
`
`Unexpected Adverse Event Report - IND
`
`
`
`
`
`Safety Report - Initial {Kowa comment:
`
`
`
`
`
`this has subsequently been identified as a
`
`
`
`
`
`
`
`follow-up report to SN046}
`
`
`
`
`Transfer of IND Ownership from Sankyo
`
`
`
`
`
`
`to KRI
`
`Acceptance from Sankyo of IND
`
`
`
`
`
`Ownership by KRI
`
`
`
`Japan, Post-Marketing: Serious,
`
`
`
`Unexpected Adverse Event Report - IND
`
`
`
`
`
`Safety Report - Initial and follow-up #1
`
`
`
`
`
`
`(last submission by Sankyo)
`
`
`
`
`
`DATE
`
`
`11/8/04
`
`
`12/14/04
`
`
`1/21/05
`
`
`2/1/05
`
`3/3/05
`
`
`3/23/05
`
`
`3/30/05
`
`
`3/31/05
`
`
`3/31/05
`
`
`Information Amendments
`
`
`
`
`
`IND Safety Reports
`
`
`
`
`Other
`
`
`Other
`
`
`IND Safety Reports
`
`
`
`
`4/12/05
`
`
`Correspondence
`
`
`Transfer of Sponsor-Sankyo
`
`
`
`
`4/18/05
`
`
`IND Safety Report
`
`
`
`
`4/25/05
`
`
`IND Safety Report
`
`
`
`
`Japan, Post-Marketing: Serious,
`
`
`
`Unexpected Adverse Event Report - IND
`
`
`
`
`
`Safety Report - Initial (First Submission
`
`
`
`
`
`by KRI)
`
`
`Study NK-104: Serious, Unexpected
`
`
`
`
`Adverse Event Report - 15-Day
`
`
`
`
`Expedited Report (Initial)
`
`
`
`
`12
`
`
`Sawai Ex 1002
`Page 167 of 266
`
`

`
`U.S. Patent No. 5,856,336
`Application for Extension of Patent Term
`
`DATE
`
`TYPE
`
`5/13/05
`
`IND Safety Report
`
`6/1/05
`
`IND Safety Report
`
`7/18/05
`
`Other
`
`7/21/05
`
`IND Safety Reports
`
`7/26/05
`
`IND Safety Reports
`
`DESCRIPTION
`Study NK-104: Serious, Unexpected
`Adverse Event Report - 15-Day
`Expedited Report (Initial), Japan, Post-
`Marketing Serious, Unexpected Adverse
`Event Report - IND Safety Report -
`Follow-up #1
`Study NK-104; Serious, Unexpected
`Adverse Event Report - 15-Day
`Expedited Report (Initial), Japan, Post-
`Marketing Serious, Unexpected Adverse
`Event Report - END Safety Report -
`Follow-up #1
`End-of-Phase II Meeting Request
`Study NK-104: Serious, Unexpected
`Adverse Event Report - 15-Day
`Expedited Report (Initial), Japan, Post-
`Marketing Serious, Unexpected Adverse
`Event Report - IND Safety Report -
`Follou-up #1
`Japan, Post-Marketing: Serious,
`Unexpected Adverse Event Report - IND
`Safety Report - Initial (First Submission
`by KRI)
`
`7/29/05
`
`Correspondence
`
`EoP 2 Mtg Req Granted
`
`8/4/05
`
`IND Safety Reports
`
`8/19/05
`
`Other
`
`8/23/05
`9/2/05
`9/9/05
`9/14/05
`9/16/05
`9/27/05
`
`General Correspondence
`rND Safety Reports
`Annual Report
`Other
`Information Amendments
`Information Amendments
`
`Japan, Post-Marketing: Serious,
`Unexpected Adverse Event Report - IND
`Safety Report - Initial (First Submission
`by KRI)
`End of Phase 2 Meeting Background
`Package
`New Company Point of Contact
`1 initial 3 follow-ups reports
`Annual Report Document
`End-of-Phase II CMC Meeting Request
`Statistical Analysis Report
`Tox 078
`
`13
`
`•u r'.s.
`
`Sawai Ex 1002
`Page 168 of 266
`
`

`
`U.S. Patent No. 5,856,336
`
`
`
`
`Application for Extension of Patent Term
`
`
`
`
`
`
`
`
`DATE
`
`9/28/05
`
`10/18/05
`
`
`jpjg
`
`
`
`Correspondence
`
`IND Safety Reports
`
`
`
`
`10/25/05 Other
`
`
`
`
`10/27/05
`
`
`Information Amendments
`
`
`
`
`11/1/05
`
`11/30/05
`
`
`Correspondence
`
`IND Safety Reports
`
`
`
`
`12/8/05
`
`
`Correspondence
`
`
`
`1/3/06
`
`1/17/06
`
`
`Correspondence
`
`Correspondence
`
`
`
`2/1/06
`
`
`Information Amendments
`
`
`
`3/1/06
`
`
`
`Correspondence
`
`
`
`3/9/06
`
`
`
`Other
`
`
`
`3/10/06
`3/15/06
`
`
`
`
`
`IND Safety Reports
`
`
`
`Correspondence
`
`
`
`3/21/06
`
`
`Other
`
`
`
`3/27/06
`
`3/31/06
`
`4/4/06
`
`
`New Protocol
`
`
`New Protocols
`
`New Protocol
`
`
`
`
`
`
`5/5/06
`
`
`IND Safety Reports
`
`
`
`
`5/12/06
`
`6/1/06
`
`6/1/06
`
`
`
`
`Protocol Amendments
`
`Correspondence
`
`Correspondence
`
`
`
`6/27/06
`
`
`IND Safety Reports
`
`
`
`
`
`14
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`DESCRIPTION
`EoP 2 MtgReq 11-29-05
`
`
`
`
`
`Initial Written Report
`
`
`
`End of Phase 2 Meeting (CMC Focus)-
`
`
`
`
`
`Background Document
`
`
`Request for Division/ECAC Evaluation of
`
`
`
`
`Carcinogenicity Data
`
`
`EoP-2 MtgMinutes of 9-20-05
`
`
`
`
`Initial Written Report
`
`
`
`Kowa QA Meeting Cancellation Letter,
`
`
`
`
`EOP2 CMC response
`
`
`
`Correction Letter
`
`
`SN0073 White Paper
`
`
`
`Information Amendment: Clinical
`
`
`
`Response to EOP 2 Meeting Minutes
`
`
`
`
`
`SN0075 Proteinuria
`
`
`Request for Type B Meeting - Phase 3
`
`
`
`
`
`
`Guidance
`
`2 Initial and 3 follow-up reports
`
`
`
`
`
`Mtg Rqt Denied Letter NK-104
`
`
`
`
`
`Background Information for FDA
`
`
`
`Response to Questions
`
`
`
`protocol NK-104-1.21, Mar, 2006 IB
`
`
`
`
`
`9 EU Phase 3 protocols
`
`
`
`
`
`protocol NK-104-1.22
`
`
`Initial Report of Adverse Event; Follow-
`
`
`
`
`
`Up Reports of Adverse Events.
`
`
`
`
`
`protocol NK-104-1.25
`
`
`
`SN0078
`
`SN0080
`
`NK-104-0051 Initial ReportFollow-up
`
`
`Reports:ELIYA 3598 follow-up
`
`
`
`#2ELIVA 2657ELIVA 3873 follow-up #1
`
`
`
`
`
`and #2
`
`
`
`Sawai Ex 1002
`Page 169 of 266
`
`

`
`
`U.S. Patent No. 5,856,336
`
`
`
`Application for Extension of Patent Term
`
`
`
`
`
`
`
`
`DATE
`
`
`
`TYPE
`
`
`
`6/29/06
`
`
`
`IND Safety Reports
`
`
`
`
`
`7/10/06
`
`
`
`IND Safety Reports
`
`
`
`
`
`8/4/06
`
`
`
`IND Safety Reports
`
`
`
`
`
`8/9/06
`
`8/11/06
`
`8/30/06
`
`
`
`IND Safety Reports
`
`
`
`Protocol Amendments
`
`IND Safety Reports
`
`
`
`
`
`
`9/8/06
`
`
`
`IND Safety Reports
`
`
`
`
`
`
`9/22/06
`9/27/06
`
`10/3/06
`
`
`
`Protocol Amendments
`
`IND Safety Reports
`
`
`
`Protocol Amendments
`
`
`
`
`
`
`10/17/06
`
`
`
`IND Safety Reports
`
`
`
`
`
`10/26/06
`10/30/06
`
`
`
`
`
`11/3/06
`
`
`
`Information Amendment
`
`IND Annual Report
`
`
`Special Protocol
`
`Assessment
`
`
`
`
`
`
`
`
`DESCRIPTION
`
`2 Initial and 1 follow-up reportsELIVA
`
`
`
`
`
`
`3338 and ELIVA 4169 Initial ReportsNK-
`
`
`
`
`
`
`104-0051 follow up report #1
`
`
`
`
`
`ELIVA 1532 Initial Report
`
`
`
`
`ELIVA 4374 Initial ReportFollow Up
`
`
`
`
`
`Reports:ELIVA 2657ELIVA 3338ELIVA
`
`
`
`4168ELIVA 1854NK-104-0051
`
`
`ELIVA 1968
`
`
`NK-104-1.23, NK-104-1.25
`
`
`
`NK-104-0061
`
`A2006 1676-001 Initial Report2A2006
`
`
`
`
`0040.005 follow-up #21A2005 0562.003
`
`
`
`
`follow-up #1NK-104-0061 follow-up #1
`
`
`
`
`Nk-104-1.23US, Amend #2
`
`
`A2006 1773.001
`
`NK-104-1.23US, Amend #2
`
`
`
`NK-1040073 Initial ReportA20061773-
`
`
`002 follow-upA20061676-002 follow-up
`
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`104 IV. 102 EU; SPH003; SPH008
`
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`
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`July 12, 2005-July 11,2006
`
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`
`
`
`
`
`
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`rasH2 carcinogenicity protocol
`
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`11/14/06
`
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`IND Safety reports
`
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`
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`12/6/06
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`IND Safety Reports
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`12/13/06
`
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`Correspondence
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`
`12/27/06
`
`
`
`Response to FDA request
`
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`
`
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`1/23/07
`
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`IND Safety reports
`
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`A2006 1939-001 initial;
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`10001.2006.USNK104, initial; ELIVA
`
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`4374, F/U 1; A2006 1773.003/004 F/U
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`2&3; NK-104-0073 F/U 1
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`ELIVA 2001/A20060643 initial & F/U;
`
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`10001.2006.USNK104 F/U
`
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`
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`CAC Report 12-13-06 NK-104 Spec
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`
`
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`Protocol Assess
`
`
`Response to FDA comments on SAPs for
`
`
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`NK-104-301 and NK-104-302
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`1 initial (A2007-0046-001), 6 F/U
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`15
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`Sawai Ex 1002
`Page 170 of 266
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`

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`U.S. Patent No. 5,856,336
`
`
`
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`Application for Extension of Patent Term
`
`
`
`
`
`
`
`DATE
`
`
`TYPE
`
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`1/25/07
`
`
`Correspondence
`
`
`DESCRIPTION
`
`Comments from Dec 27, 2006 Serial #101
`
`
`
`
`
`
`Letter
`
`Initial Written Report(20070173-003)
`
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`QTc Draft Protocol
`
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`
`
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`A20070390-001/002- Initial & F/U &
`
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`Medical Review & Analysis of Similar
`
`
`
`
`
`Events
`
`English translation of Japanese NDA
`
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`
`
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`clinical summary
`
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`IND Safety Reports (1 initial and 2 F/U)
`
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`A20070545-001/002, A20070390-003 #3,
`
`
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`A20078070173-005 #2
`
`
`Comments from April 10, 2007 Serial
`
`
`
`
`
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`#104 Letter
`
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`A20070589-002
`
`A20070545-003, follow-up report #2
`
`
`
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`Proposed Trade Name - Request for FDA
`
`
`
`
`
`
`Opinion (Livalo®)
`
`
`NK-104-1.34US/Thomas Hunt, MD
`
`
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`NK-104-0190 Initial
`
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`2 initial, A20070777 & A20070780 ; 2
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`
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`F/U NK-104-0190 & A20060092
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`1 initial, A20070778
`
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`4 initial, NK-104-205, NK-104-207,
`
`
`
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`A20070806, A20070777: 1 F/U,
`
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`
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`A20070780
`
`Annual Report
`July 12, 2006-July 11,2007
`
`
`
`
`
`
`
`Information Ammendment MET 067; SPH 011; SPH 012
`
`
`
`
`
`
`
`
`Request for Type B Meeting - FDA Pre-
`
`
`
`
`
`
`NDA Guidance Meeting Clinical and
`
`
`
`
`
`Nonclinical
`
`
`3/2/07
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`4/10/07
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`4/13/07
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`5/8/07
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`5/11/07
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`5/29/07
`
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`5/30/07
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`6/12/07
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`6/26/07
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`7/23/07
`
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`8/17/07
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`9/4/07
`
`
`9/11/07
`
`
`9/20/07
`
`9/24/07
`
`
`10/4/07
`
`
`IND Safety reports
`
`
`
`Request for FDA
`
`
`
`Review/Comment
`
`
`IND Safety Report
`
`
`
`
`Information Amendment
`
`
`
`IND Safety Reports
`
`
`
`
`Correspondence
`
`
`IND Safety Reports
`
`
`
`
`Request for FDA
`
`
`
`Review/Comment
`
`New Protocol
`
`
`IND Safety Report
`
`
`
`
`IND Safety Reports
`
`
`
`
`IND Safety Report
`
`
`
`
`IND Safety Reports
`
`
`
`
`Request for FDA
`
`
`
`Review/Comment
`
`
`10/25/07
`
`
`Correspondence
`
`
`NK-104 pre-NDA Meeting Confirm
`
`
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`
`
`•i'
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`16
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`Sawai Ex 1002
`Page 171 of 266
`
`

`
`U.S. Patent No. 5,856,336
`
`
`
`
`Application for Extension of Patent Term
`
`
`
`
`
`
`
`
`DATE
`
`
`
`TYPE
`
`
`
`11/15/07
`
`
`Information Amendment
`
`
`
`
`12/6/07
`
`
`12/7/07
`
`
`Pre-NDA Meeting
`
`
`Background document
`
`
`Information Amendment
`
`
`
`
`12/14/07
`
`
`IND Safety Reports
`
`
`
`
`12/20/07
`
`
`IND Safety Reports
`
`
`
`
`1/2/08
`
`
`IND Safety Report
`
`
`
`
`
`DESCRIPTION
`
`Vol 1 -NK-104-1.21US,NK-104-
`
`
`
`
`1.22US, NK-104-1.25US, NK-104-301
`
`
`
`Vol 2 - NK-104-302, NK104-304, and
`
`
`
`
`
`NK-104-306
`
`
`Meeting Jan 28, 2008
`
`
`
`
`
`MET073 FBM06-T350FR
`
`
`NK-104-0190 follow-up report #4,
`
`
`
`
`A20070777-003/004 follow-up reports #3
`
`
`
`
`and #4 and A20070806-002/003 reports
`
`
`
`
`
`#2 and #3
`
`
`
`A20070918-001 for a case of
`
`
`
`
`
`oculomucocutaneous syndrome reported
`
`
`
`with Livalo®, In addition one follow-up
`
`
`
`
`
`
`report is enclosed for NK-104-205, a case
`
`
`
`
`
`
`of macula hole previously reported in
`
`
`
`
`
`
`SN0114, which has been downgraded.
`
`
`
`
`A20070901-002 for a case of renal
`
`
`
`
`
`
`impairment reported with Livalo®,
`
`
`
`
`(A20070901-001), is also included
`
`
`
`
`
`
`
`
`
`2/27/08
`
`
`Correspondence
`
`
`
`FDA Pre-NDA Meeting Mins
`
`
`
`
`
`
`4/4/08
`
`
`New Protocol
`
`
`
`
`4/8/08
`
`
`Response to FDA request
`
`
`
`for Information
`
`
`
`
`
`4/15/08
`
`
`Correspondence
`
`
`
`4/16/08
`
`
`General Correspondence
`
`
`
`
`4/30/08
`
`
`Correspondence
`
`
`
`
`5/13/08
`
`
`IND Safety Report
`
`
`
`
`
`
`
`
`
`17
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Protocol for US study NK-104-1.37US ,
`
`
`
`Also enclosed is a form FDA 1572 and
`
`
`
`
`
`
`
`CV for the Principal Investigator, Dr.
`
`
`
`
`
`
`Aziz Laurent as well as a transfer of
`
`
`
`
`
`
`
`obligations statement to the CRO, PPD
`
`
`
`
`
`
`Development LLP
`
`
`Pre-NDA meeting held January 28, 2008
`
`
`
`
`Data Definition Table (DDT)
`
`
`
`
`Pre NDA Meeting Follow-up Comment
`
`
`
`
`Received April 15, 2008
`
`
`
`RESPONSE REQUESTED - PRE-NDA
`
`
`MEETING CMC FOLLOW-UP
`
`
`
`
`Pre-NDA Response FDA 4-30-2008
`
`
`
`(SN0126)
`
`A20070918-003 follow-up to
`
`
`A20070918-001
`
`
`Sawai Ex 1002
`Page 172 of 266
`
`

`
`U.S. Patent No. 5,856,336
`
`
`
`
`Application for Extension of Patent Term
`
`
`
`
`
`
`
`DATE
`
`
`TYPE
`
`
`5/27/08
`
`
`IND S