`
`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`APOTEX CORP.,
`Petitioner
`
`v.
`
`ALCON RESEARCH, LTD.,
`Patent Owner.
`
`
`Case IPR2013-00428
`U.S. Patent No. 8,268,299 B2
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`
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`DECLARATION OF STEPHEN SHANNON, MBA, Ph.D.
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`1
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`ALCON 2058
`Apotex Corp. v. Alcon Research, Ltd.
`Case IPR2013-00428
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`I.
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`I, Stephen Shannon, MBA, Ph.D., hereby declare as follows:
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`INTRODUCTION
`1.
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`I am over the age of eighteen and otherwise competent to make this
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`declaration.
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`2.
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`I have been asked by counsel to provide a declaration attesting to how
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`certain data in the specification of U.S. Patent No. 8,268,299 (the “’299 patent”)
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`related to preservative efficacy testing (“PET”), sometimes called antimicrobial
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`effectiveness testing (“AET”), were generated.
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`II. BACKGROUND AND QUALIFICATIONS
`3.
`I am currently on the Alcon R&D Microbiology Leadership Team,
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`and, as such, I am responsible for the management and oversight of preservative
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`efficacy testing conducted at Alcon.
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`4.
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`Prior to assuming my current position in 2012, I was part of the R&D
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`Microbiology Management Team, which included managing the PET working
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`group at Alcon. I held that position for more than six years.
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`5.
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`I have been involved with PET at Alcon since I began my
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`employment with the company in 1995.
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`6.
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`I received a Ph.D. in Quantitative Biology (Microbiology) from The
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`University of Texas in 2006. I also received an MBA (Information Systems) from
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`2
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`
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`The University of Texas in 2001, and a Bachelors of Science degree (Marine
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`Biology) from Texas A&M University in 1991.
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`III. DATA IN THE ’299 PATENT SPECIFICATION
`7.
`As a Manager in the R&D Microbiology Department, I was involved
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`in the preservative efficacy testing the R&D Microbiology Department conducted
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`of certain formulations described in the specification of the ’299 patent, including
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`the Examples discussed herein. As such, I have first-hand knowledge of the testing
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`described below.
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`8.
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`Preservative efficacy refers to the ability of a formulation to maintain
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`acceptable levels of antimicrobial activity. The requirements for preservative
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`efficacy are spelled out in the United States Pharmacopeia (“USP”), or in one of its
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`various foreign counterparts, such as the European Pharmacopeia (“Ph. Eur.”).
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`9.
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`At Alcon, the R&D Microbiology Department performs PET on
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`formulations prepared by another group; the R&D Microbiology Department does
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`not prepare the formulations to be tested. Rather, a separate group prepares the
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`formulations and provides them to the R&D Microbiology Department for testing.
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`10.
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`I am familiar with the way in which Alcon keeps its records related to
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`PET. In its usual and ordinary course of business, Alcon issues numbered
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`laboratory notebooks to scientists, who use the notebooks to record their work
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`relating to the testing of formulations, including PET. Notebooks may relate to
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`3
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`
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`more than one project. Each notebook page should generally identify the particular
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`notebook number and the page number, the title of the experiment and the project
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`number.
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`11. Alcon also maintains an electronic database of PET results. This
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`database is called the Laboratory Information Management System, referred to as
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`LIMS.
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`12. Alcon maintains laboratory notebooks and LIMS reports in the usual
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`and ordinary course of its business, and did so during the time of the PET
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`discussed herein of certain Example formulations described in the ’299 patent.
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`13. Examples D – F, L – N, and U – W as set forth in the specification of
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`the ’299 patent describe formulations which were provided to the Microbiology
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`Department for PET. The ’299 patent identifies the particular formulation by
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`listing the formulation identification number (“FID”) and lot number for each
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`formulation. I am familiar with the PET of the particular formulations described in
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`Examples D – F, L – N, and U – W of the ’299 patent, which was conducted by the
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`scientists in the Microbiology Department.
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`14. Each formulation described in Examples D – F, L – N, and U – W of
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`the ’299 patent was tested according to standard practices used within the field of
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`microbiology. The formulations in Examples D – F and L – N were subject to an
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`organism challenge test, according to the methods described in the USP 24 for
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`4
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`
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`category 1A products (which includes ophthalmic products). In an organism
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`challenge test, a sample of a particular formulation is inoculated with known levels
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`of different types of bacteria and fungi. The samples are then evaluated at intervals
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`of 7, 14 and 28 days to determine if the preservative system in the formulation was
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`capable of killing, or inhibiting the propagation of, the organisms introduced into
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`the formulation.
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`15. The amount of antimicrobial activity at the particular time intervals is
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`used to assess whether the formulation satisfies USP 24 requirements. In general,
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`for bacteria, formulations must have sufficient anti-bacterial activity to reduce an
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`initial inoculum of approximately 105 to 106 bacteria by one log (i.e., a 90%
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`reduction in the population) over a period of seven days and by three logs (i.e., a
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`99.9% reduction in the population) over a period of fourteen days, and must also
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`show no increase in the microorganism population following the conclusion of the
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`14-day period. For fungi, the formulations must maintain stasis (i.e., no growth)
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`relative to the population of the initial inoculum over the entire 28-day test period.
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`These USP 24 standards are substantially the same as the requirements in the
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`subsequent versions of the USP up through and including USP 27.
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`16. The formulations described in Examples U – W were tested using a
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`modified PET screen test. The test method itself is similar to that described in the
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`preceding paragraphs, but different time intervals are applied during the testing.
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`5
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`Instead of the samples being evaluated at 7, 14 and 28 days, bacterial levels are
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`assessed at 6 hours, 24 hours, and 7 days, and fungi levels are assessed at 7 days.
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`The modified test has been shown to be reliable for predicting whether a
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`composition will meet either the USP or Ph. Eur. B. standards.
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`17. To satisfy the Ph. Eur. B standard, the formulation must show a
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`reduction as to the bacteria of 1 log at 24 hours, and 3 logs at 7 days, with no
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`increase thereafter, and, for the fungi, a reduction of 1 log by day 14, and no
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`increase thereafter.
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`18. The procedures and results for each test are described in detail in the
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`respective laboratory notebook entries. True and correct copies of the relevant
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`laboratory notebook entries are attached as exhibits to this declaration as follows:
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`SAMPLE ID
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`EXHIBIT
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`EXAMPLE
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`FID
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`D
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`E
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`F
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`L
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`M
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`N
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`U
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`106737
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`106757
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`106039
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`107047
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`109032
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`109033
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`112148
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`LOT
`NO.
`04-
`36171
`04-
`36176
`04-
`36405
`04-
`37157
`05-
`40452
`05-
`40453
`07-
`46931
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`LAB NB NO.
`& PAGE
`10750:19
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`200191978
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`10545:41
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`200191982
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`10750:21
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`200193447
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`10545:51
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`200197918
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`10750:81
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`200213082
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`10750:81
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`200213084
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`12586:63
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`200249214
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`6
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`2069
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`2070
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`2071
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`2061
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`2062
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`2062
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`2072
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`V
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`W
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`112286
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`112287
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`07-
`47249
`07-
`47250
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`12034:91
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`200250480
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`12034:91
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`200250481
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`2073
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`2073
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`19. For clarity, there is a typographical error in the formulation lot
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`number listed in the ’299 patent for example W. The specification incorrectly lists
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`the lot number as 07-47632. The correct lot number is 07-47250, as is reflected in
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`the laboratory notebook.
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`20. Once testing on each formulation was completed, the final results
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`were recorded in the laboratory notebooks and entered into LIMS. A form
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`reflecting the data recorded in LIMS was then provided to Alcon’s formulation
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`development group, or the data were made available to them in LIMS.
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`21. Based on my involvement and the involvement of the R&D
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`Microbiology Department in the preservative efficacy testing of Examples D – F,
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`L – N, and U – W, I have personal knowledge that, aside from the one
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`typographical error mentioned in paragraph 19, the PET data set forth in the ’299
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`patent are true and correct for Examples D – F, L – N, and U – W.
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`22.
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`I hereby declare under penalty of perjury under the laws of the United
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`States of America that the foregoing is true and correct, and that all statements
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`made of my own knowledge are true and that all statements made on information
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`and belief are believed to be true.
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`7
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`Respectfully submitted,
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`Dated
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`57-“ 9-7” QED/LIL
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`\Qg‘k %I Qua.-.
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`Stephen Shannon, MBA, PhD.
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`8
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