`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-00040
`U.S. Patent 7,326,708
`__________________
`
`DECLARATION OF LOU ANN EADER
`
`1
`
`Merck Exhibit 2105, Page 1
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`DECLARATION OF LOU ANN EADER
`
`I, Lou Ann Eader, hereby declare as follows:
`
`1.
`
`I am employed by Merck Sharp & Dohme Corp. (“Merck”) as a
`
`Director, Global Regulatory Affairs. I joined Merck in October 1997, and became
`
`the custodian of the Januvia® regulatory file at Merck in February 2012.
`
`2.
`
`In the regular course of Merck’s business, a Regulatory Liaison is
`
`assigned to be a point of contact with the FDA for his/her assigned project(s).
`
`This individual is responsible for submissions for that program’s NDA(s) during
`
`the time of their assignment to the program. I am, and have been since February
`
`2012, the current Regulatory Liaison for the Januvia® NDA.
`
`3.
`
`NDA submissions and correspondence are archived in an electronic
`
`database. That database is maintained as the official copy of the NDA at Merck.
`
`As the Regulatory Liaison for the Januvia® NDA, I have personal knowledge of
`
`the contents of the Januvia® NDA electronic database. One of my routine
`
`responsibilities as a Regulatory Liaison is to maintain and update during the
`
`regular course of Merck’s business, the official copy of the Januvia® NDA
`
`archive.
`
`4.
`
`EX2106 is a true and correct copy of the Synopsis and
`
`Comprehensive Study Summary from the Clinical Study Report for Protocol 005,
`
`dated November 15, 2005, as submitted to the FDA as part of the Januvia® NDA.
`
`2
`
`Merck Exhibit 2105, Page 2
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`DECLARATION OF LOU ANN EADER
`
`5.
`
`EX2107 is a true and correct copy of the Synopsis and
`
`Comprehensive Study Summary from the Clinical Study Report for Protocol 006,
`
`dated April 1, 2005, as submitted to the FDA as part of the Januvia® NDA.
`
`6.
`
`EX2108 is a true and correct copy of Module 3.2.P.5.4 Batch
`
`Analyses, dated November 14, 2005, as submitted to the FDA as part of the
`
`Januvia® NDA.
`
`*
`
`*
`
`*
`
`I hereby declare that all statements made herein of my own knowledge true
`
`and that all statements made on information and belief are believed to be true; and
`
`further that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both,
`
`under Section 1001 of Title 18 of the United States Code.
`
`Dated: August 19, 2020
`
`/Lou Ann Eader/
`Lou Ann Eader
`
`Lou
`Eader_9360(Signature)
`
`Digitally signed by Lou
`Eader_9360(Signature)
`Date: 2020.08.19 23:55:12 -04'00'
`
`3
`
`Merck Exhibit 2105, Page 3
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
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