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`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
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`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners
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`V.
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`ALMIRALL, LLC,
`Patent Owner
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`Case IPR2019-00207
`Patent 9,517,219
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`SUPPLEMENTAL DECLARATON OF DAVID W. OSBORNE, PH.D.
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`1 of 4
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`Almirall EXHIBIT 2065
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`Amneal v. Almirall
`IPR2019-00207
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`IPR2019-00207
`Supplemental Declaration of David W. Osborne, Ph.D.
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`I, David W. Osborne, do hereby declare as follows:
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`1.
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`I am over the age of 18 and otherwise competent to make this
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`declaration. I have been retained as an expert on behalf of patent owner Almirall,
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`LLC ("Almirall"). I understand this declaration is being submitted to supplement
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`my first declaration, which was submitted in connection with Almirall's Patent
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`Owner Response to the Petition for Inter Partes Review ("IPR") of claims 1-8 of
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`U.S. Patent No. 9,517,219 ("the '219 patent") (Ex. 1001).
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`2.
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`I am being compensated for my time in connection with this IPR at
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`my standard legal consultant rate of $500/hr. My compensation is not contingent
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`on the outcome of this case.
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`Exhibit 2049 (Poulsen)
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`3.
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`Exhibit 2049, Boyd Poulsen, Development Process in Topical Dosage
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`Forms, AAPSIFDA Joint Workshop on Topical Product Development: Principles
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`and Criteria! for the Development and Optimization of Topical Therapeutic
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`Products, Arlington, VA (Mar. 26, 1990) ("Poulsen"), is a copy of the program for
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`an AAPS/FDA Joint Workshop on Topical Product Development titled Principles
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`and Criteria for the Development and Optimization of Topical Therapeutic
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`Products, which took place March 26-28, 1990, at the Hyatt Regency Crystal City
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`in Arlington, Virginia, and the printed presentation of Boyd J. Poulsen, Ph.D.,
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`2
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`IPR2019-00207
`Supplemental Declaration of David W. Osborne, Ph.D.
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`titled "Development Process in Topical Dosage Forms," presented at 10:50 a.m. on
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`Monday, March 26, 1990, as part of that Joint Workshop.
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`4.
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`The program was printed and distributed in advance of the Joint
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`Workshop. The Joint Workshop was put on jointly by the AAPS, which is the
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`American Association of Pharmaceutical Scientists, a professional scientific
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`organization with thousands of members, and the FDA. The Joint Workshop was
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`open to the public, provided they paid a fee for attendance.
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`5.
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`Dr. Poulsen's presentation was printed and distributed to all attendees
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`of the Joint Workshop.
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`6.
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`I personally attended the Joint Workshop and Dr. Poulsen's
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`presentation. I estimate there were 300-500 people in attendance.
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`7.
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`In advance of the Joint Workshop, I, like other attendees, received in
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`the mail a printed copy of the program for the Joint Workshop, setting forth the
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`schedule of the workshop, topics of presentations to be given at the workshop, and
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`various other items relating to the workshop.
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`8.
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`I confirm that Pages 1-4 of Exhibit 2049 are true and accurate copies
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`of the printed program in advance of the Joint Workshop.
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`9.
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`At Dr. Poulsen's presentation at the Joint Workshop, I, like other
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`attendees, received a printed copy of Dr. Poulsen's presentation.
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`IPR2019-00207
`Supplemental Declaration of David W. Osborne, Ph.D.
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`10.
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`I confirm that Pages 5- 50 of Exhibit 2049 are true and accurate copies
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`of the printed presentation of Dr. Poulsen distributed at the Joint Workshop, with
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`my handwritten notes taken during the presentation. My handwritten notes appear
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`on Pages 5 (my name), 8, 11, 16, 21- 24, 46 and 49.
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`I hereby declare that all statements made herein of my own knowledge are
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`true and that all statements made on information and belief are believed to be true;
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`and further that these statements are made with the knowledge that willful false
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`statements and the like are punishable by fine, imprisonment, or both, under
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`Section 1001 of Title 18 of the United States Code.
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`this .3Q_th day of August, 2019.
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`~
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`-----.:1;;.10,l
`David W. Osborne, Ph.D.
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