`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`SLAYBACK PHARMA LLC,
`
`Petitioner,
`
`v.
`
`EYE THERAPIES, LLC,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`__________________
`
`DECLARATION OF ROBERT GORMAN JR. IN RESPONSE TO
`SLAYBACK’S OBJECTIONS TO PATENT OWNER’S EXHIBIT NOS.
`2028, 2057-2058, 2156, 2166-2168, AND 2195-2196
`
`Eye Therapies Exhibit 2215, 1 of 5
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`I, Robert Gorman, Jr., declare as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`I have been asked to submit this declaration on behalf of Eye Therapies,
`
`LLC (“Eye Therapies” or “Patent Owner”), which I understand is being submitted
`
`in response to Slayback Pharma LLC’s (“Slayback” or “Petitioner”) objections to
`
`Patent Owner’s Exhibits 2028, 2057-2058, 2156, 2166-2168, and 2195-2196.
`
`2.
`
`I have personal knowledge of the facts set forth herein, including the
`
`record keeping practices as Bausch and production of Bausch documents related to
`
`this matter.
`
`3.
`
`I am currently Senior Vice President, Assistant General Counsel,
`
`Global Intellectual Property within the Bausch + Lomb family of companies
`
`(“Bausch”). I have been in my role for the past five years.
`
`II.
`
`DISCUSSION
`
`Bausch’s Objected-To Regulatory Documents
`I understand Slayback has objected to EX-2028, EX-2166-2168, and
`
`4.
`
`EX-2195-2196, on the basis of hearsay and authenticity. A summary chart, briefly
`
`describing those exhibits, is provided below:
`
`Exhibit
`EX-2028
`
`Summary
`An excerpt of New Drug Application
`(“NDA”) No. 208144, Section 3.2.P.5.6
`
`Eye Therapies Exhibit 2215, 2 of 5
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`EX-2166
`
`EX-2167
`
`EX-2168
`
`EX-2195
`
`EX-2196
`
`Justification of Specifications – Multi-
`Dose Unit
`
`An excerpt of Investigational New Drug
`(“IND”) No. 108524, Clinical Study
`Report of Study No. 10-100-0008
`
`An excerpt of IND No. 108524, Clinical
`Study Report of Study No. 11-100-0015
`
`An excerpt of IND No. 108524, Clinical
`Study Report of Study No. 13-100-0005
`
`An excerpt of NDA No. 208144, Section
`2.2 Introduction
`
`An excerpt of NDA No. 208144, 2.3.P.1
`Description and Composition of Drug
`Product
`
`5.
`
`EX-2028, EX-2166-2168, and EX-2195-2196 are true and correct
`
`copies of excerpts of NDA No. 208144 and IND No. 108524, which are regulatory
`
`filings associated with the commercially available product known as Lumify and
`
`were submitted to FDA. Such regulatory filings are timely prepared, submitted, and
`
`kept in the ordinary course of business, by—or from information transmitted by—
`
`employees, agents, or representatives with knowledge of the acts, events, or
`
`conditions recorded.
`
`Bausch’s Objected-To Commercial Documents
`I understand Slayback has objected to EX-2057-2058 and EX-2156 on
`
`6.
`
`the basis of hearsay and authenticity. A summary chart, briefly describing those
`
`exhibits, is provided below:
`
`Eye Therapies Exhibit 2215, 3 of 5
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Exhibit
`
`EX-2057
`
`EX-2058
`
`EX-2156
`
`Summary
`
`IRI Panel Data
`
`IRI Point-of-Sale Data
`
`Lumify ECP A&U Report, March 27, 2020
`
`7.
`
`EX-2057 and EX-2058 are true and correct copies of exports of “IRI
`
`data.” The declaration of John Ferris explains in detail how and when IRI data is
`
`used in the industry and sourced by the Consumer Data Science department at
`
`Bausch. See EX-2023, ¶¶ 27-32.
`
`8.
`
`EX-2156 is a true and correct record of a survey conducted for Bausch
`
`by Ipsos Healthcare (“Ipsos”). The declaration of John Ferris explains in detail how
`
`and when this survey was conducted, and that this type of survey is routinely
`
`conducted and relied upon in the industry. See EX-2023 at ¶¶ 14-18.
`
`9.
`
`I declare that all statements made herein of my knowledge are true, that
`
`all statements made herein on information and belief are believed to be true, and 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.
`
`Eye Therapies Exhibit 2215, 4 of 5
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Executed on September 20, 2022.
`
`Robert Gorman, Jr.
`Senior Vice President,
`Assistant General Counsel,
`Global Intellectual Property
`Bausch + Lomb
`
`Eye Therapies Exhibit 2215, 5 of 5
`Slayback v. Eye Therapies - IPR2022-00142
`
`
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