`Case 1:20-cv-00393-LO-TCB Document 874-6 Filed 01/21/22 Page 1 of 3 PagelD# 23304
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`EXHIBIT 6
`EXHIBIT6
`(PUBLIC)
`(PUBLIC)
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`
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`Case 1:20-cv-00393-LO-TCB Document 874-6 Filed 01/21/22 Page 2 of 3 PageID# 23305
`Case 1:20-cv-00393-LO-TCB Document 874-6 Filed 01/21/22 Page 2 of 3 PagelD# 23305
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`ALEXANDRIA DIVISION
`
`RAL STRATEGIC HOLDINGS, INC. and
`R.J. REYNOLDS VAPOR COMPANY,
`
`Plaintiffs and Counterclaim
`Defendants,
`
`Civil Action No. 1:20-cv-393
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`v.
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`ALTRIA CLIENT SERVICES LLC; PHILIP
`MORRIS USA INC.; and PHILIP MORRIS
`PRODUCTSS.A.,
`
`Defendants and Counterclaim
`Plaintiffs.
`
`
`AMENDED AND SUPPLEMENTED OPENING EXPERT REPORT
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`OF STACY EHRLICH
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`
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`426/91
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`Stacy Ehrlich
`
`April 26, 2021
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`
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`Case 1:20-cv-00393-LO-TCB Document 874-6 Filed 01/21/22 Page 3 of 3 PageID# 23306
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
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`limits, battery end of discharge voltage, battery maximum charging current, battery
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`maximum discharging current, battery upper limits charging voltage, PDU voltage
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`operating range, and PDU current operating range.145
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`91.
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`FDA’s review of the IQOS PMTA confirms that the Agency examines closely
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`information related to battery performance and safety “to ensure product consistency and reduce
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`concerns of malfunction.”146
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`92.
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`In public presentations, FDA has likewise emphasized that its PMTA review
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`includes analysis of “[b]attery use and foreseeable misuse leading to overhearing [stet], fire, and
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`explosion during operation, charging, storage, and transportation.”147
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`93.
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`While I offer no opinion on whether that
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`94.
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`I understand that the technology described in the ‘545 Patent prevents the battery
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`from providing inconsistent power and thus ensures that the user inhales a consistent aerosol from
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`puff-to-puff and through the life of the cartridge. Consistent puffs and uniform delivery,
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`particularly of nicotine, contribute to user satisfaction, which can facilitate switching to potentially
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`145 Prepublication PMTA Rule at 176; FDA Marks Historic Public Health Milestone with
`Finalization of Two Key Rules for Companies Seeking to Market New Tobacco Products, FDA
`(Jan. 19, 2021), https://www.fda.gov/news-events/press-announcements/fda-marks-historic-
`public-health-milestone-finalization-two-key-rules-companies-seeking-market-new.
`146 See, e.g., 1199_RESP00011697-1199_RESP00011818 at 1199_RESP00011721, 1723, 1725,
`1757, 1759, 1787.
`147 See Premarket Tobacco Product Application Content Overview, FDA at 11 (Oct. 28, 2019),
`https://www.fda.gov/media/133445/download.
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`40
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