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`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 1 of 51 PagelD# 32428
`
`EXHIBIT 2
`EXHIBIT 2
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 2 of 51 PageID# 32429
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`ALEXANDRIA DIVISION
`
`RAI STRATEGIC HOLDINGS, INC. and
`R.J. REYNOLDS VAPOR COMPANY,
`
`Plaintiffs and Counterclaim Defendants,
`
`ALTRIA CLIENT SERVICES LLC; PHILIP
`MORRIS USA INC.; and PHILIP MORRIS
`PRODUCTSS.A..,
`
`Defendants and Counterclaim Plaintiffs.
`
`
`
`Case No. 1:20-cv-00393-LO-TCB
`
`DECLARATION OF CHARLESA. LEYES
`
`I, Charles A. Leyes, declare:
`
`bs
`
`I am overeighteen years of age and am competent totestify to the matters
`
`stated in this declaration. The statements made herein are based on mypersonal knowledge,
`
`except where stated, in which case the statements are based on information and belief.
`
`Z.
`
`I am an employee of RAI Services Company, a subsidiary of Reynolds
`
`American Inc. and an affiliate of Defendant R.J. Reynolds Vapor Company(“Reynolds”).
`
`I serve as Managing Counsel and have responsibility for certain patentlitigation matters
`
`within the Reynolds family of companies, including the above-captioned litigation.
`
`a
`
`I
`
`am aware of the implications of disclosing the confidential and
`
`competitively sensitive information produced in this matter.
`
`I am also familiar with
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 3 of 51 PageID# 32430
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`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 3 of 51 PagelD# 32430
`
`Reynolds’s business and the sensitive nature of Reynolds’s confidential business
`
`information.
`
`4.
`
`I makethis declaration in support of Reynolds’s Motion to Seal Confidential
`
`Trial Exhibits and Trial Transcripts (“Motion”) in the above-captioned case.
`
`a;
`
`The confidential exhibits and expectedtrial testimony that Reynolds seeks to
`
`seal fall into the following categories: (a) confidential and proprietary information made
`
`available to FDA as part of the regulatory process, and Reynolds’s internal documents
`
`related to its confidential regulatory strategies: (b) CAD files and source code for the Vuse
`
`products; (c) agreements and related documents between Reynolds and non-parties Fontem
`
`and Nicoventures (and their affiliated entities); (d) technical documents from non-party
`
`suppliers: (e) financial forecasts, cost analyses, future business plans, including research
`
`and development, and historical financial data on the individual Vuse products; and (f)
`
`testimonyrelated to these categories.
`
`6.
`
`I am informed andbelieve that the Pre-Market Tobacco Product Applications
`
`(“PMTAs”) were submitted confidentially to FDA and that the agency maintains the
`
`confidentiality of the PMTAs to the extent the information contained in the PMTAsis
`
`exempt from public disclosure under federal
`
`law. The PMTAs contain confidential
`
`technical details and specifications for the four Vuse products.
`
`In addition to the product-
`
`related details,
`
`the structure and content of Reynolds’s PMTA submissions are also
`
`confidential and competitively sensitive, because they provide insight into Reynolds’s
`
`decisions and strategy regarding scientific content, tests, and data and the organization of
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 4 of 51 PageID# 32431
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`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 4 of 51 PagelD# 32431
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`this information as provided in the PMTAs. Disclosure of the information contained in the
`
`PMTAswould cause substantial and irreparable harm to Reynolds’s competitive position
`
`by giving Reynolds’s competitors insight
`
`into Reynolds’s product designs, product
`
`formulations, regulatory strategy, marketing decisions, and business practices. Reynolds’s
`
`decisions regarding regulatory submissionsare held in strict confidence as disclosure could
`
`allow competitors to outmaneuver Reynolds in the regulatory process.
`
`7.
`
`Attached hereto as Exhibit A is a true and correct copy of Marketing Granted
`
`Orders from FDA dated October 12, 2021, covering the Vuse Solo power unit and Vuse
`
`replacement cartridge Original 4.8%. Reynolds was the first manufacturer to receive
`
`Marketing Granted Orders from FDA foran electronic nicotine delivery system (“ENDS”)
`
`product. FDA has since granted marketing authorization for tobacco-flavored Vuse Vibe
`
`and Vuse Ciro. Exhibit B is a true and correct copy of Marketing Granted Orders from
`
`FDA dated May12, 2022, covering the Vuse Vibe power unit and Vibe replacement tank
`
`Original 3.0% and Vuse Ciro power unit and Ciro replacement cartridge Original 1.5%,
`
`respectively.
`
`In issuing the Marketing Granted Orders to Reynolds, FDA determined,
`
`based on its review of Reynolds’s PMTAs, that permitting the marketing of these Vuse
`
`Solo, Vibe, and Ciro products is appropriate for the protection of the public health.
`
`Disclosure of Reynolds’s intellectual property, technical product details, and technical
`
`know-howdescribed in Reynolds’s PMTAs would give Reynolds’s competitors an unfair
`
`advantage by giving them insight
`
`into Reynolds’s confidential
`
`technical capabilities,
`
`product development, andtradesecrets, such as the e-liquid composition, without making
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 5 of 51 PageID# 32432
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`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 5 of 51 PagelD# 32432
`
`the same investment in the developmentof their own products.
`
`8.
`
`I am informed and believe that other documents pertaining to Reynolds’s
`
`regulatory strategy, but not necessarily related to the Vuse PMTAs, remain confidential
`
`(RX-0784, RX-0785, RX-0966, RX-0835, RX-1163, RX-1725, PX-312 (slides 59-61),
`
`PX-314 (slides 40-45), PX-316, PX-317, PX-325, PX-515).
`
` Reynolds’s regulatory
`
`strategy is held in strict confidence as disclosure could allow competitors to outmaneuver
`
`Reynolds in the regulatory process.
`
`9.
`
`I aminformed and believe that the CAD files and source code for the Vuse
`
`products remain confidential and provide a level of technical detail regarding the Vuse
`
`products that are not attainable through a physical tear down of the products. For example.
`
`I am informed and believe that the CAD files reveal internal dimensions ofthe product.
`
`manufacturing tolerances, manufacturing notes, material compositions. version revision
`
`history, and design notes, among other highly confidential technical information, and that
`
`the source code provides the control algorithms for the Vuse products. Disclosure of the
`
`CAD files or source code of the Vuse products would give Reynolds’s competitors an
`
`unfair advantage by giving them insight into Reynolds’s confidential technical capabilities,
`
`product development, and trade secrets, without making the same investment
`
`in the
`
`developmentof their own products.
`
`10.
`
`Lam informed and believe that the agreement between Reynolds and Fontem
`
`(andtheir affiliated entities) concern the acquisition ofcertain intellectual property rights
`
`and that the parties agreed to treat the terms of the agreements as confidential.
`
`I am
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 6 of 51 PageID# 32433
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`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 6 of 51 PagelD# 32433
`
`informedand believe that the exhibits related to the Fontem agreementeither recite terms
`
`from the agreement or discuss negotiation strategies regarding the agreement.
`
`I am
`
`informed and believe that the terms of Nicoventures Holdings Limited’s termination of the
`
`BAT-Reynolds Vapour Collaboration Agreement remain confidential.
`
`I am informed and
`
`believe that
`
`the BAT-Reynolds Vapour Collaboration Agreement concerned a cross-
`
`license ofcertain intellectual property rights. Disclosure of the terms of the agreement
`
`between Reynolds and Fontem(and their affiliated entities) and the related documents. or
`
`the BAT-Reynolds Vapour Collaboration Agreement termination, would disadvantage
`
`Reynoldsin future contract negotiations if its business and patent-licensing strategies were
`
`made available to the public.
`
`11.
`
`1 am informed and believe that
`
`the technical documents created by
`
`Reynolds’s
`
`suppliers who are not parties
`
`to the above-captioned matter
`
`remain
`
`confidential.
`
`I am informed and believe that the documents disclose detailed technical
`
`schematics, product cost analyses, and invoices. Disclosure of such information would put
`
`Reynolds at a competitive disadvantage. both with its current suppliers by jeopardizing the
`
`current relationship and with anyfuture potential suppliers while giving competitors non-
`
`public information regarding the technical details and cost details of the Vuse products.
`
`I
`
`am informed andbelievethat at least some ofthe third-party supplier documents are subject
`
`to contractual confidentiality obligations.
`
`12.
`
`I am informed and believe that
`
`the trial
`
`testimony of expert witnesses
`
`regarding the damages issues in the above-captioned matter is expected to disclose
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 7 of 51 PageID# 32434
`
`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 7 of 51 PagelD# 32434
`
`confidential information consisting offinancial projections, market forecasts, various costs
`
`analyses for Reynolds’s vapor products, financial data regarding the individual Vuse
`
`productlines, and Reynolds’s internal business decisions regarding future plans for product
`
`distribution and marketing. This information is not publicly known. Disclosure of such
`
`information would put Reynolds at a competitive and financial disadvantage by allowing
`
`competitors, suppliers, and other third parties access to financial data that could be used to
`
`undercut Reynolds in competitive purchasing and sales situations, as well as in preparing
`
`competitive sales, consumer research, marketing, product design, licensing strategies, and
`
`product distribution strategies. Disclosure of specific cost
`
`information and bills of
`
`materials will allow competitors and business partners to gain leverage against Reynolds
`
`in business and supply agreement negotiations. As just one example, Reynolds’s suppliers
`
`could use cost information to negotiate higher price terms. Information about Reynolds’s
`
`future business plans, including plans for its electronic nicotine delivery system products,
`
`could jeopardize relationships with wholesale and retail distributors and give competitors
`
`insight into Reynolds’s marketingstrategies.
`
`I declare under penalty of perjury that the foregoingis true and correct.
`
`Executed this 27th day of May, 2022.
`
`Charles A. Leyes
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 8 of 51 PageID# 32435
`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 8 of 51 PagelD# 32435
`
`EXHIBIT A
`EXHIBIT A
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 9 of 51 PageID# 32436
`
` U.S. Food & Drug Administration
`
`
`10903 New Hampshire Avenue
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`
`
`
`MARKETING GRANTED ORDERS
`
`
`
`
`October 12, 2021
`
`
`
`
`
`
`
`
`
`R.J. Reynolds Vapor Company
`
`Attention: Aaron P. Williams, Ph.D.
`
`Senior Vice President, Scientific & Regulatory Affairs
`RAI Services Company
`
`401 North Main Street
`
`Winston-Salem, NC 27101
`
`FDA Submission Tracking Numbers (STNs): PM0000551, PM0000553, PM0000560
`
`Dear Dr. Williams:
`
`
`We completed review of your above-referenced PMTAs1 and are issuing marketing granted orders for
`
`
`the tobacco products identified in Appendix A.
`
`Based on our review of your PMTAs, we determined that permitting the marketing of the new
`tobacco products, as described in your applications and specified in Appendix A, is appropriate for
`
`
`the protection of the public health. It should be noted that our determination that the marketing of
`these products is APPH is based on the submitted microbial stability data2. The issuance of these
`
`marketing granted orders confirms that you have met the requirements of section 910(c) of the
`FD&C Act and authorizes marketing of your new tobacco products. Under the provisions of section
`
`910, you may introduce or deliver for introduction into interstate commerce the tobacco products,
`in accordance with the marketing order requirements outlined in these orders, including all
`
`appendices.
`
`
`The authority to market the new tobacco products under these orders is also contingent upon
`
`the conditions listed in these orders and subject to the requirements in the enclosed appendices.
`
`
`
`The requirements in these orders are intended to help ensure that the marketing of your products will
`continue to be appropriate for the protection of the public health, taking into account, among other
`factors, initiation among non-users, particularly youth. However, compliance with these requirements
`alone is not a guarantee that the marketing of the products will remain appropriate for the protection
`
`
`1 Premarket Tobacco Product Applications (PMTAs) submitted under section 910 of the Federal Food, Drug, and Cosmetic Act
`
` (FD&C Act)
`, but did not provide data that would allow
`2 In your PMTAs, you stated that the shelf life of the subject products is
`
`. The data provided support microbial stability of
`FDA to evaluate whether the products are microbially stable over
`the products over
`. The stability data for
` is acceptable and there are no other stability concerns, so the
`lack of stability data fo
` does not preclude an APPH finding for the subject products. If you would like FDA to
`evaluate additional microbial stability data for a longer period, submit this information in a post-market report.
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 10 of 51 PageID# 32437
`
`
`
` PM0000551, PM0000553, PM0000560
`
`
`
`
`Page 2 of 20
`
`of the public health, particularly if, despite these measures, there is a significant uptake in youth
`initiation, for example. FDA will continue to monitor the marketing of your products.
`
`
`Based on our review of your PMTAs, the marketing restrictions in Appendix D are necessary to our
`conclusion that permitting the marketing of the new tobacco products is appropriate for the protection
`of the public health. Absent these restrictions, a marketing granted order for these applications could
`not issue consistent with the requirements of section 910(c) of the FD&C Act. Relatedly, we support
`certain aspects of your marketing plan, as described in your PMTAs, that are intended to help address
`the potential for youth use of your products. Specifically, you stated you intend to use the following
`measures to help reduce youth appeal of your marketing materials: “No testimonials by sports figures
`or celebrities or any person with special appeal to persons under 21 years of age; No person appearing
`in any advertising materials shall be under age 25 or be styled to look under age 25; Content shall not
`include characters, images, or themes designed to target youth; Content shall not be related to youth
`or youth-oriented activities; Content shall not suggest that use of R.J. Reynolds Vapor Company's
`("RJRV") products is essential to social prominence, distinction, success or sexual attraction, nor shall
`any content picture a person using any RJRV products in an exaggerated manner; and Content shall not
`depict persons participating in, or obviously just having participated in, a physical activity requiring
`stamina or athletic conditioning beyond that of normal recreation.” We encourage you to implement
`these measures because they are likely to help further mitigate risks to youth. We also recommend
`that you take additional steps to limit youth exposure to your print and point-of-sale advertising,
`
`including, for example, limiting advertising to print publications where 85% or more of the readership
`
`is 21 years of age or older and/or selecting publications that do not over-index for youth.
`
`Additionally, these orders are conditioned upon the products conforming with any applicable current
`or future tobacco product standards, unless specifically exempted under these orders or the product
`standard(s).
`
`
`Our finding that permitting the marketing of the new tobacco products is APPH does not mean FDA
`
`has “approved” the new tobacco products specified in Appendix A; therefore, you may not make any
`express or implied statement or representation in a label, labeling, or through the media or
`advertising, that the new tobacco products specified in Appendix A are approved by FDA (see Section
`
`
`301(tt) of the FD&C Act).
`
`
`The products subject to these marketing granted orders are subject to withdrawal or temporary
`
`suspension as described in section 910(d) of the FD&C Act.
`
`You may be eligible to submit a supplemental PMTA for modification(s)3 made to tobacco products
`that received marketing granted orders, by cross-referencing content in the PMTA and postmarket
`reports for the original tobacco products subject to this letter. Applicants that have questions about
`whether it would be appropriate to submit a supplemental PMTA for modification(s) they are seeking
`to implement should contact their Regulatory Health Project Manager (RHPM) within the Office of
`Science for more information.
`
`
`We remind you that all regulated tobacco products, including the tobacco products specified in
`Appendix A, are subject to the requirements of the FD&C Act and its implementing regulations.
`
`3 We note that any modifications made to a tobacco product would render it a new tobacco product that would be subject to
`the premarket review requirements under section 910 of the FD&C Act.
`
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 11 of 51 PageID# 32438
`
`
`
` PM0000551, PM0000553, PM0000560
`
`
`
`
`Page 3 of 20
`
`These requirements include, but are not limited to, annual registration, listing of products, listing
`of ingredients, reporting of harmful and potentially harmful constituents, and packaging,
`
`
`labeling, and advertising requirements. It is your responsibility to ensure the tobacco products
`specified in Appendix A comply with all applicable statutory and regulatory requirements. FDA
`
`will monitor your compliance with all applicable statutes and regulations.
`
`
`In accordance with 40 CFR 1506.6, we will make your Environmental Assessment (EA) publicly
`available.
`
`If you discontinue the manufacture, preparation, compounding or processing for commercial
`
`distribution of these tobacco products and later decide to reintroduce the products into the market,
`
`please contact the Office of Science prior to reintroduction.
`
`We encourage you to submit all regulatory correspondence electronically via the CTP Portal4,5 using
`eSubmitter.6 Alternatively, submissions may be mailed to:
`
`
`Food and Drug Administration
`
`Center for Tobacco Products
`
`Document Control Center (DCC)
`
`Building 71, Room G335
`
`10903 New Hampshire Avenue
`
`Silver Spring, MD 20993-0002
`
`
`
`The CTP Portal and FDA’s Electronic Submission Gateway (ESG) are generally available 24 hours a day,
`seven days a week; if the upload is successful, submissions are considered received by DCC on the day of
`upload. Submissions delivered to DCC by courier or physical mail will be considered timely if received
`during delivery hours on or before the due date7; if the due date falls on a weekend or holiday, the
`delivery must be received on or before the preceding business day. We are unable to accept regulatory
`
`submissions by e-mail.
`
`
`
` 4 https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal
`
`
`5 FDA’s Electronic Submission Gateway (ESG) is still available as an alternative to the CTP Portal.
`
`
`
`6 https://www.fda.gov/industry/fda-esubmitter
`
`
`7 https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/contact-ctp
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 12 of 51 PageID# 32439
`
`
`
` PM0000551, PM0000553, PM0000560
`
`
`
`
`Page 4 of 20
`
`If you have any questions, please contact Barbara Banchero, Regulatory Health Project Manager, at
`(301) 796-1937 or Barbara.Banchero@fda.hhs.gov.
`
`
`If you have any questions regarding postmarket activities for the tobacco products subject of these
`
`orders, please contact Lillian Ortega, Director, Division of Enforcement and Manufacturing, at CTP-OCE-
`
`Postmarket@fda.hhs.gov.
`
`
`
`Sincerely,
`
`
`Digitally signed by Matthew R. Holman -S
`
`Date: 2021.10.12 10:54:57 -04'00'
`
`Matthew R. Holman, Ph.D.
`
`Director
`
`Office of Science
`
`Center for Tobacco Products
`
`
`
`
`Enclosures:
`
`Appendix A – New Tobacco Products Subject of This Letter
`
`Appendix B – Postmarket Recordkeeping and Retention
`Appendix C – Postmarket Reporting
`
`
`Appendix D – Marketing Restrictions
`
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 13 of 51 PageID# 32440
`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 13 of 51 PagelD# 32440
`
`PM0000551, PM0000553, PMO0000560
`
`
`
`
`
`Page 5 of 20
`
`
`
`
`
`
`
`
`
`Appendix A®
`
`
`
`
`
`
`New Tobacco Products Subject of This Letter
`CommonAttributes of PMTA
`
`
`
`
`Submission date
`
`
`
`
`
`October 10, 2019
`
`
`
`
`
`October 17, 2019
`Receipt date
`
`
`
`
`
`R.J. Reynolds Vapor Company
`Applicant
`
`
`
`
`
`
`
`Product manufacturer|R.J. Reynolds Vapor Company
`
`
`
`
`
`
`
`Product category
`ENDS(Electronic Nicotine Delivery System)
`
`Attributes?
`New Tobacco Product
`
`
`
`PM0000551
`STN
`
`
`Product name
`Vuse Solo Power Unit
`
`
`
`
`
`
`
`
`
`
`Product sub-category
`ENDS Component
`
`
`
`
`Package type
`Paperboard Carton
`1 Power Unit
`
`
`
`
`
`Package quantity
`
`None
`Characterizing flavor’°
`
`
`
`Additional properties
`
`
`
`
`
`
`
`
`
`
`
`Length: 87 mm
`Diameter: 9.6 mm
`
`
`
`
`
`
`
`
`Battery capacity: 2 270 milliAmpere hours (mAh)
`
`Wattage: 3.00 W2!
`
`
`
`
`
`
`Universal Serial Bus (USB) charger
`PM0000553
`
`Vuse ReplacementCartridge Original 4.8% G1!”
`
`
`
`
`
`
`
`
`Closed E-cigarette
`
`
`
`Paperboard Carton/Blister Pack
`
`
`2 Cartridges
`
`Original
`
`
`
`STN
`
`Product name
`
`
`
`
`Product sub- category
`
`
`Package type
`
`
`Package quantity
`
`Characterizing flavor
`Nicotine
`
`
`
`57.4 mg/mL
`concentration
`
`
`E-liquid volume
`PG/VG ratio
`
`
`
`Additional properties
`
`
`
`
`
`
`
`
`
` 0.5 mL/cartridge
`G1 Tube Material: Stainless Steel
`
`
`
`
`21/79
`
`
`
`
`Length: 37.6 mm
`Diameter: 9.6 mm
`
`
`
`
`
`
`
`
`
`
`
`
`
`® Brand/sub-brand or other commercial name used in commercial distribution.
`
`
`
`
`
`
`
`
`
`® We interpret package type to mean container closure system and package quantity to mean product quantity within the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`container closure system, unless otherwise identified.
`
`
`
`
`
`
`
`1 Provided as part of product labeling
`
`
`
`
`
`
`
`
`
`1 The initial target wattage for a puff is(b), (4) % W for®!™ milliseconds, which then dropsto a target of (b)(4) % W for
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the remainder of the puff duration
`
`
`
`
`
`
`2 The Vuse Solo “Original” e-liquid is a tobacco flavored e-liquid.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 14 of 51 PageID# 32441
`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 14 of 51 PagelD# 32441
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`PM0000551, PM0000553, PM0000560
`
`
`
`
`
`Page 6 of20
`
`
`
`
`
`
`
`PM0000560
`STN
`
`
`
`Vuse ReplacementCartridge Original 4.8% G2”
`Product name
`
`
`
`
`
`
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`Product sub-category|Closed E- cigarette
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`Package type
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`Package quantity
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`Characterizing flavor
`Nicotine
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`concentration
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`E-liquid volume
`PG/VGratio
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`Additional properties
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`57.4 mg/mL
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`0.5 mL/cartridge
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`21/79
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`Length: 37.6 mm
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`Diameter:9.6mm
`G2 Tube Material: (b) (4)
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`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 15 of 51 PageID# 32442
`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 15 of 51 PagelD# 32442
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`PM0000551, PM0000553, PMO0000560
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`Appendix B
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`Postmarket Recordkeeping and Retention
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`Under section 910(f) of the FD&C Act, this order requires that you establish and maintain the records
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`listed below. At any time during the retention period described in this order, FDA may request that you
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`provide any of the documents described below.
`In addition, under section 704 of the FD&C Act, FDA
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`mayinspect your establishment(s) and request to inspect any record(s) described below.
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`The following records must be retained according to the retention periods described below. These
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`records mustbelegible, in English, and available for inspection and copying by officers or employees
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`duly designated by the Secretary, upon request.
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`[Description__——=~S~*~“‘“~SCSCSCSCSCSCSC*d Raton Pe
`Record.
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`Prior PMTAs
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`Each PMTA submitted prior to marketing orders
`4 years from the date
`that FDA issues the
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`marketing order
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`4 years from the date the
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`report was submitted to
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`FDA or until FDA inspects
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`the records, whichever
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`4 years from the date of
`distribution of the last
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`batch of each product
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`subject to this order
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`4 years from the date of
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`the order or 4 years
`from the conclusion of
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`the study, whichever
`occurs later
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`Postmarket reports, including periodic and adverse
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`experience reports as describedin this order
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`Correspondence with FDA pertaining to each
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`authorized product
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`Postmarket reports
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`Correspondence with FDA
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`Study data
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`Certifications and amendments to certifications
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`Nonclinicalor clinical study documentation including:
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`Source data;
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`Study protocols (including statistical analysis
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`plan) and amendments showingthe dates
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`and reasonsfor each protocolrevision;
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`Institutional Review Board (IRB) or
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`Independent Ethics Committee (IEC)
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`approvals;
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`Informed consent forms;
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`Correspondence with study
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`monitors/investigators/contract research
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`organizations/sponsors/IRB/IEC;
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`Investigatorfinancial disclosure statements;
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`Progress reports;
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`Monitoring reports;
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`Adverse experience reports;
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`Case report forms/subject diaries/medical
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`records/laboratory reports;
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`Subject dataline listings/observations
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`records;
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`Test article accountability records;
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`Study results/protocol summaries/study
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`reports; and
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`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 16 of 51 PageID# 32443
`Case 1:20-cv-00393-LO-TCB Document 1243-2 Filed 05/27/22 Page 16 of 51 PagelD# 32443
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`PM0000551, PM0000553, PMO0000560
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`Page 8 of 20
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`[DescriptionCdRetentionPeriod
`Record
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`Manufacturing records
`Records pertaining to the manufacture, in process
`4 years from the date of
`distribution of each
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`and release testing, production process (including any
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`changesto the process,facility, or controls),
`batch of each product
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`packaging, storage, and stability monitoring and
`subject to this order
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`testing (including protocol and results)
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`implementation
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`Records and reports of all manufacturing deviations,
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`investigations, and corrective and preventive actions
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`including, but not limited to, those deviations
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`associated with processing, testing, packing, labeling,
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`storage, holding and distribution; and any deviation
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`that may affect the characteristics of each final
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`product
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`A list of distributors and retailers of the products,
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`including brick-and-mortar and digital® (including
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`internet/online and mobile}
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`Any available information (not to include personally
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`identifiable information) about product purchasers,
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`such as purchasers’ demographics(e.g., age, gender,
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`race/ethnicity, geographic region) and previous or
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`currentuse of other tobacco products(i.e., dual use}
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`With respectto individuals underthe federal
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`minimum age of sale of tobacco products, policies
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`and procedures regarding restrictions on access to
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`the products, including purchaser age and identity
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`verification processes
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`4 years from the date of
`distribution of each
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`batch of each product
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`subject to this order
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`Records pertaining to any and all complaints
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`associated with the tobacco product that is the
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`subject of this order; such records may also include
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`your analysis of those complaints
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`4 years from the date of
`distribution of each
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`batch of each product
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`subject to this order
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`Health hazard analyses, if performed voluntarily or
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`directed by FDA
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`Specimens ofall labeling (includingall labeling
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`variations, such as thosereflecting different required
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`warnings), labels, inserts/onserts, instructions, and
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`other accompanying information
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`4 years from the date of
`distribution of each
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`batch of each product
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`subject to this order
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`4 years from the date of
`initial dissemination to
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`the public
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`Copies of all advertising, marketing, and/or
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`promotional materials published, disseminated to
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`consumers, or for use in engaging or communicating
`with consumers
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`4 years from the date of
`initial dissemination to
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`the public or
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`Sales and/or distribution
`records
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`Complaints
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`Health hazard analysis
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`Labeling
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`Advertising, marketing and
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`promotional materials and
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`plans
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`13 For the purposes ofthis order, here and throughout the document, “digital” includes internet/online and mobile.
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`channel and by product, including any: Use of competent and reliable data sources,
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`Copies of all advertising and marketing plans
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`including strategic creative briefs and paid media
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`plans, by channel and by product, and the details,
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`dollar amount(s) and flighting of such plans, by
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`methodologies, and technologies to
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`establish, maintain, and monitor highly
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`targeted advertising and marketing plans
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`and media buys, includingalist of all data
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`sources used to target advertising and
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`marketing plans and media buys;
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`Targeting of specific group(s) by age-
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`range(s), including young adults, ages 21-24,
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`and other demographic or psychographic
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`characteristics that reflect your intended
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`audience(s), including the source(s) of such
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`data;
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`With respectto individuals underthe federal
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`minimum age of sale of tobacco products,
`actions taken to restrict access to the
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`products and limit exposure to the products’
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`labeling, advertising, marketing, and/or
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`promotion;
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`Use of owned, earned, shared, or paid media
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`to create labeling for, advertise, market,
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`and/or promote the products;
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`Use of broadcast, satellite, or cable TV
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`media, or broadcastor satellite radio media,
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`including copies of media buy schedules pre-
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`launch, program lists, projected percent
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`audience compositions by age breakouts
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`(i.e., 214, 2-11, 12-17, 18-24, 25-54, 55+) by
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`program, projected audienceindices by age
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`breakouts(i-e., 2-11, 12-17, 18-24, 25-54,
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`55+) by program, reach and frequency goals,
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`and any othertargeting or purchasing
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`parameters;
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`Use of partners, influencers, bloggers, or
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`bra