18 unchanged sentences
In order to obtain marketing authorizations, manufacturers of practically all e-liquid, e-cigarette or other vaping products would have to use the PMTA pathway.
−Removed: The continued sale of any e-liquid product containing nicotine derived from tobacco for which a PMTA was filed by September 9, 2020 and continues to remain subject to pending FDA review is subject to the FDA’s enforcement discretion, as the one-year period following the September 9, 2020 application deadline has expired even though the FDA had not yet taken action to approve or deny the PMTA.
−Removed: The Company’s subsidiaries, Humble Juice and Twelfth State Brands, filed PMTAs for their respective lines of finished Deemed New Tobacco Products by the September 9, 2020 deadline.
−Removed: On September 16, 2021, Humble Juice received a Marketing Denial Order (the “MDO”) dated September 15, 2021 issued by the FDA with respect to the PMTAs filed by
−Removed: Humble Juice, denying the PMTAs with respect to Humble Juice’s product line other than its tobacco-flavored e-liquids products, the PMTA for which remains subject to further FDA review.
−Removed: On November 2, 2021, Humble Juice received notice dated November 2, 2021 from the FDA rescinding the MDO.
−Removed: As a result of the FDA’s rescission of the MDO, the PMTAs submitted by both Humble Juice and Twelfth State Brands remain subject to FDA review.
−Removed: The Company cannot predict whether the PMTAs filed by the Company’s subsidiaries will ultimately be approved by the FDA to permit continued sale of these products.
−Removed: Further, the Company cannot predict whether the FDA, in its exercise of enforcement discretion with respect to Company products that are subject to PMTAs that are under pending review by the FDA, will continue not to seek enforcement to prohibit the sale of such products or that if it seeks enforcement will seek merely to cease any further sale of the products and not any additional remedies, including fines or penalties.
−Removed: The failure to ultimately obtain FDA marketing authorizations in response to these PMTAs could prevent the Company’s subsidiaries from marketing and selling their respective vaping products containing tobacco-derived ingredients in the United States and, thus, may have a material effect on the business, financial condition, and results of operations of the Company.
+Added: The continued sale of any e-liquid product containing nicotine derived from tobacco for which a PMTA was filed by September 9, 2020 and continues to remain subject to pending FDA review is subject
+Added: to the FDA’s enforcement discretion, as the one-year period following the September 9, 2020 application deadline has expired even though the FDA had not yet taken action to approve or deny the PMTA.
+Added: The Company’s remaining e-liquid subsidiary, Twelfth State Brands, filed a PMTA for its respective line of finished Deemed New Tobacco Products by the September 9, 2020 deadline.
+Added: The PMTA remains subject to FDA review.
+Added: The Company cannot predict whether the PMTA filed by its subsidiary will ultimately be approved by the FDA to permit continued sale of its products.
+Added: Further, the Company cannot predict whether the FDA, in its exercise of enforcement discretion with respect to the products being sold by the Company's subsidiary while the PMTA is under pending review by the FDA, will continue not to seek enforcement to prohibit the sale of such products or that if it seeks enforcement will seek merely to cease any further sale of the products and not any additional remedies, including fines or penalties.
+Added: The failure to ultimately obtain FDA marketing authorizations in response to its PMTA could prevent the Company’s subsidiary from marketing and selling vaping products containing tobacco-derived ingredients in the United States and, thus, may have a material effect on the business, financial condition, and results of operations of the Company.
Order dated August 21, 2020 of the U.S.
5 unchanged sentences
and Its Affiliated Debtors dated August 13, 2020, incorporated by reference to Exhibit 2.2 to the Current Report on Form 8-K of Old Holdco, Inc., filed on August 24, 2020 (File No.
−Removed: Third Amendment and Restatement Agreement dated 12 August 2021 among Pyxus International, Inc., Pyxus Parent, Inc., Pyxus Holdings, Inc., Alliance One International Holdings, Ltd., Alliance One Tobacco (Kenya) Limited, Alliance One Tobacco (Malawi) Limited, Alliance One Tobacco (Tanzania) Limited, Alliance One Tobacco (Uganda) Limited, Alliance One Zambia Limited and Eastern and Southern African Trade and Development Bank (filed herewith)
+Added: Executive Employment Agreement executed on October 27, 2021, with an effective date of November 1, 2021, between Flavia Landsberg and Pyxus International, Inc., incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K of Pyxus International, Inc., filed on November 15, 2021 (File No.
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)
10 unchanged sentences
Pyxus International, Inc.
−Removed: November 10, 2021
+Added: February 10, 2022
/s/ Philip C.
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.