Risk Factors.
−Removed: There have been no material changes to Embecta’s risk factors from those described in “Risk Factors” included within the 2022 Form 10-K.
+Added: There have been no material changes to Embecta’s risk factors from those described in “Risk Factors” included within the 2023 Form 10-K, except for the addition of the following risk factor:
+Added: In the first quarter of Embecta’s fiscal year 2024, Embecta submitted its first 510(k) premarket filing to the FDA for its proprietary disposable insulin delivery system.
+Added: We cannot predict when, if ever, such submission will be cleared by the FDA, as the FDA can refuse to grant a 510(k) clearance for many reasons, including the system may not be deemed by the FDA to be substantially equivalent to appropriate predicate devices under the 510(k) pathway, the system may not satisfy the FDA’s safety or effectiveness requirements, or changes in FDA clearance policies or adoption of new regulations may require additional data.
+Added: Even if cleared by the FDA or foreign regulatory agencies, future generations of our systems, expanded indications for use of future systems, our software platforms or any other system under development, may not be cleared for the indications that are necessary or desirable for successful commercialization.
Exhibit Description
−Removed: 3.1 Amended and Restated Bylaws of Embecta Corp., effective August 2, 2023.
−Removed: (Incorporated by reference to the Company’s Current Report on Form 8-K filed on August 3, 2023.)
−Removed: 3.2 Amended and Restated Bylaws of Embecta Corp., effective August 2, 2023, marked to show amendments.
−Removed: (Incorporated by reference to the Company’s Current Report on Form 8-K filed on August 3, 2023.)
+Added: 10.1* Amendment No.
+Added: 1 to the Embecta Corp.
+Added: 2022 Employee and Director Equity-Based Compensation Plan
31.1* Certification of Chief Executive Officer, pursuant to SEC Rule 13a–14(a)
10 unchanged sentences
EMBECTA CORP.
−Removed: August 8, 2023
+Added: February 9, 2024
/s/ Devdatt Kurdikar
2 unchanged sentences
(Principal Executive Officer)
−Removed: August 8, 2023
+Added: February 9, 2024
/s/ Jacob Elguicze
2 unchanged sentences
(Principal Financial Officer)
−Removed: August 8, 2023
+Added: February 9, 2024
/s/ Brian Capone
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.