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Item 9A. Controls and Procedures

2025-03-20 compared with 2024-03-15 · 46 added, 51 removed, 154 unchanged (39% of the section changed)

1 unchanged sentence

of Disclosure Controls and Procedures

management, including our Chief Executive Officer and Chief Financial Officer, evaluated, as of the end of the period covered by

this Form 10-K, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the

Exchange Act).

Based on that evaluation, our management, including our Chief Executive Officer and Chief Financial Officer, concluded

that, as of December 31, 2023, our disclosure controls and procedures were effective at the reasonable assurance level.

management, including our Chief Executive Officer and Chief Financial Officer, evaluated, as of the end of the period covered by this

Form 10-K, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange

Based on that evaluation, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that, as

of December 31, 2024, our disclosure controls and procedures were effective at the reasonable assurance level.

Annual Report on Internal Control Over Financial Reporting

management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules

13a-15(f) and 15d-15(f) of the Exchange Act.

Our management, under the supervision and with the participation of our Chief Executive

Officer and Chief Financial Officer, conducted an evaluation of the effectiveness of our internal control over financial reporting

as of December 31, 2023 based on the framework in Internal Control-Integrated Framework issued by the Committee of Sponsoring

Organizations of the Treadway Commission (2013 Framework).

Based on the results of its evaluation, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our

internal control over financial reporting was effective as of December 31, 2023.

management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-15(f)

and 15d-15(f) of the Exchange Act.

Our management, under the supervision and with the participation of our Chief Executive Officer and

Chief Financial Officer, conducted an evaluation of the effectiveness of our internal control over financial reporting as of December

31, 2024 based on the framework in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway

Commission (2013 Framework).

Based on the results of its evaluation, our management, including our Chief Executive Officer and Chief

Financial Officer, concluded that our internal control over financial reporting was effective as of December 31, 2024.

Report of the Registered Public Accounting Firm

10 unchanged sentences

Directors, Executive Officers and Corporate Governance

required by this Item is incorporated by reference to

our Proxy Statement for our

Annual Meeting of Stockholders for the fiscal year ended December 31, 2023, which will be filed with the Securities and Exchange Commission,

pursuant to Regulation 14A, no later than 120 days after the end of the 2023 fiscal year covered by this Form 10-K,or alternatively,

by amendment to this Form 10-K under cover of Form 10-K/A no later than the end of such 120 day period.

required by this Item is incorporated by reference to our Proxy Statement for our Annual Meeting of Stockholders for the fiscal year

ended December 31, 2024, which will be filed with the Securities and Exchange Commission, pursuant to Regulation 14A, no later than 120

days after the end of the 2024 fiscal year covered by this Form 10-K,or alternatively, by amendment to this Form 10-K under cover of

Form 10-K/A no later than the end of such 120 day period.

Executive Compensation

required by this Item is incorporated by reference to

our Proxy Statement for our

Annual Meeting of Stockholders for the fiscal year ended December 31, 2023, which will be filed with the Securities and Exchange Commission,

pursuant to Regulation 14A, no later than 120 days after the end of the 2023 fiscal year covered by this Form 10-K,or alternatively,

by amendment to this Form 10-K under cover of Form 10-K/A no later than the end of such 120 day period.

required by this Item is incorporated by reference to our Proxy Statement for our Annual Meeting of Stockholders for the fiscal year

ended December 31, 2024, which will be filed with the Securities and Exchange Commission, pursuant to Regulation 14A, no later than 120

days after the end of the 2024 fiscal year covered by this Form 10-K,or alternatively, by amendment to this Form 10-K under cover of

Form 10-K/A no later than the end of such 120 day period.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

required by this Item is incorporated by reference to

our Proxy Statement for our

Annual Meeting of Stockholders for the fiscal year ended December 31, 2023, which will be filed with the Securities and Exchange Commission,

pursuant to Regulation 14A, no later than 120 days after the end of the 2023 fiscal year covered by this Form 10-K,or alternatively,

by amendment to this Form 10-K under cover of Form 10-K/A no later than the end of such 120 day period.

required by this Item is incorporated by reference to our Proxy Statement for our Annual Meeting of Stockholders for the fiscal year

ended December 31, 2024, which will be filed with the Securities and Exchange Commission, pursuant to Regulation 14A, no later than 120

days after the end of the 2024 fiscal year covered by this Form 10-K,or alternatively, by amendment to this Form 10-K under cover of

Form 10-K/A no later than the end of such 120 day period.

Certain Relationships and Related Transactions, and Director Independence

required by this Item is incorporated by reference to

our Proxy Statement for our

Annual Meeting of Stockholders for the fiscal year ended December 31, 2023, which will be filed with the Securities and Exchange Commission,

pursuant to Regulation 14A, no later than 120 days after the end of the 2023 fiscal year covered by this Form 10-K,or alternatively,

by amendment to this Form 10-K under cover of Form 10-K/A no later than the end of such 120 day period.

required by this Item is incorporated by reference to our Proxy Statement for our Annual Meeting of Stockholders for the fiscal year

ended December 31, 2024, which will be filed with the Securities and Exchange Commission, pursuant to Regulation 14A, no later than 120

days after the end of the 2024 fiscal year covered by this Form 10-K,or alternatively, by amendment to this Form 10-K under cover of

Form 10-K/A no later than the end of such 120 day period.

Principal Accountant Fees and Services

required by this Item is incorporated by reference to

our Proxy Statement for our

Annual Meeting of Stockholders for the fiscal year ended December 31, 2023, which will be filed with the Securities and Exchange Commission,

pursuant to Regulation 14A, no later than 120 days after the end of the 2023 fiscal year covered by this Form 10-K,or alternatively,

by amendment to this Form 10-K under cover of Form 10-K/A no later than the end of such 120 day period.

required by this Item is incorporated by reference to our Proxy Statement for our Annual Meeting of Stockholders for the fiscal year

ended December 31, 2024, which will be filed with the Securities and Exchange Commission, pursuant to Regulation 14A, no later than 120

days after the end of the 2024 fiscal year covered by this Form 10-K,or alternatively, by amendment to this Form 10-K under cover of

Form 10-K/A no later than the end of such 120 day period.

Exhibit and Financial Statements

22 unchanged sentences

Certificate of Designation of Preferences, Rights and Limitations of the Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on February 23, 2024).

Certificate of Second Amendment to the Amended and Restated Certificate of Incorporation of Biofrontera Inc.

filed April 25, 2024 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on April 30, 2024).

Description of Securities

2 unchanged sentences

Form of Purchaser Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Form 8-K filed with the SEC on December 3, 2021).

Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Form 8-K filed with the SEC on December 3, 2021).

Form of Unit Purchase Option (incorporated by reference to Exhibit 4.3 to the Company’s Form 8-K filed with the SEC on December 3, 2021)

Form of 2022 Purchaser Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 20, 2022)

Form of 2022 Pre-funded Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on May 20, 2022)

Form of Inducement Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Form 8-K filed with the SEC on July 28, 2022).

5 unchanged sentences

Form of Common Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 2, 2023)

Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on November 2, 2023)

Form of Series B-3 Convertible Preferred Stock Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on February 23, 2024)

Form of Senior Secured Convertible Note dated November 22, 2024 (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on November 27, 2024)

Amended and Restated License and Supply Agreement dated June 16, 2021 by and among Biofrontera Pharma GmbH, Biofrontera Bioscience GmbH and Biofrontera Inc.

10 unchanged sentences

(incorporated by reference to Exhibit 4.16 to Biofrontera AG’s Form 20-F filed with the SEC on April 29, 2019).

Supply Agreement dated March ___, 2018 by and between Ferrer Internacional, S.A.

Agreement dated March 2018 by and between Ferrer Internacional, S.A.

and Cutanea Life Sciences, Inc.

(incorporated by reference to Exhibit 4.17 to Biofrontera AG’s Form 20-F filed with the SEC on April 29, 2019).

Employment Agreement – Erica Monaco (incorporated by reference to Exhibit 10.6 to Amendment No.

2 to the Company’s Form S-1 filed with the SEC on August 12, 2021).

Second Intercompany Revolving Loan Agreement dated March 31, 2021 by and between the Company and Biofrontera AG (incorporated by reference to Exhibit 10.7 to the Company’s Form S-1 filed with the SEC on July 6, 2021).

(incorporated by reference to

Exhibit 4.17 to Biofrontera AG’s Form 20-F filed with the SEC on April 29, 2019).

Amended and Restated Master Contract Services Agreement, by and among the Company, Biofrontera AG, Biofrontera Pharma GmbH and Biofrontera Bioscience GmbH (incorporated by reference to Exhibit 10.8 to the Company’s Form S-1 filed with the SEC on July 6, 2021).

20 unchanged sentences

Amended Settlement Allocation Agreement dated March 31,2022 between the Company and Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, Biofrontera Development GmbH, Biofrontera Neuroscience GmbH, (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on April 5, 2022).

Amendment to Employment Agreement effective as April 1, 2022 — Erica Monaco (incorporated by reference to Exhibit 10.2 to the Company’s Form 8-K filed with the SEC on April 5, 2022).

Form of Securities Purchase Agreement for 2022 Private Placement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 20, 2022)

22 unchanged sentences

Amended and Restated Business Loan and Security Agreement between Biofrontera Inc.

and Agile Capital Funding, LLC and Agile Lending, LLC, dated as of December 21, 2023

and Agile Capital Funding, LLC and Agile Lending, LLC, dated as of December 21, 2023 (incorporated by reference to Exhibit 10.34 of the Company’s Form 10-K filed with the SEC on March 15, 2024)

Business Loan and Security Agreement between Biofrontera Inc.

and Cedar Advance, LLC, dated as of December 21, 2023

and Cedar Advance, LLC, dated as of December 21, 2023 (incorporated by reference to Exhibit 10.35 of the Company’s Form 10-k filed with the SEC on March 15, 2024)

Confidential Settlement Agreement and Mutual Release, dated as of December 27, 2023 and effective as of December 22, 2023, by and between the Company and Maruho (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on January 3, 2024)

4 unchanged sentences

(incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on February 20, 2024)

Form of Securities Purchase Agreement, dated February 19, 2024, by and amount Biofrontera Inc.

Form of Securities Purchase Agreement, dated February 19, 2024, by and among Biofrontera Inc.

and the purchasers named therein (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on February 23, 2024)

1 unchanged sentence

and Roth Capital Partners, LLC (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on February 23, 2024)

Form of Securities Purchase Agreement dated November 21, 2024 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on November 27, 2024)

Security Agreement dated as of November 21, 2024 between the Company and the Collateral Agent (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on November 27, 2024)

2021 Omnibus Incentive Plan (as amended and restated (as amended and restated on June 12, 2024) (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on June 14, 2024)

Insider Trading Policy

List of Subsidiaries of the Company

4 unchanged sentences

Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002

Compensation Clawback Policy, as approved by the Board of Directors on November 29, 2023

Compensation Clawback Policy, as approved by the Board of Directors on November 29, 2023 (incorporated by reference to Exhibit 97.1 in the Company’s Form 10-K filed with the SEC on March 15, 2024)

XBRL Instance Document

21 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.

What changed 10-K

Item 9A. Controls and Procedures