What changed in this filing

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Item 9A. Controls and Procedures

2024-02-29 compared with 2023-03-09 · 124 added, 142 removed, 134 unchanged (67% of the section changed)

5 unchanged sentences

Our management has carried out an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 154-15(e) under the Exchange Act), as of December 31, 2023.

Due to the material weaknesses in internal control over financial reporting as described below, our principal executive officer and principal financial officers concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were not effective.

Based on this evaluation, our principal executive officer and principal financial officers concluded that our disclosure controls and procedures were effective as of December 31, 2023.

Management’s Annual Report on Internal Control over Financial Reporting

10 unchanged sentences

In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control — Integrated Framework (2013).

This assessment resulted in management identifying certain material weaknesses in internal control over financial reporting as described below.

As a result, management has concluded that, as of December 31, 2022, our internal control over financial reporting is not effective.

Notwithstanding the identified material weaknesses, management has concluded that the Consolidated Financial Statements included in this Annual Report on Form 10-K present fairly, in all material respects, the Company’s financial position, results of operations and cash flows for the periods disclosed in conformity with U.S.

The Company's independent registered public accounting firm, EisnerAmper LLP, who audited the consolidated financial statements included in this Annual Report on Form 10-K issued an adverse opinion on the effectiveness of the Company's internal control over reporting.

EisnerAmper LLP's report is included herein.

Material Weaknesses in Internal Control over Financial Reporting

Upon evaluation of our internal control over financial reporting we identified certain material weaknesses in our controls at our Novitium subsidiary.

We completed the acquisition of Novitium in November of 2021 and shortly thereafter, began the integration of Novitium’s policies, processes, people, technology, and operations into our system of internal control over financial reporting.

In 2022, we completed the integration of Novitium’s order to cash cycle into ANI’s system of procedures and contracts, and the controls were successfully tested and found to be operating as prescribed, however, we found material weaknesses in other key processes.

The Company did not maintain an effective control environment in the Novitium subsidiary as a result of the following:

● Lack of adequate personnel resources in Novitium team to implement appropriate process controls addressing Novitium activity.

● Turnover in key finance personnel at Corporate that were tasked with driving / managing implementation of internal controls at Novitium, including the Corporate Controller.

While we have seasoned temporary personnel in these corporate positions, we did not have adequate bandwidth to maintain focus on compliance with internal controls.

● Delays in execution of the extraction of the Procure to Pay cycle integration plan for the subsidiary, including creation of the Accounts Payable centers of excellence whereby processes at Novitium would be combined with legacy processes.

These factors contributed to the weaknesses in the following control activities, specifically, the following process areas related to activity at Novitium did not have effective controls in place and were not operating effectively for a sufficient amount of time:

● Purchase to Pay (Purchasing, Accounts Payable, and Cash Disbursements)

● Manufacturing and Inventory

● Human Resources/Payroll

● Financial Statement Close (limited to those pertaining to the Novitium subsidiary level that were not incorporated into overall Company controls)

● Information technology general controls

The areas noted above had one or more of the following specific compliance exceptions:

● Certain controls were not implemented as designed.

● Documented controls not being performed consistently for all applicable transactions.

● Control performance not being adequately documented and evidenced.

● Materiality thresholds used in certain control performance were not consistent with documented control design.

● Controls not in place nor operating for a sufficient amount of time/number or instances.

● Changes to control performance upon employee turnover.

● Information technology general controls (“ITGC”) which could result in misstatements potentially impacting all Novitium related financial statement accounts and disclosures.

Specifically, Novitium user access controls were not appropriately designed and maintained to adequately restrict user and privileged access to financial applications and data to the appropriate personnel.

In addition to the above Material Weaknesses related to our Novitium subsidiary, we also identified a material weakness in our ITGC.

Specifically, our evaluation of our ITGC’s identified that user access controls were not

operating effectively to adequately restrict user access to our network and financial applications and data.

The Company attributes the findings primarily due to significant turnover in its IT personnel during the year.

We determined that the designed internal controls were not operating effectively as detailed above, and therefore did not reduce the risk of a material error occurring and going undetected in our financial statements to an acceptable level giving rise to the material weaknesses in the four Novitium related process areas noted above as well as overall ITGC related to user access.

Remediation of Material Weaknesses

The Company is committed to the planning and implementation of remediation efforts to address the material weaknesses.

The Company is in the process of establishing formal processes through which it intends to remediate the identified material weaknesses and enhance the Company’s overall control environment, including the following:

Novitium Related:

● Refine and complete its plan to incorporate procure to pay cycle into the overall company controls.

● For those controls that remain at the Novitium subsidiary, review the existing control documentation and revise and upgrade as appropriate to address all identified risks.

● Ensure Novitium processes and controls have adequate resources to properly perform identified controls including hiring of additional resources with the requisite skills to consistently perform control procedures without material exception.

● Implement its ERP and other systems as appropriate to support the internal control structure.

● Ensure all personnel are properly trained as to the importance of and specifics over the internal controls for which they are responsible, including consistent, repeatable performance of such controls.

ITGC Related:

● Management will ensure proper staffing of IT personnel and ensure all personnel are properly trained as to the importance of and specifics over the internal controls for which they are responsible, including consistent, repeatable performance of such controls.

When fully implemented, the Company believes that the measures described above will appropriately remediate the identified material weaknesses, although management may determine that taking additional measures to remediate the material weaknesses may be necessary.

As part of its remediation efforts, the Company will continue to implement and document associated policies, procedures and internal controls and will test the ongoing operating effectiveness of the new and existing policies, procedures and internal controls in future periods.

Management intends to begin the above remediation efforts immediately and expects all remediation efforts to be completed in 2023.

While the material weaknesses cannot be considered completely remediated until the applicable policies, procedures, and internal controls have operated for a sufficient period of time, management has determined that our timetable for completing the remediation efforts in 2023 will provide sufficient time to provide its assessment over the effectiveness of internal controls as of December 31, 2023.

Based on this assessment, management has concluded that, as of December 31, 2023, our internal control over financial reporting is effective.

Management has concluded that the Consolidated Financial Statements included in this Annual Report on Form 10-K present fairly, in all material respects, the Company’s financial position, results of operations and cash flows for the periods disclosed in conformity with U.S.

As disclosed in Item 9A.

Controls and Procedures in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, we identified material weaknesses related to an ineffective control environment at our Novitium subsidiary, and information technology general controls (“ITGCs”) in the areas of user access over certain information technology systems that support our financial reporting processes.

As of December 31, 2022, we determined that the designed internal controls were not operating effectively in Novitium related processes including (i) purchase to pay (purchasing, accounts payable, and cash disbursements);

(ii) manufacturing and inventory;

(iii) human resources/payroll;

(iv) financial statement close;

and (v) information technology related controls, as well as overall ITGC related to user access which were not operating effectively to adequately restrict user access to our network and financial applications and data, and therefore did not reduce the risk of a material error occurring and going undetected in our financial statements to an acceptable level giving rise to the material weaknesses.

During the fiscal year ended December 31, 2023, we implemented our material weakness remediation plan that included:

(i) refining and completing our plan to incorporate procure to pay cycle into the overall company controls;

(ii) review and revise control documentation for controls at our Novitium subsidiary;

(iii) ensure Novitium processes and controls have adequate resources to properly perform identified controls including hiring of additional resources with the requisite skills to consistently perform control procedures without material exception;

(iv) implement one ERP system for the entire company to support the internal control structure;

and (v) ensure all personnel are properly trained as to the importance of and specifics over the internal controls for which they are responsible, including consistent, repeatable performance of such controls.

We completed our testing of the operating effectiveness of the implemented controls and found them to be effective.

As a result, we have concluded the material weaknesses have been remediated as of December 31, 2023.

Our independent registered public accounting firm, EisnerAmper LLP, has issued an attestation report on the effectiveness of our internal control over financial reporting, which is included in Item 8.

Financial Statements and Supplementary Data of this Annual Report on Form 10-K.

Changes in Internal Control over Financial Reporting

Other than the material weaknesses and remediation efforts discussed above, there were no changes in our internal control over financial reporting during the quarter ended December 31, 2022, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

There were no changes in our internal control over financial reporting during the quarter ended December 31, 2023, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Other Information

Oakville Sale

On November 6, 2023, ANI Pharmaceuticals Canada Inc., a wholly owned subsidiary of the Company, entered into an agreement (the “Agreement”) with Mastercom Inc.

for the purchase and sale of the Company's Oakville, Ontario former manufacturing facility at a total purchase price of approximately 17.9 million Canadian dollars, or approximately $13.0 million US Dollars based on the current exchange rate, subject to certain market adjustments.

On December 22, 2023, the Agreement was terminated by mutual agreement.

In February 2024, the Company entered into an agreement for the purchase and sale of the Oakville site, for a purchase price of 19.2 million Canadian Dollars, or approximately $14.2 million US Dollars, based on the current exchange rate.

The sale is expected to close in March 2024.

Trading Arrangements

Our directors and officers (as defined in Exchange Act Rule 16a-1(f)) may from time to time enter into plans or other arrangements for the purchase or sale of our shares that are intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or may represent a non-Rule 10b5-1 trading arrangement under the Exchange Act.

On November 27, 2023 , Mr.

Muthusamy Shanmugam , Head of R&D and COO of NJ Operations, adopted a trading arrangement for the sale of securities of the Company’s common stock (a “Rule 10b5-1 Trading Plan”) that is intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c).

Shanmugam's Rule 10b5-1 Trading Plan, which has a term from March 4, 2024 through November 29, 2024, provides for the sale of up to 400,000 shares of common stock pursuant to the terms of the plan.

On December 12, 2023 , Mr.

Chad Gassert , Sr.

Vice President, Corporate Development and Strategy , adopted a trading arrangement for the sale of securities of the Company’s common stock (a “Rule 10b5-1 Trading Plan”) that is intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c).

Gassert's Rule 10b5-1 Trading Plan, which will terminate September 30, 2024, provides for the sale of up to 100,000 shares of common stock pursuant to the terms of the plan.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

12 unchanged sentences

Certain Relationships and Related Transactions, and Director Independence

Governance” in our definitive proxy statement for our 2023 annual meeting, to be filed with the SEC pursuant to Regulation 14A no later than 120 days after the close of our fiscal year, and is incorporated herein by reference.

Information required by this item with respect to certain relationships and related transactions and director independence will be set forth under the captions “Certain Relationships and Related Transactions” and “Corporate Governance” in our definitive proxy statement for our 2024 annual meeting, to be filed with the SEC pursuant to Regulation 14A no later than 120 days after the close of our fiscal year, and is incorporated herein by reference.

Principal Accountant Fees and Services

4 unchanged sentences

(a) Financial Statements:

The consolidated balance sheets of the Registrant as of December 31, 2022 and 2021, the related consolidated statements of operations, statements of comprehensive income, changes in stockholders’ equity, and cash flows for each of the years ended December 31, 2022, 2021, and 2020, the footnotes thereto, and the reports of EisnerAmper LLP, independent registered public accounting firm, are filed herewith.

The consolidated balance sheets of the Registrant as of December 31, 2023 and 2022, the related consolidated statements of operations, statements of other comprehensive income (loss) , changes in stockholders’ equity, and cash flows for each of the years ended December 31, 2023, 2022, and 2021, the footnotes thereto, and the reports of EisnerAmper LLP, independent registered public accounting firm, are filed herewith.

(b) Financial Statement Schedules:

5 unchanged sentences

FOR THE YEAR ENDED DECEMBER 31, 2023

Method of Filing

Exhibit Method of Filing

2.1 Amended and Restated Agreement and Plan of Merger, dated as of April 12, 2013, by and among BioSante Pharmaceuticals, Inc., ANI Merger Sub, Inc.

1 unchanged sentence

Incorporated by reference to Exhibit 2.1 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on April 12, 2013 (File No.

Asset Purchase Agreement, dated as of December 26, 2013, by and between ANI Pharmaceuticals, Inc.

and Teva Pharmaceuticals USA, Inc.

Incorporated by reference to Exhibit 2.2 to ANI’s Annual Report on Form 10-K as filed for the fiscal year ended December 31, 2013 (File No.

2.2 Agreement and Plan of Merger dated March 8, 2021 by and among ANI Pharmaceuticals, Inc., Nile Merger Sub LLC, Novitium Pharma LLC, Esjay LLC, Chali Properties, LLC, Chad Gassert, Muthusamy Shanmugam and Thorappadi Vijayaraj and Shareholder Representative Services LLC as the representative of the Company Members

10 unchanged sentences

Incorporated by reference to Exhibit 4.1 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on November 26, 2021 (File No.

Method of Filing

Generic Wholesale Service Agreement, dated as of May 1, 2006, between ANI Pharmaceuticals, Inc.

and Cardinal Health, First Amendment to Generic Wholesale Service Agreement, dated as of July 10, 2008, Letter Agreement, dated as of July 10, 2008, regarding assignment of the Generic Wholesale Service Agreement to ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc., Letter from Cardinal Health, dated December 22, 2008 Regarding Increase in Base Service Fee, and Second Amendment to Generic Wholesale Service Agreement, dated May 7, 2012 (2)

Incorporated by reference to Exhibit 10.59 to ANI’s Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No.

Employment Agreement, entered into by the Company and James G.

Incorporated by reference to Exhibit 10.4 to ANI’s Current Report on Form 8-K filed January 22, 2020 (File No.

Employment Agreement, entered into by the Company and Stephen P.

Incorporated by reference to Exhibit 10.2 to ANI’s Current Report on Form 8-K filed January 22, 2020 (File No.

Employment Agreement between Nikhil Lalwani and ANI Pharmaceuticals, Inc., dated July 24, 2020

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K filed August 3, 2020 (File No.

Exhibit Method of Filing

Employment Agreement between Muthusamy Shanmugam and the Company, dated as of March 8, 2021 and effective as of November 19, 2021.

Incorporated by reference to Exhibit 10.3 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on November 26, 2021 (File No.

Employment Agreement between and Christopher Mutz and the Company, dated February 10, 2021.

Incorporated by reference to Exhibit 10.26 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (File No.

Employment Agreement between Ori Gutwerg and the Company, dated January 18, 2021.

Incorporated by reference to Exhibit 10.27 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (File No.

Employment Agreement between Chad Gassert and the Company, dated March 8, 2021.

Incorporated by reference to Exhibit 10.28 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (File No.

Employment Agreement between Meredith Cook and the Company, dated June 21, 2022.

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022 (File No.

Employment Agreement between Krista Davis and ANI Pharmaceuticals, Inc.

dated July 14, 2022.

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2022 (File No.

10.10 Amendment No.

2 to Asset Purchase Agreement, dated as of July 10, 2015, between Teva Pharmaceuticals, Inc.

2 to Asset Purchase Agreement , dated as of July 10, 2015, Teva Pharm aceuticals, Inc.

and ANI Pharmaceuticals, Inc .

3 unchanged sentences

Incorporated by reference to Exhibit 10.2 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2015 (File No.

ANI Pharmaceuticals, Inc.

2016 Employee Stock Purchase Plan

Incorporated by reference to Appendix A to the Registrant’s Definitive Proxy Statement on Schedule 14A filed with the Commission on April 14, 2016

Asset Purchase Agreement between H2-Pharma, LLC and ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2016 (File No.

10.12 Asset Purchase Agreement between Cranford Pharmaceuticals, LLC and ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.2 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2016 (File No.

Employment Agreement, entered into by the Company and Stephen P.

Incorporated by reference to Exhibit 10.2 to ANI’s Current Report on Form 8-K filed January 22, 2020 (File No.

Asset Purchase Agreement between Cranford Pharmaceuticals, LLC and ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2017 (File No.

Method of Filing

Asset Purchase Agreement between Holmdel Pharmaceuticals, LP and ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.2 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2017 (File No.

10.13 Asset Purchase Agreement between AstraZeneca AB, AstraZeneca UK Limited, and ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.25 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 (File No.

Stock Purchase Agreement by and among WellSpring Pharma Services Inc., WSP Pharma Holdings, LLC, ANI Pharmaceuticals Canada Inc., and ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2018 (File No.

Amended and Restated Credit Agreement between Citizens Bank, N.A.

and ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.22 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (File No.

Amendment No.

4 to Asset Purchase Agreement between ANI Pharmaceuticals, Inc.

and Teva Pharmaceuticals USA, Inc.

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2019 (File No.

10.14 Asset Purchase Agreement between Amerigen Pharmaceuticals LTD.

1 unchanged sentence

Incorporated by reference to Exhibit 10.24 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (File No.

ANI Pharmaceuticals, Inc.

Amended and Restated 2022 Stock Incentive Plan

Incorporated by reference Appendix A to ANI Pharmaceuticals, Inc.’s definitive proxy statement dated March 25, 2022 filed with the Securities and Exchange Commission on March 25, 2022 (File No.

Form of Restricted Stock Grant Agreement

Incorporated by reference to Appendix A to ANI’s Definitive Proxy Statement for the 2022 Virtual Annual Meeting filed on March 25, 2022 (File No.

Form of Stock Option Agreement

Incorporated by reference to Appendix A to ANI’s Definitive Proxy Statement for the 2022 Virtual Annual Meeting filed on March 25, 2022 (File No.

Employment Agreement between Nikhil Lalwani and ANI Pharmaceuticals, Inc., dated July 24, 2020

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K filed August 3, 2020 (File No.

Inducement Stock Option Award Agreement, effective as of September 8, 2020, between ANI Pharmaceuticals, Inc.

and Nikhil Lalwani

Incorporated by reference to Exhibit 10.2 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020 (File No.

Credit Agreement, dated as of November 19, 2021 by and among the Company, certain of the Company’s subsidiaries, as

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K as filed with the

guarantors, Truist Bank, as Administrative Agent and other parties party thereto.

Securities and Exchange Commission on November 26, 2021 (File No.

Method of Filing

10.15 Credit Agreement, dated as of November 19, 2021 by and among the Company, certain of the Company’s subsidiaries, as guarantors, Truist Bank, as Administrative Agent and other parties party thereto.

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on November 26, 2021 (File No.

Exhibit Method of Filing

10.16 Equity Commitment and Investment Agreement, dated as of March 8, 2021, by and between the Company and Ampersand 2020 Limited Partnership

Incorporated by reference to Exhibit 10.2 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on March 9, 2021 (File No.

Employment Agreement between Muthusamy Shanmugam and the Company, dated as of March 8, 2021 and effective as of November 19, 2021.

Incorporated by reference to Exhibit 10.3 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on November 26, 2021 (File No.

10.17 Sublicense Agreement, dated as of October 30, 2009, by and between ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc., and Jazz Pharmaceuticals, Inc.

3 unchanged sentences

Incorporated by reference to Exhibit 10.25 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (File No.

Employment Agreement between and Christopher Mutz and the Company, dated February 10, 2021.

Incorporated by reference to Exhibit 10.26 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (File No.

001-31812Filed herewith

Employment Agreement between Ori Gutwerg and the Company, dated January 18, 2021.

Incorporated by reference to Exhibit 10.27 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (File No.

Employment Agreement between Chad Gassert and the Company, dated March 8, 2021.

Incorporated by reference to Exhibit 10.28 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (File No.

Employment Agreement between Meredith Cook and the Company, dated June 21, 2022.

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022 (File No.

Employment Agreement between Krista Davis and ANI Pharmaceuticals, Inc.

dated July 14, 2022.

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2022 (File No.

10.19 Asset Purchase Agreement between Cranford Pharmaceuticals, LLC and ANI Pharmaceuticals, Inc.

1 unchanged sentence

10.20 Asset Purchase Agreement between Holmdel Pharmaceuticals, LP and ANI Pharmaceuticals, Inc.

Incorporated by reference to Exhibit 10.2 to ANI’s Quarterly Report on Form 10-Q for the

fiscal quarter ended March 31, 2022 (File No.

Incorporated by reference to Exhibit 10.2 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2022 (File No.

A NI Pharmaceuticals, Inc.

2016 Employee Stock Purchase Plan

Incorporated by reference to Appendix A to ANI’s Definitive Proxy Statement on Schedule 14A filed with the Commission on April 14, 2016

ANI Pharmaceuticals, Inc.

Amended and Restated 2022 Stock Incentive Plan

Incorporated by reference Appendix A to ANI Pharmaceuticals, Inc.’s definitive proxy statement dated March 25, 2022 filed with the Securities and Exchange Commission on March 25, 2022 (File No.

Amendment No.

2023-1 to ANI Pharmaceuticals, Inc.

Amended and Restated 2022 Stock Incentive Plan (including form of Performance Stock Unit Award Agreement)

Incorporated by reference to Exhibit 10.1 to ANI's Form S-8 filed on June 23.

2023 (File No.

Amendment No.

2024-2 to ANI Pharmaceuticals, Inc.

Amended and Restated 2022 Stock Incentive Plan

Filed herewith

Form of Restricted Stock Grant Agreement

Incorporated by reference to Appendix A to ANI’s Definitive Proxy Statement for the 2022 Virtual Annual Meeting filed on March 25, 2022 (File No.

Form of Stock Option Agreement

Incorporated by reference to Appendix A to ANI’s Definitive Proxy Statement for the 2022 Virtual Annual Meeting filed on March 25, 2022 (File No.

Inducement Stock Option Award Agreement, effective as of September 8, 2020, between ANI Pharmaceuticals, Inc.

and Nikhil Lalwani

Incorporated by reference to Exhibit 10.2 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020 (File No.

Exhibit Method of Filing

ANI Pharmaceuticals, Inc.

Executive Incentive Bonus Plan

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K filed on February 28, 2022 (File No.

10.29 Amendment No.

1 to the Credit Agreement, dated as of July 3, 2023 by and among the Company, and Truist Bank, as Administrative Agent.

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2023 (File No.

10.30 Underwriting Agreement, dated May 11, 2023, by and between ANI Pharmaceuticals, Inc.

and Guggenheim Securities, LLC

Incorporated by reference to Exhibit 1.1 to ANI’s Current Report on Form 8-K filed on May 12, 2023 (File No.

10.31 Purchase and Sale Agreement between ANI Pharmaceuticals Canada Inc.

and Mastercom Inc.

Filed herewith

10.32 Amendment to Purchase and Sale Agreement between ANI Pharmaceuticals Canada Inc.

and Mastercom Inc.

Filed herewith

10.33 Notice of Termination of Purchase and Sale Agreement between ANI Pharmaceuticals Canada Inc.

and Mastercom Inc.

Filed herewith

10.34 Form of Indemnification Agreement

Filed herewith

21 List of subsidiaries

9 unchanged sentences

Furnished herewith

97.1 A NI Pharmaceuticals, Inc.

Amended and Restated Clawback Pol icy

Filed herewith

101 The following financial information from this annual report on Form 10-K for the fiscal year ended December 31, 2023, formatted in Inline XBRL:

2 unchanged sentences

Filed herewith

Method of Filing

104 The cover page from the Company Annual Report on Form 10-K for the year ended December 31, 2023 formatted in inline XBRL (included in Exhibit 101)

Filed herewith

____________________

(1) All exhibits to this exhibit have been omitted pursuant to Item 601(b)(2) of Regulation S-K.

10 unchanged sentences

(principal executive officer)

March 9, 2023

February 29, 2024

/s/ Stephen P.

2 unchanged sentences

(principal financial and accounting officer)

March 9, 2023

February 29, 2024

Pursuant to the requirements the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

/s/ Nikhil Lalwani

Director, President, and

March 9, 2023

Nikhil Lalwani

Name Capacity Date

/s/ Nikhil Lalwani Director, President, and

Chief Executive Officer

(principal executive officer)

February 29, 2024

Nikhil Lalwani

/s/ Stephen P.

Senior Vice President, Finance and

Carey Senior Vice President, Finance and

Chief Financial Officer

(principal financial and accounting officer)

March 9, 2023

/s/ Muthusamy Shanmugam

Director, Head of Research and Development and Chief Operating Officer of New Jersey Operations

March 9, 2023

(principal financial and accounting officer) February 29, 2024

/s/ Muthusamy Shanmugam Director, Head of Research and Development and Chief Operating Officer of New Jersey Operations February 29, 2024

Muthusamy Shanmugam

/s/ Patrick D.

Director and Chairman of the Board of

March 9, 2023

Walsh Director and Chairman of the Board of

Directors February 29, 2024

/s/ Thomas J.

March 9, 2023

Haughey Director February 29, 2024

Nash, M.D., M.B.A.

March 9, 2023

Director February 29, 2024

Nash, M.D., M.B.A.

/s/ Robert E.

March 9, 2023

/s/ Jeanne Thoma

March 9, 2023

/s/ Antonio Pera

March 9, 2023

/s/ Renee Tannenbaum

March 9, 2023

/s/ Matthew J.

Leonard Director February 29, 2024

/s/ Jeanne Thoma Director February 29, 2024

/s/ Antonio Pera Director February 29, 2024

/s/ Renee Tannenbaum Director February 29, 2024

Renee Tannenbaum

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