What changed in this filing

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Item 9A. Controls and Procedures

2021-03-11 compared with 2020-02-27 · 89 added, 192 removed, 86 unchanged (77% of the section changed)

1 unchanged sentence

Evaluation of Disclosure Controls and Procedures

Disclosure controls and procedures are

controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted

under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), is recorded, processed, summarized, and reported

within the time periods specified in the Securities and Exchange Commission's rules and forms.

Disclosure controls and procedures

include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports

filed under the Exchange Act is accumulated and communicated to management, including our principal executive officer and principal

financial officer, as appropriate, to allow timely decisions regarding required disclosure.

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 15d-15(e) under

the Exchange Act), as of December 31, 2019.

Based upon that evaluation, our principal executive officer and principal financial

officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective.

In designing and evaluating our disclosure controls and procedures, we recognize that any controls and procedures, no matter how

well designed and operated, can provide only reasonable assurance of achieving the desired control objectives.

Management’s Annual Report on Internal Control over

Financial Reporting

Our management is responsible for establishing

and maintaining adequate internal control over our financial reporting.

Internal control over financial reporting is defined in

Rules 13a-15(f) and 15d-15(f) under the Exchange Act as a process designed by, or under the supervision of, a company’s

principal executive and principal financial officers and effected by a company’s board of directors, management, and other

personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements

for external purposes in accordance with U.S.

Our internal control over financial reporting includes those policies

and procedures that:

pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect transactions and dispositions

of its assets;

provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in

accordance with U.S.

GAAP, and that receipts and expenditures are being made only in accordance with authorizations of management

and directors;

provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of

assets that could have a material effect on our consolidated financial statements.

Because of its inherent limitations, internal

control over financial reporting may not prevent or detect misstatements.

Projections of any evaluation of effectiveness to future

periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance

with the policies or procedures may deteriorate.

Management assessed the effectiveness of

our internal control over financial reporting as of December 31, 2019.

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).

Based on this assessment, our management

has concluded that, as of December 31, 2019, our internal control over financial reporting is effective based on those criteria.

The effectiveness of our internal control

over financial reporting as of December 31, 2019 has been audited by EisnerAmper LLP, an independent registered public accounting

firm, as stated in their attestation report, which is included herein.

Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.

Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.

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 15d-15(e) under the Exchange Act), as of December 31, 2020.

Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective.

In designing and evaluating our disclosure controls and procedures, we recognize that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives.

Management’s Annual Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over our financial reporting.

Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as a process designed by, or under the supervision of, a company’s principal executive and principal financial officers and effected by a company’s board of directors, management, and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S.

Our internal control over financial reporting includes those policies and procedures that:

● pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect transactions and dispositions of its assets;

● provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S.

GAAP, and that receipts and expenditures are being made only in accordance with authorizations of management and directors;

● provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of assets that could have a material effect on our consolidated financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Management assessed the effectiveness of our internal control over financial reporting as of December 31, 2020.

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).Based on this assessment, our management has concluded that, as of December 31, 2020, our internal control over financial reporting is effective based on those criteria.

The effectiveness of our internal control over financial reporting as of December 31, 2020 has been audited by EisnerAmper LLP, an independent registered public accounting firm, as stated in their attestation report, which is included herein.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control

over financial reporting during the quarter ended December 31, 2019 that have materially affected, or are reasonably likely

to materially affect, our internal control over financial reporting, except as noted below.

There were no changes in our internal control over financial reporting during the quarter ended December 31, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Other Information

Directors and Executive Officers of the Registrant

The text of our Code of Ethics, which applies

to our principal executive officer, principal financial officer, principal accounting officer or controller, and persons performing

similar functions, is posted on our website, www.anipharmaceuticals.com, under the “Corporate Governance”

of the “Investors”

section of the site.

We will disclose on our website amendments to, and, if any are granted, waivers

of, our Code of Ethics for our principal executive officer, principal financial officer, or principal accounting officer, controller,

or persons performing similar functions.

Information required by this item with

respect to our directors will be set forth under the caption “Election of Directors”

in our definitive proxy statement

for our 2020 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 our executive officers will be set forth under the caption “Executive Officers of the Company”

in our definitive

proxy statement for our 2019 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 compliance with Section 16(a) of the Exchange Act will be set forth under the caption “Section 16(a) Beneficial

Ownership Reporting Compliance”

in our definitive proxy statement for our 2020 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 our audit committee, our audit committee financial expert, and any material changes to the way in which our security

holders may recommend nominees to our Board of Directors will be set forth under the caption “Corporate Governance”

in our definitive proxy statement for our 2020 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.

Directors, Executive Officers, and Corporate Governance

The text of our Code of Ethics, which applies to our principal executive officer, principal financial officer, principal accounting officer or controller, and persons performing similar functions, is posted on our website, www.anipharmaceuticals.com, under the “Governance” subsection of the “Investors” section of the site.

We will disclose on our website amendments to, and, if any are granted, waivers of, our Code of Ethics for our principal executive officer, principal financial officer, or principal accounting officer, controller, or persons performing similar functions.

Information required by this item with respect to our directors will be set forth under the caption “Election of Directors” in our definitive proxy statement for our 2021 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 our executive officers will be set forth under the caption “Executive Officers of the Company” in our definitive proxy statement for our 2021 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 compliance with Section 16(a) of the Exchange Act will be set forth under the caption “Delinquent Section 16(a) Reports” in our definitive proxy statement for our 2021 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 our audit committee, our audit committee financial expert, and any material changes to the way in which our security holders may recommend nominees to our Board of Directors will be set forth under the caption “Corporate Governance” in our definitive proxy statement for our 2021 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.

Executive Compensation

Information required by this item with

respect to executive compensation will be set forth under the caption “Executive Compensation”

in our definitive proxy

statement for our 2020 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.

Security Ownership of Certain Beneficial Owners

and Management and Related Stockholder Matters

Information required by this item with

respect to security ownership of certain beneficial owners and management will be set forth under the captions “Security

Ownership of Certain Beneficial Owners”

and “Security Ownership of Directors and Executive Officers”

in our definitive

proxy statement for our 2020 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.

Certain Relationships and Related Transactions,

and Director Independence

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

2020 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 executive compensation will be set forth under the caption “Executive Compensation” in our definitive proxy statement for our 2021 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.

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

Information required by this item with respect to security ownership of certain beneficial owners and management will be set forth under the captions “Security Ownership of Certain Beneficial Owners” and “Security Ownership of Directors and Executive Officers” and information relating to our equity compensation plans will be

set forth under “Equity Compensation Plan Information” in our definitive proxy statement for our 2021 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.

Certain Relationships and Related Transactions, and Director Independence

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 2021 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

Information required by this item with

respect to principal accounting fees and services will be set forth under the caption “Ratification of Selection of Independent

Registered Public Accountants”

in our definitive proxy statement for our 2020 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.

Exhibits, Financial Statement Schedules

Information required by this item with respect to principal accounting fees and services will be set forth under the caption “Ratification of Selection of Independent Registered Public Accountants” in our definitive proxy statement for our 2021 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.

Exhibits and Financial Statement Schedules

Documents filed as part of this report on Form 10-K:

(a) Financial

The consolidated balance sheets of the Registrant

as of December 31, 2019 and 2018, 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, 2019, 2018, and 2017, the footnotes thereto,

and the reports of EisnerAmper LLP, independent registered public accounting firm, are filed herewith.

(b) Financial

Statement Schedules:

All schedules have been omitted because they are

not applicable or the required information is included in the consolidated financial statements or notes thereto.

Exhibits included or incorporated by reference

(a) Financial Statements:

The consolidated balance sheets of the Registrant as of December 31, 2020 and 2019, 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, 2020, 2019, and 2018, the footnotes thereto, and the reports of EisnerAmper LLP, independent registered public accounting firm, are filed herewith.

(b) Financial Statement Schedules:

All schedules have been omitted because they are not applicable or the required information is included in the consolidated financial statements or notes thereto.

Exhibits included or incorporated by reference herein:

see Exhibit Index on page 105.

PHARMACEUTICALS, INC.

ANI PHARMACEUTICALS, INC.

EXHIBIT INDEX TO ANNUAL REPORT ON FORM 10-K

11 unchanged sentences

Incorporated by reference to Exhibit 3.1 to ANI’s Current Report on Form 8-K as filed with the Securities and Exchange Commission on February 16, 2017 (File No.

Indenture, dated December 10, 2014, between ANI Pharmaceuticals, Inc.

and The Bank of New York Mellon

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 December 10, 2014 (File No.

First Supplemental Indenture, dated December 10, 2014, between ANI Pharmaceuticals, Inc.

and The Bank of New York Mellon (including the form of the 3.00% Convertible Senior Note due 2019)

Incorporated by reference to Exhibit 4.2 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on December 10, 2014 (File No.

ANI Pharmaceuticals, Inc.

Fifth Amended and Restated 2008 Stock Incentive Plan

Incorporated by reference to Appendix A to ANI's Definitive Proxy Statement on Schedule 14A as filed with the Securities and Exchange Commission on April 6, 2017 (File No.

Method of Filing

Form of Incentive Stock Option Agreement under the ANI Pharmaceuticals, Inc.

Fifth Amended and Restated 2008 Stock Incentive Plan (included in Exhibit 10.1)

Incorporated by reference to Appendix A to ANI's Definitive Proxy Statement on Schedule 14A as filed with the Securities and Exchange Commission on April 6, 2017 (File No.

Form of Non-Statutory Option Agreement under the ANI Pharmaceuticals, Inc.

Fifth Amended and Restated 2008 Stock Incentive Plan (included in Exhibit 10.1)

Incorporated by reference to Appendix A to ANI's Definitive Proxy Statement on Schedule 14A as filed with the Securities and Exchange Commission on April 6, 2017 (File No.

Description of Securities

Filed herwith

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

2 unchanged sentences

Employment Agreement, entered into by the Company and Arthur S.

Incorporated by reference to Exhibit 10.1 to ANI's Current Report on Form 8-K filed January 22.

2020 (File No.

Incorporated by reference to Exhibit 10.1 to ANI’s Current Report on Form 8-K filed January 22, 2020 (File No.

Employment Agreement, entered into by the Company and Robert Schrepfer

Incorporated by reference to Exhibit 10.3 to ANI's Current Report on Form 8-K filed January 22.

2020 (File No.

Incorporated by reference to Exhibit 10.3 to ANI’s Current Report on Form 8-K filed January 22, 2020 (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.

Convertible note hedge transaction confirmation, dated December 4, 2014, by and between Nomura Global Financial Products Inc.

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 December 8, 2014 (File No.

Warrant transaction confirmation, dated December 4, 2014, by and between Nomura Global Financial Products Inc.

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 December 8, 2014 (File No.

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

Method of Filing

Additional convertible note hedge transaction confirmation, dated December 5, 2014, by and between Nomura Global Financial Products Inc.

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 December 10, 2014 (File No.

Additional warrant transaction confirmation, dated December 5, 2014, by and between Nomura Global Financial Products Inc.

Incorporated by reference to Exhibit 10.4 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on December 10, 2014 (File No.

Amendment No.

13 unchanged sentences

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.

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.

4 unchanged sentences

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.

Method of Filing

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

5 unchanged sentences

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.

Asset Purchase Agreement

between Amerigen Pharmaceuticals LTD.

Asset Purchase Agreement between Amerigen Pharmaceuticals LTD.

and ANI Pharmaceuticals, Inc.

Filed herewith

Restricted Stock Grant Agreement

Filed herewith

Incentive Option Agreement

Filed herewith

Form of Non- Statutory Stock Option Agreement

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.

Sixth Amended and Restated 2008 Incentive Plan

Incorporated by reference to Exhibit 10.1 to ANI’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2020 (File No.

Form of Restricted Stock Grant Agreement

Incorporated by reference to Appendix A to ANI’s Definitive Proxy Statement for the 2020 Virtual Annual Meeting filed on April 23, 2020 (File No.

Form of Option Agreement

Filed herewith

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.

List of subsidiaries

6 unchanged sentences

Filed herewith

Method of Filing

Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Rule 18 U.S.C.

1 unchanged sentence

Furnished herewith

The following materials from ANI Pharmaceuticals, Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, formatted in XBRL (Extensible Business Reporting Language):

(i) the audited consolidated Balance Sheets, (ii) the audited consolidated Statements of Operations, (iii) the audited consolidated Statements of Comprehensive Income, (iv) the audited consolidated Statements of Stockholders’

The following financial information from this annual report on Form 10-K for the fiscal year ended December 31, 2020, formatted in Inline XBRL:

(i) the audited consolidated Balance Sheets, (ii) the audited

Filed herewith

consolidated Statements of Operations, (iii) the audited consolidated Statements of Comprehensive Income, (iv) the audited consolidated Statements of Stockholders’ Equity;

(v) the audited consolidated Statements of Cash Flows, and (vi) Notes to consolidated Financial Statements.

The cover page from the Company Annual Report on Form 10-K for the year ended December 31, 2020 formatted in inline XBRL (included in Exhibit 101)

Filed herewith

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

ANI will furnish the omitted exhibits

to the SEC upon request by the SEC.

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

ANI will furnish the omitted exhibits to the SEC upon request by the SEC.

(2) Confidential treatment has been granted with respect to redacted portions of this document.

Confidential treatment has been requested with respect to redacted portions of this document.

contract or compensatory plan or arrangement required to be filed as an exhibit to this Annual Report on Form 10-K pursuant

to Item 15(a).

Pursuant to the requirements of Section 13

or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned, thereunto duly authorized.

* Management contract or compensatory plan or arrangement required to be filed as an exhibit to this Annual Report on Form 10-K pursuant to Item 15(a).

Form 10-K Summary

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

ANI PHARMACEUTICALS, INC.

/s/ Arthur S.

/s/ Nikhil Lalwani

Nikhil Lalwani

President and Chief Executive Officer

(principal executive officer)

February 27, 2020

March 11, 2021

/s/ Stephen P.

1 unchanged sentence

Chief Financial Officer

(principal financial officer)

February 27, 2020

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

/s/ Arthur S.

(principal financial and accounting officer)

March 11, 2021

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

February 27, 2020

March 11, 2021

Nikhil Lalwani

Chief Executive Officer

/s/ Robert E.

/s/ Patrick D.

Director and Chairman of the Board of

February 27, 2020

March 11, 2021

/s/ Thomas J.

February 27, 2020

March 11, 2021

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

February 27, 2020

March 11, 2021

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

/s/ Thomas A.

February 27, 2020

/s/ Patrick D.

February 27, 2020

/s/ Robert E.

March 11, 2021

/s/ Jeanne Thoma

March 11, 2021

/s/ Antonio Pera

March 11, 2021

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