What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2022-03-15 compared with 2021-03-11 · 53 added, 17 removed, 158 unchanged (31% 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 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.

16 unchanged sentences

Changes in Internal Control over Financial Reporting

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.

There were no changes in our internal control over financial reporting during the quarter ended December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting, except as noted below.

On November 19, 2021, we acquired all the issued and outstanding equity interests of Novitium Pharma LLC (“Novitium”).

In conjunction with the transaction, we are currently in the process of integrating Novitium’s policies, processes, people, technology, and operations into the consolidated company, and integrating Novitium’s operations into our system of internal control over financial reporting.

As permitted by the Securities and Exchange Commission rules, we excluded Novitium from the assessment of internal control over financial reporting for the year ending December 31, 2021.

Other Information

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Not applicable.

Directors, Executive Officers, and Corporate Governance

8 unchanged sentences

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

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.

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 2022 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

1 unchanged sentence

Principal Accountant Fees and Services

Our independent registered public accounting firm is EisnerAmper LLP , Philadelphia, Pennsylvania , Auditor Firm ID:

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 2022 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.

17 unchanged sentences

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.

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

Incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 9, 2021 (File No.

Certificate of Amendment of the Restated Certificate of Incorporation of BioSante Pharmaceuticals, Inc., dated as of July 17, 2013, Certificate of Amendment of the Restated Certificate of Incorporation of BioSante Pharmaceuticals, Inc., dated as of June 1, 2012, and Restated Certificate of Incorporation of BioSante Pharmaceuticals, Inc.

2 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.

Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock of the Company, effective as of November 19, 2021.

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 November 26, 2021 (File No.

Description of Securities

Filed herwith

Incorporated by reference to Exhibit 4.1 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (File No.

Registration Rights Schedule to the Merger Agreement, effective as of November 19, 2021

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.

1 unchanged sentence

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 Arthur S.

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.

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.

Method of Filing

Amendment No.

16 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, 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.

14 unchanged sentences

Form of Option Agreement

Filed herewith

Incorporated by reference to Exhibit 10.20 to ANI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 (File No.

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

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, 2020 (File No.

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.

Method of Filing

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.

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

Filed herewith

Master Product Development and Collaboration Agreement, dated as of July 11, 2011, by and among ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc.

and RiconPharma LLC (2)

Filed herewith

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

Filed herewith

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

Filed herewith

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

Filed herewith

List of subsidiaries

10 unchanged sentences

The following financial information from this annual report on Form 10-K for the fiscal year ended December 31, 2021, 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;

(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 Mezzanine Equity and Stockholders’ Equity;

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

Filed herewith

Method of Filing

The cover page from the Company Annual Report on Form 10-K for the year ended December 31, 2021 formatted in inline XBRL (included in Exhibit 101)

2 unchanged sentences

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.

(2) Confidential treatment has been granted with respect to redacted portions of this document or certain information has been omitted from this exhibit in accordance with Regulation S-K Item 601(b)(10)(iv).

The Company agrees to furnish supplementally a copy of any omitted information to the Securities and Exchange Commission upon its request.

* 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).

8 unchanged sentences

/s/ Stephen P.

Vice President, Finance and

Senior Vice President, Finance and

Chief Financial Officer

7 unchanged sentences

Chief Executive Officer

(principal executive officer)

/s/ Stephen P.

Senior Vice President, Finance and

Chief Financial Officer

(principal financial and accounting officer)

March 15, 2022

/s/ Muthusamy Shanmugam

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

March 15, 2022

Muthusamy Shanmugam

/s/ Patrick D.

13 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