What changed in this filing

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Item 4. Controls and Procedures

2025-08-14 compared with 2025-02-13 · 55 added, 66 removed, 37 unchanged (77% of the section changed)

1 unchanged sentence

of Disclosure Controls and Procedures

term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, refers to controls

and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits

under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and

Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required

to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s

management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding

required disclosure.

As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management, with the participation of our

Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the

end of the period covered by this Quarterly Report on Form 10-Q.

Based on that evaluation, our Chief Executive Officer and our Chief

Financial Officer concluded that our disclosure controls and procedures were not effective as of December 31, 2024 to ensure that

information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed,

summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms and such information

is accumulated and communicated to management as appropriate to allow timely decisions regarding required disclosures.

Report on Internal Control Over Financial Reporting

term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),

refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports

that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in

the Securities Exchange Commission’s (the “SEC”) rules and forms.

Disclosure controls and procedures include, without limitation, controls and procedures designed to

ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is

accumulated and communicated to the company’s management, including its principal executive officer and principal financial

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

As required by Rules 13a-15(b) and 15d-15(b) of the

Exchange Act, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the

effectiveness of our disclosure controls and procedures based on the criteria set forth by the Committee of Sponsoring Organizations

of the Treadway Commission on Internal Control (“COSO”), as of the end of the period covered by this Quarterly Report on

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

controls and procedures were not effective as of June 30, 2025 to ensure that information required to be disclosed by the Company in

reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods

specified in SEC rules and forms and such information is accumulated and communicated to management

as appropriate to allow timely decisions regarding required disclosures.

material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a

reasonable possibility that a misstatement of our annual or interim financial statements will not be prevented or detected on a timely

As of June 30, 2025, we identified the following control deficiencies that we believe constituted individually, and in the aggregate,

material weaknesses in the design and operation components of our internal controls within the COSO framework:

We were unable to formalize and implement revised controls, policies and procedure documentation to evidence a system of internal controls,

including testing of such revised controls, that was consistent with available personnel and resources;

We failed to maintain effective control activities over our control environment, risk assessment, information technology and monitoring

components and;

We had insufficient segregation of duties, oversight of work performed and lack of compensating controls in our finance and accounting

functions due to limited personnel and resources.

Management’s Report on Internal Control Over Financial Reporting

control over financial reporting refers to the process designed by, or under the supervision of, our Chief Executive Officer and Chief

Financial Officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding

Financial Officer, and effected by our Board, 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 generally

accepted accounting principles, and includes those policies and procedures that:(1) pertain to the maintenance of records that in reasonable

accepted accounting principles, and includes those policies and procedures that:

(i) pertain to the maintenance of records that in reasonable

detail accurately and fairly reflect the transactions and dispositions of our assets;

(2) provide reasonable assurance that transactions

(ii) provide reasonable assurance that transactions

are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles,

18 unchanged sentences

may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate.

given the inherent limitations in a cost-effective system of internal control, financial statement misstatements due to error or fraud

may occur and may not be detected.

Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance

of achieving their objectives.

We conduct periodic evaluations of our systems of controls to enhance, where necessary, our control policies

and procedures.

given the inherent limitations in a system of internal control, financial statement misstatements due to error or fraud may occur and

may not be detected.

Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance of achieving

their objectives.

We conduct periodic evaluations of our systems of controls to enhance, where necessary, our control policies and procedures.

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

5 unchanged sentences

over financial reporting.

Based on its evaluation, the Company has concluded that due to the material weaknesses in our internal control

over financial reporting noted below, our disclosure controls and procedures were not effective as of December 31, 2024 at the reasonable

assurance level.

We were unable to formalize and implement revised controls, policies and procedure documentation to evidence a system of internal controls,

including testing of such revised controls, that was consistent with available personnel and resources;

We failed to maintain effective control activities over our control environment, risk assessment, information technology and monitoring

We had insufficient segregation of duties, oversight of work performed and lack of compensating controls in our finance and accounting

functions due to limited personnel and resources.

Based on its evaluation, utilizing those criteria, management has determined that, as of June 30, 2025, because

of the material weaknesses described below, our internal control over financial reporting was not effective.

material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a

reasonable possibility that a misstatement of our annual or interim financial statements will not be prevented or detected on a timely

As of June 30, 2025, we identified the following control deficiencies that we believe constituted individually, and in the aggregate,

material weaknesses in the design and operation components of our internal controls within the COSO framework:

deficiencies in our internal controls over financial reporting and disclosure controls and procedures are described above and our efforts

to remediate these deficiencies are described below.

Please also see “Risk Factors” in Item 1A-Risk of our Annual Report on Form 10-K for the period ended March

in Internal Controls Over Financial Reporting

the quarter ended June 30, 2025, as a result of reviews and assessments of internal controls over financial reporting conducted by the

Company’s Chief Financial Officer, the Company identified material weaknesses in internal controls over financial reporting as further detailed above

and began remediation efforts which are detailed below, with such activities expected to result in further changes in internal control

over financial reporting as necessary to remediate the identified material weaknesses.

efforts to address material weaknesses in internal controls over financial reporting

2 unchanged sentences

management, analysis and reporting of operations emanating from the Company’s manufacturing, marketing and distribution of its

Elite Laboratory label product line.

Please note that these material weaknesses cannot be considered remediated until the applicable

remedial controls operate for a sufficient period of time, allowing management, through testing, to reach a conclusion on such controls

design and operational effectiveness.

in Internal Controls Over Financial Reporting

have been no changes in our internal controls over financial reporting during the nine months ended December 31, 2024 that have materially

affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Elite Label product line.

Please note that these material weaknesses cannot be considered remediated until the applicable remedial controls

operate for a sufficient period of time, allowing management, through testing, to reach a conclusion on such controls design and operational

effectiveness.

II - OTHER INFORMATION

LEGAL PROCEEDING S

filed a paragraph IV certification with its ANDA to generic Oxycontin and after Elite got acceptance of the ANDA by the FDA Elite

sent the patentee and NDA holder a Notice Letter.

This was followed by a patent infringement suit filed by Purdue Pharma in which

fifteen patents were asserted in Purdue’s Complaint.

parties submitted stipulations and proposed orders on January 12, 2024 and July 12, 2024 staying all matters for six months

with the possibility of further extensions subject to the court’s approval and based on the circumstances of the pending

Accord I and Accord II case.

The parties submitted a stipulation and proposed order on September 24, 2024 staying all matters until

the Federal Circuit’s decision in the pending the Accord I appeal.

has already asserted claims of infringement of certain patents against Accord Healthcare Inc.

In Purdue Pharma L.P., et al.

Accord Healthcare Inc.

, Civil Action No.

20-1362(RGA) in the District of Delaware (“the Accord I case”), the

district court found the asserted claims invalid due to obviousness;

that decision was affirmed by the Federal Circuit on December

Purdue is considering whether to seek Supreme Court review of the recent Federal Circuit decision in the Accord I case.

In another patent infringement case against Accord (“the Accord II case”),

the district court found the asserted claims of another patent invalid due to obviousness.

The parties submitted a stipulation and proposed order on January 30, 2025 staying the proceedings for 30 days to

enable the parties to meet and confer regarding the impact of the Accord I and Accord II decisions on this case.

have been no material changes in the risk factors described in our Annual Report on Form 10-K for the fiscal year ended March 31,

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

DEFAULTS UPON SENIOR SECURITIES

MINE SAFETY DISCLOSURES

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-Q

Item 4. Controls and Procedures