What changed in this filing

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Item 4. Controls and Procedures

2025-02-13 compared with 2024-11-14 · 32 added, 6 removed, 71 unchanged (35% of the section changed)

12 unchanged sentences

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 September 30, 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.

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

39 unchanged sentences

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 September 30, 2024 at the reasonable

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

assurance level.

13 unchanged sentences

in Internal Controls Over Financial Reporting

have been no changes in our internal controls over financial reporting during the six months ended September 30, 2024 that have materially

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.

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