8-K - ELTP - Equibles

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

D.C. 20549

FORM

8-K

CURRENT

REPORT

PURSUANT

TO SECTION 13 OR 15(D)

OF

THE SECURITIES EXCHANGE ACT OF 1934

December 9, 2021

Date

of Report (Date of earliest event reported)

ELITE

PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Nevada	001-15697	22-3542636
(State<br> or other jurisdiction	(Commission	(IRS<br> Employer
of<br> incorporation)	File<br> Number)	Identification<br> No.)

165 Ludlow Avenue, Northvale, New Jersey

07647

(Address of principal executive offices)

(201)

750-2646

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common<br> Stock, par value $0.001 per share	ELTP	OTCQB

Item1.01 Entry Into A Material Definitive Agreement

On December 6, 2021, Elite Pharmaceuticals Inc. (“Elite”) signed a License and Distribution Agreement with Dexcel Ltd. (Or Akiva, Israel) to be the exclusive distributor of Elite’s generic version of Adderall® for Israel.

Elite’s generic version of Adderall® is an immediate-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate). Adderall^®^is a central nervous system (CNS) stimulant, indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Dexcel will market the 10 mg, 20 mg, and 30 mg tablets.

Elite will manufacture and package the generic product under Dexel’s label. Dexcel will provide sales, marketing, and distribution, at its own expense. Dexel will pay an agreed upon transfer price for the product and will share any profits when the net selling price exceeds a floor price. Elite’s generic Adderall® product is jointly owned by Elite and Mikah Pharma LLC . The License Agreement term is three years and may be extended for additional 1-year periods should specific terms be met.

Item9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit<br> No.	Description
104	Cover<br> Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated:<br> December 9, 2021	ELITE<br> PHARMACEUTICALS, INC.
	By:	/s/ Nasrat Hakim
		Nasrat<br> Hakim, President and CEO