Current Report Filing (8-k)
December 09 2021 - 10:47AM
Edgar (US Regulatory)
0001053369
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0001053369
2021-12-09
2021-12-09
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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
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22-3542636
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(State
or other jurisdiction
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(Commission
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(IRS
Employer
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of
incorporation)
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File
Number)
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Identification
No.)
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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:
☐
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
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☐
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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
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Trading
Symbol(s)
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Name
of each exchange on which registered
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Common
Stock, par value $0.001 per share
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ELTP
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OTCQB
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Item
1.01 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.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit
No.
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Description
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104
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Cover
Page Interactive Data File (embedded within the Inline XBRL document).
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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:
December 9, 2021
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ELITE
PHARMACEUTICALS, INC.
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By:
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/s/
Nasrat Hakim
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Nasrat
Hakim, President and CEO
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