Current Report Filing (8-k)
March 11 2019 - 4:04PM
Edgar (US Regulatory)
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
March 11, 2019 (March 7, 2019)
Date of Report (Date of earliest event reported)
ELITE PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its
charter)
Nevada
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001-15697
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22-3542636
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer 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)
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(Former name or former address, if changed since last report.)
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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 communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement 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. ☐
Item 1.01 Entry Into A Material Definitive Agreement.
On March 7, 2019, Elite Pharmaceuticals
Inc. (“Elite”) signed a License, Supply and Distribution Agreement with Lannett Company, Inc., (“Lannett”)
to market two Elite generic products in the United States. Lannett will be the exclusive U.S. distributor for two generic products
that Elite and SunGen Pharma (Princeton, NJ) co-developed and co-own.
The first product that Lannett will launch
is a generic version of
Adderall®, an immediate-release mixed salt of
a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine
Aspartate,
Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg tablets.
The second product is
an
extended-release CNS stimulant which
is under review by the FDA.
Under the Agreement, Lannett will provide sales,
marketing, and distribution for the products and Elite will manufacture the product. Lannett, Elite and SunGen will each receive
a share of the profits. The term of the License Agreement is three years
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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.
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ELITE PHARMACEUTICALS,
INC.
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Dated: March 11, 2019
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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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