Wednesday, April 01, 2020 1:59:44 PM
"Under the terms of the Agreement, the product will be owned jointly by Elite and SunGen. Elite shall have the exclusive right to market and sell the product using Elite's label. Elite will also manufacture and package the product on a cost-plus basis."
https://elite.irpass.com/profiles/investor/ResLibraryView.asp?ResLibraryID=87711&GoTopage=2&Category=2163&BzID=2258&t=2180&G=939
The last 10Q also provides this info on the the Elite, SunGen Pharma and
Lannett partnerships:
Page F26:
https://s3.amazonaws.com/sec.irpass.cc/2258/0001213900-20-003097.pdf
On August 24, 2016, the Company entered into the SunGen Agreement. The SunGen Agreement provides that Elite and SunGen Pharma LLC will engage in the research, development, sales, and marketing of four generic pharmaceutical products. Two of the products are classified as CNS stimulants (the “CNS Products”) and two of the products are classified as beta blockers (the “Beta Blocker Products”).
Under the terms of the SunGen Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will share in the profits from sales of the Products. Upon approval, the know-how and intellectual property rights to the products will be owned jointly by Elite and SunGen. SunGen shall have the exclusive right to market and sell the Beta Blocker Products using SunGen’s label and Elite shall have the exclusive right to market and sell the CNS Products using Elite’s label. Elite will manufacture and package all four products on a cost-plus basis.
On December 1, 2016 and July 24, 2017, Elite Labs and SunGen executed an amendment to the parties’ 2016 Development and License Agreement (the “Amended Agreement”), to undertake and engage in the research, development, sales and marketing of four additional generic pharmaceutical products bringing the total number of products under the amended agreement to eight. The product classes for the additional four products include antidepressants,antibiotics,and antispasmodics.
Under the terms of the Amended Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will share substantially in the profits from sales of the products. Upon approval, the know-howand intellectual property rights to the products will be owned jointly by Elite and SunGen. Three products will be owned jointly by Elite and SunGen; three shall be owned by SunGen while Elite shall have the marketing rights once the products are approved by the FDA; and two shall be owned by Elite while SunGen shall have the marketing rights once the products are approved by the FDA. Elite will manufacture and package all eight products on a cost-plus basis.
On December 10, 2018, the Company received approval from the FDA for an ANDA filed fora generic version of Adderall®,an immediate-release mixed salt ofa single entity amphetamine product (Dextroamphetamine Saccharate,Amphetamine Aspartate, Dextroamphetamine Sulfate,Amphetamine Sulfate), with strengths of 5mg, 7.5mg. 10mg, 12.5mg, 15mg, 20mg, and 30mg tablets. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. This approval represents the first FDA approval received for a product co-developed with SunGen under the SunGen Agreement. The first commercial shipment of this product occurred in April 2019. The product is currently marketed by Lannett Company Inc. (“Lannett”) under license granted pursuant a strategic marketing alliance dated March 6, 2019 (the “Lannett Alliance”).
The information shown above clearly shows Elite will have a share in the sales profits as well as garner revenue from the manufacturing and packaging of the Adderall XR product on a cost plus basis.
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