ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
On July 6, 2016, Elite Laboratories, Inc. (“Elite”) (a subsidiary of Elite Pharmaceuticals, Inc.) and SunGen Pharma LLC (“SunGen”) executed a new agreement (the “Agreement”) to undertake and engage in the research, development, sales and marketing of generic pharmaceutical products. The parties will initially develop five generic products based upon a unique drug delivery platform technology used for extended release products. The parties may also develop additional such products using the technology. The product classes include CNS stimulants, anticonvulsives, antipsychotics, and antihypertensives.
Under the terms of the Agreement, Elite and SunGen will share the responsibilities and costs of the development of these products and will share in the profits from sales of the Products. Upon FDA approval, the know-how and intellectual property rights to the products will be owned jointly by Elite and SunGen. Elite and SunGen shall have the right to market and sell the Product(s) using their respective labels. Elite and SunGen shall be responsible for all permits, licenses, and distribution costs for the Product(s) Elite or SunGen sells. Elite will manufacture and package all products on a cost plus basis.
Either Party shall have the option to terminate this Agreement upon six months’ written notice to the other Party if, in the terminating Party's reasonable judgment, the Product ceases to be commercially viable. The Agreement also is terminable upon the occurrence of a "Termination Event" as defined in the Agreement, including standard solvency, breach of material terms and adverse changes in the intellectual property environment events.
For more information on the SunGen Agreement please see the July 12, 2017 press release, a copy of which is furnished herewith as Exhibit 99.1.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description |
| 99.1 | Press Release dated July 12, 2017. |
ELITE PHARMACEUTICALS INC /NV/ ExhibitEX-99.1 2 v470685_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Elite Announces New Development and License Agreement with SunGen Pharma LLC NORTHVALE,…To view the full exhibit click here
About ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP)
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company. The Company is principally engaged in the development and manufacture of oral, controlled-release products. The Company develops and manufactures generic products, products using controlled-release drug technology, products utilizing abuse deterrent technologies, and it develops and markets generic controlled-release and abuse deterrent pharmaceutical products. Its segments include Abbreviated New Drug Applications (ANDA’s) for generic products and New Drug Applications (NDA’s) for branded products. The Company owns approximately six different approved ANDA’s. The Company’s product, SequestOx, is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone, which incorporates five milligram, 10 milligram, 15 milligram, 20 milligram and 30 milligram doses of oxycodone into capsules. SequestOx is used for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.