ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
On July 24, 2017, Elite Laboratories, Inc. (“Elite”) (a subsidiary of Elite Pharmaceuticals, Inc.) and SunGen Pharma LLC (“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 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. 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.
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 28, 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 28, 2017 |
ELITE PHARMACEUTICALS INC /NV/ ExhibitEX-99.1 2 v471785_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Elite Announces Co-Development of Four Additional Products with SunGen Pharma 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.