Elite Pharmaceuticals Inc (ELTP)

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Like I said...




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Licensing, Manufacturing and Development Agreements
Sales and Distribution Licensing Agreement with Epic for Abuse-Deterrent ELI-200
On June 4, 2015, Elite Pharmaceuticals Inc. and its wholly-owned subsidiary Elite Laboratories, Inc. (collectively, “Elite”) executed an exclusive
License Agreement (the “Agreement”) with Epic Pharma LLC. (“Epic”), to market and sell in the United States, ELI-200, an undisclosed opioid
with sequestered naltrexone capsules, owned by Elite. Epic will have the exclusive right to market ELI-200 and its various dosage forms as listed
in Schedule A of the Agreement (the “Products”). Epic is responsible for all regulatory and pharmacovigilance matters related to the products.
Pursuant to the Agreement, Elite will receive a license fee and milestone payments. The license fee will be computed as a percentage of net sales
of the Products as defined in the Agreement by Epic. Elite will manufacture the product for sale by Epic on a cost plus basis and both parties
agree to execute a separate Manufacturing and Supply Agreement. The license fee is payable quarterly for the term of the Agreement. Epic shall
pay to Elite certain milestone payments as defined by the Agreement. The first milestone payment was due and was received upon signing the
agreement. Subsequent milestone payments are due upon the filing of a New Drug Application (“NDA”) with the U.S. Food and Drug
Administration (“FDA”) for the Products and upon receipt of the approval letter for the NDA from the FDA. The term of the License Agreement
is five years and may be extended for an additional five years upon mutual agreement of the parties. Elite can terminate the Agreement on 90
days’ written notice in the Event that Epic does not pay to Elite certain minimum annual license fees over the initial five year term of the
Agreement. Either party may terminate this Agreement upon a material breach and failure to cure that breach by the other party within a
specified period.
· Phendimetrazine 35mg
· Isradipine 2.5mg and Isradipine 5mg
· Hydroxyzine 10mg, Hydroxyzine 25mg and Hydroxyzine 50mg
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Manufacturing and License Agreement with Epic Pharma LLC
On October 2, 2013, Elite executed the Epic Pharma Manufacturing and License Agreement. This agreement granted Epic Pharma certain rights
to manufacture, market and sell in the United States and Puerto Rico the 12 approved ANDAs acquired by Elite pursuant to the Mikah Purchase
Agreement. Of the 12 approved ANDAs, Epic Pharma will have the exclusive right to market six products as listed in Schedule A of the Epic
Pharma Manufacturing and License Agreement, and a non-exclusive right to market six products as listed in Schedule D of the Epic Pharma
Manufacturing and License Agreement. Epic Pharma is responsible for all regulatory and pharmacovigilance matters related to the products and
for all costs related to the site transfer for all products. Pursuant to the Epic Pharma Manufacturing and License Agreement, Elite will receive a
license fee and milestone payments. The license fee will be computed as a percentage of the gross profit, as defined in the Epic Pharma
Manufacturing and License Agreement, earned by Epic Pharma a result of sales of the products. The manufacturing cost used for the calculation
of the license fee is a predetermined amount per unit plus the cost of the drug substance (API) and the sales cost for the calculation is
predetermined based on net sales. If Elite manufactures any product for sale by Epic Pharma, then Epic Pharma shall pay to Elite that same
predetermined manufacturing cost per unit plus the cost of the API. The license fee is payable monthly for the term of the Epic Pharma
Manufacturing and License Agreement. Epic Pharma shall pay to Elite certain milestone payments as defined by the Epic Pharma Manufacturing
and License Agreement. To date, milestones totaling $1,000,000 have been earned and received in relation to the signing of the Epic Pharma
Manufacturing and License Agreement and the filing and approval by the FDA of supplements relating to the transfer of manufacturing site for
Isradipine 2.5mg and Isradipine 5mg. The term of the Epic Pharma Manufacturing and License Agreement is five years and may be extended for
an additional five years upon mutual agreement of the parties. Twelve months following the launch of a product covered by the Epic Pharma
Manufacturing and License Agreement, Elite may terminate the marketing rights for any product if the license fee paid by Epic Pharma falls
below a designated amount for a six month period of that product. Elite may also terminate the exclusive marketing rights if Epic Pharma is
unable to meet the annual unit volume forecast for a designated product group for any year, subject to the ability of Epic Pharma, during the
succeeding six month period, to achieve at least one-half of the prior year’s minimum annual unit forecast. The Epic Pharma Manufacturing and
License Agreement may be terminated by mutual agreement of Elite and Epic Pharma, as a result of a breach by either party that is not cured
within 60 days notice of the breach, or by Elite as a result of Epic Pharma becoming a party to a bankruptcy, reorganization or other insolvency
proceeding that continues for a period of 30 days or more.