ACURA PHARMACEUTICALS, INC. (NASDAQ:ACUR) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01
Entry into a Material Definitive Agreement. |
License, Commercialization and Option Agreement with
MainPointe Pharmaceuticals, LLC
On March 16, 2017, Acura Pharmaceuticals, Inc. (we or the
Company) entered into a License, Commercialization and Option
Agreement (the Agreement) with MainPointe Pharmaceuticals, LLC, a
Kentucky limited liability company (MainPointe) to commercialize
Nexafed and Nexafed Sinus Pressure Pain in the United States and
Canada. Nexafed and Nexafed Sinus Pressure Pain utilize our
Impede technology and are currently marketed by us in the United
States. Our Impede technology is directed at minimizing the
extraction and conversion of pseudoephedrine, or PSE, into
methamphetamine. Under the terms of the Agreement we are
transferring existing inventory and equipment relating to such
products to MainPointe and licensing our Impede technology
intellectual property rights to MainPointe for such products as
well as certain future PSE-containing products. MainPointe is
responsible for all development, manufacturing and
commercialization activities with respect to products covered by
the Agreement.
On signing, MainPointe paid us an upfront licensing fee of $2.5
million plus approximately $425,000 for inventory and equipment
being transferred. We will receive a 7.5% royalty on sales of
licensed products. The royalty payment for each product will
expire on a country-by-country basis when the Impede patent
rights for such country have expired or are no longer valid;
provided that if no Impede patent right exists in a country, then
the royalty term for that country will be the same as the royalty
term for the United States. After the expiration of a royalty
term for a country, MainPointe retains a royalty free license to
our Impede technology for products covered by the Agreement in
such country.
MainPointe has the option to expand the territory beyond the
United States and Canada to the European Union (and the United
Kingdom), Japan and South Korea for payments of $1 million,
$500,000 and $250,000, respectively. In addition, MainPointe has
the option to add to the Agreement certain additional products,
or Option Products, containing PSE and utilizing the Impede
technology for a fee of $500,000 per product (for all product
strengths). If the territory has been expanded prior to the
exercise of a product option, the option fee will be increased to
$750,000 per product. If the territory is expanded after the
payment of the $500,000 product option fee, a one-time $250,000
fee will be due for each product. If a third party is interested
in developing or licensing rights to an Option Product,
MainPointe must exercise its option for that product or its
option rights for such product will terminate.
The Agreement may be terminated by either party for a material
breach of the other party, or by Acura if MainPointe challenges
certain of its patents. Upon early termination of the Agreement,
MainPointes licenses to the Impede technology and all products
will terminate. Upon termination, at Acuras request the parties
will use commercially reasonable efforts to transition the
Nexafed and Nexafed Sinus Pressure Pain products back to Acura.
A press release regarding the Agreement is attached as Exhibit
99.1.
The inclusion of a description of the Agreement under Item 1.01
of this Current Report on Form 8-K shall not be deemed an
acknowledgement that the Agreement is a material agreement not
made, or deemed not to be made, in the ordinary course of our
business.
Amendment to Loan Agreement with Oxford Finance
On March 16th, 2017, we, and our subsidiary, Acura Pharmaceutical
Technologies, Inc. (APT, and together with Acura, the Borrowers)
and Oxford Finance LLC (Oxford or the Lender), as collateral
agent and as lender, entered into an amendment dated as of March
15, 2017 (the Amendment) to the Loan and Security Agreement (the
Loan Agreement) dated December 27, 2013, as previously amended,
to which the Lender made a term loan to us in the principal
amount of $10.0 million (the Term Loan). to the Amendment, (i)
the Borrowers granted the Lender a security interest in their
intellectual property, subject to the rights of existing
licensees; (ii) the Lender consented to the terms of our
Agreement withMainPointe (as described above); and (iii) with
respect to the fiscal year ended December 31, 2016 only, the
Lender waived the requirement that we receive an unqualified
opinion from our auditor with respect to our audited financial
statements.
Item 2.01 |
Completion of Acquisition or Disposition of Assets. |
Item 1.01 is incorporated by reference.
Item 2.03 |
Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant. |
The Section of Item 1.01 entitled Amendment to Loan Agreement
with Oxford Finance is incorporated herein by reference.
This Report contains forward-looking statements about Nexafed
products and Impede technology. However, substantial risks and
uncertainties exist in the process of commercialization and
further development and regulatory review with respect to such
further development. There can be no assurance that Nexafed and
Nexafed Sinus Pressure Pain or that other products utilizing
Impede technology will prove to be commercially successful or
that they will be developed in other strengths or for other
countries Accordingly, investors in the Company should recognize
that there is no assurance that the Company will receive any of
the royalties described above or any payments for exercising an
option for the additional products or territories. Furthermore
that the Company may not be able to continue in business or fund
its continuing operations without additional capital, whether
raised through strategic transactions or in the capital markets
or through receipt of royalty payments. Currently royalties
received are not sufficient to sustain our operations. For
further discussion of these and other risks and uncertainties,
see the Companys Annual Report on Form 10-K for the year ended
December 31, 2015, under the heading Risks Factors, and its most
recent quarterly report on Form 10-Q and its other public
disclosures filed with the U.S. Securities and Exchange
Commission.
Item 9.01 | Financial Statements and Exhibits |
Exhibit Number | Description | |
99.1 | Press Release of the Registrant dated March 16th, 2017. |
About ACURA PHARMACEUTICALS, INC. (NASDAQ:ACUR)
Acura Pharmaceuticals, Inc. is a pharmaceutical company. The Company is engaged in the research, development and commercialization of technologies and products intended to address medication abuse and misuse. The Company has discovered and developed three platform technologies, which can be used to develop multiple products. The Company’s Oxaydo Tablets (oxycodone HCl, CII), which utilizes the Aversion Technology, is an approved and immediate-release (IR) oxycodone product in the United States. The Company’s Impede technology products include Nexafed and Nexafed Sinus Pressure + Pain. Its third deterrent technology is Limitx, which is designed to retard the release of active drug ingredients when too many tablets are accidently or purposefully ingested. The Company’s Aversion and Limitx technologies are intended to address methods associated with opioid and its Impede technology is directed at the extraction and conversion of pseudoephedrine into methamphetamine. ACURA PHARMACEUTICALS, INC. (NASDAQ:ACUR) Recent Trading Information
ACURA PHARMACEUTICALS, INC. (NASDAQ:ACUR) closed its last trading session up +0.040 at 0.550 with 513,075 shares trading hands.