UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): June 16, 2009
Cornerstone Therapeutics Inc.
(Exact Name of Registrant as Specified in Its Charter)
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| Delaware
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000-50767
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04-3523569 |
| (State or Other Jurisdiction
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(Commission
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(IRS Employer |
| of Incorporation)
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File Number)
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Identification No.) |
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| 1255 Crescent Green Drive, Suite 250, Cary, NC
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27518 |
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(Zip Code) |
Registrant’s telephone number, including area code: (919) 678-6611
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)) |
TABLE OF CONTENTS
Item 1.01. Entry into a Material Definitive Agreement.
On June 16, 2009 Cornerstone Therapeutics Inc. (the “Company”), Neos Therapeutics, L.P. (“Neos”)
and Coating Place, Inc. (“Coating Place”) entered into an amendment (the “Amendment”) to the
development and manufacturing agreement by and among Neos, Coating Place and Cornerstone BioPharma,
Inc. (“CBI”), a wholly owned subsidiary of the Company, entered into on February 27, 2008, and
supplemented on June 19, 2008 (the “Neos/Coating Place Development Agreement”).
Under the Neos/Coating Place Development Agreement, CBI obtained an exclusive license under Neos’s
patent-pending Dynamic Variable Release® technology and Dynamic Time Release Suspension® technology
and Coating Place’s patent-pending drug resin complex technology to develop, manufacture and
commercialize extended-release antihistamine and antitussive combination products (“Product”) to
compete directly in the U.S. narcotic cough suppressant market, subject to obtaining necessary
approvals from the FDA.
The Amendment modifies the Neos/Coating Place Development Agreement primarily to clarify (i) the
amounts payable to Neos related to manufacturing and supplying Product, (ii) the amounts payable to
Coating Place for supply of its drug resin complex used in manufacturing Product, (iii) the
Company’s allowable expenses for purposes of determining the net profits from sales of Product,
(iv) the characteristics and specifications of Product, and (v) the technology licensed by Neos and
Coating Place will include any of their respective new patent applications or divisions or
continuations of existing patent applications with valid claims that cover the Product.
Additionally, the Amendment provides that the Company may at any time expand the territory for the
Neos and Coating Place technology licenses to include any other countries besides the U.S. The
Amendment also amends the termination provisions to provide that any party may terminate the
agreement if a Product is not commercially launched on or before February 27, 2015. Prior to the
Amendment, this termination right was allowed if commercial launch did not occur by February 27,
2013. Finally, the Amendment also makes certain administrative adjustments to several other
provisions of the Neos/Coating Place Development Agreement, including with respect to payment terms
under the agreement. All terms of the Neos/Coating Place Development Agreement not modified by the
Amendment remain in full force and effect.
In addition to the Neos/Coating Place Development Agreement, in March 2008, CBI and Neos entered
into a development, license and service agreement pursuant to which CBI obtained an exclusive
license under Neos’s patent-pending Dynamic Variable Release® technology to develop, manufacture and
commercialize an anticholinergic and antihistamine combination product in the United States,
subject to obtaining necessary approvals from the FDA. In August 2008, CBI and Neos entered into a
products development agreement, which amended and restated an earlier agreement CBI and Neos had
entered into in December 2006, pursuant to which CBI engaged Neos to develop extended-release
liquid products to be sold by doctor’s prescription only using Neos’s patent-pending Dynamic Time
Release Suspension® technology.
A copy of the Amendment is attached as Exhibit 10.1 to this Current Report on Form 8-K, and the
Company refers you to such exhibit for the complete terms of the Amendment, which are incorporated
herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
See the Exhibit Index attached hereto.