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Exhibit 10.1

AMENDMENT NO. 1 TO DEVELOPMENT AND MANUFACTURING AGREEMENT

     This Amendment No. 1 to Development and Manufacturing Agreement (this “Amendment”) is dated June 16, 2009 (the “Amendment Date”), by and between Cornerstone BioPharma, Inc. a Nevada corporation with its principal offices located at 1255 Crescent Green Drive, Suite 250, Cary, NC 27518 (“Company”), NEOS Therapeutics, L.P., a Texas limited partnership (“Manufacturer”) with its principal offices located at 2940 N. Hwy. 360, Suite 100, Grand Prairie, TX 75050 and Coating Place, Inc. , a Wisconsin corporation (“Supplier”) with its principal offices located at 200 Paoli Street, P.O. Box 930310, Verona, WI, 53593. Manufacturer, Supplier and Company sometimes are referred to herein individually as a “Party” and collectively as the “Parties.”

     The effective date of this Amendment (the “Effective Date”) shall be [***].

     WHEREAS, the Parties previously entered into that certain Development and Manufacturing Agreement dated as of February 27, 2008 (the “Development Agreement”), as supplemented by an Addendum dated as of June 19, 2008 (the “Addendum”, together with the Development Agreement, are referred herein to as the “Agreement”); and

     WHEREAS, the Parties desire to amend certain terms of the Agreement by way of this Amendment.

     NOW, THEREFORE, in consideration of the promises made herein and other good and valuable consideration, the receipt and sufficiency of all of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:

     1. All capitalized terms used in this Amendment and not otherwise defined herein shall have the meanings given to them in the Agreement.

     2. The following Definitions are hereby added to Section 1 of the Agreement:

“Billable Rate” means the rate at which work is billed and is less than or equal to [***] per hour unless mutually agreed upon in writing by the Parties in advance of work performed.

“Gross Revenues” means the gross amounts invoiced by Company and its affiliates and/or sublicensees on sales of the Product. Transfers of Product among Company and its affiliates and/or sublicensees for the purpose of subsequent resale to third parties will not generate gross revenues with respect to such transfers but the gross amounts invoiced in connection with the subsequent resale of the Product to third parties will be included in the calculation of Gross Revenues.

“Net Sales” means the Company’s Gross Revenues less customary reductions, including but not limited to the following: discounts, launch

 

[***]

 

Confidential portions of the exhibit have been omitted and filed separately with the Securities and Exchange Commission.

 


 

or stocking discounts, returns, rebates, chargebacks, transportation and insurance expenses, and tariffs, duties, excises and sales taxes imposed upon and paid directly with respect to such sales, all calculated in accordance with GAAP.

     3. The Definition in Section 1


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