AMENDMENT NO. 1 TO DEVELOPMENT AND MANUFACTURING AGREEMENT

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

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 for “Manufacturer Adjusted COGs” is hereby deleted in its entirety and replaced with the following:

“Manufacturer Adjusted COGs” means [***]. Manufacturer may increase Manufacturer Adjusted COGs up to [***] with at least [***] days written notice to Company and Supplier prior to the increase. If, for any reason, the Manufacturer desires to take an increase on Manufacturer Adjusted COGs by an amount greater than [***], Manufacturer shall provide written notice to Company and Supplier with appropriate justification for same, and Company and Supplier must agree in writing to the increase. If the requested increase is approved by Company and Supplier, such increase will not take effect until [***] days after the date Manufacturer’s written notice to Company and Supplier was delivered.

     4. The Definition in Section 1 for “Net Profits” is hereby deleted in its entirety and replaced with the following:

“Net Profits” means [***], all calculated in accordance with GAAP.

     5. The Definition in Section 1 for “Supplier Adjusted COGs” is hereby deleted in its entirety and replaced with the following:

“Supplier Adjusted COGs” means [***]. Supplier and Company further agree that in no event will Supplier Adjusted COGS be greater than Supplier’s true cost of manufacture of the Drug Resin Complex plus Supplier’s standard mark-up which shall be evidenced to Company via documentation for comparable Drug Resin Complexes, but in no event shall exceed [***] of Supplier’s true cost of manufacture. If for any reason the Supplier desires to take an increase Supplier Adjusted COGs by an amount greater than [***], Supplier shall provide written notice to Company and Manufacturer with appropriate justification for same, and Company and Manufacturer must agree in writing to the increase. If the requested increase is approved by Company and Manufacturer, such increase will not take effect until [***] days after the date Supplier’s written notice to Company and Manufacturer was delivered.