exv10w14






Exhibit 10.14




Cornerstone Biopharma, Inc.




2000 Regency Parkway, Suite 244




Cary, NC 275l8




February 15, 2008




Allan M. Weinstein, M.D.

Pharmaceutical Innovations, LLC

3301 New Mexico Avenue, N.W., Suite 302

Washington, D.C. 20016




Re: Cornerstone License Agreement dated August 31, 2006, as amended — Second Amendment




Dear Allan:



This letter will serve to reflect our agreement regarding an amendment of the above-referenced
license agreement (the “Agreement”). As you know, Cornerstone Biopharma, Inc. (“Cornerstone”)
exercised its right under Section 6.03 of the Agreement to terminate the Agreement with respect to
the Licensed Product referenced in Section 1.10(ii) (Allerx HC) by providing written notice to
Pharmaceutical Innovations, LLC on December 22, 2007 of such intent. The parties wish to amend the
Agreement to reflect such partial termination as well as make other modifications to the Agreement.



Section 1.10 of the Agreement is hereby deleted in its entirety and replaced with the following.





“1.10. Licensed Products” shall mean the following prescription day-night
products which fall within the scope of one or more valid claims of any PI
Patent: (i) a product (which may be known as AlleRx PE) consisting of 40 mg.
phenylephrine/2.5 mg. methscopolamine nitrate, for daytime use and 10 mg.
phenylephrine/8 mg. chlorpheniramine maleate/2.5 mg. methscopolamine nitrate
for nighttime use; and (ii) a product consisting of 120 mg.
pseudoephedrine/2.5 mg. methscopolamine nitrate, for daytime use and 8 mg.
chlorpheniramine maleate/2.5 mg. methscopolamine nitrate/an attenuated dose
of pseudoephedrine or phenylephrine for nighttime use.


Section 4.03 of the Agreement is hereby deleted in its entirety and replaced with the following:





“4.03 With respect to the Licensed Products referenced in Section 1.10
hereof, Cornerstone shall pay to PI Minimum Royalty Payments equal to Three
Hundred Thousand Dollars ($300,000) per Calendar Year for the term of this
Agreement beginning with Calendar Year 2007 and ending at the beginning of
the Seven Year Period (such Minimum Royalty Payments to be pro rated for
periods of less than twelve months); provided, however, that the Minimum
Royalty Payments for Calendar Year 2007 shall be One Hundred Fifty Thousand
Dollars ($150,000). To clarify regarding pro













 







ration, by way of example, if the PI Patents expire on August 31, 2011, the
Minimum Royalty Payment for that Calendar Year shall be 66 2/3% of $300,000
or $200,000.”


Please sign where indicated below to confirm that this letter constitutes the Second Amendment to
the Agreement and that Sections 1.10 and 4.03 now read as shown above.




	 	 	 	 	 
	 	Very truly yours,

 	 
	 	/s/ Craig Collard
 	 
	 	Craig Collard/President & Chief Executive Officer 	 
	 	 	 
	 



	 	 	 
	Acknowledged and agreed:

	 	 
	 
	 	 
	Pharmaceutical Innovations, LLC
	 	 
	 
	 	 
	/s/ Allan Weinstein
	 	 
	 
	 	 
	Name: Allan Weinstein, M.D.
	 	 
	Title: President
	 	 
	Date: 2-15-2008
	 	 

















 








Termination and Mutual Release Agreement




     This Termination and Mutual Release Agreement (this “Agreement”) is made and entered into
effective as of February 15, 2008, by and between (i) Pharmaceutical Innovations, LLC (“PI”) and
(ii) Cornerstone BioPharma, Inc. (“Cornerstone”).



RECITALS:




     R-1. PI and Cornerstone are parties to a certain Cornerstone License Agreement dated August
31, 2006 (the “License Agreement”) relating to the commercialization of a product with amoxicillin
clavulante and a decongestant expectorant or another anti-infective and decongestant expectorant.



     R-2. PI and Cornerstone desire to terminate the License Agreement, and to settle all claims
and obligations, known and unknown, related to the Agreement and the Licensed Product.



     NOW THEREFORE, in consideration of the mutual promises set forth herein, and other good and
valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties
hereto agree as follows:



     1. Incorporation of Recitals. The preambles set forth above are incorporated herein
and made a substantive part of this Agreement.



     2. Definitions.



     (a) References in this Agreement to PI and to Cornerstone shall mean those entities and their
respective owners, employees, principals, partners, members, managers, directors, officers,
affiliates, parent or subsidiary companies, predecessors, successors, assigns, designees,
subcontractors or consultants, attorneys and insurers, whether past, present or future.



     (b) As used herein, “Claims” means any and all claims, cross-claims, demands, actions, causes
of action, rights, suits, judgments, liens, damages, attorneys’ fees, interest, losses of service,
expenses, costs and compensation of any nature whatsoever accruing through the date of this
Agreement, known or unknown, disclosed or undisclosed, whether in law or equity or otherwise,
liquidated or contingent, and relating to or arising out of or based upon any act, condition,
occurrence or transaction relating to the License Agreement or the Licensed Product, except for any
claims arising from the terms of this Agreement.



     3. Mutual Releases.



     (a) Release by PI. In consideration of the terms of this Agreement, PI hereby fully
and forever releases, acquits, and discharges Cornerstone from any and all Claims.



     (b) Release by Cornerstone. In consideration of the terms of this Agreement,
Cornerstone hereby fully and forever releases, acquits, and discharges PI from any and all Claims.













 





     4. Termination of License Agreement. The parties acknowledge and agree that the
License Agreement is hereby terminated and shall be deemed null and void and of no further effect.



     5. Miscellaneous.



     (a) Cooperation. The parties hereto hereby agree to execute and deliver any and all
other instruments or documents necessary to carry out this Agreement. The parties shall cooperate
fully with each other and with their respective counsel in connection with any steps required to be
taken as part of their respective obligations under this Agreement. Except as otherwise provided
herein, each party shall bear its own costs and expenses incurred in connection with such
cooperation.



     (b) Entire Agreement; No Oral Modification. This writing constitutes the entire
agreement of the parties with respect to the subject matter hereof and may not be modified, amended
or terminated except by a written agreement specifically referring to this Agreement and signed by
the parties hereto prior to the effective date of any such modification, amendment or termination.



     (c) Governing Law. This Agreement shall be governed by and interpreted in accordance
with the laws of the State of Maryland.



     (d) Counterparts. This Agreement may be executed in one or more counterparts, and
shall be effective when all parties have signed a counterpart hereof.



     IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above
written.



	 	 	 	 	 	 	 	 	 
	Pharmaceutical Innovations, LLC	 	 	 	Cornerstone BioPharma, Inc.
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ Allan M. Weinstein
	 	 	 	By:
	 	/s/ Craig Collard
	 

	 	 
	 	 	 	 	 	 
	Allan M. Weinstein, M.D.	 	 	 	Craig Collard
	President	 	 	 	President and CEO







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