exv10w1






Exhibit 10.1




AMENDMENT NO. 4




relating to that certain



SPONSORED RESEARCH AND LICENSE AGREEMENT



between



CORNERSTONE THERAPEUTICS INC., FORMERLY KNOWN AS CRITICAL

THERAPEUTICS, INC.,



and



THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH



dated as of



JANUARY 1, 2003



THIS AMENDMENT NO. 4 is made the 3rd day of August, 2010




BETWEEN:





	(1)	 	Cornerstone Therapeutics Inc., formerly known as Critical Therapeutics, Inc., a Delaware
corporation (“CTI”); and
	 
	(2)	 	The Feinstein Institute for Medical Research, a New York not-for-profit corporation
(“Feinstein”)





RECITALS:





	 	(A)	 	CTI and Feinstein entered into a Sponsored Research and License Agreement, dated
January 1, 2003.
	 
	 	(B)	 	The said Sponsored Research and License Agreement was modified by that certain Letter
Agreement between CTI and Feinstein dated February 3, 2004, and was amended by each of
Amendment No. 1 dated September 18, 2006, Amendment No. 2 dated January 8, 2007 and
Amendment No. 3 dated June 29, 2007 and that certain Letter Agreement effective September
26, 2007. The Sponsored Research and License Agreement as so modified and so amended is
referred to herein as the “Original Agreement”.
	 
	 	(C)	 	In November 2008, Cornerstone BioPharma Holdings merged with Critical Therapeutics,
Inc. and Critical Therapeutics, Inc. changed its name to Cornerstone Therapeutics Inc.
	 
	 	(D)	 	CTI and Feinstein have agreed to amend the Original Agreement by and upon the terms
of this Amendment No. 4.







 




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




1









 










OPERATIVE PROVISIONS:




1. Introduction, Definitions and Interpretation





	1.1.	 	This Amendment No. 4 is supplemental to the Original Agreement.
	 
	1.2.	 	In this Amendment No. 4, the expression “this Amendment No. 4” shall mean this Amendment No.
4, including its recitals and schedules.
	 
	1.3.	 	Except where expressly provided to the contrary in this Amendment No. 4:






	 	1.3.1	 	all capitalized terms used in this Amendment No. 4 shall have the same
meanings as are assigned thereto in the Original Agreement, as amended by this
Amendment No. 4; and
	 
	 	1.3.2	 	this Amendment No. 4 shall be interpreted in the same manner as the Original
Agreement.






	1.4.	 	References to clauses and Articles herein are to clauses and Articles of the Original
Agreement.





2. Amendments



NOW THEREFORE, in consideration of the mutual covenants contained in the Original Agreement and in
this Amendment No. 4 and other good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the parties agree that with effect from the Amendment No. 4 Date (as
defined below), the Original Agreement is hereby amended as follows:



2.1.
Article 1 shall be amended by insertion of the following additional definition after Article 1.2(d).:



     “1.2(e). “Amendment No. 4 Date” shall mean August 3rd, 2010.”


2.2. The parties acknowledge and agree that Cornerstone Therapeutics Inc. has succeeded to Critical
Therapeutics, Inc.’s interest in the Original Agreement, that all references to Critical
Therapeutics, Inc. or CTI in the Original Agreement are references to Cornerstone Therapeutics Inc.
and that Cornerstone Therapeutics Inc. is required to satisfy the obligations of Critical
Therapeutics, Inc. set forth in the Original Agreement.



2.3. The parties acknowledge and agree that the Research Term has expired.



2.4. The parties acknowledge and agree that prior to the Amendment No. 4 Date, CTI returned certain
Feinstein Patent Rights to Feinstein pursuant to Section 5.4 of the




2









 







Original Agreement and made certain changes to the Field of the Original Agreement. By this Amendment No. 4, CTI and Feinstein
negate and nullify the prior return of any and all Feinstein Patent Rights and also negate and
nullify any and all prior changes to the Field. An amended, updated and restated Schedule 1.7,
including all patent applications and patents included in the definition of Feinstein Patent Rights
as of the Amendment No. 4 Date is attached hereto as Exhibit A and is incorporated herein. The
Schedule 1.7 attached hereto as Exhibit A supersedes and replaces all prior versions of Schedule
1.7.



2.5. The parties acknowledge and agree that the following patent applications (which are included
in Schedule 1.7) and all patent rights claiming priority (directly or indirectly) thereto are
jointly owned by Feinstein and SetPoint Medical Corporation (formerly Innovative Metabolics, Inc.),
a Delaware corporation (“SetPoint”): U.S. Patent Application No. [***] and PCT Patent Application
No. [***], “[***]”, and U.S. Patent Application No. [***] and PCT Patent Application No. [***],
“[***]”. CTI acknowledges and agrees that there is no agreement between SetPoint and CTI regarding
these jointly owned patent rights and that all rights granted by Feinstein to CTI for these jointly
owned patent rights are subject to and limited by SetPoint’s rights under 35 U.S.C. Section 262.



2.6. The parties acknowledge and agree that the following patent applications (which are included
in Schedule 1.7) and all patent rights claiming priority (directly or indirectly) thereto are
jointly owned by Feinstein and a third party (presumably [***]): U.S. Patent Application No. [***]
and PCT Patent Application No. [***], “[***]”. CTI acknowledges and agrees that there is no
agreement between the third party and CTI regarding these jointly owned patent rights and that all
rights granted by Feinstein to CTI for these jointly owned patent rights are subject to and limited
by the third party’s rights under 35 U.S.C. Section 262.



2.7. CTI hereby acknowledges and agrees that the following patent applications (which are not
included in Schedule 1.7) and all patent rights claiming priority (directly or indirectly) thereto
are owned solely by SetPoint: U.S. Provisional Patent Application No. [***] and U.S. Utility
Patent Application No. [***], “[***]”, and U.S. Provisional Patent Application Nos. [***] and [***]
and PCT Patent Application No. [***], “[***]”.



2.8 With respect to those Feinstein Patent Rights previously returned to Feinstein by CTI and
referenced above in paragraph 2.4 of this Amendment No. 4, CTI acknowledges its obligation
consistent with Article 5.2 of the Original Agreement to reimburse Feinstein for all of the patent
prosecution costs incurred by Feinstein following such return. In full settlement of such
obligation, upon execution of this Amendment No. 4, CTI shall pay to Feinstein the amount of [***]
Dollars ($[***]).




3. No Other Amendments; Confirmation






 




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




3









 









Save as amended by this Amendment No. 4, the parties hereto confirm that the Original
Agreement shall continue in full force and effect in all respects.




4. Counterparts



This Amendment No. 4 may be signed in any number of counterparts with the same effect as if the
signatures to each counterpart were upon a single instrument, and all such counterparts together
shall be deemed an original of this Amendment No. 4.




5. Governing Law and Jurisdiction



This Amendment No. 4 shall be governed by and construed in accordance with the laws of the State of
New York without regard to any conflict of laws provisions thereof.



IN WITNESS whereof the parties have executed and delivered this Amendment No. 4 as of the Amendment
No. 4 Date.




	 	 	 	 	 
	CTI



Cornerstone Therapeutics Inc.

 	 	 
	By:  	/s/ Andrew Powell
 	 	 
	 	Name:  	Andrew Powell 	 	 
	 	Title:  	Secretary 	 	 
	 
	Feinstein



The Feinstein Institute For Medical Research

 	 	 
	By:  	/s/ Kirk R. Manogue, PhD
 	 	 
	 	Name:  	Kirk R. Manogue, PhD 	 	 
	 	Title:  	Vice President, Technology Transfer 	 	 



4









 






	 	 	 	 	 



EXHIBIT A to AMENDMENT No. 4




SCHEDULE 1.7



	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
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	Docket	 	Docket	 	 	 	 	 	 	filing date and	 	 	 	 	 	 	 
	Number	 	Number	 	 	Application Title	 	 	priority	 	 	Inventor(s)	 	 	Status	 
	[***]
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	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 








 




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




5









 










	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	CRTX	 	Attorney	 	 	 	 	 	 	Application number,	 	 	 	 	 	 	 
	Docket	 	Docket	 	 	 	 	 	 	filing date and	 	 	 	 	 	 	 
	Number	 	Number	 	 	Application Title	 	 	priority	 	 	Inventor(s)	 	 	Status	 
	[***]
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	[***]	 	Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.




6









 










	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	CRTX	 	Attorney	 	 	 	 	 	 	Application number,	 	 	 	 	 	 	 
	Docket	 	Docket	 	 	 	 	 	 	filing date and	 	 	 	 	 	 	 
	Number	 	Number	 	 	Application Title	 	 	priority	 	 	Inventor(s)	 	 	Status	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
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	[***]	 	Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.




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	CRTX	 	Attorney	 	 	 	 	 	 	Application number,	 	 	 	 	 	 	 
	Docket	 	Docket	 	 	 	 	 	 	filing date and	 	 	 	 	 	 	 
	Number	 	Number	 	 	Application Title	 	 	priority	 	 	Inventor(s)	 	 	Status	 
	[***]
	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 
	[***]
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	[***]
	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 








 




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




8









 










	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	CRTX	 	Attorney	 	 	 	 	 	 	Application number,	 	 	 	 	 	 	 
	Docket	 	Docket	 	 	 	 	 	 	filing date and	 	 	 	 	 	 	 
	Number	 	Number	 	 	Application Title	 	 	priority	 	 	Inventor(s)	 	 	Status	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]
	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(end)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 






 




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





9