AMENDMENT


 


 


This first Amendment to the Exclusive License Agreement between
NORTH CAROLINA STATE UNIVERITY (“NCSU”) and 22nd CENTURY LIMITED, LLC (“LICENSEE”)
executed March 6, 2009 (the “Agreement”) is entered into on the 9th day of August 2012, (“Amendment Effective
Date”).


 


WHEREAS, on June 22nd, 2009 the Family Smoking Prevention and
Tobacco Control Act was enacted granting the U.S. Food and Drug Administration (“FDA”) regulatory control over all
tobacco products; and


 


WHEREAS, Licensee has initiated a program for commercial development
of a Licensed Product that is a Smoking Cessation Aid under Investigational New Drug application 103,589 filed with the FDA and
completed a 238 subject Phase II trial in 2012; and


 


WHEREAS, as of the Amendment Effective Date, Licensee’s
research, development and commercialization of Licensed Products, including that of its former sublicensee, have satisfied Licensee’s
due diligence obligations; and


 


WHEREAS NCSU and LICENSEE, (collectively “the Parties”)
wish to amend the Agreement; and


 


NOW THEREFORE, in consideration of the mutual covenants
set forth herein, the Parties hereby agree as follows:


 


		1.	The Agreement is amended as follows:



 


		(a)	Paragraph 1.03 of the Agreement is amended to read as follows:



 


		1.03	“Materials(s)” means Vector 21-41 seed covered by Plant Variety Protection Certificate No. 200100039 in the U.S.,
together with any progeny, mutants, derivatives, or replicated forms thereof, and all cells or plant tissues containing such material,
including any replicated and derivative forms thereof.



 


		(b)	The last sentence of Paragraph 4.01 is amended to read
as follows:



 


Variations from Appendix C must be expressly approved
by NCSU in writing, such approval not to be unreasonably withheld including that NCSU shall consider that factors causing such
delays may be regulatory in nature and may be beyond the control of the Licensee.


 


		(c)	The last two sentences of Paragraph 4.02 are amended
to read as follows:



 


Should Licensee anticipate not meeting any such
Development/Commercialization milestones, it may outline the reasons in writing to NCSU prior to the deadline and request a
reasonable extension of time or amendment of the milestone. NCSU shall reasonably consider any such request from
Licensee.


 






    	 



    	 



    
 


		(d)	The first sentence of Paragraph 10.01 of the Agreement is amended to read as follows:



 


10.01 – Term. This
Agreement shall become effective upon the Effective Date and, unless sooner terminated in accordance with any of the provisions
herein, shall remain in full force and effect until the date of expiration of the last to expire of the Patent Rights or the expiration
of Plant Variety Protection Certificate No. 200100039, whichever is later; provided however, that in those countries in which no
patent contained in the Patent Rights issues, this Agreement shall expire in such countries upon the earlier of (i) ten (10) years
after the first commercial sale of a Licensed Product or (ii) December 31, 2019 (the “Term”).


 


		(e)	Licensee’s address provided in Article 12 is amended
to read as follows:



 


22nd Century Limited, LLC


Attn: Joseph Pandolfino


9530 Main Street


Clarence, NY 14031


 


 


		(f)	The address provided in 12.03 is amended to read as follows:



 


22nd Century Limited, LLC


c/o Foley & Lardner LLP


3000 K Street, N.W., Sixth Floor


Washington, D.C. 20007


 


		(g)	Appendix A is amended to include the following Patent
Rights:



  


	MBSS
    Ref. No.	Country	Application
    Type	Application
    No.	Filing
    Date	Patent
    No.	Status	 
	 
	 	Israel	Foreign	 	 	159213	Granted	 
	5051.784.NZ	New Zealand	Foreign	 	 	530238	Granted	 
	5051.784.SG	Singapore	Foreign	2003073590	6/6/2002	P-101253	Granted	 
	5051.784.ZA	South Africa	Foreign	200400084	6/6/2002	200400084	Granted	 
	5051.784.TW	Taiwan	Foreign	 	 	I-256340	Granted	 
	5051.784	United States	Foreign	10/729121	12/5/2002	6907887	Granted	 


 






    	 



    	 



    
 


		(h)	The three milestones of Appendix C are amended to read
as follows:



 


December 31, 2013 – Licensee will have initiated
a phase III clinical trial for a Licensed Product that is a Smoking Cessation Aid.


 


December 31, 2014 – Licensee will have applied
for FDA approval for sale of a Licensed Product that is a Smoking Cessation Aid.


 


December 31, 2015 – Licensee will have completed
first commercial sale of Licensed Product that is a Smoking Cessation Aid.


 


		(g)	Appendix D is amended to read as follows:



 


 


APPENDIX D


ROYALTY REPORT FORM


 


22nd Century Limited, LLC Agreement Royalty Report for the Period
____________through___________.


 


Instructions: Please fill in all boxes (write "none"
if not applicable), and sign and date at bottom.


 


Prod.#_________ Prod. Name: ___________________


NCSU Patents: ___________________


Please provide patent numbers and patent
application numbers of all NCSU patents related to this product.


Government Approvals: ___________________


Date of First Commercial Sale: ___________________


 


	Country	Gross Billings	Deductions	Type of Deduction	Net Sales	Royalty Rate	Royalties Due
	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	Subtotal for Product	 


 


Prod.#_________ Prod. Name: ___________________


NCSU Patents: ___________________


Please provide patent numbers and patent
application numbers of all NCSU patents related to this product.


Government Approvals: ___________________


Date of First Commercial Sale: ___________________


 


	Country	Gross Billings	Deductions	Type of Deduction	Net Sales	Royalty Rate	Royalties Due
	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	Subtotal for Product	 


 


USE ADDITIONAL SHEETS FOR ADDITIONAL PRODUCTS.


 


Total amount enclosed $_______________


 


22nd Century Limited, LLC


By:Date:


 


Name and Title: ________________________________


 






    	 



    	 



    
 


		2.	All terms and conditions of the Agreement not specifically modified by this Amendment remain in full force and effect.



 


 


IN WITNESS WHEREOF, the Parties hereto have executed
this Amendment on the dates set forth below.


 





	NORTH CAROLINA STATE UNIVERSITY	22nd CENTURY LIMITED, LLC
	 	 
	 	 
	/s/ Billy B. Houghteling	/s/ Joseph Pandolfino
	Billy B. Houghteling	Joseph Pandolfino
	Executive Director	Chief Executive Officer
	 	 
	Date:  August 9, 2012	Date:  August 14, 2012