Exhibit 10.21

 

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

 

	
 
    	

    
	
 
    	
 
    
	
Otsuka   Pharmaceutical Co., Ltd
    	
Justin   Gover
    
	
Licensing   Department
    	
Managing   Director
    
	
3-2-27,   Otedori Chuo-ku,
    	
 
    
	
Osaka   540-0021 Japan
    	
1   Cavendish Place
    
	
Attention:   Director
    	
London   W1G 0QD
    
	
 
    	
 
    
	
Legal   Affairs Department
    	
E-mail: jdg@gwpharm.com
    
	
Shinagawa   Grand Central Tower,
    	
Tel:   +44 (0)20 7291 0555
    
	
2-16-14,   Konan
    	
Fax:   +44 (0)20 7291 0550
    
	
Minato-ku
    	
 
    
	
Tokyo,   108-8242 Japan
    	
 
    
	
Attention:   Director
    	
 
    
	
 
    	
 
    
	
21   October 2010
    	
 
    
	
 
    	
 
    
	
Dear   Sirs
    	
 
    


 

Development and License Agreement dated February 14, 2007 (the “Development and License Agreement”) by and among GW Pharma Ltd and its Affiliates (collectively “GW Pharma”), GW Pharmaceuticals Plc, and Otsuka Pharmaceutical Co., Ltd. (“Otsuka”)

 

On November 1, 2008, GW Pharma, GW Pharmaceuticals and Otsuka entered into the first amendment to the Development and License Agreement (“Amendment No. 1”).

 

Section 6(f) of Amendment No. 1 states that in the event that (i) the Study (as defined in Amendment No. 1) is completed or terminated by decision of the JDC with an effective date between *** and *** (inclusive), then the enrollment target for the Study will be *** enrolled subjects, and (ii) *** fewer than *** subjects have been enrolled in the Study, (a) the provisions of Sections 6 (b), (c), (d), (e), (g) and (h) of Amendment No. I shall no longer apply and (b) the next milestone payment due and payable by Otsuka to GW Pharma under Section 4.12 of the Development and License Agreement shall be reduced according to the number of patients actually enrolled into the Study.

 

At the JDC meeting which was held on September 23, 2009 the JDC decided to stop opening new clinical investigation sites as part of the Study. The Parties have agreed that this decision of the JDC qualifies as a decision to terminate the Study for the purposes of Section 6(f) of Amendment No. 1.

 

As the foregoing decision was a decision reached by the JDC with an effective date between *** and *** and as fewer than *** subjects had been enrolled into the Study on ***, pursuant to Section 6(f) of Amendment No. 1 there should therefore be a reduction of US $*** in the next milestone payment due and payable by Otsuka to GW Pharma under Section 4.12 of the Development and License Agreement.

 




***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 











 

Notwithstanding the provision of Section 6 (f), subsequent to the JDC meeting which was held on September 23, 2009 the Parties have agreed that the next milestone payment due and payable by Otsuka to GW Pharma under Section 4.12 of the Development and License Agreement (being the payment of US$*** upon first administration of the Existing Licensed Product in a Phase III Clinical Study designed to support filing of the NDA for the First Indication pursuant to Section 4.12(a) of the Development and License Agreement) shall be reduced by US$***.

 

We therefore believe that:

 

(i)                                     Section 4.12(a) of the Development and License Agreement is amended to read as follows:

 

“US$*** upon first administration of the Existing Licensed Product in a Phase III Clinical Study designed to support filing of the NDA for the First Indication”; and

 

(ii)                                  Section 6 of Amendment No.1 no longer applies and is of no further effect.

 

Capitalized terms undefined in this letter agreement shall bear the meanings as provided in Section 1.1 of the Development and License Agreement unless otherwise specified.

 

If you agree with to the terms as set out above, please evidence your agreement to the terms as set out above by signing where indicated below on both originals and return one original execution copy to us, retaining the other original execution copy for your records.

 

	
Yours   faithfully
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
/s/ Justin Gover
    	
 
    
	
For   and on behalf of
    	
 
    
	
GW   Pharma Limited
    	
 
    
	
Name:   Justin Gover
    	
 
    
	
Title:   Managing Director
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
Agreed   by Otsuka Pharmaceutical Co., Ltd.:
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
/s/ Kazumichi Kobayashi
    	
 
    
	
Otsuka   Pharmaceutical Co, Ltd
    	
 
    
	
Name:   Kazumichi Kobayashi
    	
 
    
	
Title:   Senior Operating Officer, Deputy General Manager
    	
 
    
	
Date:   December 3, 2010
    	
 
    


 




***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.