Exhibit 10.80

 

Change Order Form # 10

 

Change order under Agreement dated:  The Development and Clinical Supplies Agreement dated June 19, 2009, as amended by the Amendment dated as of December 31, 2009, the Second Amendment dated as of September 16, 2010, the Third Amendment dated as of September 29, 2010 and the Fourth Amendment dated March 2, 2011 (the “Agreement”).  Fourth Amendment to Development and Clinical Supplies Agreement dated March 2, 2011

 

Between:  Radius Health, Inc and 3M

 

Project Name:  For the development of Radius’s BA-058 compound delivered via 3M’s Microstructured Transdermal Delivery System

 

Change requested by:  Radius

Name:  Gary Hattersley

Company:  3M is providing this proposal for a formal stability bracketing study

Date:  28 September 2011

Description of change:  Change Order to conduct a formal stability study bracketing study on approximately [*]% peptide by weight coated on [*] mcg/array and [*] mcg/array in Phase II packaging with/without desiccant.

 

Radius is requesting 3M manufacture [*]mcg and [*]mcg/array strengths and place on formal stability.  The [*] and [*]mcg/array strength will be packaged with desiccant; in a 3rd arm of the study, [*]mcg/array samples will be packaged without desiccant.  Attached is proposed stability study.

 

Drug Product Testing

 

	
Condition
    	
 
    	
Tests
    	
 
    	
Time points
    
	
NA
    	
 
    	
Content, Purity, Total Moisture, Depth of Coating, in vivo release
    	
 
    	
Initial
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
25C
    	
 
    	
Content, Purity, Aggregation
    	
 
    	
1,2,3,6 months
    
	
25C
    	
 
    	
Total Moisture
    	
 
    	
3, 6 months
    
	
5C
    	
 
    	
Content, Purity, Aggregation
    	
 
    	
1, 3, 6, 9, 12 months
    
	
5C
    	
 
    	
Total Moisture
    	
 
    	
3, 6, 12 months
    


 

Ready-to-Coat Testing

 

	
Condition
    	
 
    	
Tests
    	
 
    	
Time points
    
	
NA
    	
 
    	
Content, Purity, Viscosity
    	
 
    	
Initial
    
	
25C
    	
 
    	
Content, Purity
    	
 
    	
12 hours, 24 hours, 2 days, 3 days
    
	
25C
    	
 
    	
Viscosity
    	
 
    	
12 hours, 2 days
    
	
5C
    	
 
    	
Content, Purity, Viscosity
    	
 
    	
1 month, 2 months, 3 months
    


 




* Confidential Treatment Requested by the Registrant.  Redact Portion Filed Separately with the Commission.

 











 

3M estimates this work will be conducted over a 2-3 week period and require approximately 270 hours.  The stability costs for the RTC will be $[*]per pull point.  The stability costs for the arrays will be $[*]per pull point.  7.1 grams of BA-058 will be needed.

 

Except to the extent expressly amended by this Change Order, the terms and conditions of the Agreement remain in full force and effect.  The term “Agreement”, as used in the Agreement, shall henceforth be deemed to be a reference to the Agreement as amended by this Change Order.

 

Requested task, dates and costs are approved by:

 

	
Company:   Radius Health, Inc
    	
Company:   3M
    
	
Name:   Nick Harvey
    	
Name:   Mary Mathisen
    
	
Signature:
    	
/s/   Nick Harvey
    	
 
    	
Signature:
    	
/s/   Mary Mathisen
    
	
Position:   CFO
    	
Position:   Commercialization Mgr
    
	
Date   (dd/mm/yy): 29/9/11
    	
Date   (dd/mm/yy): 3 October 2011