Exhibit 10.1

 

STRICTLY CONFIDENTIAL

 

Confidential Treatment Requested  Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

 

Change Order Form # 12

 

Change order under Agreement dated: 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: Mark Tomai

Company:  3M

Date:  03 Feb 2012

Description of change:

 

Radius has requested further development of a ready-to-coat formulation for preparation of sMTS supplies with increased stability compared to the current formulation.

 

OBJECTIVE

 

Optimize a new formulation for sMTS-BA058 to target a scalable formulation with a final configuration that provides 2 years stability under refrigerated conditions and 3 month stability at [*]C.

 

BACKGROUND

 

Initial experiments in using excipients to stabilize the sMTS-BA058 drug product show that certain excipients can dramatically increase the stability of the drug product.  These changes need to be investigated and evaluated with container-closure system (CCS) options.

 

PROCEDURE

 

1.              A composition and coatability study designed as a factorial experiment examining the effect of API concentration and different excipients.

 

2.              A drying study to determine the effect of a drying step on the performance of the trial formulations will be completed.  The study will be started concurrently with Step 1, as coated arrays are prepared.

 

3.              A study evaluating the potential for terminal sterilization of trial formulations will be completed.  Generally, the FDA requires proof that terminal sterilization is not feasible prior to giving approval of a product prepared by aseptic techniques.

 




[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Therefore, this study needs to be completed to support strategic planning for development of the commercial product.

 

DELIVERABLES

 

·                  Formulations designed for improved stability.

 

·                  Development report describing viability of terminal sterilization for sMTS-BA058.

 

TIMING

 

The required effort in hours, duration of the study in months, and expected end dates (assuming a 01 Mar 2012 start date) for the major tasks covered by this work plan are summarized in the table below.

 

	
Task
    	
 
    	
Estimated
   Effort
   (hours)
    	
 
    	
Estimated
    Duration
   (months)
    	
 
    	
End Date
    
	
Composition and   Coatability
    	
 
    	
[*]
    	
 
    	
3
    	
 
    	
20 May 2012
    
	
Terminal Sterilization   Evaluation
    	
 
    	
[*]
    	
 
    	
2
    	
 
    	
27 May 2012
    
	
Drying Study
    	
 
    	
[*]
    	
 
    	
4
    	
 
    	
20 Jul 2012
    


 

Total elapsed time estimated: 4 months

Total hours estimated: [*] hours

Total direct costs: ~ $40,000

 

In all other respects, the terms and conditions of the Agreement remain in full force and effect.

 

Requested task, dates and costs are approved by:

 

	
Company: Radius   Health, Inc
    	
 
    	
Company: 3M
    
	
Name: B. N. Harvey
    	
 
    	
Name: Mark Tomai
    
	
 
    	
 
    	
 
    
	
Signature: 
    	
/s/ B.N. Harvey
    	
 
    	
Signature: 
    	
/s/ Mark Tomai
    
	
Position: CFO
    	
 
    	
Position: Head of MTS   Business Development
    
	
 
    	
 
    	
 
    
	
Date (dd/mm/yy): 23/02/12
    	
 
    	
Date (dd/mm/yy): 23/02/12
    
					


 






[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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