Document:

Exhibit 10.35

 

	
Confidential   Treatment Requested

Under 17 C.F.R.   §§ 200.80(b)(4) and 230.406
    	
 
    

 

Change Order Form # 14

 

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 Health, Inc.

Name: Michele Gehrt

Company:  3M

Date:  20Jul2012

Description of change: Radius has requested the addition of work to perform residual drug analysis and microscopic evaluation of BA058-sMTS patches and arrays (placebo, 50, 100, and 150 mcg/array) following use in the Phase II Clinical Study.

 

SCOPE:

[*] patches will be returned to 3M for residual drug analysis and microscopic evaluation.  The 11 clinical sites will collect the patches and ship them to 3M on a monthly basis.  The patches will be labeled with patient number, sample date, visit number and kit number.  The patches will be stored (at the clinical sites, 3M and PACE) and shipped at [*]°C.  Upon receipt at 3M, the samples will be segregated according to visit number. Patches that are dislodged from the collar during shipping will not be tested.  The analyses will be done at the end of the clinical study at which time Radius will instruct 3M to select certain patches by patient number.

 

Residual drug analysis will be done using 3M Method-07-001836.

 

Microscopic analysis will be done using a [*]x magnification and looking for microneedle fracture, breakage, chipping, deformation, or other damage.  Results for each array will be recorded on the attached observations sheet (Attachment 1) and observation summary sheet (Attachment 2).  Digital photos will be recorded.  An example image is included as Attachment 3.

 

[*] 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.

 

 

The following table summarizes the patches to be analyzed.

 

	
Description
    	
 
    	
Number   of Patches
    	
 
    
	
Used   patches for Microscopic Analysis

·      [*] patches per dose

·      4 doses:  placebo, 50   mcg, 100 mcg, 150 mcg

·      Patches collected at Day [*]
    	
 
    	
 

 

[*]
    	
 
    
	
Un-used   patches for Microscopic Analysis

·      [*] patches per dose

·      2 doses:  placebo, 150   mcg

·      Patches collected at end of study (Day 180)
    	
 
    	
 

 

[*]
    	
 
    
	
Used   patches for Residual Drug Analysis

·      [*] patches per dose per timepoint

·      4 doses:  placebo, 50   mcg, 100 mcg, 150 mcg

·      Patches collected at Day [*], Day [*], Day [*]
    	
 
    	
 

 

[*]
    	
 
    

 

DELIVERABLES:

·                  Summary report describing residual BA058 content of arrays

·                  Summary report describing the type and frequency of visual observations.

 

TIMING:

 

The estimated effort in hours is summarized in the table below.

 

	
Task
    	
 
    	
Estimated Effort (hours)
    
	
Preparation, review and approval of testing protocols and reports
    	
 
    	
[*]
    
	
Collection and organization of samples
    	
 
    	
[*]
    
	
Residual drug analysis and microscopic analysis
    	
 
    	
[*]
    
	
Total additional hours
    	
 
    	
[*]
    

 

Total estimated hours:  [*]

Estimated completion date:  August 2013 (60 days after end of clinical study)

Total estimated direct costs:  $5,000 (analytical supplies and storage costs at PACE)

 

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: Nick Harvey
    	
 
    	
Name:   Michele Gehrt
    
	
Signature:
    	
/s/ Nick Harvey 
    	
 
    	
Signature:
    	
/s/   Michele Gehrt
    
	
Position: CFO 
    	
 
    	
Position:   Commercialization Mgr
    
	
Date (dd/mm/yy): 15/08/2012
    	
 
    	
Date   (dd/mm/yy):15/08/2012
    
					

 

[*] 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.

 

 

ATTACHMENT 1 — OBSERVATIONS

 

Sample ID:

 

	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 

 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

Describe appearance of patch:

 

Enter code for damaged array on to chart.

 

Codes: R — break, C — chip, K — crack, D — bend, L — blunt, F — partial fill

 

Add sequence number for digital image.

 

[*] 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.

 

 

ATTACHMENT 2 — SUMMARY OBSERVATIONS

 

	
Sample   ID
    	
 
    	
Microneedle   fracture
   (breaks, cracks, and
   chips)
    	
 
    	
Deformation   of
   the needle
   (bends and/or
   blunting)
    	
 
    	
Comments
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    
	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    

 

[*] 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.

 

 

	
 
    	
 
    	
Breaks
    	
 
    	
Cracks
    	
 
    	
Chips
    	
 
    	
Bends
    	
 
    	
Blunting
    	
 
    	
 
    

 

ATTACHMENT 3 — EXAMPLE IMAGE

 

[*]

 

[*] 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.Exhibit 10.36

 

	
Confidential   Treatment Requested
    	
 
    
	
Under 17 C.F.R.   §§ 200.80(b)(4) and 230.406
    	
 
    

 

Change Order Form # 15

 

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 Health, Inc.

Name: Michele Gehrt

Company:  3M

Date:  16July2012

Description of change: Radius has requested the addition of work to perform qualification testing of (3) lots of Phosphate Buffer Solution (from Amresco) per the findings of the QP audit.

 

SCOPE:

Three (3) different lots of Phosphate Buffer Solution (PBS) are to be sourced from Amresco and qualification testing to be performed.  The testing will include appearance (color, clarity, odor), pH and sterility and will be performed by Nelson Labs. Two (2) lots are available immediately and the testing of these two lots will be initiated upon receipt at Nelson labs.  The third lot will not be available for approximately 6-8 weeks dependent upon the depletion of inventory at the supplier.  This lot will be tested as soon as available.

 

DELIVERABLES:

·                  Test results for appearance, pH and sterility

 

TIMING:

The estimated effort in hours and costs are summarized in the table below.

 

	
Task
    	
 
    	
Estimated Effort
   (hours)
    	
 
    	
Estimated Cost
   (dollars)
    	
 
    
	
3M Coordination of testing (ordering, shipping, reporting)
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    
	
PBS
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    
	
Nelson Labs: appearance, pH and sterility analysis
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    
	
Total additional hours/cost
    	
 
    	
[*]
    	
 
    	
$
    	
2,150
    	
 
    
							

 

[*] 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.

 

 

Estimated completion date (4 weeks after receipt of PBS):  August 2012 for two (2) lots; October 2012 for the third lot (depending on availability from Amresco).

 

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:   Nick Harvey
    	
 
    	
Name:   Michele Gehrt
    
	
Signature:
    	
/s/   Nick Harvey
    	
 
    	
Signature:
    	
/s/   Michele Gehrt
    
	
Position:   CFO
    	
 
    	
Position:   Commercialization Mgr
    
	
Date   (dd/mm/yy): 16/07/2012
    	
 
    	
Date   (dd/mm/yy): 16/07/2012
    
					

 

[*] 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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