Confidential Treatment Requested
Exhibit 10.2
STRICTLY CONFIDENTIAL
Confidential Treatment Requested |
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Under 17 C.F.R. §§ 200.80(b)(4) and |
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240.24b-2 |
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Change Order Form # 13
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 Radiuss BA-058 compound delivered via 3Ms Microstructured Transdermal Delivery System
Change requested by: Radius
Name: Mark Tomai
Company: 3M
Date: 12Apr2012
Description of change:
Radius has requested further development of a ready-to-coat formulation for preparation of sMTS supplies with increased stability.
OBJECTIVE
Test stability of new formulations for sMTS-BA058 to target a scalable formulation with a final configuration that provides long-term stability under refrigerated conditions and supports short-term exposure at [*]C. Prepare associated documentation to support clinical use of the new formulation.
BACKGROUND
A composition and coatability study is described in Change Order 12. This Change Order describes the work needed to assess the stability of the formulation options developed in Change Order 12, and the effect of container-closure system (CCS) options.
PROCEDURE
1. A stability study examining the effect of packaging. The study uses the arrays coated under Change Order 12, and will be started concurrently with Change Order 12 as coated arrays are prepared.
[*] 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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DELIVERABLES
· Stability Testing:
· [*]°C/ambient
· [*], [*], and [*] months for up to [*] formulations
· [*], [*], [*], [*], and [*] months for up to [*] formulations
· [*]°C/[*]%RH
· [*], [*], and [*] months for up to [*] formulations
· [*], [*], [*], [*], and [*] months for up to [*] formulations
· Formulation Screening Testing:
· [*]°C/[*]%RH at [*], [*], and [*] months for up to [*] formulations
· Tests to include:
· Content and purity at all time points
· Moisture and either dissolution or in-vivo release at initial time point and at [*] months, only
· Development report on effect of packaging options and final drying process, if any.
· Development report supporting performance and characterization of selected formulation.
TIMING
The required effort in hours, duration of the study in months, and expected end dates for the study covered by this work plan are summarized in the table below.
Task |
| Estimated |
| Estimated |
| End Date |
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Stability Study |
| [*] |
| 24 |
| May 2014 |
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Total elapsed time estimated: 2 years
Total hours estimated: [*] hours
Total direct costs: ~ $3,000
[*] 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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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: Mark Tomai | ||
Signature: | /s/ Nick Harvey |
| Signature: | /s/ Mark Tomai |
Position: CFO |
| Position: Head of MTS Business Development | ||
Date (dd/mm/yy): 30/04/12 |
| Date (dd/mm/yy): 01/05/12 | ||
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