Confidential Treatment Requested Under 17 C.F.R. 200.80(b)(4) and 240.24b-2 Change Order Form # 12
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 |
| Estimated |
| 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 | ||
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| Signature: | /s/ B.N. Harvey |
| Signature: | /s/ Mark Tomai |
| Position: CFO |
| Position: Head of MTS Business Development | ||
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| 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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