Change Order No. 15 to Development and Clinical Supplies Agreement between Radius Health, Inc. and 3M (July 16, 2012)
This change order, agreed between Radius Health, Inc. and 3M, adds new work to their existing Development and Clinical Supplies Agreement. Radius requests 3M to coordinate qualification testing of three lots of Phosphate Buffer Solution from Amresco, with testing performed by Nelson Labs for appearance, pH, and sterility. Two lots will be tested immediately, and the third when available. The estimated cost is $2,150, with completion expected by August and October 2012. All other terms of the original agreement remain unchanged.
Exhibit 10.36
| Confidential Treatment Requested |
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| Under 17 C.F.R. §§ 200.80(b)(4) and 230.406 |
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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 |
| Estimated Cost |
| |
| 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.
