Change Order Form #32 to Development and Clinical Supplies Agreement between Radius Health, Inc. and 3M (July 22, 2016)
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Summary
Radius Health, Inc. and 3M have agreed to a change order under their existing Development and Clinical Supplies Agreement. Radius has requested that 3M develop and perform pH testing for the Ready to Coat (RTC) formulation of the abaloparatide product, supporting its further development and comparability to an existing injection product. 3M will develop the testing method, purchase necessary equipment, and provide progress updates. The agreement outlines estimated costs, effort, and duration for the work. All other terms of the original agreement remain unchanged.
EX-10.6 8 rdus06301610qex10d6.htm EXHIBIT 10.6 Exhibit
Exhibit 10.6
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
Change Order Form # 32
Change order under Agreement dated: Fifth Amendment to Development and Clinical Supplies Agreement dated December 14, 2012
Between: Radius Health, Inc and 3M
Project Name: For the development of Radius’ Abaloparatide compound delivered via 3M’s Microstructured Transdermal Delivery System
Change requested by: Radius
Name: Michele Gehrt
Company: 3M
Date: 22July2016
Description of change:
Radius has requested that 3M complete pH testing in support of the Phase I clinical supplies of the sMTS abaloparatide (ABL) product. A method will be developed to test the Ready to Coat (RTC). The activities and deliverables in this Workplan are intended to support the further development of an optimized, sMTS abaloparatide product that demonstrates comparability (including pharmacokinetic bioequivalence or bioavailability) to the abaloparatide-SC injection product. The total estimated costs are $[*].
Scope:
3M will conduct the tasks necessary to complete the development of a pH method for the RTC.
Assumptions:
• | RTC pH method development |
◦ | A probe will need to be purchased to test smaller volumes of formulation |
Deliverables:
• | pH method for RTC |
• | Presentations at JTT meetings outlining work as progressed. |
Timing:
The required effort in hours, duration of the study in months, and estimated costs for the work plan are summarized in the table below.
Task | Estimated Effort (hours) | Estimated Duration (month) | Estimated Direct Costs ($) |
RTC pH Method Development | 55 | 2 | $[*] |
[*] 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.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
Change Order Form # 32
Total Estimated Costs: $[*]
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: Ehab Hamed | Name: Michele Gehrt |
Signature: /s/ Ehab Hamed | Signature: /s/ Michele Gehrt |
Position: Director | Position: Commercialization Mgr |
Date (dd/mm/yy): 22 Jul 2016 | Date (dd/mm/yy): 22/07/2016 |
2
[*] 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.
