Confidential Treatment Requested Under 17 C.F.R. 200.80(b)(4) and 240.24b-2
Exhibit 10.46
| Confidential Treatment Requested |
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CHANGE ORDER
AMENDED LETTER OF PAYMENT AUTHORIZATION
Amendment No. 01
January 20th, 2012
Gary Hattersley, Ph.D.
Vice President, Biology
RADIUS HEALTH, INC.
5th Floor
300 Technology Square
Cambridge, MA 02139
United States
***@***
| RE: |
| STUDY PN 670364 |
| Study Title: A 2-Year Subcutaneous Injection Carcinogenicity Study Of BA058 And PTH In The Fisher 344 Rat |
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| AS PER FINAL PROTOCOL DATED: December 29, 2010 AS PER PROTOCOL AMENDMENT # 1, 2 and 5
STUDY START: Week of January 17, 2010 | ||
Dear Gary,
This communication is to serve as an Amended Letter of Payment Authorization (ALOPA) for the above referenced study, which will be performed at Charles River Laboratories Preclinical Services as set forth below. Charles River Laboratories Preclinical Services shall perform these services in accordance with the existing Service Agreement executed between Charles River Laboratories Preclinical Services and RADIUS HEALTH, INC. Once fully executed, this ALOPA shall be incorporated into and made part of the existing Service Agreement.
Summary of Changes:
· 48 animals added for TK population
· Blood smear evaluation added
· 1 time point of TK removed
· TK analysis removed
· Histopathology on TK animals removed
· 7 tissues added for histopathology
· ADA sampling added
· 5 occasions of dose analysis added
· 30 spare animals removed
· Acclimation extended by 1 week
· Pharmacy preparation modified
· Organ weight report removed
· PTH 1-34 analysis added for Group 5 sample
[*] 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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The price of this Protocol Amendment is as follows:
| Authorized Price (After discount) |
| $ [*] (as per signed LOPA dated: November 16, 2010) |
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| Additional Charge |
| $ [*] |
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| Additional with additional [*]% goodwill discount: |
| $ [*] |
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| Revised Price |
| $ 2,489,035 US |
The payment schedules of this study are as follows:
·$ [*] First payment at study authorization
·75% Equal monthly installments
·Additional Charge Due upon receipt of invoice
·5% Upon receipt of draft report
·5% Upon receipt of final report or forty five (45) days after issuance of draft report (whichever comes first)
Please sign and return this document via facsimile or email (contact information below). Should you have any questions or require any additional information, please do not hesitate to call me. We look forward to being of service.
Best regards,
| /s/ Stéphane Besner |
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| Stéphane Besner, B.Sc. M.B.A |
| /s/ B. Nicholas Harvey |
| Senior Client Manager, Sales & Marketing |
| Authorized Sponsor Representative |
| Charles River Laboratoires |
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| Preclinical Services Montreal Inc. |
| B. Nicholas Harvey, Chief Financial Officer |
| 22022 Transcanadienne |
| Print (Name and Title) |
| Senneville, Québec, Canada H9X 3R3 |
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| Tel: (514) 630-2436 Fax: (514) 630-8230 |
| January 20, 2012 |
| e-mail ***@*** |
| Date |
| Web site: www.criver.com |
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If a PO is required, please submit PO with Letter of Payment Authorization or fax to ###-###-####.
c.c. S. Pryce, D. Tremblay, S Y. Smith, B. Attella, Main File
CRT: 22633, 22708, 22709, 22748, 23477
V:\CLIENTS\Radius\2012\670364.L6.20Jan12 - ALOPA1.doc
[*] 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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