CLINICAL TRIAL SERVICES AGREEMENT AMENDMENT NO. 9 TO WORK STATEMENT NB-1
Exhibit 10.4
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Execution copy |
CLINICAL TRIAL SERVICES AGREEMENT AMENDMENT NO. 9 TO WORK STATEMENT NB-1
RADIUS HEALTH, INC., a Delaware corporation (“Radius”) and NORDIC BIOSCIENCE CLINICAL DEVELOPMENT VII A/S, a Danish corporation (“NB”) that is a wholly-owned subsidiary of Nordic Bioscience Clinical Development A/S entered into the certain Clinical Trial Services Agreement (“Agreement”) and that certain Work Statement NB-1 under the Agreement as of March 29, 2011 (“Effective Date”), and entered into an Amendment Xx. 0, Xxxxxxxxx Xx. 0, Xxxxxxxxx Xx. 0, Amendment Xx. 0, Xxxxxxxxx Xx. 0, Xxxxxxxxx No. 6,Amendment No. 7 and Amendment No. 8 to Work Statement NB-1 as of December 9, 2011, June 18, 2012, November 6, 2013, March 28, 2014, May 19, 2014, July 22, 2014, July 22, 2014 and August 15, 2014 respectively, (as amended, “Work Statement NB-1”).
Pursuant to Section 2.3, 2.11 and 11.7 of the Agreement, the parties wish to enter into this Amendment No. 9 to Work Statement NB-1 (“Amendment No. 9”) effective as of 12 March, 2015 (“Amendment Date”). Capitalized terms used in this Amendment No. 9 and not defined herein are used with the meanings ascribed to them in the Agreement and Work Statement NB-1.
NOW THEREFORE, in consideration of the mutual covenants and promises contained in this Amendment No. 9, the parties agree as follows:
1. Additional bioanalytical activities
At Radius request, NB will perform additional testing of bone biomarkers (CTX-I and P1NP) in the biomarker subgroup samples obtained at 1 months and 3 months of treatment with Abaloparathide as well as baseline samples obtained at 6, 12 and 18 months stored at -20°C.
(b) A new section at the bottom Attachment B to Work Statement NB-1 (Budgets, Fees, Pass-through Costs, and Payment Schedule) is hereby amended to read in full as follows:
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Budget |
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Euro |
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Test fee, subtotal |
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€ |
183,600 |
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Sample/Study Management |
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€ |
1,800 |
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Data transfer |
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€ |
2,200 |
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TOTAL |
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€ |
187,600 |
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(c) The “Payment Schedule” set forth in Attachment B to Work Statement NB-1 (Attachment 2 to the Agreement) is amended to add a new Paragraph (17) immediately following Paragraph (16) of the Payment Schedule, which shall read in full as follows:
“(17) Payment for “Additional bioanalytical activities” will be paid upon receipt of invoice after delivery of final report.”
2. Ratification. Except to the extent expressly amended by this Amendment No. 9, all of the terms, provisions and conditions of the Agreement and Work Statement NB-1 are hereby ratified and confirmed and shall remain in full force and effect. The term “Work Statement NB-1”, as used in the Agreement, shall henceforth be deemed to be a reference to Work Statement NB-1 as amended by this Amendment No. 9.
3. General. This Amendment No. 9 may be executed in counterparts, each of which will be deemed an original with all such counterparts together constituting one instrument.
IN WITNESS WHEREOF the parties have caused this Amendment No. 9 under Work Statement NB-1 to be executed by their respective duly authorized officers, and have duly delivered and executed this Amendment No. 9 under seal as of the Amendment Date.
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NORDIC BIOSCIENCE CLINICAL DEVELOPMENT VII A/S | |
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/s/ Xxxxxxx X. Xxxxxxxx |
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/s/ Jeppe Xxxxxx Xxxxxxxx |
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By: Xxxxxxx X. Xxxxxxxx |
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By: |
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Title: 12 March 2015 |
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Title: CEO 12 March, 2015 |
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Notice Address |
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Notice Address |
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Nordic Bioscience Clinical Development VII A/S | |
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000 Xxxxxx Xxxxxx |
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Herlev Hovedgade 207 |
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Waltham, MA 02451 |
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2730 Herlev |
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USA |
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Denmark |
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Attn: President & CEO |
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Attn: CEO |
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Phone: 00.000.000.0000 |
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Phone: 00.0000.0000 |
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Fax: 00.000.000.0000 |
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Fax: 00.0000.000 |
