Exhibit 10.4

 

 

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 No. 1, Amendment No. 2, Amendment No. 3, Amendment
No. 4, Amendment No. 5, Amendment 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:

 

Budget

 

Euro

 

Test fee, subtotal

 

€

183,600

 

Sample/Study Management

 

€

1,800

 

Data transfer

 

€

2,200

 

TOTAL

 

€

187,600

 

 

(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.

 

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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.

 

 

RADIUS HEALTH, INC.

 

NORDIC BIOSCIENCE CLINICAL DEVELOPMENT VII A/S

 

 

 

 

 

 

/s/ Gregory C. Williams

 

/s/ Jeppe Ragnar Andersen

By: Gregory C. Williams

 

By:

Title: 12 March 2015

 

Title: CEO 12 March, 2015

 

Notice Address

 

Notice Address

Radius Health, Inc.

 

Nordic Bioscience Clinical Development VII A/S

950 Winter Street

 

Herlev Hovedgade 207

Waltham, MA 02451

 

2730 Herlev

USA

 

Denmark

Attn: President & CEO

 

Attn: CEO

Phone: 01.617.551.4000

 

Phone: 45.4452.5251

Fax: 01.617.551.4701

 

Fax: 45.4452.525

 

2

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