CLINICAL TRIAL SERVICES AGREEMENT AMENDMENT NO. 7 TO WORK STATEMENT NB-1
Exhibit 10.15
Execution copy
CLINICAL TRIAL SERVICES AGREEMENT AMENDMENT NO. 7 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, and Amendment No. 6 to Work Statement NB-1 as of December 9, 2011, June 18, 2012, November 6, 2013, March 28, 2014, May 19, 2014 and July 22, 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. 7 to Work Statement NB-1 (“Amendment No. 7”) effective as of July 22, 2014 (“Amendment Date”). Capitalized terms used in this Amendment No. 7 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. 7, the parties agree as follows:
1. Addition of SAE Narrative Writing and Review (a) At Radius request and direction, NB will assign qualified personnel to write Serious Adverse Event (SAE) narratives and perform SAE narrative review for BA058-05-003 according to version 1 of the narrative writing procedures agreed upon May 23rd, 2014.
(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 |
| |
|
SAE Narrative writing (each) |
|
€ |
115 |
|
|
SAE Narrative review (each) |
|
€ |
60 |
|
“The price per narratives written is €115, and the price per narrative review is €60, paid by invoice on a quarterly basis based on actual work performed.”
2. Ratification. Except to the extent expressly amended by this Amendment No. 7, 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. 7.
3. General. This Amendment No. 7 may be executed in counterparts, each of which will be deemed an original with all such counterparts together constituting one instrument.
[remainder of this page intentionally left blank - signature page follows]
IN WITNESS WHEREOF the parties have caused this Amendment No. 7 under Work Statement NB-1 to be executed by their respective duly authorized officers, and have duly delivered and executed this Amendment No. 7 under seal as of the Amendment Date.
|
|
NORDIC BIOSCIENCE CLINICAL | |
|
|
|
|
|
|
|
|
|
/s/ Xxxxxx X. Xxxx |
|
/s/ Jeppe Xxxxxx Xxxxxxxx |
|
By: R.E. Xxxx |
|
By: Jeppe Xxxxxx Xxxxxxxx |
|
Title: President & CEO |
|
Title: CEO |
|
|
|
|
|
Notice Address |
|
Notice Address |
|
|
Nordic Bioscience Clinical Development VII A/S | |
|
000 Xxxxxxxx, 0xx Xxxxx |
|
Herlev Hovedgade 207 |
|
Xxxxxxxxx, XX 00000 |
|
2730 Herlev |
|
USA |
|
Denmark |
|
Attn: President & CEO |
|
Attn: CEO |
|
Phone: 00.000.000.0000 |
|
Phone: 00.0000.0000 |
|
Fax: 00.000.000.0000 |
|
Fax: 00.0000.000 |
