Document:

Exhibit 10.7(d)

 

CLINICAL TRIAL SERVICES AGREEMENT AMENDMENT NO. 5 TO WORK STATEMENT NB-3

 

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 a Clinical Trial Services Agreement dated March 29, 2011 (“Agreement”) and Work Statement NB-3 under the Agreement (“Work Statement NB-3”) as of February 21, 2013 (“Effective Date”), and entered into an Amendment No. 1, Amendment No. 2, Amendment No. 3 and Amendment No. 4 to Work Statement NB-3 as of February 28, 2014, March 23, 2015, July 8, 2015 and October 21, 2015 (as amended, “Work Statement NB-3”).

 

Pursuant to Section 2.3, 2.11 and 11.7 of the Agreement, the parties wish to enter into this Amendment No. 5 to Work Statement NB-3 (“Amendment No. 5”) effective as of January 15, 2016 (“Amendment Date”). Capitalized terms used in this Amendment No. 5 and not defined herein are used with the meanings ascribed to them in the Agreement and Work Statement NB-3.

 

The purpose of this Amendment no. 5 is to collect individual patient drug accountability log for patients in Radius’ BA058-05-003 clinical trial.

 

NOW THEREFORE, in consideration of the mutual promises contained in the Agreement and for other good and valuable consideration the receipt and adequacy of which each of the parties does hereby acknowledge, the parties hereby agree to the terms of this Amendment No. 5 to Work Statement NB-3 as follows:

 

1. Additional Monitoring Services:

 

(a)         At Radius’ request, NB will perform additional Monitoring Visits at the sites listed in section 1(b) to collect patient specific drug logs in Radius’ BA058-05-003 clinical trial.

 

(b)         NB shall collect drug logs at sites: 102, 103, 111, 121, 123, 124, 131, 132, 133, 141, 145, 151, 161 and 181. It is estimated that 45 monitoring days are needed to collect the drug logs at the aforementioned sites. Other sites may be added to the list if the sites are not willing to make copies themselves.

 

(c)          NB shall coordinate drug log collection at all sites except US sites and site 101, including sites not mentioned in 1(b). This is done remotely by asking for the site’s assistance in copying the drug logs and sending the documents to the appropriate individual.

 

(d)         Radius will compensate NB for the Monitoring Services as set forth in Attachment 1.  All documents should be collected and sent to Radius by 29 February 2016, if at all possible.

 

This Amendment No. 5 to Work Statement NB-3 contains the following Attachments, each of which is made a part hereof:

 

Attachment 1     –     Budget Summary including Payment Schedule

 

2. Ratification.  Except to the extent expressly amended by this Amendment No. 5, all of the terms, provisions and conditions of the Agreement and Work Statement NB-3 are hereby ratified and confirmed and shall remain in full force and effect. The term “Work Statement NB-3”, as used in the Agreement, shall henceforth be deemed to be a reference to Work Statement NB-3 as amended by this Amendment No. 5.

 

/s/GW

 

 

3.  General.  This Amendment No. 5 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. 5 under Work Statement NB-3 to be executed by their respective duly authorized officers, and have duly delivered and executed this Amendment No. 5 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: Chief   Development Officer
    	
 
    	
Title: CEO
    
	
22 Jan 2016
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Notice Address
    	
 
    	
Notice Address
    
	
Radius   Health, Inc.
    	
 
    	
Nordic Bioscience   Clinical Development VII A/S
    
	
201 Broadway, 6th Floor
    	
 
    	
Herlev Hovedgade   205-207
    
	
Cambridge, MA 02139
    	
 
    	
2730 Herlev
    
	
USA
    	
 
    	
Denmark
    
	
Attn: President & CEO
    	
 
    	
Attn: CEO, Jeppe Ragnar Andersen
    
	
Phone: 01.617.551.4700
    	
 
    	
Phone: 45.4452.5252
    
	
Fax: 01.617.551.4701
    	
 
    	
Fax: 45.4452.521
    

 

2

 

Attachment 1 - Budget

 

Budget and Invoicing Schedule

 

NB shall submit monthly invoices to Radius in accordance with the following on a work performed basis:

 

·                  EUR 2,500 per monitoring day as per section 1(b) (not to exceed EUR 112,500)

 

·                  EUR 150 per site not listed in section 1(b) for which NB coordinates collection of drug logs through the site staff. Details of the cost will itemized on the invoice.  It is anticipated that this will not exceed 8 sites (or EUR 1,200)

 

·                  Any costs outside this agreement (i.e. additional fees required by sites for time and materials above the EUR 150) will be managed on a case-by-case basis and must be approved by Radius.

 

Pass-through includes shipping and office supplies. Shipping will wherever possible be done on Radius’s UPS account.

 

/s/GW

 

3Exhibit 10.11(a)

 

AMENDMENT NO. 3

TO

DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT

 

This Amendment No. 3 (the “Amendment”) to the DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is entered into on December 31, 2015 by and between Radius Health Inc., a Delaware corporation, with its principal office at 950 Winter Street, Waltham, MA 02451, United States of America (“RADIUS”) and LONZA Sales Ltd, a Swiss company having an address at Muenchensteinerstrasse 38, CH-4002 Basel, Switzerland (together with its Affiliates, “Manufacturer”) and upon execution will be incorporated into the Development and Manufacturing Services Agreement between RADIUS and Manufacturer dated October 16, 2007 (the “Original Agreement”), as amended to date. Capitalized terms used in this Amendment will have the same meaning as set forth in the Agreement as amended to date.

 

WHEREAS, RADIUS and Manufacturer are parties to the Agreement; and

 

WHEREAS, RADIUS and Manufacturer are parties to Amendment No. 1, entered into on May 19, 2011, and Amendment No. 2, entered into on January 30, 2014, to the Agreement (such Amendment No. 1 and Amendment No. 2 together with the Original Agreement, the “Agreement”);

 

WHEREAS, the Parties are in the process of negotiating a commercial manufacturing services agreement (the “Commercial Agreement”); and

 

WHEREAS, the Parties desire to further amend the Agreement as set forth herein.

 

NOW THEREFORE, in consideration of the above premises and the mutual covenants herein set forth, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:

 

1.              Amendment to Section 14.1. The Parties hereby agree to extend the term of the Agreement to the earlier of a) the date on which the Commercial Agreement becomes effective, or b) March 31, 2016, unless earlier terminated pursuant to Section 14 of the Agreement. Any further extensions of the term shall be mutually agreed by the Parties.

 

2.              Pending Work Orders. Any and all Work Orders entered into, or Purchase Orders issued, under and during the term of the Agreement which are still pending at the time the Commercial Agreement becomes effective shall immediately become governed by, and incorporated in and made a part of, such Commercial Agreement.

 

3.              Ratification. All lawful actions taken by RADIUS and Manufacturer which are consistent with the terms of the Agreement are hereby authorized, approved and ratified, regardless of whether any such actions were taken prior to the date of this Amendment.

 

4.              Remainder of Agreement. Except as modified by this Amendment, all other terms and provisions of the Agreement shall remain in full force and effect in accordance with their terms.

 

5.              Entire Agreement. This Amendment and the Agreement supersede all other prior agreements, understandings, representations and warranties, oral or written between the parties hereto in respect of the subject matter hereof.

 

 

6.              Governing Law; Jurisdiction. This Amendment shall be construed, interpreted and enforeced in accordance with the internal substantive laws of the State of New York, without reference to the choice of law doctrine of such state.

 

7.              Counterparts; Delivery. This Amendment may be executed in any number of counterparts, each of which shall for all purposes be deemed an original and all of which shall constitute the same instrument. Delivery of an executed signature page of this Amendment by facsimile or other electronic transmissions shall be as effective as delivery of an original executed counterpart of this Amendment.

 

[Remainder of Page Intentionally Left Blank]

 

2

 

IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed by their respective authorized representatives effective as of the date first above written.

 

	
LONZA SALES LTD.
    	
 
    	
RADIUS HEALTH, INC.
    
	
 
    	
 
    	
 
    
	
By: 
    	
/s/ Michael Maskus
    	
 
    	
By:
    	
/s/ David C. Hanley
    
	
Name:
    	
Michael Maskus
    	
 
    	
Name:
    	
David C. Hanley
    
	
Title:
    	
Associate Director
    	
 
    	
Title:
    	
Executive Director, Technical   Operations
    
	
 
    	
 
    	
Commercial Development
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Cordula Altekrüger
    	
 
    	
Reviewed By
    
	
Name:
    	
Cordula Altekrüger
    	
 
    	
CA
    
	
Title:
    	
Senior Legal Counsel
    	
 
    	
Legal Dept.
    
						

 

3

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