Document:

Exhibit 10.2

 

INTERIM SUPPLY AGREEMENT

 

This Interim Supply Agreement (this “Agreement”) is entered into as of 9th day of October, 2013 (the “Effective Date”) by and among NuPathe, Inc., a Delaware corporation (“NuPathe”), LTS Lohmann Therapy Systems, Corp., a Delaware corporation (“LTS”) and LTS Lohmann Therapie-Systeme AG, a company organized under the laws of Germany (“LTS AG”).

 

WHEREAS, LTS and NuPathe entered into that certain Commercial Supply and License Agreement (“CSLA”);

 

WHEREAS, NuPathe desires to purchase Drug Product (as defined in the CSLA) from LTS AG for the period of time until the LTS facility in West Caldwell is qualified to manufacture the Drug Product (the “Interim Period”);

 

WHEREAS, LTS and LTS AG agree to have LTS AG manufacture and sell to NuPathe the Drug Product for the Interim Period;

 

WHEREAS, the parties wish for the terms and conditions of the CSLA to apply to the purchase by NuPathe and sale by LTS AG of the Drug Product for the Interim Period;

 

NOW THEREFORE, in consideration of the foregoing recitals, mutual covenants and agreements set forth herein, the parties hereto agree as follows:

 

AGREEMENT:

 

1.                                      All capitalized terms that are set forth herein but not defined herein shall have the meanings assigned in the CSLA.

 

2.                                      NuPathe shall deliver purchase orders for the Drug Product during the Interim Period to LTS AG directly (the “Interim Purchase Orders”) and all invoicing shall be made by, and payments made to, LTS AG in connection therewith.

 

3.                                      All of the Interim Purchase Orders are made pursuant to the terms and conditions of the CSLA and all such terms and conditions shall apply in connection with the manufacture and supply of the Drug Product pursuant to the Interim Purchase Orders.

 

4.                                      LTS AG assumes the rights and obligations of LTS as set forth in the CSLA with respect to Drug Product manufactured and supplied by LTS AG pursuant to the Interim Purchase Orders.

 

5.                                      The quality agreement to be entered into by NuPathe and LTS AG shall be the quality agreement governing the manufacture and supply of the Drug Product in connection with the Interim Purchase Orders.

 

 

6.                                      NuPathe shall use its Commercially Reasonable Efforts to make the appropriate filing with the FDA in order to have the LTS facility in West Caldwell approved as an acceptable manufacturer of the Drug Product, and take all other necessary actions in connection therewith, as soon as possible.

 

7.                                      Except as expressly set forth herein, nothing in this Agreement shall amend or modify the CSLA.

 

8.                                      This Agreement shall be governed under the laws of the State of New Jersey.

 

[Signature Page Follows.]

 

 

IN WITNESS WHEREOF, the parties hereto have caused this agreement to be duly executed and effective as of the Effective Date.

 

 

	
 
    	
LTS   LOHMANN THERAPIE-
    
	
 
    	
SYSTEME   AG
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Ulrich Sielaff
    
	
 
    	
Name:
    	
Ulrich   Sielaff
    
	
 
    	
Title:
    	
General   Counsel
    
	
 
    	
 
    
	
 
    	
By:
    	
Dr.   Joerg Mayer
    
	
 
    	
Name:
    	
Dr.   Joerg Mayer
    
	
 
    	
Title:
    	
Head   of Business Development,
    
	
 
    	
 
    	
Europe
    
	
 
    	
 
    
	
 
    	
LTS LOHMANN THERAPY SYSTEMS,
    
	
 
    	
CORP.
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/ Joachim Franke
    
	
 
    	
Name:
    	
Joachim   Franke
    
	
 
    	
Title:
    	
CEO
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Jennifer Everett
    
	
 
    	
Name:
    	
Jennifer   Everett
    
	
 
    	
Title:
    	
Vice   President — Finance
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
NUPATHE   INC.
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Terri Sebree
    
	
 
    	
Name:
    	
Terri   Sebree
    
	
 
    	
Title:
    	
PresidentExhibit 10.2

 

Execution Copy

 

CLINICAL TRIAL SERVICES AGREEMENT AMENDMENT NO. 1 TO WORK STATEMENT NB-2

 

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-2 under the Agreement (“Work Statement NB-2”) as of February 21, 2012 (“Effective Date”).

 

Pursuant to Section 2.3, 2.11 and 11.7 of the Agreement, the parties wish to enter into this Amendment No. 1 to Work Statement NB-2 (“Amendment No. 1”) effective as of November 6, 2013 (“Amendment Date”). Capitalized terms used in this Amendment No. 1 and not defined herein are used with the meanings ascribed to them in the Agreement and Work Statement NB-2.

 

NOW THEREFORE, in consideration of the mutual covenants and promises contained in this Amendment No. 1, the parties agree as follows:

 

1. Addition of Antibody Surveillance Program (a) At Radius’ request, NB will initiate an antibody surveillance program at CCBR and non-CCBR sites to monitor any patients with positive antibodies in the clinical study that is the subject of Work Statement NB-2 (collectively, “Ab Services”). Radius wishes to provide for payment to NB for these Ab Services under Work Statement NB-2.

 

(b)  The NB representations and warranties set forth in Sections 8.2, 8.3, 8.5 and 8.6(ii) of the Agreement shall apply to the personnel, including Clinical Investigators, that perform the Ab Services.  NB shall be responsible for securing the applicable representations and warranties from these clinical study sites and personnel, including Clinical Investigators.

 

(c) A new section at the bottom Attachment B to Work Statement NB-2 (Budgets, Fees, Pass-through Costs, and Payment Schedule*) is hereby amended to read in full as follows:

 

“Antibody — BA058-05-007

 

Cost Proposal 08 October 2013

 

	
Sponsor:
    	
 
    	
RADIUS
    	
 
    	
 
    
	
Protocol   ID:
    	
 
    	
Antibody - BA058-05-007
    	
 
    	
 
    
	
Development   Phase:
    	
 
    	
N/A
    	
 
    	
 
    
	
Disease:
    	
 
    	
Osteoporosis
    	
 
    	
 
    
	
Nordic   Start Study Activity
    	
 
    	
1-Jun-13
    	
 
    	
 
    
	
Expected   Date of first follow up patient first visit
    	
 
    	
20-Nov-13
    	
 
    	
Based   on FPLT 20-MAR-2013
    
	
Expected   Date of last follow up patient first visit
    	
 
    	
31-Dec-13
    	
 
    	
Based   on LPLT 31-JUN-2013
    
	
Expected   Date of last follow up patient last visit
    	
 
    	
1-Jul-14
    	
 
    	
Based   on Last FUP last visit 6 months after Last FUP first vist
    
	
Expected   Length of total Follow-up period (months):
    	
 
    	
12
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Duration   of Nordic Involvement
    	
 
    	
13
    	
 
    	
 
    
	
Number   of visits per patient:
    	
 
    	
2
    	
 
    	
Estimated   2 extra samples per positive patient up to a period of 12 months after last   study drug.
    
	
Number   of Countries:
    	
 
    	
4
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Number   of Sites:
    	
 
    	
9
    	
 
    	
 
    

 

1

 

	
Total Budget
    	
 
    	
EURO
    	
 
    	
 
    
	
Clinic   Fee
    	
 
    	
€40 per scheduled visit; €96 per unscheduled visit
    	
 
    	
All   visits unsheduled
    
	
CRO   Activities (Nordic Bioscience)
    	
 
    	
19,630
    	
 
    	
Period   until LPLV in 005 is partly covered in existing work orders. Only extra is   increased study and site management and pharmacovigilance
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Central   Lab Fee (Synarc Lab)
    	
 
    	
€26.40 per sample per patient
    	
 
    	
Shipment   not included. Shipment be invoiced as pass through. Estimated to be 4.000   Euro
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
EDC   system
    	
 
    	
0
    	
 
    	
Not   applicable
    

 

	
Pass through Cost
    	
 
    	
EURO
    	
 
    	
 
    
	
Translation
    	
 
    	
Not included
    	
 
    	
 
    
	
Investigator   Meeting
    	
 
    	
Not included
    	
 
    	
 
    
	
Lab   shipments
    	
 
    	
Not included
    	
 
    	
 
    
	
Submission   to EC and CA
    	
 
    	
Not included
    	
 
    	
 
    
	
EDC   system
    	
 
    	
Not included
    	
 
    	
 
    
	
Data   Monitoring Committe
    	
 
    	
Not included
    	
 
    	
 
    
	
Patient   insurrance
    	
 
    	
Not included
    	
 
    	
 
    
	
Annual   reports to the FDA
    	
 
    	
Not included
    	
 
    	
 
    
	
External   advisory Board
    	
 
    	
Not included
    	
 
    	
 
    
	
Statistical   Data analysis and Clinical Study Report
    	
 
    	
Not included
    	
 
    	
 
    

 

The CRO fee is not subject to any adjustment for the number of antibody positive patients. The Clinic Fee and Central Lab Fee will be adjusted to reflect the actual number of antibody positive patients and visits completed for surveillance activities. The Central Lab Fee will be adjusted on a pro rata basis based on the number of samples per antibody positive patient.

 

The purchase price for the Ab Services shall be paid solely in cash as follows:

 

(a)  The CRO fee shall be paid in fixed monthly installments over the expected 13 month period of delivery of the Ab Services commencing June 1, 2013 with an expected last patient, last follow-up visit of July 1, 2015 equal to €1,510 per month.

 

(b) The Clinic fee shall be paid as clinic visits and procedures are performed based on a scheduled visit fee of €40 and an unscheduled visit fee of €96.

 

(c) The Central Lab Fee shall be paid as clinic visits and procedures are performed based on €26.40 per sample per antibody positive patient.

 

(d) Shipping shall be paid as a pass-through costs as incurred.

 

2.  Ratification.  Except to the extent expressly amended by this Amendment No. 3, all of the terms, provisions and conditions of the Agreement and Work Statement NB-2 are hereby ratified and confirmed and shall remain in full

 

2

 

force and effect.  The term “Work Statement NB-2”, as used in the Agreement, shall henceforth be deemed to be a reference to Work Statement NB-2 as amended by this Amendment No. 1.

 

3.  General.  This Amendment No. 1 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]

 

3

 

IN WITNESS WHEREOF the parties have caused this Amendment No. 1 to be executed by their respective duly authorized officers, and have duly delivered and executed this Amendment No. 1 under seal as of the Amendment Date.

 

	
RADIUS HEALTH, INC.
    	
 
    	
NORDIC   BIOSCIENCE CLINICAL
   DEVELOPMENT VII A/S
    
	
 
    	
 
    	
 
    
	
/s/   B. Nicholas Harvey
    	
 
    	
/s/   Bente Juel Riis
    
	
By:   B.N. Harvey
    	
 
    	
By:   Bente Juel Riis
    
	
Title:   CFO
    	
 
    	
Title:   CEO
    
	
 
    	
 
    	
 
    
	
Notice   Address
    	
 
    	
Notice   Address
    
	
Radius   Health, Inc.
    	
 
    	
Nordic   Bioscience Clinical Development VII A/S
    
	
201 Broadway, 6th Floor
    	
 
    	
Herlev   Hovedgade 207
    
	
Cambridge, MA 02139
    	
 
    	
2730 Herlev
    
	
USA
    	
 
    	
Denmark
    
	
Attn:   President
    	
 
    	
Attn:   Clinical Trial Leader &   Medical Advisor / Clinical Studies
    
	
Phone:   01.617.444.1834
    	
 
    	
Phone:   45.4452.5251
    
	
Fax:   01.617.551.4701
    	
 
    	
Fax:   45.4452.525

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