Exhibit 10.34

 

Amendment 1 (“this Amendment”)
to the Development and Clinical Supply Agreement 
with the Contract Number: E86A1D4C-B3F9

Between

Ultragenyx Pharmaceutical Inc.
60 Leveroni Court, Novato, CA 94949, USA 
(“Ultragenyx’’)

and

Rentschler Biotechnologie GmbH,
Erwin-Rentschler-Str. 21, 88471 Laupheim, Germany 
(“Rentschler’’)

Rentschler and/or Ultragenyx are hereinafter referred to as “Party” or “Parties”.

The Parties amend their Development and Clinical Supply Agreement with the Contract Number: E86A1D4C-B3F9, effective as of 31 August 2012, (“the Agreement”) as follows:


	
1.
	
Section 2.4 is changed and reads as follows:




If (1) Ultragenyx cancels or postpones the Services concerning Drug Product for a rea­ son within Ultragenyx’s control and not the result of Rentschler’s policies, or (2) other deviations to the respective timelines stated in Schedule Two are caused by reasons within Ultragenyx’s control and not the result of Rentschler’s policies, then in either case, Rentschler is entitled to require that Ultragenyx pay the following reimbursement for the unused production facilities:

 


		
	
Cancellation period prior to the beginning of the Drug Product manufacturing
	
Exit fee (percentage of total fees for the Drug Product manufacturing)

	
More than 13 weeks
	
No exit fee

	
12- 9 weeks
	
30%

	
8 - 5 weeks
	
60%

	
4 - 3 weeks
	
90%

	
2 weeks and less
	
100%




1




 

Rentschler shall use commercially reasonable efforts to mitigate any losses or damages it may incur due to Ultragenyx’s cancellation or postponement regarding the Drug Product.  If Rentschler mitigates such losses or damages so that it incurs no damage or significantly less damage as a result of the cancellation or postponement in the provision of materials or information, Ultragenyx must only reimburse Rentschler for the unmitigated costs of the cancellation or postponement. This in particular applies if Rentschler can use the production time for another order.

For clarity, if Ultragenyx notifies Rentschler of a cancellation or postponement prior to the thirteenth week before the production time, then the foregoing reimbursement shall not be owed to Rentschler; provided, however, that any actual expenses for activities performed by Rentschler with regard to the cancelled or postponed batch (e.g. preparation of manufacturing documentation) shall be borne by Ultragenyx and may be invoiced by Rentschler to Ultragenyx.


	
2.
	
No change or modification of this Amendment shall be valid or binding upon the Parties unless such change or modification is in writing and duly executed by the Parties.





	
3.
	
Except as specifically set forth herein, all other terms and conditions of the Agreement shall remain unchanged and in full force and effect. In the event of a conflict between the provisions of this Amendment and the provisions of the Agreement, the provisions of this Amendment shall control.





	
4.
	
This Amendment comes into force immediately after both parties have signed this Amendment.  This Amendment may be executed by facsimile or AdobeTM Portable Document Format (PDF) sent by electronic mail and in one or more counterparts each of which will be deemed an original, but all of which together shall constitute one and the same instrument.  It shall form an integral part of the Agreement.




 


					
	
Signed on behalf of
Rentschler Biotechnologie GmbH
	
 
	
 
	
 

	
Date:
	
23 OKT. 2014
	
 
	
Date:
	
23/10/14

	
Signature:
	
/s/ Dr. Klaus Schoepe
	
 
	
Signature:
	
/s/ Thomas Lottner

	
Printed Name:
	
Dr. Klaus Schoepe
	
 
	
Printed Name:
	
Thomas Lottner

	
Position:
	
VP Project Management
	
 
	
Position:
	
VP Commercial Management

	
 
	
 
	
 
	
 
	
 

	
Signed on behalf of
Ultragenyx Pharmaceutical Inc.
	
 
	
If second signature is required:

	
Date:
	
4 Nov 2014
	
 
	
Date:
	
 

	
Signature:
	
/s/ Steven Jungles
	
 
	
Signature:
	
 

	
Printed Name:
	
Steven Jungles
	
 
	
Printed Name:
	
 

	
Position:
	
SVP Tech ops
	
 
	
Position:
	
 

	
 
	
 
	
 
	
 
	
 




 

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