Document:

Amendment No.1 to Services Agreement with Lonza Biologics PLC

 Exhibit 10.31 
  
 Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information
subject to the confidentiality request. Omissions are designated as [*****]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 
  
 AMENDMENT NO. 1 
  
 to the 
  
 Services Agreement 
  
 dated 6 June 2000 
  
 between 
  
 LONZA BIOLOGICS PLC 
  
 and 
  
 XCYTE THERAPIES, INC. 
  

 1 

 THIS AMENDMENT is made the 10th day of January, 2001. 
  
 BETWEEN

  
 LONZA BIOLOGICS PLC of 228 Bath Road, Slough, Berkshire SL1 4DY, England
(hereinafter referred to as “LB”), and 
  
 XCYTE THERAPIES, INC.
of 1124 Columbia Street, Suite 130, Seattle, Washington 98104, USA (hereinafter referred to as “Customer”). 
  
 WHEREAS 
  
 A. Customer and LB entered into a services agreement dated 6 June 2000 (hereinafter referred to as “the Agreement”), under which LB is required to perform the Services as stated therein. 
  
 B. Customer would like LB to carry out additional activities under the Agreement. 

 
 C. LB is willing to carry out the additional activities. 
  
 NOW THEREFORE it is hereby agreed by the parties to amend the Agreement as follows:

  

	1.	A new Stage 14 shall be added to Schedule 2 to the Agreement to read as follows: 

  

	  	“14.0 Stage 14 [**] 

  

	 	14.1	Objectives 

  

	 	14.1.1	Production of [**] from the [**] Cell Line 

  

	 	14.2	Activities 

  

	 	14.2.1	Performance of [**] to [**] from the [**] Cell Line 

  

	 	14.2.2	[**] of [**]. 

  

	 	  	Note: A proportion of the [**] will be used to [**]. 

  

	 	14.2.3	[**] product from [**]. 

  

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	[*]	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the
omitted portions. 

	 	14.2.4	[**] into [**] to be specified by the Customer. [**] or as agreed with the Customer. 

  

	 	14.2.5	Analyze the [**] by [**]. Measure levels of [**] in the [**]. 

  

	 	14.2.6	Ship Product (approximately [**]) to Customer. The Customer accepts that the [**] may not be complete at the time of shipment. 

  

	 	14.2.7	Issue a [**] of the Activities to the Customer. 

  

	 	  	Note: The [**] will be defined at the end of Stage 3 and used to [**] the Pilot Batch (Stage 5). [**] may be made to the purification process after [**] and prior to the [**] (Stage
6). 

  

	 	  	Stage 14 will commence by agreement with the [**]. This Stage will be complete upon [**]. It is estimated that this Stage will be complete [**] from commencement of the Stage.”

  

	2.	The following shall be added to Schedule 3 of the Agreement: 

  

	 	“1.0	Price 

  

	 	  	In consideration for LB carrying out the Services as detailed in Schedule 2 the Customer shall pay LB as follows: 

  

	 Stage

	 	 	 	 Price (UK £ Sterling)

	Stage 14	 	[**]	 	£ [**]

  

	 	2.0	Payment 

  

	 	  	Payment by the Customer of the Price for each Stage and substage shall be made against LB’s invoices as follows: 

  

	 	2.1	For Stage 14 

  

	 	  	Fee of £ [**] upon [**] of Stage 14. 

  

	 	  	Fee of £ [**] upon [**] of Stage 14.” 

  

	3.	Save as herein provided all other terms and conditions of the Agreement shall remain in full force and effect. 

  
 IN WITNESS WHEREOF the parties have caused this Amendment No. 1 to be executed by their
respective representatives thereunto duly authorized as of the day and year first above written. 
  

 3 
  

	[*]	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the
omitted portions. 

	 Signed for and behalf of
	  	 /s/:
	  	 Judith Symes

	  	 
	 LONZA BIOLOGICS PLC
	  	 Company Secretary
	  	 Title

				
	 Signed for and behalf of
	  	 /s/:
	  	 Ronald J. Berenson

	  	 
	 XCYTE THERAPIES
	  	 President and CEO
	  	 Title

  

 4Amendment No.2 to Services Agreement with Lonza Biologics PLC

 Exhibit 10.32 
  
 Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information
subject to the confidentiality request. Omissions are designated as [*****]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 
  
 AMENDMENT NO. 2 
  
 to the 
  
 Services Agreement Relating to 
  
 the Cell Line Known as [**] 
  
 Expressing Product XR- [**] 
  
 dated 6 June
2000 
  
 Between 
  
 LONZA BIOLOGICS PLC 
  
 and 
  
 XCYTE THERAPIES INC 
  

 1 

 THIS SECOND AMENDMENT is made the 18th day of April 2001 to an Agreement dated 6 JUNE 2000. 
  
 between 
  
 LONZA BIOLOGICS PLC of 228 Bath Road, Slough, Berkshire, SL1 4DY, England (hereinafter referred to as “LB”) 
  
 and 
  
 XCYTE THERAPIES INC. of 1124 Columbia Street, Suite 130, Seattle, Washington 98104, USA (hereinafter referred to as “the Customer”) 
  
 WHEREAS 
  

	A.	Customer and LB entered into the Agreement dated 6th June 2000 (hereinafter referred to as “the Agreement”), under which LB is required to perform the Services as stated therein. 

  

	B.	Customer would like LB to carry out additional activities under the Agreement. 

  

	C.	LB is willing to undertake at the discretion of LB the additional activities. 

  

NOW THEREFORE IT IS HEREBY AGREED as follows: 
  

	1.	Schedule 2 to the Agreement shall be amended to include the Services as set out in Appendix 1 hereto. 

  

	2.	Schedule 3 of the Agreement shall be amended to include provision of payment for the above mentioned additional Services, as set out in Appendix 2 hereto. 

 

	3.	Save as herein provided all other terms and conditions of the Agreement shall remain in full force and effect. 

  

 2 

 AS WITNESS the hands of the duly authorized representatives of the parties hereto the day and year first before written.

  
 SIGNED BY: 
  

	 For and in behalf of
	  	 /s/ Judith Symes

	 LONZA BIOLOGICS PLC
	  	 Secretary

	 	  	 Title

		
	 SIGNED BY:
	  	 
		
	 For and in behalf of
	  	 /s/ Ronald J. Berenson

	 XCYTE THERAPIES INC
	  	 President & CEO

	 	  	 Title

  

 3 

 APPENDIX 1 
  

Stages 15, 16, 17 of the Services shall be added to Schedule 2 as follows: 
  
 SCHEDULE 2 
  
 “Stage 15 – [**] 
  

	 	Note:	This Stage to be undertaken by mutual agreement between LB and Customer. 

  

	15.1	Objectives 

  

	 	15.1.1	To carry out a [**] at [**]. 

  

	 	15.1.2	To store [**] for further [**]. 

  

	15.2	Activities 

  

	 	15.2.1	Recover [**] from the MCB or WCB and [**] to [**]. Carry out [**]. 

  

	 	15.2.2	To carry out a series of [**] to evaluate the effect of [**] on [**]. 

  

	 	15.2.3	Carry out [**] at [**]. 

  

	 	15.2.4	Clarify [**]. Refine the [**] of the [**] stage in the Process. 

  

	 	15.2.5	Measure [**] and across [**]. 

  

	 	15.2.6	Store [**]. 

  

	 	15.2.7	Review requirements (if any) for [**] that may be needed following this study. Any such [**] are subject to agreement. 

  

	 	15.2.8	Produce a [**] on the [**] operations. 

  

	 	Note:	The following operational activities 15.2.9 – 15.2.11 to be agreed between LB and Customer. 

  

	 	15.2.9	[**] using procedure established in Stage 3 to be agreed between LB and Customer. 

  

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omitted portions. 

	 	15.2.10	Test [**] by [**]. Also test by the[**]. 

  

	 	15.2.11	Issue [**] on the [**]. 

  

	15.3	Timescale 

  

	  	Stage 15 shall be complete upon the issuance of the summary report. It is estimated that the summary report will be issued [**] from the commencement of the Stage.

  
 “Stage 16 – [**] 
  

	 	Note:	This Stage to be undertaken by mutual agreement between LB and Customer. 

  

	16.1	Objectives 

  

	 	16.1.1	To prepare cGMP documentation for use in manufacture of [**]. 

  

	 	16.1.2	To carry out a [**]. 

  

	 	16.1.3	To evaluate the ability of the Process to produce Product meeting the [**] included in the draft Specification. 

  

	 	16.1.4	To store [**] for further processing. 

  

	16.2	Activities 

  

	Note:	This Stage to be undertaken by mutual agreement between LB and Customer. 

  

	 	16.2.1	Prepare cGMP documentation. The documentation shall cover: 

  

	 	•	[**] manufacturing directions and in-Process controls contained in the manufacturing directions. 

  

	 	•	Materials Specifications (as required) 

  

	 	•	Sampling protocols. 

  

	 	16.2.2	Recover [**] from the MCB or WCB and [**] to [**]. Carry out [**]. 

  

	 	16.2.3	Clarify [**]. Refine the [**] of the [**] stage in the Process. 

  

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omitted portions. 

	 	16.2.4	Measure [**] and across [**]. 

  

	 	16.2.5	Store [**]. 

  

	 	16.2.6	Review requirements (if any) for [**] that may be needed following this study. Any such [**] are subject to agreement. 

  

	 	16.2.7	Produce a [**] on the [**] operations. 

  

	16.3	Timescale 

  

	  	Stage 16 shall be complete upon the issuance of the summary report. It is estimated that the summary report will be issued [**] from the commencement of the Stage.

  
 Stage 17 – [**] 
  

	 	Note:	This Stage to be undertaken at the discretion of LB on behalf of the Customer. 

  

	17.1	Objectives 

  

	 	17.1.1	To [**] from one of the [**] batches produced at either [**] by the [**] process defined in Stage 3. 

  

	17.2	Activities 

  

	 	17.2.1	[**] at [**] of the [**] batches produced at either [**] by the process defined in Stage 3. 

  

	 	17.2.2	Test [**] by [**]. Also test by the [**]. 

  

	 	17.2.3	Review requirements (if any) for [**] that may be needed following this study before GMP production. Any such [**] are subject to agreement between Biologics and the Customer with
consideration to [**] requirements. 

  

	 	17.2.4	Produce a 5 page summary report on the [**]. 

  

	17.3	Timescale 

  

	  	Stage 17 shall be complete upon the issuance of the summary report. It is estimated that the summary report will be issued [**] from the commencement of the Stage.”

  

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omitted portions. 

 APPENDIX 2 
  

The following shall be added to Schedule 3 of the Agreement 
  

	“1.0	Price 

  

	  	In consideration for LB carrying out the additional Services as detailed in Schedule 2 the Customer shall pay LB as follows: 

  

	 Stage

	 	 Description

	 	 Cost Price
(UK £ sterling)

	 15
	 	 [**]
	 	 £[**]*

	 15 including option
	 	 [**]
	 	 £[**]

	 16
	 	 [**]
	 	 £[**] **

	 17
	 	 [**]
	 	 £[**]

	*	In the event the [**] activities are undertaken by LB the price of Stage 15 shall revert to the price for Stage 15 including option. 

	**	Price to be confirmed. The value of the Stage is subject to confirmation between LB and Customer prior to commencement. 

  

	2.0	Payment 

  

	  	Payment by the Customer of the Price for each Stage shall be made against LB invoices that will be issued as follows: 

  

	 Stage

	 	 Payment

	For Stage 15	 	[**] upon commencement of Stage 15.
[**] upon issue of summary report to Customer.
		
	For Stage 15	 	[**] upon commencement of Stage 15.
		
	Option	 	[**] upon issue of summary report to Customer.

  

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omitted portions. 

	For Stage 16	 	[**] upon commencement of Stage 16.
[**] upon issue of summary report to Customer.
		
	For Stage 17	 	[**] upon commencement of Stage 16.
[**] upon issue of summary report to Customer.

  

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	[*]	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the
omitted portions.

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