Exhibit 10.43
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. 4
TO THE
SERVICES AGREEMENT
between
LONZA BIOLOGICS PLC.
and
XCYTE THERAPIES INC.
RELATING TO [**]
THIS AMENDMENT is made the 2nd day of August, 2004
BETWEEN
1. | Lonza Biologics plc. of 228 Bath Road, Slough, SL1 4DX, Berkshire, England (“LB”) and |
2. | Xcyte Therapies Inc. of 1124 Columbia Street, Suite 130, Seattle, Washington 98104, USA (“Customer”). |
WHEREAS
A. | The parties have entered into an Agreement dated 6th June 2000 relating to the supply of Services (as therein defined), and |
B. | The parties now wish to amend the terms of the Agreement |
THEREFORE it is hereby agreed by and between the parties that the Agreement shall be amended as follows: -
1. | Stage 16 shall be added to Schedule 2 as follows: |
STAGE 16 - PRODUCTION OF CGMP PRODUCT AT [**] SCALE FOR [**] |
16.1 | Objective | |||||
16.1.1 | To manufacture[**] in accordance with the principles of cGMP. Product to be produced as one lot. | |||||
16.2 | Activities | |||||
16.2.1 | After receiving[**], recover[**] and expand culture to[**]. | |||||
Note: | Cells from two ampoules of the WCB will be recovered and passaged separately. Only cells derived from one ampoule will be used to inoculate the[**]. | |||||
16.2.2 | Perform[**] at [**]. | |||||
16.2.3 | Cryopreserve an[**] for testing as required by the Customer. | |||||
16.2.4 | Clarify[**]. | |||||
16.2.5 | [**] by procedure established[**]. | |||||
16.2.6 | Test [**] against the[**]. | |||||
16.2.7 | Undertake review of lot documentation and disposition of Product by LB QA group. |
[**] | 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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16.2.8 | Review requirements (if any) for Process modifications in order to meet Specification for manufacture of subsequent lots. Any such Process modifications are subject to agreement. | |||||
16.2.9 | Deliver Product to Customer. | |||||
16.2.10 | Undertake quality assurance review of lot documentation and issue Certificate of Analysis or other appropriate summary of analysis. | |||||
16.3 | Timescale | |||||
This Stage will commence as soon as the[**] is available for use and the Process development activities and cGMP documents are complete. | ||||||
This Stage shall be complete upon quality assurance review of lot documentation. It is estimated that Product will be delivered[**] from commencement of this Stage. If Customer requests in writing, the Product can be shipped in quarantine prior to release. It is estimated that this shipment could occur[**] from commencement of this Stage. |
2. | Schedule 3, Part 1 shall be amended as follows: |
“Stage 16 Production of cGMP product at[**] for[**] | £[**]” |
3. | Schedule 3, Part 2 Price shall be amended as follows: |
“For Stage 16 |
[**]on out of freeze of [**] |
[**]upon completion [**].” |
4. | 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 to be executed by their representatives thereunto duly authorized as of the day and year first written.
Signed by | /s/ Ronald J. Berenson | |||
for and on behalf of Xcyte Therapies Inc. | ||||
Signed by | /s/ Judith Symes | |||
for and on behalf of Lonza Biologics plc. |
[**] | 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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