Exhibit 10.5

  *   Confidential Treatment has been requested for the marked portions of this
exhibit pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.

QUALITY AGREEMENT for TRU-016
between
TRUBION PHARMACEUTICALS, INC.
and
LONZA SALES AG
     This Quality Agreement (“Quality Agreement”) is dated effective as of
November ___, 2008, and it defines the roles and responsibilities for the
quality operations between TRUBION PHARMACEUTICALS, INC. (“Trubion” and
“Customer”) and LONZA SALES AG (“Lonza”) with respect to the manufacture of
Customer’s product commonly referred to as TRU-016 under that certain
Manufacturing Services Agreement dated as of November 21, 2005, between Trubion
and Lonza Biologics, Inc. (“Biologics”) (as amended and novated, the “MSA”).
Concurrently herewith, the parties are also entering into an amendment to
manufacturing services in order to amend the MSA as appropriate for the
manufacture of TRU-016 (the “Amendment”). Lonza is the successor in interest to
Biologics under the MSA pursuant to that certain Novation Agreement effective as
of January 1, 2007, among Trubion, Lonza and Biologics.
The parties agree as follows:
This is the Quality Agreement referred to in Section 2.2.3 of the Amendment and
attached as Exhibit A-016 to the Amendment. When used in this Quality Agreement,
the term “Product” shall have the meaning given in the MSA, and refers to
TRU-016 and/or to the form of TRU-016 manufactured under the MSA, as the context
requires. Any capitalized term used but not defined in this Quality Agreement
shall have the meaning given in the MSA. This Quality Agreement may be amended
by written agreement of the parties. In the event of a conflict between the
Quality Agreement and the MSA, the MSA shall control. This Quality Agreement may
be executed in counterparts, each of which shall be deemed an original, and all
of which, taken together, shall constitute one and the same instrument. This
Quality Agreement shall be effective upon full execution, and a signature
transmitted via facsimile or other electronic means shall be deemed to be and
shall be as effective as an original signature. This Quality Agreement may be
amended by written agreement of the parties; no modifications will be binding
unless executed in writing by both parties. This Quality Agreement is governed
by, and this Quality Agreement and the obligations of the parties will be
determined in accordance with, the laws of the State of New York, without
reference to its choice of law rules. New York’s choice of law rules shall not
be invoked for the purpose of applying the law of another jurisdiction.
The responsibilities and rights of the parties under this Quality Agreement are
set forth below.

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A. Overall Responsibilities
This Quality Agreement outlines the responsibilities of the Customer and Lonza
with respect to the quality assurance of Product (TRU-016) manufactured and
supplied by Lonza for the Customer under the terms of the MSA.
This Quality Agreement takes the form of a detailed list of activities
associated with the manufacture, testing and release of Product. Responsibility
for each activity is assigned to either the Customer or Lonza, or is assigned to
both the Customer and Lonza.
The Customer acknowledges that certain activities and obligations under the
Quality Agreement may be performed by Lonza’s Affiliates having expertise in the
relevant areas, provided that Lonza shall remain responsible to Customer for the
acts and omissions of their Affiliates.
This detailed list describes generic quality activities that would be performed
by both parties for Product used by Customer for further manufacturing use in
the preparation of human parenteral Drug Products for clinical trial supply. The
specific Services to be provided by Lonza will be set out in the MSA (and the
Amendment and any other amendments to the MSA) on Price and other terms
acceptable to both parties.
Lonza is responsible for ensuring that the quality requirements for Product are
as specified in the approved Product Specification and that Product is
manufactured, tested and stored in accordance with the ICH Q7 consensus
guideline ‘Good Manufacturing Practice for Active Pharmaceutical Ingredients’,
US FDA 21 CFR 210/211, The Rules Governing Medicinal Products in the European
Union, Volume IV Part II and all other laws, rules and agency regulations as
applicable to API manufacture.
The Customer is responsible for shipping and the final review, approval and
release of Product for use in clinical trial supply. The Customer is responsible
for technical oversight, Product Specifications and Regulatory Agency filings.
B. Specific Responsibilities
Lonza has primary accountability to ensure these responsibilities are executed
in accordance with this Quality Agreement. Note also that “Right to Audit” shall
not imply that Customer’s audit rights are limited to those boxes where “Right
to audit” appears.
1.0 Organization and Personnel

     
Lonza Responsibility
  Customer Responsibility and Right
 
   
•     Ensure adequate number of personnel have appropriate training, skills,
knowledge and experience to manufacture and test Product to cGMP.
 
•     Right to audit.

2.0 Premises and Equipment

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•     Ensure premises, environment, utilities equipment and computerised systems
are properly designed, validated and maintained in accordance with cGMP.
 
•     Right to audit.

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2.0 Premises and Equipment

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•     Ensure Product is manufactured and tested only at sites as agreed with
Customer.
 
•     Right to audit.
 
   
•     Ensure appropriate separation and controls are in place for operation for
multi-Product facility.
 
•     Right to audit.
 
   
•     Ensure that the manufacturing premises and activities are legally
registered, certified or licensed by the applicable regulatory agencies.
 
•     Right to audit.
 
   
•     Supply customer with copies of relevant registrations, certificates or
licenses if applicable.
 
•     Right to audit.
 
   
•     Notify customer of new products being manufactured by Lonza that could
result in changes to Customer’s current processes (for example cleaning or line
clearance).
 
•     Right to audit.

3.0 Raw Materials for Process and Packaging of Product

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•     Source, test and release raw materials and primary packaging of
appropriate quality for processing of Product.
 
•     Right to audit.
 
   
•     Ensure that all animal derived raw materials used for Product are
appropriately tested in line with current regulatory guidance.
 
•     Right to audit.
 
   
•     Qualify or approve vendors of raw materials in accordance with the
relevant standard operating procedure. Provide list of vendors as required.
 
•     Right to audit.
 
   
•     Retain representative samples of critical raw materials. Store under
appropriate conditions according to the relevant standard operating procedure.
 
•     Right to audit.
 
   
•     Qualify raw materials in accordance with the relevant standard operating
procedure.
 
•     Right to audit.

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4.0 Cell Banks

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•     Prepare, characterise and store cell bank if requested by Customer.
 
•     Agree to testing strategy.
 
   
•     Jointly agree to specifications and test methods to enable release of
cell banks for use in Lonza’s multi-Product manufacturing facility.
 
•     Jointly agree to specifications and test methods where required to enable
Product manufactured from cell banks to be released for use in clinical trial
supply.
 
   
•     Provide generic shipping validation data where available if requested by
Customer.
 
•     Right to audit or perform shipping validation.

5.0 Product Specification

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•     Jointly review, approve, and issue the following Drug Substance and Drug
Product Specification(s) as required:
o Drug Substance Release
o Drug Substance Stability
o Drug Product Release
o Drug Product Stability
 
•     Jointly review and approve, within 10 business days, or within a mutually
agreed timeframe, the following Drug Substance and Drug Product Specification(s)
as required:
o Drug Substance Release
o Drug Substance Stability
o Drug Product Release
o Drug Product Stability

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6.0 Production and Process Control

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•     Prepare, approve and maintain documents relating to facility, equipment
and test methods.
 
•     Right to audit.
 
   
•     Jointly review Process Descriptions, approve and issue.
 
•     Jointly review and approve Process Descriptions. Provide review comments
and/or approval within 5 business days or upon mutually agreed upon timeframe.
 
   
•     Prepare Master Batch Records for each processing step. Provide to Customer
for review and comment additional Master Batch Record documentation as mutually
agreed upon.
 
•     For the Master Batch Records mutually agreed upon to be reviewed by the
Customer, provide review comments and/or approval within 5 business days or upon
mutually agreed upon timeframe.
 
   
•     Define and perform in-process controls and testing program.
 
•     Agree to in-process testing strategy.
 
   
•     Designate unique batch numbers for raw materials, process materials and
Product.
 
•     Right to audit.
 
   
•     Manufacture of Product to Product Specification, cGMP standards and
current regulatory submissions made available to Lonza as appropriate.
 
•     Right to audit.

•     Provide relevant sections of regulatory submissions to Lonza as
appropriate.
 
   
•     Ensure QA representatives are on-site or available at all times during
manufacture and testing of product.
 
•     Right to audit.
 
   
•     Permit Customer’s person on plant to be present in Lonza’s facility during
normal business hours to observe the runs and observe Lonza’s performance, at
times and for durations to be agreed upon with Customer.

•     It if is determined that the Customer representative/consultants are also
engaged by a Third Party biologics manufacturer reasonably determined by Lonza
to be a competitor of Lonza, Lonza shall not be required to permit access to
Lonza’s facility.
 
•     Right to designate 1 of its employees or consultants as Customer’s person
on plant, to be present in Lonza’s facility during normal business hours to
observe the runs and observe Lonza’s performance, at times and for durations to
be agreed upon with Lonza.

•     Customer to ensure there are appropriate 3-way confidentiality agreements
in place with any representative/consultants used. Provide Customer
representative/ consultants list to Lonza at least 10 business days in advance
of such representative/consultants first trip to Lonza’s facility.
 
•     While at Lonza’s facility, Customer’s representative shall comply with all
of Lonza’s applicable policies and procedures, and, at Lonza’s option, shall be
escorted by Lonza personnel.
 
•     While at Lonza’s facility, Customer’s representative shall comply with all
Lonza’s applicable policies and procedures, and,at Lonza’s option, shall be
escorted by Lonza personnel.

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6.0 Production and Process Control

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•     Perform product specific cleaning validation of small parts/miscellaneous
equipment.
 
•     Right to audit.

7.0 Product Storage, Labelling and Packaging Prior to Shipment

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•     Store, label and package the Product as defined in the Product
Specification.
 
•     Right to audit.

8.0 Shipment

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•     Notify Customer of proposed shipment date.
 
•     Agree to shipment date (notify Lonza if specific shipment date is
required).
 
   
•     Ship Product on behalf of Customer to locations designated by Customer.
 
•     Acknowledge receipt of Product.
 
   
•     Provide generic shipping validation data for Product where available if
requested by Customer.
 
•     Right to audit or perform specific shipping validation.
 
   
•     If Product is to be shipped under quarantine ensure written confirmation
received from Customer to authorise shipment of Product under quarantine prior
to shipment.
 
•     Provide Lonza with written confirmation to authorise shipment of Product
under quarantine.

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9.0 Laboratory Controls

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•      Perform Product release testing against Product Specification.
 
•      Right to audit.
 
   
§      Jointly approve Product-specific analytical Test Methods
 
§      Jointly approve Product-specific analytical Test methods
 
   
•      If requested by Customer, provide copies of raw data and testing records
 
•      Right to receive copies of raw data and testing records
 
   
•      Notify Customer of confirmed out of specification (OOS) Product release
testing results where possible within one (1) business day and not to exceed
three (3) business days of the out of specification being confirmed.
 
•      Review confirmed out of specification reports; comment on corrective and
preventative actions. For target specifications discuss impact on quality of the
Product.
 
   
•      Take and retain Bulk Product samples from each batch sufficient for at
least two (2) full biochemical specification analyses for use in the event of an
investigation on Product released for clinical trial supply.
 
•      Right to audit.
 
   
•      Store the above samples under appropriate conditions.
   
 
   
•      Retain samples for the period defined in the relevant standard operating
procedure.
 
•      Right to audit.
 
   
•      Notify Customer of intent to destroy retention samples with option to
send samples to Customer.
 
•      Approve destruction of samples or request receipt of samples.
 
   
          If reference prepared by Lonza
            If reference prepared by Lonza
 
   
•      Prepare, characterise and store Product reference standard if requested
by the Customer.
 
•      Right to audit.
 
   
§      Jointly approve Product reference standard protocol and report
 
§      Jointly approve Product reference standard protocol and report
 
   
•      Provide reference standard characterisation report if required.
   
 
   
          If reference supplied by Customer
            If reference supplied by Customer
 
   
•      Store characterized Product reference standard under appropriate
conditions.
 
•      Supply characterised Product reference standard with Certificate of
Analysis.

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10.0 Use of Contract Testing Laboratories

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•     Qualify Contract Testing Laboratories for raw material release testing,
in-process testing and Product release testing.
 
•     Right to audit.
 
   
•     Notify Customer of Contract Testing Laboratories intended to be used for
Product release testing.
 
•     Consent or reject to the use of Contract Testing Laboratories.

11.0 Product Release

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•     Review Batch Record for compliance to cGMP and the Product Specification.
 
•     Right to audit.
 
   
•     Provide Customer with copies of main operational steps from Batch Record.
This will include the Certificate of Analysis (including TSE / BSE statements),
a summary of batch related deviations and environmental monitoring summaries.
 
•     Right to audit Batch Records prior to Customer release or, if appropriate,
review copies of batch records provided by Lonza. Provide advance notice of
intent to audit/review Batch Records no fewer than 10 business days. Each Batch
Record audit/review will be limited to no more than 2 representatives and 2 days
per Process Lot, unless otherwise mutually agreed.
 
 
 
•     Right to audit related ancillary documents (i.e. media/buffer records) at
Lonza if appropriate. (Lonza proprietary information will be omitted).
 
   
•     Prepare a Certificate of Analysis for Drug Substance /Statement of Testing
for vialled Drug Product, if applicable, and release Product to Customer for
further manufacturing use.
 
•     Release Drug Product for clinical trial supply.

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12.0 Deviations and Failed Run Reports

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•     Initiate investigations, evaluate and define follow up actions and final
approval of deviations and failure investigation reports.
 
•     Right to audit.
 
   
•     Notify the Customer of deviations identified by Lonza QA as external,
where possible within one (1) business day and not to exceed
three (3) business days of the event being assigned as external.
 
•     Review/approve external deviations; comment on corrective and preventative
actions. Agree to the impact on the quality of the Product prior to release by
Lonza for further manufacturing use. Comments and approval for external
deviations to be provided within 10 business days.
 
   
•     Provide a list and summary of all product related deviations (see section
11.0). If requested, provide Customer with full copies (e.g. PDF) of deviation
and investigation reports.
 
•     Review report.
 
   
•     Notify Customer of failed runs where possible within one (1) business day
and not to exceed three (3) business days of failure being identified.
 
•     Review failure investigation report and comment on corrective and
preventative actions.
 
   
•     Where possible within one (1) business day and not to exceed
three (3) business days of event being identified; notify Customer of any events
which may impact batches previously shipped or released.
 
•     Right to audit.

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13.0 Change Control Procedures

     
Lonza Responsibility
  Customer Responsibility and Right
 
   
Customer proposed changes
  Customer proposed changes
 
   
•     Process change through change control and notify Customer of change
approval. If change rejected discuss reasons for rejection with Customer.
 
•     Propose Customer changes and provide rationale in writing.
 
   
Lonza proposed changes
  Lonza proposed changes
 
   
•     Propose Product specific changes in writing and provide rationale for
change to Process Descriptions; test methods; sampling plans; specifications for
key raw materials (animal and / or human derived raw materials, chromatography
resins and final formulation excipients); Product Specification(s) and stability
program. Process change through change control.
 
•     Approve proposed Product specific changes prior to implementation within
an agreed timeframe (not to exceed 10 business days).
 
   
•     Inform Customer of changes to key personnel as identified in Appendix 1.
 
•     Right to audit.
 
   
•     Inform Customer of changes to major items of equipment, premises and
utilities used for manufacture of Product.
 
•     Right to audit.
 
   
All changes
  All changes
 
   
•     With Customer define strategy for notifying change to Regulatory Agency as
appropriate.
 
•     With Lonza define strategy for notifying change to Regulatory Agency as
appropriate.
 
   
•     Inform Customer of Product batches manufactured with the change until
regulatory approval obtained, if required.
 
•     Ensure Product is not distributed until Regulatory approval obtained, if
required.

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14.0 Reprocessing / Rework

     
Lonza Responsibility
  Customer Responsibility and Right
 
   
•     With Customer agree to reprocessing or rework procedures, where possible
prior to execution. (Reprocessing is performed using an external planned
deviation; Rework is performed using a change control.)
 
•     Provide approval in writing for reprocessing or rework to Lonza, prior to
execution.
 
   
•     Provide documented reason and justification for reprocessing or rework
event.
 
•     Provide documented reason and justification for reprocessing or rework
event.
 
   
•     With Customer agree the appropriate testing required prior to the release
of Product.
 
•     With Lonza agree the appropriate testing required prior to the release of
Product.

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15.0 Audit

     
Lonza Responsibility
  Customer Responsibility and Right
 
   
•    [*] cGMP compliance audit permitted per year to cover all Products not to
exceed [*] and [*]. Additionally, the Customer may request ‘for cause’ audits to
address Product quality issues.

•    Permit Customer representatives access to warehousing, manufacturing areas,
laboratories and manufacturing documents including all standard operating
procedures (Lonza proprietary information will be omitted), raw data and records
for audit purposes. Customer representatives to be escorted at all times by
Lonza personnel.

•     If it is determined that the Customer representative/consultants are also
engaged by a Third Party biologics manufacturer reasonably determined by Lonza
to be a competitor of Lonza, Lonza shall not be required to permit access to the
Lonza facility.
 
•     Provide reasonable notice of intention to audit (thirty (30) calendar
days).

•     Hold an exit meeting to discuss observations

•     Provide an audit report within thirty (30) calendar days of completion of
audit.

•     Customer to ensure there are appropriate 3-way confidentiality agreements
in place with any representative/consultants used. Provide Customer
representative/consultants list to Lonza (at least (10) calendar days) in
advance of such representative/consultants first trip to Lonza’s facility.

 
   
•    Allow the Customer to observe operations related to Product manufacturing
and testing providing other Customer’s confidentiality is respected.
   
 
   
•    Provide a written response to all audit findings that require corrective
action within twenty (20) business days of receipt of the audit report. Response
to include expected timelines.
   
 
   
•    Provide updates to the Customer, upon request, on the implementation of the
corrective actions.
   

16.0 Product Complaints and Recall

     
Lonza Responsibility
  Customer Responsibility
 
   
•    Respond to requests for data to assist Customer in their investigation.
Agree to a timeline for response.
 
•    Receive and investigate Product complaints and instigate Product recall, as
appropriate.

*Confidential Treatment Requested.

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17.0 Batch Records

     
Lonza Responsibility
  Customer Responsibility
 
   
•     Retain records associated with manufacture and testing of Product,
including records associated with the inspection and release of raw materials
and primary packaging components for a minimum of fifteen (15) years from date
of manufacture of Product.
 
•     Right to audit.
 
   
•    Notify Customer of intent to destroy records with option to send records
(Lonza proprietary information will be omitted) to Customer.

or

 
•    Approve destruction or request receipt of records.
•    Agree terms with Customer for future storage.
   

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18.0 Process Validation

        
Lonza Responsibility
  Customer Responsibility and Rights
 
   
•    With Customer define process validation plans for Product including
analytical validation and stability studies.
 
•    With Lonza define process validation plans for Product including analytical
validation and stability studies.
 
   
Where process validation is performed by Lonza
  Where process validation is performed by Lonza
 
   
•     Provide Customer with Product specific validation protocol(s) for approval
prior to execution.
 
•    Approve Product specific validation protocol(s) within 5 business days or
mutually agreed upon timeframe.
 
   
•    Provide Customer with draft Product specific validation report(s) for
review and comment.
 
•    Review and comment on Product specific validation report(s) or within 5
business days or mutually agreed upon timeframe.
 
   
•    Issue Customer with copy of approved Product specific validation report(s).
   
 
   
Where Process validation is performed by Customer
  Where Process validation is performed by Customer
 
   
•    Incorporate specifications in cGMP documentation.
 
•    Provide Lonza with process validation report(s).
 
   
Product Specific Cleaning Validation performed by Lonza
  Product Specific Cleaning Validation performed by Lonza
 
   
•    Perform product specific cleaning validation in conjunction with process
validation.
 
•    Right to audit.

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19.0 Regulatory Agency Inspection

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
Pre-approval GMP inspections
  Pre-approval GMP inspections
 
   
•    Provide Customer with regular debriefs.

•    Review inspection observations with Customer.
 
•    Provide on site representatives for pre-approval inspections and
involvement in Product requests relating to Customer responsibilities.
 
   
•    Notify Customer of proposed responses and corrective action plans regarding
the Product, process or systems relating to Product.
 
•    Comment on proposed inspection responses to observations relevant to
Product.
 
   
•    If it is determined that the Customer representative/consultants are also
engaged by a Third Party biologics manufacturer reasonably determined by Lonza
to be a competitor of Lonza, Lonza shall not be required to permit access to the
Lonza facility.
 
•    Provide Customer representative/ consultants list to Lonza (at least
(10) calendar days) in advance of such representative/consultants first trip to
Lonza’s facility.

•    Customer to ensure there are appropriate 3-way confidentiality agreements
in place with any representative/consultants used.
 
   
Routine GMP inspection
  Routine GMP inspections
 
   
•    Inform Customer of Regulatory Agency inspections affecting manufacture or
testing of Product.
 
•    For Regulatory Agency inspections regarding Product, provide assistance
when requested by Lonza.
 
   
•    Notify Customer of inspection observations (including Deficiency Letters)
regarding the Product, process or systems relating to the Product.
 
•    Comment on proposed inspection responses to observations relevant to
Product.

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20.0 Regulatory Submissions

     
Lonza Responsibility
  Customer Responsibility and Rights
 
   
Customer’s regulatory application
  Customer’s regulatory application
 
   
•    Review and comment on relevant sections of Customer’s Regulatory
Application.
 
•    Prepare and provide Lonza with copy of relevant sections of Regulatory
Application for review and comment prior to submission to Regulatory Agency.

•    Provide Lonza with copy of relevant sections of Regulatory Application as
submitted to Regulatory Agency.
 
   
Teleconferences and meetings with the Regulatory Agencies
  Teleconferences and meetings with the Regulatory Agencies
 
   
•    Attend teleconferences and meetings between the Customer and Regulatory
Agencies arranged to specifically discuss topics relating to Lonza’s
responsibilities.
 
•    Arrange for Lonza personnel to have option to attend teleconferences and
meetings between Customer and Regulatory Agencies to specifically discuss topics
relating to Lonza’s responsibilities.
 
   
Comparability protocol(s)
  Comparability protocol(s)
 
   
•    Within agreed timeframe respond to requests for data to assist Customer in
preparing their Comparability Protocol and Report.
 
•    Provide Comparability Protocol and Report to Regulatory Agency.

The parties have executed this Quality Agreement for TRU-016 as of the date
first written below.
Lonza Sales AG

                     
Name:
  Gerry Kennedy       Signature:   /s/ GERRY KENNEDY    
 
 
 
         
 
   
 
                   
Title:
          Date:   27 Nov 08    
 
 
 
AUTHORIZED SIGNATORY          
 
   
 
                   
Name:
  Karen Fallon       Signature:   /s/ KAREN FALLON    
 
 
 
         
 
   
 
                   
Title:
          Date:   27 Nov 08    
 
 
 
AUTHORIZED SIGNATORY          
 
   
 
                   
Name:
  Sue Crow       Signature:   /s/ SUE CROW    
 
 
 
         
 
   
 
                   
Title:
  VP Quality       Date:   4 Dec 08    
 
 
 
QUALITY ASSURANCE SIGNATORY          
 
   

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Confidential

                      Trubion Pharmaceuticals, Inc.                
 
                   
Name:
  /s/ PETER A. THOMPSON       Signature:   Peter Thompson, MD, FACP    
 
 
 
         
 
   
 
                   
Title:
  Chairman, President & CEO       Date:   12/5/08    
 
 
 
         
 
   

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CONFIDENTIAL
Appendix 1 to Quality Agreement for TRU-016 — Key Personnel

      Trubion   Lonza
Technical Coordinator:
  [*]
Gilles Lefebvre
Associate Director, Process Development
  [*]
Tel: +1 206 859 6617
  [*]
Fax: +1 206 838 0503
  [*]
Email: glefebvre@trubion.com
  [*]
 
   
Director of Quality Assurance:
  [*]
Sally Gould
Sr. Director, Regulatory Affairs & Quality Assurance
  [*]
Tel: +1 206 838 0510
  [*]
Fax: +1 206 838 0503
   
Email: sgould@trubion.com
  [*]
 
   
VP of Manufacturing:
  [*]
Vijay Yabannavar
VP, PD & Manufacturing
  [*]
Tel: 1 206 859 6661
  [*]
Fax: +1 206 838 0503
   
Email: vyabannavar@trubion.com
  [*]
 
   
 
  [*]
 
  [*]
 
  [*]
 
  [*]

*Confidential Treatment Requested.

Page 18 of 28

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CONFIDENTIAL
Exhibit B
Coordinators
TRUBION

     
Trubion’s Primary Business Coordinator
Trubion’s Backup Business Coordinator
Trubion’s Primary Technical Coordinator
Trubion’s Backup Technical Coordinator
  [*]
[*]
[*]
[*]
 
   
 
  LONZA
 
   
Lonza’s Primary Business Coordinator
Lonza’s Backup Business Coordinator
Lonza’s Primary Technical Coordinator
Lonza’s Backup Technical Coordinator
  [*]
[*]
[*]
[*]

*Confidential Treatment Requested.

Page 19 of 28

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CONFIDENTIAL
Exhibit D-016
Initial List of Critical Raw Materials
CONFIDENTIAL

          Description   Vendor   Part Number
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]
[*]
  [*]   [*]

*Confidential Treatment Requested.

Page 20 of 28

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CONFIDENTIAL
Exhibit E-016
[*]
Part I — Copy of Bulk Drug Specification

             
CONFIDENTIAL
           
[*]
  [*]   [*]   [*]
[*]
           
[*]
  [*]   [*]   [*]  
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
             
[*]
  [*]   [*]   [*]  
[*]
           

*Confidential Treatment Requested.

Page 21 of 28

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CONFIDENTIAL

             
[*]
  [*]   [*]   [*]
[*]
           
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
             
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]  
[*]
           

*Confidential Treatment Requested.

Page 22 of 28

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CONFIDENTIAL

             
[*]
  [*]   [*]   [*]
[*]
           
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
           
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]  
[*]
             
[*]
             
[*]
             
[*]
           

*Confidential Treatment Requested.

Page 23 of 28

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CONFIDENTIAL
Exhibit E-016 (continued)
[*]

             
[*]
  [*]   [*]   [*]
[*]
           
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
           
[*]
  [*]   [*]   [*]
[*]
           
[*]
  [*]   [*]   [*]
[*]
           
[*]
  [*]   [*]   [*]
[*]
  [*]   [*]   [*]
[*]
           
[*]
  [*]   [*]   [*]

[*]
*Confidential Treatment Requested.

Page 24 of 28

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CONFIDENTIAL
Schedule 1-016
Description of Product
For purposes of the Agreement, the term “Product” means the proprietary Small
Modular ImmunoPharmaceutical (SMIP™) protein known as TRU-016.

Page 25 of 28

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CONFIDENTIAL
Schedule 2-016
Description of Services
For purposes of this Schedule, “Services” means the Runs and the other
manufacturing services and other services to be performed by Lonza under the
Agreement and the Quality Agreement, as such Services are more particularly
described below, in the body of the Agreement and in the Quality Agreement.
The following notes are applicable to all Services described in this Schedule:

                 
[*]
               
[*]
      [*]   [*]   [*]
 
  [*]   [*]   [*]   [*]
 
              [*]

                                         
 
  [*]                   [*]                
[*]
      [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]
 
  [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]
 
  [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]
 
  [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]

[*]

                                         
 
  [*]                   [*]                
[*]
      [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]
 
  [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]
 
  [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]
 
  [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]

[*]

                                         
 
  [*]                   [*]                
[*]
      [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]
 
  [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]
 
  [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]

[*]
*Confidential Treatment Requested.

Page 26 of 28

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CONFIDENTIAL
Schedule 3-016
Pricing and Terms of Payment
In consideration for Lonza carrying out the Services as detailed in
Schedule 2-016, Trubion shall pay Lonza as follows:

          Stage   Description   Price (US$)1
Stage 1
  [*]   [*]
Stage 2
  [*]   [*]
Stage 3
  [*]   [*]
Stage 4
  [*]   [*]
Stage 5
  [*]   [*]
Stage 6
  [*]   [*]
Stage 7
  [*]   [*]
Stage 8
  [*]   [*]
Stage 9
  [*]   [*]

 

Notes:     1.   In addition to the prices listed in the table above, Trubion
shall reimburse Lonza for reasonable out-of-pocket expenses for insurance and
transportation which are incurred by Lonza in performing the Services. Expenses
which exceed [*] must be pre-approved by Trubion.   2.   Invoices for these
Services shall be issued, and payments shall be made, in U.S. dollars.   3.  
Section 8 (Claims) of the Agreement shall apply to Stage [*]. With respect to
the other Stages, the parties agree as follows: In the event of any defect or
nonconformance in any Services or deliverables arising out of Lonza’s [*] shall,
at [*] option, either [*]at [*].   4.   Stage [*] may be cancelled in accordance
with Section 4.2(b) of the Agreement. The other Stages may be cancelled or
terminated [*].   5.   If Trubion cancels a Stage prior to [*]. If [*] Trubion
terminates that Stage, [*] For the avoidance of doubt, the parties agree that
this Note 5 does not apply to Stage [*].

*Confidential Treatment Requested.

Page 27 of 28

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CONFIDENTIAL
Payment by Trubion of the Price for each Stage shall be made against Lonza’s
invoices as follows:
For Stage 1
[*] upon [*] of Stage 1
[*] upon [*] of Stage 1
For Stage 2
[*] upon [*] of Stage 2
[*] upon [*] of Stage 2
For Stage 3
[*] upon [*] of Stage 3
[*] upon [*] of Stage 3
For Stage 4
[*] upon [*] out of freeze
[*] upon [*] of Stage 4
The price for Stage 4 is the full amount and is inclusive of [*], with the
exception of [*]; the cost of [*] required for this Stage will be invoiced
separately and shall be [*] in addition to the price for
Stage 4. [*]For Stage 5
[*] upon [*] of Stage 5
[*] upon [*] of Stage 5
For Stage 6
[*] upon [*] of Stage 6
[*] upon [*] of Stage 6
[*]For Stage 7
[*] upon [*] of Stage 7
[*] upon [*] of Stage 7
For Stage 8
[*] upon [*] of Stage 8
[*] upon [*]
[*] upon [*]
[*] upon [*]
For Stage 9
[*] upon [*] of Stage 9
[*] upon [*]
[*] upon [*]
[*] upon [*]
*Confidential Treatment Requested.

Page 28 of 28