exv10w5









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.




Page 1 of 28









 








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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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Confidential




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
	 	 
	 	 	 	 

	 	 






Page 16 of 28









 




Confidential




	 	 	 	 	 	 	 	 	 	 	 
	Trubion Pharmaceuticals, Inc.	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Name:

	 	/s/ PETER A. THOMPSON
	 	 	 	Signature:
	 	Peter Thompson, MD, FACP	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Title:

	 	Chairman, President & CEO
	 	 	 	Date:
	 	12/5/08	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 






Page 17 of 28









 





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









 








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











 





CONFIDENTIAL




Exhibit D-016

Initial List of Critical Raw Materials




CONFIDENTIAL




	 	 	 	 	 
	Description	 	Vendor	 	Part Number
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]






*Confidential Treatment Requested.




Page 20 of 28









 







CONFIDENTIAL




Exhibit E-016




[*]




Part I — Copy of Bulk Drug Specification





	 	 	 	 	 	 	 
	CONFIDENTIAL
	 	 	 	 	 	 
	[*]

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

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

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

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

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

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

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






*Confidential Treatment Requested.




Page 21 of 28









 







CONFIDENTIAL




	 	 	 	 	 	 	 
	[*]

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

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

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

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

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

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






*Confidential Treatment Requested.





Page 22 of 28









 







CONFIDENTIAL




	 	 	 	 	 	 	 
	[*]

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

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

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

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

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

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

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

	 	 
	 	 
	 	 
	 
	[*]

	 	 
	 	 
	 	 
	 
	[*]

	 	 
	 	 
	 	 
	 
	[*]

	 	 
	 	 
	 	 








*Confidential Treatment Requested.






Page 23 of 28









 







CONFIDENTIAL




Exhibit E-016 (continued)




[*]




	 	 	 	 	 	 	 
	[*]

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

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

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

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

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

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

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

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

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

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

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

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

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

	 	[*]
	 	[*]
	 	[*]






[*]




*Confidential Treatment Requested.





Page 24 of 28









 








CONFIDENTIAL




Schedule 1-016

Description of Product



For purposes of the Agreement, the term “Product” means the proprietary Small Modular
ImmunoPharmaceutical (SMIPTM) protein known as TRU-016.





Page 25 of 28









 








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









 







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









 







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