Exhibit 10.36





April 27, 2006


CONFIDENTIAL DRAFT


[*]=CERTAIN
INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.


	
  ScinoPharm Taiwan, Ltd.

  	
  Biddle Sawyer Pharma LLC

  
	
  No. 1 Nan-Ke 8th Rd.

  	
  21 Penn Plaza, 360 West 31st St.

  
	
  Tainan Science-based Industrial Park

  	
  New York, NY 10001-2727

  
	
  Tainan County 741, Taiwan

  	
  U.S.A.

  
	
  Attn:

  	
  [*]

  	
   

  
	
  CC:

  	
  [*]

  	
   

  



 


Re:  AMENDMENT NO. 4 TO TD-6424 SUPPLY AGREEMENT


Dear [*]:


Theravance, Inc., a
Delaware corporation, having a principal place of business at 901 Gateway Boulevard, South San Francisco, CA
94080, U.S.A. (“THERAVANCE”)
and ScinoPharm Taiwan, Ltd., a Taiwan Corporation, having a principal place of
business at No. 1, Nan-Ke 8th Road, Tainan Science-based Industrial Park, Shan-Hua, Tainan County 74144, Taiwan (“SCINOPHARM”), and Biddle
Sawyer Pharma LLC, having a principal place of business at 21 Penn Plaza, 360
West 31st Street,
New York, NY 10001-2727, U.S.A.
(“BSP”), previously entered into a Supply Agreement for Supply of TD-6424 dated
May 10, 2002, as amended (the “Agreement”).  THERAVANCE and SCINOPHARM
wish to further amend the Agreement to provide for SCINOPHARM to manufacture
and supply to THERAVANCE [*] of Product for
validation and launch supply as described in the attached Exhibit A—”Scope of Work” pursuant to the terms and
conditions of the Agreement, as amended hereby. 
Accordingly, the parties hereby agree as follows:


1.                                       The
parties agree that the attached Project Proposal, Exhibit A-1, is hereby added
to the Agreement to provide for manufacture of validation and launch supply
batches.  This new Exhibit A-1 does not
supersede any previous Exhibit A.


2.                                       The
parties agree that the attached Commercial Quality Agreement, Exhibit C-1, is
hereby added to the Agreement and is applicable to the






[*]=CERTAIN
INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.









 



 


new
Exhibit A-1 attached.  This revised
Exhibit C-1 does not supersede any previous Exhibit C.


3.                                       The
parties agree that the Packaging and Shipping Instructions attached to the
Agreement as Exhibit D are not applicable to the work to be performed
pursuant to the new Exhibit A-1. 
New Packaging and Shipping Instructions will be attached as a new
Exhibit D-1 by subsequent agreement of the parties.


4.                                       Except
as amended hereby, the Agreement remains in full force and effect. Capitalized
terms used herein and in the attached exhibits have the meanings given to them
in the Agreement unless otherwise define herein.


Please
indicate your agreement to the foregoing by signing the enclosed copy of this
letter where indicated below and returning it to me in the envelope provided.


	
   

  	
  Very truly yours,

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  /s/ Arthur L. Campbell

  	
   

  
	
   

  	
  Arthur L. Campbell

  
	
   

  	
  Senior Vice President, Technical Operations

  
	
   

  	
  Theravance, Inc.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  Accepted and Agreed:

  
	
   

  	
  SCINOPHARM Taiwan, Ltd.

  
	
   

  	
  No. 1 Nan-Ke 8th Rd.

  
	
   

  	
   

  	
  Tainan Science-based Industrial Park

  
	
   

  	
   

  	
  Tainan County 741, Taiwan

  
	
   

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Jo Shen

  	
   

  
	
   

  	
  Dr. Jo Shen

  
	
   

  	
  President & CEO

  
	
   

  	
   

  
	
   

  	
  Biddle Sawyer Pharma LLC

  
	
   

  	
  21 Penn Plaza, 360 West 31st St.

  
	
   

  	
  New York, NY 10001-2727

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ R.E. Chavkin

  	
   

  
	
   

  	
  R.E. Chavkin

  
	
   

  	
  President

  	
  5/11/06

  
						



 



 2
 






 



 


EXHIBIT
A-1

SCOPE OF WORK


[*]






[*]=CERTAIN
INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.



 3
 






 



 


EXHIBIT C-1



 4
 






 



 


QUALITY AGREEMENT


BETWEEN


Theravance, Inc.


AND


ScinoPharm Taiwan, Ltd.



 5
 






 



 


TABLE OF
CONTENTS


	
  I.

  	
  Annual Product Reviews and Annual Reports

  
	
   

  	
   

  
	
  II.

  	
  Document and Reserve Sample Retention

  
	
   

  	
   

  
	
  III.

  	
  Deviations and Failure Investigations

  
	
   

  	
   

  
	
  IV.

  	
  Complaint and Adverse Event Handling

  
	
   

  	
   

  
	
  V.

  	
  Stability

  
	
   

  	
   

  
	
  VI.

  	
  Recalls

  
	
   

  	
   

  
	
  VII.

  	
  NDA Field Alerts

  
	
   

  	
   

  
	
  VIII.

  	
  Control Documents and Change Control Implementation

  
	
   

  	
   

  
	
  IX.

  	
  Label Copy Approval

  
	
   

  	
   

  
	
  X.

  	
  Regulatory Contacts

  
	
   

  	
   

  
	
  XI.

  	
  Audits by Theravance, Inc.

  
	
   

  	
   

  
	
  XII.

  	
  Raw Material/Packaging Component Testing/Vendor
  Audit of Raw Materials and Components

  
	
   

  	
   

  
	
  XIII.

  	
  Finished Product Testing

  
	
   

  	
   

  
	
  XIV.

  	
  Disposition of Materials

  
	
   

  	
   

  
	
  XV.

  	
  Validation/Qualification

  
	
   

  	
   

  
	
  XVI.

  	
  Sub-Contractors

  
	
   

  	
   

  
	
  XVII.

  	
  Restricted Compounds

  
	
   

  	
   

  
	
  XVIII.

  	
  Quality Contact List

  
	
   

  	
   

  
	
  XIX.

  	
  Roles & Responsibilities

  



 



 6















 


	
  THERAVANCE PRODUCTS:

  	
  TD-6424 HCl (DS for Telavancin)

  
	
   

  	
   

  
	
   

  	
   

  
	
  CONTRACT FACILITY:

  	
  ScinoPharm Taiwan, Ltd.

  
	
   

  	
  No. 1 Kan-Ke 8th Rd.

  
	
   

  	
  Tainan Science-Based Industrial Park

  
	
   

  	
  Tainan County 741, Taiwan

  



 


Theravance and ScinoPharm hereby agree to the
following terms relating to key quality and regulatory systems involved in the
manufacture and/or packaging of the above-noted products.


I.         ANNUAL
PRODUCT REVIEWS AND ANNUAL REPORTS


ScinoPharm shall prepare an Annual Product Review (“APR”)
for each Product as required by current Good Manufacturing Practices and
applicable regulations, including 21 C.F.R. §211.180(e). A
copy of the ScinoPharm APR for Theravance products must be forwarded to
Theravance QA within 10 business days after completion of the APR. The APR
shall be completed within 30 calendar days of its due date, established by a
schedule mutually agreed upon by both parties.


For Theravance NDA products, Theravance shall be
responsible for preparing the Annual Report as required by applicable
regulations, including 21 C.F.R.§§ 314.70(g)(3), 314.81(b)(2),
and/or 601.12(d), (f)(3). At least [*] before the Annual Report due date (i.e.,
the Product anniversary date), Theravance QA shall request in writing from
ScinoPharm the chemistry, manufacturing and controls data required for
submission of the Annual Report. ScinoPharm shall provide the information to
Theravance QA no later than 30 calendar days after the request.


II.       DOCUMENT
AND RESERVE SAMPLE RETENTION


All documents, records, and reports associated with
the manufacture, holding, storage, packaging, or testing of any Product lot,
including investigation reports, shall be retained by ScinoPharm for at least
[*] beyond the expiration date of the finished Product lot, or as otherwise
required by applicable law. All such documents, records, and reports must be
maintained by ScinoPharm in such a manner that they are (i) readily retrievable
and (ii) stored in an environment suitable to prevent damage or loss.
ScinoPharm shall provide copies of all such documents and information to
Theravance QA as reasonably requested. ScinoPharm will supply Theravance QA
with a complete set of the batch records for each lot of each product produced
for Theravance.


ScinoPharm shall retain samples from each incoming lot
of raw material used in the manufacture of any Product in an amount sufficient
to perform two complete repetitions of analytical testing as required by
material specification. ScinoPharm shall also retain samples of the packaged
finished Product for each lot of Product in an amount sufficient 






[*]=CERTAIN
INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS. 


 



 7
 








 


to perform two complete repetitions of full finished
Product analytical testing. ScinoPharm shall store retain samples under
conditions consistent with the labeling for a minimum of 2 year after the
expiration of the finished Product. Documentation of performance of examination
of reserve samples in accordance with 21 CFR § 211.170(b)
shall be maintained with stability data for Products.


III.      DEVIATIONS
AND FAILURE INVESTIGATIONS


Except as provided in Sections IV and V, ScinoPharm
must notify Theravance QA within 1 business days of the occurrence of a
confirmed out-of specification (OOS) result or major process deviation relating
to a Product. ScinoPharm shall make all Quality decisions regarding any such
out-of-specification result or major process deviation involving a Theravance
Product in consultation with Theravance QA. Any additional studies that may be
needed as part of the investigation are to be reviewed and approved by
Theravance prior to the initiation of the study. ScinoPharm is to provide
Theravance QA notification of any such out-of-specification result or major
process deviation involving split batches and provide copies of resulting
studies and investigations.


All investigations regarding OOS results or major
process deviations for Theravance Product must be completed, documented, and approved
by ScinoPharm and Theravance QA prior to issuance of a Certificate of
Compliance or a Certificate of Analysis pursuant to Section XIV. All
investigations regarding OOS results or major process deviations for Split lots
are to be provided to Theravance QA for review.


IV.      COMPLAINT
AND ADVERSE EVENT HANDLING


ScinoPharm shall investigate Product complaints
forwarded to ScinoPharm by Theravance. ScinoPharm shall comply with all
reasonable Theravance requests in connection with the investigation of any Product
complaint. ScinoPharm must provide Theravance with information regarding any
Product complaint investigation as reasonably requested by Theravance.


ScinoPharm shall complete and document each Product
complaint investigation within 30 calendar days after initial receipt of the
complaint by ScinoPharm, unless otherwise agreed by Theravance QA., whose
consent shall not be unreasonably withheld or delayed. If new information is
received, the ScinoPharm must respond within 30 calendar days of receipt of the
new information. If the investigation will exceed 45 calendar days, ScinoPharm
must provide Theravance QA with an interim report, including test results to
date and a target completion date, on or before the 45th calendar day of the investigation. ScinoPharm
must forward a copy of the final investigation report to Theravance QA within 5
business days after the completion of the investigation. Theravance QA shall be
responsible for determining, in its reasonable discretion, when a complaint
investigation has been completed and shall have sole responsibility for
responding to the complainant (if applicable).


ScinoPharm shall perform
preliminary investigations for all expedited complaints. Expedited complaints
involve but are not limited to allegations of tampering or mixed 


 



 8
 








 


product sourced
within the same manufacturing and/or packaging facility. Within 3 business
days, ScinoPharm must provide Theravance QA a preliminary investigation report
which shall include but is not limited to; review of manufacturing and/or
packaging records, review of analytical records and evaluation of retain
samples. Expedited complaint investigations must be completed within 14
calendar days of initial receipt of the complaint.


ScinoPharm shall notify Theravance QA of a confirmed
out-of-specification result pertaining to a complaint sample within 1 business
day of the occurrence of the out-of-specification result. Any
out-of-specification results relating to a Product complaint sample must be
investigated as described in Section V.


V.       STABILITY


Theravance and ScinoPharm shall document mutually
agreed-upon stability protocols, analytical methods and procedures, and
specifications for each Product. The stability protocol must detail, among
other information, specifications, storage conditions, test intervals, and a
description of approved container/closure systems.


ScinoPharm shall be responsible for conducting
stability testing pursuant to the applicable stability protocols. ScinoPharm
shall assure that an adequate number of samples, representative of lot
production, required for full stability testing through expiration are taken
and stored in accordance with conditions specified in the protocol.


If a stability study is not initiated within 30 days
of generation of release test result , the time zero data (data generated at
the start of the stability study) must be generated by new analysis rather than
extracted from release test results.


For stability samples requiring testing at weekly or
monthly (less than three months) intervals, the tests must be initiated within
seven (7) calendar days following the scheduled pull date. Daily and weekly
samples may be pulled one (1) business day prior to the scheduled pull date.


For stability samples requiring testing at the three
months or longer intervals (including at the expiry test station/label expiry
date) must be initiated within 14 calendar days following the scheduled pull
date.


Monthly stability samples must be pulled no earlier
than seven (7) days prior to the last day of the month in which the sample
expires.


ScinoPharm
must report any confirmed out-of-specification results relating to a Product
lot to Theravance QA within 1 business day of the occurrence. ScinoPharm must
use its best efforts to complete and document an investigation with regard to
any such out-of-specification result within 30 business days of the initial
out-of-specification result. If the investigation will exceed 30 business days,
ScinoPharm must provide Theravance QA with an interim report, including test
investigation. A copy of the final investigation report must be forwarded to
Theravance QA within 5 business days of completion of the 


 



 9
 








 


investigation. ScinoPharm must provide Theravance with
information regarding any investigation as reasonably requested by Theravance.


Any result obtained during stability testing that is
outside of recommended storage conditions (i.e. accelerated) or beyond expiry
is not considered to be within the definition of out-of-specification results.


ScinoPharm must investigate any significant (those
which indicate future testing will yield OOS results) trends regarding a
Product in an effort to determine the cause of the trend. Any such trends must
be reported to Theravance QA within 5 business days of identification of the
trend. ScinoPharm must provide Theravance QA with a report discussing the facts
and ScinoPharm’ conclusions within 5 business days of completion of the
investigation. ScinoPharm shall supply Theravance QA quarterly reports of all
stability results relating to Theravance Products. Theravance QA will provide
copies to the applicable markets.


VI.      RECALLS


Theravance shall have sole responsibility for
initiating and managing any Recall of Theravance Products, provided that
Theravance shall consult with ScinoPharm prior to initiating any Recall for
which it appears that ScinoPharm might bear expenses for the Recall. Upon
receiving direction from any governmental or Regulatory Authority having
jurisdiction to Recall any Product from the market, the receiving party shall
immediately notify the other party.


VII.    NDA FIELD ALERTS


Theravance shall be responsible for determining the
need for, and for filing, any NDA Field Alert Report and/or follow-up reports
relating to a Theravance Product. Theravance shall forward to ScinoPharm a copy
of any NDA Field Alert Report or follow-up report relating to a Product within
3 business days after its filing.


VIII.   CONTROL
DOCUMENTS AND CHANGE CONTROL IMPLEMENTATION


Any
change(s) made to the Specifications, including but not limited to the manufacturing
process and/or analytical methods which may affect the quality or performance
of the Product, exceed validation parameters or commitments made in regulatory
filings must be approved by Theravance QA., in writing, prior to implementation
for routine production or Release of any lot made after the revision. Documents
referenced in this Section must be amended as required by the Product
Application or license or as required by applicable laws, rules, regulations or
regulatory agencies. Copies of all revised documents applicable to Theravance products are to be provided to
Theravance QA at time of issuance. Theravance QA will provide copies to the
applicable markets.


 



 10
 








 


IX.      LABEL
COPY APPROVAL


In the packaging of the Products, ScinoPharm shall use
only labels and labeling approved in compliance with standards/specifications
provided by Theravance QA.


X.       REGULATORY
CONTACTS


Theravance shall be solely responsible for all
contacts and communications with any regulatory agency with respect to all
matters relating to Theravance Products.


Unless required by law or a regulatory agency,
ScinoPharm shall have no contacts or communication with any regulatory agency
regarding any Theravance Product without the consent of Theravance QA, which
consent shall not be unreasonably withheld or delayed. ScinoPharm shall notify
Theravance QA promptly, and in no event later than 1 calendar day, after
ScinoPharm receives any contact or communication from any regulatory agency
regarding a Product.


ScinoPharm shall provide Theravance QA with copies of
all communications received from or sent to any regulatory agency with respect
to any Product within 1 calendar day after receipt or sending of the
communication, as the case may be.


ScinoPharm shall inform Theravance QA of any inquiry
from a regulatory agency specifically relating to a Theravance Product and
shall allow a Theravance representative, at its discretion, to participate in
any further contacts or communications relating to a Product if reasonably
practicable. ScinoPharm will secure agreement from Theravance QA, which shall
not be unreasonably withheld or delayed, prior to making commitment to a
regulatory agency regarding the Products. ScinoPharm shall comply with all
reasonable requests and comments by Theravance with respect to all contacts and
communications with a regulatory agency relating to a Product.


ScinoPharm must make available to Theravance any data
and/or information, including samples, required to ensure Theravance’s
compliance with its regulatory filings. Theravance reserves the right to submit
such data to regulatory agencies as required to maintain compliance with its
regulatory filings.


XI.      AUDITS BY THERAVANCE, INC.


Theravance shall have access to ScinoPharm facilities
at a mutually agreeable time for the sole purpose of auditing ScinoPharm
operations compliance with cGMPs and the content of this Agreement. Theravance
shall be permitted to periodically review ScinoPharm facilities, equipment,
process, and records associated with the Product or as necessary as follow-up
to failure investigations and/or audit observations.


XII.    RAW MATERIAL/PACKAGING COMPONENT
TESTING/VENDOR AUDIT OF RAW MATERIALS AND COMPONENTS


ScinoPharm
will perform all the required raw material and packaging component testing
using approved analytical methods. ScinoPharm shall receive, sample, test,
release, hold, 


 



 11
 








 


and store any raw material or packaging component
supplied for the manufacturing or packaging of the Product in accordance with
current Good Manufacturing Practices, Theravance specifications, and applicable
laws, rules, and regulations. ScinoPharm
shall be responsible for the rejection of all raw materials and packaging
components that do not conform with the applicable specification. ScinoPharm
will be responsible for the destruction of all excess or rejected raw materials
and packaging components as per the company’s applicable approved standard
operating procedures.


ScinoPharm is responsible for auditing the vendor of
any material that is supplied by ScinoPharm for the Product and will provide
Theravance with an audit status statement upon request. If the vendor of any
material for the Product has been previously audited and approved by
Theravance, ScinoPharm is not required to perform a re-audit. Theravance, Inc.
is responsible for auditing the vendor of any material that is supplied by
Theravance, Inc. and will provide ScinoPharm with an audit status statement
upon request. 


XIII.   FINISHED
PRODUCT TESTING


ScinoPharm will perform finished product testing using
the approved analytical methods. Any material supplied by or for Theravance
shall be manufactured, held, stored, packaged, and tested in accordance with
current Good Manufacturing Practices, Theravance specifications, and applicable
laws, rules, and regulations.


XIV.   DISPOSITION
OF MATERIALS


Subject to the terms of this Agreement, ScinoPharm
shall be responsible for determining whether to release or reject any
Theravance Product lot to Theravance. Before shipment by ScinoPharm to
Theravance of any Product lot, ScinoPharm shall provide Theravance QA with
copies of a Certificate of Compliance, a Certificate of Analysis and all
investigation reports relating to the Product lot and await receipt of
Theravance Release Authorization for shipment of that lot to Theravance for distribution,
further processing, and/or further packaging. Final lot disposition for
non-U.S. Theravance products will be done by the responsible QP or Quality
Authority for that market.


A Certificate of Analysis (C of A) is a comprehensive listing of all analytical tests, test procedures, specifications
and test results corresponding to those specifications for an individual lot of
product.


A Certificate of Compliance is a certification that
the product was processed, packaged and stored in accordance with cGMPs,
specifications and ScinoPharm’s SOPs. Additionally, the certification states
that the product meets all specifications, no investigations remain unresolved
and all reconciliations and accountability have been satisfactorily completed.
The certificate must include the Product identification, lot number, expiration
date and final product yield.


Disposition
of any excess, expired or rejected materials shall be in accordance with
procedures for certified destruction or other means. Rejection of any lot of
finished product will be completed as per the approved SOP of the site
completing the rejection.


 



 12














 


 


ScinoPharm shall make documentation or completion of
disposition available to Theravance upon reasonable request.


ScinoPharm shall prepare
any Theravance Product in accordance with the NOTE for Guidance on Minimizing
the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and
Veterinary Medicinal Product, published by the European Agency for the
Evaluation of Medicine (EMEA).


ScinoPharm shall provide
Theravance a TSE certificate annually for each Theravance Product.  ScinoPharm is responsible for procuring TSE
certificates of all materials used in the preparation Theravance Product.


Within thirty (30) days
after notification that the Product does not meet the Specifications by
Theravance, ScinoPharm has the right to request that both Parties shall conduct
a joint investigation to determine whether such Product meets such
Specifications.  This joint investigation
may include, upon agreement by the Parties, the assistance of outside
consultants.  If resolution cannot be
reached, the Parties agree to send a sample of the Drug Product in question to
an independent testing laboratory suitable to both Parties.  The cost of this testing will be paid by the
Party that was in error with respect to whether or not the Product meets the
Specifications.


ScinoPharm will correct
or replace, at no additional cost to Theravance, any batch of Drug Product that
does not conform to the Specifications, provided that such failure to conform
does not arise from a change in the process agreed to by Theravance or from
Theravance’s negligence.  If Product must
be returned by Theravance due to a failure of the Product to meet the
Specifications, ScinoPharm  shall, at
Theravance’s sole option; (i) reprocess the Drug Product, if applicable, (ii)
reimburse Theravance for the cost of all raw materials, starting materials and
components provided by Theravance and return transportation and insurance
costs, or (iii) replace the rejected Product as soon as possible at no
extra cost to Theravance.


XV.         VALIDATION/QUALIFICATION


Theravance and ScinoPharm
agree to the following Validation/Qualification Policy for the Product:


1.                                       Equipment
and facilities/utilities qualification/validation shall be performed for
process, packaging, analytical methods, cleaning, and computerized systems.


2.                                       Validation
shall consist of prospective performance on at least three consecutive
production batches.  Validation must be
conducted with commercial production/analytical processes and equipment.


3.                                       Revalidation
shall be performed for significant changes to existing manufacturing process,
packaging, analytical, etc. (as determined by Theravance QA).  The number of batches required for
revalidation will be determined by Theravance and ScinoPharm based on the
significance of the change.



 13
 






 



 


4.                                       Theravance colleagues shall have the right to be
present during the manufacture of validation and launch batches.


5.                                       Cleaning
Validation shall involve three replicate runs of cleaning procedure for contact
equipment during Process and Packaging Validation, except for dedicated
equipment which will require one verification run of the cleaning procedure.


6.                                       Theravance shall have the right to require full or
partial revalidation for changes made to the validated product, based on a
shared change control system and an assessment of the significance of the
change.  ScinoPharm will notify
Theravance QA of any planned changes to a validated process or associated
procedures sufficiently in advance to allow Theravance an opportunity to assess
the change(s) and any ramifications.  No
changes shall be made to the validated process or product without prior written
consent of Theravance QA.  Copies of
associated documents are to be provided to Theravance QA.  Theravance QA will forward these documents to
the applicable markets.


XVI.        SUB-CONTRACTORS


ScinoPharm will not use
sub-contracted service providers for manufacturing, packaging, testing, storage
or distribution of the Products without prior written notice and concurrence of
Theravance QA., which concurrence shall not be unreasonably withheld or
delayed.


XVII.      RESTRICTED COMPOUNDS


ScinoPharm shall not use
Theravance Product equipment to manufacture a product containing any of the
following compounds without Theravance QA written prior consent:


[*]


XVIII.               QUALITY CONTACT LIST


THERAVANCE,
INC.


	
  Name

  	
   

  	
  Telephone

  Number

  	
   

  	
  Fax. Number

  	
   

  	
  E-mail Address

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  



 






[*]=CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS. 


 



 14
 






 



 


CONTRACTOR OPERATIONS


 


	
  Name

  	
   

  	
  Telephone

  Number

  	
   

  	
  Fax. Number

  	
   

  	
  E-mail Address

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 



 15
 






 



 


XIX.        ROLES & RESPONSIBILITIES


	
  Process

  	
   

  	
  ScinoPharm

  	
   

  	
  Theravance

  	
   

  
	
  Raw Materials & Packaging Components

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Ordering

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Specifications

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Sampling

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Release

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Manufacturing/Packaging Process Control

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sampling

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Testing

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Finished Product

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Retain Sampling

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Retain Storage

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Testing

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Batch Records

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Review of Batch Records

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Final Release to Distribution

  	
   

  	
  X

  	
   

  	
  X

  	
   

  
	
  Storage

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Shipment

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Quality Assurance

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Annual Product Review

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Annual Report

  	
   

  	
   

  	
   

  	
  X

  	
   

  
	
  Change Control

  	
   

  	
  X

  	
   

  	
  X

  	
   

  
	
  Contact List

  	
   

  	
  X

  	
   

  	
  X

  	
   

  
	
  Deviations/Investigations

  	
   

  	
  X

  	
   

  	
  X

  	
   

  
	
  Drug Listing

  	
   

  	
   

  	
   

  	
  X

  	
   

  
	
  Internal Audits

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  NDA Changes

  	
   

  	
   

  	
   

  	
  X

  	
   

  
	
  Product Complaints

  	
   

  	
  X

  	
   

  	
  X

  	
   

  
	
  Recalls and Field Alerts

  	
   

  	
   

  	
   

  	
  X

  	
   

  
	
  Regulatory Audits

  	
   

  	
  X

  	
   

  	
  X

  	
   

  
	
  Stability Testing

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Monitoring of Operations

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Quality Control

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Quality Inspection

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Rejects

  	
   

  	
  X

  	
   

  	
   

  	
   

  



 



 16
 






 



 


	
  Documents

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Audit Report

  	
   

  	
  X

  	
   

  	
  X

  	
   

  
	
  Batch Record

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Certificate of Analysis

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Certificate of Compliance

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Investigation/Deviation
  Reports

  	
   

  	
  X

  	
   

  	
  X

  	
   

  
	
  Master Batch Record

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Packaging Record

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Validation Protocol

  	
   

  	
  X

  	
   

  	
   

  	
   

  
	
  Validation Report

  	
   

  	
  X

  	
   

  	
   

  	
   

  



 


In Witness Whereof, the
parties have caused this Agreement to be duly executed in their respective
names and on their behalf, as of the date first above written.


Theravance, Inc.


	
  /s/ Arthur L. Campbell

  	
   

  
	
  By:

  	
  Arthur L. Campbell

  
	
  Title:

  	
  Senior Vice President, Technical Operations

  
			



 


ScinoPharm
Taiwan, Ltd.


	
  By:

  	
  /s/ Younan Shih

  	
   

  
	
  Title: V.P.
  Quality & Regulatory

  



 


Biddle Sawyer Pharma LLC


	
  By:

  	
  /s/ R.E. Chavkin

  	
   

  
	
  Robert E.
  Chavkin

  
	
  President

  



 



 17