Exhibit 10.36

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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

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

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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

 

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EXHIBIT A-1
SCOPE OF WORK

[*]

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

3

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EXHIBIT C-1

4

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QUALITY AGREEMENT

BETWEEN

Theravance, Inc.

AND

ScinoPharm Taiwan, Ltd.

5

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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

 

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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

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

 

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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

 

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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

 

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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.

 

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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,

 

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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.

 

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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.

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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

[*]

 

[*]

 

[*]

 

[*]

[*]

 

[*]

 

[*]

 

[*]

 

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

 

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CONTRACTOR OPERATIONS

 

Name

 

Telephone
Number

 

Fax. Number

 

E-mail Address

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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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

 

 

 

 

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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

 

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