NOTE TO USERS

This Quality Agreement template was developed by the Bulk Pharmaceutical Task Force (BPTF),
an affiliate organization of the Society of Chemical Manufacturers and Affiliates (SOCMA), as a
guide for drafting a Quality Agreement relating to the manufacture and release of substances
regulated by the Food and Drug Administration The template is based on the collective experience
of industry members, but is not intended to be exhaustive or inclusive of all pertinent requirements.
The information herein is offered in good faith, but is provided WITHOUT ANY WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Users are cautioned
that the information upon which this template is based is subject to change. The responsibility
allocations in the template are largely defined by the fact that only one party is in a position to
exercise the responsibility identified. To the extent that the responsibility is shown as shared or can
be assigned to the other party, the template allocation represents the experience of the BPTF
members as to common practice. Parties utilizing the template are free to allocated responsibility
and notification timing in any manner that assures all regulatory obligations are met.

SOCMA and BPTF do not endorse the products or processes of any particular manufacturer, and
this template is not intended to provide specific advice, legal or otherwise. Following this template
does not guarantee compliance with applicable laws, rules, and regulations. Users should consult
with their legal and technical advisors and other sources. SOCMA, BPTF, and their members and
agents do not assume any responsibility for a user’s compliance with applicable laws, rules and
regulations, and disclaim any liabilities arising out of or relating to the use of this template or
reliance on any information contained herein.
 Quality Agreement

by and between

Supplier Name:

Address:

and

Client Name:

Address:

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 Table of Contents

Supplier’s & Client’s Name……………………………………………………………………….5

Custom Manufacturer’s Quality Agreement Template……………………………………………6
1. Effective Date…………… ................................................................................................. 6
2. Scope ……………………………………………………………………………………..6
3. Other Agreement.....................................................................................................……….6
4. Amendments to Quality Agreement ................................................................................... 6
5. Term of Quality Agreement ................................................................................................ 7
6. Use of Third-Parties……. ................................................................................................... 7
7. Survival Clause………….. ................................................................................................. 7
8. Assignment……………….. ............................................................................................... 8
9. Product Specifications ........................................................................................................ 8
10. Shipping Under Quarantine ................................................................................................ 8
11. Resolution of Quality Issues ............................................................................................... 8
12. Debarment…………………. .............................................................................................. 9
13. Choice of Law: Jurisdiction/Miscellaneous ........................................................................ 9
14. Manufacturing and Testing Location(s).............................................................................. 9
15. Quality Responsibilities Table .......................................................................................... 10
Compliance Requirements .................................................................................................... 10
Right to Audit ......................................................................................................................... 10
Regulatory Inspections and Exchanges ............................................................................... 11
Regulatory Filings and Regulatory Status* ......................................................................... 11
Complaints and Recalls ......................................................................................................... 12
Animal Derived Materials ..................................................................................................... 12
Validation/Qualification ........................................................................................................ 13
Documentation and Records ................................................................................................. 13
Annual Product Reviews ....................................................................................................... 14
Change Control ...................................................................................................................... 14
Deviations................................................................................................................................ 15
Reprocess and Batch Adjustments /Rework/Retest............................................................ 15
Production and In Process Controls, Packaging and Labeling ......................................... 15
Storage and Distribution ....................................................................................................... 16
Laboratory Controls .............................................................................................................. 16
Stability (must decide Client or Supplier or NA)* if supplied by Client, Client will
provide all necessary information to the supplier. .............................................................. 17
Recalls ..................................................................................................................................... 17
APPENDIX 1: Definition of Product …………………………………………………………….18
APPENDIX 2: Contacts and Responsibilities…………………………………………………….19
APPENDIX 3: Product Specifications……………………………………………………………20

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APPENDIX 4: List of Approved Subcontractors…………………………………………………21

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 Supplier’s & Client’s Name

Supplier’s Name (“Supplier”) and Client’s Name (“Client”) wish to define the individual
responsibilities of the parties as to the quality aspects of manufacturing and release of Product as
defined in Appendix 1 to ensure compliance with the approved Product application and/or Client
requirements.

In order to do so, this Quality Agreement (“Quality Agreement”) takes the form, in part, of a
detailed listing of activities associated with manufacture, supply, production, analysis, and release
of Product. Unless otherwise indicated, responsibility for each activity is assigned to either Client,
Supplier, or is assigned to both Supplier and Client.

In consideration of the parties’ agreement to perform the activities provided in this Quality
Agreement and for other valuable consideration the receipt and sufficiency of which is hereby
acknowledged, and intending to be legally bound, Supplier and Client agree as provided in this
Quality Agreement as follows:

Client Supplier

Signature Signature

Name Name

Title Title

Signed the ____ day of___________ Signed the ____ day of___________
in the year 20__ in the year 20__

Page 5 of 21 Business Confidential

 Custom Manufacturer’s Quality Agreement Template

Effective Date

The Effective Date of this Quality Agreement shall be the date of last signature (the
“Effective Date”).

Scope

This Quality Agreement outlines the responsibilities of Supplier and Client with respect to
the quality assurance of the Product manufactured and/or supplied by Supplier for Client.

Other Agreement

This Quality Agreement is in addition to all other agreements between the parties, if any,
(the “Supply Agreement”) regarding the subject matter hereof. If there are any direct
conflicts between the terms of this Quality Agreement and the Supply Agreement, the
following will prevail:

Quality Agreement

Supply Agreement

Amendments to Quality Agreement

This Quality Agreement may be amended by the written consent of both parties.

The parties agree to amend terms of this Quality Agreement that must be amended in order
that the Product continue to meet regulatory requirements of applicable regulatory
agencies, as may exist from time to time.

If an amendment to this Quality Agreement is proposed, the proposing party will circulate
the proposed amendment to the appropriate contact person at Supplier and Client for
review and internal approval. The appropriate contact person at Supplier and Client is
listed in Appendix 2 (Contacts and Responsibilities).

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Term of Quality Agreement

This Quality Agreement shall commence on the Effective Date and shall remain in effect
for as long as the Supplier supplies Product to Client unless the Quality Agreement is
terminated earlier in accordance with the terms of this Quality Agreement.

Either party may terminate this Quality Agreement upon thirty (30) days written notice to
the other party.

Use of Third-Parties

Supplier shall not allow a third party to manufacture, package, label, inspect, test and
release Product unless Supplier has disclosed in writing to Client the Supplier’s use of a
third party and the Client has provided written approval for the specific third party use. If
Supplier employs a third party to perform any or part of the manufacturing, packaging,
labelling, inspection, testing, release and/or handling of Product that is supplied to Client,
Supplier shall assure that the third party has been fully qualified via the Supplier’s third
party qualification process prior to performing such activity(ies) unless the Client is
providing the qualification of the third party. In this case, the Client will provide the
Supplier written qualification documentation. A list of approved subcontractors is
contained in Appendix 4. The party employing the subcontractor should have a quality
agreement in place consistent with this agreement. Supplier shall have entered into a
written confidentiality agreement with any third party providing for confidentiality of all
Client information under obligations of confidentiality similar to and requiring the same
protection or greater protection of confidential information as the obligations of
confidentiality between Supplier and Client. Supplier shall, however, retain all obligations
under this Agreement whether or not a third party manufactures, packages, labels, inspects,
tests, releases and/or handles Product. If a third party is used by Supplier to manufacture,
package, label, inspect, test, release and/or handle Products, Client may, upon request,
review the list of such third party(ies) during an on-site visit and/or audit pursuant to the
Right To Audit section of this Agreement. Client agrees to treat such information as
Confidential Information of Supplier and agrees not to contact any such parties in
connection with this Agreement without Supplier’s prior consent.

Survival Clause

All regulatory obligations contained herein that are required of either party or both parties
by an applicable regulatory authority shall survive termination of this Quality Agreement.

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Assignment

Supplier shall not assign any or all of its rights or obligations under this Quality Agreement
without Client’s prior written consent. Client’s consent shall not be required in connection
with a merger, consolidation, or a sale of all or substantially all of Supplier’s assets or the
subject matter of this Quality Agreement to another party (an “Assignment Transaction”).
In the event of an Assignment Transaction, Supplier shall provide written notice to Client
to the appropriate contact person indicated in Appendix 2 (Contacts and Responsibilities).
Client shall have the right to assign any or all of its rights or obligations under this Quality
Agreement without the consent of Supplier. In the event of an assignment, the assigning
party shall continue to be bound by all pre-existing obligations under this Quality
Agreement including all obligations of confidentiality and non-disclosure.

Product Specifications

Product specifications are listed in Appendix 3.

Changes to the agreed upon specifications must be mutually agreed upon and
communicated in writing between the parties to this Quality Agreement, except for
compendial changes which can be implemented without mutual agreement. Compendial
changes must be implemented by the compendial implementation date and communicated
between the Supplier and Client.

Shipping Under Quarantine

Shipping of batches/lots which have not been released.

If Client requests the shipment of quarantined or non-conforming material, Client will

comply with Supplier's policy by signing a "waiver" attesting that Client is aware of the
status of the material and is responsible for controlling its use which includes ensuring the
lots/batch under quarantine do not enter into the marketplace until released.

Resolution of Quality Issues

Quality related disagreements between Supplier and Client that are not resolved in the
normal course of business shall be brought to the attention of the appropriate contact
person for notices at the Supplier and Client, in writing, as listed in Appendix 2 (Contacts
and Responsibilities). If both parties agree that a resolution of the disagreement is
reasonably possible, then both Supplier and Client shall agree to work jointly to develop a
strategy for such resolution. Supplier and Client further agree to record such resolution in
writing.

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Debarment

Supplier warrants and represents that it is not debarred under the Generic Drug
Enforcement Act of 1992, 21 U.S.C. 335[a] (the “Generic Drug Enforcement Act”), and
that it has not been convicted of a crime for which it could be debarred under the Generic
Drug Enforcement Act. In connection with the Product, the Supplier further warrants and
represents, in that it shall not use in any capacity the services of any person debarred under
the Generic Drug Enforcement Act, or convicted of a crime for which a person can be
debarred under the Generic Drug Enforcement Act.

Choice of Law: Jurisdiction/Miscellaneous

This Quality Agreement shall be construed and the relationship between the parties
determined in accordance with the laws in the State of ______________________, United
States of America, without regard to the conflicts of law principals thereof. Any and all
disputes between the parties arising out of or related to this Quality Agreement shall be
heard in the state and federal courts located in the State of ____________________, and
the parties hereby consent and submit to the jurisdiction of such courts.

All appendices to this Quality Agreement are attached hereto and incorporated herein by
reference. In this Quality Agreement, unless the contrary intention appears: (a) the words
"including" and "include" mean "including, but not limited to";(b) the singular includes the
plural and vice versa; (c) a reference to a person or entity (including Supplier or Client)
includes a reference to the person's executors, administrators, successors, substitutes and
assigns; and (d) headings are for reference only and do not form part of this contract.

Manufacturing and Testing Location(s)

Product will be manufactured and tested at the following location:

Address(es):

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Quality Responsibilities Table
§ Responsibilities Not Client Supplier
Applicable
1. Compliance Requirements
1.01 Implement procedures and/or documented training to meet   
obligations under this Agreement.
1.02 Follow applicable current Good Manufacturing Practices   
(cGMPs), including ICH Q7: International Conference on
Harmonization Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients (API) and locally imposed
requirements.
1.03 Manufacture, package, ship, store and test the Product and   
materials in an environment meeting the applicable GMP
regulations, which is designed, constructed and maintained in a
manner that a) permits the operation therein to be performed under
clean, sanitary and orderly conditions; b) permits the effective
cleaning of pertinent surfaces; and c) prevents the contamination
of the Product and the addition of extraneous material to the
Product.
1.04 Manufacture the Product in adherence to applicable regulatory   
submissions, such as Drug Master File (DMF) if applicable.
1.05 Operate in compliance with applicable environmental,   
occupational health and safety laws and regulations.
1.06 Maintain a quality unit that is independent of production that   
fulfils both quality assurance and quality control responsibilities.
1.07 Involve the quality unit in all quality related matters and have them   
review and approve all quality critical related documents.
1.08 As it relates to this Quality Agreement, notify the other party of   
name change, corporate reorganization, consolidation, merger or
acquisition or sale of the party’s company. Notify other party of
key personnel changes.
1.09 Maintain internal GMP audit program.   
1.10 Maintain external GMP audit program for suppliers of raw  * 
materials and components, or other suitable qualification program.
*Client may qualify a supplier and take this responsibility but
must be clearly defined for each material

2. Right to Audit
2.01 Client has the right to audit Supplier’s facilities and systems and   
review documents as they relate to the manufacture of Product.
Such inspections and document review shall be conducted by
Client at a time, date and duration mutually agreeable to the
Supplier and Client and subject to Client signature of a separate
confidentiality agreement with the Supplier entity owning the
production site.
2.02 Client retains the right to conduct reasonable "for cause" audits.   
Specific goals/scope of the audit, proposed dates and names of the
auditors will be agreed upon mutually by the Client and the
Supplier.

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 § Responsibilities Not Client Supplier
Applicable
2.03 Issue Supplier a confidential audit report summarizing audit   
observations.
2.04 Issue responses to all observations documented in the issued audit   
report in writing to Client Quality Assurance within 30 days of
receipt of the report.

3. Regulatory Inspections and Exchanges

3.01 Notify Client as soon as the inspection directly involves the   
Product. Client may be allowed to observe the inspection and
contribute input into the discussion. Supplier is responsible for
managing the inspection and determining appropriate Client
interaction. Notify Client within three business days of the receipt
of a Regulatory Authority inspection report, deficiency letter or
written regulatory compliance observation, which contains any
significant adverse findings that relate to the Product or the
facilities used to produce, test or warehouse the Product sold to
Client. A significant adverse finding is herein defined as the
following: conditions, practices, or processes that adversely affect
or may potentially adversely affect product or service quality
and/or the rights, safety or well being of subjects/patients and/or
the quality and integrity of data, documentation, or other materials
or information addressed in the inspection.
3.02 As they relate directly to either Product or the facilities used to   
produce, test, or warehouse, the Product sold to client, Supplier
shall provide copies or a summary of the inspection report,
deficiency letter or written regulatory compliance observation
within 5 business days. These shall be edited to exclude Supplier
or other client's proprietary information.

4. Regulatory Filings and Regulatory Status*

4.01 Client is responsible for determining the regulatory filing   
requirements and process. Supplier shall provide information and
documentation to facilitate regulatory filings. Financial
considerations for this shall be contained within a Supply
Agreement.

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 § Responsibilities Not Client Supplier
Applicable
4.02 (select one approach, if one is not selected then it is Not Applicable)   
  
DMF filing/amendments   
NDA/ANDA CMC filing/changes   
4.03 Responsible for communicating to the other party approvals,   
deficiencies or rejections by agencies regarding submissions,
amendments or updates.
4.04 Responsible for submission and maintenance of registrations as   
follows:   
Drug substance listing   
Site establishment registration   
Or Labeler code as required.   
4.05 Client shall provide Supplier with the following information   
regarding the use of the product:

 Clinical phase of development of the drug product or

drug substance that Product is used in and any change
regarding this status
 Intended use of the drug product or drug substance in
which that Product is used
 Regulatory agencies with which the drug product or
drug substance is filed and if Product is included in the
filing.
4.06 Notify Supplier if Supplier will be named in any governmental   
filing prior to such filing being made.
4.07 Coordinate the activities necessary to ensure readiness prior to   
Regulatory Agency Pre-Approval Inspection (PAI).

5. Complaints and Recalls

5.01 Have written procedures in place to document, investigate, and   
respond to all quality related complaints.
5.02 Assist in investigations as reasonably requested by Client for   
complaints associated with Product.
5.03 Retain complaint investigation records and evaluate trends and   
severity. Implement corrective and preventive actions as
necessary.
5.04 Suppliers will have procedures in place to facilitate the recall of an   
API as necessary. Suppliers will provide assistance to the client for
the recall of drug product incorporating the supplier’s API.

6. Animal Derived Materials

6.01 Evaluate and control the risk of Transmissible Spongiform   
Encephalopathy (TSE) for raw materials and components.
Maintain appropriate records for each lot of animal derived
material to ensure traceability. Where required by local
regulations, Supplier will assure that the country of origin or
slaughtering information (either or both, which ever can be
obtained from the manufacturer) will be documented and provided
to Client.

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 § Responsibilities Not Client Supplier
Applicable
7. Validation/Qualification
7.01 Determine according to Product lifecycle and guidance documents   
when process validation is required.
7.02 Have a written master validation/qualification plan for the   
facilities, equipment/instruments, manufacturing process, cleaning
procedures, analytical procedures, in process control tests and
computerized systems as appropriate. These to be approved by the
quality unit. Client may provide validated methods, process
validation, and in-process controls. Written copies to be
provided to Supplier.
7.03 Responsible for developing, preparing and maintaining validation   
documentation approved by the quality unit, including protocols,
reports and associated documentation.
7.04 Qualify as necessary all critical systems and equipment used for   
the manufacture and control of Product (Installation Qualification
(IQ), Operational Qualification (OQ), and/or Performance
Qualification (PQ)).
7.05 Allow viewing of the validation documentation for the Product   
during an onsite audit.

8. Documentation and Records

8.01 Have a controlled system to initiate, review, revise, approve,   
obsolete and archive all Good Manufacturing Practices
documentation. At a minimum, all production, control, and
distribution records should be retained for at least 1 year after the
expiry date of the batch. For APIs with retest dates, records should
be retained for at least 3 years after the batch is completely
distributed.
8.02 Supplier shall generate the master batch production record,   
labeling and packaging procedures for the manufacture of the
Product based on the information supplied by Client. Both parties
may approve the master batch production record.

Any changes to the master batch production record, labeling and

packaging procedures for the manufacture of the Product shall go
through Supplier change control system and may be approved by
Client. Supplier’s change control system will include maintenance
of a revision history file and justification for changes initiated by
both parties. Client shall provide justification for changes initiated
by Client.
8.03 Maintain a document control system for specifications and test   
methods, including: raw materials, Product labeling, packaging
materials and other materials that would likely affect product
quality.

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 § Responsibilities Not Client Supplier
Applicable
8.04 Will provide the following document for lot/batch produced:   
Complete Certificate of Analysis for the Product, containing "at
minimum" the following information:
 Supplier Product number
 Supplier lot/batch number
 Name of Product
 Name of the test
 Specification limit
 Expiration or retest date, if applicable
 Test result (as a numerical value, unless designated
Pass/Fail in the specification limit, statistical values can
be used if data supports their use except for assays and
impurity tests), including retest results if required
 Quality Assurance approval and date.
 Manufacturing Site (name and address)
 Manufacturing Date

Requested copies of:

Batch Records 
Significant Deviations 
Analytical Data 
Certificate of Origin 
Certificate of Compliance 
Others…  


8.05 Where applicable, electronic signatures used on the certificate of   
analysis or other controlled documents should be authenticated and
secure.

9. Annual Product Reviews

9.01 Have procedures to conduct and document annual product reviews,   
if applicable.
9.02 Allow viewing of the Annual Product Review (APR) for the   
Product during an on-site audit. Client approval is optional.

10. Change Control

10.01 Have established written procedures for control of changes   
impacting the Product including manufacturing components or
process, computer hardware/software, Product specifications, test
methods, vendors, and subcontractors, if applicable. (If Client
requires approval, list documents under Client approval here).
10.02 Notify and gain approval from Client within a reasonable time of   
intent to make changes that could impact the identity, strength,
safety, potency, stability, purity, or regulatory status prior to
implementation of the change (called significant*).
10.03 Issue to Client a written evaluation of the significant* change   
including change justification so that Client can determine the
impact of use of Product in Client’s finished product.
10.04 Jointly establish a strategy to secure regulatory approvals for   
significant changes, as necessary.

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 § Responsibilities Not Client Supplier
Applicable

11. Deviations
11.01 Have procedures for the identification, investigation, and reporting   
of deviations and Out-of-Specification (OOS) results that occur
during the manufacture and testing of the Product.
11.02 Document and explain all deviations. Investigate OOS results and   
critical deviations. Extend the investigation to other lots that may
have been associated with the failure as appropriate. Include
preventive actions and track these to completion.
11.03 Evaluate deviations to determine impact on  
validation/qualification studies.
11.04 Notify Client of significant deviations within 3 business days   

12. Reprocess and Batch Adjustments /Rework/Retest

12.01 Have procedures for batch adjustments and reprocessing, if   
applicable. Reprocessing is defined as introducing an intermediate
or API, including one that does not conform to standards or
specifications, back into the process and repeating a crystallization
step or other appropriate chemical or physical manipulation steps
(e.g. distillation, filtration, chromatography, and milling) that are
part of the manufacturing process.
12.02 Will not blend Out of Specification batches with other batches for   
the purpose of meeting specifications.
12.03 Have a protocol for Product requiring rework describing the   
rationale and justification for rework for approved filed rework
processes, if applicable. Rework is defined as subjecting an
intermediate or API that does not conform to standards or
specifications to one or more processing steps that are different
from the established manufacturing process to obtain an acceptable
quality intermediate or API (e.g. recrystallizing with a different
solvent).
12.04 Receive written approval by Client for reprocessing and reworking   
outside of approved filed processes.
12.05 Will not perform recovery of materials and/or solvents unless   
approved procedures and specifications are in place.

Production and In Process Controls, Packaging and

13.
Labeling
13.01 Procure, test as required, and release raw materials and packaging   
and labeling materials used in manufacture of Product. Client
approval is optional.
13.02 Establish and document specifications for raw materials, Product   
labelling and packaging materials and other materials that would
likely affect product quality. Client approval is optional.
13.03 Prepare/develop master batch production records in accordance   
with applicable cGMP requirements or guidelines, as applicable
for lifecycle of product. Client approval is optional.

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 § Responsibilities Not Client Supplier
Applicable
13.04 Inspect, weigh and measure raw materials used for Product   
manufacturing and verify critical weighing by a second individual
or validated automated system.
13.05 Manufacture Product in a manner that prevents contamination by   
other materials including carryovers.
13.06 Provide product label to include: name and address of the   
manufacturer, identifying code, batch number, quantity of
contents, storage and special transport conditions if applicable, the
retest or expiry date and any special requirements. Revise label per
change control as necessary.
13.07 Review and approval of batch production records by quality unit   
prior to batch release.
13.08 Release Product by quality unit. Client release is an option.   

14. Storage and Distribution

14.01 Maintain storage facilities appropriate for conditions specified on   
the Product label. Maintain records of any critical storage
conditions.
14.02 Have systems for controlling quarantined, rejected or recalled   
materials.
14.03 Provide Material Safety Data Sheets or equivalent. (select one)   
14.04 Notify client in a timely manner if Supplier finds a quality issue   
post Supplier release/shipment.

15. Laboratory Controls

15.01 Have written procedures for sample management, testing,   
approval, disposition, recording, storage, retention and disposal of
laboratory data.
15.02 Retain samples as required by regulatory agencies.   
15.03 Have written procedures and appropriately document the   
preparation, use and management of reagents, solutions, and
standards.
15.04 Have appropriate specifications and test procedures for the Product   
which are consistent with the applicable approved filing and/or
compendial monograph.
15.05 Test Product in accordance with approved validated or qualified   
methods and specifications using calibrated equipment.
15.06 Have a program for qualification, calibration, and preventive   
maintenance of all analytical equipment.
15.07 Responsible for analytical method development, qualification and   
or validation as appropriate. If provided by the Client, Client will
provide written copies to the Supplier.
15.08 Responsible for transferring any developed methods to Supplier.   
15.09 If commercially available reference standards are not available,   
reference standards for the Product will be provided.

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 § Responsibilities Not Client Supplier
Applicable
Stability (must decide Client or Supplier or NA)* if
16. supplied by Client, Client will provide all necessary
information to the supplier.
16.01 Maintain a documented, ongoing stability program to monitor the   
stability of the Product using stability indicating procedures.
16.02 Data analysis and trending reporting will be performed.   
16.03 OOS notification to other party will be provided in a timely   
manner.
16.04 Use data to confirm appropriateness of storage conditions and   
retest or expiry date.
16.05 Store stability samples in commercial size and/or simulated market   
containers under ICH storage conditions.
16.06 Place the first three commercial production batches and at least   
one batch per year (if a batch is produced in the year) on stability
or as required by applicable regulatory agencies.

17. Recalls
17.01 In the event that either Client or Supplier determines that an event   
or circumstance has occurred relating to the manufacture or
stability of the Product which may result in the need for a recall,
stock recovery or market withdrawal of Client's finished drug
product, Supplier and Client shall consult with each other in a
timely manner. The final decision to recall any of the Client's drug
products shall be made by Client.
17.02 Notification of the recall or similar action to the authorities,   
distributors and customers of the finished drug product shall be
made by Client

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 APPENDIX 1: Definition of Product

“Product” shall mean the following Products:

Page 18 of 21 Business Confidential

 APPENDIX 2: Contacts and Responsibilities

Contact Person for Notices

(including Notices of Amendment, Assignment,Termination, Resolution of Quality Issues)

Supplier Client

Name:

Title:

Phone/Fax:

Address
(mail/delivery):

E-mail Address:

With a Copy to:

Name:

Title:

Phone/Fax:

Address
(mail/delivery):

E-mail Address:

Page 19 of 21 Business Confidential

 APPENDIX 3: Product Specifications

Page 20 of 21 Business Confidential

 APPENDIX 4: List of Approved Subcontractors

Page 21 of 21 Business Confidential