CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF
THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY
FILED WITH THE COMMISSION.***

Exhibit 10.9
 
CONFORMED COPY

CONTRACT MANUFACTURE
AGREEMENT

THIS AGREEMENT is made the 25 day of August 2005

BETWEEN
 
(1)
UCB Pharma Limited, registered number 00209905, having its registered office at
208 Bath Road, Slough, Berkshire, SL1 3WE (“UCB”);

(2)
Celltech Manufacturing Services Limited, registered number 4066383, having its
registered office at 208 Bath Road, Slough, Berkshire SL1 3WE (“INYX”); and

(3)
INYX, INC, a corporation organised under the laws of Nevada whose principal
office is at 825 Third Avenue, 40th Floor, New York, United States (“Parent
Guarantor”).

RECITALS:

(A)
INYX carries on the business of, inter alia, manufacture, assembly and packaging
of pharmaceutical products.

(B)
UCB wishes INYX to manufacture the Products (as hereinafter defined) and INYX is
willing to manufacture the Products on the terms and conditions hereinafter set
out.

THE PARTIES AGREE AS FOLLOWS:

1.
DEFINTIONS

   

1.1
In this Agreement the following terms shall have the following meanings unless
the context otherwise requires:

 
“Affiliates”
means in respect of each party any company which at the relevant time is a
subsidiary of that party’s holding company or any subsidiary of such a
subsidiary, and where such party is a “subsidiary” of another company, its
“holding company”, if that other company: (a) holds a majority of the voting
rights in it; or, (b) is a member of it and has the right to appoint or remove a
majority of its board of directors; or, (c) is a member of it and controls
alone, pursuant to an agreement with other shareholders or members, a majority
of the voting rights in it, or if it is a subsidiary of a party which is itself
a subsidiary of that other Company. In this definition, “party” includes any
body corporate;
     

 
 
CONFIDENTIAL TREATMENT

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“Ashton Facility”
means the manufacturing facility as described in the Sale and Purchase Agreement
between the parties, dated [__ August 2005] and includes any other INYX facility
which may be used from time to time pursuant to Article 4.1;
       
“Batch”
means a uniquely identified or identifiable quantity of raw materials, starting
materials, packaging materials or Product which has been processed in one
process or series of processes to the extent that such quantity could be
expected to be homogeneous;
       
“Business Days”
means any day Monday to Friday on which the banks in London are generally open
for business;
       
“Central Warehouse”
means the Dunstable facility or any other warehouse situated in England as
notified by UCB to INYX in writing from time to time;
       
“Certificate of Conformance”
means a document signed by a Qualified Person stating and confirming that the
Product(s) to which such document refers has been Manufactured in accordance
with the Specifications and GMP or materials to which such document refers meet
the Specifications;
       
“Completion Date”
means the Completion Date as defined in the Sale and Purchase Agreement;
       
“Contract Year”
means each consecutive 12 month period from the Completion Date;
       
“Cost of Production”
means, as relevant to the context in which the phrase is used, both the
individual and overall cost of material, labour and overheads to INYX in
Manufacturing the Product;
       
“Data”
 
means master data, transactional data (including but not limited to, forecasts,
replenishment plans, production and capacity plans, procurement schedules,
receipts and shipments, stock, quality data and batch records);
       
“Force Majeure”
means, in relation to either party, any failure of suppliers or machinery (which
for the avoidance of doubt shall include all information technology, software
and hardware related to such machinery), strike, lock-out or other form of
industrial action, civil commotion, act of God, fire, explosion, flood, failure
of utilities, war or hostilities, acts of Government or Government appointed
agents, embargoes or other export restrictions, or perils of the sea, or any
circumstance beyond the reasonable control of that party;
       
“Firm Period”
means the binding element of the Forecast as set out in Article 7.2, being the
first three (3) months of the Forecast; first (1st) month 100% of the Forecast
is binding, second (2nd) month of the Forecast is 80% binding, third (3rd) month
60% of the Forecast is binding;
       
“Forecast”
has the meaning given to it in Article 7.2;
     

 
 
CONFIDENTIAL TREATMENT
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“GMP”
means, as relevant to the Product, the principles and guidelines of good
manufacturing practice as contained in either directive 2001/83/EC (medicinal
products for human use) or directive 91/412/EEC (medicinal products for
veterinary use), as such principles and guidelines are interpreted and expanded
in “The Rules Governing Medicinal Products in the European Community, Volume IV.
Good Manufacturing Practice for Medicinal Products”, together with those rules
and guidelines contained in the Orange Book;
       
“GMP Agreement”
means the agreement (attached to this Agreement as Schedule 1) between the
parties governing the GMP principles to be respected in the Manufacture of the
Products and setting out or otherwise identifying the Specifications for and
technical terms and conditions for the Manufacture of the Products and complying
with those rules and guidelines contained in the Orange Book;
       
“Information”
means any information, technology, know-how, data or commercial information of a
proprietary or confidential nature, including without limiting the foregoing,
Technical Information and price data disclosed pursuant to or in connection with
this Agreement or as a consequence of it, whether orally or in writing;
       
“Initial Term”
means a period commencing from the Completion Date and expiring at the end of
the fifth (5th) Contract Year following such Completion Date;
       
“Manufacture”
means the production of the Product from the Raw Materials and shall, where
relevant, include purchase, manufacturing, formulating, assembling, packaging,
label, artwork, storage at the Ashton Facility, handling, testing and quality
control and quality assurance, logistics, technical support and regulatory
support, and “Manufactured”, “Manufacturing” and “Manufacturer” shall be
interpreted accordingly;
       
“Orange Book”
means the publication “Rules and Guidance for Pharmaceutical Manufacturers and
Distributors 2002” published by the Medicines and Healthcare Products Regulatory
Agency including any subsequent edition thereof, as such publication might be
amended or reissued from time to time; 
       
“Presentation”
means the presentations specified in Schedule 2 in which the Products are to be
marketed, distributed, sold or used;
       
“Process Improvements”
means all improvements, modifications or adaptations to any process employed by
INYX and at any time during the continuance of this Agreement used in the
conduct of Manufacture, and not exclusively capable of employment in the
Manufacture of the Product;
       
“Products”
means the products specified and described in Schedule 2 and “Product” shall
mean any one of them;
       
“Purchaser”
means INYX Europe Limited, a company registered in England whose registered
office is at 6 Seymour Court, Manor Park, Runcorn, Cheshire WA7 1SY;
     

 
 
CONFIDENTIAL TREATMENT
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“Purchaser’s Group”
the Purchaser and any subsidiary or holding company of the Purchaser or of any
holding company or subsidiary of such holding company or subsidiary;
       
“Qualified Person”
means the person so designated in accordance with EC Directive 2001/83/EC and
employed by INYX or UCB as the case may be;
       
“Raw Materials”
means the raw materials specified in the Specifications and any other raw
materials ingredients and excipients and packaging or other components which are
required by INYX to conduct the Manufacture;
       
“Regulatory Approval”
means any product licence, marketing authorisation or clinical trials
certificate issued by the relevant Regulatory Authority and in terms permitting,
as appropriate, the importation, distribution, sale, marketing or use of the
Product and for the avoidance of doubt shall not include any authority to
perform “special” manufacturing or dispensing services pursuant to any order
made under the Medicines Act 1968, which authority is commonly referred to as a
“specials licence”;
       
“Regulatory Authority”
means the United Kingdom Medicines and Healthcare Products Regulatory Agency or
any equivalent competent body in any jurisdiction as relevant to the Products
and the territories in which the Products are to be marketed or used;
       
“Sale and Purchase Agreement”
means the agreement for the sale and purchase of the entire issued share capital
of INYX between UCB, Purchaser and the Parent Guarantor dated 25 August 2005;
       
“Service Agreement”
means the agreement for the performance and supply of services at the Ashton
Facility, entered into between the parties, dated 25 August 2005;
       
“SKU”
means stock keeping unit;
       
“Specifications”
means the specifications for the Product as specified in the GMP Agreement;
       
“Technical Information”
means all know-how, registration data, experience, instructions, standards,
methods, test and trial results, manufacturing processes, hazard assessments,
quality control standards, formulae, specifications, storage data, samples,
drawings, designs, descriptions of packaging materials and all other relevant
information relating to the Product or the design, Manufacture, storage or use
of the Product;
       
“Trade Mark(s)”
means the trade mark(s) set out in Schedule 2 which are either owned by UCB or
to which UCB has the necessary right of use; and
       
“Validation”
means the process of proving, in accordance with the principles of GMP, the
reproducibility, efficacy, and repeatability of any procedure, process,
equipment, material, testing equipment, test, activity or system and the ability
thereof to achieve the result which is intended to be achieved, as further
detailed in the GMP Agreement.

 
 
CONFIDENTIAL TREATMENT
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1.2
Any reference in this Agreement to “writing” or cognate expressions includes a
reference to mail, cable, facsimile transmission or comparable means of
communication.

   

1.3
Words in this Agreement importing the singular meaning shall where the context
so admits include the plural meaning and vice versa.

   

1.4
The headings in this Agreement are for convenience only and shall not affect its
interpretation.

   

2.
Condition Precedent

This Agreement shall commence on the Completion Date on condition that the Sale
and Purchase Agreement is completed. If for any reason the Completion Date does
not occur and the Sale and Purchase Agreement does not complete, this Agreement
shall terminate with immediate effect with no liability for any party in respect
of any breach including future breach.

   

3.
Validation & Changes

     

 
3.1
The process for the Manufacture of the Products has been validated and agreed by
the parties as set out in the GMP Agreement. In the event that any additional
Validation work is required as a result of any change to the method of
manufacture or equipment used in the Manufacture then the parties shall agree
how the cost thereof shall be apportioned between them.

     

 
3.2
Where a party (the initiator party) requires or requests any changes to be made
to the artwork utilised on or to the validation of any of the Products it will
give not less than three (3) months notice thereof to the other party. Any costs
incurred by the initiator party as a result of such change shall be borne by it
together with the cost of any packaging materials that are written off as a
result of such changes. For the avoidance of doubt the parties shall bear the
costs equally between them of any changes to such artwork as a result of or in
connection with the sale of Ashton Facility.

   

4.
Contract Manufacture

     

 
4.1
UCB hereby exclusively appoints INYX to Manufacture the requirements for the
Products of UCB and of UCB’s Affiliates, with the exception of ***, at the
Ashton Facility and UCB shall ensure that UCB’s Affiliates shall use INYX as
exclusive manufacturer of the Products required by UCB’s Affiliates; provided
INYX can, from time to time, use its other manufacturing facilities with the
prior written consent of UCB, such consent not to be unreasonably withheld or
delayed, and INYX accepts such appointment. During the period of this Agreement
INYX will Manufacture for UCB the Product in accordance with this Agreement and
the GMP Agreement, and UCB shall acquire its requirements for the Product from
INYX.

     

 
4.2
INYX shall Manufacture the Products in compliance with the technical provisions
of the Service Agreement between the parties. For the avoidance of doubt, the
price of such Manufacture shall be included in the price for the Products as set
out in Schedule 2 to this Agreement.

     

 
4.3
INYX covenants that:

     

 
4.3.1
it has, and will use reasonable commercial endeavours to maintain during the
term of this Agreement, a manufacturer’s licence in accordance with section 8 of
the Medicines Act 1968 as amended from time to time and will inform UCB of all
inspections by the Relevant Authorities and of their findings which relate to or
are relevant to the Product;

     

 
 
CONFIDENTIAL TREATMENT
5

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4.3.2
it will conduct the Manufacture in accordance with the GMP Agreement;

     

 
4.3.3
any Raw Materials employed by INYX in the Manufacture and not supplied by or on
behalf of UCB will at the time of use comply with the Specifications and the GMP
Agreement;

     

 
4.3.4
it will allow, at least twice during any twelve (12) month period of this
Agreement and during normal business hours and upon reasonable notice,
authorised representatives of UCB and/or representatives of any Government or
Regulatory Authority acting on UCB’s behalf to inspect the relevant parts of the
Ashton Facility where the Manufacture of the Product is carried out or the
Product or Raw Materials are stored and to inspect the process of Manufacture.
To the extent that any cost is incurred as a direct result of such inspection
the reasonable out of pocket costs of such inspection shall be payable by UCB.
Notwithstanding the foregoing, INYX’s obligation to allow such visitors is on
condition that: (a) UCB procures that such visitors agree in writing to observe
the requirements of INYX regarding security, health and safety, confidentiality
or any other applicable regulations at the relevant premises; (b) any visit
shall be under the specific supervision of INYX (without relieving any visitors
of any obligations with respect to any damage or injury caused by them); (c) UCB
indemnifies and shall keep indemnified INYX against any damage to INYX’s
property or any personal injury which is caused by any act or omission of any of
UCB’s employees or authorised agents or nominated visitors on INYX’s premises;
and (d) UCB uses its best endeavours to ensure that any visit is of minimal
disruption to INYX’s day to day business. INYX shall promptly inform UCB of any
visit or inspection of or at the Ashton Facility by any Government or Regulatory
Authority, including the results of such inspection and possible remedies
imposed by such authorities. Compliance with any such imposed remedies shall
automatically become part of INYX’s obligations under this Agreement;

     

 
4.3.5
it will upon written request and at the cost of UCB supply UCB with reasonable
quantities of samples of the Product Manufactured by it provided that no
Manufacture is required primarily for the purpose of providing UCB with the said
samples. INYX shall retain a quantity of samples of each production Batch of the
Products equal to twice the amount reasonably required to conduct the relevant
analysis;

     

 
4.3.6
it shall retain for a maximum of six (6) years manufacturing, analytical and
distribution records and shall retain such samples of the Products as are
required by, and in the manner and for the duration specified by the GMP
Agreement. During the said six (6) year period, it shall make such records
available to UCB upon reasonable notice. Upon INYX deciding to dispose of such
records or samples, INYX shall notify UCB of such decision taken by INYX. In the
absence of any response from UCB within three (3) months of notification, INYX
may destroy or otherwise dispose of the said records or such samples as it sees
fit; and

     

 
4.4
INYX may at any time undertake any change to the Ashton Facility or equipment
provided that any such change shall not be of detriment to the Product. In the
event that any such change will necessitate or make desirable a variation to any
Regulatory Approval for the Product then INYX will notify the proposed change in
writing to UCB, such change not to be carried out without prior written consent
from UCB, not to be unreasonably withheld or delayed. UCB will use all
reasonable endeavours to obtain such required or desired variation. Any costs
associated with the change will be to the account of INYX. Should such variation
not be obtained for any reason, and should as a result INYX be unable to
Manufacture the Product in or on the changed premises or facilities or
equipment, then the parties shall enter into bona fide discussions with a view
to agreeing upon such alternative arrangements as may be fair and reasonable.

 
CONFIDENTIAL TREATMENT
6

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  4.5 UCB covenants that:

 

 
4.5.1
it has and will maintain throughout the term of this Agreement appropriate
Regulatory Approvals for the Product for the United Kingdom and for any other
jurisdiction or territory for which the Product is being Manufactured or in
which the Product is to be marketed distributed sold or used;

     

 
4.5.2
prior to entering into this Agreement it will be responsible for assessing and
confirms that it has assessed the competence of INYX to carry out the
Manufacture of the Product in accordance with GMP as set out in the GMP
Agreement;

     

 
4.5.3
any Raw Materials and other products to be provided by it shall comply with the
Specifications and where appropriate shall be accompanied by a Certificate of
Conformance from UCB;

     

 
4.5.4
it has notified INYX of any special requirements in respect of record-keeping
that may be necessary to comply with UCB’s adverse event/defect/recall
procedure; and

     

 
4.5.5
it shall notify INYX of any hazards to the health or safety of any personnel of
INYX and UCB shall keep INYX so advised throughout the continuance of this
Agreement, whether such hazards or possibilities are inherent in the Product or
otherwise.

   

5.
GMP Agreement and Technical Information

     

 
5.1
The respective responsibilities of INYX and UCB relating to the Manufacture of
the Product, the way in which each Batch of the Product is to be Manufactured
and checked for compliance with and adherence to the appropriate Specifications
and GMP, the responsibility for purchasing materials, testing and releasing
materials and undertaking production and quality control including in-process
controls as well as sampling and analysis shall be as specified in the GMP
Agreement. The provisions of the GMP Agreement shall prevail over any
conflicting provisions set out in Articles 3 and 4 of this Agreement.

     

 
5.2
Subject to UCB complying in all respects with its relevant obligations under
this Agreement and the GMP Agreement, INYX shall be responsible for ensuring the
safe operation of the process of Manufacture of the Product at the Ashton
Facility and in particular that the Technical Information supplied by UCB can be
safely used at the Ashton Facility.

     

 
5.3
Any alteration to the GMP Agreement must be agreed in writing between the
parties.

   

6.
Duration

     

 
6.1
Unless sooner terminated as hereinafter provided, this Agreement shall come into
force on the Completion Date hereof and shall continue in force for the Initial
Term and thereafter for consecutive one (1) year periods, unless terminated by
either party giving to the other not less than twelve (12) months’ written
notice prior to the end of the Initial Term or any renewal term (for the
avoidance of doubt, the date on which this Agreement shall terminate under such
notice shall not be before the end of the Initial Term).

   

7.
Supply Chain Management

     

 
7.1
Except as otherwise set out in the Service Agreement, supply chain management
for the Products shall occur in accordance with the principles set out in this
Article 7.

     

 
7.2
UCB shall provide INYX with a monthly rolling forecast for the volume of
Products on a line by line basis per SKU for eighteen (18) months (the
“Forecast”). The Forecast will be sent by UCB to INYX each month by no later
than the seventh (7th) day of each calendar month. Each Forecast shall be
binding as follows:

 
 
 
CONFIDENTIAL TREATMENT
7

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7.2.1 first (1st) month forecast: 100% of the Forecast;
 
7.2.2 second (2nd) month forecast: 80% of the Forecast; and
 
7.2.3 third (3rd) month forecast: 60% of the Forecast.
 

 
7.3
UCB will determine the stock policy per SKU. The stock policy will set the
minimum Product stock level at two (2) months stock and the maximum stock level
at four (4) months stock per SKU, unless agreed otherwise. The stock policy will
be revised on a six (6) monthly basis. UCB shall provide INYX with written
notice of the stock policy per SKU as soon as is reasonably practicable after
the stock policy is revised.

     

 
7.4
UCB shall provide INYX on a weekly basis with written notice of the stock levels
per SKU and by location.

     

 
7.5
INYX will calculate a replenishment plan for the Products on a monthly basis
using the Firm Period, the actual stock and the stock policy. INYX shall provide
to UCB in writing the replenishment plan by no later than the fourteenth (14th)
day of each calendar month. The replenishment plan will then be discussed in a
monthly meeting between the parties and agreed for acceptance by the parties.
The replenishment plan shall detail replenishment on a weekly basis and the
replenishment plan shall be firm in terms of timing and quantity on a monthly
basis.

     

 
7.6
The Products shall be supplied to UCB ex-works (Incoterms 2000). Unless
specified otherwise risk in each Batch of the Product shall pass to UCB on
delivery provided that ownership in each Batch of the Product shall remain
vested in INYX until payment is received from UCB in respect of that Batch of
the Product. For the avoidance of doubt ownership in each Batch of the Product
shall pass to UCB when payment is made in accordance with the provisions of
Article 9.2.

     

 
7.7
INYX shall certify each Batch of Products within fifteen (15) Business Days for
sterile Products and seven (7) Business Days for non-sterile Products after
complete batch receipt at the Central Warehouse and INYX shall supply a
Certificate of Conformance with each Batch of the Product. If a Batch is not
released within the timeframes mentioned, UCB shall have the right to return the
Product to Ashton Facility at INYX’s costs.

     

 
7.8
All Products shall be delivered and released to the Central Warehouse with a
shelf-life of at least ninety per cent. (90%) of their original shelf-life or
sixteen (16) months for short shelf-life products (for the avoidance of doubt
products with a short shelf life are products with a shelf life of two (2)
years). All Product stock delivered to the Central Warehouse with a shorter
shelf-life will be subject to negotiation.

     

 
7.9
UCB shall inspect and/or test the Product as soon as practicable following
delivery. Subject to Article 7.6, failure by INYX to Manufacture the Product in
accordance with Specifications shall be the only reason for which UCB may reject
the Product. If UCB wishes to reject any delivery of Product it must notify INYX
within thirty (30) days of whichever is the later of receipt of the Product or
receipt of the relevant Certificate of Conformance and such notification must be
in writing and include a detailed indication of the reasons for rejection. UCB
shall be deemed to have accepted the Product and shall not be entitled to reject
the same unless it provides such written notification within the said period of
thirty (30) days. INYX shall notify UCB within fifteen (15) days of receipt of
such notification of rejection whether it accepts UCB’s claim. If INYX does not
accept the claim or UCB disagrees then an independent laboratory mutually agreed
by the parties (or failing agreement the Medicines and Healthcare Products
Regulatory Agency Laboratory in Edinburgh) shall be requested to analyse an
appropriate amount of the Product from the Batch or Batches in dispute. The
independent laboratory shall act as expert not arbitrator and the cost of its
analysis shall be paid by the party against whom the laboratory findings were
made. Two samples shall be supplied, one by UCB from the Batches in question and
one by INYX from any samples that it has retained. The results of the said
analysis shall be binding on the parties. Pending resolution of the dispute, and
upon UCB’s request, INYX shall supply a replacement Batch of Product forthwith
and in any event within forty five (45) days at the cost specified in and
otherwise upon the terms of this Agreement.

     

 
 
CONFIDENTIAL TREATMENT
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7.10
If:

 
(a)
the outcome of the process specified in Article 7.8 is that the independent
laboratory determines that the Product does not conform to the Specifications
due to the breach of any terms of this Agreement by INYX; or

     

 
(b)
if INYX accepts that the Product does not conform to the Specifications due to
the breach of any terms of this Agreement by INYX,

 
INYX shall Manufacture and deliver to UCB a sufficient quantity of the Product
to replace the defective Batch or Batches. If the independent laboratory
determines that the relevant Batches of Product were Manufactured in accordance
with the Specifications or that any defect did not arise due to the breach of
any terms of this Agreement by INYX, INYX shall have no liability or obligation
to UCB in respect of such Batches.
 
8.
Intellectual Property and Improvements

     

 
8.1
UCB hereby authorises INYX to use the Trade Marks and UCB’s other intellectual
property on or in relation to the Products for the purpose only of exercising
its rights and performing its obligations under this Agreement.

     

 
8.2
Each party hereby acknowledges that it shall not acquire any rights in respect
of any of the other party’s intellectual property in relation to the Products or
the Manufacture thereof or of the goodwill associated therewith.

     

 
8.3
Except as is necessary for the proper performance of this Agreement by the
parties, no licence, express or implied, is granted by this Agreement by either
party to the other under any of its intellectual property rights.

     

 
8.4
Title to and property in all Manufacturing Records (as defined below) and
Process Improvements generated by INYX directly in connection with the
Manufacture of the Products shall be and remain at all times exclusively vested
in UCB, and INYX hereby disclaims any right thereto; provided that INYX shall be
entitled to a royalty-free, irrevocable licence to use the Process Improvements
in its business.

     

 
8.5
The Manufacturing Records (which shall include but not be limited to all Batch
documentation and Validation data) shall be treated as Information of UCB and
shall not be used or disclosed by INYX other than for the purposes of this
Agreement and where necessary for disclosing to the relevant regulatory
authorities in order to comply with regulatory requirements relating to the
Product and its Manufacture by INYX.

     

 
8.6
No Process Improvements shall be employed by INYX in the Manufacture of the
Products unless the terms upon which such Process Improvements are to be
employed by INYX have been agreed with UCB.

     

 
8.7
Title to and property in all Data shall be and remain at all times exclusively
vested in INYX and UCB hereby disclaims any right thereto; provided that UCB
shall be entitled to a royalty-free, irrevocable licence to use and to copy the
Data and INYX undertakes to grant to UCB unlimited access to the Data.

   

9.
Prices

     

 
9.1
All orders for the Product for delivery from the Completion Date will (subject
to Article 9.3 below) be at the price(s) set out in Schedule 2.

     

 
 
CONFIDENTIAL TREATMENT
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9.2
***

Year 1:   ***
Year 2:  ***
Year 3:  ***
Year 4:  ***
Year 5:  ***
 

 
9.3
Invoices will be submitted to UCB when the Product has been delivered in
accordance with Article 7.5. INYX will invoice UCB on a monthly basis for the
goods delivered during the term of this Agreement. UCB will pay to INYX the full
invoice value for the Product in Pounds Sterling (£) within thirty (30) days of
invoice date. If INYX so requires payment will be made direct into INYX’s bank
account by bank transfer and upon written request by INYX, INYX will provide UCB
with the necessary details of INYX’s bank account and will take whatever actions
are necessary to facilitate payment by bank transfer. In the event of a delay of
more than seven (7) days in collection of the Products when they have been
notified to UCB as being available for collection INYX reserves the right to
make charges for storage.

     

 
9.4
If as a result of any inspection of INYX’s premises as referred to in Article
4.3.4 or otherwise a requirement is imposed by a competent authority which leads
to or requires a change in the Cost of Production or to the Specification of the
Product then upon written notification by INYX to UCB INYX and UCB will meet to
discuss any increase to the price of the Product, the date upon which such price
increase will take effect and any other consequences arising from such changes.
If within one (1) month of the said notification by INYX the parties are unable
to agree an increased price for the relevant Product, the price of such Product
shall be increased by the amount of the increase of the Cost of Production of
that Product or by the amount required to comply with the Specification of that
Product. However, if such change is the result of non-compliance with GMP by
INYX, then INYX shall pay for such change.

     

 
9.5
The parties shall each use their respective reasonable endeavours throughout the
term of this Agreement to seek improvements in the process for Manufacture of
the Products, the purchasing of Raw Materials and the ordering, delivery and
invoicing of the Products so that where possible the prices for the Products set
out in Schedule 2 or as adjusted from time to time can be reduced and the
benefit of the savings shared equally between the parties hereto. UCB shall have
the right to assist in the feasibility study of any such improvement project.
INYX will disclose to UCB all information needed for any such feasibility study.
UCB shall have the right (at UCB’s cost) to audit and have audited INYX’s books
pertaining to this Agreement with the sole purpose of monitoring the cost
improvement. This right shall be exercised upon reasonable notice.

     

 
9.6
In the event that any of UCB’s customers (including UCB Affiliates) finds itself
in an out-of-stock situation for any Product for more than three (3) weeks as a
result of the breach of any terms of this Agreement by INYX, INYX shall pay UCB
compensation equal to UCB’s gross profit for the period (excluding the first
three (3) weeks referred to above) where such out-of-stock situation continues
to exist. The gross profit for these purposes will be calculated on the basis of
the forecasted net sales minus the COGS for the Product concerned for that
customer. The provisions of this Article are without prejudice to UCB’s rights
under Article 10.1 hereafter. For the avoidance of doubt INYX shall not be
liable for an out-of-stock situation resulting from lack of availability of the
materials and components unless such out-of-stock situation is a result of the
breach of any terms of this Agreement by INYX.

     

 
9.7
INYX may review the price annually and enter into negotiations with UCB to
increase the price of Product to take account of any increased Cost of
Production or Raw Material costs provided that such review shall not occur prior
to twenty four (24) months after the Completion Date and thereafter shall not
occur more than one time during any period of twelve (12) months during the term
of this Agreement.  If the parties are unable to agree an increased price the
price shall be increased by the amount of the increase from the date of the
previous price review (or in the case of the first price review, the Completion
Date) of the Prices Indices of the United Kingdom Output for Products of
Manufacturing Industries other than food beverages and tobacco manufacturing
industries (commonly referred to as the “Manufacturers (Other) Index”) published
by the office of National Statistics or any successor or replacement Index. Any
increase will be supported by a detailed costs breakdown which will include
supplier documentation in respect of any material increase.

   

 
 
CONFIDENTIAL TREATMENT
10

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10.
LIMITATION OF LIABILITY AND INDEMNITY - GENERAL

     

 
10.1
Subject to Article 10.3, neither party shall in any circumstances be liable to
the other party nor any third party for any consequential or indirect loss,
except where an out-of-stock situation caused by the breach of any terms of this
Agreement by INYX results in UCB having lost or having to indemnify customers.

     

 
10.2
Subject to the provisions of Article 10.3 hereof, INYX shall indemnify and shall
keep UCB indemnified and hold it harmless against any and all third party
actions, claims, judgments, damages, law suits costs or expenses or professional
fees brought against, suffered or incurred by UCB resulting from a breach of
contract by INYX Provided That the provisions of this Article 10.2 shall not
apply to any event which would constitute a breach of contract for which a
remedy is provided to UCB elsewhere in this agreement including, but not limited
to, Articles 7.8, 9.6 and 12.

     

 
10.3
Notwithstanding any other provision of this Agreement, neither party limits its
liability for:

 

 
(a)
negligence or fraud by it or its employees or its subcontractors; or

 
(b)
death or personal injury caused by its negligence or that of its employees,
agents or subcontractors (as applicable).

 

 
10.4
Subject to Article 10.3, the total aggregate liability of INYX arising under
this Agreement (including but not limited to INYX’s liability in connection with
Articles 9.5, 10.1 and 11.1) shall not exceed the following amounts:

  

 
(a)
***;

 
(b)
***; and

 
(c)
***

     

 
10.5
Subject to the provisions of Article 10.3 hereof, UCB shall indemnify and shall
keep INYX indemnified and hold it harmless against any and all third party
claims, actions, judgements, damages, lawsuits, costs or expenses or
professional fees brought against suffered or incurred by INYX in relation to or
arising out of the storage, sale, distribution or use of the Product, resulting
from a breach of contract by UCB.

     

 
10.6
Subject to Article 10.3 and 10.12, the total aggregate liability of UCB arising
under this Agreement shall not exceed the following amounts:

  

 
(a)
***;

 
(b)
***; and

 
(c)
***

     

 
10.7
The party claiming the benefit of any indemnity hereunder must promptly notify
the other of any claim, not accept any compromise or settlement of such claim or
take any material steps in relation to such claim without the prior consent of
the other party and shall co-operate fully with the other party in the handling
of any such claim.

     

 
 
CONFIDENTIAL TREATMENT
11

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10.8
Each Party undertakes to ensure that it has in place product liability insurance
with a reputable insurer in an amount appropriate for its business and products
of the type the subject of this Agreement, and for its obligations under this
Agreement. At either party’s request the other party shall provide evidence of
the existence and maintenance of such cover.

     

 
10.9
Each Party will have appropriate inventory and Stock in Transit insurance, as is
customary for the industry.

     

 
10.10
Nothing in this Article 10 shall in any way reduce or affect each party’s
general duty to mitigate loss suffered by it.

     

 
10.11
The parties acknowledge and agree that clause 8.8 of the Sale and Purchase
Agreement contains provisions which limit the liability of INYX for the
specified time and in specified circumstances which are a direct result of the
temporary closure of the Sterile Production Unit (as defined therein) prior to
Completion or within a period of 45 days following Completion.

   

11.
Confidentiality

     

 
11.1
Each party (“Discloser”) agrees to maintain as secret and confidential all
Information obtained from the other (“Recipient”) both pursuant to this
Agreement and prior to and in contemplation of it, to respect Discloser’s
proprietary rights therein, to use the same exclusively for the purpose of this
Agreement and for no other use and to disclose the same only to those of its
professional advisers, including legal financial and risk assessment advisers,
authorised sub-contractors and employees to whom and to the extent that such
disclosure is reasonably necessary for the purpose of this Agreement.
Furthermore, Recipient agrees to maintain as secret and confidential all other
information obtained from Discloser which the Discloser has designated as
confidential.

     

 
11.2
The foregoing obligations of Article 11.1 above shall not apply to Information
which:

     

 
11.2.1
the Recipient can prove by documentary evidence was already in its possession
and at its free disposal before disclosure by Discloser;

     

 
11.2.2
is subsequently lawfully disclosed to the Recipient without any obligations of
confidence by a third party who has not derived it directly or indirectly from
the Discloser or any of the Discloser’s Affiliates; or

     

 
11.3
is or becomes generally available to the public (in printed publications in
general circulation) through no act or default of Recipient or its agents or
employees.

     

 
11.4
Discloser is required to disclose by law.

     

 
11.5
Recipient shall allow access to the Discloser’s Information exclusively to those
of its employees who have reasonable need to see and use it for the purposes of
this Agreement and shall inform each of the said employees of the confidential
nature of the Information and of the obligations on Recipient in respect thereof
and ensure that each of its employees having access to the Information is
contractually bound by obligations of confidentiality and shall take such steps
as may be necessary to enforce such obligations.

   

12.
Adverse Drug Events and Product Recalls

     

 
12.1
UCB shall be responsible for conducting any recall of defective Products and
INYX shall co-operate with and give all reasonable assistance to UCB in
conducting any such recall in accordance with the provisions of the GMP
Agreement. The costs and expenses of such recall shall be met by UCB except
where such recall is a result of any negligent act or omission on INYX’s part,
in which event, INYX shall meet all costs and expenses thereof.

     

 
 
CONFIDENTIAL TREATMENT
12

--------------------------------------------------------------------------------

 

 
12.2
Each Party shall keep the other informed of any adverse drug event involving the
Products or products containing the same active ingredient as the Products
coming to their attention and able to be disclosed to the other.

     

 
12.3
Each party shall keep the other informed of any material change or event in the
market relevant to the Products coming to their attention and able to be
disclosed to the other.

   

13.
Termination

     

 
13.1
Either party may forthwith terminate this Agreement by written notice to the
other if:

     

 
13.2
that other party is in material breach of any of the provisions of this
Agreement and, in the case of a breach capable of remedy, fails to remedy the
same within ninety (90) days or within one hundred and twenty (120) days if
concerning the sterile production unit in the Ashton Facility of receipt of a
written notice specifying the breach and requiring its remedy; or

     

 
13.3
an encumbrancer takes possession or a receiver is appointed over any of the
property or assets of that other party; or

     

 
13.4
that other party makes any voluntary arrangement with its creditors or becomes
subject to an administration order; or

     

 
13.5
that other party goes into liquidation except for the purposes of amalgamation
or reconstruction and in such manner that the company resulting therefrom
effectively agrees to be bound by or assume the obligations imposed on that
other party under this Agreement.

     

 
13.6
For the purposes of Article 13.1 a breach shall be considered capable of remedy
if the party in breach can comply with the provision in question in all respects
other than as to the time of performance provided that time of performance is
not of the essence.

     

 
13.7
Any waiver by either party of a breach of any provision of this Agreement shall
not be considered a waiver of any subsequent breach of the same or any other
provision.

     

 
13.8
The rights to terminate this Agreement given by this Article 13 shall be without
prejudice to any other right or remedy of either party in respect of the breach
concerned (if any) or any other breach.

     

 
13.9
***

   

14.
Consequences of Termination

 
14.1
Termination of this Agreement for any reason shall not bring to an end any
provisions of this Agreement which, in order to give effect to their meaning,
need to survive its termination and such provisions shall remain in full force
and effect thereafter and in particular but without limiting the scope of the
foregoing obligations of the parties under Articles 9, 11, 12, 13, 14, 18, 20,
21, 22, 23, and this Article 14.

 
14.2
On termination of this Agreement for any reason:

     

 
14.2.1
INYX shall at UCB’s option either immediately cease Manufacture or complete
Manufacture of all Products which have been ordered prior to the date of
termination of this Agreement and UCB shall notify INYX of its election on
termination of this Agreement;

     

 
14.2.2
subject to Article 14.2.1 each party shall deliver up to the other all
materials, reports, and other documents (including copies thereof) in its
possession or control containing Information of the other party, and each will
cease to make use of the other’s Information;

 
 
CONFIDENTIAL TREATMENT
13

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  14.2.3 UCB shall pay INYX for all Products which are subject to the Firm
Period and which have been ordered in accordance with the replenishment plan at
prices then prevailing and shall take delivery of such Product as soon as
possible when it is notified by INYX that it is available for collection;

 

 
14.3
UCB will be obliged to purchase and shall pay INYX for:

     

 
(a)
all stocks of Raw Materials purchased by INYX in accordance with Article 7 with
a maximum of three (3) months forecast at a price equal to the book value or the
cost thereof, whichever is lower; and

     

 
(b)
all work in progress purchased by INYX in accordance with Article 14.2.1 at
prices then prevailing.

     

 
14.4
UCB will collect all Raw Materials and all work in progress free of charge. In
case of withdrawal of the Product under Article 13.5, the same principles shall
apply.

   

15.
Escalation Provisions

     

 
15.1
In the event only it is specified herein that these escalation provisions shall
apply to any dispute or disagreement being and remaining unresolved, then until
resolution thereof:

     

 
15.2
the parties shall as soon as reasonably practicable commence good faith
negotiations to resolve the dispute or disagreement;

     

 
15.3
should such good faith negotiations not take place or should such good faith
negotiations not resolve the dispute or disagreement within a reasonable period,
but in any event within twenty one (21) days of commencement of the
negotiations, the dispute or disagreement shall immediately be referred to the
respective senior management of the parties for their resolution (for the
avoidance of doubt senior management for UCB is head of GTSO and for INYX is VP
Global Sales & Marketing); and

     

 
15.4
should the respective senior management of the parties fail to resolve the
dispute or disagreement within fourteen (14) days of it being referred to them,
then either party may by written notice to the other forthwith terminate this
Agreement, and neither party shall be liable to the other in respect of any
consequence of such termination.

   

16.
Force Majeure

     

 
16.1
If either party is affected by Force Majeure it shall forthwith notify the other
party of the nature and extent thereof.

     

 
16.2
Each party shall be deemed not to be in breach of this Agreement, nor otherwise
be liable to the other by reason of any delay in performance, or
non-performance, of any of its obligations hereunder to the extent that such
delay or non-performance is due to any Force Majeure of which it has notified
the other party and the time for performance of that obligation shall be
extended accordingly.

     

 
16.3
If the Force Majeure in question prevails for a continuous period in excess of
three (3) months, the parties shall enter into bona fide discussions with a view
to agreeing upon such alternative arrangements as may be fair and reasonable. If
the parties cannot agree such alternative arrangements then either party shall
be entitled to terminate this Agreement immediately by written notice.

   

 
 
CONFIDENTIAL TREATMENT
14

--------------------------------------------------------------------------------

 
17.
Notices

     

 
17.1
Any notice or other information required or authorised by this Agreement to be
given by either party to the other may be given by hand or sent to the other by
first class registered pre-paid post, telex, facsimile transmission or
comparable means of communication. Service of any legal proceedings concerning
or arising out of this Agreement shall be effected by causing the same to be
delivered to the secretary of the party to be served at its registered office,
or to such other address as may be notified by the party concerned in writing
from time to time.

     

 
17.2
Any notice or other information given by post pursuant to Article 17.1 which is
not returned to the sender as undelivered shall be deemed to have been given on
the third day after the envelope containing the same was so posted. Proof that
the envelope containing any such notice or information was properly addressed,
pre-paid, registered and posted, and that it has not been so returned to the
sender, shall be sufficient evidence that such notice or information has been
duly given.

     

 
17.3
Any notice or other information sent by telex, cable, facsimile transmission or
comparable means of communication shall be deemed to have been duly sent on the
date of transmission, provided that a confirming copy thereof is sent by first
class registered pre-paid post to the other party at the address referred to in
Article 17.1 within twenty four (24) hours after transmission.

   

18.
Liaison

     

 
18.1
Upon signature of this Agreement the parties will each identify in writing the
person responsible for the day to day operation of this Agreement including
purchasing, RA, QA, QC, SCM, IS/IT, Production, Artwork.

   

19.
Material Adverse Impact

     

 
19.1
Should there occur any event or circumstance which is not the result of any act
or omission of INYX and which INYX reasonably believes has a material adverse
affect on its ability to Manufacture or on its business generally, then the
parties shall, at INYX’s request, meet to discuss in good faith the possible
consequences of any such event or circumstance and its implications for INYX and
its business. Should the parties not reach agreement reasonably acceptable to
INYX regarding their ongoing relationship in light of the said event or
circumstance, then either party may, by three (3) months’ notice to the other
party, terminate this Agreement.

   

20.
Non-solicitation of Employees

     

 
20.1
UCB shall not during the term of this Agreement nor for a period of one (1) year
after its expiry or termination for whatever reason whether directly or
indirectly and in any capacity whatsoever (whether on its own behalf or on
behalf of any other person or firm) solicit the services of or approach any
employee or officer of INYX with a view to recruiting that person for the
purposes of employment.

     

 
20.2
INYX shall not during the term of this Agreement nor for a period of one (1)
year after its expiry or termination for whatever reason whether directly or
indirectly and in any capacity whatsoever (whether on its own behalf or on
behalf of any other person or firm) solicit the services of or approach any
employee or officer of UCB with a view to recruiting that person for the
purposes of employment.

   

21.
***

   

 
 
CONFIDENTIAL TREATMENT
15

--------------------------------------------------------------------------------

 
22.
General

     

 
22.1
INYX may assign the benefit of this Agreement to any other member of the
Purchaser’s Group or to any lender or holder of debt securities issued by any
member of the Purchaser’s Group for the time being or any agent of such lender
or holder and if it does so:

     

 
22.1.1
the assignee may enforce the obligations on the part of UCB under this Agreement
as if it had been named in this Agreement or therein as INYX

     

 
22.1.2
as between UCB and INYX, UCB may nevertheless enforce this Agreement against
INYX as if the assignment had not occurred;

     

 
22.1.3
the assignment shall not in any way operate so as to increase the liability of
INYX or UCB; and

     

 
22.1.4
the assignee will not be liable or obligated in any way by reason of such
assignment or exercising the rights so assigned.

    A liquidator or administrator, or any receiver or other person or entity
entitled to enforce any security or rights under this Agreement may enter into
any other assignment or transfer of any such rights, provided that such
assignment shall not in any way operate so as to increase the liability of UCB
or INYX.

     

    Except as permitted by this Clause 22.1 none of the rights or obligations
under this Agreement shall be assigned or transferred by either party without
the prior written consent of the other.

     

 
22.2
Nothing in this Agreement shall create, or be deemed to create, a partnership
between the parties.

     

 
22.3
This Agreement, the GMP Agreement and the Service Agreement and other Schedules
contain the entire agreement between the parties with respect to its subject
matter, supersedes all previous agreements and understandings between the
parties, and may not be modified except by an instrument in writing signed by
the duly authorised representatives of the parties.

     

 
22.4
Each party acknowledges that, in entering into this Agreement, it does not do so
on the basis of or in reliance on any representation, warranty or other
provision except as expressly provided in this Agreement, and accordingly all
conditions, warranties or other terms implied by statute or common law are
hereby excluded to the fullest extent permitted by law.

     

 
22.5
If any provision of this Agreement is agreed by the parties to be or is held by
any court or other competent authority to be void or unenforceable in whole or
part, the other provisions of this Agreement and the remainder of the affected
provisions shall continue to be valid save that such illegal void or
unenforceable provision or part thereof shall be deemed to be excised herefrom.

     

 
22.6
This Agreement shall be governed by and construed in all respects in accordance
with the laws of England, and the parties hereby submit to the exclusive
jurisdiction of the English courts.

   

23.
PARENT GUARANTEE

     

 
23.1
The Parent Guarantor, as primary obligor, unconditionally and irrevocably
guarantees, by way of continuing guarantee to UCB, the payment and performance
by INYX, when due, of all amounts and obligations under this Agreement. This
guarantee shall remain in full force and effect until all such amounts and
obligations have been irrevocably paid and discharged in full.

     

 
 
CONFIDENTIAL TREATMENT
16

--------------------------------------------------------------------------------

 

 
23.2
The Parent Guarantor’s obligations under this clause:

     

     

 
23.3
constitute direct, primary and unconditional obligations to pay on demand by UCB
any sum which INYX is liable to pay under this Agreement and to perform on
demand any obligation of INYX under this Agreement without requiring UCB first
to take any steps against INYX or any other person; and

     

 
23.4
shall not be affected by any matter or thing which but for this provision might
operate to affect or prejudice those obligations, including:

     

 
(a)
any time or indulgence granted to, or composition with, INYX or any other
person; or

     

 
(b)
any amendment of this Agreement; or

     

 
(c)
the taking, variation, renewal or release of, or refusal or neglect to perfect
or enforce, any right, remedy or security against INYX or any other person; or

     

 
(d)
any legal limitation, disability or other circumstance relating to INYX or any
unenforceability or invalidity of any obligation of INYX under this Agreement.

 
24.
COUNTERPARTS

 
This Agreement may be executed in two or more counterparts, each of which shall
be deemed to be an original, but all of which together shall constitute one and
the same instrument.

IN WITNESS whereof this Agreement has been executed by the duly authorised
representatives of the parties the day and year first above written

CONFIDENTIAL TREATMENT
17

--------------------------------------------------------------------------------

For and on behalf of
UCB PHARMA LTD

Signed : 
PETER NICHOLLS
H S BAINS
     
Name :
PETER NICHOLLS
H S BAINS
     
Title :
DIRECTOR
DIRECTOR

For and on behalf of
CELLTECH MANUFACTURING SERVICES LIMITED

Signed :
PETER NICHOLLS
MARK GLYN HARDY
     
Name :
PETER NICHOLLS
MARK GLYN HARDY
     
Title :
DIRECTOR
DIRECTOR

For and on behalf of
INYX, INC

Signed : 
JACK KACHKAR
       
Name :
JACK KACHKAR
       
Title :
CHAIRMAN AND CEO
 

 
CONFIDENTIAL TREATMENT
18

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SCHEDULE 1

GMP-AGREEMENT FOR PHARMACEUTICAL PRODUCTS

ON CONTRACT MANUFACTURE

BETWEEN  UCB Pharma Ltd (“UCB”)

AND  Ashton Pharmaceuticals Limited (“CONTRACT ACCEPTOR”), with registered
offices at Ashton

WHEREAS the parties wish to set out the respective duties of UCB and CONTRACT
ACCEPTOR with respect to Good Manufacturing Practices (GMP);

WHEREAS on ______date____________ the Parties have entered into a Contract
Manufacturing Agreement for the PRODUCTS (the “FRAME AGREEMENT”);

NOW THEREFORE THE PARTIES HAVE AGREED AS FOLLOWS:

1. Scope of this Agreement

This GMP-AGREEMENT contains the respective obligations of UCB and CONTRACT
ACCEPTOR with respect to GMP to be respected for the manufacture of the PRODUCTS
as set out herein. The GMP requirements for the manufacture, storage and
quality, as well as the duties and responsibilities of UCB and CONTRACT ACCEPTOR
relating to the manufacture of the PRODUCT are defined in detail in the ECcGMP’s
guidelines (Guide to Good Manufacturing Practice for Medicinal PRODUCT in the
European Community, volume IV). These Guidelines (including all defined terms)
are an integral part of this Agreement.

This GMP-AGREEMENT relates to the manufacture of the following PRODUCT(s),
further described in Exhibit 1 to this GMP-AGREEMENT and hereinafter referred to
as “PRODUCT(S)”:
 
PRODUCT(S)
GALENICAL FORM
DOSAGE
 
Refer to exhibit 1
 

 
Contacts for this GMP-AGREEMENT until further notification:

At UCB:
D Killick (Quality Assurance Manager - Qualified Person)
At CONTRACT ACCEPTOR :
E. Prady (Head of Quality - Qualified Person)

 
2. RESPONSIBILITIES

Under the terms and conditions hereinafter set out, UCB appoints CONTRACT
ACCEPTOR to perform and conduct with respect to the PRODUCT(S) all the
operations which are marked with “X” in the column titled CONTRACT ACCEPTOR in
the matrix of responsibilities herebelow.
 
CONFIDENTIAL TREATMENT
19

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During the term of this GMP-AGREEMENT, CONTRACT ACCEPTOR undertakes that it
shall manufacture and/or pack and/or control the quality of the PRODUCT(S) and
conduct CONTRACT ACCEPTOR’s operations in strict compliance with:
 

i)   the current Good Manufacturing Practices; and       ii)   the formula,
technical specifications, manufacturing processes and quality control and
release procedures described in the relevant exhibits attached.

 
N/A shall mean: “not applicable”.

A.
General
       
UCB
CONTRACT ACCEPTOR
 
Valid manufacturing licence available
 
X
.
Formulation / data sheet
X
 
 
Manufacturing procedures / batch sheets
 
X
 
Registered formula, process, etc.
X
 
 
Scale-up procedures
 
X
 
Validation master plan
 
X
 
Validation protocol
 
X
 
Validation report
 
X
 
Validation procedures
 
X
 
Analytical specifications and methods and IPC (In process control)
X
   
Validation of analysis methods
 
X
 
Specific procedures relating to product incl. safety, occupational health,
security, storage and transport conditions
 
X
 
Labelling instructions
 
X
 
Cleaning procedures
 
X
 
Validation of cleaning procedures prior to production
 
X
 
Validation of cleaning procedures after production
 
X
 
Stability testing
 
X
 
Stability protocol
 
X
 
Stability test methods
 
X
 
Stability report
 
X
       
B.
Bulk Manufacture
       
UCB
CONTRACT ACCEPTOR
B.1
Raw Materials
     
Purchase of excipients or raw materials.
 
X
 
Supplier evaluation
 
X
 
Analysis
 
X
 
Release
 
X
 
Storage of reference samples
 
X
 
Procurement / order free of charge of active substance
NA
NA
 
Analysis
NA
NA
 
Release
NA
NA
 
Identity control of active substance
 
X
 
Storage of reference sample
 
X
B.2
Manufacture
     
Validation of scale-up/manufacturing process
 
X
 
Master of Manufacturing formula
 
X
 
Master of Processing instructions
 
X
 
Manufacture following agreed procedure
 
X
 
Allocation of batch numbers for bulk
 
X
   
UCB
CONTRACT ACCEPTOR

 
 
CONFIDENTIAL TREATMENT
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B.3
Analysis and controls
     
Perform in process - controls
 
X
 
Validate the methods of analysis for new products
 
X
 
Purchase of necessary reference standards
 
X
 
Analysis
 
X
 
Release for packaging
 
X
 
Storage of reference sample
 
X
 
Certificate of Conformance
 
X
       
C.
Primary Packaging / Semi-finished Product
       
UCB
CONTRACT ACCEPTOR
C.1
Packaging Components
     
Specifications for unprinted primary packaging materials (unprinted PPM)
X
   
Supplier evaluation
 
X
 
Procurement of unprinted PPM
 
X
 
Methods of testing unprinted PPM
 
X
 
Specifications for printed primary packaging materials
X
   
Specifications for text/Artwork
X
   
Supplier evaluation
 
X
 
Procurement of printed PPM
 
X
 
Methods of testing printed PPM
 
X
 
Testing
 
X
 
Release
 
X
 
Allocation of batch numbers for PPM
 
X
 
Storage of reference samples
 
X
       
C.2
Primary packaging
     
Allocation of batch numbers
 
X
 
Allocation of expiry dates
 
X
 
Code to be used
 
X
 
Master of packaging instructions
 
X
 
Control of the semi-finished product (S.F.P.)
 
X
 
Release of the S.F.P. for Final Packaging
 
X
 
Storage of reference samples for the S.F.P.
 
X
 
Performing stability studies in final packages
 
X
       
D.
Secondary Packaging / Finished Product
   
UCB
CONTRACT ACCEPTOR
D.1
Secondary Packaging Components
     
Specifications for printed secondary packaging materials (text) (printed
SPM)/artwork
X
  
 
Specifications for printed SPM (physical)
 
X
 
Methods of testing printed SPM
 
X
 
Supplier evaluation
 
X
 
Procurement of printed SPM
 
X
 
Control
 
X
 
Release for use
 
X
 
Allocation of batch numbers for printed SPM
 
X
 
Storage of reference samples
 
X

 
 
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D.2
Secondary Packaging
   
D.2.1
Allocation of batch numbers
 
X
D.2.2
Allocation of expiry dates
 
X
D.2.3
Code to be used
 
X
D.2.4
Master of packaging instructions
 
X
D.2.5
Paletisation instructions
X
 
D.2.6
Master of shipping label
 
X
D.2.7
Test of the finished product
 
X
D.2.8
Issue certificate of quality
 
X
D.2.9
QP Certification of the finished product....
 
X
D.2.10
Release of the finished product for sale/distribution to market
X
 
D.2.11
Storage of reference/ retention samples for the finished product
 
X

 
3.
PERFORMANCE INSTRUCTIONS

UCB shall supply the formulation, procedures and analytical specifications;
these are binding on CONTRACT ACCEPTOR. Changes may be made only with the
written consent of UCB following due change control procedures at either end.
Deviations from the process or the control procedure must be brought to the
attention of UCB and the release for shipment of the relevant batch requires the
written consent of UCB.

4.
MATERIALS

The active substances and excipients have to fulfil the requirements of UCB
(specifications, methods of testing, authorised supplier). Any deviation from
the specifications or requirements must have the prior written approval of UCB.
Any reference standard for testing must be accompanied by a CoA listing storage
requirements, expiration date and any correction factor that needs to be
applied.

CONTRACT ACCEPTOR shall be responsible that all its deliveries of such material
are clearly and visibly labelled with all necessary markings. This applies in
particular to the PRODUCT names, which have to be identical with the information
laid down in specifications, manufacturing and packaging instructions, storage
instructions, remarks on quarantine and warning indications.

Goods supplied to the Buyer by the Seller will not contain materials of animal
origin and no animal derived reagents will be used in their manufacture.
Provided that in the event Goods are supplied to the Buyer which do not comply
with above, then the Seller will confirm, by production of a relevant
certificate, that the Goods comply with the European Pharmacopoeia General
Chapter 5.2.8 “Minimising the risk of transmitting animal spongiform
encephalopathy agents via medical products”.

5.
ANALYSIS AND TESTS

CONTRACT ACCEPTOR has to perform the analysis and tests according to the
specifications and methods defined by UCB.
A batch specific analytical report or certificate of conformance containing the
recorded results of the analysis is to be provided for every single delivery of
the end PRODUCT. The certificate lay-out and content must conform with the
requirements of UCB.

Label Component specifications: CONTRACT ACCEPTOR will only use labels and
labelling approved in writing by UCB.

 
CONFIDENTIAL TREATMENT
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6.
DOCUMENTATION

Masters
Master Batch Records shall mean the documents used by CONTRACT ACCEPTOR as
technical instructions and records to manufacture, pack and test the PRODUCTS.
Those documents will be based on information provided by UCB. CONTRACT ACCEPTOR
is authorised to transcribe those documents into its own format, provided they
will be approved in writing by UCB prior to use.

Manufacture and expiry dates
The date of manufacture is the first day of compounding the PRODUCT. UCB
provides the rules to allow CONTRACT ACCEPTOR to calculate the expiration date
for the batches to be manufactured.

Manufacturing and equipment data
CONTRACT ACCEPTOR is responsible for the safe keeping and retention of records
of machine usage (previous PRODUCT manufactured in non-dedicated machinery),
cleaning, maintenance, calibration, raw material batch numbers and
certification, IPC results and parameters, test results in accordance with all
applicable laws, rules, regulations and guidelines.

Retention
CONTRACT ACCEPTOR will retain, at minimum, batch production records, quality
control records, validation data and other documentation including investigation
reports for at least one (1) year 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 CONTRACT ACCEPTOR in such a manner
that they are readily retrievable and stored in an environment suitable to
prevent damage or loss. CONTRACT ACCEPTOR shall provide copies of all such
documents and information to UCB or its designee, as reasonably requested,
within five (5 ) Business Days.

7.
DEVIATIONS AND INVESTIGATIONS

A deviation is defined as any abnormal event that may occur during the
processing of a batch, or is a departure from Specifications, approved Master
Batch Record or Method of testing.

Any deviation that occurs must be documented in the batch record. The
significant deviations will be forwarded to UCB in conjunction with the
Certificate of Conformity / Analysis).

Excepted as provided in sections “Complaints” and “Stability”, CONTRACT ACCEPTOR
must notify UCB within five (5) Business Days of the occurrence of a confirmed
out-of specification (“OOS”) result or major process deviation (deviations
potentially effecting product quality, safety, identity, purity or efficacy)
relating to the PRODUCT. A confirmed OOS result is defined as a result from a
raw material, in-process, or finished product testing which does not meet
specifications.
All Quality decisions regarding any such out-of-specification result or major
process deviation involving the PRODUCT shall be made by CONTRACT ACCEPTOR in
consultation with UCB. In all cases, UCB will have the final review and decision
making responsibility as to the impact of the deviation(s) on the PRODUCT; this
includes the disposition of the affected batch. Reworking or reprocessing
protocols require UCB approval prior to execution. All investigations must be
completed, documented and approved by CONTRACT ACCEPTOR prior to issuance of a
Certificate of Compliance or a Certificate of Conformance. A copy of the
completed investigation must be provided to UCB prior to PRODUCT release by
CONTRACT ACCEPTOR.

CONTRACT ACCEPTOR will notify UCB in writing of any batch of PRODUCT rejected by
CONTRACT ACCEPTOR.

CONTRACT ACCEPTOR will notify UCB in writing of any problems that may impact or
invalidate a batch previously shipped to UCB or its Affiliates or Agents.

Some deviations or investigations may require additional testing, stability or
validation be conducted. This work will be performed as agreed by both parties.
 
 
CONFIDENTIAL TREATMENT
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8.
RELEASE

CONTRACT ACCEPTOR shall ensure and certify that the PRODUCT has been made
according to cGMP’s, specifications and methods documented in the Master Batch
Record. This includes a complete and thorough review of the executed batch
record. The certificate issued by CONTRACT ACCEPTOR will show the batch numbers
and quantities in each shipment.

The final market release will be undertaken by UCB based on his internal
procedures and the data and documentation provided by CONTRACT ACCEPTOR. UCB or
its affiliates may perform confirmatory testing to validate any CONTRACT
ACCEPTOR’s data.

9.
REFERENCE SAMPLES AND RETENTION SAMPLES

CONTRACT ACCEPTOR will retain samples of Raw Materials (except water, compressed
gasses and highly volatile compounds) and Active ingredients for at least one
year beyond the expiration of the PRODUCT in which used and will retain samples
of the PRODUCT for at least one year beyond its expiration. The amount retained
shall be three times the quantity required to carry out all of the testing
required to meet the specifications.
CONTRACT ACCEPTOR shall keep those samples at the disposal of UCB and the
competent authorities pertaining to the manufacture and analysis of the PRODUCT
and shall not dispose thereof unless so authorised in writing by UCB

10.
STABILITY TESTING

 
Processing of the stability data is the responsibility of CONTRACT ACCEPTOR.
CONTRACT ACCEPTOR is obliged to provide UCB with the results of the tests
available. So far as test methods are not available from UCB, CONTRACT ACCEPTOR
has to provide the validated methods of analysis to be used. Microbiological
tests have to be carried out in addition to the chemical stability which UCB
shall specify.

Routine stability

CONTRACT ACCEPTOR is responsible for maintaining a routine stability programme
for the PRODUCT and to provide UCB with a stability report at least once a year.
The stability protocol will be agreed to in writing by UCB. At a minimum, one
lot of each strength and in each package type (smallest to largest) of PRODUCT
will be placed on stability each year for products on the market. Any change to
the stability programme/protocol must be approved by UCB.

Development and validation batches stability

CONTRACT ACCEPTOR is responsible for performing any stability required to
support the PRODUCT. The stability protocol will be agreed to in writing by UCB.
Any change to the stability protocol must be approved by UCB. Results will be
reported within 14 calendar days following the scheduled pull date.

Testing intervals
For finished packaged product stability, if the product remains unpackaged
(i.e., bulk storage) for more than 30 days, the time zero data (data generated
at the start of the stability study) must be generated by new analysis rather
than extracted from release testing results.

For stability samples requiring testing at the three months or longer intervals
(including at the expiry test station/label expiry date) the tests 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.

 
CONFIDENTIAL TREATMENT
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Stability failures

CONTRACT ACCEPTOR must report any confirmed problem or out-of-specification
results relating to the PRODUCT lot to UCB within five (5) Business Day of the
occurrence. CONTRACT ACCEPTOR must use its best efforts to complete and document
an investigation with regard to any such out-of-specification result within 20
Business Days of the initial out-of-specification result. If the investigation
will exceed 20 Business Days, CONTRACT ACCEPTOR must provide UCB with an interim
report, including the test investigation. A copy of the final investigation
report must be forwarded to UCB within five (5) Business Days of completion of
the investigation. CONTRACT ACCEPTOR must provide UCB with information regarding
any investigation requested by UCB as agreed upon by both parties.

UCB and CONTRACT ACCEPTOR must investigate any significant trends (those which
indicate future testing may yield OOS results) regarding the PRODUCT in an
effort to determine the cause of the trend. Any such trends identified by
CONTRACT ACCEPTOR must be reported to UCB within five (5) Business Days of
identification of the trend. CONTRACT ACCEPTOR must provide UCB with a report
discussing the facts and CONTRACT ACCEPTOR’s conclusions within five (5)
Business Days of completion of the investigation. Any such trends identified by
UCB will be reported to CONTRACT ACCEPTOR within five (5) Business Days of
identification of the trend. CONTRACT ACCEPTOR must use its best efforts to
assist UCB in completion of an investigation discussing the facts and
conclusions.

11.
VALIDATION/QUALIFICATION

 
Both parties agree to the following Validation/Qualification Policy.

UCB representatives shall have the right to attend the manufacture of validation
and launch batches.

Equipment and facilities/utilities qualification/validation shall be performed
for process, packaging, analytical methods, cleaning, and computerised systems.
Process Validation shall consist of prospective performance on at least three
consecutive production batches and must be conducted with commercial
production/analytical processes and equipment.

Manufacturer will not use any validation protocol or issue a report unless UCB
have first approved such validation protocol or report. UCB will approve or
reject all protocols and validation reports within fifteen (15) Business Days of
receipt.

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

The cleaning procedure and analytical methodology will be reviewed by both
parties before the first Product Batches are manufactured.

Revalidation shall be performed for significant changes to existing
manufacturing processes, packaging, analysis, etc. (as determined by UCB). UCB
shall have the right to required 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. CONTRACT ACCEPTOR will notify UCB
of any planned changes to a validated process or associated procedures
sufficiently in advance to allow UCB 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 UCB. The number of batches required for
revalidation will be determined by UCB and CONTRACT ACCEPTOR based on the
significance of the change.
 

 
CONFIDENTIAL TREATMENT
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12.
DISPUTE RESOLUTION

 
In the event that a dispute arises between CONTRACT ACCEPTOR and UCB in the
analysis of the PRODUCTs, the resolution will proceed in stages. The first stage
requires direct communication between analysts from both parties to determine
that the methods of analysis are the same and are being executed in the same
manner at both sites. Second, carefully controlled, split samples should be sent
from one site to the other for analysis in an attempt to reach agreement. Should
there be a failure to achieve resolution, analysts from both parties will be
required to communicate to work through the analysis of a mutually agreeable
sample. If these actions fail to achieve resolution, and only after these
avenues have been exhausted, a qualified referee laboratory will be used to
achieve resolution. This laboratory must be agreeable to both parties prior to
use. The results from this referee laboratory will be used to determine
resolution, but whatever the outcome, UCB retains the right to determine PRODUCT
release status. The payment for engaging the referee laboratory shall be
negotiated between the parties.

13.
AUDITS AND INSPECTIONS

 
CONTRACT ACCEPTOR shall permit duly authorised representatives of UCB upon
reasonable notice during normal working hours to inspect the premises, the
machinery and all activities related to the manufacture of the PRODUCT to ensure
that the GMP rules are observed and during such inspections UCB shall be
permitted to inspect all documents relating to the PRODUCT.

CONTRACT ACCEPTOR shall allow inspections (if any) from the competent
authorities in accordance with Directive 2001/83/ECC and/or in accordance with
local regulations.

CONTRACT ACCEPTOR will notify UCB and vice-versa without delay of any planned
inspection which impacts the PRODUCT.

CONTRACT ACCEPTOR shall promptly provide UCB with copies of all correspondence
between CONTRACT ACCEPTOR and any regulatory authorities regarding the
MANUFACTURING of the PRODUCT.

CONTRACT ACCEPTOR shall inform UCB of any relevant information following any
inspection that could impact on the future supply of the PRODUCT.

UCB and CONTRACT ACCEPTOR may accept audits of vendors for any material involved
in the manufacture of the PRODUCT from the other party. The party that performed
the audit is responsible for providing an audit status statement and all
appropriate documentation to the other party upon request. Alternatively, UCB
may determine it necessary to audit a specific vendor. In this case, UCB will
coordinate and schedule the audit with CONTRACT ACCEPTOR.

14.
REGULATORY CONTACTS

 
UCB shall be solely responsible for all contacts and communications with any
regulatory agency with respect to all matters relating to the PRODUCT.

Unless required by law or a regulatory agency, CONTRACT ACCEPTOR shall have no
contacts or communication with any regulatory agency regarding the PRODUCT
without the consent of UCB which consent shall not be unreasonably withheld or
delayed. CONTRACT ACCEPTOR shall notify UCB promptly, and in no event later than
one Business Day, after CONTRACT ACCEPTOR receives any contact or communication
from any regulatory agency regarding the PRODUCT.

CONTRACT ACCEPTOR shall provide UCB with copies of all communications received
from or sent to any regulatory agency, with respect to the PRODUCT within one
(1)Business Day after receipt or sending of the communication, as the case may
be.
 
 
CONFIDENTIAL TREATMENT
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CONTRACT ACCEPTOR shall inform UCB of any inquiry from a regulatory agency
specifically relating to PRODUCT and shall allow the UCB representative at its
discretion to participate in any further contacts or communications relating to
the PRODUCT if reasonably practicable. CONTRACT ACCEPTOR will secure agreement
from UCB, which shall not be unreasonably withheld or delayed, prior to making a
commitment to a regulatory agency regarding the PRODUCT. CONTRACT ACCEPTOR shall
comply with all reasonable requests and comments by UCB with respect to all
contacts and communications with a regulatory agency relating to the PRODUCT.

15.
COMPLAINTS AND ADVERSE EVENTS HANDLING

 
Complaints brought to the attention of UCB have to be directly and without delay
passed on to CONTRACT ACCEPTOR and vice versa.

CONTRACT ACCEPTOR shall investigate and document Product complaints forwarded to
CONTRACT ACCEPTOR by UCB. CONTRACT ACCEPTOR shall comply with UCB requests in
connection with the investigation of any Product complaint, as agreed upon by
both parties. CONTRACT ACCEPTOR must provide UCB with information regarding any
Product complaint investigation requested by UCB, as agreed upon by both
parties.

CONTRACT ACCEPTOR shall complete and document the product complaint
investigation within 30 Business Days after initial receipt of the complaint by
CONTRACT ACCEPTOR, unless otherwise agreed by UCB. If the investigation will
exceed 30 Business Days, CONTRACT ACCEPTOR must provide UCB with an interim
report, including test results to date and a target completion date, on or
before the 30th Business Day of the investigation. CONTRACT ACCEPTOR must
complete the complaint investigation within 60 Business Days after initial
receipt of the complaint by CONTRACT ACCEPTOR. CONTRACT ACCEPTOR must forward a
copy of the final investigation report to UCB within five (5) Business Days
after the completion of the investigation. UCB 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).

CONTRACT ACCEPTOR shall notify UCB of an out-of-specification result pertaining
to a complaint sample within two (2) Business Day of the occurrence of the
out-of-specification result. Any out-of-specification results relating to the
product complaint sample must be investigated as described in section
“Stability”.

CONTRACT ACCEPTOR shall retain unused Product complaint samples conditions for a
minimum of 90 calendar days after a copy of the complaint investigation report
has been sent to UCB.

16.
RECALLS

 
UCB shall have sole responsibility for initiating and managing any recall of the
PRODUCT. UCB shall notify CONTRACT ACCEPTOR prior to initiating any recall of
the PRODUCT.

Upon receiving, from any governmental or regulatory authority having
jurisdiction, any direction to recall any of the PRODUCT from the market, the
receiving party shall immediately notify the other party.

17.
CONTROL DOCUMENTS AND CHANGE CONTROL IMPLEMENTATION

Any change(s) made to the Specifications, Master Production and Control records
or other established control documents including but not limited to the
manufacturing process and/or analytical methods which may affect the quality or
performance of the PRODUCT or exceed validation parameters or regulatory filings
must be approved by UCB 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
licence or as required by applicable laws, rules, regulations, or regulatory
agencies.
 
 
CONFIDENTIAL TREATMENT
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Both parties shall obtain all regulatory approvals prior to implementation.

Change control documentation initiated by CONTRACT ACCEPTOR will be forwarded to
UCB. UCB will process the change via UCB change management procedure and provide
notification of approval/rejection to CONTRACT ACCEPTOR within 10 Business Days.
If more than 10 days elapse, UCB will notify CONTRACT ACCEPTOR and a revised
completion date will be agreed upon.

Change control documentation initiated by UCB will be forwarded to CONTRACT
ACCEPTOR for their evaluation. If CONTRACT ACCEPTOR agrees with proposed change,
UCB will approve proposed change and provide CONTRACT ACCEPTOR with UCB
approval. CONTRACT ACCEPTOR will then process and approve the change through
CONTRACT ACCEPTOR’s change control system within 10 Business Days. If more than
10 days elapse, CONTRACT ACCEPTOR will notify UCB and a revised completion date
will be agreed upon.

18.
ANNUAL PRODUCT REVIEWS

 
CONTRACT ACCEPTOR shall prepare an Annual Product Review (“APR”) for the PRODUCT
covering the activities executed during the review period.

This report will be a review of any changes in the manufacturing, packaging,
testing, or validation of the product in the previous year; a summary of lots
made, released, and rejected; a stability report. Also, control charting or
trend analysis of key product parameters will be performed on an annual basis.
Any abnormalities will be explained in the annual review.

A copy must be forwarded to UCB within 10 Business Days after completion of the
APR.

The APR shall be completed within 30 days of its due date, established by a
schedule mutually agreed upon by both parties.

19.
QUALITY

CONTRACT ACCEPTOR shall refrain from any activity which could adversely affect
the quality of the PRODUCT.

Should CONTRACT ACCEPTOR become aware of any issue that could affect the
quality, safety identity, purity or efficacy of any UCB product produced at his
plant, he will notify UCB in writing within two (2) Business Days of the
discovery.

20.
TRANSFER OF TASKS TO THIRD PARTIES OR TO ANOTHER SITE

 
CONTRACT ACCEPTOR shall not transfer or subcontract any of the manufacturing,
packaging, storing, testing (in-process, release, stability) of the PRODUCT to
other sites or third parties without the prior written agreement of UCB, with
the exception of the list of subcontractors listed in annexe.
Validation testing may be conducted by a Third Party contractor chosen by
Manufacturer.

21.
GENERAL TERMS AND CONDITIONS

 
Materials Check
Unused materials received from UCB:

 
q
are and remain property of UCB,

 
q
mode of disposal :
 
to be returned to UCB or
 
to be destroyed by CONTRACT ACCEPTOR.

 
 
CONFIDENTIAL TREATMENT
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Upon expiration or termination of this Agreement for any reason whatsoever,
CONTRACT ACCEPTOR shall return to UCB all documentation handed over to him;
 
batch documents, samples, etc. shall be kept:
 

 
q
at UCB;

 
q
at CONTRACT ACCEPTOR
for a period of (see point 3 - Retention).

 

Changes to this GMP-AGREEMENT

Any additions, changes or cancellations of parts of this GMP-AGREEMENT are to be
made in written form such modifications will involve version control of the
document. Modifications shall be conducted through the designated Quality
Assurance representatives of both companies.

Duration

Unless provided otherwise in a FRAME AGREEMENT (if any) between the Parties
dated ________, this GMP-AGREEMENT is valid for an undetermined period of time.
Termination terms are as stipulated in the FRAME AGREEMENT. This GMP-AGREEMENT
shall automatically come to an end simultaneously with the FRAME AGREEMENT. Any
section of this agreement which has a predefinite retention, survival or
maintenance period (for example raw date storage, product complaints, sample
retention) shall survive the termination of this Agreement for the period
defined in the appropriate section.

Storage

CONTRACT ACCEPTOR shall store the active substances, auxiliary and packaging
materials as well as the (finished) product in suitable, if necessary, air
conditioned rooms under sufficient control so as to prevent their deterioration
and theft.

Confidentiality

Both parties will treat as confidential all data supplied by the other in
connexion with the Manufacture/Control of the PRODUCT.

Security

CONTRACT ACCEPTOR has and will maintain controlled access to his premises.

22.
VALIDATION/QUALIFICATION

 

22. DOCUMENTS TO BE SUPPLIED TO UCB

CONTRACT ACCEPTOR shall supply the following documents to UCB and shall keep the
validity of the documents under 22.1 and 22.2 in force throughout the duration
of the GMP-AGREEMENT:  
 

      On request   Always 
22.1
 
Copy of latest manufacturing licence from the relevant governmental or other
competent authorities
[ ]
[X]
22.2
 
Copy of site master file (at contract signature, and at every renewal)
[X]
[ ]

 
 
CONFIDENTIAL TREATMENT
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22.3
 
Recipe (complete formula) CONTRACT ACCEPTOR applies (once, before starting and
at every new version)
[X]
[ ]
22.4
 
Copy of the manufacturing instructions (batch sheets) including the in-process
controls in place (once, before starting)
[X]
[ ]
22.5 
 
(at every new version)
[ ]
[x]
22.6 
 
Data on the validated method of analysis used including the specifications
       
- Active ingredients
[X]
[ ]
   
- The excipients
[X]
[ ]
   
- The primary packaging material
[X]
[ ]
   
- The finished PRODUCT (finished pack)
[X]
[ ]
22.7
 
Results of the stability data when applicable
 
 
 
[X]
22.8
 
With every batch of the end PRODUCT(s), CONTRACT ACCEPTOR shall address
       
- Batch-specific analytical report
[X]
[ ]
   
- Batch-specific certificate of conformance
To the Quality Assurance Department of UCB
[ ]
[X]
22.9
 
Certification by a qualified person of the Quality Assurance Department of
performance of a review of the batch documentation including the IPC and
monitoring data and of the completeness and conformity of the results.
[ ]
[X]
   
CONTRACT ACCEPTOR immediately inform UCB in the event of significant deviations
observed during production, quality control and/or batch record review.
[ ]
[X]

 
 
CONFIDENTIAL TREATMENT
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22.10
 
Result of analysis (measured results) for the following items used for the
batches concerned
       
- Active ingredients
[X]
[ ]
   
- Excipients
[X]
[ ]
   
_ Primary packing materials
[X]
[ ]

 
Done in two copies, each party having received its copy.
 

CONTRACT ACCEPTOR
 
UCB
     
/s/ Jack Kachkar
 
/s/ H.S. Bains
Name: Dr. Jack Kachkar
 
Name: Harb Bains   
Title: Director
 
Title: Director

 

 
/s/ Jack Kachkar
 
/s/ Marc Glyn Hardy
Name: Jack Kachkar
 
Name: Marc Glyn Hardy
Title: Chairman and CEO
 
Title: Director
           
Place:
 
Place:
Date:
 
Date:

CONFIDENTIAL TREATMENT
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LIST OF EXHIBITS TO THE GMP-AGREEMENT BETWEEN UCB AND CONTRACT ACCEPTOR
 

Exhibit 1:
The PRODUCT.

 

 
Product formulation

 
Product specification

 
(Master) manufacturing instructions/Bill of Materials or equivalent

 
QC method of analysis (including stability methods if any)

 
Storage conditions

 
Shelf life - bulk - finished product

 
Primary container

 
Shipping conditions

   

Exhibit 2:
The RAW MATERIALS supplied by UCB including starting materials reagents,
solvents, process aids and primary packaging.

 

 
List

 
Specifications

 
Methods of analysis

 
Storage conditions

 
Shelf life

 
Approved/authorized/certified suppliers/manufacturers

 
Scientific data necessary for cleaning validation (LD50, toxicity, solubility,
product dose per patient)

 
Toxicity data (material safety data sheet)

 
Exhibit 3:
The RAW MATERIALS supplied by CONTRACT ACCEPTOR

 

 
List

 
Specifications

 
Methods of analysis

 
TSE/solvent information

 
Approved/authorised/certified suppliers/manufacturers

 
Exhibit 4:
PACKAGING MATERIALS

 
Exhibit 5:
REWORKING

 
Exhibit 6:
ADMINISTRATIVE INFORMATION

 
Contract prepared by:
 
Primary contact people
UCB
David Killick
Quality Assurance Manager
UCB
Unit 11-14 Foster Avenue
Woodside Park
Dunstable
Bedfordshire
LU5 5TA
Tel: +44 (0) 1582 813120
Fax: +44 (0) 1582 813151
e-mail: david.killick@celltechgroup.com
after 16/05/05 : e-mail: david.killick@ucb-group.com
 
CONFIDENTIAL TREATMENT
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It is the responsibility of both parties to keep this contact list up to date.
 
The exhibits may be updated independently from the core agreement. The revised
versions shall become part of this Agreement when they have been agreed in
accordance with Article 22.3 of the Agreement.
 
UCB will be responsible for the maintenance of exhibits and for ensuring that
the information is in compliance with the Marketing Authorisations.
 
UCB will provide specific information and will advise CONTRACT ACCEPTOR of any
changes through formalised change control procedures.

CONFIDENTIAL TREATMENT
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EXHIBIT 1: FINISHED PRODUCT SPECIFICATIONS.
***

CONFIDENTIAL TREATMENT

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SCHEDULE 2
Product Details and Prices

***
 
 
CONFIDENTIAL TREATMENT

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