Exhibit
10.27


 


Certain  portions of this
Exhibit have been omitted pursuant to a request for confidentiality. Such
omitted 


portions, which are marked with brackets
[     ] and an asterisk*, have been separately filed
with the 


Commission


 


AGREEMENT


 


 


between


 


 


LONZA BIOLOGICS PLC


 


 


and


 


 


ACORDA THERAPEUTICS


 

















 


THIS AGREEMENT is made the 29th day of
April 2003


 


BETWEEN


 


1.                                       LONZA BIOLOGICS PLC, the registered office of
which is at 228 Bath Road, Slough, Berkshire SL1 4DY, England (“LB”); and


 


2.                                       ACORDA THERAPEUTICS, 15 Skyline Drive, Hawthorne,
New York 10532, United States (“Customer”).


 


WHEREAS


 


A.                                   Customer is the proprietor of the recombinant
human glial growth factor (rhGGF2), and


 


B.                                     LB has the expertise in the evaluation and
production of recombinant proteins for therapeutic use using such Cell Lines,
and


 


C.                                     Customer wishes to contract LB for Services
relating to the Cell Line as described in the Agreement, and


 


D.                                    LB is prepared to perform such Services for
Customer on the terms and conditions set out herein.


 


NOW THEREFORE it is agreed as follows:


 


1.                                       In this Agreement, its recitals and the Schedules
hereto, the words and phrases defined in Schedule 4 hereto and in the Standard
Terms for Contract Services set out in Schedule 5 hereto shall have the meanings
set out therein.


 


2.                                       Subject to the Standard Terms for Contract
Services set out in Schedule 5 and any Special Terms, LB agrees to perform the
Services and the Customer agrees to pay the Price together with any additional
costs and expenses that fall due hereunder.


 


3                                          3.1                                 Any notice or other communication to be given
under this Agreement shall be delivered personally or sent by facsimile
transmission, or if facsimile transmission is not available, by first class
pre-paid post addressed as follows:


 


	
  3.1.1

  	
  If to LB to:

  	
  Lonza Biologics plc

  	
   

  	
   

  
	
   

  	
   

  	
  228 Bath Road

  	
   

  	
   

  
	
   

  	
   

  	
  Slough

  	
   

  	
   

  
	
   

  	
   

  	
  Berkshire SL1 4DY

  	
   

  	
   

  
	
   

  	
   

  	
  England

  	
   

  	
   

  
	
   

  	
   

  	
  Facsimile: 01753 777001

  	
   

  	
   

  
	
   

  	
  For the attention of:

  	
  The Head of Legal Services

  	
   

  	
   

  



 


2

















 


	
  3.1.2

  	
  If to the
  Customer to:

  	
  Acorda
  Therapeutics

  	
   

  	
   

  
	
   

  	
   

  	
  15 Skyline Drive

  	
   

  	
   

  
	
   

  	
   

  	
  Hawthorne

  	
   

  	
   

  
	
   

  	
   

  	
  New York 10532

  	
   

  	
   

  
	
   

  	
   

  	
  United States

  	
   

  	
   

  
	
   

  	
   

  	
  Facsimile: +01
  914 347 4560

  	
   

  	
   

  
	
   

  	
  For the
  attention of:

  	
  Eric W. T.
  Chojnicki

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  or to such other
  destination as either party hereto may hereafter notify to the other in
  accordance with the provisions of this Clause 3.

  



 


3.2                                 All such notices or other communications shall be
deemed to have been served as follows:


 


3.2.1                        if
delivered personally, at the time of such delivery;


 


3.2.2                        if sent by
facsimile, upon receipt of the transmission confirmation slip showing
completion of the transmission;


 


3.2.3                        if sent by
first class pre-paid post, ten (10) business days (Saturdays, Sundays and Bank
or other public holidays excluded) after being placed in the post.


 


AS WITNESS the hands of the duly authorised
representatives of the parties hereto the day and year first above written.


 


	
  Signed for and on behalf of

  	
   

  	
   

  
	
  LONZA BIOLOGICS PLC

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TITLE

  
	
   

  	
   

  	
   

  
	
  Signed for and on behalf of

  	
   

  	
   

  
	
  ACORDA THERAPEUTICS

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TITLE

  



 


3

















 


SCHEDULE
1


 


“Cell Line” shall mean the CHO Cell Line provided by the Customer
expressing Product.


 


“Product” shall mean the recombinant human glial growth factor (rhGGF2)


 


A.                                    SPECIFICATION
FOR BULK PURIFIED PRODUCT


 


Below is a list of tests typically carried out as GMP Specification
testing for a recombinant protein product by LB.  During the course of the Services LB and Customer will agree the
testing appropriate to a GMP Specification for Product.


 


	
  Test

  No.

  	
   

  	
  Criterion

  	
   

  	
  Method

  (Lonza Biologics SOP

  number)

  	
   

  	
  Draft
  Specification

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.

  	
   

  	
  Characteristics

  	
   

  	
   

  	
   

  	
   

  
	
  1.1

  	
   

  	
  Appearance (visual)

  	
   

  	
  60516C

  	
   

  	
  Clear, colourless liquid

  
	
  1.2

  	
   

  	
  Protein concentration

  (A280) E0.1% = TBC

              1cm

  	
   

  	
  60284C

  	
   

  	
  To be advised by Customer 

  
	
  1.3

  	
   

  	
  pH at 24 ±
  1°C

  	
   

  	
  60328C

  	
   

  	
  pH 6.5 ± 0.5

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  
  

  

  

  
	
  TBC: To be confirmed by Customer

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.

  	
   

  	
  Identity

  	
   

  	
   

  	
   

  	
   

  
	
  1.4

  	
   

  	
  Isoelectric focusing

  	
   

  	
  Protocol to be decided

  	
   

  	
  For information only. Comparable to reference.

  

  Report number of visible bands and pI range

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.

  	
   

  	
  Activity

  	
   

  	
   

  	
   

  	
   

  
	
  1.5

  	
   

  	
  Sialic acid content

  	
   

  	
  Protocol to be decided

  	
   

  	
  Comparable to reference

  
	
  1.6

  	
   

  	
  Oligosaccharide profiling

  	
   

  	
  60837C

  	
   

  	
  Comparable to reference

  
	
  1.7

  	
   

  	
  Peptide mapping

  	
   

  	
  Protocol to be decided

  	
   

  	
  Comparable to reference

  



 


4

















 


	
  Test

  No.

  	
   

  	
  Criterion

  	
   

  	
  Method

  (Lonza Biologics

  SOP number)

  	
   

  	
  Draft
  Specification

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.

  	
   

  	
  Purity

  	
   

  	
   

  	
   

  	
   

  
	
  1.8

  	
   

  	
  Novex SDS-electrophoresis (4-20% gel)

  

  Coomassie blue

  	
   

  	
  60805C

  	
   

  	
  Report result. Target specification:

  

  Report result as % purity and comparison to reference

  
	
  1.9

  	
   

  	
  Gel permeation HPLC

  	
   

  	
  To be decided

  	
   

  	
  Report result, target specification:

  Area % of monomer, %aggregates and % fragments.

  
	
  1.10

  	
   

  	
  RP – HPLC

  	
   

  	
  To be decided

  	
   

  	
  Report result. Target specification:

  % purity

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5.

  	
   

  	
  Impurities

  	
   

  	
   

  	
   

  	
   

  
	
  Test

  No.

  	
   

  	
  Criterion

  	
   

  	
  Method
  (Lonza

  Biologics SOP

  number)

  	
   

  	
  Specification

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.11

  	
   

  	
  Hamster DNA

  	
   

  	
  60841C

  	
   

  	
  Report result. Target specification:

  Target: Less than or equal to 10.0 pg per mg (by A280) protein

  
	
  1.12

  	
   

  	
  CHO Host cell protein

  	
   

  	
  60845C

  	
   

  	
  Report result. Target specification:  

  Report the number and molecular weight of bands detected, and percentage of
  Host Cell Protein to Total Protein concentration w/w.

  



 


5

















 


	
  Test

  No.

  	
   

  	
  Criterion

  	
   

  	
  Method
  (Lonza

  Biologics SOP

  number)

  	
   

  	
  Specification

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.

  	
   

  	
  Safety

  	
   

  	
   

  	
   

  	
   

  
	
  1.13

  	
   

  	
  Extended bioburden by direct inoculation

  	
   

  	
  TM-25043

  	
   

  	
  No growth detected after 14 days

  
	
  1.14

  	
   

  	
  Endotoxins (LAL)

  	
   

  	
  60186C

  	
   

  	
  For information only.

  Less than or equal to 1.0 Eu per mg (by A280) protein

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.

  	
   

  	
  Sample from production
  fermenter on day of harvest

  
	
  1.15

  	
   

  	
  Mycoplasmas

  	
   

  	
  BioReliance

  102003A FDA points to consider

  	
   

  	
  Hoeschst stain negative

  

  Cell Line – no growth detected

  
	
  1.16

  	
   

  	
  In
  Vitro test (4 cell lines: 
  MRC5, VERO, 

  CHO-K1, )

  

  Or Q=-PCR for mvm 

  	
   

  	
  Q One Protocol

  38163

  

  Q One Protocol

  37149

  	
   

  	
  Negative

  

  Report result 

  
	
  1.17

  	
   

  	
  Number of virus-like particles per ml of bulk
  harvest (EM)

  	
   

  	
  Q One Protocol

  38131

  	
   

  	
  Report Result

  



 


	
  8.

  	
   

  	
  Final Bulk Product
  Disposition

  	
   

  	
   

  
	
  Final Formulation Buffer

  	
   

  	
  To be confirmed by Customer

  
	
  Bottling of Bulk Product:

  	
   

  	
   

  
	
  Containers

  	
   

  	
  Nalgene high density polyethylene

  
	
  Denominations

  	
   

  	
  Bulk x 1 litre (residual x 125mL).

  
	
  Product storage conditions

  	
   

  	
  2 – 8 °C

  
	
  Shipment temperature

  	
   

  	
  2 – 8 °C

  



 


Note:


 


Bulk Product will be dispensed into 1L nalgenes, filling to a tolerance
of ±10% of the nominal volume of the container.


 


Any remaining Product will be in 125 mL nalgenes, filling to a
tolerance of ±10% of the nominal
volume of the container.


 


Any 125 mL containers not filled with a tolerance of ±10%
will be labelled as Customer samples and not be released for clinical use.


 


6

















 


B.                                    SPECIFICATION
FOR A MASTER OR WORKING CELL BANK


 


Starting Material Definition


 


A Master Cell Bank (MCB) or Working Cell Bank (WCB) of a cryopreserved
CHO cell line will be imported from the Customer and stored in individual
ampoules in liquid nitrogen refrigerators.


 


General Master Cell Bank
Specification


 


1.                                       In
order for the Cell Line to be accepted into LB’s cGMP facility, the following
testing is required and the appropriate specifications achieved.


 


	
  Test

  No.

  	
   

  	
  Test

  	
   

  	
  Method

  	
   

  	
  Result

  
	
  1.1

  	
   

  	
  Mycoplasma 

  (DNA Stain)

  	
   

  	
  Compliant with FDA Points to Consider or European pharmacopeia

  	
   

  	
  Negative

  
	
  1.2

  	
   

  	
  Mycoplasma 

  (Direct Isolation)

  	
   

  	
  Compliant with FDA Points to Consider or European
  pharmacopeia

  	
   

  	
  No growth detected

  
	
  1.4

  	
   

  	
  Sterility

  	
   

  	
  Lonza SOP 60159C or testing laboratory protocol

  	
   

  	
  No growth detected after 14 days

  
	
  1.5

  	
   

  	
  Species Identity 

  (Isoenzyme analysis)*

  	
   

  	
  Testing Laboratory Protocol

  	
   

  	
  Hamster

  
	
  1.6

  	
   

  	
  In
  vitro virus  test 

  (with 3 cell lines: MRC5, VERO, CHO)*

  	
   

  	
  Testing Laboratory Protocol

  	
   

  	
  Negative

  
	
  1.7

  	
   

  	
  Hamster Antibody Production*

  	
   

  	
  Testing Laboratory Protocol

  	
   

  	
  Negative

  



 












*these tests may be performed on a linearly related cell stock.


 


7

















 


SCHEDULE
2


 


CONTENTS


 


	
  Supply of Customer Materials and
  Customer Know How

  
	
   

  	
   

  
	
  1

  	
  Stage 1 - Cell Line Importation,
  Cell Culture Process Transfer and Evaluation of Growth and Productivity of a
  CHO Cell Line

  
	
   

  	
   

  
	
  2

  	
  Stage 2 - Establish Assays for
  Product Concentration

  
	
   

  	
   

  
	
  3.

  	
  Stage 3 - Purification Process
  Evaluation

  



 


8

















 


Supply
of Customer Materials
and Customer Know How


 


Prior to commencement of the Services at LB or, if
appropriate, prior to the commencement of the relevant Stage of the Services,
Customer shall supply LB with the following:


 


(i)                                     Sufficient
information on the Product to allow a risk assessment as required by the
“Genetically Modified Organisms (Contained Use) (Amendment)” Regulations 1996
and a safety assessment by LB’s Biological Safety Committee.


 


(ii)                                  If
available, a reference standard sample (approximately 60mg) of the Product
suitable for the purposes intended.


 


(iii)                               At
least 2 identical ampoules of viable frozen cells from the Master cell bank
(MCB) for the purposes of performing development work, and sufficient Working
cell bank (WCB) ampoules of the Cell Line, to perform any subsequent GMP
manufacture, each containing approximately 1x107 cells per ampoule and which
express Product. The Cell Line is understood to be clonal, stable and suitable
for the purpose intended.


 


(iv)                              These
ampoules shall be sent to LB’s cGMP facility in the UK to allow the Services
contained herein to commence.


 


(v)                                 Copies
of the Customer’s test reports for all mycoplasma, sterility and virus testing
carried out on the MCB and WCB of the Cell Line.  This information needs to be reviewed by LB’s QA department to
confirm acceptability for release of the Cell Line into the cGMP facility at LB
if required.


 


(vi)                              List
of materials, supplier and catalogue numbers that Customer proposes LB use.


 


(vii)                           Details
of the formulation buffer for the bulk Product, including excipient
concentrations, pH and protein concentration.


 


(viii)                        Details of
the purification process, as developed by the Customer, including buffer
formulations, operating conditions for the column chromatography steps, example
chromatograms, expected yields, etc


 


(ix)                                Copy
of USDA permit for shipping, cells, samples and Product from UK into USA.


 


(x)                                   Copies
of reports and procedures describing the analytical, cell culture and purification
procedures developed by Customer (if available):


 


•                  Cell
Line history and characterization


•                  Master
cell bank creation


•                  Working
cell bank creation


•                  Viability
and homogeneity on cell revival


•                  Cell
Line stability study (including method of generation number calculation)


•                  Purification
process development reports


•                  Assay
development and assay validation reports for all assays to be transferred to
LB.


 


For the avoidance of doubt LB shall source materials
from those suppliers nominated by Customer in accordance with Schedule 4 Clause
1.


 


9

















 


Stage 1 - Cell Line Importation, Cell Culture Process Transfer and Evaluation of
Growth and Productivity of a CHO Cell Line


 


1.1                               Objectives


 


1.1.1                        To import
Customer’s Cell Line (MCB or WCB) and Process in to LB’s Development and GMP
manufacturing facility


 


1.1.2                        To ensure
that sufficient test information is available for rapid transfer of the
selected Cell Line to LB’s GMP manufacturing facility.  Testing for potential adventitious agents is
required so that all cell lines and products are protected for customers.


 


1.1.3                        To
determine fermentation production kinetics and evaluate the fermentation
procedures proposed by the Customer for production of Product from the Cell
Line.


 


1.1.4                        To
evaluate the growth and productivity of a CHO Cell Line supplied by the
Customer in batch and fed-batch fermentation.


 


Before the commencement of this Stage, the project has
to undergo a Risk Assessment by LB’s Biological Safety Committee.  This activity takes approximately 4 weeks.


 


Stage 1 is designed to ensure that all the testing and
relevant history with regard to the creation of the Cell Line, including
productivity data at various scales (if available) is transferred to LB.  If additional testing is required to comply
with LB’s requirements for use of the Cell Line in the GMP facility, this will
be performed or out-sourced as needed. 
Additional testing will incur extra cost.  Mycoplasma and sterility testing have to be performed by LB prior
to acceptance of the Cell Line into the GMP facility, unless satisfactory
reports are provided.


 


1.2                               Activities


 


1.2.1                        Carry out
and complete the risk Assessment by Lonza’s Biological Safety Committee.


 


1.2.2                        Receive
the incoming Cell Line into quarantine in LB’s cGMP facility in the UK.


 


1.2.3                        Review the
testing carried out on either the MCB or WCB of the Cell Line supplied by the
Customer.  Determine the acceptability
of the Cell Line for entry into LB’s cGMP facility by approval of the following
reports:


 


	
  (a) Virus Testing:-

  	
   

  	
  (i) In vitro
  test assay  (3 cell lines:-

  MRC-5, VERO and CH0-K1)

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (ii) Hamster Antibody Production (HAP)

  
	
   

  	
   

  	
   

  
	
  (b) Isoenzyme Analysis

  	
   

  	
  (Cell Line identity)

  
	
   

  	
   

  	
   

  
	
  (c) Sterility

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  (d) Mycoplasma

  	
   

  	
   

  



 


1.2.4                        Following
review, inform the Customer of the acceptability of the Cell Line for entry
into LB’s cGMP facility.  If approved,
establish standard maintenance, storage and release procedures for the Cell
Line at LB.


 


10

















 


 


Certain  portions of this
Exhibit have been omitted pursuant to a request for confidentiality. Such
omitted 


portions, which are marked with brackets
[     ] and an asterisk*, have been separately filed
with the 


Commission


 


1.2.5                        Receive
process information and define any process modifications required for operation
at LB.


 


1.2.6                        Visit the
Customer and observe process performed by Customer, if required, as part of the
technology transfer.


 


1.2.7                        Source any
required raw materials that are not currently used within LB facility in
accordance with Clause 1 of Schedule 4, based upon the list of materials
provided by the Customer for the cell culture Process developed by the
Customer.  At LB’s request, Customer
will provide to LB specific raw materials that Customer proposes LB use in the
Process.


 


1.2.8                        Evaluate
revival and inoculum expansion of the Cell Line in shake flask culture in
CD-CHO using the Customer’s Process. 
Adapt this inoculum expansion process as appropriate to fit LB’s cGMP
facility.


 


1.2.9                        Carry out
a time course of cell growth in a series of shake flasks to evaluate for
example; cell culture medium, feeds and other nutrient additions on Product
accumulation, nutrient utilization and Product quality.  The final experimental plan will be agreed
with the Customer prior to initiation of this Section 1.2.9.  LB will evaluate Product accumulation using
the assays established in Stage 2 of the services.  Samples will be sent to the Customer for analysis of Product
characteristics.  Results from these trials
will determine the experimental plan for the laboratory scale evaluation in
Section 1.2.10.


 


1.2.10                  Carry out a time
course of cell growth and Product accumulation in two laboratory scale
fermenters (up to 2 x 10 litres scale) using parameters defined in Section
1.2.9.


 


1.2.11                  Evaluate product
accumulation using assays established in Stage 2 and provide samples to
customer for Product quality analysis.


 


1.2.12                  Prepare a
summary report.


 


Evaluation Point


Review and agree with Customer whether to proceed with
the selected media and process. 
Identify and agree with the Customer any further process optimisation
that may be required.  These activities
will be outlined in a subsequent stage and performed at additional cost.


 


Timescale


Stage 1 can commence once the Customer Materials are
available and LB’s Biological Safety Committee has approved the programme.  Stage 1 is expected to take [*] months and
will be complete upon issue of a summary report.


 


11

















 


 


Certain  portions of this
Exhibit have been omitted pursuant to a request for confidentiality. Such
omitted 


portions, which are marked with brackets
[     ] and an asterisk*, have been separately filed
with the 


Commission


 


Stage
2 – Establish Assays
for Product Concentration


 


2.1                               Objectives


 


To import ELISA and RP-HPLC assay methods from the
Customer to determine product concentration.


 


2.2                               Activities


 


2.2.1                        Receive
ELISA and RP-HPLC assay methods, assay reagents and product reference from
Customer.


 


2.2.2                        Establish
the assays for routine use with LB.  If
further development of the assays is required for satisfactory operation within
LB’s laboratories then additional activities will be required.  The scope and subsequent price of these
activities (if required) will be agreed with the Customer.


 


Timescale


 


It is estimated that Stage 2 will take [*] months to complete


 


12

















 


Stage
3 – Purification
Process Transfer and Evaluation


 


3.1                               Objectives


 


3.1.1                        To
evaluate purification of the Product by the process provided by the Customer
and make recommendations on modifications to the process.


 


3.1.2                        To
establish a purification Process suitable for purification of Product for use
in clinical studies manufactured at 200L fermentation scale.


 


3.1.3                        To provide
a sample of Product purified using the selected Process to the Customer for
evaluation.


 


3.2                               Activities


 


3.2.1                        Receive
complete details of the purification process developed by the Customer,
including buffer formulations, process operating parameters with tolerances,
information on performance of the purification process at the Customer’s
facility, etc. Source and qualify new raw materials as required.


 


3.2.2                        Observe
the purification process at the Customer’s laboratories.


 


Note: If at this
point difficulties in supply or adaptation to LB’s equipment and procedures are
identified, these will be discussed with the Customer. Extra costs may be
incurred if specialist equipment or resins have to be sourced.


 


3.2.3                        Import
Customer’s purification process. Design a purification process based on the
Customer’s process that will fit with LB’s equipment and procedures.


 


3.2.4                        Receive
cell culture supernatant produced under Stage 1.


 


3.2.5                        Run
through the Customer’s purification process at laboratory scale. Take
in-process and purified product samples and ship to the Customer for analysis.
(No analysis of the purified product is planned at LB).


 


3.2.6                        Evaluate
operating conditions for any Ultrafiltration steps and for a DV20 virus filter
to be inserted into the purification process at an appropriate point
(operational parameters for purification of Product will be evaluated in this
Stage, not virus removal).  At least one
further viral reduction/inactivation step will be required.  A list of options for consideration will be
provided to the Customer.  The scope and
timing of a specific programme which may require further development activities
will be agreed between LB and the Customer. This will be in a subsequent stage
at additional cost with activities to be defined.


 


3.2.7                        If
sufficient Product is produced at laboratory scale deliver a sample (5mg or
less) of Product to Customer for evaluation.


 


Evaluation Point:


 


3.2.8                        Review the
performance of the purification process with the Customer.  Review requirements (if any) for Process
modifications that may be needed following this study.  Any such Process modifications are subject
to agreement with Customer.  Additional
work will be performed in a subsequent stage at additional cost.


 


13

















 


3.2.9                        Issue
report of activities to Customer.  This
shall include:


 


•                                          a
summary of the key experimental data generated in this Stage;


•                                          an
outline of the recommended manufacturing Process including an estimate of the
expected yield of Product from the Cell Line at 200L production scale.


 


3.3                               Timescale


 


Stage 3 shall commence any time after Product is
available from Stage 1.

Stage 3 shall be complete upon issue of the report of activities. It is
estimated that this will be 3 months from provision of product from laboratory
scale fermenters carried out under Stage 1.


 


14

















 


Certain  portions of this
Exhibit have been omitted pursuant to a request for confidentiality. Such
omitted 


portions, which are marked with brackets
[     ] and an asterisk*, have been separately filed
with the 


Commission


 


SCHEDULE
3


 


Price and Terms of
Payment


 


1.                                       Price


 


In consideration for LB carrying out the Services as detailed in
Schedule 2 the Customer shall pay LB as follows: 


 


	
  Stage

  	
   

  	
   

  	
   

  	
  Price (UK
  £

  Sterling)

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Stage 1

  	
   

  	
  Cell Line Importation, Cell Culture Process Transfer
  and Evaluation of Growth and Productivity of a CHO Cell Line

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Stage 2

  	
   

  	
  Establish Assays for Product Concentration.

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Stage 3

  	
   

  	
  Purification Process Transfer and Evaluation

  	
   

  	
   

  	
  [**]

  	
   

  



 


15

















 


Certain  portions of this
Exhibit have been omitted pursuant to a request for confidentiality. Such
omitted 


portions, which are marked with brackets
[     ] and an asterisk*, have been separately filed
with the 


Commission


 


2.                                       Payment


 


	
  Payment by the Customer of the Price for each Stage
  shall be made against LB’s invoices as follows:

  
	
   

  
	
  2.1

  	
   

  	
  For Stage 1

  
	
   

  	
   

  	
  [**] upon commencement of Stage 1.

  
	
   

  	
   

  	
  [**] upon completion of Stage 1.

  
	
   

  	
   

  	
   

  
	
  2.2

  	
   

  	
  For Stage 2

  
	
   

  	
   

  	
  [**] upon commencement of Stage 2.

  
	
   

  	
   

  	
  [**] upon completion of Stage 2.

  
	
   

  	
   

  	
   

  
	
  2.3

  	
   

  	
  For Stage 3

  
	
   

  	
   

  	
  [**] upon commencement of Stage 3.

  
	
   

  	
   

  	
  [**] upon completion of Stage 3.

  



 


16

















 


SCHEDULE
4


 


SPECIAL
TERMS


 


1.                                       LB
shall use all reasonable endeavours to source required raw materials that are
not currently used within LB’s facility, based upon the list of materials provided
by the Customer in accordance with Schedule 2 for the cell culture purification
and analytical procedures developed by the Customer.  At LB’s request, Customer will provide to LB specific raw
materials that Customer proposes LB use in the Process.  To the extent that LB is unable at any time,
despite using all reasonable endeavours, to obtain any materials necessary or
desirable for the carrying out of the Services from the suppliers identified by
Customer then Customer shall forthwith following request by LB supply the same
and notwithstanding any other provision in this Agreement LB shall not be
responsible for any delay in carrying out the Services caused by a delay in the
supply of such materials.


 


2.                                       At
LB’s request Customer will provide to LB appropriate GMP approval for specific
raw materials that Customer proposes LB’s use. 
LB and Customer agree that LB’s QA will make the final decision to allow
entry of a raw material into the GMP facility based upon its assessment of
audit findings, test protocols and results.


 


3.                                       The
Customer will supply the testing laboratory protocols for review and approval
by LB’s Quality department, prior to use of the Cell Line in the GMP facility.
LB and Customer agree that LB’s QA will make the final decision to allow entry
of a Cell Line into the GMP facility based upon its assessment of the testing
protocols and results.


 


17

















 


SCHEDULE 5


 


STANDARD TERMS FOR
CONTRACT SERVICES (NON GS)


 


	
  1.

  	
   

  	
  Interpretation

  
	
   

  	
   

  	
   

  
	
  1.1

  	
   

  	
  In these Standard Terms, unless the context requires
  otherwise :

  
	
  1.1.1

  	
   

  	
  “Affiliate” means any Company, partnership or other
  entity which directly or indirectly controls, is controlled by or is under
  common control with the relevant party to this Agreement. “control” means the
  ownership of more than fifty per cent (50%) of the issued share capital or
  the legal power to direct or cause the direction of the general management
  and policies of the party in question.

  
	
  1.1.2

  	
   

  	
  “Agreement” means this agreement incorporating
  Schedules 1 (Product Specification), 2 (Services) 3 (Price and Terms of
  Payment) and 4 (Special Terms) as amended or varied from time to time by
  written agreement of the parties.

  
	
  1.1.3

  	
   

  	
  “Batch” means the total Product obtained from one
  fermentation and associated purification using the Process and carried out in
  accordance with cGMP.

  
	
  1.1.4

  	
   

  	
  “Cell Line” means the cell line, particulars of
  which are set out in Schedule 1.

  
	
  1.1.5

  	
   

  	
  “cGMP” means Good Manufacturing Practices and
  General Biologics Products Standards as promulgated under the US Federal Food
  Drug and Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610) and the Guide
  to Good Manufacturing Practices for Medicinal Products as promulgated under
  European Directive 91/356/EEC.  For
  the avoidance of doubt, LB’s operational quality standards are defined in
  internal GMP policy documents.

  
	
  1.1.6

  	
   

  	
  “cGMP Product” means Product which is required under
  Schedule 2 to be manufactured in accordance with cGMP.

  
	
  1.1.7

  	
   

  	
  “Competing Contract Manufacturer” shall mean any
  party who undertakes or performs more than twenty five percent (25%) of their
  business as a third party manufacturer of monoclonal antibodies and/or
  therapeutic proteins or any product of a similar nature to that to which this
  Agreement relates.

  
	
  1.1.8

  	
   

  	
  “Customer” means Acorda Therapeutics, Inc. and its
  successors in title and lawful assigns.

  
	
  1.1.9

  	
   

  	
  “Customer Information” means all technical and other
  information not known to LB or in the public domain relating to the Cell
  Line, the Process (including for the avoidance of doubt improvements or
  modifications thereto from time to time) and the Product, from time to time
  supplied by the Customer to LB.

  
	
  1.1.10

  	
   

  	
  “Customer Materials” means the Materials supplied by
  Customer to LB (if any) and identified as such by Schedule 1 hereto.

  
	
  1.1.11

  	
   

  	
  “Deliver”, “Delivered” or “Delivery” has the meaning
  ascribed to it by Clause 5.1

  
	
  1.1.12

  	
   

  	
  “LB Know-How” means all technical and other
  information relating directly or indirectly to the Process known to LB from
  time to time other than confidential Customer Information and information in
  the public domain.

  
	
  1.1.13

  	
   

  	
  “LB Patent Rights” means all patents and patent
  applications of any kind throughout the world relating to the Process which
  from time to time LB is the owner of or is entitled to use.

  
	
  1.1.14

  	
   

  	
  “Price” means the price specified in Schedule 3 for
  the Services.

  
	
  1.1.15

  	
   

  	
  “Process” means the process for the production of
  the Product from the Cell Line, including any improvements or modifications
  thereto from time to time.

  
	
  1.1.16

  	
   

  	
  “Product” means all or any part of the product
  manufactured using the Process (including any sample thereof), particulars of
  which are set out in Schedule 1 and includes all derivatives therof.

  
	
  1.1.17

  	
   

  	
  “Customer Patent Rights” means all patents and
  patent applications of any kind throughout the world that are necessary or
  useful in performance of the Services excluding the LB Patent Rights.

  
	
  1.1.18

  	
   

  	
  “Services” means all or any part of the services the
  subject of the Agreement (including, without limitation, cell culture
  evaluation, purification evaluation, master, working and extended cell bank
  creation, and sample and bulk production), particulars of which are set out
  in Schedule 2.

  
	
  1.1.19

  	
   

  	
  “Specification” means the specification for Product,
  particulars of which are set out in Schedule 1.

  
	
  1.1.20

  	
   

  	
  “Terms of Payment” means the terms of payment
  specified in Schedule 3.

  
	
  1.1.21

  	
   

  	
  “Testing Laboratories” means any third party
  instructed by LB to carry out tests on the Cell Line or the Product.

  



 


18

















 


	
  1.2

  	
   

  	
  Unless the context requires otherwise, words and
  phrases defined in any other part of the Agreement shall bear the same
  meanings in these Standard Terms, references to the singular number include
  the plural and vice versa, references to Schedules are references to
  schedules to the Agreement, and references to Clauses are references to
  clauses of these Standard Terms.

  
	
  1.3

  	
   

  	
  In the event of a conflict between a term in
  Schedule 4 or any supplemental or additional term agreed in writing from time
  to time between the parties and these Standard Terms, the former shall
  prevail.

  
	
   

  	
   

  	
   

  
	
  2.

  	
   

  	
  Applicability of Standard Terms

  
	
   

  	
   

  	
  Unless otherwise specified, this Agreement shall not
  be effective until it (or a counterpart of it) has been signed on behalf of
  both parties.  No variation of or
  addition to this Agreement or any part thereof shall be effective unless in
  writing and signed on behalf of both parties.  Notwithstanding the above the parties hereby confirm that
  amendments to the Specification shall be effective if reduced to writing and
  signed by the quality and/or regulatory representative of both parties, which
  quality and/or regulatory representative shall be nominated from time to time
  by each party.

  
	
   

  	
   

  	
   

  
	
  3.

  	
   

  	
  Supply by Customer, Safekeeping and Customer
  Warranties and Indemnity

  
	
   

  	
   

  	
   

  
	
  3.1

  	
   

  	
  Immediately following the date of the Agreement the
  Customer shall supply to LB the Customer Information, together with full
  details of any hazards relating to the Cell Line and/or the Customer
  Materials, their storage and use.  On
  review of this Customer Information, the Cell Line and/or the Customer
  Materials shall be provided to LB at LB’s request.  Property in the Cell Line and/or the Customer Materials and/or
  the Customer Information supplied to LB shall remain vested in the Customer.

  
	
  3.2

  	
   

  	
  The Customer hereby grants LB the non-exclusive
  right to use the Cell Line, the Customer Materials and the Customer
  Information for the purpose of the Agreement.  LB hereby undertakes not to use the Cell Line, the Customer
  Materials or the Customer Information (or any part thereof) for any other
  purpose.

  
	
  3.3

  	
   

  	
  LB shall:

  
	
  3.3.1

  	
   

  	
  at all times use all reasonable endeavours to keep
  the Cell Line and/or the Customer Materials secure and safe from loss and
  damage in such manner as LB stores its own material of similar nature;

  
	
  3.3.2

  	
   

  	
  not part with possession of the Cell Line and/or the
  Customer Materials or the Product, save for the purpose of tests at the
  Testing Laboratories; and

  
	
  3.3.3

  	
   

  	
  procure that all Testing Laboratories are subject to
  obligations of confidence substantially in the form of those obligations of
  confidence imposed on LB under these Standard Terms.

  
	
   

  	
   

  	
   

  
	
  3.4

  	
   

  	
  The Customer warrants to LB that:

  
	
  3.4.1

  	
   

  	
  Customer has the right to enter into this Agreement;

  
	
  3.4.2

  	
   

  	
  Customer has and shall at all times throughout the
  term of this Agreement have the right to supply the Cell Line, the other
  Customer Materials and the Customer Information to LB and the necessary
  rights to license or permit LB to use the same for the purpose of the
  Services;

  
	
  3.4.3

  	
   

  	
  Any of the Cell Line, the other Customer Materials,
  Customer Information and Customer Patent Rights not owned by Customer are
  licensed to Customer under a licence which will permit their use by LB to
  perform the Services;

  
	
  3.4.4

  	
   

  	
  To the best of Customer’s knowledge and belief, the
  use by LB of the Cell Line, other Customer Materials, Customer Information
  and Customer Patent Rights for the Services (including without limitation the
  manufacture of the Product) will not infringe any intellectual
  property rights of any third party (provided, however, that LB shall waive
  any breach of this warranty which arises if a court of competent jurisdiction
  determines that the use by LB of the Cell Line, other Customer Materials,
  Customer Information or Customer Patent Rights for the Services infringes the
  intellectual property rights of a third party, provided that and for so long
  as Customer actually indemnifies LB pursuant to Clause 3.5); and

  
	
  3.4.5

  	
   

  	
  Customer will promptly notify LB in writing if it
  receives or is notified of a claim from a third party that the Cell Line,
  other Customer Materials, Customer Information or the Customer
  Patent Rights or that the use by LB thereof for the provision of the Services
  infringes any intellectual property rights of such third party.

  
	
   

  	
   

  	
   

  
	
  3.5

  	
   

  	
  The Customer undertakes to indemnify and to maintain
  LB promptly indemnified against any loss, damage, costs and expenses of any
  nature (including court costs and legal fees on a full indemnity basis),
  whether direct or consequential, and whether or not foreseeable or in the
  contemplation of LB or the Customer, that

  



 


19

















 


	
   

  	
   

  	
  LB may suffer arising out of or incidental to any
  breach of the warranties given by the Customer under Clause 3.4 above or any
  claims alleging LB’s use of the Cell Line, the Customer Materials or the
  Customer Information infringes any rights (including, without limitation, any
  intellectual or industrial property rights) vested in any third party
  (whether or not the Customer knows or ought to have known about the
  same)  provided that there shall be
  excluded from this indemnity all LB actual or potential profits other than
  those which are an integral part of any Price or fees which the Customer is
  obliged to pay to LB under this Agreement.

  
	
   

  	
   

  	
   

  
	
  3.6

  	
   

  	
  The obligations of the Customer under this Clause 3
  shall survive the termination for whatever reason of the Agreement.

  
	
   

  	
   

  	
   

  
	
  4.

  	
   

  	
  Provision of the Services

  
	
   

  	
   

  	
   

  
	
  4.1

  	
   

  	
  LB shall diligently carry out the Services as
  provided in Schedule 2 and shall use all reasonable efforts to achieve the
  estimated timescales therefor

  
	
  4.2

  	
   

  	
  LB shall manufacture cGMP Product to meet the
  Specification provided that there shall be no such obligation to meet the
  Specification in respect of the first three Batches of cGMP Product
  manufactured or in respect of the first cGMP Batch manufactured following any
  change in the Process agreed to or requested by Customer.

  
	
  4.3

  	
   

  	
  Due to the unpredictable nature of the biological
  processes involved in the Services, the timescales set down for the
  performance of the Services (including without limitation the dates for
  production and Delivery of Product) and the quantities of Product for
  delivery set out in Schedule 2 are estimated only.

  
	
  4.4

  	
   

  	
  Subject to Clause 4.2. the Customer shall not be
  entitled to cancel any unfulfilled part of the Services or to refuse to
  accept the Services on grounds of late performance, late delivery or failure
  to produce the estimated quantities of Product for delivery.  LB shall not be liable for any loss,
  damage, costs or expenses of any nature, whether direct or consequential,
  occasioned by:

  
	
  4.4.1

  	
   

  	
  any delay in performance or delivery howsoever
  caused; or

  
	
  4.4.2

  	
   

  	
  any failure to produce the estimated quantities of
  Product for delivery, provided that if a significant failure to produce the
  agreed estimated quantities (if any) of Product for delivery arises due to
  negligence by LB the parties shall agree a commercially reasonable mechanism
  by which to compensate Customer.

  
	
  4.5

  	
   

  	
  LB shall comply with the International Committee for
  Harmonisation regulatory requirements from time to time applicable to the
  Services as set out in Schedule 2 hereto.

  
	
   

  	
   

  	
   

  
	
  5.

  	
   

  	
  Delivery, Transportation of Product and Customer
  Tests

  
	
   

  	
   

  	
   

  
	
  5.1

  	
   

  	
  Product shall be delivered EXW (ex-works) LB
  premises (as defined by Incoterms 2000) which means (a) when LB places
  Product at the disposal of Customer at LB’s premises not cleared for export
  and not loaded onto any collecting vehicle and (b) risk and title to Product
  pass to Customer upon delivery (“Deliver,” “Delivery,” or “Delivered,” as
  appropriate). Subject to Clause 5.2, LB shall deliver to Customer the
  Certificate of Analysis not later than the date of Delivery.  Transportation of Product, whether or not
  under any arrangements made by LB on behalf of Customer, shall be made at the
  sole risk and expense of the Customer.

  
	
   

  	
   

  	
   

  
	
  5.2

  	
   

  	
  At Customer’s request, LB will Deliver Product in
  quarantine prior to delivery of the Certificate of Analysis.  Such request shall be accompanied by
  Customer’s written acknowledgement that the Product has been Delivered
  without the transmittal to Customer of a Certificate of Analysis, that
  accordingly the Product cannot be administered to humans until transmittal of
  the Certificate of Analysis, and that Customer nevertheless accepts full risk
  of loss, title and ownership of the Product. 
  The Delivery of Product in quarantine shall be subject to such testing
  requirements as LB may reasonably require, and the forty-five (45) day period
  referred to in Clause 5.8  shall run from Delivery in quarantine by
  Customer of the Product.

  
	
   

  	
   

  	
   

  
	
  5.3

  	
   

  	
  Unless otherwise agreed, LB shall package and label
  Product for Delivery in accordance with its standard operating procedures.  It shall be the responsibility of the
  Customer to inform LB in writing in advance of any special packaging and
  labeling requirements for Product. 
  All additional costs and expenses of whatever nature incurred by LB in
  complying with such special requirements shall be charged to the Customer in
  addition to the Price.

  



 


20

















 


	
  5.4

  	
   

  	
  If requested in writing by the Customer, LB will
  (acting as agent for Customer) arrange for insurance of Product whilst held
  by LB after Delivery (awaiting transportation) for a maximum of fourteen (14)
  days on terms equivalent to those under which LB insures product prior to
  Delivery. All additional costs and expenses of whatever nature incurred by LB
  in arranging such insurance shall be charged to the Customer in addition to
  the Price.

  
	
  5.5

  	
   

  	
  If requested in writing by the Customer, LB will
  (acting as agent of the Customer for such purpose) arrange the transportation
  of Product from LB’s premises to the destination indicated by the Customer
  together with insurance cover for Product in transit at its invoiced
  value.  All additional costs and
  expenses of whatever nature incurred by LB in arranging such transportation
  and insurance shall be charged to the Customer in addition to the Price.

  
	
  5.6

  	
   

  	
  Where LB has made arrangements for the
  transportation of Product, the Customer shall diligently examine the Product
  as soon as practicable after receipt. 
  Notice of all claims (time being of the essence) arising out of:

  
	
  5.6.1

  	
   

  	
  visible damage to or total or partial loss of
  Product in transit shall be given in writing to LB and the carrier within
  three (3) working days of receipt by Customer; or

  
	
  5.6.2

  	
   

  	
  non-delivery shall be given in writing to LB within
  ten (10) days after the date of LB’s despatch notice.

  
	
  5.7

  	
   

  	
  The Customer shall make damaged Product and
  associated packaging materials available for inspection and shall comply with
  the requirements of any insurance policy covering the Product notified by LB
  to the Customer.  LB shall offer the
  Customer all reasonable assistance (at the cost and expense of the Customer)
  in pursuing any claims arising out of the transportation of Product.

  
	
  5.8

  	
   

  	
  Promptly following receipt of Product or any sample
  thereof, the Customer may carry out any of the tests outlined or referred to
  in the Specification set out in Schedule 1 Subject to Clause 4.2, if such
  tests show that the Product fails to meet Specification, the Customer shall
  give LB written notice thereof within forty-five (45) days from the date of
  Delivery and shall return such Product to LB’s premises for further
  testing.  In the absence of such
  written notice Product shall be deemed to have been accepted by the Customer
  as meeting Specification.  Subject to
  Clause 4.2, if Customer has reasonably demonstrated to LB that Product
  returned to LB fails to meet Specification and that such failure is not due
  (in whole or in part) to acts or omissions of the Customer or any third party
  after Delivery, LB shall at Customer’s discretion refund that part of the Price
  that relates to the production of such Product or replace such Product at its
  own cost and expense.  In the event
  Customer requires LB to replace such Product, LB shall use all reasonable
  endeavours to do so with the minimum delay having regard to its commitments
  to third parties in the timing of such replacement.

  
	
  5.9

  	
   

  	
  Subject to Clause 4.2, if there is any dispute
  concerning whether Product returned to LB fails to meet Specification or
  whether such failure is due (in whole or in part) to acts or omissions of the
  Customer or any third party after Delivery, such dispute shall be referred
  for decision to an independent expert (acting as an expert and not as an
  arbitrator) to be appointed by agreement between LB and the Customer or, in
  the absence of agreement by the President for the time being of the
  Association of the British Pharmaceutical Industry.  The costs of such independent expert shall be borne equally
  between LB and the Customer.  The
  decision of such independent expert shall be in writing and, save for
  manifest error on the face of the decision, shall be binding on both LB and
  the Customer.

  
	
  5.10

  	
   

  	
  The provisions of Clauses 5.8 and 5.9 shall be the
  sole remedy available to the Customer in respect of Product that fails to
  meet Specification.

  
	
   

  	
   

  	
   

  
	
  6.

  	
   

  	
  Price and Terms of Payment

  
	
  6.1

  	
   

  	
  The Customer shall pay the Price in accordance with
  the Terms of Payment.

  
	
  6.2

  	
   

  	
  Unless otherwise indicated in writing by LB, all
  prices and charges are exclusive of Value Added Tax or of any other
  applicable taxes, levies, imposts, duties and fees of whatever nature imposed
  by or under the authority of any government or public authority, which shall
  be paid by the Customer (other than taxes on LB’s income).  All invoices are strictly net and payment
  must be made within thirty (30) days of date of invoice.  Payment shall be made without deduction,
  deferment, set-off, lien or counterclaim of any nature.

  
	
  6.3

  	
   

  	
  In default of payment on due date:

  
	
  6.3.1

  	
   

  	
  interest shall accrue on any amount overdue at the
  rate of four per cent (4%) above the base lending rate from time to time of
  National Westminster Bank plc, interest to accrue on a day to day basis both
  before and after judgement; and

  



 


21

















 


Certain  portions of this
Exhibit have been omitted pursuant to a request for confidentiality. Such
omitted 


portions, which are marked with brackets
[     ] and an asterisk*, have been separately filed
with the 


Commission


 


	
  6.3.2

  	
   

  	
  LB shall, at its sole discretion, and without
  prejudice to any other of its accrued rights, be entitled to suspend the
  provision of the Services or to treat the Agreement as repudiated on not less
  than ten (10) days’ prior notice in writing to Customer given at any time
  thereafter.

  
	
   

  	
   

  	
   

  
	
  7.

  	
   

  	
  LB Warranty and Limitation of Liability

  
	
   

  	
   

  	
   

  
	
  7.1

  	
   

  	
  LB warrants that :

  
	
  7.1.1

  	
   

  	
  the Services shall be performed in accordance with
  Clause 4.1 and 4.2;

  
	
  7.1.2

  	
   

  	
  unencumbered title (save for any IP rights which may
  exist) to Product will be conveyed to Customer upon Delivery;

  
	
  7.1.3

  	
   

  	
  as of the date of this Agreement the LB Information
  and the LB know how are owned by LB or LB is otherwise entitled to use them
  for the purposes of providing Services under this Agreement and during the
  term of this Agreement LB shall not do or cause anything to be done which
  would adversely affect their ownership or entitlement to use the same for
  those purposes;

  
	
  7.1.4

  	
   

  	
  LB has the necessary corporate authorisations to
  enter into this Agreement;

  
	
  7.1.5

  	
   

  	
  as of the date of this Agreement, to the best of
  LB’s knowledge and belief, the use by LB of the process (excluding any
  modifications or steps made or developed by Customer, the Customer Materials,
  Customer Information and Customer Patent Rights) and LB Patent Rights and LB
  Information for the performance of the Services as provided herein will not
  infringe any rights (including without limitation any intellectual or
  industrial property rights) vested in any third party;

  
	
  7.1.6

  	
   

  	
  LB will notify Customer in writing immediately if it
  receives or is notified of a claim from a third party that the use by LB of
  the Process and/or the LB Information or the LB Patents Rights for Services
  infringes any intellectual property rights vested in such third party;

  
	
  7.2

  	
   

  	
  Clause 7.1 is in lieu of all conditions, warranties
  and statements in respect of the Services and/or the Product whether
  expressed or implied by statute, custom of the trade or otherwise (including
  but without limitation any such condition, warranty or statement relating to
  the description or quality of the Product, its fitness or suitability for a
  particular purpose or use under any conditions whether or not known to LB)
  and any such condition, warranty or statement is hereby excluded.

  
	
  7.3

  	
   

  	
  Without prejudice to the terms of Clauses 5.10, 5.6,
  7.2, 7.4 and 7.6, the liability of LB for any loss or damage suffered by the
  Customer as a result of any breach of the Agreement or of any other liability
  of LB (including misrepresentation and negligence) in respect of the Services
  (including without limitation the production and/or supply of the Product)
  shall be limited to the payment by LB of damages which shall not exceed
  pounds sterling [**].

  
	
  7.4

  	
   

  	
  Subject to Clause 7.6, LB shall not be liable for
  the following loss or damage howsoever caused (even if foreseeable or in the
  contemplation of LB or the Customer):

  
	
  7.4.1

  	
   

  	
  loss of profits, business or revenue whether
  suffered by the Customer or any other person; or

  
	
  7.4.2

  	
   

  	
  special, indirect or consequential loss, whether
  suffered by the Customer or any other person; and

  
	
  7.4.3

  	
   

  	
  any loss arising from any claim made against the
  Customer by any other person.

  
	
  7.5

  	
   

  	
  The Customer shall indemnify and maintain LB
  promptly indemnified against all claims, actions, costs, expenses (including
  court costs and legal fees on a full indemnity basis) or other liabilities
  whatsoever in respect of :

  
	
  7.5.1

  	
   

  	
  any product liability (in respect of Product, unless
  such liability is caused by the negligent act or omission of LB in the
  production and/or supply of Product or occasioned by breach of LB warranty
  relating to IP infringement or title;

  
	
  7.5.2

  	
   

  	
  any negligent or wilful act or omission of the
  Customer in relation to the use, processing, storage or sale of the Product.

  
	
  7.6

  	
   

  	
  Nothing contained in these Standard Terms shall
  purport to exclude or restrict any liability for death or personal injury
  resulting directly from negligence by LB in carrying out the Services or any
  liability for breach of the implied undertakings of LB as to title.

  
	
  7.7

  	
   

  	
  The obligations of the Customer under this Clause 7
  shall survive the termination for whatever reason of the Agreement.

  
	
   

  	
   

  	
   

  
	
  8.

  	
   

  	
  Customer Information, LB Know-How and LB Patent
  Rights

  
	
   

  	
   

  	
   

  
	
  8.1

  	
   

  	
  The Customer acknowledges that LB Know-How and LB
  Information and LB acknowledges that Customer Information with which it is
  supplied by the other pursuant to the Agreement is supplied, subject to
  Clause

  



 


22

















 


	
   

  	
   

  	
  8.5, in circumstances imparting an obligation of
  confidence and each agrees to keep such LB Know-How and LB Information or
  such Customer Information secret and confidential and to respect the other’s
  proprietary rights therein and not at any time for any reason whatsoever to
  disclose or permit such LB Know-How or LB Information or such Customer
  Information to be disclosed to any third party save as expressly provided
  herein.

  
	
  8.2

  	
   

  	
  The Customer and LB shall each procure that all
  their respective employees, consultants, contractors and persons for whom it
  is responsible having access to confidential LB Know-How or LB Information or
  confidential Customer Information shall be subject to the same obligations of
  confidence as the principals pursuant to Clauses 8.1 and 8.3 and shall be
  bound by secrecy agreements in support of such obligations. LB and the
  Customer each undertake not to disclose or permit to be disclosed to any
  third party (including any contractors or consultants not previously approved
  in writing by the non-disclosing party, provided that such approval shall not
  be unreasonably withheld or delayed), or otherwise make use of or permit to
  be made use of (a) any trade secrets or confidential information relating to
  the technology, business affairs or finances of the other, any subsidiary,
  holding company or subsidiary or any such holding company of the other, or of
  any suppliers, agents, distributors, licensees or other customers of the
  other which comes into its possession under this Agreement. or (b) the
  commercial terms of this Agreement except to the extent that the same is
  required to be disclosed pursuant to subpoena, court order, judicial process
  or otherwise by law, provided the Receiving Party provides prompt notice to
  the Disclosing Party of such requirement in order to give the Disclosing
  Party an opportunity to timely seek a protective order or other appropriate
  judicial relief. In the event the Disclosing Party is unable to obtain a
  protective order or other appropriate judicial relief, the Receiving Party
  shall disclose only that portion of the Disclosing Party’s Confidential
  Information which is legally required to be disclosed, and ensure that all
  such Confidential Information of the Disclosing Party shall be redacted to
  the fullest extent permitted by law prior to such disclosure and that the
  Disclosing Party shall be given an opportunity to review the Confidential
  Information prior to its disclosure.

  
	
  8.3

  	
   

  	
  The obligations of confidence referred to in this
  Clause 8 shall not extend to any information which:

  
	
  8.3.1

  	
   

  	
  is or becomes generally available to the public
  otherwise than by reason of a breach by the recipient party of the provisions
  of this Clause 8;

  
	
  8.3.2

  	
   

  	
  is known to the recipient party and is at its free
  disposal prior to its receipt from the disclosing party;

  
	
  8.3.3

  	
   

  	
  is subsequently disclosed to the recipient party
  without being made subject to an obligation of confidence by a third party;

  
	
  8.3.4

  	
   

  	
  LB or the Customer may be required to disclose under
  any statutory, regulatory or similar legislative requirement, subject to the
  imposition of obligations of secrecy wherever possible in that relation; or

  
	
  8.3.5

  	
   

  	
  is developed by any servant or agent of the
  recipient party without access to or use or knowledge of the information by
  the disclosing party.

  
	
  8.4

  	
   

  	
  The Customer acknowledges that:

  
	
  8.5

  	
   

  	
  without prejudice to any other
  rights and remedies that the parties may have, the parties agree that the
  Confidential Information is valuable and that damages may not be an adequate
  remedy for any breach of the provisions of Clauses 8.1, 8.2, 8.3.  The parties agree that the relevant party
  will be entitled without proof of special damage to the remedies of an
  injunction and other equitable relief for any actual or threatened breach by
  the other party.

  
	
  8.6

  	
   

  	
  the Customer shall not at any time have any right,
  title, licence or interest in or to LB Know-How, LB Information the LB Patent
  Rights or any other intellectual property rights relating to the Process
  which are vested in LB or to which LB is otherwise entitled.

  
	
  8.7

  	
   

  	
  LB acknowledges that save as provided herein LB
  shall not at any time have any right, title, licence or interest in or to the
  Customer Information, Customer Patent Rights or any other intellectual
  property rights vested in Customer or to which the Customer is entitled.

  
	
  8.8

  	
   

  	
  The obligations of LB and the Customer under this
  Clause 8 shall survive the termination for whatever reason of the Agreement.

  
	
   

  	
   

  	
   

  
	
  9.

  	
   

  	
  Termination

  
	
   

  	
   

  	
   

  
	
  9.1

  	
   

  	
  If it becomes apparent to either LB or the Customer
  at any stage in the provision of the Services that it will not be possible to
  complete the Services for scientific or technical reasons, a sixty (60) day
  period shall be allowed for good faith discussion and attempts to resolve
  such problems.  If such problems are
  not resolved within such period, LB and the Customer shall each have the
  right to terminate the Agreement forthwith by

  



 


23

















 


Certain  portions of this
Exhibit have been omitted pursuant to a request for confidentiality. Such
omitted 


portions, which are marked with brackets
[     ] and an asterisk*, have been separately filed
with the 


Commission


 


	
   

  	
   

  	
  notice in writing. 
  In the event of such termination, the Customer shall pay to LB a
  termination sum calculated by reference to all the Services performed by LB
  prior to such termination (including a pro rata proportion of the Price for
  any stage of the Services which is in process at the date of termination) and
  all expenses reasonably incurred by LB in giving effect to such termination,
  including the costs of terminating any commitments entered into under the
  Agreement, such termination sum not to exceed the Price.

  
	
  9.2

  	
   

  	
  Customer may in its sole
  discretion terminate the Services at any time for any reason by giving not
  less than (thirty) 30 days’’ notice in writing to LB.  In the event of termination pursuant to
  this Clause 9.2 and subject to Clauses 9.3 and 9.4 the Customer shall pay LB
  a termination sum calculated in accordance with the principles of Clause 9.1
  above plus

  
	
  9.2.1

  	
   

  	
  in the event notice to
  terminate Services pursuant to this Clause 9.2 is issued to LB six (6) months
  or less before LB’s then estimated start date for any stage of those Services
  which include cGMP fermentation activities, Customer shall pay LB a sum equal
  to the [**] that stage or those stages in question, which payment shall fall
  due to LB on or before the date of termination of such Services; or

  
	
  9.2.2

  	
   

  	
  in the event notice to
  terminate Services pursuant to this Clause 9.2 is issued to LB more than six
  (6) but not more than twelve (12) months before LB’s then estimated start
  date for any stage of those Services which include cGMP fermentation
  activities, Customer shall pay LB a sum equal to [**] of the full price of
  that stage or those stages in question; which payment shall fall due to LB on
  or before the date of termination of such Services; or

  
	
  9.2.3

  	
   

  	
  The obligation to make payment under Clause 9.2
  shall be reduced (retrospectively, and hence LB shall make an appropriate
  refund to Customer) to the extent that LB mitigates its loss in this regard
  (and LB shall promptly notify the Customer of any such mitigation).  This provision shall not entitle the
  Customer to be refunded an amount greater than that paid by customer to LB
  pursuant to this Clause 9 and LB shall be entitled to deduct from the amount
  due to be refunded to Customer its reasonable personnel and associated costs
  in attempting to mitigate its loss. 
  For the avoidance of doubt LB shall be under no obligation to take any
  active steps to mitigate such loss.

  
	
  9.3

  	
   

  	
  For the avoidance of doubt activities relating to
  cGMP fermentation shall be deemed to commence with the date of removal of the
  vial of cells for the performance of the fermentation from frozen storage.

  
	
  9.4

  	
   

  	
  LB and the Customer may each terminate the Agreement
  forthwith by notice in writing to the other upon the occurrence of any of the
  following events:

  
	
  9.4.1

  	
   

  	
  if the other commits a material breach of the
  Agreement (which shall include a breach of the warranties set out in Clauses
  3 and 7 respectively) which in the case of a breach capable of remedy is not
  remedied within thirty (30) days of the receipt by the other of notice
  identifying the breach and requiring its remedy; or

  
	
  9.4.2

  	
   

  	
  if the other ceases for any reason to carry on
  business or compounds with or convenes a meeting of its creditors or has a
  receiver or manager appointed in respect of all or any part of its assets or
  is the subject of an application for an administration order or of any
  proposal for a voluntary arrangement or enters into liquidation (whether
  compulsorily or voluntarily) or undergoes any analogous act or proceedings
  under foreign law.

  
	
  9.5

  	
   

  	
  Upon the termination of the Agreement for whatever
  reason:

  
	
  9.5.1

  	
   

  	
  LB shall promptly return to the Customer all
  Customer Information and shall dispose of or return to the Customer the
  Customer Materials (and where supplied by Customer the Cell Line) and any
  materials therefrom, as directed by the Customer;

  
	
  9.5.2

  	
   

  	
  the Customer shall promptly return to LB all LB
  Know-How and LB Information it has received from LB;

  
	
  9.5.3

  	
   

  	
  the Customer shall not thereafter use or exploit the
  LB Patent Rights, the LB Know-How, or the L B Information in any way
  whatsoever;

  
	
  9.5.4

  	
   

  	
  LB and the Customer shall do all such acts and
  things and shall sign and execute all such deeds and documents as the other
  may reasonably require to evidence compliance with this Clause 9.5.

  
	
  9.6

  	
   

  	
  Termination of the Agreement for whatever reason
  shall not affect the accrued rights of either LB or the Customer arising
  under or out of this Agreement and all provisions which are expressed to
  survive the Agreement shall remain in full force and effect.

  
	
   

  	
   

  	
   

  
	
  10.

  	
   

  	
  Force Majeure

  
	
   

  	
   

  	
   

  
	
  10.1

  	
   

  	
  If LB is prevented or delayed in the performance of
  any of its obligations under the Agreement by Force Majeure and shall give
  written notice thereof to the Customer specifying the matters constituting
  Force Majeure together with such evidence as LB reasonably can give and
  specifying the period for which it is estimated that such prevention or delay
  will continue, LB shall be excused from the performance or the

  



 


24

















 


	
   

  	
   

  	
  punctual performance of such obligations as the case
  may be from the date of such notice for so long as such cause of prevention
  or delay shall continue.

  
	
  10.2

  	
   

  	
  The expression “Force Majeure” shall be deemed to
  include any cause affecting the performance by LB of the Agreement arising
  from or attributable to acts, events, acts of God, omissions or accidents
  beyond the reasonable control of LB.

  
	
   

  	
   

  	
   

  
	
  11.

  	
   

  	
  Governing Law, Jurisdiction and Enforceability

  
	
   

  	
   

  	
   

  
	
  11.1

  	
   

  	
  The construction, validity and performance of the
  Agreement shall be governed by the laws of England, and LB and the Customer
  submit to the non-exclusive jurisdiction of the Courts of England and Wales.

  
	
  11.2

  	
   

  	
  No failure or delay on the part of either LB or the
  Customer to exercise or enforce any rights conferred on it by the Agreement
  shall be construed or operate as a waiver thereof nor shall any single or
  partial exercise of any right, power or privilege or further exercise thereof
  operate so as to bar the exercise or enforcement thereof at any time or times
  thereafter.

  
	
  11.3

  	
   

  	
  The illegality or invalidity of any provision (or
  any part thereof) of the Agreement or these Standard Terms shall not affect
  the legality, validity or enforceability of the remainder of its provisions
  or the other parts of such provision as the case may be.

  
	
   

  	
   

  	
   

  
	
  12.

  	
   

  	
  Miscellaneous

  
	
   

  	
   

  	
   

  
	
  12.1

  	
   

  	
  Neither party shall be entitled to assign, transfer,
  charge or in any way make over the benefit and/or the burden of this
  Agreement without the prior written consent of the other which consent shall
  not be unreasonably withheld or delayed, save that both parties shall be
  entitled without prior written consent to assign, transfer, charge,
  sub-contract, deal with or in any other manner make over the benefit and/or
  burden of this Agreement to any company with which that party may merge, or
  transfer its assets and undertakings to any company, save that Customer shall
  not be permitted to make any assignment to a Competing Contract Manufacturer
  (as herein defined).

  
	
  12.2

  	
   

  	
  The text of any press release or other communication
  to be published by or in the media concerning the subject matter of the
  Agreement shall require the prior written approval of LB and the Customer.

  
	
  12.3

  	
   

  	
  The Agreement embodies the entire understanding of
  LB and the Customer and there are no promises, terms, conditions or
  obligations, oral or written, expressed on implied, other than those
  contained in the Agreement.  The terms
  of the Agreement shall supersede all previous agreements (if any) which may
  exist or have existed between LB and the Customer relating to the Services.

  
	
  12.4

  	
   

  	
  The parties to this Agreement do not intend that any
  term hereof should be enforceable by virtue of the Contracts (Rights of Third
  Parties) Act 1999 by any person who is not a party to this Agreement.

  



 


25