Exhibit
10.21


 


CONFIDENTIAL TREATMENT REQUESTED:


 


Portions of this Exhibit have been redacted
pursuant to a request for confidential treatment under Rule 24b-2 of the
General Rules and Regulations under the Securities Exchange Act of 1934,
as amended.  Such redacted portions have been replaced with “{***}” in this Exhibit.  An unredacted version of this document has
been filed separately with the Securities and Exchange Commission along with
the request for confidential treatment.


 


 


DATED 10th December 1998


 


 


(1)                                  LIFEHEALTH
LIMITED


 


 


AND


 


 


(2)                                  CAMBRIDGE
SELFCARE DIAGNOSTICS LIMITED


 


 






 


LICENCE AGREEMENT


 






 


 


Stringer Saul

17 Hanover Square

London W1R 9AJ


 

















 


Date: 10/12 1998


 


Parties:


 


1                                          LIFEHEALTH LIMITED an English company
registered under number 3017293 whose registered office is at Richmond House,
Old Brewery Court, Sandyford Road, Newcastle-upon-Tyne, NE2 1XG (“Lifehealth”).


 


2                                          CAMBRIDGE SELFCARE DIAGNOSTICS LIMITED an English
company registered under number 2039082 whose registered office is at Richmond
House, Old Brewery Court, Sandyford Road, Newcastle-upon-Tyne, NE2 1XG (“CSD”).


 


Recitals:


 


(A)                              Pursuant
to an agreement dated 29 May 1995 between Lifehealth and Roche, Lifehealth
acquired the rights to manufacture, use, sell or otherwise deal in certain
products, including the Product (as hereinafter defined) in the United Kingdom
and the Republic of Ireland.


 


(B)                                Pursuant
to an agreement dated 18 July 1995 between the parties, Lifehealth granted
to CSD a licence to manufacture, use, sell or otherwise deal in certain
products, including the Product in the United Kingdom and the Republic of
Ireland.


 


(C)                                Pursuant
to agreements between Roche and Lifehealth dated 04 August 1997 and 16 September 1997
Lifehealth has acquired the rights to manufacture, use, sell or otherwise deal
in the Product for all countries in the world excluding the United Kingdom and
the Republic of Ireland.


 


(D)                               The
parties have agreed that Lifehealth shall grant to CSD a licence to
manufacture, use, sell or otherwise deal in the Product for all countries in
the world subject to the terms and conditions set forth herein and that this
agreement should replace the terms of the agreement of 18 July 1995 in so
far as it relates to the Product.


 


Operative
provisions:


 


1.                                      Definitions


 


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


 


	
   

  	
  ‘Commercial Life’

  	
  means for so long as any market exists for the relevant product in
  any country which results in sufficient demand to make the continued
  production and sale of the relevant product commercially viable.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Confidential information’

  	
  means any and all information of a proprietary or confidential nature
  relating to the Product,

  



 

















 


	
   

  	
   

  	
  including, without limitation, the Information, information relating
  to Improvements, price data and customer lists whether disclosed (orally or
  in writing) and/or whether acquired prior to or pursuant to this Agreement.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘CSD’s Cost of Goods’

  	
  includes, without limitation:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  the costs of procuring all raw materials including (without
  limitation) purchase costs of the raw materials and costs incurred in their
  delivery to CSD or any contract manufacturer engaged by CSD; and

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  sums paid for the services of any contract manufacturer in the
  manufacturing of the Product and for delivery of the Product when so
  manufactured to CSD’s premises PROVIDED that the parties will consult in good
  faith with a view to agreeing an appropriate figure for this item, it being
  acknowledged that if any contract manufacturer manufactures other products
  for CSD in addition to the Product a fair allocation needs to be made between
  all the products so manufactured of the total of such costs of manufacture
  and delivery; and

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  costs incurred in preparing cartons, leaflets and any foil or other
  packaging for the Products (including, without limitation, artwork,
  organisation and printing costs); and

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (d)

  	
  tooling costs incurred by CSD with Lifehealth’s consent for equipment
  to manufacture the Product PROVIDED that Lifehealth may not withhold its
  consent to the incurring of any costs if the tooling in question is required
  in order for the Product to comply with any requirements of a Regulatory
  Authority.

  



 


2

















 


	
   

  	
  ‘Development Plan’

  	
  means the plan, to be agreed between the parties, pertaining to CSD
  seeking, obtaining and maintaining Marketing Authorisations for the Product
  in counties in the Territory

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Effective Date’

  	
  means the date of signature of this Agreement

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Financial Year’

  	
  means each period of twelve months from the 1st of July to the
  30th of June.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Improvements’

  	
  means all improvements, modifications or adaptations to any part of
  the Information and/or the Product which might reasonably be of commercial
  interest to either party in the design manufacture or supply of the Product
  and which may be made or acquired by either party during the term of this
  Agreement.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Information’

  	
  means all identifiable know-how, clinical reports, studies and
  pre-clinical studies, experience, data and all other technical or commercial
  information of Lifehealth relating to the Product whether in human or machine
  readable form and whether stored electronically or otherwise and which might
  reasonably be of commercial interest to either party in the design
  manufacture or supply of the Product or in seeking, obtaining, varying and
  maintaining any Marketing Authorisations.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Interest’

  	
  means interest (both before and after judgement) calculated at the
  rate of {***}† above the base rate from time to time of Lifehealth’s bankers
  compounded with quarterly rests.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Marketing Authorisation’

  	
  means the regulatory approval or approvals from a Regulatory
  Authority permitting the holder of the approval to market the Product in a
  country in the Territory.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Marketing Plan’

  	
  means the five (5) year plan pertaining to the marketing of the
  Product to be agreed between the parties and updated annually by mutual

  



 






† Represents material which
has been redacted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment pursuant to
Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 


3

















 


	
   

  	
   

  	
  agreement between the parties pursuant to this Agreement.

  
	
   

  	
   

  	
   

  
	
   

  	
  {***}†

  	
  {***}†

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Product’

  	
  means any pharmaceutical preparation and/or product containing
  Tetrabenazine.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Regulatory Authority’

  	
  shall mean the Medicines Control Agency in respect of the United Kingdom,
  the FDA in respect of the United States and such equivalent authority in
  respect of each of the other countries in the Territory.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Roche’

  	
  means Roche Products Limited.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Roche Agreements’

  	
  mean the agreements between Roche and Lifehealth dated 29
  May 1995, 04 August 1997 and 16 September 1997.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Specification’

  	
  means, in relation to any country in the Territory, the specification
  for the Product as appears in the Marketing Authorisation for the Product in
  the relevant country in the Territory.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Territory’

  	
  means all countries in the world.

  
	
   

  	
   

  	
   

  
	
   

  	
  ‘Total Net Receipts’

  	
  means the total monies actually received by CSD resulting from sales
  of the Product (including, for the avoidance of doubt and without limitation,
  any sums actually received by CSD from any insurer in respect of any Product
  which may be lost, damaged and/or destroyed) after deduction of VAT and any
  charges payable in respect of transport or insurance included therein but
  shall exclude extraordinary payments made to CSD by third parties for the
  acquisition by those third parties of any rights in relation to the Product,
  such payments to be dealt with in the manner set forth in Clause 6.9

  



 






† Represents material which
has been redacted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment pursuant to
Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 


4














 


2.             Grant of rights


 


2.1           The terms of this Agreement replace the
terms of the agreement between the parties dated 18 July 1995 in so far as
it relates to the Product. Otherwise the agreement dated 18 July 1995
shall remain in full force and effect.


 


2.2           For the term of this Agreement Lifehealth,
to the extent that it is capable of doing so, hereby grants to CSD:


 


2.2.1        an exclusive
licence to use its Information to manufacture Product and to seek, obtain, vary
and maintain, where possible, in the name of Lifehealth, Marketing
Authorisations and manufacturing licences for the Product; and


 


2.2.2        an exclusive
licence to use, sell, market, promote or otherwise deal in the Product
manufactured under the licence of clause 2.2.1 anywhere in the Territory.


 


2.3           The parties shall be entitled to
sub-license any wholly owned subsidiary (as defined in s 736 of the Companies
Act 1985 as amended) of the parties for so long as it is such a wholly-owned
subsidiary under the rights granted or to be granted under clause 2.2 hereof
provided that


 


2.3.1        the sub-licence
is in writing and contains obligations on the sub-licensee at least as onerous
as those set out in this Agreement; and


              


2.3.2        the parties shall
remain responsible for any and all acts and/or omissions of their sub-licensees
as though they were the acts and/or omissions of themselves under this
Agreement; and


              


2.3.3        the party
granting the sub-licence shall forthwith notify the other party in writing of
any sub-licence granted pursuant to this clause and shall at the same time
provide the other party with a copy of such sub-licence.


 


2.4           CSD shall have the right to grant
sub-licenses of any of the rights licensed under clause 2.2 and/or appoint
agents or distributors for the Product and/or to subcontract the manufacture of
the Product, to a third party (save that CSD shall not have the right to
sub-licence any such rights to a third party in respect of the United Kingdom)
on condition that CSD obtains the prior written approval of Lifehealth to the
identity of such person and the terms of their appointment. Lifehealth’s
approval to any such agreement and/or appointment shall not be unreasonably
withheld or delayed.


 


2.5           In the case of any sub-license granted by
CSD under the terms of this Agreement the terms of such sub-licence shall not
permit the sub-licensee to further sub-license the rights granted to them save
where Lifehealth has agreed in writing that a sub-licensee may have the right
to further sub-licence the rights granted.


 


2.6           CSD shall use its reasonable endeavours to
ensure that any person appointed by it pursuant to clause 2.4 above complies
with the terms of their appointment and that such person is restrained, to the
fullest extent permissible by law, from manufacturing and 


 


5

















 


distributing in competition to CSD, Lifehealth and/or
other persons appointed under this Agreement in relation to the Product.


 


2.7           Both parties agree to the fullest extent
permitted by law that they will not be involved directly or indirectly in the
manufacture, development, production, distribution, sale, promotion and/or
marketing of any Tetrabenazine product competitive to the Product without the
prior written consent of the other party such consent not to be unreasonably withheld
or delayed.


 


3.             Technical information


 


3.1           The parties acknowledge that, pursuant to
the agreement between them dated 18 July 1995 some of the Information in
Lifehealth’s possession that is reasonably necessary or desirable to enable CSD
to design, manufacture on a commercial scale and sell the Product has already
been provided to CSD as has all technical assistance. Within 30 days of the
Effective Date Lifehealth shall provide to CSD any other Information in its
possession which will assist CSD to design, manufacture on a commercial scale
and sell the Product and seek, obtain, vary and maintain Marketing
Authorisations and manufacturing licences for the Product.


 


3.2           Lifehealth warrants that all Information
disclosed to CSD by Lifehealth is, to the best of Lifehealth’s knowledge and
belief, accurate (provided always that Lifehealth will promptly correct any
significant errors in the Information subsequently discovered by Lifehealth or
CSD which CSD notifies in writing to Lifehealth and promptly inform CSD of any
changes to the Information).


 


4.             Improvements


 


4.1           Each party shall forthwith disclose to the
other in confidence and in such detail as that other may reasonably require all
Improvements that it may develop or acquire during the term of this Agreement
except in so far as such disclosure would disclose information derived from and
subject to confidentiality obligations in favour of a third party.


 


4.2           Save as otherwise provided herein,
Improvements arising from work carried out by and/or on behalf of either
Lifehealth or CSD shall be jointly owned by the parties. Neither party shall
license and/or exploit such Improvements in any way without the consent of the
other party.


 


5.             Confidentiality


 


5.1           Each party agrees to maintain secret and
confidential all Confidential Information and to use the same exclusively for
the purposes of this Agreement, and to disclose the same only to those of its
employees, contractors and sub-licensees pursuant to this Agreement (if any) to
whom and to the extent that such disclosure is reasonably necessary for the
purposes of this Agreement.


 


6

















 


5.2           The foregoing obligations of clause 5.1
above shall not apply to Confidential Information or other information which:


 


5.2.1        is or becomes
generally available to the public in eye readable form (except where due to a
breach of the terms of this Agreement or the agreement dated 18th
July 1995 or breach of the terms of appointment of any person appointed by
either party under this Agreement); or


 


5.2.2        is required to be
disclosed by an order of a court or other tribunal of competent jurisdiction.


 


5.3           The parties acknowledge that it will be
necessary to disclose Confidential Information to consultants, agents,
licensees, distributors or agents of CSD or any third party engaged by CSD to
prepare submissions or applications to Regulatory Authorities. CSD shall
ensure, prior to disclosure to any such person, that the intended recipient has
signed a confidentiality agreement on terms no less onerous than the provisions
in this Agreement and that such terms have been approved by Lifehealth (such
approval not to be unreasonably withheld or delayed).


 


5.4           Notwithstanding the foregoing provisions
the parties and any sub-licensees pursuant to this Agreement shall be entitled
to disclose the Information to actual or potential customers for the Product in
so far as such disclosure is reasonably necessary to promote the sale or use of
Product.


 


5.5           Each party shall procure that all its
employees, contractors and sub-licensees pursuant to this Agreement (if any)
who have access to any Confidential Information of the other to which the
obligations of clause 5.1 apply shall be made aware of and subject to these
obligations.


 


6.             Payment


 


6.1           CSD shall pay to Lifehealth {***}† of the
{***}† which shall be calculated in accordance with the following:


 


6.1.1        No later than the
10th day of October of each year following the
Effective Date CSD shall supply to Lifehealth an audited certificate produced
by its auditors showing the Total Net Receipts and the sum of {***}† referred
to in the definition of {***}† for the Financial Year ending 30 June in
that year.


 


6.1.2        At any time
following receipt of the said audited certificate Lifehealth may submit to CSD
an invoice for {***}† of the {***}† shown therein and CSD agrees to pay to
Lifehealth such of that amount as, at the date of the invoice, has not already
been paid to Lifehealth, plus VAT thereon (in so far as is applicable) at the
appropriate rate no later than 14 days after receipt of the said invoice.


 






† Represents
material which has been redacted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 


7

















 


6.2           In the event that, in respect of any
Financial Year, the sum of {***}† referred to in the definition of {***}† exceeds the Total Net
Receipts for that period, CSD shall be entitled to recoup from any {***}† payable to Lifehealth in the
future a sum equal to {***}† of the amount by which the sum of {***}†
referred to in the definition of {***}† exceeds the Total Net
Receipts for that period.


 


6.3           CSD shall account direct to Roche (or to
any such other party, if any, as may be entitled thereto) for the amount of any
royalties due to be paid pursuant to the Roche Agreements.


 


6.4           Should CSD become aware that the cumulative
sum of the Total Net Receipts in any Financial Year of the Agreement have
exceeded {***}† CSD shall notify Lifehealth of such in writing and
thereafter, subject to the following, payments to Lifehealth of its {***}† of the {***}† based on management accounts
prepared by CSD shall be made quarterly within thirty (30) days of the end of
each quarter of the Financial Year in respect of the {***}† from the Total Net Receipts
in excess of {***}† SAVE THAT the parties acknowledge that CSD’s priority
is to apply such funds as are necessary to meet the obligations jointly agreed
under the Marketing Plan and the Development Plan and thus CSD shall make any
quarterly payments contemplated hereunder only when that can be done without
jeopardising the ability of CSD to achieve the objectives jointly agreed
pursuant to the Marketing Plan and the Development Plan.


 


6.5           Should CSD become aware that the cumulative
sum of the Total Net Receipts in any Financial Year of the Agreement has
exceeded {***}† CSD shall notify Lifehealth of such in writing and
thereafter, subject to the following, payments to Lifehealth of its {***}† of the {***}† based on management accounts
prepared by CSD shall be made monthly within thirty (30) days of the end of
each month of the Financial Year in respect of the {***}† from the Total Net Receipts
in excess of {***}† SAVE THAT the parties acknowledge that CSD’s priority
is to apply such funds as are necessary to meet the obligations jointly agreed
under the Development Plan and the Marketing Plan and thus CSD shall make any
monthly payments contemplated hereunder only when that can be done without
jeopardising the ability of CSD to achieve the objectives jointly agreed in the
Marketing Plan and the Development Plan.


 


6.6           The parties agree that the {***}† is to be shared {***}† between the parties subject
to the terms set forth in this Agreement. If interim payments have been made to
Lifehealth under clauses 6.4 and/or 6.5 the parties shall carry out an
appropriate reconciliation once the {***}† has been determined in
accordance with clauses 6.1 and 7.2 so that each party receives {***}† of the {***}† for any Financial Year and
both parties agree to make any payments that are necessary to achieve that end.
All sums due under this Agreement shall be paid in Sterling to the credit of
the recipient’s bank account to be designated in writing by the recipient and
shall be made in full without deduction of taxes charges and other duties that
may be imposed except in so far as any such deduction may be credited in full
by Lifehealth against Lifehealth’s own tax liabilities (except in relation to
VAT). The 


 






† Represents material which
has been redacted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment pursuant to Rule 24b-2
under the Securities Exchange Act of 1934, as amended.


 


8

















 


parties agree to co-operate in all respects necessary
to take advantage of such double taxation agreements as may be available.


 


6.7           If part of the Total Net Receipts shall not
be received by CSD in Sterling then it shall be convened to Sterling for the
purposes of calculation of the Total Net Receipts at the exchange rate at which
CSD does actually convert it to Sterling or if it is not so converted within
the relevant period the exchange rate shall be deemed to be the spot rate for
Sterling quoted by Lifehealth’s bankers at close of business on the business
day immediately on which the monies were received by CSD.


 


6.8           The parties shall, save as provided herein,
share equally any extraordinary payments made to CSD by third parties for the
acquisition by those third parties of any rights pertaining to the Product.
Save as provided herein, CSD shall pay to Lifehealth, within seven (7) days
of clearance of any such extraordinary payment contemplated herein, an amount
equal to {***}† of that extraordinary payment.


 


6.9           If as a requirement of the agreement giving
rise to an extraordinary payment CSD is obliged to incur costs and/or expenses,
including, but not limited to, a requirement to develop or further develop the
Product, which has not already been provided for in the allocation of funds to
implement the Development Plan and/or Marketing Plan then the parties shall
meet to agree any necessary revisions to the Development Plan and/or Marketing
Plan as appropriate.


 


6.10         If at the time of receipt of any
extraordinary payment there exists a carried forward shortfall under clause 6.2
and/or the agreement giving rise to the extraordinary payment imposes an
immediate obligation upon CSD to expend any costs or expenses not provided for
in the Development Plan and/or Marketing Plan which cannot be met out of the
then Total Net Receipts then CSD shall be entitled to deduct and retain from
the extraordinary payment the amount of the shortfall and/or such costs and
expenses and CSD shall pay to Lifehealth, within seven (7) days of receipt
of the extraordinary payment {***}† of the balance remaining of the
extraordinary payment. The amount deducted shall form part of the Total Net
Receipts and the amount of any immediate actual costs and expenses incurred
shall be included in those items {***}† the Total Net Receipts to
give the {***}†.


 


7.             Records and reports


 


7.1           CSD agrees to keep true and accurate
records and books of account containing all data necessary for the
determination of Total Net Receipts and the {***}† which records and books of
account shall upon reasonable notice of Lifehealth be open at all reasonable
times during business hours for inspection by Lifehealth or an independent accountant
selected by Lifehealth and acceptable to CSD (which acceptance shall not be
unreasonably withheld) for the purpose of verifying the accuracy of CSD’s
reports 


 






† Represents material which
has been redacted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment pursuant to Rule 24b-2
under the Securities Exchange Act of 1934, as amended.


 


9

















 


hereunder. The accountant may take copies of the records
and books of account but shall not disclose to Lifehealth any information
relating to the business or affairs of CSD other than such information as
relates to the calculation of the Total Net Receipts and {***}†. Lifehealth
shall be solely responsible for the costs of the accountant.


 


7.2           If the independent accountant appointed
pursuant to clause 7.1 above certifies that the amount of royalties due to
Lifehealth in respect of any period differs from the amount of royalties
actually paid to Lifehealth for that period then CSD shall forthwith pay such
shortfall plus Interest thereon to Lifehealth upon Lifehealth serving a copy of
such certificate upon CSD. If the shortfall for that period exceeds five
percent (5%) of the amount actually paid for that period and the reason for
such variation is the failure of CSD to provide to its auditors correct or
sufficient information then CSD shall also reimburse Lifehealth for the costs
of the independent accountant.


 


7.3           CSD shall maintain a register of agreements
entered into in carrying out its obligations under this agreement including but
not limited to all sub-licence, agency, distribution confidentiality,
consultancy, technical and contract manufacturing agreements. Lifehealth shall
have the right to inspect said register of agreements during normal working
hours and on the provision of reasonable notice. In the event that Lifehealth
signs a confidentiality or other such agreement pertaining to the Product, the
Information or the Improvements, it shall provide a copy of such to CSD and CSD
shall place of copy of any such agreement in the register of agreements.


 


7.4           Lifehealth agrees to maintain confidential
all financial information received with respect to CSD’s operations pursuant to
the foregoing clauses 6.1 and 7.1.


 


8.             Regulatory Approvals and
Development Plan


 


8.1           As soon as practicable following the
Effective Date the parties shall agree the Development Plan. The Development
Plan shall address, amongst other things, the proposed activities of the
parties with regard to the seeking, obtaining, varying and maintaining of
Marketing Authorisations, the costs of implementing the proposed activities,
the time frame within which the proposed activities are to be achieved, the
procedure for the review of the proposed objectives and a non-binding forecast
by CSD of the Total Net Receipts and {***}† for the next Financial Year
of the Agreement and a non-binding forecast of its anticipated expenditure in
carrying out its obligations pursuant to this Agreement and the Development
Plan for the next two (2) Financial Years (hereinafter “the Anticipated
Expenditure”). The Anticipated Expenditure for any year should not exceed the
forecast {***}† for that year except by written agreement of the
parties.


 






† Represents material which
has been redacted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment pursuant to Rule 24b-2
under the Securities Exchange Act of 1934, as amended.


 


10

















 


8.2           The Development Plan shall be reviewed and
revised bi-monthly at meetings which shall take place between the parties. At
those bi-monthly meetings the parties shall agree the level of expenditure to
be committed to the Development Plan.


 


8.3           Lifehealth shall during the agreement of
the Development Plan, at each revision of the Development Plan and otherwise
upon request by CSD provide advice concerning the Product and such other
strategic advice as is required or requested.


 


8.4           Should CSD encounter any obstacle to
achieving one of the objectives in the Development Plan such that achieving
that objective becomes, in the opinion of CSD, economically undesirable, the
parties shall meet to discuss the difficulty encountered by CSD and endeavour
to determine a strategy to overcome the difficulty.


 


8.5           Lifehealth shall provide to CSD, at the
cost of Lifehealth, all information in its possession regarding the Product so
as to assist CSD in obtaining Marketing Authorisations.


 


8.6           CSD shall be responsible, either by itself
or through agents, consultants, distributors or licensees appointed by CSD with
the prior approval of Lifehealth, for preparing and submitting all applications
for Marketing Authorisations and/or manufacturing licences and variations or
renewals of the same in countries in the Territory save that Lifehealth shall
provide such assistance in carrying out the said tasks as CSD reasonably
requests.


 


8.7           All Marketing Authorisations shall be in
the name of Lifehealth unless such is not possible or the parties agree
otherwise. CSD shall ensure, to the extent that it is permissible under the
laws of the relevant part of the Territory, that all Marketing Authorisations
which are not in the name of Lifehealth shall be capable of assignment to
Lifehealth or its nominee.


 


8.8           Upon termination of the agreement with the
holder of the Marketing Authorisation and the request of Lifehealth, CSD shall
procure, to the extent that it is legally permissible to do so and at the cost
of Lifehealth, that the relevant Marketing Authorisation is assigned to
Lifehealth or its nominee. Upon the termination of this Agreement and the
request of Lifehealth, CSD shall procure , to the extent that it is legally
permissible to do so and at the cost of Lifehealth, that all Marketing
Authorisations are assigned to Lifehealth or its nominee.


 


8.9           For the avoidance of doubt, CSD shall be in
control of the day to day conduct and implementation of the Development Plan.


 


8.10         In the event that CSD decides, with the
written agreement of Lifehealth, to pay any sum in respect of any objective in
the Development Plan or to bring about commercial advantage to the parties in
respect of the sales or distribution of the Product which will 


 


11

















 


result in the sum of {***}† referred to in the
definition of {***}† exceeding the Total Net Receipts for that
period, the provisions of clause 6.2 shall apply.


 


8.11         Should any regulatory authority, court of
law or governmental body or agency in any country in the Territory require
discontinuance of the sale of the Product in that country, then the Product
shall be withdrawn from sale in that country and the associated costs
(including the repurchase of relevant stock Product where commercially
desirable or CSD is obliged to do so) shall be {***}† the Total Net Receipts
for the purposes of calculating the {***}†.


 


8.12         Should the parties :


 


8.12.1      agree that the
Product has reached the end of its useful Commercial Life in the Territory or
any part thereof; or


 


8.12.2      agree to cease
implementation of the Development Plan


 


they shall ensure
that all relevant costs have been paid from the Total Net Receipts and to this
end shall produce all necessary statements and make all necessary payments.


 


9.             Marketing Plan


 


9.1           The parties shall, within ninety (90) days
of the Effective Date, agree the Marketing Plan setting forth details of the
manner in which the Product will be marketed in the Territory for the
immediately succeeding five (5) years of the Term of this Agreement.


 


9.2           Within sixty (60) days of the each
anniversary of the Effective Date the parties shall review and revise the
Marketing Plan by mutual agreement.


 


9.3           The parties shall, in determining the
Marketing Plan and any amendment to or revision of the Marketing Plan, take
account of the reasonable strategic importance of any country in the Territory
to the overall marketing strategy for the Product, the likely commercial return
to be made in marketing the Product in a particular country in the Territory
and the financial resources available to the parties to market the Product in a
particular country in the Territory.


 


9.4           In the event that Lifehealth, for {***}†
years, seeks to revise the Marketing Plan so as to include commencement of marketing
of the Product in a particular country in the Territory and CSD, for those {***}†
does not agree with such a revision and the reason for CSD’s unwillingness to
agree to the revision relates to 


 






† Represents material which
has been redacted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment pursuant to
Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 


12

















 


factors other than those set forth in clause 9.3,
Lifehealth may, by written notice, terminate this Agreement only insofar as it
relates to the country in issue.


 


10.          Performance


 


10.1         During the continuance of this Agreement
CSD shall:


 


10.1.1      carry out the
Marketing Plan and the Development Plan as widely as its resources reasonably
permit;


 


10.1.2      ensure that all
Product supplied by CSD complies with the Specifications and is manufactured in
accordance with the requirements of any relevant Regulatory Authority and shall
upon reasonable notice from Lifehealth give Lifehealth or its authorised
representative access at any reasonable time to the premises of CSD for the
purpose of ensuring that CSD is observing these obligations;


 


10.1.3      ensure that it
complies with all requirements of any Regulatory Authority in the Territory in
so far as such requirements relate to an acknowledgement to the effect that the
Product is subject to a licence from Lifehealth; and


 


10.1.4      not act as agent
of Lifehealth and specifically not give any indication that it is acting
otherwise than as principal and in advertising or selling Product not make any
representation or give any warranty on behalf of Lifehealth.


 


11.          Indemnities and Insurance


 


11.1         The parties have agreed that they shall be
jointly liable in equal shares for any liability arising pursuant to this
Agreement and accordingly the parties agree to indemnify and keep indemnified
the other party against any and all costs, damages, claims, expenses and/or
other liabilities arising from any third party claim (whether in contract, tort
or otherwise) concerning:-


 


11.1.1      the Product;


 


11.1.2      the Information;


 


11.1.3      the manufacture
of the Product;


 


11.1.4      the use of the
Product;


 


11.1.5      the packaging of
the Product;


 


11.1.6      the sale, distribution,
marketing or promotion of the Product;


 


11.1.7      the infringement
of the intellectual rights of a third party by the acts set forth previously in
this sub-clause, the Product or the Information; and/or


 


11.1.8      the negligence or
wilful malfeasance of either party;


 


13














 


provided that the
above indemnity shall not apply to any such liabilities which arise as a result
of any breach of any contract, any breach of duty of care and/or any acts
and/or omissions of the party claiming under the indemnity which have not been
approved by the party not claiming under the indemnity.


 


11.2         In relation to clause 11.1 above a matter
agreed in the Development Plan, Marketing Plan or otherwise agreed in writing
or at any meeting between the parties shall be deemed approved for the purposes
of clause 11.1 provided that full disclosure of all relevant information and
factors of which each party is aware have been made to the other party before
reaching such agreement.


 


11.3         In the event that a claim is made by any
third party in any country in the Territory against either of the parties
relating to this Agreement details of the claim shall be sent, as soon as is
practicable, by the party that received the claim to the other party. The
parties shall discuss and agree a course of action for dealing with the claim
including but not limited to whether the claim will be defended and the means
by which the claim will be defended, how the parties will pay the legal costs
of the action and how the parties will pay any award of damages and/or costs made
against either of them.


 


11.4         Both parties shall ensure that they have in
place and maintain product liability insurance with a reputable insurer to
cover the risks associated with this Agreement to the value of {***}†. Either
party shall, on the request of the other party, provide evidence of the
existence and maintenance of such insurance. If possible, such insurance shall
be in the joint names of the parties, or in the alternative note the interest
of the other party. The cost of taking out and maintaining such insurance shall
be an expense to be deducted from the Total Net Receipts. Each year the parties
shall review and if necessary alter the extent of cover under the joint
insurance policy.


 


11.5         Neither party shall be liable to the other
to the extent that the other party’s loss, claim, damages, costs, expenses,
award and/or other liability is covered by a policy of insurance.


 


11.6         Nothing in this Agreement shall exclude
and/or limit the liability of either party for death or personal injury due to its
negligence or any other liability which it is not permitted to exclude or limit
as a matter of law.


 


12.          Intellectual property


 


12.1         To the best of Lifehealth’s knowledge and
belief the exercise of the rights granted or to be granted to CSD hereunder will
not result in the infringement of valid patents or other intellectual property
rights of third parties.


 


12.2         Where the parties have developed or
acquired an Improvement to which clause 4 above applies they shall not publish
the same or do anything that might prejudice the validity of 


 






† Represents material which
has been redacted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment pursuant to Rule 24b-2
under the Securities Exchange Act of 1934, as amended.


 


14

















 


any patent that might subsequently be granted on it
until the parties have agreed on whether or not patent protection will be
sought for the Improvement.


 


12.3         CSD shall sell the Product under its
generic name unless the parties mutually agree otherwise.


 


13.          Packaging


 


13.1         CSD shall be responsible for ensuring that
all packaging, labelling, inserts and Patient Information Leaflets comply with
the laws and requirements of Regulatory Authorities of the countries in the
Territory where the Product is sold.


 


13.2         CSD shall provide to Lifehealth a printers’
proofs of the final draft of any labelling, packaging, package inserts and
Product Information Leaflets for approval. For countries in the Territory where
Lifehealth is the holder of the Marketing Authorisation, Lifehealth shall
notify CSD within five (5) working days if it requires any changes to be
made to the printers’ proofs unless Lifehealth has notified CSD that its
representative who would check such printer’s proof is unavailable for any
period due to holiday or illness in which case such period of 5 days shall not
commence until that person returns to work. Failure by Lifehealth to provide
such notice within the required time period shall constitute acceptance of the
printers’ proofs.


 


13.3         Any substantive changes in the packaging
shall be discussed and agreed between the parties pursuant to the Development
Plan


 


14.          Warranties


 


14.1         In addition to any other warranties and representations
set forth elsewhere in this Agreement, Lifehealth hereby warrants:


 


14.1.1      that it has
acquired the rights to manufacture, use, sell and distribute the Product from
Roche as set forth in the recitals to this Agreement;


 


14.1.2      that it is not aware
of any issued or pending patent or any other intellectual property right of any
third party which could be infringed by CSD in carrying out its obligations
under this Agreement;


 


14.1.3      that it has no
knowledge of the existence of any data, clinical or otherwise, which suggests
there may exist safety and/or efficacy concerns with the Product for any
application of the Product; and


 


14.1.4      that it has not
developed or acquired the rights to any product, device or system that is or is
likely to be directly competitive with the Product.


 


14.2         In addition to any representations and
warranties set forth elsewhere in this Agreement CSD hereby warrants:-


 


15

















 


14.2.1      that it will
comply with all laws pertaining to the packaging, manufacture, marketing or
sale of the Product in any country in the Territory in which it manufactures
and/or sells the Product;


 


14.2.2      that it will
manufacture the Product or have it manufactured to Specification and in
accordance with any applicable requirements of any Regulatory Authority in the
countries in which the Product is manufactured and/or sold; and


 


14.2.3      that it has not
developed or acquired the rights to any product, device or system that is or is
likely to be directly competitive with the Product.


 


14.3         In addition to any representations and
warranties set forth elsewhere in this Agreement, each party hereby warrants to
the other:-


 


14.3.1      that they have
the corporate power and authority to execute and deliver this agreement and to
carry out all the terms and provisions hereof in so far as they apply to each
other respectively;


 


14.3.2      that they are not
prevented from entering into any of the obligations set forth in this
Agreement; and


 


14.3.3      that the
execution and delivery of this Agreement has been duly authorised by all
necessary corporate action.


 


15.          Product Recall and Adverse
Events Procedures


 


15.1         In the event that it proves necessary to
recall any quantity of the Product, the parties shall follow the product recall
procedure set forth in Schedule 2 to this Agreement as amended from time to
time.


 


15.2         Should any adverse event occur concerning
the Product the parties shall follow the procedure set forth in Schedule 1 to
this Agreement as amended from time to time.


 


16.          Term and termination


 


16.1         Unless terminated earlier in accordance
with the following provisions of this clause this Agreement shall continue for
the Commercial Life of the Product in the Territory.


 


16.2         If either party is in breach of any
obligation on it hereunder and, in the case of a breach capable of remedy, it
shall not have been remedied by the defaulting party within 30 days of written
notice specifying the breach and requiring its remedy, or if either party
becomes insolvent, has a receiver appointed over the whole or any part of its
assets, enters into any compound with creditors, or has an order made or
resolution passed for it to be wound up (otherwise than in furtherance of a
scheme for amalgamation or reconstruction) then the other party or in the case
of breach the parry not in breach of the obligation or condition may forthwith
terminate this Agreement by written notice without prejudice to the accrued
rights of either party.


 


16

















 


16.3         Termination of this Agreement for any
reason shall not bring to an end:


 


16.3.1      the
confidentiality obligations on the parties hereto;


 


16.3.2      CSD’s obligations
to pay sums which have accrued due or which will become due in respect of sales
of the Product;


 


16.3.3      the obligations
on the parties pursuant to clauses 4, 5, 6, 7, 8.7, 11, and 16;


 


16.4         On termination of this Agreement for any
reason CSD shall continue to have the right for a period of 12 months from the
date of termination to complete deliveries on contracts in force at that date
and to dispose of Product already manufactured subject to payment to Lifehealth
of sums thereon in accordance with the terms set forth in this Agreement.


 


16.5         On termination of this Agreement for any
reason CSD shall offer to Lifehealth, save as is necessary for the performance
of obligations under clause 16.4, at cost all stocks of Product and promotional
and other literature relating thereto in its possession or control and shall
provide Lifehealth with all reasonable facilities to inspect the same.


 


16.6         On termination of this Agreement for any
reason CSD shall deliver up to Lifehealth all production manuals and all other
documents or materials whether human or machine readable and whether stored
electronically or otherwise (including copies thereof) in its possession or
control containing Information remaining subject to the confidentiality
obligations of clause 5 hereof.


 


16.7         On termination of this Agreement for any
reason the parties shall undertake an account to each other for sums paid
pursuant to this Agreement in the same manner as would normally take place
after each Financial Year of this Agreement under clause 6 hereof.


 


16.8         In the event of termination of this
Agreement for breach of the Agreement the party in breach shall cease to have
the right to utilise the Improvements and all rights in the Improvements shall
vest in the party not in breach.


 


16.9         On the termination of this Agreement for
any reason CSD (save where expressly permitted by this Agreement) shall not
anywhere in the Territory for a period of 12 months after such termination be
involved directly or indirectly in the manufacture, development, production,
distribution, sale, promotion and/or marketing of any Product in competition
with Lifehealth and/or its agents, licensees and distributors.


 


16.10       For the avoidance of doubt on the
termination of this Agreement for any reason CSD shall not use any Confidential
Information (for so long as it remains confidential pursuant to clause 5.2)
directly or indirectly in the manufacture, development, production,
distribution, sale, promotion and/or marketing of any Product.


 


17.          Force majeure


 


17.1         If either party to this Agreement is
prevented or delayed in the performance of any of its obligations under this
Agreement by force majeure, and if such party gives written notice 


 


17

















 


thereof to the other party specifying the matters
constituting force majeure, together with such evidence as it reasonably can
give and specifying the period for which it is estimated that such prevention
or delay will continue then the party in question shall be excused the
performance or the punctual performance as the case may be as from the date of
such notice for so long as such cause of prevention or delay shall continue up
to a maximum period of 3 months.


 


17.2         If the event of force majeure persists for
a period of 3 months from the date of notification of such as provided for in
clause 17.1 above, either party may, by written notice to the other, terminate
this Agreement.


 


17.3         For the purpose of this Agreement ‘force
majeure’ shall be deemed to be any cause affecting the performance of this
Agreement arising from or attributable to acts, events, omissions or accidents
beyond the reasonable control of the party to perform and without prejudice to
the generality thereof shall include the following:


 


17.3.1      strikes,
lock-outs or other industrial action;


 


17.3.2      civil commotion,
riot, invasion, war threat or preparation for war;


 


17.3.3      fire, explosion,
storm, flood, earthquake, subsidence, epidemic or other natural physical
disaster;


 


17.3.4      impossibility of
the use of railways, shipping, aircraft, motor transport or other means of
public or private transport; and


 


17.3.5      political
interference with the normal operations of any party.


 


18.          General


 


18.1         This Agreement shall be binding upon and
enure to the benefit of the parties hereto and their respective legal
successors but shall not otherwise be assignable by either party without the
prior written consent of the other which consent shall not be unreasonably
withheld.


 


18.2         This Agreement constitutes the entire
agreement and understanding of the parties and supersedes all prior written or
oral representations agreements or understandings between them relating to the
subject matter of this Agreement other than any false misrepresentation made by
a party to induce the other party to enter into this Agreement.


 


18.3         No variation or amendment of this Agreement
shall bind either party unless made in writing and agreed to in writing by duly
authorised officers of both parties.


 


18.4         If any provision of this Agreement is
agreed by the parties to be illegal void or unenforceable under any law that is
applicable hereto or if any court or other authority of competent jurisdiction
in a final decision so determines this Agreement shall continue in force save
that such provision shall be deemed to be excised herefrom with effect from the
date of such agreement or decision or such earlier date as the parties may
agree.


 


18

















 


18.5         The headings in this Agreement are for
convenience only and are not intended to have any legal effect.


 


18.6         A failure by either party hereto to
exercise or enforce any rights conferred upon it by this Agreement shall not be
deemed to be a waiver of any such rights or operate so as to bar the exercise
or enforcement thereof at any subsequent time or times.


 


18.7         Should Lifehealth receive an offer from a
third party to acquire a controlling interest in it or an offer from a third
party to purchase its business relating to the Product or should Lifehealth
decide that it wishes to sell its business relating to the Product it must
provide CSD with notice of the offer or the decision and CSD shall have first
option to negotiate to either purchase the business of or controlling interest
in Lifehealth. If CSD and Lifehealth do not agree terms for the purchase of the
business of or a controlling interest in Lifehealth within ninety (90) days of
CSD exercising its option hereunder, Lifehealth shall be entitled to continue
negotiations with the aforementioned third party or any other third party for
the acquisition by those third parties of the business of or controlling
interest in Lifehealth.


 


19.          Notices


 


19.1         Any notice required to be given hereunder
by either party to the other shall be in writing and shall be served by sending
the same by registered or recorded delivery post to the address of the other
party as given herein or to such other address as that party may have
previously notified to the party giving notice as its address for such service.


 


19.2         All notices documents communications and
any other data to be provided under this Agreement shall be in the English
language unless otherwise agreed.


 


20.          Governing law and disputes


 


20.1         The construction validity and performance
of this Agreement shall be governed in all respects by English Law.


 


20.2         All disputes arising in any way out of or
affecting this Agreement shall be subject to the non-exclusive jurisdiction of
the English courts to which the parties hereto agree to submit.


 


IN WITNESS
WHEREOF this Agreement was signed by the parties on the day of the year first
hereinbefore written


 


	
  Signed by Mark Evans

  	
  )

  	
   

  
	
  for and on behalf of

  	
  )

  	
  /s/          MARK
  EVANS

  
	
   

  	
   

  	
   

  
	
  CAMBRIDGE SELFCARE

  	
  )

  	
   

  
	
  DIAGNOSTICS LIMITED

  	
  )

  	
  /s/          P.
  MURRAY

  
	
  in the presence of:

  	
   

  	
   

  



 


19

















 


	
  Signed by

  	
  )

  	
   

  
	
  for and on behalf of

  	
  )

  	
   

  
	
  LIFEHEALTH LIMITED

  	
  )

  	
  /s/          P.
  MURRAY

  
	
  in the presence of

  	
   

  	
   

  



 


20

















 


SCHEDULE
1


 


ADVERSE
EXPERIENCE REPORTING


 


AND
PROVISION OF MEDICAL INFORMATION


 


1.             ADVERSE EXPERIENCE
REPORTING


 


CSD shall use its
reasonable endeavours to obtain and record written medical confirmation and
relevant detail of all suspected or alleged adverse reactions to the Product
reported to CSD or coming to its attention and shall ensure by means of a
written log that all such cases and the dossiers of information relating to
them are uniquely identified and retrievable.


 


1.2           CSD in accordance
with the attached reporting procedure:-


 


(a)           shall comply with
all legal and regulatory requirements in those countries  in the Territory in which the Product is sold
concerning the reporting of adverse experiences to the Product;


 


(b)           shall use all
reasonable efforts to inform Lifehealth within one working day CSD and
Lifehealth consult and agree course of action of all serious adverse reactions
to the Product of which it is aware or made aware of. In the event that a
serious adverse reaction is recorded, CSD and Lifehealth shall consult and
agree a course of action to deal with the serious adverse reaction;


 


(c)           shall respond
promptly to reasonable requests from Lifehealth for further information on any
adverse experience reported under (b) above; and


 


(d)           shall provide to
Lifehealth every six (6) months a report summarising all adverse
experiences or a report confirming no adverse experiences. Lifehealth and CSD
shall review the report provided hereunder and identify trends or changes in
pattern of adverse experience and agree a course of action to respond to any
such trends or changes;


 


2.             PROVISION OF MEDICAL
INFORMATION


 


2.1           CSD shall
provide, in so far is it is able, answers to questions raised by doctors or by
paramedical personnel or by any other persons entitled to such information.


 


2.2           Each party shall
provide to the other as soon as is practicable after it becomes aware of any
toxicological or any other information insofar as it relates to the Product
which is relevant to the use, indications and contra-indications or safety of
the Product.


 


2.3           Lifehealth shall
notify CSD of:


 


(a)           any revision of
clinical recommendations and precautions relevant to the Product; and


 


21

















 


(b)           toxicological or
any other information insofar as it relates to the Product which becomes
available to Lifehealth which is relevant to the use, indications and
contra-indications or safety of the Product.


 


2.4           During the term
of this Agreement Lifehealth shall use its reasonable efforts to provide CSD
with relevant data and access to Lifehealth’s staff as CSD reasonably request
to assist CSD properly to answer questions relating to the Product raised by
doctors or by paramedical personnel or by any other persons entitled to such
information.


 


3.             PRODUCT COMPLAINTS


 


3.1           CSD shall provide
to Lifehealth, as soon as CSD becomes aware of it, any information about any
complaint received from users of the Product.


 


SPONTANEOUS
ADVERSE EVENT (ADE) REPORTING PROCEDURE - INDIVIDUAL CASE REPORTS


 


All Adverse Event
(ADE) reports provided to Lifehealth should be directed to a named individual,
nominated by CSD. The nominated contact will be responsible for all
communication between Lifehealth and CSD.


 


Standard form
ADE1/C shall be used to record the initial report of an adverse experience. As
much information as possible about the ADE shall be requested and recorded.


 


Each ADE Report
shall be assigned an identifying number by the nominated contact. All serious
ADEs reported to CSD are to be forwarded as soon as possible, i.e. on the same
working day.


 


CSD shall follow
up an ADE report to obtain additional details, and where the reporter is a non
health professional, medical confirmation. Form ADE1/D may be used to
obtain follow-up information and written confirmation of the initial report.


 


CSD will log the
initial report into its centralised procedure, and assign a central reference
number. Lifehealth will acknowledge receipt of the report and advise CSD of the
central reference number assigned.


 


CSD will submit
the ADE report to Regulatory Authorities in all countries where the Product is
sold, including the Regulatory Authority in the country where the report
originated, according to regulatory requirements. Lifehealth will be copied on
any correspondence with any Regulatory Authority.


 


22

















 


SCHEDULE
2


 


PRODUCT
RECALL PROCEDURE


 


Initiating
Product Recall


 


CSD shall carry
out a recall of the Product whenever so directed or requested by a Regulatory
Authority or other governmental authority in the Territory. In the absence of
any such direction or request CSD shall only carry out a recall of the Product
when so requested by Lifehealth. CSD shall immediately inform Lifehealth of any
request from a Regulatory Authority for the Product to be recalled. The cost of
any recall of Product shall be an expense to be {***}† the Total Net Receipts
in the calculation of the {***}†


 






† Represents material which has been redacted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment pursuant to Rule 24b-2 under the Securities Exchange Act of
1934, as amended.


 


23