Exhibit 10.33


 


PharmAthene,
Inc.


Confidential
Materials Omitted and Filed Separately with the


Securities and
Exchange Commission


Confidential
Portions denoted by [***]


 


MASTER
SERVICES AGREEMENT


 


THIS
AGREEMENT is made this 15th day of December
2004 between:


 


1.             AVECIA
LIMITED whose registered office is at PO Box 42, Hexagon House,
Blackley, Manchester, M9 8ZS acting through its Avecia Biotechnology business (“Avecia”); and


 


2.             THE
SECRETARY OF STATE FOR DEFENCE, acting through the Defence Science and Technology
[***].


 


WHEREAS


 


(A)          Dstl has expertise in
the non-clinical, clinical and regulatory development of vaccines and support
of programmes therefor (“the Field”).  Dstl also has expertise in the conduct of
Good Laboratory Practice (“GLP”) potency
assays.


 


(B)           Avecia has been awarded
a contract from the National Institute of Allergy and Infectious Diseases (“NIAID”) (part of the United States Government) (Contract No. [***])
under which Avecia will, inter alia,
continue to develop a recombinant [***] based on a single sub-unit protective
antigen [***] and carry out Phase II clinical trials in respect of the Vaccine
(“the Prime Contract”).


 


(C)           Avecia wishes to enter
into an arrangement with Dstl in order to make use of Dstl’s expertise to
assist Avecia to fulfil its obligations under the Prime Contract.


 


(D)          Dstl is willing to enter
into an arrangement with Avecia on the following conditions.


 


NOW IT IS HEREBY AGREED AS FOLLOWS:


 


1.             Performance of the Services


 


1.1           Subject to the terms and conditions hereinafter
set out Avecia engages Dstl and Dstl undertakes to give professional advice and
assistance to Avecia in the Field and, in particular, to provide the services
listed in more detail in Schedule 1. 
Such advice, assistance and services are referred to in this Agreement
as “the Services”.


 


1.2           The Services shall be performed at the times
and locations mutually agreed between the parties.


 


1.3           Dstl warrants that:


 


1.3.1       it shall perform the Services to the best of its
ability and in accordance with the standards of care and skill to be reasonably
expected of a provider of similar services competent in the Field; and


 


1.3.2       all personnel employed by Dstl to carry out the
Services shall be suitably qualified and accredited with appropriate
professional organisations and 


 


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no principal or employee of Dstl has been debarred by United States
Food and Drug Administration, nor have debarment or disqualification
proceedings been commenced and Dstl agrees to notify Avecia promptly if such
proceedings are commenced.


 


2.             Performance of GLP Potency Assays


 


2.1           Dstl shall carry out the potency assays (“the GLP Potency Assays”) in accordance with GLP (in
compliance with The United Kingdom Good Laboratory Practice Monitoring
Authority) and in accordance with the provisions of Schedule which relate to
the GLP Potency Assays.


 


2.2           For Drug Product release testing or
Stability testing, Dstl shall complete the required analysis and provide to
Avecia QC (Billingham) and nominee (i.e. stability site) finalised QA reviewed
potency results, approved by Dstl’s Quality Assurance unit, in respect of each
sample of the Vaccine on which a potency assay has been carried out, within 75
calendar days of the mutually agreed assay start date of such sample set out in
Schedule 2.  This deadline may be
extended in exceptional or unforeseen circumstances by mutual agreement between
Avecia and Dstl.  In the event that Dstl
is either unable to:  (i) complete
the GLP Potency Assays within the 75 calendar day period above or (ii) carry
out the number of GLP Potency Assays agreed between the parties pursuant to
Schedule 2, then in each case Dstl shall prioritise the GLP Potency Assays as
directed in writing by Avecia subject to mutual agreement between Avecia and
Dstl.  In such cases it is understood
that it shall take longer than 75 calendar days for Dstl to provide the
finalised QA reviewed potency results. 
All such requests for prioritisation shall be issued in writing by Sean
Doherty, QC Vaccines Manager, Avecia QC (Billingham) for the attention of [***].
[***] shall have no liability to Avecia for any delay to Avecia’s programme of
work under the Prime Contract which arises as a result of late delivery of an
approved report where such late delivery is as a consequence of late delivery
of the relevant sample by Avecia or its subcontractors or where a sample is
delivered which does not comply with the agreed sample presentation as defined
in the Quality Agreement set out at Schedule 5, or to the extent that such
delay is caused by Avecia’s instruction to Dstl regarding prioritisation of the
work.


 


2.3           If the report delivered to Avecia is
discovered to be inaccurate or Dstl fails to carry out the GLP Potency Assays
in accordance with GLP and in accordance with the provisions of Schedule 2
which relate to the GLP Potency Assays, Dstl shall repeat the GLP Potency
Assays at a time directed by Avecia (taking into consideration the impact on
the schedule for other GLP Potency Assays, but otherwise at Dstl’s own expense
and at no additional cost to Avecia.


 


2.4           Dstl shall complete all development
activities related to the potency assay by the date for completion thereof
stated in Schedule 1.


 


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2.5           Dstl shall complete the validation of the
potency assay, which includes the preparation of an approved validation report
by the date for completion thereof stated in Schedule 1.


 


2.6           For the purpose of permitting a quality and
compliance audit, including to ascertain compliance with GLP, Dstl shall grant
to authorised representatives of Avecia and NIAID, upon reasonable notice,
access to the Facility.  Dstl shall
promptly respond to NIAID’s or Avecia’s request and the parties shall agree on
the time, scope and manner of the audit. 
Such access shall be granted subject to the following provisions:


 


2.6.1       Avecia and/or NIAID shall bear the cost of such
audit unless such audit ascertains non-compliance with GLP or other agreed
quality related issues.


 


2.6.2       Prior to any audit involving NIAID personnel,
Avecia shall procure the entry by NIAID into a confidentiality agreement
between Dstl and NIAID to ensure the confidentiality of Dstl’s information.


 


2.6.3       Access shall be subject to and in compliance with
Dstl and MOD Visitor and Security procedures.


 


2.6.4       Prior to any audit Avecia shall submit in
writing to Dstl for approval, a list of those representatives who may need to
enter the site for the purpose of, or in connection with, the audit, giving
such particulars as Dstl may require, including full details of birthplace and
parentage of any such Representative who: 
a) was not born in the United Kingdom; or b) if he was born in the
United Kingdom, was born of parents either or both of whom were not born in the
United Kingdom.


 


2.6.5       Prior to the commencement of the audit Dstl
shall notify Avecia in writing which representatives have been approved for
admission to the site.


 


2.6.6       Notwithstanding the provisions above if, in the
opinion of Dstl, any representative shall misconduct himself, or it shall not
be in the public interest for any person to be allowed access, then Avecia or
NIAID shall remove such person without delay on being required to do so.


 


2.6.7       The decision of Dstl upon any matter arising under
Clauses 2.6.3 to 2.6.6 inclusive shall be final and conclusive.


 


3.             Duration


 


This Agreement shall be deemed
to have commenced on 1st October 2003
and shall continue for the period of the Prime Contract or any extension,
variation or replacement thereof, currently estimated to be 13th October 2006.


 


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4.             Price and Payment


 


4.1           The consideration for the Services and the
GLP Potency Assays is set out in Schedule 3 (“the Pricing
Schedule”).


 


4.2           Dstl shall issue monthly invoices in arrears
in respect of the cost of the Services and the GLP Potency Assays set out in
Parts A and B of the Pricing Schedule on the 8th day of each month and Avecia shall pay such
sums by the end of the month following the month of the date of the relevant
invoice, subject to formal sign-off by Avecia that the breakdowns submitted
under Clause 4.5 represent an accurate reflection of the work carried out
during the period invoiced.  Avecia shall
make payment by means of the Bankers Automated Clearing Service (BACS) directly
into Dstl’s nominated bank account.


 


4.3           In addition to payment of the cost of the
Services and the GLP Potency Assays, Avecia shall pay to Dstl the fee set out
in Part C of the Pricing Schedule. 
The total fee shall be payable in monthly instalments as described in Part C
of the Pricing Schedule from the date of signature of this Agreement.  Dstl shall issue a separate invoice for each
monthly instalment of the fee, which shall be separate from the Dstl Invoice
for costs rendered under Clause 4.2 above. 
Avecia shall settle such invoices by the end of the month following the
month of the date of the invoice.


 


4.4           Since the total fee is a percentage of
actual cost, as set out in Part C of the Pricing Schedule, a review
mechanism will be put in place whereby appropriate adjustments to the fee are
made to ensure that it is in line with actual cost.  The review period will be six monthly.


 


4.5           Avecia shall, in its sole discretion, have
the right to withhold payment of any invoice submitted under Clause 4.3 if Dstl
does not perform according to the performance targets set out in Clauses 2.2,
2.4 and 2.5 of this Agreement and in accordance with Schedule 1, as assessed by
Avecia’s Contracting Officer.  In the
event that Dstl disputes Avecia’s assessment of Dstl’s performance, the
provisions of Clause 16.2 shall apply.


 


4.6           Dstl shall keep activity records detailing
the work carried out by it under this Agreement, including a breakdown of the
number of hours spent by each person in carrying out such work.  Dstl shall provide a breakdown of the number
of hours spent by each person in carrying out the work under this Agreement
with each invoice submitted under Clause 4.2. 
Avecia shall be entitled to inspect all activity records and supporting
documentation at Dstl’s premises on reasonable notice and during normal
business hours.


 


4.7           Dstl will not make any purchase or incur any
liability on behalf of Avecia nor in any way bind Avecia nor do anything likely
to cause Dstl to be taken by third parties as acting as an agent of Avecia,
except with Avecia’s specific prior written authorisation.


 


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4.8           Dstl will be responsible for all income tax
liabilities and national insurance or similar contributions in respect of any
fees payable hereunder and hereby agrees to indemnify Avecia in respect of any
claims which may be made against Avecia by the relevant authorities in respect
of income tax or national insurance or similar contributions and any costs,
interest, penalties and gross up which may be found due in respect of such
fees.


 


4.9           With the exception of Avecia’s review of [***]
activity records and supporting documentation which shall take place under
Clause 4.6 above, any financial audit shall take place in the following manner:


 


4.9.1        [***] shall make available for inspection
and/or audit all records mutually agreed as necessary to substantiate its
performance under this Agreement.  Said
records are subject to inspection and audit by appropriate audit agencies.  Dstl agrees to retain any and all records
associated with this Agreement for three (3) years following Avecia’s
final payment and until such time as any disputes arising therefrom are
resolved.  All audit disallowances under
this Agreement shall be the responsibility of Dstl.


 


4.9.2        [***] shall maintain accurate records of all
costs incurred in the performance of this work. 
Dstl warrants that it conducts audits, which it believes meet the
standards as required by OMB Circulars, federal cost principles, or cost
accounting standards applicable to its performance as a recipient of US
Government funds, that such audit has revealed no material findings and agrees
to provide Avecia with audit report(s) attesting to the fact that Dstl’s
records covering the period of this Agreement have been audited in accordance
with such requirements.


 


5.             Confidentiality


 


5.1           [***] shall at all times while this
Agreement remains in force and thereafter keep confidential any and all commercial
and technical information relating to any of the existing or planned products,
business, research and/or development activities, customers and suppliers of
Avecia and/or any subsidiary or associated company of Avecia and all other
information relating to Avecia and/or any subsidiary or associated company of
Avecia and/or to any of the activities or financial affairs of Avecia or any
such subsidiary or associated company which it may acquire or to which he may
have access during or by virtue of its participation in this Agreement and any
information generated in its provision of the Services and performance of the
GLP Potency Assays (“the Confidential
Information”).  The
Confidential Information shall be used by Dstl for the sole purpose of fulfilling
its obligations under this Agreement and shall not at any time while this
Agreement is in force or thereafter be disclosed by Dstl to any third party
without the prior written consent of Avecia. 
PROVIDED THAT Dstl shall have the right to use, or have used, any
information generated in its performance of the tasks allocated to it under
this Agreement for any United Kingdom Government purpose free of any payments
to Avecia, its subcontractors or the US Government.


 


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5.2           The obligations of confidentiality contained
in Clause [***] shall not apply to any Confidential Information which:


 


	
  (a)

  	
  is now or hereafter becomes available to
  the public otherwise than by a breach of this Agreement: or

  
	
   

  	
   

  
	
  (b)

  	
  in the case of Confidential Information
  received by Dstl from Avecia Dstl can show that such Confidential Information
  was in its possession free from obligations of confidentiality prior to such
  receipt; or

  
	
   

  	
   

  
	
  (c)

  	
  is received by Dstl from a third party who
  has not directly or indirectly received it from Avecia and who has not
  imposed any restrictions as to its disclosure.

  



 


6.             Intellectual Property


 


6.1           In this Article 6, the following terms
shall have the meanings attributed to them:


 


	
  Background IP

  	
  Intellectual Property generated by [***]:

  
	
   

  	
   

  
	
   

  	
  (1)

  	
  prior to
  this Agreement,

  
	
   

  	
  (2)

  	
  independently
  of this Agreement, or

  
	
   

  	
   

  
	
   

  	
  and, in any
  case, necessary for the performance of the Prime Contract.

  
	
   

  	
   

  
	
  Development Contract

  	
  the contract between Dstl and Avecia dated 19th February 2002 under
  which Avecia carved out process development and production work in relation
  to the Vaccine on behalf of Dstl.

  
	
   

  	
   

  
	
  Foreground IP

  	
  Intellectual Property generated by Dstl under this Agreement.

  
	
   

  	
   

  
	
  Intellectual Property

  	
  all know-how, inventions, discoveries, devices, data, utility models,
  patents, designs, copyrights, or other industrial or intellectual property
  and all applications therefor.

  



 


6.2           Dstl grants to Avecia a royalty-free,
world-wide licence (with the right to grant sub-licences) to use Background 1P
to perform the Prime Contract, and any other contract awarded by NIAID which
covers the same or substantially similar work to that covered by the Prime
Contract.  PROVIDED THAT no rights are
hereby granted to Avecia to use, or have used, Background IP for the
manufacture and supply of doses of recombinant protective antigen anthrax
vaccine which meet the regulatory deliverables as required for drug licensure
in the USA, which rights are already available to Avecia under the licence
agreement reference [***] offered by Dstl to Avecia on 29th April 2004.


 


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6.3           In addition to the licence referred to in
Clause 6.2, with respect to any Foreground IP, including subject inventions in
which Dstl retains title under FAR clause [***], Avecia shall have a
nonexclusive, non-transferable, irrevocable, paid-up licence to practice or
have practiced for or on behalf of Avecia the subject invention throughout the
world.  Dstl shall ensure that it secures
these rights for Avecia when placing sub-contracts under this Agreement.


 


6.4           In consideration for the licences set out in
Clauses 6.2 and 6.3, Avecia shall supply to Dstl, a complete set of all data
produced by Avecia and its subcontractors (other than Dstl) in the performance
of the Prime Contract, and Dstl shall have the right to use, or have used, the
said data, free of any payments to Avecia, its subcontractors or the US
Government, for any United Kingdom Government purpose.  Avecia shall ensure that it secures these
rights for Dstl when placing sub-contracts under the Prime Contract.  For the avoidance of doubt, if and to the
extent that the said data includes Avecia’s Background Intellectual Property
(as defined in the Development Contract), then nothing in this Clause 6.4 shall
be construed so as to vary Avecia’s rights in respect of such Background
Intellectual Property set out in clause 7.1 of the Development Contract.


 


7.             Termination


 


7.1           Avecia may terminate this Agreement immediately
by notice in writing at any time.


 


7.2           Upon termination of this Agreement, Dstl, if
requested by Avecia, shall immediately deliver up to Avecia all copies of and
other embodiments of any work in progress pursuant to the Services or the GLP
Potency Assays and any correspondence, documents, specifications, and any other
property belonging to Avecia or NIAID which may be in its possession.


 


7.3           In the event of termination for any reason,
the provisions of FAR Clause [***], incorporated by reference under Clause
12.1, shall apply.


 


8.             Key Personnel


 


The following individuals (“Key Personnel”) are considered to be essential to the work
being performed hereunder:


 


	
  Name

  	
   

  	
  Title

  
	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  



 


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None of the Key Personnel shall
be replaced in his/her role for the duration of this contract unless otherwise
agreed between the parties.  Dstl shall
ensure that any replacement for a role possesses similar qualifications and
experience to the Key Personnel it proposes to replace.


 


9.             Publicity And Publication


 


9.1           During the term of this Agreement neither
party shall use the other party’s name in any advertising or promotional
material unless the other party gives its prior written approval.  The party wishing to issue such advertising
or promotional material shall provide a copy thereof to the other for review.


 


9.2           Without prejudice to any other provision in
this Agreement neither party shall publish any information obtained under this
Agreement including the results of work conducted without the prior written
permission of the other party.  Such
permission shall not be unreasonably withheld or delayed.  Such permission shall be given where security
considerations allow and subject to appropriate protection of the party’s
Intellectual Property.


 


9.3           Any request for publication shall be
submitted in writing.


 


9.4           In the event of any publication the
provisions of HHSAR [***] shall apply.


 


10.          Compliance with Rules


 


Whilst providing the Services
and carrying out the GLP Potency Assays, Dstl shall observe and comply with all
applicable local legislation and any relevant regulations and codes of practice
issued thereunder and with all other applicable legal or regulatory
requirements and all policies, procedures, regulations and rules of Avecia
or applicable at any premises of Avecia to which Dstl may have access whilst
providing the Services or carrying out the GLP Potency Assays hereunder.


 


11.          Liability and Indemnity


 


11.1         Subject to Clause 11.2 below, Avecia shall
defend, indemnify and hold Dstl and its directors, officers, employees and
affiliates (“Dstl Indemnified Parties”)
harmless from and against (1) any damage or loss suffered by the Dstl
Indemnified Parties and (2) all third party claims, liabilities,
judgements and other costs (including, but not limited to, reasonable attorney
fees and expenses incurred in investigating, defending and settling claims and
in enforcing Avecia’s obligations under this Clause 11.1) (collectively “Avecia Liabilities”) of any kind resulting from the use,
sale, distribution, advertising or marketing of the Vaccine by or on behalf of
Avecia.


 


11.2         Avecia’s obligations to Dstl Indemnified
Parties under Clause 11.1 shall not extend to any Avecia Liabilities to the
extent that such Avecia Liabilities arise as a result of the negligence, wilful
misconduct or breach of this Agreement by the Dstl Indemnified Parties.


 


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11.3         Dstl shall defend, indemnify and hold Avecia,
and its directors, officers, employees and affiliates (“Avecia
Indemnified Parties”) harmless from and against (1) any damage
or loss suffered by the Avecia Indemnified Parties and (2) all third party
claims, liabilities, judgements and other costs (including, but not limited to,
reasonable attorney fees and expenses incurred in investigating, defending and
settling claims and in enforcing Dstl’s obligations under this Clause 11.3) of
any kind resulting from the negligence, wilful misconduct or breach of this
Agreement by Dstl (collectively “Dstl Liabilities”).  Save to the extent that such Dstl Liabilities
are due to the wilful misconduct of Dstl, Dstl’s liability under this Clause
11.3 to Avecia shall be limited to [***] per incident.


 


11.4         Dstl’s obligations to Avecia Indemnified
Parties under Clause 11.3 shall not extend to any Dstl Liabilities to the
extent that such Dstl Liabilities arise as a result of the negligence, wilful
misconduct or breach of this Agreement by the Avecia Indemnified Parties or
their subcontractors.


 


12.          FAR and HHSAR Flowdown Provisions


 


The FAR and HHSAR clauses
contained in the Prime Contract and listed in Schedule 4 are incorporated by
reference into this Agreement.


 


13.          Assignment and Subcontracting


 


13.1         Neither party to the Contract shall give,
bargain, sell, assign, or otherwise dispose of the Contract or any part
thereof, or the benefit or advantage of the Contract or any part thereof,
without the previous consent in writing of the other party, such consent not to
be unreasonably withheld or delayed.


 


13.2         Dstl shall not be entitled to subcontract any
part of this Agreement.


 


14.          Entire Agreement and Scope Changes


 


14.1         This Agreement constitutes the entire agreement
of the parties in relation to the provision of the Services and, save as set
out in Clause 14.2 below, shall not be modified or varied except as agreed in
writing by Avecia and Dstl.


 


14.2         Avecia shall be entitled to make changes to
the scope of the Services or the GLP Assays by giving not less than 60 days’
notice in writing to Dstl.  In the case
of a reduction in the Services or number of GLP Assays, Dstl shall carry out
the reduced Services or number of GLP Assays as directed by Avecia in such written
notice and the fees payable under Clause 4 shall be adjusted accordingly.  In the case of an increase in the Services or
number of GLP Assays, Dstl shall provide a written proposal of the increased
cost therefor and shall carry out such increased Services of GLP Assays on
written agreement by Avecia.


 


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15.          Force Majeure


 


15.1         Either party shall not be liable for any
failure to perform or any delay in performing its obligations if the failure or
delay is due directly or indirectly to any cause beyond the reasonable control
of that party, which shall include but is not limited to the following:


 


	
  15.1.1

  	
  any Act of God, fire, flood, explosion,
  accident, civil disturbance, emergency or period of armed conflict;

  
	
   

  	
   

  
	
  15.1.2

  	
  any major plant or equipment failure which
  results in closure of a facility;

  
	
   

  	
   

  
	
  15.1.3

  	
  the postponement of any trial or test as a
  result of adverse weather conditions or conditions being otherwise unsafe;
  and

  
	
   

  	
   

  
	
  15.1.4

  	
  in the case of the Contractor, the
  withdrawal of facilities or resources due to specific direction from a higher
  UK Government authority.

  



 


15.2         In the event of a delay arising from such
circumstances, the affected party will provide full details to the other party
and shall take all reasonable steps to mitigate the effect of the delay.  Performance of the party’s obligations under
this contract shall be suspended for such time as the delay continues.


 


16.          Law, Disputes and Jurisdiction


 


	
  16.1

  	
  This Agreement is governed by and shall be
  construed and interpreted in accordance with the laws of England and Wales.
  Any proceedings between the parties shall be conducted in the English
  language.

  
	
   

  	
   

  
	
  16.2

  	
  In the event of any dispute, difference or
  disagreement concerning this Agreement, the parties shall seek to resolve the
  matter within 30 days by referring it to the Commercial Director, Vaccines
  Business, Avecia Biotechnology, the Head of Commercial Services, DSTL and, if
  Avecia considers it necessary, the Contracting Officer under the Prime
  Contract.

  
	
   

  	
   

  
	
  16.3

  	
  The parties agree to refer any matter or
  dispute which is not able to be resolved pursuant to Clause 15.2 to
  settlement in good faith by Alternative Dispute Resolution (“ADR”).

  
	
   

  	
   

  
	
  16.4

  	
  In the event that a dispute arises between
  NIAID and Avecia which relates to the Services but which is not also the
  subject of a dispute between Avecia and Dstl, Dstl shall provide reasonable
  assistance to Avecia in order for Avecia to pursue the matter in accordance
  to FAR Clause [***], incorporated into the Prime Contract by reference.

  



 


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Signed for and on behalf of AVECIA LIMITED by


 


	
  Signature:

  	
  /s/ Derrick
  Nicholson

  	
   

  
	
   

  	
   

  
	
  Name:

  	
  Derrick
  Nicholson

  	
   

  
	
   

  	
   

  
	
  Position:

  	
  C.F.O.

  	
   

  
	
   

  	
   

  
	
  Date:

  	
  9 December
  2004

  	
   

  



 


Signed for and on behalf of THE SECRETARY OF STATE FOR DEFENCE, acting through the Defence Science
and Technology Laboratory by


 


	
  Signature:

  	
  [***]

  	
   

  
	
   

  	
   

  
	
  Name:

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  
	
  Position:

  	
  [***]

  	
   

  
	
   

  	
   

  
	
  Date:

  	
  [***]

  	
   

  



 


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[Schedule 1 -
The Services]


 


[***]


 


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[***]


 


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[***]


 


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[Schedule 2 -
The GLP Potency Assays]


 


[***]


 


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[***]


 


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[***]


 


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[Schedule 3 -
The Pricing Schedule]


 


[***]


 


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[***]


 


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Schedule 4 - [***]


 


[***]


 


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Schedule 4 - [***]


 


[***]


 


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Schedule 4 - [***]


 


[***]


 


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[Schedule
5 - Quality Agreement]


 


[***]


 


 


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