Exhibit 10.34
PRIVATE BETWEEN THE
PARTIES
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 18 th day of August 2005
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, [***]
.
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)
[***]
(C)
Avecia wishes to enter into an
arrangement with Dstl in order to make use of [***] 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
[***] 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
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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
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1.3.2
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all personnel employed by
Dstl to carry out the Services shall be suitably qualified and
accredited with appropriate professional organisations and 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.
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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 2 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 eighty seven (87) 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 eighty seven (87) 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 eighty seven (87) calendar days for Dstl to provide the
finalised QA reviewed potency results. All such requests for
prioritisation shall be issued in writing by [***] Vaccines
Manager, Avecia QC (Billingham) for the attention of [***].
Dstl 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
For the purpose
of permitting a quality and compliance audit, including to
ascertain compliance with GLP, Dstl shall grant to authorised
representatives of
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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:
2.4.1
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.
2.4.2
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.
2.4.3
Access shall be
subject to and in compliance with Dstl and MOD Visitor and Security
procedures.
2.4.4
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.
2.4.5
Prior to the
commencement of the audit Dstl shall notify Avecia in writing which
representatives have been approved for admission to the
site.
2.4.6
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.
2.4.7
The decision of
Dstl upon any matter arising under Clauses 2.4.3 to 2.4.6 inclusive
shall be final and conclusive.
3.
Duration
This Agreement shall be deemed to
have commenced on 1 st October 2004 and shall
continue for the period of the Prime Contract or any extension,
variation or replacement thereof, currently estimated to be 31
st March 2007.
4.
Price and
Payment
4.1
The consideration
for the Services and the GLP Potency Assays is set out in
[***].
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 8 th 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
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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 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.
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.
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4.9
With the
exception of Avecia’s review of Dstl’s 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
Dstl shall make
available for inspection and/or audit all records mutually agreed
as necessary to su
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