DATED 2007 GENVEC, INC. and COBRA BIOLOGICS LIMITED MASTER SERVICES AGREEMENT Number: [GenVec 001] December 21, 2007
Exhibit
10.26
DATED 2007
GENVEC,
INC.
and
COBRA
BIOLOGICS LIMITED
_____________________________________
Number:
[GenVec
001]
_____________________________________
December
21, 2007
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
1
CONTENTS
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1
|
Definitions
and Interpretations
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4
|
|
2
|
Services
|
7
|
|
3
|
GenVec
Materials
|
10
|
|
4
|
Capacity
Reservation & Associated Fees
|
11
|
|
5
|
Delivery
& Retention of Deliverables
|
11
|
|
6
|
Compensation
& Payment
|
12
|
|
7
|
Defective
Services or Deliverables
|
13
|
|
8
|
Services
Involving the Release of Materials Processed by Third
Parties
|
14
|
|
9
|
Term
& Termination
|
14
|
|
10
|
Confidentiality
|
17
|
|
11
|
Rights
in Data and Intellectual Property
|
18
|
|
12
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Warranties
|
19
|
|
13
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Indemnification
|
20
|
|
14
|
Insurance
|
21
|
|
15
|
Limitations
of Warranties and Liabilities
|
22
|
|
16
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Regulatory
Matters
|
23
|
|
17
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Notices
|
23
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|
18
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Force
Majeure
|
23
|
|
19
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Restriction
on Hiring Cobra Personnel
|
24
|
|
Records,
Access to Facility and Audits
|
24
|
|
|
21
|
Miscellaneous
|
25
|
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
2
THIS
MASTER SERVICES AGREEMENT
(this
“Agreement”),
effective as of December 21, 2007 (the “Effective
Date”),
is by
and between:
GENVEC,
INC.,
a
Delaware corporation, having its principal place of business at ▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (“GenVec”),
and
COBRA
BIOLOGICS LIMITED,
a
corporation registered in England and Wales (Company Number 02710654) and
a
wholly owned subsidiary of Cobra Biomanufacturing Plc., having its principal
place of business at The ▇▇▇▇▇▇▇▇▇▇ Building, ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇ (“Cobra”).
BACKGROUND
GenVec
is
engaged in the research, development and clinical testing of pharmaceutical
or
biological products and requires from time to time the provision of certain
services in respect of the production of its products.
Cobra
provides contract research and development and technical consultancy services
relating to the processing, development, scale-up and the generation of
pharmaceutical and biological products.
GenVec
desires that Cobra provide it with certain such consultancy and related
services, as described below, and Cobra desires to do so, on the terms and
conditions set forth below.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
3
WHEREFORE,
THE PARTIES AGREE AS FOLLOWS.
AGREEMENT
1. Definitions
and Interpretations.
For
purposes of this Agreement, the following definitions shall apply, and the
terms
defined herein in plural shall include the singular and vice-versa: In these
conditions the following words have the following meanings:
1.1. Definitions.
|
Affiliate
|
With
respect to any person or entity, any other person or entity which
directly
or indirectly controls, is controlled by or is under common control
with
such person or entity.
|
|
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cGMP
|
Current
Good Manufacturing Practices regulations and guidelines applicable
to the
manufacture of pharmaceuticals and biologics intended for use in
clinical
trials in the United States and/or the European Union, including
those
described in the U.S. Food, Drug & Cosmetics Act (21 U.S.C. Section
301 et seq.) and regulations promulgated
thereunder, and in ICH guide Q7a “ICH Good Manufacturing Practice Guide
for Active Pharmaceutical Ingredients,” as applied to investigational
drugs (Section 19).
|
|
|
Capacity
Reservation Fee
|
As
defined in Section 4.1.
|
|
|
Claims
|
As
defined in Section 13.1.
|
|
|
Cobra
Materials
|
As
defined in Section 2.4.
|
|
|
Committed
Costs
|
Any
costs incurred or committed to by Cobra in advance of the provision
of
Deliverables which cannot be cancelled or offset through reasonable
commercial efforts, including the procurement of materials, equipment,
maintenance and subcontract services, but excluding the costs of
Facility
modifications and associated capital equipment.
|
|
|
Confidential
Information
|
As
defined in Section 10.1.
|
|
|
GenVec
Materials
|
Any
products, DNA, protein, cell lines, cell banks, virus, biological
matter,
equipment or other tangible materials that are supplied by GenVec
to Cobra
for use in performing the
Services.
|
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
4
|
GenVec
Property
|
As
defined in Section 11.2.
|
|
|
Data
|
Any
data, documentation or records resulting from or related to the
performance of the Services.
|
|
|
Debarred
Entity or
Debarred Individual
|
An
entity or individual, as applicable, that has been debarred by
the United
States Food and Drug Administration (“FDA”)
pursuant to 21 U.S.C. §335(a) or (b).
|
|
|
Defect
or
Defective
|
With
respect to Deliverables: Deliverables that, at the time of Delivery,
fail
to meet any purchase criteria, Specifications or other requirements
provided in a Service Schedule or otherwise agreed to by the
parties.
With
respect to Services: Services that fail to comply with Section
2.3 or any
other requirements expressly provided therefor in a Service
Schedule.
|
|
|
Deliverables
|
All
reports and materials that Cobra is to provide to GenVec pursuant
to a
Service Schedule.
|
|
|
Delivery
|
The
Shipper’s collection of Deliverables from Cobra’s facility.
|
|
|
Disclosing
Party
|
As
defined in Section 10.1.
|
|
|
Facility
|
As
defined in Section 2.4.
|
|
|
First
Reserved Date
|
As
defined in Section 4.1.
|
|
|
Intellectual
Property (“IP”)
|
All
inventions, processes, improvements, patents, trade marks, trade
names and
copyrights (whether or not registered or capable of being registered),
logos, know-how, trade secrets, Confidential Information and any
other
similar rights subsisting anywhere in the world, and all rights
to apply
for, and applications for, registered protection of the
foregoing.
|
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
5
|
Pre-existing
IP
|
As
defined in Section 11.1.
|
|
|
Price
|
The
total charges for Services to be performed pursuant to a Service
Schedule.
|
|
|
Processed
Materials
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As
defined in Section 8.1.
|
|
|
Project
Manager
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As
defined in Section 2.6.
|
|
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New
IP
|
As
defined in Section 11.1.
|
|
|
Qualified
Person
|
As
defined in Section 8.1.
|
|
|
Recipient
|
As
defined in Section 10.1.
|
|
|
Reserved
Slot
|
As
defined in Section 4.1.
|
|
|
Services
|
All
work to be performed by Cobra for GenVec under this Agreement and
all
Service Schedules.
|
|
|
Service
Schedule
|
A
written statement describing the Services to be performed with
respect to
a given project, the Price of such Services and any other terms
relevant
to such Services, which has been agreed upon and signed by both
parties,
as such statement may be modified from time to time upon the written
agreement of the parties.
|
|
|
Shipper
|
As
defined in Section 5.2.
|
|
|
Shortage
|
As
defined in Section 7.1.
|
|
|
Specifications
|
The
specifications, standards, limits, criteria and other requirements
(if
any) provided in a Service Schedule or otherwise agreed to by the
parties
to which Deliverables should conform.
|
|
|
Working
Day
|
Any
day other than a Saturday, Sunday or English public
holiday.
|
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
6
1.2. Interpretations.
1.2.1. Any
reference in this Agreement to a “Article”, “Section,” “subsection” or
“Schedule” is to an article, section, subsection or schedule of this
Agreement.
1.2.2. Any
phrase introduced by the terms "including," "include" or any similar expression
shall be construed as illustrative and shall not limit the sense of the words
preceding such
phrase.
2. Services
2.1. Service
Schedules.
2.1.1. Formation.
This
Agreement shall govern the relationship between Cobra and GenVec. Services
to be
performed hereunder shall be described in detail in a document (which may
be
titled a “Service Proposal”) that, once signed by both parties, shall be deemed
to be a Service Schedule that is part of this Agreement. Cobra shall be
obligated to perform those services that are described in a Service Schedule,
as
well as any agreed incidental service, function or responsibility not
specifically described in a Service Schedule, but that is commercially
reasonable and required for the proper performance and provision of such
services, functions and responsibilities. With the prior agreement of both
parties, those services not agreed as incidental will be carried out under
an
additional or amended Service Schedule executed by both parties in advance
of
such services being provided, in accordance with the provisions of Section
2.5
below.
2.1.2. Effect.
Each
Service Schedule, along with this Agreement, shall be deemed (a) the entire
agreement between the parties with respect to the Services described in such
Service Schedule, and (b) separate and distinct from any other Service
Schedule combined with this Agreement.
2.1.3. Conflicts.
To the
extent the terms of any Service Schedule conflict with other terms of this
Agreement, such other terms of this Agreement shall control, unless the Service
Schedule expressly provides otherwise. No purchase order issued by GenVec
shall
modify or amend any terms of a Service Schedule or this Agreement.
2.2. Subcontracting.
Cobra shall not sub-contract any Services to a third party without GenVec’s
prior written consent, which shall not be unreasonably withheld. Cobra
shall
ensure that any permitted subcontractor has been bound, in writing, to
obligations of confidentiality and non-use of GenVec’s Confidential Information
that are at least as restrictive as those provided in Sections 10.1 - 10.5,
prior to disclosing any such information to the subcontractor. Where the
subcontractor has been selected by Cobra and/or Cobra is directing the
subcontracted activities, Cobra shall be responsible for each permitted
subcontractor’s performance hereunder (including, without limitation, any breach
of this Agreement by such subcontractor), as if Cobra were itself performing
such activities.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
7
2.3. Performance
Standards.
Cobra
shall perform the Services and deliver the Deliverables pursuant to the Service
Schedule and in accordance with the Specifications, applicable laws, cGMPs
and
the terms of this Agreement. Cobra will carry out work in accordance with
the
Service Schedule, but cannot guarantee the outcome of development Services
and
in the case of cGMP Deliverables, cannot guarantee the outcome of such cGMP
deliverables and related Services until such time as both parties have agreed
*.
2.4. Facility;
Resources. Unless
otherwise set forth in a Service Schedule, Cobra shall perform the Services
at
Cobra’s manufacturing facility identified in the Service Schedule (the
“Facility”).
Cobra
may not change the Facility without GenVec’s prior written consent. Cobra will
ensure that the Facility has sufficient qualified personnel, production
capacity, manufacturing resources, and quality systems necessary to properly
perform the Services in accordance with this Agreement and that the Facility
is
operated in compliance with cGMPs and all applicable laws for such period
as
there are executed Service Schedules requiring the use of the Facility. Except
to the extent otherwise provided in a Service Schedule or in any schedule
of
items to be supplied by GenVec (“GenVec Materials”), which can be added as an
appendix to the Agreement with the written consent of both parties, Cobra
shall
obtain and maintain in the Facility sufficient dedicated equipment and other
associated resources necessary to perform the Services (“Cobra
Materials”).
for
such period as there are executed Service Schedules requiring the use of
the
Facility. Cobra shall only obtain Cobra Materials from reputable and verified
suppliers, shall inspect and test such Cobra Materials, as appropriate, prior
to
engaging in any Services therewith, and shall establish a source of supply
for
all Cobra Materials sufficient to ensure Cobra’s ability to fulfill its
obligations hereunder in a timely and cost-efficient manner. Cobra shall
use
commercially reasonable efforts to procure all Cobra Materials at the lowest
prices reasonably available, consistent with such matters as security and
sources of supply, quality of product, volume requirements, terms and conditions
of supply and the Services Schedule. In no event shall Cobra use GenVec
Materials either for itself or for third parties without the express, written
consent of GenVec.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
8
2.5. Changed
Services
2.5.1. Must
be Agreed in Writing.
No
changes to a Service Schedule, Services thereunder or the Price of Services
shall be implemented unless and until the parties have agreed on such change,
in
writing, signed by a person authorized to bind the respective party, through
a
written change order (a “Variation”)
or an
amendment to the Service Schedule.
2.5.2. Either
Party May Request.
Either
party may request that changes be made to a given Service Schedule. If manifest
changes are requested, then to the extent possible, Cobra shall provide GenVec
with a written statement that describes in detail the proposed changes, any
anticipated change in Price resulting therefrom and any other relevant facts
that Cobra believes GenVec may reasonably require. Cobra shall implement
such
changes when and if the parties agree upon them, in writing.
2.5.3. Required
Changes.
If
either party requests a change to a Service Schedule or Services thereunder
that
(a) the requesting party reasonably deems to be necessary in light of any
Data, or (b) are required as a result of any changes in applicable laws,
regulations (including those governing cGMP and good laboratory practices),
safety requirements, best practices or manufacturing requirements, and the
other
party does not agree to such changes within 30 days of the request, the
requesting party shall have the right to terminate this Agreement upon written
notice to the other party, subject to the provisions of Section 9.3. Prior
to
the giving of any notice of change hereunder by Cobra, Cobra shall provide
a
written good-faith estimate of the costs of such change, and any change in
price
caused by such change shall be based on such costs, to which Cobra may add
a
commercially reasonable margin.
2.6. Project
Management.
Within
20
days
from the Effective Date, each party shall designate in writing one person
to be
that party’s project manager (“Project
Manager”)
for
issues associated with the Services and the performance of this Agreement.
Each
party my substitute or replace its Project Manager at any time by providing
written notice to the other party. Each party shall make its Project Manager
available for status meetings, telephone consultation, and otherwise as
reasonably required to facilitate the performance of the Services in accordance
with this Agreement. The Project Managers shall meet as needed to discuss
(i)
Cobra’s performance of the Services, (ii) action items from previous meetings to
ensure completion of outstanding issues; and (iii) any personnel-related
issues
that affect the Services. The Project Managers shall also meet on a [quarterly]
basis for business review meetings to discuss the status of the project and
the
performance of the Services. The Project Manager for Cobra (including any
replacements thereof) shall have the requisite skills and experience to
facilitate the performance of the Services in accordance with this Agreement.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
9
3. GenVec
Materials
3.1. Provision
of Materials.
GenVec
shall use commercially reasonable efforts to timely provide Cobra with any
and
all GenVec Materials described in the relevant Service Schedule or in the
attached schedule of GenVec Materials. In the event that GenVec does not
supply
GenVec Materials on a timely basis, the agreed timelines for the program
may be
reasonably extended (e.g., by the same amount of time as the amount of the
delay), unless such extension is not warranted under the circumstances.
3.2. Instructions.
GenVec
shall provide Cobra with all relevant instructions and information concerning
the storage and handling of GenVec Materials, including all relevant health
and
safety information, (a) prior to delivery of such materials to Cobra or
(b) where such information involves non standard and/or special
requirements, at least 10 Working Days prior to delivery of such materials
to
Cobra.
3.3. Ownership
and Use.
GenVec
Materials shall be and shall remain the property of GenVec. Cobra shall not
use
GenVec Materials for any purpose other than the provision of Services, without
GenVec’s written consent, and shall not transfer or permit the transfer of any
GenVec Materials to any third party, other than permitted sub-contractors
in
accordance with Section 2.2. Cobra shall limit access to GenVec Materials
to
employees and/or sub-contractors of Cobra who have a need to access such
materials in connection with the provision of Services. Cobra shall not place
a
lien or security interest on, or otherwise encumber the GenVec Materials.
Cobra
shall conduct such preventative and other maintenance as is deemed commercially
reasonable by Cobra or is agreed to in writing by Cobra and GenVec.
3.4. Lost
or Damaged Materials.
Cobra
shall take reasonable measures to protect GenVec Materials from destruction,
theft or loss while in the possession and/or control of Cobra. Cobra will
have
the risk of loss or damage to the GenVec Materials while in the possession
of
Cobra. In the event of loss or damage to the GenVec Materials during such
period, Cobra will immediately notify GenVec. * Section 14 details the
responsibilities of both parties with respect to insuring GenVec Materials.
Cobra shall inspect, test, store, handle, and process the GenVec Materials
in
compliance with Specifications, cGMPs and all other applicable laws and upon
receipt of GenVec Materials, Cobra will promptly inspect and evaluate the
GenVec
Materials to confirm compliance with the specifications therefor * and in
accordance with a certification and/or inspection process agreed to in advance
by both Cobra and GenVec.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
10
4. Capacity
Reservation
and Associated Fees
4.1. Capacity
Reservation and Fee.
A
Service Schedule may provide for Cobra to reserve capacity and resources
at its
Facility for non-GMP R&D services and GMP production slots (each, a
“Reserved Slot”), on particular consecutive dates (the first of which is
referred to below as the “First
Reserved Date”),
during which Cobra will perform relevant Services. In such a case, the Service
Schedule shall require that GenVec pay, prior to the commencement of Services
thereunder, a specified non refundable fee (a “Capacity
Reservation Fee”),
as
additional consideration for services under the Service Schedule, such fee
to be
related to such reservation, as detailed in the Service Schedule, and which
shall be creditable against future Services to be performed under the Service
Schedule, but shall not be refundable except as expressly provided herein.
*.
4.2. Changes
to Reserved Slots.
If
GenVec makes a written request to change a Reserved Slot, Cobra shall use
commercially reasonable efforts to accommodate the request, subject to
availability of an appropriate Reserved Slot. *.
4.3. Cancellation
of Reserved Slots.
*
4.4. Exceptions.
*.
5. Delivery
and Retention of Deliverables
5.1. Timing.
Cobra
shall use commercially reasonable efforts to have the Deliverables ready
and
available for pickup by the Shipper on the dates specified in the relevant
Service Schedule. However, such dates are not guaranteed. Cobra shall notify
GenVec when Deliverables are available for collection and shall promptly
inform
GenVec of any delay in such availability.
5.2. Manner
of Delivery.
Unless
the parties agree otherwise in writing, (a) all Deliverables shall be made
available, at the Facility, for loading by a common carrier agreed upon by
the
parties (the “Shipper”)
and
shipment to GenVec or its designee, and (b) shipments shall be *. The
Deliverables shall be collected within * of Cobra’s notice to GenVec of their
availability (where deliverables require release prior to use, the Deliverables
will not be considered available until such time as the release is complete),
during regular business hours, at a date and time agreed by the parties,
in
advance. If the Deliverables are not collected within the *, then Cobra will,
at
the request of GenVec (a) dispatch Deliverables to GenVec, for a fee equal
* or
(b) retain the Deliverables at the facility, for a fee equal to *, until
the
Deliverables have been collected.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
11
5.3. Retention
of Deliverables or GenVec Materials.
If
GenVec wishes Cobra to retain at its facility (a) GenVec Materials or samples
of
Deliverables over and above those Cobra is required by law or regulation
to
retain, or (b) Deliverables that are available for collection by the Shipper,
such retention shall be subject to the parties’ agreement to such retention, in
additional consideration for the services provided under the relevant Service
Schedule, a fee equal to * will be payable by GenVec. GenVec will be responsible
for the insurance of such Deliverables as detailed in Section 14.
6. Compensation
and Payment
6.1. Prices
of Services.
The
Prices of Services to be performed pursuant to a given Service Schedule shall
be
as provided in such Service Schedule.
6.2. Taxes.
Prices
are exclusive of any applicable VAT and/or other sales/transaction taxes,
for
which GenVec shall additionally be liable and as such Cobra reserves the
right
to charge GenVec for any such VAT and/or other sales/transaction taxes.
6.3. Other
Costs.
Unless
provided otherwise in a Service Schedule, any costs of shipping, consumables,
insurance or importation of Deliverables and GenVec Materials, raw materials
or
of packaging materials, * shall be added by Cobra from time to time to give
a
total amount, and in additional consideration for services under the Service
Schedule a fee equal to the total amount shall be charged to GenVec separately.
6.4. Travel
Expenses.
GenVec
shall reimburse Cobra for all reasonable, necessary and documented travel
and
accommodation expenses involved in the provision of Services, to the extent
such
expenses are agreed upon by the parties, in writing and are consistent with
GenVec’s travel reimbursement policy (a copy of which has been provided to
Cobra), provided that such request for expenses conforms to and complies
with
the then-applicable Travel and Expense Reimbursement Policy of .GenVec.
6.5. Timing
of Payments.
Capacity Reservation Fees shall be due * after the parties’ execution of the
Service Schedule to which such fees relate and GenVec’s receipt of invoice, and
in any case prior to Cobra’s making a firm reservation of capacity for the
relevant Services. The balance of the Price of Services shall be payable
within
* of GenVec’s receipt of applicable invoice. Timing of invoicing shall be as
provided in the relevant Service Schedule.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
12
6.6. Late
Payments. Payments
shall be deemed to be made only when Cobra has received cash or cleared funds
covering the amounts due. If GenVec fails to make any payment in full on
its due
date, Cobra shall charge GenVec interest on the unpaid balance at the rate
of *.
In the event that the invoice is queried within * of receipt, Cobra will
not
apply this charge until * after such time as the query has been resolved.
Both
parties agree to act in good faith and act reasonably to resolve all queries
promptly.
7. Defective
Services or Deliverables
7.1. Acceptance
and Rejection.
|
7.1.1
|
GenVec
shall have * following GenVec’s receipt of Deliverables, (i) to accept
them (ii) to notify Cobra, in writing that the Deliverables do
not meet
the warranties set forth in Article 12, cGMPs or the agreed Specifications
(in each case, “Defective”)
and/or (iii) to notify Cobra, in writing, that Deliverables due
to GenVec
are missing from the shipment (a “Shortage”).
Upon
request by Cobra, GenVec shall return to Cobra, at Cobra’s expense, any
Deliverables rejected hereunder as defective, unless it would not
be
reasonably possible to do so. Failure
to notify Cobra of a Defect or Shortage within such * period *,
or to
return rejected Deliverables, upon request by Cobra, as required
under
this Section 7.1, shall be deemed an acceptance of the relevant
Deliverables and/or Services. The criteria for testing that Deliverables
are not Defective will be agreed to in advance in writing by both
Cobra
and GenVec.
|
|
7.1.2
|
If
GenVec cannot determine that the Deliverables are Defective within
the *
period described above through reasonable testing at the date of
delivery
(a “Latent
Defect”),
then GenVec shall be entitled to notify Cobra of the Latent Defect
within
* of the discovery thereof. Following such notification and upon
request
by Cobra, GenVec shall return to Cobra, at Cobra’s expense, any
Deliverables rejected under this Section 7.1.2 as Defective, unless
it
would not be reasonably possible to do so. Latent Defects shall
only be
those Defects that are the result of a cause assignable to the
fault of
Cobra, *.
|
7.2. Disputes
Regarding Defects.
In the
event of a dispute over whether Deliverables are Defective, the parties shall
provide a representative sample of such Deliverables to an agreed upon,
independent testing laboratory, for analysis and a final, binding determination
of whether the Deliverables are Defective and the cause thereof. The party
that
the determination disfavors shall bear the costs of the analysis.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
13
7.3. Remedies
for Defective Deliverables/Services.
With
respect to (a) any Deliverables timely rejected pursuant to Section 7.1.1,
or
rejected pursuant to 7.1.2. and, in each case, determined by Cobra or an
independent laboratory, pursuant to Section 7.2, to be Defective, and (b)
any
Shortages, Cobra shall, with the agreement of GenVec, *, at no additional
charge
to GenVec, at which time the Deliverables shall be subject to further acceptance
testing by GenVec.
7.4. GenVec’s
Sole of Remedy.
The
remedy provided in Section 7 shall be GenVec’s sole remedy for the Delivery of
Defective Deliverables or the performance of Defective Services hereunder.
8. Services
Involving the Release of Materials Processed by Third Parties.
8.1. Access
and Assistance to Qualified Person.
This
Article 8 applies to Services involving the release by Cobra, through a
Qualified
Person
(as that
term is defined in Article
48 of Directive 2001/83/EC),
of
materials that have been processed, in whole or in part, by a third party
(“Processed
Materials”).
In
any such case, GenVec,
at its own cost, shall (a) ensure that the Qualified Person is named on any
relevant marketing authorization and shall (a) provide the Qualified Person
with
unrestricted access to GenVec’s premises, personnel, procedures, documentation
and information (including any dossiers upon which marketing authorizations
have
been granted, together with any variations affecting such approvals) relevant
to
or associated with such product and (b) provide the Qualified Person with
such assistance as is reasonably requested by the Qualified Person from time
to
time.
8.2. Replacement
of Qualified Person.
Where a
Qualified Person named in the Service Schedule is no longer able to perform
the
Services, GenVec shall, at Cobra’s cost, provide Cobra with such assistance as
is necessary and/or desirable to have an alternative Qualified Person named
on
any relevant marketing authorization.
8.3. Limitation
on Liability for Services by Qualified Person.
Neither
Cobra nor any Qualified Person shall have any liability to GenVec in any
way
related to the release of a Processed Material, except where the liability
arises as a direct result of a violation by the Qualified Person of his
statutory obligations as a Qualified Person.
9. Term
and Termination
9.1. Term.
The
term of this Agreement shall be five (5) years from the Effective Date, unless
(a) at that time, Services are being performed pursuant to a Service
Schedule, in which case, the term shall extend through the completion of
all
pending Service Schedules, or (b) this Agreement is terminated in accordance
with Section 9.2.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
14
9.2. Termination.
9.2.1. Termination
by Cobra.
Cobra
may terminate this Agreement or Services remaining to be performed under
any
Service Schedule, at any time, with or without cause, upon at least 720 days’
written notice to GenVec, subject to Section 9.3.
9.2.2. Termination
by GenVec. GenVec may terminate this Agreement or Services remaining to be
performed under any Service Schedule, at any time, with or without
cause,
upon at
least 60 days’ written notice to Cobra (subject to this section 9) on condition
that at same time as serving written notice on Cobra GenVec pays to Cobra
a
termination payment calculated in accordance with [Appendix 2], (which shall
apply to termination of the first Service Schedule, A393) and any other
termination payment specified in any other Service Schedule.
[If
GenVec terminates this agreement, Cobra shall use commercially reasonable
efforts to fill any vacated reserved slots with another customer. GenVec
shall be liable only for the portion of the payment of the relevant Termination
Fee that was charged to GenVec and not recovered by Cobra from another customer
and after taking into account all reasonable and documented Services and
Deliverables provided to GenVec in connection with such Reserved Slot and
any
Committed Costs prior to notice of cancellation.]
9.2.3. For
Breach.
Either
party may terminate this Agreement or the Service Schedule at issue upon
thirty
30 days notice informing the other party that it is in material breach of
any of
its obligations hereunder and stating the reasons therefor, unless the notified
party has cured such breach within such 30-day notice period.
9.2.4. For
Insolvency.
Either
party may terminate this Agreement upon the occurrence of any of the following
events: (a) the other party makes an assignment for the benefit of its creditors
or files a voluntary petition under federal or state bankruptcy or insolvency
laws, (b) a receiver or custodian is appointed for all or substantially all
of
the other party's business, (c) proceedings are instituted against the
other party under federal or state bankruptcy or insolvency laws that have
not
been stayed or dismissed within sixty (60) days, (d) all or substantially
all of
the other party's business or assets become subject to attachment, garnishment
or other process or (e) a court or other governmental authority of competent
jurisdiction determines that the other party is insolvent.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
15
9.3. Duties
upon Termination.
Upon
the
termination of any Service Schedule(s) (whether terminated individually or
in
connection with the termination of this Agreement):
9.3.1. Payment.
GenVec
shall pay to Cobra, within * of receipt of invoice, (a) if this Agreement is
terminated by GenVec pursuant to Section 9.2, any Capacity Reservation Fee
(or
part thereof) that has not previously been paid; (b) for all Services
satisfactorily provided pursuant to the relevant Service Schedule(s), up to
the
date of termination; and (c) if this Agreement is terminated by GenVec
pursuant to Section 9.2,2. for all documented and reasonable committed costs
and
expenses (both internal and external) related to such Services that GenVec
approved in writing and Cobra, acting reasonably, is unable to avoid, or if
applicable pursuant to Section 9.2.2, a termination fee as detailed in Section
9.2.2.
9.3.2. Transfer
Assistance.
To the
extent requested by GenVec *, Cobra shall provide reasonable technology transfer
and termination assistance services to GenVec in the event that GenVec transfers
any of the services provided hereunder by Cobra to itself or to a third party.
The purpose of this assistance shall include the following: (i) to enable GenVec
to obtain from a successor provider, or to provide for itself, services to
substitute or replace those provided by Cobra, and (ii) for Cobra to assist
GenVec during the termination assistance period, so that GenVec or its successor
provider can provide those services terminated and to eliminate or minimize
any
disruption or deterioration of the Services during and as a result of the
handover. * In the event that Cobra terminates this Agreement without cause,
then Cobra shall provide its labour within the services described in the
preceding sentences *
9.3.3. Return
or Destruction of GenVec’s Materials.
9.3.3.1. Cobra
shall, within * of receipt of a written request by GenVec, either return to
GenVec or destroy, as requested by GenVec, * any and all GenVec Materials
obtained in connection with the relevant Service Schedule(s), and samples of
any
Deliverables in Cobra’s possession produced thereunder, together with any
relevant Data; except that Cobra shall be entitled to retain in its archive,
at
its own expense, one copy of such GenVec Materials, samples of Deliverables,
Data and other information, to the extent that they are required to be stored
by
Cobra under applicable law, regulations or rules.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
16
9.3.3.2. If
Cobra
does not receive such a request from GenVec within * of termination, Cobra
shall
send written notice to GenVec. If GenVec does not respond within * of receipt
of
such notice, Cobra shall be entitled to destroy, at GenVec’s cost any and all
such GenVec Materials, samples of Deliverables, Data and other information
relating to the relevant Service Schedule(s), except for any that are required
to be retained at Cobra’s facility, pursuant to Section 5.3.
10. Confidentiality
10.1. Definitions. During
the term of this Agreement, each party (a “Disclosing
Party”)
may
provide to the other (a “Recipient”),
information, economic information, business or research strategies, trade
secrets, Intellectual Property and material embodiments thereof, and Cobra
may
generate Data (collectively, “Confidential
Information”).
(For
purposes of this Article 10, Data shall be deemed to be GenVec’s Confidential
Information, GenVec shall be deemed the Disclosing Party with respect thereto,
and Cobra shall be deemed the Recipient thereof.)
10.2. Exclusions.
Confidential Information shall not include information that (a) the Recipient
can prove, by competent evidence, was in its possession prior to receipt from
the Disclosing Party, (b) was furnished to the Recipient by a third party
without breach of a duty of confidentiality, (c) was or became, through no
fault
of the Recipient, publicly known, (d) the Recipient can demonstrate by
contemporaneous written records was developed by or for the Recipient
independently of the disclosure of Confidential Information by the Disclosing
Party or its Affiliates or (e) is required by law, regulation or rule to be
disclosed, provided that the Recipient notifies the Disclosing Party of such
requirement as soon as reasonably practicable, and cooperates in action that
the
Disclosing Party reasonably elects to take in order to protect the
confidentiality of such Confidential Information.
10.3. Obligations.
Unless
the parties agree otherwise in writing, the Recipient (a) shall maintain the
Disclosing Party’s Confidential Information in confidence, (b) shall allow
access only to those employees, permitted subcontractors or agents who need
to
see and use such Confidential Information in order for the Recipient to perform
its obligations hereunder and who are bound by obligations of confidentiality
and nonuse that are no less restrictive than the ones set forth herein, (c)
shall use such information solely in the performance of this Agreement, and
(d)
shall at all times protect such information from misuse or disclosure with
at
least the same degree of care it uses to protect its own Confidential
Information, such care to be of the type and degree that would be used by a
reasonable and prudent business person in the biopharmaceutical industry. The
confidentiality obligations herein shall survive the expiration or termination
of this Agreement.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
17
10.4. Responsibility
for Employees and Agents.
Each
party shall be responsible for the acts and/or omissions of its employees,
agents and representatives under Sections 10.1 – 10.3 (whether or not they
remain its employees and/or representatives), as if they were such party’s own
acts or omissions.
10.5. Ownership
and Return.
Each
party’s Confidential Information shall at all times be its sole and exclusive
property. At any time, upon the written request of the Disclosing Party, or
upon
termination or expiration of this Agreement, the Recipient shall return or
destroy (at the election of the Disclosing Party) all Confidential Information
of the Disclosing Party in its possession (including all copies, abstracts
or
summaries thereof), except that the Recipient may retain one copy of the
Disclosing Party’s Confidential Information solely for archival purposes.
10.6. Supercession
of Prior Confidentiality Agreement.
Any
information previously exchanged between the parties in connection with any
Services or this Agreement and meeting the definition hereunder of Confidential
Information shall be governed by the terms of this Article 10. Any
confidentiality or non-disclosure agreement previously executed by the parties
in connection with such information is hereby terminated and superseded by
this
Article 10 to the extent thereof.
11. Rights
in Data and Intellectual
Property
11.1. Pre-existing
IP.
This
Agreement shall not affect the ownership of any Intellectual Property owned
by
or licensed to either party as of the Effective Date (“Pre-existing
IP”).
IP
arising out of the performance of the Services which relates to manufacturing
services in general developed in whole or in part by Cobra during the term
of
this Agreement shall be referred to as “New
IP”.
11.2. Ownership.
As
between the parties, subject to Cobra’s rights in any of its Pre-Existing
IP, GenVec
shall own all right, title, and interest in and to the Deliverables, the Data
and all technology, know-how, inventions, discoveries, ideas, concepts,
trade-secrets, improvements, processes, documents, information, or data, whether
patentable or not, which result from the Services or the GenVec Materials which
is not New IP (“GenVec
Property”),
and
to the extent Cobra has or may acquire or be deemed to have acquired any rights
therein, Cobra hereby transfers and assigns its right, title, and interest
in
such property to GenVec. Upon GenVec’s request at any time, Cobra agrees to
deliver to GenVec any and all documents and information necessary to protect
GenVec’s interest in the GenVec Property. Cobra further agrees, during the term
hereof, promptly to notify GenVec in writing of any such
developments.
New IP
shall be the sole property of Cobra, and shall be subject to the rights of
GenVec pursuant to Section 11.4.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
18
11.3. GenVec
License. GenVec hereby grants to Cobra a nonexclusive,
royalty-free, limited, non-transferable license, for the term of this Agreement
to use the GenVec Property and GenVec’s Pre-existing IP and sublicense the same
to subcontractors approved by GenVec, but in each case, solely to the extent
necessary to perform the Services in accordance with this Agreement and to
otherwise comply with the obligations hereunder. *.
11.4. Cobra
License.
Cobra
hereby grants to GenVec a non-exclusive, fully paid, royalty-free, irrevocable
license, with the right to sublicense, to any Cobra Pre-Existing IP that Cobra
incorporates into the Deliverables or is used to produce the Deliverables on
condition that during such time Cobra is providing GenVec with contract
manufacturing and development services and such license shall cease if Cobra
ceases to be conducting such contract manufacturing and development services
for
GenVec..
This
license shall survive the termination or expiration of this Agreement in
accordance with the provisions of Section 9.3.2 above. Cobra hereby grants
to
GenVec a non-exclusive, irrevocable license to practice any New IP that is
required for the manufacturer, development, use or sale of GenVec’s product.
12. Warranties.
12.1. By
Cobra.
Cobra
warrants to GenVec that:
| (a) |
the
Services will be performed (i) in a professional and workmanlike
manner
with at least that degree of care and skill as is practiced by other
recognized firms in providing services of a similar nature and (ii)
in
compliance with all cGMPs, laws, rules and regulations applicable
thereto,
|
| (b) |
all
Services required, pursuant to a Service Schedule, to be performed
in
accordance with Good Laboratory Practices or Medicines Control Agency
guidelines shall be performed in accordance with such practices or
guidelines, as applicable,
|
| (c) |
Cobra
has the right to use the Pre-existing IP of Cobra that is used in
performing the Services and such Pre-existing IP of Cobra, (i) has
never
been, is not currently, and during the term will not become, a Debarred
Entity and (ii) to the best of its knowledge no Debarred Entity or
Debarred Individual, including subcontractors or parties, will perform
any
services on GenVec’s behalf. If Cobra becomes aware of FDA investigations
of, or debarment proceedings against, Cobra or any person performing
Services, then Cobra will immediately notify GenVec of any such
circumstances during the term of this Agreement
|
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
19
12.2. Mutual.
Each
party represents and warrants to the other that (i) to its knowledge, it has
the
right to grant the licenses granted hereunder and to provide the Confidential
Information provided hereunder; (ii) it has all requisite power and authority
(corporate and otherwise) to enter into this Agreement and has been duly
authorized by all necessary actions in the execution and delivery hereof by
the
officer or individual whose name is signed on its behalf below; (iii) its
execution and delivery of this Agreement and the performance of its obligations
hereunder do not and will not conflict with or result in a breach of or a
default under its organizational instruments or any other agreement, instrument,
order, or law applicable to it or by which it may be bound; and (iv) this
Agreement has been duly and validly executed and delivered by it and constitutes
its valid and legally binding obligation, enforceable in accordance with its
terms, except as enforcement may be limited by bankruptcy, insolvency or other
laws of general application relating to or affecting the enforcement of
creditors’ rights and except as enforcement is subject to general equitable
principles.
13. Indemnification.
13.1. By
GenVec.
GenVec
shall defend/indemnify and hold harmless Cobra and its Affiliates,
subcontractors, and their respective directors, officers, employees and agents,
including any Qualified Persons, from and against any and all third party
claims, damages, liabilities, losses, costs and expenses, including reasonable
attorneys’ fees (collectively, “Claims”)
(a) arising out of GenVec’s negligence or willful misconduct, except to
the extent that such a Claim arises out of the negligence or willful misconduct
of Cobra, or (b) alleging the infringement of third-party rights by Cobra’s use,
in performing the Services, of any process, method, Specification or information
supplied to Cobra by GenVec (GenVec’s liability shall include acts or omission
of its directors, officers, employees, and agents), or (c) [breach by GenVec
of
any of its warranties or representations hereunder], or (d) relating to
Deliverables or Services associated therewith after such Deliverables have
been
accepted by GenVec
13.2. By
Cobra.
Cobra
shall defend/indemnify and hold harmless GenVec and its Affiliates, and their
respective directors, officers, employees and agents, from and against any
and
all Claims arising out of (a) Cobra’s negligence or willful misconduct, except
to the extent that such a Claim arose out of the negligence or willful
misconduct of GenVec, (b) breach by Cobra of any of its warranties or
representations hereunder, or (c) a party alleging the infringement of
third-party rights related to the Services of any process, method,
Specification, Cobra Pre-existing IP or information, other than that supplied
to
Cobra by GenVec. (Cobra’s liability shall include acts or omission of its
directors, officers, employees, subcontractors, and agents), or (d) relating
to
Deliverables or Services associated therewith before such Deliverables have
been
accepted by GenVec.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
20
13.3. Indemnification
Procedures. Each
party shall inform the other as soon as reasonably practicable after learning
of
any Claim for which indemnity could be sought under Section 13.1 or Section
13.2. A party
seeking indemnity (a) shall permit the indemnifying party to assume full
responsibility to investigate, prepare for and defend against the Claim,
(b) shall reasonably assist the indemnifying party, at the indemnifying
party’s reasonable expense, in the investigation of, preparation for and defense
of such Claim and (c) shall not compromise or settle such Claim without the
indemnifying party’s prior written consent, not to be unreasonably
withheld.
14. Insurance.
14.1. Of
Both Parties.
Each
party represents and warrants that it has and shall maintain (a) any and all
insurance required by applicable laws and regulations and (b) commercial general
liability insurance, including blanket contractual liability insurance covering
such party with respect to its obligations hereunder, with limits of liability
that are commercially reasonable * Such coverage shall be maintained for not
less than * following expiration or termination of this Agreement or, if such
coverage is of the “claims made” type, for * following expiration or termination
of this Agreement. Some or all such insurance may be in the form of
self-insurance.
14.2. Of
Cobra.
Cobra
represents and warrants that it presently maintains and shall continue to
maintain, at its expense, all-risk property damage insurance coverage with
blanket replacement cost limits and deductibles adequate to cover the value
of
GenVec Materials, GenVec Property, Cobra Materials, , equipment, etc. that
will
be in Cobra’s possession while such equipment is in Cobra’s possession, custody
or control.
14.3. GenVec
will be
responsible for the cost of insurance of GenVec Materials and
raw
materials, to be arranged by Cobra and agreed to in writing by both parties,
any
liability for GenVec Materials and raw materials under such agreement will
be
limited to the value of the insurance cover obtained. Such costs * shall be
added by Cobra from time to time to give a total amount, and in additional
consideration for services under the Service Schedule a fee equal to the total
amount shall be charged to GenVec separately.
14.4. Proof
of Coverage.
Upon
request, each party will provide the other with a certificate of insurance
evidencing the above and showing the name of the issuing company, the policy
number, the effective date, the expiration date and the limits of liability.
The
insurance certificate shall further provide for a minimum of * notice to the
insured of a cancellation of, or material change in, the insurance.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
21
15. Limitations
of Warranties and Liabilities.
15.1. Limitation
of Warranties.
15.1.1. Except
for the warranties expressly provided in this Agreement (including in any
Service Schedule), NEITHER
PARTY MAKES ANY WARRANTY, EXPRESS OR IMPLIED, REGARDING ANY SERVICES,
DELIVERABLES OR OTHER MATERIALS PROVIDED HEREIN, INCLUDING ANY WARRANTY OF
THEIR
FITNESS FOR USE, MERCHANTABILITY, QUALITY, OR NON-INFRINGEMENT OF THIRD PARTY
RIGHTS.
Any
representation or warranty made by any person or entity, including employees
or
representatives of Cobra that are inconsistent herewith, shall be disregarded
and shall not be binding on Cobra, unless made in writing and signed by an
authorized representative of Cobra.
15.1.2. Notwithstanding
anything to the contrary provided in Section
12.1
or
elsewhere in this Agreement, in no event shall Cobra be liable for any Defect
in
Services and/or Deliverables to the extent arising from any information,
Specification and/or other requirement supplied to Cobra by GenVec.
15.2. Limitations
on Damages.
15.2.1. EXCEPT
IN
THE CASE OF VIOLATION OF ARTICLE 10, IN NO EVENT SHALL EITHER PARTY BE LIABLE
TO
THE OTHER FOR LOST PROFITS (OTHER THAN THE PROFIT ELEMENT IN THE PRICES OF
SERVICES), SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE OR INDIRECT DAMAGES
IN
CONNECTION WITH THIS AGREEMENT.
15.2.2. [EXCEPT
IN THE CASE OF A PARTY’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT]
THE
TOTAL
LIABILITY OF EITHER PARTY TO THE OTHER PARTY WITH RESPECT TO SERVICES TO BE
PERFORMED PURSUANT TO ANY SERVICE SCHEDULE SHALL NOT EXCEED *.
15.3. Exception
to Limitations.
Notwithstanding anything provided to the contrary herein, nothing in this
Agreement shall exclude or limit the liability of a party; to the extent such
liability may not be excluded or limited, as a matter of law.
15.4. Cobra’s
employees, sub-contractors and/or agents are not authorized to make any
representations or warranties concerning the Services unless confirmed by a
Director of Cobra in writing.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
22
16. Regulatory
Matters.
In
addition to any other record-keeping and reporting requirements set forth
herein
or in a Service Schedule, Cobra shall keep all records and reports required
to
be filed with the FDA and any other governmental agencies in connection with
the
performance of the Services, and shall make the Deliverables produced hereunder
and the facilities used in performing the Services available at reasonable
business hours for inspection by representatives of such agencies. Cobra
shall
notify GenVec of any inspection, investigation or inquiry by the FDA or other
governmental agency that relates in any way to Cobra’s performance under any
Service Schedule, and shall send GenVec a copy of any report on the results
of
any such inspection, investigation or inquiry. Cobra shall fully cooperate
with
GenVec during any such inspection, investigation or other inquiry, including,
but not limited to, allowing a representative of GenVec to be present during
all
portions of any such inspection, investigation or other inquiry and sharing
with
GenVec any other information related thereto to the extent relevant to the
performance of the Services. Cobra shall discuss any response to observations
or
notifications received in connection with any such inspection, investigation
or
other inquiry and shall give GenVec an opportunity to comment upon any proposed
response before it is made.
17. Notices.
Any
legal notice to be given under this Agreement shall be in writing and shall
be
delivered by an internationally recognized courier or facsimile transmission
(with receipt confirmed by automatic transmission report), addressed to the
parties as follows (or as a party may designate in a notice delivered to the
other party pursuant to this Article 17). Notices shall be deemed delivered
upon
receipt.
|
If
to Cobra:
|
If
to GenVec:
|
|
Cobra
Biologics Limited
|
GenVec,
Inc.
|
|
The
▇▇▇▇▇▇▇▇▇▇ Building
|
65
West ▇▇▇▇▇▇▇ Mill Road
|
|
The
Science Park
|
▇▇▇▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇, ▇▇▇▇▇
|
|
Keele,
Staffordshire, ST5 5SP, UK
|
USA
|
|
Attention:
____________________
|
Attention:
____________________
|
|
Fax.
No. _____________________
|
▇▇▇.▇▇.
______________________
|
18. Force
Majeure.
Neither
party shall be liable to the other for any delay or failure in performance
of
this Agreement to the extent that such delay is due to events outside that
party’s reasonable control, including acts of God, war, flood, fire, labor
disputes, strikes, lock-outs, riots, civil commotion, malicious damage,
explosion, governmental actions and any other similar events. If either party
is
affected by any such event, then the time for performance shall be extended
for
a period equal to the period that such event delayed such performance.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
23
19. Restriction
on Hiring
Personnel.
19.1. GenVec
shall
not, during the term of this Agreement and for a period of * thereafter,
directly or indirectly induce
or
solicit any person who is an employee of Cobra, to accept employment or other
work that would result in such person ceasing or limiting the amount of work
previously performed on behalf of Cobra, without the prior written consent
of
Cobra. The above prohibition shall not apply to any personnel that respond
to an
indirect solicitation (e.g., through a newspaper, magazine or trade journal
advertisement).
19.2. Cobra
shall
not, during the term of this Agreement and for a period of * thereafter,
directly or indirectly induce or solicit any person who is an employee, agent
or
consultant of GenVec, to accept employment or other work that would result
in
such person ceasing or limiting the amount of work previously performed on
behalf of GenVec, without the prior written consent of GenVec. The above
prohibition shall not apply to any personnel that respond to an indirect
solicitation (e.g., through a newspaper, magazine or trade journal
advertisement).
20.
RECORDS, ACCESS TO FACILITY AND AUDITS
20.1. Records.
Cobra
shall establish and maintain complete, accurate and authentic data, books and
records of the work performed hereunder. Without limiting the generality of
the
foregoing, Cobra shall monitor and maintain reasonable records respecting its
compliance with cGMPs, including the process of establishment and implementation
of the operating procedures and the training of personnel as are reasonably
necessary to assure such compliance. Cobra agrees that, in response to any
complaint or in the defense by GenVec of any litigation, hearing, regulatory
proceeding or investigation relating to the Services, Cobra shall make available
to GenVec upon reasonable prior written notice, such Cobra employees and records
reasonably necessary to permit the effective response to, defense of, or
investigation of such matters at reasonable cost to GenVec. [Access to financial
data and accounting records shall be restricted to copies of relevant supplier
invoices and employee expense claims which have been recharged to GenVec,
applicable stock usage records and employee timesheets.
20.2. Inspection
and Audit.
GenVec
and its representatives shall have the opportunity to converse with Cobra’s
personnel and visit, inspect and audit the Facility and all data, records,
reports, information, licenses, permits and other documentation relating to
the
Services for the purpose of assuring Cobra’s compliance with its obligations
under this Agreement including verification of the Prices due hereunder and
Cobra’s compliance with applicable law. GenVec’s exercise of its inspection and
audit rights hereunder shall in no way waive, modify, or diminish Cobra’
obligations under this Agreement, or impose any obligation to inspect, audit,
or
act upon GenVec. Cobra shall cooperate with GenVec and its representatives
and
provide such assistance as GenVec and its representatives reasonably require
in
carrying out such inspections and audits. Access to financial data and
accounting records shall be restricted to copies of relevant supplier invoices
and employee expense claims which have been recharged to GenVec, applicable
stock usage records and employee timesheets.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
24
20.3. Follow-up.
Following any review or audit, GenVec shall have the right to conduct (or have
its representatives conduct) a review meeting with Cobra to obtain factual
concurrence with issues identified in the findings. Cobra and GenVec shall
review the findings of each review and audit promptly after the issuance of
the
resulting report or findings and shall mutually agree upon the appropriate
manner, if any, in which to respond to the changes suggested by the audit
report. Cobra shall provide to GenVec a plan and schedule for any necessary
corrective action for GenVec’s approval and shall complete such corrective
actions in accordance with the approved plan and schedule. To the extent that
any Cobra review or audit, or any audit performed by GenVec or its
representatives, reveals any overpayment by GenVec, then Cobra shall promptly
reimburse (or at GenVec’s request, credit such overpayment) to GenVec the
overcharge by Cobra. In the event the overpayment exceeds * of the fees due
over
the period audited, then Cobra shall also reimburse to GenVec the costs of
such
audit.
20.4. Survival.
Cobra’s
obligation and GenVec’s rights under this Section 20 shall survive for a period
of * following expiration or termination of this Agreement.
21. Miscellaneous
21.1. Independent
Contractors.
The
parties are independent contractors hereunder, and nothing contained in this
Agreement shall be construed to place them in the relationship of partners,
principal and agent, employer and employee or joint venturers. Neither party
shall have the power or right to bind or obligate the other party, nor shall
either party hold itself out as having such authority.
21.2. Waiver.
No
waiver of any term or condition of this Agreement shall be valid or binding
on
either party unless made in writing by the party to be charged. The failure
of
either party at any time to enforce, or to require performance by the other
party of any provision of this Agreement, shall in no way be construed as a
present or future waiver of such provision or of any other
provision.
21.3. Severability.
If any
provision of this Agreement is held by any competent authority to be invalid
or
unenforceable, in whole or in part, the validity of the other provisions of
this
Agreement and the remainder of the provision in question shall not be
affected.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
25
21.4. No
Third-party Rights.
No
third party shall have the right to enforce the terms of this Agreement. The
rights of any third party to enforce this Agreement may be varied and/or
extinguished by agreement between the parties, without the consent of any such
third party.
21.5. Assignment.
Neither
party may assign any of its rights or obligations under this Agreement without
the prior written consent of the other party, except for an assignment to a
party’s successor in interest by way of a merger or the purchase of all or
substantially all of such party’s assets or business to which this Agreement
relates. Notwithstanding the preceding sentence, Cobra may not assign this
Agreement to any this party (by way of merger or the purchase of all or
substantially all of its assets) to a competitor of GenVec, without GenVec’s
prior written consent.
21.6. Construction
and Headings.
All
section titles or headings contained in this Agreement are for convenience
only,
will not be deemed a part hereof or thereof and will not affect the meaning
or
interpretation of this Agreement or Service Schedule.
21.7. Governing
Law.
This
Agreement shall be governed by and interpreted in accordance with the laws
of
the State of New
York,
excluding that body of law pertaining to conflict of laws.
21.8. Dispute
Resolution.
21.8.1. Except
as
otherwise provided in Sections 7.2 and 21.8.2, any dispute arising out of or
in
connection with this Agreement, shall be referred to arbitration by a single
arbitrator. The arbitration shall be carried out in accordance with the Rules
of
Arbitration of the International Chamber of Commerce in force as at the date
of
the dispute. The arbitration shall be held in London, England, if initiated
by
GenVec and in Gaithersburg, Maryland, USA if initiated by Cobra. All decisions
of the arbitrator shall be final and binding on the parties and may be enforced
in any court of competent jurisdiction. The party favored by the arbitrator’s
decision shall be entitled to the costs of the arbitration and reasonable
attorneys’ fees.
21.8.2. Either
party shall be entitled to seek relief from a State of Maryland, USA court
of
competent jurisdiction to enjoin a breach of Section 3.3, Sections 10.1 - 10.6
or Article 11.
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
26
21.9. Nature
of this Agreement.
The
parties agree that this Agreement is for the provision of Services - in
particular the conduct of tests and other work and the provision of expert
reports, and that, to the extent that any Service Schedule requires the delivery
of Deliverables, such Deliverables are incidental to the delivery of Services.
21.10. *
21.11. Further
Assurances.
Each
party shall execute, acknowledge and deliver such further instruments, and
take
such further actions as may be reasonably necessary or appropriate to carry
out
the purposes and intent of this Agreement.
21.12. Entire
Agreement.
This
Agreement and any Service Schedules executed hereunder constitute the entire
agreement of the parties with respect to the subject matter hereof and supersede
all prior or contemporaneous understandings or agreements between them, whether
written or oral, respect to such subject matter., with the exception of the
Quality Agreement executed on even date herewith. In the event of conflict
between the terms of this Agreement and the terms of the Quality Agreement
on
matters pertaining to GMPs, the terms of the Quality Agreement shall govern,
and
any breach of the Quality Agreement shall be deemed a breach of this Agreement.
For all other matters, the terms of this Agreement shall govern. No amendment
or
modification of this Agreement shall be valid or binding on the parties unless
made in writing and signed by the duly authorized representatives of both
parties.
IN
WITNESS WHEREOF,
the
parties hereto have each caused this Agreement to be executed by their
duly-authorized representatives as of the date first above written.
|
GENVEC,
INC.
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By:
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
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By:
▇▇▇▇ ▇. ▇▇▇▇▇▇▇
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Signature:
/s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
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Signature:
/s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇
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Print
Name: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
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Print
Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇▇
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Title:
Chief Executive
|
Title:
CEO
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Date:
1/23/08
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||
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|
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
27
Appendix
1: Capacity Reservation Fee Worksheet for Service Schedule
A393
Components
of Capacity Reservation Fee:
*
*
*
*
*
Occupancy
Charge per Month During Consistency Runs:
*
Estimated
Months in Suite per Consistency Run: *
Portion
of Capacity Reservation Fee Per Reserved Consistency Run:
*
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
28
Appendix
2: Termination for Service Schedule A393
Maximum
Termination fee rate: $ *
Termination
fee to apply beginning *
Maximum
Termination fee to apply beginning *
Reduction
of Termination fee to begin *
|
Date
of Termination
|
Milestone
|
Termination
Fee
|
% of Max Termination Fee
|
|||||||
|
(Based
on project
schedule)
|
$
|
|||||||||
|
Month
1
|
*
|
*
|
||||||||
|
Month
2
|
*
|
*
|
||||||||
|
Month
3
|
*
|
*
|
||||||||
|
Month
4
|
*
|
*
|
*
|
|||||||
|
Month
5
|
*
|
*
|
||||||||
|
Month
6
|
*
|
*
|
||||||||
|
Month
7
|
*
|
*
|
||||||||
|
Month
8
|
*
|
*
|
*
|
|||||||
|
Month
9
|
*
|
*
|
||||||||
|
Month
10
|
*
|
*
|
*
|
|||||||
|
Month
11
|
*
|
*
|
||||||||
|
Month
12
|
*
|
*
|
||||||||
|
Month
13
|
*
|
*
|
||||||||
|
Month
14
|
*
|
*
|
||||||||
|
Month
15
|
*
|
*
|
||||||||
|
Month
16
|
*
|
*
|
*
|
|||||||
|
Month
17
|
*
|
*
|
||||||||
|
Month
18
|
*
|
*
|
*
|
|||||||
|
Month
19
|
*
|
*
|
||||||||
|
Month
20
|
*
|
*
|
*
|
|||||||
|
Month
21
|
*
|
*
|
||||||||
|
Month
22
|
*
|
*
|
*
|
|||||||
Confidential
*
The
asterisk denotes that confidential portions of this exhibit have been omitted
in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission.
29