MASTER PRODUCT SALE AGREEMENT
EXHIBIT
10.3
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This
MASTER PRODUCT SALE AGREEMENT (this “Agreement”) is entered into as of
September 12, 2008 between BioCancell Therapeutics, Ltd., a corporation
organized under the laws of the State of Israel, with a principal business
address at Xxxx Science Center, 0 Xxxxxx Xxxxxx, Xxx Xxxxxxx, Xxxxxxxxx 00000
Israel (“CUSTOMER”), and VGXI USA, a business entity registered in the state of
Texas, having an address at 0000 Xxxxxxxx Xxxxxx Xxxxx Xxxxx 000, Xxx Xxxxxxxxx,
Xxxxx 00000, (“VGX”) a DBA of VGX International Inc. at 000-0 Xxxxxx-xxxx,
Xxxxxxx-xx, Xxxxx, Xxxxx, with reference to the following facts:
BACKGROUND
A. VGX
has developed specific expertise and technology relating to production and
testing of DNA plasmids and is in the business of developing, manufacturing and
testing plasmid based products for research and therapeutic benefit, in a manner
complying with cGMP as appropriate.
B. CUSTOMER
desires to have VGX produce, from time to time, certain quantities of products
for human clinical and/or non-human use (“Contract Materials”), on each
occasion, on the terms and conditions set forth in this Agreement and Purchase
Order therefore.
NOW,
THEREFORE, in consideration of the above premises and the mutual covenants
hereinafter recited, the Parties agree as follows:
1. Definitions.
When used
in this Agreement, each of the following terms shall have the meanings as set
forth in this Article
1.1. “VGX
Background Technology” shall mean VGX proprietary information, trade secrets,
and/or know-how used by VGX in the
performance of this Agreement and owned by VGX prior to the date hereof,
including, but not limited to, information relating to materials, devices and
methods for fermenting bacteria and the purification and testing of DNA
Plasmids.
1.2.
“Affiliates” shall mean any corporation, firm, limited liability company,
partnership or other entity, which directly or indirectly controls or is
controlled by or is under the common control with a Party, or any corporation,
firm, limited liability company, partnership or other entity of behalf of which
either Party is acting as an agent, advisor, or distributor.
1.3. “Agreement”
shall mean this Master Product Sale Agreement, as amended from time to
time.
1.4. “Xxxx
of Testing” shall be the tests agreed to for each particular Purchase Order. The
Xxxx of Testing will be considered a draft until mutually agreed upon in writing
for a particular Purchase Order.
1.5. “Biosafety
Level I” shall mean a basic level of containment that relies on standard
microbiological practices with no special primary or secondary barriers
recommended other than a sink for hand washing, in which work is done with
defined and characterized strains of viable microorganisms not known to
cause disease in healthy adult humans and classified as such by the relevant
authorities, regulations or law.
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1.6. “Calendar
Year” shall mean each successive period of twelve (12) consecutive calendar
months commencing on January 1 and ending on December 31.
1.7. “Cell
Banking Activities” shall mean the creation, testing, and maintenance of a
Master Cell Bank (MCB) and/or a Manufacturer’s Working Cell
Bank (MWCB) under cGMP conditions, containing copies of the Parent Plasmid, each
of which will meet the Specifications as finalized pursuant to a particular
Purchase Order.
1.8. “Commencement
Date” with respect to any particular order, shall mean the first date specified
in the Purchase Order.
1.9. “Contract
Materials” shall mean all of the materials to be produced by VGX for CUSTOMER as
specified in a particular Purchase Order including Product. The Parties hereto
will prepare and sign new Purchase Order for each new DNA plasmid that VGX is to
produce hereunder.
1.10. “CUSTOMER
Materials” shall mean all materials sent by CUSTOMER to VGX related to this
Agreement and to the applicable Purchase Order and documentation.
1.11. “CUSTOMER
Background Technology” shall mean all data, information, know-how, trade
secrets, copyrights, designs, databases, discoveries, improvements and
inventions (whether patentable or not) related to the Information and/or the
CUSTOMER Materials that are owned, licensed or controlled by CUSTOMER or its
Affiliates prior to the date hereof.
1.12. ‘‘Direct
Materials Costs” shall mean the cost to VGX of materials utilized in the
performance of Production Services, including freight-in costs, sales and excise
taxes imposed thereon and customs duty and charges levied by government
authorities, and all costs of packaging components.
1.13. “External
Testing Costs” shall mean the cost of any tests listed as “contract” on the
draft or final Xxxx of Testing, as well as any other testing not performed at
the VGX facility.
1.14. “FDA”
shall mean the U.S. Food and Drug Administration.
1.15. “Good
Laboratory Practices” or “GLP” shall mean prescribed practices and policies
related to all laboratory manufacturing and test methods intended to assure
quality, safety and integrity of the resulting product, with the intent that
such product shall be subject to oversight by U.S. regulatory authorities and
the corresponding authorities of the European Union, Member States of the
European Union, and other countries to the extent they are
applicable.
1.16. “Good
Manufacturing Practices” or “GMP” shall mean the good manufacturing
practices required by the U.S. Food and Drug Administration for the manufacture
and testing of pharmaceutical and biological materials, and the corresponding
requirements of the European Union, Member States of the European Union, and
other countries to the extent they are applicable. “cGMP” or “current GMP” shall
mean the GMP practices in effect at a particular time.
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1.17. “Information”
means all (a) techniques and data pertaining and/or related to the Contract
Materials, including, but not limited to, ideas, inventions (including
patentable inventions), practices, methods, knowledge, know-how, trade secrets,
skill, experience, documents, apparatus, clinical and regulatory strategies,
test data, including pharmacological, toxicological and clinical test data,
analytical and quality control data, manufacturing, patent and legal data or
descriptions and (b) chemical formulations, compositions of matter, product
samples and assays pertaining and/or related to the Contract
Materials.
1.18. “Manufacturer’s
Working Cell Bank” or “MWCB” shall mean viable E. coli containing Parent
Plasmid, cultured from the MCB under GMP conditions, diluted in glycerol and
stored in sealed vials at less than minus sixty degrees Celsius.
1.19. “Master
Cell Bank” or “MCB” shall mean viable E. coli containing Parent Plasmid,
transformed directly from CUSTOMER supplied stock under GMP conditions, diluted
in glycerol and stored in sealed vials at less than minus sixty
degrees Celsius.
1.20. “Party”
shall mean either CUSTOMER or VGX as the case may be.
1.21. “Parent
Plasmid” shall mean the original DNA plasmid construct, prepared by CUSTOMER and
provided to VGX, listed in a particular Purchase Order.
1.22. “Person”
shall mean a natural person, a corporation, a partnership, a trust, a joint
venture, any governmental authority or any other entity or
organization.
1.23. “Pilot
DNA Services”
shall mean the production of Research DNA at a sufficiently large scale as to
provide a reasonable indication of the growth, quality and yield of a GMP batch
produced with the same cell bank.
1.24. “Pilot
DNA” shall mean the Research DNA produced as a result of the Pilot DNA
Services.
1.25. “Price”
shall mean the amount payable to VGX in U.S. dollars for the performance of
Production Services hereunder with respect to any Purchase Order.
1.26. “Product”
shall mean finished goods in final container/closure or other deliverable listed
as a line item in any Purchase Order to be delivered to CUSTOMER.
1.27. “Production
Services” shall mean the activities to be performed by VGX hereunder, which
shall mean the production of the Contract Materials and relevant supporting
documentation accordingly to the Purchase Order.
1.28. “Project
Technology” shall mean and include all data, information, know-how, trade
secrets, copyrights, designs, databases, processes, compounds, discoveries, new
uses, improvements and inventions (whether patentable or not) that are
conceived, generated, derived, developed or reduced to practice solely by one
Party or jointly by both Parties and that arise out of the performance of this
Agreement and all patents and other intellectual property rights relating
thereto.
1.29. “Purchase
Order” means a purchase order agreement for a
specific project.
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1.30. “Research
Cell Bank” or “RCB” shall mean a small cell bank produced under research
conditions used for the production of Research DNA only. This material is
provided “as-is”.
1.31. “Research
DNA” shall mean a small amount of DNA prepared by VGX under Research Laboratory
Conditions from the RCB as an initial indication of growth, yield, and quality
characteristics. This material is provided “as-is”
1.32. “Research
Laboratory Conditions” shall mean practices and policies generally accepted by
trained scientists to assure quality and integrity of laboratory experiments.
Such practices include, but are not necessarily limited to, aseptic techniques
to avoid microbial contamination, accurate measurements and calculations and
documentation of research results.
1.33. “Resuspension
Buffer” shall mean the liquid used to resuspend DNA in the finished Product
and having the composition specified by the CUSTOMER.
1.34. “Sample
Plasmid” shall mean a DNA plasmid supplied by CUSTOMER, of sufficiently similar
characteristics to the Parent Plasmid to perform initial quality control assay
evaluations and/or initial process development testing. Sample Plasmid and
Parent Plasmid should be the same plasmid whenever possible to ensure the
validity of the results.
1.35. “Specifications”
means, with respect to any Product, the specifications therefore as set forth in
a Purchase Order for such Product.
1.36. “Third
Party” means any person or entity other than VGX or CUSTOMER.
2. Purchase
Orders.
2.1. Supply. During the
term of, and subject to the terms and conditions in this Agreement, CUSTOMER may
purchase from, and have Contract Materials produced by, VGX. Neither shall
CUSTOMER have any commitment to purchase any minimum quantity of Contract
Materials nor shall VGX have any commitment to produce and sell any minimum
quantity of Contract Materials. CUSTOMER shall become obligated to purchase, and
VGX shall be obligated to produce Contract Materials only upon execution and
delivery by both VGX and CUSTOMER of a Purchase Order for such Contract
Material, as set forth below.
Neither
VGX nor CUSTOMER may amend a Purchase Order after it has been executed, except
according to the provisions of Section 12 or by mutual agreement in writing as
provided in Section 13.5. CUSTOMER may cancel an existing Purchase Order prior
to the Commencement Date and forfeit any prepayments made for such Purchase
Order. For each new Product that is to be produced by VGX pursuant to this
Agreement, the Parties will prepare and sign a Purchase Order, and upon signing,
such new Purchase Order shall become a part of this Agreement. Each such new
Purchase Order shall specifically reference this Agreement and be signed by both
Parties hereto. Each new Purchase Order will contain project details for the
production and testing of some or all of the Contract
Material.
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2.2. Project
Specifications. VGX will produce under cGMP conditions the specified
amounts or number of cycles of Contract Materials and Product. Such Product will
be produced, tested, released and delivered to CUSTOMER according to the
schedule in the Purchase Order. VGX shall ship the Contract Materials
directly to CUSTOMER, or to a recipient address provided by the CUSTOMER to VGX
in writing. VGX will keep in its possession any required documentation,
regulatory retains, and will maintain certain additional samples and/or cell
banks at the request of CUSTOMER for an additional fee (to be determined in the
applicable Purchase Order).
2.3. Laboratory Test Production
of Research DNA. To the extent not previously completed with respect
to any Purchase Order, within one (1) week of the Commencement Date, CUSTOMER
will supply VGX with more than fifteen (15) milligrams of each Parent Plasmid or
more than ten (10) vials of a qualified cell bank containing Parent Plasmid for
VGX use and retain. If required, VGX shall perform, under Research Laboratory
Conditions, the experiments listed as scheduled in the particular Purchase Order
to establish optimum fermentation and purification conditions for the Parent
Plasmid, to determine yield, stability, purity and form of the plasmid
DNA.
2.4. Modification If Research
Results Not Satisfactory.
If the Research DNA produced pursuant to Section 2.3 above does not meet the
draft productivity or purity standards set forth in the Purchase Order, CUSTOMER
and VGX shall then meet and negotiate, in good faith, appropriate modifications
to the Agreement to address the failure to meet the criteria. VGX will produce
additional Research DNA batches if deemed necessary by mutual written agreement
between VGX and CUSTOMER. The cost of producing the additional batches will be
borne by CUSTOMER if the Research DNA does not meet the draft productivity
or purity standards set forth in the Purchase Order in whole or in part as a
result of the negligence of CUSTOMER. The cost of producing the additional
batches will be borne by VGX, if the Research DNA does not meet the draft
productivity or purity standards set forth in the Purchase Order in whole or in
part as a result of the negligence of VGX. If the Parties dispute whether
Research DNA is conforming or non-conforming, or the reasons for non-conformity,
samples of the batch of Research DNA will be submitted to a mutually acceptable
laboratory or consultant for resolution, whose determination of conformity or
non-conformity, and the cause thereof if non-conforming, shall be binding upon
the Parties. The Party decided to be in the wrong shall bear the costs of such
laboratory or consultant. If the Parties agree that VGX should take other
actions to address the purity or productivity problems, they will also agree
upon the appropriate modifications to the payments and execute on appropriate
amendment. If the Parties are unable to reach an agreement despite good faith
negotiations, either Party may terminate this Agreement or Purchase Order by
written notice to the other.
2.5. Testing to Release
Manufacture. If the Research DNA produced meets the standards, VGX shall
produce and perform relevant testing needed to release the MCB and/or MWCB into
its facility, or evaluate and test any CUSTOMER supplied MCB and/or MWCB as
appropriate. Such work shall be performed in accordance with the schedule in the
Purchase Order.
2.6. Pilot Production of Research
DNA. To the extent not previously
completed with respect to any Purchase Order, if required, VGX shall perform,
under Research Laboratory Conditions, the Pilot DNA Services as defined in
Section 1.23 above, pursuant to the Specifications set forth in the Purchase
Order.
2.7. Finished
Product Production. If the Pilot DNA produced by VGX
meets the standards in the draft Xxxx of Testing, the final Xxxx of Testing will
be signed by VGX and the CUSTOMER and attached to the Purchase Order Agreement.
VGX shall then commence with preparing for each Parent Plasmid under GMP
conditions the specified number of production cycles of finished Product. Such
finished Product will be produced, tested, released and delivered to
CUSTOMER according to the schedule in the particular Purchase
Order.
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2.8. Pilot Production
Unsatisfactory. If the
Pilot DNA produced by VGX does not meet the standards in the draft Xxxx of
Testing, VGX and CUSTOMER will discuss the possible amendment of the Xxxx of
Testing. VGX will produce an additional Pilot DNA batch if deemed necessary
by mutual written agreement between VGX and CUSTOMER. The cost of producing the
additional batch will be borne by CUSTOMER if the Pilot DNA does not meet the
standards in the draft Xxxx of Testing as a result of the negligence of
CUSTOMER. The cost of producing the additional batches will be borne by VGX, if
the Pilot DNA does not meet the standards in the draft Xxxx of Testing as a
result of the negligence of VGX. If the Parties dispute whether Pilot DNA is
conforming or non-conforming, or the reasons for non-conformity, samples of the
batch of Pilot DNA will be submitted to a mutually acceptable laboratory or
consultant for resolution, whose determination of conformity or non-conformity,
and the cause thereof if non-conforming, shall be binding upon the Parties. The
Party decided to be in the wrong shall bear the costs of such laboratory or
consultant. If the Parties agree that VGX should take other actions to address
the purity or productivity problems, they will also agree upon the appropriate
modifications to the payments in the Purchase Order and execute an appropriate
amendment. If the Parties are unable to reach an agreement despite good faith
negotiations, either Party may terminate this Agreement or Purchase Order
by written notice to the other.
3. Materials
and Information.
Promptly after execution
of a Purchase Order pursuant to Section 2.1, CUSTOMER shall deliver to VGX all
materials and Information that are reasonably necessary for VGX to produce and
manufacture the Products, and that such Purchase Order provides are to be
delivered by CUSTOMER to VGX. Information supplied pursuant to this Article 3
shall be in a format acceptable to VGX. CUSTOMER shall bear the risk of loss of,
and damage to, such materials and Information until actual receipt by VGX.
Following their receipt, VGX shall be responsible for the risk of loss of, and
damage to, such materials and Information. Information provided pursuant to this
Article 3 shall be regarded as Confidential Information.
4. Production.
4.1. Performance of Work.
VGX shall produce the Product in accordance with this Agreement, the Purchase
Order therefore, any agreed technical or descriptive specifications, and in
compliance with cGMP and the requirements of any applicable regulatory agency or
other governmental authority and all applicable laws and
regulations.
The
Parties agree that VGX may subcontract the performance of certain production
services necessary for the performance of this Agreement to VGXI Inc. In
addition, subject to CUSTOMER’s prior written consent, VGX may subcontract the
performance of certain testing services necessary for the performance of this
Agreement. CUSTOMER shall agree to VGX’s use of subcontractors, only if they
meet the cGLP regulations. VGX will not change subcontractors without CUSTOMER’S
written approval.
4.2. Quality
Control and Assurance.
(i) VGX
shall manufacture Product in compliance and in accordance with the
Specifications and all applicable laws and regulations. Prior to each shipment
of Product, VGX shall perform quality control testing on Product in accordance
with Specifications as outlined in the Purchase Order. VGX shall, during and
after the term of this Agreement, maintain such records and data that document
its compliance with this Section 4.2 as reasonably requested by CUSTOMER
and as required by law and regulation applicable to the
manufacture of the Product, and shall make such information available to
CUSTOMER upon its request. In performing its obligations under this Agreement,
VGX shall comply with all applicable environmental and health and safety
laws.
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(ii)
Subject to the provisions of Section 4.7 below, if the
Parties determine, prior to the delivery of any batch of Product that such
Product fail to meet any of the Specifications, VGX shall, at its sole cost,
either discard the Product and shall bear the loss resulting therefrom, or if it
is possible, correct the deficiency in and/or repackage such batch of Products,
as CUSTOMER may, in its sole discretion, direct.
(iii) CUSTOMER
shall be entitled to carry out such procedures as CUSTOMER requires for the
analysis and validation of the Products prior to acceptance
thereof.
(iv) VGX
shall promptly notify CUSTOMER in writing of any major incidents or anomalous
results observed by VGX during the manufacture of the Products. VGX shall take
all reasonable measures to ensure that the affected Products are not released
until the Parties reach agreement on appropriate corrective measures and/or
other actions to be taken by VGX.
4.3. Change
Order.
The
Specifications shall be amended to the extent necessary to comply with changes
in applicable laws and/or regulations or the requirements of applicable
regulatory agencies. In addition, the Specifications shall be amended as
CUSTOMER may reasonably request from time to time with the mutual consent of the
Parties. VGX shall not make without CUSTOMER’s prior written consent any change
in (i) the manufacturing facility which would have an impact on the Product or
require submissions to or approvals from any regulatory agency or, (ii) the
manufacturing process. VGX undertakes that any such change(s) shall, in each
case, comply with cGMP, this Agreement, the requirements of all applicable
regulatory agencies and all applicable laws, rules and regulations, including
but not limited to the Federal Food, Drug and Cosmetic Act and the regulations
promulgated pursuant thereto, and without limiting the foregoing, with the
standard of care customary in the industry. In the event such amendment (whether
as a result of changes in applicable laws or the requirements of applicable
regulatory agencies or at CUSTOMER’s reasonable request or otherwise) requires
additional cost or schedule adjustments for the manufacture of the Product
hereunder, the Parties shall agree in good faith on an equitable adjustment to
Price and/or schedule, as appropriate.
4.4. Delays
in Production.
Each
Party will promptly notify the other Party in writing if it believes that there
are likely to be changes in the work schedule contained in the Purchase Order.
Such notice will include the reasons for such changes in the schedule and the
proposed new schedule for the incomplete portion of the work. VGX is responsible
for any delays in the production or delivery of Contract Materials except for
delays caused by the lack of delivery by CUSTOMER of material Information or
CUSTOMER Materials in a timely manner, as agreed to in advance. In the event of
any delays in the production or delivery of Contract Materials for which VGX is
responsible pursuant to this Section 4.4, the payment schedule set forth in the
Purchase Order shall be amended accordingly. In addition, the aggregate amount
payable to VGX pursuant to the Purchase Order shall be reduced by 5% per each
month of delay. In the event that a delay is for a period of less than an entire
month, the penalty amount for such partial period shall be adjusted
proportionately (e.g. in the event of a delay of 75 days, the aggregate amount
payable pursuant to the Purchase Order will be reduced by 25%). In the event
that CUSTOMER requests VGX to delay the production or delivery of Contract
Materials, than the aggregate amount payable to VGX pursuant to the Purchase
Order shall be increased by 5% per each month of delay. In the event that a
delay is for a period of less than an entire month, the penalty amount for such
partial period shall be adjusted proportionately.
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A delay
of less then 30 days, at the first month of delay, will not be considered as a
delay.
4.5. Audits
by CUSTOMER.
(i)
Upon the written request of
CUSTOMER, VGX shall permit CUSTOMER or an independent consulting firm
specializing in pharmaceutical manufacturing facility inspections selected by
CUSTOMER and reasonably acceptable to VGX, at CUSTOMER’S expense, to have access
during VGX normal business hours to inspect such of the records and facilities
of VGX, as may be reasonably necessary to verify that Products manufactured by
VGX are manufactured in accordance with Good Manufacturing Practices and conform
to the Specifications as outlined in a Purchase Order which is dated not more
than twelve (12) months prior to the date of such request. CUSTOMER’s right to
inspection shall continue until twelve (12) months from delivery of the
Products. Only information that is related to this Agreement will be the subject
of such inspection. VGX shall make all efforts to address any GMP or
Specifications deficiencies found by CUSTOMER in such inspection
(ii)
CUSTOMER may make a
preproduction inspection of the facilities upon reasonable notice, prior to
signing the first Purchase Order. VGX shall make all good faith efforts to
address any GMP deficiencies found by CUSTOMER in any pre-production inspection.
If deficiencies are addressed to CUSTOMER’s satisfaction in a reasonable time
period, this Agreement or the applicable Purchase Order will continue. If
deficiencies are not addressed to CUSTOMER’s satisfaction, CUSTOMER may
terminate this Agreement or the applicable Purchase Order by written notice to
VGX and neither Party shall have any further liability hereunder as a result of
such termination.
(iii) CUSTOMER
shall treat all information subject to review under this Section 4.5 in
accordance with the confidentiality provisions of this Agreement, and shall
cause its consultants who review such information to be bound by the same
confidentiality provisions.
4.6. Certificate
of Release and Analysis. Concurrent with its delivery of Product, VGX shall deliver to CUSTOMER the
certificate of pharmaceutical release and a written report summarizing
analytical and manufacturing documentation which will include the final
certificate of analysis for such Product.
4.7. Non
Conforming Product
(i)
Upon VGX’s release of a batch of Product, VGXI shall provide CUSTOMER, or
CUSTOMER’s designee, copies of batch records, test results and a certificate of
analysis, if appropriate to the batch, stating the test results from the quality
control assay performed by VGX. Within sixty (60) calendar days after receipt by
CUSTOMER of the documentation, CUSTOMER shall determine whether the Product
conforms to Specifications and has been manufactured in accordance with the
batch record, VGX’s current SOPs, and the Purchase Order.
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(ii)
If (i) any batch of Product conforms to the Specifications, or (ii)
CUSTOMER fails to notify VGX within the applicable time period that any batch of
Product does not conform to the Specifications, then CUSTOMER shall be deemed to
have accepted the Product and waived its right to revoke
acceptance.
(iii) If
CUSTOMER believes any batch of Product does not conform to the Specifications,
it shall notify VGX by telephone, including a detailed explanation of the
non-conformity, and shall confirm such notice in writing via overnight delivery
to VGX. Upon receipt of such notice, VGX will investigate such alleged
non-conformity, and (i) If VGX agrees such Product is non-conforming, deliver to
CUSTOMER a corrective action plan within thirty (30) calendar days after receipt
of CUSTOMER’s written notice of non-conformity, or (ii) if VGX disagrees with
CUSTOMER’s determination that the batch of Product is non-conforming, VGX shall
so notify CUSTOMER by telephone within the thirty (30) calendar day period and
provide CUSTOMER with evidence to substantiate its claim as well as confirm such
notice in writing by overnight delivery.
(iv) If
the Parties dispute whether Product is conforming or non-conforming, samples of
the batch of Product will be submitted to a mutually acceptable laboratory or
consultant for resolution, whose determination of conformity or non-conformity,
and the cause thereof if non-conforming, shall be binding upon the parties. The
Party decided to be in the wrong shall bear the costs of such laboratory or
consultant.
4.8. Remedies for Non Conforming
Product. In the event VGX agrees that the batch of Product is
non-conforming in whole or in part as a result of the negligence of VGX or the
laboratory determines that the shipment of Product is non-conforming in whole or
in part as a result of the negligence of VGX, then CUSTOMER, shall subject to
the provisions of Section 4.4 above, allow VGX at its expense to replace such
non-conforming Product within forty-five (45) calendar days from the date
Product is determined to be non-conforming, and in the event that VGX is unable
to timely replace such non-conforming Product asset forth above, than CUSTOMER,
shall be granted a full refund of the payments paid pursuant to the Purchase
Order. In addition, the due date for the final invoice issued at completion of
production of the Product will be extended until the date at which replacement
Product is released and determined to be conforming by VGX and
CUSTOMER.
4.9. Samples and Batch
Records. VGX shall prepare and maintain or cause to be prepared and
maintained batch records and samples, properly stored, from each lot or batch of
Product manufactured and shipped hereunder sufficient to perform each quality
control test identified in the Specifications. Batch records will be reviewed
and approved by VGX and the CUSTOMER prior to commencement of production of
Contract Materials. Any material change to an approved batch record will be
reviewed and approved by VGX and the CUSTOMER prior to said change being
implemented. Any deviation from the manufacturing process specified in the batch
record must be documented in the copy of the batch record for that batch. All
batch records will be made available to CUSTOMER in English upon completion of
each batch. Copies of the batch records will be sent to the CUSTOMER with the
certificate of analysis. All documentation related to the manufacturing of
Contract Materials shall be archived with VGX during and after the
manufacturing, in accordance with its document retention policies and cGMP, for
at least one (1) year after the expiration date of each respective batch
manufactured. CUSTOMER shall be contacted before destruction of any specific
records regarding Contract Materials and shall be given the option to retain
such documents. All batch record and related documentation shall be regarded as
Confidential Information hereunder.
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If a
DMF/BMF will be required by the regulatory authorities (such as the FDA, EMEA
etc), VGX will submit such a file at a time which will be sufficient enough for
these authorities to approve the submission before the full release of the
batch. VGX will provide the CUSTOMER with authorization letter that enables the
regulatory authorities to review the DMF/BMF regarding the production process of
the Product.
4.10. Inspections
by Government Agencies.
(i)
If any governmental agency shall inspect any facility at which any Product is
manufactured or the records with respect to the Production Services or the
compliance by VGX with laws and regulations applicable to the manufacturing of
such Product, VGX shall notify CUSTOMER of such inspection, the results thereof
and, if VGX was required, as a result of any such inspection, to take any
corrective action in order to comply with any applicable law or regulation, any
such action it has taken in response to such requirement.
(ii)
VGX will notify CUSTOMER promptly upon receipt of any correspondence
from a regulatory agency, which relates to the Production Services and promptly
provide the CUSTOMER a copy thereof. CUSTOMER shall be entitled to review and
approve in advance VGX’s responses and submissions, but such approval shall not
be unreasonably withheld. In addition and subject to the foregoing, VGX shall
provide to the regulatory agencies all documents and information requested by
such authority, and shall submit to all inquiries, audits and inspections by the
regulatory agencies.
(iii) VGX
hereby agrees to provide (i) all information and assistance which is
reasonably necessary for or useful in the preparation of comprehensive and
complete regulatory submissions including without limitation applications or
materials required to obtain marketing approval of Product, and (ii) access to
the manufacturing facility and pertinent information to applicable regulatory
agencies inspectors conducting the pre-approval inspection. CUSTOMER shall have
the sole right to prepare and make any such submissions, applications or
materials and shall own any and all rights and interest therein.
5. Shipment
and Delivery.
5.1. Storage. VGX shall
store each batch of Product ordered pursuant to a Purchase Order in accordance
with the specifications in that Purchase Order, or, if not specified therein, in
accordance with good commercial standards. In no case will VGX be responsible
for the storage of a batch for greater than two months from quality release.
Without derogating from the foregoing, VGX shall store the Contract Materials in
accordance with the instructions provided by CUSTOMER from time to time and in
compliance with the requirements of any applicable regulatory agency or other
governmental authority and all applicable laws and regulations.
5.2. Packing. VGX shall pack each batch of
Product ordered pursuant to a Purchase Order in accordance with the
specifications in that Purchase Order and as per CUSTOMER instructions, or, if
not specified therein, in accordance with good commercial standards. Such
packaging shall be at VGX’s expense.
5.3. Shipment. Delivery
shall take place in the manner and at such times as shall be agreed between the
Parties on the Purchase Order. VGX shall notify CUSTOMER, in writing, not less
than ten (10) business days before shipment of a batch of Product that such
batch will be ready for shipment by the date specified in such notice. CUSTOMER
shall be obligated to notify VGX of the route and carrier by which CUSTOMER
desires such batch to be shipped to it. If VGX receives notice of the route
and carrier by which CUSTOMER desires a batch of Product to be shipped no
later than five (5) business days before the date stated in VGX’s notice to
CUSTOMER, VGX shall ship such batch in accordance with CUSTOMER’s directions;
however, if CUSTOMER fails to notify VGX as provided, VGX may ship such batch of
Product by a carrier and on a route selected by VGX. For purposes of this
Section 5.3, a “business day” is a day when VGX’s
production facilities and administrative offices are generally open for
business. Each Product will be considered suitable for shipment following the
successful completion of all tests listed in the Purchase Order, or sooner if
risk of loss and title are transferred via written request of the
Customer.
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5.4. All
customs, duties, taxes, license fees, insurance premiums, and other third Party
expenses relating to the sale or transportation and delivery shall be paid by
CUSTOMER. All shipments shall be shipped FCA VGX by a common carrier designated
by CUSTOMER. VGX shall be responsible for the loading of the Product on
departure and shall bear risk of loss and all costs of such
loading.
5.5 The
following documents shall be provided by VGX together with each consignment of
Products delivered by it:
(i) a
statement of the quantity; and
(ii) a
certificate of analysis and any other document required by the exporting agent
appointed by CUSTOMER.
5.6. Notice of Receipt.
Upon receipt of finished Product, CUSTOMER shall notify VGX of its
receipt.
5.7. Risk of Loss. Title
to and risk of loss to all Contract Materials and other items shipped by VGX
shall pass to CUSTOMER upon delivery to shipper.
6.
Intended Use
Specifications.
6.1. CUSTOMER Use Only.
All Contract Materials are being manufactured hereunder exclusively for the
CUSTOMER. The CUSTOMER shall use the Contract Materials only for its own
purposes or studies under CUSTOMER’s control. For the avoidance of doubt, this
Section 6.1 is intended to prevent the resale of the Contract Materials to Third
Parties, and is not intended to limit the use of the Contract Materials by the
CUSTOMER for its own purposes.
6.2. CUSTOMER Proprietary
Materials. All CUSTOMER Materials and materials derived from CUSTOMER
Materials shall remain CUSTOMER’s proprietary property. VGX Shall use such
CUSTOMER Materials solely for the purposes of this Agreement and will not
forward CUSTOMER Materials to Third Parties except in connection with work by
approved subcontractors, and subject to the confidentiality undertakings set
forth herein.
6.3. CUSTOMER Use. The
CUSTOMER agrees to use the Contract Materials in compliance with all regulations
and laws and warrants, and that such materials shall only be used for commercial
purposes including civil research and development, quality control, clinical
research and/or validation of process steps. The CUSTOMER will maintain full
documentation in accordance with its standard procedures on the use of the
Contract Materials.
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6.4. Other Laws and
Regulations. In performing its obligations under this Agreement, VGX
shall comply with all applicable environmental and health and safety laws. VGX
shall be solely responsible for determining how to carry out these
obligations.
6.5. Customer
Responsibility. FDA and ICH guidelines provide that a sponsor seeking a
license is considered the “manufacturer” even if they use a contract
manufacturing organization, and the sponsor is responsible for ensuring GMP
compliance for those activities that have been contracted out (US FDA 21 CFR
600.3(t), ICH Q7A Section 2). Therefore, VGX shall provide Customer, its
employees, agents, and consultants reasonable access to VGX facilities,
records, and personnel in order that appropriate inspections, evaluations,
testing and audits may be carried out. Customer shall notify VGX in writing of
any noted compliance deficiencies during any visit, audit, or at any time when
Customers Contract Materials are being produced, packaged, shipped, or stored.
VGX will use good faith efforts to correct any noted deficiencies in a
reasonable time. Failure to correct any such deficiency to Customer’s reasonable
satisfaction shall be grounds for Customer to terminate this Agreement as
specified in Section 12.3 upon written notice to VGX. Any inspections made by
the CUSTOMER shall not relieve VGX of any of its obligations under this
Agreement.
7.
Payment
7.1. Price. The price
payable by CUSTOMER for all work performed and Contract Materials and Product
delivered pursuant to a Purchase Order shall be the Price specified therefore in
that Purchase Order. All payments made under this Agreement are non-refundable
except as specified in Sections 4 and 12. All Prices set forth in the Purchase
Order shall be inclusive of any and all fees, charges and taxes of any type or
nature.
7.2. Invoices. Upon its execution, and concurrent with its
delivery of a Purchase Order unless otherwise specified in the applicable
Purchase Order, VGX shall deliver to CUSTOMER an invoice for one hundred percent
(100%) of the Price stated therein for Pilot DNA Services and twenty percent
(20%) of all other services listed in the Purchase Order. For the avoidance of
doubt, production capacity and Commencement Date will not be considered to be
reserved until such time as Customer has made an appropriate non refundable
payment. Thirty (30) days prior to the scheduled Commencement Date of each line
item of a Purchase Order, VGX shall deliver to CUSTOMER an invoice for thirty
percent (30%) for each line item. Upon, and concurrent with, its delivery of
each Contract Material as specified in the amount and order of a particular
Purchase Order, VGX shall deliver to CUSTOMER an invoice for the remaining fifty
percent (50%) of the Price stated in the Purchase Order for such Contract
Material. Payment for External Testing Costs, shipping costs, and all additional
costs listed in a Purchase Order shall be made within thirty (30) days of
receipt of an invoice therefore from VGX. VGX’s delay or failure to provide
invoices shall not terminate CUSTOMER’s obligation to pay VGX for any Contract
Material including Product delivered to CUSTOMER pursuant to the terms of this
Agreement or the Purchase Order or to pay VGX for any Contract Material or
Product being manufactured pursuant to the terms of this Agreement or any
Purchase Order.
7.3. Price Modification. The
amounts set forth in each Purchase Order are based on the number of experiments
and production cycles provided therein. The yield and quality for each
production batch of Contract Material may not be determined prior to
commencement of the Agreement or particular Purchase Order. If after the initial
research and pilot stages are completed the plasmid yield or quality does not
meet the needs of the CUSTOMER, the Parties shall negotiate the steps to take
and appropriate price adjustments as provided in Section 2. If either Party
terminates the Agreement pursuant to Section 2, VGX shall retain all payments
made prior to the date of termination. All Contract Materials for which CUSTOMER
has paid and which have not been shipped to the CUSTOMER prior to the date of
termination, shall be shipped immediately to the CUSTOMER. In any event all
price modifications will be mutually agreed in writing.
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7.4. Time For Payment. CUSTOMER shall pay VGX the full amount
specified in each invoice within thirty (30) days of date of receipt of the
invoice.
7.5. Method of Payment.
All amounts due and payable shall be paid in United States Dollars. Payment
shall be wired via electronic funds transfer to the account specified by VGX in
respect of which payment is made.
7.6. Late Payment. If
CUSTOMER fails to pay any amount when due, or VGX fails to refund any amount
when due, it shall pay as a late charge to the other Party an amount equal to
0.67% per month on the amount unpaid, or if less, the maximum amount permitted
by law, such amount to accrue from the date when payment was due until the date
when paid in full. In all cases failure of Customer to provide payment according
to the agreed schedule listed in any Purchase Order will cause VGX to delay the
scheduled Commencement Date of the particular line item by thirty days after
outstanding payments are received, or move the project task to the next
available production slot, at the sole discretion of VGX. Such notification will
be provided to the Customer in writing. However, VGX may resort to the
aforementioned measures only after providing CUSTOMER with written notice of
such default and only if said default is not cured by CUSTOMER within fifteen
(15) calendar days after receipt by the CUSTOMER of written notice of such
default.
8.
Warranties.
8.1. Representations and Warranties
of Both Parties. Each Party hereby represents and warrants to the other
Party as follows:
(i) Such Party is a
corporation duly organized, validly existing and in good standing under the laws
of the jurisdiction in which it is incorporated.
(ii) Such Party (i)
has the corporate power and authority and the legal right to enter into this
Agreement and to perform its obligations hereunder, and (ii) has taken all
necessary corporate action on its part to authorize the execution and delivery
of this Agreement and the performance of its obligations hereunder. This
Agreement has been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, binding obligation, enforceable against such Party
in accordance with its terms.
(iii) All necessary
consents, approvals and authorizations of all governmental authorities and other
Persons required to be obtained by such Party in connection with this Agreement
have been obtained.
8.2. VGX Representations and
Warranties. VGX hereby covenants,
represents and warrants to CUSTOMER that:
(a) All
Product will, on the date of delivery by VGX to CUSTOMER, comply with the
applicable laws, regulations and regulatory guidelines, the Specifications
therefor set forth in this Agreement and in the Purchase Order pursuant to which
such Product was ordered.
(b) Title
to all Product sold hereunder shall pass to CUSTOMER as provided herein free and
clear of any security interest, lien or other encumbrance.
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(c)
(i) The execution, delivery and performance of this Agreement does not conflict
with, violate or breach any agreement to which VGX is a party or by which it is
bound or VGX’s constituent documents, (ii) VGX is not prohibited or limited by
any law or agreement (to which it is a party or by which it is bound) from
entering into and performing this Agreement and (iii) the performance of this
Agreement will not create any conflict with any other business or activity
engaged in by VGX.
(d) The
Production Services will be performed in compliance with this Agreement, cGMP,
the requirements of all applicable regulatory agencies and all applicable laws,
rules and regulations, including but not limited to the Federal Food, Drug and
Cosmetic Act and the regulations promulgated pursuant thereto, and, without
limiting the foregoing, with the standard of care customary in the Product
manufacturing industry.
(e) The
Production Services will be performed by trained individuals in a professional,
xxxxxxx-like manner.
(f)
VGX has obtained, and will maintain in effect throughout the term of this
Agreement, all such approvals, licenses and permits as maybe required under
applicable laws, rules, regulations and requirements to perform the Production
Services hereunder in accordance herewith, and to operate the manufacturing
facility for the Contract Materials for the purposes of manufacturing Contract
Materials under and in accordance with this Agreement for clinical use in human
pharmaceuticals, and it shall during the term of this Agreement comply, at all
times, with the requirements set forth (i) in any such approvals, licenses and
permits and (ii) by relevant authorities and applicable laws, rules and
regulations for its manufacturing facility for manufacture of the Contract
Materials for clinical use in human pharmaceuticals.
8.3. Disclaimer of
Warranties. EXCEPT AS EXPRESSLY PROVIDED IN SECTION 8.2. VGX MAKES NO
REPRESENTATION OR WARRANTY AS TO ANY CUSTOMER MATERIALS, EXPRESS OR IMPLIED, AND
VGX SPECIFICALLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY, WARRANTY OF FITNESS
FOR A PARTICULAR PURPOSE, WARRANTY OF SYSTEM INTEGRATION, WARRANTY OF
EFFECTIVENESS.
9.
Liability,
Indemnification and Insurance.
9.1. Limitation on
Liability. Neither Party shall be
liable for any special, consequential, incidental, exemplary or punitive damages
of the other Party.
9.2. Responsibility and
Control. VGX and CUSTOMER shall each be solely responsible for the safety
of its own employees, agents, licensees or sublicensees with respect to Product,
and each shall hold the other harmless with regard to any liability for damages
or personal injuries resulting from acts of its respective employees, agents or
servants to the extend that such damages are not due to gross negligence or
willful misconduct of the other Party.
9.3. Indemnification by
CUSTOMER. CUSTOMER shall indemnify, defend
and hold harmless VGX from all losses, liabilities, damages and expenses
(including reasonable attorneys’ fees and costs) that VGX may suffer or incur as
a result of any claims, demands, actions or other proceedings made or instituted
by any Third Party arising out of (a) any alleged or actual infringement or
other violation of any patents, patent rights, trademarks, trade xxxx rights,
copyrights, trade secrets, proprietary rights and processes or other such rights
related to the Product except as related to the materials or the process
utilized by VGX in the manufacture of the Product as set forth in Section 9.4
hereof; (d) any alleged or actual loss, damage or injury including death, which
arises from the use of any Product which conforms to the specifications and
warranties set in Section 8.2.; and (c) any negligent act or omission or willful
misconduct by CUSTOMER, its Affiliates or its or their directors, officers,
employees, agents or subcontractors.
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9.4. Indemnification by VGX.
Notwithstanding Section 9.1 hereof, VGX shall indemnify, defend and hold
harmless CUSTOMER from all losses, liabilities, damages and expenses (including
reasonable attorneys’ fees and costs) that CUSTOMER may suffer or
incur as a result of any claims, demands, actions or other proceedings made or
instituted by any Third Party arising out of (a) any alleged or actual
infringement or other violations of any patents, patent rights, trade secrets,
proprietary rights or other such rights related to the process utilized by VGX
in the manufacture of the Product; (b) the performance of Production Services;
and (c)any negligent act or omission or willful misconduct by VGX, its
Affiliates or its or their directors, officers, employees, agents or
subcontractors.
9.5. Notice and Assistance. An indemnifying Party will
not be obligated to indemnify and hold harmless any indemnified Party unless the
indemnified Party gives the indemnifying Party prompt notice of any claim, suit
or action brought against the indemnified Party, after it becomes aware of it,
allows the indemnifying Party to defend the same (without prejudice to the right
of the indemnified Party to participate at through counsel of its own choosing),
renders the indemnifying Party all assistance reasonably necessary in defending
against such claim, suit or action at the indemnifying Party’s expense, and does
not compromise or settle such claim or action without the indemnifying Party’s
prior written consent.
9.6.
Insurance. VGX and
CUSTOMER shall maintain comprehensive general liability insurance, during the
term of this Agreement and for one (1) year beyond the
expiration date of the Product, comprehensive general liability insurance on a
claims-made basis, with endorsements for product liability with annual coverage
limits of not less than the value of the Products underlying all active Purchase
Orders, per claim. All of the Parties’ insurance policies shall be issued by
insurers acceptable to the other Party. Each Party shall name the other Party as
an additional insured on its policies with respect to the Party’s liabilities to
the other Party under this Agreement. The minimum level of insurance set forth
herein shall not be construed to create a limit on the Parties’ liability
hereunder. On the Commencement Date, each Party shall furnish to the other Party
a certificate of insurance evidencing such coverage as of such date. Each such
certificate of insurance, as well as any certificates evidencing new or modified
coverages of the insured Party, shall include a provision whereby thirty (30)
days written notice must be received by the other Party prior to coverage
modification or cancellation by either the insured Party or the insurer. In
addition, each Party shall promptly notify the other Party of any cancellation
or modification of such insurance coverage and of any new or modified coverage.
In the case of a modification or cancellation of such coverage, each Party shall
promptly provide the other Party with a new certificate of insurance evidencing
that the Party’s coverage meets the requirements in the first sentence of this
Section 9.6.
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10.
Confidentiality.
10.1. Confidential
Information. During the term of this Agreement, and for a period of five
(5) years following the expiration or earlier termination hereof, each Party
shall maintain in confidence all information (including samples) and data of a
proprietary or confidential nature, whether in oral, written, graphic,
machine-readable form or in any other form disclosed by the other Party (the
“Confidential Information”), and shall not use, disclose or grant the use of the
Confidential Information except on a need-to-know basis to those directors,
officers, employees, consultants, contractors, governmental regulatory agencies,
(sub)licensees or permitted assignees, to the extent that such disclosure is
reasonably necessary in connection with such Party’s activities as expressly
authorized by this Agreement. To the extent that disclosure is authorized by
this Agreement, prior to disclosure, each Party hereto shall obtain agreement of
any such Person to hold in confidence and not make use of the Confidential
Information for any purpose other than those permitted by this
Agreement.
10.2. Terms of
this Agreement. Subject to Section 10.3 below, neither Party shall
disclose any terms or conditions of this Agreement to any Third Party without
the prior consent of the other Party.
10.3. Permitted
Disclosures. The confidentiality obligations contained in this Article 10
shall not apply to the extent that (a) the receiving Party (the “Recipient”) is
required (i) to disclose information by applicable law, regulation or order of a
governmental agency or a court of competent jurisdiction, or (ii) to disclose
information to any governmental authority for purposes of obtaining approval to
test or market a Product, provided in either case that the Recipient shall
provide written notice thereof to the other Party and sufficient opportunity to
object to any such disclosure or to request confidential treatment thereof; or
(b) the Recipient can demonstrate that (i) the disclosed information was public
knowledge at the time of such disclosure by the other Party hereunder, or
thereafter became public knowledge, other than as a result of actions of the
Recipient in violation hereof; (ii) the disclosed information was rightfully
known by the Recipient (as shown by its written records) prior to the date of
disclosure to the Recipient by the other Party hereunder; or (iii) the disclosed
information was disclosed to the Recipient on an unrestricted basis from a
source unrelated to any Party to this Agreement and not under a duty of
confidentiality to the other Party. CUSTOMER agrees that VGX may use, subject to
CUSTOMER’s prior written consent (which consent shall not be unreasonably
withheld) CUSTOMER’s corporate name in certain marketing and other
publications and presentations, as example of, but not limited to, a client
list. In addition, CUSTOMER may disclose the terms of this Agreement to
potential investors or business partners.
11.
Intellectual
Property
11.1 Notwithstanding
anything to the contrary, as between the Parties, (i) all VGX Background
Technology, shall remain exclusively owned by VGX, (ii) all CUSTOMER Background
Technology shall remain exclusively owned by CUSTOMER.
11.2. Subject
to the restrictions set forth in the license agreement between CUSTOMER and
Yissum Research Development Company of the Hebrew University of Jerusalem Ltd.,
the Parties agree that title to and property in any and all Project Technology
shall be and remain at all times exclusively vested in the Parties as
follows:
(i)
Project Technology directly related to improvements in the existing
manufacturing process of the Product shall be exclusively owned by
VGX;
(ii)
All other Project Technology shall be exclusively owned by CUSTOMER.
11.3. Each
Party hereby assigns and transfers to the other Party any Project Technology
that may be created hereunder, to the extent such Project Technology is owned by
the receiving Party, in accordance with and subject to the allocation of
ownership described in Section 11.2 above, and promptly upon the creation of any
such Project Technology, each
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Party
shall notify the other Party of such Project Technology and furnish to the owner
thereof all related information, details, data and documents. Each Party, at any
time and from time to time upon notice by the owner of the Project Technology,
as promptly as practicable, shall execute and shall cause its employees and
consultants, past or present, to execute, such documents as are necessary and
requested to evidence the ownership provided for in this Agreement, of the
owner’s entire right, title and interest in such inventions and other
properties, including executing any documents necessary for the owner to obtain
United States or foreign letters patent or other intellectual property
protections and rights, executing any transfers of ownership of patent letters
or other intellectual property protections and rights, and executing short form
assignments intended for recording with the U.S. Patent and Trademark Office, or
any other entity.
11.4. Each Party has obtained or shall
obtain appropriate written agreements
from all of its respective employees, consultants and subcontractors, without
limitation, and executed at or as of the commencement of employment, consultancy
or engagement, that requires all discoveries and inventions conceived or reduced
to practice, as applicable, by any person during the term of this Agreement to
be promptly reported, fully disclosed and assigned to such Party.
12. Term
of Agreement,
Renewal,
Termination.
12.1. Term. This Agreement
shall commence on the date first written above, and unless earlier terminated in
accordance with the provisions of this Article II, shall continue in full force
and effect until the completion of the Production Services, and in any case as
long as any Purchase Order is in force. Thereafter, the term of this Agreement
shall be renewed tor successive one (1) year periods upon mutual
agreement.
12.2. Termination After Research or Pilot Work. Either Party may
terminate this Agreement as provided in Section 2.
12.3. Termination for
Cause. If either Party breaches any provision of this Agreement, the
other Party may give written notice to the breaching Party that if the
default is not cured within thirty (30) days of the date of such notice, the
Agreement will be terminated automatically. If the non-breaching Party
gives such notice and the breach is not cured during such thirty (30) day
period, then this Agreement shall terminate automatically at the end of such
thirty (30) day period.
Should
CUSTOMER terminate this Agreement pursuant to this Section 12.3. VGX shall
reimburse to CUSTOMER all monies paid by CUSTOMER in respect of outstanding
uncompleted Purchase Order(s), including any reasonable additional direct costs
incurred while fulfilling CUSTOMERS obligations to produce the Product according
to the Purchase Order(s) under this Agreement, less the cost of those Production
Services performed by VGX, under such Purchase Order(s), which are compliant
with this Agreement and can be exploited by CUSTOMER. Such repayment and VGX
liabilities toward CUSTOMER shall be within the limits stated in section 9.1 in
the event of such a breach.
Should
VGX terminate this Agreement pursuant to this Section 12.3 for breach, then upon
termination CUSTOMER shall pay VGX an amount equal to (i) all amounts due for
completed Purchase Orders, plus (ii) all amounts that were already spent by VGX,
prior to the termination, on any signed and uncompleted Purchase Order. The
terms of this Section will also apply if CUSTOMER reduces the quantities or the
number of batches of products for any signed Purchase Order.
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12.4 Termination by Mutual
Agreement This Agreement may be terminated at any time by written
agreement of the Parties.
12.5. Termination for Violation of
Ethical Principles. If a Party (including its employees, subcontractors,
agents, servants, licensees) uses the Contract Materials in a manner
inconsistent with ethical principles as defined in the Helsinki Declaration by
the World Medical Association, the other Party shall be allowed to terminate
this Agreement and any Purchase Order at any time without prior notice and shall
have no liability to the other Party as a result of such termination. The
provisions of Section 12.3 above regarding the obligation to make payments upon
the breach of this Agreement shall apply.
12.6. Termination without
Cause. Either Party may terminate this Agreement by written notice during
any period when no Purchase Order is currently active, meaning (i) no activities
are planned or being performed by VGX for the CUSTOMER, (ii) no Contract
Materials are due to be delivered to the CUSTOMER, (iii) neither Party owes the
other any payment or refund.
12.7. Returned Materials.
On the termination of this Agreement, VGX and CUSTOMER each shall return to the
other all information (including the materials) which it possesses or controls
that belongs to the other, or which contains the other Party’s Confidential
Information, except that each may retain a copy solely for record keeping
purposes.
12.8. Insolvency. Either
party may terminate this Agreement upon notice to the other if the other party
becomes insolvent, is adjudged bankrupt, applies for judicial or extra-judicial
settlement with its creditors, makes an assignment for the benefit of its
creditors, voluntarily files for bankruptcy or has a receiver or trustee (or the
like) in bankruptcy appointed by reason of its insolvency, or in the event an
involuntary bankruptcy action is filed against the other party and not dismissed
within ninety (90) days, or if the other party becomes the subject of
liquidation or dissolution proceedings or otherwise discontinues
business.
12.9. Survival. Articles 8,
9, 10, 11, 12 and 13 shall survive any termination or expiration of this
Agreement.
13.
Miscellaneous
Provisions.
13.1. Successors and
Assigns. Neither this Agreement nor any interest hereunder shall be
assignable by either Party without the written consent of the other (which
approval shall not be unreasonably withheld), and any attempted assignment
without such consent shall be null and void; provided, however, that either
Party may, without consent, assign this Agreement to its successors in the event
of the merger or consolidation of it or the business with which the Product are
associated with another company, including the sale of all or substantially all
of such Party’s stock or assets, provided that the assignee has the abilities to
fulfill all of assignor’s obligations hereunder and the assignee assumes in
writing all of assignor’s rights and obligations hereunder. This
Agreement shall be binding upon the successors and permitted assignees of
the Parties.
13.2. Notices. All notices or other communications
required or permitted to be given hereunder shall be in writing and shall be
delivered by hand, courier, or facsimile and confirmed in writing, as
follows:
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If to
VGX, as follows:
VGXI
USA
0000
Xxxxxxxx Xxxxxx Xxxxx, Xxxxx 000
Xxx Xxxxxxxxx,
XX 00000 XXX
If to
CUSTOMER, as follows:
BioCancell
Therapeutics, Inc.
Xxxx
Science Center, 0 Xxxxxx Xxxxxx
Xxx
Xxxxxxx, Xxxxxxxxx 00000 Israel
or in any
case to such other address or addresses as hereafter shall be furnished as
provided in this Section 13.2 by any Party hereto to the other Party. Any notice
delivered pursuant to this Section 13.2 shall he deemed delivered when (i)
delivered by hand, (ii) sent by facsimile (with written confirmation of
transmission), (iii) seven (7) days following delivery by registered or
certified mail (return receipt requested) or two (2) days following delivery by
an internationally recognized overnight delivery
service, in each case to the appropriate addresses and facsimile numbers set
forth above (or to such other addresses and facsimile numbers as a Party may
designate by notice to the other Party).
13.3. Public Disclosure.
Subject to any disclosure requirements under applicable law, regulation or order
of a governmental agency or a court of competent jurisdiction, the Parties
hereto will agree in advance on a press release or any other statement or
communication regarding the subject matter of this Agreement or the transactions
contemplated hereby. In the case of public disclosure of this Agreement, no
reference will be made to the financial terms of this Agreement or the Product
name, quantity, or intended use.
13.4. Entire Agreement.
This Agreement and its appendices constitute the entire agreement between the
Parties with respect to the subject matter hereof and supersede all prior
agreements or understandings of the Parties relating thereto.
13.5. Amendment. This Agreement may be modified or
amended only by written agreement of the Parties hereto.
13.6. Counterparts. This Agreement may be executed
in any number of counterparts, each of which shall be deemed an original but all
of which together shall constitute a single instrument.
13.7. Governing Law. Any
dispute arising under or in relation to this Agreement shall be resolved by
arbitration to be held in London, England and to be governed by the London Court
of International Arbitration Rules then in force. Each such arbitration shall be
conducted by a panel of
three arbitrators, one of
whom shall be appointed by each of
CUSTOMER and VGX, and the third arbitrator, who shall be the chairman of the
tribunal, shall be appointed by the two-party appointed
arbitrators.
13.8. Captions. All section
titles or captions contained in this Agreement and in any appendix referred to
herein or annexed to this Agreement are for convenience only, shall not be
deemed a part of this Agreement and shall not affect the meaning or
interpretation of this Agreement.
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13.9.
Construction. This
Agreement shall be deemed to have been drafted by both VGX and CUSTOMER and
shall not be construed against either Party as the draftsperson
hereof.
13.10. Expenses. In the event
a dispute between the Parties hereunder is resolved through litigation or other
proceeding or a Party must engage an attorney (including internal counsel) to
enforce its right hereunder, the prevailing Party shall be entitled to
reimbursement of all reasonable fees and disbursements incurred in connection
with such litigation.
13.11. Independent
Contractors. Nothing contained herein shall be deemed to create any joint
venture or partnership between the Parties hereto, and, except as is expressly
set forth herein, neither Party shall have any right by virtue of this Agreement
to bind the other Party in any manner whatsoever.
13.12. Severability. If any
provision of this Agreement is held to be illegal, invalid or unenforceable
under present or future laws effective while this Agreement remains in effect,
the legality, validity and enforceability of the remaining provisions shall not
be affected thereby, and in lieu of each such illegal, invalid or unenforceable
provision there shall be added automatically, as a part of the document, a
provision that is legal, valid and enforceable, and as similar in terms to such
illegal, invalid or unenforceable provision as may be possible while giving
effect to the benefits and burdens for which the Parties have bargained
hereunder.
13.13. Force Majeure.
Neither Party shall be liable to the other for its failure to perform any of its
obligations under this Agreement, during any period in which such performance is
delayed because rendered impracticable or impossible due to earthquakes,
governmental regulation, fire, flood, interruption of supply of key raw
materials, civil disorders, and acts of God. As soon as there is an indication
of an event of force majeure, the Party affected by it will advise the other
Party immediately or as soon as practical of the existence and effect of such
event on this Agreement and about the measures to be taken to mitigate such
effect. The affected Party is obligated to mitigate the effect and damages and
to resume the fulfillment of the contractual obligations as quickly as
possible.
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IN
WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the date
first above written.
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VGXI
USA, a DBA of VGX International Inc.
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By:
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/s/
Joon Suelt
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Name:
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Joon Suelt
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Title:
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Vice President
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BIOCANCEEL
THERAPEUTICS LTD.
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By:
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/s/ Xxxxx
Xxxxxxxxx
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Name:
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Xxxxx Xxxxxxxxx
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Title:
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VP Technology &
Qh
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