THIS EXHIBIT HAS BEEN REDACTED
AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
This Supply
Agreement (this “ Agreement ”) is made as of
this 31 st
day of March, 2009 (the
“Execution Date”), by and among Novavax, Inc., a
Delaware corporation having an address at 9920 Belward Campus
Drive, Rockville, Maryland 20850, United States of America (“
Novavax ”) and CPL Biologicals Limited, a limited
company incorporated under the laws of India having an address at
“Cadila Corporate Campus”, Sarkhej-Dholka Road, Bhat,
Ahmedabad - 382210, Gujarat, India (“ Company ”)
. Novavax and Company
are sometimes referred to herein each individually as a
“Party” and collectively as the
“Parties.”
WHEREAS , Company, a joint venture formed pursuant to a
Joint Venture Agreement (the “ Joint Venture Agreement
”) dated as of the date hereof between Novavax and Cadila
Pharmaceuticals Limited, organized under the laws of India, was
formed for developing, manufacturing, marketing and selling the
Products (as defined in the Joint Venture Agreement) in India to
cater the needs of the market in India; and
WHEREAS , Novavax has granted to Company a license to
certain of Novavax’s patents, patent applications and
know-how for the Company to develop and commercialize certain
Novavax Products (as defined in the Joint Venture Agreement) (the
“ License ”); and
WHEREAS , in connection with the foregoing, Novavax is
willing to supply certain pre-clinical and clinical supplies of the
Novavax Seasonal Product to Company and Company wishes to buy
Products from Novavax under the terms and conditions of this
Agreement.
NOW, THEREFORE,
in consideration of the foregoing premises and the mutual covenants
set forth below, and for other good and valuable consideration, the
receipt of which is hereby acknowledged, and intending to be
legally bound hereby, Novavax and Company hereby agree as
follows:
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1.
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Definitions
. References in the body
of this Agreement to “ Sections ” will refer to
the sections of this Agreement. In addition, as used herein, the
following initially capitalized terms will have the following
meanings
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1.1
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“ Bankruptcy Event
” means, with respect to a specified person, (i) the
filing by such person in any court or agency, pursuant to any
statute or regulation of any state or country, a petition in
bankruptcy or insolvency or for reorganization or for an the
appointment of a receiver or trustee of such other Party or of its
assets, (ii) the filing against such person of an involuntary
petition for any bankruptcy or insolvency proceeding which petition
is not dismissed within sixty (60) days after filing,
(iii) the making by such person of an assignment for the
benefit of its creditors, (iv) the taking of possession of a
substantial part of the assets of such person by a lien holder or
other encumbrancer, or (v) the levy or enforcement
of
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1
THIS EXHIBIT HAS BEEN REDACTED
AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
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any
distress, execution or other process upon or against a substantial
part of the assets of such person.
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1.2
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“ cGMP ” means
then current Good Manufacturing Practices.
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1.3
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“ Company Indemnitee
” has the meaning set forth in Section 8.2
.
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1.4
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“ Defect ” or
“ Defective ” means any non-conformance with the
Specifications or the existence of any impurity, contaminant or any
other defect that renders the Products unfit for human
use.
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1.5
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“ Effective Date
” means the date on which the condition precedent set forth
in Article 11 is first satisfied.
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1.6
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“ First Commercial Sale
” means the first sale for monetary value for use or
consumption by the general public of the Novavax Products in
India.
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1.7
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“ Fully-Loaded Cost
” means the direct costs and expenses for manufacturing the
Products (including quality assurance/quality control charges and
including escalation costs, if any), and indirect costs that are
reasonably attributable and fairly allocable to the manufacture of
Product reasonably determined by Novavax’s internal
accounting in accordance with United States generally accepted
accounting practices.
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1.8
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“ Indeminitee ”
means a Company Indemnitee or Novavax Indemnitee, as
applicable.
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1.9
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“ Indemnitor ”
means Company or Novavax, as applicable.
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1.10
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“ Joint Venture
Agreement ” has the meaning set forth in the
Recitals.
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1.11
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“ Laws ” means
all (a) applicable laws, statutes, rules, regulations,
ordinances and other pronouncements having the effect of law of the
United States and India; and (b) any guideline or directive of
the World Health Organization or other applicable non-governmental
agency.
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1.12
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“ License ” has
the meaning set forth in the Recitals.
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1.13
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“ Losses ” has
the meaning set forth in Section 8.1 .
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1.14
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“ Manufacturin g
Facility ” means the manufacturing facility or
facilities of Novavax used to manufacture the Products.
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1.15
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“ Novavax Indemnitee
” has the meaning set forth in Section 8.1
.
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1.16
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“ Novavax Products
” has the meaning set forth in the Joint Venture
Agreement.
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2
THIS EXHIBIT HAS BEEN REDACTED
AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
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1.17
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“ Novavax Seasonal
Product ” means the Seasonal Influenza Licensed Product
as defined in the License.
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1.18
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“ Order Requirements
” has the meaning set forth in Section 3.2
.
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1.19
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“ Products ”
means Novavax’s pre-clinical and clinical supplies of the
Novavax Seasonal Product which conform to the
Specifications.
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1.20
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“ Purchase Order
” has the meaning set forth in Section 3.2
.
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1.21
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“ Specifications
” means Novavax’s standard specifications and
manufacturing criteria for the Products (consistent with cGMP), a
written copy of which shall be provided by Novavax to the Company
within thirty (30) days after the Effective Date, as amended
from time to time by mutual written agreement of the
Parties.
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1.22
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“ Third Party ”
means a person or entity other than (a) Novavax, (b) Company,
(c) an Affiliate of Novavax or (d) an Affiliate of
Company
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1.23
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“ Transfer Price
” has the meaning set forth in Section 4.1
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2.
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Manufacture and
Supply .
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2.1
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General Obligations
. Novavax shall sell to
Company, and Company shall purchase from Novavax, the Products in
accordance with the terms and conditions of this
Agreement.
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2.2
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Manufacturing Standards
. All Products supplied
by Novavax to Company will be manufactured in accordance with any
applicable Laws including, without limitation, cGMP and any
requirements set forth herein.
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3.
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Product Supply, Orders and
Delivery .
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3.1
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Purchase Orders
. Purchase and delivery
of the Products shall be made pursuant to written or electronic
individual purchase orders issued by Company to Novavax (each a
“ Purchase Order ”). Company shall submit such
Purchase Orders to Novavax as far in advance as reasonably
practicable, but in any event not less than twelve (12) weeks in
advance of the delivery date(s) requested in such Purchase Order. A
Purchase Order shall be deemed to be accepted by Novavax when
Novavax returns a written or electronic order acknowledgement to
Company. Novavax shall promptly return a written or electronic
order acknowledgement to Company for each Purchase Order received
unless Novavax will be unable to timely meet Company’s
requirement for Product as set forth in the applicable Purchase
Order. Purchase Orders shall specify quantities ordered, delivery
dates, and delivery and shipping instructions. Inconsistencies
between a Purchase Order and this Agreement shall be resolved in
favor of this Agreement.
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3
THIS EXHIBIT HAS BEEN REDACTED
AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
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Company acknowledges that Novavax
may be prevented from meeting a delivery date and/or order quantity
set forth in a Purchase Order (the “ Order
Requirements ”) as a result of the Manufacturing Facility
production schedule, and in such event Novavax will use
commercially reasonable efforts to meet the Order Requirements at
such time as the Manufacturing Facility production schedule
reasonably permits. If Novavax anticipates that it will be unable
to meet Order Requirements for a reason other than the
Manufacturing Facility production schedule, Novavax will notify
Company immediately of such inability, and the Parties will
negotiate in good faith a new mutually acceptable delivery date
and/or quantity.
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3.2
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Certificate of Analysis
. Novavax shall deliver
with each shipment a certificate of analysis consistent with cGMP
executed by an authorized representative of Novavax, accompanied by
a statement that the Products were manufactured according to the
Specifications.
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3.3
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Delivery . The Products shall be packaged
according to the Specifications and supplied FCA (Incoterms 2000)
the Manufacturing Facility. Insurance on Products in transit shall
be the responsibility of Company and Company shall be responsible
for clearing the Products for import into India. Novavax shall
provide any assistance reasonably requested by Company to clear the
Products for import into India at Company’s expense. Company
agrees to designate a carrier prior to or at the time of entry of
each Purchase Order hereunder; however, if Company fails to
designate a carrier prior to or on its purchase order, Novavax may
select a carrier for the account and risk of Company.
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4.1
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Price. The price at which the Products will
be sold to Company by Novavax hereunder will be 110% of the
Fully-Loaded Cost therefore (the “ Transfer Price
”). Novavax will include with each shipment of Product an
invoice setting forth the Transfer Price for the Product in the
shipment.
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4.2
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Payment. Payment shall be due to Novavax
thirty (30) days after Company’s receipt of the
Products.
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4.3
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Books and Records
. Novavax will keep
accurate books and accounts of record in connection with its
manufacture of Products in sufficient detail to permit verification
of the Fully-Loaded Cost and the Transfer Price for Product
purchased by Company as set forth in this Article 4. Novavax
will maintain its records for the sale of Products for a period of
three (3) years from the end of each year in which such sales
occurred.
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4.4
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Audits . Company, at its expense, through
an internationally recognized, independent accountant reasonably
acceptable to Novavax, will have the right to
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4
THIS EXHIBIT HAS BEEN REDACTED
AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
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access Novavax’s relevant
books and records upon reasonable advanced notice once per year for
the sole purpose of verifying the Fully-Loaded Cost and the
Transfer Price for Product purchased by Company; such access will
be conducted during Novavax’s ordinary business hours, and
the books and records for a given time period may only be audited
once. Said accountant will execute a confidentiality agreement with
Novavax in customary form and will only disclose to Company whether
Novavax’s invoices were accurate and if they were not, any
information necessary to explain the source of the inaccuracy. If
such audit determines that Novavax charged Company more than the
amount properly owed in respect of any quarter, then Novavax will
reimburse Company any excess amount paid by Company within thirty
(30) days of the completion of the audit, and if the amount
paid exceeds ten percent (10%) of the amount actually owed over the
audited period, Novavax will also reimburse Company for the
reasonable costs of such audit (including the fees and expenses of
the certified public accountant). In the event such audit
determines that Novavax charged Company less than the amount
properly owed in respect of any quarter, then Company will
pa
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