THE REGISTRANT HAS APPLIED FOR
CONFIDENTIAL TREATMENT OF CERTAIN PROVISIONS OF
THIS EXHIBIT WITH THE SECURITIES AND EXCHANGE COMMISSION. THE
CONFIDENTIAL PORTIONS OF
THIS EXHIBIT ARE MARKED WITH ASTERISKS ( ***** ) AND HAVE BEEN OMITTED. THE OMITTED
PORTIONS OF
THIS EXHIBIT WILL BE FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO
A REQUEST FOR CONFIDENTIAL TREATMENT.
AGREEMENT, (this
“Agreement” ) is dated as of October 18,
2005 by and between Novavax, Inc., a Delaware corporation having
its principal place of business at 508 Lapp Road, Malvern,
Pennsylvania 19355, (“ Novavax ” or
“Supplier” ) and Esprit Pharma, Inc., a Delaware
corporation having its principal place of business at 2 Town Center
Boulevard, East Brunswick, New Jersey 08816 (
“Esprit” or “Buyer” ).
Supplier and Purchaser may be referred to individually as a
“Party” or collectively as the
“Parties . ”
WHEREAS, Supplier
has been engaged in the of development, manufacture, and supply of
a product to be marketed, distributed and sold under the
Estrasorb ® brand by Supplier;
WHEREAS, on the
date hereof, Buyer and Supplier also entered into a license
agreement for the license by Supplier to Buyer of certain
intellectual property enabling the manufacture sale and use by
Purchaser of topically- or transdermally-administered product
containing no active ingredient other than17ß estradiol
(excluding contraceptive products, Selective Estrogen Receptor
Modulators and products administered vaginally, orally, nasally,
through the gum or by injection) which utilize Supplier’s
micellar nanoparticle technology in the field of women’s
health in product that is marketed under Supplier’s NDA
#21-371 (the “ License Agreement ”);
WHEREAS,
concurrently with the execution and delivery of this Agreement and
the License Agreement, ESPRIT has executed and delivered to NOVAVAX
an $8.0 million promissory note due December 30, 2005
constituting a portion of the consideration for the License
Agreement (the “ Promissory Note ”);
WHEREAS,
concurrently with the execution and delivery of this Agreement, the
License Agreement and the Promissory Note, New Enterprise
Associates, Domain Associates, LLC and Apax Partners, or certain of
their affiliates (the “ Private Equity Investors
”) have executed and delivered to NOVAVAX an agreement to
fund Esprit with the principal amount due under the Promissory Note
within ten (10) business days of Esprit’s default of any of
its obligations thereunder for the express purpose of satisfying
ESPRIT’s obligations under the Promissory Note;
and
WHEREAS, Buyer
desires to have Supplier manufacture Product (as defined in
Article 1 below) under the Estrasorb ® brand for sale by Buyer or its
designee.
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NOW, THEREFORE, in
consideration of the mutual promises, covenants and agreements
hereinafter set forth, and for other good and valuable
consideration, the receipt and efficiency of which are hereby
acknowledge, the parties hereto agree as follows:
As used throughout
this Agreement, each of the following terms shall have the
respective meaning set forth below:
“Affiliate” of a Party shall mean any entity
which directly or indirectly controls, is controlled by or is under
common control with such entity, and for such purpose
“control” shall mean (i) directly or indirectly
owning, controlling or holding more than fifty percent (50%) of the
securities or other ownership interests representing the equity,
the voting stock or general partnership interest in an entity or
(ii) the possession, direct or indirect, of the power to
direct or cause the direction of the management or the policies of
the entity, whether through the ownership of voting securities, by
contract or otherwise. Any such corporation, entity or business
structure shall only be considered an Affiliate for so long as such
ownership or control exists.
“cGMP” shall mean good manufacturing practices
according to 21 CFR Parts 210 and 211.
“ CPI
” shall mean United States Department of Labor, Bureau of
Labor Statistics, Consumer Price Index, All Urban Consumers, United
States City Average, All Items, (1982-84=100) excluding the food
and energy components, or the successor index that most closely
approximates the CPI.
“Cardinal” shall mean Cardinal Health Inc. as
the contract manufacturer of the Product pursuant to the Cardinal
Agreement.
“Cardinal Agreement” shall mean the letter
agreement between Cardinal, Supplier and Buyer of even date
herewith.
“Cardinal Facility” shall mean Cardinal’s
manufacturing facility for the Product located at 3001 Red Lion
Rd., Philadelphia, Pa. 10014
“Damages” shall have the meaning ascribed to
such term in Section 16.01.
“FDA” means the United States Food and Drug
Administration and successor bodies.
“Intellectual Property Rights” shall mean the
intellectual property, trade secrets, know-how, technology and
information, whether or not protected by patents, to the extent
required in the reasonable judgment of Supplier to manufacture the
Product.
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“License
Agreement” shall mean the license agreement referred to
in the second recital of this Agreement.
“ Net
Sales “ has the meaning ascribed to such term in the
License Agreement.
“Permitted Raw Materials Inventory” shall have
the meaning ascribed to such term in Section 8.03(b).
“Product” shall mean Estrasorb, as more fully
described on Schedule A to this Agreement, manufactured
and packaged in accordance with the Specifications (hereinafter
defined).
“Raw
Materials” shall mean the materials, components, and
packaging required to manufacture and package the Product in
accordance with the Specifications.
“Specifications” shall mean the specifications
for the design, composition, product safety assurance, manufacture,
packaging, and/or quality control of the Product, as set forth on
Schedule B attached hereto and made a part hereof, as
the same may hereafter be modified by mutual agreement of the
parties in writing.
“Supply
Year” shall mean each consecutive 365-day period (or
366-day period in the event of a leap year) during the Term,
commencing on the date of this Agreement.
“Territory” shall mean the United States, Mexico
and Canada.
“Term” shall have the meaning ascribed to such
term in Article 6.
“ Unit of
Product ” means a month of therapy of Product for an
individual end user.
During the Term,
Supplier shall supply Buyer with those quantities of Product as
ordered by Buyer pursuant to this Agreement, subject to the
ordering procedures set forth in Article 4 below. Supplier
shall sell Product exclusively to Buyer for sale in the Territory .
Each Product sold hereunder will conform to the Specifications for
such Product. Subject to the terms and conditions herein, Supplier
will provide the facility, equipment , labor, and supervision
necessary for the production of the Product in sufficient
quantities as required herein.
3.01 Transfer
Price . The transfer price of Product from Novavax to Esprit
during any Supply Year will be equal to (i) $***** per Unit of
Product for the first $***** of Net Sales in such Supply Year and
(ii) $***** per Unit of Product for the excess over the first
$***** of Net
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Confidential
information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential
treatment request.
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Sales for such
Supply Year. Notwithstanding anything to the contrary contained
herein, the transfer price of Product from Novavax to Esprit
(a) that constitutes samples (including current sample
inventory) as designated by Novavax, will be $***** per week of
therapy of Product for an individual end user of Product and
(b) that constitutes short-dated trade inventory (in stock for
equal to or less than one year from the date of packaging) as
designated by Novavax and as set forth on Schedule 3.01
attached hereto will be $***** per Unit of Product. All transfer
prices referred to in this Section 3.01 shall be increased (on
a compounded basis) on ***** and ***** by and amount equal to the
product of (i) the then current transfer price and (ii) *****.
For the remainder of the Term, the transfer price of Product from
Novavax to Esprit will be *****% of Novavax’s fully burdened
manufacturing cost. The parties agree that the aggregate amount
contemplated by clause (b) above will be paid in cash by wire
transfer on the date of this Agreement.
3.02 Payment
Terms . Payment terms on all orders shall be ***** (*****) days
from the date of invoice. Invoicing shall occur upon
shipment.
FORECASTS, CAPACITY;
ORDERS
4.01 Forecasts;
Capacity; Capital Expenditures . At the beginning of each
calendar quarter during the Term, Buyer shall provide Supplier with
a binding written forecast of Buyer’s requirements for
Product for the shorter of the following 12 months or the
remainder of the Term (each, a “ Rolling 12 Month
Forecast ”). Each Rolling 12 Month Forecast will be
binding within a range of + *****% of the stated amount
within such Rolling 12 Month Forecast; provided that the first
three months of the each Rolling 12 Month Forecast will be binding
without reference to the foregoing range. Attached hereto as
Appendix 1 is an initial binding forecast for Product
to be purchased pursuant to this Agreement between the date of this
Agreement and the placement of subsequent purchase orders for
Product in accordance with Section 4.02, below.
Appendix 2 sets forth the capacity expectation for
Buyer’s requirements during the Term on a monthly basis (
“Capacity” ). The parties understand and agree
that any capital expenditures, incurred by Supplier in connection
with the performance of its obligations under this Agreement will
be borne by Supplier, it being understood that Supplier and Buyer
will consult in good faith regarding any such capital expenditure
prior to its incurrence. Notwithstanding anything to the contrary
contained herein, the parties understand and agree that up to
$***** of incremental expenses related to increasing manufacturing
Capacity shall be borne by Buyer. The parties further understand
that the foregoing forecasts and Capacity shall include both sample
and trade quantities of Product. Supplier will use commercially
reasonable efforts to meet Buyers demand for Product.
4.02 Change
Orders . Quarterly requirements contained in any 12 Month
Rolling Forecast may be changed with ***** days prior written
notice from Buyer to Supplier provided that Supplier consents to
such change order in writing (which consent may be withheld by
Supplier in its sole discretion)
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Confidential
information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential
treatment request.
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4.03
Example . For illustrative purposes only, assuming execution
and delivery of this Agreement on September 30, 2005, Buyer
will deliver (i) its first 12 Month Rolling Forecast on
October 1, 2005 for the succeeding 12 month period and
(ii) its second 12 Month Forecast on December 31, 2005
for the succeeding 12 month period. Quarterly requirements
contained in the forecasts will be binding, subject to change in
accordance with Section 4.01 and Section 4.02.
4.04
Conflicts . To the extent of any conflict or inconsistency
between this Agreement and any purchase order, purchase order
release, confirmation, acceptance or any similar document, the
terms of this Agreement shall govern.
ADDITIONAL UNDERSTANDINGS OF THE
PARTIES
5.01 Other
Affiliates . If any other Affiliate of Buyer desires to
purchase the Product from Supplier under the terms of this
Agreement, then, upon the execution of a copy of this Agreement by
such Affiliate, Supplier shall accord such Affiliate all of the
benefits hereof and treat such affiliate as a “ Buyer
” for the purposes of this Agreement; provided,
however, that this section will not be construed to relieve Esprit
of any of its obligations hereunder
5.02 Exclusive
Rights . During the Term, Supplier shall supply Buyer, on an
exclusive basis, with the Product for sale in the Territory and
neither Supplier nor any of its Affiliates shall sell or distribute
the Product.
5.03 Metered
Dose Delivery . Notwithstanding anything to the contrary
contained herein, the parties understand and agree that Supplier is
developing developed a metered dose bottle for the administration
of Estrasorb ( “Metered Dose Delivery” ) and
that the parties will, commencing on the date hereof, initiate the
development and implementation of Metered Dose Delivery. The
parties understand and agree that costs and expenses of the
development and implementation of Metered Dose Delivery will be
borne as follows: (a) the first $***** by Esprit and
(b) any amount in excess of $***** by Novavax. All such costs
and expenses will be paid by the applicable Party as such costs and
expenses are incurred. The parties will work together in good faith
to launch Metered Dose Delivery by *****.
5.04
Insurance . Each of Supplier and Buyer agrees to procure and
maintain in full force and effect during the Term valid and
collectible insurance policies of a type and coverage amount
consistent with Supplier’s and Buyer’s past practice
prior to the date hereof. Should Supplier require additional
insurance to be carried by Buyer, any incremental cost will be for
the account of Buyer. Buyer’s and Supplier’s existing
policies are listed on Schedule D attached hereto. Upon
Buyer’s request, Supplier shall provide to Buyer a
certificate of coverage or other written evidence reasonably
satisfactory to Buyer of such insurance coverage. Upon
Supplier’s request, Buyer shall provide to Supplier a
certificate of coverage or other written evidence reasonably
satisfactory to Supplier of such insurance coverage.
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Confidential
information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential
treatment request.
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5.05
Personnel . During the Term, Supplier shall maintain a
workforce of appropriate size, training and experience sufficient
in the reasonable judgment of Supplier for manufacturing the
Product in an amount not to exceed Capacity. If Buyer requires
additional personnel for maintaining its equipment and facilities
and otherwise necessary to fulfill Supplier’s other
obligations hereunder, the incremental cost thereof will be borne
solely by Buyer. The parties agree that the personnel requirements
associated with the performance of Buyer’s obligations
hereunder are set forth on Appendix 3 attached
hereto.
5.06 Product
Returns . All Product returns and all costs and expenses
associated therewith (a) for Products sold prior to the date
hereof will be for the account of Supplier; (b) for Products sold
on or after the date hereof will be for the account of Buyer; and
(c) for partial lot #092304T17 will be for the account of
Supplier. Medicaid chargebacks and rebates (a) occurring within the
first ***** days after the date hereof will be for the account of
Supplier and (b) occurring thereafter will be for the account
of Buyer.
The term of this
Agreement shall commence on the date hereof and remain in effect
until ***** (the “Expiration Date” ), unless
sooner terminated as expressly provided under this Agreement (the
“Term” ). Notwithstanding anything to the
contrary contained herein, this Agreement will be effective as
follows: with respect to Esprit’s obligation under the last
sentence of Section 3.01 and under Section 5.03, the date
of this Agreement and (b) with respect to all other terms and
conditions of this Agreement, the Business Day immediately
following the satisfaction in full of Esprit’s obligations to
pay principal and interest under the Promissory Note on the
Maturity Date (as defined therein).
7.01 Breach
. This Agreement may be terminated, prior to the Expiration Date,
by either Party by giving 90 days written notice of its intent
to terminate and stating the grounds therefor if the other Party
shall materially breach or materially fail in the observance or
performance of any representation, warranty, guarantee, covenant or
obligation under this Agreement. The Party receiving the notice
shall have 75 days from the date of receipt thereof to cure
the breach or failure. Notwithstanding anything to the contrary
contained herein, payment defaults will have a ten (10) day
cure period. In the event such breach or failure is cured, the
notice shall be of no effect.
7.02
Termination of License Agreement . Subject to earlier
expiration or termination, this Agreement will terminate
simultaneously with the termination of the License
Agreement.
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Confidential
information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential
treatment request.
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7.03
Insolvency, Etc. This Agreement may be terminated, prior to
the Expiration Date, upon 30 days written notice by either
Party: (i) in the event that the other Party hereto shall
(a) apply for or consent to the appointment of, or the taking
of possession by, a receiver, custodian, trustee or liquidator of
itself or of all or a substantial part of its property, (b) make a
general assignment for the benefit of its creditors,
(c) commence a voluntary case under the United States
Bankruptcy Code, as now or hereafter in effect (the
“Bankruptcy Code” ), (d) file a petition
seeking to take advantage of any law (the “Bankruptcy
Laws” ) relating to bankruptcy, insolvency,
reorganization, winding-up, or composition or readjustment of
debts, or (e) take any corporate action for the purpose of
effecting any of the foregoing; or (ii) if a proceeding or
case shall be commenced against the other Party hereto in any court
of competent jurisdiction, seeking (a) its liquidation,
reorganization, dissolution or winding-up, or the composition or
readjustment of its debts, (b) the appointment of a trustee,
receiver, custodian, liquidator or the like of the Party or of all
or any substantial part of its assets, or (c) similar relief
under any Bankruptcy Laws, or an order, judgment or decree
approving any of the foregoing shall be entered and continue
unstayed for a period of 60 days; or (iii) an order for
relief against the other Party hereto shall be entered in an
involuntary case under the Bankruptcy Code.
7.04 Effect of
Termination . Notwithstanding the termination of this Agreement
for any reason, each Party hereto shall be entitled to recover any
and all Damages which such Party shall have sustained by reason of
the breach by the other Party hereto of any of the terms of this
Agreement. Termination of this Agreement for any reason shall not
release either Party hereto from any liability which at such time
has already accrued or which thereafter accrues from a breach or
default prior to such expiration or termination, nor affect in any
way the survival of any other right, duty or obligation of either
Party hereto which is expressly stated elsewhere in this Agreement
to survive such termination. In the case of a termination under
Section 7.01 above, the non-defaulting Party may pursue any
remedy available in law or in equity with respect to such breach,
subject to the terms of Section 17.01.
(a) In the
event that this Agreement expires or is terminated for any reason
(other than Supplier’s material breach, gross negligence or
willful misconduct), Buyer shall be responsible for purchasing from
Supplier (at Supplier’s cost) such Permitted Raw Materials
Inventory conforming with the Specifications to the extent such
Permitted Raw Materials Inventory has not been fully utilized prior
to the expiry or earlier termination of this Agreement, provided
that such Permitted Raw Materials Inventory has a shelf life of not
more 365 days. Buyer shall accept delivery of any such
Permitted Raw Materials Inventory within five days after such
expiration or termination at the location designated by Buyer. If
Buyer instructs Supplier to scrap any such Permitted Raw Material
Inventory, Buyer shall pay for such Permitted Raw Materials
Inventory as provided in the immediately preceding sentence plus
reimburse Supplier’s incremental expenses directly related to
the proper disposition of the scrapped Permitted Raw Materials
Inventory.
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8.01
Delivery . All charges for packing, hauling, storage, bar
coding, and transportation to point of delivery are not included in
the Transfer Price and Transfer Price shall be F.O.B. Cardinal
Facility (i.e., Buyer will pay for shipment). All shipments must be
accompanied by a packing slip which describes the articles, states
the purchase order number and shows the shipment’s
destination. Supplier agrees to promptly forward the original bill
of lading or other shipping receipt for each shipment in accordance
with Buyer’s instructions. Supplier further agrees to
promptly render, after delivery of goods or performance of
services, correct and complete invoices to Buyer, and to accept
payment by check or at Buyer’s discretion, other cash
equivalent (including electronic transfer of funds).
8.02
Shipment . The risk of loss with respect to Product shall
remain with Supplier until the point at which any such Product is
delivered to the loading dock at the Cardinal Facility. Supplier
will pack all Product ordered hereunder in a manner suitable for
shipment and sufficient to enable the Product to withstand the
effects of shipping, including handling during loading and
unloading.
8.03
Inventory . (a) Supplier will maintain inventory of
Product on a first-in, first-out basis. In no event shall Supplier
be required to, and Supplier will not, order more than *****
months’ Raw Materials at Capacity and Supplier will use
commercially reasonable efforts to manage such inventory as
efficiently as possible.
(b) To
shorten lead times hereunder and to support variations in demand,
as and if necessary, Supplier shall during the Term maintain such
inventory of Raw Materials as are reasonably required to
manufacture and package Product in accordance with the
Specifications in a quantity equivalent to ***** (*****) month of
Buyer’s forecasted purchase volume (the foregoing amount of
inventory which conforms to the Specifications being hereinafter
referred to collectively as the “Permitted Raw Material
Inventory” ) or such other specific amount of Permitted
Raw Material Inventory as may be agreed to by both parties in
writing in advance. Supplier’s purchase price and the cost of
carrying Permitted Raw Material Inventory shall be for the account
of Buyer. The quantity of Permitted Raw Material Inventory shall be
adjusted by Supplier as needed based upon Buyer’s average
monthly purchase volume as forecasted in Buyer’s rolling
forecast. In the event that Buyer’s requirements for Product
materially exceed Buyer’s current forecasted needs, Supplier
shall draw from the Permitted Raw Material Inventory to meet such
excess requirements. Supplier shall then replenish the Permitted
Raw Material Inventory within ***** days.
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Confidential
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Securities and Exchange Commission pursuant to a confidential
treatment request.
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8
Buyer shall have
the right, upon reasonable notice to Supplier and during regular
business hours, to inspect and audit not more than ***** per *****
month period the facilities being used by Supplier for production
and storage of the Product to assure compliance by Supplier with
cGMP and applicable FDA and other rules and regulations and with
other provisions of this Agreement. Supplier shall notify Buyer as
promptly as practicable of any audit, review or inspection by any
regulatory authority relating, directly or indirectly, to the
Product, and shall in any event notify Buyer of any such audit,
review or inspection within 24 hours of Supplier’s first
being informed of any such event. Supplier and Buyer will work
together to remedy or cause the remedy of any deficiencies which
may be noted in any such audit or, if any such deficiencies can not
reasonably be remedied within such seven day period, develop a
written plan to remedy such deficiencies as soon as possible; and
the costs of such remedy shall be borne by the Supplier.
DEFECTIVE
PRODUCT/INSPECTIONS/TESTING
10.01
Disposition of Defective Product . Buyer shall notify
Supplier of the existence and nature of any non-compliance or
defect and Supplier shall have a reasonable opportunity, not to
exceed ***** days from receipt of notification, to inspect such
defective Product and provide Buyer with detailed written
instructions to return or dispose of such defective Product. Buyer
shall have no obligation to pay for any Product that is subject to
such a claim of non-compliance or defect. If Supplier fails to so
inspect and instruct Buyer as to the disposition of such defective
Product, Buyer may dispose of such defective Product as it sees fit
and Supplier shall promptly (i) reimburse Buye
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