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. LICENSE AGREEMENT by and between WYETH HOLDINGS...
Exhibit 10.1
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.
TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [ * * *] AND
HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
by and between
WYETH HOLDINGS CORPORATION
and
NOVAVAX, INC.
dated as of
July 5, 2007
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
THIS AGREEMENT is made as of July 5, 2007 by and between Wyeth Holdings Corporation, having a place
of business at Five Xxxxxxx Xxxxx, Xxxxxxx, Xxx Xxxxxx 00000 X.X.X. (“Wyeth”), and Novavax, Inc., a
Delaware corporation, having its principal place of business at 0000 Xxxxxxx Xxxxxx Xxxxx,
Xxxxxxxxx, Xxxxxxxx 00000 X.X.X. (“Novavax”). Wyeth and Novavax may each be referred to herein
individually as a “Party” and collectively as the “Parties”.
Wyeth is the owner of the Licensed Patent Rights, as defined below.
Novavax wishes to obtain a license under the Licensed Patent Rights, to practice the processes
included or claimed in the Licensed Patent Rights and to make, have made, use and sell Products, as
defined below.
Wyeth is willing to grant such a license to Novavax on the terms and conditions of this
Agreement.
Wyeth and Novavax have therefore agreed as follows.
1. DEFINITIONS
The following terms shall have the meanings indicated in this Agreement:
1.1. “Agreement” means this Agreement, including all schedules hereto.
1.2. “Affiliate” means as of any point in time and for so long as such relationship
continues to exist with respect to any Person, any other Person controlled by, controlling, or
under common control with either such Person. For this purpose, “control” means direct or indirect
beneficial ownership of at least fifty percent (50%) interest in the voting stock (or the
equivalent) of such Person or having the right to direct, appoint or remove a majority or more of
the members of its board of directors (or their equivalent), or having the power to control the
general management of such Person, by contract, law or otherwise. Notwithstanding the foregoing,
the term “Affiliate” shall not include Persons in which a Party or its Affiliates owns a majority
of the ordinary voting power to elect a majority of the board of directors or other governing body,
but is restricted from electing such majority by contact or otherwise, until such time as such
restrictions are no longer in effect.
1.3. “Applicable Percentage” means [* * *].
1.4. “Avian Influenza Strain” means strain of influenza A from a subtype of influenza
virus circulating among birds (and not circulating among humans).
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
1.5. “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 any material part of the assets of such
Person by a lien holder or other encumbrancer, or (v) the levy or enforcement of any distress,
execution or other process upon or against any of the material assets of such Person.
1.6. “Commercially Reasonable Efforts” means those diligent efforts consistent with
the exercise of prudent scientific and business judgment, as applied by a party to the development
and commercialization of its own pharmaceutical products at a similar stage of development and with
similar market potential, but in any event at least those efforts and resources normally used by a
similarly situated company in the biotechnology/pharmaceutical industry with respect to a product
owned by such company or to which such company has similar rights, which is of similar commercial
potential at a similar stage in its development or product life.
1.7. “Covered Product” means any unit of any Product the manufacture, sale or use of
which is covered by any claim within the Licensed Patent Rights in any country where such unit of
Product is manufactured, sold or used. For the avoidance of doubt, (a) if a unit of Product is
manufactured in a country where at least one (1) claim of the Licensed Patent Rights covers the
manufacture, sale or use of such unit of Product but such unit of Product is sold or used in
another country where the manufacture, sale or use of such unit of Product is not covered by any
claim of the Licensed Patent Rights, such unit of Product is a Covered Product for purposes of this
Agreement, and the royalty owed on such Covered Product pursuant to Section 3.1.6 shall be due and
owing on the Net Sales arising from sales of such Covered Product in the country in which sold, and
(b) if a unit of Product is manufactured in a country where no claim of any Licensed Patent Right
covers the manufacture, sale or use of such unit of Product but such unit of Product is sold or
used in another country where at least one (1) claim of the Licensed Patent Rights covers the
manufacture, sale or use of such unit of Product, such unit of Product is a Covered Product for
purposes of this Agreement, and the royalty owed on such Covered Product pursuant to Section 3.1.6
shall be due and owing on the Net Sales arising from sales of such Covered Product in the country
in which sold; and (c) if a unit of Product is manufactured in a country where no claim of any
Licensed Patent Right covers the manufacture, sale or use of such unit of Product, and such unit of
Product is sold or used in another country where the manufacture, sale or use of such unit of
Product is not covered by any claim of the Licensed
Patent Rights, such unit of Product is not a Covered Product for purposes of this Agreement,
and no royalty would be owed on such Product.
1.8. “Effective Date” means the date referenced in the opening paragraph of this
Agreement.
1.9. “Field” means human vaccines for the prevention and treatment of one or more
Indications.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
1.10. [* * *].
1.11. “Indication” means each of Seasonal Flu, Pandemic Flu, [* * *].
1.12. “Licensed Patent Rights” means the patent applications described on Schedule
1, all patent applications that claim priority thereto, all divisionals, continuations or
continuations-in-part thereof (to the extent claiming priority to the patent applications described
on Schedule 1), all patents that issue therefrom, and any reissue, re-examination, renewal,
supplementary protection certificate or extension of any such patent, and any foreign counterparts
and equivalents of any of the foregoing.
1.13. “Net Sales” means the gross amount invoiced for any sale of any Product by
Novavax, any Novavax Affiliate or any permitted sublicensee, as appropriate (a “Selling Person”),
to a non-Affiliate in a bona fide arm’s length transaction, less the following deductions, in each
case to the extent specifically related to the Product and taken by the Selling Person or otherwise
paid for or accrued by the Selling Person in accordance with GAAP (“Permitted Deductions”):
(i) trade, cash, promotional and quantity discounts and wholesaler fees;
(ii) taxes on sales (such as excise, sales or use taxes or value added taxes) to the extent
imposed upon and paid directly with respect to the sales price (and excluding national, sales or
local taxes based on income);
(iii) freight, insurance, packing costs and other transportation charges to the extent
included in the invoice price to the buyer;
(iv) amounts repaid or credits taken by reason of damaged goods, rejections, defects, expired
dating, recalls, returns or because of retroactive price reductions; and
(v) charge back payments and rebates granted to (a) managed healthcare organizations, (b)
federal, state and/or provincial and/or local governments or other agencies, (c)
purchasers and reimbursers, or (d) trade customers, including wholesalers and chain and
pharmacy buying groups.
It is understood that accruals taken as a deduction against Net Sales will be periodically reviewed
by Novavax in accordance with GAAP and if any accrual is reversed by a Selling Person a
corresponding credit will be made to Net Sales in the period in which the reversal is made. Net
Sales of any Product that is a Combination Product (for purposes hereof, a “Combination Product”
means any product that comprises a Product and other therapeutically or diagnostically active
compounds or ingredients that are not Products) shall be a fraction of such Net Sales reasonably
determined as follows:
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Except as provided below, the Net Sales amount for a sale of a Combination Product (a
“Combination Sale”) shall equal the gross amount invoiced for the Combination Sale, reduced
by the Permitted Deductions (the “Net Combination Sale Amount”), multiplied by the fraction
A/(A+B), where:
A is the invoice price, in the country where such Combination Sale
occurs, of the Product contained in the Combination Product, if sold
as a separate Product in such country by the Selling Person and B is
the aggregate of the invoice price or prices, in such country, of
such other products or active ingredients/components, as the case
may be, included in the Combination Product if sold separately in
such country by the Selling Person.
In the event that the Selling Person sells the Product included in a Combination Product as
a separate Product in a country, but does not separately sell all of the other products or
active ingredients/components, as the case may be, included in such Combination Product in
such country, the calculation of Net Sales resulting from such Combination Sale shall be
determined by multiplying the Net Combination Sale Amount by the fraction A/C where:
A is the Selling Person’s average wholesale price, in such country,
of the Product contained in such Combination Product when sold as a
separate Product by the Selling Person, and C is the average
wholesale price, in such country, charged by the Selling Person for
the entire Combination Product.
In the event that the Selling Person does not sell the Product included in a Combination
Product as a separate Product in the country where such Combination Sale occurs, but does
separately sell all of the other products or active ingredients/components, as the case may
be, included in the Combination Product in such country, the calculation of Net Sales
resulting from such Combination Sale shall be determined by multiplying the Net Combination
Sale Amount by the fraction (C-D)/C, where:
C is the average wholesale price, in such country, charged by the
Selling Person for the entire Combination Product, and D is the
average wholesale price charged by the Selling Person for the other
products or active ingredients/components, as the case may be,
included in the Combination Product.
Where the calculation of Net Sales resulting from a Combination Sale in a country cannot be
determined by any of the foregoing methods, the calculation of Net Sales for such Combination Sale
shall be that portion of the Net Combination Sale Amount reasonably determined in good faith by the
Parties as properly reflecting the value of the Product included in the Combination Product.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
1.14. “Non-seasonal Human Influenza Strain” means a strain of influenza A virus that
has infected a human, and has not been included in the annual seasonal trivalent composition, A
Non-seasonal Human Influenza Strain can be from a subtype that includes any combination of
hemagglutinin and neuraminidase. As of the Effective Date, Non-seasonal Human Influenza Strains
currently come from, but are not limited to, influenza A subtypes X0X0, X0X0, X0X0, X0X0, X0X0,
X0X0, X0X0, X0X0, X0X0, and H9N2.
1.15. “Non-seasonal Influenza Strain” means a Non-seasonal Human Influenza Strain, an
Avian Influenza Strain, or any influenza strain that is not a Seasonal Influenza Strain.
1.16. “Pandemic Flu” means influenza caused by a Non-seasonal Influenza Strain.
1.17. “Party” means each party to this Agreement and their respective successors and
permitted assigns.
1.18. “Person(s)” means any natural person(s) or legal entity.
1.19. “Product” means any product in any Field containing VLPs.
1.20. [* * *].
1.21. “Royalty Payments” is defined in Section 6.
1.22. “Seasonal Flu” means influenza caused by a Seasonal Influenza Strain.
1.23. “Seasonal Influenza Strain” means a strain of influenza virus circulating widely
among humans, that is an influenza B virus or influenza A virus strain designated by World Health
Organization (the “WHO”) and/or Centers for Disease Control and Prevention, the United States
Department of Health and Human Services (the “CDC”) as a vaccine target for the preparation of the
annual influenza vaccine trivalent composition. As of the Effective Date, current Seasonal
Influenza Strains are from influenza A subtypes H1N1 and H3N2 and influenza B.
1.24. “Territory” means all countries in the world.
1.25. “Third Party” means any Person other than Wyeth, Novavax or their respective
Affiliates.
1.26. “VLP” means a self-assembling virus-like particle [* * *].
2. LICENSE RIGHTS; DUE DILIGENCE
2.1. Non-Exclusive License. Subject to the terms and conditions of this Agreement,
Wyeth hereby grants to Novavax a non-exclusive license, with the limited right to grant sublicenses
as set forth in Section 2.2, under the Licensed Patent Rights to research, develop, make, have
made, use, sell, offer for sale and import Products in the Field in the Territory.
2.2. Sublicensing. Notwithstanding anything herein to the contrary, Novavax shall
have the right to grant sublicenses only as follows:
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
2.2.1. Sublicenses to Third Parties. Novavax shall have the right, without the
consent of Wyeth, but with prompt (and in any case within ten (10) days after execution of
the relevant sublicense agreement) written notice to Wyeth, to grant sublicenses under the
license granted to Novavax herein to Third Parties for purposes of development and/or
commercialization of Products; provided, that Novavax must obtain the prior written consent
of Wyeth to sublicense the Licensed Patent Rights to any Third Party where such sublicense
does not include a license to development and/or commercialization rights under other patent
applications, patents or technology owned or controlled by Novavax, to such Third Party.
2.2.2. Wyeth Retained Licensing Rights. For the avoidance of doubt, Wyeth
retains the right (a) for itself and for its Affiliates, successors and assigns to research,
develop, make, have made, use, sell and import Products and to otherwise make, use, sell and
import Products and other products under the Licensed Patent Rights, and (b) to grant
licenses and sublicenses to Third Parties to research, develop, make, have made, use, sell
and import Products and other products.
2.2.3. Sublicense Agreements; Payments; Copies of Sublicense Agreements.
Novavax shall provide to Wyeth a copy of all sublicense agreements entered into under this
Agreement within ten (10) days of the effective date of each sublicense agreement; provided,
that Novavax may redact from such copy any information that is not reasonably necessary to
establish Novavax’s compliance with the terms and conditions of this Agreement. In addition
to the Royalty Payments and milestones payments described in Section 3 (which would be
payable in full for Net Sales made by sublicensees and the achievement of the relevant
milestone events by sublicensees), Novavax shall pay to Wyeth [* * *] of all additional
amounts received by Novavax as consideration for any sublicense to the Licensed Patent
Rights granted under this Agreement (i.e., such additional amounts being equal to the
difference of payments received by Novavax from a sublicensee covered by this Section 2.2.3
less amounts paid to Wyeth by Novavax under Section 3.1 on Product sales or the achievement
of Product milestone events, as applicable), payable within thirty (30) days after receipt
of any such payment by Novavax, other than any amounts payable (i) as bona fide payments for
the cost of research and development services actually performed, (ii) as equity or debt
funding, or (iii) for any fair market value purchases of materials from Novavax by a Third
Party sublicensee. By way of example in the context of milestone payments, if Novavax
receives [* * *] from a sublicensee upon [* * *] by such sublicensee, then Novavax would be
entitled to deduct the [* * *] payment due pursuant to Section 3.1.3.1 in calculating the
payments due under this Section and, subject to the terms and conditions of this Agreement,
the resulting payment under this Section would be [* * *]. By way of
example in the context of royalty payments, if Novavax receives an [* * *] royalty from
a sublicensee for Product sales, then Novavax would be entitled to deduct the [* * *]
royalty due Wyeth pursuant to Section 3.1.6 in calculating the payments due under this
Section and, subject to the terms and conditions of this Agreement, the resulting payment
under this Section would be [* * *] of the [* * *] royalty on Product sales. Novavax shall
be responsible for the payment of any royalties or other payments provided for hereunder,
regardless of whether the terms of any sublicense provides for such amount to be paid by the
sublicensee directly to Novavax. Novavax shall promptly provide to Wyeth any other
information or documents reasonably requested by Wyeth to ascertain Novavax’s compliance
with this Section 2.2. All sublicenses granted hereunder shall be consistent with and
subject to the terms and conditions of this Agreement, including without limitation all
payment obligations of Novavax hereunder.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
2.3 Restriction on other Rights. No right or license is granted to Novavax in or to
any right or interest of Wyeth that is not specifically set forth in this Agreement.
2.4 Due Diligence. Novavax shall use Commercially Reasonable Efforts to develop,
manufacture and commercialize at least one Product in each Indication in the Territory. Wyeth
acknowledges and agrees that, as of the Effective Date, Novavax’s development efforts will be
directed primarily at the Seasonal Flu and Pandemic Flu Indications. Novavax shall provide to
Wyeth on each annual anniversary of the Effective Date a written report detailing its Product
research, development, manufacturing and commercialization activities. Any such reports will be
held in strict confidence by Wyeth and not disclosed to any Third Party and Wyeth will use such
reports only for purposes of this Agreement. Novavax shall comply with all applicable laws and
regulations. Novavax shall be responsible for obtaining all regulatory approvals required for the
development, manufacture and sale of Products.
3 PAYMENTS
3.1 Payments. Novavax shall make the following payments to Wyeth as consideration for
the rights granted by Wyeth hereunder:
3.1.1 Licensing Fee. Within fifteen (15) days after the Effective Date,
Novavax shall pay Wyeth a non-refundable licensing fee of [* * *].
3.1.2 Annual License Maintenance Fee. Novavax shall pay to Wyeth an annual
license maintenance fee of [* * *] for each Indication (i.e., a total of U.S. [* * *] for
all [* * *] Indications) with respect to which this Agreement has not expired or been
terminated, such amount payable on or before each annual anniversary of the Effective Date.
Each annual license maintenance fee for a particular Indication shall be payable on each
such anniversary until the First Commercial Sale of any Product for such Indication in the
Territory.
3.1.3 Milestone Payments for Products other than Pandemic Flu Products.
Novavax shall pay to Wyeth the following non-refundable milestone payments within thirty
(30) days after the date when each Product, other than a Product labeled solely for Pandemic
Flu (i.e., if a Product is indicated solely for Pandemic Flu, the milestones in this Section
3.1.3 shall not apply, but if a Product is indicated for Pandemic Flu and one or more other
Indications, both this Section 3.1.3 and Section 3.1.4 shall apply as set forth in Section
3.1.5), reaches a milestone described below with respect to each Indication (whether
achieved by or on behalf of Novavax or any of its Affiliates or sublicensees):
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
3.1.3.1 [* * *];
3.1.3.2 [* * *];
3.1.3.3 [* * *]; and
3.1.3.4 [* * *].
The total of all milestone payments that will be payable under this Section 3.1.3 for each
Product is [* * *].
3.1.4 Milestone Payments for Pandemic Flu Products. Novavax shall pay to Wyeth
the following non-refundable milestone payment within thirty (30) days after the date when
each Product for Pandemic Flu (whether indicated solely for Pandemic Flu or indicated for
Pandemic Flu and one or more other Indications) reaches the milestone described below
(whether achieved by or on behalf of Novavax or any of its Affiliates or sublicensees):
3.1.4.1 [* * *]
3.1.4.2 [* * *].
3.1.5 Multiple Indications; Etc. As used in Sections 3.1.3 and 3.1.4, “each
Product” means, a Product for a separate Indication. Accordingly, for the avoidance of
doubt, if a Product achieves an event described in Section 3.1.3 or 3.1.4 above for more
than one Indication (e.g., [* * *]), the relevant milestone would be payable for each such
Indication (in the example given above, a total of [* * *] million would be payable). In
addition, if Novavax pays the [* * *] milestone referred to in Section 3.1.3 above for a
Product without having paid the [* * *] milestones (or both) for such Product, Novavax shall
at the same time pay such [* * *] milestones. If Novavax pays the milestone referred to in
Section 3.1.3.4 above for a Product without having paid the [* * *] milestones (or both) for
such Product, Novavax shall at the same time pay such [* * *] milestones. For clarity, (a)
with respect to any Product for Seasonal Flu for which milestone payments have been paid for
the Seasonal Flu Indication, an addition or change to the Seasonal Influenza Strains
targeted by such Product would not alone constitute a separate Product for Seasonal Flu and
no additional milestone payments would be payable solely on account of any such addition or
change, (b) with respect to any Product for Pandemic Flu for which the milestone payments
under Section 3.1.4 has been paid, a change within the specific Non-seasonal Influenza
Strain(s) targeted by such Product (i.e., a change within H5N1) would not alone constitute a
separate Product for Pandemic
Flu, and accordingly no additional milestone payment would be payable under Section
3.1.4 solely on account of the [* * *] of such a Product containing any such change, but [*
* *] and (c) a Product indicated for both Pandemic Flu and Seasonal Flu shall be subject to
the milestone payments in both Section 3.1.3 and Section 3.1.4 upon achievement of the
events described therein.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
3.1.6 Royalties. Novavax shall pay or cause to be paid to Wyeth, pursuant to
Section 3.4, a royalty equal to the Applicable Percentage of all Net Sales of all Covered
Products by Novavax or any of its Affiliates or permitted sublicensees (“Royalty
Payments”).
3.2 Records. During the term of this Agreement and for three (3) years thereafter,
Novavax shall (and shall cause its Affiliates and permitted sublicensees to) keep complete and
accurate records of sales of Products and such other matters as may affect the determination of any
amount payable to Wyeth hereunder in sufficient detail to enable certified public accountants
engaged by Wyeth to determine any amounts payable to Wyeth under this Agreement. Novavax shall
(and shall cause its Affiliates and permitted sublicensees to) permit certified public accountants
engaged by Wyeth, at Wyeth’s expense (except as provided below), to examine not more than once in
any twelve-month period per Person its books, ledgers, and records during regular business hours
for the purpose of and to the extent necessary to verify any report required under this Agreement
or the accuracy of any amount payable hereunder. In addition, Novavax shall (and shall cause its
Affiliates and permitted sublicensees to) permit Wyeth or its representatives to examine
periodically any documents relating to its sublicensing of the Licensed Patent Rights during
regular business hours. Should any examination conducted by Novavax or its representatives
pursuant to the provisions of this paragraph result in an increase of more than 10% of any payment
due Wyeth hereunder, Novavax shall be obligated to reimburse any out of pocket expenses incurred by
Wyeth with respect to such examination within thirty (30) days after receipt of an invoice therefor
from Wyeth.
3.3 Reports. Within thirty (30) days after March 31, June 30, September 30 and
December 31 of each year, Novavax shall deliver to Wyeth a true and accurate report, giving such
particulars of the business conducted by Novavax, its Affiliates and permitted sublicensees during
the preceding quarter under this Agreement as are pertinent to an accounting for any Royalty
Payments or other payments hereunder. Each such report will contain at least the following
information: the number and kind of Products sold in each country, total gross invoice amounts for
each such Product, deductions applicable to determine Net Sales thereof, a calculation of the
amount due to Wyeth for the relevant period and the exchange rate used to convert any Royalty
Payments into United States Dollars. Each report also will contain Novavax’s good faith,
non-binding estimate of total Net Sales for all Products by Novavax, its Affiliates and its
permitted sublicensees for each of the four consecutive calendar quarters beginning with the
calendar quarter in which such report is delivered. In addition to the foregoing, Novavax shall
notify Wyeth promptly of the receipt by Novavax or any of its Affiliates or permitted sublicensees
of any marketing authorization or approval or other regulatory approval with respect to any
Product. Any reports provided by Novavax pursuant to
this Section 3.3 will be held in strict confidence by Wyeth and not disclosed to any Third
Party and Wyeth will use such reports only for purposes of this Agreement.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
3.4 Payments. Within thirty (30) days of the end of each calendar quarter in which
any Net Sales occur, Novavax shall calculate the Royalty Payments owed to Wyeth and shall remit to
Wyeth the amount owed to Wyeth. For purposes of determining when a sale of a Product occurs, the
sale shall be deemed to occur on the date of invoice to the purchaser of the Product. All other
payments to be made to Wyeth hereunder shall be made on the dates specified herein. All late
payments shall accrue interest at the rate of [* * *] per month from the date due through the date
paid.
3.5 Form of Payment; Taxes. All amounts payable to Wyeth hereunder shall be payable
in United States Dollars without deductions for taxes, assessments, fees, or charges of any kind.
Novavax shall be responsible for the payment of all withholding taxes imposed by any country on any
royalty or other payment payable to Wyeth hereunder and the percentage or other amounts payable to
Wyeth hereunder shall not be reduced to reflect the payment of any such withholding tax. All
amounts payable to Wyeth hereunder shall be payable in United States dollars by wire transfer of
immediately available funds to an account designated in writing by Wyeth, or by such other method
as Wyeth may reasonably designate, provided, however, that if the law of any
foreign country prevents any payment payable to Wyeth hereunder to be made by wire transfer of
immediately available funds to such account, or as otherwise designated by Wyeth, or prevents any
such payment to be made in United States Dollars, Wyeth agrees to accept such royalty in form and
place as permitted, including deposits by Novavax in the applicable foreign currency in a local
bank or banks in such country designated by Novavax. If any currency conversion is required in
connection with any payment to Wyeth hereunder, such conversion shall be made at the buying rate
for the transfer of such other currency as quoted by The Wall Street Journal on the last business
day of the applicable accounting period, in the case of any payment payable with respect to a
specified accounting period, or, in the case of any other payment, the last business day prior to
the date of such payment.
4 [* * *]
4.1
[* * *].
5 PROTECTION OF INTELLECTUAL PROPERTY RIGHTS
5.1 Patent Prosecution/Patent Costs. Wyeth shall be responsible for the prosecution,
maintenance and renewal, of all Licensed Patent Rights at its own expense, and will consult with
Novavax in connection with such activities.
5.2 Infringement by Third Parties. Novavax shall promptly advise Wyeth in writing of
any infringement or suspected infringement of any of the Licensed Patent Rights of which Novavax
becomes aware. In the case of any infringement of any Licensed Patent Rights by any
Third Party (an “Infringer”) during the term of this Agreement, Wyeth shall have the
right under Wyeth’s control and at Wyeth’s expense to prosecute any Third Party infringement of the
Licensed Patents. Subject to Wyeth’s control of any such proceeding, Novavax shall have the right,
at its own expense and using counsel of its choosing, to participate in such proceeding. Novavax
shall assist Wyeth as reasonably requested in taking any such action against any such Infringer.
Any amount recovered by or reimbursed to Wyeth as a result of any action taken by Wyeth under this
Section 5.2 (including, without limitation, from any settlement or other voluntary disposition
thereof) will be retained solely by Wyeth.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
5.3 Patent Marking. Novavax shall use appropriate patent marking on Products.
Novavax shall register or record this Agreement as is required by law or regulation in any country.
6 INDEMNIFICATION; ETC.
6.1 Indemnification.
6.1.1 Novavax shall indemnify, defend and hold harmless Wyeth, its Affiliates, and
their respective directors, partners, officers, managers, employees and agents and their
respective successors, heirs and assigns (each an “Indemnitee”), against any liability,
damage, deficiency, loss, obligation or expense of any kind (including reasonable attorneys’
fees and expenses of litigation) incurred by or imposed upon any Indemnitee through any
claim, suit or action by a Third Party to the extent arising out of or relating to (a) any
death, illness, personal injury, property damage, improper business practices, violation of
law or governmental regulation, rule or order, or other loss or harm arising out of the
research, development, manufacture, sale, use or other disposition of any Product by
Novavax, its Affiliates or sublicensees (whether based on negligence or other tort,
warranty, strict liability, or any other theory) or (b) any breach of this Agreement by
Novavax.
6.1.2 Each Indemnitee will notify Novavax within sixty (60) days after it becomes aware
of a claim for which indemnification may be sought hereunder (but failure to give such
notice shall not relieve Novavax of its indemnification obligations hereunder except solely
to the extent that Novavax is actually prejudiced by such failure. Novavax, upon request of
the Indemnitee, shall retain counsel reasonably satisfactory to the Indemnitee to represent
the Indemnitee and shall pay the fees and expenses of such counsel related to such
proceeding. The Indemnitee agrees to cooperate fully with Novavax in the defense of any
such claim, action or proceeding, or any litigation resulting from any such claim. In any
such proceeding, the Indemnitee shall have the right to retain its own counsel, but the fees
and expenses of such counsel shall be at the expense of the Indemnitee unless (a) Novavax
and the Indemnitee shall have mutually agreed to the retention of such counsel or (b) the
named parties to any such proceeding (including any impleaded parties) include both Novavax
and the Indemnitee and representation of both parties by the same counsel would be
inappropriate due to actual or potential differing interests between them. All such fees
and expenses shall be reimbursed as they are incurred. Novavax shall not be liable for any
settlement of any proceeding effected without its written consent, but if settled with such
consent or if there be a final judgment for the plaintiff, Novavax agrees to indemnify the
Indemnitee from and against any loss or liability by reason of such settlement or judgment.
Novavax shall
not, without the written consent of the Indemnitee, effect any settlement of any
pending or threatened proceeding in respect of which the Indemnitee is, or arising out of
the same set of facts could have been, a party and indemnity could have been sought
hereunder by the Indemnitee, unless such settlement includes an unconditional release of the
Indemnitee from all liability on claims that are the subject matter of such proceeding.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
6.1.3 This Section 6.1 shall survive expiration or termination of this Agreement.
6.2 Warranty Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, EACH PARTY
MAKES NO EXPRESS OR IMPLIED WARRANTY INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR ANY IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY OF
THE LICENSED PATENT RIGHTS OR ANY PRODUCTS OR OTHERWISE AND HEREBY DISCLAIMS THE SAME. EXCEPT AS
PROVIDED BELOW, WYETH MAKES NO EXPRESS OR IMPLIED WARRANTY THAT THE MANUFACTURE, USE OR SALE OF ANY
PRODUCT WILL NOT INFRINGE ANY PATENT OR OTHER RIGHT OF ANY PARTY AND HEREBY DISCLAIMS THE SAME.
6.3 Representations and Warranties of Wyeth. Wyeth hereby represents, warrants and
covenants to Novavax that Wyeth has the full right and authority to execute and perform this
Agreement and the execution and performance of this agreement by Wyeth will not conflict with,
cause a default under or violate any existing contractual obligation that may be owed by Wyeth to
any Third Party.
6.4 Representations and Warranties of Novavax. Novavax hereby represents, warrants
and covenants to Novavax that Novavax has the full right and authority to execute and perform this
Agreement and the execution and performance of this agreement by Novavax will not conflict with,
cause a default under or violate any existing contractual obligation that may be owed by Novavax to
any Third Party.
6.5 Insurance.
6.5.1 Beginning at the time any Product is being used or sold (including in any
clinical trial) by Novavax or by an Affiliate or permitted sublicensee of Novavax, Novavax
shall, at its sole cost and expense, procure and maintain commercial general liability
insurance in amounts not less than $2,000,000 per occurrence with a $5,000,000 annual
aggregate and naming the Indemnitees as additional insureds. Such commercial general
liability insurance shall provide: (i) product liability coverage; and (ii) broad form
contractual liability coverage for Novavax’s indemnification obligations under this
Agreement. The minimum amounts of insurance coverage required shall not be construed to
create a limit of Novavax’s liability with respect to its indemnification or other
obligations under this Agreement. All insurance shall be procured with carriers having an
A.M. Best rating of A- VII or better.
6.5.2 Novavax shall provide Wyeth with a certificate of insurance upon request of
Wyeth. Novavax shall provide Wyeth with written notice at least fifteen (15) days prior to
the cancellation, non-renewal or material change in such insurance; if Novavax does not
obtain replacement insurance providing comparable coverage within such fifteen (15) day
period, Novavax shall have the right to terminate this Agreement effective at the end of
such fifteen (15) day period without notice or any additional waiting periods.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
6.5.3 Novavax shall maintain such commercial general liability insurance beyond the
expiration or termination of this Agreement during: (i) the period that any Product is being
commercially distributed or sold; and (ii) a reasonable period after the period referred to
in clause (i) above, which in no event shall be less than five (5) years.
6.5.4 This Section 6.5 shall survive expiration or termination of this Agreement.
7 TERM AND TERMINATION
7.1 Term. This Agreement will be effective as of the Effective Date and will remain
in effect as long as there is at least one (1) claim of the Licensed Patent Rights that covers the
manufacture, sale or use of any Product anywhere in the Territory.
7.2 Termination by Wyeth.
7.2.1 Termination for Cause.
| 7.2.1.1 | By Indication. Wyeth shall have the right to terminate this Agreement and the license granted hereunder on an Indication-by-Indication basis upon Novavax’s material breach of its obligations under Section 2.4 for a particular Indication. | ||
| 7.2.1.2 | Entire Agreement. Wyeth shall have the right to terminate this Agreement and the license granted hereunder upon the happening of any of the following events: | ||
| (i) Novavax fails to pay or cause to be paid any payment which has become due to Wyeth under this Agreement within thirty (30) days after the due date and written notice from Wyeth to Novavax specifying the payments due; | |||
| (ii) Novavax is in material breach of or default under this Agreement other than any payment obligation referred to in clause (i) above or the obligations referred to in clause (ii) above and has not cured such breach or default within ninety (90) days after written notice from Wyeth to Novavax specifying the nature of such breach or default. |
7.3 Bankruptcy Event. Wyeth may, at its option, terminate this Agreement immediately
upon notice to Novavax if a Bankruptcy Event occurs with respect to the Novavax.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
7.4 Termination after Challenge. If Novavax or any of its Affiliates or sublicensees
determines to make, file or maintain any claim, demand, lawsuit, cause of action or other action or
proceeding, including without limitation by reexamination, opposition, interference, declaratory
judgment proceeding or invalidity or nullity proceeding, alleging that a Licensed Patent Right is
invalid, unenforceable, or not infringed by the development, manufacture, use, sale, or importation
of a Product (collectively, an “Action”), Novavax shall notify Wyeth in writing of such
determination (such notice a “Challenge Notice”) no less than ninety (90) days prior to making or
filing such Action in any court or other governmental organization. For clarity, any claims made
by Novavax in the defense of infringement actions commenced by or on behalf of Wyeth or its
Affiliates will not be treated as Actions for purposes of this Section 7.4. If Wyeth receives a
Challenge Notice from Novavax, Wyeth may, at its option and in its sole discretion deem the receipt
of the Challenge Notice to be a material breach of this Agreement and terminate this Agreement by
providing written notice of termination to Novavax, and if Wyeth so chooses, xxx Novavax for
infringement and/or breach of contract in any forum of competent jurisdiction of Wyeth’s choosing;
provided that the foregoing will not operate to waive any rights or defenses under law or equity.
If Wyeth does not terminate the Agreement as provided in the previous sentence, then all amounts
payable to Wyeth under this Agreement after the date of the Challenge Notice shall be doubled until
such time as a court of competent jurisdiction or other governmental organization determines in an
unappealed or unappealable decision that the subject Licensed Patent Rights are invalid or
unenforceable, or, in the case of alleged non-infringement, that the Licensed Patent Rights are not
infringed. For the avoidance of doubt, all such payments shall be made directly to Wyeth in
accordance with the terms hereof and Novavax shall not have the right to make any such payments in
or under any escrow arrangement. Novavax acknowledges and agrees that in the event that Novavax
makes, files, or maintains an Action and/or fails to show that any Licensed Patent Right is
invalid, unenforceable, or, in the case of asserted non-infringement, not infringed, Wyeth will
suffer costs, expenses and damages that would be of uncertain amount and difficult to prove, and
that in addition, if Novavax fails in any such Action, after such an outcome the Licensed Patent
Right would be of even greater value than before such Action. Therefore, the Parties agree that in
such event, the immediate increase in amounts payable under this Agreement contemplated in this
Section 7.4 is a fair and reasonable amount both to compensate Wyeth for the unanticipated expense
of defending such an Action against its own licensee and as liquidated damages that are
proportionate to Wyeth’s presumable injury from such Action and, if applicable, the increased value
of the Licensed Patent Rights that would result in such event. Application of this liquidated
damages provision shall not prevent Wyeth from augmenting its protection by such other remedies as
may be available. This Section 7.4 shall be of the essence of this Agreement.
Notwithstanding anything to the contrary in this Agreement, if Novavax or any of its
Affiliates or sublicensees is subject to a discovery request, subpoena or court order relating to
one or more of the Licensed Patent Rights related to any Action (other than a discovery request,
subpoena, court order, or Action initiated by or on behalf of Novavax or any of its Affiliates or
sublicensees), Novavax, such Affiliate or such sublicensees shall provide prompt notice to Wyeth of
such discovery request, subpoena or court order such that Wyeth may take any steps necessary to
obtain a protective or other order. If reasonable efforts to obtain such protective or other order
are unsuccessful, of if further delay in compliance with such discovery request, subpoena or court
order is reasonably likely to result in a finding of contempt, Novavax, such Affiliate or such
sublicensee may comply with such discovery request, subpoena or court order.
-14-
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
7.5 Termination by Novavax. Novavax shall have the right to terminate this Agreement
in whole or on an Indication-by-Indication basis upon ninety (90) days written notice to Wyeth
given after the complete and final cessation of any and all activities relating to the development,
manufacture for commercial purposes, commercialization, marketing or sale of Products, whether
through the development, manufacture, commercialization, marketing or sale of Products or
otherwise, and whether by Novavax, its Affiliates or permitted sublicensees.
7.6 Effect of Expiration or Termination.
7.6.1 Upon expiration or termination of this Agreement for any reason, nothing herein
shall be construed to release either Party from any obligation that matured prior to the
effective date of such termination.
7.6.2 Upon termination of this Agreement for any reason, any sublicense granted
hereunder with respect to which the sublicensee is not then in breach or default shall
continue as a direct license between the sublicensee and the Wyeth on the terms of this
Agreement, provided that the sublicensee agrees in writing, within thirty (30) days after
termination of this Agreement, to be bound by the terms of this Agreement.
7.6.3 The provisions of Article 8 (General) and Sections 5.2 (Infringement by Third
Parties) (but only with respect to infringement occurring prior to termination), 6.1
(Indemnification), 6.2 (Warranty Disclaimer), 6.5 (Insurance) and 7.6 (Effect of
Termination) shall survive any expiration or termination of this Agreement for any reason.
In addition, Wyeth’s obligation pursuant to Section 2.4 and 3.3 to retain Novavax’s reports
in confidence shall survive for a period of five (5) years after any expiration or
termination of this Agreement for any reason.
7.6.4 Novavax may, after termination of this Agreement, sell all Products which are in
inventory at the time of termination, and complete and sell Products which Novavax can
clearly demonstrate were in the process of manufacture at the time of such termination,
provided that Novavax shall pay to Wyeth any Royalty Payments due on the sale of such
Products and shall submit reports, in accordance with this Agreement.
8 GENERAL
8.1 Assignment. This Agreement shall be binding upon and shall inure to the benefit
of each Party and each Party’s respective transferees, successors and assigns, provided,
however, that Novavax shall not have the right to assign this Agreement or its rights or
obligations hereunder to any other Person without the prior written consent of the Wyeth other than
as set forth in the next sentence. Novavax may assign this Agreement and all of its rights and
obligations under this Agreement to any single Person to which Novavax transfers (whether by
merger, stock sale, or sale of all or substantially all of the assets of Novavax) or licenses on an
exclusive, worldwide basis all or substantially all of the assets and other rights and interests of
Novavax necessary for, involved in or related to the development, manufacture, marketing,
commercialization or importation of Products to which this Agreement relates; provided that the
transferee or licensee of such assets, rights and interests must agree in writing with Wyeth to
assume all obligations of Wyeth hereunder and to be bound by all of the terms and conditions of
this Agreement and Novavax shall provide Wyeth with written notice of any such transaction promptly
after consummation thereof. Any purported assignment in violation of the provisions of this
paragraph shall be null and void.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
8.2 Publicity. Neither Party shall issue any news release or other public
announcement relating to this Agreement, including any of its terms, or to the performance of
either Party hereunder, without the prior written approval of the other Party. Once the text or
substance of any announcement has been so approved, it may be repeated without further approval.
8.3 Use of Name. Except as may be agreed to by the Parties pursuant to Section 8.2,
neither Party shall use the name of the other in connection with this Agreement, the Licensed
Patent Rights, the Products or any related matter in any press releases, public announcements or
other publicity or advertising materials without the prior written approval of the other Party.
8.4 Entire Agreement/Amendments. This Agreement constitutes the entire and only
agreement between the Parties relating to Licensed Patent Rights, and all prior negotiations,
representations, agreements and understandings are superseded hereby, except that the terms of the
Confidential Disclosure Agreement between the Parties, dated as of December 6, 2005, will continue
in accordance with its terms. No agreements amending, altering or supplementing the terms hereof
may be made except by means of a written document signed by a duly authorized representative of
each Party.
8.5 Notices. Any notice, communication or payment required or permitted to be given
or made hereunder shall be in writing and, except as otherwise expressly provided in this
agreement, shall be deemed given or made and effective (i) when delivered personally; or (ii) when
delivered by telex or telecopy (if not a payment); or (iii) when received if sent by overnight
express; or (iv) upon confirmation of receipt if mailed by certified or registered mail, postage
prepaid and return receipt requested, in each case addressed to Parties at their address stated
below, or to such other address as such Party may designate by written notice in accordance with
the provisions of this Section 8.5.
| NOVAVAX: | Novavax, Inc., | |||
| 0000 Xxxxxxx Xxxxxx Xxxxx | ||||
| Xxxxxxxxx, Xxxxxxxx 00000 | ||||
| Fax: (000) 000-0000 | ||||
| Attention: Xxxxxxx X. Xxxx, Xx., SVP Commercial Operations | ||||
| WYETH: | Wyeth Holdings Corporation | |||
| c/o Wyeth Pharmaceuticals | ||||
| 000 Xxxxxx Xxxx, XX-0 | ||||
| Xxxxxxxxxxxx, XX 00000 | ||||
| Fax: (000) 000-0000 | ||||
| Attention: Senior Vice President, Business Development | ||||
| Pharma, and Head, Worldwide Licensing |
-16-
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
| With a copy to: | Wyeth | |||
| Five Xxxxxxx Xxxxx | ||||
| Xxxxxxx, Xxx Xxxxxx 00000 | ||||
| Fax: (000) 000-0000 | ||||
| Attention: General Counsel |
8.6 Governing Law; Jurisdiction. This Agreement shall be construed and enforced in
accordance with the domestic substantive laws of The State of New York without regard to any choice
or conflict of laws rule or principle that would result in the application of the domestic
substantive law of any other jurisdiction other than, in regard to any question affecting the
construction or effect of any patent, the law of the jurisdiction under which such patent is
granted. This Agreement shall not be subject to (i) the United Nations Conventions on Contracts
for the International Sale of Goods; (ii) the 1974 Convention on the Limitation Period in the
International Sale of Goods (the “1974 Convention”); or (iii) the Protocol amending the 1974
Convention, done at Vienna April 11, 1980. Any legal or other action hereunder shall be brought in
the State and federal courts of New York. The Parties consent to the personal jurisdiction and
venue of such courts in the event of any legal or other action.
8.7 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY
INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION,
DAMAGES FOR LOSS OF PROFITS OR EXPECTED SAVINGS OR OTHER ECONOMIC LOSSES, OR FOR INJURY TO PERSONS
OR PROPERTY) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS
WHETHER SUCH PARTY KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES; PROVIDED THAT THE
FOREGOING SHALL NOT APPLY TO ANY CLAIM FOR INDEMNIFICATION UNDER SECTION 6.1. WYETH’S AGGREGATE
LIABILITY FOR ALL DAMAGES OF ANY KIND RELATING TO THIS AGREEMENT OR ITS SUBJECT MATTER SHALL NOT
EXCEED THE AMOUNT PAID BY NOVAVAX TO WYETH UNDER THIS AGREEMENT. The foregoing exclusions and
limitations shall apply to all claims and actions of any kind, whether based on contract, tort
(including but not limited to negligence), or any other grounds.
8.8 Headings. Headings included herein are for convenience only, and shall not be
used to construe this Agreement.
8.9 Independent Contractors. For the purposes of this Agreement and all services to
be provided hereunder, each Party shall be, and shall be deemed to be, an independent contractor
and not an agent, partner, joint venturer or employee of the other Party. Neither Party shall have
authority to make any statements, representations or commitments of any kind, or to take any
action which shall be binding on the other Party, except as may be explicitly provided for
herein or authorized in writing.
8.10 Severability. If any provision of this Agreement shall be found by a court of
competent jurisdiction to be void, invalid or unenforceable, the same shall either be reformed to
comply with applicable law or stricken if not so conformable, so as not to affect the validity or
enforceability of this Agreement.
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
8.11 Force Majeure. Neither Party shall be responsible or liable to the other Party
for nonperformance or delay in performance of any terms or conditions of this Agreement due to acts
or occurrences beyond the control of the nonperforming or delayed Party, including, but not limited
to, acts of God, acts of government, wars, riots, strikes or other labor disputes, shortages of
labor or materials, fires, and floods, provided the nonperforming or delayed Party provides to the
other Party written notice of the existence of and the reason for such nonperformance or delay.
8.12 No Waiver. Failure of either Party to enforce a right under this Agreement shall
not act as a waiver of that right or the ability to later assert that right relative to the
particular situation involved or to terminate this Agreement arising out of any subsequent default
or breach.
8.13 Counterparts. This Agreement may be executed in any number of counterparts, each
of which shall constitute an original document, but all of which shall constitute the same
agreement.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly
authorized representatives as of the date first set forth above.
| NOVAVAX, INC. | WYETH HOLDINGS CORPORATION | |||||||
By:
|
/s/ Xxxxxxx X. Xxxx, Xx. | By: | /s/ Xxxxxx X. Xxxxx | |||||
| Name: Xxxxxxx X. Xxxx, Xx. | Name: Xxxxxx X. Xxxxx | |||||||
| Title: SVP Commercial Operations | Title: Senior Vice President | |||||||
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CONFIDENTAL
SCHEDULE 1
LICENSED PATENT RIGHTS
LICENSED PATENT RIGHTS
[* * *]
-19-
