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.
LICENSE AGREEMENT
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.
LICENSE AGREEMENT
THIS
AGREEMENT is made as of July 5, 2007 by and between Wyeth
Holdings Corporation, having a place of business at Five Giralda
Farms, Madison, New Jersey 07940 U.S.A. (“Wyeth”), and
Novavax, Inc., a Delaware corporation, having its principal place
of business at 9920 Belward Campus Drive, Rockville, Maryland 20850
U.S.A. (“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.
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.
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.
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.
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 H1N1, H3N2, H5N1, H5N2, H5N3,
H2N2, H7N2, H7N7, H9N1, 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.
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.
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.
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
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