THIS EXHIBIT HAS BEEN REDACTED
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TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND
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COMMISSION.
EXCLUSIVE LICENSE
AGREEMENT
This Agreement,
effective as of February 26, 2007 (the “Effective
Date”), is between the University of Massachusetts
(“University”), a public institution of higher
education of the Commonwealth of Massachusetts as represented by
its Worcester campus, and Novavax, Inc. (“Company”), a
publicly traded corporation having a principal location at 9920
Belward Campus Drive, Rockville, MD, 20850.
WHEREAS,
University is owner by assignment of the invention claimed in the
United States Patent Applications listed on Exhibit A relating
to the University’s invention disclosure number * * *;
and
WHEREAS, Company
desires to obtain an exclusive license to develop and commercialize
products incorporating certain Virus-Like Particles, under the
rights of University in any patent rights claiming those
inventions; and
WHEREAS,
University is willing to grant Company an exclusive license on the
terms set forth in this Agreement;
NOW, THEREFORE,
University and Company agree as follows:
1.1. “
Affiliate ” means any legal entity (such as a
corporation, partnership, or limited liability company) that is
controlled by Company. For the purposes of this definition, the
term “control” means (i) beneficial ownership of
at least fifty percent (50%) of the voting securities of a
corporation or other business organization with voting securities
or (ii) a fifty percent (50%) or greater interest in the net
assets or profits of a partnership or other business organization
without voting securities.
1.2. “
Confidential Information ” means any and all
information furnished by one party (the “Disclosing
Party”) to the other party (the “Receiving
Party”) in connection with this Agreement that is
specifically designated as confidential in accordance with the
terms of Article 7.
1.3. “
Field ” means the diagnosis, prevention and/or
treatment of any diseases and conditions in humans.
1.4. “
Licensed Product ” means any product that cannot be
developed, manufactured, used, or sold without infringing one or
more claims under the Patent Rights.
1.5. “
Market Approval ” means approval for the sale of
Licensed Product by the United States FDA or its counterpart in
other countries. In Europe, this means the approval of the European
Medicines Evaluation Agency (“EMEA”).
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1.6. “
Net Sales ” means the gross amount billed or invoiced
on sales of Licensed Products by Company, its Sublicensees and
Affiliates, less the following: (a) customary trade, quantity,
or cash discounts to non-affiliated brokers or agents to the extent
actually allowed and taken; (b) amounts repaid or credited by
reason of rejection or return; (c) to the extent separately
stated on purchase orders, invoices, or other documents of sale,
any taxes or other governmental charges levied on the production,
sale, transportation, delivery, or use of a Licensed Product which
is paid by or on behalf of Company, its Sublicensee or Affiliate;
(d) outbound transportation costs prepaid or allowed and costs
of insurance in transit; and (e) chargebacks and rebates to
managed healthcare organizations or to federal, state and local
governments, their agencies, or to trade customers, including
without limitation, wholesalers, hospital buying groups and chain
pharmacy buying groups.
In any transfers
of Licensed Products between Company and its Sublicensees or
Affiliates, Net Sales are calculated based on the final sale of the
Licensed Product to an independent third party. If Company, its
Affiliates or Sublicensees receive non-monetary consideration for
any Licensed Products, Net Sales are calculated based on the fair
market value of that consideration. If Company or its Affiliates or
Sublicensees use or dispose of a Licensed Product in the provision
of a commercial service, the Licensed Product is sold and the Net
Sales are calculated based on the sales price of the Licensed
Product to an independent third party during the same Royalty
Period or, in the absence of sales, on the fair market value of the
Licensed Product as determined by the parties in good
faith.
1.7. “
Patent Rights ” means (i) the patent applications
listed on Exhibit A and (ii) any divisional, continuation or
continuation in part of those patent applications to the extent the
claims are directed to subject matter specifically described
therein (but excluding any continuation in part application to the
extent of any claim covering an invention arising from and subject
to the Sponsored Research Agreement) as well as any patents issued
on these patent applications and any reissues or, reexaminations,
or substitutions of such patents or patent applications, and any
foreign counterparts to the foregoing patents and patent
applications.
1.8. “
Phase I Clinical Trial ” shall have the meaning
ascribed by the FDA and as promulgated under 21 C.F.R. §
312.21(a).
1.9. “
Phase II Clinical Trial ” shall have the meaning
ascribed by the FDA and as promulgated under 21 C.F.R. §
312.21(b).
1.10. “
Royalty Period ” means the partial calendar quarter
commencing on the date on which the first Licensed Product is sold
and every complete or partial calendar quarter thereafter during
which either (a) this Agreement remains in effect or
(b) Company has the right to complete and sell
work-in-progress and inventory of Licensed Products pursuant to
Section 8.6.
1.11. “
Sponsored Research Agreement ” means that certain
Sponsored Research Agreement entered into by and between Company
and University dated as of February 26, 2007.
1.12. “
Sublicense Income ” means payments or other value that
Company receives from a Sublicensee to the extent made in
consideration of the sublicense of the rights granted Company under
Section 2.1., including without limitation license fees,
milestone payments, and license maintenance
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fees, but
excluding the following payments: (a) royalties on Net Sales,
(b) payments for milestone events for which a milestone is
payable to University under Section 4.3, (c) payments
made in consideration for the issuance of equity or debt securities
of Company to the extent of fair market value, and
(d) payments specifically committed to the development of
Licensed Products.
1.13. “
Sublicensee ” means any permitted sublicense of the
rights granted Company under this Agreement in accordance with the
terms of Section 2.2.
2.1. License
Grant . Subject to the terms of this Agreement and the
University’s retained rights under Section 2.3,
University grants to Company an exclusive, worldwide,
royalty-bearing license (with the right to sublicense through
multiple tiers) under the Patent Rights to develop, make, have
made, use, and sell Licensed Products in the Field.
2.2.
Sublicenses . Company may grant sublicenses of its rights
under Section 2.1. with the consent of University, which
consent may not be unreasonably withheld or delayed. All sublicense
agreements executed by Company pursuant to this Article 2
shall expressly bind the Sublicensee to the terms of this Agreement
applicable to a Sublicense. Company shall promptly furnish
University with a fully executed copy of any sublicense
agreement.
(a)
University . University retains the right to practice and
use the Patent Rights for academic, non-commercial research
(excluding the use with any clinical trial), teaching, and
non-commercial patient care without payment of compensation to
Company. University may license its retained rights under this
Section to other academic or non-commercial research institutions
(for use by faculty members, post-doctoral fellows, and students)
solely for the purpose of practicing the rights retained under this
Section and subject to terms of this Agreement, provided that
University will promptly notify Company of any such
license.
(b)
Federal Government . To the extent that any invention
claimed in the Patent Rights has been funded by the federal
government, this Agreement and the grant of any rights in Patent
Rights are subject to and governed by federal law as set forth in
35 U.S.C. §§ 201-211, and the regulations promulgated
thereunder, as amended, or any successor statutes or regulations.
Company acknowledges that these statutes and regulations reserve to
the federal government a royalty-free, non-exclusive,
non-transferable license to practice any government-funded
invention claimed in the Patent Rights. If any term of this
Agreement fails to conform with those laws and regulations, the
relevant term is an invalid provision and shall be modified by the
parties pursuant to Section 11.10.
3. Company
Obligations Relating to Commercialization .
3.1. Diligence
Requirements . Company shall use or shall cause its Affiliates
or Sublicensees to use diligent efforts to develop Licensed
Products and to introduce Licensed Products into the commercial
market. Upon receipt of Market Approval for a Licensed Product,
Company and its
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Affiliates or
its Sublicensees shall make such Licensed Products reasonably
available to the public. Specifically, Company shall fulfill the
following obligations:
(a) On or
before execution of this Agreement, Company shall furnish
University with a written research and development plan under which
Company intends to develop Licensed Products (it being understood
that such obligation is achieved upon the execution of the
Sponsored Research Agreement).
(b) Within
sixty (60) days after the start of each calendar year, Company
shall furnish University with a written report on the progress of
its efforts during the prior year to develop and commercialize
Licensed Products, including without limitation research and
development efforts, efforts to obtain regulatory approval,
marketing efforts, and sales figures. The report shall also contain
a discussion of intended efforts and sales projections for the
current year.
If University
determines that Company has not fulfilled its obligations under
this Section 3.1, University shall furnish Company with
written notice of the determination. Within ninety (90) days
after receipt of the notice, Company shall either (i) cure
such material breach or (ii) negotiate with University a
mutually acceptable schedule of revised diligence obligations,
failing which University may, immediately upon written notice to
Company, terminate this Agreement or convert the exclusive license
into a non-exclusive license and grant additional licenses to third
parties to the Patent Rights in the Field. Any activities performed
by Company’s Affiliates or Sublicensees shall be deemed
activities of Company for purposes of determining Company’s
compliance with the terms of this Section 3.1.
(a)
Indemnity . Company and its Affiliates shall indemnify,
defend, and hold harmless University and its trustees, officers,
faculty, students, employees, and agents and their respective
successors, heirs and assigns (the “Indemnitees”),
against any liability, damage, loss, or expense (including
reasonable attorneys fees and expenses of litigation) incurred by
or imposed upon any of the Indemnitees by third parties in
connection with any claims, suits, actions, demands or judgments
arising out of any theory of liability (including without
limitation actions in the form of tort, warranty, or strict
liability and regardless of whether the action has any factual
basis) to the extent caused by any product, process, or service
that is made, used, or sold pursuant to any right or license
granted under this Agreement. However, indemnification does not
apply to any liability, damage, loss, or expense to the extent
attributable to (i) the gross negligence or intentional
misconduct of the Indemnitees, (ii) breach by an Indemnitee of
any obligation, warranty or representation set forth in this
Agreement, or (iii) the settlement of a claim, suit, action,
or demand by Indemnitees without the prior written approval of
Company.
(b)
Procedures . The Indemnitees agree to provide Company with
prompt written notice of any claim, suit, action, demand, or
judgment for which indemnification is sought under this Agreement.
Company agrees, at its own expense, to provide attorneys reasonably
acceptable to University to defend against any claim. The
Indemnitees shall cooperate fully with Company in the defense and
will
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permit Company
to conduct and control the defense and the disposition of the
claim, suit, or action (including all decisions relative to
litigation, appeal, and settlement). However, any Indemnitee may
retain its own counsel, at the expense of Company, if
representation of the Indemnitee by the counsel retained by Company
would be inappropriate because of actual or potential differences
in the interests of the Indemnitee and any other party represented
by that counsel. Company agrees to keep University informed of the
progress in the defense and disposition of the claim and to consult
with University regarding any proposed settlement.
(c)
Insurance . Company and its Affiliates shall maintain
insurance that is reasonably adequate to fulfill any potential
obligation to the Indemnitees, but not less than one million
dollars ($1,000,000) for injuries to any one person arising out of
a single occurrence and five million dollars ($5,000,000) for
injuries to all persons arising out of a single occurrence. Company
shall provide University, upon request, with written evidence of
insurance. Company and its Affiliates shall continue to maintain
such insurance after the expiration or termination of this
Agreement during any period in which Company, its Affiliate(s) or
Sublicensee(s) continues to make, use, or sell a product that was a
Licensed Product under this Agreement.
3.3. Use of
University Name . In accordance with Section 7.3., Company
and its Affiliates and Sublicensees may not use the name
“University of Massachusetts” or any variation of that
name in connection with the marketing or sale of any Licensed
Products.
3.4. Marking of
Licensed Products . To the extent commercially feasible and
consistent with prevailing business and legal practices, Company
shall mark and shall cause its Affiliates and Sublicensees to mark
all Licensed Products that are manufactured or sold under this
Agreement with the number of each issued patent under the Patent
Rights that applies to a Licensed Product.
3.5. Compliance
with Law . Company shall comply with, and shall ensure that its
Affiliates and Sublicensees comply with, all local, state, federal,
and international laws and regulations applicable to the
development, manufacture, use, and sale of Licensed Products.
Company expressly agrees to comply with the following:
(a) Company,
its Affiliates and Sublicensees shall obtain all necessary
approvals from the United States Food & Drug Administration and
any similar governmental authorities of any foreign jurisdiction in
which Company, its Affiliate or Sublicensee makes, uses, or sells
Licensed Products.
(b) Company,
its Affiliates and Sublicensees shall comply with all United States
laws and regulations controlling the export of commodities and
technical data applicable to the Licensed Products, including
without limitation all Export Administration Regulations of the
United States Department of Commerce. Among other things, these
laws and regulations prohibit or require a license for the export
of certain types of commodities and technical data to specified
countries and foreign nationals. Company hereby gives written
assurance that it will comply with and will cause its Affiliates
and Sublicensees to comply with all United States export control
laws and regulations applicable to the Licensed Products, that it
bears sole responsibility for any violation of those laws and
regulations by itself, or its Affiliates or Sublicensees, and that
it will indemnify, defend, and hold
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University
harmless (in accordance with Section 3.2.) for the
consequences of any violation applicable to the Licensed
Products.
(c) To the
extent that any invention claimed in the Patent Rights has been
partially funded by the United States government, and only to the
extent required by applicable laws and regulations, Company agrees
that any Licensed Products used or sold in the United States will
be manufactured substantially in the United States or its
territories. Current law provides that if domestic manufacture is
not commercially feasible under the circumstances, University may
seek a waiver of this requirement from the relevant federal agency
on behalf of Company.
4.
Consideration for Grant of Rights .
4.1. License
Fee . In partial consideration of the rights granted Company
under this Agreement, Company shall pay to University, within
thirty (30) days of the Effective Date, a license fee of * *
*. This license fee payment is nonrefundable and is not creditable
against any other payments due to University under this
Agreement.
4.2. License
Maintenance Fee . Within thirty (30) days of the beginning
of each calendar year during the term of this Agreement, Company
shall pay to University an annual license maintenance fee payment
in the amount of * * *. These license maintenance fees are
nonrefundable and are not creditable against any other payments due
to University under this Agreement.
4.3. Milestone
Payments . Company shall pay University the following milestone
payments for each Licensed Product (but only once with respect to
each Licensed Product, irrespective of the number of indications
for which such Licensed Product may be developed or approved)
within thirty (30) days after the occurrence of each event by
Company and its Affiliates:
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These milestone
payments are nonrefundable and are not creditable against any other
payments due to University under this Agreement.
4.4. Base
Royalties . In partial consideration of the rights granted
Company under this Agreement, Company shall pay to University a
royalty on aggregate, annual Net Sales during each calendar year of
all Licensed Products, at the following rates:
(a) * * * of
the portion of annual, worldwide Net Sales of Licensed Products
that is less than or equal to * * *;
(b) * * * of
the portion of annual, worldwide Net Sales of Licensed Products
that is greater than * * * but less than or equal to * * *;
and
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(c) * * * of
the portion of annual, worldwide Net Sales of Licensed Products
that is greater than * * *.
4.5. Minimum
Royalty . Beginning January 1, * * *, and within thirty
(30) days of each subsequent calendar year during the term of
this Agreement, Company shall pay University a minimum royalty
payment of * * *. Minimum royalty payments are creditable against
royalties payable for Net Sales during the same calendar year. If
Company fails to make any minimum royalty payment, that failure is
a material breach of its obligations under this Agreement, and
University may terminate this Agreement in accordance with
Section 8.3.
4.6. Royalty
Term . Royalties due under Section 4.4 shall commence upon
the First Commercial Sale of a Licensed Product in a particular
country and will expire on a country-by-country basis upon the
expiration of all issued patents or the abandonment of all pending
patent applications within the Patent Rights that, absent a
license, would be infringed in such country by the use or sale of
the Licensed Product in such country (“Royalty Term”).
As used in this Agreement, “First Commercial Sale”
shall mean, with respect to any Licensed Product, the first sale or
other transfer of such Licensed Product by Company, its
Affiliate(s) or Sublicensee(s) to an unaffiliated customer for
resale, use or consumption and not solely for evaluation or
testing.
4.7. Other
Payments to University . In the event Company is legally
required to make base royalty payments to University for a Licensed
Product under any license agreement between the Parties other than
this Agreement (whether directly or on behalf of a Sublicensee),
Company may offset a total of * * * of such other base royalty
against payments due to University under Sections 4.4 in the
same Royalty Period under this Agreement. However, such offset may
not reduce the royalty payments payable under Section 4.4 to
less than * * * in the Royalty Period.
4.8.
Third-Party Royalties . In the event Company or any of its
Affiliates or Sublicensees makes royalty payments to one or more
third parties in connection with the manufacture, use or sale of
Licensed Products, then Company may offset a total of * * * of such
payments against any royalty payments that are due to University in
the same Royalty Period. However, such offset may not reduce the
royalty payments under Section 4.4 to less than * * * in the
Royalty Period.
4.9. Sublicense
Income . Company shall pay University a total of * * * of all
Sublicense Income pursuant to any sublicense agreement entered into
between Company and a Sublicensee within the first twelve
(12) months after the Effective Date of this Agreement,
provided that the Sponsored Research Agreement is not voluntarily
terminated by Company prior to the expiration thereof. If
Comp
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