H1N1 LICENSE AGREEMENT
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.
EXHIBIT
10.45
This
License Agreement (the “Agreement”) is executed as of
this October 6, 2009 (the “Effective Date”), by and between Novavax,
Inc., a Delaware corporation having an
address at 0000 Xxxxxxx Xxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxx 00000, Xxxxxx Xxxxxx
of America (“Novavax”)
and
CPL Biologicals Private Limited, a limited company incorporated under the
laws of India having an address at “Cadila Corporate Campus”, Sarkhej-Dholka
Road, Bhat, Ahmedabad – 382210, Gujarat, India (“Company”). Novavax
and Company are sometimes referred to herein each individually as a “Party” and
collectively as the “Parties.”
Whereas,
Novavax is a specialty biopharmaceutical company engaged in the research,
development and commercialization of its virus like particle technology into
vaccine products for the prevention of infectious diseases such as seasonal
influenza and other infectious diseases;
Whereas,
Novavax Controls the Licensed Rights, as defined below;
Whereas,
Company wishes to obtain a license under the Licensed Rights, to practice the
processes included or claimed in the Licensed Rights and to Develop and
Commercialize Licensed Product; and
Whereas,
Novavax is willing to grant such license on the terms and conditions of this
Agreement.
Now,
Therefore, in consideration of the foregoing premises and the mutual
covenants set forth below, and for other good and valuable consideration, the
receipt of which is hereby acknowledged, Novavax and Company hereby agree as
follows:
ARTICLE
1
References
in the body of this Agreement to “Sections” will refer to the sections of this
Agreement. In addition, as used herein, the following initially
capitalized terms will have the following meanings:
1.1 “Affiliate” means any
corporation or other business entity controlled by, controlling, or under common
control with a Party, with “control” (for purposes of
this Section 1.1 only) meaning (a) direct or indirect beneficial ownership of
fifty percent (50%) or more of the voting stock (or, in the case of a
non-corporate entity, of the equity interests with the power to direct the
management and policies) of such corporation or other business entity, or (b)
possession, directly or indirectly, of the power to direct, or cause the
direction of, the management and policies of such corporation or other business
entity, whether through the ownership of voting securities, by contract, or
otherwise; provided that for purposes of this Agreement, Novavax and Cadila
Pharmaceuticals Limited shall not be deemed to be an Affiliate of
Company.
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.
1.2 “Business Day” means any day other than
a Saturday, Sunday or other day on which the principal commercial banks located
in Mumbai, India and Washington, DC, United States are not open for business
during normal business hours.
1.3 “Commercialize” or “Commercialization” means
all activities that are undertaken to prepare for launch before Regulatory
Approval (including pricing and reimbursement approvals) undertaken after
Regulatory Approval for Licensed Product and that relate to the commercial
marketing and sale of Licensed Product including advertising, sales, marketing,
promotion, distribution, and phase IV clinical trials.
1.4 “Control” means, with respect to
any intellectual property right, that a Party owns or has a license to such item
or right, and has the ability to grant a license or sublicense in or to such
right without violating the terms of any agreement or other arrangement with any
Third Party existing at the time that this Agreement first requires such Party
to grant the other Party such license or sublicense, provided that, for the
avoidance of doubt, if the ability to grant such license or sublicense without
violating the terms of any such agreement or other arrangement arises after such
time, the license or sublicense shall be deemed granted hereunder at such later
date.
1.5 “Develop” or “Development” means the performance of
all non-clinical, pre-clinical and clinical development, manufacturing and
regulatory activities for a Licensed Product that are required to obtain
Regulatory Approval of a Licensed Product in the Territory.
1.6 “Developed Know-How” has the
meaning in Section 5.1.
1.7 “Effective Date” means the date
set forth in the preamble.
1.8 “Governmental Authority” means any applicable
court, agency, department or other instrumentality of any foreign, federal,
state, county, city or other political subdivision.
1.9 “IND” means a U.S. Food and
Drug Administration investigational new drug application, or its foreign
equivalent.
1.10 “Joint Venture Agreement”
means the Amended and Restated Joint Venture Agreement by and between Novavax
and Cadila Pharmaceuticals Limited, dated June 29, 2009, as amended from time to
time.
1.11 “Know-How” means all tangible
and intangible (a) techniques, technology, practices, trade secrets,
inventions (whether patentable or not), methods, protocols, processes, formulas,
knowledge, know-how, skill, experience, records, documents, data and results
(including pharmacological, toxicological, non-clinical and clinical test data
and results), analytical and quality control data, results or descriptions,
software and algorithms and (b) compositions of matter, cells, cell lines,
assays, animal models and physical, biological or chemical
material.
2
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1.12 “Laws” means all applicable
laws, statutes, rules, regulations, ordinances and other pronouncements having
the effect of law of any federal, national, multinational, state, provincial, or
other political subdivision, domestic or foreign.
1.13 “Licensed Product” means
Novavax’s current monovalent intra-muscular H1N1 influenza vaccine containing a
virus like particle (VLP) consisting of [* * *] designated as pandemic by the
World Health Organization (WHO) Collaborating Centers for Reference and Research
on Influenza located at the Centers for Disease Control and Prevention (CDC) in
Atlanta, Georgia, together with any minor modifications thereto including, by
way of example but not limitation, changes to any excipient, changes arising
from a change in manufacturing process, or change in dosage. [* *
*].
1.14 “Licensed Rights” means the
Novavax Patents and any and all Know-How, including any Developed Know-How,
owned or Controlled by Novavax at any time during the term of this Agreement
which is used or embodied in, or useful for developing or manufacturing, any
Licensed Product, including, without limitation, Know-How regarding Novavax’s
proprietary baculovirus insect cell expression and manufacturing system and
improvements thereto.
1.15 “Novavax Patents” means any and
all Patents in the Territory owned or Controlled by Novavax at any time during
the term of this Agreement covering or claiming a Licensed Product and/or the
manufacture or use thereof including, without limitation, the Patents listed on
Schedule
1.
1.16 “Patent” means any and all (a)
issued patents and inventors’ certificates and re-examinations, reissues,
renewals, extensions, registrations, substitutions, supplementary protection
certificates and term restorations with respect to any of the foregoing, and (b)
pending applications for patents and inventors’ certificates and patents that
issue therefrom, including, without limitation, provisional applications,
continuations, continuations-in-part, divisional and substitute applications
with respect to any of the foregoing.
1.17 “Program Data” means (a)
research, preclinical, clinical, manufacturing and similar data, information,
material and results, (b) regulatory filings and approvals, and (c) sales and
marketing information.
1.18 “Regulatory Approval” means any
and all approvals (including supplements, amendments, pre- and post-approvals,
pricing and reimbursement approvals), licenses, registrations or authorizations
of any national, supra-national, regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity, that are
necessary for the manufacture, distribution, use or widespread sale of a
Licensed Product in a regulatory jurisdiction in the Territory.
3
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1.19 “Regulatory Authority” means
any Governmental Authority with responsibility for granting any licenses or
approvals necessary for the marketing and sale of pharmaceutical products in the
Territory.
1.20 “Regulatory Documentation”
means, with respect to a Licensed Product, all Regulatory Filings and supporting
documents created, submitted to a Regulatory Authority, and all data contained
therein, including, without limitation, any Investigational New Drug
Application, New Drug Application, Marketing Authorization Application, foreign
counterparts thereof, Investigator’s Brochures, drug master files,
correspondence to and from a Regulatory Authority, minutes from teleconferences
with Regulatory Authorities, registrations and licenses, regulatory drug lists,
advertising and promotion documents shared with Regulatory Authorities, adverse
event files, complaint files and manufacturing records.
1.21 “Regulatory Filing” means the foreign
counterparts of an Investigation New Drug Application, New Drug Application,
Marketing Authorization Application and any other filings required by Regulatory
Authorities relating to the study, Development, manufacture or Commercialization
of any Licensed Product in the Territory.
1.22 “Technical Services Agreement”
means that certain Amended and Restated Technical Services Agreement between
Novavax and Company dated as of the date hereof, as amended from time to
time.
1.23 “Territory” means
India.
1.24 “Third Party” means a person or
entity other than (a) Novavax, (b) Company, (c) an Affiliate of Novavax or (d)
an Affiliate of Company.
1.25 “U.S.” means the United States
of America.
ARTICLE
2
2.1 License Grant to
Company. Novavax hereby grants to Company an exclusive, fully
paid-up, royalty-free (except as expressly set forth in Section 2.7),
non-transferable, right and license under the Licensed Rights during the term of
this Agreement to (a) research, develop, use, sell, have sold, offer to sell and
import Licensed Product in the Territory, and (b) make (and have made solely by
Cadila Pharmaceuticals Ltd., a company incorporated under the laws of India
(“Cadila”) or an Affiliate of Cadila,
subject to Novavax’s approval described below) Licensed Product in the Territory
solely to develop, use, sell, have sold, offer to sell and import Licensed
Product in the Territory. The foregoing license shall be exclusive
for Licensed Product in the Territory, even as to Novavax, provided that Novavax
retains the right to perform its obligations under this Agreement, the Technical
Services Agreement and any other agreement between Company and
Novavax.
4
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Novavax
shall be reasonable in granting or withholding its approval to permit Cadila or
an Affiliate of Cadila to make Licensed Product in the
Territory. Novavax’s approval shall be subject to its consideration
of, among other things, any documentation or agreement surrounding such
manufacturing of the Licensed Product (which, in any case, shall be solely for
the benefit of the Company), the safeguards in place with regard to any such
manufacturing, the protection of the Licensed Rights, and Novavax’s ability to
conduct reasonable due diligence on any Affiliate of Cadila. In no
event does the license grant to the Company under this Section 2.1 permit the
Company to have Licensed Product made by a Third Party other than Cadila or an
Affiliate of Cadila, subject to the approval described above.
2.2 License Grant to Novavax.
The Company hereby grants to Novavax a fully paid-up, royalty-free
exclusive right and license under Developed Know-How owned or Controlled by the
Company, including any Patents that issue therefrom, to (a) research, develop,
use, sell, have sold, offer to sell and import (i) Licensed Product and (ii)
other influenza vaccines outside the Territory, and (b) make and have made (i)
Licensed Product and (ii) other influenza vaccines outside the Territory solely
to develop, use, sell, have sold, offer to sell and import Products outside the
Territory.
2.3 Sublicenses. Company
shall not sublicense the Licensed Rights to any Third Party without the prior
written consent of Novavax, which consent may be withheld in its sole
discretion. Upon execution of a sublicense, after receipt of Novavax
consent, Company will notify Novavax of the execution of the sublicense and
provide a copy to Novavax promptly following execution thereof.
2.4 No Implied Rights or Licenses.
No right or license, other than those expressly set forth in this
Agreement are granted to either party hereunder, and no additional rights will
be deemed granted to either party by implication, estoppel or
otherwise. All rights not expressly granted by either party to the
other hereunder are reserved.
(a) Company
shall keep complete and accurate notes, accounts and records of all Program Data
with respect to Licensed Product, including the manufacture
thereof. Novavax shall have the right to access, use and reference
for its Development and Commercialization of its products outside the Territory
Program Data related to Licensed Product in the possession or control of the
Company. The Company shall provide such cooperation and assistance as
reasonably requested by Novavax from time to time to effectuate the foregoing,
including, without limitation by providing access to and disclosure of Program
Data to Novavax and by providing such authorization and consents required for
reference to regulatory filings and approvals.
(b) Company
shall have the right to access, use and reference for its Development and
Commercialization of Licensed Product in the Territory Program Data related to
Licensed Product in the possession or control of Novavax. Novavax
shall provide such cooperation and assistance as reasonably requested by Company
from time to time to effectuate the foregoing, including, without limitation by
providing access to and disclosure of Program Data to Company and by providing
such authorization and consents required for reference to regulatory filings and
approvals.
5
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.
2.6 Grey Market. The
Parties reasonably cooperate to formulate and implement reasonable precautions
designed to prevent Licensed Product made or sold by or for such Party or its
respective Affiliates and permitted sublicensees from being sold outside of its
respective territory (i.e., outside the Territory for the Company and inside the
Territory for Novavax). Further, each Party will take reasonable
measures so that its distributors, Affiliates and wholesalers to whom the
Company or Novavax provides its respective Licensed Product are aware of the
respective territorial limitations.
2.7 Third Party License
Agreements. The license granted under Section 2.1 may be
subject to applicable terms and conditions of a license agreement with a Third
Party, under which any Licensed Rights are sublicensed to the Company hereunder
by Novavax (each a “Third Party License
Agreement”). Novavax shall be responsible for maintaining the
Third Party License Agreements and for any payments owed by Novavax thereunder;
provided, however, that if a royalty is owed on sales of Licensed Product by or
for the Company in the Territory under such Third Party License Agreement, such
payments will be paid by Company.
2.8 Combination Products
Reservation. Novavax shall not, directly or indirectly, (i)
engage in, promote, or finance the research, development, or commercialization
of, or (ii) grant any license, or any similar rights with respect to, to a Third
Party, in each case of (i) and (ii), a Licensed Product in combination with
another active ingredient, antigen or adjuvant in the Territory.
ARTICLE
3
(a) General. Company
will have sole responsibility, at Company’s sole expense, for all Development
and Commercialization of Licensed Product in the Territory in accordance with
the terms of this Agreement.
6
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.
(b) Development and Commercialization of
Licensed
Product. Prior to [* * *],
Company shall present to Novavax for its written approval Development plans for
the Licensed Product which shall specify preclinical studies (including a
toxicology program and other preclinical testing), human clinical trials,
manufacturing scale up, Regulatory Approval strategy and any other significant
Development activities, that Company plans to perform to obtain Regulatory
Approval of such Licensed Product in the Territory (the “H1N1 Development
Plans”). Novavax may reasonably request adjustments to
activities described in such Development plans as a condition to granting its
approval. In no event shall Company materially alter a H1N1
Development Plan without Novavax’s prior written consent. Company
shall conduct Development of such Licensed Product in a manner that is
materially consistent with the H1N1 Development Plans. All clinical
trial protocols for Licensed Product conducted by Company shall require the
prior written approval of Novavax. Prior to [* * *], Company shall
present to Novavax for its written approval a plan to Commercialize the Licensed
Product which shall specify a multi-year marketing and public relations
strategy, operational plans to implement such strategies and any other
significant Commercialization activities (the “H1N1 Commercialization
Plan”). Novavax may reasonably request adjustments to the
Commercialization plan as a condition to granting its approval. In no
event shall Company materially alter the H1N1 Commercialization Plan without
Novavax’s prior written consent. Company shall conduct
Commercialization of such Licensed Product in a manner that is materially
consistent with the H1N1 Commercialization Plan. Novavax acknowledges
that the Licensed Product are being contributed by Novavax to the Company in
accordance with the Joint Venture Agreement and that if the Company cannot
Develop and Commercialize such Licensed Product it will not obtain the value of
such contribution. Company acknowledges that Novavax (or its
affiliates or licensees) are Developing and Commercializing Licensed Product
outside the Territory and Company’s activities could raise safety concerns and
have an impact on Novavax’s activities including the Regulatory Approval and
regulatory profile of an approved Licensed Product outside the
Territory. Accordingly, taking into account Novavax’s and Company’s
respective interests including, without limitation, as provided in the two
preceding sentences, Novavax shall not unreasonably withhold, delay or condition
any of its consents or approvals hereunder.
3.2 Regulatory Affairs. Company will be responsible for
developing Regulatory Documentation and preparing and submitting Regulatory
Filings, seeking Regulatory Approvals, and maintaining Regulatory Approvals for
Licensed Product in the Territory. Novavax will cooperate with
Company in preparing and filing all such reports in accordance with the
Technical Services Agreement. To effectuate such cooperation, the
Parties hereby agree to amend and amend Section 1.1(t) of the Technical Services
Agreement to revise the definition of “Novavax Products” to read in its entirety
as follows:
3.3 “Novavax
Product” shall mean (i) the Novavax Products (as defined in the Joint Venture
Agreement), and (ii) the Licensed Product (as that term is defined in the
License Agreement by and between Novavax and Company, dated October 6, 2009).
3.4 Manufacture and
Supply. Company will be responsible for the manufacture of
Licensed Product in the Territory and for all costs associated
therewith. Certain amount of supply of preclinical and clinical
supply of Licensed Product will be made under the Amended and Restated Supply
Agreement, dated as of June 29, 2009, between Company and Novavax, as amended
from time to time (the “Supply
Agreement”). To effectuate such amount of supply under the
Supply Agreement, the Parties hereby agree to amend and amend Section 1.19 of
the Supply Agreement to revise the definition of “Products” to read in its
entirety as follows:
“Products” means
Novavax’s pre-clinical and clinical supplies of the Novavax Seasonal Product and
the Licensed Product (as that term is defined in the License Agreement by and
between Novavax and Company, dated October 6, 2009), in each case which conform
to the Specifications.
7
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.
3.5 Adverse Event
Reporting. Company will maintain a record of all non-medical
and medical Licensed Product-related complaints and reports of Adverse Events in
the Territory with respect to any Licensed Product Developed or Commercialized
by the Company. At the request of either party, Novavax and the
Company shall enter into reasonable and customary pharmacovigilance agreement
with respect to sharing of adverse event data and information for Licensed
Product as required to comply with applicable laws and regulations.
3.6 Development and Commercial
Reporting. During the Term of this Agreement, Company will provide
a half-yearly written progress report to Novavax summarizing the Development and
Commercialization of Licensed Product(s) during the prior six months. Each such progress report
will be provided to Novavax by Company no later than March 1st or
September 1st (as the
case may be) of each year following the Effective Date.
3.7 Minor
Modifications. During the Term of this Agreement, Novavax will
promptly provide Company with details of any minor modifications it makes to the
Licensed Product as Novavax develops it for Regulatory Approval.
ARTICLE
4
RESERVED
ARTICLE
5
5.1 Disclosure. During
the Term, the Parties will promptly disclose to one another all Know-How
(whether patentable or not) developed, conceived or reduced to practice during
the Development, manufacture or Commercialization of a Licensed Product which is
regarding or directed to a Licensed Product (“Developed
Know-How”). Novavax shall also disclose to the Company any
Know-How within the Licensed Rights obtained, licensed or generated after the
Effective Date which is not included within the Developed Know-How.
5.2 Ownership. Novavax
shall own all Developed Know-How and any other intellectual property that is
conceived and reduced to practice solely by Novavax. The Company
shall own all Developed Know-How and any other intellectual property that is
conceived and reduced to practice solely by Company. Novavax and the
Company shall jointly own in accordance with U.S. Laws regarding joint ownership
of the applicable type of intellectual property, all Developed Know-How and any
other intellectual property that is conceived or reduced to practice by Novavax
and Company jointly.
8
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.
5.3 Prosecution and Maintenance of
Patents. Novavax shall have the sole and exclusive right and
authority to control the filing, prosecution, maintenance, and renewal of all
Novavax Patents and any Patents that result from Developed Know-How which is
owned by Novavax or jointly owned as provided in Section 5.2, at its own
expense. Company shall have the sole and exclusive right and
authority to control the filing, prosecution, maintenance and renewal of any
Patents that result from Developed Know-How owned by Company as provided in
Section 5.2. With respect to any such Patents in the Territory and
with respect to any such Patents that are subject to the license granted to
Novavax in Section 2.2 anywhere in the world (the “ROW Patents”), the prosecuting
party shall (i) provide the other party with copies of all material filings,
documentation and correspondence from, sent to or filed with patent offices in
the Territory or anywhere in the world for the ROW Patents, and (ii) provide the
other party with a reasonable opportunity to comment upon all filings and
actions with such patent offices in advance of submissions to such patent
offices. For purposes of this Section 5.3, “filing,
prosecution and maintenance” of patents shall be deemed to include, without
limitation, appeals to administrative or judicial entities having jurisdiction
over patentability, the conduct of interferences or oppositions, and/or requests
for re-examinations, reissues or extensions of patent terms.
5.4 Abandoned
Patents. In the event the prosecuting party determines not to
initiate patent prosecution for any particular patentable Developed Know-How
invention or to cease prosecution or maintenance of, or otherwise abandon, any
Patents that are the subject of Section 5.3 in the Territory, or with respect to
ROW Patents anywhere in the world (which the prosecuting party may do in its
sole discretion), the prosecuting party shall provide reasonable prior written
notice to the other party sufficient for the other party to timely initiate or
take over the prosecution and maintenance of such Patent and timely file any
required documents and responses with the relevant government patent office in
the Territory, or with respect to ROW Patents anywhere in the world, with
respect thereto, and the other party may elect (in its sole discretion) to
prosecute and maintain such Patent, at the other party’s sole
expense. In such event, upon the request of and, at the expense of
the other party, the prosecuting party shall assign to the other party all of
its right, title and interest in, to and under such Patent which the prosecuting
party has decided to abandon and provide reasonable cooperation to the other
party with respect thereto (including, without limitation, providing necessary
information and executing relevant documents).
(a) Infringement by Third
Parties. In the event that Novavax or the Company becomes
aware of or has reasonable suspicions of third party activities in the Territory
that could constitute infringement of the Novavax Patents or Patents that issue
from Developed Know-How in the Territory, or with respect to ROW Patents
anywhere in the world, or misappropriation of the Novavax Know-How or Developed
Know-How in the Territory, or with respect to Developed Know-How any that is
subject to the license granted to Novavax in Section 2.2 anywhere in the world
(“ROW Know-How”), then
such party shall promptly notify the other parties of such third party
activities, including identification of the third party and delineation of the
facts relating to such third party activities. The Company shall have
the right (but shall not be obligated) to enforce the Novavax Patents, Novavax
Know-How and Developed Know-How against any actual or alleged infringement or
misappropriation thereof in the Territory by a third party (by bringing a suit,
action or proceeding against such third party), at the Company’s sole
expense. Novavax shall have the right (but shall not be obligated) to
enforce the ROW Patents and ROW Know-How within the scope of the licenses
granted to Novavax in Section 2.2 against any actual or alleged infringement or
misappropriation thereof outside the Territory by a third party (by bringing a
suit, action or proceeding against such third party), at Novavax’s sole
expense. If the Company does not enforce the Novavax Patents or
Know-How by (i) one hundred (100) days following the notice of alleged
infringement or (ii) thirty (30) days before the time limit, if any, set forth
in the appropriate laws and regulations for the filing of such an action,
whichever comes first, then Novavax shall have the right (but not the
obligation) to enforce the Novavax Patents and Novavax Know-How against any
actual or alleged infringement or misappropriation thereof in the Territory by a
third party (by bringing a suit, action or proceeding against such party), at
Novavax’s sole expense. The non-prosecuting party shall reasonably
cooperate with the prosecuting party in such enforcement activities, at the
prosecuting party’s expense, including by agreeing to be named as a party to (or
bringing in its own name) such suit, action or proceeding for the benefit of the
non-prosecuting party if required for such enforcement action to
proceed. The prosecuting party shall keep the non-prosecuting party
reasonably informed regarding any such enforcement action and shall consider in
good faith the reasonable comments and suggestions of the non-prosecuting party
related to such suit, action or proceeding. All recoveries received
by the prosecuting party from any such enforcement action shall be retained by
the prosecuting party.
9
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.
(b) Challenge by Third
Parties. Novavax and Company will each notify the other Party
in writing within ten (10) Business Days of learning of any alleged or
threatened opposition, reexamination request, action for declaratory judgment,
nullity action, interference or other attack upon the validity, title or
enforceability of the Licensed Rights or the ROW Patents or ROW Know-How by a
Third Party. Owner of the subject Patent will have the right (but not
the obligation) to defend any such challenge in the Territory. If the
owner of the subject Patent commences a defense against the alleged or
threatened challenge (i) within sixty (60) days following the detection of the
alleged challenge, or (ii) ten (10) Business Days before the time limit, if any,
set forth in appropriate Laws and regulations for making a filing in defense of
such a challenge, whichever comes first, then the owner of the subject Patent
will so notify the other party promptly. Notwithstanding the
foregoing, if any such action for declaratory judgment, nullity action, or other
attack upon the validity, title or enforceability of the Licensed Right includes
or will include counterclaims of infringement of the Licensed Rights, ROW
Patents or ROW Know-How by the Third Party, control of such action or other
attack shall be governed by Section 5.5(a).
ARTICLE
6
6.1 Confidentiality. The
Parties anticipate that under this Agreement each Party will provide
confidential and/or proprietary information to the other Party and that the use
and disclosure of such information shall be governed by Article 18 of the Joint
Venture Agreement which is hereby incorporated by reference.
10
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.
6.2 Publication.
(a) Each
Party shall have the right to publish the data and results related to Licensed
Product, subject to the rest of this Section 6.2. Prior to public
disclosure or submission for publication of a proposed publication describing
the results of any scientific or clinical activity relating to a Licensed
Product, the Party proposing such publication shall send the other Party by
expedited delivery a copy of the proposed publication to be submitted and shall
allow the other Party a reasonable time period (but not more than sixty (60)
days from the date of confirmed receipt) in which to determine whether the
proposed publication contains subject matter for which patent protection should
be sought (prior to publication of such proposed publication) for the purpose of
protecting an invention, or whether the proposed publication contains the
Confidential Information of such other Party, or whether the proposed
publication contains information that is reasonably likely to have a material
adverse impact on the development or commercialization of Licensed
Product. Following the expiration of applicable time period for
review, the Party proposing such publication shall be free to submit such
proposed publication for publication and publish or otherwise disclose to the
public such scientific or clinical results, subject to the procedures set forth
in Section 6.2(b).
(b) If
the Party reviewing such publication believes that the subject matter of the
proposed publication by the other Party contains Confidential Information of the
Party or a patentable invention owned by the Party or in which it otherwise has
exclusive rights hereunder, then prior to the expiration of the applicable time
period for review, such Party shall notify the Party proposing such publication
in writing of such belief. On receipt of written notice from the
other Party that such proposed publication contains its Confidential
Information, the Party proposing publication shall remove such Confidential
Information from such proposed publication prior to any publication thereof,
unless the other Party agrees otherwise in writing. On receipt of
written notice from the other Party that such proposed publication contains a
patentable invention owned by it or in which it otherwise has exclusive rights
hereunder, the Party proposing publication shall delay public disclosure of such
information or submission of the proposed publication for an additional period
of thirty (30) days to permit preparation and filing of a patent application on
such invention. The Party proposing publication shall thereafter be
free to publish or disclose such information.
ARTICLE
7
7.1 Mutual
Warranties. Each of Novavax and Company hereby represents,
warrants and covenants to the other as of the Effective Date that:
(a) it
has full corporate power and authority to enter into this Agreement and to carry
out the provisions hereof, and this Agreement is legally binding upon it and
enforceable in accordance with its terms.
11
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.
(b) the
execution, delivery and performance of this Agreement by it does not conflict
with any agreement, instrument or understanding, oral or written, to which it is
a party or by which it may be bound, nor violate any Law of any governmental
authority having jurisdiction over it;
(c) it
has not granted, and during the Term it will not grant, any right to any Third
Party that would conflict with the rights granted to the other Party
hereunder. It has (or will have at the time performance is due)
maintained and will maintain and keep in full force and effect all agreements
necessary to perform its obligations hereunder; and
(d) all
necessary consents, approvals and authorizations of all governmental authorities
and other persons required to be obtained by such Party to enter into, or
perform its obligations under, this Agreement have been obtained.
7.2 Representations by
Novavax. In addition to the representations and warranties
made in Section 7.1, Novavax hereby represents, warrants and covenants to
Company as of the Effective Date that:
(a) the
Licensed Rights are subsisting and are not the subject of any interference,
re-issue, re-exam, opposition or appeal proceedings;
(b) no
Third Party has filed, pursued or maintained or, to the best of its knowledge,
threatened in writing to file, pursue or maintain any claim, lawsuit, charge or
other action involving any Licensed Right including any claim, lawsuit, charge,
or action alleging that any Licensed Right is invalid or
unenforceable;
(c) and
to the best of its knowledge, all employees and agents of Novavax who have
performed any activities on its behalf in connection with research regarding the
Licensed Rights have properly assigned to Novavax the whole of their rights in
any intellectual property made, discovered or developed by them as a result of
such research, and no Third Party has any rights to any such intellectual
property;
(d) the
Licensed Rights are free and clear of any liens, charges, encumbrances or rights
of others, to possession or use that may interfere with Novavax’s possession or
use under this Agreement;
(e)
it has sufficient rights to
grant the licenses granted to the Company hereunder; and
(f)
all third party agreements
licensing any Licensed Rights to Novavax, which are sublicensed to the Company
hereunder, are currently in full force and effect, and it has not received
notice of material breach or termination thereof.
12
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.
7.3 DISCLAIMER OF
WARRANTIES. Except as expressly set forth herein, EACH PARTY
EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE
PRACTICES, IN ALL CASES WITH RESPECT THERETO. Without limiting the
generality of the foregoing, each Party expressly does not warrant, and
disclaims any warranties with regards to: (a) the success of any
study or test commenced under this Agreement, (b) the safety or usefulness
for any purpose of the technology or Materials it provides or discovers under
this Agreement; and/or (c) the validity, enforceability, or non-infringement of
any intellectual property rights or technology it provides or licenses to the
other Party under this Agreement.
ARTICLE
8
8.1 Indemnification by
Company. Company will indemnify, defend and hold harmless
Novavax, its affiliates, directors, officers and employees (each a “Novavax Indemnitee”) from and
against any and all liability, loss, damage or expense (including without
limitation reasonable attorneys fees) it may suffer as the result of Third Party
claims, demands, actions and proceedings brought against it (collectively,
“Losses”) to the extent
such Losses result from the (a) negligence or willful misconduct by Company, its
Affiliates, employees, agents, or Third Party contractors, or (b) manufacture,
use, sale, or offer for sale of a Licensed Product in the Territory due to a
design defect or a manufacturing defect, including but not limited to, a Loss
related to the death of or injury to a Third Party. Company’s
obligation to indemnify Novavax pursuant to this Section 8.1 will not apply to
the extent of any Loss that arises from the (i) material breach by Novavax of
its representations, warranties or covenants contained within this Agreement,
(ii) negligence or willful misconduct of any Novavax Indemnitee, or (iii) a
manufacturing defect of Licensed Product supplied by Novavax under the Supply
Agreement.
8.2 Indemnification by
Novavax. Novavax will indemnify, defend and hold harmless
Company, its affiliates, directors, officers and employees (each a “Company Indemnitee”) from and
against any and all Losses to the extent such Losses result from the (a)
negligence or willful misconduct by Novavax, its Affiliates, employees, agents
or Third Party contractors, or (b) manufacture, use, sale, or offer for sale of
a Licensed Product outside the Territory due to a design defect or a
manufacturing defect, including but not limited to, a Loss related to the death
of or injury to a Third Party. Novavax’s obligation to indemnify the
Company Indemnitee pursuant to this Section 8.2 will not apply to the extent of
any Loss that arises from the (i) material breach by Company of its
representations, warranties or covenants contained within this Agreement or (ii)
negligence or willful misconduct of any Company Indemnitee.
8.3 Procedures. Indemnitor’s
agreement to indemnify, defend and hold harmless an Indemnitee is conditioned on
Indemnitee (a) providing prompt written notice of any claim giving rise to an
indemnification obligation hereunder but only if a failure to so notify causes
prejudicial harm to the Indemnitor’s ability to defend, (b) permitting
Indemnitor to assume full responsibility to investigate, prepare for and defend
against any such claim, (c) providing reasonable assistance in the defense of
such claim at Indemnitor’s reasonable expense, and (d) not compromising or
settling such claim without Indemnitor’s advance written
consent.
13
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.
8.4 Insurance. Each Party
will maintain comprehensive general liability insurance coverage, including
products liability, in amounts it reasonably determines are appropriate with
respect to the Development and Commercialization of Licensed Product in its
respective territory.
8.5 Limitation of
Liability. EXCEPT TO THE EXTENT (A) SUCH PARTY MAY BE REQUIRED TO
INDEMNIFY THE OTHER PARTY UNDER THIS ARTICLE 8, OR (B) AS REGARDS A BREACH OF A
PARTY’S RESPONSIBILITIES PURSUANT TO ARTICLE 6, NEITHER PARTY NOR ITS RESPECTIVE
AFFILIATES WILL BE LIABLE TO THE OTHER PARTY FOR ANY LOSS OF PROFITS, LOSS OF
BUSINESS OR INTERRUPTION OF BUSINESS, OR FOR ANY OTHER INDIRECT, INCIDENTAL,
SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES UNDER THIS AGREEMENT,
WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE, EVEN IF SUCH
PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES.
ARTICLE
9
9.1 Term and
Termination. The term of this Agreement will commence on the
Effective Date and will continue until (a) the Company provides sixty (60) days
prior written notice of termination to Novavax, (b) the Parties mutually agree
in writing to terminate the Agreement, or (c) Novavax terminates the Joint
Venture Agreement by providing a Notice of Termination under and pursuant to
Section 11.2 of the Joint Venture Agreement. In no event shall either
Party have the right to terminate this Agreement based upon any breach by the
other Party, and to the extent that any right to terminate is provided under any
Laws, the Parties hereby waive such right.
9.2 Breach and
Remedies. In addition to any remedies available under any
laws, the following remedies shall be available to a party in the event of the
following breaches
(a) In
the event that Section 2.6 is materially breached by either party, the
non-breaching party shall be entitled to damages equal to its lost profit from
lost sales of Licensed Product in or out of the Territory (as applicable) due to
the “grey market” breach.
(b) In
the event that Company (i) materially alters an X0X0 Xxxxxxxxxxx Xxxx xx X0X0
Commercialization Plan for Licensed Product without Novavax’s prior written
consent, or (ii) initiates a clinical trial of Licensed Product without
Novavax’s approval or materially deviates from an approved clinical trial
protocol for Licensed Product without the prior written consent of Novavax, then
Novavax shall have right to obtain injunctive relief with respect to such breach
before any court of competent jurisdiction in accordance with Section
10.3.
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.
9.3 Survival. The
following provisions of this Agreement shall survive expiration or termination
of this Agreement for any reason: Article 8 and Sections 6.1 and
7.3. In the event that this Agreement is terminated under 9.1(c), the
license grant under Section 2.2 shall survive as a fully paid, exclusive license
solely under Developed Know-how owned or Controlled by Company, including any
Patents that issue therefrom, as of the effective date of termination (i.e.,
excluding any intellectual property developed or acquired after such date of
termination).
ARTICLE
10
10.1 Disputes. The
Parties recognize that disputes as to certain matters may from time to time
arise during the Term which relate to either Party’s rights and/or obligations
hereunder. It is the objective of the Parties to establish procedures
to facilitate the resolution of disputes arising under this Agreement in an
expedient manner by mutual cooperation and without resort to
litigation. To accomplish this objective, the Parties agree to follow
the procedures set forth in this Article 10 if and when a dispute arises under
this Agreement.
10.2 Arbitration. Any
dispute arising between the Parties out of or in connection with the
implementation or interpretation of this Agreement shall, if not settled
amicably within ninety (90) days from the date that the dispute arose, be
finally settled by three (3) arbitrators. Each Party shall be entitled to
appoint one (1) arbitrator and the two (2) so appointed shall appoint the third
arbitrator in accordance with the Indian Arbitration and Conciliation Act,
1996. It is hereby agreed that Part I of the Indian Arbitration and
Conciliation Act, 1996 (except for the provisions of Section 9 thereof) shall
not apply to the arbitration under this Agreement. The language of the
arbitration proceedings shall be English and its place shall be
Singapore. The arbitral award or determination shall be final and
subject to no appeal and shall deal with the question of costs of arbitration
and all matters related thereto.
The
Parties agree that it would be impossible or inadequate to measure and calculate
their damages from any breach of the Agreement though great and
irreparable. Accordingly, each Party agrees that if the other Party
breaches this Agreement, the non-breaching party will have available, in
addition to any other right or remedy available, the right to obtain an
injunction from a court of competent jurisdiction restraining such breach or
threatened breach and specific performance of any provision of this
Agreement.
10.3 Equitable
Claims. Notwithstanding anything to the contrary in this
Article 10, either Party has the right to seek temporary injunctive relief
or any other interim equitable remedy in any court of competent jurisdiction as
may be available to such Party under the laws applicable to such jurisdiction
that may be necessary to protect the rights or property of that Party until such
time as any dispute underlying such temporary injunctive relief or any other
interim equitable remedy has been resolved in accordance with Section
10.2.
10.4 Governing Law. The
substantive laws of India will govern the resolution of all disputes,
controversies and claims under, arising out of or relating to the validity,
construction, enforceability or performance of this Agreement and any related
remedies, without giving effect to any choice of law rules.
15
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.
10.5 Award. Each Party
will abide by any arbitral award rendered pursuant to this Article
10. If a Party resists enforcement of an arbitral award, any costs,
fees or taxes incident to enforcement will be charged against that Party to the
extent permitted by Law. Each Party will bear its own legal fees for
arbitration, and the arbitrator(s) will assess their costs, fees and expenses
against the Party losing the arbitration.
10.6 Injunctive
Relief. If a Party makes a sufficient showing under the rules
and standards set forth in the rules of civil procedure and applicable Law, the
arbitrator may, and the Parties will abide by, injunctive measures after either
Party submits in writing for arbitration claims requiring immediate
relief. Notwithstanding the foregoing, and in accordance with Section
10.3, a Party will also be free at any time to bring an Equitable Claim to any
court of competent jurisdiction without submitting such request to an
arbitrator.
10.7 Confidentiality. Any
arbitration proceeding, including without limitation the existence of any
dispute submitted to arbitration and any arbitral award or decision, will be
Confidential Information of both Parties, and the arbitrator(s) will issue
appropriate protective orders to safeguard each Party’s Confidential
Information, provided that such Confidential Information may be disclosed solely
as necessary in connection with the enforcement of an arbitral award or as
otherwise required by Law (subject to Article 6).
ARTICLE
11
11.1 Entire
Agreement. This Agreement (including its Exhibits) sets forth
all the covenants, promises, agreements, warranties, representations, conditions
and understandings between the Parties with respect to the subject matter hereof
and supersedes and terminates all prior agreements and understanding between the
Parties with respect to such subject matter. No subsequent
alteration, amendment, change or addition to this Agreement will be binding upon
the Parties unless reduced to writing and signed by the respective authorized
officers of the Parties.
11.2 Third Party
Contractors. The Parties will perform their obligations under
this Agreement as Third Party contractors and nothing contained in this
Agreement will be construed to be inconsistent with such relationship or
status. This Agreement will not constitute, create or in any way be
interpreted as a joint venture or partnership of any kind.
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.
11.3 Notices. Any notice,
request, demand, waiver, consent, approval or other communication permitted or
required under this Agreement (“Notice”) will be in writing,
will refer specifically to this Agreement and will be deemed given only if sent
by electronic mail (with receipt confirmed), facsimile transmission (with
transmission confirmed) or by an internationally recognized delivery service
that maintains records of delivery, addressed to the Parties at their respective
addresses specified in this Section 11.3 or to such other address as the Party
to whom notice is to be given may have provided to the other Party in accordance
with this Section 11.3. Any notice delivered by electronic mail or
facsimile will be confirmed by a hard copy delivered as soon as practicable
thereafter by an internationally recognized overnight delivery
service. Such Notice will be deemed to have been given on the second
Business Day (at the place of delivery) after deposit with an internationally
recognized delivery service. This Section 11.3 is not intended to
govern the day-to-day business communications necessary between the Parties in
performing their obligations under the terms of this Agreement.
If
to Novavax:
|
Novavax,
Inc.
|
0000
Xxxxxxxx Xxxxxx Xxxxx
|
|
Xxxxxxxxx
Xxxxxxxx 00000
|
|
Attn: Xxx
Xxxx, Senior Vice President
|
|
Email:
Xxxxx@Xxxxxxx.xxx
|
|
Facsimile
No.: 000-000-0000
|
|
If
to Company:
|
CPL
Biologicals Private Limited
|
Cadila
Corporate Campus
|
|
Sarkhej-Dholka
Road
|
|
Bhat,
Ahmedabad – 382210
|
|
Gujarat,
India
|
|
Email:
xxxxxx@xxxxxxxxxxxx.xx.xx
|
|
Facsimile
No.: +91 (02718) 225031
|
11.4 Assignment.
(a) Novavax
may not assign this Agreement, in whole or in part, without the advance written
consent of the Company; provided, however, that this Agreement shall be
automatically assigned to Novavax’s successor in connection with the
acquisition, merger or sale of Novavax or the sale, transfer, lease, assignment
or disposal of all or substantially all of the property or assets of Novavax,
whether by way of a single transaction or a series of related transactions, and
such successor shall be fully bound by the terms and conditions
hereof.
(b) The
Company may not assign this Agreement, in whole or in part, without the advance
written consent of Novavax; provided, however, that this Agreement shall be
automatically assigned to the Company’s successor in connection with the sale,
transfer, lease, assignment or disposal of all or substantially all of the
property or assets of the Company , whether by way of a single transaction or a
series of related transactions, including a Change in Control of the Company (as
that term is defined in Schedule II of the Joint Venture Agreement), and such
successor shall be fully bound by the terms and conditions hereof; provided that
any such automatic assignment by Company within the scope of Schedule II of the
Joint Venture Agreement shall only be effective if such transaction was approved
by Novavax under and pursuant to the Joint Venture Agreement for so long as such
approval rights of Novavax under the Joint Venture Agreement have not been
terminated.
17
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.
(c) Any
assignment or purported assignment by either Party in violation of this Section
11.4 will be null and void.
11.5 Force Majeure. Both
Parties will be excused from the performance of their obligations under this
Agreement (except for the obligation to pay money) to the extent that such
performance is prevented by force majeure and the nonperforming Party promptly
provides notice of the prevention to the other Party. Such excuse
will be continued so long as the condition constituting force majeure continues
and the nonperforming Party takes reasonable efforts to remove the
condition. For purposes of this Agreement, force majeure will include
conditions beyond the control of the Parties, including without limitation, an
act of God, voluntary or involuntary compliance with any regulation, Law or
order of any government, war, civil commotion, labor strike or lock-out, acts of
terrorism, epidemic, failure or default of public utilities or common carriers,
destruction of production facilities or materials by fire, earthquake, storm or
like catastrophe.
11.6 Headings. The
headings for each article and section in this Agreement have been inserted for
convenience of reference only and are not intended to limit or expand on the
meaning of the language contained in the particular article or
section.
11.7 No Strict
Construction. This Agreement has been prepared jointly and
will not be strictly construed against either Party.
11.8 Ambiguities. Ambiguities
and uncertainties in this Agreement, if any, will not be interpreted against
either Party, irrespective of which Party may be deemed to have caused the
ambiguity or uncertainty to exist.
11.9 English
Language. All notices required or permitted to be given
hereunder, and all written, electronic, oral or other communications between the
Parties regarding this Agreement will be in the English
language. This Agreement is in the English language only, which
language will be controlling in all respects, and all versions hereof in any
other language will be for accommodation only and will not be binding upon the
Parties.
11.10 No Waiver. Any delay in
enforcing a Party’s rights under this Agreement or any waiver as to a particular
default or other matter will not constitute a waiver of such Party’s rights to
the future enforcement of its rights under this Agreement, excepting only as to
an express written and signed waiver as to a particular matter for a particular
period of time.
11.11 Severability. If
one or more of the provisions in this Agreement are deemed unenforceable by Law,
then such provision will be deemed stricken from this Agreement and the
remaining provisions will continue in full force and effect and shall be
interpreted to give full effect to the commercial agreement between the
Parties.
11.12 Counterparts. This
Agreement may be executed in one or more identical counterparts, each of which
will be deemed to be an original, and which collectively will be deemed to be
one and the same instrument.
[Signature
Page to Follow]
18
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.
In Witness
Whereof, the Parties have by duly authorized persons executed this
Agreement as of the Effective Date.
Novavax,
Inc.
|
CPL
Biologicals Private Limited
|
|||
By:
|
/s/ Xxxxx Xxxxxxx
|
By:
|
/s/ Xxxxx X. Xxxx
|
|
Xxxxx
Xxxxxxx
|
Xxxxx
X. Xxxx
|
|||
President
and CEO
|
Director
|
[Signature
Page to H1N1 License Agreement]
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.
Schedule
1
[* *
*]