THIS EXHIBIT HAS BEEN REDACTED
AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
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EXCHANGE COMMISSION.
SEASONAL / OTHER LICENSE AGREEMENT
This License Agreement (the
“ Agreement ”) is executed this March 31,
2009 (the " Execution Date ”), to be effective as set
forth in Article 4, by and between Novavax, Inc. , a Delaware
corporation having an address at 9920 Belward Campus Drive,
Rockville, Maryland 20850, United States of America (“
Novavax ”) and CPL Biologicals 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 Products; 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:
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,
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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.
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 a particular
Licensed Product and that relate to the commercial marketing and
sale of such 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 on which the
condition precedent set forth in Article 4 is first
satisfied.
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 Joint Venture
Agreement by and between Novavax and Cadila Pharmaceuticals
Limited, dated March 31, 2009.
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.
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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 (a) Novavax’s
current trivalent, intra-muscular seasonal influenza vaccine
containing a virus like particle (VLP) consisting of an avian
influenza M1 protein or influenza M1 protein containing an avian
influenza M1 L-domain sequence and a seasonal influenza HA and
seasonal influenza NA described in the U.S. IND No. BB-IND
13787 and appropriate diluent(s) wherein the seasonal HA and
seasonal NA under the IND are recommended 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, (“ Seasonal
Influenza Licensed Product ”) and (b) vaccines
consisting of a virus like particle (VLP) consisting of an
avian influenza M1 protein or influenza M1 protein containing an
avian influenza M1 L-domain sequence and one or more antigens from
(i) chikun gunya virus, (ii) [* * *] dengue fever), (iii)
hepatitis E [* * *] (“ Other Products ”),
together with, in each case of both (a) and (b), 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, or substitution of
one or more seasonal influenza HAs and/or NAs designated by the CDC
for seasonal influenza HAs and/or NAs designated by the
corresponding authority in India (e.g., the WHO in India). Licensed
Product shall include any Other Product used in combination with
another active ingredient, antigen or adjuvant. [* * *] Licensed
Product shall include the trivalent, intra-muscular seasonal
influenza vaccine containing a virus like particle
(VLP) consisting of an avian influenza M1 protein or influenza
M1 protein containing an avian influenza M1 L-domain sequence and a
seasonal influenza HA and seasonal influenza NA that Novavax
launches for commercial sale in the United States after Regulatory
Approval of such vaccine; it being understood that for so long as
(but only for so long as) such vaccine is being developed in
clinical trials by or for Novavax in support for commercial launch
in the United States, such vaccine shall be deemed a Licensed
Product hereunder prior to commercial launch (for the purpose of
allowing the Company to develop and launch such product in the
Territory in accordance with the terms and conditions of this
Agreement promptly following its launch by Novavax in the United
States).
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 Products, 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
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EXCHANGE COMMISSION.
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.
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
Technical Services Agreement between Novavax and Company dated as
of the date hereof.
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.
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
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 Products in the Territory, and (b) make (and
have made solely by Cadila or an Affiliate of Cadila, subject to
Novavax’s approval described below) Licensed Products in the
Territory solely to develop, use, sell, have sold, offer to sell
and import Licensed Products in the Territory. The foregoing
license shall be exclusive for Licensed Products 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.
Novavax shall be
reasonable in granting or withholding its approval to permit Cadila
or an Affiliate of Cadila to make Licensed Products 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 Products made by a Third Party.
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) Seasonal Influenza
Licensed Products and (ii) other seasonal influenza vaccines
outside the Territory, and (b) make and have made
(i) Seasonal Influenza Licensed Products and other seasonal
influenza vaccines outside the Territory solely to develop, use,
sell, have sold, offer to sell and import Seasonal Influenza
Products outside the Territory. For clarity, the license grant to
Novavax under this Section 2.2 does not include the right
research, develop, use, make, have made, sell, have sold, offer to
sell and import the Other 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.
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EXCHANGE COMMISSION.
2.5 Research
Data; Right of Reference.
(a) Company
shall keep complete and accurate notes, accounts and records of all
Program Data with respect to Licensed Products, 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
Products 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 Products in the
Territory Program Data related to Licensed Products 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.
2.6 Grey
Market. The Parties reasonably cooperate to formulate and
implement reasonable precautions designed to prevent Licensed
Products 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 Products 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.
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EXCHANGE COMMISSION.
LICENSED PRODUCT DEVELOPMENT AND
COMMERCIALIZATION
3.1
Development and Commercialization of Licensed
Products.
(a)
General. Company will have sole responsibility, at
Company’s sole expense, for all Development and
Commercialization of Licensed Products in the Territory in
accordance with the terms of this Agreement.
(b)
Development and Commercialization of Seasonal Influenza Licensed
Products. Prior to [* * *], Company shall present to Novavax
for its written approval Development plans for the Seasonal
Influenza 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 Products in the Territory (the “ Seasonal
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 Seasonal Development Plan without
Novavax’s prior written consent. Company shall conduct
Development of such Licensed Products in a manner that is
materially consistent with the Seasonal Development Plans. All
clinical trial protocols for Seasonal Influenza Licensed Products
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 Seasonal Influenza
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 “ Seasonal 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 Seasonal Commercialization Plan
without Novavax’s prior written consent. Company shall
conduct Commercialization of such Licensed Products in a manner
that is materially consistent with the Seasonal Commercialization
Plan. Novavax acknowledges that the Licensed Products 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 Products it will not obtain the value
of such contribution. Company acknowledges that Novavax (or its
affiliates or licensees) are Developing and Commercializing
Licensed Products 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.
(c)
Development and Commercialization of Other Products. Before
beginning any Development or Commercialization activities with
respect to an Other Product, Company shall present to Novavax
Development plans and Commercialization plans, as the case may be,
for such Other Product and material alterations to such plans.
Novavax may review and comment on such Other Product Development
plans and Commercialization plans and material
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alterations to
such plans and Company will consider in good faith the reasonable
comments of Novavax. Company shall conduct Development and
Commercialization of such Other Product in a manner that is
materially consistent with such Other Product Development plans and
Commercialization plans.
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 Products in the Territory. As set forth in the
Technical Services Agreement, Novavax will cooperate with Company
in preparing and filing all such reports.
3.3
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 Supply
Agreement, dated as of March 31, 2009, between Company and
Novavax (the “ Supply Agreement ”).
3.4 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 Deve
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