THIS EXHIBIT HAS BEEN REDACTED
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TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND
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COMMISSION.
JOINT VENTURE
AGREEMENT
Page 1 of 56
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COMMISSION.
AMENDED AND RESTATED JOINT VENTURE
AGREEMENT
This agreement
(“Agreement”) is made this 29th day of June,
2009
Cadila
Pharmaceuticals Limited, a COMPANY incorporated under the laws of
India having its office at ‘Cadila Corporate Campus’,
Sarkhej-Dholka Road, Bhat, Ahmedabad – 382210, Gujarat, INDIA
herein represented by Dr. Rajiv I. Modi in his capacity as
Managing Director (hereinafter referred to as
“Cadila”),
Novavax Inc.,
incorporated and existing under the laws of the State of Delaware,
United States of America (USA), having its principal office at
9920 Belward Campus Drive, Rockville, MD 20850, USA herein
represented by Dr. Rahul Singhvi, in his capacity as President
and CEO (hereinafter referred to as “Novavax”),
and
The COMPANY (as
defined below).
“Cadila” and “Novavax”
together are referred to as “Parties”, and individually
as a “Party”)
Whereas Cadila
is engaged in research, development, manufacture and marketing of
various pharmaceutical preparations in India and in various other
countries. It possesses technical know-how and expertise in setting
up manufacturing facilities, producing pharmaceutical, herbal,
biotech and medicinal products as well as selling and marketing
such products in different markets around the world.
Whereas Novavax
is engaged in manufacturing seasonal and non-seasonal influenza
vaccine Products as well as a platform for developing and
manufacturing virus-like particle based products and selling and
marketing such products in the different markets around the
world;
Whereas Cadila
has formed a Joint Venture Company (the “COMPANY”) in
India for developing, manufacturing, marketing and selling
pharmaceutical and medicinal Products as mentioned hereinafter to
cater the needs of the market in India. The parties intend that the
COMPANY will establish US and India cGMP acceptable manufacturing
facilities in India and the structure for developing, producing,
marketing and selling pharmaceutical products either directly or
through partners / contractors as further described broadly in this
Agreement;
Whereas, the
Parties entered into a Joint Venture Agreement, dated as of March
31, 2009, relating to the Parties’ investment in, and the
governance and operation of, the COMPANY and certain other matters
(the “Original Joint Venture Agreement”) and the
Ancillary Agreements (as defined below), and have contributed, or
have caused to be contributed, the executed Back-up Licenses (as
defined below) to the Cayman JV (as defined below);
Whereas, the
COMPANY has been converted into a private limited company under the
Companies Act, 1956; and
Whereas,
concurrently herewith, the Parties have approved the Articles of
Incorporation and/or Statutes of the COMPANY attached as
Exhibit H and other necessary documents required for
registration of the COMPANY; and
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Whereas, the
Parties wish to amend and restate the Original Joint Venture
Agreement,
NOW, THEREFORE,
the Parties and the COMPANY hereby agree as follows:
Conditions Precedent &
Interpretations / Definitions
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1.1
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Interpretations /
Definitions
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1.1.1
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For
the purpose of this Agreement, the following definitions of certain
terms used herein shall apply unless the context otherwise
requires.
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(i)
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“Ancillary Agreements”
shall have the meaning assigned to such term in Section
18.1;
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(ii)
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“Backup Licenses” shall
collectively mean license agreements that replicate the Licenses,
substituting the Cayman JV as the licensee therein, as attached
hereto as Exhibit A .
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(iii)
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“Business” shall have
the meaning provided in Article 7.
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(iv)
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“Business Plan” shall
mean a business plan and budget that includes a plan and budget for
strategy, sales, expenses, profit and loss, capital expenditure and
cash flows of the COMPANY for the Financial Year to which it
relates and the subsequent two (2) Financial Years, and any
other matters determined by the Board of Directors.
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The
Business Plan shall include in particular, in relation to the
Financial Year to which it relates, the following:
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(a)
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an
operating budget and balance sheet forecast;
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(b)
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annual projected profit and loss
account and cash flow statement broken down monthly;
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(c)
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an
estimate of working capital requirements and capital
expenditures;
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(d)
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the
amount (if any) that is considered prudent to retain for the
purpose of meeting the working capital requirements, out of those
profits of the previous Financial Year (where applicable) that are
available for distribution to Shareholders;
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(e)
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a
management report giving business objectives for the Financial
Year; and
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(f)
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A
financial report which shall include an analysis of the financial
performance of the COMPANY for the previous Financial Year (where
applicable) compared with the Business Plan for such Financial
Year, identifying variations in sales, expenses, profit and loss,
cash flows and other material financial items.
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The
Business Plan shall be prepared under the guidance of the Chief
Executive Officer of the COMPANY and shall be considered official
when approved by the Board of Directors of the COMPANY.
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(v)
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“Cayman JV” shall mean
CPL Biologics Ltd., an exempted company organized under the laws of
the Cayman Islands.
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(vi)
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“Completion” means the
completion of all activities set forth in
Section 3.4.
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(vii)
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“Completion Date” shall
have the meaning provided in Section 3.3.
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(viii)
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“Confidential
Information” shall have the meaning provided in
Section 18.1.
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(ix)
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“Effective Date” means
March 31, 2009.
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(x)
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“Financial Year” in
relation to the COMPANY shall mean a financial accounting period of
twelve (12) months beginning on April 1; provided that the
first Financial Year will consist of period beginning on the date
of formation of the COMPANY to March 31 of next year.
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(xi)
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“Group” in relation to a
person or entity means any direct or indirect wholly owned
subsidiary of such person or entity, any person or entity of which
such person or entity is a direct or indirect wholly owned
subsidiary (its “Holding Company”) and any other direct
or indirect wholly owned subsidiaries of any such Holding Company.
The term “Group” shall also include affiliates of
Cadila consisting of the family members of the promoters, their
Hindu undivided families (HUFs), family trust and closely held
companies owned by the family members and trusts either singly or
jointly.
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(xii)
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“Know-How” means all
tangible and intangible (a) techniques, technology, practices,
trade secrets, inventions (whether patentable or not),
methods,
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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. Know-How
shall in any event exclude any Patents.
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(xiii)
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“Licenses” shall
collectively mean:
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(a)
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“Cadila License” which
shall mean the Cadila Product License to be entered into by the
COMPANY and Cadila the form of which is attached hereto as
Exhibit B ;
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(b)
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“Seasonal and Other Vaccine
License” which shall mean the Vaccine License for the current
seasonal influenza vaccine and [* * *] vaccine targets to be
entered into by the COMPANY and Novavax the form of which is
attached hereto as Exhibit C ; and
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(c)
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“Additional Vaccine
License” which shall mean a license to an additional VLP
vaccine product which may be entered into by the COMPANY and
Novavax after the Completion Date.
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The
Seasonal and Other Vaccine License and Additional Vaccine License
shall be referred to as the “Novavax
Licenses”.
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(xiv)
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“Party” and
“Parties” shall mean when used in the singular either
Cadila or Novavax as may be applicable and wherever used in the
plural shall mean Cadila and Novavax.
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(xv)
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“Patents” shall mean 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, including, without limitation, provisional
applications, continuations, continuations-in-part, divisional and
substitute applications with respect to any of the
foregoing.
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(xvi)
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“Products” shall
collectively mean:
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(a)
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“Novavax Products” which
shall mean (i) seasonal influenza vaccine, (ii) the
additional vaccine that is the subject of the Additional Vaccine
License if such Additional Vaccine License is entered into, and
(iii) VLP vaccines including a viral antigen selected from a chikun
gunya virus, a [* * *] ([* * *] dengue fever), a hepatitis E [* *
*] (each an “Additional Novavax Product”), all as
specifically defined in the Novavax Licenses;
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(b)
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“Cadila Products” which
shall mean (i) Cadila’s current vaccine product known as
Cadi-05, including its use for melanoma, head and neck, small cell
lung, bladder and HRPC cancers, (ii) Cadila’s
proprietary Mycobacterium W immuvac adjuvant for use with
therapeutic vaccines against cancer, (iii) Cadila’s
biogeneric erythropoietin product, G-CSF product, hyaluronic acid
product, and streptokinase product that are generic versions of
approved biologic pharmaceutical products (excluding in any event
any small molecule products, generic or otherwise), and
(iv) Cadila’s biological diagnostic products: the
Typhigen Kit, the ELIK HIV kit, the ELIK HCV kit, the CADISPOT
1&2 HIV kit and the NEVA HIV kit, all as specifically defined
in the Cadila License;
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(c)
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any
products developed, purchased or in-licensed by the COMPANY
including, without limitation, any vaccine, adjuvant, biosimilar
diagnostic, biological product, and a combination of (a), (b),
(c) and (d) (or component(s) of any of them); and
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(d)
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Any
Future Contributed Products that are licensed to the COMPANY in the
future in accordance with Section 7.8.
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(xvii)
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“Future Contributed
Products” shall collectively mean:
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(a)
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“Cadila Future Products”
which shall mean any (i) therapeutic vaccine against cancer
product, (ii) Cadila proprietary adjuvant for use with
vaccines, and (iii) Cadila biogeneric product that is a
generic version of an approved biologic pharmaceutical product
(excluding in any event any small molecule products, generic or
otherwise), in each case
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developed, purchased or in-licensed
by Cadila that is not a Cadila Product; and
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(b)
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“Novavax Future
Products” which shall mean any VLP-based vaccine product
developed, purchased or in-licensed by Novavax that is not a
Novavax Product, excluding in any event any RSV VLP-based vaccine
product.
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(xviii)
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“Shareholder” shall mean
a shareholder of the COMPANY.
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(xix)
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“Shares” shall mean the
equity shares of the COMPANY.
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(xx)
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“Supply Agreements”
shall collectively mean:
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(a)
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“Cadila Supply
Agreement” which shall mean the Supply Agreement to be
entered into by the COMPANY and Cadila the form of which is
attached hereto as Exhibit D ; and
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(b)
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“Novavax Supply
Agreement” which shall mean the Supply Agreement to be
entered into by the COMPANY and Novavax the form of which is
attached hereto as Exhibit E .
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(xxi)
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“Technical Services
Agreements” shall collectively mean:
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(a)
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“Cadila Technical Services
Agreement” which shall mean the Technical Services Agreement
to be entered into by Cadila and the COMPANY, the form of which is
attached hereto as Exhibit F ; and
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(b)
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“Novavax Technical Services
Agreement” which shall mean the Technical Services Agreement
to be entered into by Novavax and the COMPANY, the form of which is
attached hereto as Exhibit G .
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(xxii)
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“Territory” shall have
the meaning provided in Article 4.
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(xxiii)
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“Transfer” means to
transfer, grant any security interest over, or otherwise dispose
of, voluntarily or involuntarily, by operation of law or otherwise,
or grant any person any rights in or over. A “Transfer”
means any such transfer, grant or disposal.
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(xxiv)
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“VLP” shall mean
virus-like particle.
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COMMISSION.
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1.2
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References to “Statutes”
or Statutory provisions shall be construed to include references to
those statutes or provisions as amended or re-enacted (whether with
or without modification) from time to time or as their application
is modified by other provisions (whether before or after the date
of this Agreement) and shall include any statute or provision of
which they are re-enactments (whether with or without modification)
and shall also include any orders, regulations, instruments or
other subordinate legislation under the relevant statute or
statutory provision.
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1.3
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The
headings in this Agreement are for ease of reference only and shall
not in any way affect its construction or
interpretation.
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1.4
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Reference to a Party to this
Agreement shall include its successors in title and permitted
assigns.
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1.5
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Unless expressly stated to the
contrary in this Agreement:
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1.5.1
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words denoting the singular include
the plural and vice versa, words denoting any one gender include
all genders and vice versa;
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1.5.2
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a
reference to a recital or clause is a reference to a recital or
clause of this Agreement and a reference to a sub-clause is a
reference to a sub-clause of the clause in which the reference
appears;
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1.5.3
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the
words and phrases “other”, “including” and
“in particular” shall not limit the generality of any
preceding words or be construed as being limited to the same class
as the preceding words where a wider construction is
possible;
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1.5.4
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references to persons include
individuals, bodies corporate, unincorporated associations and
partnerships; and
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1.5.5
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all
obligations, representations and warranties on the part of two or
more persons are entered into, given or made by such persons
jointly and severally.
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Establishment of the
COMPANY
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2.1
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The
name of the COMPANY shall be “CPL Biologicals Private
Limited”.
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2.2
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Equity Shares
. Pursuant to the
Articles of Association, the authorised share capital of the
COMPANY shall be Rs [* * *] (Rupees [* * *]) divided into [* * *]
Shares of Rs [* * *] each and the issued, subscribed and paid up
share capital of the COMPANY shall be Rs [* * *] (Rupees [* * *])
divided into [* * *] Shares of Rs [* * *] each.
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2.3
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The
issued share capital, subject to the provisions of Article 11,
shall be subscribed as set forth on Schedule I, as amended
from time to time in accordance with the terms hereof.
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2.4
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Any
stamp duty payable upon such issue and allotment shall be borne by
the COMPANY.
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EFFECTIVE DATE;
COMPLETION
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3.1
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The
Ancillary Agreements shall be effective on and from the Completion
Date.
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3.2
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Conditions Precedent
: The obligation of
Novavax to subscribe to the Shares is subject to the complete
satisfaction / fulfilment (with proof of fulfilment), or waiver of
the following pre-closing conditions (“Conditions
Precedent”):
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3.2.1
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The
COMPANY shall have obtained any required approvals of the foreign
investment promotion board of India (“FIPB”) and the
Reserve Bank of India for issue of Shares to Novavax in
consideration of transfer of the Novavax Licenses to the
COMPANY;
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3.2.2
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Cadila shall have caused the
shareholders of the COMPANY other than Cadila to transfer their
Shares to Cadila, concurrently with the Completion.
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3.3
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Completion : Completion shall take place at a
venue as shall be agreed in writing by the Parties within fifteen
(15) days of notice from the COMPANY to the Parties that all
the Conditions Precedent (other than the Condition Precedent set
forth in Section 3.2.2) have been fulfilled, or on such other date
as the Parties may agree in writing (“Completion
Date”). The transactions contemplated under this Agreement to
be consummated on the Completion Date shall be deemed to occur
simultaneously
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and
no such transaction shall be consummated unless all such
transactions are consummated.
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3.4
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On
the Completion Date:
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3.4.1
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The
COMPANY shall hold a meeting of the Board of Directors to approve
the calling of an extra ordinary general meeting of the
Shareholders for (i) issue of Shares to Cadila and Novavax as
contemplated under Section 3.4.4 of this Agreement and
(ii) adoption of the Articles of Association in the form
attached to this Agreement as Exhibit H , and
(iii) appointment of the persons nominated by Cadila and
Novavax as Directors in accordance with this Agreement who have
obtained their respective Director Identification Numbers and
Digital Signature Certificates and who are otherwise qualified to
act as the directors of the Company;
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3.4.2
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The
COMPANY shall hold a meeting of the Shareholders for (i) issue
of Shares to Cadila and Novavax as contemplated under
Section 3.4.4 of this Agreement; (ii) adoption of the
Articles of Association in the form attached to this Agreement as
Exhibit H , and (iii) appointment of the persons
nominated by Cadila and Novavax as Directors in accordance with
this Agreement who have obtained their respective Director
Identification Numbers and Digital Signature Certificates and who
are otherwise qualified to act as the directors of the
Company;
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3.4.3
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The
Company shall provide certified copies of resolutions passed at the
meetings contemplated by section 3.4.1 and 3.4.2;
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3.4.4
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The
COMPANY shall issue to each Party the number of shares shown
opposite such Party’s name on Schedule I, free and clear
from all encumbrances; and
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3.4.5
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The
COMPANY shall provide the Parties with share certificates in
respect of the Shares and duly register such Shares in the name of
the Parties in the COMPANY’s Register of Members.
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3.5
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Post Completion Events
:
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3.5.1
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Within five (5) business days
from the Completion Date, the COMPANY shall file all requisite
forms and returns as may be required to be filed with any
government authority under applicable law, including without
limitation:
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(a)
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Form 2, Form 23 and
Form 32 of the Companies (Central Government’s) General
Rules & Forms with the relevant Registrar of Companies;
and
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(b)
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all
relevant filings required to be made before the Reserve Bank of
India.
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3.5.2
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The
COMPANY shall deliver to the Parties a certified true copy of all
the acknowledged filings including those with the Ministry of
Corporate Affairs and the Reserve Bank of India and a certified
true copy of the Memorandum and Articles of Association of the
COMPANY.
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3.6
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Conduct between Effective Date and
Completion Date :
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3.6.1
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During the period between the
Effective Date and the Completion Date, Cadila shall ensure and
shall procure that the COMPANY does not, without the prior written
consent of Novavax:
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(i)
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do
anything that is contrary to this Agreement including without
limitation (a) take any decision or action in respect of any matter
listed in Schedule II; (b) entering into any commitment or
transaction or do anything which is not contemplated by this
Agreement; (c) entering into any Related Party Transaction
save and except as provided in this Agreement or; (d) passing
of or join in the passing of or permitting the passing of any
resolution of the shareholders of the COMPANY which is not
contemplated by this Agreement; or
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(ii)
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do
or permit anything to be done which would be contrary to the
provisions of applicable law.
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3.6.2
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If
Cadila or COMPANY becomes aware that the happening of an event has
resulted in a breach of any representations and warranties of
Cadila in Section 25.6 or there has been any event or
circumstance which would cause the representations and warranties
of Cadila in Section 25.6 to be untrue or inaccurate in any
material respect, then they shall immediately notify Novavax of
that fact in writing with all relevant information in relation to
that event or, as the case may be, breach of such representations
and warranties.
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3.6.3
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Cadila shall cause the COMPANY to,
simultaneously furnish to Novavax all such documents and
information as is provided to Directors or Shareholders, and notice
and
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minutes of all meetings of
Shareholders, the Board and any committees thereof (including
attachments and exhibits as are held, during this period) relating
to the period between Effective Date and the Completion
Date.
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3.7
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The
Parties shall use commercially reasonable efforts in good faith to
fulfil the Conditions Precedent within 120 days after the
Effective Date (the “Long Stop Date”). If Completion in
accordance with section 3.4 does not occur on or before the Long
Stop Date, the Parties shall:
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3.7.1
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effect the joint venture
contemplated by this Agreement and the Ancillary Agreements through
the Cayman JV, and in connection therewith the Parties shall amend
and restate the Memorandum and Articles of Association of the
Cayman JV and execute and deliver such other documents, agreements
and instruments so as to replicate in the Cayman JV as nearly as
possible the terms and conditions set forth in this Agreement and
the Ancillary Agreements, and shall execute and deliver such other
documents, agreements and instruments as may be necessary and
desirable to effect the foregoing as promptly as reasonably
practicable; and
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3.7.2
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promptly cause the Cayman JV to take
such steps as are reasonably necessary to establish a subsidiary
organized under the laws of India or ensure that the COMPANY
becomes a wholly owned subsidiary of the Cayman JV.
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3.8
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In
the event that Completion takes place in accordance with section
3.4, the Parties shall cause (i) all agreements in relation to
the Cayman JV to be terminated and (ii) the Cayman JV to be
dissolved and liquidated.
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The COMPANY
shall carry on its business in the Territory of India (the
“Territory”). The Territory may only be changed by
mutual, written agreement between the Parties.
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5.1
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The
COMPANY shall use commercially reasonable efforts to obtain all
permits, approvals and licenses necessary for the operation of the
COMPANY.
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BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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5.2
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Cadila and Novavax shall reasonably
assist the COMPANY to arrange for the necessary licences and
permissions to be granted by the Ministry of Health and other
government authorities.
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Issue and Transfer of
Shares
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6.1
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No
Shareholder shall (a) Transfer any Share or interest in any
Share in the COMPANY or (b) permit the Transfer of any interest in
the Shareholder unless (i) it is expressly permitted under
this Agreement or (ii) the other Shareholder gives its prior
written consent; provided, however, that as to the interests in the
COMPANY that are owned directly by Novavax or Cadila, the
restriction set forth in Section 6.1(b) shall not
apply.
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6.2
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Notwithstanding Section 6.1, a
Shareholder may permit the Transfer of an interest in it to a
person in its Group without compliance with the provisions of
Section 6.4 and Section 6.5 with the prior written
consent of the other Shareholder, which consent shall not be
unreasonably withheld.
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6.3
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Notwithstanding Section 6.1, a
Shareholder may Transfer all of its Shares in the COMPANY to a
person in its Group without compliance with the provisions of
Section 6.4 and Section 6.5 with the prior written
consent of the other Shareholder, which consent shall not be
unreasonably withheld, provided that, at the time of the Transfer
and in relation to the Shares being transferred:
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6.3.1
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the
transferring Shareholder procures that the transferee enters into
this Agreement on the same terms as applicable to the transferring
Shareholder in relation to those Shares immediately prior to the
Transfer; and
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6.3.2
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the
transferring Shareholder guarantees and indemnifies the other Party
in respect of all the obligations and any liability of the
transferee under this Agreement.
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6.3.3
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if
the transferee at any time ceases to be a part of the Group of the
transferring Shareholder, that transferee shall Transfer all its
Shares back to the transferring Shareholder.
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6.4
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If
either Shareholder (“Offeror”) wishes to dispose of or
Transfer some or all of its Shares pursuant to a bona fide written
offer (the “Proposed Offer”) from an unaffiliated third
party (the “Proposed Transferee”), it shall first offer
such Shares to the other Shareholder (“Offeree”) by
notice in writing (“Transfer Notice”) at a price per
Share
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COMMISSION.
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not
less favourable to the Offeree than that set forth in the Proposed
Offer and, to the extent the consideration in the Proposed Offer is
non-cash consideration, such non-cash consideration shall be
replaced with cash representing a fair value of the non-cash
consideration if governmental approval is needed by either of the
parties to effect the purchase or sale of the Shares which are the
subject of the Proposed Offer, and on other reasonably similar and
no less favorable terms and conditions to the Offeree than, as
those set forth in the Proposed Offer. On or before expiry of
thirty (30) days from the date of receipt of the Transfer
Notice, the Offeree shall notify the Offeror in writing of its
intentions to accept or reject the offer, and in the event of it
accepting the offer (“Acceptance Notice”), the Offeree
shall be entitled to an additional period of ninety (90) days
or such other mutually agreed extended period from the date of the
Acceptance Notice (“Completion Period”) to obtain the
approval of the relevant government authority(ies) and to complete
the purchase of the Shares from the Offeror.
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6.5
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In
the event that the Offeree fails to complete the purchase of the
Shares within the Completion Period or if the Offeree has rejected
the offer, the Offeror shall be entitled to dispose of the offered
shares to the Proposed Transferee, provided that the price of the
Shares is not more favourable to the Proposed Transferee than that
offered to the Offeree, and on other reasonably similar and no more
favorable terms and conditions to the Proposed Transferee than, as
those offered to the Offeree. If the Offeror fails to dispose of
such Shares within one hundred twenty (120) days after the
Completion Period (or one hundred twenty (120) days after the
date on which the Offeree rejected the offer), the Offeror shall
not offer to dispose of or Transfer such Shares except pursuant to
Section 6.4 and this Section 6.5.
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6.6
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In
the event the Offeree is unwilling or unable to purchase the
Offered Shares identified in the Transfer Notice and the Offeror
proposes to proceed to Transfer the Offered Shares to a Proposed
Transferee, the Offeror may only Transfer its Shares to the
Proposed Transferee if the Offeror causes the Proposed Transferee
to give the Offeree the right, but not the obligation
(“Tag-Along Right”), to require the Proposed Transferee
to purchase all of the Shares of the Offeree (“Tag Along
Shares”) simultaneously with the purchase of the Shares from
the Offeror (“Offered Shares”) at the same price per
Share; provided, however, that if the Proposed Transferee is only
willing to buy less than the Offered Shares and Tag Along Shares
(such shares which the Proposed Transferee is not willing to
purchase is hereinafter referred to “Excess Shares”),
then the number of Offered Shares and the Tag Along Shares shall be
reduced
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THIS EXHIBIT HAS BEEN REDACTED
AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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on
a pro rata basis to the extent of the Excess Shares. The Offeree
shall exercise the Tag-Along Right within ninety (90) days
from date of receipt of the Transfer Notice.
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6.7
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In
order to be entitled to exercise its tag-along right pursuant to
Section 6.6, the Offeree must agree to make to the Proposed
Transferee on behalf of itself the same representations,
warranties, indemnities, covenants and assurances as the Offeror
agrees to make in connection with the Transfer and agree to the
same conditions to the Transfer as the Offeror (except that in the
case of representations, warranties, indemnities, covenants and
assurances pertaining specifically to the Offeror, including,
without limitation, representations, warranties, indemnities,
covenants and assurances pertaining to the rights licensed by the
Offeror under the Licenses, the Offeree shall make comparable
representations, warranties, indemnities, covenants and assurances
pertaining specifically to itself and its rights licensed to the
Offeror under the Licenses); provided, however, that (a) the
Offeree shall not be required to make any non-competition,
non-solicitation or similar restrictive covenants that would exceed
the scope of the covenants set forth in Article 22, and
(b) the Offeree shall not be required to make any
representations, warranties, indemnities, covenants and assurances
with respect to the rights it licensed to the Offeror under the
Licenses that would exceed the scope of the corresponding
representations, warranties, indemnities, covenants and assurances
in the Licenses. All such representations, warranties, indemnities,
covenants and assurances shall be made by the Offeror and the
Offeree severally and not jointly. Except with respect to
individual representations, warranties, indemnities, covenants and
other assurances of the Offeree relating to (i) the
unencumbered title to its Shares and (ii) the power, authority
and legal right to transfer its Shares, the aggregate liability of
the Offeree shall not exceed the Offeree’s pro
rata share of any such liability to be determined in
accordance with the Offeree’s portion of the total number of
Shares included in such transfer; provided that, in any
event, the aggregate liability of the Offeree shall not exceed the
proceeds the Offeree received in connection with the
transfer.
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6.8
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The
aggregate liability of the Offeree under any representations,
warranties, indemnities, covenants or other assurances which it may
give to a Proposed Transferee shall be limited to the consideration
payable by the Proposed Transferee to the Offeree for the number of
Shares to be sold to the Proposed Transferee.
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6.9
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It
is expressly clarified and agreed between the Parties that if, for
any reason whatsoever, the Proposed Transferee is unable to acquire
the Tag Along Shares at a price stated in the Transfer Notice (in
accordance with this Article 6), the Proposed
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Page 15 of 56
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TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Transferee shall not acquire any of
the Offered Shares, and if any such Transfer is not consummated
before the Completion Period, then such Transfer shall not be made
without first repeating and re-extending to the Offeree the rights
set out in this Article 6.
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6.10
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The
COMPANY shall place a legend on all share certificates in respect
of the Shares, stating as follows:
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“THIS CERTIFICATE AND THE
SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT IN ALL RESPECTS
TO THE RESTRICTIONS CONTAINED IN THE AMENDED AND RESTATED JOINT
VENTURE AGREEMENT DATED JUNE 29, 2009 BY AND BETWEEN CADILA
PHARMACEUTICALS LIMITED AND NOVAVAX, INC. AND SHALL BE VALID DURING
THE SUBSISTENCE OF THE SAID AGREEMENT.”
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6.11
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The
COMPANY shall ensure that all share certificates in respect of the
Shares shall bear the legend as provided in Section 6.10. The
COMPANY shall further ensure that all Share certificates, as
mentioned herein, issued without the above legend shall be replaced
with new Share certificates bearing the above legend.
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6.12
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In
the event that any of the Shares are to be dematerialised, then
prior to any such dematerialization, the Shareholders shall enter
into appropriate undertakings and documents with the Depository and
the Depository Participant to the effect that all such Shares (to
be dematerialized) are subject in all respects to the restrictions
contained in this Agreement and shall be valid during the
subsistence of this Agreement.
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6.13
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Upon the sale of all Shares held by
a Shareholder, as may be permitted by and in accordance with the
provisions of this Article 6, the rights and obligations of
such selling Shareholder under this Agreement shall terminate;
provided, however, that the selling Shareholder shall remain liable
for the following obligations and liabilities: (i) any
liabilities and obligations of the selling Shareholder accrued as
of the date of such sale; (ii) any obligations of the selling
Shareholder under Article 18; (iii) any obligations of
the selling Shareholder under Section 22.2 for a period of one
(1) year after the date of such sale; (iv) any
obligations of the selling Shareholder under Section 23.3;
(v) liability for breach of any representations and warranties
of the selling Shareholder under this Agreement; and (vi) the
obligations of the selling Shareholder under Section 25.6; and
provided, further, that such termination shall not affect any
Ancillary Agreements or other agreements, except to the extent
expressly stated otherwise therein.
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Page 16 of 56
THIS EXHIBIT HAS BEEN REDACTED
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TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND
HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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7.1
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The
business of the COMPANY (the “Business”) shall include
researching, developing, manufacturing, marketing and selling of
Products in the Territory.
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7.2
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The
Business shall be conducted in accordance with the Business Plan
prepared under the guidance of the Chief Executive Officer and
approved by the Board of Directors of the COMPANY pursuant to
Article 8 hereof, as amended by the Board of Directors from
time to time. The first Business Plan shall be proposed to the
Board of Directors within ninety (90) days from the Effective
Date. At the time the first Business Plan is proposed to the Board
of Directors, the Chief Executive Officer shall also propose a
schedule of development milestones (the “Milestones”),
and corresponding amounts of cash investment to be made by Cadila,
pursuant to Section 11.2, upon achievement of such Milestones.
The Milestones and corresponding investment amounts shall become
binding upon approval by unanimous approval of the Board of
Directors.
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7.3
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The
COMPANY shall use its commercially reasonable efforts to establish
a manufacturing facility in India that complies with US and India
cGMP, through which the manufacturing part of the Business of the
COMPANY shall be undertaken, within the ‘time-frame’
set in the Business Plan. The manufacturing facility shall be
consistent with the applicable equipment, processes and procedures
used by Novavax and Cadila in their manufacturing facilities, based
in part on technology licensed to the COMPANY under the Licenses.
Until the manufacturing facility is established, Novavax and Cadila
will supply the COMPANY with Novavax Products and Cadila Products,
respectively, for research and development purposes pursuant and
subject to the Supply Agreements in accordance with the terms and
conditions set forth therein.
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7.4
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Cadila and Novavax, pursuant and
subject to the respective Technical Services Agreements, shall
provide reasonable assistance to COMPANY in establishing such
manufacturing facility.
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7.5
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Except as may be otherwise provided
herein, the COMPANY shall be operated as an independent
entity.
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COMMISSION.
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7.6
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The
COMPANY shall use its commercially reasonable efforts to obtain at
its own expense regulatory approvals and registration for licensing
of Products in the Territory. Cadila and Novavax, pursuant and
subject to the Technical Services Agreement, shall provide
reasonable assistance to the COMPANY in obtaining such regulatory
approvals and registrations.
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7.7
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The
COMPANY shall use its commercially reasonable efforts to establish
within 12 months from the Effective Date, a commercialization
plan for each Product in the Territory either directly or with help
of a commercial partner as approved by the Board of Directors of
the COMPANY.
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7.8
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The
COMPANY, Cadila and Novavax shall grant certain negotiation rights
to each other for certain future products as follows:
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7.8.1
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The
COMPANY and Cadila hereby grant to Novavax a first right of refusal
for Future Novavax Products that are (a) vaccines
corresponding to the type of vaccine provided under (iii) of
Novavax Products (as the same may be amended under
Section 23.3 of this Agreement) developed by or within the
COMPANY for development and exploitation outside the Territory, and
(b) vaccines included in Cadila Products developed by or
within the COMPANY for development and exploitation in the United
States, Spain, China and any other country in the world excluding
those countries set forth in Schedule IV , in each case
as provided in 7.8.3 below. For the avoidance of doubt and
notwithstanding anything to the contrary, no such right of first
negotiation or similar restriction shall apply to (I)
Cadila’s own development, manufacture or commercialization of
Cadila Products developed by or within the COMPANY (by itself or
through its affiliates) for development and exploitation in the
countries set forth in Schedule IV , (II) the
adjuvant described in (ii) of Cadila Products (including,
without limitation, combinations of the adjuvant with one or more
antigens, but excluding the Cadi-05 products described in
(i) of Cadila Products), or (III) any vaccine products
developed by the Company which are not described in (a) or (b)
above.
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7.8.2
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Novavax hereby grants to COMPANY a
first right of refusal for Novavax Future Products developed by or
within Novavax for exploitation in the Territory as provided in
Section 7.8.3 below. Cadila hereby grants to the COMPANY a
first right of refusal for Cadila Future Products developed by or
within Cadila for exploitation in the Territory as provided in
Section 7.8.3 below.
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7.8.3
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Prior to entering into any agreement
with a third party granting a license or other right to develop or
commercialize any product described in 7.8.1 and 7.8.2 above (each,
an “RFR Product”), the Party, or COMPANY, as the case
may be, subject to the right of first negotiation with respect to
its applicable RFR Product under Sections 7.8.1 or 7.8.2 above
(“Owner”) shall first notify the beneficiary of such
right of first negotiation (the “RFR Holder”) of its
desire to do so and thereupon enter into good faith negotiations
with the RFR Holder for a period of at least one hundred twenty
(120) days from the date of such notice, for terms of an
agreement governing the development and commercialization of such
RFR Product under mutually acceptable terms and conditions. If the
parties cannot reach agreement on terms by the end of such
120 day period (or, if earlier, upon notice from the RFR
Holder that it does not desire to exercise its negotiation rights
hereunder), despite each party’s good faith efforts to do so,
then the Owner shall be free to enter into license agreements with
Third Parties with respect to such RFR Product with respect to the
development and/or commercialization thereof (or otherwise develop
or commercialize such RFR Product itself or through one of its
Affiliates); provided, however, that for six months after the end
of such one hundred twenty (120) day period, the Owner shall
not enter into any agreement with a Third Party on business terms
(e.g., financial terms, scope of rights granted, and similar terms
typically found in a term sheet for such a transaction) more
favorable to such Third Party than the business terms of the last
written proposal (if any) made by the RFR Holder. For the avoidance
of doubt, the Owner shall be free to conduct discussions and
negotiations with Third Parties for any RFR Product before and/or
during the 120 day period described above so long as no
agreement is entered into for such RFR Product prior to the end of
such 120 day period (or earlier if the RFR Holder provides
notice of its desire not to exercise its negotiation rights) and
the Owner otherwise complies with its negotiation obligations
described above.
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7.9
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Agreements Regarding Development of
Products. The COMPANY, at its own expense, shall be responsible for
the preclinical and clinical development, and regulatory
activities, necessary for the development and regulatory approval
of the Products in the Territory, in addition to any clinical
development work already completed by Cadila and Novavax (or
subsequently completed by Cadila and Novavax outside the
Territory). Cadila and Novavax, pursuant and subject to the
Technical Services Agreements, shall provide the COMPANY reasonable
cooperation and assistance with respect to such development and
regulatory activities of the COMPANY. Pursuant and subject to the
Novavax Licenses, Novavax has certain
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rights to approve the clinical trial
protocols for any clinical trial of certain Novavax
Products.
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7.10
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Other than the restrictions set
forth in Article 22.2, and subject to the exclusive license
grants in the Licenses, Novavax and Cadila are not restricted in
their ability to develop and commercialize biotechnology, vaccine
and pharmaceutical products in and out of the Territory alone or
under partnership, joint venture or licensing arrangements with
other persons and entities.
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8.1
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The
Board of Directors of the COMPANY (the “Board”) shall
consist of 5 (five) members
(“Directors”).
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8.2
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Cadila shall nominate three
(3) of the Directors, including the Chairman of the Board (the
“Cadila Directors”), and Novavax shall nominate two
(2) Directors (the “Novavax Directors”). Each of
Cadila and Nova
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