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AMENDED AND RESTATED JOINT VENTURE AGREEMENT

Joint Venture JV Agreement

AMENDED AND RESTATED JOINT VENTURE AGREEMENT | Document Parties: NOVAVAX INC | Cadila Pharmaceuticals Limited You are currently viewing:
This Joint Venture JV Agreement involves

NOVAVAX INC | Cadila Pharmaceuticals Limited

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Title: AMENDED AND RESTATED JOINT VENTURE AGREEMENT
Governing Law: Delaware     Date: 8/10/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

AMENDED AND RESTATED JOINT VENTURE AGREEMENT, Parties: novavax inc , cadila pharmaceuticals limited
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Exhibit 10.4

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.

CADILA NOVAVAX

 

AMENDED AND RESTATED

JOINT VENTURE
AGREEMENT

 

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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.

AMENDED AND RESTATED JOINT VENTURE AGREEMENT

This agreement (“Agreement”) is made this 29th day of June, 2009

BETWEEN

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”)

PREAMBLE

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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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.

Whereas, the Parties wish to amend and restate the Original Joint Venture Agreement,

NOW, THEREFORE, the Parties and the COMPANY hereby agree as follows:

Article 1

Conditions Precedent & Interpretations / Definitions

1.1

 

Interpretations / Definitions

 

1.1.1

 

For the purpose of this Agreement, the following definitions of certain terms used herein shall apply unless the context otherwise requires.

 

(i)

 

“Ancillary Agreements” shall have the meaning assigned to such term in Section 18.1;

 

 

(ii)

 

“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 .

 

 

(iii)

 

“Business” shall have the meaning provided in Article 7.

 

 

(iv)

 

“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.

 

 

 

 

The Business Plan shall include in particular, in relation to the Financial Year to which it relates, the following:

 

 

(a)

 

an operating budget and balance sheet forecast;

 

 

(b)

 

annual projected profit and loss account and cash flow statement broken down monthly;

 

 

(c)

 

an estimate of working capital requirements and capital expenditures;

 

 

(d)

 

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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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.

 

(e)

 

a management report giving business objectives for the Financial Year; and

 

 

(f)

 

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.

 

 

 

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.

 

 

(v)

 

“Cayman JV” shall mean CPL Biologics Ltd., an exempted company organized under the laws of the Cayman Islands.

 

 

(vi)

 

“Completion” means the completion of all activities set forth in Section 3.4.

 

 

(vii)

 

“Completion Date” shall have the meaning provided in Section 3.3.

 

 

(viii)

 

“Confidential Information” shall have the meaning provided in Section 18.1.

 

 

(ix)

 

“Effective Date” means March 31, 2009.

 

 

(x)

 

“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.

 

 

(xi)

 

“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.

 

 

(xii)

 

“Know-How” means all tangible and intangible (a) techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods,

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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.

 

 

 

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.

 

 

(xiii)

 

“Licenses” shall collectively mean:

 

(a)

 

“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 ;

 

 

(b)

 

“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

 

 

(c)

 

“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.

 

 

 

 

The Seasonal and Other Vaccine License and Additional Vaccine License shall be referred to as the “Novavax Licenses”.

 

 

(xiv)

 

“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.

 

 

(xv)

 

“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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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.

 

(xvi)

 

“Products” shall collectively mean:

 

(a)

 

“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;

 

 

(b)

 

“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;

 

 

(c)

 

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

 

 

(d)

 

Any Future Contributed Products that are licensed to the COMPANY in the future in accordance with Section 7.8.

 

 

(xvii)

 

“Future Contributed Products” shall collectively mean:

 

(a)

 

“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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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.

 

 

 

developed, purchased or in-licensed by Cadila that is not a Cadila Product; and

 

 

(b)

 

“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.

 

(xviii)

 

“Shareholder” shall mean a shareholder of the COMPANY.

 

 

(xix)

 

“Shares” shall mean the equity shares of the COMPANY.

 

 

(xx)

 

“Supply Agreements” shall collectively mean:

 

 

(a)

 

“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

 

 

(b)

 

“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 .

 

(xxi)

 

“Technical Services Agreements” shall collectively mean:

 

 

(a)

 

“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

 

 

(b)

 

“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 .

 

(xxii)

 

“Territory” shall have the meaning provided in Article 4.

 

 

(xxiii)

 

“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.

 

 

(xxiv)

 

“VLP” shall mean virus-like particle.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

1.2

 

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.

 

1.3

 

The headings in this Agreement are for ease of reference only and shall not in any way affect its construction or interpretation.

 

1.4

 

Reference to a Party to this Agreement shall include its successors in title and permitted assigns.

 

1.5

 

Unless expressly stated to the contrary in this Agreement:

 

1.5.1

 

words denoting the singular include the plural and vice versa, words denoting any one gender include all genders and vice versa;

 

1.5.2

 

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;

 

1.5.3

 

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;

 

1.5.4

 

references to persons include individuals, bodies corporate, unincorporated associations and partnerships; and

 

1.5.5

 

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.

Article 2

Establishment of the COMPANY

2.1

 

The name of the COMPANY shall be “CPL Biologicals Private Limited”.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

2.2

 

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.

 

2.3

 

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.

 

2.4

 

Any stamp duty payable upon such issue and allotment shall be borne by the COMPANY.

Article 3

EFFECTIVE DATE; COMPLETION

3.1

 

The Ancillary Agreements shall be effective on and from the Completion Date.

 

3.2

 

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”):

 

3.2.1

 

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;

 

3.2.2

 

Cadila shall have caused the shareholders of the COMPANY other than Cadila to transfer their Shares to Cadila, concurrently with the Completion.

 

3.3

 

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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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.

 

 

and no such transaction shall be consummated unless all such transactions are consummated.

 

3.4

 

On the Completion Date:

 

3.4.1

 

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;

 

3.4.2

 

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;

 

3.4.3

 

The Company shall provide certified copies of resolutions passed at the meetings contemplated by section 3.4.1 and 3.4.2;

 

3.4.4

 

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

 

3.4.5

 

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.

 

3.5

 

Post Completion Events :

 

3.5.1

 

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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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.

 

(a)

 

Form 2, Form 23 and Form 32 of the Companies (Central Government’s) General Rules & Forms with the relevant Registrar of Companies; and

 

 

(b)

 

all relevant filings required to be made before the Reserve Bank of India.

 

3.5.2

 

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.

 

3.6

 

Conduct between Effective Date and Completion Date :

 

3.6.1

 

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:

 

(i)

 

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

 

 

(ii)

 

do or permit anything to be done which would be contrary to the provisions of applicable law.

 

3.6.2

 

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.

 

3.6.3

 

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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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.

 

 

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.

 

3.7

 

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:

 

3.7.1

 

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

 

3.7.2

 

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.

 

3.8

 

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.

Article 4

Territory

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.

Article 5

Roles of the Parties

5.1

 

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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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.

5.2

 

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.

Article 6

Issue and Transfer of Shares

6.1

 

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.

 

6.2

 

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.

 

6.3

 

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:

 

6.3.1

 

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

 

6.3.2

 

the transferring Shareholder guarantees and indemnifies the other Party in respect of all the obligations and any liability of the transferee under this Agreement.

 

6.3.3

 

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.

 

6.4

 

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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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.

 

 

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.

 

6.5

 

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.

 

6.6

 

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

Page 14 of 56


 

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.

 

 

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.

 

6.7

 

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.

 

6.8

 

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.

 

6.9

 

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

Page 15 of 56


 

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.

 

 

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.

 

6.10

 

The COMPANY shall place a legend on all share certificates in respect of the Shares, stating as follows:

 

 

 

“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.”

6.11

 

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.

 

6.12

 

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.

 

6.13

 

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.

Page 16 of 56


 

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.

Article 7

Business of the COMPANY

7.1

 

The business of the COMPANY (the “Business”) shall include researching, developing, manufacturing, marketing and selling of Products in the Territory.

 

7.2

 

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.

 

7.3

 

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.

 

7.4

 

Cadila and Novavax, pursuant and subject to the respective Technical Services Agreements, shall provide reasonable assistance to COMPANY in establishing such manufacturing facility.

 

7.5

 

Except as may be otherwise provided herein, the COMPANY shall be operated as an independent entity.

Page 17 of 56


 

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.

7.6

 

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.

 

7.7

 

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.

 

7.8

 

The COMPANY, Cadila and Novavax shall grant certain negotiation rights to each other for certain future products as follows:

 

7.8.1

 

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.

 

7.8.2

 

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.

Page 18 of 56


 

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.

7.8.3

 

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.

 

7.9

 

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

Page 19 of 56


 

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.

 

 

rights to approve the clinical trial protocols for any clinical trial of certain Novavax Products.

 

7.10

 

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.

Article 8

Board of Directors

8.1

 

The Board of Directors of the COMPANY (the “Board”) shall consist of 5 (five) members (“Directors”).

 

8.2

 

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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