Option Agreement

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NOVAVAX INC | CPL BIOLOGICALS LIMITED

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Title: Option Agreement
Date: 5/11/2009
Industry: Biotechnology and Drugs Sector: Healthcare

Option Agreement, Parties: novavax inc , cpl biologicals limited

Exhibit 10.8

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

This Option Agreement (the “ Agreement ”) is effective this March 31, 2009 (the “ Effective Date ”), by and between Novavax, Inc. , a Delaware corporation having an address at 9920 Belward Campus Drive, Rockville, Maryland 20850, United States of America (“ Novavax ”) and CPL Biologicals Limited , a limited company incorporated under the laws of India having an address at “Cadila Corporate Campus”, Sarkhej-Dholka Road, Bhat, Ahmedabad — 382210, Gujarat, India (“ Company ”). Novavax and Company are sometimes referred to herein each individually as a “Party” and collectively as the “Parties.”

RECITALS

Whereas, Novavax is a specialty biopharmaceutical company engaged in the research, development and commercialization of its virus like particle technology into vaccine products for the prevention of infectious diseases such as influenza and other infectious diseases;

Whereas, Company wishes to obtain an option to obtain a license to Novavax’s pandemic influenza vaccine product when and if the same comes under the Control of Novavax in the Territory; and

Whereas, Novavax is willing to grant such option as partial consideration for shares of Company in accordance with the Joint Venture Agreement.

Now, Therefore, in consideration of the foregoing premises and the mutual covenants set forth below, and for other good and valuable consideration, the receipt of which is hereby acknowledged, Novavax and Company hereby agree as follows:

ARTICLE 1

DEFINITIONS

References in the body of this Agreement to “Sections” will refer to the sections of this Agreement. In addition, as used herein, the following initially capitalized terms will have the following meanings:

1.1 “Affiliate” means any corporation or other business entity controlled by, controlling, or under common control with a Party, with “control” (for purposes of this Section 1.1 only) meaning (a) direct or indirect beneficial ownership of fifty percent (50%) or more of the voting stock (or, in the case of a non-corporate entity, of the equity interests with the power to direct the management and policies) of such corporation or other business entity, or (b) possession, directly or indirectly, of the power to direct, or cause the direction of, the management and policies of such corporation or other business entity, whether through the ownership of voting securities, by contract, or otherwise; provided that for purposes of this Agreement, Novavax and Cadila Pharmaceuticals Limited shall not be deemed to be an Affiliate of Company.

1.2 “Business Day” means any day other than a Saturday, Sunday or other day on which the principal commercial banks located in Mumbai, India and Washington, DC, United States are not open for business during normal business hours.

1.3 “Control” means, with respect to any intellectual property right, that a Party owns or has a license to such item or right, and has the ability to grant a license or sublicense in or to such right without violating the terms of any agreement or other arrangement with any Third Party existing at the time that this Agreement first requires such Party to grant the other Party such license or sublicense, provided that, for the avoidance of doubt, if the ability to grant such license or sublicense without violating the terms of any such agreement or other arrangement arises after such time, the license or sublicense shall be deemed granted hereunder at such later date.

1.4 “Joint Venture Agreement” means the Joint Venture Agreement by and between Novavax and Cadila Pharmaceuticals Limited, dated March 31, 2009.

1.5 “Know-How” means all tangible and intangible (a) techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, protocols, processes, formulas, knowledge, know-how, skill, experience, records, documents, data and results (including pharmacological, toxicological, non-clinical and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms and (b) compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical material.

1.6 “Laws” means all applicable laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, or other political subdivision, domestic or foreign.

1.7 “Licensed Product” means Novavax’s current intra-muscular pandemic influenza vaccine containing a virus like particle (VLP) consisting of an avian influenza M1 protein or influenza M1 protein containing an avian influenza M1 L-domain sequence and a pandemic influenza HA and pandemic influenza NA described in the U.S. IND No. BB-IND 13419 wherein the pandemic HA and pandemic NA under the IND are classified as pandemic by the World Health Organization (WHO) Collaborating Centers for Reference and Research on Influenza located at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, together with any minor modifications thereto including, by way of example but not limitation, changes to any excipient, changes arising from a change in manufacturing process, or change in dosage. [* * *] Licensed Product shall include the pandemic influenza vaccine containing a virus like particle (VLP) consisting of an avian influenza M1 protein or an influenza M1 protein containing an avian influenza M1 L-domain sequence and a pandemic influenza HA and pandemic influenza NA that is launched by or for Novavax for commercial sale in the United States after Regulatory Approval of such vaccine; ; it being understood that for so long as (but only for so long as) such vaccine is being developed in clinical trials by or for Novavax in support for commercial launch in the United States, such vaccine shall be deemed a Licensed Product hereunder prior to commercial launch (for the purpose of allowing the Company to develop and launch such product in the Territory in accordance with the terms and conditions of this Agreement promptly following its launch by Novavax in the United States).

1.8 “Licensed Rights” means the Novavax Patents and any and all Know-How, including any Developed Know-How, owned or Controlled by Novavax at any time during the term of this Agreement which is used or embodied in, or useful for developing or manufacturing, any Licensed Product.

1.9 “Novavax Patents” means any and all Patents in the Territory owned or Controlled by Novavax at any time during the term of this Agreement covering or claiming a Licensed Product and/or the manufacture or use thereof including, without limitation, the Patents listed on Schedule 1 .

1.10 “Patent” means any and all (a) issued patents and inventors’ certificates and re-examinations, reissues, renewals, extensions, registrations, substitutions, supplementary protection certificates and term restorations with respect to any of the foregoing, and (b) pending applications for patents and inventors’ certificates and patents that issue therefrom, including, without limitation, provisional applications, continuations, continuations in part, divisional and substitute applications with respect to any of the foregoing.

1.11 “Territory” means India.

1.12 “Third Party” means a person or entity other than (a) Novavax, (b) Company, (c) an Affiliate of Novavax or (d) an Affiliate of Company.

ARTICLE 2

OPTION

2.1 Option Grant to Company. Novavax hereby grants to Company an exclusive, fully paid-up, royalty-free (except as expressly provided in the License Agreement) non-transferable, right and option to obtain an exclusive license in the Territory (the “Option”) under the form of License Agreement attached hereto as Exhibit A that has been executed by Novavax, exercisable at Company’s option and sole discretion, upon the later of (a) the approval of the Foreign Investment Promotion Board for the issuance to Novavax of 120,000,000 shares of Company and (b) the earlier of termination or expiration (the “ Exercise Trigger Date ”) of the Third Party agreement to which a portion of the technology that is the subject of the License Agreement is subject. Novavax shall promptly provide notice to Company upon occurrence of the Exercise Trigger Date having been met together with reasonable documentation establishing that the Exercise Trigger Date has been met (the “ Trigger Notice ”)

2.2 Exercise of Option. At any time after the Exercise Trigger Date for two (2) years of Company having received the Trigger Notice, Company may exercise the Option by sending a written notice to Novavax, along with a fully executed copy of such License Agreement.

2.3 Effectiveness of License. Immediately upon receipt of the signed Notice and fully executed License by Novavax, the License Agreement shall become immediately and automatically effective as of such date.

2.4 No Implied Rights or Licenses. No right or license, other than those expressly set forth in this Agreement, are granted to either party hereunder, and no additional rights will be deemed granted to either party by implication, estoppel or otherwise. All rights not expressly granted by either party to the other hereunder are reserved.

ARTICLE 3

CONFIDENTIALITY

The Parties anticipate that under this Agreement each Party will provide confidential and/or proprietary information to the other Party and that the use and disclosure of such information shall be governed by Article 18 of the Joint Venture Agreement which is hereby incorporated by reference.

ARTICLE 4

REPRESENTATIONS AND WARRANTIES

4.1 Mutual Warranties. Each of Novavax and Company hereby represents, warrants and covenants to the other as of the Effective Date that:

(a) it has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof, and this Agreement is legally binding upon it and enforceable in accordance with its terms.

(b) the execution, delivery and performance of this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any Law of any governmental authority having jurisdiction over it; and

(c) all necessary consents, approvals and authorizations of all governmental authorities and other persons required to be obtained by such Party to enter into, or perform its obligations under, this Agreement have been obtained.

4.2 Representations by Novavax. In addition to the representations and warranties made in Section 4.1, Novavax hereby represents, warrants and covenants to Company that:

(a) as of the Effective Date, the Licensed Rights are subsisting and are not the subject of any interference, re-issue, re-exam, opposition or appeal proceedings;

(b) as of the Effective Date and the Exercise Trigger Date, no Third Party has or will have filed, pursued or maintained or, to the best of its knowledge, threatened in writing to file, pursue or maintain any claim, lawsuit, charge or other action involving any Licensed Right including any claim, lawsuit, charge, or action alleging that any Licensed Right is invalid or unenforceable;

(c) as of the Effective Date and to the best of its knowledge, all employees and agents of Novavax who have performed any activities on its behalf in connection with research regarding the Licensed Rights have properly assigned to Novavax the whole of their rights in any intellectual property made, discovered or developed by them as a result of such research, and no Third Party has any rights to any such intellectual property;

(d) as of the Exercise Trigger Date, the Licensed Rights will be free and clear of any liens, charges, encumbrances or rights of others, to possession or use that may interfere with Novavax’s possession or use under this Agreement;

(e) as of the Exercise Trigger Date, it will have sufficient rights to grant the licenses granted to the Company hereunder;

(f) as of the Effective Date and the Exercise Trigger Date, it has not granted, and during the Term it will not grant, any right to any Third Party that would conflict with the rights granted to the other Party hereunder. It has (or will have at the time performance is due) maintained and will maintain and keep in full force and effect all agreements necessary to perform its obligations hereunder; and

(g) as of the Effective Date and the Exercise Trigger Date, all third party agreements licensing any Licensed Rights to Novavax, which are sublicensed to the Company hereunder, are currently in full force and effect, and it has not received notice of material breach or termination thereof.

4.3 DISCLAIMER OF WARRANTIES . Except as expressly set forth herein, EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO. Without limiting the generality of the foregoing, each Party expressly does not warrant, and disclaims any warranties with regards to: (a) the success of any study or test commenced under this Agreement, (b) the safety or usefulness for any purpose of the technology or Materials it provides or discovers under this Agreement; and/or (c) the validity, enforceability, or non-infringement of any intellectual property rights or technology it provides or licenses to the other Party under this Agreement.

ARTICLE 5

INDEMNIFICATION

5.1 Indemnification by Novavax. Novavax will indemnify, defend and hold harmless Company, its Affiliates, directors, officers and employees (each a “ Company Indemnitee ”) from and against any and all liability, loss, damage or expense (including without limitation reasonable attorneys fees) it may suffer as the result of Third Party claims, demands, actions and proceedings brought against it (collectively, “ Losses ”) to the extent such Losses result from the negligence or willful misconduct by Novavax, its Affiliates, employees, agents or Third Party contractors.

Novavax’s obligation to indemnify the Company Indemnitee pursuant to this Section 5.1 will not apply to the extent of any Loss that arises from the (i) material breach by Company of its representations, warranties or covenants contained within this Agreement or (ii) negligence or willful misconduct of any Company Indemnitee.

5.2 Procedures. Indemnitor’s agreement to indemnify, defend and hold harmless an Indemnitee is conditioned on Indemnitee (a) providing prompt written notice of any claim giving rise to an indemnification obligation hereunder but only if a failure to so notify causes prejudicial harm to the Indemnitor’s ability to defend, (b) permitting Indemnitor to assume full responsibility to investigate, prepare for and defend against any such claim, (c) providing reasonable assistance in the defense of such claim at Indemnitor’s reasonable expense, and (d) not compromising or settling such claim without Indemnitor’s advance written consent.

5.3 Limitation of Liability. EXCEPT AS REGARDS A BREACH OF A PARTY’S RESPONSIBILITIES PURSUANT TO ARTICLE 3, NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES WILL BE LIABLE TO THE OTHER PARTY FOR ANY LOSS OF PROFITS, LOSS OF BUSINESS OR INTERRUPTION OF BUSINESS, OR FOR ANY OTHER INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES UNDER THIS AGREEMENT, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES.

ARTICLE 6

TERM

6.1 Term and Termination. The term of this Agreement will commence on the Effective Date and will continue until (a) expiration of the Option as provided in Section 2.2, (b) the Parties mutually agree in writing to terminate the Agreement, or (c) Novavax terminates the Joint Venture Agreement by providing a Notice of Termination under and pursuant to Section 11.2 of the Joint Venture Agreement (the “Term” ).

ARTICLE 7

DISPUTE RESOLUTION

7.1 Disputes. The Parties recognize that disputes as to certain matters may from time to time arise during the Term which relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Article 7 if and when a dispute arises under this Agreement.

7.2 Arbitration. Any dispute arising between the Parties out of or in connection with the implementation or interpretation of this Agreement shall, if not settled amicably within ninety (90) days from the date that the dispute arose, be finally settled by three (3) arbitrators. Each Party

shall be entitled to appoint one (1) arbitrator and the two (2) so appointed shall appoint the third arbitrator in accordance with the Indian Arbitration and Conciliation Act, 1996. It is hereby agreed that Part I of the Indian Arbitration and Conciliation Act, 1996 (except for the provisions of Section 9 thereof) shall not apply to the arbitration under this Agreement. The language of the arbitration proceedings shall be English and its place shall be Singapore. The arbitral award or determination shall be final and subject to no appeal and shall deal with the question of costs of arbitration and all matters related thereto.

7.3 Equitable Claims. Notwithstanding anything to the contrary in this Article 7, either Party has the right to seek temporary injunctive relief or any other interim equitable remedy in any court of competent jurisdiction as may be available to such Party under the laws applicable to such jurisdiction that may be necessary to protect the rights or property of that Party until such time as any dispute underlying such temporary injunctive relief or any other interim equitable remedy has been resolved in accordance with Section 7.2.

7.4 Governing Law. The substantive laws of India will govern the resolution of all disputes, controversies and claims under, arising out of or relating to the validity, construction, enforceability or performance of this Agreement and any related remedies, without giving effect to any choice of law rules.

7.5 Award. Each Party will abide by any arbitral award rendered pursuant to this Article 7. If a Party resists enforcement of an arbitral award, any costs, fees or taxes incident to enforcement will be charged against that Party to the extent permitted by Law. Each Party will bear its own legal fees for arbitration, and the arbitrator(s) will assess their costs, fees and expenses against the Party losing the arbitration.

7.6 Injunctive Relief. If a Party makes a sufficient showing under the rules and standards set forth in the rules of civil procedure and applicable Law, the arbitrator may, and the Parties will abide by, injunctive measures after either Party submits in writing for arbitration claims requiring immediate relief. Notwithstanding the foregoing, and in accordance with Section 7.3, a Party will also be free at any time to bring an Equitable Claim to any court of competent jurisdiction without submitting such request to an arbitrator.

7.7 Confidentiality. Any arbitration proceeding, including without limitation the existence of any dispute submitted to arbitration and any arbitral award or decision, will be Confidential Information of both Parties, and the arbitrator(s) will issue appropriate protective orders to safeguard each Party’s Confidential Information, provided that such Confidential Information may be disclosed solely as necessary in connection with the enforcement of an arbitral award or as otherwise required by Law (subject to Section 7.3).

ARTICLE 8

MISCELLANEOUS

8.1 Entire Agreement. This Agreement (including its Exhibits) sets forth all the covenants, promises, agreements, warranties, representations, conditions and understandings

between the Parties with respect to the subject matter hereof and supersedes and terminates all prior agreements and understanding between the Parties with respect to such subject matter. No subsequent alteration, amendment, change or addition to this Agreement will be binding upon the Parties unless reduced to writing and signed by the respective authorized officers of the Parties.

8.2 Third Party Contractors. The Parties will perform their obligations under this Agreement as Third Party contractors and nothing contained in this Agreement will be construed to be inconsistent with such relationship or status. This Agreement will not constitute, create or in any way be interpreted as a joint venture or partnership of any kind.

8.3 Notices. Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement ( “Notice” ) will be in writing, will refer specifically to this Agreement and will be deemed given only if sent by electronic mail (with receipt confirmed), facsimile transmission (with transmission confirmed) or by an internationally recognized delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in this Section 8.3 or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Section 8.3. Any notice delivered by electronic mail or facsimile will be confirmed by a hard copy delivered as soon as practicable thereafter by an internationally recognized overnight delivery service. Such Notice will be deemed to have been given on the second Business Day (at the place of delivery) after deposit with an internationally recognized delivery service. This Section 8.3 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement.


If to Novavax:		Novavax, Inc.
		9920 Belaward Campus Drive
		Rockville Maryland 20850
		Attn: Ray Hage, Senior Vice President
		Email: Rhage@Novavax.com
		Facsimile No.: 240-268-2122

If to Company:		CPL Biologicals Limited
		Cadila Corporate Campus
		Sarkhej-Dholka Road
		Bhat, Ahmedabad — 382210
		Gujarat, India
		Attn: Dr. Rajiv I. Modi, Managing Director
		Email: rimodi@cadilapharma.co.in
		Facsimile No.: +91 (02718) 225031

8.4 Assignment.

(a) Novavax may not assign this Agreement, in whole or in part, without the advance written consent of the Company; provided, however, that this Agreement shall be automatically assigned to Novavax’s successor in connection with the acquisition, merger or sale of Novavax or the sale, transfer, lease, assignment or disposal of all or substantially all of the

property or assets of Novavax, whether by way of a single transaction or a series of related transactions, and such successor shall be fully bound by the terms and conditions hereof.

(b) The Company may not assign this Agreement, in whole or in part, without the advance written consent of Novavax; provided, however, that this Agreement shall be automatically assigned to the Company’s successor in connection with the sale, transfer, lease, assignment or disposal of all or substantially all of the property or assets of the Company , whether by way of a single transaction or a series of related transactions, including a Change in Control of the Company (as that term is defined in Schedule II of the Joint Venture Agreement), and such successor shall be fully bound by the terms and conditions hereof; provided that any such automatic assignment by Company within the scope of Schedule II of the Joint Venture Agreement shall only be effective if such transaction was approved by Novavax under and pursuant to the Joint Venture Agreement for so long as such approval rights of Novavax under the Joint Venture Agreement have not been terminated.

8.5 Headings. The headings for each article and section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular article or section.

8.6 No Strict Construction. This Agreement has been prepared jointly and will not be strictly construed against either Party.

8.7 Ambiguities. Ambiguities and uncertainties in this Agreement, if any, will not be interpreted against either Party, irrespective of which Party may be deemed to have caused the ambiguity or uncertainty to exist.

8.8 English Language. All notices required or permitted to be given hereunder, and all written, electronic, oral or other communications between the Parties regarding this Agreement will be in the English language. This Agreement is in the English language only, which language will be controlling in all respects, and all versions hereof in any other language will be for accommodation only and will not be binding upon the Parties.

8.9 No Waiver. Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter will not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, excepting only as to an express written and signed waiver as to a particular matter for a particular period of time.

8.10 Severability. If one or more of the provisions in this Agreement are deemed unenforceable by Law, then such provision will be deemed stricken from this Agreement and the remaining provisions will continue in full force and effect and shall be interpreted to give full effect to the commercial agreement between the Parties.

8.11 Counterparts. This Agreement may be executed in one or more identical counterparts, each of which will be deemed to be an original, and which collectively will be deemed to be one and the same instrument.

[Signature Page to Follow]

In Witness Whereof, the Parties have by duly authorized persons executed this License Agreement as of the Effective Date.


Novavax, Inc.		CPL Biologicals Limited

By:	/s/ Rahul Singhvi Rahul Singhvi	By:	/s/ Rajiv I. Modi Rajiv I. Modi
	President and Chief Executive Officer		Managing Director

[Signature Page to License Agreement]

Exhibit A

Form of License Agreement executed by Novavax

LICENSE AGREEMENT

This License Agreement (the “ Agreement ”) is executed this March 31, 2009 (the “ Execution Date ”), to be effective as set forth in Article 4, by and between Novavax, Inc. , a Delaware corporation having an address at 9920 Belward Campus Drive, Rockville, Maryland 20850, United States of America (“ Novavax ”) and CPL Biologicals Limited , a limited company incorporated under the laws of India having an address at “Cadila Corporate Campus”, Sarkhej-Dholka Road, Bhat, Ahmedabad — 382210, Gujarat, India (“ Company ”). Novavax and Company are sometimes referred to herein each individually as a “Party” and collectively as the “Parties.”

RECITALS

Whereas, on the Effective Date, Novavax will Control the Licensed Rights, as defined below;

Whereas, Company wishes to obtain a license as of the Effective Date under the Licensed Rights, to practice the processes included or claimed in the Licensed Rights and to Develop and Commercialize Licensed Product; and

Whereas, Novavax is willing to grant such license on the terms and conditions of this Agreement.

ARTICLE 1

DEFINITIONS

voting stock (or, in the case of a non-corporate entity, of the equity interests with the power to direct the management and policies) of such corporation or other business entity, or (b) possession, directly or indirectly, of the power to direct, or cause the direction of, the management and policies of such corporation or other business entity, whether through the ownership of voting securities, by contract, or otherwise; provided that for purposes of this Agreement, Novavax and Cadila Pharmaceuticals Limited shall not be deemed to be an Affiliate of Company.

1.3 “Commercialize” or “Commercialization” means all activities that are undertaken to prepare for launch before Regulatory Approval (including pricing and reimbursement approvals) undertaken after Regulatory Approval for a particular Licensed Product and that relate to the commercial marketing and sale of such Licensed Product including advertising, sales, marketing, promotion, distribution, and phase IV clinical trials.

1.4 “Control” means, with respect to any intellectual property right, that a Party owns or has a license to such item or right, and has the ability to grant a license or sublicense in or to such right without violating the terms of any agreement or other arrangement with any Third Party existing at the time that this Agreement first requires such Party to grant the other Party such license or sublicense, provided that, for the avoidance of doubt, if the ability to grant such license or sublicense without violating the terms of any such agreement or other arrangement arises after such time, the license or sublicense shall be deemed granted hereunder at such later date.

1.5 “Develop” or “Development” means the performance of all non-clinical, pre-clinical and clinical development, manufacturing and regulatory activities for a Licensed Product that are required to obtain Regulatory Approval of a Licensed Product in the Territory.

1.6 “Developed Know-How” has the meaning in Section 5.1.

1.7 “Effective Date ” means the date on which the condition precedent set forth in Article 4 is first satisfied.

1.8 “Governmental Authority” means any applicable court, agency, department or other instrumentality of any foreign, federal, state, county, city or other political subdivision.

1.9 “IND” means a U.S. Food and Drug Administration investigational new drug application, or its foreign equivalent.

1.10 “Joint Venture Agreement” means the Joint Venture Agreement by and between Novavax and Cadila Pharmaceuticals Limited, dated March 31, 2009.

1.11 “Know-How” means all tangible and intangible (a) techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, protocols, processes, formulas, knowledge, know-how, skill, experience, records, documents, data and results

(including pharmacological, toxicological, non-clinical and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms and (b) compositions of matter, cells, cell lines, assays, animal models and physic

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