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
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
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
OPTION TO OBTAIN LICENSE
Β Β Β Β Β This Option Agreement (the βAgreementβ) is effective this MarchΒ 31, 2009 (the
βEffective Dateβ), by and between Novavax, Inc., a Delaware corporation having an address
at 0000 Xxxxxxx Xxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxx 00000, Xxxxxx Xxxxxx of America (βNovavaxβ)
and CPL Biologicals Limited, a limited company incorporated under the laws of India having
an address at βCadila Corporate Campusβ, Sarkhej-Dholka Road, Bhat, Xxxxxxxxx β 000000, Xxxxxxx,
Xxxxx (βCompanyβ). Novavax and Company are sometimes referred to herein each individually
as a βPartyβ and collectively as the βParties.β
RECITALS
Β Β Β Β Β 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;
Β Β Β Β Β Whereas, Company wishes to obtain an option to obtain a license to Novavaxβs pandemic
influenza vaccine product when and if the same comes under the Control of Novavax in the Territory;
and
Β Β Β Β Β Whereas, Novavax is willing to grant such option as partial consideration for shares
of Company in accordance with the Joint Venture Agreement.
Β Β Β Β Β 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
Β Β Β Β Β References in the body of this Agreement to βSectionsβ will refer to the sections of this
Agreement. In addition, as used herein, the following initially capitalized terms will have the
following meanings:
Β Β Β Β Β 1.1 βAffiliateβ means any corporation or other business entity controlled by, controlling, or
under common control with a Party, with βcontrolβ (for purposes of this SectionΒ 1.1 only) meaning
(a)Β 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)Β 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
Β
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β Β Β Β Β 1.2 βBusiness Dayβ 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.
Β Β Β Β Β 1.3 βControlβ 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.
Β Β Β Β Β 1.4 βJoint Venture Agreementβ means the Joint Venture Agreement by and between Novavax and
Cadila Pharmaceuticals Limited, dated MarchΒ 31, 2009.
Β Β Β Β Β 1.5 βKnow-Howβ means all tangible and intangible (a)Β 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)Β compositions of
matter, cells, cell lines, assays, animal models and physical, biological or chemical material.
Β Β Β Β Β 1.6 βLawsβ 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.
Β Β Β Β Β 1.7 βLicensed Productβ means Novavaxβs current intra-muscular pandemic influenza vaccine
containing a virus like particle (VLP)Β 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.Β BB-IND 13419 wherein the pandemic HA and pandemic NA
under the IND are classified as pandemic by the World Health Organization (WHO)Β Collaborating
Centers for Reference and Research on Influenza located at the Centers for Disease Control and
Prevention (CDC)Β 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)Β 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).
2
Β
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β Β Β Β Β 1.8 βLicensed Rightsβ 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.
Β Β Β Β Β 1.9 βNovavax Patentsβ 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
ScheduleΒ 1.
Β Β Β Β Β 1.10 βPatentβ means any and all (a)Β issued patents and inventorsβ certificates and
re-examinations, reissues, renewals, extensions, registrations, substitutions, supplementary
protection certificates and term restorations with respect to any of the foregoing, and (b)Β pending
applications for patents and inventorsβ 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.
Β Β Β Β Β 1.11 βTerritoryβ means India.
Β Β Β Β Β 1.12 βThird Partyβ means a person or entity other than (a)Β Novavax, (b)Β Company, (c)Β an
Affiliate of Novavax or (d)Β an Affiliate of Company.
ARTICLE 2
OPTION
Β Β Β Β Β 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 βOptionβ) under the form of License
Agreement attached hereto as ExhibitΒ A that has been executed by Novavax, exercisable at Companyβs
option and sole discretion, upon the later of (a)Β the approval of the Foreign Investment Promotion
Board for the issuance to Novavax of 120,000,000 shares of Company and (b)Β the earlier of
termination or expiration (the βExercise Trigger Dateβ) 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 βTrigger Noticeβ)
Β Β Β Β Β 2.2 Exercise of Option. At any time after the Exercise Trigger Date for two (2)Β 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.
Β Β Β Β Β 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.
3
Β
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β Β Β Β Β 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
Β Β Β Β Β 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 ArticleΒ 18 of the Joint Venture Agreement which is hereby incorporated by
reference.
ARTICLE 4
REPRESENTATIONS AND WARRANTIES
Β Β Β Β Β 4.1 Mutual Warranties. Each of Novavax and Company hereby represents, warrants and covenants
to the other as of the Effective Date that:
Β Β Β Β Β Β Β Β Β Β (a)Β 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.
Β Β Β Β Β Β Β Β Β Β (b)Β 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
Β Β Β Β Β Β Β Β Β Β (c)Β 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.
Β Β Β Β Β 4.2 Representations by Novavax. In addition to the representations and warranties made in
SectionΒ 4.1, Novavax hereby represents, warrants and covenants to Company that:
Β Β Β Β Β (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;
Β Β Β Β Β (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;
4
Β
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β Β Β Β Β (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;
Β Β Β Β Β (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 Novavaxβs possession or use under this Agreement;
Β Β Β Β Β (e) as of the Exercise Trigger Date, it will have sufficient rights to grant the
licenses granted to the Company hereunder;
Β Β Β Β Β (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
Β Β Β Β Β (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.
Β Β Β Β Β 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)Β the success of any study or test commenced under this Agreement, (b)Β the
safety or usefulness for any purpose of the technology or Materials it provides or discovers under
this Agreement; and/or (c)Β 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
Β Β Β Β Β 5.1 Indemnification by Novavax. Novavax will indemnify, defend and hold harmless Company, its
Affiliates, directors, officers and employees (each a βCompany Indemniteeβ) 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, βLossesβ) to the extent such Losses result from the negligence or willful
misconduct by Novavax, its Affiliates, employees, agents or Third Party contractors.
5
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Novavaxβs obligation to indemnify the Company Indemnitee pursuant to this SectionΒ 5.1 will not
apply to the extent of any Loss that arises from the (i)Β material breach by Company of its
representations, warranties or covenants contained within this Agreement or (ii)Β negligence or
willful misconduct of any Company Indemnitee.
Β Β Β Β Β 5.2 Procedures. Indemnitorβs agreement to indemnify, defend and hold harmless an Indemnitee
is conditioned on Indemnitee (a)Β 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 Indemnitorβs ability to defend, (b)Β permitting Indemnitor to assume full responsibility to
investigate, prepare for and defend against any such claim, (c)Β providing reasonable assistance in
the defense of such claim at Indemnitorβs reasonable expense, and (d)Β not compromising or settling
such claim without Indemnitorβs advance written consent.
Β Β Β Β Β 5.3 Limitation of Liability. EXCEPT AS REGARDS A BREACH OF A PARTYβS
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
Β Β Β Β Β 6.1 Term and Termination. The term of this Agreement will commence on the Effective Date and
will continue until (a)Β expiration of the Option as provided in SectionΒ 2.2, (b)Β the Parties
mutually agree in writing to terminate the Agreement, or (c)Β Novavax terminates the Joint Venture
Agreement by providing a Notice of Termination under and pursuant to SectionΒ 11.2 of the Joint
Venture Agreement (the βTermβ).
ARTICLE 7
DISPUTE RESOLUTION
Β Β Β Β Β 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 Partyβs 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 ArticleΒ 7 if and when a dispute arises under this Agreement.
Β Β Β Β Β 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)Β days from the date that the dispute arose, be finally settled by three (3)Β arbitrators. Each
Party
6
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
shall be entitled to appoint one (1)Β arbitrator and the two (2)Β so appointed shall appoint the
third arbitrator in accordance with the Indian Arbitration and Conciliation Act, 1996. It is
hereby agreed that PartΒ I of the Indian Arbitration and Conciliation Act, 1996 (except for the
provisions of SectionΒ 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.
Β Β Β Β Β 7.3 Equitable Claims. Notwithstanding anything to the contrary in this ArticleΒ 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 SectionΒ 7.2.
Β Β Β Β Β 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.
Β Β Β Β Β 7.5 Award. Each Party will abide by any arbitral award rendered pursuant to this ArticleΒ 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.
Β Β Β Β Β 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 SectionΒ 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.
Β Β Β Β Β 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 Partyβs 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 SectionΒ 7.3).
ARTICLE 8
MISCELLANEOUS
Β Β Β Β Β 8.1 Entire Agreement. This Agreement (including its Exhibits) sets forth all the covenants,
promises, agreements, warranties, representations, conditions and understandings
7
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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.
Β Β Β Β Β 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.
Β Β Β Β Β 8.3 Notices. Any notice, request, demand, waiver, consent, approval or other communication
permitted or required under this Agreement (βNoticeβ) 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 SectionΒ 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 SectionΒ 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 SectionΒ 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.
Β | Β | Β |
If to Novavax:
|
Β | Novavax, Inc. |
Β
|
Β | 0000 Xxxxxxxx Xxxxxx Xxxxx |
Β
|
Β | Xxxxxxxxx Xxxxxxxx 00000 |
Β
|
Β | Attn: Xxx Xxxx, Senior Vice President |
Β
|
Β | Email: Xxxxx@Xxxxxxx.xxx |
Β
|
Β | Facsimile No.: 000-000-0000 |
Β |
Β | Β |
If to Company:
|
Β | CPL Biologicals Limited |
Β
|
Β | Cadila Corporate Campus |
Β
|
Β | Sarkhej-Dholka Road |
Β
|
Β | Bhat, Ahmedabad β 382210 |
Β
|
Β | Gujarat, India |
Β
|
Β | Attn: Xx.Β Xxxxx X. Xxxx, Managing Director |
Β
|
Β | Email: xxxxxx@xxxxxxxxxxxx.xx.xx |
Β
|
Β | Facsimile No.: +91 (02718)Β 225031 |
Β Β Β Β Β 8.4 Assignment.
Β Β Β Β Β Β Β Β Β Β (a)Β 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
Novavaxβs 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
8
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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.
Β Β Β Β Β Β Β Β Β Β (b)Β 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 Companyβs 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 ScheduleΒ 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 ScheduleΒ 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.
Β Β Β Β Β Β Β Β Β Β (c)Β Any assignment or purported assignment by either Party in violation of this SectionΒ 8.4
will be null and void.
Β Β Β Β Β 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.
Β Β Β Β Β 8.6 No Strict Construction. This Agreement has been prepared jointly and will not be strictly
construed against either Party.
Β Β Β Β Β 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.
Β Β Β Β Β 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.
Β Β Β Β Β 8.9 No Waiver. Any delay in enforcing a Partyβs rights under this Agreement or any waiver as
to a particular default or other matter will not constitute a waiver of such Partyβs 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.
Β Β Β Β Β 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.
9
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β Β Β Β Β 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]
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β Β Β Β Β In Witness Whereof, the Parties have by duly authorized persons executed this License
Agreement as of the Effective Date.
Β | Β | Β | Β | Β | Β | Β | Β | Β | Β | Β |
Novavax, Inc. | Β | Β | Β | CPL Biologicals Limited | Β | Β | ||||
Β |
Β | Β | Β | Β | Β | Β | Β | Β | Β | Β |
By:
|
Β | /s/ Xxxxx Xxxxxxx
Β
Xxxxx Xxxxxxx
|
Β | Β | Β | By: | Β | /s/ Xxxxx X. Xxxx
Β
Xxxxx X. Xxxx
|
Β | Β |
Β
|
Β | President and Chief Executive Officer | Β | Β | Β | Β | Β | Managing Director | Β | Β |
[Signature Page to License Agreement]
Β
Β
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ExhibitΒ A
Form of License Agreement executed by Novavax
LICENSE AGREEMENT
Β Β Β Β Β This License Agreement (the βAgreementβ) is executed this MarchΒ 31, 2009 (the
βExecution Dateβ), to be effective as set forth in ArticleΒ 4, by and between Novavax,
Inc., a Delaware corporation having an address at 0000 Xxxxxxx Xxxxxx Xxxxx, Xxxxxxxxx,
Xxxxxxxx 00000, Xxxxxx Xxxxxx of America (βNovavaxβ) and CPL Biologicals Limited, a
limited company incorporated under the laws of India having an address at βCadila Corporate
Campusβ, Sarkhej-Dholka Road, Bhat, Xxxxxxxxx β 000000, Xxxxxxx, Xxxxx (βCompanyβ).
Novavax and Company are sometimes referred to herein each individually as a βPartyβ and
collectively as the βParties.β
RECITALS
Β Β Β Β Β 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;
Β Β Β Β Β Whereas, on the Effective Date, Novavax will Control the Licensed Rights, as defined
below;
Β Β Β Β Β 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
Β Β Β Β Β Whereas, Novavax is willing to grant such license on the terms and conditions of this
Agreement.
Β Β Β Β Β 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
Β Β Β Β Β References in the body of this Agreement to βSectionsβ will refer to the sections of this
Agreement. In addition, as used herein, the following initially capitalized terms will have the
following meanings:
Β Β Β Β Β 1.1 βAffiliateβ means any corporation or other business entity controlled by, controlling, or
under common control with a Party, with βcontrolβ (for purposes of this SectionΒ 1.1 only) meaning
(a)Β direct or indirect beneficial ownership of fifty percent (50%) or more of the
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
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EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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.
Β Β Β Β Β 1.2 βBusiness Dayβ 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.
Β Β Β Β Β 1.3 βCommercializeβ or βCommercializationβ 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.
Β Β Β Β Β 1.4 βControlβ 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.
Β Β Β Β Β 1.5 βDevelopβ or βDevelopmentβ 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.
Β Β Β Β Β 1.6 βDeveloped Know-Howβ has the meaning in SectionΒ 5.1.
Β Β Β Β Β 1.7 βEffective Dateβ means the date on which the condition precedent set forth in ArticleΒ 4 is
first satisfied.
Β Β Β Β Β 1.8 βGovernmental Authorityβ means any applicable court, agency, department or other
instrumentality of any foreign, federal, state, county, city or other political subdivision.
Β Β Β Β Β 1.9 βINDβ means a U.S. Food and Drug Administration investigational new drug application, or
its foreign equivalent.
Β Β Β Β Β 1.10 βJoint Venture Agreementβ means the Joint Venture Agreement by and between Novavax and
Cadila Pharmaceuticals Limited, dated MarchΒ 31, 2009.
Β Β Β Β Β 1.11 βKnow-Howβ means all tangible and intangible (a)Β techniques, technology, practices, trade
secrets, inventions (whether patentable or not), methods, protocols, processes, formulas,
knowledge, know-how, skill, experience, records, documents, data and results
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(including pharmacological, toxicological, non-clinical and clinical test data and results),
analytical and quality control data, results or descriptions, software and algorithms and
(b)Β compositions of matter, cells, cell lines, assays, animal models and physical, biological or
chemical material.
Β Β Β Β Β 1.12 βLawsβ 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.
Β Β Β Β Β 1.13 βLicensed Productβ means Novavaxβs current intra-muscular pandemic influenza vaccine
containing a virus like particle (VLP)Β 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 described in the U.S. IND No.Β 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)Β 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)Β 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).
Β Β Β Β Β 1.14 βLicensed Rightsβ means the Novavax Patents and any and all Know-How, including any
Developed Know-How, owned or Controlled by Novavax at any time during the term of this Agreement
which is used or embodied in, or useful for developing or manufacturing, any Licensed Product,
including, without limitation, Know-How regarding Novavaxβs proprietary baculovirus insect cell
expression and manufacturing system and improvements thereto.
Β Β Β Β Β 1.15 βNovavax Patentsβ 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
ScheduleΒ 1.
Β Β Β Β Β 1.16 βPatentβ means any and all (a)Β issued patents and inventorsβ certificates and
re-examinations, reissues, renewals, extensions, registrations, substitutions, supplementary
protection certificates and term restorations with respect to any of the foregoing, and (b)Β pending
applications for patents and inventorsβ 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.
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β Β Β Β Β 1.17 βProgram Dataβ means (a)Β research, preclinical, clinical, manufacturing and similar data,
information, material and results, (b)Β regulatory filings and approvals, and (c)Β sales and
marketing information.
Β Β Β Β Β 1.18 βRegulatory Approvalβ means any and all approvals (including supplements, amendments,
pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or
authorizations of any national, supra-national, regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity, that are necessary for the
manufacture, distribution, use or widespread sale of a Licensed Product in a regulatory
jurisdiction in the Territory.
Β Β Β Β Β 1.19 βRegulatory Authorityβ means any Governmental Authority with responsibility for granting
any licenses or approvals necessary for the marketing and sale of pharmaceutical products in the
Territory.
Β Β Β Β Β 1.20 βRegulatory Documentationβ means, with respect to a Licensed Product, all Regulatory
Filings and supporting documents created, submitted to a Regulatory Authority, and all data
contained therein, including, without limitation, any Investigational New Drug Application, New
Drug Application, Marketing Authorization Application, foreign counterparts thereof, Investigatorβs
Brochures, drug master files, correspondence to and from a Regulatory Authority, minutes from
teleconferences with Regulatory Authorities, registrations and licenses, regulatory drug lists,
advertising and promotion documents shared with Regulatory Authorities, adverse event files,
complaint files and manufacturing records.
Β Β Β Β Β 1.21 βRegulatory Filingβ means the foreign counterparts of an Investigation New Drug
Application, New Drug Application, Marketing Authorization Application and any other filings
required by Regulatory Authorities relating to the study, Development, manufacture or
Commercialization of any Licensed Product in the Territory.
Β Β Β Β Β 1.22 βTechnical Services Agreementβ means that certain Technical Services Agreement between
Novavax and Company dated as of the date hereof.
Β Β Β Β Β 1.23 βTerritoryβ means India.
Β Β Β Β Β 1.24 βThird Partyβ means a person or entity other than (a)Β Novavax, (b)Β Company, (c)Β an
Affiliate of Novavax or (d)Β an Affiliate of Company.
Β Β Β Β Β 1.25 βU.S.β means the United States of America.
ARTICLE 2
LICENSES
Β Β Β Β Β 2.1 License Grant to Company. Novavax hereby grants to Company an exclusive, fully paid-up,
royalty-free (except as expressly set forth in SectionΒ 2.7), non-transferable, right and license
under the Licensed Rights during the term of this Agreement to (a)Β research, develop, use,
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EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
sell, have sold, offer to sell and import Licensed Product in the Territory, and (b)Β make (and
have made solely by Cadila or an Affiliate of Cadila, subject to Novavaxβs approval described
below) Licensed Product in the Territory solely to develop, use, sell, have sold, offer to sell and
import Licensed Product in the Territory. The foregoing license shall be exclusive for Licensed
Product in the Territory, even as to Novavax, provided that Novavax retains the right to perform
its obligations under this Agreement, the Technical Services Agreement and any other agreement
between Company and Novavax.
Β Β Β Β Β Novavax shall be reasonable in granting or withholding its approval to permit Cadila or an
Affiliate of Cadila to make Licensed Product in the Territory. Novavaxβs approval shall be subject
to its consideration of, among other things, any documentation or agreement surrounding such
manufacturing of the Licensed Product (which, in any case, shall be solely for the benefit of the
Company), the safeguards in place with regard to any such manufacturing, the protection of the
Licensed Rights, and Novavaxβs ability to conduct reasonable due diligence on any Affiliate of
Cadila. In no event does the license grant to the Company under this SectionΒ 2.1 permit the
Company to have Licensed Product made by a Third Party
Β Β Β Β Β 2.2 License Grant to Novavax. The Company hereby grants to Novavax a fully paid-up,
royalty-free exclusive right and license under Developed Know-How owned or Controlled by the
Company, including any Patents that issue therefrom, to (a)Β research, develop, use, sell, have
sold, offer to sell and import non-seasonal influenza vaccines outside the Territory, and (b)Β make
and have made non-seasonal influenza vaccines outside the Territory solely to develop, use, sell,
have sold, offer to sell and import non-seasonal influenza vaccines outside the Territory.
Β Β Β Β Β 2.3 Sublicenses. Company shall not sublicense the Licensed Rights to any Third Party without
the prior written consent of Novavax, which consent may be withheld in its sole discretion. Upon
execution of a sublicense, after receipt of Novavax consent, Company will notify Novavax of the
execution of the sublicense and provide a copy to Novavax promptly following execution thereof.
Β Β Β Β Β 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.
Β Β Β Β Β 2.5 Research Data; Right of Reference.
Β Β Β Β Β Β Β Β Β Β (a)Β Company shall keep complete and accurate notes, accounts and records of all Program Data
with respect to Licensed Product, including the manufacture thereof. Novavax shall have the right
to access, use and reference for its Development and Commercialization of its products outside the
Territory Program Data related to Licensed Product in the possession or control of the Company.
The Company shall provide such cooperation and assistance as reasonably requested by Novavax from
time to time to effectuate the foregoing, including, without limitation by providing access to and
disclosure of Program Data to Novavax and by providing such authorization and consents required for
reference to regulatory filings and approvals.
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EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β Β Β Β Β Β Β Β Β Β (b)Β Company shall have the right to access, use and reference for its Development and
Commercialization of Licensed Product in the Territory Program Data related to Licensed Product in
the possession or control of Novavax. Novavax shall provide such cooperation and assistance as
reasonably requested by Company from time to time to effectuate the foregoing, including, without
limitation by providing access to and disclosure of Program Data to Company and by providing such
authorization and consents required for reference to regulatory filings and approvals.
Β Β Β Β Β 2.6 Grey Market. The Parties reasonably cooperate to formulate and implement reasonable
precautions designed to prevent Licensed Product made or sold by or for such Party or its
respective Affiliates and permitted sublicensees from being sold outside of its respective
territory (i.e., outside the Territory for the Company and inside the Territory for Novavax).
Further, each Party will take reasonable measures so that its distributors, Affiliates and
wholesalers to whom the Company or Novavax provides its respective Licensed Product are aware of
the respective territorial limitations.
Β Β Β Β Β 2.7 Third Party License Agreements. The license granted under SectionΒ 2.1 may be subject to
applicable terms and conditions of a license agreement with a Third Party, under which any Licensed
Rights are sublicensed to the Company hereunder by Novavax (each a βThird Party License
Agreementβ). Novavax shall be responsible for maintaining the Third Party License Agreements
and for any payments owed by Novavax thereunder; provided, however, that if a royalty is owed on
sales of Licensed Product by or for the Company in the Territory under such Third Party License
Agreement, such payments will be paid by Company.
Β Β Β Β Β 2.8 Combination Products Reservation. Novavax shall not, directly or indirectly, (i)Β engage
in, promote, or finance the research, development, or commercialization of, or (ii)Β grant any
license, or any similar rights with respect to, to a Third Party, in each case of (i)Β and (ii), a
Licensed Product in combination with another active ingredient, antigen or adjuvant in the
Territory.
ARTICLE 3
LICENSED PRODUCT DEVELOPMENT AND COMMERCIALIZATION
Β Β Β Β Β 3.1 Development and Commercialization of Licensed Product.
Β Β Β Β Β Β Β Β Β Β (a) General. Company will have sole responsibility, at Companyβs sole expense, for all
Development and Commercialization of Licensed Product in the Territory in accordance with the terms
of this Agreement.
Β Β Β Β Β Β Β Β Β Β (b) Development and Commercialization of Licensed Product. Within [* * *] days of the
Effective Date, Company shall present to Novavax for its written approval Development plans for the
Licensed Product which shall specify preclinical studies (including a toxicology program and other
preclinical testing), human clinical trials, manufacturing scale up, Regulatory Approval strategy
and any other significant Development activities, that Company plans to perform to obtain
Regulatory Approval of such Licensed Product in the Territory (the
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WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
βDevelopment Plansβ). Novavax may reasonably request adjustments to activities described in
such Development plans as a condition to granting its approval. In no event shall Company
materially alter a Development Plan without Novavaxβs prior written consent. Company shall conduct
Development of such Licensed Product in a manner that is materially consistent with the Development
Plans. All clinical trial protocols for Licensed Product conducted by Company shall require the
prior written approval of Novavax. At least [* * *] prior to anticipated commercial launch,
Company shall present to Novavax for its written approval a plan to Commercialize the Licensed
Product which shall specify a multi-year marketing and public relations strategy, operational plans
to implement such strategies and any other significant Commercialization activities (the
βCommercialization Planβ). Novavax may reasonably request adjustments to the Commercialization
plan as a condition to granting its approval. In no event shall Company materially alter the
Commercialization Plan without Novavaxβs prior written consent. Company shall conduct
Commercialization of such Licensed Product in a manner that is materially consistent with the
Commercialization Plan. Novavax acknowledges that the Licensed Product is being contributed by
Novavax to the Company in accordance with the Joint Venture Agreement and that if the Company
cannot Develop and Commercialize such Licensed Product it will not obtain the value of such
contribution. Company acknowledges that Novavax (or its affiliates or licensees) are Developing
and Commercializing Licensed Product outside the Territory and Companyβs activities could raise
safety concerns and have an impact on Novavaxβs activities including the Regulatory Approval and
regulatory profile of an approved product outside the Territory. Accordingly, taking into account
Novavaxβs and Companyβs respective interests including, without limitation, as provided in the two
preceding sentences, Novavax shall not unreasonably withhold, delay or condition any of its
consents or approvals hereunder.
Β Β Β Β Β 3.2 Regulatory Affairs. Company will be responsible for developing Regulatory Documentation
and preparing and submitting Regulatory Filings, seeking Regulatory Approvals, and maintaining
Regulatory Approvals for Licensed Product in the Territory. As set forth in the Technical Services
Agreement, Novavax will cooperate with Company in preparing and filing all such reports.
Β Β Β Β Β 3.3 Manufacture and Supply. Company will be responsible for the manufacture of Licensed
Product in the Territory and for all costs associated therewith. Certain amount of supply of
preclinical and clinical supply of Licensed Product will be made under the Supply Agreement, dated
as of MarchΒ 31, 2009, between Company and Novavax (the βSupply Agreementβ).
Β Β Β Β Β 3.4 Adverse Event Reporting. Company will maintain a record of all non-medical and medical
Licensed Product-related complaints and reports of Adverse Events in the Territory with respect to
any Licensed Product Developed or Commercialized by the Company. At the request of either party,
Novavax and the Company shall enter into reasonable and customary pharmacovigilance agreement with
respect to sharing of adverse event data and information for Licensed Product as required to comply
with applicable laws and regulations.
Β Β Β Β Β 3.5 Development and Commercial Reporting. During the Term of this Agreement, Company will
provide a half-yearly written progress report to Novavax summarizing the Development and
Commercialization of Licensed Product(s) during the prior six months. Each
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such progress report will be provided to Novavax by Company no later than March 1st
or September 1st (as the case may be) of each year following the Effective Date.
Β Β Β Β Β 3.6 Minor Modifications; Intent. During the Term of this Agreement, Novavax will promptly
provide Company with details of any minor modifications it makes to the Licensed Product as Novavax
develops it for Regulatory Approval. [* * *]
ARTICLE 4
CONDITION PRECEDENT
Β Β Β Β Β This Agreement, including the license grants, obligations and benefits herein, shall only
become effective if, and shall automatically become effective upon, exercise and delivery of the
option granted by Novavax to Company in accordance with the Joint Venture Agreement and that
certain Option to Obtain License dated as of March31, 2009, unless earlier terminated.
ARTICLE 5
INTELLECTUAL PROPERTY
Β Β Β Β Β 5.1 Disclosure. During the Term, the Parties will promptly disclose to one another all
Know-How (whether patentable or not) developed, conceived or reduced to practice during the
Development, manufacture or Commercialization of a Licensed Product which is regarding or directed
to a Licensed Product (βDeveloped Know-Howβ). Novavax shall also disclose to the Company any
Know-How within the Licensed Rights obtained, licensed or generated after the Effective Date which
is not included within the Developed Know-How.
Β Β Β Β Β 5.2 Ownership. Novavax shall own all Developed Know-How and any other intellectual property
that is conceived and reduced to practice solely by Novavax. The Company shall own all Developed
Know-How and any other intellectual property that is conceived and reduced to practice solely by
Company. Novavax and the Company shall jointly own in accordance with U.S. Laws regarding joint
ownership of the applicable type of intellectual property, all Developed Know-How and any other
intellectual property that is conceived or reduced to practice by Novavax and Company jointly.
Β Β Β Β Β 5.3 Prosecution and Maintenance of Patents. Novavax shall have the sole and exclusive right
and authority to control the filing, prosecution, maintenance, and renewal of all Novavax Patents
and any Patents that result from Developed Know-How which is owned by Novavax or jointly owned as
provided in SectionΒ 5.2, at its own expense. Company shall have the sole and exclusive right and
authority to control the filing, prosecution, maintenance and renewal of any Patents that result
from Developed Know-How owned by Company as provided in SectionΒ 5.2. With respect to any such
Patents in the Territory and with respect to any such Patents that are subject to the license
granted to Novavax in SectionΒ 2.2 anywhere in the world (the βROW Patentsβ), the prosecuting party
shall (i)Β provide the other party with copies of all material filings, documentation and
correspondence from, sent to or filed with patent offices in the Territory or anywhere in the world
for the ROW Patents, and (ii)Β provide the other party with a reasonable
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WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
opportunity to comment upon all filings and actions with such patent offices in advance of
submissions to such patent offices. For purposes of this Section 5.3, βfiling, prosecution and
maintenanceβ of patents shall be deemed to include, without limitation, appeals to administrative
or judicial entities having jurisdiction over patentability, the conduct of interferences or
oppositions, and/or requests for re-examinations, reissues or extensions of patent terms.
Β Β Β Β Β 5.4 Abandoned Patents. In the event the prosecuting party determines not to initiate patent
prosecution for any particular patentable Developed Know-How invention or to cease prosecution or
maintenance of, or otherwise abandon, any Patents that are the subject of SectionΒ 5.3 in the
Territory, or with respect to ROW Patents anywhere in the world (which the prosecuting party may do
in its sole discretion), the prosecuting party shall provide reasonable prior written notice to the
other party sufficient for the other party to timely initiate or take over the prosecution and
maintenance of such Patent and timely file any required documents and responses with the relevant
government patent office in the Territory, or with respect to ROW Patents anywhere in the world,
with respect thereto, and the other party may elect (in its sole discretion) to prosecute and
maintain such Patent, at the other partyβs sole expense. In such event, upon the request of and,
at the expense of the other party, the prosecuting party shall assign to the other party all of its
right, title and interest in, to and under such Patent which the prosecuting party has decided to
abandon and provide reasonable cooperation to the other party with respect thereto (including,
without limitation, providing necessary information and executing relevant documents).
Β Β Β Β Β 5.5 Enforcement of Patents.
Β Β Β Β Β Β Β Β Β Β (a) Infringement by Third Parties. In the event that Novavax or the Company becomes aware of
or has reasonable suspicions of third party activities in the Territory that could constitute
infringement of the Novavax Patents or Patents that issue from Developed Know-How in the Territory,
or with respect to ROW Patents anywhere in the world, or misappropriation of the Novavax Know-How
or Developed Know-How in the Territory, or with respect to Developed Know-How any that is subject
to the license granted to Novavax in SectionΒ 2.2 anywhere in the world (βROW Know-Howβ), then such
party shall promptly notify the other parties of such third party activities, including
identification of the third party and delineation of the facts relating to such third party
activities. The Company shall have the right (but shall not be obligated) to enforce the Novavax
Patents, Novavax Know-How and Developed Know-How against any actual or alleged infringement or
misappropriation thereof in the Territory by a third party (by bringing a suit, action or
proceeding against such third party), at the Companyβs sole expense. Novavax shall have the right
(but shall not be obligated) to enforce the ROW Patents and ROW Know-How within the scope of the
licenses granted to Novavax in SectionΒ 2.2 against any actual or alleged infringement or
misappropriation thereof outside the Territory by a third party (by bringing a suit, action or
proceeding against such third party), at Novavaxβs sole expense. If the Company does not enforce
the Novavax Patents or Know-How by (i)Β one hundred (100)Β days following the notice of alleged
infringement or (ii)Β thirty (30)Β days before the time limit, if any, set forth in the appropriate
laws and regulations for the filing of such an action, whichever comes first, then Novavax shall
have the right (but not the obligation) to enforce the Novavax Patents and Novavax Know-How against
any actual or alleged infringement or misappropriation thereof in the Territory by a third party
(by bringing a suit, action or proceeding against such party), at
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Novavaxβs sole expense. The non-prosecuting party shall reasonably cooperate with the
prosecuting party in such enforcement activities, at the prosecuting partyβs expense, including by
agreeing to be named as a party to (or bringing in its own name) such suit, action or proceeding
for the benefit of the non-prosecuting party if required for such enforcement action to proceed.
The prosecuting party shall keep the non-prosecuting party reasonably informed regarding any such
enforcement action and shall consider in good faith the reasonable comments and suggestions of the
non-prosecuting party related to such suit, action or proceeding. All recoveries received by the
prosecuting party from any such enforcement action shall be retained by the prosecuting party.
Β Β Β Β Β Β Β Β Β Β (b) Challenge by Third Parties. Novavax and Company will each notify the other Party in
writing within ten (10)Β Business Days of learning of any alleged or threatened opposition,
reexamination request, action for declaratory judgment, nullity action, interference or other
attack upon the validity, title or enforceability of the Licensed Rights or the ROW Patents or ROW
Know-How by a Third Party. Owner of the subject Patent will have the right (but not the
obligation) to defend any such challenge in the Territory. If the owner of the subject Patent
commences a defense against the alleged or threatened challenge (i)Β within sixty (60)Β days
following the detection of the alleged challenge, or (ii)Β ten (10)Β Business Days before the time
limit, if any, set forth in appropriate Laws and regulations for making a filing in defense of such
a challenge, whichever comes first, then the owner of the subject Patent will so notify the other
party promptly. Notwithstanding the foregoing, if any such action for declaratory judgment,
nullity action, or other attack upon the validity, title or enforceability of the Licensed Right
includes or will include counterclaims of infringement of the Licensed Rights, ROW Patents or ROW
Know-How by the Third Party, control of such action or other attack shall be governed by Section
5.5(a).
ARTICLE 6
CONFIDENTIALITY; PUBLICATION
Β Β Β Β Β 6.1 Confidentiality. The Parties anticipate that under this Agreement each Party will provide
confidential and/or proprietary information to the other Party and that the use and disclosure of
such information shall be governed by ArticleΒ 18 of the Joint Venture Agreement which is hereby
incorporated by reference.
Β Β Β Β Β 6.2 Publication.
Β Β Β Β Β Β Β Β Β Β (a)Β Each Party shall have the right to publish the data and results related to Licensed
Product, subject to the rest of this SectionΒ 6.2. Prior to public disclosure or submission for
publication of a proposed publication describing the results of any scientific or clinical activity
relating to a Licensed Product, the Party proposing such publication shall send the other Party by
expedited delivery a copy of the proposed publication to be submitted and shall allow the other
Party a reasonable time period (but not more than sixty (60)Β days from the date of confirmed
receipt) in which to determine whether the proposed publication contains subject matter for which
patent protection should be sought (prior to publication of such proposed publication) for the
purpose of protecting an invention, or whether the proposed publication contains the Confidential
Information of such other Party, or whether the proposed publication contains information that is
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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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
reasonably likely to have a material adverse impact on the development or commercialization of
Licensed Product. Following the expiration of applicable time period for review, the Party
proposing such publication shall be free to submit such proposed publication for publication and
publish or otherwise disclose to the public such scientific or clinical results, subject to the
procedures set forth in SectionΒ 6.2(b).
Β Β Β Β Β Β Β Β Β Β (b)Β If the Party reviewing such publication believes that the subject matter of the proposed
publication by the other Party contains Confidential Information of the Party or a patentable
invention owned by the Party or in which it otherwise has exclusive rights hereunder, then prior to
the expiration of the applicable time period for review, such Party shall notify the Party
proposing such publication in writing of such belief. On receipt of written notice from the other
Party that such proposed publication contains its Confidential Information, the Party proposing
publication shall remove such Confidential Information from such proposed publication prior to any
publication thereof, unless the other Party agrees otherwise in writing. On receipt of written
notice from the other Party that such proposed publication contains a patentable invention owned by
it or in which it otherwise has exclusive rights hereunder, the Party proposing publication shall
delay public disclosure of such information or submission of the proposed publication for an
additional period of thirty (30)Β days to permit preparation and filing of a patent application on
such invention. The Party proposing publication shall thereafter be free to publish or disclose
such information.
ARTICLE 7
REPRESENTATIONS AND WARRANTIES
Β Β Β Β Β 7.1 Mutual Warranties. Each of Novavax and Company hereby represents, warrants and covenants
to the other as of the Execution Date that:
Β Β Β Β Β Β Β Β Β Β (a)Β 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.
Β Β Β Β Β Β Β Β Β Β (b)Β 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;
Β Β Β Β Β Β Β Β Β Β (c)Β 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
Β Β Β Β Β Β Β Β Β Β (d)Β 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.
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β Β Β Β Β 7.2 Representations by Novavax. In addition to the representations and warranties made in
SectionΒ 7.1, Novavax hereby represents, warrants and covenants to Company that:
Β Β Β Β Β (a) as of the Execution Date, the Licensed Rights are subsisting and are not the
subject of any interference, re-issue, re-exam, opposition or appeal proceedings;
Β Β Β Β Β (b) as of the Execution Date, no Third Party has filed, pursued or maintained or, to
the best of its knowledge, threatened in writing to file, pursue or maintain any claim,
lawsuit, charge or other action involving any Licensed Right including any claim, lawsuit,
charge, or action alleging that any Licensed Right is invalid or unenforceable;
Β Β Β Β Β (c) as of the Execution 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;
Β Β Β Β Β (d) as of the Effective Date, the Licensed Rights are free and clear of any liens,
charges, encumbrances or rights of others, to possession or use that may interfere with
Novavaxβs possession or use under this Agreement;
Β Β Β Β Β (e) as of the Effective Date, it has sufficient rights to grant the licenses granted to
the Company hereunder; and
Β Β Β Β Β (f) as of the Effective 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.
Β Β Β Β Β 7.3 DISCLAIMER OF WARRANTIES. Except as expressly set forth herein, EACH PARTY EXPRESSLY
DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE
WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE
OF DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO. Without limiting the
generality of the foregoing, each Party expressly does not warrant, and disclaims any warranties
with regards to: (a)Β the success of any study or test commenced under this Agreement, (b)Β the
safety or usefulness for any purpose of the technology or Materials it provides or discovers under
this Agreement; and/or (c)Β the validity, enforceability, or non-infringement of any intellectual
property rights or technology it provides or licenses to the other Party under this Agreement.
ARTICLE 8
INDEMNIFICATION
Β Β Β Β Β 8.1 Indemnification by Company. Company will indemnify, defend and hold harmless Novavax, its
affiliates, directors, officers and employees (each a βNovavax Indemniteeβ)
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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, βLossesβ) to the extent such Losses result from the
(a)Β negligence or willful misconduct by Company, its Affiliates, employees, agents, or Third Party
contractors, or (b)Β manufacture, use, sale, or offer for sale of a Licensed Product in the
Territory due to a design defect or a manufacturing defect, including but not limited to, a Loss
related to the death of or injury to a Third Party. Companyβs obligation to indemnify Novavax
pursuant to this SectionΒ 8.1 will not apply to the extent of any Loss that arises from the (i)
material breach by Novavax of its representations, warranties or covenants contained within this
Agreement, (ii)Β negligence or willful misconduct of any Novavax Indemnitee, or (iii)Β a
manufacturing defect of Licensed Product supplied by Novavax under the Supply Agreement.
Β Β Β Β Β 8.2 Indemnification by Novavax. Novavax will indemnify, defend and hold harmless Company,
its affiliates, directors, officers and employees (each a βCompany Indemniteeβ) from and against
any and all Losses to the extent such Losses result from the (a)Β negligence or willful misconduct
by Novavax, its Affiliates, employees, agents or Third Party contractors, or (b)Β manufacture, use,
sale, or offer for sale of a Licensed Product outside the Territory due to a design defect or a
manufacturing defect, including but not limited to, a Loss related to the death of or injury to a
Third Party. Novavaxβs obligation to indemnify the Company Indemnitee pursuant to this SectionΒ 8.2
will not apply to the extent of any Loss that arises from the (i)Β material breach by Company of its
representations, warranties or covenants contained within this Agreement or (ii)Β negligence or
willful misconduct of any Company Indemnitee.
Β Β Β Β Β 8.3 Procedures. Indemnitorβs agreement to indemnify, defend and hold harmless an Indemnitee
is conditioned on Indemnitee (a)Β 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 Indemnitorβs ability to defend, (b)Β permitting Indemnitor to assume full responsibility to
investigate, prepare for and defend against any such claim, (c)Β providing reasonable assistance in
the defense of such claim at Indemnitorβs reasonable expense, and (d)Β not compromising or settling
such claim without Indemnitorβs advance written consent.
Β Β Β Β Β 8.4 Insurance. Each Party will maintain comprehensive general liability insurance coverage,
including products liability, in amounts it reasonably determines are appropriate with respect to
the Development and Commercialization of Licensed Product in its respective territory.
Β Β Β Β Β 8.5 Limitation of Liability. EXCEPT TO THE EXTENT (A)Β SUCH PARTY MAY BE REQUIRED TO
INDEMNIFY THE OTHER PARTY UNDER THIS ARTICLE 8, OR (B)Β AS REGARDS A BREACH OF A PARTYβS
RESPONSIBILITIES PURSUANT TO ARTICLE 6, NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES WILL BE LIABLE
TO THE OTHER PARTY FOR ANY LOSS OF PROFITS, LOSS OF BUSINESS OR INTERRUPTION OF BUSINESS, OR FOR
ANY OTHER INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES UNDER THIS
AGREEMENT, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE, EVEN IF SUCH PARTY
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES.
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ARTICLE 9
TERM; BREACH
Β Β Β Β Β 9.1 Term and Termination. The term of this Agreement will commence on the Execution Date and
will continue until (a)Β the Company provides sixty (60)Β days prior written notice of termination to
Novavax, (b)Β the Parties mutually agree in writing to terminate the Agreement, or (c)Β Novavax
terminates the Joint Venture Agreement by providing a Notice of Termination under and pursuant to
SectionΒ 11.2 of the Joint Venture Agreement. In no event shall either Party have the right to
terminate this Agreement based upon any breach by the other Party, and to the extent that any right
to terminate is provided under any Laws, the Parties hereby waive such right.
Β Β Β Β Β 9.2 Breach and Remedies. In addition to any remedies available under any laws, the following
remedies shall be available to a party in the event of the following breaches
Β Β Β Β Β Β Β Β Β Β (a)Β In the event that SectionΒ 2.6 is materially breached by either party, the non-breaching
party shall be entitled to damages equal to its lost profit from lost sales of Licensed Product in
or out of the Territory (as applicable) due to the βgrey marketβ breach.
Β Β Β Β Β Β Β Β Β Β (b)Β In the event that Company (i)Β materially alters a Development Plan or Commercialization
Plan for Licensed Product without Novavaxβs prior written consent, or (ii)Β initiates a clinical
trial of Licensed Product without Novavaxβs approval or materially deviates from an approved
clinical trial protocol for Licensed Product without the prior written consent of Novavax, then
Novavax shall have right to obtain injunctive relief with respect to such breach before any court
of competent jurisdiction in accordance with SectionΒ 10.3.
Β Β Β Β Β 9.3 Survival. The following provisions of this Agreement shall survive expiration or
termination of this Agreement for any reason: ArticleΒ 8 and SectionsΒ 6.1 and 7.3. In the event
that this Agreement is terminated under 9.1(c), the license grant under SectionΒ 2.2 shall survive
as a fully paid, exclusive license solely under Developed Know-how owned or Controlled by Company,
including any Patents that issue therefrom, as of the effective date of termination (i.e.,
excluding any intellectual property developed or acquired after such date of termination).
ARTICLE 10
DISPUTE RESOLUTION
Β Β Β Β Β 10.1 Disputes. The Parties recognize that disputes as to certain matters may from time to
time arise during the Term which relate to either Partyβs 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 ArticleΒ 10 if and when a dispute arises under this Agreement.
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β Β Β Β Β 10.2 Arbitration. Any dispute arising between the Parties out of or in connection with the
implementation or interpretation of this Agreement shall, if not settled amicably within ninety
(90)Β days from the date that the dispute arose, be finally settled by three (3)Β arbitrators. Each
Party shall be entitled to appoint one (1)Β arbitrator and the two (2)Β so appointed shall appoint
the third arbitrator in accordance with the Indian Arbitration and Conciliation Act, 1996. It is
hereby agreed that PartΒ I of the Indian Arbitration and Conciliation Act, 1996 (except for the
provisions of SectionΒ 9 thereof) shall not apply to the arbitration under this Agreement. The
language of the arbitration proceedings shall be English and its place shall be Singapore. The
arbitral award or determination shall be final and subject to no appeal and shall deal with the
question of costs of arbitration and all matters related thereto.
The Parties agree that it would be impossible or inadequate to measure and calculate their damages
from any breach of the Agreement though great and irreparable. Accordingly, each Party agrees that
if the other Party breaches this Agreement, the non-breaching party will have available, in
addition to any other right or remedy available, the right to obtain an injunction from a court of
competent jurisdiction restraining such breach or threatened breach and specific performance of any
provision of this Agreement.
Β Β Β Β Β 10.3 Equitable Claims. Notwithstanding anything to the contrary in this ArticleΒ 10, either
Party has the right to seek temporary injunctive relief or any other interim equitable remedy in
any court of competent jurisdiction as may be available to such Party under the laws applicable to
such jurisdiction that may be necessary to protect the rights or property of that Party until such
time as any dispute underlying such temporary injunctive relief or any other interim equitable
remedy has been resolved in accordance with SectionΒ 10.2.
Β Β Β Β Β 10.4 Governing Law. The substantive laws of India will govern the resolution of all disputes,
controversies and claims under, arising out of or relating to the validity, construction,
enforceability or performance of this Agreement and any related remedies, without giving effect to
any choice of law rules.
Β Β Β Β Β 10.5 Award. Each Party will abide by any arbitral award rendered pursuant to this ArticleΒ 10.
If a Party resists enforcement of an arbitral award, any costs, fees or taxes incident to
enforcement will be charged against that Party to the extent permitted by Law. Each Party will
bear its own legal fees for arbitration, and the arbitrator(s) will assess their costs, fees and
expenses against the Party losing the arbitration.
Β Β Β Β Β 10.6 Injunctive Relief. If a Party makes a sufficient showing under the rules and standards
set forth in the rules of civil procedure and applicable Law, the arbitrator may, and the Parties
will abide by, injunctive measures after either Party submits in writing for arbitration claims
requiring immediate relief. Notwithstanding the foregoing, and in accordance with SectionΒ 10.3, a
Party will also be free at any time to bring an Equitable Claim to any court of competent
jurisdiction without submitting such request to an arbitrator.
Β Β Β Β Β 10.7 Confidentiality. Any arbitration proceeding, including without limitation the existence
of any dispute submitted to arbitration and any arbitral award or decision, will be Confidential
Information of both Parties, and the arbitrator(s) will issue appropriate protective
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CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
orders to safeguard each Partyβs 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 SectionΒ 6.3).
ARTICLE 11
MISCELLANEOUS
Β Β Β Β Β 11.1 Entire Agreement. This Agreement (including its Exhibits) sets forth all the covenants,
promises, agreements, warranties, representations, conditions and understandings between the
Parties with respect to the subject matter hereof and supersedes and terminates all prior
agreements and understanding between the Parties with respect to such subject matter. No
subsequent alteration, amendment, change or addition to this Agreement will be binding upon the
Parties unless reduced to writing and signed by the respective authorized officers of the Parties.
Β Β Β Β Β 11.2 Third Party Contractors. The Parties will perform their obligations under this Agreement
as Third Party contractors and nothing contained in this Agreement will be construed to be
inconsistent with such relationship or status. This Agreement will not constitute, create or in
any way be interpreted as a joint venture or partnership of any kind.
Β Β Β Β Β 11.3 Notices. Any notice, request, demand, waiver, consent, approval or other communication
permitted or required under this Agreement (βNoticeβ) 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 SectionΒ 11.3 or to such other address as the Party to whom
notice is to be given may have provided to the other Party in accordance with this SectionΒ 11.3.
Any notice delivered by electronic mail or facsimile will be confirmed by a hard copy delivered as
soon as practicable thereafter by an internationally recognized overnight delivery service. Such
Notice will be deemed to have been given on the second Business Day (at the place of delivery)
after deposit with an internationally recognized delivery service. This SectionΒ 11.3 is not
intended to govern the day-to-day business communications necessary between the Parties in
performing their obligations under the terms of this Agreement.
Β | Β | Β |
If to Novavax:
|
Β | Novavax, Inc. |
Β
|
Β | 0000 Xxxxxxxx Xxxxxx Xxxxx |
Β
|
Β | Xxxxxxxxx Xxxxxxxx 00000 |
Β
|
Β | Attn: Xxx Xxxx, Senior Vice President |
Β
|
Β | Email: Xxxxx@Xxxxxxx.xxx |
Β
|
Β | Facsimile No.: 000-000-0000 |
Β |
Β | Β |
If to Company:
|
Β | CPL Biologicals Limited |
Β
|
Β | Cadila Corporate Campus |
Β
|
Β | Sarkhej-Dholka Road |
Β
|
Β | Bhat, Ahmedabad β 382210 |
Β
|
Β | Gujarat, India |
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WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β | Β | Β |
Β
|
Β | Attn: Xx.Β Xxxxx X. Xxxx, Managing Director |
Β
|
Β | Email: xxxxxx@xxxxxxxxxxxx.xx.xx |
Β
|
Β | Facsimile No.: +91 (02718)Β 225031 |
Β Β Β Β Β 11.4 Assignment.
Β Β Β Β Β Β Β Β Β Β (a)Β 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
Novavaxβs 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.
Β Β Β Β Β Β Β Β Β Β (b)Β 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 Companyβs 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 ScheduleΒ 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 ScheduleΒ 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.
Β Β Β Β Β Β Β Β Β Β (c)Β Any assignment or purported assignment by either Party in violation of this SectionΒ 11.4
will be null and void.
Β Β Β Β Β 11.5 Force Majeure. Both Parties will be excused from the performance of their obligations
under this Agreement (except for the obligation to pay money) to the extent that such performance
is prevented by force majeure and the nonperforming Party promptly provides notice of the
prevention to the other Party. Such excuse will be continued so long as the condition constituting
force majeure continues and the nonperforming Party takes reasonable efforts to remove the
condition. For purposes of this Agreement, force majeure will include conditions beyond the
control of the Parties, including without limitation, an act of God, voluntary or involuntary
compliance with any regulation, Law or order of any government, war, civil commotion, labor strike
or lock-out, acts of terrorism, epidemic, failure or default of public utilities or common
carriers, destruction of production facilities or materials by fire, earthquake, storm or like
catastrophe.
Β Β Β Β Β 11.6 Headings. The headings for each article and section in this Agreement have been inserted
for convenience of reference only and are not intended to limit or expand on the meaning of the
language contained in the particular article or section.
17
Β
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β Β Β Β Β 11.7 No Strict Construction. This Agreement has been prepared jointly and will not be
strictly construed against either Party.
Β Β Β Β Β 11.8 Ambiguities. Ambiguities and uncertainties in this Agreement, if any, will not be
interpreted against either Party, irrespective of which Party may be deemed to have caused the
ambiguity or uncertainty to exist.
Β Β Β Β Β 11.9 English Language. All notices required or permitted to be given hereunder, and all
written, electronic, oral or other communications between the Parties regarding this Agreement will
be in the English language. This Agreement is in the English language only, which language will be
controlling in all respects, and all versions hereof in any other language will be for
accommodation only and will not be binding upon the Parties.
Β Β Β Β Β 11.10 No Waiver. Any delay in enforcing a Partyβs rights under this Agreement or any waiver
as to a particular default or other matter will not constitute a waiver of such Partyβs 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.
Β Β Β Β Β 11.11 Severability. If one or more of the provisions in this Agreement are deemed
unenforceable by Law, then such provision will be deemed stricken from this Agreement and the
remaining provisions will continue in full force and effect and shall be interpreted to give full
effect to the commercial agreement between the Parties.
Β Β Β Β Β 11.12 Counterparts. This Agreement may be executed in one or more identical counterparts,
each of which will be deemed to be an original, and which collectively will be deemed to be one and
the same instrument.
[Signature Page to Follow]
18
Β
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.
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Β Β Β Β Β In Witness Whereof, the Parties have by duly authorized persons executed this License
Agreement as of the Execution Date.
Β | Β | Β | Β | Β | Β | Β | Β | Β | Β | Β |
Novavax, Inc. | Β | Β | Β | CPL Biologicals Limited | Β | Β | ||||
Β |
Β | Β | Β | Β | Β | Β | Β | Β | Β | Β |
By:
|
Β | /s/ Xxxxx Xxxxxxx | Β | Β | Β | By: | Β | Β | Β | Β |
Β
|
Β | Β
Xxxxx Xxxxxxx
|
Β | Β | Β | Β | Β | Β
Xxxxx X. Xxxx
|
Β | Β |
Β
|
Β | President and Chief Executive Officer | Β | Β | Β | Β | Β | Managing Director | Β | Β |
[Signature Page to License Agreement]
Β