Exhibit 10.28

 

 

EVALUATION AND OPTION AGREEMENT

 

 

This EVALUATION and OPTION Agreement (“AGREEMENT”) is made effective as of the
8th day of February, 2016 (“EFFECTIVE DATE”), between

 

VARIATION BIOTECHNOLOGIES, INC., 310 Hunt Club East, Ottawa, ON, K1V 1C1 (“VBI”)
of the other part.(hereinafter referred to as “VBI”) and

 

GLAXOSMITHKLINE BIOLOGICALS SA, a company registered in Belgium under number RPM
Nivelles – BE – 0440 872 918 and having a place of business at 89, rue de
l’Institut, B-1330 Rixensart, Belgium (herein referred to as "GSK") on the other
part, 

 

 

WHEREAS:

 

VBI is the exclusive holder of certain VBI PATENT rights and related VBI
KNOW-HOW regarding the TECHNOLOGY;

 

GSK wishes to receive the MATERIALS to be able to carry out the EVALUATION
described below, in order to evaluate the TECHNOLOGY;

 

VBI is willing to grant GSK an exclusive OPTION to enter into either a SPONSORED
collaboration and option agreement or a LICENSE AGREEMENT related to the
TECHNOLOGY in the FIELD.  

 

 

NOW, THEREFORE, THE PARTIES HAVE AGREED AS FOLLOWS:  

 

 

1.

DEFINITIONS

 

1.1

For purposes of this AGREEMENT, the following words and phrases shall have the
following meanings whether used in the singular or in the plural:

 

"Affiliate"

shall mean any corporation, firm, partnership, person or other entity which,
whether de jure or de facto, directly or indirectly owns, is owned by or is
under common ownership with a PARTY to this AGREEMENT or which actually
controls, is controlled by or is under common control with a PARTY to this
AGREEMENT. For the purpose hereof, ownership shall mean the power to vote on the
affairs of an entity to the extent of at least fifty percent (50%) of the equity
(or such lesser percentage which is the maximum allowed to be owned by an entity
in a particular jurisdiction) and control shall mean the power to decisively
direct the affairs of an entity

   

"AGREEMENT"

shall mean the present evaluation and option agreement, as well as all
SCHEDULEs.

   

"ARISING INTELLECTUAL PROPERTY”

or “ARISING IP” shall mean any invention (whether patentable or not) and
know-how generated, conceived or reduced to practice under the EVALUATION. For
the avoidance of doubt, the RESULTS are not included in ARISING INTELLECTUAL
PROPERTY. The general term ARISING INTELLECTUAL PROPERTY shall be inclusive of
VBI ARISING I P, GSK ARISING I P and OTHER ARISING I P as they are later
defined.

  

 
 

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"CONFIDENTIAL INFORMATION"

shall mean any information disclosed by or on behalf of one PARTY to the other
PARTY in any form (e.g. in oral, written, graphic, or electronic form),
including but not limited to related know-how, research and development,
manufacturing, financial and commercialisation plans and/or information, and
trade secrets which is clearly designated, labelled or marked as such at the
time of its disclosure or, if disclosed orally, is documented in any written
correspondence (including email or meeting notes or minutes) and would
reasonably be expected to have been confidential in nature.

   

"DISCLOSING PARTY"

shall mean the PARTY disclosing CONFIDENTIAL INFORMATION.

   

"EFFECTIVE DATE"

shall mean the date first written above.

   

"EVALUATION"

shall mean the activities conducted by VBI and GSK respectively, as described in
Appendix A.

   

“FIELD”

shall mean any and all vaccines based **1, for the prevention or treatment of
any infectious diseases in humans.

   

“GSK ARISING IP”

Shall mean any ARISING IP that is solely and exclusively related to the GSK
MATERIALS or to any improvements that relate solely and exclusively to the GSK
MATERIALS and which do not specifically relate to the TECHNOLOGY.

   

“GSK MATERIALS”

Shall mean the materials and any related data and know-how to be supplied by GSK
to VBI for formulation as part of the EVALUATION, as listed in Appendix A.

   

“LICENSE AGREEMENT”

shall have the meaning ascribed to such term in Article 6.1.

   

"MATERIAL(S)"

Shall mean the materials to be supplied by VBI to GSK to conduct the EVALUATION,
as listed in Appendix A.

   

“NEGOTIATION PERIOD”

shall have the meaning ascribed to such term in Article 6.2.

   

“OPTION”

shall mean the exclusive and irrevocable option to enter into the SPONSORED
COLLABORATION AND OPTION AGREEMENT or the LICENSE AGREEMENT, as provided in
Article 6.1.

   

“OTHER ARISING IP” 

All other ARISING IP which does not qualify as either VBI ARISING IP or GSK
ARISING IP shall be “OTHER ARISING IP”

   

“OPTION PERIOD”

shall have the meaning ascribed to such term in Article 6.1 and 6.2.

   

"PARTY" or "PARTIES"

shall respectively mean one of the parties to this AGREEMENT and these parties
collectively.

  

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Information omitted pursuant to a Confidential Treatment Request filed with the
SEC on February 9, 2016. 
 

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"RECEIVING PARTY"

shall mean the PARTY receiving CONFIDENTIAL INFORMATION.

   

"RESULTS"

shall mean the results related to the MATERIALS and the TECHNOLOGY obtained from
the EVALUATION.

   

“SPONSORED COLLABORATIONAND OPTION AGREEMENT”

shall have the meaning ascribed to such term in Article 6.1.

   

“TECHNOLOGY”

the Lipid Particle Vaccine (LPV TM) technology owned or controlled by VBI,
consisting of mixtures of vesicle-forming lipids and proprietary mixtures of
excipients, for combination with vaccine antigens in proprietary ratios for
formulation using a patented formulation process to stabilize vaccine antigens.

   

“TERM”

shall have the meaning ascribed to such term in Article 8.1.

   

“VBI ARISING IP”

Shall mean any ARISING IP that is solely and exclusively related to the
TECHNOLOGY or to any improvements that relate solely and exclusively to the
TECHNOLOGY and which do not specifically relate to the GSK MATERIALS.

   

"VBI KNOW-HOW"

shall mean all present and future technical information, and know-how which
relate to the TECHNOLOGY.

   

"VBI PATENTS"

shall mean all patents and patent applications which are or become owned and/or
controlled (including by way of license), in whole or in part, by VBI and as to
which VBI otherwise has, now or in the future, the right to grant licences which
generically or specifically claim the TECHNOLOGY in whole or in part. Included
within the definition of VBI PATENTS are any continuations, continuations in
part, divisions, patents of addition, reissues, renewals or extensions thereof
(including SPCs). A non-exhaustive list of VBI PATENTS is provided in Appendix
C.

 

2.

EVALUATION– MATERIAL TRANSFER

 

 

2.1

Promptly after the EFFECTIVE DATE, GSK shall transfer the GSK MATERIALS to VBI
at no charge to VBI, for the sole purpose of enabling VBI to conduct its
activities described in the EVALUATION.

 

 

2.2

Within the timelines described in the EVALUATION, VBI will make available to GSK
the MATERIALS at no charge in order to enable GSK to conduct its activities
described in the EVALUATION. GSK shall only use the MATERIALS for the purposes
of performing the EVALUATION as specified in this AGREEMENT, according to the
timelines set forth in Appendix A. The formulation will be blinded for the
purpose of the EVALUATION; GSK will have the right to request details on the
formulation composition only if required for the purpose of patent filing and
prosecution as permitted under Article 5 or for GSK to make its decision to
exercise its OPTION or not under Article 6.

 

 

2.3

Both Parties shall use the GSK MATERIALS and the MATERIALS in accordance with
all applicable laws, regulations and guidelines, including those related to
ethical treatment of animals. GSK shall have the right to subcontract part of
its activities under the EVALUATION to an AFFILIATE or a third party, subject to
all of the same limitations on the use of the MATERIALS and the TECHNOLOGY as
are applicable to GSK under this AGREEMENT.

  

 
 

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2.4

The Parties will use reasonable efforts to conduct the EVALUATION within the
timelines set forth in Appendix A.

 

 

2.5

VBI hereby grants GSK a non-exclusive license under VBI PATENTS and VBI KNOW-HOW
related to the MATERIALS in the FIELD for the sole purpose of performing the
EVALUATION under the terms and conditions of this AGREEMENT.

 

 

2.6

GSK hereby grants VBI a non-exclusive license under GSK intellectual property
rights to use the GSK MATERIALS for the sole purpose of performing the
EVALUATION under the terms and conditions of this AGREEMENT.

 

 

2.7

Upon expiry or termination of this AGREEMENT, unless agreed otherwise between
the Parties, GSK shall destroy the MATERIALS resulting from the EVALUATION, and
VBI will destroy or return, at GSK’s expense, any remaining GSK MATERIAL to GSK.

  

 

3.

CONFIDENTIALITY – PRESS RELEASE

 

3.1

Each PARTY shall remain the owner of its CONFIDENTIAL INFORMATION. Each PARTY
shall use the other PARTY's CONFIDENTIAL INFORMATION only for the purpose of
this AGREEMENT, which in the case of GSK shall include evaluating its interest
in exercising the OPTION described below and for entering into a LICENSE
AGREEMENT or a SPONSORED COLLABORATION AND OPTION AGREEMENT regarding the
further use of MATERIALS and/or TECHNOLOGY in the FIELD, and each PARTY shall
not use or exploit the other PARTY's CONFIDENTIAL INFORMATION for its own
benefit or for the benefit of any third party without the prior written consent
of the other PARTY. The PARTIES' AFFILIATES shall not be considered third
parties.

 

3.2

Each PARTY shall hold the other PARTY's CONFIDENTIAL INFORMATION in the
strictest confidence and shall not disclose, communicate or in any way divulge
it to any other person or entity. Each PARTY shall only be entitled to disclose
the other PARTY's CONFIDENTIAL INFORMATION to those of its employees,
AFFILIATES, subcontractors and consultants who have a legitimate need to know
such CONFIDENTIAL INFORMATION for the purposes permitted in this AGREEMENT.
Those persons shall in turn be bound by a duty of confidentiality and non-use
obligation at least equal to those set forth in this AGREEMENT and shall have
been made aware of the confidential nature of the CONFIDENTIAL INFORMATION.

 

3.3

The PARTIES will only make copies of the CONFIDENTIAL INFORMATION if strictly
required for the purpose of the EVALUATION or the AGREEMENT.

 

3.4

All obligations regarding non-disclosure and non-use shall remain in full force
and effect for ten (10) years from the date of the last disclosure of
CONFIDENTIAL INFORMATION. Notwithstanding this AGREEMENT, either PARTY may use
or disclose the other PARTY's CONFIDENTIAL INFORMATION to the extent it is able
to demonstrate, by clear and convincing evidence, preferably in writing, that
such CONFIDENTIAL INFORMATION:

 

 

a.

was in the public domain or was the subject of public knowledge at the time of
disclosure by the DISCLOSING PARTY, or became part of the public domain or the
subject of public knowledge through no fault, negligence or breach of contract
on the part of the RECEIVING PARTY, its AFFILIATES or any party to whom the
RECEIVING PARTY disclosed the CONFIDENTIAL INFORMATION in accordance with this
AGREEMENT;

  

 
 

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b.

was lawfully in its possession or in the possession of its AFFILIATES and known
to it prior to disclosure by the DISCLOSING PARTY as evidenced by documents
predating the date of disclosure;

 

 

c.

became available to the RECEIVING PARTY or its AFFILIATES through a third party
without any obligation to the DISCLOSING PARTY;

 

 

d.

was subsequently and independently developed as shown by written records by its
employees who had no knowledge of any such CONFIDENTIAL INFORMATION; or

 

 

e.

was required to be disclosed by law or by a court or governmental order,
provided the RECEIVING PARTY in such case shall promptly notify the DISCLOSING
PARTY in writing of any such obligation and shall provide adequate opportunity
to the DISCLOSING PARTY to object to such disclosure or request confidential
treatment thereof.

 

3.5

Except to AFFILIATES, subcontractors involved in the EVALUATION, accountants and
attorneys and except as required by law, each PARTY shall not disclose to any
other person or entity CONFIDENTIAL INFORMATION received from the other PARTY
nor the terms of this AGREEMENT or the nature or content of negotiations leading
to the conclusion of this AGREEMENT. The PARTIES will ensure that any AFFILIATE
or any third party that is entitled to receive such CONFIDENTIAL INFORMATION (i)
has been advised of the RECEIVING PARTY'S obligations of confidence in respect
of the DISCLOSING PARTY'S CONFIDENTIAL INFORMATION; and (ii) has agreed to
honour personally those obligations of confidence.

 

3.6

The DISCLOSING PARTY assumes no liability for injury, loss or damage arising
from, and makes no representation in connection with, the use of any
CONFIDENTIAL INFORMATION by the RECEIVING PARTY, except in cases of negligence
or intentional misconduct on the part of the DISCLOSING PARTY.

 

3.7

The Parties agree that the terms of this Agreement are the Confidential
Information of both Parties, subject to the special authorized disclosure
provisions set forth in Section 3.8 and 3.9.

 

3.8

On or after the Effective Date, VBI shall have the right to issue a public
announcement of the execution of this AGREEMENT, in the form agreed by the
Parties as set forth in Appendix D.

 

3.9

Except for the public announcement described in in Section 3.8, neither Party
nor such Party’s Affiliates will make any public announcements, press releases,
regulatory filing or other public disclosures, written or oral, whether to the
public, the press, stockholders or otherwise, concerning this AGREEMENT or its
terms (a “Public Statement”), except: with the prior written consent of the
other Party (such consent not to be unreasonably delayed or withheld but may be
conditional upon certain restrictions as to the content and/or distribution of
such Public Statement to ensure consistency with GSK’s policies). Each Party
shall provide the other with an advance copy of any such Public Statement at
least seven (7) business days prior to its scheduled release, or if seven (7)
business days is not possible due to a Party’s regulatory filing requirements,
as many days as possible within the constraints. Each Party furthermore shall
have the right to review and recommend changes to any such Public Statement and
the Party whose Public Statement has been reviewed shall remove any CONFIDENTIAL
INFORMATION of the reviewing Party that the reviewing Party reasonably deems to
be inappropriate for disclosure.

   

 
 

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4.

RESULTS – REPORTS - PUBLICATION

 

4.1

GSK shall disclose to VBI the RESULTS obtained from the EVALUATION conducted
hereunder, by providing VBI with a final written report after completion of the
EVALUATION as described in the section on activities to be performed by GSK in
Appendix A.

 

4.2

Any RESULTS and any information arising from the EVALUATION conducted hereunder
shall be considered as GSK’s CONFIDENTIAL INFORMATION and shall not be disclosed
or made available by VBI to any third party without GSK's prior written consent,
except as provided in Section 4.3 or as permitted under Section 5.1.

 

4.3

The publication of the RESULTS and other CONFIDENTIAL INFORMATION of GSK will
not take place without the consent of GSK. In the event VBI wishes to publish
the RESULTS and GSK consents to it, VBI will submit for review a copy of any
proposed publication of the RESULTS at least sixty (60) days prior to submission
for publication. If GSK determines that the proposed publication contains
patentable subject matter and/or any of its CONFIDENTIAL INFORMATION, GSK may
require VBI to delay the publication or presentation for a period of time not to
exceed ninety (90) days for the purpose of deleting such other CONFIDENTIAL
INFORMATION and/or filing appropriate patent applications relating to such
subject matter. Each party will be acknowledged, consistent with academic
standards, in any publications or other public disclosures of the RESULTS by
co-authorship or acknowledgement, whichever is appropriate. During the TERM of
this AGREEMENT, GSK agrees that VBI may use the RESULTS as follows:

 

 

i)

During the EVALUATION and until the expiry of the OPTION PERIOD, for a) internal
research purposes only, outside the FIELD and (b) patent application filings and
patent prosecution submissions as permitted under Section 5.1, subject always
to: unless explicitly permitted in writing by GSK, (x)GSK will not be named, (y)
the **2 vaccine candidate and any proprietary details thereof will not be
disclosed,

 

 

ii)

Following the OPTION PERIOD, and during the NEGOTIATION PERIOD, VBI will have
the right to use the RESULTS as described in 4.3(i) and only outside of the
FIELD in connection with (a) licensing the TECHNOLOGY, VBI PATENTS or VBI
KNOW-HOW to third parties, and (b) support of research on stabilization of **2
provided however that (in connection with a) and b): unless explicitly permitted
in writing by GSK, (x)GSK will not be named, (y) the **2 vaccine candidate and
any proprietary details thereof will not be disclosed, and

 

 

iii)

In the event that GSK decides not to exercise the OPTION, or the PARTIES fail to
execute a SPONSORED collaboration and option agreement or a LICENSE AGREEMENT
during the negotiation period, VBI may use the results as described in section
6.5.

 

5.

ARISING INTELLECTUAL PROPERTY RIGHTS

 

5.1

Either PARTY shall inform the other PARTY promptly of any ARISING IP generated
under this AGREEMENT. Subject to the provisions contained in Section 5.2, all
ARISING IP shall be owned as follows:

 

 

5.1.1

OTHER ARISING IP shall be owned solely by GSK and subject to the license of
rights to VBI as described in 5.2. GSK shall have the first right, at its costs,
to seek patent protection of OTHER ARISING IP. GSK shall consult with VBI on the
preparation and filing, prosecution and maintenance of patents to protect the
OTHER ARISING IP and will take VBI’s comments reasonably into account. It is
understood and agreed that the ownership by GSK of the GSK ARISING IP and OTHER
ARISING IP does not imply the grant of a license to, VBI PATENTS, VBI Arising
IP, VBI KNOW-HOW, or to any other elements of the TECHNOLOGY, unless and until
VBI grants to GSK a license to such intellectual property.

 

 

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2 Information omitted pursuant to a Confidential Treatment Request filed with
the SEC on February 9, 2016. 
 

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5.1.2

GSK ARISING IP shall be owned solely by GSK. GSK shall have the first right, at
its costs, to seek patent protection of GSK ARISING IP. GSK may, at its
discretion, consult with VBI on the filing of new patents to protect the GSK
ARISING IP.

 

 

5.1.3

VBI ARISING IP shall be owned solely by VBI. VBI shall have the first right, at
its costs, to seek patent protection of VBI ARISING IP. VBI may, at its
discretion, consult with GSK on the filing of new patents to protect the VBI
ARISING IP.

 

 

5.1.4

Each Party shall provide the other with regular reports as to its progress in
seeking patent protection for such ARISING IP. Each Party shall provide
reasonable assistance and information needed for the preparation, filing,
prosecution and maintenance of such patents, including details on the
formulation composition of the MATERIALS to be provided by VBI to GSK, or
RESULTS to be used by VBI.

 

5.2

VBI RETAINED RIGHTS: GSK hereby grants to VBI a royalty-free, co-exclusive
license, with the right to sublicense, to OTHER ARISING IP solely to the extent
required to practice the TECHNOLOGY, VBI Patents, VBI ARISING IP or VBI Know-How
outside of the FIELD. For the purpose of this Article 5.2, co-exclusive license
means that GSK will not grant another license to OTHER ARISING IP outside the
FIELD to third parties, but reserves the right to practice OTHER ARISING IP for
its own purposes, either itself or through its AFFILIATES, subcontractors and
collaborators.

 

5.3

Either PARTY shall promptly notify the other PARTY of any decision not to pursue
the filing, prosecution, or maintenance of a patent covering ARISING IP in
adequate time to allow the other PARTY, at its own cost, to effectuate such
filing, prosecution, or maintenance if it so desires.

  

 

6.

OPTION

 

 

6.1

VBI hereby grants GSK an OPTION to, at GSK’s sole discretion,

 

 

i)

enter into a collaboration and option agreement in the FIELD, that will include
an exclusive option for GSK to be granted a worldwide exclusive license with the
right to grant sublicenses under any and all of VBI PATENTS, VBI ARISING IP and
VBI KNOW-HOW to use the TECHNOLOGY in the FIELD (“SPONSORED COLLABORATION AND
OPTION AGREEMENT”) ; or

 

 

ii)

to enter directly into an exclusive, worldwide license with the right to grant
sublicense under any and all of VBI PATENTS, VBI ARISING IP and, VBI KNOW-HOW to
use the TECHNOLOGY in the FIELD (“LICENSE AGREEMENT”).

  

  GSK may exercise the OPTION during the period starting as of the EFFECTIVE
DATE of this AGREEMENT and ending **3 calendar days after completion of the
EVALUATION (‘OPTION PERIOD’) extendable upon mutual written agreement between
the PARTIES. It is understood and agreed that GSK’s OPTION includes any and all
available Intellectual Property in control of VBI that is required to
exclusively practice the VBI TECHNOLOGY within the FIELD for a single set of
economic terms.    

6.2

GSK may exercise the OPTION at its sole discretion at any time during the OPTION
PERIOD by giving written notice to VBI which notice shall specify whether GSK
elects such OPTION under Section 6.1(i) or Section 6.1(ii). If and when GSK
exercises the OPTION the terms and provisions of the SPONSORED collaboration and
option agreement or the LICense AGREEMENT shall be finalized in good faith
between the PARTIES, subject to due diligence and GSK senior management
approval, and such agreement shall be executed as soon as feasible after the
exercise of the OPTION by GSK, but no later than **4 calendar days after the
date GSK exercises the OPTION (“NEGOTIATION PERIOD”). The SPONSORED
collaboration and option agreement will include inter alia the terms agreed for
the exclusive license (that will apply if and when GSK exercises its option to
get a license) and other terms that are customary for this type of agreement.

 

 

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3 Information omitted pursuant to a Confidential Treatment Request filed with
the SEC on Februar 9, 2016. 
 

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6.3

If GSK does not exercise the OPTION within the OPTION PERIOD, VBI will be free
to license any and all of VBI PATENTS, VBI ARISING IP and VBI KNOW-HOW in the
FIELD to any third party and GSK’s OPTION right under this AGREEMENT will
expire.

 

6.4

In the event that GSK elects to exercise the OPTION, but no agreement is
executed during the negotiation period, VBI agrees not to make an offer within
the Field on more favorable terms than the terms offered by GSK to any third
party for a period of **4 months starting from the end of the negotiations,
without first offering GSK the same terms to be offered to the third party.

 

6.5

In the event that GSK decides not to exercise the OPTION, or the PARTIES fail to
execute a SPONSORED collaboration and option agreement or a LICENSE AGREEMENT
during the negotiation period, VBI will have the right to use the RESULTS in
connection with (i) licensing the TECHNOLOGY, VBI PATENTS or VBI KNOW-HOW to
third parties, (ii) patent application filings and patent prosecution
submissions as permitted under Section 5.1, and (iii) support of research on
stabilization of **4 provided however that (in connection with i), ii) and iii):
unless explicitly permitted in writing by GSK, (x)GSK will not be named, (y) the
**4 vaccine candidate and any proprietary details thereof will not be disclosed.

 

6.6

In the event that GSK decides not to exercise the OPTION, or the PARTIES fail to
execute a SPONSORED collaboration and option agreement or a LICENSE AGREEMENT
during the negotiation period, GSK will grant to VBI a royalty-free,
non-exclusive license, with the right to sublicense, to OTHER ARISING IP solely
to the extent required to practice the TECHNOLOGY, VBI Patents, VBI ARISING IP
or VBI Know-How inside of the FIELD, provided however that: unless explicitly
permitted in writing by GSK, (x)GSK will not be named, (y) the **4 vaccine
candidate and any proprietary details thereof will not be disclosed..

  

 

 

7.

OPTION AND EVALUATION FEE

      In consideration for the OPTION and the EVALUTION to be conducted
hereunder, GSK shall pay to VBI an option and evaluation fee of **4, upon
execution of this AGREEMENT by the PARTIES, which OPTION and EVALUATION fee
shall be payable on execution of this AGREEMENT and due the first working day of
the month following the expiry of sixty (60) calendar days from the date of
receipt of the corresponding invoice.

 

 

8.

TERM and TERMINATION

 

8.1

The Agreement is effective as of the EFFECTIVE DATE and shall remain in effect
until i) the expiry of the OPTION PERIOD or ii) expiration of the negotiation
period if GSK has exercised its OPTION (the “TERM”) . The PARTIES may mutually
agree to extend the duration of the Agreement by written amendment. Articles 3
(CONFIDENTIALITY), 4.2, 4.3, 5 (ARISING INTELLECTUAL PROPERTY RIGHTS), 6.3, 6.4,
6.5, 6.6 (OPTION), 8.1 and Article 11 shall survive termination of this
AGREEMENT for a period of five (5) years.

 

 

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4 Information omitted pursuant to a Confidential Treatment Request filed with
the SEC on February 9, 2016. 
 

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8.2

If either PARTY breaches any of the terms or conditions of this AGREEMENT and
fails to remedy that breach within thirty (30) days after receipt of notice of
such breach from the other PARTY, the PARTY giving notice may, at its option and
in addition to any other remedies it may have in law or in equity, terminate
this AGREEMENT by sending written notice of termination to the other PARTY.

 

8.3

GSK shall have the right to terminate this AGREEMENT at any time if it decides
not to continue the EVALUATION, by sending a written notice of termination to
VBI and returning any remaining MATERIALS to VBI.

  

 

9.

CHANGE OF CONTROL

   

9.1

The Agreement may not be assigned or otherwise transferred, nor may any right or
obligation hereunder be assigned or transferred by either PARTY without the
prior written consent of the other PARTY, which consent shall not be
unreasonably withheld, except that the Parties may assign this AGREEMENT to any
of its AFFILIATES without prior consent.

 

9.2

GSK hereby consents any change of control which may arise as a result of the
merger described by VBI with SciVac as referenced in SEC filings dated October
26th 2015.

  

 

10.

WARRANTY

 

10.1

VBI represents and warrants to GSK that :

 

 

a)

it currently has, and will maintain throughout the term of this AGREEMENT, the
ability to grant the OPTION that is contemplated by this AGREEMENT.

 

 

b)

it has not granted and will not grant any right to any third party relating to
the TECHNOLOGY that would conflict with the rights granted hereunder.

 

10.2

Each PARTY hereby represents and warrants that it is duly organized and validly
existing under the laws of the state or country of its incorporation and has
full corporate power and authority to enter into this AGREEMENT and to carry out
the provisions hereof.

 

10.3

Each PARTY hereby represents and warrants that this AGREEMENT has been duly
executed and delivered on behalf of such PARTY, and constitutes a legal, valid,
and binding obligation of such PARTY that is enforceable against it in
accordance with its terms.

  

 

11.

MISCELLANEOUS

 

11.1

The relationship between GSK and VBI is one of independent contractors. GSK and
VBI are not and shall not be deemed a joint venture, partners, principal and
agent, master and servant, or employer-employee and shall be deemed to have no
relationship other than as independent contracting PARTIES. Neither PARTY shall
have the authority to bind or obligate the other in any manner except as is
expressly provided herein or authorized in writing.

 

11.2

The failure of either PARTY at any time to exercise any of their respective
rights under the AGREEMENT shall not be deemed a waiver thereof, nor shall such
failure in any way prevent either PARTY, as the case may be, from subsequently
asserting or exercising such rights.

 

11.3

The provisions of the AGREEMENT are severable. If any provision of the AGREEMENT
is found to be invalid or unenforceable under any controlling body of law, such
invalidity or unenforceability shall not affect the validity or enforceability
of the remaining provisions. The PARTIES agree to replace the invalid or
unenforceable provision with a like provision in order to accomplish the intent
of the PARTIES to the extent permitted by applicable law.

  

 
 

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11.4

The AGREEMENT shall be construed, governed, interpreted and applied in
accordance with the laws of England. All disputes arising out of or in
connection with this AGREEMENT that cannot be settled amicably by the PARTIES
shall be submitted to the courts of London.

 

11.5

VBI acknowledges receipt of the ‘Prevention of Corruption – Third PARTY
Guidelines’ attached hereto as Appendix B, and agrees to perform its obligations
under the AGREEMENT in accordance with the principles set out therein. VBI shall
comply fully at all time with all applicable laws and regulations, including but
not limited to applicable anti-corruption laws, of the territory in which VBI
conducts business with GSK. GSK shall be entitled to terminate this AGREEMENT
immediately on written notice to VBI, if VBI fails to perform its obligations in
accordance with this Article 11.5, VBI shall have no claim against GSK for
compensation for any loss of whatever nature by virtue of the termination of
this AGREEMENT in accordance with this Article 11.5. To the extent (and only to
the extent) that the laws of the territory provide for any such compensation to
be paid to VBI upon the termination of this AGREEMENT, VBI hereby expressly
agrees to waive (to the extent possible under the laws of the territory) its
right to such payment or to repay such amount to GSK.

 

11.6

This AGREEMENT contains the entire understanding between the PARTIES hereto with
respect to the subject matter contained herein and supersedes all prior written
or oral communications, negotiations, understandings or agreements of any kind
with respect to such subject matter.

 

11.7

This AGREEMENT and any amendment hereto may be executed in counterparts and all
such counterparts taken together shall be deemed to constitute one and the same
instrument. If this AGREEMENT is executed in counterparts, no signatory hereto
will be bound until both the PARTIES named below have duly executed a
counterpart of this AGREEMENT.

  

 

IN WITNESS WHEREOF, the PARTIES have caused this AGREEMENT to be executed by
their duly authorised representatives as of the EFFECTIVE DATE.

 

 

 

 

GLAXOSMITHKLINE BIOLOGICALS SA

 

 

   

By:

 

Title:

     

VARIATION BIOTECHNOLOGIES, INC

 

 

 

 

By:JEFF BAXTER

Title:CHIEF EXECUTIVE OFFICER

  

 
 

--------------------------------------------------------------------------------

 

  

Appendix A: EVALUATION

 

 

 

SCHEDULE A: DESCRIPTION OF THE SERVICES/ PROJECT / WORKPACKAGE(S)

 

 **5

 

--------------------------------------------------------------------------------

5 Information omitted pursuant to a Confidential Treatment Request filed with
the SEC on February 9, 2016. 
 

--------------------------------------------------------------------------------

 

  

Appendix B: PREVENTION OF CORRUPTION – THIRD PARTY GUIDELINES

 

The GSK Anti-Bribery and Corruption Policy (POL-GSK-007) requires compliance
with the highest ethical standards and all anti-corruption laws applicable in
the countries in which GSK (whether through a third PARTY or otherwise) conducts
business. POL-GSK-007 requires all GSK employees and any third PARTY acting for
or on behalf of GSK to ensure that all dealings with third PARTIES, both in the
private and government sectors, are carried out in compliance with all relevant
laws and regulations and with the standards of integrity required for all GSK
business. GSK values integrity and transparency and has zero tolerance for
corrupt activities of any kind, whether committed by GSK employees, officers, or
third-PARTIES acting for or on behalf of the GSK.

 

Corrupt Payments – GSK employees and any third PARTY acting for or on behalf of
GSK, shall not, directly or indirectly, promise, authorise, ratify or offer to
make or make any “payments” of “anything of value” (as defined in the glossary
section) to any individual (or at the request of any individual) including a
“government official” (as defined in the glossary section) for the improper
purpose of influencing or inducing or as a reward for any act, omission or
decision to secure an improper advantage or to improperly assist the company in
obtaining or retaining business.

 

Government Officials – Although GSK´s policy prohibits payments by GSK or third
PARTIES acting for or on its behalf to any individual, private or public, as a
“quid pro quo” for business, due to the existence of specific anticorruption
laws in the countries where we operate, this policy is particularly applicable
to “payments” of “anything of value” (as defined in the glossary section), or at
the request of, “government officials” (as defined in the glossary section).

 

Facilitating Payments – For the avoidance of doubt, facilitating payments
(otherwise known as “greasing payments” and defined as payments to an individual
to secure or expedite the performance of a routine government action by
government officials) are no exception to the general rule and therefore
prohibited.

 

GLOSSARY

 

The terms defined herein should be construed broadly to give effect to the
letter and spirit of the ABAC Policy. GSK is committed to the highest ethical
standards of business dealings and any acts that create the appearance of
promising, offering, giving or authorising payments prohibited by this policy
will not be tolerated.

 

Anything of Value: this term includes cash or cash equivalents, gifts, services,
employment offers, loans, travel expenses, entertainment, political
contributions, charitable donations, subsidies, per diem payments, sponsorships,
honoraria or provision of any other asset, even if nominal in value.

 

Payments: this term refers to and includes any direct or indirect offers to pay,
promises to pay, authorisations of or payments of anything of value.

 

Government Official shall mean:

 

●

Any officer or employee of a government or any department, agency or instrument
of a government;

 

●

Any person acting in an official capacity for or on behalf of a government or
any department, agency, or instrument of a government;

 

●

Any officer or employee of a company or business owned in whole or part by a
government;

 

●

Any officer or employee of a public international organisation such as the World
Bank or United Nations;

 

●

Any officer or employee of a political PARTY or any person acting in an official
capacity on behalf of a political PARTY; and/or

 

●

Any candidate for political office.

  

 
 

--------------------------------------------------------------------------------

 

 

Appendix C: VBI PATENTS

  

 

VBI Vaccines LPV™ Patent Summary

 

VARIATION OWNED PATENTS AND PATENT APPLICATIONS

Patent Family:

Methods for Preparing Liposomes and Formulation Produced Therefrom

 

Inventors:

David Evander Anderson and Andrei Ogrel

Priority Date(s):

July 6, Oct. 30th, 2009

VBI-009-1/VBI-009-2

US 61/223,196 and

US 61/256,912

Country

Number

Agent

Filing Date

Reference No.

Status or Patent No.

PCT

PCT/US10/41078

WO 11/005769

Choate

(0041)

06/07/10

VBI-009PC

●National Phase

Canada

2,767,392

BLG

06/07/10

VBI-009CA

●Pending

US

13/377,365

Choate

06/07/10

VBI-009US

●Pending

Europe

10797727.4

BLG

06/07/10

VBI-009EP

●Allowed

Japan

2012-519672

BLG

06/07/10

VBI-009JP

●Allowed

China

201080039405.6

BLG

06/07/10

VBI-009CN

●Pending

Australia

2010270722

BLG

06/07/10

VBI-009AU

●Allowed

Brazil

112012 0008269

BLG

06/07/10

VBI-009BR

●Pending

Israel

217375

BLG

06/07/10

VBI-009IL

●Pending

India

1069/DELNP/2012

BLG

06/07/10

VBI-009IN

●Pending

Mexico

MX/A/2012/000372

BLG

06/07/10

VBI-009MX

●Allowed

Patent Family:

Compositions and Methods for Treating Influenza

 

Inventors:

David Evander Anderson, Jeff Baxter, Andrei Ogrel and Ron Boch

Priority Date(s):

July 6, 2010 & Jan. 10, 2011

VBI-015-2/ VBI-015-4

US 61/361,898 and

US 61/431,218

Country

Number

Agent

Filing Date

Reference No.

Status or Patent No.

PCT

PCT/US11/43094

WO 12/006367

Choate

(0073)

06/07/11

VBI-015PC1

●National Phase

Canada

2,840,079

BLG

06/07/11

VBI-015CA

●Pending

US

13/808,155

Choate

06/07/11

VBI-015US

● Pending

Europe

11804305.8

BLG

06/07/11

VBI-015EP

●Pending

Japan

2013-518810

BLG

06/07/11

VBI-015JP

●Pending

China

201180042971.7

BLG

06/07/11

VBI-015CN

●Pending

Australia

2011276223

BLG

06/07/11

VBI-015AU

●Pending

Brazil

1120130003944

BLG

06/07/11

VBI-015BR

●Pending

Israel

224022

BLG

06/07/11

VBI-015IL

●Pending

India

1077/DELNP/2013

BLG

06/07/11

VBI-015IN

●Pending

Mexico

MX/A/2012/015232

BLG

06/07/11

VBI-015MX

●Pending

  

 
 

--------------------------------------------------------------------------------

 

 

Patent Family:

Compositions and Methods for Treating Viral Infections

Inventors:

David Evander Anderson, Tanvir Ahmed, Jasminka Bozic and Marc Kirchmeier

Priority Date:

January 13, 2011 

VBI-023-1

US 61/432,567

Country

Number

Agent

Filing Date

Reference No.

Status or Patent No.

PCT

PCT/US12/21388

WO 12/097346

Choate

(0080)

13/01/12

VBI-023PC

●National Phase

Canada

2,862,864

BLG

13/01/12

VBI-023CA

●Pending

US

13/979,322

Choate

13/01/12

VBI-023US

●Pending

Europe

12734104.8

BLG

13/01/12

VBI-023EP

●Pending

China

201280008709.5

BLG

13/01/12

VBI-023CN

●Pending

Brazil

1120130179392

BLG

13/01/12

VBI-023BR

●Pending

India

7052/DELNP/2013

BLG

13/01/12

VBI-023IN

●Pending

Mexico

MX/A/2013/008106

BLG

13/01/12

VBI-023MX

●Pending

Patent Family:

Methods for Preparing Vesicles and Formulations Produced Therefrom

Inventors:

David Evander Anderson, Yvonne Perrie, Jit Wilkhu and Marc Kirchmeier

Priority Date:

January 13, 2011

VBI-024-1

US 61/432,569

Country

Number

Agent

Filing Date

Reference No.

Status or Patent No.

PCT

PCT/US12/21389

WO 12/097347

Choate

(0081)

13/01/12

VBI-024PC

●National Phase

Canada

2,862,871

BLG

13/01/12

VBI-024CA

●Pending

US

13/979,317

Choate

13/01/12

VBI-024US

●Pending

Europe

12733900.0

BLG

13/01/12

VBI-024EP

●Pending

China

201280008692.3

BLG

13/01/12

VBI-024CN

●Pending

Australia

2012205315

BLG

13/01/12

VBI-024AU

●Pending

Brazil

1120130180749

BLG

13/01/12

VBI-024BR

●Pending 

India

7053/DELNP/2013

BLG

13/01/12

VBI-024IN

●Pending

Mexico

MX/A/2013/008104

BLG

13/01/12

VBI-024MX

●Pending

  

 
 

--------------------------------------------------------------------------------

 

 

Patent Family:

Compositions and Methods for Treating Viral Infections

Inventors:

David Evander Anderson

Priority Date:

January 12, 2012

VBI-026-1

US 61/585,971

Country

Number

Agent

Filing Date

Reference No.

Status or Patent No.

PCT

PCT/US13/21277

PCT/IB13/000453

WO 13/104995

Choate

(0091)

to BLG

12/01/13

VBI-026PC

●National Phase

Canada

2,894,442

BLG

12/01/13

VBI-026CA

●Pending

US

14/371,935

Choate

12/01/13

VBI-026US

●Pending

Europe

13736246.3

BLG

12/01/13

VBI-026EP

●Pending

India

6138/DELNP/2014

BLG

12/01/13

VBI-026IN

●Pending

Australia

2013208693

 

BLG

12/01/13

VBI-026AU

●Pending

China

201380009711.9

BLG

12/01/13

VBI-026CN

●Pending

Patent Family:

Methods and Compositions for Therapeutic Agents

Inventors:

Marc Kirchmeier

Priority Date:

January 27, 2012

VBI-027-1

US 61/591,837

Country

Number

Agent

Filing Date

Reference No.

Status or Patent No.

PCT

PCT/US13/23079

PCT/IB13/000454

WO 13/111012

Choate

(0092)

to BLG

25/01/13

VBI-027PC

●National Phase

Canada

2,894,467

BLG

25/01/13

VBI-027CA

●Pending

US

14/373,930

Choate

25/01/13

VBI-027US

●Pending

Europe

13741121.1

BLG

25/01/13

VBI-027EP

●Pending

India

6319/DELNP/2014

BLG

25/01/13

VBI-027IN

●Pending

Russia

2014133089

BLG

25/01/13

VBI-027RU

●Pending

Vietnam

1-2014-02863

BLG

25/01/13

VBI-027VN

●Pending

Australia

2013213345

BLG

25/01/13

VBI-027AU

●Pending

China

201380006793.1

BLG

25/01/13

VBI-027CN

●Pending

  

 
 

--------------------------------------------------------------------------------

 

 

Appendix D: AGREED PRESS RELEASE

  

 

VBI Vaccines Announces Research Collaboration with GlaxoSmithKline to Enhance
Vaccine Stability

CAMBRIDGE, MA (XX, 2015) – VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI”) has entered
into a research collaboration with GlaxoSmithKline Biologicals SA (“GSK”) to
evaluate its LPV™ Platform. . VBI’s LPV Platform is a proprietary formulation
and process that enables the development of vaccines and biologics with improved
stability and preserved potency.

 

Under the terms of the research collaboration, GSK has the option to negotiate
an exclusive license to VBI’s LPV Platform Platform for use in a defined field.
Further terms of the collaboration were not disclosed.

 

“With our partners, we seek to develop a next generation of vaccines and
biologics with improved stability characteristics that allow for consistently
safe and effective administration in both established and emerging markets,”
said Jeff Baxter, VBI’s President and CEO. “We’re thrilled to be working with
GlaxoSmithKline, a leading global healthcare company, to explore the potential
of the LPV technology to their pipeline. This collaboration further validates
the significant potential of our LPV Platform.”

 

Stability is a critical issue potentially affecting vaccine potency, safety, and
ultimately patient access. The LPV Platform uses a proprietary formulation and
process to enclose and protect the antigen (active component) of a vaccine or
biologic. VBI has completed proof of concept studies on a number of vaccine and
biologic targets that demonstrate the LPV Platform’s ability to preserve potency
under stress conditions.

 

To learn more about the LPV Platform, visit:
http://www.vbivaccines.com/technology/thermostable-platform/.

 

 

About VBI Vaccines Inc.

 

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company developing novel
technologies that seek to expand vaccine protection in large underserved
markets. VBI’s eVLP Platform allows for the design of enveloped (“e”) virus-like
particle (“VLP”) vaccines that closely mimic the target virus. VBI’s lead eVLP
asset is a prophylactic cytomegalovirus (“CMV”) vaccine; VBI has initiated work
for GMP manufacturing of its CMV candidate for use in formal preclinical and
Phase I trials. VBI’s second platform is a thermostable technology that enables
the development of vaccines and biologics that can preserve vaccine potency and
withstand storage or shipment at fluctuating temperatures. VBI has completed
proof of concept thermostability studies on a number of vaccine and biologic
targets. VBI is headquartered in Cambridge, MA with research facilities in
Ottawa, Canada.

 

Website Home: http://www.vbivaccines.com/

News and Insights: http://www.vbivaccines.com/wire/

Investors: http://ir.vbivaccines.com/

 

 

Company Contact

 

Perri Maduri, Communications Executive

Phone: (617) 830-3031 x124

Email: ir@vbivaccines.com

 

 

Investor Contacts

 

Robert B. Prag, President

The Del Mar Consulting Group, Inc.

Phone: (858) 794-9500

Email: bprag@delmarconsulting.com

 

Scott Wilfong, President

Alex Partners, LLC

Phone: (425) 242-0891

Email: scott@alexpartnersllc.com

 

 
 

--------------------------------------------------------------------------------

 

  

Forward-Looking Statement Disclosure

 

This press release contains certain “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995, as amended,
including statements regarding the efficacy of potential products, the timelines
for bringing such products to market, and the availability of funding sources
for continued development of such products. Forward-looking statements are based
on management’s estimates, assumptions, and projections, and are subject to
uncertainties, many of which are beyond the control of VBI. Actual results may
differ materially from those anticipated in any forward-looking statement.
Factors that may cause such differences include the risks that potential
products that appear promising to VBI cannot be shown to be efficacious or safe
in subsequent preclinical or clinical trials, VBI will not obtain appropriate or
necessary governmental approvals to market these or other potential products,
VBI may not be able to obtain anticipated funding for its development projects
or other needed funding, and VBI may not be able to secure or enforce adequate
legal protection, including patent protection, for its products. All
forward-looking statements included in this press release are made only as of
the date of this press release, and VBI does not undertake any obligation to
publicly update or correct any forward-looking statements to reflect events or
circumstances that subsequently occur or of which we hereafter become aware.

 

More detailed information about VBI and risk factors that may affect the
realization of forward-looking statements, including the forward-looking
statements in this press release, is set forth in VBI’s filings with the
Securities and Exchange Commission (the “Commission”). VBI urges investors and
security holders to read those documents free of charge at the Commission’s Web
site at http://www.sec.gov. Interested parties may also obtain those documents
free of charge from VBI. Forward-looking statements speak only as to the date
they are made, and except for any obligation under the U.S. federal securities
laws, VBI undertakes no obligation to publicly update any forward-looking
statement as a result of new information, future events or otherwise.