Exhibit 10.5

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

DATED 23 October 2014

(1) THE KATHOLIEKE UNIVERSITEIT LEUVEN
(2) UNIVERSITY HOSPITAL ANTWERP
(3) BRABANT PHARMA LIMITED

Collaboration and License Agreement

[brabantcollaborationa_image1.gif]

 

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CONTENTS
 
 
 
 
 
 
 
 
Page
 
 
 
 
 
 
 
 
 
1
 
GRANT OF LICENSE AND CONSULTING SERVICES
 
2
 
 
 
 
 
 
 
 
 
2
 
DEFINITIONS
 
 
 
 
3
 
 
 
 
 
 
 
 
 
3
 
INTELLECTUAL PROPERTY AND INVENTIONS
 
5
 
 
 
 
 
 
 
 
 
4
 
RESEARCH USES, REPORTS AND PUBLICATIONS
 
6
 
 
 
 
 
 
 
 
 
5
 
CONFIDENTIALITY
 
 
 
 
6
 
 
 
 
 
 
 
 
 
6
 
TERMINATION OF LICENSE
 
 
 
7
 
 
 
 
 
 
 
 
 
7
 
TRANSFER OF DATA
 
 
 
 
8
 
 
 
 
 
 
 
 
 
8
 
REPRESENTATION, WARRANTIES AND LIABILITY
 
8
 
 
 
 
 
 
 
 
 
9
 
FURTHER COVENANTS
 
 
 
9
 
 
 
 
 
 
 
 
 
10
 
MISCELLANEOUS PROVISIONS
 
 
 
9

 

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THIS COLLABORATION AND LICENSE AGREEMENT (the Agreement") is made 23 October
2014 (the "Effective Date")
BETWEEN:-
(1)
The Katholieke Universiteit Leuven, for the purposes of this Agreement
represented by its department KU LEUVEN RESEARCH & DEVELOPMENT, having its
office in 3000 Leuven, Waaistraat 6 - box 5105, Belgium, VAT number BE
0419.052.173, (hereinafter referred to as "KU LEUVEN R&D" and

UNIVERSITY HOSPITAL ANTWERP, having its offices at Wilrijkstraat 10, 2650
Edegem, Belgium, registered under company number 0874.619.603, and duly
represented by Mr. Johnny Van der Straeten, Managing Director, who entrusts the
execution of this Agreement to Prof. Dr. B. Ceulemans, Department of
Neurology-Child Neurology, hereinafter referred to as "UZA",
UZA and KU LEUVEN R&D jointly referred to as the "Institution"
on one hand, and
(2)
BRABANT PHARMA LIMITED of Scotsgrove House, Uxmore Road, Checkendon,
Oxfordshire, United Kingdom RG8 0TD ("Brabant")

on the other hand.
Hereinafter collectively referred to as "the Parties" or individually referred
to as "a Party"
RECITALS
The Parties entered into a Collaboration and License Agreement on 1 September
2012 which was subsequently amended by a Deed of Amendment dated 5 September
2013 (hereinafter "the Previous Agreement");
Pursuant to the Deed of Amendment dated 1 September 2012 Brabant was granted
rights in respect of the Patent Rights;
The Parties wish to amend and restate the Previous Agreement with effect from
the Effective Date of this Agreement;
The research team of Prof. Ceulemans at UZA, the research team of Prof. Lagae of
KU Leuven R&D and Brabant are continuing to perform an ongoing study on the use
of fenfluramine for the treatment of Dravet Syndrome or related conditions
stemming from infantile epilepsy (the "Study");
Currently, no regulatory approval in the EU or US has been granted for the use
of fenfluramine for the treatment of Dravet Syndrome or related conditions
stemming from infantile epilepsy;
Brabant has expressed its interest in the Data;
Brabant is willing to use the Data to obtain regulatory approval for the use of
fenfluramine for the treatment of Dravet Syndrome or related conditions stemming
from infantile epilepsy;
Brabant is willing to supply the Institution with fenfluramine for the
performance of the Study and is willing to receive an exclusive licence to use
the Data for Direct Exploitation (as defined below);
Institution is willing to grant such a licence under the terms and conditions
set forth herein;
Whereas KU LEUVEN R&D has been designated by the Board of Directors of the
Katholieke Universiteit Leuven to enter into agreements relating to services,
research and/or intellectual property;
Therefore, the Parties agree as follows:

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1.
    GRANT OF LICENSE AND CONSULTING SERVICES

1.1
For a period of thirty six (36) months starting from the 1st of September, 2012
(the "Term") Institution grants Brabant a worldwide exclusive license for use of
Data and the Patent Rights for Direct Exploitation ("the License") and to
sub-license (including the grant of any option over a sub-licence) such to Third
Parties (the “Sub-licence”). The Licence in respect of the Data and the Patents
Rights will terminate on written notice from Institution if none of the
following milestones have been achieved within the aforesaid period:

1.1.1
Commencement of work on a new dosage form of fenfluramine;

1.1.2
Submission of an application for marketing approval with a regulatory authority
;

1.1.3
Market approval by a regulatory authority; or

1.1.4
Commencement of a clinical trial as requested by a regulatory authority.

1.2
On completion of any of the milestones in 1.1.1 and 1.1.2 above, the Term of the
Licence will be extended for a an additional period of five (5) years (5). On
completion of any of the milestones in 1.1.3 and 1.1.4 above, the Term of the
License will be extended for a an additional period of twenty five (25) years.

1.3
Upfront consideration for the License of [***] was paid on the commencement of
the Previous Agreement.

1.4
Institution and Brabant may agree in writing to extend the Term of the Licence.

1.5
Institution will receive [***]% of the Revenue ([***]%) that Brabant receives
from a Third Party, for instance in case Brabant Sublicenses the Patent Rights
to a Third Party or in case Brabant lets another organization rely on the Data
or New Data to submit an application to a Regulatory Authority. Brabant shall
inform Institution fully on any potential and future Revenues of a Sublicense
deal.

1.6
Brabant shall pay Institution a royalty of [***]% on Net Sales of fenfluramine.
The royalties shall be due and payable in EURO within [***] of the end of each
calendar year with respect to the 12 month period ending on the last day of such
calendar year by wire-transfer to the accounts specified in writing by
Institution ([***]%). Within [***] of the end of each calendar year, Brabant
shall send Institution a written report disclosing the Net Sales for the just
ended calendar year and the royalties due to Institution, containing at least
the following information:

1.6.1
the amount of fenfluramine sold by Brabant, or its Affiliates;

1.6.2
the gross price charged by Brabant, or its Affiliates for fenfluramine in each
country;

1.6.3
the calculation of Net Sales, including a detailed and documented listing of
applied deductions;

1.6.4
a detail on the applied exchange rates (if applicable);

1.6.5
the total royalties in EURO.

If no amounts are due to Institution for any calendar year, the report shall so
state.
An independent certified public or chartered accountant of Institution's choice
shall have the right, on reasonable notice, during business hours to, no more
than [***], inspect Brabant's, and its Affiliates' books of account and records
to verify any reports and payments made under this Agreement up to
***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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[***] after termination of this Agreement. In the event that any inspection
reveals an underpayment in excess of [***]%, Brabant shall bear the full cost of
such inspection and shall remit any amounts due to Institution (increased by
interest) on Institution's first request.
1.7
Brabant has manufactured up to 1kg of fenfluramine for use in the Study in
accordance with current Good Manufacturing Practices and all Applicable Laws (as
defined below) and regulations and shall deliver such material to Institution
DDP Incoterms 2013.

1.8
Brabant may retain the services of Institution to act as a consultant to
Brabant, and Institution agrees to consult with Brabant, with respect to the
regulatory approval process of fenfluramine. Institution will carry out
consulting services to a maximum of 10 (ten) working days per annum (the
"Consultancy"). In full and exclusive compensation for such consulting services
provided by Institution under this Agreement, Brabant will pay Institution [***]
euro per working day (a working day means eight (8) working hours). Brabant will
further reimburse Institution for the reasonable expenses of travel, lodging and
meals (where overnight stay is required) that are necessary in providing the
consulting services under this Agreement, provided that such expenses are
supported by original receipts and that Institution obtains the written
authorization of Brabant prior to incurring such expenses. Institution shall
send quarterly invoices to Brabant for the amounts that became due under this
under this Section 1.8 during the immediately preceding calendar quarter.
Invoices shall be addressed for the attention of Rick Stewart, Scotsgrove House,
Uxmore Road, Checkendon, Oxfordshire, United Kingdom RG8 OTD. All invoices shall
be paid by bank transfer within [***] from the invoice date.

1.9
Brabant shall not disclose the Data to Third Parties, except that Brabant may
disclose the Data (i) to its employees, directors, Affiliates, advisors,
potential investors, potential sub-licensees, potential purchasers, financing
sources, interns, agents, independent contractors and consultants on a
need-to-know basis, provided that Brabant has executed appropriate written
agreements with each such individual or entity sufficient to enable compliance
with all the provisions of this Agreement; or (ii) to a Regulatory Authority for
the purposes set out in section 1.1.2.

2.
    DEFINITIONS.

2.1
For the purposes of this Agreement, "Applicable Laws" shall mean all national
and local laws, ordinances, rules and regulations as amended, re-enacted or in
force from time to time applicable to this Agreement or activities contemplated
hereunder, including the rules and regulations of the relevant Regulatory
Authority;

2.2
For the purposes of this Agreement, "Data" shall mean (i) any and all
information regarding the use of fenfluramine obtained in the Study and
currently in possession of Institution or subsequently obtained in the Study
related to treatment of patients, whether provided through physician notes,
patient self-reporting, clinical monitoring, prescription history, insurance
claims, or other forms reducible to electronic or documentary records (such
information constitutes Institution’s Confidential Information) and (ii) the
Patent Application (as defined in article 2.4.) and (a) all divisional or
continuation, in whole or in part, applications based on the foregoing (b) any
continuations-in-part in the USA thereof; (c) any and all issued and unexpired
patents and any further applications resulting from any of the applications
described above; (d) any and all issued and unexpired reissues, re-examinations,
renewals or extensions based on any of the patents described in (c) above and
shall also include the Supplementary Protection Certificates (SPCs) and the
period of protection provides by SPCs (hereinafter the “Patent Rights”).

2.3
For the purposes of this Agreement "Patent Application" shall mean the patent
application in the United States pertaining to fenfluramine for the treatment of
Dravet Syndrome (application number 13/887/014).

2.4
For the purposes of this Agreement, "Revenue" shall mean all proceeds and equity
received from the Sub-licensing the Data and/or the Patent Rights and/or New
Data including but not limited to any of the following: (a) license fees, option
fees, documentation fees, lump sum payments, up-front

***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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payments, signing fees (whether at the stage of development, marketing or
otherwise), success, bonus, maintenance and periodic (including annual)
payments, royalty and minimum royalty payments, marketing fees, distribution
fees, franchise fees, (c) where any sub-licence is to be granted under
cross-licensing arrangements, the value of any third party licence obtained
under such arrangements; (d) any premium paid over the fair market value of
shares, options or other securities in respect of any of the share capital of
Brabant; (e) any loan, guarantee or other financial benefit made or given other
than on normal market terms; and (f) any Equity Securities, shares, options or
other securities obtained from a Third Party in relation to the Data and/or
Patent Rights and/or New Data. To avoid any misunderstanding, Revenue does not
include compensation for services performed by either Party for a Third Party,
sums that, because of the terms under which they are provided, may only be used
by Brabant for funding research and which are not available for other
distribution or use or sums received from Research Use.

2.5
For the purposes of this Agreement,"Marketing exclusivity" and "Data
exclusivity" is a protection granted for achieving market authorization or
registration of medicinal products of a "Regulatory Authority" a which have been
authorized in accordance with the provisions of the Applicable Laws and for
members of the European Medicines Agency REGULATION (EC) No 726/2004 OF THE
EUROPEAN PARLIAMENT AND OF THE COUNCIL (31 March 2004). "Data exclusivity" is
the period of time during which the medicines authorities are not allowed to
consult the dossier of an originator to verify the safety and efficacy of the
active moiety in the application for marketing authorization of a generic
medicine. "Marketing exclusivity" and "Data exclusivity" include similar forms
that exist or will occur with other Regulatory Authorities such as FDA (United
States), in Japan, China or other countries.

2.6
For the purposes of this Agreement, "Regulatory Authority" shall mean any
regulatory authority that has responsibility for granting registrations of
fenfluramine, and the following Regulatory Authorities shall be referred to
herein as: "FDA", meaning United States Food and Drug Administration and "EMA",
meaning European Medicines Agency.

2.7
For the purposes of this Agreement, "Affiliate" shall mean any enterprise (a
company, a person, or group of persons whether incorporated or not) entitled to
carry on business in any country, which now or hereafter directly or indirectly
controls, is controlled by, or is under common control with a Party; "Control"
in an affiliate requires ownership of more than fifty percent (50%) of (1)
voting stock of a company which has issued voting stock or (2) ownership
interest in any other enterprise, or requires (direct or indirect) effective
control through board memberships, voting rights, proxies, or similar
arrangements.

2.8
For the purposes of this Agreement, "Research Use" shall mean shall mean use of
Data and/or Patent Rights and/or New Data for all purposes other than for Direct
Exploitation or licensing to Third Parties

2.9
For the purposes of this Agreement "Direct Exploitation" means to Exploit the
Data, New Data and/or the Patent Right itself.

2.10
For the purposes of this Agreement, "Exploitation" means the production,
reproduction, performance, promotion, publicity, development, manufacture,
marketing, advertisement, distribution, licensing, sub-licensing, importation,
exportation, translation, localisation, display, rental, lease, lending, sale
and any other form of commercial exploitation, submit Data to a regulatory
agency for instance to prove safety and efficacy of a drug and to obtain
"Marketing exclusivity" and/or "Data exclusivity" of such regulatory agency and
to prevent generic drug manufacturers or Third Parties from relying on this Data
in their own applications or to prevent generic drug manufacturers or Third
Parties from commercializing fenfluramine for certain indications and the
authorisation of any Third Party to do any of the foregoing and "to Exploit"
shall be interpreted accordingly.

2.11
For the purposes of this Agreement, "Third Party" shall mean any individual,
enterprise, authority, or any other organizations or economic entities other
than the Parties.

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2.12
For the purposes of this Agreement, "Net Sales" means the gross amount invoiced
for fenfluramine by Brabant or its Affiliates to unaffiliated Third Parties,
based on the list price for fenfluramine after deduction of:

2.12.1
[***];

2.12.2
[***];

2.12.3
[***]; and

2.12.4
[***].

Sales of fenfluramine between Brabant, or its Affiliates shall not be considered
sales to Third Parties and shall be excluded from Net Sales calculations. For
clarity, sales of fenfluramine by Brabant, or its Affiliates to a distributor
shall be considered sales to Third Parties and shall be included in Net Sales
calculations. All deductions from Net Sales set forth above shall be duly
documented by Brabant, and its Affiliates in their books of account and to the
extent possible be separately stated on purchase orders, invoices, or other
documents of sale. No deductions shall be made for commissions paid to
individuals whether they be with independent sales agencies or regularly
employed by Brabant, Affiliates and sublicensees on their payroll, or for cost
of collections. Net Sales shall occur on the date of billing, or, if not billed,
when delivered by Brabant, or its Affiliates. Non-monetary consideration shall
not be accepted by Brabant without the prior written consent of Institution
which shall not be unreasonably withheld.
3.
    INTELLECTUAL PROPERTY AND INVENTIONS

3.1
All future intellectual property rights directly related to fenfluramine in the
treatment of Dravet Syndrome or related conditions stemming from infantile
epilepsy and (i) arising directly from the Study and any information regarding
the use of fenfluramine obtained in the Study (ii) created by Brabant and/or the
research team of Prof. Lagae of KU Leuven R&D and/or the research team of Prof.
Ceulemans at UZA shall be Confidential Information of Institution and Data
licensed to Brabant under the terms of this Agreement. For clarity, and without
limitation, (a) future intellectual property rights directly related to
fenfluramine in the treatment of Dravet Syndrome or related conditions stemming
from infantile epilepsy created by Brabant that do not derive directly from the
Study or any information regarding the use of fenfluramine obtained in the Study
shall belong to Brabant and (b) future intellectual property rights created in
any clinical trials regarding fenfluramine other than the Study, in any
formulations of fenfluramine or in any regulatory submissions created by or on
behalf of Brabant, shall belong to Brabant ((a) and (b) hereinafter jointly
referred to as the “New Data”).

3.2
Brabant shall have full responsibility for, and shall exclusively control the
preparation, prosecution, any extension (including any supplementary protection
certificate) and maintenance of the Patent Application and any and all
applicable patent rights in the Data. Brabant shall pay all costs and expenses
of filing, prosecuting and maintaining the same. Brabant shall not be in breach
of this Agreement if it does not pursue the filing or prosecuting of the same.
However, Brabant shall not give up any Patent Rights without prior notice to the
Institution who shall be entitled to take over the cost and maintenance of any
such and Brabant will have no further rights to such patent application or
patent. Brabant shall on an ongoing basis promptly furnish copies of all patent
related documents to Institution shall consult with Institution in all aspects
of the preparation, filing, prosecution and maintenance of patent applications
and patents included within the Licensed Patent Rights and shall provide
Institution sufficient opportunity to comment on any document that Brabant
intends to file or to cause to be filed with the relevant intellectual property
or patent office and shall regularly - or upon request of the Institution -
inform the Institution on the status of the patents and patent applications.

3.3
Brabant shall have the exclusive right but not the obligation to institute or
defend infringement actions against Third Parties relating to the Data and the
Patent Rights (the "Actions") at Brabant's sole cost

***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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and expense. Brabant shall not be in breach of this Agreement if it does not
institute or defend the same. However Brabant shall inform Insititution of any
infringement of any of the Patent Rights transferred hereunder forthwith upon
such infringement coming to its notice and of any Revenue from a settlement
thereon.

3.4
Institution shall promptly:

3.4.1
disclose to Brabant in writing the details of any Actions and any pending
Actions; and

3.4.2
provide reasonable assistance to Brabant at its own cost and expense in relation
to Section 3.1; and

3.4.3
provide reasonable assistance to Brabant at Brabant’s cost and expense in
relation to Section 3.3

4.
    RESEARCH USES , REPORTS AND PUBLICATION

4.1
Notwithstanding the License granted in paragraph 1.1 above, Institution retains
the rights to use the Data for Research Use and patient care.

4.2
Institution reserves the right to publish findings based upon the Data. However,
before publishing or making any public disclosure, Institution will give Brabant
an opportunity to review the proposed publication and related illustrations and
will consider modifications and/or reasonable delays suggested by Brabant to
enable the filing of applications for patents or to remove any Confidential
Information received from Brabant.

4.3
Brabant shall have at least [***] within which to review the proposed
publication and will either give written concurrence for immediate publication
or suggest the above-noted modifications and/or reasonable delays. In any event,
such reasonable delays shall not exceed [***] from the date of receipt of the
proposed publication by Brabant.

4.4
Publication by either of the Parties to this Agreement shall give proper credit
to the other Party, unless one of the Parties to this Agreement requests
otherwise.

4.5
Brabant shall grant access to Institution to any and all Brabant originated
clinical trial data to the extent it relates to fenfluramine for Institution's
non-exclusive use. Publication of Brabant originated clinical trial data shall
subject to Brabant's agreement.

4.6
On completion of the Study Institution shall produce a final report in respect
of the Study incorporating such details as Brabant may reasonably instruct from
time to time.

4.7
The Parties agree, at least once every six months during the term of this
Agreement, or at such other intervals and at such locations as may be agreed
between them from time to time, to arrange and attend at their own cost (unless
otherwise agreed) by their duly authorised representatives, meetings to discuss
and review the progress and status of the Study and any other studies concerning
fenfluramine or the use of fenfluramine for the treatment of Dravet Syndrome or
related conditions stemming from infantile epilepsy undertaken by the
Institution and the Institution in relation to the same, and consider proposals
and agree actions in relation to the same with a view to ensuring the due and
proper completion of the Study or any other studies concerning fenfluramine or
the use fenfluramine for the treatment of Dravet Syndrome or related conditions
stemming from infantile epilepsy undertaken by the Institution in accordance
with such dates and quality standards as may be agreed between the Parties. Such
meetings may also be held by conference call.

4.8
The Institution shall, within [***], provide full details to Brabant of any
serious adverse event or other key clinical event arising from the Study.

***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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5.
    CONFIDENTIALITY

5.1
Both Parties agree to accept disclosure of Confidential Information (meaning
information considered by a reasonable business person as confidential,
including but not limited to the Data) from the other Party pursuant to this
Agreement in strict confidence and agree to only use such Confidential
Information for the purposes envisaged under this Agreement and not to use for
their own benefit or for the benefit of others, nor disclose Confidential
Information to anyone other than their employees or employees of any of their
Affiliates, and then only on a strictly applied “need to know” basis provided
that such employees have been informed of the confidential nature of the
Confidential Information.

5.2
Any disclosure of Confidential Information in writing shall be marked
“confidential”. Any disclosure of Confidential Information by other means will
be documented in writing by the Party disclosing Confidential Information within
[***] from oral disclosure and an appropriately marked copy shall be delivered
forthwith to the other Party. "Confidential Information" also includes any
information which due to its character or nature, a reasonable person in a like
position to the recipient of such information under this Agreement, and under
like circumstances, would treat as confidential.

5.3
For this agreement Confidential Information shall not include, and the above
confidentiality undertaking shall in no event restrict or impair both Parties’
right to use or disclose any information which:

5.3.1
at the time of disclosure is in the public domain or thereafter becomes part of
the public domain through no fault of the Party receiving Confidential
Information;

5.3.2
the Party receiving Confidential Information can conclusively establish that it
was in its possession prior to the time of disclosure with no prior duty of
confidentiality;

5.3.3
is independently made available to the Party receiving Confidential Information
by a Third Party who is not thereby in violation of a confidential relationship;

5.3.4
the Party receiving Confidential Information can conclusively establish that it
was independently developed by or for it without use of the Confidential
Information of the other Party;

5.3.5
is required to be disclosed by law, regulation, or court of governmental order,
provided that the Party that has disclosed such Confidential Information has
reasonably notified the other Party prior to such disclosure of such
requirement. For the avoidance of doubt, the foregoing will include any
submission of Data or New Data to Regulatory Authorities in connection with an
application for marketing approval with such a Regulatory Authority.

***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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5.4
Both Parties further represent that it will not use Confidential Information of
the other Party for filing a patent application or for filing any other
proceeding in any patent office or court.

5.5
The obligation of both Parties not to use or disclose each other’s Confidential
Information as set forth in the preceding paragraphs, shall extend for a period
of [***] from the date of disclosure of such Confidential Information or until
an agreement is reached between the Institution and Brabant providing for such
use or disclosure, whichever occurs first.

5.6
Parties will not use the other Parties’ name or that of any of the other
Parties’ employee, agent or representative nor disclose to any Third Party any
details of services being performed by the Institution under this Agreement
without the other Party’s prior express written consent such consent not to be
unreasonably withheld or delayed.

5.7
Nothing in this Clause 5 or otherwise in this Agreement shall prevent, restrict
or impair Brabant from disclosing the Data pursuant to its commercialisation
activities following the first grant of Marketing exclusivity/Data exclusivity
from a Regulatory Authority to Brabant for fenfluramine.

6.
    TERMINATION OF LICENSE

6.1
End of term termination: This Agreement and Brabant's right to use the Data and
the Patent Rights shall terminate at the end of the Term.

6.2
Termination by cause:

6.2.1
Brabant shall cause one or more of its Affiliates or sub-contractors to, or
shall itself use commercially reasonable efforts to: (a) develop and
commercialize fenfluramine for the treatment of (i) Dravet Syndrome; or (ii)
related conditions stemming from infantile epilepsy , or (iii) any & all other
indications in the European Union, or (b) seek approval of fenfluramine for the
treatment of Dravet Syndrome in the United States.

6.2.2
Up until the day of submission of an application for marketing approval with a
regulatory authority or the commencement of a clinical trial as requested by a
regulatory authority, Brabant may terminate this Agreement by giving 180 days
written notice to Institution. Thereafter, Brabant shall have no right to
terminate this Agreement except under Section 6.3.

6.2.3
If Brabant (a) becomes insolvent, shall make an assignment for the benefit of
creditors, or shall have a petition in bankruptcy filed for or against it or for
any similar relief has been filed against Brabant, or (b) fails to remedy a
material breach of this Agreement within thirty (30) days after written notice
by Institution; than Institution may terminate this License forthwith by giving
a written notice of termination to Brabant.

6.2.4
Termination by cause returns any and all rights on Data and Patent Rights
thereunder to Institution.

6.3
Brabant may terminate this Agreement forthwith upon written notice to
Institution, if Institution (a) fails to remedy a material breach of this
Agreement within thirty (30) days after written notice by Brabant; or (b)
becomes insolvent, or if proceedings are instituted against it for
reorganization or other relief under any bankruptcy law, or if any substantial
part of its assets come under the jurisdiction of a receiver or trustee in an
insolvency proceeding authorized by law.

6.4
Sections 1.9, 2, 5, 8.3, 8.4 and 10.6 of this Agreement shall survive
termination.

7.
    TRANSFER OF DATA

7.1
Data shall be transferred by Institution to Brabant in de-identified form in
accordance with Applicable Laws.

***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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7.2
Notwithstanding the provisions of Section 7.1, Institution will grant access to
all original (non de-identified) data to an independent data monitor appointed
by Brabant, for the purposes of data verification using source document
verification. It is explicitly understood that all communications regarding data
verification issues, from the independent data monitor to Brabant, will be
provided in a de-identified format.

7.3
Institution and Brabant agree to transfer Data electronically into the United
States from areas that restrict such transfer, including, without limitation,
states of the European Union, on legally compliant terms.

8.
    REPRESENTATION, WARRANTIES, LIABILITY AND WAIVERS THEREOF

8.1
Warranties. Institution hereby represents that it has the full right and power
to enter into this Agreement and to grant the exclusive License set forth in
this Agreement.

8.2
Nothing in this Agreement shall be construed:

8.2.1
as a warranty or representation that anything made, used, sold or otherwise
disposed of under any license granted in this Agreement is or will be free from
infringement by patents, copyrights, trade secrets, trademarks, or other rights
of Third Parties;

8.2.2
as a warranty that the Study or Consultancy will be successful in any way or
that any specific results will be obtained;

8.2.3
as a warranty as to the condition, originality, patentability, non-infringement
or fitness for a particular purpose of the results of the Study or the
Consultancy;

8.2.4
as granting by implication, estoppel or otherwise any licenses or rights under
patents or other intellectual property rights of Institution other than
expressly granted herein; or

8.2.5
as a warranty that Data is patentable or that Brabant will be successful in
securing the grant of any patent relating to any technology or any reissue or
extensions under this Agreement.

8.3
Limitation of Liability. EXCEPT UNDER THE INDEMNITY SET FORTH HEREINBELOW, IN NO
EVENT WILL EITHER PARTY BE LIABLE FOR LOST PROFITS, OR ANY SPECIAL, INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF
LIABILITY, ARISING IN ANY WAY IN CONNECTION WITH THIS AGREEMENT. THIS LIMITATION
WILL APPLY EVEN IF EITHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED
REMEDY.

8.4
Brabant shall at all times during and after the Term indemnify, defend, and hold
Institution and its employees harmless from and against any and all liabilities,
losses, claims, demands, suits, proceedings, expenses, recoveries and damages,
including reasonable attorneys' fees and other costs of litigation, losses or
causes of any action arising out of any allegation by Third Parties in
connection with Brabant's, its Affiliates ' or sublicensees ' development,
manufacturing, marketing or sale of fenfluramine.

8.5
Section 8.3 shall not apply to any liability that cannot be excluded by
Applicable Laws (including but not limited to fraud, personal injury or death
due to a Party's negligence), or which arises from the fraud or wilful
misconduct of a Party, a Party's intentional withholding of material
information, and the granting, during the Term, by the Institution to a Third
Party of rights to the Data for seeking regulatory approval for the use of
fenfluramine for the treatment of Dravet Syndrome or related conditions stemming
from infantile epilepsy. For clarity, nothing herein shall limit the liability
of either party for death or personal injury arising from negligence.

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9.
    FURTHER COVENANTS

9.1
Both Institution and Brabant shall maintain secure systems for storage of
patient health information consistent with Applicable Laws.

9.2
Institution and Brabant each recognize that aspects of theLicense, including its
exclusivity, could be limited by future government action or court decree.
Should a government order or a ruling of a court of competent jurisdiction
effectively alter the terms of the License, the Parties agree to reform this
Agreement in a manner to preserve its intent, while preserving, to the extent
practicable, the timely transfer of Data.

10.
    MISCELLANEOUS PROVISIONS

10.1
This Agreement represents the whole agreement and understanding between the
Parties and supersedes all other agreements and understandings between the
Parties or any of them relating to the subject matter of this Agreement,
including but not limited to the Previous Agreement.

10.2
No variation of this Agreement shall be effective unless it is in writing and
signed by or on behalf of each of the Parties.

10.3
No waiver of any breach of or default under this Agreement shall be effective
unless such waiver is in writing and has been signed by the Party against which
it is asserted. No delay in exercising, or failure to exercise, any right, power
or remedy provided by law or under this Agreement shall affect that right, power
or remedy or operate as a waiver thereof.

10.4
Nothing in this Agreement and no action taken by the Parties pursuant to this
Agreement shall constitute, or be deemed to constitute, a partnership,
association, joint venture or other co-operative entity between the Parties, nor
shall either Party act as the agent of the other Party for any purpose.

10.5
This Agreement may be executed in any number of counterparts and by the Parties
on separate counterparts, but shall not be effective until each Party has
executed at least one counterpart. Each counterpart shall constitute an original
of this Agreement, but all the counterparts shall together constitute one and
the same agreement.

10.6
This Agreement shall be governed by the laws of [***]. Both parties shall
attempt to settle any dispute concerning the interpretation hereof or their
performance hereunder in an amicable way. Should such attempts fail, then both
Parties hereby agree that said disputes shall be finally settled under the Rules
of Arbitration of the [***] by one arbitrator appointed in accordance with the
said Rules such arbitration to be held in [***] save that nothing herein shall
prevent any of the Parties seeking and obtaining interim injunctive relief in
any relevant jurisdiction.

10.7
This Agreement will incur to the benefit of and be binding upon Brabant, its
successors, and assigns (including without limitation, any corporate entity
which may acquire all or substantially all of the assets or business of Brabant
in the field of this Agreement). No assignment of this Agreement, either in
whole, or in part, or of any of the rights and obligations hereunder, can be
made by Brabant without prior written consent of Institution such consent not to
be unreasonably withheld delayed or conditioned. Consent shall not be necessary
for any assignment or transfer of this Agreement to a company that is an
Affiliate of Brabant or in case of assignment, transfer or sale to a Third Party
of all or substantially all of the portion of its business (including any
(application for) marketing approval) to which this Agreement relates. Brabant
will give Institution at least one month prior written notice of such intended
assignment, transfer or sale.

SIGNED by or on behalf of the Parties.
SIGNED by or on behalf of KU LEUVEN R&D:

***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.

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/s/ Koenraad Debackere
Prof. dr. ir. Koenraad Debackere
Managing Director

/s/ Paul Van Dun

Paul Van Dun
General Manager

For Approval

/s/ Lieven Lagae

Prof. dr. Lieven Lagae
Supervisor

SIGNED by or on behalf of UNIVERSITY HOSPITAL ANTWERP

/s/ Johnny Van der Straeten

Mr. Johnny Van der Straeten
Managing Director

For Approval

/s/ B. Ceulemans

Prof. Dr. B. Ceulemans
Department of Neurology-Child Neurology

SIGNED by or on behalf of BRABANT PHARMA LIMITED

Name: /s/ Rick Stewart
Title: Director

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