edsa_ex101





  Exhibit 10.1







 



CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT
BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE
HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

 


	
 

	
 

	


License Agreement


 

	
 


	
 

	
 

	

dated
April 17, 2020


 


	
 

	
 

	

between


 

	
 


	
 

	
 

	


NovImmune SA


Chemin
des Aulx 14, 1228 Plan-les-Ouates, Switzerland


 

	

(hereinafter
NI)


 


	
 

	
 

	

and

	
 


	
 

	
 

	


Edesa Biotech Research, Inc.


100 Spy
Court, Markham, Ontario, Canada, L3R 5H6]

	

(hereinafter
LICENSEE)


 


	
 

	
 

	
 

	
 


	
 

	
 

	
 







 



	

License
Agreement between NovImmune and Edesa Biotech Research

	
 
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Table
of Contents

 


	
1.

	
DEFINITIONS

	
 5


	
 

	
 

	
 


	
2.

	
LICENSE

	
 5


	
 

	
2.1 Construct License


	
 5


	
 

	
2.2 Retained Rights


	
 5


	
 

	
 

	
 


	
3.

	
COST AND RISK; SPECIAL INDEMNITY


	
 6


	
 

	
 

	
 


	
4.

	
LICENSE FEES


	
 6


	
 

	
4.1 Upfront Payment


	
 6


	
 

	
4.2 Royalties


	
 6


	
 

	
4.3 [__] - Milestone Payments


	
 7


	
 

	
4.4 [__] - Milestone Payments


	
 7


	
 

	
4.5 Currency Conversion


	
 8


	
 

	
4.6 Reporting


	
 8


	
 

	
4.7 Payment


	
 8


	
 

	
4.8 Taxation


	
 9


	
 

	
4.9 Right to Purchase


	
 9


	
 

	
 


	
 


	
5.

	
BOOKS AND RECORDS; AUDITS


	
 9


	
 

	
5.1 Procudures


	
 9


	
 

	
5.2 Cost of Audits


	
 10


	
 

	
5.3 Retention Period


	
 10


	
 

	
 


	
 


	
6.

	
INTELLECTUAL PROPERTY


	
 10


	
 

	
6.1 Allocation of IP


	
 10


	
 

	
6.2 IP Responsibility Prosecution


	
 10


	
 

	
6.3 Third Party Infringement


	
 11


	
 

	
6.4 Infringement of Third Party's IP


	
 11


	
 

	
6.5 Transfer of the IND


	
 11


	
 

	
 


	
 


	
7.

	
REPRESENTATIONS AND WARRANTIES;
INDEMNITIES


	
 11


	
 

	
7.1 Representations and Warranties


	
 11


	
 

	
7.2 Indemnities


	
 12


	
 

	
7.3 Exclusions and Limitations


	
 12


	
 

	
 


	
 


	
8.


	
CONFIDENTIALITY AND PUBLIC
ANNOUNCEMENTS


	
 12


	
 

	
 


	
 


	
9.


	
TERM AND TERMINATION


	
 12


	
 


	
9.1 Term


	
 12


	
 


	
9.2 Termination for Cause


	
 12


	
 


	
9.3 Effects of Termination


	
 13







	
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10.


	
FINAL PROVISIONS


	
13


	
 


	
10.1 Entire Agreement


	
13


	
 


	
10.2 Written Form


	
13


	
 


	
10.3 Severability


	
13


	
 


	
10.4 Assignment


	
13


	
 


	
10.5 Independent Contractor


	
13


	
 


	
10.6 Further Assurances


	
13


	
 


	
10.7 Notices


	
14


	
 


	
10.8 Force Majeure


	
14


	
 


	
10.9 Waiver


	
14


	
 

	
10.10 Annexes


	
14


	
 

	
10.11 Governing Law


	
14


	
 

	
10.12 Arbitration


	
14






 

 

 

 

 


	

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Table of Annexes

 


	


Number of Annex

	


Name of Annex


	

Annex
1

	

Definitions


	

Annex 2.1(b)

	

Licensed
Patents


	

Annex
3(c)

	

Development
Plan


	

Annex
4.1(a)

	

Preferred Share
Terms


	

Annex
4.1(b)

	

Securities Purchase
Agreement







 



	

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WHEREAS, NI has developed, generated and produced certain
monoclonal antibodies (the Monoclonal Antibodies) and NI owns IP
(as defined) in the Monoclonal Antibodies;

 



WHEREAS, LICENSEE is interested in the development and
commercialization of the Monoclonal Antibodies known as [___]
(Anti-TLR4) ([___]) and [___] (Anti-CXCL10) ([___]) (each a
Construct, jointly the
Constructs); [Nature of constructs omitted
as competitively sensitive information.]

 

WHEREAS, NI is willing to grant LICENSEE
the license rights necessary to do so;

 

WHEREAS, NI has an existing inventory of
[___], and the Parties (as defined) shall enter into a separate
supply agreement concurrently with the signing of this agreement
pursuant to which NI intends to supply to LICENSEE, and LICENSEE
intends to purchase from NI, certain amounts of [___];[Nature of constructs omitted
as competitively sensitive information.]

 

NOW, THEREFORE, in consideration of the
mutual covenants and obligations contained herein and intending to
be legally bound hereby, the Parties agree as follows:
 




1.1111.

DEFINITIONS





 


Capitalized
terms used in this Agreement (as defined) shall have the meanings
assigned to them in Annex 1.

  




2.

LICENSE





 

 

2.1
Construct
License

 




(a)

Subject to the
terms and conditions of this Agreement, NI agrees to grant and
hereby grants to LICENSEE an exclusive, worldwide license, with the
right to sublicense, to develop, test, register (including, without
limitation, to file and amend applications for, and to hold
marketing authorisations as well as regulatory approvals),
manufacture, contract manufacture, modify, market, sell, distribute
and promote the Constructs and Licensed Products (as defined) in
the Licensed Field (as defined) (the Construct License).





 




(b)

The Construct
License shall include rights to exploit: (i) the Licensed Patents
(as defined) and (ii) the Know-How (as defined) and other IP
controlled by NI as reasonably necessary to commercialize the
Constructs or either of them (the latter referred to as
“Other Licensed
IP”). 





 




(c)

For the avoidance
of doubt, LICENSEE shall have the right to appoint sub-distributors
and/or sub-contractors for, developing, marketing, testing, selling
and manufacturing of the Licensed Products.





 




(d)

To the extent
available and/or permissible in any given jurisdiction, LICENSEE
shall have the right to register the Construct License, and NI
shall support any of LICENSEE's filings to such end by issuing and
executing deeds and other documents required to perfect such
license registrations upon LICENSEE's due request.





 

2.2
Retained
Rights

 


Unless
expressly provided for in this Agreement, this Agreement does not
grant any right or license to a Party under any of the other
Party’s IP or to the IP of Third Parties (as defined).
Notwithstanding anything in this Agreement, NI shall be free to
make use of all Monoclonal- and Bispecific Antibodies that are not
subject to the Construct License.


 


 
	

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3.
COST AND RISK;
SPECIAL INDEMNITY

 




(a)

LICENSEE shall be
responsible at its own cost and risk for the research, development,
testing, registration, manufacture, use, marketing, distribution
and commercialization of the Constructs and Licensed Products and
to obtain all necessary licenses, rights and authorizations as
necessary, however, in accordance with the terms and conditions of
this Agreement.





 




(b)

Notwithstanding any
general liability and indemnity under this Agreement but subject to
the provisions of Section 7.3, LICENSEE
shall indemnify and hold NI and its Affiliates (as defined) and
each of their officers, directors, employees, agents and
representatives from and against any and all third party
liabilities, claims, demands, actions, suits, losses, damages,
costs, and expenses (including reasonable attorneys' fees) arising
out of or in connection with LICENSEE's and its sub-licensees' and
sub-contractors' actions and omissions in the course of the
research, development, testing, registration, making, use,
marketing, distribution and commercialization of the Constructs and
any of the Licensed Products.





 




(c)

LICENSEE will be
responsible for the development of the Constructs in accordance
with the plan set forth in Annex 3(c) (the Development Plan), including the
development targets (the Development Targets) referenced therein.
LICENSEE shall provide NI with progress updates in accordance with
the Development Plan by no later than sixty (60) days from the end
of each 6-month period following the Effective Date, for the first
two years of this Agreement and, thereafter, within sixty (60) days
following each twelve (12) month anniversary of the Effective Date.
The Parties acknowledge and agree the Development Plan is based on
the best estimation of goals and timelines at the time of execution
of this Agreement and may be amended by mutual agreement in writing
over the course of its implementation by LICENSEE. After the
submission by LICENSEE of a Development Plan update, the Parties
shall meet (in person or through other means) and work in good
faith to agree on an amendment and adjustment of the Development
Plan as reasonably needed.





 

4.
LICENSE
FEES

 

4.1
Upfront
Payment

 


Within
thirty (30) calendar days of the Effective Date (as defined),
LICENSEE shall pay to NI a non-refundable fee of USD 2,500,000 for
the Construct License (the "Upfront
Payment"). At the option of the LICENSEE, the Upfront
Payment will be paid in either cash or through the issuance,
assignment and transfer to NI of Series A-1 Preferred Shares in the
share capital of Edesa Biotech, Inc. in accordance with the terms
set out in Annexes 4.1(a) and 4.1(b), or a combination of cash payment and
Series A-1 Preferred Shares.

 

4.2


Royalties

 


LICENSEE
shall pay to NI tiered royalties on Net Sales (as defined) or, as
the case may be, Sublicensing Revenues of Licensed Products, each
on a Licensed Product-by-Licensed Product and country-by-county
basis as follows (the Royalty
Payments):

 


	

Commercialization

	

Royalty
Rate (%)


	

Net
Sales in countries, in which LICENSEE commercializes the Licensed
Products on its own (directly or through subsidiaries or
distributors)

	


[___]% of Net Sales


	

With
respect to countries, in which LICENSEE does not commercialize the
Licensed Products on its own but through sublicensing

	

[___]%
of Sublicensing Revenue






 



[Royalty
rates omitted as competitively sensitive
information.]

 




4.3

4.3     [___]
– Milestone Payments





 


	

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As
regards [___] and/or Licensed Products based on [___], upon
occurrence of following events (the Milestone Event), LICENSEE shall pay to
NI the following payments (the Milestone Payments):

 


	

Milestone
Event regarding [___]

	

Milestone
Payment


 


	


Dosing of the first patient into the first stage of a Phase II
Clinical Trial (as defined)

	

USD
[___]


	

Earlier
of either (i) dosing of the first patient into the second stage of
a Phase II Clinical Trial or
(ii) completion of the Phase II
Clinical Trial

	

USD
[___]


	

Dosing
the first patient in the initial Phase
III Clinical Trial (as defined)

	

USD
[___]


	

Submission
of BLA (as defined) to the FDA (as defined)

	

USD
[___]


	

Upon
submission of a BLA or equivalent in Europe

	

USD
[___]


	

Upon
submission of a BLA or equivalent in Japan

	

USD
[___]


	

Receipt
of first marketing authorization by FDA

	

USD
[___]


	

Receipt
of first marketing authorization in Europe

	

USD
[___]


	

Receipt
of first marketing authorization in Japan

	

USD
[___]


	

First
Commercial Sale (as defined) in the United States

	

USD
[___]


	

First
Commercial Sale in Europe

	

USD
[___]


	

First
Commercial Sale in Japan

	

USD
[___]


	

First
annual occurrence of global Net Sales of USD
50,000,000

	

USD
[___]


	

First
annual occurrence of global Net Sales of USD
100,000,000

	

USD
[___]


	

First
annual occurrence of global Net Sales of USD
250,000,000

	

USD
[___]


	

First
annual occurrence of global Net Sales of USD
500,000,000

	

USD
[___]


	

First
annual occurrence of global Net Sales of USD
1,000,000,000

	

USD
[___]






 



[Nature
of constructs and quantum of milestone payments omitted as
competitively sensitive information.]



 




4.4


4.4      [___]–
Milestone Payments





 


As
regards [___] and/or the Licensed Products based on [___], upon
occurrence of following Milestone Events, LICENSEE shall pay to NI
the following Milestone Payments:

 


	

Milestone
Event regarding [___]

	

Milestone
Payment


	

Dosing
the first patient in the initial Phase
III Clinical Trial

	

USD
[___]


	

Submission
of BLA to the FDA

	

USD
[___]


	

Upon
submission of a BLA or equivalent in Europe

	

USD
[___]


	

Upon
submission of a BLA or equivalent in Japan

	

USD
[___]


	

Receipt
of first marketing authorization by FDA

	

USD
[___]


	

Receipt
of first marketing authorization in Europe

	

USD
[___]


	

Receipt
of first marketing authorization in Japan

	

USD
[___]


	

First
Commercial Sale in the United States

	

USD
[___]


	

First
Commercial Sale in Europe

	

USD
[___]


	

First
Commercial Sale in Japan

	

USD
[___]


	

First
annual occurrence of global Net Sales of USD
50,000,000

	

USD
[___]


	

First
annual occurrence of global Net Sales of USD
100,000,000

	

USD
[___]


	

First
annual occurrence of global Net Sales of USD
250,000,000

	

USD
[___]


	

First
annual occurrence of global Net Sales of USD
500,000,000

	

USD
[___]


	

First
annual occurrence of global Net Sales of USD
1,000,000,000

	

USD
[___]






 


[Nature
of constructs and quantum of milestone payments omitted as
competitively sensitive information.]

 


	

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4.5
Currency
Conversion

 




(a)

Currency
conversions, if any, shall be made at the average rates of exchange
rates reported by Thomson Reuters or OANDA (or any other qualified
source that is acceptable and agreed upon by both Parties) for the
applicable Calendar Quarter (as defined).





 




(b)

All payments owed
under this Agreement shall be made in USD and by wire transfer to a
bank and account designated in writing by NI, unless otherwise
specified in writing by NI.





 

4.6

Reporting

 




(a)

Net Sales and
Sublicensing Revenues of Licensed Products and Royalty Payments and
Milestone Payments thereon in accordance with this Agreement shall
be calculated on a Licensed Product-by-Licensed Product and
country-by-country basis and reported for each Calendar Quarter
within forty-five (45) calendar days following the end of the
quarter.





 




(b)

Each quarterly
report shall include the following
pieces of information provided for each Licensed Products and each
country where sales have actually been made:





 




(i)

Licensed Product
and country of sales;





 




(ii)

gross sales and
sublicensing revenue in local currency;





 




(iii)

exchange rates used
in determining the amount of USD;





 




(iv)

gross sales and
sublicensing revenue in USD;





 




(v)

deductions from
sales and sublicensing revenue to calculate Net Sales and
Sublicensing Revenue pursuant to the definition of Net Sales and
Sublicensing Revenue; for the avoidance of doubt, the amount of
each deduction listed in the definition of Net Sales shall be
detailed;





 




(vi)

Royalty rate
applied to calculate Royalty Payments;





 




(vii)

Net Sales and
Sublicensing Revenue in USD to be divided into (i) Net Sales
relating to Licensed Products based on [___] and (ii) Net Sales
relating to Licensed Products based on [___]; [Nature of constructs omitted as competitively
sensitive information.];





 




(viii)

gross Royalty
Payments in USD;





 




(ix)

withholding taxes,
if any, required by law to be deducted from gross Royalty Payments
or Milestone Payments;





 




(x)

net Royalty
Payments actually owed and to be paid to NI.





 

4.7

Payment

 




(a)

Based on the
quarterly reports received, and further upon the occurrence of any
Milestone Event, NI will provide to LICENSEE correct and duly
detailed invoices, and invoices shall be paid within thirty (30)
days of receipt.





 




(b)

In the event that
any payment due hereunder is not made when due, the payment shall
accrue interest from the due date at the rate of five percent (5%)
per annum The payment of such interest shall not limit NI from
exercising any other rights it may have because of non-payment or
late payment.





 
	

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4.8

Taxation

 




(a)

All fees and
royalties are being understood and agreed as net of taxes such as
VAT (as defined) or other levies. To the extent any fees and
royalties are subject to taxation in any jurisdiction, LICENSEE
agrees to bear such taxes.





 




(b)

All fees and
royalties shall be paid free and clear of all deductions and
withholdings whatsoever, unless the deduction or withholding is
required by law or any governmental agency. If any deduction or
withholding is required by law, LICENSEE shall pay to NI such sum
as will, after the deduction or withholding has been made, leave NI
with the same amount as it would have been entitled to receive in
the absence of any such requirement to make a deduction or
withholding.





 




(c)

The Parties shall
cooperate and exercise their Commercially Reasonable Efforts (as
defined) to ensure that any withholding taxes imposed on LICENSEE
are reduced as far as possible under the provisions of the
applicable double tax treaty. LICENSEE shall furnish NI with the
best available evidence of payment whenever LICENSEE deducts such
tax from any payments due to NI.





 




(d)

If VAT is owed on
fees and royalties hereunder and cannot be settled by filing a
notification instead of paying the VAT, VAT (or equivalent tax)
shall be added to the applicable fee or LICENSEE shall pay the
royalty and such VAT (or equivalent tax) owing. The Parties shall
cooperate and exercise their Commercially Reasonable Efforts (as
defined) to allow to the extent possible under applicable laws and
regulations recovery of any such VAT (or equivalent tax) paid. In
particular, NI shall provide invoices in accordance with applicable
VAT law and any other documentation reasonably required by LICENSEE
to obtain a refund of such VAT.





 

4.9
Right to
Purchase

 




(a)

As from completion
of the [___], the LICENSEE shall have
the right to notify NI in writing at any point in time henceforth
during the Term of its interest to purchase (i) the Licensed
Patents (as defined) and (ii) the Know-How (as defined) and a
royalty-free license for other IP controlled by NI as reasonably
necessary to commercialize the Constructs. Upon receipt by NI of
such notification, the Parties shall negotiate in good faith and
endeavour to agree on the terms of such IP purchase, including,
without limitation, on the purchase price [___].





 


[Commencement of option period
and methodology of calculating
purchase price omitted as competitively sensitive
information.]

 




(b)

For the avoidance
of doubt, however, failing an agreement to execute the requested IP
purchase by LICENSEE, the Construct License shall continue
unaffected, and LICENSEE shall have the right to notify its
interest to purchase again at any time [___]. If and when an
agreement can be reached, the parties will work expeditiously to
complete the purchase and sale contemplated within this Section 4.9
within [___] days
of LICENSEE's written notice upon customary terms acceptable to
both Parties acting reasonably and in good faith.





 


[Information pertaining to
option period and timing to complete purchase and sale omitted as
competitively sensitive information.]

 




(c)

During the Term, NI
shall not assign, sell or transfer any of Licensor’s right,
title or interest in or to Licensed Patents or the Know-How to a
Third Party unless:





 



(i) 

NI has first, by
written notice to LICENSEE, offered to LICENSEE the right to
acquire from NI such right, title or interest proposed to be
assigned, sold or transferred by NI [___]; and





 



(ii) 

LICENSEE has not
accepted NI’s offer by written notice of acceptance within
[___] days after receipt by LICENSEE of NI’s
offer;





 


in
which event NI may assign, sell or transfer to such Third Party the
right, title or interest in or to Licensed Patents or the Know-How
on the terms set out in [___]; provided that such Third Party
acquiring such right, title or interest in or to the Licensed
Patents or Know-How shall agree in writing: (x) to be bound to the
terms and conditions of this Agreement to the same extent as and
instead of NI; and (y) that, therefore, LICENSEE shall be direct
beneficiary of such agreement with the right to enforce such
agreement on such Third Party. If LICENSEE accepts an offer from NI
under this paragraph, the parties will work expeditiously to
complete the purchase and sale to LICENSEE contemplated in this
paragraph.

 


[Information pertaining to
right of first refusal terms and timing omitted as competitively
sensitive information.]

 

5.



BOOKS AND RECORDS; AUDITS

 

5.1

Procedures

 




(a)

LICENSEE shall keep
full and accurate accounting records related to the Net Sales and
Sublicensing Revenues of Licensed Products and all reporting
obligations according to this Agreement in sufficient detail and in
compliance with internationally accepted accounting and bookkeeping
standards (International Financial Reporting Standards (IFRS) or
Generally Accepted Accounting Principles (GAAP)). Such records,
together with all necessary supporting data, shall be kept at
LICENSEE's offices at the address set forth above or such other
address as LICENSEE may communicate in writing to NI.





 
	

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(b)

Upon reasonable
notice to LICENSEE, NI shall have the right during normal business
hours to have an independent certified public accountant, selected
by NI and reasonably acceptable to LICENSEE, to audit on a
confidential basis LICENSEE's records pertaining to Net Sales and
Sublicensing Revenue of Licensed Products to verify fees and
royalties payable pursuant to this Agreement; provided, however,
that such audit shall not (a) take place more frequently than once
in a Calendar Year (as defined), or (b) cover records for more than
the preceding three (3) years.





 




(c)

If deemed necessary
in the sole discretion of the accountant, the accountant shall, at
NI’s expense, be permitted to consult with and obtain the
assistance of consultants selected by the accountant and reasonably
acceptable to LICENSEE.





 




(d)

The results of the
examination shall be final and binding on the Parties, subject to
either Party's right to bring the case to arbitration in accordance
with Section 10.12, but solely on the
ground of arbitrary findings of the examination.





 

5.2
Cost of
Audits

 


The
fees and expenses of an audit shall be borne by NI; provided,
however, that if an audit reveals that LICENSEE underpaid fees or
royalties due to NI under this Agreement as to the period being
audited by more than seven point five percent (7.5%) of the amount
that was payable for such period, then LICENSEE shall, in addition
to paying immediately to NI any such shortfall, reimburse NI for
the cost of such audit.

 

5.3
Retention
Period

 


Subject
to any statutory provisions on the keeping of records applicable,
LICENSEE shall retain all books and records required to be
maintained under Section 5 for
not less than five (5) years from the date of the Royalty Payment
to which they pertain.

 

6.


INTELLECTUAL PROPERTY

 

6.1


Allocation of IP

 




(a)

NI shall own any
and all existing IP in the Constructs.





 




(b)

LICENSEE shall
own any and all newly created IP resulting from the exploitation of
the Construct License, such as, without limitation, IP in Construct
modifications, improvements and innovative combinations of either
of the Constructs with newly developed or existing other constructs
and any filings with regulators, including, without limitation,
IND, and any marketing authorisations and other regulatory
approvals filed or obtained by or under the control of LICENSEE
during the Term (all together referred to as Edesa IP).





 

6.2


IP Responsibility | Prosecution

 




(a)

LICENSEE shall be
responsible to prosecute, maintain and enforce upon its sole
discretion (such discretion to be exercised, however, in compliance
with, and to be without prejudice to, the terms and conditions of
this Agreement, including, without limitation, this
Section 6) the Licensed Patents
and Edesa IP.





 




(b)

In the event that
LICENSEE decides to cease prosecution or maintenance of any
Licensed Patent and/or Edesa IP, it shall promptly (but in any case
not less than three months prior to such ceasing of prosecution or
maintenance) notify NI of that election, and it shall be NI's sole
and unrestricted option to prosecute or not at its own
expense.





 



(c) 

For the avoidance
of doubt, if any of the Licensed Patent or Other Licensed IP
belongs to a patent family disclosing and claiming inventions other
than the Constructs, then NI shall control its prosecution. In the
event that NI decides to cease prosecution or maintenance of such
Licensed Patent or Other Licensed IP, it shall promptly (but in any
case not less than three months prior to such ceasing of
prosecution or maintenance) notify LICENSEE of that election, and
it shall be LICENSEE's sole and unrestricted option to prosecute or
not at its own expense.





 
	

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6.3
Third
Party Infringement

 




(a)

If, during the term
of this Agreement, either Party becomes aware that any Third Party
is infringing any Licensed Patents, Know-how or Other Licensed IP,
it shall promptly notify the other Party and provide to the other
Party all non-privileged information in its possession concerning
such infringement.





 




(b)

LICENSEE shall have
the first right to instigate action and legal proceedings against
such Third Party, and NI shall provide such assistance as LICENSEE
may reasonably request. LICENSEE shall bear the expense of any
legal proceeding instigated by it. If LICENSEE does not timely
instigate appropriate action or legal proceedings against the Third
Party infringement, or if any action or legal proceedings
instigated by LICENSEE do not reasonably protect NI's interest in
the Licensed Patents, NI shall have the right but no obligation
whatsoever to instigate any action and/or legal proceedings against
the Third Party as NI deems reasonable in its own
discretion.





 




(c)

If an infringement
concerns a patent or any other IP owned by LICENSEE, LICENSEE shall
have sole discretion in the decision to instigate legal proceedings
at its expense.





 

6.4
Infringement of
Third Party’s IP

 




(a)

To the knowledge
of NI and as per the Effective Date, there are no current, pending
or threatened legal claims, objections, litigation, judgments or
settlements against the Licensed Patents and the Know-How pursuant
to the Construct License and to the knowledge of NI, the Licensed
Patents and the Know-How pursuant to the Construct License do not
infringe on any IP of a Third Party. However, LICENSEE acknowledges
that NI has not conducted, and was under no obligation to conduct,
any FTO analysis or other research of potential conflicts with
Third Party IP.





 




(b)

NI does not
represent nor warrant or covenants, nor does NI assume any
liability whatsoever towards LICENSEE or any other person, that the
exploitation of the Construct License does not or may not infringe
upon any IP of a Third Party. It shall be LICENSEE's sole
responsibility to conduct due FTO analyses in view of any intended
exploitation.





 

6.5
Transfer
of the IND

 


Subject
to the terms of this Agreement, within 30 days of the Effective
Date, the Parties will file a request to transfer the IND for the
Licensed Products from NI to the LICENSEE.

 

7.

REPRESENTATIONS AND WARRANTIES;
INDEMNITIES

 

7.1

Representations and Warranties

 




(a)

Each Party
represents, warrants and covenants that: (i) it has the requisite
power and authority to enter into, execute, deliver and perform its
obligations under this Agreement; and (ii) it is in compliance with
all applicable laws related to such performance, including having
obtained all necessary permits and licenses; and (iii) it has not
entered and will not enter into any agreements inconsistent with
the provisions hereof.





 




(b)

Other than
expressly provided for in section 6.4(a), no Party
does represent or warrant nor does it assume any liability of any
kind for the validity and/or enforceability of any IP involved in
the exploitation of the Construct License, nor for the efficacy or
merchantability of the Constructs or Licensed
Products.





 




(c)

NI does not
represent or warrant nor does it assume any liability that
governmental authorities or any other institution or supervisory
board or similar agencies shall approve the Licensed Products. NI
does not represent or warrant that any Licensed Products made or
having been made by LICENSEE nor any other activities by LICENSEE
under or in relation with this Agreement do not infringe upon IP of
Third Parties, subject however to the representations and
warranties set forth in sub-paragraph (f).





 




(d)

NI represents and
warrants that, to the knowledge of NI and as per the Effective
Date, there are no legal claims, litigation, judgments or
settlements, whether against or owed by NI or pending legal claims
or litigation, in each case relating to the Constructs, the
Licensed Patents and the Know-How or NI’s rights thereto, and
to the knowledge of NI, there are no current, pending or threatened
legal claims or objections relating to the Licensed Patents,
Constructs, or NI’s rights thereto.





 




(e)

NI represents and
warrants that it owns all right, title and interest in and to the
Licensed Patents, Know-how and Other Licensed IP, and has the right
to grant the LICENSEE the rights and licenses that it purports to
grant hereunder and has not granted any Third Party rights that
would interfere or be inconsistent with the LICENSEE’s rights
hereunder.





 




(f)

Notifications of
and/or claims for misrepresentations and/or breaches of warranties
may be made, raised and filed as provided for by the applicable
law.





 
	

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7.2

Indemnities

 


The
Parties shall indemnify, defend, and hold harmless each other and
their Affiliates and their officers, directors, employees, agents
and representatives from and against any and all liabilities,
claims, demands, actions, suits, losses, damages, costs, and
expenses (including reasonable attorneys' fees) arising out of or
in connection with a breach of warranty or misrepresentation or any
other breach of contract; provided that no Party shall be required
to indemnify the other or its Affiliates to the extent that the
other Party's gross negligence or wilful misconduct has contributed
to the damage.

 

7.3
Exclusions and
Limitations

 




(a)

Neither Party shall
be liable to the other Party, under whatever theory, for any
indirect, special, punitive or consequential damages, or loss of
profit, loss revenue, or loss of opportunity, for any cause of
action a Party may have against the other Party arising
hereunder.





 



(b) 

All liabilities and
obligations for indemnification hereunder shall expire two (2)
years from the date of termination or expiry of this Agreement,
except with respect to claims already notified to the other Party
prior to the end of such two (2) year period.





 

8.


CONFIDENTIALITY AND PUBLIC
ANNOUNCEMENTS

 




(a)

Each Party shall
keep strictly confidential all Confidential Information (as
defined) obtained from or about the other Party, and it shall have
its officers and employees execute confidentiality covenants duly
protecting such Confidential Information of the other
Party.





 




(b)

Each Party agrees
(i) not to use Confidential Information received from the other for
any purpose other than the performance of its obligations
hereunder, and (ii) not to disclose Confidential Information so
received to any Third Party, except as is required by mandatory
statutes or a court, stock exchange or governmental authority or
otherwise for the good faith performance of its obligations and
exercise of its rights hereunder (e.g., for patent filings, for the
filing of applications for regulatory approvals,
etc.).





 




(c)

In the event that a
disclosure of Confidential Information to a Third Party becomes
necessary or required, and such disclosure is not otherwise
permitted under this Agreement, the Receiving Party (as defined)
requested to disclose shall give to the Disclosing Party (as
defined) the greatest practical prior written notice so as to
permit the latter to take all possible action to perfect and/or
safeguard its rights in the Confidential Information.





 




(d)

The obligations of
the Parties relating to Confidential Information shall expire five
(5) years after termination or expiry of this
Agreement.





 




(e)

Each
Party shall be as careful to preserve the confidential nature of
the other Party's Confidential Information as it is with its own
proprietary information.





 




(f)

Subject
to any statutory, governmental or stock exchange disclosure
requirements, neither Party shall make any public announcement
concerning the transactions contemplated herein or make any public
statement which includes the name of the other Party or any of its
Affiliates, or otherwise use the name of the other Party or any of
its Affiliates in any public statement or document without the
written consent of the other Party.





 

9.
TERM AND
TERMINATION

 

9.1


Term

 




(a)

This Agreement
shall enter into force on the Effective Date and shall remain in
effect for twenty-five (25) years from the First Commercial Sale in
the first country (the Initial
Period).





 




(b)

Subsequently, the
Agreement shall automatically and repeatedly renew for five (5)
year periods (the Renewal
Periods) unless either Party terminates the Agreement by
giving notice of termination to the other Party at least six (6)
months prior to the expiry of the Initial Period or a Renewal
Period (the Initial Period and the Renewal Periods constitute the
Term of the
Agreement).





 


9.2
Termination for
Cause

 




(a)

Either Party may
terminate this Agreement upon written notice to the other Party in
the event the other Party materially breaches this Agreement and
fails to cure such breach, if curable, within sixty (60) calendar
days after receipt of written notice of breach from the
non-breaching Party requesting the remedy of the breach and
expressly threatening to otherwise terminate the Agreement. In case
of incurable breach of contract, the right to terminate arises with
the breach immediately and is to be exercised within sixty (60)
days thereof.







 
	

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(b)

This Agreement may
be terminated upon written notice by NI if the LICENSEE (i) makes a
general assignment for the benefit of creditors; (ii) files any
petition, or commences any proceeding voluntarily, for any relief
under any bankruptcy or insolvency laws or any law relating to the
relief of debtors; (iii) consents to the entry of an order in an
involuntary bankruptcy or insolvency case; (iv) is the subject of
an order or decree for relief against it by a court of competent
jurisdiction in an involuntary case under any bankruptcy or
insolvency laws or any law relating to the relief of debtors, which
order or decree is unstayed and in effect for a period of 60
consecutive days; (v) is subject to appointment, with or without
its consent, of any receiver, liquidator, custodian, assignee,
trustee, sequestrator or other similar official of such other Party
or any substantial part of its property; or (vi) admits in writing
of its inability to pay its debts generally as they become
due.





 




(c)

If NI alleges that
the LICENSEE has failed to use Commercially Reasonable Efforts to
develop the Constructs in accordance with the Development Plan by
failing to meet the Development Targets, NI shall provide the
LICENSEE with written notice. If Commercially Reasonable Efforts to
develop the Constructs in accordance with the Development Plan have
not commenced within sixty (60) days of receipt of written notice
of such failure by the LICENSEE, or if such Commercially Reasonable
Efforts have commenced in time but are discontinued and not resumed
by LICENSEE within thirty (30) days of another written notice, NI
may serve notice of termination with immediate effect of the
Agreement.





 

9.3


Effects of Termination.

 




(a)

Upon termination or
expiry of this Agreement, LICENSEE shall remain entitled to
continue to use any Know-How available to LICENSEE as of the date
of the termination or expiry of this Agreement. For the avoidance
of doubt, this right of continued use does not refer to the use of
(i) any of the Licensed Patents or Other Licensed IP still in force
at the time of termination and (ii) any additions to the Know-How
as available upon termination or expiry of the
Agreement.





 




(b)

To the extent the
sale of Licensed Products is still covered by Licensed Patents or
Other Licensed IP upon termination of this Agreement, LICENSEE and
its Affiliates and sub-licensees shall be permitted to sell
Licensed Products during a period of one-hundred-twenty (120) days
of termination, provided, however, that the sale of such Licensed
Products will be subject to the terms of this Agreement including,
but not limited to, the payments due and at the rates and times
provided herein and the rendering of reports in connection
therewith.





 




(c)

The termination or
expiry of this Agreement for any reason shall not relieve the
Parties of any obligations accruing prior thereto and shall be
without prejudice to the rights and remedies of either Party with
respect to the breach of any of the provisions of this
Agreement.





 




(d)

Upon Termination
for Cause of this Agreement by NI, LICENSEE shall provide, and
hereby grants, a non-exclusive, irrevocable, and royalty-free
license to make use of Edesa IP as is reasonably necessary for NI
to commercialize the Constructs.





 




(e)

Sections 5, 6.1, 6.2, 7.2, 7.3, 8, 9.3 and 10 shall
survive any expiry or termination of this Agreement.





 

10.


FINAL PROVISIONS

 

10.1
Entire
Agreement

 


This
Agreement, together with the annexes and any other document
referred to in this Agreement, constitutes the entire agreement
between the Parties concerning the subject matter hereof and
supersedes all written or oral prior agreements or understandings
with respect thereto.

 


10.2
Written
Form

 


The
termination and any changes or amendments of this Agreement,
including the waiver of any provisions, are effective only if made
in writing. This also applies to a waiver of this formal
requirement.

 

10.3
Severability

 


In the
event that any provision, clause or application of this Agreement
is invalidated or unenforceable for any reason whatsoever, this
Agreement shall remain binding and in full force and effect except
for such invalidated or unenforceable provision, clause or
application. The Parties agree to use all Commercially Reasonable
Efforts to substitute any provision that shall be illegal or
unenforceable in good faith by another suitable provision that
maintains the economic purpose and the intent originally pursued by
them.

 

10.4
Assignment

 


Other
than to an Affiliate or to a Party's successor to a part or all of
the business to which this Agreement relates (including in
connection with any company merger, company trade sale, sale of
stock, sale of assets or other similar transaction), neither this
Agreement nor any interest herein shall be assignable or otherwise
transferable by a Party without the other Party’s prior
written consent, which shall not be unreasonably
withheld.


 



10.5
Independent
Contractor

 


The
relationship of NI to LICENSEE is that of independent contractor.
In no event shall either Party hold itself out to others or allow
itself to be considered the agent, employee, or representative of
the other Party.

 

10.6
Further
Assurances

 


Each
Party will, from time to time and at all times, without further
consideration perform the acts and execute and deliver the
documents and give the assurances necessary to give effect to this
Agreement.

 
	

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10.7

Notices

 




(a)

All notices
hereunder shall be in writing and shall be delivered personally,
mailed by overnight delivery, registered or certified mail, postage
prepaid, mailed by express mail service or given by facsimile or by
electronic mail to the designated representative(s) of the Parties
at the following addresses of the respective Parties:









	
If
to NI:

	
NovImmune
SA

Chemin
des Aulx 14

1228
Plan-les-Ouates

Switzerland

Attn:
Oliver Eckelmann

Fax
No.:

Email:






 


	
If
to LICENSEE:

	
Edesa Biotech
Research, Inc.

100
Spy Court

Markham,
Ontario, L3R 5H6

Canada

Attn:
Michael Brooks

Fax
No.:

Email:






 


[Personal information
omitted.]

 




(b)

Notices shall be
effective upon receipt if personally delivered, on the third
Business Day (as defined) following the date of mailing if sent by
certified or registered mail, and on the second Business Day
following the date of delivery to the express mail service if sent
by express mail, or the date of transmission if sent by facsimile.
A Party may change its address listed above by written notice to
the other Party.





 

10.8
Force
Majeure

 



(a) 

Any delay in the
performance of any of the duties or obligations of either Party
under this Agreement caused by an event outside the affected
Party's reasonable control shall not be considered a breach of this
Agreement, and the time required for performance shall be extended
for a period equal to the period of such delay. Such events shall
include, without limitation: acts of God; acts of terrorism; riots;
embargoes; labour disputes, including strikes, lockouts, job
actions, or boycotts; fires; explosions; earthquakes; floods;
shortages of material or energy; or other unforeseeable causes
beyond the reasonable control and without the fault or negligence
of the Party so affected. The Party so affected shall give prompt
notice to the other Party of such cause and shall take whatever
reasonable steps are necessary to relieve the effect of such cause
as rapidly as possible.





 



(b) 

Notwithstanding the
foregoing, the Parties acknowledge that uncertainties and events
outside control of the Parties related to the ongoing COVID-19
pandemic, such as emergency proclamations by national governments,
quarantines and travel restrictions, may prevent performance under
this Agreement. The Parties agree to enter into good faith
negotiations to amend development and milestones timelines
specified in this Agreement if a Party provides notice to the other
Party that such events prevent the Party, in spite of its good
faith and diligent efforts, to meet its performance
obligations.





 

10.9

Waiver

 


No
waiver of any of the terms of this Agreement shall be valid unless
in writing and signed by an authorized representative of the
Parties. Failure by either Party to enforce any rights under this
Agreement shall not be construed as a waiver of such rights, nor
shall a waiver by either Party in one or more instances be
construed as constituting a continuing waiver or as a waiver in
other instances.

 

10.10

Annexes

 


All
Annexes are incorporated herein by reference.

 

10.11
Governing
Law

 


This
Agreement has been construed in accordance with and shall be
governed by the substantive laws of Switzerland with the exclusion
of the UN Convention on International Sales of Goods (Vienna
Convention).

 

10.12

Arbitration

 


All
disputes arising out of or in connection with this Agreement,
including disputes on its conclusion, binding effect, amendment and
termination, shall be resolved, to the exclusion of the ordinary
courts, by arbitration in accordance with the Rules of Arbitration
of the International Chamber of Commerce in force on the date when
the notice of arbitration is submitted in accordance with these
Rules. The number of arbitrators shall be three (3), and they shall
be appointed in accordance with the Rules of Arbitration. The seat
of the arbitration shall be in London. The arbitral proceedings
shall be conducted in English.

 
	

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IN WITNESS WHEREOF, each Party has caused this Agreement to
be executed on its behalf by its duly authorized representatives as
of the Effective Date.

 


	

Place
and Date: _Switzerland April 17, 2020


 



NovImmune SA

	
 


	

/s/
Nicolas Fischer

	

/s/
Oliver Eckelmann


	

Nicolas
Fischer


 


 


 

	

Oliver
Eckelmann


 


	

Place
and Date: _Canada April 17, 2020__


 



Edesa Biotech Research, Inc.

	
 


	

/s/
Pardeep Nijhawan

	

/s/
Michael Brooks


	


 Pardeep Nijhawan

	

Michael
Brooks







 




 








	

Annex
1 to the License Agreement between
NovImmune and Edesa Biotech Research

	


1 | 6







 

 





 



Annex 1

 



Definitions

 


As used
in this Agreement and in any of the Annexes thereto in capitalized
form, the terms set forth below shall have the following meaning,
irrespective of whether used in the singular or plural. To the
extent terms are also defined in one or several Sections of the
Agreement and discrepancies in definitions occur, the definitions
set forth in this Annex 1 shall
prevail.

 



Affiliate shall mean any individual, corporation,
association or other business entity that directly or indirectly
controls, is controlled by, or is under common control with the
Party in question. As used in this definition, the term control
shall mean the direct or indirect ownership of more than fifty
percent (>50%) of the stock having the right to vote for
directors thereof or the ability to otherwise control the
management of the corporation or other business entity whether
through the ownership of voting securities, by contract,
resolution, regulation or otherwise.

 



Agreement shall mean this present License Agreement with its
Annexes.

 



Annex shall mean any of the numbered Annexes to this
Agreement.

 



BLA shall mean Biologic Application License as regulated
under FDA 21 CFR 600 – 680.

 



Business Day shall mean a day other than a Saturday or
Sunday or other day on which commercial banks in Zurich,
Switzerland are authorized or required by law to
close.

 



Calendar Quarter shall mean the four quarters of a Calendar
Year, each Calendar Quarter starting on January 1, April 1, July 1
and October 1.

 



Calendar Year shall mean the period of time beginning on
January 1 and ending December 31, except for the first year which
shall begin on the Effective Date and end on December
31.

 



Commercially Reasonable Efforts shall mean the level of
diligence, effort and resources required to carry out a particular
task or obligation in a manner consistent with the reasonable
general practices that a company within the pharmaceutical industry
at a similar size and similarly situated to NI or LICENSEE (as
applicable) applies in the exercise of its reasonable business
discretion relating to other pharmaceutical products which are of
similar market potential and at a similar stage in their
development or product life.

 



Confidential Information shall mean any and all information,
data or know-how, whether technical or non-technical, oral or
written, that is disclosed by one Party or its Affiliates
(Disclosing Party) to the
other Party or its Affiliates (Receiving Party). Confidential
Information shall not include any information, data or know-how
that:

 




(a)

as reasonably
evidenced by the Receiving Party, was generally available to the
public at the time of disclosure, or information that becomes
available to the public after disclosure by the Disclosing Party
other than through fault (whether by action or inaction) of the
Receiving Party or its Affiliates,





 




(b)

can be evidenced by
written records to have been already known to the Receiving Party
or its Affiliates prior to its receipt from the Disclosing
Party,





 




(c)

is obtained at any
time lawfully from a Third Party under circumstances permitting its
use or disclosure, as reasonably evidenced by the Receiving
Party,





 




(d)

is developed
independently by the Receiving Party or its Affiliates as evidenced
by written records other than through knowledge of Confidential
Information,





 




(e)

is required to be
disclosed by the Receiving Party of its Affiliates to comply with a
court or administrative order provided the Receiving Party or its
Affiliates furnishes prompt notice (in no event less than three (3)
Business Days) to the Disclosing Party to enable it to resist such
disclosure, provided however
that the exception in this sub-paragraph (e) shall apply
only for the purpose of complying with such court or administrative
order and that, for the avoidance of doubt, such disclosed
information shall otherwise remain Confidential
Information,





 



 







 






	
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(f)

is required to be disclosed by the Receiving Party
to fulfill stock exchange disclosure requirements,
or





 




(g)

is approved in
writing by the Disclosing Party for release by the Receiving
Party.





 


The
terms of this Agreement shall be considered Confidential
Information of either of the Parties.

 



Construct(s) shall have the meaning set forth in the second
whereas clause.

 



Construct License shall have the meaning set forth in
Section 2.1(a).

 



Development Plan shall have the meaning set forth in Section
3(c) and shall be further detailed in Annex 3.

 



Development Targets shall have the meaning set forth in
Section 3(c) and shall be further detailed in Annex 3

 



Disclosing Party shall have the meaning set forth in the
definition of Confidential Information.

 



Edesa IP shall have the meaning set forth in Section
6.1(b).

 



Effective Date shall mean the date on which the last Party
executes this Agreement.

 



FDA shall mean the U.S. Food and Drug Administration
or any successor entity as defined in the U.S. Federal Food, Drug
and Cosmetic Act.

 



First Commercial Sale shall mean, on a country-by-country
basis, the first invoiced sale of a Licensed Product to a Third
Party by or for LICENSEE following the receipt of any regulatory
approval required for the sale of such Licensed Product, or if no
such regulatory approval is required, the date of the first
invoiced sale of a Licensed Product to a Third Party by or for
LICENSEE in such country.

 



FTO shall mean Freedom to Operate.

 



IND shall mean an Investigational New Drug application in
the United States, a Clinical Trial Application in Canada, or a
foreign equivalent application or submission for approval to
conduct human clinical investigations filed with or submitted to a
Regulatory Authority in conformance with the requirements of such
Regulatory Authority.

 



Initial Period shall have the meaning set forth in Section
9.1.

 



IP stands for Intellectual Property rights and shall mean
patents along with all applications, reissues, continuations,
continuations-in-part, revisions, divisions, extensions and
re-examinations, supplementary protection certificates, any other
rights to inventions, copyright and related rights as well as, to
the extent required in the context, trademarks, trade names and
domain names, rights in get-up, rights in goodwill or rights to sue
for passing off, rights in designs, rights in computer software,
rights in data and database rights and any other intellectual
property rights, in each case whether registered or unregistered
and including all applications (and rights to apply) for and all
similar or equivalent rights or forms of protection which subsist
in any part of the world.

 



Know-How shall mean all documented information relating to
the Constructs as controlled by and reasonably available at NI. For
the avoidance of doubt, Know-How shall also include access to all
Constructs-related clinical, non-clinical data, manufacturing and
safety information available at NI for purposes of obtaining and
maintaining regulatory approvals. For avoidance of doubt, Know-How
shall include any draft and any completed and submitted regulatory
filings, including but not limited to INDs.

 



 







 






	
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Licensed Field shall mean all therapeutic, prophylactic and
diagnostic applications of the Constructs in humans and
animals.

 



Licensed Patent(s) shall mean all patents and patent
applications owned by NI listed and/or to be listed during the Term
in Annex
2.1(b), claiming any of the
Constructs or their manufacture, formulation or use in the Licensed
Field, including any patents issuing on such patent applications,
and further including any substitution, extension or supplementary
protection certificate, reissue, re-examination, renewal, division,
continuation or continuation-in-part of any of the
foregoing.

 



Licensed Product shall mean any product in the Licensed
Field which is, contains or comprises any of the Constructs,
regardless of such product’s methods of application (such as
systemically, locally into tumors, intravenously, subcutaneously,
orally, etc.), forms (e.g.
active pharmaceutical ingredient (API), finished dose forms,
kits) or formulations
or dosages, or the manufacture, use, or sale.

 



Milestone Events shall have the meaning set forth in Section
4.3.

 



Milestone Payments shall have the meaning set forth in
Section 4.3.

 



Monoclonal Antibodies shall have the meaning set forth in
the first whereas clause.

 



Net Sales shall mean, with respect to each given country or
jurisdiction, the gross amount invoiced for sales of Licensed
Products by LICENSEE, its Affiliates and its distributors,
exclusive of inter-company or group transfers or sales and
exclusive of transfers of samples of Licensed Products; less the
gross-to-net deductions taken in accordance with internationally
accepted financial reporting standards as of the date of the
invoice for such sales, to the extent actually allowed and incurred
with respect to such sales and accounted for on a Licensed
Product-by-Licensed Product basis.

 


By way
of example, the gross-to-net deductions taken in accordance with
internationally accepted financial reporting standards as of the
Effective Date include the following:

 




(a)

credits, reserves
or allowances granted for (i) damaged, outdated, returned,
rejected, withdrawn or recalled Licensed Product, (ii) wastage
replacement and short-shipments; (iii) billing errors and (iv)
indigent patient and similar programs (e.g., price
capitation);





 




(b)

governmental price
reductions and government mandated rebates;





 




(c)

chargebacks,
including those granted to wholesalers, buying groups and
retailers;





 




(d)

customer credits,
rebates, including cash sales incentives for prompt payment, cash
and volume discounts, wholesaler and pharmacy allowances including
initial distribution allowances;





 




(e)

freight, fees for
services charges, postage and duties, shipping and insurance
charges relating to such Licensed Product;





 




(f)

taxes, duties and
any other governmental charges or levies imposed upon or measured
by the import, export, use, manufacture or sale of a Licensed
Product (excluding income or franchise taxes).





 

 


Any
such deductions need to be customary under applicable International
Financial Reporting Standards (IFRS) or Generally Accepted
Accounting Principles (GAAP), as applicable, to the extent actually
incurred, allowed, accrued or paid.

 



 







 






	
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Notice of Conversion shall have the meaning as set forth in Annex
5.

 



Other Licensed IP shall have the meaning set forth in
Section 2.1(b).

 



Parties shall mean both NI and LICENSEE.

 



Party shall mean either NI or LICENSEE.

 



Phase II Clinical Trial shall mean a human clinical trial in
any country that would satisfy the requirements of 21 C.F.R. §
312.21(b) FDCA, as amended from time to time, and the foreign
equivalent thereof.

 



Phase III Clinical Trial shall mean a human clinical trial
that is prospectively designed to demonstrate statistically whether
a product is safe and effective for use in humans in a manner
sufficient to obtain regulatory approval to market such product in
patients having the disease or condition being studied as described
in 21 C.F.R. § 312.21(c) FDCA, as amended from time to time,
and the foreign equivalent thereof.

 



Receiving Party shall have the meaning set forth in the
definition of Confidential Information.

 



Regulatory Authority means a government agency or entity
that exercises a legal right to control the use or sale of the
Licensed Products in a jurisdiction and may take enforcement action
to ensure that such Licensed Products commercialized within such
jurisdiction comply with applicable law.

 



Renewal Period(s) shall have the meaning as set forth in Section
9.1.

 



Royalty Payments shall have the meaning as set forth in
Section 4.2.

 



Sublicensee shall mean any Third Party to which LICENSEE
permits the commercialization of Constructs or Licensed Products in
countries where LICENSEE does not commercializes such Construct(s)
or Licensed Products on its own, whether directly or through
Affiliates or distributors.

 



Sublicensing Revenue shall mean the gross amount of all
revenues, royalties, receipts, and monies, including upfront
payments, milestone payments, and license fees, earned or received
by the LICENSEE from Sublicensee(s) with respect to the Constructs
minus any reasonable costs of goods and/or costs incurred by
LICENSEE as directly related to ongoing commercialization
activities by Sublicensee(s) of the Constructs incurred by the
LICENSEE. Accounting for any such revenues needs to be customary
under applicable International Financial Reporting Standards (IFRS)
or Generally Accepted Accounting Principles (GAAP), as applicable,
to the extent actually earned, allowed, accrued or
received.

 



Term shall have the meaning as
set forth in Section 9.1.

 



Third Party shall mean a
natural person, corporation, partnership, joint venture, trust, any
governmental authority or other business entity or organization,
and any other recognized organization other than the Parties and/or
their Affiliates.

 



Upfront Payment shall have the meaning as set forth in
Section 4.1.

 



USD shall mean US Dollars, being the lawful currency in the
United States of America.

 



VAT shall mean value-added tax.

 


[Annexes
4.1(a) and 4.1(b) have been filed as separate exhibits to this
filing with the Securities and Exchange
Commission.]