Blueprint





 





 



Exhibit
10.6

 

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
AND DEVELOPMENT AGREEMENT


 





This
License and Development Agreement ("Agreement") is made effective
as of [date] ("Effective
Date") by and between Pendopharm, a division of Pharmascience Inc,
located at 6111 Royalmount, Suite 100, Montreal, Quebec, H4P 2T4,
Canada (hereinafter "Pendopharm"), and Edesa Biotech Inc., a
Canadian corporation having its principal place of business at 100
Spy Court Markham, Ontario, L3R 5H6, Canada (hereinafter
"Edesa").

 





RECITALS


 





WHEREAS, Edesa Controls the rights to
certain intellectual property rights and know-how with respect to
two novel agonists in specific formulations (EB02 Topical cream,
EB03 Suppository and EB04);

 





WHEREAS, Edesa is
planning to perform proof-of-concept clinical trials for EB02
and EB04;


 




WHEREAS, Pendopharm is
a specialty pharmaceutical company active in the
development
and marketing of specialty pharmaceutical products in
Canada;


 





WHEREAS, Pendopharm
desires to obtain from Edesa certain exclusive rights to use the US
Data Package (as hereinafter defined) and the New Drug Application
("NDA") created in respect of EB02, EB03 and EB04 to prepare a New
Drug Submission ("NDS") to the competent Regulatory Authority in
Canada, in order to obtain Marketing Authorization (as defined
below) in Canada for EB02, EB03 and EB04;

 


WHEREAS, Pendopharm
also desires to obtain certain exclusive rights with respect to
importation, distribution, marketing and sale of EB02, EB03 and
EB04 in the territory of Canada;


 





WHEREAS, Edesa is
willing to (i) grant such exclusive right to use the US Data
Package to Pendopharm and the NDA if Edesa owns or controls such
NDA for use in the preparation of an NDS in the territory of
Canada; and (ii) grant Pendopharm certain exclusive rights under
its intellectual property rights and know-how with respect to
importation, distribution, marketing and sale of EB02, EB03 and
EB04 in the territory of Canada;


 





WHEREAS, Pendopharm is
entering into this Agreement knowing that a complete US Data
Package and NDA meeting the requirements of the FDA in order to
obtain a Marketing Authorization for use of the Licensed Products
will be available if and only if the proof of concept clinical
trials are successful and Edesa can continue to raise further funds
in future rounds of financing, otherwise Pendopharm acknowledges
that a US Data Package and NDA may never be completed or
available.


 


NOW, THEREFORE, Edesa
and Pendopharm, intending to be legally bound, hereby agree as
follows:


 




 

1








 





 


ARTICLE
1


DEFINITIONS


 


In this
Agreement, the below terms and expressions shall have the following
meanings, and such meanings shall apply equally to both the
singular and plural forms of the terms defined:


 




1.1.
Definitions.

 




(a)


"Acceptance to Proceed" shall
have the meaning set forth in Section 2.3.






  




(b)


"Affiliate" shall mean any
corporation or other entity, which directly or indirectly controls,
is controlled by or is under common control with a Party to this
Agreement. A corporation or other entity shall be regarded as in
control of another corporation or entity if it owns or directly or
indirectly controls more than fifty percent (50%) of the voting
stock or other ownership interest of the other corporation or
entity, or if it possesses, directly or indirectly, the power to
direct or cause the direction of the management and policies of the
corporation or other entity or the power to elect or appoint more
than fifty percent (50%) of the members of the governing body of
the corporation or other entity.






  




(c)


"Agreement" shall mean this
License and Development Agreement and its Exhibits.






 




(d)


"Alliance Manager" shall mean a
representative appointed by each of the Parties responsible for the
tasks set forth in Section 4.2(c).






 




(e)


"Applicable Law" shall mean all
applicable law, rules and regulations, including any rules,
regulations, guidelines or other requirements of any Regulatory
Authority that may be in effect from time to time.






 




(f)


"Business Day" shall mean a day
other than a Saturday or Sunday or any public holiday on which
banking institutions in Toronto or Montreal, Canada, are closed for
business.






 




(g)


"Calendar Quarter" shall mean
each successive period of three (3) calendar months commencing on
January 1, April 1, July 1 and October 1.






 




(h)


"Calendar Year" shall mean each
successive period of twelve (12) calendar months commencing on
January 1 and ending on December 31.






 




(i)


"Cipher Agreement" shall mean
the exclusive license agreement between the Cipher Pharmaceuticals Inc and Edesa
dated as of June 15th 2016.






 




(j)


"Claim" has the meaning set
forth in Section 7.3(b).






 




(k)


"Confidential Information" shall
have the meaning set forth in Section 12.l(a).






 




(l)


"Control" shall mean, with
respect to any item of Information, Regulatory Documentation,
Patent, Licensed Technology or Intellectual Property Right, 
possession of the right, whether directly or indirectly, and
whether by ownership, license or otherwise (other than by operation
of the assignments, license and other grants of rights in this
Agreement) to assign or grant a license, sublicense or other right
to or under, such Information, Regulatory Documentation, Patent,
Licensed Technology or Intellectual Property Right as provided for
in this Agreement without violating the terms of any agreement or
other arrangement with any Third Party.






 




 






 

2








 





 





(m)

"Development" shall mean all
activities related to preclinical and other non-clinical testing,
test method development and stability testing, toxicology,
formulation, process development, manufacturing scale-up,
qualification and validation, quality assurance and quality control
related to the foregoing manufacturing activities, clinical studies
and post-approval studies, including manufacturing in support
thereof, statistical analysis and report writing, the preparation
and submission of drug approval applications, regulatory affairs
with respect to the foregoing and all other activities otherwise
requested or required by a Regulatory Authority as a condition or
in support of obtaining or maintaining marketing authorization.
When used as a verb, "Develop" shall mean to engage in
Development.






 







(n)

"Drug Master File" shall mean
the drug master file filed with a Regulatory Authority with respect
to the Licensed Products that will be created as development of the
products occurs.






 







(o)

"Edesa" shall have the meaning
set forth in the first and opening paragraph of this
Agreement.






 







(p)

"Edesa License" shall have the
meaning set forth in Section 5.1.






 







(q)

"Edesa IP Improvements" shall
have the meaning set forth in Section 7.l(b).






 







(r)

"Effective Date" shall have the
meaning set forth in the first and opening paragraph of this
Agreement.






 







(s)

"EMA" shall mean the European
Medicines Agency.





 







(t)

"Existing Edesa IP" shall have
the meaning set forth in Section 7.l(a).






 






(u)

"FDA" means the United States
Food and Drug Administration and any successor agency
thereto.






 







(v)

"Field" shall mean human
therapeutic use in the conditions of hemorrhoids and anal
fissures.






 







(w)

"First Commercial Sale" shall
mean, with respect to a Licensed Products in the Territory, the
first commercial sale of such product after Marketing Authorization
for such product has been granted by Health Canada.





 




(x)

"Health Canada" means the
Canadian Federal Department
known as
Health Canada and any
successor agency thereto.






 







 

3








 





 




(y)

"Indemnified Party" shall have
the meaning set forth in Section 9.5.






 







(z)

"Information" shall mean all
technical, scientific and other know-how and information, trade
secrets, knowledge, technology, means, methods, processes,
practices, formulae, instructions, skills, techniques, procedures,
experiences, ideas, technical assistance, designs, drawings,
assembly procedures, computer programs, apparatuses,
specifications, data, results and other material, including
biological, chemical, pharmacological, toxicological,
pharmaceutical, physical and analytical, pre-clinical, clinical,
safety, manufacturing and quality control data and information
including study designs and protocols; assays and biological
methodology; whether or not confidential, proprietary, patented or
patentable, in written, electronic or any other form now known or
hereafter developed, including the Regulatory
Documentation.






 







(aa)


"Intellectual Property Rights"
shall mean all rights in and to ideas, inventions, discoveries,
know-how, data, databases, documentation, reports, materials,
writings, designs, computer software, processes, principles,
methods, techniques and other information in whatever form,
including patents, utility patents, copyrights and any rights or
property similar to any of the foregoing in any part of the world,
whether registered or not, provided that such rights or property
are considered as intellectual property according to the Applicable
Law ("Intellectual Property").






 







(bb)


"Knowledge" and/or "known" shall mean, with respect
to any representation or warranty or other statement in this
Agreement qualified by knowledge of a Party, the actual knowledge
of the members of the management board of such Party.






 







(cc)


"Licensed Know-How" shall mean
all Information not generally known to the public and not covered
or claimed by published Licensed Patents, which Edesa owns, has
under license, or otherwise Controls on the Effective Date and at
all times during the Term necessary for Pendopharm to exploit the
Licensed Products and Licensed Patents.






 




(dd)


"Licensed Patents" shall mean
all existing or future regular, continuation, divisional,
continuation-in-part, re-exam, reissue, term extended patent and
patent applications ("Patents") in the Territory directly or
indirectly claiming priority to or immediately derived from the
patent applications licensed to Edesa under the Yissum Agreement
and/or Cipher Agreement, as listed in Exhibit 1.37.





 







(ee)


"Licensed Products(s)" shall
mean EB02, a topical anorectal formulation of Hyaluronic Acid (HA)
conjugated with dipalmitoyl phosphotidyl-ethanolamine (DPPE), EB03,
an anorectal suppository formulation of Hyaluronic Acid (HA)
conjugated with dipalmitoyl phosphotidyl-ethanolamine (DPPE)
licensed pursuant to the Yissum
Agreement and EB04, a topical
anorectal formulation of Levo-salbutamol licensed pursuant to the Cipher
Agreement.





 







(ff)


"Licensed Technology" shall mean
the Licensed Patents and the Licensed Know-How.






 




 

4








 





 




(gg)

"Losses" shall have the meaning
set forth in Section 9.1.





 





(hh)


"Marketing Authorization" shall
mean, with respect to the Territory, authorization from the
Regulatory Authority necessary to commercially distribute, sell or
market the Licensed Products in the Territory.






 





(ii)

"NDA" shall mean a New Drug
Application, and which consists of at least a complete registration
file in Common Technical Document (CTD) format.





 




jj)


"NDS" shall mean a New Drug
Submission which consists of at least a complete registration file
in Common Technical Document (CTD) format.





 





(kk)


"Net Sales" shall mean with
respect to the Licensed Products for any period, means the gross
amount invoiced and billed by Pendopharm or its Affiliates to
unrelated Third Parties (excluding any Sublicensee) for the Product
in the Territory, less:






 







(i)

Trade, quantity and
cash discounts actually allowed or paid;





 







(ii)

Commissions,
discounts, refunds, rebates (including wholesaler fees),
chargebacks, retroactive price adjustments, and any other
allowances actually allowed or paid which effectively reduce the
net selling price;






 







(iii)

Actual Product
returns and allowances;






 







(iv)

Any sales, use,
excise, value added taxes or similar taxes measured by the billing
amount, when included in billing;






 







(v)

Any freight,
postage, shipping, and insurance charges related to delivery of the
Product from an applicable warehouse, all to the extent included in
the third party invoices; and






 







(vi)

Custom, import and
export duties actually paid.






 





Any
refund or reimbursement of any of the foregoing amounts previously
deducted from Net Sales shall be appropriately credited to Net
Sales, or adjusted through allowances, upon receipt
thereof.


 





For
greater certainty "Net Sales" shall not include (i) sales or
transfers between members of the group comprised of Pendopharm,
Sublicensees, and their Affiliates; (ii) provision of Product for
the purpose of conducting Clinical Trials in order to obtain
Regulatory Approvals; (iii) disposal of reasonable quantities of
Licensed Products for promotional or advertising purposes or
regulatory or governmental purposes, but not to exceed 5% of Gross
Sales ; and (iv) transfers or dispositions of reasonable quantities
of Licensed Products to patients unable to purchase the Licensed
Products, but not to exceed 5% of Gross Sales.

 





Such
amounts shall be determined from the books and records of
Pendopharm or its Affiliates or Sublicensees, as applicable,
maintained in accordance with IFRS, consistently applied, except where
IFRS is not the standard, in which case whatever the accounting
standard is in effect will be applied.


 







 

5








 





 


Once
the Licensed Products are approved for sale in the Territory by the
applicable Regulatory Authority, if the Licensed Products are sold
as part of a bundled transaction and there is no individual price
for the Licensed Products in the transaction documentation
(agreement, invoice etc.), the amount to be included in Net Sales
shall be determined based on the pro rata allocation of the amount
invoiced for all products included in such bundled transaction,
based on the average per unit net sales price (calculated for the
Calendar Quarter being reported) for such Licensed Products and the
average per unit net sales price (calculated for the Calendar
Quarter being reported) for every other product included in such
bundled transaction and the number of units of Licensed Products
and every other product included in such bundled
transaction.


 







(11)

"Pendopharm License" has the
meaning ascribed to it in Section 5.2.






 




(mm)

"Pendopharm IP" shall have the
meaning ascribed to it in Section 7.l(c). 






 




(nn)


"Pendopharm IP Improvements"
shall have the meaning ascribed to it in Section
7.1(d).






 







(oo)


"Parties" shall mean Pendopharm
and Edesa and " " shall mean either one of them.





 







(pp)

"Payment" shall have the meaning
set forth in Section 6.2(d).






 







(qq)


"Regulatory Approval" shall mean
any and all approvals, licenses, registrations or authorizations of
any Regulatory Authority necessary to commercially distribute, sell
or market a Licensed Products, including, where applicable, (i)
pricing or reimbursement approval, (ii) pre- and post-approval
marketing authorizations, (iii) labeling approval, (iv) technical,
medical and scientific data.





 







(rr)


"Regulatory Authority" shall
mean any applicable supra-national, federal, national, regional,
state, provincial or local regulatory agencies, departments,
bureaus, commissions, councils or other government entities
regulating or otherwise exercising authority with respect to the
Development and exploitation of the Licensed Products.






 







(ss)


"Regulatory Documentation" shall
mean all applications, registrations, licenses, authorizations and
approvals, including all Regulatory Approvals, the US Data Package,
all correspondence submitted to or received from Regulatory
Authorities and all supporting documents and all clinical studies
and tests relating to the Licensed Products and all data contained
in any of the foregoing, including, if applicable, all
investigational new drug applications, marketing authorization
applications, regulatory drug lists, advertising and promotion
documents, clinical data, adverse event files and complaint
files.






 







(tt)

"Rest of the World" shall mean
any country of the world other than the Territory.






 




 

6








 





 




(uu)


"Sublicensee" shall mean any
Affiliate of Pendopharm or Third Party to whom Pendopharm has
sublicensed its rights to the Licensed Products in accordance with
Section 5.3.





 




(vv)

"Territory" shall mean Canada,
including all provinces and territories.






 







(ww)

"Term" shall have the meaning
set forth in Section 10.1.






 







(xx)


"Third Party" shall mean any
person or entity other than Edesa or Pendopharm and their
respective Affiliates.






 







(yy)

"Trademarks" shall have the
meaning ascribed to it in Section 7.4.






 







(zz)


"US Data Package" shall mean all
clinical and non-clinical data (including without limitation all
Development, formulation and manufacturing information (including
the open part of the Drug Master File), Information and Regulatory
Documentation owned or Controlled by Edesa, to be used for the
submission of an NDA to the U.S. Food and Drug Administration
("FDA") for obtaining Marketing Authorization for sale of the
Licensed Products in the USA.






 







(aaa)


"Yissum Agreement" shall mean
the exclusive license agreement between the Yissum Research
Development Company and Edesa dated as of June 29,
2016.






 





ARTICLE
2


DEVELOPMENT
AND DATA SHARING


 







2.1.

USA
Development.






 





Edesa
shall use reasonable commercial efforts to Develop the Licensed
Products in the indications of hemorrhoids (with respect to EB02)
and anal fissures (with respect to EB04) for the purposes of
obtaining Regulatory Approval with the FDA.


 







2.2.

Provision
of US Data Package.





 





On a
Licensed Product by Licensed Product basis, Edesa agrees to provide
Pendopharm with the US Data Package within sixty (60) Business Days
of submission of the NDA to the FDA in the United States. Within
the ninety (90) day period following the provision of the US Data
Package to Pendopharm, Edesa will use reasonable efforts to answer
potential questions Pendopharm may have and, upon Pendopharm' s
request, provide any additional documents relating to the US Data
Package that Edesa may have in its possession or
Control.

 




2.3.

Acceptance
to Proceed.





 





Within
ninety (90) days of its receipt of the US Data Package , Pendopharm
will, on a Licensed Product by Licensed Product basis, inform Edesa
in writing if Pendopharm would like to proceed with the preparation
and submission of a Marketing Authorization application for the
Licensed Products to the competent Canadian Regulatory Authority
("Acceptance to Proceed").


 







 

7








 





 




2.4.

Failure
to provide Acceptance to Proceed.






 





If
Pendopharm does not provide Edesa with the Acceptance to Proceed
within the period provided for in Section 2.3, Edesa will be
entitled to, for the Licensed Product for which Pendopharm has not
provided its Acceptance to Proceed, remove the Licensed Product
from the scope of the license granted in this Agreement with
immediate effect by giving written notice to Pendopharm, whereby
all rights to that specific Licensed Product in the Territory
granted to Pendopharm under this Agreement shall revert back to
Edesa and Section 10.7(a) shall apply.

 




2.5.

Development
Responsibility.





 


If
Pendopharm declares Acceptance to Proceed, Pendopharm will be
responsible for obtaining Marketing Authorization and any other
Regulatory Approvals which may be required in the Territory for the
sale and marketing of the Licensed Product in the Field and for
generating any additional data which may be required for obtaining
Marketing Authorization in the Territory at its own
cost.

 




2.6.

Marketing
Authorization Application.






 





Pendopharm shall,
at the earliest possible time after receipt of the US Data Package
from Edesa, discuss with the competent Canadian Regulatory
Authority whether Marketing Authorization in the Territory can be
obtained on the basis of the US Data Package or whether additional
clinical studies have to be performed in the Territory.
If
no further clinical studies should be required, Pendopharm will,
subject to Section 2.3, use reasonable efforts to submit a
Marketing Authorization application for the Licensed Products to
the competent Regulatory Authority in the Territory.

 




2.7.

Additional
Clinical Studies and further Development.






 







(a)

Scope. If after
discussions with the competent Regulatory Authorities in the
Territory, Pendopharm is required to conduct further clinical
studies or further Development, Pendopharm shall establish the
scope and the design of any studies required in the Territory in
order to obtain the Marketing Authorization for the Licensed
Products, and shall seek Edesa prior written approval of the
clinical studies or further Development, such consent shall not be
unreasonably withheld or delayed.






 







(b)

Regulatory
Approval. Subject to Section 2.9, Pendopharm shall use reasonable
commercial efforts to initiate the clinical studies or further
Development without delay.






 







(c)

Ownership of Data
from Additional Clinical Studies. As between Pendopharm and Edesa,
Pendopharm shall own all data arising from the additional clinical
studies conducted or Development done by Pendopharm in the
Territory and Pendopharm hereby agrees to assign all right, title
and interest therein to Edesa at Termination in accordance with
Section 10.7(a).






 







2.8.

Clinical
Trial Material.






 





If
Pendopharm determines that clinical studies shall be performed in
the Territory, Edesa will supply the required clinical supply of
the Licensed Products to Pendopharm at actual cost. Detailed
supply
terms and responsibilities of the Parties regarding quality will be
agreed in a separate supply agreement prior to the commencement of
the supply of Licensed Products to Pendopharm, with the proviso
that such additional terms must reasonably enable Edesa to meet the
terms agreed with Edesa's contract manufacturer.


 




 

8








 






 







2.9.

Data
Sharing.





 


The
Parties will establish a shared website for the exchange of the
information in relation to the Licensed Products to be exchanged
between the Parties pursuant to the terms of this Agreement. Edesa
will commence providing information pertaining to the US Data
Package to Pendopharm after completion of the proof of concept
clinical trials for each of the products and as such information
becomes available. Each Party shall provide to the other Party
copies of all clinical and non-clinical data and other results and
analyses with respect to any Development activities with respect to
the Licensed Products in the Field, for each of the Licensed
Products and when and as such data, results and analyses become
available and as soon as reasonably practicable. Subject to
Applicable Law in the relevant territory, the aforesaid obligation
shall also include data generated by Edesa's licensees and/or
Pendopharm's Sublicensees, but shall, for purposes of clarity,
exclude any commercial information. Such clinical and non-clinical
data shall be prepared in the English language and in a format
generally accepted by Regulatory Authorities, such as the FDA,
Health Canada and/or the EMA. Further, any clinical studies
undertaken by or on behalf of a Party shall include consents and
authorizations which allow release of all protected health
information of the study participants to the other Party and its
licensees to the extent permitted by the Applicable Law and such
releases and/or authorizations shall contain language which makes
it clear to the study participant that any information related to
the Licensed Products shall be kept confidential. Each Party shall
furnish to the other Party regularly, at least every half a year,
reports including the clinical and non-clinical data generated by
it in the preceding half a year. For the avoidance of doubt, both
Parties agree to only enter into any agreements with Sublicensees
and/or Third Parties if the Sublicensee/Third Party undertakes the
same obligations regarding disclosure and access to clinical and
non-clinical data as Pendopharm undertakes pursuant to this
Agreement, in particular pursuant to the foregoing
sentences.


 







2.10.

Pricing
and Reimbursement Approvals.






 





Pendopharm shall be
responsible for all pricing and reimbursement approval proceedings
relating to the Licensed Products in the Territory.


 







2.11.

Regulatory
Records.






 





Pendopharm and
Edesa each shall maintain, or cause to be maintained, records of
their respective Development activities with respect to the
Licensed Products in the Field in sufficient detail and in good
scientific manner appropriate for patent and regulatory purposes,
which shall be complete and accurate and shall fully and properly
reflect all work done and results achieved in the performance of
their respective Development activities, and which shall be
retained by such Party for at least three (3) years after the
termination of this Agreement, or for such longer period as may be
required by Applicable Law. Not more than once in a Calendar Year,
each Party shall have the right, during normal business hours and
upon reasonable notice, to inspect and copy any such records of the
other Party. A Party shall provide the other Party with such
additional information regarding the Development activities in
relation to this Agreement as such Party may reasonably request
from time to time.


 




 

9








 





 




2.12.

Alliance
Management pre-Commercialization.





 





After
execution of this Agreement, Pendopharm and Edesa shall appoint one
representative of each organization who will meet by teleconference
at least two (2) times per year until the end of Phase III clinical
trials in order to update each other on medical affairs and
regulatory affairs and other relevant matters related to the
Licensed Products in the Territory. Each party will use reasonable
efforts to satisfy the requests of the other representative for
access to specific information and documentation.

 





ARTICLE
3


REGULATORY


 







3.1.

Adverse
Event Reporting.





 





Subject
to the terms of this Agreement, no later than three (3) months
before market launch in the Territory, Edesa and Pendopharm shall
discuss and develop mutually acceptable guidelines and procedures
for (a) the investigation, exchange, receipt, recordation,
communication (as between the Parties) and exchange of Adverse
Event Experience information and all other information required by
either Party in order to meet its pharmacovigilance
responsibilities and (b) for the handling of any oral or written
communication of dissatisfaction regarding the identity, quality,
durability, reliability or performance of the Licensed Products,
including appearance, low fills, foreign materials, foreign
product, defective packaging or defective labeling. "Adverse Event
Experience" shall mean (i) any finding from tests in laboratory
animals or in vitro that suggests a significant risk for human
subjects including reports of mutagenicity, teratogenicity or
carcinogenicity and (ii) any undesirable, untoward or noxious event
or experience associated with the clinical, commercial or other use
or occurring following administration, of the Licensed Products in
humans, occurring at any dose, whether expected or unexpected and
whether or not considered related to or caused by the Licensed
Products, including such an event or experience as occurs in the
course of the use of the Licensed Products in professional
practice, in a clinical trial, from overdose, whether accidental or
intentional, from abuse, from withdrawal or from a failure of
expected pharmacological or biological therapeutic action of the
Licensed Products, and including those events or experiences that
are required to be reported to any Regulatory Authority in the
Territory.

 




3.2.

Recall
of Licensed Products.






 







(a)

In the event that
any Regulatory Authority issues or requests a recall or takes
similar action in connection with the Licensed Products or in the
event either Party determines that an event, incident or
circumstance has occurred that may result in the need for a recall
or market withdrawal, the Party notified of or desiring such recall
or similar action shall, within twenty-four (24) hours, advise the
other Party thereof by telephone (and confirm by email or
facsimile), email or facsimile.






 







(b)

Pendopharm will use
best efforts to withdraw the Licensed Products from the market
without delay, if Edesa or any Regulatory Authority demands a
recall of the Licensed Products in the Territory.






 







(c)

Pendopharm shall
bear all reasonable costs of recall of the Licensed Products in the
Territory except if such recall is due to Edesa's negligence or
willful misconduct, in which event Edesa
shall bear the costs of said recall. For the purpose of this
Agreement, costs of a recall shall not include loss of profit of
either Party.





 






 

10







 





 




ARTICLE
4


SUPPLY
AND COMMERCIALIZATION


 







4.1.

Supply
of Licensed Products.






 





Edesa
will supply the Licensed Products to Pendopharm subject to the
terms of a separate supply agreement, the terms of which shall be
agreed by the parties in good faith, with the proviso that such
additional terms must reasonably enable Edesa to meet the terms
agreed with Edesa's contract manufacturer. On a product by product
basis, the parties will enter into good faith negotiations within
thirty (30) days of Edesa's receipt of Pendopharm's Acceptance to
Proceed.

 




4.2.

Commercialization






 







(a)

General. Pendopharm
shall have sole responsibility for the commercialization of the
Licensed Products in the Territory, and all costs and expenses
associated with its commercialization of the Licensed Products in
the Territory shall be borne by Pendopharm. Pendopharm may, in its
sole discretion, choose whether to commercialize the Licensed
Products itself or, subject to Section 5.3, to collaborate with
Affiliates, Sublicensees or distributors.





 







(b)

Compliance with
Laws. Pendopharm shall comply in all material respects with all
Applicable Law with respect to the commercialization of the
Licensed Products in the Territory. In this regard, Edesa shall
provide Pendopharm with all information required in order for
Pendopharm to comply with the Patented Medicines Price Review Board
(PMPRB) Regulations.






 







(c)

Alliance
Management. After completion of a positive phase III clinical trial
of at least one of the Licensed Products, Pendopharm and Edesa
shall appoint one representative of each organization ("Alliance
Manager") who will meet by teleconference at least two (2) times
per year during the Term in order to update each other on
commercial activities (including, but not limited to, marketing and
reimbursement, sales performance, key market information,
forecasts), medical affairs, regulatory affairs, and supply chain
activities, changes, and plans relevant to the Licensed Products in
the Territory. Each party will use reasonable efforts to satisfy
the requests of the other Party's Alliance Manager for access to
specific information and documentation.






 







(d)

Marketing and
Promotion. Once Market Authorization has been granted for each of
the Licensed Products, Pendopharm shall be responsible
for:






 







(A)

the marketing and
promoting the Licensed Products in the Territory, which shall
include sales and marketing activities, managing tender processes
and submissions (public, hospitals and federal programs),
reimbursement activities, information exchange with Regulatory
Authorities and customers.





 






 

11







 





 




(B)

communicating with
customers, hospitals, pharmacies, payers and other health care
professionals.






 







(C)

using commercially
reasonable efforts for the commercialization of the Licensed
Products.






 







(D)

the provision of
all customer service, query handling, maintenance and development
of customer data in the Territory.





 







(e)

Ownership of
Customer Data. All customer data remains at all times the property
of Pendopharm. Notwithstanding the foregoing, if this Agreement is
terminated pursuant to Section 10.3 by Edesa, Pendopharm shall
transfer customer data to Edesa.





 







(f)

Training. Edesa
shall have the right, at its own cost, to provide trainings to
Pendopharm's sales representatives or product trainings, if Edesa
considers this necessary or useful, the frequency and location of
such trainings to be agreed on by the parties.





 




(g)

Marketing Material.
Edesa will provide international marketing materials, to Pendopharm
in electronic form. Pendopharm will be responsible for ensuring
that said marketing materials comply with Applicable Law prior to
using them in the Territory.






 







(h)

Conditions of Sale
by Pendopharm. Pendopharm has sole responsibility for the terms and
conditions of sale of the Licensed Products to customers in the
Territory.






 





ARTICLE
5



GRANT
OF LICENSE

 




5.1.

Grant
of License Rights to Pendopharm.





 





During
the Term of this Agreement, Edesa hereby grants to Pendopharm the
following licenses:


 







(a)

an exclusive,
royalty-bearing, non-sublicensable, non-transferable license to use
the US Data Package and, to the extent referenced in the US Data
Package, the Licensed Technology, for the sole purpose of preparing
the Canadian data package to obtain Market Authorization for the
Licensed Products to allow Pendopharm to distribute, market and
sell Licensed Products in the Field in the Territory;
and






 







(b)

the event
Pendopharm obtains Market Authorization for such Licensed Products
in the Territory, an exclusive, royalty-bearing, sublicensable,
non-transferable license to distribute, market and sell the
Licensed Products in the Field in the Territory.





 


(collectively, the
"Edesa License").


 







5.2.

Grant
of License Rights to Edesa.






 





During
the term of this Agreement, Pendopharm hereby grants to Edesa, an
exclusive, royalty-free, sub-licensable:


 




 

12








 





 




(a)

right to use the
clinical trial data, if Development is required pursuant to Section
2.7; and






 







(b)


right to use and
reproduce and amend the NDS, outside of the Territory.
(collectively, the "Pendopharm License").





 




5.3.

Pendopharm
Sublicenses.





 





(a)

Pendopharm shall
have the right to sublicense its rights granted pursuant to Section
5.1(b),
provided that the sublicense shall be at arm's length, conform to
the terms hereof, and (A) if granted to Affiliates of Pendopharm,
be notified to Edesa promptly after the grant of such sublicense
and (B) if granted to any Third Parties, be subject to the prior
written consent of Edesa, which consent shall not be unreasonably
withheld, conditioned or delayed (C) each sublicense agreement will
contain terms and conditions:





  




(i)

specifying that
such written agreement terminates upon termination of this
Agreement;





  




(ii)

consistent with the
relevant terms and conditions of this Agreement protecting the
rights of Edesa under this Agreement including imposing obligations
of confidentiality on each such sublicensee;





  




(iii)

that assign and
transfer all right, title and interest in and to any and all
inventions or work product developed by such Sublicensee relating
to the Licensed Products in the course of performing activities
under such sublicense to Edesa;





  




(iv)

that do not impose
any payment obligations or liability on Edesa without the prior
written consent of Edesa;





  




(v)

that Pendopharm
shall require each Sublicensee to provide it with regular written
royalty reports that include at least the detail that Pendopharm is
required to provide to Edesa pursuant to this Agreement which
reports, Pendopharm shall have the right to provide to Edesa upon
request;





 




(vi)

that Pendopharm
shall provide Edesa with an executed copy of each sublicense
agreement within five (5) Business Days of its
execution.





 




5.4.

Retained
Rights.





 


Except
as expressly provided herein, the parties grant no other right or
license to the other party, including any rights or licenses to the
Licensed Patents, the Licensed Know-How, any other Patents or other
Intellectual Property Rights, or any improvements to any of the
foregoing.


 




 

13








 





 


ARTICLE
6


PAYMENTS

 








6.1.

Royalty
Payments Pendopharm.






 







(a)

General. In
consideration of the Edesa License provided hereunder, Pendopharm
shall pay to Edesa a tiered royalty in the amounts set forth in
Section (c) below on all Net Sales by Pendopharm or its
Sublicensees of all Licensed Products in the
Territory.






 







(b)

Royalty Term.
Pendopharm's obligation to pay royalties shall expire, on a
Licensed Product-by-Licensed Product basis, on the later to occur
of:






 







(i)

13th anniversary of the
First Commercial Sale of the Licensed Product in the
Territory,






 







(ii)

the expiration date
in the Territory of the last-to-expire Patent of the Licensed
Patents relating to the Licensed Product,






 







(iii)

the expiration date
of the applicable regulatory or data exclusivity covering the
Licensed Product in the Territory,





 


(as
applicable, the "Royalty Term").

 







(c)

Tiered Royalty
Rate. Pendopharm will pay to Edesa royalties, on a Licensed Product
by Licensed Product basis, at the following rates:





 
 



	


Annual Net Sales (Canadian dollars)


	


Royalty Rate 


	

Aggregate annual
Net Sales for each Licensed Product less than or equal to [  ]
million Canadian dollars ($[  ])

	

[ 
]% of Net Sales


	

Aggregate annual
Net Sales for each Licensed Product greater than [  ] million
Canadian dollars ($[  ]) and less than or equal
to


$[ 
]


	

[ 
]% of Net Sales


	

Aggregate annual
Net Sales for each Licensed Product greater than [  ] million
Canadian dollars ($[  ])

	

[  ]% of Net
Sales






 







(d)

Royalty Payment
Reports, Exchange Rates. From the date of First Commercial Sale of
the Licensed Products until the expiration of the Term, Pendopharm
shall within [thirty (30)
days] after each Calendar Quarter pay to Edesa the royalties
due under this Agreement for such Calendar Quarter and furnish to
Edesa a written quarterly report showing: (i) the Net Sales of the
Licensed Products sold by Pendopharm and its Sublicensees during
the reporting period; and (ii) the royalties due
thereon.






 







(e)

Generic
Competition. At such time as a generic equivalent is available for
sale in the Territory by a Third Party, Edesa authorizes Pendopharm
and its Affiliates to market a generic [equivalent to be supplied] by Edesa
("Authorized Generic") in the Territory. The royalties payable by
Pendopharm to Edesa for Authorized Generic will be
equal to [  ] percent ([  ]%) of the Royalty Rates
referred to in Section 6.l(c).





 



 

14







 






 







(f)

Taxes.






 







(i)

General. Any taxes,
levies or other duties ("Taxes") paid or required to be withheld
under the appropriate local tax laws by any one of the Parties
("Withholding Party") on account of monies payable to the other
Party under this Agreement shall, be deducted from the amount of
monies otherwise payable to the other Party under this Agreement
and shall be paid or remitted to the applicable governmental
authority within the time required by Applicable Law. The
Withholding Party shall secure and send to the other Party within a
reasonable period of time proof that any such Taxes required to be
withheld by the Withholding Party have been duly paid or remitted
for the benefit of the other Party.





 





6.2.

Audits,
Audit Disputes.





 







(a)

Audits. Upon
advance notice of not less than thirty (30) days, Pendopharm,
following the First Commercial Sale of the Licensed Products, shall
permit Edesa or an independent auditor designated by Edesa (each a
"Representative") to have access during normal business hours to
such books and records of Pendopharm as may be reasonably necessary
to verify the accuracy of the royalty reports and other Payments
described herein. Such audit will not be conducted more often that
once in a calendar year.





 







(b)

Auditor's Fees. The
fees charged by such auditor shall be paid by Edesa unless the
audit discloses that the royalties or other Payments payable by
Pendopharm for the audited period are underpaid by more than five
percent (5%), in which case Pendopharm shall pay the reasonable
fees and expenses charged by such auditor and, as the case may be,
a further amount equal to the amount of the underpaid royalty or
Payments plus interest. Any overpayment will be refundable or
credited against future royalties. Pendopharm shall include in each
sublicense granted by it pursuant to this Agreement a provision
requiring the Sublicensees to make reports to Pendopharm, to keep
and maintain books and records of sales made pursuant to such
sublicense and to grant access to such books and records to Edesa's
Representative to the same extent required of Pendopharm under this
Agreement. Edesa agrees that all information subject to review
under this Section 6.2 or under any sublicense agreement will be
confidential and that Edesa will cause its Representative to retain
all such information in confidence in accordance with the
confidentiality provisions of Article 12.





 




(c)

Audit Dispute. In
the event of a dispute regarding such books and records, including
the amount of royalties and other Payments owed to Edesa hereunder,
Edesa and Pendopharm shall work in good faith to resolve the
disagreement. If the Parties are unable to reach a mutually
acceptable resolution of any such dispute within thirty (30) days,
the dispute shall be submitted for decision to a certified public
accounting firm mutually selected by each Party's certified public
accountants or to such other Third Party as the Parties shall
mutually agree ("Expert"). The
decision of the Expert shall be final and the costs of such
decision as well as the initial audit shall be borne between the
Parties in such manner as the Expert shall determine. Not later
than ten (10) days after such decision and in accordance with such
decision, Pendopharm shall pay the underpaid royalties and other
Payments or Edesa shall reimburse such excess payments, as
applicable.





 






 

15







 






 







(d)

Payment. All
Payments to be made under this Agreement shall be made in CAD.
Pendopharm shall pay interest to Edesa on the aggregate amount of
any payments that are not paid on or before the date such payments
are due under this Agreement at a rate per annum equal to one
percent (I%) per month, calculated on the number of days such
payments are paid after the date such payments are due and
compounded monthly.





 





ARTICLE
7


INTELLECTUAL
PROPERTY


 




7.1.

Ownership
of Existing IP, Inventions and Joint Inventions.
Licenses.





 







(a)

Existing Edesa IP.
As between the Parties, Edesa shall own or Control, all
Information, Licensed Technology, Licensed Products and the US Data
Package and any Intellectual Property Rights therein, existing on
the Effective Date ("Existing IP").






 







(b)

Edesa IP
Improvements All modifications or improvements to the Existing IP,
conceived, prepared, developed or created either solely by Edesa,
or jointly with Pendopharm, shall be the exclusive property of
Edesa (the "Edesa IP Improvements"). Any Improvement shall be
included within the definition of Licensed Know-How and shall
become subject to the terms of this Agreement.






 







(c)

Pendopharm IP. As
between the Parties, Pendopharm shall own or Control, the right to
use the clinical trial data, if Development is required pursuant to
Section 2.7, the Trademarks and any Intellectual Property Rights
therein ("Pendopharm IP").






 




(d)

Pendopharm IP
Improvements All modifications or improvements to the Pendopharm
IP, conceived, prepared, developed or created either solely by
Pendopharm, or jointly with Edesa, shall be the exclusive property
of Pendopharm (the "Pendopharm IP Improvements"). Any Pendopharm IP
Improvements shall be included within the definition of the
Pendopharm License and shall become subject to the terms of this
Agreement.





 




(e)

Ownership of
Regulatory Approvals. As between Pendopharm and Edesa, Pendopharm
shall own all right, title and interest in and to all Regulatory
Approvals with respect to the Licensed Products in the
Territory.





 







7.2.

Maintenance
and Prosecution of Licensed Patents.






 




Edesa
or its licensees, through patent attorneys or agents of its or
their choice and at its or their sole cost and expense, shall have
the right, but not the obligation, to file, obtain, prosecute and
maintain the Licensed Patents and all foreign counterparts thereof
owned or Controlled by Edesa on the Effective Date and at all times
during the Term. With respect to the Territory, Edesa shall not,
and shall perform reasonable endeavours to procure that its
licensees other than Pendopharm, do not, abandon or cease the
prosecution of any such application for a Licensed Patents or
permit any registration of a Licensed Patents issuing therefrom to
lapse without first notifying Pendopharm and permitting Pendopharm
to continue the preparation, filing, prosecution and maintenance of
such applications or registrations or pay any required fees in the
name of Edesa, at Pendopharm's expense and through patent attorneys
of its choice. Pendopharm shall not become an assignee of any
Licensed Patent as a result of its continuing the prosecution or
registration of a Patent or paying any fees according to this
Section 0. If Pendopharm makes such expenses, Pendopharm shall have
the right to deduct such expenses from any royalty payment to be
made to Edesa pursuant to Section 6.1.


 




 

16








 






 







7.3.

Enforcement
and Third Party Infringement
Claims.






 







(a)

Rights and
Procedures. A party shall notify the other party of any
infringement, misappropriate or other violation of the Intellectual
Property Rights of the other party of which it becomes aware. The
other party may, at its sole discretion, bring proceedings or take
such action as it may deem appropriate to stop any such
infringement, misappropriate or other violation. If the other party does take
any such action or proceedings, the parties shall cooperate at
their own expense, in such action. The parties shall not be
permitted to bring proceedings or take other actions in respect of
infringement, misappropriation or violation of the other parties
Intellectual Property Rights without the prior written consent of
the other party.






 







(b)

Claims.
If any third
party commences an action or proceeding claiming the infringement,
misappropriation or other violation of its Intellectual Property
Rights by a party (a "Claim"), the parties shall immediately notify
each other party once they become aware of the Claim. Each party
shall, at its sole discretion, either defend any such Claim on its
own, permit the other party to participate in the defence of any
Claim, or permit the other party to defend such Claim on its own.
Neither party shall settle any Claim without the prior written
consent of the party. The parties shall cooperate at their own
expense, in any such defence of a Claim.





 




7.4.

Trademarks.





 


Subject
to Sections 10.4 and 10.5, Pendopharm shall be authorized to select
the trademark(s) for the Licensed Products(s) in the Territory in
accordance with Applicable Law and the requirements of the
Regulatory Authority (the "Trademarks"). Pendopharm shall own the
Trademarks and shall be solely responsible for the prosecution,
registration and maintenance of the Trademarks.

 




7.5.

PM(NOC)
Litigation.






 





Pendopharm shall
have the first right to commence and control any application under
the Patented Medicines (Notice of Compliance) Regulations
("PM(NOC)") in connection with the Licensed Products in the
Territory. Accordingly, Edesa shall advise Pendopharm within thirty
(30) days of any grant of any of its patents and/or patent
applications with respect to the Licensed Products, subject to
Edesa having learnt of said grant. In such case, Pendopharm shall
be responsible for all legal costs it
incurs in pursuing any such application, and Pendopharm shall be
entitled to retain any award of costs granted in its favor. The
Party who commenced and controlled such an application shall also
have the sole obligation to defend any proceeding under Article 8
of the PM(NOC) in respect of a withdrawn, dismissed or discontinued
application commenced by that Party under the PMNOC, including the
obligations to pay all legal costs incurred in defending such
proceeding and all awards of damages and costs made by the court.
Edesa, at the request of Pendopharm, shall cooperate in all
reasonable respects with Pendopharm in the pursuit or defense of
such claims including, but not limited to, Edesa accepting to be
added as a party to said application or claim where
necessary.


 




 

17








 





 





7.6.

Patent
Registry.






 





Edesa
shall consult and cooperate with Pendopharm with a view to
obtaining issued Licensed Patents that meet the criteria for
listing on the Patent Register of Health Canada pursuant to the
Patented Medicines (Notice of Compliance) Regulations ("Patent
List"). Edesa consents to Pendopharm including any such issued
Licensed Patents on the Patent List for the Licensed Products and
will provide any necessary assistance to Pendopharm in order to
list the issued Licensed Patents in a timely manner.


 


ARTICLE
8


REPRESENTATIONS
AND WARRANTIES

 





8.1.

Representation
and warranties of Edesa.





 





Edesa
hereby represents and warrants to Pendopharm that, as of the
Effective Date and unless otherwise set forth below, at all times
during the Term:


 







(a)

Edesa has the full
right, power and authority to enter into this Agreement, to perform
its obligations under this Agreement and the fulfillment of its
obligations and performance of its activities hereunder do not
materially conflict with, violate, or breach or constitute a
default under any material contractual obligation, including the
Yissum Agreement or the Cipher Agreement, or a court or
administrative order by which Edesa is bound.  






 







(b)

all necessary
consents, approvals and authorizations of all government
authorities and other persons required to be obtained by Edesa as
of the Effective Date in connection with the execution, delivery
and performance of this Agreement have been obtained.






 







(c)

Edesa does not have
any current knowledge that would cause any of its representations
or warranties to Pendopharm to be incorrect or untrue.





 




(d)

to the knowledge of
Edesa, neither Edesa nor any of its Affiliates, nor any of its
employees or agents (i) is debarred, excluded, suspended, proposed
for debarment or otherwise ineligible for participation in any
federal, state or provincial health care program; (ii) has been
convicted of or had a civil judgment rendered against it for
commission of fraud or a criminal offense; and (iii) is presently
indicted for or otherwise criminally or civilly charged by a
governmental entity or agency with commission of any of the offenses set
out in this paragraph.





 






 

18







 





 





(e)

Edesa shall, and
shall cause its Affiliates and agents to, comply with laws, rules,
regulations and guidelines and related to the performance of its
obligations hereunder and applicable including the
Food and Drugs Act (Canada) and
its regulations promulgated thereunder.






 







(f)

Edesa has, and
shall maintain during the Term, facilities, personnel, experience
and expertise sufficient in quality and quantity to perform its
obligations hereunder and it shall so perform with reasonable due
care and in conformity with current generally accepted industry
standards and procedures applicable in the Territory.






 







(g)

Edesa shall comply
during the Term of this Agreement, at its sole cost and expense,
with all Applicable Law in force in the Territory pertaining to and
in relation to Edesa's activities with regard to the Licensed
Products and the performance of its obligations under this
Agreement.






 







(h)

to Edesa Knowledge,
as of the Effective Date, there is no civil, criminal or
administrative judgment, action, suit, demand, claim, hearing,
notice of violation or investigation proceeding, pending or
threatened against Edesa that could materially and adversely affect
the ability of Edesa to carry out its obligations under this
Agreement.






 







(i)

Edesa shall
immediately notify Pendopharm if, at any time during the Term of
this Agreement, Edesa becomes aware that it, or any of its
Affiliates is convicted of an offense that would subject Pendopharm
or Edesa to exclusion, suspension or debarment from any program in
relation to the activities contemplated under this
Agreement.





 







(j)

Edesa takes all
commercially reasonable precautions, in line with industry norms,
to protect its confidential information and intellectual property
from unauthorized disclosure.






 








8.2.

Representation
and warranties of Pendopharm.






 





Pendopharm hereby
represents and warrants to Edesa that as of the Effective Date and,
unless otherwise set forth below, at all times during the
Term:


 







(a)

Pendopharm has the
full right, power and authority to enter into this Agreement, to
perform its obligations under this Agreement and the fulfillment of
its obligations and performance of its activities
hereunder.






 




(b)

all necessary
consents, approvals and authorizations of all government
authorities and other persons required to be obtained by Pendopharm
as of the Effective Date in connection with the execution, delivery
and performance of this Agreement have been obtained.






 







(c)

Pendopharm does not
have any current knowledge that would cause any of its
representations or warranties to Edessa to be incorrect or
untrue.





 






 

19







 





 





(d)

to the knowledge of
Pendopharm, neither Pendopharm nor any of its Affiliates, nor any
of its employees or agents (i) is debarred, excluded, suspended,
proposed for debarment or otherwise ineligible for participation in
any federal, state or provincial health care program; (ii) has been
convicted of or had a civil judgment rendered against it for
commission of fraud or a criminal offense; and (iii) is presently
indicted for or otherwise criminally or civilly charged by a
governmental entity or agency with commission of any of the
offenses set out in this paragraph.






 







(e)

Pendopharm shall,
and shall cause its Affiliates and agents to, comply with laws,
rules, regulations and guidelines and related to the performance of
its obligations hereunder and applicable including the Food and Drugs Act
(Canada) and its regulations promulgated thereunder.






 







(f)

Pendopharm has, and
shall maintain during the Term, facilities, personnel, experience
and expertise sufficient in quality and quantity to perform its
obligations hereunder and it shall so perform with reasonable due
care and in conformity with current generally accepted industry
standards and procedures applicable in the Territory.





 







(g)

Pendopharm shall
comply during the Term of this Agreement, at its sole cost and
expense, with all Applicable Law in force in the Territory
pertaining to and in relation to Pendopharm's activities with
regard to the Licensed Products and the performance of its
obligations under this Agreement.






 







(h)

to Pendopharm's
Knowledge, as of the Effective Date, there is no civil, criminal or
administrative judgment, action, suit, demand, claim, hearing,
notice of violation or investigation proceeding, pending or
threatened against Pendopharm that could materially and adversely
affect the ability of Pendopharm to carry out its obligations under
this Agreement.






 







(i)

Pendopharm shall
immediately notify Edessa if, at any time during the Term of this
Agreement, Pendopharm becomes aware that it, or any of its
Affiliates is convicted of an offense that would subject Edesa or
Pendopharm to exclusion, suspension or debarment from any program
in relation to the activities contemplated under this
Agreement.






 







(j)

Pendopharm takes
all commercially reasonable precautions, in line with industry
norms, to protect its confidential information and intellectual
property from unauthorized disclosure.





 







(k)

Pendopharm shall
only use Confidential Information, Information and Regulatory
Documentation within the Territory in accordance with the terms and
conditions of this Agreement.






 








8.3.

No
Reliance by Third Parties.





 





The
representations and warranties of each Party set forth in this
Agreement are intended for the sole and exclusive benefit of the
other Party hereto, and may not be relied upon by any Third
Party.


 




 

20








 





 


ARTICLE
9


INDEMNIFICATION


 




9.1.

Pendopharm
Indemnity Obligations.






 





PendopharmPendopharm
agrees to defend, indemnify and hold Edesa, its Affiliates, its
sub-contractors and its licensees and their respective directors,
officers, employees and agents (each a "Edesa Indemnity Party")
harmless against any and all claims, suits, judgments, losses,
liabilities, damages, costs, fees and expenses (including
reasonable attorneys' fees) (collectively, "Losses") resulting from
or arising out of (i) the negligence or willful misconduct on the
part of PendopharmPendopharm, its Affiliates, sub-contractors and
Sublicensees and their respective directors, officers, employees
and agents (each a "PendopharmPendopharm Indemnity Party") in
relation to the carrying out of this Agreement, (ii) the negligent
or willful breach by a Pendopharm Indemnity Party of any terms of
this Agreement, or (iii) the breach,
whether negligent or not, of any of Pendopharm's representations
and warranties in Article 8 of this Agreement by a
PendopharmPendopharm Indemnity Party, except for those Losses which
Edesa has an obligation to indemnify a PendopharmPendopharm
Indemnity Party pursuant to Section 9.2 hereof, as to which Losses
each Party shall indemnify the other to the extent of their
respective liability, and provided further that Pendopharm shall
not be obligated to indemnify any Edesa Indemnity Party for any
Losses to the extent such Losses arise as a result of negligence or
willful misconduct on the part of such Edesa Indemnity
Party.

   







9.2.

Edesa
Indemnity Obligations.





 





Edesa
agrees to defend, indemnify and hold Pendopharm, its Affiliates,
its sub-contractors and its Sublicensees and their respective
directors, officers, employees and agents harmless against any and
all Losses resulting from or arising out of (i) the negligence or
willful misconduct on the part of any Edesa indemnity Party in
relation to the carrying out of this Agreement, (ii) the negligent
or willful breach by a Edesa Indemnity Party of any terms of this
Agreement, or (iii) the breach, whether negligent or not, of any of
Edesa's representations and warranties in Article 8 of this
Agreement by an Edesa Indemnity Party, except for those Losses
which Pendopharm has an obligation to indemnify a Edesa Indemnity
Party pursuant to Section 9.1 hereof, as to which Losses each Party
shall indemnify the other to the extent of their respective
liability, and provided further that Edesa shall not be obligated
to indemnify any Pendopharm Indemnity Party for any Losses to the
extent such Losses arise as a result of negligence or willful
misconduct on the part of such Pendopharm Indemnity
Party.

 




9.3.

Survival.






 


The
indemnification obligations set forth in this Article 9 shall
survive the termination or expiration of this Agreement and remain
in full force and effect for a term ending three (3) years after
the end of the shelf life of the last Licensed Products sold by
Pendopharm, its Affiliates or a Sublicensee in relation to any
claim based on events which occur during the Term
hereof.

 




9.4.

Limitation
of Liability.






 


TO THE
FULL EXTENT ALLOWED BY LAW THE PARTIES EXCLUDE ANY LIABILITY,
WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY
OTHER LEGAL THEORY, FOR CONSEQUENTIAL, SPECIAL, INDIRECT,
INCIDENTAL, PUNITIVE OR EXEMPLARY DAMAGES OR OTHER SIMILAR OR LIKE
DAMAGES OR DAMAGES FOR LOSS OF
PROFITS, REVENUES OR DATA, ARISING OUT OF OR IN CONNECTION WITH
THIS AGREEMENT OR THE PERFORMANCE OR BREACH HEREOF, EVEN IF THE
PARTY HAS BEEN ADVISED OF THE POSSIBILITY THEREOF.


 




 

21








 






 







9.5.

Indemnification
Claims






 







(a)

Notice of Claim.
All indemnification claims in respect of a Party, its Affiliates
and Sublicensees and their respective directors, officers,
employees and agents shall be made solely by such Party to this
Agreement ("Indemnified Party"). The Indemnified Party shall give
the indemnifying Party prompt written notice ("Indemnification
Claim Notice") of any Losses or discovery of fact upon which such
Indemnified Party intends to base a request for indemnification
under Section 9.1 or 9.2, as applicable. In no event shall the
indemnifying Party be liable for any Losses that result from any
delay in providing such notice. Each Indemnification Claim Notice
must contain a description of the claim and the nature and amount
of such Loss (to the extent that the nature and amount of such Loss
is known at such time). The Indemnified Party shall furnish
promptly to the indemnifying Party copies of all notices and
documents received in respect of any Losses and claims asserted by
Third Parties ("Third Party Claims").






 







(b)

Control of Defense.
At its option, the indemnifying Party may assume the defense of any
Third Party Claim by giving written notice to the Indemnified Party
within thirty (30) days after the indemnifying Party's receipt of
an Indemnification Claim Notice or such shorter delay as may be
required in order to ensure a timely response to any Third Party
Claims. The assumption of the defense of a Third Party Claim by the
indemnifying Party shall not be construed as an acknowledgment that
the indemnifying Party is liable to indemnify the Indemnified Party
in respect of the Third Party Claim, and nothing shall constitute a
waiver by the indemnifying Party of any defenses it may assert
against the Indemnified Party's claim for indemnification. Upon
assuming the defense of a Third Party Claim, the indemnifying Party
may appoint as lead counsel in the defense of the Third Party Claim
any legal counsel selected by the indemnifying Party. In the event
the indemnifying Party assumes the defense of a Third Party Claim,
the Indemnified Party shall immediately deliver to the indemnifying
Party all original notices and documents (including court papers)
received by the Indemnified Party in connection with the Third
Party Claim. Should the indemnifying Party assume the defense of a
Third Party Claim, except as provided in Section 9.S(c), the
indemnifying Party shall not be liable to the Indemnified Party for
any legal expenses subsequently incurred by such Indemnified Party
in connection with the analysis, defense or settlement of the Third
Party Claim. In the event that it is ultimately determined that the
indemnifying Party is not obligated to indemnify, defend or hold
harmless the Indemnified Party from and against the Third Party
Claim, the Indemnified Party shall reimburse the indemnifying Party
for any and all costs and expenses (including reasonable attorneys'
fees and costs of suit) and any Third Party Claims incurred by the
indemnifying Party in its defense of the Third Party
Claim.





 




(c)

Right to
Participate in Defense. Without limiting Section 9.S(b) above, any
Indemnified Party shall be entitled to participate in, but not
control, the defense of such Third Party
Claim and to employ counsel of its choice for such purpose;
provided, however, that such employment shall be at the Indemnified
Party's own expense unless, subject to any potentially required
consent of an insurer, if applicable, (i) the employment thereof
has been specifically authorized by the indemnifying Party in
writing, (ii) the indemnifying Party has failed to assume the
defense and employ counsel in accordance with Section 9.5(b) or has
assumed defence and then failed to diligently defend the Third
Party Claim (in which case the Indemnified Party shall control the
defense) or (iii) the interests of the Indemnified Party and the
indemnifying Party with respect to such Third Party Claim are
sufficiently adverse to prohibit the representation by the same
counsel of both parties under Applicable Law, ethical rules or
equitable principles.





 






 

22







 






 







(d)

Settlement. With
respect to any Third Party Claims relating solely to the payment of
money damages in connection with a Third Party Claim and that shall
not result in the Indemnified Party becoming subject to injunctive
or other relief or otherwise adversely affecting the business of
the Indemnified Party in any manner, and as to which the
indemnifying Party shall have acknowledged in writing the
obligation to indemnify the Indemnified Party hereunder, the
indemnifying Party shall have the sole right to consent to the
entry of any judgment, enter into any settlement or otherwise
dispose of such Loss, on such terms as the indemnifying Party, in
its sole discretion, shall deem appropriate. Notwithstanding the
foregoing, in such a case the indemnifying Party agrees to consult
with the Indemnified Party in good faith in relation to any
settlement. With respect to all other Losses in connection with
Third Party Claims, where the indemnifying Party has assumed the
defense of the Third Party Claim in accordance with Section 9.5(b),
the indemnifying Party shall have authority to consent to the entry
of any judgment, enter into any settlement or otherwise dispose of
such Loss provided it obtains the prior written consent of the
Indemnified Party, which consent shall not be unreasonably withheld
or delayed. The indemnifying Party shall not be liable for any
settlement or other disposition of a Loss by an Indemnified Party
that is reached without the written consent of the indemnifying
Party. Regardless of whether the indemnifying Party chooses to
defend or prosecute any Third Party Claim, no Indemnified Party
shall admit any liability with respect to or settle, compromise or
discharge, any Third Party Claim without the prior written consent
of the indemnifying Party, such consent not to be unreasonably
withheld, conditioned or delayed.





 







(e)

Cooperation.
Regardless of whether the indemnifying Party chooses to defend or
prosecute any Third Party Claim, the Indemnified Party shall, and
shall cause each Indemnified Party to, cooperate in the defense or
prosecution thereof and shall furnish such records, information and
testimony, provide such witnesses and attend such conferences,
discovery proceedings, hearings, trials and appeals as may be
reasonably requested in connection therewith. Such cooperation
shall include access during normal business hours afforded to
indemnifying Party to, and reasonable retention by the Indemnified
Party of, records and information that are reasonably relevant to
such Third Party Claim, and making the indemnified Parties and
other employees and agents available on a mutually convenient basis
to provide additional information and explanation of any material
provided hereunder, and the
indemnifying Party shall reimburse the Indemnified Party for all
its reasonable and documented out-of-pocket expenses in connection
therewith.





 



 

23







 






 





ARTICLE
10 


TERM
AND TERMINATION


 







10.1.

Term.





 





This
Agreement will enter into effect on the Effective Date and remain
in effect until expiration as described in Section 6.1(b) or until
termination in accordance with Sections 10.2 to 10.6
hereof.


 







10.2.

Termination
by Pendopharm.






 





Pendopharm shall
have the right to terminate this Agreement upon one-hundred and
twenty (120) days prior
written notice to Edesa.


 







10.3.

Termination
by Edesa





 


Edesa
shall have the right to terminate this Agreement upon thirty (30)
days written notice to Pendopharm, in the event Edesa (i) is unable
to recruit the requisite number of participants in the proof of
concept clinical study or (ii)
the proof of concept clinical study is unable to be completed due
to a failure of obtaining the required approval (e.g. ethics board
approval) or has been terminated due to concerns regarding the
safety of participants following the use of the Licensed
Products.

 




10.4.

Termination
for Material Breach.





 


If
either Party commits a material breach of this Agreement, the other
Party shall have the right to terminate this Agreement by giving
written notice to the breaching Party in sufficient detail to
ascertain and respond to the alleged breach. Termination shall take
effect sixty (60) days after receipt of such notice by the
breaching Party unless within the same time period the breach has
been cured.


 







10.5.

Liquidation,
Bankruptcy, Insolvency.






 





To the
extent permitted under Applicable Law, if one of the Parties shall
go into liquidation, other than for the purpose of a bona fide
reorganization, or a receiver or trustee be appointed for its
property or estate, or if such Party files for a voluntary petition
in bankruptcy or application for insolvency or is adjudged bankrupt
or insolvent, and whether or not any of the aforesaid acts be the
outcome of a voluntary act of that Party, the other Party shall be
entitled to terminate this Agreement forthwith by written notice to
the first Party.

 




10.6.

Termination
of the Yissum or the Cipher Agreement





 







a)

In the event that
the Yissum Agreement is terminated and Edesa no longer controls the
Licensed Products identified as EB02 and EB03, this Agreement will
immediately terminate in respect ofEB02 and EB03 upon receipt of
written notice from Edesa to Pendopharm.





 






 

24







 





 





b)

In the event that
the Cipher Agreement is terminated and Edesa no longer controls the
Licensed Product identified as EB04, this Agreement will
immediately terminate in respect 0£ EB04 upon receipt of written
notice from Edesa to Pendopharm of such termination.





 







10.7.

Effects
oi Termination.






 







(a)

With the exception
of termination pursuant to Section 10.4 where Pendopharm is the
breaching party, the following shall occur in the event of
termination pursuant to Sections 10.2 to 10.6:






 







(i)

the Edesa License
and the Pendopharm License shall terminate
immediately;






 







(ii)

Pendopharm shall
cease all sales of the Licensed Products within 90 days from the
date of termination;






 







(iii)

Pendopharm shall
assign and set over to Edesa, all right, title and interest in the
Pendopharm IP, the Pendopharm IP Improvements and the Regulatory
Approvals in the Territory;






 







(iv)

Pendopharm shall
provide to Edesa, at its own expense, any and all documents,
Information, data files, records, and other materials, relevant for
the Development, manufacture and commercialization of the Licensed
Products in the Territory in its possession, and all Confidential
Information and other data, files, records and other materials
received from Edesa, provided, however, that Pendopharm shall be
permitted to retain one (1)
copy of such
Confidential Information and other materials for the sole purpose
of performing any continuing obligations hereunder or for archival
purposes. All retained Confidential Information shall continue to
be subject to the terms of this Agreement for the period set forth
in Section 12.l(a).





  




(b)

In the event of
termination pursuant to Section 10.4 where Edesa is the breaching
party, the following shall occur at Termination:






 







(i)

the Edesa License
and the Pendopharm License shall terminate
immediately;






 







(ii)

each Party shall
return all Confidential Information and all other Information,
data, files, records and other materials received from the other
Party required to commercialize the Licensed Products in the
Territory, in accordance with Section 12.3 hereof.





 







(c)

In the event of
termination pursuant to Section 10.6 (a), the provisions of this
Agreement shall remain in full force and effect in respect of the
Licensed Product identified as EB04. Similarly, in the event of
termination pursuant to Section 10.6 (b), the provisions of this
Agreement shall remain in full force and effect in respect of the
Licensed Products identified as EB02 and EB03.





 






 

25







 





 





(d)

Surviving
Provisions. In any event, any termination or expiration of this
Agreement, shall be without prejudice to:





 







(i)

the confidentiality
rights and obligations under Article 12 that survive termination or
expiration;






 







(ii)

any other rights or
remedies which either Party may then or thereafter have hereunder;
and






 







(iii)

either Party's
obligation to make any payments due pursuant to this Agreement
which accrue prior to termination or expiration, and at the time of
termination or expiration, all such payments due shall be made in
full within forty-five (45) days unless the Parties agree
otherwise.






 





ARTICLE
11


FORCE
MAJEURE

 


Neither
Party shall be held liable or responsible to the other Party or be
deemed to have defaulted under or be in breach of this Agreement
for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from
causes beyond the reasonable control of the affected Party,
including fire, floods, earthquakes, embargoes, epidemics, war,
acts of war, terrorist acts, insurrections, riots, civil
commotions, strikes, lockouts or other labor disturbances, act of
God or acts, omissions or delays in acting by any Regulatory
Authority or the other Party; provided, however, that the Party so
affected shall use reasonable commercial efforts to avoid or remove
such causes of non-performance, and shall continue performance
hereunder with reasonable dispatch whenever such causes are
removed. The affected Party shall provide the other Party with
prompt written notice of any delay or failure to perform that
occurs by reason of force majeure, stating the nature of the event,
its anticipated duration, and any action being taken to avoid or
minimize its effects. In the event that such force majeure
event (i) lasts for more
than one hundred eighty (180) days and (ii) has a material adverse
effect on the performance of the obligations of the affected Party,
the non-affected Party shall have the right to terminate this
Agreement upon written notice to the affected Party.

 





ARTICLE
12


CONFIDENTIALITY

 




12.1.

Nondisclosure
Obligations.





 







(a)

General. At all
times during the term of this Agreement and for a period of ten
(10) years thereafter, either Party ("Receiving Party") shall, and
shall cause its officers, directors, employees and agents to, keep
strictly confidential, and not publish or otherwise disclose, and
not use for any purpose, any Confidential Information furnished or
otherwise made known to it, directly or indirectly, by the other
Party ("Disclosing Party"), except to the extent such disclosure or
use is expressly permitted by the terms of this Agreement or is
reasonably necessary for the performance of the Receiving Party's
obligations hereunder and provided that such disclosure is made on
a need-to-know basis on conditions that the party to which such
disclosure is made, prior to the disclosure of the Confidential
Information, signed a written confidentiality agreement under which
it undertakes  to keep the Confidential Information
confidential for the same time periods and to the same extent as
provided for under this Agreement. "Confidential Information" shall
mean any information provided by one Party to the other Party
relating to the terms of this Agreement and the collaboration of
the Parties hereunder, including any Information relating to the
Licensed Technology, the Development or commercialization of the
Licensed Products, the Marketing Authorizations and other
Regulatory Approvals, or the scientific, regulatory or business
affairs or other activities of either Party to the extent,
permitted under Applicable Law. The US Data Package and all other
data and information resulting from clinical studies shall be the
Confidential Information of the Party that owns such data and
information.  













 

26








 






 







(b)

Limitations. The
obligation not to use and disclose Confidential Information shall
not apply to any part of such Confidential Information that can be
shown by written documents:





 





(i)

is, at the time of
disclosure by the Disclosing Party to the Receiving Party or
thereafter becomes part of the public domain other than by
unauthorized acts of the Receiving Party;






 








(ii)

has been disclosed
to the Receiving Party by a Third Party, provided such Third Party
was in lawful possession of the Confidential Information and was
under no confidentiality obligation vis-a-vis the Disclosing
Party;






 








(iii)

prior to disclosure
by the Disclosing Party, was already in the legal possession of the
Receiving Party; provided such Confidential Information was not
obtained directly or indirectly from the Disclosing Party pursuant
to another confidentiality agreement between the
Parties;






 








(iv)

has been
independently developed by the Receiving Party without any
reference to the Disclosing Party's Confidential
Information;






 







(c)

In addition to the
foregoing limitations, Confidential Information can be
disclosed:






 








(i)

to government or
other Regulatory Authorities to the extent that such disclosure is
reasonably necessary to obtain an issuance of a Licensed Patent or
Regulatory Approvals and Marketing Authorizations for and to
Commercialize the Licensed Products, provided that the Receiving
Party notifies the Disclosing Party reasonably in advance of such
disclosure; or






 








(ii)

pursuant to
interrogatories, requests for information or documents, subpoena,
court order, civil investigative demand issued by a court or
governmental agency or as otherwise required by Applicable Law,
provided that, to the extent reasonably practicable, the Receiving
Party notifies the Disclosing Party immediately upon receipt
thereof and grants the Disclosing Party the possibility to seek
legal protection against such disclosure and limits the scope of
disclosure to that portion of the Confidential Information that is
legally required to be disclosed.





 



 

27







 





 





12.2.

Terms.
Publications. Press Release.





 




(a)

Terms of this
Agreement, Press Release.





 








(i)

Edesa and
Pendopharm each agree not to disclose any terms or conditions of
this Agreement or the Agreement as such to any Third Party without
the prior written consent of the other Party, such consent not to
be unreasonably withheld, except as required by Applicable
Law.






 








(ii)

Neither Party shall
originate any publicity, news release or public announcement,
written or oral relating to this Agreement, including its existence
or the negotiations without the prior written approval of the other
Party, which approval shall not be unreasonably withheld, except as
required by Applicable Law or the rules of a stock
exchange.






 







12.3.

Return
oi Confidential Information.





 


Upon the effective date of expiration or
termination of this Agreement for any reason, either Party may
request in writing, and the other Party shall either, with respect
to Confidential Information to which such other Party does not
retain rights hereunder: (i) promptly destroy all copies of such
Confidential Information in the possession of the other Party and
confirm such destruction in writing to the requesting Party; or
(ii) promptly deliver to the requesting Party, at the other Party's
expense, all copies of such Confidential Information in the
possession of the other Party; provided, however, the other Party
shall be permitted to retain one (1) copy of such Confidential
Information for the sole purpose of performing any continuing
obligations hereunder or for archival purposes as well as
electronic copies which are automatically generated by computer
systems during back up procedures. All retained Confidential
Information shall continue to be subject to the terms of this
Agreement for the period set forth in Section 12.1.


 





ARTICLE
13


MISCELLANEOUS

 







13.1.

Entire
Agreement.






 





This
Agreement together with the Exhibits hereto contains the entire
understanding of the Parties with respect to the subject matter
hereof. All prior express or implied agreements and understandings,
either oral or written, are superseded by this Agreement. This
Agreement may be amended and the written form requirement set forth
herein may be waived only by a written instrument duly executed by
all Parties hereto.

 




13.2.

Assignment.






 





This
Agreement shall be binding upon and inure to the benefit of the
Parties hereto and their respective successors and permitted
assigns.


 







(a)

Assignment. Neither
Party may assign any of its rights or benefits under this
Agreement, or transfer any of its duties or obligations, in whole
or in part, except with the prior written consent of the other
Party. Notwithstanding the foregoing, either Party may assign this
Agreement to an Affiliate without the consent of the other Party,
provided that such assigning Party shall at all times remain liable
for the assignee's compliance with the terms of this
Agreement.





 



 

28







 






 







(b)

Effects. Any
assignment or transfer by a Party other than in accordance with the
terms hereof shall be null and void and shall entitle the other
Party to terminate this Agreement with immediate
effect.





 







13.3.

Notice.






 





Any
notice required or permitted hereunder shall be in writing, shall
refer specifically to this Agreement, and shall be delivered
personally by hand, by an overnight courier service or by facsimile
transmission, and shall be addressed to the Party to whom it is to
be given at the address or facsimile number shown
below:

 


	
 If to
Pendopharm:

	
 Pendopharm, a
division of Pharmascience Inc.


	
 

	
 6111 Royalmount
Avenue, Suite 100


	
 

	
 Montreal, Quebec,
H4P 2T4


	
 

	
 


	
 

	
 Attention:
Vice-President,
Pendopharm


	
 

	
 Fax No.:
514-807-9483


	
 

	
 


	
 with a copy to:

	
 General Counsel and
Corporate Secretary


	
 

	
 Fax No.: (514)
342-3654


	
 

	
 


	
 If to Edesa:

	
 Edesa Biotech
Inc.


	
 

	
 100 Spy Court,
Markham, Ontario, L3R 5H6


	
 

	
 


	
 

	
 Attention:
CEO


	
 

	
 Fax No.:
905-475-9962


	
 

	
 


	
 with a copy to:

	
 ●


	
 

	
 Fax No.:
●






    





Each
Party may, at any time, substitute for its previous record address
any other address by giving prior written notice of the
substitution in accordance with this Section 13.3. Any such notice
shall be deemed to have been given and received on the date of
delivery, if received prior to 5:00 p.m. local time, on a Business
Day. If the notice is received after 5:00 p.m., local time on a
Business Day, or is received on a day which is not a Business Day,
then such notice shall be deemed to have been given and received on
the first Business Day thereafter.

 




13.4.

Waiver.





 


The
failure of either Party to insist upon the strict performance of
any provisions hereof or to exercise any right or remedy shall not
be deemed a waiver of any right or remedy with respect to any
existing or subsequent breach or default; the election by either
Party of any particular right or remedy shall not be deemed to
exclude any other; and all rights and remedies shall be
cumulative.


 




 

29








 





 




13.5.

Severability.





 


In the
event any provisions of this Agreement are or become invalid or
unenforceable the remaining provisions of this Agreement shall
remain in effect. The invalid or unenforceable provisions shall be
replaced by a valid or enforceable one which most closely reflects
the original commercial intent of the Parties.


 







13.6.

Governing
Law and Dispute Resolution.






 







(a)

Laws. This
Agreement shall be governed by and construed in accordance with the
laws of the Province of Quebec and the laws of Canada which apply
therein, without regards to any conflict of law
provisions.






 







(b)

Dispute Resolution.
Any dispute, disagreement, controversy or claim arising out of or
relating to this Agreement, shall be exclusively submitted to the
courts of the Province of Quebec, Canada.






 







13.7.

Non-Solicitation.





 





During
the Term and for a period of two (2) years thereafter, neither
Party shall actively recruit or solicit any employee of the other
Party or its Affiliates. For the avoidance of doubt, nothing shall
limit a Party from engaging in general recruitment efforts through
advertisements so long as the employees of the other Party and its
Affiliates are not specifically targeted in such recruitment
effort.


 







13.8.

Independent
Contractors.






 





It is
expressly agreed that Edesa and Pendopharm shall be independent
contractors and that the relationship between the two Parties shall
not constitute a partnership, joint venture or agency. Neither
Edesa nor Pendopharm shall have the authority to make any
statements, representations or commitments of any kind, or to take
any action, which shall be binding on the other, without the prior
consent of the other Party to do so.


 




13.9.

Mutual
Cooperation.






 





Each of
the Parties shall use all reasonable efforts to take, or cause to
be taken, all action or do or cause to be done, and to assist and
cooperate with each other Party in doing, all things necessary,
proper or advisable to consummate and make effective, in the most
expeditious manner practicable, the transactions contemplated by
this Agreement (in each case, to the extent that the same is within
the control of such Party).


 




13.10.

Further
Assurances.






 





Each
Party shall promptly do, execute, deliver or cause to be done,
executed and delivered all further acts, documents and things in
connection with this Agreement that the other Party may reasonably
require for the purposes of giving effect to this
Agreement.

 







13.11.

Language.






 




The
parties have expressly required that this Agreement and all
documents and notices relating hereto be drafted
in English. Les parties aux
presentes ont expressement exige que la presente convention et tous
les documents et avis qui y sont afferents soient rediges en
anglais.

 







13.12.

Counterparts.






 





This
Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.


 


 



[Signature page follows.]


 


 


 


 




 

30








 





 


IN
WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first set forth above.


 







	

 

	
For
and on behalf of

	

 


	

 

	
 

	

 


	

 

	

PENDOPHARM, A DIVISION OF PHARMASCIENCE INC.

	

 


	

 

	

 

	

 

	

 


	

	
By:  

	
/s/ David
Goodman

	

 


	

 

	

 

	
Name: David
Goodman

	

 


	

 

	

 

	
	

 


	

 


	

 

	

	

 


	

 

	

 

	Title: CEO
	

 


	

 

	

 

	
	

 


	

 

	

For
and on behalf of

	

 


	

 

	

 

	
	

 


	

 

	

EDESA
BIOTECH INC.


	

 


	

 

	

 

	
	

 


	

 

	

By:

	
/s/ Pardeep Nijhawan
	

 


	

 

	

 

	Name: Pardeep
Nijhawan	

 


	

 

	

 

	
	

 


	

 

	

 

	

	

 


	

 

	

 

	Title:
CEO	

 






 

   





 

31








 





 



EXHIBIT 1.37

 






Edesa Licensed Patents (as of July 31, 2017)

 





CA
2,558,416


 





CA
2,834,918


 





CA
2,761,590


 





CA
2,604,758


 


 


 


 




 

32