Document:

Blueprint

 

Exhibit 10.2

 

 
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.

 

 

Execution Version: 29/06/16

 

EXCLUSIVE LICENSE AGREEMENT

 

by and between

 

YISSUM RESEARCH DEVELOPMENT COMPANY OF THE HEBREW UNIVERSITY OF
JERUSALEM LTD

 

and

 

EDESA BIOTECH INC.

 

June 29, 2016

 

 

 

 

 

TABLE
OF CONTENTS

 

	

 

	

Pages 

	

ARTICLE 1 DEFINITIONS

	

 1

	

ARTICLE 2 SCOPE

	

 6

	

2.1            
Scope

	

 6

	

ARTICLE 3 PRODUCT DEVELOPMENT AND COMMERCIALIZATION

	

 7

	

3.1            
Overview

	
 7

	

3.2            
Conduct of Development and Commercialization

	

 7

	

3.3            
Development Plan

	
 7

	

3.5            
Rights to Sublicense

	

 7

	

ARTICLE 4 MANUFACTURE AND SUPPLY

	

 9

	

4.1            
Responsibility for Manufacturing and Supply

	

 9

	

ARTICLE 5 REGULATORY.

	

 9

	

5.1            
Regulatory Obligations

	

 9

	

5.2            
Safety Reporting

	

 10

	

5.3            
Recalls

	

 10

	

5.4             
Pricing and Reimbursement

	

 10

	

ARTICLE 6 PAYMENTS

	

 10

	

6.1            
Milestone Payments

	

 10

	

6.2            
Product Royalties

	

 11

	

6.3            
Reports; Payment of Royalty

	

 11

	

6.4            
Audits

	

 12

	

6.5             
Payment Exchange Rate

	

 13

	

6.6            
Tax Withholding

	

 13

	

6.7            
Late Payments

	

 13

	

ARTICLE 7 LICENSES; EXCLUSIVITY

	

 13

	

7.1            
Exclusive License and Right to Sublicense

	

 13

	

7.2             
No Implied Licenses

	

 13

	

7.3             
Retained Rights

	

 13

	

ARTICLE 8 CONFIDENTIALITY; PUBLICATION

	

 14

	

8.1            
Nondisclosure Obligation

	

 14

	

8.2            
Publicity; Use of Names

	

 15

	

ARTICLE 9 REPRESENTATIONS AND WARRANTIES

	

 17

	

9.1             
Representations and Warranties of YISSUM

	

 17

	

9.2             
Representations and Warranties and Covenants of EDESA.

	

 18

                     

 

 

 

TABLE
OF CONTENTS

(continued)

  

	

9.3            Representations and
Covenants of Both Parties

	

 19

	

9.4           
No Other Representations or Warranties

	

 19

	

ARTICLE 10 INDEMNIFICATION

	

 20

	

10.1         General
Indemnity By EDESA.

	

 20

	

10.2         Limited
Indemnity To Be Granted to EDESA.

	

 20

	

10.3         
Defense

	

 21

	

10.4         
Settlement.

	

 21

	

10.5         
Notice

	

 21

	

10.6         
Permission by EDESA.

	

 21

	

10.7         Limitation of
Liability

	

 21

	

10.8        
Insurance

	

 22

	

ARTICLE 11 INVENTIONS; PATENT PROVISIONS

	

 22

	

11.1         Ownership of
Intellectual Property

	

 22

	

11.2         Patent
Prosecution

	

 22

	

11.3        
Fees

	

 22

	

11.4        
Enforcement.

	

 23

	

11.5        
Defense

	

 23

	

ARTICLE 12 TERM AND TERMINATION

	

 24

	

12.1        
Term

	

 24

	

12.2         Termination
for Cause

	

 24

	

12.3         
Termination Without Cause

	

 25

	

12.4          Effect
of Termination

	

 25

	

12.5        
Survival.

	

 27

	

ARTICLE 13 MISCELLANEOUS

	

 27

	

13.1          Force
Majeure

	

 27

	

13.2         
Assignment.

	

 27

	

13.3         
Severability

	

 27

	

13.4         
Notices

	

 27

	

13.5         
Applicable Law and Litigation

	

 28

	

13.6          Entire
Agreement; Amendments

	

 29

	

13.7         
Independent Contractors

	

 29

	

13.8         
Waiver

	

 29

	

13.9         
Cumulative Remedies

	

 29

	

13.10      Waiver of Rule of
Construction

	

 29

	

13.11       Further
Assurances

	

 29

	

13.12       Construction

	

 30

	

13.13       Currency

	

 30

	

13.14       Dispute
Resolution

	

 30

	

13.15       Statute of
Limitations

	

 32

	

13.16       Injunctive and Other
Interim Relief.

	

 32

	

13.17       Execution in
Counterparts; Facsimile Signatures

	

 33

 

 

 

EXCLUSIVE LICENSE AGREEMENT

 

 

This
Agreement ("Agreement"),
effective as of June 29, 2016 ("Effective Date"), is entered into by
and between Yissum Research Development Company of the Hebrew
University of Jerusalem, an Israeli corporation with its principal
office at Hi-Tech Park, Edmond J. Safra Campus, Givat-Ram,
Jerusalem P.O. Box 39135, Jerusalem 91390 Israel ("YISSUM"), and Edesa Biotech Inc., an
Ontario corporation with its principal office at I 00 Spy Court,
Markham, Ontario, L3R 5H6 ("EDESA"). YISSUM and EDESA may be
referred to herein individually as a "Party" or collectively as the
"Parties". Reference to a
Party shall be deemed to include that Patty's
Affiliates.

 

RECITALS:

 

	

A.

	

YISSUM
owns the rights to certain know-how, patents and data relating to
MRX-6 (a topical formulation of a Hyaluronic Acid (HA) conjugated
with dipalmitoyl PHOSPHATIDYL-ethanolamine (DPPE) (the "Product") developed by Professor Saul
Yedgar (the "Researcher"),
of the Hebrew University of Jerusalem (the "University") and Akari Therapeutics
(f/k/a Celsus Therapeutics), the previous licensee of the Licensed
Technology (as defined below).

 

	

B.

	

EDESA
is a pharmaceutical company having expertise in the discovery,
development, manufacturing and commercialization of innovative
human pharmaceutical products.

 

	

C.

	

EDESA
and YISSUM desire to enter into an agreement under which EDESA will
obtain exclusive rights to develop the Product for therapeutic,
prophylactic and diagnostic uses in topical dermal applications and
anorectal applications (but excluding ophthalmological
uses)(collectively, the "Field").

 

Concurrently with
the execution of this Agreement, EDESA is executing a consulting
agreement with the Researcher, under which the Researcher shall
provide certain consulting services to EDESA. In consideration of
the foregoing premises and the mutual covenants herein contained,
the Parties hereby agree as follows:

 

ARTICLE 1 DEFINITIONS

 

Unless
specifically set forth to the contrary herein, the following terms,
whether used in the singular or plural, shall have the respective
meanings set forth below:

 
	

1.1

	

"Adverse Event"
shall
mean any undesirable medical occurrence in a patient or clinical
investigation subject administered the Product that must be
reported to the relevant regulatory authority and which does not
necessarily have to have a causal relationship with the
Product.

 

	

1.2

	

"ADRC" has the meaning set
forth in Section 13.14.

   

	

1.3

	

"Affiliate" means with respect to a Party, any person or
entity controlling, controlled by or under common control with such
Party. For purposes of this Section 1.3, "control" shall mean: (a) in the
case of a corporate entity, direct or indirect ownership of fifty
percent (50%) or more of the stock or shares having the right to
vote for the election of directors of such corporate entity; and
(b) in the case of an entity that is not a corporate entity, the
possession, directly or indirectly, of the power to direct, or
cause the direction of, the management or policies of such entity,
whether through the ownership of voting securities, by contract or
otherwise.

 

 

1

 

  

	

1.4

	

"Arbitration Panel Finalization" has the meaning set forth
in Section 13.14.

 

	

1.5

	

"Calendar Quarter" means the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September
30 and December 31.

 

	

1.6

	

"Calendar Year" means the respective periods of twelve (12)
months commencing on January 1 and ending on December
31.

 

	

1.7

	

"Claimant" has the meaning set forth in Section
13.14.

 

	

1.8

	

"Clinical Material(s)" means the Product formulated in
accordance with the Specifications and applicable Canadian, United
States and/or foreign laws, rules and regulations: (a) for
preclinical activities; and (h) for administration to subjects in
Clinical Trials.

 

	

1.9

	

"Clinical Trial(s)" means clinical trials in each with
respect to the Product in the Field.

 

	

1.10

	

"Commercialization" or "Commercialize" means activities
undertaken after obtaining Regulatory Approval relating
specifically to the launch, promotion, marketing, sales force
recruitment, pricing determination, sale, use and distribution of a
pharmaceutical product and post-launch medical activities,
including: (a) manufacturing and distribution for commercial sale,
(b) strategic marketing, sales force detailing, advertising, and
market and product support; (c) medical education and liaison; (d)
all customer support and product distribution, invoicing and sales
activities; (e) all post-Regulatory Approval regulatory activities,
including those necessary to maintain Regulatory Approvals; (f)
target product profile, pricing, formulary and reimbursement
related activities including pricing and reimbursement approvals;
and (g) organizing formulary access and drug
distribution.

 

	

1.11

	

"Confidential Information" has the meaning set fo1th in
Section 8.1.

 

	

1.12

	

"Confirmatory Efficacy Study" means a second human Clinical
Trial to confirm with statistical significance the efficacy and
safety of the Product in the Field.

 

 

	

1.13

	

"Control," "Controls" or "Controlled by" means (except as
used in Section 1.3), with respect to any item of or right under
the Licensed Technology, the ability of a Party (whether through
ownership or license, other than pursuant to this Agreement) to
grant access to, or a license or sublicense of, such item or right
as provided for herein without violating the terms of any agreement
or other arrangement with any Third Party existing at the time such
Party would be required hereunder to grant the other Party such
access or license or sublicense.

 

 

2

 

  

	

1.14

	

"Debarred" has the meaning set forth in Section Error! Reference source not
found..

 

	

1.15

	

"demand for arbitration" has the meaning set forth in
Section 13.14.

 

	

1.16

	

"Develop" or "Development" or "Developing" means research,
discovery, process development, manufacturing for preclinical and
clinical uses, preparation for drng reimbursement, preparation and
initiation of medical education and liaison activities and
preclinical and clinical drng or biological development activities,
including test method development and stability testing,
toxicology, formulation, quality assurance/quality control
development, statistical analysis, preclinical and clinical studies
and regulatory affairs, Regulatory Approval and registration, in
each case, of a Product for use in the Field.

 

	

1.17

	

"EDESA Indemnitee(s)"
has the
meaning ascribed to it in Section 10.2.

 

	

1.18

	

"EDESA Data" means any proprietary scientific, technical,
clinical or regulatory information, results and data of any type
whatsoever, in any tangible or intangible form whatsoever,
including databases, safety information, filings, practices,
methods, techniques, specifications, formulations, formulae,
knowledge, know-how, skill, experience, test data including
pharmacological, medicinal chemistry, biological, chemical,
biochemical, toxicological and clinical test data, analytical and
quality control data, stability data, studies and procedures, and
manufacturing process and development information, results and data
that are related to the Product (or a composition containing the
Product or the manufacturing or use of the Product).

 

	

1.19

	

"EMEA" means the European Medicines Evaluation Agency or any
successor agency thereto.

 

	

1.20

	

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

 

	

1.21

	

"Field" has the meaning ascribed to it in the
recitals.

 

	

1.22

	

"First Commercial Sale" means, with respect to the Product
in the Field, the first sale to a Third Party for end use or
consumption of the Product in the Field in a country in the
Territory after Regulatory Approval of the Product in the Field has
been granted by the Regulatory Authority of such
country.

 

	

1.23

	

"ICH" means the International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use.

 

	

1.24

	

"IFRS" means International Financial Regulatory Standards as
the same may be in effect from time to time.

 

	

1.25

	

"IND" means 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.

 

 

3

 

   

	

1.26

	

"Indemnifying Party" has the
meaning ascribed to it in Section Error! Reference source not
found..

 

	

1.27

	

"indemnitee" has the meaning
ascribed to it in Section Error! Reference source not
found..

 

	

1.28

	

"Indication" means any separate and distinct disease (or
stage of disease), disorder or medical condition in humans or
non-human animals which a Product is intended to treat, prevent,
diagnose, monitor or ameliorate and which, for a Product candidate,
is intended to be reflected in the labeling for such Product as an
approved indication, and which, for an approved Product, is
reflected in the labeling for such Product.

 

	

1.29

	

"Information" means any and all scientific, pre-clinical,
clinical, regulatory, manufacturing, marketing, financial and
commercial information and data related to the Product, in any
tangible or intangible fom1.

 

	

1.30

	

"Knowledge" shall mean actual knowledge of any of the
current officers of the Party gained in the regular course of the
relevant Party's business.

 

	

1.31

	

"Licensed Technology" means (a) all Patents; (b) any regulatory approvals relating to
the Product; (c) any proprietary scientific, technical, clinical or
regulatory information, results and data of any type whatsoever, in
any tangible or intangible form whatsoever, including databases,
safety information, filings, practices, methods, techniques,
specifications, formulations, formulae, knowledge, know-how, skill,
experience, test data including pharmacological, medicinal
chemistry, biological, chemical, biochemical, toxicological and
clinical test data, analytical and quality control data, stability
data, studies and procedures, and manufacturing process and
development information, results and data and (d) any proprietary
biological, chemical or physical materials; all Controlled by
YISSUM or the Researcher as of the Effective Date or at any time
during the Term, including any active pharmaceutical ingredient
related to the product in the case of each of (a), (b), (c) and (d)
that are: (i) related to the Product (or a composition containing
the Product or the manufacturing or use of the Product); and (ii)
necessary or useful for EDESA to exercise the rights licensed to it
under this Agreement or to perform its obligations under this
Agreement.

 

	

1.32

	

"NDA" or "New Drug Application" means an application
submitted to FDA pursuant to 21 U.S.C. § 505(6) or a Canadian
or foreign equivalent application or submission to a Regulatory
Authority which contains complete details of the manufacture and
testing of a new drug, for purposes of obtaining Regulatory
Approval for such new drug in the applicable jurisdiction, for a
particular Indication, and also includes a Biologics License
Application.

 

	

1.33

	

"Net Sales" means the gross amount invoiced and billed by
EDESA or its Affiliates to
unrelated Third Parties (excluding any Sublicense) for the Product
in the Territory, less:

 

	

(a)

	

Trade,
quantity and cash discounts actually allowed or paid;

 

 

4

 

   

	

(b)

	

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;

 

	

(c)

	

Actual
Product returns and allowances;

 

	

(d)

	

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

 

	

(e)

	

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

 

	

(f)

	

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 sales or transfers
between members of the group comprised of EDESA, Sublicensees, and
their Affiliates.

 

For
greater ee1tainty, provision of Product for the purpose of
conducting Clinical Trials in order to obtain Regulatory Approvals
shall not be deemed to be a sale.

 

Such
amounts shall be determined from the books and records of EDESA 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. EDESA further agrees that in determining
such amounts, it will use EDESA's then current standard procedures
and methodology, including EDESA's then current standard exchange
rate methodology for the translation of foreign currency sales into
U.S. Dollars, consistently applied.

 

	

1.34

	

"Patent(s)" means: (a) all patents and patent applications
in any country or supranational jurisdiction; and (b) any
provisionals, substitutions, divisions, continuations,
continuations in part, reissues,
renewals, registrations, confirmations, reexaminations,
extensions, supplementary protection ce1tificates and the
like, of any such patents or patent applications Controlled by YISS
UM or the Researcher where the Researcher is listed as an inventor,
as of the Effective Date or at any time during the Term that are
related to the Product (or a composition containing the Product or
the manufacturing or use of the Product) and necessary or useful
for EDESA to exercise the rights licensed to it under this
Agreement or to perform its obligations under this Agreement,
including, without limitation, the Patents listed in Appendix
B.

 

	

1.35

	

"Phase III Clinical Study" means a human clinical study to
confirm with statistical significance the efficacy and safety of
the Product in the Field performed to obtain Regulatory Approval
for the Product.

 

 

5

 

 

	

1.36

	

"Product" has the meaning ascribed to it in the
recitals.

 

	

1.37

	

"Regulatory Approval(s)" means all approvals or
authorizations by Regulatory Authorities necessary to market and
sell the Product in the Field in the Territory.

 

	

1.38

	

"Regulatory Authority" means any applicable government
regulatory authority involved in granting approvals for the conduct
of Clinical Trials or for an NDA in the Territory, including in the
United States, the FDA, and in Canada, Health Canada.

 

	

1.39

	

"Respondent" has the meaning set forth in Section
13.14.

 

	

1.40

	

"Royalties" has the meaning set forth in Section
6.2.

 

	

1.41

	

"Specifications" means the specifications for the Product as
provided by Yissum as part of the Licensed Technology.

 

	

1.42

	

"Sublicensee" means a Third Party that is granted a
sublicense under the licenses granted to a Party under this
Agreement.

 

	

1.43

	

"Sublicensing Fees" has the meaning set forth in Section
6.2.

 

	

1.44

	

"Sublicensing Revenue" means the net amount of all revenues,
royalties, receipts, and monies, including upfront payments,
milestone payments, and license fees, earned or received by EDESA
and its Affiliate(s) from Sublicensee(s) with respect to the
Product.

 

	

1.45

	

"Term" has the meaning set forth in Section
12.1.

 

	

1.46

	

"Territory" means the entire world.

 

	

1.47

	

"Third Party" means an entity other than: (a) EDESA and its
Affiliates; and (b) YISSUM and its Affiliates.

 

	

1.48

	

"United States" means the United States of America and its
territories and possessions, including the Commonwealth of Puerto
Rico and the U.S. Virgin Islands.

 

	

1.49

	

"YISSUM indemnitee(s)" has the meaning ascribed lo it in
Section 10.1.

 

ARTICLE 2 SCOPE

 

	

2.1

	
 
Scope.

 

Pursuant to and
subject to the terms of this Agreement: (a) EDESA will be
exclusively responsible for the Development of the Product in the
Territory in the Field with the goal of obtaining Regulatory
Approval for the Product, and, once Regulatory Approval has been
obtained, for the Commercialization of the Product; and (b) EDESA
will have exclusive rights to Develop and Commercialize the Product
as fu1ther set forth in Section 3.1, in exchange for royalty and
other payments to be made to YISSUM as described in Article
6.

 

 

6

 

ARTICLE 3

PRODUCT DEVELOPMENT AND COMMERCIALIZATION.

 

	

3.1

	

  Overview.

 

From
and after the Effective Date, EDESA shall have full responsibility
and authority, at its sole cost and expense, for the Development
and Commercialization of the Product in the Field in the Territory,
including (a) the conduct of all Clinical Trials and (b) seeking
Regulatory Approvals for the Product. Upon EDESA 's request, YISSUM
will promptly execute such letters as may be required in order to
effect transfer to EDESA of any IND, for filing with the relevant
Regulatory Authorities.

 

	

3.2

	
 
Conduct
of Development and Commercialization.

 

EDESA
shall use commercially reasonable efforts to Develop and
Commercialize the Product in the Field in the Territory in
accordance with the Development Plan, as defined in Section 3.3.
For purposes of this Agreement, "commercially reasonable efforts"
means such efforts as would be employed by EDESA for a product at a
similar development stage, having similar market potential and
having similar commercial and scientific advantages and
disadvantages based on conditions then prevailing. EDESA shall
report to YISSUM through the Development Plan as to the status of
Development and Commercialization of the Product in the
Field.

 

	

3.3

	
 
Development
Plan

 

   
          EDESA will be
responsible for the Development of the Product in accordance with
the plan (the "Development
Plan") set fo1ih in Appendix A, including the development
targets (the "Development
Targets") referenced therein. EDESA shall periodically
prepare an update to the Development Plan and deliver same to
YISSUM within sixty (60) days of the end of every 6- month period
following the execution of this Agreement, for the first two years
of this Agreement and, thereafter, within sixty (60) days following
each twelve (12) month anniversary of the execution of this
Agreement. The parties acknowledge and agree the Development
Targets will initially be based on the Parties best estimation of
what can be accomplished and will be adjusted by mutual agreement
in light of EDESA 's actual
Development experience. After the submission of each Development
Plan update, the Pa11ies will meet (in person or through other
means) and work in good faith to amend and adjust the Development
Plan and Development Targets as needed.

 

	

3.4

	
 
Sponsored
Research.

 

EDESA
shall sponsor research by or under the direction of the Researcher
in connection with the development of the Licensed Technology and
the Products as needed. EDESA shall consider in good faith (but is
not obligated to approve) requests from the Researcher to sponsor
research to be conducted by or under the direction of Researcher to
develop the Licensed Technology.

 

	

3.5

	
 
Rights
to Sublicense.

 

EDESA
shall have tbc right to engage Third Parties (each a "Sublicensee") to perform any of its
activities or obligations hereunder, provided that EDESA shall be
responsible for ensuring

 

 

7

 

 

that,
prior to any such engagement, any Sublicensees are subject to a
agreement (a "Sublicense
Agreement") containing terms and conditions: (i) specifying
that such written agreements terminate upon termination of this
Agreement; (ii) consistent with the relevant terms and conditions
of this Agreement protecting the rights of YISSUM under this
Agreement including imposing obligations of confidentiality on each
such Sublicensee; (iii) that vest ownership of any and all
inventions developed by such Sublicensee relating lo Products in
the course of performing activities under such sublicense in EDESA;
and (iv) that do not impose any payment obligations or liability on
YISSUM without the prior written consent of YJSSUM. EDESA shall
require each Sublicensee to provide it with regular written royalty
reports that include at least the detail that EDESA is required to
provide to YJSSUM pursuant to this Agreement. Upon request, EDESA
shall provide such reports to YISSUM. EDESA shall provide YISSUM
with an executed copy of each Sublicense Agreement within thirty
(30) days of its execution.

 

 

8

 

ARTICLE 4 MANUFACTURE AND SUPPLY

 

	

4.1

	
 
Responsibility
for Manufacturing and Supply.

 

(a) EDESA will be responsible, at its own
cost, for the manufacture of Product and Clinical Materials.
Promptly following the execution of this Agreement, YISSUM shall
deliver to EDESA copies of all Jnfom1ation in its possession or
Control, including manufacturing know how, and any and all original
processes, records, directly related to the manufacture and supply
of the Product and Clinical Materials in accordance with the
applicable Specifications.

 

(b) Upon the request of EDESA, YISSUM
shall promptly ship to EDESA any unexpired active pharmaceutical
ingredient for the Product in its possession or
Control.

 

ARTICLE 5 REGULATORY

 

	

5.1

	
 
Regulatory
Obligations.

 

EDESA
shall be responsible, al its own cost, for, and shall have the sole
right to control, all regulatory activities and strategy associated
with JNDs, NDAs and all other submissions for Regulatory Approvals,
all Regulatory Approvals, and the maintenance of such submissions
and Regulatory Approvals, as well as seeking approval for
reimbursement or pricing of a Product in the Territory, in each
case with respect to the Product in the Field, including
communicating and preparing and filing all reports including all
INDs and NDAs with the applicable Regulatory Authorities. YISSUM
shall reasonably cooperate with EDESA as requested, in preparing
and filing all such reports, and YISSUM shall provide EDESA with
all available information, including regulatory, technical and
clinical data concerning the Product to enable EDESA to prepare and
file such rep011s. EDESA shall pay all governmental fees associated
with obtaining and maintaining any and all Regulatory Approvals
including any establishment license fees of EDESA or Third Pai1ies
which must be paid with respect to facilities used in the
manufacture of the Product by or on behalf of EDESA.

 

 

9

 

   

	

5.2

	
 
Safety
Reporting.

 

EDESA
shall be responsible for all regulatory activities relating to the
Product in the Field including: (i) management and monitoring of
safety and Adverse Event/experience information for; (ii)
regulatory reporting; (iii) managing the global safety data base
for the Product; and (iv) reviewing and approving of safety
information for inclusion in the Product label in the Ten-itory,
including the costs and expenses thereof.

 

	

5.3

	

  Recalls.

 

EDESA
shall be responsible for any recall decision and the conduct of any
recall in respect of the Product in the Field, including the costs
and expenses thereof.

 

	

5.4

	
 
Pricing
and Reimbursement.

 

EDESA
shall be solely responsible for selling the price for the Product
in the Field and may do so without discussion or consultation with
YISSUM.

 

ARTICLE 6 PAYMENTS

 

	

6.1

	
 
Milestone
Payments.

 

EDESA
shall immediately notify YISSUM of the achievement of any of the
following development and commercial milestones, all for the
Product in the Field, and EDESA shall pay to YISSUM the milestone
payments listed below which shall be due and payable within thirty
(30) days after the event for which the payment is due (or, for
milestones based on Net Sales, within thirty (30) days after the
end of the Calendar Year with respect to which such milestone is
triggered):

 

	
Upon Execution of
this Agreement

	
 

	
[ 
] 

	
 
 

	
 

	
 
 

	
Upon the 6-month
Anniversary of the Execution of this
Agreement

	
 

	
[ 
] 

	
 
 

	
 

	
 
 

	
Upon the dosing of
the 1st patient into a Confirmatory Efficacy Study for the
first Indication for
which Regulatory Approval will be sought.

	
 

	
[ 
] 

	
 

	
 

	
 
 

	
Upon receipt of the
first Regulatory Approval for the Product from the FDA

	
 

	
[ 
] 

	
 

	
 

	
 
 

	
Upon the First
Commercial Sale of the Product in the United
States

	
 

	
[ 
] 

	
 
 

	
 

	
 
 

	
First occurrence of
$[  ] million in aggregate Net Sales in a Calendar Year in
countries where EDESA or an Affiliate directly Commercializes the
Product

	
 

	
[ 
] 

 

 

10

 

 

	
First occurrence of
$[  ]
million in aggregate Net Sales in a Calendar Year in countries
where EDESA or an Affiliate directly Commercializes the
Product

	
 

	
[ 
] 

	
   
 

	
 

	
 
 

	
First occurrence of
$[  ]
million in aggregate Net Sales in a Calendar Year in countries
where EDESA or an Affiliate directly Commercializes the
Product

	
 

	
[ 
] 

	
   
 

	
 

	
 
 

	
Upon divestiture of
substantially all of the assets of the EDESA, during the process of
evaluating the assets of the EDESA, EDESA shall pay YISSUM:

	
 

	
[ 
]% of the valuation of the Licensed Technology by an
external objective expert, if the transaction is closed within 5
years from the date of the execution of this Agreement

	
 

	
 

	
 
 

	
   
 

	
 

	
[  ]%
of the valuation of the Licensed Technology by an external
objective excet, if the transaction is closed after 5 years from
the date of the execution of this Agreement

For
clarity, the aggregate Net Sales that are taken into account in
order to calculate the achievement of a specific sales threshold
milestone for a Calendar Year cannot also be taken into account in
order to calculate the achievement of additional sales threshold
milestone(s) in that same calendar year.

 

	

6.2

	
 
Product
Royalties.

 

EDESA
shall pay to YISSUM a royalty of  [  ]%
of Net Sales ("Royalties")
of the Product in the countries in the Territory where it or an
Affiliate directly Commercializes the Product. EDESA shall pay to
YISSUM an amount equal to  [  ]%
of Sublicensing Revenue received by EDESA and its Affiliates
("Sublicensing Fees") in the
countries in the Territory where it does not directly Commercialize
the Product.

 

	

 6.3

	
 
Reports;
Payment of Royalty.

 

Following the
earlier of (a) the First Commercial Sale of the Product and (b)
execution of a Sublicense Agreement with a Sublicensee, EDESA shall
furnish to YISSUM written reports for each fiscal quarter and each
fiscal year; each such report showing in relation to the reporting
period, as applicable: (i) the Net Sales of the Product in the
Territory and the royalties payable under this Agreement in respect
thereof; and (ii) Sublicensing Revenues received and the
Sublicensing Fees payable under this Agreement in respect thereof.
Reports in respect of a fiscal quarter shall be due on the
thirtieth (30th) day following the close of such fiscal quarter and
annual reports shall be due on the sixtieth (60th) day following
the close of such fiscal year. Royalties and Sublicensing Fees
shown to have accrued by each report shall be due and payable on
the date such

 

 

11

 

report
is due. EDESA shall keep complete and accurate records in
sufficient detail to enable the Royalties and Sublicensing Fees
payable hereunder to be determined.

 

	

6.4

	

  Audits.

 

	

(a)

	

EDESA
will keep and maintain (and to the extent applicable, will cause
its Affiliates, and their respective Sublicensees, distributors,
assignees and transferees to keep and maintain) proper and complete
records and books of account in such form and detail as is
necessary for the determination of the amounts payable by EDESA (on
behalf of itself and its Affiliates and their respective
Sublicensees, distributors, assignees and transferees) to YISSUM
under this Agreement and for the purposes of this
Agreement.

 

	

(b)

	

Upon
the written request of YISSUM and not more than once in each
Calendar Year, EDESA shall permit an independent certified public
accounting firm of nationally recognized standing in the United
States (that has been retained on an hourly or flat fee basis and
receives no contingency fee or other bounty or bonus fee) selected
by YISSUM, at YISSUM's expense, to have access during normal
business hours to such of the records of EDESA as may be reasonably
necessary solely to verify the accuracy of the royalty reports
hereunder for any Calendar Year ending not more than thirty six
(36) months prior to the date of such request. This right to audit
shall remain in effect throughout the life of this Agreement and
for a period of three (3) years after the termination of this
Agreement.

 

	

(c)

	

YISSUM
shall share the accounting firm's final written report with EDESA
within thirty (30) days of its receipt by YISSUM. If such
accounting firm identifies a discrepancy by EDESA made during such
period, EDESA shall pay YISSUM the amount of the discrepancy within
thirty (30) days of the date YISSUM delivers to EDESA such
accounting firm's written report so concluding, or as otherwise
agreed upon by the Parties. The fees charged by such accounting
firm shall be paid by YISSUM unless the underpayment exceeded ten
percent (10%) of the amount owed by EDESA to YISSUM for such
Calendar Year, in which case, EDESA shall pay to YISSUM the
reasonable fees charged by such accounting firm which fees shall
not exceed $25,000. EDESA shall pay interest on the amounts owed to
YISSUM, and said interest shall be calculated as being 2% greater
than the U.S. commercial prime rate as published by the Wall Street
Journal on the date of the first discrepancy identified in the
audit, and shall accrue from the date payments should have been
made.

 

	

(d)

	

EDESA
shall include in each sublicense granted by it pursuant to this
Agreement a provision requiring the Sublicensee to make reports to
EDESA, to keep and maintain records of sales made pursuant to such
sublicense and to grant access to such records by YISSUM's
independent accountant to the same extent required of EDESA under
this Agreement.

 

	

(e)

	

YISSUM
shall treat all financial information subject to review in
accordance with the confidentiality and non-use provisions of this
Agreement, and shall cause its accounting firm to
enter into an acceptable confidentiality agreement with EDESA, its
Affiliates or Sublicensees, as applicable obligating it to retain
all such information in confidence pursuant to such confidentiality
agreement.

 

 

 

12

 

 

	

6.5

	
 
Payment
Exchange Rate.

 

All
payments to be made by one Party to the other under this Agreement
shall be made in United States dollars by bank wire transfer in
immediately available funds to a bank account designated in writing
by the Party receiving the payment. In the case of sales outside
the United States, royalty payments by EDESA to YISSUM shall be
converted to United States Dollars in accordance with the
following: the rate of currency conversion shall be calculated
using a simple average of mid-month and month-end rates as provided
by the spot rate as published by The Wall Street Journal, New York
City Edition for such accounting period.

 

	

6.6

	
 
Tax
Withholding.

 

The
Parties will withhold taxes with respect to payments under this
Agreement under applicable law.

 

	

6.7

	
 
Late
Payments.

 

EDESA
shall pay interest to YISSUM 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
(1%) per month, calculated on the number of days such payments are
paid after the date such payments are due and compounded
monthly.

   

ARTICLE 7 LICENSES; EXCLUSIVITY

 

	

7.1

	
 
Exclusive
License and Right to Sublicense.

 

Subject
to the terms and conditions of this Agreement, YISSUM hereby grants
EDESA and its Affiliates an exclusive, worldwide, royalty-bearing
license, with the right to grant sublicenses in accordance with
Section 3.5 above, to use the Licensed Technology for the
Development and Commercialization of the Product in the Field in
the Territory.

 

	

7.2

	
 
No
Implied Licenses.

 

Except
as explicitly set forth in this Agreement, neither Party nor its
Affiliates grants any license, express or implied, under its
intellectual property rights to the other Party. Without limiting
the foregoing, this Agreement and the licenses and rights granted
herein do not and shall not be construed to confer any rights upon
either Party or its Affiliates by implication, estoppel, or
otherwise as to any of the other Party's or its Affiliates'
intellectual property, except as otherwise expressly set forth
herein.

 

	

7.3

	
 
Retained
Rights

 

 

13

 

  

Notwithstanding the
provisions of Section 7.1, above, YISSUM, on behalf of the
University, may submit requests to EDESA to make, use and practice
portions of the Licensed Technology solely for the University's own
non-commercial academic and teaching purposes provided that a
specific request is submitted to EDESA by, or on behalf, of the
University employee wishing to make such use, with such portions
and purposes to be identified in the request. EDESA will not
unreasonably withhold, condition or delay its consent to such
YISSUM requests.

 

ARTICLES CONFIDENTIALITY; PUBLICATION

 

	

8.1

	
 
Nondisclosure
Obligation.

 

	

(a)

	

Except
as provided in this Section 8.1, all confidential or proprietary
information disclosed by one Party or any of its Affiliates to the
other Party or any of its Affiliates hereunder in connection with
this Agreement, whether disclosed or provided prior to or after the
Effective Date and whether provided orally, visually,
electronically or in writing, shall be maintained in confidence by
the receiving Party and shall not be disclosed to any Third Party
or used for any purpose except as set fo1ih herein without the
prior written consent of the disclosing Party, until five (5) years
following the Term of this Agreement, except to the extent that
such Information:

 

	

(i)

	

is
known by the receiving Party at the time of its receipt, and not
through a prior disclosure by the disclosing Party under a
confidentiality agreement, as documented by the receiving Party's
business records;

 

	

(ii)

	

is or
becomes part of the public domain through no fault of the receiving
Party;

 

	

(iii)

	

is
subsequently disclosed to the receiving Party by a Third Party who
may lawfully do so and is not under an obligation of
confidentiality to the disclosing Party; or

 

	

(iv)

	

is
developed by the receiving Party independently of Information
received from the disclosing Party, as documented by the receiving
Party's business records.

 

All
information disclosed by one Party to the other hereunder, other
than described in Subsections (i) through (iv) above, is
hereinafter referred to as "Confidential Information". The
Information and the Licensed Technology and the terms and
conditions of this Agreement shall be deemed the Confidential
lnformation of both Parties.

 

	

(b)

	

Each
Party may disclose Confidential lnformation of the other Party,
without such other Party's prior written consent, to its and its
Affiliates' directors, officers, employees, agents, consultants,
Sublicensees, suppliers, and other persons or entities
who:

 

14

 

  

	

(i)

	

need to
know such Confidential Information to assist the Party in
fulfilling its obligations hereunder or, the case of YISSUM,
otherwise assists YISSUM in the Development or Commercialization of
the Product outside of the Field; and

 

	

(ii)

	

are
bound by written confidentiality and non-use obligations consistent
with those the Party uses to protect its own Confidential
Information.

 

(c)
Each Party shall promptly disclose to the other Party the nature
and scope of any breach of this provision by it, or its Affiliates,
directors, officers, employees, agents, consultants, Sublicensees,
suppliers, or other persons or entities permitted hereunder and the
steps taken to contain and address the breach.

 

(d)
Each Party may also disclose the Confidential Information of the
other Party, without such other Party's prior written consent, to
any person, entity, or government or Regulatory Authority to the
extent that the law requires such disclosure, including filings
pursuant to applicable securities or tax laws and regulations. The
Party disclosing such Confidential Information shall take such
actions as are reasonable to preserve the confidentiality of such
Confidential Information, such as requesting confidential
treatment. In addition, EDESA may also disclose YISSUM's
Confidential Information, without the YISSUM's prior written
consent, to any person, entity, or government or Regulatory
Authority to the extent that such disclosure is necessary for
obtaining, maintaining, or amending any Regulatory Approvals,
seeking approval for reimbursement or pricing of a Product in the
Territory or satisfying any other regulatory obligation regarding
the Product. Each Party may also disclose the Confidential
Information of the other Party, without such other Party's prior
written consent, pursuant to an order of a Regulatory Authority or
court of competent jurisdiction, provided that it: (i) promptly
notifies the other Party of the required disclosure in order to
provide such Party an opportunity to take legal action to prevent
or limit such disclosure and, if asked, reasonably assists the
other Party in pursuing such action; and (ii) shall only disclose
the Confidential Information to the minimum extent required by
law.

 

	

8.2

	
 
Publicity;
Use of Names.

 

	

(a)

	

The
Parties shall issue a mutually acceptable press release announcing
the execution of this Agreement. A Party may issue any subsequent
press release relating to this Agreement or activities conducted
hereunder upon prior written approval of the other Party, such
approval not to be unreasonably withheld or delayed; provided,
however, that no approval of the other Party shall be required if a
subsequent press release solely discloses the information that: (I)
a milestone under this Agreement has been achieved and/or any
payments associated therewith have been received; (2) the filing
and/or Regulatory Approval of the NDA with the FDA or the EMEA
generally has occurred (provided, however, that specific dates of
filing shall not be disclosed); (3) commercial launch of the
Product in any country or any information that has previously been
approved and disclosed as permitted by this Section 8.2. In the
case of items (1 )-(3) of the preceding sentence,

 

 

15

 

 

the
disclosing Party shall provide the other Party a copy of such
proposed disclosures prior to the proposed release and consider in
good faith any comments the other Party may make, where
practicable, and in light of any reporting obligations of such
disclosing Party under applicable laws, rules or regulations,
including applicable securities law, Except as otherwise provided
in this Section 8.2(a), neither Party shall use the name,
trademark, trade name or logo of the other Party or its employees,
or, in the case of YISSUM, the name or logo of the University or
the name of its employees, in any publicity or news release
relating to this Agreement or its subject matter, without the prior
express written permission of the other Party,

 

 

16

 

  

	

(b)

	

Notwithstanding
the terms of this Article 8, either Party shall be permitted to
disclose the existence and terms of this Agreement, to the extent
required, in the reasonable opinion of such Party's legal counsel,
to comply with applicable laws, rules or regulations, including the
rules and regulations promulgated by securities law regulatory
agencies or any other govenm1ental agency, Notwithstanding the
foregoing, before disclosing this Agreement or any of the terms
hereof pursuant to this Section 8.2(b), the Parties shall consult
with one another on the terms of this Agreement for which
confidential treatment will be sought in making any such
disclosure, If a Party wishes to disclose this Agreement or any of
the tem1s hereof in accordance with this Section 8.2(b), such Party
agrees, at its own expense, to seek confidential treatment of the
portions of this Agreement or such terms as may be reasonably
requested by the other Party, provided that the disclosing Party
shall always be entitled to comply with legal
requirements.

 

	

(c)

	

Either
Party may also disclose the existence and terms of this Agreement
to its legal counsel, investment bankers, accountants and advisors,
and to potential Sublicensees, Third Party contractors, investors,
lenders or acquirers, and their legal counsel, investment bankers,
accountants and advisors, in each case under an agreement or in the
case of legal counsel, a professional obligation, to keep the tem1s
of this Agreement confidential under terms of confidentiality and
non-use substantially similar lo the terms contained in this
Agreement and to use such Confidential lnfon11ation solely for the
purpose permitted pursuant to this Section 8.2(c).

 

ARTICLE 9 REPRESENTATIONS AND WARRANTIES

 

	

9.1

	
 
Representations
and Warranties of YISSUM.

 

Y!SSUM
represents and warrants lo EDESA that as of the Effective
Date:

 

	

(a)

	

subject
to Section 9.l(d) below, it has the full right, power and authority
to enter into this Agreement, to perform its obligations under this
Agreement, and to grant the license granted under Section 7.1, and
the fulfillment of its obligations and performance of its
activities hereunder will not materially conflict with, violate,
or breach or
constitute a default under any material contractual obligation or
court or administrative order by which YISSUM is currently
bound;

   

 

 

17

 

  

	

(b)

	

to the
Knowledge of YISSUM, there are no legal claims, judgments or
settlements against or owed by YISSUM or pending legal claims or
litigation, in each case relating to the Product the YISSUM
Licensed Technology including, without limitation, legal claims
made by the Researcher;

 

	

(c)

	

subject
to Section I 3.11, all necessary consents, approvals and
authorizations of all government authorities and other persons
required to be obtained by YISSUM as of the Effective Date in
connection with the execution, delivery and performance of this
Agreement have been obtained;

 

	

(d)

	

based
on the accuracy of the information provided to YISSUM by the
Researcher, YISSUM Controls the right, title and interest in and to
the Licensed Technology, and has the right to grant to EDESA the
licenses that it purports to grant hereunder and has not granted
any Third Party rights that would interfere or be inconsistent with
EDESA 's rights hereunder;

 

	

(e)

	

to the
Knowledge of YISSUM, there is no action, suit, inquiry,
investigation or other proceeding threatened, pending or ongoing
brought by any Third Party that alleges the use of the Licensed
Technology or the Development and/or Commercialization of the
Product would infringe or misappropriate the intellectual property
or intellectual property rights of any Third Party (and it has not
received any notice alleging such an infringement or
misappropriation). In the event that YISSUM becomes aware of any
such action or proceeding, it shall promptly notify EDESA in
writing;

 

	

(f)

	

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

 

	

9.2

	
 
Representations
and Warranties and Covenants of EDESA.

 

EDESA
represents and warrants to YISSUM that as of the Effective
Date:

 

	

(a)

	

it 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 or court or
administrative order by which EDESA is bound;

 

	

(b)

	

subject
to Section 13.11, 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 YISSUM to be incorrect or
untrue;

 

 

18

 

	

(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;

 

	

(e)

	

EDESA
(i) acknowledges that the Patents listed in Appendix B3 are
currently in the process of being assigned in full to Yissum and,
until such assignments are perfected, they are not part of the
Licensed Technology; and (ii) that Yissum has agreed to included
them as part of the Licensed Technology once such assignments have
been perfected.

 

	

9.3

	
 
Representations
and Covenants of Both Parties.

 

Each
Party 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 to such
Party, including the United States Food, Drug and Cosmetics Act and
the Food and Drugs Act (Canada) and the regulations promulgated
thereunder, and their foreign counterparts.

 

	

9.4

	
 
No
Other Representations or Warranties.

 

	

(a)

	

EXCEPT
AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR
WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF
THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR
ON BEHALF OF A PARTY. ALL REPRESENTATIONS AND WARRANTIES, WHETHER
ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY
EXCLUDED. SPECIFICALLY,

 

	

(b)

	

IN
PARTICULAR, YISSUM MAKES NO EXPRESS OR IMPLIED WARRANTIES THAT THE
USE BY EDESA, ITS AFFILIATES OR ANY OTHER THIRD PARTY OF THE
LICENSED TECHNOLOGY WILL NOT INFRINGE ANY PATENT, COPYRIGHT,
TRADEMARK OR OTHER RIGHTS OF ANY THIRD PARTY. IN ADDITION, NOTHING
IN THIS AGREEMENT MAY BE DEEMED A REPRESENTATION OR WARRANTY BY
YISSUM AS TO THE ACCURACY, SAFETY, EFFICACY, OR USEFULNESS, FOR ANY
PURPOSE, OF THE LICENSED TECHNOLOGY, WHICH IS BEING LICENSED TO
EDESA STRICTLY ON AN "AS IS" BASIS. YISSUM HAS NO OBLIGATION,
EXPRESS OR IMPLIED, TO SUPERVISE, MONITOR, REVIEW OR OTHERWISE
ASSUME RESPONSIBILITY FOR THE PRODUCTION, MANUFACTURE, TESTING,
MARKETING OR SALE OF ANY PRODUCT. TO THE EXTENT PERMITTED BY
APPLICABLE LAW, NEITHER YISSUM NOR
THE RESEARCHER, NOR TI-IE UNIVERSITY, NOR TI-IE REPRESENTATIVES OF
YISSUM AND/OR OF THE UNIVERSITY SHALL HAVE ANY LIABILITY WHATSOEVER
TO EDESA, AN AFFILIATE OR A SUBLICENSEE, OR TO ANY THIRD PARTY FOR
OR ON ACCOUNT OF ANY INJURY, LOSS, OR DAMAGE, OF ANY KIND OR NATURE
WHETHER DIRECT OR INDIRECT, SUSTAINED BY EDESA, AN AFFILIATE OR A
SUBLICENSEE, OR BY ANY THIRD PARTY, FOR ANY DAMAGE ASSESSED OR
ASSERTED AGAINST EDESA, OR FOR ANY OTHER LIABILITY INCURRED BY OR
IMPOSED UPON THE COMPANY OR ANY OTHER PERSON OR ENTITY, DIRECTLY OR
INDIRECTLY ARISING OUT OF OR IN CONNECTION WITH OR RESULTING FROM
THIS AGREEMENT AND/OR TI-IE EXERCISE OF THE LICENSE, INCLUDING, (i)
THE PRODUCTION, MANUFACTURE, USE, PRACTICE, LEASE, OR SALE OF ANY
PRODUCT; (ii) THE USE OF THE LICENSED TECHNOLOGY; OR
(i) ANY ADVERTISING OR
OTHER PROMOTIONAL ACTIVITIES WITH RESPECT TO ANY OF THE
FOREGOING.

 

 

 

19

 

 

ARTICLE 10 INDEMNIFICATION

 

	

10.1

	
 
General
Indemnity By EDESA.

 

EDESA
shall indemnify and hold harmless YISSUM, its Affiliates, the
University, and their respective directors, officers, employees and
agents (individually and collectively, the "YISSUM Indemnitee(s)") from and against
all losses, liabilities, damages and expenses (including reasonable
legal fees and costs) incurred in connection with any claims,
demands, actions or other proceedings by any Third Party
(individually and collectively, "Losses") first arising after the
Effective Date to the extent arising from: (a) the Development or
Commercialization of the Product by EDESA or any of its Affiliates
or Sublicensees; (b) the use of the Product manufactured or sold by
EDESA or any of its Affiliates or Sublicensees by any purchasers
thereof including any product liability claim; (c) the use by EDESA
or any of its Affiliates or Sublicensees of the Licensed
Technology; except to the extent such Losses result directly from,
or arise directly out of, the gross negligent or willful misconduct
of the YISSUM Indcmnitee(s).

 

	

10.2

	
 
Limited
Indemnity To Be Granted to EDESA.

 

   
            In the
event that the YISSUM Licensed Technology is licensed by YISSUM lo
a Third Party for Development and Commercialization outside the
Field (a "Non-Field
License"), YISSUM shall ensure that such Non-Field License
include an obligation by such Third Party licensee to indemnify and
hold harmless EDESA who will be included as a party similar lo a
YISSUM Indemnitee hereunder, along with its Affiliates, and their
directors, officers, employees and agents (individually and
collectively, the "EDESA
Indenmitee(s)") from and against all Losses first arising
after the execution of such Non-Field License to the extent arising
from: (a) the Development or Commercialization of the YISSUM
Licensed Technology outside the Field by such Third Party licensee;
(b) the use of the Product manufactured or sold by Third Party
licensee outside the Field by any purchasers thereof including any
product liability claim; (c) the use by Third Party licensee of the
Licensed Technology; except to the extent such Losses result
directly from, or arise directly out of, the gross negligent or
willful misconduct of the EDESA Indemnitee(s). Notwithstanding the
foregoing, YISSUM's obligation pursuant to this Section 10.2 shall
be contingent upon EDESA assuming a similar written obligation
towards any Third Party licensee granted a Non-Field
License.

 

 

20

 

   

	

10.3

	

  Defense.

 

If any
such claims or actions are made, the YISSUM Indemnitee shall be
defended at the EDESA's sole expense by counsel selected by EDESA
and reasonably acceptable to the YISSUM indemnitee, provided that
the YISSUM indemnitee may, at its own expense, also be represented
by counsel of its own choosing. EDESA shall have the sole right to
control the defense of any such claim or action, subject to the
terms of this Article 10.

 

	

10.4

	

  Settlement.

 

EDESA
may settle any such claim, demand, action or other proceeding or
otherwise consent to an adverse judgment: (a) with prior written
notice to the YISSUM indemnitee but without the consent of the
YISSUM indemnitee, where the only liability to the Indemnitee is
the payment of money and EDESA makes such payment; or (b) in all
other cases, only with the prior written consent of the YISSUM
indemnitee, such consent not to be unreasonably
withheld.

 

	

10.5

	

  Notice.

 

The
YISSUM indemnitee shall notify EDESA promptly of any claim, demand,
action or other proceeding under Section 10.1 or Section 10.2 and
shall reasonably cooperate with all reasonable requests of EDESA
with respect thereto.

 

	

10.6

	
 
Permission
by EDESA.

 

The
YISSUM indemnitee may not settle any such claim, demand, action or
other proceeding or otherwise consent to an adverse judgment in any
such action or other proceeding or make any admission as to
liability or fault without the express written permission of
EDESA.

 

	

10.7

	
 
Limitation
of Liability.

 

NEITHER
PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL,
INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES OR FOR LOST PROFITS
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT,
REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 10.7 IS
INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS
OR OBLIGATIONS OF EDESA UNDER ARTICLE 10 OR ARTICLE 12.3, OR
DAMAGES AVAILABLE FOR EITHER PARTY'S BREACH OF CONFIDENTIALJTY
OBLIGATIONS IN ARTICLE 8.

 

21

 

 

	

10.8           

	

  Insurance.

 

EDESA
shall maintain in good standing throughout the Tem1 of this
Agreement and for a period of seven (7) years thereafter, product
liability insurance policies in respect of the Product with an
internationally recognized insurer or insurers licensed to do
business in the Territory in an amount of not less than $2.0
million per occurrence, and not less than $2.0 million in the
aggregate, on such terms and conditions as are customary in the
industry. EDESA shall provide proof of such insurance to YISSUM
within thirty (30) days of the Effective Date and thereafter from
time to time within thirty (30) days of request of proof of such
insurance.

 

ARTICLE 11 INVENTIONS; PATENT PROVISIONS

 

	

11.1

	
 
Ownership
of Intellectual Property.

 

As
between the Parties, YISSUM shall remain the sole and exclusive
owner of the Licensed Technology. EDESA shall be the sole and
exclusive owner of all patents, trademarks, know-how, data and
other intellectual property that is conceived, discovered,
invented, made or first reduced to practice by, or on behalf of,
EDESA on or after the Effective Date, including all improvements,
variations, modifications or enhancements of the Licensed
Technology conceived, discovered, invented, made or first reduced
to practice by, or on behalf of, EDESA after the Effective Date and
including the EDESA Data.

 

	

11.2

	
 
Patent
Prosecution

 

EDESA
will be responsible for preparing, filing, prosecuting and
maintaining the Patents in Yissum's name, and may elect to file
applications for such other patents as EDESA deems necessary to
protect the Licensed Technology ("Patent Management"). EDESA will (a)
provide to Yissum all material information and documents received,
prepared or filed in connection with the Patents, (ii) consult with
YISSUM before taking any substantive actions related to the Patent
Management and (iii) consider all comments and changes suggested by
YISSUM in relation to the Patent Management. If EDESA intends to
abandon, allow to lapse, or not continue the Patent Management of
any Patent, then EDESA will, not less than 60 days before any
required action relating to such Patent, notify YISSUM and YISSUM
will then have the right, al its option, to assume the Patent
Management of such Patent, in which case such Patent will be
excluded from the Licensed Technology. To assist EDESA with the
Patent Management, YISSUM will, al the reasonable request of EDESA,
cooperate with EDESA, including provision of required information,
and will execute and deliver documents (including powers of
attorney) and do such other reasonable acts as EDESA may
request.

 

	

11.3

	

  Fees

 

From
May 9 2016, EDESA shall be responsible for (a) all costs associated
with the Patent Management of the Patents listed in Appendices B(l)
and B(2); and (b) fifty percent (50%) of all costs associated with
the Patent Management of the Patents listed in Appendix 13(3) until
such time as the Patents listed in Appendix B(3) are fully assigned
to Yissum (the "Full
Assignment"), at which point EDESA shall be responsible for
all costs associated with the Patent Management of the Patents
listed in Appendix 13(3). Within 60 days of the receipt of any
invoice in relation to the

 

 

22

 

 

costs
associated with the Patent Management of the Patents listed in
Appendix B(3) until their Full Assignment, YISSUM will reimburse
EDESA for one-half of such costs. Such Patent costs will not he
refunded to YISSUM (in whole or in pait) under any
circumstances.

 

	

11.4

	

  Enforcement.

 

	

(a)

	

Notice. Each Party shall promptly provide, but in no event
later than forty-five (45) days, the other with written notice
reasonably detailing any known or alleged infringement or
misappropriation of any Licensed Technology.

 

	

(b)

	

Enforcement of Intellectual Property Rights. EDESA shall
have the right, but not the obligation, lo institute and direct
legal proceedings against any Third Party believed to be infringing
or misappropriating or otherwise violating the Licensed Technology.
YISSUM agrees to co-operate to the extent reasonably necessary,
including signing of all necessary documents to vest in EDESA the
right to start such legal proceedings, provided that all the direct
and indirect costs and expenses of bringing and conducting the
legal proceedings are paid by EDESA (except for the expenses of
YISSUM's counsel, if any). All amounts recovered by EDESA as the
result of such legal proceedings will accrue to the benefit of
EDESA, provided that such amounts awarded as compensation for lost
sales revenue will be included in EDESA's Sublicensing Revenue if
the action occurs in any country in the territory EDESA docs not
directly commercialize the Product and treated as Net Sales in any
country in the Territory that EDESA commercializes the Product
(after deduction of EDESA's costs and expenses of legal
proceedings) upon which Royalties will be paid to
YISSUM.

 

	

11.5

	

  Defense.

 

	

(a)

	

Each
Party shall notify the other in writing of any allegations it
receives from a Third Party that the Development or
Commercialization of the Product or use of the Licensed Technology
infringes the intellectual properly rights of such Third Party.
Such notice shall be provided promptly, but in no event after more
than fo1ty five (45) days, following receipt of such
allegations.

 

	

(b)

	

In the
event that a Party receives notice that it or any of its Affiliates
have been individually named as a defendant in a legal proceeding
by a Third Party alleging infringement of a Third Party's patents
or other intellectual property right as a result of the Development
or Commercialization of the Product or use of the Licensed
Technology, such Party shall immediately notify the other Party in
writing and in no event notify such other Party later than forty
five (45) days after the receipt of such notice. Such written
notice shall include a copy of any summons or complaint (or the
equivalent thereof) received regarding the foregoing. Each Party
shall asse1i and not waive the joint defense privilege with respect
to all communications between the Parties reasonably the subject
thereof. In such event, the Parties shall agree how best to
mitigate or control the defense of any such legal proceeding;
provided however, that EDESA shall assume the primary
responsibility for the conduct of the defense of any such claim
that is specific to the Field, at EDESA's expense, and YISSUM
shall assume the primary responsibility for the conduct of the
defense of any other such claim, at YlSSUM's expense.
Notwithstanding the foregoing, YISSUM may forego assuming the
primary responsibility for the conduct of the defense of any such
claim outside the Field, in which case EDESA shall have the right,
but not the obligation, to assume such primary responsibility at
its own expense. The Party that does not assume primary
responsibility for the conduct of the defense shall have the right,
but not the obligation, to participate and be separately
represented in any such suit at its sole option and at its own
expense. Each Party shall reasonably cooperate with the Party
conducting the defense of the claim. If a Party or any of its
Affiliates have been individually named as a defendant in a legal
proceeding relating to the alleged infringement of a Third Pa1ty's
patents or other intellectual property right as a result of the
Development or Commercialization of the Product, the other Party
shall be allowed to join in such action, at its own expense.

 

 

 

23

 

   

	

(c)

	

Status; Settlement. The Parties shall keep each other
informed of the status of and of their respective activities
regarding any litigation or settlement thereof initiated by a Third
Party concerning the Development or Commercialization of the
Product or the Licensed Technology; provided, however, that no
settlement or consent judgment or other voluntary final disposition
of a suit under this subsection 11.5(c) may be unde1taken by a
Party without the consent of the other Party which consent shall
not be unreasonably withheld or delayed.

 

ARTICLE
12

 

TERM
AND TERMINATION

 

	

12.1

	
 
Term.

 

This
Agreement shall be effective as of the Effective Date and shall
expire on a country by-country basis on (a) the date of expiry of
the last valid Patent in such country; (b) the date of expiry of
any period of exclusivity granted to the Product by a Regulatory
Authority in such country or (c) the date that is fifteen (15)
years after the First Commercial Sale, whichever is last to occur,
unless terminated earlier in accordance with this Agreement (the
"Term").

 

	

12.2

	
 
Termination
for Cause.

 

(a) Breach. This Agreement may be terminated
upon written notice by either Party if the other Party has
materially breached its obligations under this Agreement and has
not cured such breach within forty-five (45) days of receipt of
written notice of such breach by the other Party.

 

(b) Bankruptcy. This Agreement may be
terminated upon written notice by either Party if the other Party
(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 prope1iy; or (vi) admits
in writing of its inability to pay its debts generally as they
become due.

 

 

24

 

 

(c) Failure to Develop. If YISSUM alleges
that EDESA has failed to use commercially reasonable efforts to
Develop the Product, this Agreement may be terminated by YISSUM
upon written notice to EDESA if commercially reasonable efforts to
Develop the Product have not commenced within two hundred and sixty
(260) days of receipt of written notice of such failure by
EDESA.

 

	

12.3

	
 
Termination
Without Cause.

 

EDESA
may terminate this Agreement in its entirety if it decides, in its
sole discretion, that the Development and Commercialization of the
Product is no longer commercially viable.

 

	

12.4

	
 
Effect
of Termination.

 

	

(a)

	

Upon
the termination of this Agreement, then:

 

	

(i)

	

The
license granted to EDESA under Section 7.1 and any sublicenses that
have been granted to a Sublicensee with respect to Licensed
Technology shall terminate.

 

	

(ii)

	

Unless
the Parties agree otherwise, all activities underway at the time of
termination shall be terminated as soon as possible except for
winding down activities (including such activities) in connection
with any Clinical Trials (the cost of which shall continue to be
borne by EDESA as provided in this Agreement until completion of
such activities in the normal course). For the sake of clarity the
costs of winding down activities shall include any incured costs or
otherwise unavoidable wind down costs that would otherwise have
been payable by EDESA.

 

	

(iii)

	

Unless
this Agreement is terminated by EDESA pursuant to Section 12.2(a)
or 12.2(b), EDESA shall transfer and assign YISSUM, upon YISSUM's
request, all of the EDESA Data and any patent applications and
issued patents relating to the Product owned by EDESA (the
"EDESA Assigned IP"),
provided that YISSUM pays all reasonable, out-of-pocket expenses
actually incurred by EDESA in connection with such transfer and
assignment. EDESA shall fully cooperate with the Licensor to effect
such transfer and assignment and shall execute any document and
perform any acts required to do so. The EDESA DATA SHALL BE
PROVIDED ON AN "AS IS, WHERE IS" BASIS WITHOUT ANY EXPRESS OR
IMPLIED WARRANTIES AS TO THE FITNESS FOR A PARTICULAR PURPOSE,
MERCHANTABILITY OR CONDITION OR AS TO THE NON-INFRINGEMENT OF ANY
INTELLECTUAL PROPERTY RIGHTS OF ANY PERSON OR AS TO ANY OTHER
MATTER.

 

 

25

 

 

	

(iv)

	

Without
derogating from the force and effect of the foregoing assignment
undertaking in Section 12.4(a)(iii), the Parties acknowledge and
agree that if under applicable law the aforesaid assignment
undertaking will not be fully enforceable, then the pm1 (if any) of
such undertaking which is enforceable shall remain in full force
and effect, and the part (or whole) which is not enforceable shall
be automatically replaced with an in-evocable grant by EDESA to
YISSUM, binding upon all of EDESA'S acquirers, successors and
assignees, of an unrestricted, perpetual, irrevocable, world-wide,
royalty-free, exclusive license to use, exploit, Transfer and
sub-license (on a multi-tier basis) the EDESA Assigned IP for any
and all purposes and uses

 

	

(v)

	

Notwithstanding
anything to the contrary in this Section 12.4, if this Agreement is
terminated by EDESA pursuant to Section 12.2 or 12.3, EDESA shall
have the right to sell its remaining inventory of Product(s) so
long as EDESA has fully paid, and continues to pay fully when due,
any and all Royalties and Sublicensee Fees owed to YISSUM hereunder
based on such sales.

 

	

(vi)

	

Following
any termination of this Agreement, YISSUM shall pay to EDESA
[  ]% of the amounts received by YISSUM or its Affiliates as
royalties or sublicensing fees arising from the license of the
Licensed Technology to a Third Party, up to a maximum amount equal
to twice the documented amount EDESA has expended on the
Development or Commercialization of the Product. In furtherance of
EDESA's right under this Section 12.4(vi), YISSUM shall provide
prompt notice to EDESA upon the execution of any such license and
shall thereafter provide to EDESA written reports for each Calendar
quarter and each Calendar Year; each such report showing in
relation to the reporting period, as applicable: the royalties and
sublicensing fees received by YISSUM under such license. Reports in
respect of a Calendar Quarter shall be due on the thirtieth (30th)
day following the close of such Calendar Quarter and annual reports
shall be due on the sixtieth (60th) day following the close of such
Calendar Year. Royalties and sublicensing fees shown to have been
received in each report shall be due and payable by YISSUM on the
date such report is due. YJSSUM shall keep complete and accurate
records in sufficient detail to enable the royalties and
sublicensing fees received by YISSUM under such license to be
determined and EDESA shall have the right to audit such records on
terms consistent with those set forth in Section 6.4 of this
Agreement. For purposes of this Section 12.4(vi), the terms
"royalties" and "sublicensing fees" in relation to amounts received
from Third Patties shall have the same meanings as are set forth in
this Agreement, but replacing references to "EDESA" with the name
of the Third Party to whom YISSUM has licensed the Licensed
Technology.

 

	

(b)

	

If
either Party has the right to terminate this Agreement under
Section 12.2, it may at its sole option, elect either to: (i)
terminate this Agreement and pursue any legal or equitable remedy
available to it; or (ii) maintain this Agreement in effect and
pursue any legal or equitable remedy available to it.

 

26

 

   

	

12.5

	

  Survival.

 

Any
payments accruing hereunder shall continue to be due and owing
following termination of this Agreement. In addition, the following
provisions shall survive the termination of this Agreement for any
reason: Articles 1, 6.4, 8, 9, 10, 11, 12 and 13.

 

ARTICLE
13 MISCELLANEOUS

 

	

13.1

	
 
Force
Majeure.

 

Neither
Party shall be held liable to the other Party nor be deemed to have
defaulted under or breached this Agreement for failure or delay in
performing any obligation under this Agreement to the extent such
failure or delay is caused by or results from causes beyond the
reasonable control of the affected Party including embargoes, war,
acts of war (whether war be declared or not), insurrections, riots,
civil commotions, strikes, lockouts or other labour disturbances,
fire, floods, or other acts of God, or acts, omissions or delays in
acting by any governmental authority or the other Party. The
affected Patty shall notify the other Party of such force majeure
circumstances as soon as reasonably practical, and shall promptly
under take reasonable efforts necessary to mitigate such force
majeure circumstances.

 

	

13.2

	

  Assignment.

 

Either
Patty may assign its rights or obligations under this Agreement
without prior written notice to the other Patty or as part of a
sale of all or substantially all of its assets to a Third Party,
provided that such Third Party agrees, in writing, to assume the
assigning Party's obligations under this Agreement.

 

	

13.3

	

  Severability.

 

If any
one or more of the provisions contained in this Agreement is held
invalid, illegal or unenforceable in any respect, the validity,
legality and enforceability of the remaining provisions contained
herein shall not in any way be affected or impaired thereby, unless
the absence of the invalidated provision(s) adversely affects the
substantive rights of the Parties. The Parties shall in such an
instance use their commercially reasonable efforts to replace the
invalid, illegal or unenforceable provision(s) with valid, legal
and enforceable provision(s) which, insofar as practical, implement
the purposes of this Agreement.

 

	

13.4

	

  Notices.

 

All
notices which are required or permitted hereunder shall be in
writing and sufficient if delivered personally, sent by email (and
promptly confirmed by personal delivery, registered or

 

 

27

 

certified mail or
overnight courier), sent by nationally-recognized overnight courier
or sent by registered or certified mail, postage prepaid, return
receipt requested, addressed as follows:

 

	
 if to YISSUM,
to:

	
 YISSUM

	
 

	
 Attn: VP, Health
Care

	
 

	
 Hi-Tech Park,
Edmond J. Safra
Campus,

	
 

	
 Givat-Ram,

	
 

	
 Jerusalem P.O. Box
39135, Jerusalem,

	
 

	
 Israel Email:
shoshi.keynan@yissum.co.il

	
 

	
 

	
 with a copy (which
shall not constitute notice) to:

	
 Attn: General
Counsel

	
 

	
 Email:
bob.trachtenberg@yissum.co.il

	
 

	
 

	
 if to EDESA,
to: 

	
 Edesa Biotech
Inc.

	
 

	
 Attn: Director I 00
Spy Cornt

	
 

	
 Markham, Ontario
L3R5H6

	
 

	
 Email:
par@exzell.com

	
 

	
 

	
 with a copy (which
shall not constitute notice) to:

	
 Attn: Wojtek Baraniak ■

	
 

	
 Email:
wbaraniak@fasken.com

	
 

	
 

	
 

	
 

 

or to
such other address as the Party to whom notice is to be given may
have furnished to the other Party in writing in accordance
herewith. Any such notice shall be deemed to have been given: (a)
when delivered if personally delivered or sent by email on a
business day; (b) on the business day after dispatch if sent by
nationally-recognized overnight courier; or (c) on the fifth
business day following the date of mailing if sent by
mail.

 

	

13.5

	
 
Applicable
Law and Litigation.

 

This
Agreement shall be governed by and construed in accordance with the
laws of the England and Wales, without reference to any rules of
conflict of laws. For controversies, claims and disputes not
covered by the arbitration provisions pursuant to Section 13.14,
and for injunctive or other equitable interim relief in relation to
all controversies, claims and disputes arising out of or relating
to this Agreement, the Patties irrevocably and unconditionally: (a)
consent to the exclusive jurisdiction of the courts of England,
located in London for any action, suit or proceeding and relating
to injunctive or other equitable relief, and agree not to commence
any action, suit or proceeding related thereto except in such
courts; and (b) waive any objection to the laying of venue of any
action, suit or proceeding in the courts of England, located in
London and waive and agree not to plead or
claim in any such court that any such action, suit or proceeding
brought in any such court has been brought in an inconvenient
forum.

 

 

28

 

 

	

13.6

	
 
Entire
Agreement; Amendments.

 

This
Agreement contains the entire understanding of the Parties with
respect to the subject matter hereof. All express or implied
agreements and understandings, either oral or written, with regard
to the subject matter hereof are superseded by the terms of this
Agreement. On the Effective Date, the confidentiality agreement
between the Parties effective February 17 2016 shall terminate and
all Confidential Information exchanged thereunder shall be deemed
Confidential Information of the Party disclosing such information
and protected under this Agreement. This Agreement may be amended,
or any term hereof modified, only by a written instrument duly
executed by authorized representatives of both
Parties.

 

	

13.7

	
 
Independent
Contractors.

 

The
Parties shall be independent contractors and the relationship
between the Parties shall not constitute a pm1nership, joint
venture or agency. Neither Party 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 Party, without
the prior written consent of the other Party.

 

	

13.8

	

  Waiver.

 

The
waiver by either Pm1y of any right hereunder, or the failure of the
other Party to perform, or a breach by the other Party, shall not
be deemed a waiver of any other right hereunder or of any other
breach or failure by such other Party whether of a similar nature
or otherwise.

 

	

13.9

	
 
Cumulative
Remedies.

 

No
remedy referred to in this Agreement is intended to be exclusive,
but each shall be cumulative and in addition to any other remedy
referred to in this Agreement or otherwise available under
law.

 

	

13.10

	
 
Waiver
of Rule of Construction.

 

Each
Party has had the opportunity to consult with legal counsel in
connection with the review, draf1ing and negotiation of this
Agreement. Accordingly, the rule of construction that any ambiguity
in this Agreement shall be construed against the draf1ing Party
shall not apply.

 

	

13.11

	
 
Further
Assurances.

 

Each
Party shall duly execute and deliver, or cause to be duly executed
and delivered, such further instruments and do and cause to be done
such further acts and things, including the filing of such
assignments, agreements, documents and instruments, as may be
necessary or as the other Pm1y may reasonably request in connection
with this Agreement or to carry out more effectively the provisions
and purposes, or to better assure and confirm unto such other Party
its rights and remedies under this Agreement. Each Pm1y shall use
its conm1ercially reasonable effo11s to take all actions necessary
or advisable under applicable laws to consummate and make effective
the transactions
contemplated by this Agreement including the taking of such
reasonable actions as are necessary to obtain any requisite
approvals, consents, orders, exemptions or waivers by any
governmental authority.

 

 

29

 

 

	

13.12

	

  Construction.

 

Except
where the context otherwise requires, wherever used, the singular
will include the plural, the plural the singular, the use of any
gender will be applicable to all genders, and the word "or" is used
in the inclusive sense (and/or). The captions of this Agreement are
for convenience of reference only and in no way define, describe,
extend or limit the scope or intent of this Agreement or the intent
of any provision contained in this Agreement. The term "including"
as used herein means including, without limiting the generality of
any description preceding such tenn. References to "Section" or "Sections" are
references to the numbered sections of this Agreement,
unless expressly stated otherwise.

 

	

13.13

	

  Currency.

 

All
payments under this Agreement shall be made in United States
Dollars. All references to "dollars" or"$" in this Agreement are to
United States Dollars.

 

	

13.14

	
 
Dispute
Resolution.

 

	

(a)

	

Any
controversy, claim or dispute arising out of or relating to this
Agreement shall first be submitted to the CEO of each Party for
attempted resolution. If the CEOs of the Parties do not resolve
such matter within thirty (30) days of the matter being submitted
to them, then such matter shall be resolved through binding
arbitration as follows. For the sake of clarity, this Section 13.14
is not intended to alter the rights of the Parties as established
by Article 2, Governance, herein. The dispute shall be resolved by
final and binding arbitration. The place of arbitration shall be
London, England. The arbitration shall be in accordance with the
rules of LCIA except as
modified herein. The number of arbitrators shall be three. The
language of the arbitration shall be English.

 

	

(b)

	

The
Party wishing to commence an arbitration ("Claimant") shall notify the other
party ("Respondent") in
writing of its decision to commence arbitration hereunder
(sometimes referred to in this Agreement as its "demand for arbitration"), setting out
briefly its claims in its notice, and with its notice, name the
arbitrator it is appointing.

 

	

(c)

	

The
Respondent shall, within thirty (30) days of receipt of a demand
for arbitration, notify the Claimant in writing of the name of the
arbitrator it is appointing.

 

	

(d)

	

The
third arbitrator shall be chosen by the first two arbitrators
within twenty (20) days after the second of such arbitrators was
appointed.

 

	

(e)

	

All
arbitrators shall be chosen taking into account the type of issues
to be addressed in the arbitration, whether legal, business,
scientific, or a combination thereof, and having regard to their
availability to conduct the arbitration within the times
provided below.
(The date on which the third arbitrator is appointed 1s the
"Arbitration
Panel Finalization").

 

 

30

 

 

	

(f)

	

Within
thirty (30) days of completion of the hearing, the arbitrators
shall render a reasoned arbitration award describing, in writing,
the essential finding and conclusions on which the decision is
based, including the calculation of any damages awarded. Any
monetary award shall be made within thirty (30) days of the
rendering of such award.

 

	

(g)

	

All
information and documents in relation to the arbitration shall be
deemed Confidential lnfo1111ation lo the full extent permitted by
law. No individual shall be appointed as an arbitrator unless the
individual first agrees in writing to be bound by this subsection
and to conduct the arbitration in a manner that in his/her
judh'1nent is most likely to maintain the confidentiality of
Confidential Information. Neither Party may retain any expert in
connection with the arbitration unless the expert first agrees in
writing to be bound by this subsection, as applicable. The fact of
and subject matter of the arbitration, including the fact that any
dispute has been submitted to arbitration, and all evidence given
and submissions made in connection with any arbitration, shall be
Confidential Information, and shall be treated as such by the
Parties and all persons employed by or contracted to them. Any
meetings, conferences or hearings in connection with or during the
arbitration may be attended only by those individual persons whose
presence, in the opinion of the arbitral tribunal, is reasonably
necessary for the determination or other resolution of the dispute
and such person first agrees in writing to be bound by the
provisions of these sections, as applicable. The obligations under
this subsection continue notwithstanding any determination or other
resolution of the arbitration.

 

	

(h)

	

The
arbitrators shall be paid reasonable fees plus expenses. These fees
and expenses, along with the reasonable legal fees and expenses of
the prevailing Party (including all expe1t witness fees and
expenses), the fees and expenses of a court reporter, and any
expenses for a hearing room, shall be paid as follows:

 

	

(i)

	

If the
arbitrators rule in favour of one Party on all disputed issues in
the arbitration, the losing Party shall pay l 00% of such fees and
expenses.

 

	

(ii)

	

If the
arbitrators rule in favour of one Party on some issues and the
other Pmty on other issues, the arbitrators shall issue with the
ruling a written determination as lo how such fees and expenses
shall be allocated between the Parties. The arbitrators shall
allocate fees and expenses in a way that bears a reasonable
relationship to the outcome of the arbitration, with the Party
prevailing on more issues, or on issues of greater value or
gravity, recovering a relatively larger share of its legal fees and
expenses.

 

	

(i)

	

Any
final award of the arbitrators shall be final, conclusive and
binding on the Parties, and judgment may be entered in any court of
competent jurisdiction. To the extent lawful, the Parties exclude
any right of review or appeal lo Canadian, United Stales, English,
Israeli or other court, including in connection with any question
of law
arising in the arbitration or in connection with any award or
decision made by the arbitrators, except as is necessary to
recognize or enforce such award or decision.

 

 

31

 

 

	

13.15

	
 
Statute
of Limitations.

 

In no
event will a demand for arbitration be made after the date when
institution of a legal or equitable proceeding based upon such a
dispute between the Parties would otherwise be barred by the
applicable statute of limitations.

 

	

13.16

	
 
Injunctive
and Other Interim Relief.

 

Nothing
in this Agreement shall be construed as limiting in any way the
right of a Party to seek injunctive or other interim relief from a
court of competent jurisdiction with respect to any actual or
threatened breach of this Agreement, or to preserve or protect any
property or assets pending an arbitral award, or otherwise in
support of the contemplated or pending arbitration. No such court
application shall be taken as a waiver or impairment of
arbitration.

 

	

13.17

	
 
Execution
in Counterparts; Facsimile Signatures.

 

This
Agreement may be executed in counterparts, each of which
counterpart, when so executed and delivered, shall be deemed to be
an original, and all of which counterparts, taken together, shall
constitute one and the same instrument even if both Parties have
not executed the same counterpart. Signatures provided by facsimile
transmission or scanned and emailed copies shall be deemed to be
original signatures.

 

[Remainder of the Page Intentionally Left Blank]

 

 

32

 

 

The
Parties have executed this Agreement as of the Effective
Date.

 

	

 

	
YISSUM PHARMACEUTICALS
INC>

	

 

	

 

	

 

	

 

	

 

	

	
By:  

	
/s/ Shoshi
Keynan

	

 

	

 

	

 

	
Name: Shoshi
Keynan  

	

 

	

 

	

 

	

Title:
VP Licensing, Pharmaceuticals 

	

 

	

 

	

 

	

 

	

 

	

 

	

By: 

	

/s/
Yaacov Michlin

	

 

	

 

	

 

	

Name:
Yaacov
Michlin

	

 

	

 

	

 

	

Title:
CEO of Yissum

	

 

 

	

 

	
RESEARCHER

	

 

	

 

	

 

	

 

	

 

	

	
By:  

	
/s/ Saul
Yedger 

	

 

	

 

	

 

	
Name: Saul
Yedger   

	

 

	

 

	

 

	

Title:
Professor 

	

 

 

	

 

	
EDESA BIOTECH INC.

	

 

	

 

	

 

	

 

	

 

	

	
By:  

	
/s/ Pardeep
Nijhawan 

	

 

	

 

	

 

	
Name: Pardeep
Nijhawan   

	

 

	

 

	

 

	

Title:
Director 

	

 

	

 

	

 

	

 

	

 

	

 

	

By:

	

 

	

 

	

 

	

 

	

Name:

	

 

	

 

	

 

	

Title:

	

 

	

 

	

 

	

 

	

 

 

 

 

33

 

 

Appendix
A (Development Plan)

 

 
First 6
months from Execution of the Agreement

 

 

	

●

	

External
Review of the existing IND

 

	

●

	

Preparation
of regulatory documents for meeting with Regulatory
Authorities

   

	

●

	

Meeting
with the Researcher to discuss potential research projects relevant
to the development of the Product.

 

Within
the 6-12 months from the Execution of the Agreement

 

	

●

	

Request
for meeting with or submission of questions to Regulatory
Authorities

 

	

●

	

Meeting/Interaction
with Regulatory Authorities

 

	

●

	

Review
of feedback/responses from Regulatory Authorities

 
	

●

	

Identification and engagement
of CMO to produce Product Within the 12-18 months from Execution of
the Agreement

 

	

●

	

Submission
of IND or equivalent if no additional studies are required by the
regulatory authorities or initiation of any studies mandated by
Regulatory Authorities to submit IND or equivalent

 

Within
the 18-24 months from Execution of the Agreement

 

	

●

	

Initiation
of first clinical study if IND or equivalent if Regulatory
Authorities required no addition studies for approval or completion
and submission of IND or
equivalent if additional pre -clinical studies were required by
Regulatory Authorities.

 

 
Every
additional 12 months

 

	

●

	

Parties
meet to discuss specific targets but EDESA will continue to use
reasonable efforts to advance the Product.

 

 

34

 

Appendix
B

(Patents)

 

	

(1)

	

Licensed
Composition of Matter Patents:

 

 

	

Patent/Application

	

Title

	

Yissum
ref.

	

us 8,865,878

	

Use of
Lipid Conjugates In the Treatment of Disease

	

2510-51

	

CA
2,558,416

	

Use of
Lipid Conjugates In the Treatment of Disease

	

2510-18

	

EP
1758595

	

Use of
Lipid Conjugates In the Treatment of Disease

	
 

 

	

(2)

	

Method
of Use or Other patents.

 

 

	

Patent/Application

	

Title

	

Yissum
ref.

	

us 7,772,196

	

Use of
Lipid Conjugates In the Treatment of Disease

	

2510-14

	

us 8,901,103

	

Use of
Lipid Conjugates In the Treatment of Disease

	

2510-44

	

AU
2011201154

	

Use of
Lipid Conjugates In the Treatment of Disease

	

2507-AU

 

	

(3)

	

Patents
need to be assigned to Yissum

 

 

	

Patent/Application

	

Title

	

Yissum
ref.

	

us 2014-0199241

us 14/115,869

	

LIPOSOMES
COMPRISING POLYMER- CONJUGATED LIPIDS AND RELATED USES

	

4097-08

	

CA
2834918

	

LIPOSOMES
COMPRISING POLYMER-

CONJUGATED LIPIDS
AND RELATED USES

	

4097-06

	

EP
2706988

	

LIPOSOMES
COMPRISING POLYMER-

CONJUGATED LIPIDS
AND RELATED USES

	

4097-04

	

us 2015-0119567

us 14/525111

	

Lipid-polymer
conjugates, their preparation and use

thereof

	

3860-09

	

CA
2761590

	

Lipid-polymer
conjugates, their preparation and use

	

3860-08

 

 

35

 

 

	
 

	

thereof

	
 

	

El'
2429532

	

Lipid-polymer
conjugates, their preparation and use

thereof

	

3860-04

 

 

36Blueprint

 

 

Exhibit 10.3

 

FIRST
AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT

 

This
First Amendment ("First Amendment"),
effective as of April 3, 2017 ("Effective Date"), is
entered into by and between Yissum Research Development Company of
the Hebrew University of Jerusalem, an Israeli corporation with its
principal office at Hi-Tech Park, Edmond

J.
Safra Campus, Givat-Ram, Jerusalem P.O. Box 39135, Jerusalem 91390
Israel ("YISSUM"), and Edesa
Biotech Inc., an Ontario corporation with its principal office at
100 Spy Court, Markham, Ontario, L3R 5H6 ("EDESA"). YISSUM and
EDESA may be referred to herein individually as a "Party" or collectively
as the "Parties". Reference to
a Party shall be deemed to include that Party's
Affiliates.

 

RECITALS:

 

A.

The Parties
executed a license agreement on June 29, 2016 (the "License Agreement")
pursuant to which Yissum granted EDESA an exclusive, worldwide
license to use the Licensed Technology for the Development and
Commercialization of the Product in the Field in the Territory;
and

 

B.

Pursuant to the License Agreement, the Licensed
Technology did not include the Patents listed in Appendix B/3
annexed to the License Agreement (the "B/3 Patents") since at that time they were not fully assigned
to YISSUM; but YISSUM had agreed to include them in the Licensed
Technology upon full assignment of such patents to
YISSUM.

 

C.

Pursuant to the
License Agreement, EDESA agreed to pay fifty percent (50%) of all
costs associated with the Patent Management of the B/3 Patents
until YISSUM had received full assignment of such patents, at which
point, EDESA would be responsible for one hundred percent (100%) of
all costs associated with the Patent Management of the B/3
Patents.

 

D.

The Pa1iies wish to
amend Appendix Band certain sections of the License Agreement with
respect to the B/3 Patents, as well as other patents.

 

In
consideration of the foregoing premises and the mutual covenants
herein contained, the Parties hereby agree as follows:

 

1.

Interpretation and
Definitions

 

1.1.

The preamble and
appendices annexed to this First Amendment constitute an integral
part hereof and shall be read jointly with its terms and
conditions.

 

1.2.

In this Amendment,
unless otherwise required or indicated by the context, the singular
shall include the plural and vice-versa, the masculine gender shall
include the female gender, and the use of the word "or" shall mean
"and/or".

 

1.3.

The headings of the
sections in this Amendment are for the sake of convenience only and
shall not serve in the interpretation of the
Agreement.

 

 

1

 

 

1.4.

In this Amendment,
capitalized terms shall have the meanings set forth in the License
Agreement, unless provided otherwise herein.

 

2.

The Parties
acknowledge that the U.S. and Canadian patents that are part of the
B/3 Patents have been fully assigned to YISSUM as of March 26, 2017
(the "Assignment
Date") and shall be included in the Licensed Technology, and
further acknowledge that by reason of such assignment, pursuant to
section 11.3 of the License Agreement, EDESA is responsible for one
hundred percent (100%) of all costs associated with the Patent
Management of these patents as of the Assignment Date.

 

3.

The following US
patent, which was always owned solely by Yissum but was licensed to
Celsus, shall be added to Appendix B/1 of the License
Agreement:

 

US
Patent No. 8,383,787: Use of Lipid Conjugates In the Treatment of
Disease (Yissum Ref: 2510-90).

 

4.

The Parties have
agreed to update the version of Appendix B annexed to the License
Agreement by replacing it in its entirety by the new Appendix B
attached to this First Amendment.

 

5.

This First
Amendment shall be read together with the License Agreement and
shall represent the complete current understanding between the
Parties hereto with respect to the subject matter
hereof.

 

6.

Unless otherwise
specifically stated in this First Amendment, all of the terms and
conditions set forth in the Agreement remain in full force and
effect. In any event of a conflict between and conditions contained
in this First Amendment and the License Agreement, the terms
contained in this First Amendment shall govern.

 

7.

This First
Amendment may be executed in counterparts and executed signature
pages may be sent by fax and e-mail via PDF, all of which taken
together shall be deemed to constitute one and the same
instrument.

 

[Signature on the next page]

 

 

2

 

 

IN WITNESS WHEREOF, the
parties have caused this First Amendment to be executed by their
duly authorized representatives as of the Effective
Date.

 

	

YISSUM

	
 

	

EDESA
BIOTECH INC.

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	

By:

	

/s/
Shoshi Keynan

	
 

	

By:

	

/s/
Pardeep Nijhawan

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	

Name:

	

Shoshi
Keynan, Ph.D.

	
 

	

Name:

	

Pardeep
Nijhawan

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	

Title:

	

VP
Licensing, Pharmaceuticals

	
 

	

Title:

	

Director

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	

By:

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	

Name:

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	

Title:

	
 

	
 

	
 

	
 

	
 

 

Prof.
Yedgar Acknowledgment

 

/s/ Saul Yedgar

 

 

3

 

 

Appendix B

 

(Patents)

 

(1)

Licensed
Composition of Matter Patents:

 

 

	

Patent/Application

	

Title

	

Yissum
ref

	

us 8,865,878

	

Use of
Lipid Conjugates In the Treatment of Disease

	

2510-51

	

CA
2,558,416

	

Use of
Lipid Conjugates In the Treatment of Disease

	

2510-18

	

EP
1758595

	

Use of
Lipid Conjugates In the Treatment of Disease

	

2510-19

	

us 8,383,787:

	

Use of
Lipid Conjugates In the Treatment of Disease

	

2510-60

	

us 2014-0199241

us 14/115,869

	

Liposomes
comprising polymer- Conjugated lipids and uses

	

4097-08

	

CA
2834918

	

Liposomes
comprising polymer- Conjugated lipids and

uses

	

4097-06

	

us 2015-0119567

us 14/525111

	

Lipid-polymer
conjugates, their preparation and uses

thereof

	

3860-09

	

CA
2761590

	

Lipid-polymer
conjugates, their preparation and uses

thereof

	

3860-08

 

(2)

Method of Use or
Other patents.

 

	

Patent/Application

	

Title

	

Yissum
ref.

	

us 7,772,196

	

Use of
Lipid Conjugates In the Treatment of Disease

	

2510-14

	

us 8,901,103

	

Use of
Lipid Conjugates In the Treatment of Disease

	

2510-44

	

AU
2011201154

	

Use of
Lipid Conjugates In the Treatment of Disease

	

2507-AU

 

 

 

 

4

 

 

(3)

Patents still need
to be assigned to Yissum and included in the Licensed
Technology.

 

	

Patent/Application

	

Title

	

Yissum
ref.

	

EP
2706988

	

Liposomes
comprising polymer-Conjugated lipids and

uses

	

4097-04

	

EP
2429532

	

Lipid-polymer
conjugates, their preparation and uses

thereof

	

3860-04

 

 

 

 

 

 

 

 

 

 

 

 

5

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