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. EXCLUSIVE LICENSE AGREEMENT by and between Dr. Saul Yedgar and EDESA...
Exhibit 10.1
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE
EXHIBIT
BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE
COMPETITIVE
HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.
by and between
▇▇. ▇▇▇▇ ▇▇▇▇▇▇
and
EDESA BIOTECH RESEARCH INC.
March 16, 2021
TABLE
OF CONTENTS
|
|
Page
|
|
|
Article 1 DEFINITIONS
|
1
|
|
|
Article 2
SCOPE
|
7
|
|
|
2.1
|
Scope.
|
7
|
|
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.
|
8
|
|
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.
|
9
|
|
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.
|
14
|
|
Article 8 CONFIDENTIALITY; PUBLICATION
|
14
|
|
|
8.1
|
Nondisclosure
Obligation.
|
14
|
|
8.2
|
Publicity;
Use of Names.
|
15
|
|
Article 9 REPRESENTATIONS AND WARRANTIES
|
16
|
|
|
9.1
|
Representations
and Warranties of LICENSOR.
|
16
|
|
9.2
|
Representations
and Warranties and Covenants of EDESA.
|
17
|
|
9.3
|
Representations
and Covenants of Both Parties.
|
17
|
|
9.4
|
No
Other Representations or Warranties.
|
18
|
-i-
TABLE OF CONTENTS
(continued)
|
|
Page
|
|
|
Article 10 INDEMNIFICATION
|
18
|
|
|
10.1
|
General
Indemnity By EDESA.
|
18
|
|
10.2
|
Limitation
of Liability.
|
19
|
|
10.3
|
Insurance.
|
20
|
|
Article 11 INVENTIONS; PATENT PROVISIONS
|
20
|
|
|
11.1
|
Ownership
of Intellectual Property.
|
20
|
|
11.2
|
Patent
Prosecution
|
20
|
|
11.3
|
Fees
|
20
|
|
11.4
|
Enforcement.
|
20
|
|
11.5
|
Defense.
|
21
|
|
Article 12 TERM AND TERMINATION
|
22
|
|
|
12.1
|
Term.
|
22
|
|
12.2
|
Termination
for Cause.
|
22
|
|
12.3
|
Termination
Without Cause.
|
22
|
|
12.4
|
Effect
of Termination.
|
22
|
|
12.5
|
Survival.
|
25
|
|
Article 13 MISCELLANEOUS
|
25
|
|
|
13.1
|
Force
Majeure.
|
25
|
|
13.2
|
Assignment.
|
25
|
|
13.3
|
Severability.
|
25
|
|
13.4
|
Notices.
|
26
|
|
13.5
|
Applicable
Law and Litigation.
|
26
|
|
13.6
|
Entire
Agreement; Amendments.
|
27
|
|
13.7
|
Independent
Contractors.
|
27
|
|
13.8
|
Waiver.
|
27
|
|
13.9
|
Cumulative
Remedies.
|
27
|
|
13.10
|
Waiver
of Rule of Construction.
|
27
|
|
13.11
|
Further
Assurances.
|
27
|
|
13.12
|
Construction.
|
28
|
|
13.13
|
Currency.
|
28
|
|
13.14
|
Dispute
Resolution.
|
28
|
|
13.15
|
Statute
of Limitations.
|
38
|
|
13.16
|
Injunctive
and Other Interim Relief.
|
30
|
|
13.17
|
Execution
in Counterparts; Facsimile Signatures.
|
30
|
-ii-
This
Agreement (“Agreement”), effective as of March
16, 2021 (“Effective
Date”), is entered into by and between ▇▇▇▇ ▇▇▇▇▇▇, an
individual with principal residence at [___________]
(“LICENSOR”),
and Edesa Biotech Research Inc., an Ontario corporation with its
principal office at ▇▇▇ ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇
(“EDESA”).
LICENSOR 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.
[Principal residence of LICENSOR
omitted.]
RECITALS:
A.
LICENSOR owns the
rights to certain know-how, patents and data relating to
formulations containing Di-Palmitoyl Phosphatidyl-Ethanolamine
(DPPE)-conjugated Hyaluronic Acid (HA), or its derivatives (the
“Products”)
developed by LICENSOR.
B.
EDESA is a
pharmaceutical company having expertise in the discovery,
development, manufacturing and commercialization of innovative
human pharmaceutical products.
▇.
▇▇▇▇▇ and LICENSOR
desire to enter into an agreement under which EDESA will obtain
exclusive rights to develop and commercialize the Products for
therapeutic, prophylactic and diagnostic uses in all applications
other than those covered in the Yissum License Agreement (as
defined below) (the “Field”).
In
consideration of the foregoing premises and the mutual covenants
herein contained, the Parties hereby agree as follows:
ARTICLE 1
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, or
the equivalent of the foregoing under Applicable Law in the
relevant jurisdiction.
1.2
“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 1.2
only, “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.
-2-
1.3
“Applicable Law” means the laws,
rules, statutes, orders, ordinances, regulations, written guidance
and written guidelines having binding effect, and other written
requirements of any Governmental Authority that having binding
effect and may be in effect from time to time and that are
applicable to a Party or a Party’s activities under this
Agreement.
1.4
“Calendar Quarter” means the
respective periods of three (3) consecutive calendar months ending
on March 31, June 30, September 30 and December 31.
1.5
“Calendar Year” means the
respective periods of twelve (12) months commencing on January 1
and ending on December 31.
1.6
“Claimant” has the meaning set
forth in Section 13.15.
1.7
“Clinical Material(s)” means the
Product formulated in accordance with the Specifications and
Applicable Law in the relevant jurisdiction: (a) for preclinical
activities; and (b) for administration to subjects in Clinical
Trials.
1.8
“Clinical Trial(s)” means clinical
trials (as defined in the Applicable Law in the relevant
jurisdiction) with respect to the Product in the
Field.
1.9
“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.
1.10
“Confidential Information” has the
meaning set forth in Section 8.1.
1.11
“Control,” “Controls” or “Controlled by” means (except as
used in Section 1.2), 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.
1.12
“demand for arbitration” has the
meaning set forth in Section 13.15.
1.13
“Develop” or “Development” or
“Developing”
means research, discovery, process development, manufacturing for
preclinical and clinical uses, preparation for drug reimbursement,
preparation and initiation of medical education and liaison
activities and preclinical and clinical drug 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.
-3-
1.14
“DTAA” means the Convention between
the Government of Canada and the Government of the State of Israel
for the Avoidance of Double Taxation and the Prevention of Fiscal
Evasion with respect to Taxes on Income.
1.15
“EDESA Data” means any 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 data, data and results arising from the
conduct of Clinical Trials, analytical and quality control data,
stability data, studies and procedures, and manufacturing process
and development information, results and data that: (a) are
conceived, discovered, invented, made or first reduced to practice
by, or on behalf of, EDESA on or after the Effective Date; and (b)
are related to the Product (or a composition containing the Product
or the manufacturing or use of the Product).
1.16
“EMA” means the European Medicines
Agency or any successor agency thereto.
1.17
“FDA” means the United States Food
and Drug Administration or any successor agency
thereto.
1.18
“Field” has the meaning ascribed to
it in the recitals.
1.19
“First Commercial Sale” means, with
respect to a Product in the Field, the first sale to a Third Party
for end use or consumption of such Product in the Field in a
country in the Territory after Regulatory Approval of such Product
in the Field has been granted by the Regulatory Authority of such
country, but excluding sales made under special access or similar
program authorized by an applicable Regulatory
Authority.
1.20
“Governmental Authority” means any
supranational, national, federal, state, provincial, country, city
or local government or any agency, department, authority, court, or
other instrumentality thereof, including any Regulatory
Authority.
1.21
“IFRS” means International
Financial Regulatory Standards as the same may be in effect from
time to time.
1.22
“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.
1.23
“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.
-4-
1.24
“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 form.
1.25
“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.
1.26
“Licensed Technology”
means:
(a)
all
Patents;
(b)
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 data, clinical trial data,
analytical and quality control data, stability data, studies and
procedures (including any data submitted as part of the IND), and
manufacturing process and development information, results and
data; and
(c)
any proprietary
biological, chemical or physical materials (including any active
pharmaceutical ingredient);
and in
the case of items listed in paragraphs (a), (b) and (c) only, that
are Controlled by LICENSOR as of the Effective Date or at any time
during the Term and: (i) related directly and only to the Product
(or a composition containing the Product or the manufacturing or
use of the Product); or (ii) necessary for EDESA to exercise the
rights licensed to it under this Agreement or to perform its
obligations under this Agreement.
1.27
LICENSOR Indemnitee(s)” has the
meaning ascribed to it in Section 10.1
1.28
“NDA” or “New Drug Application” means an
application submitted to FDA pursuant to 21 U.S.C. § 505(b) or
a Canadian or foreign equivalent application or submission to a
Regulatory Authority under Applicable Law in the relevant
jurisdiction 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.
1.29
“Net Sales” means the gross amount
invoiced, billed and
collected by EDESA or
its Affiliates to unrelated Third Parties (excluding any
Sublicensee) for the Product in the Territory, less:
(a)
Trade, quantity and
cash discounts actually allowed or paid;
-5-
(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 respective Affiliates.
In the
event that EDESA or its Affiliates or anyone on their behalf
receives non-monetary consideration for any Product or in the case
of transactions not at arm’s length between EDESA or its
Affiliates and the recipient of the Product, Net Sales shall be
calculated based on the fair market value of such consideration or
transaction, assuming an arm’s length transaction made in the
ordinary course of business.
For
greater certainty, provision of Product for the purpose of
conducting Clinical Trials in order to obtain Regulatory Approvals
shall not be deemed to be a sale for the purposes of calculating
Net Sales.
Such
amounts shall be determined from the books and records of EDESA or
its Affiliates or Sublicensees, as applicable, maintained in
accordance with US GAAP, consistently applied, except where US GAAP
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.
1.30
“Patent(s)” means:
(a)
all patents and
patent applications in any country or supranational jurisdiction;
and
-6-
(b)
any provisionals,
substitutions, divisions, continuations, continuations in part,
reissues, renewals, registrations, confirmations, reexaminations,
extensions, supplementary protection certificates and the like, of
any such patents or patent applications;
that
are Controlled by LICENSOR, as of the Effective Date or at any time
during the Term and that: (i) related to the Product (or a
composition containing the Product or the manufacturing or use of
the Product); or (ii) 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 patent applications and patents listed in Appendix
A.
1.31
“Products” has the meaning ascribed
to it in the recitals.
1.32
“Regulatory Approval(s)” means all
approvals or authorizations by Regulatory Authorities necessary to
market and sell the Product in the Field in the
Territory.
1.33
“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.
1.34
“Respondent” has the meaning set
forth in Section 13.15(b).
1.35
“Royalties” has the meaning set
forth in Section 6.2.
1.36
“Specifications” means the
specifications for the Product as provided by LICENSOR as part of
the Licensed Technology.
1.37
“Sublicensee” means a Third Party
that is granted a sublicense under the licenses granted to a Party
under this Agreement.
1.38
“Sublicensing Fees” has the meaning
set forth in Section 6.2.
1.39
“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.
1.40
“Term” has the meaning set forth in
Section 12.1.
1.41
“Territory” means the entire
world.
1.42
“Third Party” means an entity other
than: (a) EDESA and its Affiliates; and (b) LICENSOR and its
Affiliates.
1.43
“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.
-7-
1.44
“Yissum License Agreement” means
the Exclusive License Agreement entered into by EDESA and Yissum
Research Development Company of the Hebrew University of Jerusalem
dated June 29, 2016, as amended by the First Amendment to the
Exclusive License Agreement dated April 3, 2017 and the Second
Amendment to the Exclusive License Agreement dated May 7,
2017.
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 in the Territory
in the Field; and (b) EDESA will have exclusive rights to Develop
and Commercialize the Product as further set forth in Section
3.1, in exchange for royalty and other payments to be made
to LICENSOR as described in Article 6.
ARTICLE 3
PRODUCT DEVELOPMENT AND COMMERCIALIZATION.
From
and after the Effective Date and during the Term, 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, LICENSOR 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 LICENSOR through the Development
Plan as to the status of Development and Commercialization of the
Product in the Field.
a)
Within sixty (60)
days of the Effective Date, the Parties will meet (in person or
through other means) and work in good faith to create a mutually
agreeable plan for the Development of the Product by EDESA (the
“Development
Plan”), including development targets (the
“Development
Targets”). EDESA shall be responsible for executing
the Development Plan and will allocate the time and resources
required to do so. EDESA shall periodically prepare an update to
the Development Plan and deliver same to LICENSOR within sixty (60)
days following each twelve (12) month anniversary of the execution
of this Agreement and shall keep LICENSOR reasonably informed
concerning the Development Plan, its progress and its results on an
oral basis.
-8-
b)
The Parties will
meet (in person or through other means) and work in good faith to
amend and adjust the Development Plan as needed, in good faith
judgment, in order to improve EDESA’s ability to meet the
Development Targets. Notwithstanding the foregoing or anything to
the contrary in this Agreement, EDESA shall not be entitled to
change the Development Targets or the time frames for achieving the
Development Targets without LICENSOR’s prior written consent
which shall not be unreasonably withheld. Such consent shall not be required
in connection with a Development Target delayed or revised due to
an action, decision, recommendation or position taken by a
Regulatory Authority to the extent that EDESA continues to actively
and continuously invest the required financial resources to meet
the respective Development Target, as confirmed to LICENSOR in
writing by EDESA’s senior management.
c)
An EDESA
representative and LICENSOR shall meet or conduct a teleconference
(at their election) no less than once every Calendar Year during
the term of this Agreement commencing with the Effective Date, at
locations and times to be mutually agreed upon by the Parties, (i)
to review the progress being made under the Development Plan and
the progress being made in any other research and development
activities conducted by EDESA, its Affiliates and Sublicensees
relating to Products, (ii) to review and agree upon any necessary
or desired revisions to the then current Development Plan, (iii) to
review the progress being made towards fulfilling the Development
Targets and (iv) to discuss intended efforts for fulfilling such
targets.
3.5
Rights
to Sublicense.
EDESA
shall have the 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 that, prior to any
such engagement, any Sublicensees are subject to an 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 LICENSOR
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 to
Products in the course of performing activities under such
sublicense in EDESA; and (iv) that do not impose any payment
obligations or liability on LICENSOR without the prior written
consent of LICENSOR. 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 LICENSOR
pursuant to this Agreement. Upon request, EDESA shall provide such
reports to LICENSOR. EDESA shall provide LICENSOR with an executed
copy of each Sublicense Agreement within thirty (30) days of its
execution. Any breach of the terms of this Agreement by a
Sublicensee, including any act or omission by a Sublicensee which
would have constituted a breach of this Agreement had it been an
act or omission by EDESA, shall constitute a breach of this
Agreement by EDESA.
-9-
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 including the Clinical Materials. Promptly following the
execution of this Agreement, LICENSOR shall deliver to EDESA copies
of all Information 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 including the Clinical Materials in accordance with the
applicable Specifications in its possession or Control, all at
EDESA’s sole cost and expense.
(b) Upon
the request of EDESA, LICENSOR shall promptly ship to EDESA any
unexpired active pharmaceutical ingredient for the Product in its
possession or Control at EDESA’s sole cost and
expense.
ARTICLE 5
REGULATORY
5.1
Regulatory
Obligations.
EDESA
shall be responsible, at its own cost, for, and shall have the sole
right to control, all regulatory activities and strategy associated
with INDs, 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. LICENSOR
shall reasonably cooperate with EDESA as requested, in preparing
and filing all such reports, and LICENSOR shall provide EDESA with
all available information, including regulatory, technical and
clinical data concerning the Product to enable EDESA to prepare and
file such reports, at EDESA’s sole cost and expense. 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 Parties which must be
paid with respect to facilities used in the manufacture of the
Product by or on behalf of EDESA.
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 database for
the Product; and (iv) reviewing and approving of safety information
for inclusion in the Product label in the Territory, including the
costs and expenses thereof.
-10-
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 setting the price for the Product
in the Field, and may do so without discussion or consultation with
LICENSOR.
ARTICLE 6
6.1
Milestone
Payments.
EDESA
shall immediately notify LICENSOR of the achievement of any of the
following development and commercial milestones, all for the
Products in the Field, and EDESA shall pay to LICENSOR the
milestone payments listed below which shall be due and payable
within forty (40) days after the event for which the payment is due
(or, (i) for milestones based on Net Sales, within forty (40) days
after the end of the Calendar Year with respect to which such
milestone is triggered, (ii) for the first payment with respect to
the execution, upon execution of this Agreement):
|
Upon
Execution of this Agreement
|
$[__]
|
|
Upon
the 6 month Anniversary of the Execution of this
Agreement
|
$[__]
|
|
Upon
the 1-year Anniversary of the Execution of this
Agreement
|
$[__]
|
|
Upon
the dosing of the 1st patient into a
Phase 2 Clinical Trial in the Field for the first Indication for
which Regulatory Approval will be sought.
|
$[__]
|
|
Upon
the dosing of the 1st patient into a
Phase 3 Clinical Trial in the Field for the first Indication for
which Regulatory Approval will be sought.
|
$[__]
|
|
Upon
receipt of the first NDA for the Product in the Field
|
$[__]
|
|
Upon
the First Commercial Sale of the Product in the Field 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
|
$[__]
|
|
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
|
$[__]
|
|
First
occurrence of $[__] million in aggregate Net Sales in a Calendar
Year in countries where EDESA or an Affiliate directly
Commercializes the Product
|
$[__]
|
-11-
For
clarity, the aggregate Net Sales that are taken into account in
order to calculate the achievement of a specific sales threshold
milestone for a Calendar Year cannot also be taken into account in
order to calculate the achievement of additional sales threshold
milestone(s) in that same calendar year. [Milestone payments and amounts of Net Sales
omitted as competitively sensitive
information.]
EDESA
shall use commercially reasonable efforts to file an IND for the
Products within the Field within [_________] ([__]) years of the
Effective Date (the “Filing
Period”). In the event EDESA fails to file such IND
within the Filing Period, it shall remit to LICENSOR a fixed
license fee in the amount of [__] US dollars (US$[__]) for each full Calendar Year
following the Filing Period within which such requirement to file
an IND for the Products within the Field remains unfulfilled (the
“Fixed License
Fee”). Such Fixed License Fee shall be paid within
sixty (60) days of the relevant anniversary of the Effective Date.
In the event the afore-said requirement remains unfulfilled after
the Filing Period during a relevant period that is less than a full
Calendar Year, the payment of such Fixed License Fee shall be
pro-rated accordingly. The payment of the Fixed License Fee shall
not derogate from EDESA’s obligations under this Agreement,
including without limitation, the obligations set forth in Section
3 above and further use of commercially reasonable efforts to file
an IND for the Products within the Field following the Filing
Period. [Number of years of Filing
Period and amount of Fixed License Fee omitted as competitively
sensitive information.]
During
the Term, EDESA shall pay to LICENSOR 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 LICENSOR 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. [Royalty percentages omitted as competitively
sensitive information.]
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 LICENSOR 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 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.
-12-
6.4
Audits.
(a)
EDESA will keep and
maintain (and to the extent applicable, will cause its Affiliates,
and their respective Sublicensees, 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, assignees and
transferees) to LICENSOR under this Agreement and for the purposes
of this Agreement.
(b)
Upon the written
request of LICENSOR 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 LICENSOR,
at LICENSOR’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)
LICENSOR shall
share the accounting firm’s final written report with EDESA
within thirty (30) days of its receipt by LICENSOR. If such
accounting firm identifies a discrepancy by EDESA made during such
period, EDESA shall pay LICENSOR the amount of the discrepancy
within thirty (30) days of the date LICENSOR 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 LICENSOR unless the underpayment
exceeded ten percent (10%) of the amount owed by EDESA to LICENSOR
for such Calendar Year, in which case, EDESA shall pay to LICENSOR
the reasonable fees charged by such accounting firm which fees
shall not exceed $25,000. EDESA shall pay interest on the amounts
owed to LICENSOR, 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 LICENSOR’s independent
accountant to the same extent required of EDESA under this
Agreement.
(e)
LICENSOR 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.
-13-
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 LICENSOR 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
VAT;
Tax Withholding.
All
amounts to be paid to LICENSOR pursuant to this Agreement are
exclusive of value added tax. EDESA shall add value added tax, if
any, to the extent required by law to all such amounts. If EDESA is
required to withhold any amounts payable hereunder to LICENSOR due
to the applicable laws of Canada, such amount will be deducted from
the payment to be made by EDESA and remitted to the appropriate
taxing authority for the benefit of LICENSOR. EDESA will withhold
only such amounts as are required to be withheld by applicable law
in Canada from which payment is being made. EDESA shall submit to
LICENSOR originals of the remittance voucher and the official
receipt evidencing the payment of the corresponding taxes with the
applicable royalty report. EDESA will cooperate with LICENSOR to
provide such information and records as LICENSOR may require in
connection with any application by LICENSOR to the tax authorities
in Canada or Israel, including attempt to obtain an exemption or a
credit for any withholding tax paid in Canada or Israel. It is
agreed that amounts payable by EDESA to LICENSOR pursuant to
section 6.1 and 6.2 hereof should be exempt based on Article
12(3)(b) of the DTAA, subject to LICENSOR providing a valid
certificate of residency from the Israeli tax authorities no less
than four (4) weeks prior to each applicable payment according to
which LICENSOR is an Israeli tax resident within the meaning of the
DTAA. EDESA shall notify LICENSOR in writing with respect to any
payment to be made by EDESA to LICENSOR under this Agreement a
reasonable time in advance (which shall be no less than four (4)
weeks), and in case that LICENSOR request to delay any payment in
order to provide the valid certificate of residency from the
Israeli tax authorities as aforesaid, then the interest payment
pursuant to Section 6.7 below shall not accrue for such
delay.
6.7
Late
Payments.
EDESA
shall pay interest to LICENSOR 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
Subject
to the terms and conditions of this Agreement, LICENSOR 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. For greater certainty, LICENSOR shall
retain the right to use the Licensed Technology in the Territory in
connection with the activities of LICENSOR or its Affiliates that
are unrelated to the Development and Commercialization of the
Product in the Field.
-14-
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.
ARTICLE 8
(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 forth herein without the
prior written consent of the disclosing Party, until [_____] ([__])
years following the Term of this Agreement, except to the extent
that such Information: [Length of
non-disclosure obligations omitted as competitively sensitive
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
Information of both Parties.
(b)
Each Party may
disclose Confidential Information 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:
-15-
(i)
need to know such
Confidential Information to assist the Party in fulfilling its
obligations hereunder; 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, and shall be liable to the
other Party for any breach of this Article 8 caused by any of the
aforesaid, as applicable.
(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,
stock exchange 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 LICENSOR's Confidential
Information, without the LICENSOR'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,
or seeking or obtaining consent from a participant in a Clinical
Trial. 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.
At its sole
discretion, EDESA may publicly disclose the execution and material
terms of this Agreement and, from time to time, milestones achieved
and activities conducted hereunder. No disclosure of the existence
of, or the terms of, this Agreement or activities conducted
hereunder, may be made by LICENSOR without the prior express
written permission by EDESA. However, that no approval of EDESA
shall be required if a subsequent public disclosure solely
discloses the information that: (1) 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 EMA generally has occurred
(provided, however, that specific dates of filing shall not be
disclosed); (3) commercial launch of the Product in any country, or
(4) any information that has previously been approved and disclosed
as permitted by this Section 8.2. 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 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 governmental agency
or applicable stock exchange on which a Party’s stock may be
listed.
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 terms
of this Agreement confidential under terms of confidentiality and
non-use substantially similar to the terms contained in this
Agreement and to use such Confidential Information solely for the
purpose permitted pursuant to this Section
8.2(c).
ARTICLE 9
9.1
Representations
and Warranties of LICENSOR.
LICENSOR
represents and warrants to EDESA that as of the Effective
Date:
(a)
LICENSOR 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 do not
materially conflict with, violate, or breach or constitute a
default under any material contractual obligation or court or
administrative order by which LICENSOR is bound;
(b)
there are no legal
claims, judgments or settlements against or owed by LICENSOR or to
the Knowledge of LICENSOR, pending legal claims or litigation, in
each case relating to the Product, the LICENSOR or Licensed
Technology;
(c)
all necessary
consents, approvals and authorizations of all government
authorities and other persons required to be obtained by LICENSOR
as of the Effective Date in connection with the execution, delivery
and performance of this Agreement have been obtained;
(d)
LICENSOR is the
exclusive legal and beneficial owner of the Patents listed in
Appendix A.
(e)
LICENSOR Controls
the right, title and interest in and to the Licensed Technology
that it purports to Control, 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;
-17-
(f)
there is no action,
suit, inquiry, investigation or other proceeding ongoing, or to the
Knowledge of LICENSOR, threatened or pending, 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 LICENSOR becomes aware of any such action or proceeding,
it shall promptly notify EDESA in writing;
(g)
to the Knowledge of
LICENSOR, the use of the Licensed Technology or the Development
and/or Commercialization of the Product will not infringe or
misappropriate the intellectual property or intellectual property
rights of any Third Party;
(h)
LICENSOR 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 LICENSOR 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)
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 LICENSOR to be incorrect or untrue;
(d)
to the Knowledge of
EDESA, neither EDESA nor any of its Affiliates, nor any of its
employees or agents (i) is debarred, excluded, suspended, proposed
for debarment or otherwise ineligible for participation in any
federal, state or provincial health care program; (ii) has been
convicted of or had a civil judgment rendered against it for
commission of fraud or a criminal offense; and (iii) is presently
indicted for or otherwise criminally or civilly charged by a
governmental entity or agency with commission of any of the
offenses set out in this paragraph;
9.3
Representations
and Covenants of Both Parties.
Each
Party shall, and shall cause its Affiliates and agents to, comply
with Applicable Laws, 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.
-18-
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, 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.
(b)
LICENSOR MAKES NO
EXPRESS OR IMPLIED WARRANTIES THAT ANY FREEDOM TO OPERATE (FTO)
SEARCH WAS MADE OR CONDUCTED BY OR ON BEHALF OF LICENSOR IN
RELATION TO ANY AND ALL PATENTS. IN ADDITION, NOTHING IN THIS
AGREEMENT MAY BE DEEMED A REPRESENTATION OR WARRANTY BY LICENSOR 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. LICENSOR 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. EXCEPT AS EXPRESSLY STATED IN THIS
AGREEMENT, TO THE EXTENT PERMITTED BY APPLICABLE LAW, NEITHER
LICENSOR, NOR THE REPRESENTATIVES OF LICENSOR 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 EDESA OR ANY OTHER PERSON OR
ENTITY, DIRECTLY OR INDIRECTLY ARISING OUT OF OR IN CONNECTION WITH
OR RESULTING FROM THIS AGREEMENT AND/OR THE 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 (iii) ANY
ADVERTISING OR OTHER PROMOTIONAL ACTIVITIES WITH RESPECT TO ANY OF
THE FOREGOING.
ARTICLE 10
EDESA
shall indemnify and hold harmless LICENSOR and its Affiliates
(individually and collectively, the “LICENSOR 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.
-19-
10.2
Defense.
If any
such claims or actions are made, the LICENSOR Indemnitee shall be
defended at EDESA's sole expense by counsel selected by EDESA and reasonably acceptable to
the LICENSOR Indemnitee, provided that the LICENSOR 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.
10.3
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 LICENSOR Indemnitee but without the consent of the
LICENSOR 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 LICENSOR
Indemnitee, such consent not to be unreasonably
withheld.
10.4
Notice.
The
LICENSOR Indemnitee shall notify EDESA promptly of any claim,
demand, action or other proceeding under Section 10.1 and
shall reasonably cooperate with all reasonable requests of EDESA
with respect thereto.
10.5
Permission
by EDESA.
The
LICENSOR 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.
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 10.6
IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE DAMAGES AVAILABLE FOR
EITHER PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS IN
Article 8.
10.7
Insurance.
EDESA
shall maintain in good standing throughout the Term 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 LICENSOR
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.
-20-
ARTICLE 11
11.1
Ownership
of Intellectual Property.
As
between the Parties, LICENSOR 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 LICENSOR's name, and may elect to file
applications for such other patents as ▇▇▇▇▇ ▇▇▇▇▇ necessary to
protect the Licensed Technology (“Patent Management”). EDESA will
(a) provide to LICENSOR all material information and documents
received, prepared or filed in connection with the Patents, (ii)
consult with LICENSOR before taking any substantive actions related
to the Patent Management and (iii) consider all comments and
changes suggested by LICENSOR 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
LICENSOR and LICENSOR will then have the right, at 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, LICENSOR will, at 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
EDESA
shall be responsible for all costs associated with the Patent
Management of the Patents listed in Appendices A as of the
Effective Date.
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,
to institute and direct legal proceedings against any Third Party
believed to be infringing or misappropriating or otherwise
violating the Licensed Technology. LICENSOR 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 LICENSOR’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,
after deduction of EDESA’s costs and expenses of legal
proceedings, 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 does not
directly commercialize the Product and treated as Net Sales in any
country in the Territory that EDESA commercializes the Product upon
which Royalties will be paid to LICENSOR.
-21-
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 property rights of such Third Party. Such notice shall
be provided promptly, but in no event after more than forty 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 assert 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 LICENSOR shall assume the primary
responsibility for the conduct of the defense of any other such
claim, at LICENSOR’s expense. Notwithstanding the foregoing,
LICENSOR 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 Party’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.
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 undertaken by
a Party without the consent of the other Party which consent shall
not be unreasonably withheld or delayed.
-22-
ARTICLE 12
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; or (b) the date that is
fifteen (15) years after the First Commercial Sale in such country,
whichever is last to occur, unless terminated earlier in accordance
with this Agreement (the “Term”).
(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 property; or (vi) admits
in writing of its inability to pay its debts generally as they
become due.
(c)
Failure to Develop or Commercialize. If
LICENSOR alleges that EDESA has failed to use commercially
reasonable efforts to Develop or Commercialize the Product,
LICENSOR shall notify EDESA of its intention to terminate this
Agreement. EDESA shall have three hundred and sixty days (360) from
receipt of notification from LICENSOR to demonstrate and satisfy
LICENSOR that commercially reasonable efforts are being used by
EDESA to Develop and Commercialize the Product, and if EDESA fails
to demonstrate and satisfy LICENSOR that commercially reasonable
efforts are being used by EDESA to Develop and Commercialize the
Product, then LICENSOR may terminate this Agreement.
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.
(a)
Upon the
termination of this Agreement, then:
-23-
(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 incurred 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 to LICENSOR, upon LICENSOR’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
LICENSOR 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.
(iv)
For the avoidance
of doubt, the Parties acknowledge and agree that neither the
termination of this Agreement for any reason nor the assignment
contemplated by Section 12.4(a)(iii) will derogate from the force
and effect of, or otherwise limit EDESA rights under, the Exclusive
License Agreement entered into by EDESA and Yissum Research
Development Company of the Hebrew University of Jerusalem dated
June 29, 2016, as amended by the First Amendment to the Exclusive
License Agreement dated April 3, 2017 and the Second Amendment to
the Exclusive License Agreement dated May 7, 2017.
(v)
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 part (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
irrevocable grant by EDESA to LICENSOR, 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. To the extent
permitted by applicable law, such license will be exclusive.
Notwithstanding anything to the contrary in Section 8 or elsewhere
in this Agreement, LICENSOR (on its own or via third parties) shall
be entitled to freely exploit the EDESA Assigned IP without any
obligation of confidentiality to EDESA.
-24-
(vi)
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 LICENSOR hereunder based on such
sales.
Following any
termination of this Agreement by LICENSOR, LICENSOR shall pay to
EDESA [__] percent ([__]%) of the amounts received by LICENSOR or
its Affiliates as royalties or sublicensing fees arising from the
license of the EDESA Assigned
IP 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 order to generate the EDESA
Assigned IP as certified by external independent auditors agreed
upon by the Parties, less any amounts received or receivable by
EDESA from Third Parties in connection with the Licensed Technology
or the EDESA Assigned IP prior to the transfer of the EDESA
Assigned IP to EDESA. In furtherance of EDESA’s right under
this Section 12.4(vi), LICENSOR shall provide prompt notice
to EDESA upon the Commercialization of any products incorporating
the EDESA Assigned IP by LICENSOR or its Affiliate and upon
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 net sales of any products incorporating the EDESA
Assigned IP and any the royalties and sublicensing fees received by
LICENSOR 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 LICENSOR on the date such report
is due. LICENSOR shall keep complete and accurate records in
sufficient detail to enable the revenue sharing payments payable by
LICENSOR and its Affiliates and the royalties and sublicensing fees
received by LICENSOR 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(vii): (x) the term
“net sales” shall have the same meaning as set forth on
this Agreement, but replacing references to “EDESA”
with “LICENSOR” and “Product” with
“products incorporating the EDESA Assigned IP”; (y) the
term “sublicensing fees” in relation to amounts
received from Third Parties shall have the same meanings as are set
forth in this Agreement, but replacing references to
“EDESA” with “LICENSOR” and
“Product” with “products incorporating the EDESA
Assigned IP”. [Percentage
omitted as competitively sensitive
information.]
-25-
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, 11.1, 12.4 and 13.
ARTICLE 13
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, pandemics, epidemics
or other viral outbreaks, governmental decisions, requests,
restrictions (including restrictions on travel and movement of
goods), or omissions or delays in acting by any governmental
authority or the other Party. The affected Party shall notify the
other Party of such force majeure circumstances as soon as
reasonably practical, and shall promptly undertake reasonable
efforts necessary to mitigate such force majeure
circumstances.
13.2
Assignment.
No
Party may assign its rights or obligations under this Agreement
without prior written consent of the other Party, which consent
shall not be unreasonably denied, conditioned or delayed, except:
(i) 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,
(ii) by LICENSOR to a successor in interest in connection with
Section 13.3 below, and (iii) that EDESA shall be entitled to
assign its rights and obligations under this Agreement to a wholly
owned subsidiary of EDESA (the “Subsidiary”) without requiring to
obtain the prior written consent of LICENSOR, provided, however, that in the event of such
assignment (a) the Subsidiary shall undertake in writing to be
bound by all the terms and conditions of this Agreement, and (b)
any such assignment shall not derogate from EDESA’s
obligations which have accrued prior to the date of such
assignment; provided, that,
in the event of any assignment by EDESA, LICENSOR shall not, as a
result of such assignment, be subject to any additional financial
or legal obligation that would not have applied to LICENSOR but for
such assignment, including without limitation, any additional tax,
impost, fee or deduction on payments (except for taxes withheld in
accordance with Section 6.6 above) made to LICENSOR pursuant to
this Agreement.
13.3
Successors
and Assigns.
Except
as otherwise expressly stated to the contrary herein, the
provisions hereof shall inure to the benefit of, and be binding
upon, heirs, executors, and administrators of the parties hereto
and their respective successors and assigns.
-26-
13.4
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.
13.5
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 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
LICENSOR, to:
|
▇▇.
▇▇▇▇ ▇▇▇▇▇▇
[_______]
Email:
|
|
with a
copy (which shall not constitute notice) to:
|
Attn:
Adv. ▇▇▇▇▇ ▇▇▇▇
Email:
|
|
if to
EDESA, to:
|
Edesa
Biotech Inc.
Attn:
President
▇▇▇ ▇▇▇
▇▇▇▇▇
▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇
▇▇▇
▇▇▇
Email:
|
|
with a
copy (which shall not constitute notice) to:
|
Attn:
▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Email:
|
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.
[Personal information
omitted.]
-27-
13.6
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, except that questions affecting the construction
and effect of any patent shall be determined by the law of the
country in which the patent shall have been granted (other than for
matters of inventorship on patents). For controversies, claims and
disputes not covered by the arbitration provisions pursuant to
Section 13.15, 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 Parties
irrevocably and unconditionally: (a) consent to the exclusive
jurisdiction of the courts of England, located in London for any
action, suit or proceeding, 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.
13.7
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. This Agreement may be amended, or any term hereof
modified, only by a written instrument duly executed by authorized
representatives of both Parties.
13.8
Independent
Contractors.
The
Parties shall be independent contractors and the relationship
between the Parties shall not constitute a partnership, 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.
13.9
Waiver.
The
waiver by either Party 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.
13.10
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.
13.11
Waiver
of Rule of Construction.
Each
Party has had the opportunity to consult with legal counsel in
connection with the review, drafting and negotiation of this
Agreement. Accordingly, the rule of construction that any ambiguity
in this Agreement shall be construed against the drafting Party
shall not apply.
-28-
13.12
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 Party 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
Party shall use its commercially reasonable efforts 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.
13.13
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 term. References to “Section” or
“Sections” are references to the numbered sections of
this Agreement, unless expressly stated otherwise.
13.14
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.
(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 13.15 is not
intended to alter the rights of the Parties as established by
Section 13.6, 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.
-29-
(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.
(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 Information to 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 judgment
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 expert 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 100% of such fees and
expenses.
(ii)
If the arbitrators
rule in favour of one Party on some issues and the other Party on
other issues, the arbitrators shall issue with the ruling a written
determination as to 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.
-30-
(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 to Canadian, United States, English, Israeli or
other courts, 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.
13.16
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.
13.17
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.
13.18
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]
-31-
The
Parties have executed this Agreement as of the Effective
Date.
|
|
|
▇▇▇▇ ▇▇▇▇▇▇
|
||
|
|
|
|
By:
|
s/ ▇▇▇▇
▇▇▇▇▇▇
|
|
|
|
|
|
Name: ▇▇▇▇
▇▇▇▇▇▇
Title: Licensor
|
|
|
|
|
By:
|
|
|
|
|
|
|
Name:
Title:
|
|
|
|
EDESA BIOTECH RESEARCH INC.
|
||
|
|
|
|
By:
|
/s/
▇▇▇▇▇▇▇ Njihawan
|
|
|
|
|
|
Name: ▇▇.
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Title: Chief
Executive Officer
|
|
|
|
|
By:
|
|
|
|
|
|
|
Name:
Title:
|
-32-
Appendix
A
(Patents)
[______________]
[List of Patents, including countries, owners, patent or application
numbers, status and expiration dates, omitted as competitively
sensitive information.]