SIF
AGREEMENT NO. 811-513437
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.
STRATEGIC INNOVATION FUND
This Agreement made
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Between:
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HER MAJESTY THE QUEEN IN RIGHT OF CANADA (“Her
Majesty”)
as
represented by the Minister of Industry
(the
“Minister”)
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And:
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Edesa
Biotech Research, Inc., a corporation duly incorporated under the
laws of Ontario, having
its head office located at 100 Spy Court, Markham, Ontario L3R
5H6
(the
“Recipient”)
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And:
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Edesa
Biotech, Inc., a corporation duly incorporated under the laws
of British Colombia,
having its head office located at 100 Spy Court, Markham, Ontario
L3R 5H6
(the
“Guarantor”)
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RECITALS
WHEREAS
I-
The Strategic
Innovation Fund (“SIF”) is designed to encourage
research and development, and accelerate the technology transfer
and commercialization of innovative products, services, and
processes; facilitate the growth and expansion of firms; secure
economically significant mandates within or to Canada; and, advance
industrial research and technology demonstration activities through
collaboration;
SIF
AGREEMENT NO. 811-513437
II-
Neither the
entering into this Agreement nor the provision by the Minister of
the Contribution is contingent upon export performance on the part
of the Recipient;
III-
The Project is in
respect to SIF’s research and development (R&D) and
commercialization Stream 1, and involves:
●
activities related
to the creation or deployment of medical countermeasures
(MCM’s), or any activity related to the response to
COVID-19;
●
activities
related to Canada’s long-term emergency preparedness;
and
●
obtaining
an R&D and/or production mandate which was previously held
outside of Canada or is being established for the first time in
relation to Canada’s emergency preparedness.
IV-
The Minister has
agreed to make a non-repayable contribution to the Recipient in
support of the Recipient’s Eligible Supported Costs (as
defined herein) of the Project with total Project costs of eighteen
million, seven hundred and thirty-eight thousand dollars
($18,738,000).
NOW, THEREFORE in
accordance with the mutual covenants and agreements herein, Her
Majesty and the Recipient agree as follows:
1.
Purpose of the Agreement
The
purpose of this Agreement is to set out respective obligations and
the terms and conditions under which the Minister will provide
funding in support of the Project (as defined herein).
In this
Agreement, a capitalized term has the meaning given to it in this
section, unless otherwise specified:
“Acquisition
or Divestiture” means an acquisition of a business,
the sale of a business or a merger or amalgamation.
“Activity”
means a significant task that must take place in order to complete
the Project. It has duration, during which time the work of that
task is performed, and may have resources and costs associated with
that task as set out in Form C1- PROJECT COSTS BREAKDOWN of
Schedule 1 - Statement of
Work.
SIF
AGREEMENT NO. 811-513437
“Affiliated
Person” means an affiliated person as defined in the
Income Tax Act, as
amended.
“Agreement”
means this contribution agreement including all the schedules
attached hereto, as such may be amended, restated or supplemented,
from time to time.
“Background
Intellectual Property” means Intellectual Property
that is not Project Intellectual Property and that is required for
the carrying out of the Project or the exploitation of the Project
Intellectual Property.
“Background Intellectual
Property Rights” means the Intellectual Property Rights in
Background Intellectual Property.
“Benefits
Commitments” means those activities described in
Subsection 6.3 of this Agreement that will generate benefits to
Canada.
“Benefits
Phase” means the period from the Project Completion Date
to and including the last day of the Term.
“Change
in Control” of the Recipient means:
(a)
if the Recipient is
a public company, the acquisition by an individual or company (or
two or more of them acting in concert) that results in its or their
direct or indirect beneficial ownership of 20% or more of
outstanding shares of voting stock of the Recipient;
or
(b)
if the Recipient is
a private company, the acquisition by an individual or company (or
two or more of them acting in concert) that results in its or their
direct or indirect beneficial ownership of 50% or more of the
voting stock in the Recipient; or
(c)
if the Recipient
enters into a binding obligation to sell, sells or otherwise
disposes of all or substantially all of its assets.
“Claim
Period” means the following quarters of a calendar
year: January 1 to March 31, April 1 to June 30, July 1 to
September 30 and October 1 to December 31.
“Collaboration”
means the Recipient’s association with one or more
Collaboration Partners for the purpose of research and
development.
“Collaboration
Partner” means, other
than the Recipient and sub-contractors, any small and medium-sized
Canadian based enterprise, any Canadian research institute, any
licensed or accredited academic, post-secondary institution in
Canada that is/are involved in the
Collaboration.
SIF
AGREEMENT NO. 811-513437
“Contribution” means
the funding, in Canadian dollars, made available by the Minister
under this Agreement.
“CO-OP Term” means a four (4) month full-time
position.
“Dispose” means,
as regards a Project Asset, the transferring outside Canada,
selling, leasing or otherwise disposing including, in the case of a
prototype or pilot plant, the transfer to commercial production,
but in any event, shall not include abandoning the Project Asset
for legitimate business reasons, such as the disposal of obsolete
or disused equipment or materials.
“Eligibility
Date” means [______]. [Eligibility date omitted as competitively
sensitive information.]
“Eligible
Costs” means the costs associated with work performed
in Canada, or outside of Canada to the extent explicitly permitted
in this Agreement that are incurred and paid by the Recipient in
respect of the Project, and in accordance with Schedule 3 -
Cost Principles, excluding
any costs prohibited or deemed ineligible elsewhere in this
Agreement.
“Eligible
Not-Supported
Costs” means those Eligible Costs that
are specifically identified in Schedule 1 - Statement of Work as not being
supported, including those Eligible Costs that are in excess of
limits imposed on indirect (overhead) costs under Schedule 3
– Cost Principles of
this Agreement.
“Eligible
Supported Costs” means any Eligible Costs, excluding
Eligible Not-Supported Costs.
“Event
of Default”
means the events of default listed in Subsection 14.1 of this
Agreement.
“Execution
Date” means the date of the last signature to this
Agreement such that the Agreement is signed and dated by all
Parties.
“Fair
Market Value” means the price that would be agreed to
in an open and unrestricted market between knowledgeable and
willing parties dealing at arm’s length, who are fully
informed and not under any compulsion to transact.
“Force
Majeure” means any cause which is unavoidable or
beyond the reasonable control of the Recipient, including war,
riot, insurrection, strikes, or any act of God or other similar
circumstance and which could not have been reasonably circumvented
by the Recipient without incurring unreasonable cost.
“FTE” or “Full Time Equivalent” means
each employee or, where applicable, intern, who works for the
Recipient on a full-time basis (i.e. they are responsible to work
at least 2,000 hours for the Recipient when calculated on an annual
basis) and, in the case of hourly paid employees or interns who are
responsible to work for the Recipient less than on a full-time
basis, each equivalent to such a full-time worker, where the number
of such equivalents is calculated by dividing (a) by (b) where (a)
= the aggregate of all hours worked by such individuals for the
Recipient including hours taken by them as paid vacation, sick
leave, and for other similar reasons, calculated on an annual
basis, and (b) = 2,000 hours.
SIF
AGREEMENT NO. 811-513437
“Government
Fiscal Year” means the period from April 1 of one year
to March 31 of the following year.
“Highly Skilled” means an employee that requires
specialized training in order to operate, manage or participate in
the Project. This may include scientists, engineers, managers and
specialized trades.
“Intellectual
Property” means all inventions, whether or not patented or
patentable, all commercial and technical information, whether or
not constituting trade secrets, and all copyrightable works,
industrial designs, integrated circuit topographies, and
distinguishing marks or guises, whether or not registered or
registrable.
“Intellectual Property
Rights” means
all rights recognized by law in or to Intellectual Property,
including but not limited to Intellectual Property rights protected
through legislation. These shall include patents, copyrights,
industrial design rights, integrated circuit topography rights,
rights in trademarks and trade names, all rights in applications
and registrations for any of the foregoing, and all rights in trade
secrets and confidential information.
“Interest
Rate” means the Bank Rate, as defined in the
Interest and Administrative
Charges Regulations, in effect on the due date, plus 300
basis points, compounded monthly. The Interest Rate for a given
month can be found at:
http://www.tpsgc-pwgsc.gc.ca/recgen/txt/taux-rates-eng.html
“Master
Schedule” means a summary-level Project schedule that
identifies the major Activities and work breakdown structure
components and Milestones as reflected in Form A – MASTER
SCHEDULE (Gantt Chart) of Schedule 1 - Statement of Work.
“Material
Change” is a significant change in the scope,
objectives, outcomes or benefits of the Project including without
limitation, the following:
(a)
The Project is not
completed or not expected to be completed by the Project Completion
Date;
(b)
the estimated Total
Eligible Supported Costs set out in Form C2 – ESTIMATED COST
BREAKDOWN BY FISCAL YEAR of Schedule 1 – Statement of Work are expected to be
reduced or are expected to be exceeded by twenty percent (20%) or
more;
(c)
a change in the
locations where the Project is to be performed as identified in
Form D – PROJECT LOCATION AND COSTS of Schedule 1 –
Statement of
Work.
SIF
AGREEMENT NO. 811-513437
“Milestone” means
a significant point or event in the Project as set forth in Form B
- MILESTONES of Schedule 1 - Statement of Work.
“Party”
means the Minister, or the Recipient or any Guarantor, and
“Parties” means
all of them.
“Project” means
the project as described in Schedule 1 - Statement of Work.
“Project
Asset” means an asset which, in whole or in part, has
been acquired, created, developed, advanced and/or contributed to
by the Contribution.
“Project
Completion Date” means [______]. [Project completion date omitted as
competitively sensitive information.]
“Project
Intellectual Property” means all Intellectual Property conceived, produced,
developed or reduced to practice in
carrying out the Project by the Recipient and/or any Affiliated Persons of the Recipient, or
any of their employees, agents,
contractors or assigns.
“Project
Intellectual Property Rights” means the Intellectual
Property Rights in the Project Intellectual Property.
“Public
Office Holder” means a public office holder as defined
in the Lobbying Act, as
amended.
“Recipient Fiscal Year” means the period for
which the Recipient’s accounts in respect of its business or
property are prepared for purposes of assessment under the
Income Tax Act, as
amended.
“Resulting
Products” means all products, services or processes
that:
a.
are produced using
the Project Intellectual Property;
b.
incorporate any of
the Project Intellectual Property; or
c.
result from or are
used to carry out the Project.
“Schedule”
means a schedule to this Agreement, including any amendments or
supplements.
“Similar
Goods” means goods or services that closely resemble
the goods or services being transferred, in respect of their
component materials, form, function and characteristics, and are
capable of performing an equivalent function as, and of being
commercially interchangeable with, the goods being
transferred.
“Technology
Readiness Level” or “TRL” means technology readiness
according to the Technology Readiness Level scale described
below.
SIF
AGREEMENT NO. 811-513437
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Technology Readiness Level
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Description
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TRL 1—Basic principles observed and reported
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Lowest level of technology readiness. Scientific research begins to
be translated into applied research and development (R&D).
Examples might include paper studies of a technology's basic
properties.
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TRL 2—Technology concept and/or application
formulated
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Invention begins. Once basic principles are observed, practical
applications can be invented. Applications are speculative, and
there may be no proof or detailed analysis to support the
assumptions.
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TRL 3—Analytical and experimental critical
function
and/or characteristic proofof concept
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Active R&D is initiated. This includes analytical studies and
laboratory studies to physically validate the analytical
predictions of separate elements of the technology.
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TRL 4—Product and/or process validation in
laboratory environment
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Basic technological products and/or processes are tested to
establish that they will work.
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TRL 5—Product and/or process validation in
relevant environment
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Reliability of product and/or process innovation increases
significantly. The basic products and/or processes are integrated
so they can be tested in a simulated environment.
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TRL 6—Product and/or process prototype demonstration
in
a relevant environment
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Prototypes are tested in a relevant environment. Represents a major
step up in a technology's demonstrated readiness. Examples include
testing a prototype in a simulated operational
environment.
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TRL 7—Product and/or process prototype demonstration
in
an operational environment
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Prototype near or at planned operational system and requires
demonstration of an actual prototype in an operational environment
(e.g. in a vehicle).
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TRL 8—Actual product and/or process completed and
qualified
through test and demonstration
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Innovation has been proven to work in its final form and under
expected conditions. In almost all cases, this TRL represents the
end of true system development.
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TRL 9—Actual product and/or process proven
successful
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Actual application of the product and/or process innovation in its
final form or function.
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SIF
AGREEMENT NO. 811-513437
“Term”
means the duration of this Agreement as set out in Subsection 3.2
of this Agreement.
“Work
Phase” means the period of time from the
Eligibility Date to and including the Project Completion
Date.
2.2
Singular/Plural. Wherever from the
context it appears appropriate, each term stated in either the
singular or plural shall include the singular and the
plural.
2.3
Entire Agreement. Unless amended in
writing by the Parties, this Agreement comprises the entire
agreement between the Parties in relation to the Project. No prior
document, negotiation, provision, undertaking or agreement in
relation to the subject matter of this Agreement has legal effect.
No representation or warranty, whether express, implied or
otherwise, has been made by the Minister to the Recipient, except
as expressly set out in this Agreement.
2.4
Inconsistency. In case of inconsistency
or conflict between a provision contained in the part of the
Agreement preceding the signatures and a provision contained in any
of the Schedules to this Agreement, the provision contained in the
part of the Agreement preceding the signatures will
prevail.
2.5
Schedules. This Agreement contains the
following Schedules as described below, whichform an integral part
of this Agreement:
Schedule 1 -
Statement of
Work
Schedule 2 -
Communications
Obligations
Schedule 3 -
Cost
Principles
Schedule 4 -
Reporting
Requirements
Schedule 5 -
Resolution
Process
3.1
Execution. This Agreement must be signed
by the Recipient and received by the Minister within thirty (30)
days of its signature by the Minister, failing which it will be
null and void.
3.2
Duration of Agreement. This Agreement
will commence on the Execution Date and will expire, subject to
Subsection 3.3, [______] years following the Project Completion
Date unless terminated earlier in accordance with the terms of this
Agreement. [Expiration date omitted as competitively
sensitive information.]
3.3
Survival Period. Notwithstanding the
provisions of Subsection 3.2 above, the rights and obligations
described in the following Sections or Subsections will survive for
a period of three (3) years beyond the Term or early termination of
the Agreement:
SIF
AGREEMENT NO. 811-513437
Section
7 - Government Funding
Subsection 8.5 -
Overpayment by Minister
Section
9 - Reporting, Monitoring, Audit and Evaluation
Subsection 10.2(d)
- Disposal of Assets
Subsection 13.1 -
Indemnification
Subsection 13.2 -
Limitation of Liability
Section
14 - Default and Remedies
Subsection 17.2 -
Interest
Subsection 17.3 -
Set-off Rights of Minister
Subsection 17.8 -
Applicable Law
4.1
Contribution. Subject to the terms and
conditions of this Agreement, the Minister agrees to make a
non-repayable Contribution to the Recipient in respect of the
Project in an amount not exceeding the lesser of (a) and (b) as
follows:
(a)
seventy-five
percent (75%) of the Eligible Supported Costs; and
(b)
fourteen million
fifty-three thousand and five hundred dollars
($14,053,500).
4.2
Funding Period. The Minister will not
contribute to any Eligible Supported Costs incurred by the
Recipient prior to the Eligibility Date or after the Project
Completion Date. In no
event will Eligible Supported Costs incurred prior to the Execution
Date exceed [______] percent ([______]%) of the “estimated Total
Eligible Supported Costs” set out in Form C2 - ESTIMATED COST BREAKDOWN BY FISCAL
YEAR of Schedule 1 - Statement of
Work. [Percentage of estimated Total Eligible
Supported Costs omitted as competitively sensitive
information.]
4.3
Fiscal Year. The payment of the Contribution per Government
Fiscal Year is estimated at amounts specified in Form C2
- ESTIMATED COST BREAKDOWN
BY FISCAL YEAR of Schedule 1 -
Statement of
Work. The Minister will have no
obligation to pay any amounts in any Government Fiscal Year other
than those specified in Form C2 - ESTIMATED COST BREAKDOWN BY FISCAL
YEAR of Schedule 1 -
Statement of
Work. If, for a given
Government Fiscal Year, the Recipient claims an amount less than
the estimated Contribution for
that Government Fiscal Year specified
in Form C2 -
ESTIMATED COST BREAKDOWN BY FISCAL YEAR of Schedule 1 - Statement of Work, the
Minister may consider any request to reprofile the excess funds to
future Government Fiscal Years before the Project Completion
Date.
4.4
Overruns. The Recipient shall be
responsible for all costs of the Project, including costoverruns,
if any.
4.5
Holdbacks. Notwithstanding any other
provisions of this Agreement, the Minister may, at the Minister's
sole discretion, withhold up to ten percent (10%) of the
Contribution until:
(a)
the Project is
completed to the satisfaction of the Minister;
SIF
AGREEMENT NO. 811-513437
(b)
the final report
described in Subsection 8.3(c) has been submitted to
thesatisfaction of the Minister;
(c)
the Minister has
approved the final claim described in Subsection 8.3.
5.
Recipient’s Obligations
5.1
Project Completion Date. The Recipient
agrees to carry out the Project in a diligent and professional
manner using qualified personnel, and complete same on or before
the Project Completion Date.
5.2
Project Location. Except as otherwise
permitted in Subsection 6.4 below, the Recipient agrees to carry
out the Project exclusively in Canada located in Toronto and the
Greater Toronto Area, Ontario, and Montreal, Quebec.
5.3
Benefits Commitments. The Recipient
agrees to conduct Benefits Commitments exclusively in Canada, as
per Subsection 6.3.
5.4
Compliance. The Recipient agrees to
satisfy and comply with all other terms, conditions and obligations
contained in this Agreement.
The
Recipient covenants and agrees to the following:
(a)
Guarantee. In consideration of the
Minister providing the Contribution, the Guarantor guarantees the
complete performance and fulfillment of every obligation of the
Recipient under this Agreement, including without limitation, the
completion of the Project in accordance with this Agreement. If the
Recipient fails to perform or otherwise satisfy any of its
obligations related to the Agreement, immediately after receiving a
written demand from the Minister, the Guarantor must perform or
satisfy, or arrange for the performance or satisfaction of, all
outstanding obligations of the Recipient. The Guarantor’s
obligations under this Guarantee are as a primary obligor and not
only as a surety. The Minister is not required to resort to or
exhaust any recourse that it may have against the Recipient or any
other person before being entitled to make claim against the
Guarantor. As a result of the forgoing, the Guarantor or the
Recipient may be compelled separately to perform any obligation
contained in this Agreement.
(b)
Taxes. Any payment to be made by the
Guarantor in respect of this Agreement shall be made free and clear
of and without deduction or withholding for or on account of any
present and future taxes, levies, imposts, stamp taxes, duties,
charges, fees deductions, withholdings, penalties or interest
(collectively, “Taxes”) provided that if the Guarantor
is required to withhold or deduct any taxes from such payments, the
sum payable shall be increased as necessary so that after making
all required withholdings or deductions, the Minister receives an
amount equal to the sum he/she would have received had no such
withholding or deduction been made.
SIF
AGREEMENT NO. 811-513437
(c)
Costs. The Guarantor agrees to reimburse
the costs and expenses incurred by the Minister in enforcing the
guarantee under Paragraph 6.1(a).
(d)
Representations. The Guarantor
represents to the Minister that it has the power and authority, and
has met all legal requirements to grant the guarantee under
Paragraph 6.1(a) and that such guarantee is enforceable against it
in accordance with its terms.
The
Recipient covenants and agrees to the following:
6.2.1
(a)
First Claim. Upon submission of
the first claim, the Recipient shall provide evidence to the
Minister, to the Minister’s satisfaction, that it has
available funds to carry out the Project and continue operating for
the remainder of the Government Fiscal Year in which the claim is
received by the Minister, or for a period of six months from the
day the claim is received by the Minister, whichever is greater. No
disbursement of the Contribution shall be made prior to the
Recipient providing such satisfactory evidence. If the Recipient
fails to satisfy such condition within one hundred and twenty (120)
days of the receipt of the first claim, the Minister may, at his
discretion, terminate the Agreement upon written
notice.
(b)
Annual. At the beginning of each new
Government Fiscal Year during the Work Phase, the Recipient shall
provide evidence to the Minister, to the Minister’s
satisfaction, that it has available funds to carry out the Project
and continue operating for that Government Fiscal Year. No
disbursement of the Contribution shall be made prior to the
Recipient providing such satisfactory evidence. If the Recipient
fails to satisfy such condition within one hundred and twenty (120)
days of the beginning of each Government Fiscal Year, the Minister
may, at his discretion, terminate the Agreement upon written
notice.
6.2.2
[______]
Strategy. Prior to the first disbursement of
the Contribution, the Recipient shall develop a [______] plan that
will be shared with the Minister, to the Minister’s
satisfaction, that will outline all efforts undertaken by the
Recipient to [______] related to the Project. This plan should also
include [______] educational awareness training for employees. The
Recipient agrees to report annually on any changes to this plan
[______]. [Nature of strategy and
timeframe omitted as competitively sensitive
information.]
SIF
AGREEMENT NO. 811-513437
6.3
Benefits
Commitments.
6.3.1
Strengthen
Canada’s response to COVID-19
(a)
The Recipient
commits to work with [______] to ensure that any
treatment developed within the scope of this Project will be
accessible and available for the Canadian population on a timely
basis. [Name of party omitted as
competitively sensitive information.]
(b)
The Recipient will
[______] to
ensure that, once commercially available, the treatment will be
made available globally. [Nature
of action omitted as competitively sensitive
information.]
(c)
The Recipient
commits to work with [______] and other parties,
in good faith and [______], to increase
domestic and global affordability and access to Resulting Products,
in accordance with relevant guidance and policies published by the
World Health Organization and the United Nations. [Name of party and nature of commitment omitted
as competitively sensitive information.]
6.3.2
Create
and maintain highly-skilled jobs in Canada
(a)
The Recipient will
create at least six (6) FTEs in Canada [______] while maintaining
its existing eight (8) FTEs in Canada, totaling fourteen (14) FTEs
[______].
[Timeframe of creating FTEs
omitted as competitively sensitive
information.]
(b)
The Recipient will
maintain [______]
fourteen (14) FTEs [______]. [Timeframe and calculation of number of FTEs
omitted as competitively sensitive
information.]
(c)
The Recipient will
provide [______].
[Nature, timeframe and recipient
of information provided omitted as competitively sensitive
information.]
(d)
To contribute to
the development of tomorrow’s workforce, the Recipient will
employ at least [______] ([______]) CO-OP Term position
in Canada [______]. [Minimum number of CO-OP Term positions in
Canada and timeframe omitted as competitively sensitive
information.]
6.3.3
Commitment
to [______]
(a)
The Recipient shall
implement a [______], which will
stipulate measurable goals and outcomes. The Recipient will report
to the Minister on progress achieved regarding its [______] on an annual basis
[______].
(b)
The Recipient will
work to increase [______] in Canada and will
report annually to the Minister on progress achieved during the
Term.
(c)
In addition to
[______], the
Recipient will commit to [______], during the
Term.
[Nature of commitments and timeframe omitted as
competitively sensitive information.]
SIF
AGREEMENT NO. 811-513437
6.4
Work
Outside of Canada
(a)
In consideration of
the Minister providing the Contribution, the Recipient may incur up
to [______]% of Eligible Supported Costs for work outside of Canada
which will be identified as foreign costs. Any costs over this
threshold will be considered ineligible and will not be subject to
claim.
[Percentage
of Eligible Supported Costs omitted as competitively sensitive
information.]
(b)
In addition to the
foreign costs allowed under Paragraph 6.4(a), up to [______]% of
Eligible Supported Costs may [______], as identified in Schedule 1
– Statement of Work.
Specifically, [______].
[Percentage
of Eligible Supported Costs and potential use of such costs omitted
as competitively sensitive information.]
(c)
The Recipient will
make best efforts to conduct all clinical trials in Canada unless
[______]. [Nature of exception omitted as competitively
sensitive information.]
6.5
Regulatory
approval for clinical trials
(a)
The Recipient must
demonstrate that it is securing the required regulatory approval
from Health Canada to undertake clinical trials as outlined within
Schedule 1 – Statement of
Work of the Project by providing the Minister, to his
satisfaction, with a copy of the following regulatory approval
documents within 30 days of receipt by the Recipient:
i.
Clinical Trials
Phase II: No Objection Letter (NOL) from Health Canada: This NOL
will be provided to the Minister no later than the [______]. For
clarity, Phase II trials include clinical trials to evaluate the
efficacy of the drug in patients with medical conditions to be
treated, diagnosed or prevented and to determine the side effects
and risks associated with the drug. [Timeline omitted as competitively sensitive
information.]
(b)
If at any time the
Recipient receives a Not Satisfactory Notice (NSN) from Health
Canada related to the Project, the Recipient will immediately
inform the Minister and the Minister may, at his discretion,
terminate the Agreement. Any Project costs incurred by the
Recipient after the date of the NSN will not be eligible for
reimbursement by the Minister.
6.6
Monitoring
progress of clinical trials
(a)
The Minister may
request that the Recipient provide copies of the pre-clinical and
clinical documents submitted to Health Canada within the Clinical
Trial Application (CTA) for Phase II.
SIF
AGREEMENT NO. 811-513437
(b)
The Recipient
acknowledges that the Minister may share, at his discretion, any of
the documentation listed above with governmental experts from the
Public Health Agency of Canada, the National Research Council,
Health Canada, the Canadian Institutes of Health Research, and
external advisors on the Minister’s Therapeutics Committee
for the purpose of validating progress related to the
Project.
6.7
Continued
engagement by [______]
(a)
[______]. This
subsection 6.7(a) constitutes an indication of intent only and
creates no liability or obligation of any nature whatsoever among
the Parties hereto with respect to [______].
(b)
[______]. This
subsection 6.7(b) constitutes an indication of intent only and
creates no liability or obligation of any nature whatsoever among
the Parties hereto with respect to [______].
[Nature of continued engagement omitted as
competitively sensitive
information.]
6.8
Annual
Benefits Reporting
(a)
In addition to
Schedule 4 - Reporting
Requirements, on an annual basis and for the Term, the
Recipient shall provide information identifying the Project’s
achievements relative to planned outcomes and benefits,
including:
i.
Number of
therapeutics and vaccines (doses) discovered, developed,
manufactured, and/or distributed;
ii.
Number of FTEs
created and maintained with average and range of salary
levels;
iii.
Market share
secured or captured;
iv.
Composition of
workforce, including diversity and gender
representation;
v.
Dollars spent on
gross Canadian R&D and gross global R&D;
vi.
Productivity
improvement levels;
vii.
Number and details
of post-secondary institution collaborations;
viii.
Number and
activities of CO-OP Term engagements; and
ix.
Training activities
of the workforce.
(b)
In addition to
Schedule 4 - Reporting
Requirements, on an annual basis and for the Term, the
Recipient shall provide information on the Project derived benefits
but not limited to information on:
i.
Number of
therapeutics and vaccines (doses) discovered, developed,
manufactured, and/or distributed;
ii.
Impact to the
growth of the Canadian supply chain;
iii.
New Intellectual
Property generated;
iv.
Licenses granted
without consent under Subsection 11.4.2;
v.
R&D and product
development levels as a function of revenue;
SIF
AGREEMENT NO. 811-513437
vi.
Details of
increased collaborations, including associated costs and
activities;
vii.
Efforts to reduce
environmental footprint and/or increase environmental
sustainability of the company;
viii.
Efforts to create
opportunities for [______] to scale and enter
the [______]
ecosystem;
ix.
Details of internal
Artificial Intelligence (AI) and Machine Learning (ML) applications
and processes; and
x.
Productivity
improvement levels.
[Nature of opportunities omitted as
competitively sensitive
information.]
6.9.
Amendment. The Recipient shall provide
written notice to the Minister of any changes which may have an
impact on Schedule 1 – Statement of Work or on the Benefits
Commitments in accordance with 6.3 of this Agreement. The Recipient
shall provide to the satisfaction of the Minister sufficient
written reasons to justify modifications to the Agreement. At the
Minister’s sole discretion, the Minister may request a formal
amendment to be executed by the Parties. The Parties agree to
negotiate in good faith such amendments. If, after following the
process in Schedule 5 – Resolution Process, failure to agree
will result in the Minister declaring an Event of Default in
accordance with 14.1 of this Agreement.
7.1
The Recipient
represents that the list below states all funding from federal,
provincial, territorial or municipal governments in Canada
(“Government Funding”), requested or received by the
Recipient or that the Recipient currently expects to request or
receive to cover any of the Eligible Supported Costs. The list
below excludes provincial and federal investment tax
credits.
|
Federal
|
$
14,053,500 (SIF)
|
|
|
$
[______]
|
|
Provincial
|
$
0
|
|
Territorial
|
$
0
|
|
Municipal
|
$
0
|
|
|
|
|
Total
|
$ [______]
|
[Portion
of the funding received by the Recipient from other agencies of the
federal government and total amount of government funding omitted
as competitively sensitive information.]
7.2
The Recipient shall
inform the Minister of any change to the amount of Government
Funding identified in Subsection 7.1. The Recipient shall also
inform the Minister of any provincial and federal investment tax
credits, received or expected to be received by the Recipient for
the Eligible Supported Costs. Such notice must be made promptly in
writing, and in any case not later than thirty (30) days following
any change. In the event of additional
Government Funding, the Minister will have the right to either
reduce the Contribution to the extent of any additional funding
received by the Recipient or require the Recipient to repay the
Contribution hereunder equal to the amount of any such additional
funding received by the Recipient in accordance with Subsection
8.5.
SIF
AGREEMENT NO. 811-513437
7.3
In no instance will
the total Government Funding (including SIF funding, provincial and
federal investment tax credits) towards Eligible Supported Costs of
the Project be allowed to exceed [______] percent ([______]%) of
total Eligible Supported Costs. [Percentage of total Eligible Supported Costs
omitted as competitively sensitive
information.]
8.1
Separate Records. The Recipient shall maintain
accounting records that account for the Contribution paid to the
Recipient and the related Project costs, separate and distinct from
any other sources of funding.
8.2
Claims Procedures. The Minister will
reimburse claims for Eligible Supported Costs submitted for a Claim
Period, provided there is no Event of Default and the claims
are:
(a)
submitted for each
Claim Period, except for the first claim which will start on the
Eligibility Date;
(b)
submitted within
forty-five (45) days of the end of each Claim Period;
(c)
accompanied with
details of all costs being claimed according to Schedule 3 –
Cost Principles, which have
been incurred by the Recipient and which will be substantiated by
such documents as may be required by the Minister and presented in
accordance with the Activities and the Milestones contained in
Schedule 1 - Statement of
Work;
(d)
certified, in a
form satisfactory to the Minister, by the chief financial officer
of the Recipient or such other person considered satisfactory to
the Minister;
(e)
adjusted, if
necessary, by including a deduction for expenses included in a
previous claim which were not eligible expenses according to
Eligible Supported Costs definition in this Agreement or which were
not paid by the Recipient;
(f)
accompanied by a
report containing:
(i)
the
Recipient’s revised projections of the Project cash flows for
the current Government Fiscal Year;
(ii)
an identification
of any planned or completed transfer to commercial production,
transfer outside of Canada, sale, lease or other disposal of
equipment funded in whole or in part by the
Contribution;
(iii)
an itemized list of
foreign sub-contracting costs, if any;
SIF
AGREEMENT NO. 811-513437
(iv)
the foreign
exchange rates used in the claim;
(v)
progress report as
specified in Subsection 1.2 of Schedule 4 - Reporting Requirements;
and
(vi)
such other
information as the Minister may request from time to
time.
(g)
accompanied by a
statement from the Recipient repeating and confirming the
representations set out in Section 10 of this Agreement as required
by Subsection 10.3, and a certification that there are no Events of
Defaults (and no state of facts exist which, with the giving of
notice or the passing of time, or both, would constitute an Event
of Default);
(h)
substantially
(± 20 percent (20%)) consistent with the cost estimates of
Schedule 1 - Statement of
Work; and
(i)
accompanied by the
Recipient’s travel policy (first claim only).
8.3
Final Claim Procedures. The Recipient
shall submit, within forty-five (45) days after the Project
Completion Date, the final claim along with:
(a)
an itemized
statement certified by the Recipient’s chief financial
officer, or such other person considered satisfactory to the
Minister, attesting to the total Eligible Supported Costs for the
Project incurred and paid;
(b)
a statement of the
total government funding (federal, provincial and municipal funding
as well as tax credits) received or requested to cover the Eligible
Supported Costs of the Project; and
(c)
a final progress
report on the Project, as more fully described in Subsection 1.3 of
Schedule 4 - Reporting
Requirements.
(a)
The Minister shall
review and approve the documentation submitted by the Recipient
following the receipt of the Recipient’s claim and in the
event of any deficiency in the documentation, the Minister will
notify the Recipient and the Recipient shall immediately take
action to address and rectify the deficiency.
(b)
Subject to the
maximum Contribution amounts set forth in Subsection 4.1 and all
other conditions contained in this Agreement, the Minister shall
pay to the Recipient a percentage of the Eligible Supported Costs
set forth in the Recipient's claim based on the sharing ratio
identified in Paragraph 4.1 (a), in accordance with the Minister's
customary practices.
SIF
AGREEMENT NO. 811-513437
(c)
The Minister may
request at any time that the Recipient provide satisfactory
evidence to demonstrate that all Eligible Supported Costs claimed
have been paid.
(d)
The Minister may
[______].
[Details of the payment procedures of the
Minister omitted as competitively sensitive
information.]
8.5
Overpayment by Minister. Where the
Minister determines that the amount of the Contribution disbursed
exceeds the amount to which the Recipient is entitled, the
Recipient shall repay to the Minister, promptly and no later than
thirty (30) days from notice from the Minister, the amount of the
overpayment together with interest at the Interest Rate from the
date of the notice to the day of payment to the Minister in full.
Any such amount is a debt due to Her Majesty and is recoverable as
such.
9.
Reporting, Monitoring, Audit and Evaluation
9.1
Reports. The Recipient agrees to provide
the Minister with the reports as described in Schedule 4 -
Reporting Requirements, to
the Minister’s satisfaction.
9.2
Additional Information. Upon request of
the Minister and at no cost to the Minister, the Recipient shall
promptly elaborate upon any report submitted or provide such
additional information as may be requested.
9.3
Minister’s Right to Audit Accounts and
Records. The
Recipient shall, at its own expense, maintain and preserve in
Canada and make available for audit and examination by the Minister
or the Minister’s representatives all books, accounts and
records relating to this Agreement or the Project held by the
Recipient, its Affiliated Persons, agents and contractors and of
the information necessary to ensure compliance with the terms and
conditions of this Agreement, including repayment to the Minister.
The Minister will have the right to conduct such audits at the
Minister’s expense as may be considered
necessary.
SIF
AGREEMENT NO. 811-513437
Unless
otherwise agreed to in writing by the Minister, the Recipient and
its Affiliated Persons, agents and contractors shall maintain and
preserve all books, accounts, invoices, receipts and records and
all other documentation related to this Agreement until the end of
the Recipient Fiscal Year that ends seven (7) years after the
fiscal year of the date on which they were created.
9.4
Auditor General Rights. The Recipient
recognizes, acknowledges and accepts that the Auditor General of
Canada may, at the Auditor General’s cost, after consultation
with the Recipient, conduct an inquiry under the authority of
subsection 7.1 (1) of the Auditor
General Act in relation to any funding agreement (as defined
in subsection 42 (4) of the Financial Administration Act) with
respect to the use of the Contribution received.
For the
purposes of any such inquiry undertaken by the Auditor General, the
Recipient shall provide, upon request and in a timely manner, to
the Auditor General or anyone acting on behalf of the Auditor
General,
(a)
all records held by
the Recipient, its Affiliated Persons, agents or contractors
relating to this Agreement and the use of the Contribution provided
under this Agreement; and
(b)
such further
information and explanations as the Auditor General, or anyone
acting on behalf of the Auditor General, may request relating to
this Agreement or the use of the Contribution.
9.5
Access to Records. The Recipient shall, at all times,
ensure that its agents, employees, assigns, contractors, and
Affiliated Persons are obligated to provide to the Minister or the
Auditor General or their authorized representatives records and
other information that are in possession of those agents,
employees, assigns, contractors, and Affiliated Persons and that
relate to this Agreement or to the use of the
Contribution.
9.6
Access to Premises. The Recipient and
its Affiliated Persons shall provide the representatives of the
Minister reasonable access to premises to inspect and assess the
progress of the Project or any element thereof and supply promptly
on request such data as the Minister may reasonably require for
statistical or Project evaluation purposes.
9.7
Evaluation. The Recipient shall, at its
own expense, participate in the preparation ofcase studies
reporting on the outcomes of the Project, to be completed by the
Minister or the Minister’s agents, in order to assist in the
Minister’s preparation of an overall evaluation of the value
and effectiveness of SIF.
SIF
AGREEMENT NO. 811-513437
10.
Representations, Warranties and Covenants
10.1
Representations. The Recipient
represents and warrants that:
(a)
it is duly
incorporated under Canadian law and validly existing and in good
standing and has the power and authority to carry on its business,
to hold property and to enter into this Agreement and undertakes to
take all necessary action to maintain itself in good standing, to
preserve its legal capacity and to remain incorporated in a
Canadian jurisdiction;
(b)
signatories to the
Agreement have been duly authorized to execute and deliver this
Agreement;
(c)
the execution,
delivery and performance of this Agreement have been duly and
validly authorized and that when executed and delivered, the
Agreement will constitute a legal, valid and binding obligation
enforceable in accordance with its terms;
(d)
it is under no
obligation or prohibition, nor is it subject to or threatened by
any actions, suits or proceedings that could or would prevent
compliance with the Agreement. The Recipient shall inform the
Minister forthwith of any such occurrence;
(e)
the execution and
delivery of this Agreement and the performance by theRecipient of
its obligations hereunder will not, with or without the giving of
notice or the passage of time or both:
(i)
violate the
provisions of the Recipient’s by-laws, any other corporate
governance document subscribed to by the Recipient or any
resolution of the Recipient;
(ii)
violate any
judgment, decree, order or award of any court, government agency,
regulatory authority or arbitrator; or
(iii)
conflict with or
result in the breach or termination of any material term or
provision of, or constitute a default under, or cause any
acceleration under, any license, permit, concession, franchise,
indenture, mortgage, lease, equipment lease, contract, permit, deed
of trust or any other instrument or agreement by which it is
bound;
(f)
it has obtained or
will obtain all necessary licences and permits in relation to the
Project, which satisfy the requirements of all regulating bodies of
appropriate jurisdiction;
(g)
it owns or holds
sufficient rights in any Intellectual Property required to carry
out the Project; and,
SIF
AGREEMENT NO. 811-513437
(h)
the description of
the Project in Schedule 1 - Statement of Work is complete and
accurate.
10.2
Covenants. The Recipient covenants and agrees
that:
(a)
it is solely
responsible for providing or obtaining the funding, in addition to
the Contribution, required to carry out the Project and the
fulfilment of the Recipient’s other obligations under this
Agreement;
(b)
no Material Change
within the control of the Recipient will be made without the prior
written consent of the Minister. In the event that the Minister
does not consent to such a Material Change, the Minister may
exercise the remedies set out in Subsection 14.3;
(c)
no Change in
Control will be made without the prior written consent of the
Minister.
(i) In
the case where the Recipient is a private company, the Recipient
shall notify the Minister, in writing, no later than thirty (30)
days prior to the date from which the Recipient expects to have a
Change in Control, and the Minister will confirm if it consents to
the Change in Control. Subject to subsection 17.13, consent will
not be unreasonably withheld.
(ii) In
the case where the Recipient is a public company, the Recipient
shall notify the Minister, in writing, of any Change in Control no
later than thirty (30) days following any Change in
Control.
(iii)
Prior to providing consent, the Minister may, as a result of
notification of the Change in Control, require additional due
diligence to determine the impacts of the Change in Control, such
as the following, but not be limited to: the legal status of the
Recipient pursuant to the Strategic Innovation Fund’s program
terms and conditions; the impact on the recipient’s finances
and the Project to ensure that the Recipient is able to complete
the Project; and, any other considerations that may emerge. The
purpose of the due diligence is to ensure that the Minister can
fully evaluate any additional considerations that were not
identified at the time of authorizing the funding. In the event
that the Minister does not consent to such a Change in Control, the
Minister may exercise the remedies set out in Subsection
14.3;
(d)
it shall retain
possession and control of all Project Assets the cost of which has
been contributed to by the Minister under the Agreement,and the
Recipient shall not Dispose of the same without the prior written
consent of the Minister, other than in the ordinary course of
business where the aggregate book value of such Project Assets for
each occurrence is no greater than [______] dollars ($[______]);
[Dollar amount omitted as competitively
sensitive information.]
SIF
AGREEMENT NO. 811-513437
(e)
it shall, in
advance and in writing, and subject to Paragraphs 10.2 (c) and (d)
of this Agreement, notify the Minister in the event of any
Acquisition or Divestiture. In the case where the Recipient is a
public company, the Recipient shall notify the Minister in writing
of any Acquisition or Divestiture contemporaneously with any press
release, or filing of a public regulatory notice in respect of such
Acquisition or Divestiture;
(f)
that it shall not
make any dividend payments or other shareholder distributions that
would prevent it from implementing the Project or satisfying any
other of the Recipient’s obligations under this Agreement,
including, without limitation, the making of repayments to the
Minister hereunder;
(g)
it shall comply
with the federal visibility requirements set out in Schedule 2 -
Communications Obligations;
and
(h)
it shall comply
with all laws and regulations applicable to it.
10.3
Renewal of Representations. It is a
condition precedent to any disbursement under this Agreement that
the representations, warranties and covenants contained in this
Agreement are true at the time of payment and that the Recipient is
not in default of compliance with any terms of this
Agreement.
11.
Intellectual Property
11.1
Background Intellectual Property. The
Recipient must own the Background
Intellectual
Property or hold sufficient Background Intellectual Property Rights
to permit the Project to be carried out.
11.2
Project Intellectual Property and
Improvements. The Recipient must exclusively own, and retain
ownership thereof in Canada, the Project Intellectual Property, the
Project Intellectual Property Rights and improvements to products,
processes and equipment as a result of the Project for the Term,
unless otherwise agreed to by the Minister.
11.3
Exploitation of Project Intellectual
Property. Unless otherwise agreed to by the Minister, the
Recipient must own or have sufficient Intellectual Property Rights
to use the Project Intellectual Property and to make, construct,
cause the construction, sell and cause the sale of the Resulting
Products.
11.4
License
of Project Intellectual Property and Background Intellectual
Property.
11.4.1
Restriction on Licenses. Except as
provided in Subsection 11.4.2, the Recipient agrees not to grant
any right or license to any of the Project Intellectual Property or
Background Intellectual Property without the prior written consent
of the Minister.
SIF
AGREEMENT NO. 811-513437
11.4.2
Permitted Licenses Without
Consent. If all the requirements in Subsection 11.4.3 are
satisfied, the Recipient may grant a right or license to any of the
Project Intellectual Property or Background Intellectual Property
provided that one or more of the following conditions is
met:
(a)
the right or
license is [______];
(b)
the right or
license is [______]; and
(c)
the right or
license is [______].
[Conditions are omitted as
competitively sensitive
information.]
11.4.3
Requirements For
Licenses Without Consent. The requirements (for the purposes
of Subsection 11.4.2) are:
(a)
the right or
license cannot prevent the Recipient from fulfilling its
obligations in this Agreement; and
(b)
the right or
license cannot prevent access, in any way, to treatments in
response to COVID-19 or Resulting Products in Canada or by
Canadians.
11.4.4
Clarification
Regarding Background Intellectual Property. Notwithstanding
Subsections 11.4.1, 11.4.2 and 11.4.3, nothing herein shall limit
the Recipient’s ability to use, commercialize and/or exploit
the Background Intellectual Property, including licensing it to
third parties, outside of and separate from the Project in a manner
that would not restrict the development, commercialization or
exploitation of the Project Intellectual Property or making or
selling Resulting Products by the Recipient.
11.5
Protection of Project Intellectual
Property. The Recipient shall take appropriate steps to
protect and enforce the Project Intellectual Property. The
Recipient shall provide information to the Minister in that regard,
upon request.
11.6
Crown Ownership of Intellectual
Property. The Crown will not have an ownership interest in
the Project Intellectual Property nor will the Crown acquire new
rights in Background Intellectual Property by virtue solely of
having provided the Contribution. Rights attributed to the Crown in
any other way including under the Public Servants Inventions Act are not
in any way affected by this Agreement.
11.7
Intellectual Property Strategy. The
Recipient will develop an Intellectual Property (IP) strategy that
will be shared with the Minister within [______] ([______]) months
of the Execution Date. This strategy will support the creation,
retention and protection of Intellectual Property ownership in
Canada; include training for employees that increases Intellectual
Property educational awareness and identify any planned
Intellectual Property training activities; include a plan to
commercialize Resulting Products domestically, including
Intellectual Property commercialization activities, such as
licensing, and anticipated collaboration activities, if any; and
include a current list of Background Intellectual Property. The
Recipient agrees to report annually on any changes to this strategy
[______]. [Number of months and
timeframe omitted as competitively sensitive
information.]
SIF
AGREEMENT NO. 811-513437
11.8
Project Intellectual Property Use in Response
to COVID-19. The Minister may require the Recipient to
assign, transfer or grant a license to use the (i) Project
Intellectual Property and Project Intellectual Property Rights; and
(ii) Background Intellectual Property and Background Intellectual
Property Rights owned by the Recipient, or licensed by the
Recipient with the right to sub-license, to a third party approved
by the Minister upon written request from the Minister, but only to
the extent necessary to ensure a sufficient domestically-sourced
supply of treatments in response to COVID-19 should the Recipient
be unable to ensure such a supply.
12.
Environmental and Other Requirements
12.1
The Recipient
represents that the Project is not a “designated
project” and is not being carried out on “federal
lands” as such terms are defined in the Impact Assessment Act, 2019
(“IAA”).
12.2
The Recipient
shall, in respect of the Project, comply with all federal,
provincial, territorial, municipal and other applicable laws,
including but not limited to, statutes, regulations, by-laws,
rules, orders, ordinances and decrees governing the Recipient or
the Project, or both, relating to environmental protection and the
successful implementation of and adherence to any mitigation
measures, monitoring or follow-up program that may be prescribed by
the Minister or other federal, provincial, territorial, municipal
tribunals or bodies, and certifies to the Minister that it has done
so to date.
12.3
The Recipient will
provide the Minister with reasonable access to any Project site for
thepurpose of ensuring that the terms and conditions of any
environmental approval are met, and that any mitigation, monitoring
or follow-up measure required has been carried out.
12.4
If as a result of
changes to the Project or otherwise, an assessment is required in
accordance with IAA for the Project, the Minister and the Recipient
agree that the Minister’s obligations under this Agreement
will be suspended from the moment that the Minister informs the
Recipient, until (i) a decision statement has been issued to the
Recipient or, if applicable, the Minister has decided that the
Project is not likely to cause significant adverse environmental
effects or the Governor in Council has decided that the significant
adverse environmental effects are justified in the circumstances,
and (ii) if required, an amendment to this Agreement has been
signed, setting out any conditions included in the decision
statement.
12.5
Aboriginal consultation. The Recipient
acknowledges that the Minister’s obligation to pay the
Contribution is conditional upon Her Majesty satisfying any
obligation that Her Majesty may have to consult with or to
accommodate any Aboriginal groups, which may be affected by the
terms of this Agreement.
12.6
Official Languages. The Recipient agrees that any
public acknowledgement of the Minister’s public support for
the Project will be expressed in both official
languages.
SIF
AGREEMENT NO. 811-513437
13.
Indemnification and Limitation of Liability
13.1
Indemnification. Except for any claims arising from the gross
negligence of, or willfulmisconduct by, the Minister’s employees,
officers, agents or servants, the Recipient agrees, at all times,
to indemnify and save harmless, the Minister and any of his
officers, servants, employees or agents from all and against all
claims and demands, actions, suits or other proceedings (and all
losses, costs and damages relating thereto) by whomsoever made,
brought or prosecuted (all of the foregoing collectively, the
“Claims”), where such Claims are
asserted or arise from the Minister being a Party to this
Agreement and exercising his rights and performing his obligations
under this Agreement, to the extent such Claims result
from:
(a)
the Project, its
operation, conduct or any other aspect thereof;
(b)
the performance or
non-performance of this Agreement, or the breach or failure to
comply with any term, condition, representation or warranty of this
Agreement by the Recipient, its Affiliated Persons, its officers,
employees and agents, or by a third party or its officers,
employees, or agents;
(c)
the design,
construction, operation, maintenance and repair of any part of the
Project; or,
(d)
any omission or
other wilful or negligent act or delay of the Recipient, its
Affiliated Person or a third party and their respective employees,
officers, or agents.
13.2
Limitation of Liability. Notwithstanding
anything to the contrary contained herein, the Minister shall not
be liable for any direct, indirect, special or consequential
damages of the Recipient nor for the loss of revenues or profits
arising from, based upon, occasioned by or attributable to the
execution of this Agreement, regardless of whether such a liability
arises in tort (including negligence), contract, fundamental breach
or breach of a fundamental term, misrepresentation, breach of
warranty, breach of fiduciary duty, indemnification or
otherwise.
13.3
Her Majesty, her
agents, employees and servants will not be held liable in the event
the Recipient enters into a loan, a capital or operating lease or
other long-term obligation in relation to the Project for which the
Contribution is provided.
14.1
Event of Default. The Minister may
declare that an Event of Default has occurred if:
(a)
the Recipient has
failed or neglected to pay Her Majesty any amount due in accordance
with this Agreement;
SIF
AGREEMENT NO. 811-513437
(b)
the Project is not
completed in accordance with Schedule 1 – Statement of Work to the
Minister’s satisfaction by the Project Completion Date or the
Project is abandoned in whole or in part;
(c)
the Recipient has
not, in the opinion of the Minister, met or satisfied a term,
covenant or condition of this Agreement;
(d)
the Recipient
becomes bankrupt or insolvent, goes into receivership, or takes the
benefit of any statute, from time to time in force, relating to
bankrupt or insolvent debtors;
(e)
an order is made or
the Recipient has passed a resolution for the winding up or
dissolution of the Recipient, or the Recipient is dissolved or
wound up;
(f)
the Recipient has,
in the opinion of the Minister, ceased to carry on business or has
sold all or substantially all of its assets or enters into a letter
of intent or binding obligation to sell all or substantially all of
its assets;
(g)
the Recipient has
not met or satisfied a term or condition under any other
contribution agreement or agreement of any kind with Her
Majesty;
(h)
the Recipient fails
to fulfill any of the contractual obligations set out in this
Agreement;
(i)
a representation,
covenant, warranty or statement contained herein or in any
document, report or certificate delivered to the Minister hereunder
or in connection therewith is false or misleading at the time it
was made; and
(j)
the Recipient fails
to comply with the obligations regarding audit and evaluation, as
set out in Section 9.
14.2
Notice and Rectification Period. Except
in the case of an Event of Default under paragraphs (d), (e) and
(f) of Subsection 14.1 above, the Minister will not declare that an
Event of Default has occurred unlessthe Parties have attempted to
resolve the issue in accordance with Schedule 5 –
Resolution Process. If the
Parties are unable to resolve this issue, the Minister may give
written notice to the Recipient of the occurrence which, in the
Minister’s opinion, constitutes an Event of Default and the
Recipient fails, within thirty (30) days of receipt of the notice,
either to correct the condition or event or demonstrate, to the
satisfaction of the Minister that it has taken such steps as are
necessary to correct the condition, failing which the Minister may
declare that an Event of Default has occurred.
SIF
AGREEMENT NO. 811-513437
14.3
Remedies on Default. If, after following
the process in Schedule 5 – Resolution Process, the Minister
declares that an Event of Default has occurred, the Minister may
immediately exercise one or more of the following remedies, in
addition to any remedy available at law:
(a)
suspend or
terminate any obligation by the Minister to contribute or continue
to contribute to the Eligible Supported Costs including any
obligation to pay any amount owing prior to the date of such
suspension;
(b)
require the
Recipient to repay to the Minister all or part of the Contribution
paid by the Minister, together with interest from the day of demand
at the Interest Rate;
(c)
require the
Recipient to pay the Minister the total of all amounts required to
be repaid pursuant to this Agreement less any amount already repaid
to the Minister together with interest from the day of demand at
the Interest Rate;
(d)
terminate the
Agreement; and
(e)
post a notice on a
Government of Canada website disclosing that the Recipient has
committed an Event of Default under the provisions of thisAgreement
and describing generally the remedies, if any, that the Minister
has accordingly exercised.
14.4
The Recipient
acknowledges the policy objectives served by the Minister’s
agreement to make the Contribution, that the Contribution comes
from the public monies, and that the amount of damages sustained by
Her Majesty in an Event of Default is difficult to ascertain and
therefore, that it is fair and reasonable that the Minister be
entitled to exercise any or all of the remedies provided for in
this Agreement and to do so in the manner provided for in this
Agreement, if an Event of Default occurs.
15.1
Compliance with Lobbying Act. The
Recipient warrants and represents:
(a)
that it has filed
all Lobbying Act returns
required to be filed in respect of persons employed by the
Recipient who communicate and/or arrange meetings with Public
Office Holders as part of their employment duties, and that it will
continue to do so;
(b)
that it has not
contracted with any person to communicate and/or arrange meetings
with Public Office Holders for remuneration that is or would be
contingent in any way upon the success of such person arranging
meetings with Public Office Holders, or upon the approval of the
Recipient’s application for SIF funding, or upon the amount
of SIF funding paid or payable to the Recipient under this
Agreement;
SIF
AGREEMENT NO. 811-513437
(c)
that it will not
contract with any person to communicate and/or arrange meetings
with Public Office Holders for remuneration that is or would be
contingent upon the success of such person arranging meetings with
Public Office Holders, or upon the amount of SIF funding paid or
payable to the Recipient under this Agreement;
(d)
all persons who are
or have been contracted by the Recipient to communicate and/or
arrange meetings with Public Office Holders in respect of this
Agreement are in full compliance with the registration and other
requirements of the Lobbying Act; and
(e)
it shall at all
times ensure that any persons contracted to communicate
and/orarrange meetings with Public Office Holders in respect of the
Agreement are in full compliance with the requirements of the
Lobbying Act.
15.2
Members of Parliament. The Recipient
represents and warrants that no member of the House of Commons will
be admitted to any share or part of this Agreement or to any
benefit to arise therefrom. No person who is a member of the Senate
will, directly or indirectly, be a party to or be concerned in this
Agreement.
15.3
Compliance with Post-Employment
Provisions. The Recipient confirms that no current or former
public servant or public officeholder to whom the Values and Ethics Code for the Public
Service, the Values and
Ethics Code for the Public Sector, the Policy on Conflict of Interest and
Post-Employment or the Conflict of Interest Act apply, will
derive a direct benefit from this Agreement unless the provision or
receipt of such benefits is in compliance with such legislation and
codes.
15.4
The Recipient
acknowledges that the representations and warranties in this
section are fundamental terms of this Agreement. In the event of
breach of these, the Minister may exercise the remedies set out in
Subsection 14.3.
16.1
Consent Required. Subject to Schedule 2
- Communications
Obligations, the Accessto Information Act, the Privacy Act and the Library and Archives Act of Canada,
each Party shall keep confidential and shall not without the
consent of the other Party disclose the contents of the Agreement
and the documents pertaining thereto, whether provided before or
after the Agreement was entered into, or of the transactions
contemplated herein.
SIF
AGREEMENT NO. 811-513437
16.2
International Dispute. Notwithstanding
Subsection 16.1 of this Agreement, the Recipient waives any
confidentiality rights to the extent such rights would impede Her
Majesty from fulfilling her notification obligations to a world
trade panel for the purposes of the conduct of a dispute, in which
Her Majesty is a party or a third party intervener. The Minister is authorized to
disclose the contents of this Agreement and any documents
pertaining thereto, whether predating or subsequent to this
Agreement, or of the transactions contemplated herein, where in the
opinion of the Minister, such disclosure is necessary to the
defence of Her Majesty’s interests in the course of a trade
remedy investigation conducted by a foreign investigative
authority, and is protected from public dissemination by the
foreign investigative authority. The Minister shall notify the
Recipient of such disclosure.
16.3
Financing, Licensing and Subcontracting.
Notwithstanding Subsection 16.1 of this Agreement, the Minister
hereby consents to the Recipient disclosing this Agreement, and any
portion or summary thereof, for any of the following
purposes:
(a)
securing additional
financing;
(b)
licensing for
commercial exploitation; or
(c)
confirming to
agents, contractors and subcontractors of the Recipient that all
agents, contractors and subcontractors must agree to provide the
Minister and the Auditor-General with access to their records and
premises, provided that any person to whom this Agreement or any
portion or summary thereof is disclosed shall execute a
non-disclosure agreement prior to such disclosure.
16.4
Repayments. Notwithstanding Subsection
16.1 of this Agreement, the Minister may disclose any information
relating to the amount of each repayment made by the Recipient
whether due or paid.
17.1
Debt due to Canada. Any amount owed to
Her Majesty under this Agreement shall constitute a debt due to Her
Majesty and shall be recoverable as such. Unless otherwise
specified herein, the Recipient agrees to make payment of any such
debt forthwith on demand.
17.2
Interest. Debts due to Her Majesty will
accrue interest in accordance with the Interest and Administrative Charges
Regulations, in effect on the due date, compounded monthly
on overdue balances payable, from the date on which the payment is
due, until payment in full is received by Her Majesty. Any such
amount is a debt due to Her Majesty and is recoverable as
such.
17.3
Set-off Rights of Minister. Without
limiting the scope of the set-off rights provided for under the
Financial Administration
Act, it is understood that the Minister may set off against
the Contribution any amounts owed by the Recipient to the Minister
under legislation or contribution agreements and the Recipient
shall declare to the Minister all amounts outstanding in that
regard when making a claim under this Agreement.
SIF
AGREEMENT NO. 811-513437
17.4
No Assignment of Agreement. No Party
shall assign the Agreement or any part thereof without the prior
written consent of the Minister. Any attempt by a Party to assign
this Agreement or any part thereof, without the express written
consent of the Minister, is void.
17.5
Annual Appropriation. Any payment by the
Minister under this Agreement is subject to there being an
appropriation for the Government Fiscal Year in which the payment
is to be made; and to cancellation or reduction in the event that
departmental funding levels are changed by Parliament. If the
Minister is prevented from disbursing the full amount of the
Contribution due to a lack or reduction of appropriation or
departmental funding levels, the Minister and the Recipient agree
to review the effects of such a shortfall in the Contribution on
the implementation of this Agreement.
17.6
Successors and Assigns. This Agreement
is binding upon the Recipient, its successors and permitted
assigns.
17.7
Event of Force Majeure. The Recipient
will not be in default by reason only of any failure in the
performance of the Project in accordance with Schedule 1 –
Statement of Work if such
failure arises without the fault or negligence of the Recipient and
is caused by any event of Force Majeure.
17.8
Applicable Law. This Agreement will be
interpreted in accordance with the laws of the province of Ontario
and federal laws of Canada applicable therein. The word
“law” used herein has the same meaning as in the
Interpretation Act, as
amended.
17.9
Dispute Resolution. If a dispute arises
concerning the application or interpretation of this Agreement, the
Parties will attempt to resolve the matter through good faith
negotiation, and may, if necessary and the Parties consent in
writing, resolve the matter through mediation or arbitration by a
mutually acceptable mediator or by arbitration in accordance with
the Commercial Arbitration Code set out in the schedule to the
Commercial Arbitration Act
(Canada), as amended, and all regulations made pursuant to
that Act.
17.10
No Amendment. No amendment to this
Agreement shall be effective unless it is made in writing and
signed by the Parties hereto.
17.11
Contribution Agreement Only. This
Agreement is a contribution agreement only, not a contract for
services or a contract of service or employment, and nothing in
this Agreement, the Parties relationship or actions is intended to
create, or be construed as creating, a partnership, employment or
agency relationship between them. The Recipient is not in any way
authorized to make a promise, agreement or contract and to incur
any liability on behalf of Her Majesty or to represent itself as an
agent, employee or partner of Her Majesty, including in any
agreement with a third party, nor shall the Recipient make a
promise, agreement or contract and incur any liability on behalf of
Her Majesty, and the Recipient shall be solely responsible for all
deductions and remittances required by law in relation to its
employees.
SIF
AGREEMENT NO. 811-513437
17.12
No Waiver. The rights and remedies of
the Minister under this Agreement shall be cumulative and not
exclusive of any right or remedy that he or she would otherwise
have. The fact that the Minister refrains from exercising a remedy
he or she is entitled to exercise under this Agreement will not
constitute a waiver of such right and any partial exercise of a
right will not prevent the Minister in any way from later
exercising any other right or remedy under this Agreement or other
applicable law.
17.13
Consent of the Minister. Whenever this
Agreement provides for the Minister to render a decision or for the
Recipient to obtain the consent or agreement of the Minister, such
decision shall be reasonable on the facts and circumstance and such
consent or agreement will not be unreasonably withheld but the
Minister may make the issuance of such consent or agreement subject
to reasonable conditions.
17.14
No conflict of interest. The Recipient
and its Affiliated Persons, consultants and any oftheir respective
advisors, partners, directors, officers, shareholders, employees,
agents and volunteersshall not engage in any activity where such
activity creates a real, apparent or potential conflict of interest
in the sole opinion of the Minister, with the carrying out of the
Project. For greater certainty, and without limiting the generality
of the foregoing, a conflict of interest includes a situation where
anyone associated with the Recipient owns or has an interest in an
organization that is carrying out work related to the
Project.
17.15
Disclose potential conflict of interest.
The Recipient shall disclose to the Minister without delay any
actual or potential situation that may be reasonably interpreted as
either a conflict of interest or a potential conflict of
interest.
17.16
Severability. Any provision of this
Agreement which is prohibited by law or otherwise deemed
ineffective will be ineffective only to the extent of such
prohibition or ineffectiveness and will be severable without
invalidating or otherwise affecting the remaining provisions of the
Agreement.
17.17
Signature in Counterparts. This
Agreement may be signed in counterparts and such counterparts may
be delivered by acceptable electronic transmission, including
portable document format (PDF), each of which when executed and
delivered is deemed to be an original, and when taken together,
will constitute one and the same Agreement.
17.18
Currency. Unless otherwise
indicated, all dollar amounts referred to in this Agreement are to
the currency of Canada.
17.19
Tax. The Recipient acknowledges that
financial funding from government programs may have tax
implications for its organization and that advice should be
obtained from a qualified tax professional.
SIF
AGREEMENT NO. 811-513437
18.
Contact Information & Notices
18.1
Form and Timing of Notice. Any notice or
other communication under this Agreement shall be made in writing.
The Minister or the Recipient may send any written notice by any
pre-paid method, including regular or registered mail, courier or
email. Notice will be considered as received upon delivery by the
courier, upon the Party confirming receipt of the email or one
(1) day after the email is
sent, whichever the sooner or five (5) calendar days after being
mailed.
18.2
Any notices to the
Minister in fulfillment of obligations such as claims, reporting,
and any other documents stipulated under
this Agreement, will be addressed to:
Strategic
Innovation Fund
Attn: Senior Director
8th
Floor
235
Queen Street
Ottawa,
Ontario K1A 0H5
Fax No:
(613) 954-5649
Email
address: to be provided by SIF upon request from the
Recipient.
Notwithstanding
the foregoing, claims forms will not be sent by email unless
otherwise agreed to in writing by the Minister.
18.3
Any notices to the
Recipient will be addressed to:
Edesa
Biotech Research, Inc.
Attn:
President
100 Spy
Court
Markham, ON L3R
5H6
Email
address: to be provided by the Recipient to SIF.
Any
notices to the Guarantor will be addressed to:
Edesa
Biotech, Inc.
Attn:
CEO
100 Spy
Court
Markham, ON L3R
5H6
Email
address: to be provided by the Recipient to SIF.
18.4
Change of Contact Information. Each of
the Parties may change the address, which they have stipulated in
this Agreement by notifying in writing the other Party of the new
address, and such change shall be deemed to take effect fifteen
(15) calendar days after receipt of such notice.
[REMAINDER
OF THIS PAGE INTENTIONALLY LEFT BLANK]
SIF
AGREEMENT NO. 811-513437
IN WITNESS WHEREOF the Parties hereto have executed this
Agreement through duly authorized representatives.
HER MAJESTY THE QUEEN IN RIGHT OF CANADA
as
represented by the Minister of Industry
|
Per:
/s/Colette
Kaminsky
|
January 9,
2021
|
|
Strategic
Innovation Fund
|
Date
|
|
Colette
Kaminsky, Director General
|
|
|
|
|
|
|
|
|
|
|
|
Edesa Biotech Research, Inc.
|
|
|
|
|
|
Per:
/s/ Michael
Brooks
|
February 2,
2021
|
|
Michael
Brooks, President
|
Date
|
|
|
|
|
I have
the authority to bind the Corporation.
|
|
|
|
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|
|
|
Edesa Biotech, Inc.
|
|
|
|
|
|
Per:
/s/Pardeep
Nijhawan
|
February 1,
2021
|
|
Pardeep
Nijhawan, CEO
|
Date
|
|
|
|
|
|
|
|
|
|
|
I have
the authority to bind the Corporation.
|
|
SIF
AGREEMENT NO. 811-513437
SCHEDULE 1 - STATEMENT OF WORK (SOW)
[______]
[Statement of Work, including the
nature of work related to the Project, timeframes, milestones and
cost breakdowns, omitted as competitively sensitive
information.]
SIF
AGREEMENT NO. 811-513437
SCHEDULE 2 - COMMUNICATIONS OBLIGATIONS
[______]
[Nature of communications obligations pursuant
to this Agreement omitted as competitively sensitive
information.]
SIF
AGREEMENT NO. 811-513437
SCHEDULE 3 - COST PRINCIPLES
[______]
[Nature of cost principles
pursuant to this Agreement omitted as competitively sensitive
information.]
SIF
AGREEMENT NO. 811-513437
SCHEDULE 4 - REPORTING REQUIREMENTS
[______]
[Nature of reporting requirements pursuant to
this Agreement omitted as competitively sensitive
information.]
SIF
AGREEMENT NO. 811-513437
SCHEDULE 5 – RESOLUTION PROCESS
[______]
[Nature of resolution process omitted as
competitively sensitive information.]
Edesa Biotech Receives C$14 million for COVID-19 Study
TORONTO, ON / ACCESSWIRE / February 2, 2021 / Edesa Biotech,
Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has
secured a commitment of up to C$14 million (US$ 11 million) from
the Government of Canada to complete the Phase 2 portion of a Phase
2/Phase 3 clinical study of its investigational drug, EB05, for the
treatment of hospitalized COVID-19 patients. The funding will also
help fund certain pre-clinical research intended to broaden the
utility of the company's experimental therapy, including treatments
for other respiratory pathogens. The funds were awarded under the
federal government's Strategic Innovation Fund following a
multi-disciplinary review of Edesa's drug technology and
plans.
"The
award of this competitive funding is an important validation of the
therapeutic potential of EB05 and the scientific rationale behind
our efforts. The funds will be targeted toward rapidly getting EB05
into the hands of physicians on the front line of this health
crisis," said Dr. Par Nijhawan, Chief Executive Officer of Edesa.
"By targeting the body's underlying response, our experimental drug
offers a potential solution that could be effective despite
variations in the virus."
The
Honorable François-Philippe Champagne, Minister of Innovation,
Science and Industry, said that Strategic Innovation Fund (SIF)
funding announced today is part of the government's plan to support
the development of novel medical countermeasures for COVID-19
patients. "As countries around the world begin to distribute and
administer COVID-19 vaccines to their populations, we cannot lose
sight of the importance of developing treatments to limit the
long-term impacts of the virus on Canadians. Today's contribution
will support Edesa as they take their promising treatment through
clinical trials and subsequent approvals. Once approved, this
therapy has the potential to be an important tool in treating and
preventing lung injuries caused by COVID-19. As the government
continues to protect and support Canadians through this pandemic,
it must also lay the foundation for a better-prepared, healthier
and more prosperous future," he said.
EB05 is
an experimental monoclonal antibody that Edesa believes could
regulate the overactive immune response associated with Acute
Respiratory Distress Syndrome (ARDS) - the leading cause of death
in COVID-19 patients. Specifically, the drug inhibits toll-like
receptor 4 (TLR4) signaling - an important mediator of inflammation
responsible for acute lung injury that has been shown to be
activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. The goal
of the experimental treatment is to suppress inflammation, fluid
accumulation and lung injury, thereby reducing the number of ICU
patients and intubation/ventilation procedures, and ultimately
saving lives.
The
company intends to use the SIF funding for Phase 2 study expenses.
Edesa's ongoing Phase 2/3 study is an adaptive, multicenter,
randomized, double-blind, placebo-controlled study to evaluate the
efficacy and safety of EB05 in adult hospitalized COVID-19
patients. Up to 316 patients will be enrolled in the first phase of
the trial. Patients will be infused intravenously with a single
dose of EB05 or placebo. Should the antibody treatment demonstrate
promising results at the Phase 2 readout, the company plans to
continue with a pivotal Phase 3 study.
"We
greatly appreciate the support of the Government of Canada and the
effort of the staff of the Innovation, Science and Economic
Development (ISED) department in leading the technical review of
our application," said Michael Brooks, PhD, President of Edesa
Biotech. "We look forward to working with the government on the
next steps in the program and continuing to build on Canada's
emergency preparedness capabilities."
In
addition to the ongoing clinical study, the SIF funding will also
be used to support a research project at a Canadian university.
Among other objectives, the in
vitro pre-clinical study will examine the potential
therapeutic utility of EB05 against a panel of pathogens, including
coronavirus variants and influenza strains.
Hospitals
and physicians interested in participating in the Phase 2/3 study
of EB05 should contact info@edesabiotech.com
or visit www.clinicaltrials.gov
(Identifier: NCT04401475)
About ARDS
Acute
Respiratory Distress Syndrome is the leading cause of death in
COVID-19 patients. The U.S. Centers for Disease Control (CDC)
reports that 20% to 42% of hospitalized COVID-19 patients develop
ARDS, which increases to 67% to 85% for patients admitted to the
ICU. Mortality among patients admitted to the ICU ranges from 39%
to 72% depending on the study and characteristics of patient
population, according to the CDC. ARDS involves an exaggerated
immune response leading to inflammation and injury to the lungs
that results in edema that deprives the body of oxygen. For
moderate to severe cases, there are currently few meaningful
treatments, other than supplemental oxygen and mechanical
ventilation, and patients suffer high mortality rates. In addition
to virus-induced pneumonia, ARDS can be caused by smoke/chemical
inhalation, sepsis, chest injury and other causes. Prior to
COVID-19, ARDS accounted for approximately 10% of intensive care
unit admissions, representing more than 3 million patients globally
each year.
About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage
biopharmaceutical company focused on developing innovative
treatments for inflammatory and immune-related diseases with clear
unmet medical needs. Edesa's lead product candidate, EB01, is a
novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor)
for the treatment of chronic allergic contact dermatitis which has
demonstrated statistically significant improvements in multiple
clinical studies. The company is developing late-stage monoclonal
antibodies that block certain immune signaling proteins, known as
TLR4 and CXCL10. These molecules are associated with a broad range
of diseases, including the inflammation associated infectious
diseases. Due to the global health emergency, Edesa has prioritized
the development of EB05 as a potential treatment for hospitalized
COVID-19 patients. The company is based in Markham, Ontario,
Canada, with a U.S. subsidiary located in Southern California. Sign
up for news
alerts.
Edesa Forward-Looking Statements
This press release may contain forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. Forward-looking statements may be identified by the use of
words such as "anticipate," "believe," "plan," "estimate,"
"expect," "intend," "may," "will," "would," "could," "should,"
"might," "potential," or "continue" and variations or similar
expressions, including statements related to: the company's belief
that EB05 could regulate the overactive immune response associated
with ARDS, the company's belief that EB05 could modulate the TLR4
signaling pathway for the benefit of patients, the company's belief
that EB05 could provide effective treatment for current and future
variations of the SARS-CoV2 virus, and the company's plans
regarding its Phase 2/3 study and the use of SIF funding. Readers
should not unduly rely on these forward-looking statements, which
are not a guarantee of future performance. There can be no
assurance that forward-looking statements will prove to be
accurate, as all such forward-looking statements involve known and
unknown risks, uncertainties and other factors which may cause
actual results or future events to differ materially from the
forward-looking statements. Such risks include: the ability of
Edesa to obtain regulatory approval for or successfully
commercialize any of its product candidates, the risk that access
to sufficient capital to fund Edesa's operations may not be
available or may be available on terms that are not commercially
favorable to Edesa, the risk that Edesa's product candidates may
not be effective against the diseases tested in its clinical
trials, the risk that Edesa fails to comply with the terms of
license agreements with third parties and as a result loses the
right to use key intellectual property in its business, Edesa's
ability to protect its intellectual property, the timing and
success of submission, acceptance and approval of regulatory
filings, and the impacts of public health crises, such as COVID-19.
Many of these factors that will determine actual results are beyond
the company's ability to control or predict. For a discussion of
further risks and uncertainties related to Edesa's business, please
refer to Edesa's public company reports filed with the U.S.
Securities and Exchange Commission and the British Columbia
Securities Commission. All forward-looking statements are made as
of the date hereof and are subject to change. Except as required by
law, Edesa assumes no obligation to update such
statements.
Contact:
Gary
Koppenjan
Edesa
Biotech, Inc.
(805)
488-2800 ext. 150
investors@edesabiotech.com
SOURCE: Edesa Biotech