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UNITED
STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
FORM
8-K
CURRENT
REPORT
PURSUANT TO
SECTION 13 OR 15(d) OF
THE SECURITIES
EXCHANGE ACT OF 1934
Date of Report
(Date of earliest event reported): August 30,
2019
Edesa Biotech,
Inc.
(Exact Name of
Registrant as Specified in its Charter)
British Columbia, Canada
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001-37619
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N/A
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(State or Other Jurisdiction of
Incorporation)
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(Commission File
Number)
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(IRS Employer Identification
No.)
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100 Spy Court
Markham, Ontario, Canada L3R 5H6
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(Address of Principal Executive
Offices)
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(905)
475-1234
Registrant’s telephone
number, including area code
N/A
(Former name or former
address, if changed since last report)
Check the appropriate box below if
the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following
provisions (see
General Instruction A.2. below):
☐
Written communications pursuant to
Rule 425 under the Securities Act (17 CFR
230.425)
☐
Soliciting material pursuant to
Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
☐
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
☐
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Indicate by check mark whether the registrant is
an emerging growth company as defined in Rule 405 of the Securities
Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth
company ☒
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange
Act. ☒
Securities registered pursuant to
Section 12(b) of the Act:
Title of each
class
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Trading
Symbol(s)
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Name of exchange on which
registered
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Common Shares
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EDSA
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The Nasdaq Capital
Market
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Explanatory
Note
On June 10,
2019, Edesa Biotech, Inc., formerly known as “Stellar
Biotechnologies, Inc.” (the “Company”), filed a
Current Report on Form 8-K with the Securities and Exchange
Commission reporting, among other items, that on June 7, 2019, the
Company completed its business combination with Edesa Biotech
Research, Inc., formerly known as Edesa Biotech Inc.
(“Edesa”).
This Current Report on Form 8-K is being filed with the Securities
and Exchange Commission to report certain contracts entered into by
Edesa prior to its business combination with the
Company.
Item 8.01 Other Items
Lease Agreement
On
January 1, 2017, Edesa entered into a lease agreement with 1968160
Ontario Inc. (the “Lease Agreement”) pursuant to which
Edesa leased approximately 2,800 square feet of office space
located at 100 Spy Court, Markham, Ontario Canada (the
“Premises”). 1968160 Ontario Inc. at the time of
entry into the agreement was an affiliate of Edesa. The Premises now serves as the corporate
headquarters of the Company. The rent per month is $8,320 (Cdn),
with the rent payment increasing by $1 per square foot every two
years. Subject to certain exceptions, the rent includes
Edesa’s proportionate share of the costs of maintaining and
repairing common areas and common facilities of the building and
Edesa’s utilities, security janitorial services and share of
insurance and property taxes for the building. The lease is
scheduled to terminate on December 31, 2022, subject to Edesa
having a right to renew the lease for an additional period of two
years. Edesa also has the right to terminate the lease at any time
upon one month’s notice to the
landlord.
The foregoing description of the
Lease Agreement contained herein does not purport to be complete
and is qualified in its entirety by reference to the Lease
Agreement, which is attached hereto as Exhibit 10.1 and
incorporated herein by reference.
License Agreement with Yissum
On
June 29, 2016, Edesa entered into an exclusive license agreement
with Yissum Research
Development Company, the technology transfer company of the Hebrew
University of Jerusalem Ltd. (“Yissum”), which
agreement was subsequently amended on each of April 3, 2017 and May
7, 2017. Pursuant to the license agreement as amended, Edesa
obtained exclusive rights throughout
the world to certain know-how, patents and data relating to a
pharmaceutical product. Edesa will use the exclusive rights to
develop the product for therapeutic, prophylactic and diagnostic
uses in topical dermal applications and anorectal applications (the
“Field”). Unless earlier terminated, the term of the
license agreement will expire on a country by country basis on the
later of (i) the date of expiry of the last valid licensed patent
in such country; (ii) the date of expiry of any period of
exclusivity granted to a product by a regulatory authority in such
country or (iii) the date that is fifteen (15) years after the
first commercial sale of a product in such
country.
Pursuant to
the license agreement, Edesa is exclusively responsible, at its
expense, for the development of the product in the Field, including
conducting clinical trials and seeking regulatory approval for the
product, and once regulatory approval has been obtained, for the
commercialization of the product. Edesa is required to use its
commercially reasonable efforts to develop and commercialize the
product in the Field in accordance with the terms of a development
plan established by the parties. Subject to certain conditions,
Edesa is permitted to engage third parties to perform its
activities or obligations under the agreement.
In exchange
for the exclusive rights to develop and commercialize the product
in the Field, Edesa is committed to payments of various amounts to
Yissum upon meeting certain milestones outlined in the license
agreement up to an aggregate amount of $18.6 million. In addition,
upon divestiture of substantially all of the assets of Edesa, Edesa
is obligated to pay Yissum a percentage of the valuation of the
licensed technology sold as determined by an external objective
expert.
Edesa also has
a commitment to pay Yissum a royalty based on net sales of the
product in countries where Edesa, or an affiliate, directly
commercializes the product and a percentage of sublicensing revenue
received by Edesa and its affiliates in the countries where the
company does not directly commercialize the
product.
The license
agreement provides that Yissum shall remain the exclusive owner of
the licensed technology and that Edesa is responsible for
preparing, filing, prosecuting and maintaining the patents on the
licensed technology in Yissum’s name. Notwithstanding the
foregoing, Edesa will be the exclusive owner of all patents and
other intellectual property that is made by or on behalf of Edesa
after the date of the agreement, including all improvements to the
licensed technology.
If Edesa
defaults or fails to perform any of the terms, covenants,
provisions or its obligations under the license agreement, Yissum
has the option to terminate the license agreement, subject to
providing Edesa an opportunity to cure such default. Edesa has the
right to terminate the agreement if it determines that the
development and commercialization of the product is no longer
commercially viable.
Subject to
certain exceptions, Edesa has undertaken to indemnify Yissum
against any liability, including product liability, damage, loss or
expense derived from the use, development, manufacture, marketing,
sale or sublicensing of the licensed product and
technology.
The foregoing description of the
agreement with Yissum contained herein does not purport to be
complete and is qualified in its entirety by reference to the
agreement, as amended, which is attached hereto as
Exhibits 10.2, 10.3 and 10.4 and incorporated herein by
reference.
License Agreement with Cipher
On
June 15, 2016, Edesa entered into an exclusive license agreement
with Cipher Pharmaceuticals
Inc., an Ontario corporation (“Cipher”). Pursuant to
the license agreement, Edesa obtained exclusive rights throughout the world to
certain know-how, patents and data relating to a pharmaceutical
product. Edesa will use the exclusive rights to develop the product
for therapeutic, prophylactic and diagnostic uses in human and
veterinary anorectal applications (the “Cipher Field”).
Unless earlier terminated, the term of the license agreement will
expire on the date that is twenty (20) years after the first
commercial sale of the product, subject to automatic renewal for
successive one (1) year periods.
Pursuant to
the license agreement, Edesa is exclusively responsible, at its
expense, for the development of the product in the Cipher Field,
including conducting clinical trials and seeking regulatory
approval for the product, and once regulatory approval has been
obtained, for the commercialization of the product. Edesa is
required to use its diligent efforts to develop and commercialize
the product in the Cipher Field in accordance with the terms of the
agreement and with a goal to maximize profits from net sales of the
product in the Cipher Field. Subject to certain conditions, Edesa
is permitted to engage third parties to perform its activities or
obligations under the agreement.
In exchange
for the exclusive rights to develop and commercialize the product
in the Field, Edesa is committed to payments of various amounts to
Cipher upon meeting certain milestones outlined in the license
agreement up to an aggregate amount of $18.5 million.
Edesa also has
a commitment to pay Cipher a royalty based on net sales of the
product in countries where Edesa, or an affiliate, directly
commercializes the product and a percentage of sublicensing revenue
received by Edesa and its affiliates in the countries where the
company does not directly commercialize the
product.
The license
agreement provides that Cipher shall remain the exclusive owner of
the licensed technology. Notwithstanding the foregoing, Edesa will
be the exclusive owner of all patents and other intellectual
property that is made by or on behalf of Edesa after the date of
the agreement, including all improvements to the licensed
technology.
If Edesa
defaults or fails to perform any of the terms, covenants,
provisions or its obligations under the license agreement, Cipher
has the option to terminate the license agreement, subject to
providing Edesa an opportunity to cure such default. Edesa has the
right to terminate the agreement without cause upon sixty (60) days
prior written notice to Cipher.
Subject to
certain exceptions, Edesa has undertaken to indemnify Cipher
against any liability, including product liability, damage, loss or
expense derived from the use, development, manufacture, marketing,
sale or sublicensing of the licensed product and
technology.
The foregoing description of the
agreement with Cipher contained herein does not purport to be
complete and is qualified in its entirety by reference to the
agreement, which is attached hereto as Exhibit 10.5 and
incorporated herein by reference.
License and Development Agreement with
Pendopharm
On August 27,
2017, Edesa entered into an exclusive license and development
agreement with Pendopharm, a division of Pharmascience Inc.
(“Pendopharm”). Pursuant to the license and development
agreement, Edesa granted to Pendopharm an exclusive license
throughout Canada to certain know-how, patents and data for the
sole purpose of obtaining regulatory approval for certain
pharmaceutical products to allow Pendopharm to distribute, market
and sell the licensed products for human therapeutic use in the
conditions of hemorrhoids and anal fissures.
On a licensed
product by licensed product basis, Edesa is required to use
reasonable commercial efforts to develop the licensed products in
the indications of hemorrhoids and anal fissures for the purposes
of obtaining regulatory approval with the United States Food and
Drug Administration (“FDA”) and provide to Pendopharm,
on a licensed product by licensed product basis, the data package
submitted to the FDA. Upon receipt of the data package, Pendopharm
will elect whether it desires to seek regulatory approval in Canada
of the applicable product. If Pendopharm elects not to seek
regulatory approval of the applicable product, the applicable
product will be removed from the license rights granted to
Pendopharm and will revert to Edesa. If Pendopharm elects to seek
regulatory approval in Canada for the sale and marketing of the
applicable product, Pendopharm will be responsible for obtaining
regulatory approval for the applicable licensed product in
Canada.
In exchange
for the exclusive rights to market, import, distribute, and sell
the pharmaceutical products, Pendopharm is required to pay Edesa a
royalty in respect of aggregate annual net sales for each
pharmaceutical product sold in Canada.
Unless earlier
terminated, the term of the license and development agreement will
expire, on a licensed product by licensed product basis, on the
later to occur of (i) the date that is thirteen (13) years after
the first commercial sale of the licensed product in Canada; (ii)
the date of expiry of the last valid licensed patent in Canada
relating to the licensed product; or (iii) the date of expiry of
any period of exclusivity granted to the licensed product by a
regulatory authority in Canada. The license and development
agreement shall also terminate upon the termination of the license
agreement with Yissum or the license agreement with Cipher, each
described above. Pendopharm also has the right to terminate the
license and development agreement for any reason upon one hundred
twenty (120) days notice to Edesa.
The license
and development agreement provides that Edesa shall remain the
exclusive owner of the licensed technology and any improvements to
the licensed technology made by Edesa or Edesa jointly with
Pendopharm.
The foregoing description of the
license and development agreement with Pendopharm contained herein
does not purport to be complete and is qualified in its entirety by
reference to the agreement, which is attached hereto as
Exhibit 10.6 and incorporated herein by
reference.
Item
9.01 Financial Statements and
Exhibits.
(d) Exhibits
Exhibit
No.
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Description of Exhibit
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Lease, dated as of January 1, 2017,
by and between the Registrant and 1968160 Ontario
Inc.
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Exclusive License Agreement, dated
as of June 29, 2016, by and between the Registrant and Yissum Research Development
Company.
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First Amendment to Exclusive License
Agreement, dated April 3, 2017, by and between the
Registrant and Yissum Research
Development Company.
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Second Amendment to Exclusive License
Agreement, dated May 7, 2017, by and between the Registrant
and Yissum Research Development
Company.
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Exclusive License Agreement, dated
as of June 15, 2016, by
and between the Registrant and Cipher Pharmaceuticals
Inc.
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License and Development Agreement,
dated as of August 27, 2017, by and between the Registrant and
Pendopharm, a division of Pharmascience
Inc.
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+
Portions of this exhibit have been omitted pursuant to Rule
601(b)(10)(iv) of Regulation S-K.
SIGNATURE
Pursuant to the requirements of the
Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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EDESA BIOTECH
INC.
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Date:
August 30, 2019
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By:
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/s/ Michael
Brooks
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Name: Michael
Brooks
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Title:
President
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Blueprint
Exhibit 10.1
LEASE
(COMMERCIAL)
Made as
of the 1st day of January, 2017 (the "Lease Commencement Date")
BETWEEN
1968160 ONTARIO INC., a Corporation
incorporated pursuant to the laws of the Province of
Ontario,
(the
"Landlord")
and-
EDESA BIOTECH INC., a Corporation
incorporated pursuant to the laws of the Province of
Ontario,
(the
"Tenant")
In
consideration of the rents, covenants and obligations stipulated
herein the Landlord and the Tenant have agreed to enter into a
lease of certain offices in the building (the "Building") located at 100 Spy Court,
Markham, ON, consisting of approximately 2,800 square feet as more
particularly shown on Schedule "A"
(the
"Premises"), subject to the
terms and conditions contained herein.
The
Landlord leases the Premises to the Tenant:
(a)
at the Rent set
forth in Section 2;
(b)
for the Term set
forth in Section 3; and
(c)
subject to the
conditions and in accordance with the covenants, obligations and
agreements herein.
(1)
Rent means the
amounts payable by the Tenant to the Landlord pursuant to this
Section.
(2)
The Tenant
covenants to pay to the Landlord, during the term of this Lease, a
fixed annual gross rent plus HST as follows:
(a)
Eight Thousand
Three Hundred Twenty Dollars ($8,320.00) per month, payable by the
Tenant in equal monthly installments, plus harmonized sales taxes
on the 1st
day of each and every month, commencing on the first day of the
month following the Lease Commencement Date. For the period between
the Lease Commencement Date and the first day of the month
following the Lease Commencement Date, the Tenant shall pay a
pro-rated amount of such annual gross rent, on the Lease
Commencement Date
(3)
Rent payment
increase by $1/sqft every two years, see Schedule B for payment
schedule.
(4)
For greater
certainty, the fixed annual gross rent described above shall
include the Tenant's proportionate share of the costs of
maintaining and repairing common areas and common facilities of the Building, unless
required due to the acts or omissions of the Tenant, the
Tenant's utilities in the Building, Tenant's security, Tenant's
janitorial services and the Tenant's share of insurance and
property taxes for the Building. Such annual gross rent shall not
include those costs associated with the Tenant's obligations of
repair of the Premises as described in this Lease or the Tenant's
insurance obligations as set out in
this Lease, or any cost incurred by the Landlord that is caused as
a result of the Tenant's acts or omissions.
(5)
Intentionally
deleted.
(6)
The Tenant shall
have non-exclusive access and use of any common areas located in
the Building including the kitchen, washrooms, lobby areas, parking
areas, staff rooms, waiting rooms
and other common areas of the Building, in common with other
tenants of the Building at no additional cost to the Tenant,
except as set out above. Cleaning staff engaged by the Tenant shall
have access to the Premises at all reasonable times. Employees of
the Tenant shall have full access to the staff room serving the
Premises. Each of the Landlord and the Tenant acknowledge that a
portion of the racking will be used by Edesa Biotech to store its
pharmaceutical products.
(7)
All payments to be
made by the Tenant pursuant to this Lease shall be delivered to the
Landlord at the Landlord's address
for service and notice as set out herein or to such other
place as the Landlord may from time to time direct in
writing.
(8)
All Rent in arrears
and all sums paid by the Landlord for expenses incurred which
should have been paid by the Tenant shall bear interest from the
date payment was due, or made, or
expense incurred until paid at a rate per annum equal to the prime
commercial lending rate of the Landlord's bank.
(9)
The Tenant
acknowledges and agrees that the payments of Rent provided for in
this Lease shall be made without any deductions for any reason
whatsoever unless expressly allowed by the terms of this Lease or
agreed to by the Landlord in writing; and no partial payment by the
Tenant which is accepted by the Landlord shall be considered as
other than a partial payment on account of rent owing and shall not
prejudice the Landlord's right to recover any rent
owing.
(1)
The Tenant shall have possession of the Premises
commencing on the Lease Commencement Date and ending on December
31, 2022, with a two year option. (the "Term").
(2)
Subject to the
Landlord's rights under this Lease, and as long as the Tenant is
not in default, the Landlord covenants that the Tenant shall have
quiet enjoyment of the Premises during the Term of this Lease
without any interruption or disturbance from the Landlord or any
other person or persons lawfully claiming through the
Landlord.
(3)
Notwithstanding any
of the foregoing, the Tenant shall have the right, upon not less
than one (1)
month's prior written notice to the Landlord, to terminate the
Term, following which the parties shall have no further obligations
to each other, save and except for the Tenant's obligations
described in Article 7 of this Lease.
(1)
The Tenant shall
not assign this Lease or sublet the whole or any part of the
Premises, unless it first obtains the consent of the Landlord in
writing, which consent shall not unreasonably be withheld or
delayed, and the Tenant hereby waives its right to the
benefit of any present or
future Act of the Legislature of Ontario which would allow the
Tenant to assign this Lease or sublet the Premises without the
Landlord's consent.
(2)
The consent of the
Landlord to any assignment or subletting shall not operate as a
waiver of the necessity
for consent to any subsequent assignment or
subletting.
(3)
Any consent granted
by the Landlord shall be conditional upon the assignee, sublessee
or occupant executing a written agreement directly with the
Landlord agreeing to be bound by all the terms of this Lease as if
the assignee, sublessee or occupant had originally executed
this Lease as
Tenant.
(4)
Any consent given
by the Landlord to any assignment or other disposition of the
Tenant's interest in this Lease
or in
the Premises shall not relieve the
Tenant from its obligations under this Lease, including the
obligation to pay rent as provided for herein.
(5)
Intentionally
deleted.
(1)
During the Term of
this Lease the Premises shall not be used for any purpose other
than a pharmaceutical/distribution office, without the express
consent of the Landlord given in writing.
(2)
The Tenant shall
not do or permit to be done at the Premises anything which
may:
(a)
constitute a
nuisance;
(b)
cause damage to the
Premises;
(c)
cause injury or
annoyance to occupants of neighbouring premises;
(d)
make void or
voidable any insurance upon the Premises; or
(e)
constitute a breach
of any by-law, statute, order or regulation of any municipal,
provincial or other competent authority relating to the
Premises.
(3)
The Tenant shall
conduct all of its operations on the Premises in strict compliance
with all environmental laws and
regulations and shall conduct such operations in accordance with prudent business
practices aimed at preventing any adverse effects, as the same are
defined under the Environmental
Protection Act. Without limiting the generality of the
foregoing, the Tenant shall obtain all required permits issued by
environmental agencies or divisions with respect to its operations
of the Premises.
(4)
The Tenant and the
Premises shall adhere to and shall be responsible for any
infractions of labour laws, municipal laws, and fire codes, and any
other laws pertaining to the Building or the Premises.
6.
REPAIR AND MAINTENANCE
(1)
The Tenant
covenants that during the term of this Lease and any renewal there
of the Tenant shall repair any damage caused to the Premises by
the Tenant, its employees, servants,
agents and invitees.
(2)
The Tenant shall be
responsible for all routine maintenance and repairs to the
Premises.
(3)
The Tenant shall be
responsible for repairs and proportional part of maintenance of the
structural components of the roof, outside walls and foundations of
the Building or any mechanical, electrical, plumbing or HVAC
systems.
(4)
The Tenant shall
permit the Landlord or a person authorized by the Landlord to enter
the Premises to
examine the condition thereof and view the state of repair at
reasonable times.
(a)
If upon such
examination repairs are found to be necessary, written notice of
the repairs required shall be given to the Tenant by or on behalf
of the Landlord and the Tenant shall make the necessary repairs
within the time specified in the notice.
(b)
If the Tenant
refuses or neglects to keep the Premises in good repair the
Landlord may, but shall not be obliged to, make any necessary
repairs, and shall be permitted to enter the Premises, by itself or
its servants or agents, for the purpose of effecting the repairs
without being liable to the Tenant for any loss, damage or
inconvenience to the Tenant in connection with the Landlord's entry
and repairs, and if the Landlord makes repairs the Tenant shall pay
the cost of them immediately as rent in addition to the fixed
annual gross rent.
(5)
Upon the expiry of
the Term or other determination of this Lease the Tenant agrees
to leave the Premises
in a clean broom-swept condition.
(6)
The Tenant shall
immediately give written notice to the Landlord of any
substantial damage that occurs
to the Premises from any cause,
7.
ALTERATIONS AND ADDITIONS
(1)
If the Tenant,
during the Term of this Lease or any renewal of it, desires to make
any alterations or additions to the Premises, including but not
limited to: erecting partitions, attaching equipment, and
installing necessary furnishings or additional equipment of the
Tenant's business, the Tenant may do so at its own expense, at any
time and from time to time, if the following conditions are met:
(a)
before undertaking
any alteration or addition the Tenant shall submit to the Landlord
a plan showing the proposed alterations or additions and items
included in the plan which are regarded by the Tenant as "Tenant's
Trade Fixtures" shall be designated as such on the plan, and the
Tenant shall not proceed to make any alteration or addition unless
the Landlord has approved the plan (including, without limitation,
the right of the Landlord to designate certain such alterations or
additions as "Non-Standard Leasehold Improvements") and agreed to
the designation of the Tenant's Trade Fixtures, and the Landlord
shall not unreasonably or arbitrarily withhold its approval;
and
(b)
any and all
alterations or additions to the Premises made by the Tenant must
comply with all applicable building code standards and by-laws of
the municipality in which the
Premises are located.
(2)
The Tenant shall be
responsible for and pay the cost of any alterations, additions,
installations or improvements that any governing authority,
municipal, provincial or otherwise, may require to be made in, on
or to the Premises.
(3)
All alterations and
additions to the Premises made by or on behalf of the Tenant, other
than the Tenant's Trade Fixtures and the Non-Standard Leasehold
Improvements, shall immediately become the property of the Landlord
without compensation to the Tenant. For greater certainty, the
Tenant shall only be entitled to remove those trade fixtures and
equipment which the Landlord and the Tenant have agreed to
designate as the "Tenant's Trade Fixtures". All other trade
fixtures and equipment shall remain the property of the
Landlord.
(4)
The Tenant agrees,
at its own expense and by whatever means may be necessary,
immediately to obtain the release or
discharge of any encumbrance that may be registered against the
Landlord's property in connection with any additions or alterations
to the Premises made by
the Tenant or in connection with any
other activity of the Tenant.
(5)
The Tenant shall
remove the Tenant's Trade Fixtures and Non-Standard Leasehold
Improvements at the end of the Term
or other termination of this Lease and the Tenant covenants
that it will make good and repair or replace as necessary any
damage caused to the Premises by the removal of the Tenant's Trade
Fixtures and Non-Standard Leasehold Improvements.
(6)
Other than as
provided in paragraph 7(5) above, the Tenant shall not, during the
Term of this Lease or anytime thereafter remove from the Premises
any alterations, additions, Trade Fixtures or other goods and
chattels of the Tenant except in the following
circumstances:
(a)
the removal of the
Tenant's Trade Fixture is in the ordinary course of
business;
(b)
the Tenant's Trade
Fixture has become unnecessary for the Tenant's business or is
being replaced by a new or similar Trade Fixture; or
(c)
the Landlord has
consented in writing to the removal;
but
in any case
the Tenant shall make good any damage caused to the Premises by the
installation or removal of any Trade Fixtures, equipment,
partitions, furnishings and any other objects whatsoever brought
onto the Premises by the Tenant;
(7)
The Tenant shall
not bring onto the Premises or any part of the Premises any
machinery, equipment or any other thing that might in the
opinion of the Landlord, by reason of its weight, size or use,
damage the Premises or overload the floor of the Premises, and
if the Premises
are damaged or overloaded as a result thereof, the Tenant shall
restore the Premises immediately or pay to the Landlord the cost of
restoring the Premises.
(8)
The Tenant shall
not allow any construction lien to arise or be registered against
the Premises, the leasehold interest of the Tenant, or the
Building.
(9)
(a)
The Tenant shall be
permitted to place signage in the reception area of the Leased
Premises to identify the Tenant's reception staff and to identify
services offered by the Tenant to patients. Costs of all such
signage shall be borne by the Tenant.
(b)
The Tenant shall be
permitted to place signage near Brock Road, subject to compliance
with applicable municipal by-laws and approval by the Landlord,
such approval not to be unreasonably or arbitrarily withheld. Costs
of all such signage shall be borne by the Tenant.
The
Tenant shall pay all personal property taxes with respect to the
Tenant's personal property on the Premises that
is not covered in the fixed
annual gross rent.
(1)
The Landlord shall obtain and maintain insurance
against any risk of physical loss or damage to property respecting
the Premises on a replacement cost basis, naming the Landlord
as an insured and the Tenant as an additional
insured.
(2)
The Tenant shall
obtain and maintain at the Tenant's sole cost and expense all risk
public liability and property damage insurance, including personal
injury, in respect of the Premises and the operations
therein, to the extent of not less than $5,000,000, inclusive of
all injuries and/or death to persons and damage to property of
others arising from any one occurrence. The Tenant shall provide
the Landlord with a copy of the above policies or certificates of
insurance, as applicable, upon request.
(3)
The Tenant
covenants to keep the Landlord indemnified against all claims and
demands whatsoever
by any person, whether in respect of damage to person or prope1iy,
arising out of or occasioned
by the maintenance, use or occupancy of the
Premises or the subletting or assignment of same or any part
thereof. And the Tenant further covenants to indemnify the Landlord
with respect to any encumbrance on
or damage to the Premises occasioned by or
arising from the act, default, or negligence of the Tenant,
its officers, agents, servants, employees, contractors,
customers, invitees or licensees and
the Tenant agrees that the foregoing indemnity shall survive
the termination of this Lease notwithstanding any provisions of
this Lease to the contrary.
10. UTILITIES
Tenant
shall pay all charges for gas, electricity, telephone and other
services and utilities used by the Tenant in the Premises during
the term of the Lease unless otherwise expressly agreed in writing
by the Landlord. Tenant acknowledges that the Premises are designed
to provide standard office use electrical facilities and standard
office lighting. Tenant shall not use any equipment or devices that
utilize excessive electrical energy or which may, in the Landlord's
reasonable opinion, overload the wiring.
11.
DAMAGE TO THE PREMISES
(1)
If the Premises or
the building in which the Premises are located, are damaged or
destroyed, in whole or in part, by fire or other peril, then the
following provisions shall apply:
(a)
if the damage or
destruction renders the Premises unfit for occupancy and impossible
to repair or rebuild using reasonable diligence within 120 clear
days from the happening of such damage or destruction, then the
Term hereby granted shall cease from the date the damage or
destruction occurred, and the Tenant shall immediately surrender
the remainder of the Term and give possession of the Premises to
the Landlord, and the rent from the time of the surrender shall
abate;
(b)
if the Premises can
with reasonable diligence be repaired and rendered fit for
occupancy within one hundred and twenty (120) days from the
happening of the damage or destruction, but the damage renders the
Premises wholly unfit for occupancy, then the rent hereby reserved
shall not accrue after the day that such damage occurred, or while
the process of repair is going on, and the Landlord shall repair
the Premises with all reasonable speed, and the Tenant's obligation
to pay rent shall resume immediately after the necessary repairs
have been, completed;
(c)
if the Premises can
be repaired within one hundred and twenty (120) days as aforesaid,
but the damage is such that the Premises are capable of being
partially used, then until such damage has been repaired, the
Tenant shall continue in possession and the rent shall abate
proportionately.
(2)
Any question as to
the degree of damage or destruction or the period of time required
to repair or rebuild shall be determined by an architect retained
by the Landlord.
(3)
Apart from the
provisions of Section 11 (1)(a) there shall be no abatement from or
reduction of the rent payable by the Tenant, nor shall the Tenant
be entitled to claim against the Landlord for any damages, general
or special, caused by fire, water, sprinkler systems, partial or
temporary failure or stoppage of services or utilities which the
Landlord is obliged to provide according to this Lease, from any
cause whatsoever.
12.
ACTS OF DEFAULT AND LANDLORD'S REMEDIES
(1)
An Act of Default
has occurred when:
(a)
the Tenant has
failed to pay rent when due, regardless of whether demand
for payment has been
made or not;
(b)
The Tenant has
breached its covenants or failed to perform any of its
obligations under this Lease;
and
(i)
the Landlord has
given notice specifying the nature of the default and the
steps
required to correct it; and
(ii)
the Tenant has
failed to correct the default as required by the
notice;
(i)
become bankrupt or
insolvent or made an assignment for the benefit of the
Creditors;
(ii)
had its property
seized or attached in satisfaction of a
judgment;
(iii)
had a receiver
appointed;
(iv)
committed any act
or neglected to do anything with the result that a Construction
Lien or other encumbrance is registered against the Landlord's
property;
(v)
without the consent
of the Landlord, made or entered into an agreement to make a sale
of its assets to which the Bulk
Sales Act applies; or
(vi)
taken action if the
Tenant is a corporation, with a view to winding up, dissolution or
liquidation.
(d)
any insurance
policy is cancelled or not renewed by reason of the use or
occupation of the Premises,
or by reason of non-payment of
premiums;
(e)
the Premises are
used by any other person or persons, or for any other purpose than
as provided for in this Lease without the written consent of the
Landlord.
(2)
When an Act of
Default on the part of the Tenant has occurred:
(a)
the current month's
rent and the next three (3) months' rent shall become due and
payable immediately; and
(b)
the Landlord shall
have the right to terminate this Lease and to reenter the Premises
and deal with them as he may choose.
(3)
If, because
an Act of Default has occurred, the Landlord exercises its right to
terminate this Lease and re-enter the Premises prior to the end of
the Term, the Tenant shall nevertheless be liable for payment of
rent and all other amounts payable by the Tenant in accordance with
the provisions of this Lease until the Landlord has re-let the
Premises or otherwise dealt with the Premises in such manner that
the cessation of payments by the Tenant will not result in loss to
the Landlord, and the Tenant agrees to be liable to the Landlord,
until the end of the Term of this Lease for payment of any
difference between the amount of rent hereby agreed to be paid for
the Term hereby granted and the rent any new tenant pays to the
Landlord.
(4)
The Tenant
covenants that notwithstanding any present or future Act of the
Legislature of the Province of Ontario, the personal property of
the Tenant during the term of this Lease shall not be exempt from
levy by distress for rent in arrears.
(a)
The Tenant
acknowledges that it is upon the express understanding that there
should be no such exemption that this Lease is entered into, and by
executing this Lease:
(i)
the Tenant waives
the benefit of any such legislative provisions which might
otherwise be available to the Tenant in the absence of this
agreement; and
(ii)
the Tenant agrees
that the Landlord may plead this covenant as an estoppel against
the Tenant if an action is brought to test the Landlord's right to
levy distress against the Tenant's property.
(b)
The Landlord shall
remit to the Tenant any surplus over the rent in arrears over the
amount received by the Landlord from any levy by distress, less any
costs reasonably incurred by the Landlord in connection therewith
and any amount which the Landlord is required by law to remit to
any governmental authority from such proceeds.
(5)
If, when an Act of Default
has occurred, the Landlord chooses not to terminate the Lease and
re-enter the Premises, the Landlord shall have the right to take
any and all necessary steps to rectify any or all Acts of Default
of the Tenant and to charge the costs of such rectification to the
Tenant and to recover the costs as rent.
(6)
If, when an Act of Default has occurred, the
Landlord chooses to waive its right to exercise the remedies available to it under this
Lease or at law the waiver shall not constitute condonation of the Act of Default, nor
shall the waiver be pleaded as an estoppel against the Landlord to
prevent its exercising its remedies with respect to a subsequent
Act of Default. No covenant, term, or condition of this Lease shall
be deemed to have been waived by the Landlord unless the waiver is
in writing and signed by the Landlord.
13.
TERMINATION UPON NOTICE AND AT END OF TERM
(1)
If the Premises are expropriated or
condemned by any competent authority the Landlord shall have the
right to terminate this Lease by giving ninety (90) clear days'
notice in writing to the Tenant.
(2)
The Tenant agrees
to permit the Landlord, during the last six (6) months of the Term of
this Lease, to display "For Rent" or "For Sale" signs or both at
the Premises and to show the Premises to prospective new tenants or
purchasers and to permit anyone having written authority of the
Landlord to view the Premises at reasonable hours without
disruption to the business of the Tenant and having regard to
patient confidentiality.
(3)
If the Tenant
remains in possession of the Premises after termination of this
Lease as aforesaid and if the Landlord then accepts rent for the
Premises from the Tenant, it is agreed that such overholding by the
Tenant and acceptance of rent by the Landlord shall create a
monthly tenancy only but the tenancy shall remain subject to all
the terms and conditions of this Lease except those regarding the
Term.
14.
SUBORDINATION AND POSTPONEMENT
(1)
This Lease and all the rights of the Tenant under
this Lease are subject and subordinate to any and all charges
against the land, buildings or improvements of which the Premises
form part, whether the charge is in the nature of a mortgage, trust
deed, lien or any other form of charge arising from the financing or re-financing,
including extensions or renewals, from time to time
in existence against the
building.
(2)
Upon request, if a
lender delivers a non-disturbance agreement in favour of the
Tenant, the Tenant will subordinate this Agreement and all rights
hereunder in such form as the Landlord requires to any and all
mortgages, or other instruments of financing, refinancing or
collateral financing as mentioned
above.
15.
INTENTIONALLY DELETED
Failure
by either patty to require performance of any term, covenant or
condition herein contained shall not be deemed to be a waiver of
such term, covenant or condition or of any subsequent breach of the
same or of any other term, covenant or condition herein contained.
The subsequent acceptance or payment of rent, hereunder by the
Landlord shall not be deemed to be a waiver of any preceding breach
by the other of any term, covenant or condition of this Lease,
other than the failure of the Tenant to pay the particular rent so
accepted, regardless of the Landlord's knowledge of such preceding breach at the time of
acceptance of such rent. No covenant, term or condition of this Lease shall be
deemed to have been waived by the Landlord or Tenant, unless such
waiver be in writing by the Landlord or Tenant.
17.
ACCORD AND SATISFACTION
No payment by the Tenant or receipt by the
Landlord of a lesser amount than the monthly rent herein stipulated
shall be deemed to be other than on account of the earliest
stipulated rent, nor shall any endorsement or statement or any
cheque or any letter accompanying any cheque or notation on any
cheque or payment as rent be deemed an accord and satisfaction, and
the Landlord may accept such cheque or payment without prejudice to
the Landlord's right to recover the balance of such rent or
pursue any other remedy in this Lease provided.
This
Lease and the schedules if any, attached hereto and forming a part
hereof, set fo1th all the covenants,
promises, agreements, conditions and understandings between the
Landlord and the Tenant concerning the Premises and there are no
covenants, promises, agreements, conditions or representations,
either oral or written, between them other than are herein and in
the said schedules, if any, set forth. Except as herein
otherwise provided, no subsequent alteration, amendment, change or
addition to this Lease shall be binding upon the Landlord or the
Tenant unless reduced to writing and signed by them.
Subject
to the other provisions of this Lease all rent required to be paid
by the Tenant hereunder shall be paid without any deduction,
abatement or set-off whatsoever.
(1)
Any notice required
or permitted to be given by one party to the other pursuant to the
terms of this Lease may be given
To the
Landlord at: 330 Hwy #7 East, Suite 510, Richmond Hill, ON L4B
3P8
To the
Tenant at the Premises.
(2)
The above addresses
may be changed at any time by giving ten (10) days written
notice.
(3)
Any notice or document so given shall be deemed
to have been received on the third (3rd) business day following the
date of mailing, if sent by registered mail or certified mail, but
shall be deemed to have been received on the next business
day if transmitted by facsimile transmission. Any party may from time to time by notice given
as provided above, change its address for the purpose of this
section.
21.
COUNTERPARTS OF THIS AGREEMENT
This
Agreement may be executed in counterparts, each of which so
executed shall be deemed to be an original, and
such counterparts together shall constitute one and the same
instrument.
The
Tenant waives and renounces the benefit of any present or future
statute taking away or limiting the Landlord's right of distress
and the Tenant covenants and agrees that notwithstanding any such
statute none of the goods and chattels of the Tenant on the Leased
Premises at any time during the Term shall be exempt from levy by
distress for rent in arrears.
23.
ENVIRONMENTAL ISSUES AND CONTAMINANTS
The
Tenant shall not do or permit anything to be done on, around or
in relation
to the Premises, or bring or keep
anything thereon which may in any way increase or cause
environmental contamination, adverse environmental effects, or
which may be in
contravention with
The Environmental
Protection Act, R.S.O. 1990, c.E.19 as amended, or any other
federal, provincial or municipal
legislation, regulation, ordinances or rules regarding
environmental protection which are currently existing or
which are enacted during the currency of this Lease. The Tenant
shall not cause, and shall not permit to be caused, the escape,
discharge, leaching, disposal, maintenance and/or the storage of
any contaminants, pollutants, radioactive material, PCB, or other
hazardous material on, around, or in relation to the Premises. The
Tenant shall be solely and totally responsible for the clean-up and
repair of any environmental damage, or adverse effects arising as a
result of the breach of the covenants herein contained. The Tenant
hereby agrees to indemnify, defend and save the Landlord and any
mortgagee harmless from any and all liability, claims, damage,
expense, causes of action, suits or judgments arising from the
Tenant's breach of this covenant, and all payments arising pursuant
to this or the preceding paragraph shall be deemed to be rent in
addition to the fixed annual gross rent and recoverable as such.
The indemnity referred to herein shall
include, but not be limited to, claims made by third parties
arising out of common law. The Tenant herein covenants to provide
immediate notice to the Landlord of any breach of the covenants
contained herein. The Tenant acknowledges that the Landlord, or its
agents, shall be permitted to enter onto the Leased Premises at any
time to inspect the Leased Premises, if it has reason to believe
that the Tenant has breached its covenant contained herein this
Section. The Landlord shall
also be entitled to take corrective action regarding any breach of
the Tenant's covenants
contained herein, at the Tenant's expense.
The
Tenant shall not at any time register notice of or a copy of this
Lease on title to the property of which the premises form part
without consent of the Landlord.
(1)
The words importing
the singular number only shall include the plural, and vice versa,
and words importing the masculine gender shall include the feminine
gender, and words importing persons shall include firms and
corporations and vice versa.
(2)
Unless the context
otherwise requires, the word "Landlord" and the word "Tenant"
wherever used herein shall be construed to include the executors,
administrators, successors and assigns of the Landlord and Tenant,
respectively.
(3)
When there are two
or more Tenants bound by the same covenants herein contained, their
obligations shall be joint and several.
[signatures on next page]
IN WITNESS WHEREOF the
Landlord and the Tenant have signed and scaled this Lease as of the
day and year first above written.
SIGNED,
SEALED AND DELIVERED
in the
presence of
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1968160 ONTARIO INC.
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)
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)
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)
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/s/
Nidhi Nijhawan
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)
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By:
Nidhi Nijhawan
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)
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Its:
President
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)
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I have authority to bind the Corporation.
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)
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)
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EDESA BIOTECH INC.
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)
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)
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)
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/s/
Dr.
Par Nijhawan
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)
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By:
Dr.
Par Nijhawan
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)
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Its:
Chief
Medical Officer
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)
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I have authority to bind the Corporation.
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Schedule "B" Rent
Payment Schedule
Start
Date
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End
Date
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Monthly
Rent
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Jan-17
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Dec-18
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$8,320.00
+HST
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Jan-19
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Dec-20
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$8,553.33
+HST
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Jan-21
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Dec-22
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$8,786.67
+HST
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Jan-23
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Dec-24
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$9,020
+HST
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Blueprint
Exhibit 10.2
CERTAIN IDENTIFIED INFORMATION HAS BEEN
EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD
LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY
DISCLOSED.
Execution Version: 29/06/16
EXCLUSIVE LICENSE AGREEMENT
by and between
YISSUM RESEARCH DEVELOPMENT COMPANY OF THE HEBREW UNIVERSITY OF
JERUSALEM LTD
and
EDESA BIOTECH INC.
June 29, 2016
TABLE
OF CONTENTS
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Pages
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ARTICLE 1 DEFINITIONS
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ARTICLE 2 SCOPE
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2.1
Scope
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ARTICLE 3 PRODUCT DEVELOPMENT AND COMMERCIALIZATION
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3.1
Overview
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3.2
Conduct of Development and Commercialization
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3.3
Development Plan
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3.5
Rights to Sublicense
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ARTICLE 4 MANUFACTURE AND SUPPLY
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4.1
Responsibility for Manufacturing and Supply
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ARTICLE 5 REGULATORY.
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5.1
Regulatory Obligations
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5.2
Safety Reporting
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5.3
Recalls
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5.4
Pricing and Reimbursement
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ARTICLE 6 PAYMENTS
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6.1
Milestone Payments
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6.2
Product Royalties
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6.3
Reports; Payment of Royalty
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6.4
Audits
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6.5
Payment Exchange Rate
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6.6
Tax Withholding
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6.7
Late Payments
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ARTICLE 7 LICENSES; EXCLUSIVITY
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7.1
Exclusive License and Right to Sublicense
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7.2
No Implied Licenses
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7.3
Retained Rights
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ARTICLE 8 CONFIDENTIALITY; PUBLICATION
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8.1
Nondisclosure Obligation
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8.2
Publicity; Use of Names
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ARTICLE 9 REPRESENTATIONS AND WARRANTIES
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9.1
Representations and Warranties of YISSUM
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9.2
Representations and Warranties and Covenants of EDESA.
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TABLE
OF CONTENTS
(continued)
9.3 Representations and
Covenants of Both Parties
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9.4
No Other Representations or Warranties
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ARTICLE 10 INDEMNIFICATION
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10.1 General
Indemnity By EDESA.
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10.2 Limited
Indemnity To Be Granted to EDESA.
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10.3
Defense
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10.4
Settlement.
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10.5
Notice
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10.6
Permission by EDESA.
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10.7 Limitation of
Liability
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10.8
Insurance
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ARTICLE 11 INVENTIONS; PATENT PROVISIONS
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11.1 Ownership of
Intellectual Property
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11.2 Patent
Prosecution
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11.3
Fees
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11.4
Enforcement.
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11.5
Defense
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ARTICLE 12 TERM AND TERMINATION
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12.1
Term
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12.2 Termination
for Cause
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12.3
Termination Without Cause
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12.4 Effect
of Termination
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12.5
Survival.
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ARTICLE 13 MISCELLANEOUS
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13.1 Force
Majeure
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13.2
Assignment.
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13.3
Severability
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13.4
Notices
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13.5
Applicable Law and Litigation
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13.6 Entire
Agreement; Amendments
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13.7
Independent Contractors
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13.8
Waiver
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13.9
Cumulative Remedies
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13.10 Waiver of Rule of
Construction
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13.11 Further
Assurances
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13.12 Construction
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13.13 Currency
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13.14 Dispute
Resolution
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13.15 Statute of
Limitations
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13.16 Injunctive and Other
Interim Relief.
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13.17 Execution in
Counterparts; Facsimile Signatures
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EXCLUSIVE LICENSE AGREEMENT
This
Agreement ("Agreement"),
effective as of June 29, 2016 ("Effective Date"), is entered into by
and between Yissum Research Development Company of the Hebrew
University of Jerusalem, an Israeli corporation with its principal
office at Hi-Tech Park, Edmond J. Safra Campus, Givat-Ram,
Jerusalem P.O. Box 39135, Jerusalem 91390 Israel ("YISSUM"), and Edesa Biotech Inc., an
Ontario corporation with its principal office at I 00 Spy Court,
Markham, Ontario, L3R 5H6 ("EDESA"). YISSUM and EDESA may be
referred to herein individually as a "Party" or collectively as the
"Parties". Reference to a
Party shall be deemed to include that Patty's
Affiliates.
RECITALS:
A.
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YISSUM
owns the rights to certain know-how, patents and data relating to
MRX-6 (a topical formulation of a Hyaluronic Acid (HA) conjugated
with dipalmitoyl PHOSPHATIDYL-ethanolamine (DPPE) (the "Product") developed by Professor Saul
Yedgar (the "Researcher"),
of the Hebrew University of Jerusalem (the "University") and Akari Therapeutics
(f/k/a Celsus Therapeutics), the previous licensee of the Licensed
Technology (as defined below).
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B.
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EDESA
is a pharmaceutical company having expertise in the discovery,
development, manufacturing and commercialization of innovative
human pharmaceutical products.
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C.
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EDESA
and YISSUM desire to enter into an agreement under which EDESA will
obtain exclusive rights to develop the Product for therapeutic,
prophylactic and diagnostic uses in topical dermal applications and
anorectal applications (but excluding ophthalmological
uses)(collectively, the "Field").
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Concurrently with
the execution of this Agreement, EDESA is executing a consulting
agreement with the Researcher, under which the Researcher shall
provide certain consulting services to EDESA. In consideration of
the foregoing premises and the mutual covenants herein contained,
the Parties hereby agree as follows:
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
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"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.
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1.2
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"ADRC" has the meaning set
forth in Section 13.14.
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1.3
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"Affiliate" means with respect to a Party, any person or
entity controlling, controlled by or under common control with such
Party. For purposes of this Section 1.3, "control" shall mean: (a) in the
case of a corporate entity, direct or indirect ownership of fifty
percent (50%) or more of the stock or shares having the right to
vote for the election of directors of such corporate entity; and
(b) in the case of an entity that is not a corporate entity, the
possession, directly or indirectly, of the power to direct, or
cause the direction of, the management or policies of such entity,
whether through the ownership of voting securities, by contract or
otherwise.
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1.4
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"Arbitration Panel Finalization" has the meaning set forth
in Section 13.14.
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1.5
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"Calendar Quarter" means the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September
30 and December 31.
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1.6
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"Calendar Year" means the respective periods of twelve (12)
months commencing on January 1 and ending on December
31.
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1.7
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"Claimant" has the meaning set forth in Section
13.14.
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1.8
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"Clinical Material(s)" means the Product formulated in
accordance with the Specifications and applicable Canadian, United
States and/or foreign laws, rules and regulations: (a) for
preclinical activities; and (h) for administration to subjects in
Clinical Trials.
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1.9
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"Clinical Trial(s)" means clinical trials in each with
respect to the Product in the Field.
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1.10
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"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.
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1.11
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"Confidential Information" has the meaning set fo1th in
Section 8.1.
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1.12
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"Confirmatory Efficacy Study" means a second human Clinical
Trial to confirm with statistical significance the efficacy and
safety of the Product in the Field.
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1.13
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"Control," "Controls" or "Controlled by" means (except as
used in Section 1.3), with respect to any item of or right under
the Licensed Technology, the ability of a Party (whether through
ownership or license, other than pursuant to this Agreement) to
grant access to, or a license or sublicense of, such item or right
as provided for herein without violating the terms of any agreement
or other arrangement with any Third Party existing at the time such
Party would be required hereunder to grant the other Party such
access or license or sublicense.
|
1.14
|
"Debarred" has the meaning set forth in Section Error! Reference source not
found..
|
1.15
|
"demand for arbitration" has the meaning set forth in
Section 13.14.
|
1.16
|
"Develop" or "Development" or "Developing" means research,
discovery, process development, manufacturing for preclinical and
clinical uses, preparation for drng reimbursement, preparation and
initiation of medical education and liaison activities and
preclinical and clinical drng or biological development activities,
including test method development and stability testing,
toxicology, formulation, quality assurance/quality control
development, statistical analysis, preclinical and clinical studies
and regulatory affairs, Regulatory Approval and registration, in
each case, of a Product for use in the Field.
|
1.17
|
"EDESA Indemnitee(s)"
has the
meaning ascribed to it in Section 10.2.
|
1.18
|
"EDESA Data" means any proprietary scientific, technical,
clinical or regulatory information, results and data of any type
whatsoever, in any tangible or intangible form whatsoever,
including databases, safety information, filings, practices,
methods, techniques, specifications, formulations, formulae,
knowledge, know-how, skill, experience, test data including
pharmacological, medicinal chemistry, biological, chemical,
biochemical, toxicological and clinical test data, analytical and
quality control data, stability data, studies and procedures, and
manufacturing process and development information, results and data
that are related to the Product (or a composition containing the
Product or the manufacturing or use of the Product).
|
1.19
|
"EMEA" means the European Medicines Evaluation Agency or any
successor agency thereto.
|
1.20
|
"FDA" means the United States Food and Drug Administration
or any successor agency thereto.
|
1.21
|
"Field" has the meaning ascribed to it in the
recitals.
|
1.22
|
"First Commercial Sale" means, with respect to the Product
in the Field, the first sale to a Third Party for end use or
consumption of the Product in the Field in a country in the
Territory after Regulatory Approval of the Product in the Field has
been granted by the Regulatory Authority of such
country.
|
1.23
|
"ICH" means the International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use.
|
1.24
|
"IFRS" means International Financial Regulatory Standards as
the same may be in effect from time to time.
|
1.25
|
"IND" means an Investigational New Drug application in the
United States, a Clinical Trial Application in Canada, or a foreign
equivalent application or submission for approval to conduct human
clinical investigations filed with or submitted to a Regulatory
Authority in conformance with the requirements of such Regulatory
Authority.
|
1.26
|
"Indemnifying Party" has the
meaning ascribed to it in Section Error! Reference source not
found..
|
1.27
|
"indemnitee" has the meaning
ascribed to it in Section Error! Reference source not
found..
|
1.28
|
"Indication" means any separate and distinct disease (or
stage of disease), disorder or medical condition in humans or
non-human animals which a Product is intended to treat, prevent,
diagnose, monitor or ameliorate and which, for a Product candidate,
is intended to be reflected in the labeling for such Product as an
approved indication, and which, for an approved Product, is
reflected in the labeling for such Product.
|
1.29
|
"Information" means any and all scientific, pre-clinical,
clinical, regulatory, manufacturing, marketing, financial and
commercial information and data related to the Product, in any
tangible or intangible fom1.
|
1.30
|
"Knowledge" shall mean actual knowledge of any of the
current officers of the Party gained in the regular course of the
relevant Party's business.
|
1.31
|
"Licensed Technology" means (a) all Patents; (b) any regulatory approvals relating to
the Product; (c) any proprietary scientific, technical, clinical or
regulatory information, results and data of any type whatsoever, in
any tangible or intangible form whatsoever, including databases,
safety information, filings, practices, methods, techniques,
specifications, formulations, formulae, knowledge, know-how, skill,
experience, test data including pharmacological, medicinal
chemistry, biological, chemical, biochemical, toxicological and
clinical test data, analytical and quality control data, stability
data, studies and procedures, and manufacturing process and
development information, results and data and (d) any proprietary
biological, chemical or physical materials; all Controlled by
YISSUM or the Researcher as of the Effective Date or at any time
during the Term, including any active pharmaceutical ingredient
related to the product in the case of each of (a), (b), (c) and (d)
that are: (i) related to the Product (or a composition containing
the Product or the manufacturing or use of the Product); and (ii)
necessary or useful for EDESA to exercise the rights licensed to it
under this Agreement or to perform its obligations under this
Agreement.
|
1.32
|
"NDA" or "New Drug Application" means an application
submitted to FDA pursuant to 21 U.S.C. § 505(6) or a Canadian
or foreign equivalent application or submission to a Regulatory
Authority which contains complete details of the manufacture and
testing of a new drug, for purposes of obtaining Regulatory
Approval for such new drug in the applicable jurisdiction, for a
particular Indication, and also includes a Biologics License
Application.
|
1.33
|
"Net Sales" means the gross amount invoiced and billed by
EDESA or its Affiliates to
unrelated Third Parties (excluding any Sublicense) for the Product
in the Territory, less:
|
(a)
|
Trade,
quantity and cash discounts actually allowed or paid;
|
(b)
|
Commissions,
discounts, refunds, rebates (including wholesaler fees),
chargebacks, retroactive price adjustments, and any other
allowances actually allowed or paid which effectively reduce the
net selling price;
|
(c)
|
Actual
Product returns and allowances;
|
(d)
|
Any
sales, use, excise, value added taxes or similar taxes measured by
the billing amount, when included in billing;
|
(e)
|
Any
freight, postage, shipping, and insurance charges related to
delivery of the Product from an applicable warehouse, all to the
extent included in the third party invoices; and
|
(f)
|
custom,
import and export duties actually paid.
|
Any
refund or reimbursement of any of the foregoing amounts previously
deducted from Net Sales shall be appropriately credited to Net
Sales, or adjusted through allowances, upon receipt
thereof.
For
greater certainty "Net Sales" shall not include sales or transfers
between members of the group comprised of EDESA, Sublicensees, and
their Affiliates.
For
greater ee1tainty, provision of Product for the purpose of
conducting Clinical Trials in order to obtain Regulatory Approvals
shall not be deemed to be a sale.
Such
amounts shall be determined from the books and records of EDESA or
its Affiliates or Sublicensees, as applicable, maintained in
accordance with IFRS, consistently applied, except where IFRS is
not the standard, in which case whatever the accounting standard is
in effect will be applied. EDESA further agrees that in determining
such amounts, it will use EDESA's then current standard procedures
and methodology, including EDESA's then current standard exchange
rate methodology for the translation of foreign currency sales into
U.S. Dollars, consistently applied.
1.34
|
"Patent(s)" means: (a) all patents and patent applications
in any country or supranational jurisdiction; and (b) any
provisionals, substitutions, divisions, continuations,
continuations in part, reissues,
renewals, registrations, confirmations, reexaminations,
extensions, supplementary protection ce1tificates and the
like, of any such patents or patent applications Controlled by YISS
UM or the Researcher where the Researcher is listed as an inventor,
as of the Effective Date or at any time during the Term that are
related to the Product (or a composition containing the Product or
the manufacturing or use of the Product) and necessary or useful
for EDESA to exercise the rights licensed to it under this
Agreement or to perform its obligations under this Agreement,
including, without limitation, the Patents listed in Appendix
B.
|
1.35
|
"Phase III Clinical Study" means a human clinical study to
confirm with statistical significance the efficacy and safety of
the Product in the Field performed to obtain Regulatory Approval
for the Product.
|
1.36
|
"Product" has the meaning ascribed to it in the
recitals.
|
1.37
|
"Regulatory Approval(s)" means all approvals or
authorizations by Regulatory Authorities necessary to market and
sell the Product in the Field in the Territory.
|
1.38
|
"Regulatory Authority" means any applicable government
regulatory authority involved in granting approvals for the conduct
of Clinical Trials or for an NDA in the Territory, including in the
United States, the FDA, and in Canada, Health Canada.
|
1.39
|
"Respondent" has the meaning set forth in Section
13.14.
|
1.40
|
"Royalties" has the meaning set forth in Section
6.2.
|
1.41
|
"Specifications" means the specifications for the Product as
provided by Yissum as part of the Licensed Technology.
|
1.42
|
"Sublicensee" means a Third Party that is granted a
sublicense under the licenses granted to a Party under this
Agreement.
|
1.43
|
"Sublicensing Fees" has the meaning set forth in Section
6.2.
|
1.44
|
"Sublicensing Revenue" means the net amount of all revenues,
royalties, receipts, and monies, including upfront payments,
milestone payments, and license fees, earned or received by EDESA
and its Affiliate(s) from Sublicensee(s) with respect to the
Product.
|
1.45
|
"Term" has the meaning set forth in Section
12.1.
|
1.46
|
"Territory" means the entire world.
|
1.47
|
"Third Party" means an entity other than: (a) EDESA and its
Affiliates; and (b) YISSUM and its Affiliates.
|
1.48
|
"United States" means the United States of America and its
territories and possessions, including the Commonwealth of Puerto
Rico and the U.S. Virgin Islands.
|
1.49
|
"YISSUM indemnitee(s)" has the meaning ascribed lo it in
Section 10.1.
|
Pursuant to and
subject to the terms of this Agreement: (a) EDESA will be
exclusively responsible for the Development of the Product in the
Territory in the Field with the goal of obtaining Regulatory
Approval for the Product, and, once Regulatory Approval has been
obtained, for the Commercialization of the Product; and (b) EDESA
will have exclusive rights to Develop and Commercialize the Product
as fu1ther set forth in Section 3.1, in exchange for royalty and
other payments to be made to YISSUM as described in Article
6.
ARTICLE 3
PRODUCT DEVELOPMENT AND COMMERCIALIZATION.
From
and after the Effective Date, EDESA shall have full responsibility
and authority, at its sole cost and expense, for the Development
and Commercialization of the Product in the Field in the Territory,
including (a) the conduct of all Clinical Trials and (b) seeking
Regulatory Approvals for the Product. Upon EDESA 's request, YISSUM
will promptly execute such letters as may be required in order to
effect transfer to EDESA of any IND, for filing with the relevant
Regulatory Authorities.
3.2
|
Conduct
of Development and Commercialization.
|
EDESA
shall use commercially reasonable efforts to Develop and
Commercialize the Product in the Field in the Territory in
accordance with the Development Plan, as defined in Section 3.3.
For purposes of this Agreement, "commercially reasonable efforts"
means such efforts as would be employed by EDESA for a product at a
similar development stage, having similar market potential and
having similar commercial and scientific advantages and
disadvantages based on conditions then prevailing. EDESA shall
report to YISSUM through the Development Plan as to the status of
Development and Commercialization of the Product in the
Field.
EDESA will be
responsible for the Development of the Product in accordance with
the plan (the "Development
Plan") set fo1ih in Appendix A, including the development
targets (the "Development
Targets") referenced therein. EDESA shall periodically
prepare an update to the Development Plan and deliver same to
YISSUM within sixty (60) days of the end of every 6- month period
following the execution of this Agreement, for the first two years
of this Agreement and, thereafter, within sixty (60) days following
each twelve (12) month anniversary of the execution of this
Agreement. The parties acknowledge and agree the Development
Targets will initially be based on the Parties best estimation of
what can be accomplished and will be adjusted by mutual agreement
in light of EDESA 's actual
Development experience. After the submission of each Development
Plan update, the Pa11ies will meet (in person or through other
means) and work in good faith to amend and adjust the Development
Plan and Development Targets as needed.
EDESA
shall sponsor research by or under the direction of the Researcher
in connection with the development of the Licensed Technology and
the Products as needed. EDESA shall consider in good faith (but is
not obligated to approve) requests from the Researcher to sponsor
research to be conducted by or under the direction of Researcher to
develop the Licensed Technology.
EDESA
shall have tbc right to engage Third Parties (each a "Sublicensee") to perform any of its
activities or obligations hereunder, provided that EDESA shall be
responsible for ensuring
that,
prior to any such engagement, any Sublicensees are subject to a
agreement (a "Sublicense
Agreement") containing terms and conditions: (i) specifying
that such written agreements terminate upon termination of this
Agreement; (ii) consistent with the relevant terms and conditions
of this Agreement protecting the rights of YISSUM under this
Agreement including imposing obligations of confidentiality on each
such Sublicensee; (iii) that vest ownership of any and all
inventions developed by such Sublicensee relating lo Products in
the course of performing activities under such sublicense in EDESA;
and (iv) that do not impose any payment obligations or liability on
YISSUM without the prior written consent of YJSSUM. EDESA shall
require each Sublicensee to provide it with regular written royalty
reports that include at least the detail that EDESA is required to
provide to YJSSUM pursuant to this Agreement. Upon request, EDESA
shall provide such reports to YISSUM. EDESA shall provide YISSUM
with an executed copy of each Sublicense Agreement within thirty
(30) days of its execution.
ARTICLE 4 MANUFACTURE AND SUPPLY
4.1
|
Responsibility
for Manufacturing and Supply.
|
(a) EDESA will be responsible, at its own
cost, for the manufacture of Product and Clinical Materials.
Promptly following the execution of this Agreement, YISSUM shall
deliver to EDESA copies of all Jnfom1ation in its possession or
Control, including manufacturing know how, and any and all original
processes, records, directly related to the manufacture and supply
of the Product and Clinical Materials in accordance with the
applicable Specifications.
(b) Upon the request of EDESA, YISSUM
shall promptly ship to EDESA any unexpired active pharmaceutical
ingredient for the Product in its possession or
Control.
EDESA
shall be responsible, al its own cost, for, and shall have the sole
right to control, all regulatory activities and strategy associated
with JNDs, NDAs and all other submissions for Regulatory Approvals,
all Regulatory Approvals, and the maintenance of such submissions
and Regulatory Approvals, as well as seeking approval for
reimbursement or pricing of a Product in the Territory, in each
case with respect to the Product in the Field, including
communicating and preparing and filing all reports including all
INDs and NDAs with the applicable Regulatory Authorities. YISSUM
shall reasonably cooperate with EDESA as requested, in preparing
and filing all such reports, and YISSUM shall provide EDESA with
all available information, including regulatory, technical and
clinical data concerning the Product to enable EDESA to prepare and
file such rep011s. EDESA shall pay all governmental fees associated
with obtaining and maintaining any and all Regulatory Approvals
including any establishment license fees of EDESA or Third Pai1ies
which must be paid with respect to facilities used in the
manufacture of the Product by or on behalf of EDESA.
EDESA
shall be responsible for all regulatory activities relating to the
Product in the Field including: (i) management and monitoring of
safety and Adverse Event/experience information for; (ii)
regulatory reporting; (iii) managing the global safety data base
for the Product; and (iv) reviewing and approving of safety
information for inclusion in the Product label in the Ten-itory,
including the costs and expenses thereof.
EDESA
shall be responsible for any recall decision and the conduct of any
recall in respect of the Product in the Field, including the costs
and expenses thereof.
5.4
|
Pricing
and Reimbursement.
|
EDESA
shall be solely responsible for selling the price for the Product
in the Field and may do so without discussion or consultation with
YISSUM.
EDESA
shall immediately notify YISSUM of the achievement of any of the
following development and commercial milestones, all for the
Product in the Field, and EDESA shall pay to YISSUM the milestone
payments listed below which shall be due and payable within thirty
(30) days after the event for which the payment is due (or, for
milestones based on Net Sales, within thirty (30) days after the
end of the Calendar Year with respect to which such milestone is
triggered):
Upon Execution of
this Agreement
|
|
[
]
|
|
|
|
Upon the 6-month
Anniversary of the Execution of this
Agreement
|
|
[
]
|
|
|
|
Upon the dosing of
the 1st patient into a Confirmatory Efficacy Study for the
first Indication for
which Regulatory Approval will be sought.
|
|
[
]
|
|
|
|
Upon receipt of the
first Regulatory Approval for the Product from the FDA
|
|
[
]
|
|
|
|
Upon the First
Commercial Sale of the Product in the United
States
|
|
[
]
|
|
|
|
First occurrence of
$[ ] million in aggregate Net Sales in a Calendar Year in
countries where EDESA or an Affiliate directly Commercializes the
Product
|
|
[
]
|
First occurrence of
$[ ]
million in aggregate Net Sales in a Calendar Year in countries
where EDESA or an Affiliate directly Commercializes the
Product
|
|
[
]
|
|
|
|
First occurrence of
$[ ]
million in aggregate Net Sales in a Calendar Year in countries
where EDESA or an Affiliate directly Commercializes the
Product
|
|
[
]
|
|
|
|
Upon divestiture of
substantially all of the assets of the EDESA, during the process of
evaluating the assets of the EDESA, EDESA shall pay YISSUM:
|
|
[
]% of the valuation of the Licensed Technology by an
external objective expert, if the transaction is closed within 5
years from the date of the execution of this Agreement
|
|
|
|
|
|
[ ]%
of the valuation of the Licensed Technology by an external
objective excet, if the transaction is closed after 5 years from
the date of the execution of this Agreement
|
For
clarity, the aggregate Net Sales that are taken into account in
order to calculate the achievement of a specific sales threshold
milestone for a Calendar Year cannot also be taken into account in
order to calculate the achievement of additional sales threshold
milestone(s) in that same calendar year.
EDESA
shall pay to YISSUM a royalty of [ ]%
of Net Sales ("Royalties")
of the Product in the countries in the Territory where it or an
Affiliate directly Commercializes the Product. EDESA shall pay to
YISSUM an amount equal to [ ]%
of Sublicensing Revenue received by EDESA and its Affiliates
("Sublicensing Fees") in the
countries in the Territory where it does not directly Commercialize
the Product.
6.3
|
Reports;
Payment of Royalty.
|
Following the
earlier of (a) the First Commercial Sale of the Product and (b)
execution of a Sublicense Agreement with a Sublicensee, EDESA shall
furnish to YISSUM written reports for each fiscal quarter and each
fiscal year; each such report showing in relation to the reporting
period, as applicable: (i) the Net Sales of the Product in the
Territory and the royalties payable under this Agreement in respect
thereof; and (ii) Sublicensing Revenues received and the
Sublicensing Fees payable under this Agreement in respect thereof.
Reports in respect of a fiscal quarter shall be due on the
thirtieth (30th) day following the close of such fiscal quarter and
annual reports shall be due on the sixtieth (60th) day following
the close of such fiscal year. Royalties and Sublicensing Fees
shown to have accrued by each report shall be due and payable on
the date such
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.
(a)
|
EDESA
will keep and maintain (and to the extent applicable, will cause
its Affiliates, and their respective Sublicensees, distributors,
assignees and transferees to keep and maintain) proper and complete
records and books of account in such form and detail as is
necessary for the determination of the amounts payable by EDESA (on
behalf of itself and its Affiliates and their respective
Sublicensees, distributors, assignees and transferees) to YISSUM
under this Agreement and for the purposes of this
Agreement.
|
(b)
|
Upon
the written request of YISSUM and not more than once in each
Calendar Year, EDESA shall permit an independent certified public
accounting firm of nationally recognized standing in the United
States (that has been retained on an hourly or flat fee basis and
receives no contingency fee or other bounty or bonus fee) selected
by YISSUM, at YISSUM's expense, to have access during normal
business hours to such of the records of EDESA as may be reasonably
necessary solely to verify the accuracy of the royalty reports
hereunder for any Calendar Year ending not more than thirty six
(36) months prior to the date of such request. This right to audit
shall remain in effect throughout the life of this Agreement and
for a period of three (3) years after the termination of this
Agreement.
|
(c)
|
YISSUM
shall share the accounting firm's final written report with EDESA
within thirty (30) days of its receipt by YISSUM. If such
accounting firm identifies a discrepancy by EDESA made during such
period, EDESA shall pay YISSUM the amount of the discrepancy within
thirty (30) days of the date YISSUM delivers to EDESA such
accounting firm's written report so concluding, or as otherwise
agreed upon by the Parties. The fees charged by such accounting
firm shall be paid by YISSUM unless the underpayment exceeded ten
percent (10%) of the amount owed by EDESA to YISSUM for such
Calendar Year, in which case, EDESA shall pay to YISSUM the
reasonable fees charged by such accounting firm which fees shall
not exceed $25,000. EDESA shall pay interest on the amounts owed to
YISSUM, and said interest shall be calculated as being 2% greater
than the U.S. commercial prime rate as published by the Wall Street
Journal on the date of the first discrepancy identified in the
audit, and shall accrue from the date payments should have been
made.
|
(d)
|
EDESA
shall include in each sublicense granted by it pursuant to this
Agreement a provision requiring the Sublicensee to make reports to
EDESA, to keep and maintain records of sales made pursuant to such
sublicense and to grant access to such records by YISSUM's
independent accountant to the same extent required of EDESA under
this Agreement.
|
(e)
|
YISSUM
shall treat all financial information subject to review in
accordance with the confidentiality and non-use provisions of this
Agreement, and shall cause its accounting firm to
enter into an acceptable confidentiality agreement with EDESA, its
Affiliates or Sublicensees, as applicable obligating it to retain
all such information in confidence pursuant to such confidentiality
agreement.
|
All
payments to be made by one Party to the other under this Agreement
shall be made in United States dollars by bank wire transfer in
immediately available funds to a bank account designated in writing
by the Party receiving the payment. In the case of sales outside
the United States, royalty payments by EDESA to YISSUM shall be
converted to United States Dollars in accordance with the
following: the rate of currency conversion shall be calculated
using a simple average of mid-month and month-end rates as provided
by the spot rate as published by The Wall Street Journal, New York
City Edition for such accounting period.
The
Parties will withhold taxes with respect to payments under this
Agreement under applicable law.
EDESA
shall pay interest to YISSUM on the aggregate amount of any
payments that are not paid on or before the date such payments are
due under this Agreement at a rate per annum equal to one percent
(1%) per month, calculated on the number of days such payments are
paid after the date such payments are due and compounded
monthly.
ARTICLE 7 LICENSES; EXCLUSIVITY
7.1
|
Exclusive
License and Right to Sublicense.
|
Subject
to the terms and conditions of this Agreement, YISSUM hereby grants
EDESA and its Affiliates an exclusive, worldwide, royalty-bearing
license, with the right to grant sublicenses in accordance with
Section 3.5 above, to use the Licensed Technology for the
Development and Commercialization of the Product in the Field in
the Territory.
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.
Notwithstanding the
provisions of Section 7.1, above, YISSUM, on behalf of the
University, may submit requests to EDESA to make, use and practice
portions of the Licensed Technology solely for the University's own
non-commercial academic and teaching purposes provided that a
specific request is submitted to EDESA by, or on behalf, of the
University employee wishing to make such use, with such portions
and purposes to be identified in the request. EDESA will not
unreasonably withhold, condition or delay its consent to such
YISSUM requests.
ARTICLES CONFIDENTIALITY; PUBLICATION
8.1
|
Nondisclosure
Obligation.
|
(a)
|
Except
as provided in this Section 8.1, all confidential or proprietary
information disclosed by one Party or any of its Affiliates to the
other Party or any of its Affiliates hereunder in connection with
this Agreement, whether disclosed or provided prior to or after the
Effective Date and whether provided orally, visually,
electronically or in writing, shall be maintained in confidence by
the receiving Party and shall not be disclosed to any Third Party
or used for any purpose except as set fo1ih herein without the
prior written consent of the disclosing Party, until five (5) years
following the Term of this Agreement, except to the extent that
such Information:
|
(i)
|
is
known by the receiving Party at the time of its receipt, and not
through a prior disclosure by the disclosing Party under a
confidentiality agreement, as documented by the receiving Party's
business records;
|
(ii)
|
is or
becomes part of the public domain through no fault of the receiving
Party;
|
(iii)
|
is
subsequently disclosed to the receiving Party by a Third Party who
may lawfully do so and is not under an obligation of
confidentiality to the disclosing Party; or
|
(iv)
|
is
developed by the receiving Party independently of Information
received from the disclosing Party, as documented by the receiving
Party's business records.
|
All
information disclosed by one Party to the other hereunder, other
than described in Subsections (i) through (iv) above, is
hereinafter referred to as "Confidential Information". The
Information and the Licensed Technology and the terms and
conditions of this Agreement shall be deemed the Confidential
lnformation of both Parties.
(b)
|
Each
Party may disclose Confidential lnformation of the other Party,
without such other Party's prior written consent, to its and its
Affiliates' directors, officers, employees, agents, consultants,
Sublicensees, suppliers, and other persons or entities
who:
|
(i)
|
need to
know such Confidential Information to assist the Party in
fulfilling its obligations hereunder or, the case of YISSUM,
otherwise assists YISSUM in the Development or Commercialization of
the Product outside of the Field; and
|
(ii)
|
are
bound by written confidentiality and non-use obligations consistent
with those the Party uses to protect its own Confidential
Information.
|
(c)
Each Party shall promptly disclose to the other Party the nature
and scope of any breach of this provision by it, or its Affiliates,
directors, officers, employees, agents, consultants, Sublicensees,
suppliers, or other persons or entities permitted hereunder and the
steps taken to contain and address the breach.
(d)
Each Party may also disclose the Confidential Information of the
other Party, without such other Party's prior written consent, to
any person, entity, or government or Regulatory Authority to the
extent that the law requires such disclosure, including filings
pursuant to applicable securities or tax laws and regulations. The
Party disclosing such Confidential Information shall take such
actions as are reasonable to preserve the confidentiality of such
Confidential Information, such as requesting confidential
treatment. In addition, EDESA may also disclose YISSUM's
Confidential Information, without the YISSUM's prior written
consent, to any person, entity, or government or Regulatory
Authority to the extent that such disclosure is necessary for
obtaining, maintaining, or amending any Regulatory Approvals,
seeking approval for reimbursement or pricing of a Product in the
Territory or satisfying any other regulatory obligation regarding
the Product. Each Party may also disclose the Confidential
Information of the other Party, without such other Party's prior
written consent, pursuant to an order of a Regulatory Authority or
court of competent jurisdiction, provided that it: (i) promptly
notifies the other Party of the required disclosure in order to
provide such Party an opportunity to take legal action to prevent
or limit such disclosure and, if asked, reasonably assists the
other Party in pursuing such action; and (ii) shall only disclose
the Confidential Information to the minimum extent required by
law.
(a)
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The
Parties shall issue a mutually acceptable press release announcing
the execution of this Agreement. A Party may issue any subsequent
press release relating to this Agreement or activities conducted
hereunder upon prior written approval of the other Party, such
approval not to be unreasonably withheld or delayed; provided,
however, that no approval of the other Party shall be required if a
subsequent press release solely discloses the information that: (I)
a milestone under this Agreement has been achieved and/or any
payments associated therewith have been received; (2) the filing
and/or Regulatory Approval of the NDA with the FDA or the EMEA
generally has occurred (provided, however, that specific dates of
filing shall not be disclosed); (3) commercial launch of the
Product in any country or any information that has previously been
approved and disclosed as permitted by this Section 8.2. In the
case of items (1 )-(3) of the preceding sentence,
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the
disclosing Party shall provide the other Party a copy of such
proposed disclosures prior to the proposed release and consider in
good faith any comments the other Party may make, where
practicable, and in light of any reporting obligations of such
disclosing Party under applicable laws, rules or regulations,
including applicable securities law, Except as otherwise provided
in this Section 8.2(a), neither Party shall use the name,
trademark, trade name or logo of the other Party or its employees,
or, in the case of YISSUM, the name or logo of the University or
the name of its employees, in any publicity or news release
relating to this Agreement or its subject matter, without the prior
express written permission of the other Party,
(b)
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Notwithstanding
the terms of this Article 8, either Party shall be permitted to
disclose the existence and terms of this Agreement, to the extent
required, in the reasonable opinion of such Party's legal counsel,
to comply with applicable laws, rules or regulations, including the
rules and regulations promulgated by securities law regulatory
agencies or any other govenm1ental agency, Notwithstanding the
foregoing, before disclosing this Agreement or any of the terms
hereof pursuant to this Section 8.2(b), the Parties shall consult
with one another on the terms of this Agreement for which
confidential treatment will be sought in making any such
disclosure, If a Party wishes to disclose this Agreement or any of
the tem1s hereof in accordance with this Section 8.2(b), such Party
agrees, at its own expense, to seek confidential treatment of the
portions of this Agreement or such terms as may be reasonably
requested by the other Party, provided that the disclosing Party
shall always be entitled to comply with legal
requirements.
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(c)
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Either
Party may also disclose the existence and terms of this Agreement
to its legal counsel, investment bankers, accountants and advisors,
and to potential Sublicensees, Third Party contractors, investors,
lenders or acquirers, and their legal counsel, investment bankers,
accountants and advisors, in each case under an agreement or in the
case of legal counsel, a professional obligation, to keep the tem1s
of this Agreement confidential under terms of confidentiality and
non-use substantially similar lo the terms contained in this
Agreement and to use such Confidential lnfon11ation solely for the
purpose permitted pursuant to this Section 8.2(c).
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ARTICLE 9 REPRESENTATIONS AND WARRANTIES
9.1
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Representations
and Warranties of YISSUM.
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Y!SSUM
represents and warrants lo EDESA that as of the Effective
Date:
(a)
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subject
to Section 9.l(d) below, it has the full right, power and authority
to enter into this Agreement, to perform its obligations under this
Agreement, and to grant the license granted under Section 7.1, and
the fulfillment of its obligations and performance of its
activities hereunder will not materially conflict with, violate,
or breach or
constitute a default under any material contractual obligation or
court or administrative order by which YISSUM is currently
bound;
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(b)
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to the
Knowledge of YISSUM, there are no legal claims, judgments or
settlements against or owed by YISSUM or pending legal claims or
litigation, in each case relating to the Product the YISSUM
Licensed Technology including, without limitation, legal claims
made by the Researcher;
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(c)
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subject
to Section I 3.11, all necessary consents, approvals and
authorizations of all government authorities and other persons
required to be obtained by YISSUM as of the Effective Date in
connection with the execution, delivery and performance of this
Agreement have been obtained;
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(d)
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based
on the accuracy of the information provided to YISSUM by the
Researcher, YISSUM Controls the right, title and interest in and to
the Licensed Technology, and has the right to grant to EDESA the
licenses that it purports to grant hereunder and has not granted
any Third Party rights that would interfere or be inconsistent with
EDESA 's rights hereunder;
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(e)
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to the
Knowledge of YISSUM, there is no action, suit, inquiry,
investigation or other proceeding threatened, pending or ongoing
brought by any Third Party that alleges the use of the Licensed
Technology or the Development and/or Commercialization of the
Product would infringe or misappropriate the intellectual property
or intellectual property rights of any Third Party (and it has not
received any notice alleging such an infringement or
misappropriation). In the event that YISSUM becomes aware of any
such action or proceeding, it shall promptly notify EDESA in
writing;
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(f)
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YISSUM
does not have any current knowledge that would cause any of its
representations or warranties to EDESA to be incorrect or
untrue.
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9.2
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Representations
and Warranties and Covenants of EDESA.
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EDESA
represents and warrants to YISSUM that as of the Effective
Date:
(a)
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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;
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(b)
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subject
to Section 13.11, all necessary consents, approvals and
authorizations of all government authorities and other persons
required to be obtained by EDESA as of the Effective Date in
connection with the execution, delivery and performance of this
Agreement have been obtained;
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(c)
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EDESA
does not have any current knowledge that would cause any of its
representations or warranties to YISSUM to be incorrect or
untrue;
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(d)
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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;
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(e)
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EDESA
(i) acknowledges that the Patents listed in Appendix B3 are
currently in the process of being assigned in full to Yissum and,
until such assignments are perfected, they are not part of the
Licensed Technology; and (ii) that Yissum has agreed to included
them as part of the Licensed Technology once such assignments have
been perfected.
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9.3
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Representations
and Covenants of Both Parties.
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Each
Party shall, and shall cause its Affiliates and agents to, comply
with laws, rules, regulations and guidelines and related to the
performance of its obligations hereunder and applicable to such
Party, including the United States Food, Drug and Cosmetics Act and
the Food and Drugs Act (Canada) and the regulations promulgated
thereunder, and their foreign counterparts.
9.4
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No
Other Representations or Warranties.
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(a)
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EXCEPT
AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR
WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF
THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR
ON BEHALF OF A PARTY. ALL REPRESENTATIONS AND WARRANTIES, WHETHER
ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY
EXCLUDED. SPECIFICALLY,
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(b)
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IN
PARTICULAR, YISSUM MAKES NO EXPRESS OR IMPLIED WARRANTIES THAT THE
USE BY EDESA, ITS AFFILIATES OR ANY OTHER THIRD PARTY OF THE
LICENSED TECHNOLOGY WILL NOT INFRINGE ANY PATENT, COPYRIGHT,
TRADEMARK OR OTHER RIGHTS OF ANY THIRD PARTY. IN ADDITION, NOTHING
IN THIS AGREEMENT MAY BE DEEMED A REPRESENTATION OR WARRANTY BY
YISSUM AS TO THE ACCURACY, SAFETY, EFFICACY, OR USEFULNESS, FOR ANY
PURPOSE, OF THE LICENSED TECHNOLOGY, WHICH IS BEING LICENSED TO
EDESA STRICTLY ON AN "AS IS" BASIS. YISSUM HAS NO OBLIGATION,
EXPRESS OR IMPLIED, TO SUPERVISE, MONITOR, REVIEW OR OTHERWISE
ASSUME RESPONSIBILITY FOR THE PRODUCTION, MANUFACTURE, TESTING,
MARKETING OR SALE OF ANY PRODUCT. TO THE EXTENT PERMITTED BY
APPLICABLE LAW, NEITHER YISSUM NOR
THE RESEARCHER, NOR TI-IE UNIVERSITY, NOR TI-IE REPRESENTATIVES OF
YISSUM AND/OR OF THE UNIVERSITY SHALL HAVE ANY LIABILITY WHATSOEVER
TO EDESA, AN AFFILIATE OR A SUBLICENSEE, OR TO ANY THIRD PARTY FOR
OR ON ACCOUNT OF ANY INJURY, LOSS, OR DAMAGE, OF ANY KIND OR NATURE
WHETHER DIRECT OR INDIRECT, SUSTAINED BY EDESA, AN AFFILIATE OR A
SUBLICENSEE, OR BY ANY THIRD PARTY, FOR ANY DAMAGE ASSESSED OR
ASSERTED AGAINST EDESA, OR FOR ANY OTHER LIABILITY INCURRED BY OR
IMPOSED UPON THE COMPANY OR ANY OTHER PERSON OR ENTITY, DIRECTLY OR
INDIRECTLY ARISING OUT OF OR IN CONNECTION WITH OR RESULTING FROM
THIS AGREEMENT AND/OR TI-IE EXERCISE OF THE LICENSE, INCLUDING, (i)
THE PRODUCTION, MANUFACTURE, USE, PRACTICE, LEASE, OR SALE OF ANY
PRODUCT; (ii) THE USE OF THE LICENSED TECHNOLOGY; OR
(i) ANY ADVERTISING OR
OTHER PROMOTIONAL ACTIVITIES WITH RESPECT TO ANY OF THE
FOREGOING.
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ARTICLE 10 INDEMNIFICATION
10.1
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General
Indemnity By EDESA.
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EDESA
shall indemnify and hold harmless YISSUM, its Affiliates, the
University, and their respective directors, officers, employees and
agents (individually and collectively, the "YISSUM Indemnitee(s)") from and against
all losses, liabilities, damages and expenses (including reasonable
legal fees and costs) incurred in connection with any claims,
demands, actions or other proceedings by any Third Party
(individually and collectively, "Losses") first arising after the
Effective Date to the extent arising from: (a) the Development or
Commercialization of the Product by EDESA or any of its Affiliates
or Sublicensees; (b) the use of the Product manufactured or sold by
EDESA or any of its Affiliates or Sublicensees by any purchasers
thereof including any product liability claim; (c) the use by EDESA
or any of its Affiliates or Sublicensees of the Licensed
Technology; except to the extent such Losses result directly from,
or arise directly out of, the gross negligent or willful misconduct
of the YISSUM Indcmnitee(s).
10.2
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Limited
Indemnity To Be Granted to EDESA.
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In the
event that the YISSUM Licensed Technology is licensed by YISSUM lo
a Third Party for Development and Commercialization outside the
Field (a "Non-Field
License"), YISSUM shall ensure that such Non-Field License
include an obligation by such Third Party licensee to indemnify and
hold harmless EDESA who will be included as a party similar lo a
YISSUM Indemnitee hereunder, along with its Affiliates, and their
directors, officers, employees and agents (individually and
collectively, the "EDESA
Indenmitee(s)") from and against all Losses first arising
after the execution of such Non-Field License to the extent arising
from: (a) the Development or Commercialization of the YISSUM
Licensed Technology outside the Field by such Third Party licensee;
(b) the use of the Product manufactured or sold by Third Party
licensee outside the Field by any purchasers thereof including any
product liability claim; (c) the use by Third Party licensee of the
Licensed Technology; except to the extent such Losses result
directly from, or arise directly out of, the gross negligent or
willful misconduct of the EDESA Indemnitee(s). Notwithstanding the
foregoing, YISSUM's obligation pursuant to this Section 10.2 shall
be contingent upon EDESA assuming a similar written obligation
towards any Third Party licensee granted a Non-Field
License.
If any
such claims or actions are made, the YISSUM Indemnitee shall be
defended at the EDESA's sole expense by counsel selected by EDESA
and reasonably acceptable to the YISSUM indemnitee, provided that
the YISSUM indemnitee may, at its own expense, also be represented
by counsel of its own choosing. EDESA shall have the sole right to
control the defense of any such claim or action, subject to the
terms of this Article 10.
EDESA
may settle any such claim, demand, action or other proceeding or
otherwise consent to an adverse judgment: (a) with prior written
notice to the YISSUM indemnitee but without the consent of the
YISSUM indemnitee, where the only liability to the Indemnitee is
the payment of money and EDESA makes such payment; or (b) in all
other cases, only with the prior written consent of the YISSUM
indemnitee, such consent not to be unreasonably
withheld.
The
YISSUM indemnitee shall notify EDESA promptly of any claim, demand,
action or other proceeding under Section 10.1 or Section 10.2 and
shall reasonably cooperate with all reasonable requests of EDESA
with respect thereto.
The
YISSUM indemnitee may not settle any such claim, demand, action or
other proceeding or otherwise consent to an adverse judgment in any
such action or other proceeding or make any admission as to
liability or fault without the express written permission of
EDESA.
NEITHER
PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL,
INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES OR FOR LOST PROFITS
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT,
REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 10.7 IS
INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS
OR OBLIGATIONS OF EDESA UNDER ARTICLE 10 OR ARTICLE 12.3, OR
DAMAGES AVAILABLE FOR EITHER PARTY'S BREACH OF CONFIDENTIALJTY
OBLIGATIONS IN ARTICLE 8.
EDESA
shall maintain in good standing throughout the Tem1 of this
Agreement and for a period of seven (7) years thereafter, product
liability insurance policies in respect of the Product with an
internationally recognized insurer or insurers licensed to do
business in the Territory in an amount of not less than $2.0
million per occurrence, and not less than $2.0 million in the
aggregate, on such terms and conditions as are customary in the
industry. EDESA shall provide proof of such insurance to YISSUM
within thirty (30) days of the Effective Date and thereafter from
time to time within thirty (30) days of request of proof of such
insurance.
ARTICLE 11 INVENTIONS; PATENT PROVISIONS
11.1
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Ownership
of Intellectual Property.
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As
between the Parties, YISSUM shall remain the sole and exclusive
owner of the Licensed Technology. EDESA shall be the sole and
exclusive owner of all patents, trademarks, know-how, data and
other intellectual property that is conceived, discovered,
invented, made or first reduced to practice by, or on behalf of,
EDESA on or after the Effective Date, including all improvements,
variations, modifications or enhancements of the Licensed
Technology conceived, discovered, invented, made or first reduced
to practice by, or on behalf of, EDESA after the Effective Date and
including the EDESA Data.
EDESA
will be responsible for preparing, filing, prosecuting and
maintaining the Patents in Yissum's name, and may elect to file
applications for such other patents as EDESA deems necessary to
protect the Licensed Technology ("Patent Management"). EDESA will (a)
provide to Yissum all material information and documents received,
prepared or filed in connection with the Patents, (ii) consult with
YISSUM before taking any substantive actions related to the Patent
Management and (iii) consider all comments and changes suggested by
YISSUM in relation to the Patent Management. If EDESA intends to
abandon, allow to lapse, or not continue the Patent Management of
any Patent, then EDESA will, not less than 60 days before any
required action relating to such Patent, notify YISSUM and YISSUM
will then have the right, al its option, to assume the Patent
Management of such Patent, in which case such Patent will be
excluded from the Licensed Technology. To assist EDESA with the
Patent Management, YISSUM will, al the reasonable request of EDESA,
cooperate with EDESA, including provision of required information,
and will execute and deliver documents (including powers of
attorney) and do such other reasonable acts as EDESA may
request.
From
May 9 2016, EDESA shall be responsible for (a) all costs associated
with the Patent Management of the Patents listed in Appendices B(l)
and B(2); and (b) fifty percent (50%) of all costs associated with
the Patent Management of the Patents listed in Appendix 13(3) until
such time as the Patents listed in Appendix B(3) are fully assigned
to Yissum (the "Full
Assignment"), at which point EDESA shall be responsible for
all costs associated with the Patent Management of the Patents
listed in Appendix 13(3). Within 60 days of the receipt of any
invoice in relation to the
costs
associated with the Patent Management of the Patents listed in
Appendix B(3) until their Full Assignment, YISSUM will reimburse
EDESA for one-half of such costs. Such Patent costs will not he
refunded to YISSUM (in whole or in pait) under any
circumstances.
(a)
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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.
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(b)
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Enforcement of Intellectual Property Rights. EDESA shall
have the right, but not the obligation, lo institute and direct
legal proceedings against any Third Party believed to be infringing
or misappropriating or otherwise violating the Licensed Technology.
YISSUM agrees to co-operate to the extent reasonably necessary,
including signing of all necessary documents to vest in EDESA the
right to start such legal proceedings, provided that all the direct
and indirect costs and expenses of bringing and conducting the
legal proceedings are paid by EDESA (except for the expenses of
YISSUM's counsel, if any). All amounts recovered by EDESA as the
result of such legal proceedings will accrue to the benefit of
EDESA, provided that such amounts awarded as compensation for lost
sales revenue will be included in EDESA's Sublicensing Revenue if
the action occurs in any country in the territory EDESA docs not
directly commercialize the Product and treated as Net Sales in any
country in the Territory that EDESA commercializes the Product
(after deduction of EDESA's costs and expenses of legal
proceedings) upon which Royalties will be paid to
YISSUM.
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(a)
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Each
Party shall notify the other in writing of any allegations it
receives from a Third Party that the Development or
Commercialization of the Product or use of the Licensed Technology
infringes the intellectual properly rights of such Third Party.
Such notice shall be provided promptly, but in no event after more
than fo1ty five (45) days, following receipt of such
allegations.
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(b)
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In the
event that a Party receives notice that it or any of its Affiliates
have been individually named as a defendant in a legal proceeding
by a Third Party alleging infringement of a Third Party's patents
or other intellectual property right as a result of the Development
or Commercialization of the Product or use of the Licensed
Technology, such Party shall immediately notify the other Party in
writing and in no event notify such other Party later than forty
five (45) days after the receipt of such notice. Such written
notice shall include a copy of any summons or complaint (or the
equivalent thereof) received regarding the foregoing. Each Party
shall asse1i and not waive the joint defense privilege with respect
to all communications between the Parties reasonably the subject
thereof. In such event, the Parties shall agree how best to
mitigate or control the defense of any such legal proceeding;
provided however, that EDESA shall assume the primary
responsibility for the conduct of the defense of any such claim
that is specific to the Field, at EDESA's expense, and YISSUM
shall assume the primary responsibility for the conduct of the
defense of any other such claim, at YlSSUM's expense.
Notwithstanding the foregoing, YISSUM may forego assuming the
primary responsibility for the conduct of the defense of any such
claim outside the Field, in which case EDESA shall have the right,
but not the obligation, to assume such primary responsibility at
its own expense. The Party that does not assume primary
responsibility for the conduct of the defense shall have the right,
but not the obligation, to participate and be separately
represented in any such suit at its sole option and at its own
expense. Each Party shall reasonably cooperate with the Party
conducting the defense of the claim. If a Party or any of its
Affiliates have been individually named as a defendant in a legal
proceeding relating to the alleged infringement of a Third Pa1ty's
patents or other intellectual property right as a result of the
Development or Commercialization of the Product, the other Party
shall be allowed to join in such action, at its own expense.
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(c)
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Status; Settlement. The Parties shall keep each other
informed of the status of and of their respective activities
regarding any litigation or settlement thereof initiated by a Third
Party concerning the Development or Commercialization of the
Product or the Licensed Technology; provided, however, that no
settlement or consent judgment or other voluntary final disposition
of a suit under this subsection 11.5(c) may be unde1taken by a
Party without the consent of the other Party which consent shall
not be unreasonably withheld or delayed.
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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; (b) the date of expiry of
any period of exclusivity granted to the Product by a Regulatory
Authority in such country or (c) the date that is fifteen (15)
years after the First Commercial Sale, whichever is last to occur,
unless terminated earlier in accordance with this Agreement (the
"Term").
(a) Breach. This Agreement may be terminated
upon written notice by either Party if the other Party has
materially breached its obligations under this Agreement and has
not cured such breach within forty-five (45) days of receipt of
written notice of such breach by the other Party.
(b) Bankruptcy. This Agreement may be
terminated upon written notice by either Party if the other Party
(i) makes a general assignment for the benefit of creditors; (ii)
files any petition, or commences any proceeding voluntarily, for
any relief under any bankruptcy or insolvency laws or any law
relating to the relief of debtors; (iii) consents to the entry of
an order in an involuntary bankruptcy or insolvency case; (iv) is
the subject of an order or decree for relief against it by a court
of competent jurisdiction in an involuntary case under any
bankruptcy or insolvency laws or any law relating to the relief of
debtors, which order or decree is unstayed and in effect for a
period of 60 consecutive days; (v) is subject to appointment, with
or without its consent, of any receiver, liquidator, custodian,
assignee, trustee, sequestrator or other similar official of such
other Party or any substantial part of its prope1iy; or (vi) admits
in writing of its inability to pay its debts generally as they
become due.
(c) Failure to Develop. If YISSUM alleges
that EDESA has failed to use commercially reasonable efforts to
Develop the Product, this Agreement may be terminated by YISSUM
upon written notice to EDESA if commercially reasonable efforts to
Develop the Product have not commenced within two hundred and sixty
(260) days of receipt of written notice of such failure by
EDESA.
12.3
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Termination
Without Cause.
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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)
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Upon
the termination of this Agreement, then:
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(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.
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(ii)
|
Unless
the Parties agree otherwise, all activities underway at the time of
termination shall be terminated as soon as possible except for
winding down activities (including such activities) in connection
with any Clinical Trials (the cost of which shall continue to be
borne by EDESA as provided in this Agreement until completion of
such activities in the normal course). For the sake of clarity the
costs of winding down activities shall include any incured costs or
otherwise unavoidable wind down costs that would otherwise have
been payable by EDESA.
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(iii)
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Unless
this Agreement is terminated by EDESA pursuant to Section 12.2(a)
or 12.2(b), EDESA shall transfer and assign YISSUM, upon YISSUM's
request, all of the EDESA Data and any patent applications and
issued patents relating to the Product owned by EDESA (the
"EDESA Assigned IP"),
provided that YISSUM pays all reasonable, out-of-pocket expenses
actually incurred by EDESA in connection with such transfer and
assignment. EDESA shall fully cooperate with the Licensor to effect
such transfer and assignment and shall execute any document and
perform any acts required to do so. The EDESA DATA SHALL BE
PROVIDED ON AN "AS IS, WHERE IS" BASIS WITHOUT ANY EXPRESS OR
IMPLIED WARRANTIES AS TO THE FITNESS FOR A PARTICULAR PURPOSE,
MERCHANTABILITY OR CONDITION OR AS TO THE NON-INFRINGEMENT OF ANY
INTELLECTUAL PROPERTY RIGHTS OF ANY PERSON OR AS TO ANY OTHER
MATTER.
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(iv)
|
Without
derogating from the force and effect of the foregoing assignment
undertaking in Section 12.4(a)(iii), the Parties acknowledge and
agree that if under applicable law the aforesaid assignment
undertaking will not be fully enforceable, then the pm1 (if any) of
such undertaking which is enforceable shall remain in full force
and effect, and the part (or whole) which is not enforceable shall
be automatically replaced with an in-evocable grant by EDESA to
YISSUM, binding upon all of EDESA'S acquirers, successors and
assignees, of an unrestricted, perpetual, irrevocable, world-wide,
royalty-free, exclusive license to use, exploit, Transfer and
sub-license (on a multi-tier basis) the EDESA Assigned IP for any
and all purposes and uses
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(v)
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Notwithstanding
anything to the contrary in this Section 12.4, if this Agreement is
terminated by EDESA pursuant to Section 12.2 or 12.3, EDESA shall
have the right to sell its remaining inventory of Product(s) so
long as EDESA has fully paid, and continues to pay fully when due,
any and all Royalties and Sublicensee Fees owed to YISSUM hereunder
based on such sales.
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(vi)
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Following
any termination of this Agreement, YISSUM shall pay to EDESA
[ ]% of the amounts received by YISSUM or its Affiliates as
royalties or sublicensing fees arising from the license of the
Licensed Technology to a Third Party, up to a maximum amount equal
to twice the documented amount EDESA has expended on the
Development or Commercialization of the Product. In furtherance of
EDESA's right under this Section 12.4(vi), YISSUM shall provide
prompt notice to EDESA upon the execution of any such license and
shall thereafter provide to EDESA written reports for each Calendar
quarter and each Calendar Year; each such report showing in
relation to the reporting period, as applicable: the royalties and
sublicensing fees received by YISSUM under such license. Reports in
respect of a Calendar Quarter shall be due on the thirtieth (30th)
day following the close of such Calendar Quarter and annual reports
shall be due on the sixtieth (60th) day following the close of such
Calendar Year. Royalties and sublicensing fees shown to have been
received in each report shall be due and payable by YISSUM on the
date such report is due. YJSSUM shall keep complete and accurate
records in sufficient detail to enable the royalties and
sublicensing fees received by YISSUM under such license to be
determined and EDESA shall have the right to audit such records on
terms consistent with those set forth in Section 6.4 of this
Agreement. For purposes of this Section 12.4(vi), the terms
"royalties" and "sublicensing fees" in relation to amounts received
from Third Patties shall have the same meanings as are set forth in
this Agreement, but replacing references to "EDESA" with the name
of the Third Party to whom YISSUM has licensed the Licensed
Technology.
|
(b)
|
If
either Party has the right to terminate this Agreement under
Section 12.2, it may at its sole option, elect either to: (i)
terminate this Agreement and pursue any legal or equitable remedy
available to it; or (ii) maintain this Agreement in effect and
pursue any legal or equitable remedy available to it.
|
Any
payments accruing hereunder shall continue to be due and owing
following termination of this Agreement. In addition, the following
provisions shall survive the termination of this Agreement for any
reason: Articles 1, 6.4, 8, 9, 10, 11, 12 and 13.
Neither
Party shall be held liable to the other Party nor be deemed to have
defaulted under or breached this Agreement for failure or delay in
performing any obligation under this Agreement to the extent such
failure or delay is caused by or results from causes beyond the
reasonable control of the affected Party including embargoes, war,
acts of war (whether war be declared or not), insurrections, riots,
civil commotions, strikes, lockouts or other labour disturbances,
fire, floods, or other acts of God, or acts, omissions or delays in
acting by any governmental authority or the other Party. The
affected Patty shall notify the other Party of such force majeure
circumstances as soon as reasonably practical, and shall promptly
under take reasonable efforts necessary to mitigate such force
majeure circumstances.
Either
Patty may assign its rights or obligations under this Agreement
without prior written notice to the other Patty or as part of a
sale of all or substantially all of its assets to a Third Party,
provided that such Third Party agrees, in writing, to assume the
assigning Party's obligations under this Agreement.
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.
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 YISSUM,
to:
|
YISSUM
|
|
Attn: VP, Health
Care
|
|
Hi-Tech Park,
Edmond J. Safra
Campus,
|
|
Givat-Ram,
|
|
Jerusalem P.O. Box
39135, Jerusalem,
|
|
Israel Email:
shoshi.keynan@yissum.co.il
|
|
|
with a copy (which
shall not constitute notice) to:
|
Attn: General
Counsel
|
|
Email:
bob.trachtenberg@yissum.co.il
|
|
|
if to EDESA,
to:
|
Edesa Biotech
Inc.
|
|
Attn: Director I 00
Spy Cornt
|
|
Markham, Ontario
L3R5H6
|
|
Email:
par@exzell.com
|
|
|
with a copy (which
shall not constitute notice) to:
|
Attn: Wojtek Baraniak ■
|
|
Email:
wbaraniak@fasken.com
|
|
|
|
|
or to
such other address as the Party to whom notice is to be given may
have furnished to the other Party in writing in accordance
herewith. Any such notice shall be deemed to have been given: (a)
when delivered if personally delivered or sent by email on a
business day; (b) on the business day after dispatch if sent by
nationally-recognized overnight courier; or (c) on the fifth
business day following the date of mailing if sent by
mail.
13.5
|
Applicable
Law and Litigation.
|
This
Agreement shall be governed by and construed in accordance with the
laws of the England and Wales, without reference to any rules of
conflict of laws. For controversies, claims and disputes not
covered by the arbitration provisions pursuant to Section 13.14,
and for injunctive or other equitable interim relief in relation to
all controversies, claims and disputes arising out of or relating
to this Agreement, the Patties irrevocably and unconditionally: (a)
consent to the exclusive jurisdiction of the courts of England,
located in London for any action, suit or proceeding and relating
to injunctive or other equitable relief, and agree not to commence
any action, suit or proceeding related thereto except in such
courts; and (b) waive any objection to the laying of venue of any
action, suit or proceeding in the courts of England, located in
London and waive and agree not to plead or
claim in any such court that any such action, suit or proceeding
brought in any such court has been brought in an inconvenient
forum.
13.6
|
Entire
Agreement; Amendments.
|
This
Agreement contains the entire understanding of the Parties with
respect to the subject matter hereof. All express or implied
agreements and understandings, either oral or written, with regard
to the subject matter hereof are superseded by the terms of this
Agreement. On the Effective Date, the confidentiality agreement
between the Parties effective February 17 2016 shall terminate and
all Confidential Information exchanged thereunder shall be deemed
Confidential Information of the Party disclosing such information
and protected under this Agreement. This Agreement may be amended,
or any term hereof modified, only by a written instrument duly
executed by authorized representatives of both
Parties.
The
Parties shall be independent contractors and the relationship
between the Parties shall not constitute a pm1nership, joint
venture or agency. Neither Party shall have the authority to make
any statements, representations or commitments of any kind, or to
take any action, which shall be binding on the other Party, without
the prior written consent of the other Party.
The
waiver by either Pm1y of any right hereunder, or the failure of the
other Party to perform, or a breach by the other Party, shall not
be deemed a waiver of any other right hereunder or of any other
breach or failure by such other Party whether of a similar nature
or otherwise.
No
remedy referred to in this Agreement is intended to be exclusive,
but each shall be cumulative and in addition to any other remedy
referred to in this Agreement or otherwise available under
law.
13.10
|
Waiver
of Rule of Construction.
|
Each
Party has had the opportunity to consult with legal counsel in
connection with the review, draf1ing and negotiation of this
Agreement. Accordingly, the rule of construction that any ambiguity
in this Agreement shall be construed against the draf1ing Party
shall not apply.
Each
Party shall duly execute and deliver, or cause to be duly executed
and delivered, such further instruments and do and cause to be done
such further acts and things, including the filing of such
assignments, agreements, documents and instruments, as may be
necessary or as the other Pm1y may reasonably request in connection
with this Agreement or to carry out more effectively the provisions
and purposes, or to better assure and confirm unto such other Party
its rights and remedies under this Agreement. Each Pm1y shall use
its conm1ercially reasonable effo11s to take all actions necessary
or advisable under applicable laws to consummate and make effective
the transactions
contemplated by this Agreement including the taking of such
reasonable actions as are necessary to obtain any requisite
approvals, consents, orders, exemptions or waivers by any
governmental authority.
Except
where the context otherwise requires, wherever used, the singular
will include the plural, the plural the singular, the use of any
gender will be applicable to all genders, and the word "or" is used
in the inclusive sense (and/or). The captions of this Agreement are
for convenience of reference only and in no way define, describe,
extend or limit the scope or intent of this Agreement or the intent
of any provision contained in this Agreement. The term "including"
as used herein means including, without limiting the generality of
any description preceding such tenn. References to "Section" or "Sections" are
references to the numbered sections of this Agreement,
unless expressly stated otherwise.
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 13.14
is not intended to alter the rights of the Parties as established
by Article 2, Governance, herein. The dispute shall be resolved by
final and binding arbitration. The place of arbitration shall be
London, England. The arbitration shall be in accordance with the
rules of LCIA except as
modified herein. The number of arbitrators shall be three. The
language of the arbitration shall be English.
|
(b)
|
The
Party wishing to commence an arbitration ("Claimant") shall notify the other
party ("Respondent") in
writing of its decision to commence arbitration hereunder
(sometimes referred to in this Agreement as its "demand for arbitration"), setting out
briefly its claims in its notice, and with its notice, name the
arbitrator it is appointing.
|
(c)
|
The
Respondent shall, within thirty (30) days of receipt of a demand
for arbitration, notify the Claimant in writing of the name of the
arbitrator it is appointing.
|
(d)
|
The
third arbitrator shall be chosen by the first two arbitrators
within twenty (20) days after the second of such arbitrators was
appointed.
|
(e)
|
All
arbitrators shall be chosen taking into account the type of issues
to be addressed in the arbitration, whether legal, business,
scientific, or a combination thereof, and having regard to their
availability to conduct the arbitration within the times
provided below.
(The date on which the third arbitrator is appointed 1s the
"Arbitration
Panel Finalization").
|
(f)
|
Within
thirty (30) days of completion of the hearing, the arbitrators
shall render a reasoned arbitration award describing, in writing,
the essential finding and conclusions on which the decision is
based, including the calculation of any damages awarded. Any
monetary award shall be made within thirty (30) days of the
rendering of such award.
|
(g)
|
All
information and documents in relation to the arbitration shall be
deemed Confidential lnfo1111ation lo the full extent permitted by
law. No individual shall be appointed as an arbitrator unless the
individual first agrees in writing to be bound by this subsection
and to conduct the arbitration in a manner that in his/her
judh'1nent is most likely to maintain the confidentiality of
Confidential Information. Neither Party may retain any expert in
connection with the arbitration unless the expert first agrees in
writing to be bound by this subsection, as applicable. The fact of
and subject matter of the arbitration, including the fact that any
dispute has been submitted to arbitration, and all evidence given
and submissions made in connection with any arbitration, shall be
Confidential Information, and shall be treated as such by the
Parties and all persons employed by or contracted to them. Any
meetings, conferences or hearings in connection with or during the
arbitration may be attended only by those individual persons whose
presence, in the opinion of the arbitral tribunal, is reasonably
necessary for the determination or other resolution of the dispute
and such person first agrees in writing to be bound by the
provisions of these sections, as applicable. The obligations under
this subsection continue notwithstanding any determination or other
resolution of the arbitration.
|
(h)
|
The
arbitrators shall be paid reasonable fees plus expenses. These fees
and expenses, along with the reasonable legal fees and expenses of
the prevailing Party (including all expe1t witness fees and
expenses), the fees and expenses of a court reporter, and any
expenses for a hearing room, shall be paid as follows:
|
(i)
|
If the
arbitrators rule in favour of one Party on all disputed issues in
the arbitration, the losing Party shall pay l 00% of such fees and
expenses.
|
(ii)
|
If the
arbitrators rule in favour of one Party on some issues and the
other Pmty on other issues, the arbitrators shall issue with the
ruling a written determination as lo how such fees and expenses
shall be allocated between the Parties. The arbitrators shall
allocate fees and expenses in a way that bears a reasonable
relationship to the outcome of the arbitration, with the Party
prevailing on more issues, or on issues of greater value or
gravity, recovering a relatively larger share of its legal fees and
expenses.
|
(i)
|
Any
final award of the arbitrators shall be final, conclusive and
binding on the Parties, and judgment may be entered in any court of
competent jurisdiction. To the extent lawful, the Parties exclude
any right of review or appeal lo Canadian, United Stales, English,
Israeli or other court, including in connection with any question
of law
arising in the arbitration or in connection with any award or
decision made by the arbitrators, except as is necessary to
recognize or enforce such award or decision.
|
In no
event will a demand for arbitration be made after the date when
institution of a legal or equitable proceeding based upon such a
dispute between the Parties would otherwise be barred by the
applicable statute of limitations.
13.16
|
Injunctive
and Other Interim Relief.
|
Nothing
in this Agreement shall be construed as limiting in any way the
right of a Party to seek injunctive or other interim relief from a
court of competent jurisdiction with respect to any actual or
threatened breach of this Agreement, or to preserve or protect any
property or assets pending an arbitral award, or otherwise in
support of the contemplated or pending arbitration. No such court
application shall be taken as a waiver or impairment of
arbitration.
13.17
|
Execution
in Counterparts; Facsimile Signatures.
|
This
Agreement may be executed in counterparts, each of which
counterpart, when so executed and delivered, shall be deemed to be
an original, and all of which counterparts, taken together, shall
constitute one and the same instrument even if both Parties have
not executed the same counterpart. Signatures provided by facsimile
transmission or scanned and emailed copies shall be deemed to be
original signatures.
[Remainder of the Page Intentionally Left Blank]
The
Parties have executed this Agreement as of the Effective
Date.
|
YISSUM PHARMACEUTICALS
INC>
|
|
|
|
|
|
|
By:
|
/s/ Shoshi
Keynan
|
|
|
|
Name: Shoshi
Keynan
|
|
|
|
Title:
VP Licensing, Pharmaceuticals
|
|
|
|
|
|
|
By:
|
/s/
Yaacov Michlin
|
|
|
|
Name:
Yaacov
Michlin
|
|
|
|
Title:
CEO of Yissum
|
|
|
RESEARCHER
|
|
|
|
|
|
|
By:
|
/s/ Saul
Yedger
|
|
|
|
Name: Saul
Yedger
|
|
|
|
Title:
Professor
|
|
|
EDESA BIOTECH INC.
|
|
|
|
|
|
|
By:
|
/s/ Pardeep
Nijhawan
|
|
|
|
Name: Pardeep
Nijhawan
|
|
|
|
Title:
Director
|
|
|
|
|
|
|
By:
|
|
|
|
|
Name:
|
|
|
|
Title:
|
|
|
|
|
|
Appendix
A (Development Plan)
First 6
months from Execution of the Agreement
●
|
External
Review of the existing IND
|
●
|
Preparation
of regulatory documents for meeting with Regulatory
Authorities
|
●
|
Meeting
with the Researcher to discuss potential research projects relevant
to the development of the Product.
|
Within
the 6-12 months from the Execution of the Agreement
●
|
Request
for meeting with or submission of questions to Regulatory
Authorities
|
●
|
Meeting/Interaction
with Regulatory Authorities
|
●
|
Review
of feedback/responses from Regulatory Authorities
|
●
|
Identification and engagement
of CMO to produce Product Within the 12-18 months from Execution of
the Agreement
|
●
|
Submission
of IND or equivalent if no additional studies are required by the
regulatory authorities or initiation of any studies mandated by
Regulatory Authorities to submit IND or equivalent
|
Within
the 18-24 months from Execution of the Agreement
●
|
Initiation
of first clinical study if IND or equivalent if Regulatory
Authorities required no addition studies for approval or completion
and submission of IND or
equivalent if additional pre -clinical studies were required by
Regulatory Authorities.
|
Every
additional 12 months
●
|
Parties
meet to discuss specific targets but EDESA will continue to use
reasonable efforts to advance the Product.
|
Appendix
B
(Patents)
(1)
|
Licensed
Composition of Matter Patents:
|
Patent/Application
|
Title
|
Yissum
ref.
|
us 8,865,878
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-51
|
CA
2,558,416
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-18
|
EP
1758595
|
Use of
Lipid Conjugates In the Treatment of Disease
|
|
(2)
|
Method
of Use or Other patents.
|
Patent/Application
|
Title
|
Yissum
ref.
|
us 7,772,196
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-14
|
us 8,901,103
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-44
|
AU
2011201154
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2507-AU
|
(3)
|
Patents
need to be assigned to Yissum
|
Patent/Application
|
Title
|
Yissum
ref.
|
us 2014-0199241
us 14/115,869
|
LIPOSOMES
COMPRISING POLYMER- CONJUGATED LIPIDS AND RELATED USES
|
4097-08
|
CA
2834918
|
LIPOSOMES
COMPRISING POLYMER-
CONJUGATED LIPIDS
AND RELATED USES
|
4097-06
|
EP
2706988
|
LIPOSOMES
COMPRISING POLYMER-
CONJUGATED LIPIDS
AND RELATED USES
|
4097-04
|
us 2015-0119567
us 14/525111
|
Lipid-polymer
conjugates, their preparation and use
thereof
|
3860-09
|
CA
2761590
|
Lipid-polymer
conjugates, their preparation and use
|
3860-08
|
|
thereof
|
|
El'
2429532
|
Lipid-polymer
conjugates, their preparation and use
thereof
|
3860-04
|
Blueprint
Exhibit 10.3
FIRST
AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
This
First Amendment ("First Amendment"),
effective as of April 3, 2017 ("Effective Date"), is
entered into by and between Yissum Research Development Company of
the Hebrew University of Jerusalem, an Israeli corporation with its
principal office at Hi-Tech Park, Edmond
J.
Safra Campus, Givat-Ram, Jerusalem P.O. Box 39135, Jerusalem 91390
Israel ("YISSUM"), and Edesa
Biotech Inc., an Ontario corporation with its principal office at
100 Spy Court, Markham, Ontario, L3R 5H6 ("EDESA"). YISSUM and
EDESA may be referred to herein individually as a "Party" or collectively
as the "Parties". Reference to
a Party shall be deemed to include that Party's
Affiliates.
RECITALS:
A.
The Parties
executed a license agreement on June 29, 2016 (the "License Agreement")
pursuant to which Yissum granted EDESA an exclusive, worldwide
license to use the Licensed Technology for the Development and
Commercialization of the Product in the Field in the Territory;
and
B.
Pursuant to the License Agreement, the Licensed
Technology did not include the Patents listed in Appendix B/3
annexed to the License Agreement (the "B/3 Patents") since at that time they were not fully assigned
to YISSUM; but YISSUM had agreed to include them in the Licensed
Technology upon full assignment of such patents to
YISSUM.
C.
Pursuant to the
License Agreement, EDESA agreed to pay fifty percent (50%) of all
costs associated with the Patent Management of the B/3 Patents
until YISSUM had received full assignment of such patents, at which
point, EDESA would be responsible for one hundred percent (100%) of
all costs associated with the Patent Management of the B/3
Patents.
D.
The Pa1iies wish to
amend Appendix Band certain sections of the License Agreement with
respect to the B/3 Patents, as well as other patents.
In
consideration of the foregoing premises and the mutual covenants
herein contained, the Parties hereby agree as follows:
1.
Interpretation and
Definitions
1.1.
The preamble and
appendices annexed to this First Amendment constitute an integral
part hereof and shall be read jointly with its terms and
conditions.
1.2.
In this Amendment,
unless otherwise required or indicated by the context, the singular
shall include the plural and vice-versa, the masculine gender shall
include the female gender, and the use of the word "or" shall mean
"and/or".
1.3.
The headings of the
sections in this Amendment are for the sake of convenience only and
shall not serve in the interpretation of the
Agreement.
1.4.
In this Amendment,
capitalized terms shall have the meanings set forth in the License
Agreement, unless provided otherwise herein.
2.
The Parties
acknowledge that the U.S. and Canadian patents that are part of the
B/3 Patents have been fully assigned to YISSUM as of March 26, 2017
(the "Assignment
Date") and shall be included in the Licensed Technology, and
further acknowledge that by reason of such assignment, pursuant to
section 11.3 of the License Agreement, EDESA is responsible for one
hundred percent (100%) of all costs associated with the Patent
Management of these patents as of the Assignment Date.
3.
The following US
patent, which was always owned solely by Yissum but was licensed to
Celsus, shall be added to Appendix B/1 of the License
Agreement:
US
Patent No. 8,383,787: Use of Lipid Conjugates In the Treatment of
Disease (Yissum Ref: 2510-90).
4.
The Parties have
agreed to update the version of Appendix B annexed to the License
Agreement by replacing it in its entirety by the new Appendix B
attached to this First Amendment.
5.
This First
Amendment shall be read together with the License Agreement and
shall represent the complete current understanding between the
Parties hereto with respect to the subject matter
hereof.
6.
Unless otherwise
specifically stated in this First Amendment, all of the terms and
conditions set forth in the Agreement remain in full force and
effect. In any event of a conflict between and conditions contained
in this First Amendment and the License Agreement, the terms
contained in this First Amendment shall govern.
7.
This First
Amendment may be executed in counterparts and executed signature
pages may be sent by fax and e-mail via PDF, all of which taken
together shall be deemed to constitute one and the same
instrument.
[Signature on the next page]
IN WITNESS WHEREOF, the
parties have caused this First Amendment to be executed by their
duly authorized representatives as of the Effective
Date.
YISSUM
|
|
EDESA
BIOTECH INC.
|
|
|
|
|
|
|
|
By:
|
/s/
Shoshi Keynan
|
|
By:
|
/s/
Pardeep Nijhawan
|
|
|
|
|
|
|
|
Name:
|
Shoshi
Keynan, Ph.D.
|
|
Name:
|
Pardeep
Nijhawan
|
|
|
|
|
|
|
|
Title:
|
VP
Licensing, Pharmaceuticals
|
|
Title:
|
Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
|
|
|
|
|
|
|
|
Name:
|
|
|
|
|
|
|
|
|
|
|
|
Title:
|
|
|
|
|
|
Prof.
Yedgar Acknowledgment
/s/ Saul Yedgar
Appendix B
(Patents)
(1)
Licensed
Composition of Matter Patents:
Patent/Application
|
Title
|
Yissum
ref
|
us 8,865,878
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-51
|
CA
2,558,416
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-18
|
EP
1758595
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-19
|
us 8,383,787:
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-60
|
us 2014-0199241
us 14/115,869
|
Liposomes
comprising polymer- Conjugated lipids and uses
|
4097-08
|
CA
2834918
|
Liposomes
comprising polymer- Conjugated lipids and
uses
|
4097-06
|
us 2015-0119567
us 14/525111
|
Lipid-polymer
conjugates, their preparation and uses
thereof
|
3860-09
|
CA
2761590
|
Lipid-polymer
conjugates, their preparation and uses
thereof
|
3860-08
|
(2)
Method of Use or
Other patents.
Patent/Application
|
Title
|
Yissum
ref.
|
us 7,772,196
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-14
|
us 8,901,103
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-44
|
AU
2011201154
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2507-AU
|
(3)
Patents still need
to be assigned to Yissum and included in the Licensed
Technology.
Patent/Application
|
Title
|
Yissum
ref.
|
EP
2706988
|
Liposomes
comprising polymer-Conjugated lipids and
uses
|
4097-04
|
EP
2429532
|
Lipid-polymer
conjugates, their preparation and uses
thereof
|
3860-04
|
Blueprint
Exhibit 10.4
SECOND
AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
This
Second Amendment ("Second Amendment"),
effective as of May 7, 2017 ("Effective Date"), is
entered into by and between Yissum Research Development Company of
the Hebrew University of Jerusalem, an Israeli corporation with its
principal office at Hi-Tech Park, Edmond J. Safra Campus,
Givat-Ram, Jerusalem P.O. Box 39135, Jerusalem 91390 Israel
("YISSUM"),
and Edesa Biotech Inc., an Ontario corporation with its principal
office at 100 Spy Court, Markham, Ontario, L3R 5H6 ("EDESA"). YISSUM and
EDESA may be referred to herein individually as a "Party" or collectively
as the "Parties". Reference to
a Party shall be deemed to include that Party's
Affiliates.
RECITALS:
A.
The Parties
executed a license agreement on June 29, 2016, as amended on April
3, 2017 (collectively, the "License Agreement")
pursuant to which Yissum granted EDESA an exclusive, worldwide
license to use the Licensed Technology for the Development and
Commercialization of the Product in the Field in the Territory;
and
B.
Pursuant to the
License Agreement, the Licensed Technology did not include the
European Patents listed in Appendix B/3 annexed to the License
Agreement (the "European B/3 Patents")
since at that time they were not fully assigned to YISSUM; but
YISSUM had agreed to include them in the Licensed Technology upon
full assignment of such patents to YISSUM.
C.
Pursuant to the
License Agreement, EDESA agreed to pay fifty percent (50%) of all
costs associated with the Patent Management of the European B/3
Patents until YISSUM had received full assignment of such patents,
at which point, EDESA would be responsible for one hundred percent
(100%) of all costs associated with the Patent Management of the
B/3 Patents.
D.
The Parties wish to
amend Appendix Band certain sections of the License Agreement with
respect to the B/3 Patents, as well as other patents.
In
consideration of the foregoing premises and the mutual covenants
herein contained, the Parties hereby agree as follows:
1.
Interpretation and
Definitions
1.1.
The preamble and
appendices annexed to this First Amendment constitute an integral
part hereof and shall be read jointly with its terms and
conditions.
1.2.
In this Amendment,
unless otherwise required or indicated by the context, the singular
shall include the plural and vice-versa, the masculine gender shall
include the female gender, and the use of the word "or" shall mean
"and/or".
1.3.
The headings of the
sections in this Amendment are for the sake of convenience only and
shall not serve in the interpretation of the
Agreement.
1.4.
In this Amendment, capitalized terms shall
have the meanings set forth in the License Agreement, unless
provided otherwise herein.
The
Parties acknowledge that EP patent No. 2706988, entitled: LIPOSOMES
COMPRISING POLYMER-CONJUGATED LIPIDS AND RELATED USES
(Yissum's Ref.
4097-04) has been fully assigned to YISSUM as of March 26, 2017
(the "Assignment
Date") and shall be included in the Licensed Technology, and
further acknowledge that by reason of such assignment, pursuant to
section 11.3 of the License Agreement, EDESA is responsible for one
hundred percent (100%) of all costs associated with the Patent
Management of this patent as of the Assignment Date.
2.
EP Patent No. No.
2429532: LIPID-POLYMER CONJUGATES, THEIR PREPARATION AND USES
THEREOF (Yissum's Ref: 3860-04), which was part of the European B/3
Patents has been abandoned and therefore is removed from the
Licensed Technology effective retroactively as of June 29,
2016.
3.
The Parties have
agreed to update the version of Appendix B annexed to the License
Agreement by replacing it in its entirety by the new Appendix B
attached to this Second Amendment.
4.
This Second
Amendment shall be read together with the License Agreement and
shall represent the complete current understanding between the
Parties hereto with respect to the subject matter
hereof.
5.
Unless otherwise
specifically stated in this Second Amendment, all of the terms and
conditions set forth in the Agreement remain in full force and
effect. In any event of a conflict between and conditions contained
in this Second Amendment and the License Agreement, the terms
contained in this Second Amendment shall govern.
6.
This Second
Amendment may be executed in counterparts and executed signature
pages may be sent by fax and e-mail via PDF, all of which taken
together shall be deemed to constitute one and the same
instrument.
[Signature on the next page]
IN
WITNESS
WHEREOF, the parties have caused this First Amendment to be
executed by their duly authorized representatives as of the
Effective Date.
YISSUM
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EDESA
BIOTECH INC.
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By:
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/s/
Yaron Danlely
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By:
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/s/
Pardeep Nijhawan
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Name:
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Yaron
Danlely
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Name:
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Pardeep
Nijhawan
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Title:
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CEO of
Yissum
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Title:
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Director
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By:
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/s/
Shoshi Keynan
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Name:
|
Shoshi
Keynan, Ph.D.
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Title:
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VP
Licensing, Pharmaceuticals
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Prof.
Yedgar Acknowledgment
/s/ Saul Yedgar
AppendixB
(Patents)
(1) Licensed
Composition of Matter Patents:
Patent/Application
|
Title
|
Yissum
re1
|
us 8,865,878
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-51
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CA
2,558,416
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-18
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EP
1758595
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-19
|
us 8,383,787:
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-60
|
us 2014-0199241
us 14/115,869
|
Liposomes
comprising polymer- Conjugated lipids and uses
|
4097-08
|
CA
2834918
|
Liposomes
comprising polymer- Conjugated lipids and uses
|
4097-06
|
us 2015-0119567
us 14/525111
|
Lipid-polymer
conjugates, their preparation and uses thereof
|
3860-09
|
CA
2761590
|
Lipid-polymer
conjugates, their preparation and uses thereof
|
3860-08
|
EP
2706988
|
Liposomes
comprising polymer-Conjugated lipids and uses
|
4097-04
|
(2) Method of Use
or Other patents.
Patent/Application
|
Title
|
Yissum
ref.
|
us 7,772,196
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-14
|
us 8,901,103
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2510-44
|
AU
2011201154
|
Use of
Lipid Conjugates In the Treatment of Disease
|
2507-AU
|
Blueprint
Exhibit 10.5
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
CIPHER
PHARMACEUTICALS INC.
and
EDESA
BIOTECH INC.
June
15, 2016
TABLE OF CONTENTS
|
Page
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ARTICLE
1 DEFINITIONS
|
1
|
ARTICLE
2 SCOPE AND GOVERNANCE
|
7
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2.1 General.
|
7
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2.2 Joint Steering Committee
|
7
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2.3 JSC Meetings
|
8
|
ARTICLE
3 PRODUCT DEVELOPMENT AND COMMERCIALIZATION
|
8
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3.1 Overview
|
8
|
3.2 Conduct of Development and
Commercialization
|
9
|
3.3 Rights to Engage
Subcontractors
|
9
|
ARTICLE
4 MANUFACTURE AND SUPPLY
|
10
|
ARTICLE
5 RECORDS
|
10
|
ARTICLE
6 REGULATORY
|
10
|
6.1 Regulatory Obligations
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10
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6.2 Safety Reporting
|
11
|
6.3 Recalls
|
11
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6.4 Pricing and Reimbursement.
|
12
|
ARTICLE
7 PAYMENTS
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12
|
7.1 Milestone Payments
|
12
|
7.2 Product Royalties
|
13
|
7.3 Royalty Stacking
|
13
|
7.4 Reports; Payment of Royalty
|
13
|
7.5 Audits
|
14
|
7.6 Payment Exchange Rate
|
14
|
7.7 Tax Withholding
|
15
|
7.8 Late Payments
|
15
|
ARTICLE
8 LICENSES; EXCLUSIVITY
|
15
|
8.1 License to Licensee
|
15
|
8.2 Sublicensing
|
15
|
8.3 License to Cipher.
|
15
|
8.4 No Implied Licenses
|
16
|
8.5 Registration and Recordation of
License
|
16
|
8.6 Non-Compete
|
16
|
ARTICLE
9 CONFIDENTIALITY; PUBLICATION
|
16
|
TABLE OF CONTENTS
(Continued)
9.1 Nondisclosure
Obligation
|
16
|
9.2 Publicity; Use of Names
|
18
|
ARTICLE 10 REPRESENTATIONS AND WARRANTIES
|
19
|
10.1 Representations and Warranties of
Cipher.
|
19
|
10.2 Representations and Warranties and Covenants of
Licensee
|
20
|
10.3 Representations and Covenants of Both
Parties
|
20
|
10.4 No Other Representations or
Warranties
|
20
|
ARTICLE 11 INDEMNIFICATION
|
21
|
11.1 General Indemnity By Licensee
|
21
|
11.2 General Indemnity By Cipher.
|
21
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11.3 Defined Indemnification Terms
|
21
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11.4 Defense
|
21
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11.5 Settlement.
|
22
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11.6 Notice
|
22
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11.7 Permission by Indemnifying
Party
|
22
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11.8 Limitation of Liability
|
22
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11.9 Insurance
|
22
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ARTICLE 12 INVENTIONS; PATENT PROVISIONS
|
23
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12.1 Ownership of Intellectual
Property
|
23
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12.2 Improvements
|
23
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12.3 Enforcement.
|
23
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12.4 Defense
|
24
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ARTICLE 13 TERM AND TERMINATION
|
25
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13.1 Term and Expiration
|
25
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13.2 Termination for Cause
|
25
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13.3 Termination Without Cause
|
26
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13.4 Effect of Termination
|
26
|
13.5 Survival.
|
27
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ARTICLE 14 MISCELLANEOUS
|
27
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14.1 Force Majeure
|
27
|
14.2 Assignment.
|
27
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14.3 Severability
|
27
|
14.4 Notices
|
27
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14.5 Applicable Law and Litigation
|
28
|
14.6 Entire Agreement; Amendments
|
28
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14.7 Independent Contractors
|
29
|
14.8 Waiver.
|
29
|
TABLE OF CONTENTS
(Continued)
14.9 Cumulative Remedies
|
29
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14.10 Waiver of Rule of Construction
|
29
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14.11 Counterparts
|
29
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14.12 Further Assurances
|
29
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14.13 Construction
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29
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14.14 Currency
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30
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14.15 Use of Third Parties
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30
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14.16 Dispute Resolutions
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30
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14.17 Statute of Limitations
|
32
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14.18 Injunctive and Other Interim
Relief
|
32
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14.19 Time of the Essence
|
32
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14.20 Execution in Counterparts; Facsimile
Signatures
|
32
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14.20
Performance by Affiliates
|
32
|
EXCLUSIVE
LICENSE AGREEMENT
This
Agreement (the "Agreement"),
effective as of June 15, 2016 (the "Effective Date"), is entered into by
and between Cipher Pharmaceuticals Inc., an Ontario corporation
with its principal office at 2345 Argentia Road, Suite 100A,
Mississauga, Ontario, L5N 8K4 ("Cipher"), and Edesa Biotech Inc., an
Ontario corporation with its principal office at 100 Spy Court,
Markham, Ontario, L3R 5H6 ("Licensee"). Cipher and Licensee may be
referred to herein individually as a "Party" or collectively as the
"Parties". Reference to a
Paity shall be deemed to include that Party's
Affiliates.
RECITALS:
A.
Cipher owns Cipher
IP relating to ASF-1096 (Levo-salbutamol and/or R-salbutamol) as
further described in Schedule "A".
B.
Licensee is a
pharmaceutical company having expertise in the discovery,
development, manufacturing and commercialization of innovative
human pharmaceutical products.
C.
Licensee wishes to
develop, manufacture, and commercialize a pharmaceutical product or
products that may Cover Cipher IP.
D.
Licensee and Cipher
desire to enter into an agreement under which Licensee would obtain
exclusive rights to the Cipher IP for therapeutic, prophylactic and
diagnostic applications of the Product in human and veterinary
medicine for Anorectal Disorders (as defined below) (collectively,
the "Field").
In
consideration of the foregoing premises and the mutual covenants
herein contained, the Parties hereby agree as follows:
ARTICLE
1
DEFINITIONS
Unless
specifically set forth to the contrary herein, the following terms,
whether used in the singular or plural, shall have the respective
meanings set forth below:
1.1.
"Adverse Event" shall
mean any undesirable medical occurrence in a patient or clinical
investigation subject administered the Product and which does not
necessarily have to have a causal relationship with the
Product.
1.2.
"ADRC" has the meaning
set forth in Section 14.16.
1.3.
"Affiliate" means with
respect to any Party, any person or entity controlling, controlled
by or under common control with such Party. For purposes of this
Section 1.3, "control" shall
mean: (a) in the case of a corporate entity, direct or indirect
ownership of fifty percent (50%) or more of the stock or shares
having the right to vote for the election of directors of such
corporate entity; and (b} in the case of an entity that is not a
corporate entity, the possession, directly or indirectly, of the
power to direct, or cause the direction of, the management or
policies of such entity, whether through the ownership of voting
securities, by contract or otherwise.
1.4.
"Anorectal Disorders"
means any condition that affects the anal region, including but not
limited to hemorrhoids, tears, fistulas and abscesses.
1.5.
"Arbitration Panel
Finalization" has the meaning set forth in Section
14.16.
1.6.
"Biologics License
Application" means the request for permission to
introduce, or deliver for introduction a biologic product into
interstate commerce.in the US, which request is filed with the
FDA.
1.7.
"Calendar Quarter" means
the respective periods of three (3) consecutive calendar months
ending on March 31, June 30, September 30 and December
31.
1.8.
"Calendar Year" means the
respective periods of twelve (12) months commencing on January I
and ending on December 31.
1.9.
"cGMP" means current good
manufacturing practices as promulgated under the United States
Federal Food, Drug, and Cosmetic Act, as amended, the Food and Drugs Act (Canada), and
similar requirements of jurisdictions outside the United States and
Canada applicable to manufacture of Clinical Materials or
Product.
1.10.
"Cipher Data" has the
meaning ascribed to it in Section 6.l(b).
1.11.
"Cipher Field" means the
dermatological field and dermatological indications.
1.12.
"Cipher Indemnitee(s)"
has the meaning ascribed to it in Section I I.
I.
1.13.
"Cipher IP" means Cipher
Licensed Patents and Cipher Licensed Know-How.
1.14.
"Cipher Licensed
Know-How" means all information and Know-How owned or
Controlled by Cipher as of the Effective Date or at any time during
the Term, that is necessary or useful for Licensee to exercise the
rights licensed to it under this Agreement or to perform its
obligations under this Agreement. Such Cipher Licensed Know-How
shall include, in particular, all pre-clinical data, clinical data,
formulation data (including batch records), chemistry,
manufacturing and controls data and regulatory data including the
Dossiers.
1.15.
"Cipher Licensed Patents"
means all:
(a)
Patent rights owned
by Cipher as of the Effective Date or at any time during the Term
as further described in Schedule "A", including the Patent rights
that, from time to time, the Parties identify as, and agree in
writing are, Cipher Licensed Patents;
(b)
continuations,
divisionals, renewals, continuations-in-part, and Patents of
addition claiming priority to the Cipher Licensed Patents described
in the foregoing subsection (a),
(c)
restorations,
extensions, supplementary protection certificates, reissues and
re-examinations of the Cipher Licensed Patents described in the
foregoing subsections (a) and (b),
and foreign equivalents
of the Cipher Licensed Patents described in the foregoing
subsections (a), (b) and (c).
(NaN.
"Claimant" has the
meaning set forth in Section 14.16.
1.17.
"Clinical Material(s)"
means the Product formulated in accordance with the Specifications
and applicable Canadian, United States and/or foreign laws, rules
and regulations: (a) for preclinical activities; and (b) for
administration to subjects in clinical trials.
1.18.
"Clinical Trial(s)" means
all pre-clinical trials and activities, clinical trials and
toxicology studies, in each with respect to the Product in the
Field.
1.19.
"Commercialization" or
"Commercialize" means ac11v1t1es undertaken after
obtaining Regulatory Approval relating specifically to the
pre-launch, launch, promotion, marketing, sales force recruitment,
pricing determination, sale, use and distribution (including
importation and exportation) of a pharmaceutical product and
post-launch medical activities, including without limitation: (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-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.
1.20.
"Confidential
Information" has the
meaning set forth in Section 9.1.
1.21.
"Control,"
"Controls" or "Controlled by" means
(except as used in Section 1.3), with respect to any item of or
right under Patents or Know-How, 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.
1.22.
"Cover" or "Covered"
means, with respect to Patents subject to this Agreement, in the
absence of a license to an unexpired, valid claim thereof, the
research, development, manufacture, use, sale, offer for sale, or
importation of the applicable invention, discovery, process, or
product would infringe such a claim (or, in the case of a claim
that has not yet issued, would infringe such a claim if it were to
issue).
1.23.
"Demand for Arbitration"
has the meaning set forth in
Section 14.16.
1.24.
"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,
without limitation, test method development and stability testing,
toxicology, formulation, quality assurance/quality control
development, statistical analysis, preclinical and clinical studies
and regulatory affairs, approval and registration, in each case, of
a Product for use in the Field.
1.25.
"Diligent Efforts" means
those efforts and resources commonly associated with the
commercially reasonable business practices and standards in
the research-based pharmaceutical industry to research, develop,
manufacture or commercialize (as appropriate) a product or compound
of similar market potential at a similar stage in its
product.
1.26.
"Dossiers" means any and
all product registration and NDA applications, including all
pre investigational new drug application consultations, and
all supporting files, writings, data, studies, and reports,
manufacturing information and clinical protocols and investigator
information, in draft and compiled in final form and submitted to
the competent local authorities for obtention of a product
registration or NDA approval.
1.27.
"EMEA" means the European
Medicines Evaluation Agency or any successor agency
thereto.
1.28.
"FDA" means the United
States Food and Drug Administration or any successor agency
thereto.
1.29.
"Field" has the meaning
ascribed to it in the recitals.
1.30.
"First
Commercial Sale" means, with respect to the Product
in the Field, the first sale to a Third Party for end use or
consumption of the Product in the Field in a country in the Territory after
Regulatory Approval of the Product in the Field has been granted by
the Regulatory Authority of such country.
1.31.
"Good
Clinical Practice" means the current good clinical
practice applicable to the clinical Development of the Product
under applicable law, to the extent such standards are not less
stringent than the U.S. current good clinical practice, including
the ICH guidelines.
1.32.
"Good
Laboratory Practice" means the current good
laboratory practice applicable to the Development of the Product
under applicable law, to the extent such standards are not less
stringent than the U.S. current good laboratory practice, including
21 C.F.R. Part 58.
1.33.
"ICH" means the
International Conference on Harmonization of Technical Requirements
for Registration of Pharmaceuticals for Human Use.
1.34.
"IFRS" means
International Financial Reporting Standards as the same may be in
effect from time to time.
1.35.
"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.
1.36.
"Indication" means any
separate and distinct disease (or stage of disease), disorder or
medical condition in humans or non-human animals which a Product is
intended to treat, prevent, diagnose, monitor or ameliorate and
which, for a Product candidate, is intended to be reflected in the
labeling for such Product as an approved indication, and which, for
an approved Product, is reflected in the labeling for such
Product.
1.37.
"Indemnifying Party" has
the meaning ascribed to it in Section 11.3.
1.38.
"Indemnitee" has the
meaning ascribed to it in Section 11.3.
1.39.
"Information" means any
and all scientific, pre-clinical, clinical, regulatory,
manufacturing, marketing, financial and commercial information and
data, in any tangible or intangible form, including all
Know-How.
1.40.
"Know-How" means (a) any
proprietary scientific or technical information, results and data
of any type whatsoever, in any tangible or intangible form
whatsoever, including databases, safety information, practices,
methods, techniques, specifications, formulations, formulae,
knowledge, know-how, skill, experience, test data including
pharmacological, medicinal chemistry, biological, chemical,
biochemical, toxicological and clinical test data, analytical and
quality control data, stability data, studies and procedures, and
manufacturing process and development information, results and data
and (b) any proprietary biological, chemical or physical
materials.
1.41.
"Knowledge" shall mean
actual knowledge of any of the current officers of the
Party.
1.42.
"Licensee Data" has the
meaning ascribed to it in Section 6.l(b).
1.43.
"Licensee Indemnitee(s)"
has the meaning ascribed to it in Section 11.2.
1.44.
"Licensee Licensed
Know-How" means all Know-How (excluding any Patents)
Controlled by Licensee as of the Effective Date or at any time
during the Term, that is: (a) related to the Product (or a
composition containing the Product, or the manufacturing or use of
the Product); and (b) reasonably necessary for Cipher to exercise
the rights licensed to it under this Agreement or to perform its
obligations under this Agreement, or to continue Development or
Commercialization of the Product for use in the Cipher
Field.
1.45.
"Licensee Licensed
Patents" means any and all Patents owned by Licensee
at any time during the Term, that are necessary or reasonably
useful for Cipher to exercise the rights licensed to it under this
Agreement or to perform its obligations under this Agreement or to
continue Development or Commercialization of the Product for use in
the Cipher Field.
1.46.
"Licensee Trademarks"
means any and all Trademarks Controlled by Licensee at any time
during the Term that are registered for or apply to the
Product.
1.47.
"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
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.
1.48.
"Net
Sales" means the gross amount invoiced by Licensee or
its Affiliates to unrelated Third Parties (excluding any
Sublicensee) for sales of the Product in the Field in the
Territory, less:
(a)
Trade, quantity and
cash discounts actually allowed or paid;
(b)
Commissions,
discounts, refunds, rebates (including but not limited to
wholesaler fees), chargebacks, retroactive price adjustments, and
any other allowances 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 applicable warehouse all to the extent included in the
third pa1ty 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 Licensee, Sublicensees,
and their Affiliates.
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.
Such
amounts shall be determined from the books and records of Licensee
or its Affiliates, as applicable, maintained in accordance with
IFRS, consistently applied. Licensee further agrees that in
determining such amounts, it will use Licensee's then current
standard procedures and methodology, including Licensee's then
current standard exchange rate methodology for the translation of
foreign currency sales into U.S. Dollars, consistently
applied.
1.49.
"Patent(s)" means: (a)
all patents and patent applications in any country or supranational
jurisdiction; and (b) any provisionals, substitutions, divisions,
continuations, continuations in part, reissues, renewals,
registrations, confirmations, reexaminations, extensions,
supplementary protection certificates and the like, of any such
patents or patent applications.
1.50.
"Phase
III Clinical Study" means a human clinical study to
confirm with statistical significance the efficacy and safety of
the Product in the Field performed to obtain Regulatory Approval
for the Product in any country.
1.51.
"Product" means ASF-1096
(Levo-salbutamol and/or R-salbutamol) and any product that is
Covered by Cipher Licensed Patents.
1.52.
"Regulatory Approval(s)"
means all approvals or authorizations by Regulatory Authorities
necessary to market and sell the Product in the Field in the
applicable jurisdiction.
1.53.
"Regulatory Authority"
means any applicable government regulatory authority involved in
granting approvals for the conduct of clinical trials or the
manufacturing, marketing, reimbursement or pricing of a Product in
the Territory, including in the United States the FDA, and in
Canada, Health Canada.
1.54.
"Respondent" has the
meaning set faith in Section 14.16.
1.55.
"Specifications" means
the Licensee's specifications for the Product.
1.56.
"Subcontractors" has the
meaning set forth in Section 3.3.
1.57.
"Sublicensee" means a Third Party that
is granted a sublicense under the licenses granted to a Party under
this Agreement.
1.58.
"Sublicensing Fees" has
the meaning set forth in Section 7.2.
1.59.
"Sublicensing Revenue"
means the net amount of all revenues, royalties, receipts, and
monies, including, without limitation, upfront payments, milestone
payments, and license fees, earned or received by Licensee and its
Affiliate(s) from Sublicensee(s) with respect to the
Product.
1.60.
"Technology Transfer" has
the meaning set forth in Article 4.
1.61.
"Term" has the meaning
set forth in Section 13.1.
1.62.
"Territory" means the
entire world.
1.63.
"Third
Party" means an entity other than: (a) Licensee and
its Affiliates; and (b) Cipher and its Affiliates.
1.64.
"Trademark(s)" means all
granted trademarks and all trademark applications in any country or
supranational jurisdiction and/or any other trademark used for the
promotion, marketing, distribution, use and/or sale of
Product.
1.65.
"United States" or
"US" means the United
States of America and its territories and possessions, including
the Commonwealth of Puerto Rico and the U.S. Virgin
Islands.
ARTICLE
2
SCOPE
AND GOVERNANCE
(a)
Scope. Pursuant to and subject to the
terms of this Agreement: (a) Licensee will be responsible for the
Development and Commercialization of the Product in the Territory
in the Field with the goal of obtaining Regulatory Approval for the
Product, as soon as commercially reasonable; (b) Licensee will have
exclusive rights to Commercialize the Product as further set forth
in Section 8.1 in exchange for royalty and other payments to be
made to Cipher as described in Article 7; and (c) responsibility
for manufacture of Clinical Materials and Product shall be as
detailed in Article 4.
(b)
Guiding Principles. The committee set
forth in this Article 2 shall perform its responsibilities under
this Agreement based on the principles of good faith, prudence and
good scientific and business judgment. The committee shall not have
any power to amend, modify or waive compliance under this
Agreement. Notwithstanding anything to the contrary in this
Agreement, no decision by either Party, or any committee set forth
in this Article 2, will be effective if such decision requires the
other Party to breach any obligation under this Agreement or to
perform any activities that are materially different or greater in
scope than those provided for specifically under this
Agreement.
2.2.
Joint
Steering Committee.
(a)
Membership. The Parties hereby establish
a Joint Steering Committee, or JSC, to coordinate and oversee
activities of the Parties under this Agreement. The JSC shall
consist of two (2) representatives from each Party although the JSC
may change the size of the JSC from time to time by mutual consent
of the members of the JSC. Each Party shall notify the other of
its representatives to the JSC within thirty (30) days of the
Effective Date. Each Party may replace its JSC representatives at
any time upon written notice to the other Party. The JSC shall be
chaired first by a representative of Licensee from the period from
the Effective Date through July 1,
2017 and thereafter the chairperson position shall rotate
annually on July 1, with
Cipher to appoint the chairperson for the second annual term, and
so forth thereafter. The chairperson shall be responsible for
calling meetings, preparing and circulating an agenda in advance of
each meeting, and preparing and issuing minutes of each meeting
within thirty (30) days thereafter. Each Party may replace any of
its appointed JSC representatives, including a chairperson, at any
time upon five (5) days' prior written notice to the other
Party.
(b)
Responsibilities. The
responsibilities of the JSC shall be:
(i)
to provide a
vehicle by which the Parties may provide to each other information
regarding the Development of the Product in their respective
Field;
(ii)
to provide a
vehicle by which Licensee and Cipher can share and discuss the
data, results and intellectual property generated by, on behalf of
or under the direction of, Cipher, Licensee or their respective
Affiliates with respect to the Product and by which Licensee and
Cipher can provide input regarding the Parties' intellectual
property strategies in respect of the Product;
(iii)
to facilitate the
exchange of Information between the Parties with respect to the
Development activities hereunder and to establish procedures for
the efficient sharing of Information necessary for the Parties to
fulfill their respective responsibilities with respect to the
Development of the Product hereunder;
(iv)
to discuss
collaborative approaches to ensure commercial viability of the
Product both within and outside of the Field;
(v)
to perform such
other functions as appropriate to further the purposes of this
Agreement, as determined by the Parties.
JSC
meetings shall be held quarterly, or on any other schedule agreed
upon by the Parties. With the consent of the representatives of
each Party serving on the JSC, other representatives of each Party
may attend meetings as non-voting observers (provided such
non-voting observers have confidentiality obligations to such Party
that are at least as stringent as those set forth in this
Agreement). A JSC meeting may be held by audio, video or other
electronic means with the consent of each Party, but at least one
meeting per year shall be held in person. Each Party shall be
responsible for all of its own expenses of participating in the JSC
meetings.
ARTICLE
3
PRODUCT
DEVELOPMENT AND COMMERCIALIZATION.
From
and after the Effective Date, Licensee shall have full
responsibility and authority, at its sole cost and expense, for the
conduct of all Clinical Trials and for the Development and
Commercialization of the Product in the
Field in the Territory. Responsibility for regulatory matters will
be as set forth in Article 6.
3.2.
Conduct
of Development and Commercialization.
Licensee shall use
Diligent Efforts to Develop and Commercialize the Product in the
Field in the Territory, in compliance with the terms and conditions
of this Agreement and with a goal to maximize profits from Net
Sales of the Product in the Field in the Territory. As between
Licensee and Cipher, Licensee shall have the sole right and
obligation to determine all pricing of the Product in the Field. In
addition, each Party and any Affiliate(s), contractor(s) or
Sublicensee(s) performing activities in connection with the
Development and Commercialization of the Product shall comply with:
(i) all applicable Good Laboratory Practices, Good Clinical
Practices and applicable cGMP requirements; and (ii) all applicable
laws and regulations. Licensee shall report to the JSC at each JSC
meeting as to the status of Development and Commercialization of
the Product in the Field.
Without
limiting the foregoing:
(a)
Licensee shall, at
its own cost, use Diligent Efforts to complete a proof of concept
study with respect to the Product in the Field;
(b)
Development and
Commercialization of the Product in the Field shall be carried out
by Licensee so as to not actively unreasonably hinder, impede or
impair the Commercialization of the Product for use in the Cipher
Field by Cipher, its Affiliates or Third Parties contracting with
Cipher. The Parties agree that any pricing decisions by Licensee
for Product in the Field shall not constitute an active
unreasonable hindrance, impediment, or impairment of the
Commercialization of the Product for use in the Cipher Field by
Cipher, its Affiliates or Third Parties contracting with Cipher.
Except as otherwise stated in this paragraph, any dispute
associated with or related to the determination of whether
Development and/or Commercialization of the Product by Licensee in
the Field actively hinders, impedes or impairs Commercialization of
the Product for use in the Cipher Field by Cipher, its Affiliates
or Third Parties contracting with Cipher shall be addressed in
accordance with Section 14.15; and
(c)
Licensee shall not
apply to register and/or use in connection with the Development and
Commercialization of Product any Trademarks owned by
Cipher.
3.3.
Rights
to Engage Subcontractors.
Except
as set forth below, Licensee shall have the right to engage Third
Party contractors to perform any of its activities or obligations
hereunder, provided that Licensee shall be responsible for ensuring
that, prior to any such engagement, any subcontractors are subject
to written agreements containing terms and conditions: (i)
consistent with the relevant terms and conditions of this Agreement
protecting the rights of Cipher under this Agreement including
imposing obligations of confidentiality on each such
subcontractor; (ii) that vests ownership of any and all
inventions developed by such subcontractor that is Covered by the
Products in the course of performing such subcontracted work in
Licensee; and (iii) that does not impose any payment obligations or
liability on Cipher without the prior written consent of Cipher,
(such subcontractor, a "Subcontractor").
ARTICLE
4
MANUFACTURE
AND SUPPLY
The
Parties will negotiate, in good faith, determining which Party or
Third Party will manufacture and supply Product and Clinical
Materials to Licensee. If the Parties determine that
Cipher is not responsible for the manufacture and supply of Product
for Licensee, Cipher shall provide to the manufacturer access to
all Product Information, manufacturing Know-How, and any and all
original processes, records, and any other Information reasonably
necessary to have the Product and Clinical Materials manufactured
in accordance with the applicable Specifications ("Technology
Transfer"), provided that such manufacturer agrees to keep
any Confidential Information confidential in accordance with the
provisions set out in this Agreement. In the event the Parties
agree that Cipher will be responsible for the manufacture and
supply of Product and Clinical Materials to Licensee, the Parties
shall negotiate the terms and conditions (including as to pricing)
of a manufacturing agreement pursuant to which Cipher shall
manufacture and supply Product or Clinical Materials for
Licensee.
ARTICLE
5
RECORDS
Each
Party shall maintain appropriate records of: (a) all significant
Development, manufacturing and Commercialization events and
activities conducted by it or on its behalf related to the Product;
and (b) all significant Information generated by it or on its
behalf in connection with research and Development of Products
under this Agreement, in each case in accordance with such Party's
usual documentation and record retention practices. Such records
shall be in sufficient detail to properly reflect, in good
scientific manner, all significant work done and results of studies
and trials undertaken, and further shall be at a level of detail
appropriate for patent and regulatory purposes. If reasonably necessary for a
Party to perform its work under this Agreement or to exercise its
rights under this Agreement, that Party may request that, and the
other Party shall provide within a reasonable time frame, such
information and data regarding its activities hereunder as is
reasonably available and reasonably related to the activities under
this Agreement. Neither Party is required to generate additional
data or prepare additional reports to comply with the foregoing
obligation. All such repo1ts, Information and data provided shall
be subject to the provisions of Article 9.
ARTICLE
6
REGULATORY
6.1.
Regulatory
Obligations.
(a)
Licensee shall be
responsible for and shall have the sole right to control, all
regulatory activities and strategy associated with IND, NDA and all
other regulatory submissions, all Regulatory Approvals, and the
maintenance of such submissions and Regulatory Approvals, 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. Cipher
shall cooperate with Licensee as requested in preparing and filing
all such reports, and Cipher shall provide Licensee with all
available information, including regulatory, technical and clinical
data concerning the Product, and any Dossiers related to the
Product, to enable Licensee to prepare and file such reports.
Licensee shall pay all governmental fees associated with obtaining
and maintaining any and all Regulatory Approvals including any
establishment license fees of Licensee or Third Parties which must
be paid with respect to facilities used in the manufacture of the
Product by or on behalf of Licensee in the Field.
(b)
Cipher shall have
the right to access and use in a timely manner any and all data and
results related to the Product that is generated by, on behalf of
or under the direction of, Licensee or its Affiliates with respect
to the Product (including all data or results contained or
referenced in Licensee's submissions or applications for Regulatory
Approvals with respect to the Product, including all reports,
correspondence and conversation logs) (the "Licensee Data"), for
the purpose of Development and Commercialization of the Product in
the Cipher Field, and Cipher may cross reference all such data in
Cipher's submissions or applications for Regulatory
Approvals.
(c)
Licensee shall have
access and the right to use, in a timely manner any and all data
and results related to the Product that is generated by, on behalf
of or under the direction of, Cipher or its Affiliates with respect
to the Product (including all data or results contained or
referenced in Cipher's submissions or applications for Regulatory
Approvals with respect to the Product, including without
limitation, all reports, correspondence and conversation logs) (the
"Cipher
Data"), for the purpose of Development and Commercialization
of the Product within the Field, and Licensee may cross reference
all such data in Licensee's submissions or applications for
Regulatory Approvals.
(d)
As between the
Parties, and excluding any Cipher Data, Licensee shall own all
right, title and interest in Licensee Data. As between the Parties,
and excluding any Licensee Data, Cipher shall own all right, title
and interest in Cipher Data.
(a)
Adverse Event
Procedures. Licensee shall be responsible for all regulatory
activities including: (i) management and monitoring of safety and
Adverse Event/experience information for the Product in the Field;
(ii) regulatory reporting; (iii) managing the global safety data
base; and (iv) reviewing and approving of safety information for
inclusion in the Product label in the Territory, in each case with
respect to the Product in the Field.
(b)
Safety Agreement.
Representatives of each Party from the affected areas will begin
meeting as soon as possible but no later than sixty (60) days after
the Effective Date of this Agreement and will work in good faith
together to develop a Safety Agreement within an agreed reasonable
time to describe safety data transfers, and Adverse Event handling
and reporting to Regulatory Authorities, which shall include timely
reporting to the other Party of Adverse Events and access to any
relevant safety data by each Party.
(c)
Third Parties. Each
Party agrees that if it contracts with a Third Party for clinical
research to be performed by such Third Party relating to the
Product, that Party agrees to require such Third Party to report to
the contracting Party the information set forth above.
Licensee 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. If Licensee recalls, detains
or retains such Product (voluntarily, or by order of a Regulatory
Authority), Cipher shall reasonably cooperate in such actions, at
Licensee's sole expense. Cipher shall be responsible for any recall
decision and the conduct of any recall in respect of the Product in
the Cipher Field, including the costs and expenses thereof.
If Cipher
recalls, detains or retains such Product (voluntarily, by order of
a Regulatory Authority), Licensee shall reasonably cooperate in
such actions, at Cipher's sole expense
6.4.
Pricing
and Reimbursement.
Licensee shall be
solely responsible for setting the price for Product in the Field
to be sold by Licensee, and shall do so without discussion or
consultation with Cipher. Cipher may provide to Licensee, in
writing, suggested resale prices or price ranges and any lawfully
derived market studies or data, provided, however, that no such
data is obtained from another Cipher collaborator and, provided,
further, however, that Licensee shall determine its selling price
in its sole discretion without discussion or consultation with
Cipher regarding such suggested prices, price levels, market
studies or data. Cipher shall be solely responsible for setting the
price for Product in the Cipher Field to be sold by Cipher, and
shall do so without discussion or consultation with Licensee.
Licensee may provide to Cipher, in writing, any lawfully derived
market studies or data, provided, however, that Cipher shall
determine its selling price in its sole discretion without
discussion or consultation with Licensee regarding such market
studies or data. The foregoing shall not apply with regard to
Product to be sold from one Party to the other, which price shall
be established by agreement.
ARTICLE
7
PAYMENTS
Licensee shall
immediately notify Cipher of the achievement of any of the
following development and commercial milestones, all for the
Product in the Field. Licensee shall pay to Cipher the milestone
payments listed below which shall be non-refundable and
non-creditable and are due and payable within thirty (30) days of the receipt by Licensee of an
invoice for payment from Cipher:
Upon enrollment of
the first study subject in a Phase III Clinical Study
|
[ ]
|
Upon receipt of
Regulatory Approval from the FDA
|
[ ]
|
First Commercial
Sale
|
[ ]
|
First occurrence of
$[ ] million in aggregate Net Sales in a Calendar Year in
those countries in which the Licensee directly
Commercializes
|
[ ]
|
First occurrence of
$[ ] million in aggregate Net Sales in a Calendar Year in
those countries in which the Licensee directly
Commercializes
|
[ ]
|
First occurrence of
$[ ] million in aggregate Net Sales in a Calendar Year in
those countries in which the Licensee directly
Commercialize
|
[ ]
|
Upon
the first occurrence of each $[ ] million incremental
increase in aggregate Net Sales in a Calendar Year beyond $[
] million in countries in which the Licensee directly
Commercializes, Licensee shall pay Cipher a milestone payment
equivalent to [ ]% of the value of the aggregate Net Sales in
such Calendar Year. For example, upon the first occurrence of
aggregate Net Sales in a Calendar Year reaching $[ ] million,
Licensee shall pay Cipher $[ ] million.
Licensee shall pay
to Cipher a royalty of [ ]% of Net Sales of the Product in
the Field in the countries in the Territory where it directly
Commercializes the Product. Licensee shall pay to Cipher an amount
equal to [ ]% of Sublicensing Revenue received by Licensee
and its Affiliates ("Sublicensing Fees")
in the countries in the Territory where it does not directly
Commercialize the Product.
The
parties recognize and agree that, in order to Develop and
Commercialize the Product in the Field, it may be necessary for
Licensee and/or its Sublicensees to make use of and/or incorporate
multiple elements of intellectual property from multiple sources.
Licensee and/or its Sublicensees will determine, in their sole
judgment, which elements of intellectual property are necessary
and/or desirable for the Development and/or Commercialization of
the Product. Royalty payments or license fees to third parties may
occur if intellectual property owned by a third party is required
or desirable for the Commercialization of the Product in the Field
and Territory. All types of payments to third parties that Licensee
and/or its Sublicensees have determined and/or may determine are
necessary or desirable to obtain licenses or other rights to use or
incorporate intellectual property or products other than the
Products in the Field and Territory, will be creditable against
royalties otherwise owed to Cipher hereunder, provided that such
payments must have been made in good faith. Notwithstanding the
foregoing, at no point shall Cipher's [ ]% royalty on Net
Sales, nor Cipher's [ ]% share of the Sublicensing Revenue be
reduced by more than [ ]% due to payments to third parties in
respect of other licenses required to Develop and Commercialize the
Product in the Field in the Territory.
7.4.
Reports;
Payment of Royalty.
(a)
During the Term,
following the First Commercial Sale of the Product, Licensee shall
furnish to Cipher a quarterly written report for the Calendar
Quarter showing: (i) the Net Sales of the Product in the Field in
countries in which the Licensee directly commercializes as well as
on a country-by-country basis (in countries in which the Licensee
directly commercializes) during the reporting period and the
royalties payable under this Agreement in respect thereof; and (ii)
Sublicensing Revenues during the reporting period and the
Sublicensing Fees payable under this Agreement in respect thereof
on a country by-country basis.
(b)
Reports shall be
due on the thirtieth (30th) day following the close of each
Calendar Quarter. Royalties and Sublicensing Fees shown to have
accrued by each royalty report shall be due and payable in
accordance with Section 7.1. Licensee shall keep complete and
accurate records in sufficient detail to enable the royalties and
Sublicensing Fees payable hereunder to be determined. The quarterly
written reports contemplated by this Section 7.3 shall include, at
a minimum, the total sales units showing the number of doses sold
and Net Sales on a country-by-country basis, where available, as
well as a breakdown of all Sublicensing Revenues (broken down by
upfront, milestone, royalty, license and other payments) on a
country-by-country basis. For each country, the total gross sales,
all deductions (broken down separately by each of the categories
set out in clauses (a) to (f) of the
definition of "Net Sales" and separately setting forth any
adjustments thereto due to refunds or reimbursements of deducted
amounts) and total Net Sales of Product for the quarter shall also
be provided.
(a)
Licensee will keep
and maintain (and to the extent applicable, will cause its
Affiliates, and their respective sub-licensees, distributors,
assignees and transferees to keep and maintain) proper and complete
records and books of account in such form and detail as is
necessary for the determination of the amounts payable by Licensee
(on behalf of itself and its Affiliates and their respective
sub-licensees, distributors, assignees and transferees) to Cipher
under this Agreement and for the purposes of this
Agreement.
(b)
Upon the written
request of Cipher and not more than once in each Calendar Year,
Licensee shall permit an independent certified public accounting
firm of nationally recognized standing (that has been retained on
an hourly or flat fee basis and receives no contingency fee or
other bounty or bonus fee) selected by Cipher and reasonably
acceptable to Licensee, at Cipher's expense, to have access during
normal business hours to such of the records of Licensee 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 thirty-six (36) months after the
termination of this Agreement.
(c)
Cipher shall share
the accounting firm's written report with Licensee within five (5)
days of its receipt by Cipher. If such accounting firm identifies a
discrepancy made during such period, the appropriate Party shall
pay the other Party the amount of the discrepancy within thirty
(30) days of the date Cipher delivers to Licensee 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 Cipher unless the underpayment exceeded the greater of: A)
ten
percent (10%) of the amount owed by Licensee to Cipher for such
Calendar Year; or BJ $25,000.00,
in which case, Licensee shall pay to Cipher the reasonable fees
charged by such accounting firm, which fees shall not exceed
$40,000 CAD. Licensee shall pay interest on the amounts owed to
Cipher, 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)
Licensee shall
include in each sublicense granted by it pursuant to this Agreement
a provision requiring the Sublicensee to make reports to Licensee,
to keep and maintain records of sales made pursuant to such
sublicense and to grant access to such records by an independent
certified public accountant selected by Licensee to the same extent
required of Licensee under this Agreement.
(e)
Cipher 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 Licensee or its Related Parties
obligating it to retain all such information in confidence pursuant
to such confidentiality agreement.
7.6.
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 Licensee to Cipher
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.
The
Parties will withhold taxes with respect to payments under this
Agreement under applicable law. Each Party will provide
documentation to the other Party as evidence of the accuracy and
payment of any such withholding tax, as applicable.
The
paying Party shall pay interest to the receiving Party on the
aggregate amount of any undisputed invoices that are not paid on or
before the date the payment of such invoices are due under this
Agreement at a rate per annum equal to the lesser of one percent
(I%) per month or the highest rate permitted by applicable law,
calculated on the number of days such payments are paid after the
date payment of such invoices is due and compounded
monthly.
ARTICLE
8
LICENSES;
EXCLUSIVITY
8.1.
License
to Licensee.
(a)
Exclusive License and
Sublicenses. Subject to the terms and conditions of this
Agreement, Cipher hereby grants to Licensee and its Affiliates an
exclusive (except with respect any rights retained by Cipher under
Section 8.l(b)), royalty-bearing license in the Territory in the
Field, with the right to grant sublicenses, under the Cipher IP and
the Cipher Data, as necessary for the Development and
Commercialization of the Product in the Field.
(b)
Cipher Retained Rights.
Notwithstanding the rights granted to Licensee in Section 8. l(a),
Cipher retains the following: (i) the right to manufacture or have
manufactured Product or Clinical Materials for use pursuant to this
Agreement as provided in and in accordance with Article 4;and (ii)
the right to Develop or Commercialize or conduct any other
activities involving the Product in the Cipher Field.
Licensee shall have
the right to grant Sublicenses under the Cipher IP to Sublicensees
on terms that are consistent with those granted to Licensee
pursuant to this Agreement.
(a)
Licensee hereby
grants Cipher an exclusive, royalty-free license, with the right to
grant sublicenses to Third Parties in accordance with this Section
8.3(b), under the Licensee Licensed Patents, Licensee Licensed
Know-How and Licensee Data solely (i) to manufacture Clinical
Materials or the Product to the extent contemplated by Article 4,
and (ii) to make or Develop, manufacture or
Commercialize Products in the Cipher Field as contemplated by
Section 8.l(b) of this Agreement.
(b)
Cipher shall only
have the right to grant a sublicense to a Third Party pursuant to
Section 8.3(a) if (i) Cipher has provided Licensee with reasonable
written notice prior to granting any such sublicense to a Third
Party and such written notice identifies the applicable
Sublicensee; and (ii) Cipher causes each Sublicensee to enter into
an agreement with Cipher. Each sublicense agreement shall
(1) be in
writing; (2) be subject to and consistent with, the terms of this
Agreement; (3) preclude assignment of such sublicense agreement and
sublicensing of the licenses granted under such sublicense
agreement to any Third Parties without Licensee's prior written
consent, such consent not to be unreasonably withheld or delayed
(4) terminate upon the termination of this Agreement in accordance
with the terms hereof, and (5) include Licensee as an intended
third party beneficiary with the right to enforce the terms of such
sublicense agreement.
8.4.
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.
8.5.
Registration
and Recordation of License.
If this Agreement or any license herein
granted is required to be registered with or reported to a national
or supranational agency of any country in which Licensee would do
business, Licensee shall, at its expense, undertake such
registration or report, and provide prompt notice and appropriate
verification of the act or registration, report or any agency
ruling resulting from such registration to Cipher. Any formal
recordation of this Agreement or any license herein granted which
is required by the law of any country, as a prerequisite to
enforceability of the Agreement or license in the courts of any
such country or for other reasons, shall be carried out by Licensee
at its expense, and appropriately verified proof of such
recordation shall be promptly provided to Cipher.
Licensee agrees
that neither it nor any of its Affiliates shall, at any time during
the Term, Develop or Commercialize the Product for use in the
Cipher Field, nor will Licensee Develop or Commercialize any
product that could act as a substitute for the Product in the
Cipher Field. Cipher agrees that neither it nor any of its
Affiliates shall, at any time during the Term, Develop or
Commercialize the Product in the Field nor will Cipher Develop or
Commercialize any product that could act as a substitute for the
Product in the Field. The Parties agree that the Development and
Commercialization of the Product by Cipher in the Cipher Field and
the Development and Commercialization of the Product by Licensee in
the Field are in compliance with this Section 8.6.
ARTICLE
9
CONFIDENTIALITY;
PUBLICATION
9.1.
Nondisclosure
Obligation.
(a)
Except as provided
in this Section 9.1, all Information and any other 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 ten (10) years following the
Term of this Agreement, except to the extent that such
Information:
(i)
is known by the receiving Party at the time of
its receipt, and not through a prior disclosure by the disclosing
Party, 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".
(b)
Each Party may
disclose Confidential Information of the other Party, without such
other Party's prior written consent, to its Affiliates' directors,
employees, agents, consultants, Sublicensees, suppliers, and other
persons or entities who:
(i)
need to know such
Confidential Information to assist the Party in fulfilling its
obligations hereunder;
(ii)
need to know such
Confidential Information to assist Cipher or Licensee, as the case
may be, in the Development or Commercialization of the Product for
use in the Cipher Field or the Field, respectively;
and
(iii)
are bound by
written confidentiality and non-use obligations consistent with
those the Party uses to protect its own Confidential
Information.
(c)
Each Party shall
promptly disclose to the other Party the nature and scope of any
breach of this provision by it, or its Affiliates, directors,
officers, employees, agents, consultants, Sublicensees, suppliers,
or other persons or entities permitted hereunder and the steps
taken to contain and address the breach.
(d)
Each Party may also
disclose the Confidential Information of the other Party, without
such other Party's prior written consent, to any person, entity, or
government or regulatory authority to the extent that the law
requires such disclosure, including filings pursuant to applicable
securities or tax laws and regulations. The Party disclosing such
Confidential Information shall take such actions as are reasonable
to preserve the confidentiality of such Confidential Information,
such as requesting confidential treatment. In addition, it may also
disclose the other Party's Confidential Information, without the
other Party'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 or satisfying any other regulatory obligation
regarding the Product. Each party may also disclose the
Confidential Information of the other Party, without such other
Party's
prior written consent, pursuant to an order of a Regulatory
Authority or court of competent jurisdiction, provided that it: (i)
promptly notifies the other Party of the required disclosure in
order to provide such Party an opportunity to take legal action to
prevent or limit such disclosure and, if asked, reasonably assists
the other Party in pursuing such action; and (ii) shall only
disclose the Confidential Information to the minimum extent
required by law.
9.2.
Publicity;
Use of Names.
(a)
The Parties shall
issue a mutually acceptable press release announcing the execution
of this Agreement. A Party may issue any subsequent press release
relating to this Agreement or activities conducted hereunder upon
prior written approval of the other Party, such approval not to be
unreasonably withheld or delayed; provided, however, that no
approval of the other Party shall be required if a subsequent press
release solely discloses the information that: (1) a milestone
under this Agreement has been achieved and/or any payments
associated therewith have been received; (2) the filing and/or
approval of the NDA with the FDA or the EMEA generally has occurred
(provided, however, that specific dates of filing shall not be
disclosed); (3) commercial launch of the Product in any country or
any information that has previously been approved and disclosed as
permitted by this Section 9.2. In the case of items (1)-(3) of the
preceding sentence, the disclosing Party shall provide the other
Party a copy of such proposed disclosures prior to the proposed
release and consider in good faith any comments the other Party may
make, where practicable, and in light of any reporting obligations
of such disclosing Party under applicable laws, rules or
regulations, including without limitation, applicable securities
law. Except as otherwise provided in this Section 9.2(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.
(b)
Notwithstanding the
terms of this Article 9, 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
without limitation the rules and regulations promulgated by
securities law regulatory agencies or any other governmental
agency. Notwithstanding the foregoing, before disclosing this
Agreement or any of the terms hereof pursuant to this Section
9.2(b), the Parties shall consult with one another on the terms of
this Agreement for which confidential treatment will be sought in
making any such disclosure. If
a Party wishes to disclose this Agreement or any of the terms
hereof in accordance with this Section 9.2(b), such Party agrees,
at its own expense, to seek confidential treatment of the portions
of this Agreement or such terms as may be reasonably requested by
the other Party, provided that the disclosing Party shall always be
entitled to comply with legal requirements.
(c)
Either Party may
also disclose the existence and terms of this Agreement to its
legal counsel, investment bankers, accountants and advisors, and to
potential Sublicensees, Third Party contractors, investors, lenders
or acquirers, and their legal counsel, investment bankers,
accountants and advisors, in each case under an agreement or in the
case of legal counsel, a professional obligation, to keep the 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 9.2(c).
ARTICLE
10
REPRESENTATIONS
AND WARRANTIES
10.1.
Representations
and Warranties of Cipher.
Cipher
represents and warrants to Licensee that as of the Effective
Date:
(a)
To Cipher's
knowledge of Cipher, Schedule "A" is a true and complete list of
all of the Cipher Licensed Patents existing in the Territory and
that it owns or controls all right, title and interest in and to
the Cipher Licensed Patents and to the Cipher Licensed
Know-How;
(b)
it has the full
right, power and authority to enter into this Agreement, to perform
its obligations under this Agreement, and to grant the licenses
granted under Section 8.1, 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 Cipher is bound;
(c)
to the knowledge of
Cipher, there are no legal claims, judgments or settlements against
or owed by Cipher or pending legal claims or litigation, in each
case relating to the Product, the Cipher Licensed Patents or the
Cipher Licensed Know-How;
(d)
subject to Section
14.11, all necessary consents, approvals and authorizations of all
government authorities and other persons required to be obtained by
Cipher as of the Effective Date in connection with the execution,
delivery and performance of this Agreement have been
obtained;
(e)
it Controls the
right, title and interest in and to the Cipher Licensed Patents and
the Cipher Licensed Know-How, and has the right to grant to
Licensee the licenses that it purports to grant hereunder and has
not granted any Third Party rights that would interfere or be
inconsistent with Licensee's rights hereunder;
(f)
it is not aware of
any other Patents, Know How or other intellectual property right
Controlled by Cipher or its Affiliates, other than that which is
licensed hereunder to Licensee, which the Development, manufacture,
use and/or Commercialization of the Product as contemplated
hereunder would infringe;
(g)
it is not aware of
any other Patents, Know How or other intellectual property right
which the Development, manufacture, use and/or Commercialization of
the Product as contemplated hereunder would infringe;
(h)
to the knowledge of
Cipher, there is no action, suit, inquiry, investigation or other
proceeding threatened, pending or ongoing brought by any Third
Party that alleges the use of the Cipher Licensed Patents, Cipher
Licensed Know-How or the Development, manufacture,
Commercialization and/or use 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 Cipher becomes aware of any such action or proceeding, it
shall promptly notify Licensee in writing;
(i)
to the knowledge of
Cipher, neither Cipher 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;("Debarred");
and
(j)
Cipher
does not have any current knowledge that would cause any of its
representations or warranties to Licensee to be incorrect or
untrue.
10.2.
Representations
and Warranties and Covenants of Licensee.
Licensee represents
and warrants to Cipher 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, to grant the licenses granted
under Section 8.2, 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
Licensee is bound;
(b)
subject to Section
14.11 all necessary consents, approvals and authorizations of all
government authorities and other persons required to be obtained by
Licensee as of the Effective Date in connection with the execution,
delivery and performance of this Agreement have been
obtained;
(c)
Licensee does not
have any current knowledge that would cause any of its
representations or warranties to Cipher to be incorrect or
untrue;
(d)
it has no products
that could be used as a substitute for the Product in the
Field;
(e)
To the knowledge of
Licensee, neither Licensee 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 ("Debarred").
10.3.
Representations
and Covenants of Both Parties.
Each
Party shall, and shall cause its Affiliates and agents to, comply
with applicable laws, rules, regulations and guidelines of health
regulatory authorities having jurisdiction in the Territory and
related to the performance of its obligations hereunder, 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; all applicable federal, provincial, state and
foreign laws and regulations applicable to health care fraud and
abuse, kickbacks, physician self-referral and false claims; and
local laws and regulations regarding the advertisement, sale and
promotion of pharmaceutical products, in each case as amended from
time to time.
10.4.
No
Other Representations or Warranties.
EXCEPT
AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR
WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF
THIRD PARTY INTELLECTUAL
PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL
REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW
OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
ARTICLE
11
INDEMNIFICATION
11.1.
General
Indemnity By Licensee.
Licensee shall indemnify and
hold harmless Cipher, its Affiliates, and their directors,
officers, employees and agents (individually and collectively, the
"Cipher 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 in the Field by Licensee or any of
its Related Parties or Subcontractors; (b) the use of the Product
in the Field manufactured or sold by Licensee or any of its Related
Parties or Subcontractors by
any purchasers thereof including, without limitation, any product
liability claim; (c) the use by Licensee or any of its Related
Parties or Subcontractors of the Cipher Licensed Patents and the
Cipher Licensed Know-How in accordance with this Agreement; (d) the
negligence, fraud or willful misconduct of Licensee in the
performance of this Agreement; or (e) Licensee's material breach of
this Agreement, except to the extent such Losses arise out of any
of Cipher Indemnitee's negligence, illegal conduct or fraud,
willful misconduct, or breach of this Agreement.
11.2.
General
Indemnity By Cipher.
Cipher
shall indemnify and hold harmless Licensee, its Affiliates, and
their directors, officers, employees and agents (individually and
collectively, the "Licensee
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 in the Cipher Field
by Cipher or any of its Related Parties or Subcontractors; (b) the
use of the Product in the Cipher Field manufactured or sold by
Cipher or any of its Related Parties or Subcontractors by any
purchasers thereof including any product liability claim; (c) the
use by Cipher or any of its Related Parties or Subcontractors of
the Licensee Licensed Know-How and Licensee Data in accordance with
this Agreement; (c) the negligence, fraud or willful misconduct of
Cipher in the performance of this Agreement; or (e) Cipher's
material breach of this Agreement, except to the extent such Losses
arise out of any of Licensee Indemnitee's negligence, fraud,
willful misconduct, or breach of this Agreement.
11.3.
Defined
Indemnification Terms.
Either
of the Licensee Indemnitee or the Cipher Indemnitee shall be an
"Indemnitee" for the purpose
of this Article 11 and Article 12, and the Party that is obligated
to indemnify the lndemnitee under Section 11.1 or Section 11.2 or
Section 12.4 shall be the "Indemnifying Party".
If any
such claims or actions are made, the Indemnitee shall be defended
at the Indemnifying Party's sole expense by counsel selected by
Indemnifying Party and reasonably acceptable to the Indemnitee,
provided that the Indemnitee may, at its own expense, also be
represented by counsel of its own choosing. The
Indemnifying Party shall have the sole right to control the defense
of any such claim or action, subject to the terms of this Article
11.
The
Indemnifying Party may settle any such claim, demand, action or
other proceeding or otherwise consent to an adverse judgment: (a)
with prior written notice to the Indemnitee but without the consent
of the Indemnitee, where the only liability to the Indemnitee is
the payment of money and the Indemnifying Party makes such payment;
or (b) in all other cases, only with the prior written consent of
the Indemnitee, such consent not to be unreasonably withheld.
Notwithstanding the foregoing, the Indemnifying Party shall not
consent to entry of any judgment or enter into any settlement of a
Third Party claim without the consent of the Indemnitee if the
effect thereof is (a) to permit any injunction, declaratory
judgement, other order or other non-monetary relief to be entered,
directly or indirectly, against any Indemnitee; or (b) to ascribe
any fault on any Indemnitee in connection with such
defense.
The
Indemnitee shall notify the Indemnifying Party promptly of any
claim, demand, action or other proceeding under Section 11.1 or
Section 11.2 and shall reasonably cooperate with all reasonable
requests of the Indemnifying Party with respect
thereto.
11.7.
Permission
by Indemnifying Party.
The
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 the Indemnifying
Party.
11.8.
Limitation
of Liability.
NEITHER
PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL,
INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES OR FOR LOST PROFITS
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT,
REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.8 IS
INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS
OR OBLIGATIONS OF EITHER PARTY UNDER ARTICLE 11 OR ARTICLE 12.4, OR
DAMAGES AVAILABLE FOR A PARTY'S BREACH OF CONFIDENTIALITY
OBLIGATIONS IN ARTICLE 9.
Each
Party 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 $5 million
per occurrence, and not less than $5 million in the aggregate, on
such terms and conditions as are customary in the industry. Each
Party shall provide proof of such insurance to the other Patty
within thirty (30) days of the Effective Date and thereafter from
time to time within thirty (30) days of request of proof of such
insurance.
ARTICLE
12
INVENTIONS;
PATENT PROVISIONS
12.1.
Ownership
of Intellectual Property.
As
between the Parties, Cipher shall remain the sole and exclusive
owner of all Cipher Licensed Patents, Cipher Licensed Know-How,
Trademarks owned by Cipher and Cipher Data, and Licensee shall
remain the sole and exclusive owner of all Licensee Licensed
Patents, Licensee Trademarks, Licensee Licensed Know-How and
Licensee Data. Each Party shall own all data, results and
inventions, whether patentable or not, conceived or reduced to
practice by or on behalf of such Party, together with all
intellectual property rights therein.
For
greater certainty, as between Licensee and Cipher, Licensee shall
own all right, title and interest in and to any improvements to the
Cipher Licensed Patents developed by Licensee.
(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, misappropriation or other violation or
challenge to the validity, scope or enforceability of any Patent or
Trademark, or misappropriation or other violation of Know-How or
Confidential Information, in each case owned or Controlled by the
other Party with respect to the Product.
(b)
Enforcement of Intellectual
Property Rights. The sole owner or Party Controlling
Patents, Trademarks, Know-How or Confidential Information shall
have, except as set out to the contrary in this subsection, the
exclusive right to institute and direct legal proceedings against
any Third Party believed to be misappropriating or otherwise
violating such Patents, Trademarks, Know-How or Confidential
Information. For clarity, Cipher shall have the first right to
initiate a lawsuit against a person accused of misappropriating or
otherwise violating Cipher Licensed Know-How and/or Cipher Licensed
Patents. If Cipher does not cause the accused person to cease
misappropriating or otherwise violating Cipher Licensed Know-How or
Cipher Licensed Patents, or commence a lawsuit against the accused
person if necessary, within forty-five (45) days after notice of
violation of such Cipher Licensed Know-How and/or Cipher Licensed
Patents, then Licensee shall be entitled (but shall not be
obligated) to take all actions reasonably necessary to cause the
accused person to cease misappropriating or otherwise violating
Cipher Licensed Patents or Cipher Licensed Know-How, including
commencement of a lawsuit against the accused person if necessary;
provided, however, that Licensee shall consult in advance with
Cipher regarding such action and may not undertake any enforcement
action without the prior approval of the JSC, such approval not to
be unreasonably withheld. The primary objective of any enforcement
action shall be to preserve exclusivity for the Product and uses
thereof in the major pharmaceutical markets. Other objectives shall
be subservient to this primary objective. All amounts recovered
from enforcement of any such rights by either Party relating to the
intellectual property licensed under this Agreement shall be first
used to reimburse each Party's costs and expenses incurred in
connection with such action, and any remainder of such recovery
shall be retained by the Party instituting the action, provided
that any remainder retained by Licensee with respect to the
enforcement of Cipher Licensed Know-How and/or Cipher Licensed
Patents shall be treated as Net Sales and shall be subject to
Licensee's royalty payment obligations at the applicable rate
specified in Section 7.2.
(c)
Cooperation in Enforcement
Proceedings. For any action by a Patty pursuant to
subsection 12.2(b), in the event that such Patty is unable to
initiate or prosecute such action solely in its own name, the other
Party will join such action voluntarily and will execute all
documents necessary for such Party to initiate, prosecute and
maintain such action. If either Party initiates an
enforcement action pursuant to subsection 12.3(b), then the other
Party shall cooperate to the extent reasonably necessary and at the
first Parties' sole expense (except for the expenses of the
non-controlling Party's counsel, if any). Upon the reasonable
request of the Party instituting any such action, such other Party
shall join the suit and can be represented in any such legal
proceedings using counsel of its own choice. Each Party shall
assert and not waive the joint defense privilege with respect to
all communications between the Parties reasonably the subject
thereof.
(d)
Settlement. The Parties
shall keep each other informed of the status of and of their
respective activities regarding any enforcement action pursuant to
subsection 12.3(b). Neither Party shall settle any litigation or
legal proceeding to enforce Cipher Licensed Patent without the
other Party's written authorization, not to be unreasonably
withheld.
(a)
Each Party shall
notify the other in writing of any allegations it receives from a
Third Party that the Development, Commercialization, manufacture or
use of the Product or any technology or intellectual property
licensed by a Party under this Agreement infringes, misappropriates
or otherwise violates the intellectual property rights of such
Third Party. Such notice shall be provided promptly, but in no
event after more than thirty (30) business 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, misappropriation or violation of a
Third Party's Patents or other intellectual property right as a
result of the Development, Commercialization, manufacture or use of
the Product or any technology or intellectual property licensed by
a Party under this Agreement, such Party shall immediately notify
the other Party in writing and in no event notify such other Party
later than thirty (30) business days after the receipt of such
notice. The Parties agree that Licensee shall assume the primary
responsibility for the conduct of the defense of any such claim
that is specific to the Field, at Licensee's expense, and Cipher
shall assume the primary responsibility for the conduct of the
defense of any other such claim, at Cipher's 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,
misappropriation or violation of a Third Party's Patents or other
intellectual property right as a result of the manufacture,
production, use, development, sale or distribution of Products, the
other Party shall be allowed to join in such action, at its own
expense.
(c)
Status; Settlement. The
Parties shall keep each other reasonably informed of the status of
and of their respective activities regarding any litigation or
settlement thereof initiated by a Third Party
concerning a Party's Development, Commercialization, manufacture or
use of the Product or any technology or intellectual property
licensed by a Party under this Agreement; provided, however, that
no settlement or consent judgment or other voluntary final
disposition of a suit under this subsection 12.4(c) may be
undertaken by a Party without the consent of the other Party which
consent shall not be unreasonably withheld or delayed; provided
that such consent shall not be required to the extent that the
settlement does not (a) adversely affect the validity,
enforceability or scope of, or admit non infringement of any
of a Party's Patents, Know-How or other intellectual property
rights; (b) give rise to liability of such other Party or its
Sublicensees; or (c) grant to a Third Party a license or covenant
not to sue under, or with respect to, any intellectual property
that the other Party owns or to which the other Party otherwise has
exclusive rights.
ARTICLE
13
TERM
AND TERMINATION
13.1.
Term
and Expiration.
The
term of this Agreement (the "Term") shall expire upon the
20th anniversary of the First
Commercial Sale, unless terminated earlier pursuant to Sections
13.2, 13.3 or the launch of the first generic entrant. The Term
shall be automatically renewed for additional successive one
(I) year periods.
13.2.
Termination
for Cause.
This
Agreement may be terminated at any time during the Term upon
written notice by either Party if the other Party is (i) in breach of its payment obligations
under this Agreement (ii) is in violation of its obligation to
maintain insurance pursuant to 11.9; or (iii) in material breach of
its other obligations under this Agreement and, in each case, has
not cured such breach within forth-five (45) days after notice
requesting cure of the breach (where reasonable steps have been
taken to address non-payment within forty five (45) days);
provided, however, that if such breach is not reasonably subject to
cure within forty-five (45)
days,
subject to reasonably diligent efforts being undertaken within
forty-five (45) days, the breaching Party shall not be deemed in
breach provided it uses reasonable best efforts to cure such breach
as promptly as possible. In addition, either Party may, at its
option, terminate this Agreement, and all rights granted herein
upon the occurrence of any of the following events of
default:
(a)
the filing by the
other Party of any petition or any application seeking
reorganization, readjustment or rearrangement of the business of
Licensee under any federal or provincial law relating to bankruptcy
or insolvency;
(b)
the making by the
other Party of any assignment or attempted assignment for the
benefit of creditors;
(c)
the other Party
becoming insolvent, as evidenced, for example (without limitation)
by (i) the appointment of a receiver or a receiver manager for all
or substantially all of the property of the other Party, (ii) the
inability of the other Party to pay its liabilities generally as
they become due, (iii) the termination of a majority of the other
Party's employees, or (iv) the other
Party ceasing, or imminently ceasing by way of a third party
petition remaining in place for 30 days, to carry on
business;
(d)
any resolution
passed, order made, or other steps taken by the other Party for the
winding up, liquidation or other termination of the existence of
the other Party; or
(e)
if the
other Patty assigns or attempts to assign this Agreement or any
rights hereunder contrary to this Agreement without the prior
written notification of the Party.
13.3
Termination
Without Cause.
Upon
sixty (60) days prior written notice to Cipher, Licensee may
terminate this Agreement in its entirety without
cause.
13.4.
Effect
of Termination.
(a)
Upon the
termination of this Agreement:
(i)
Within sixty (60)
days of expiration of termination of this Agreement (or such later
date with respect to those costs that are incurred but cannot be
reported as of such date), Licensee shall pay Cipher all undisputed
amounts due to Cipher under this Agreement as of the effective date
of such expiration or termination.
(ii)
Notwithstanding
anything to the contrary in this Section 13.4, if this Agreement
terminates pursuant to Section 13.2 or 13.3 at the request of
Licensee, Licensee shall have the right to sell its remaining
inventory of Product(s) so long as Licensee has fully paid, and
continues to pay fully when due, any and all undisputed invoiced
amounts corresponding to Royalties and Sublicensee Revenues owed to
Cipher hereunder based on such sales.
(iii)
Notwithstanding
Section 13.4, Licensee will not terminate the license granted to
Cipher pursuant to Section 8.3 of this Agreement under the Licensee
Licensed Patents, the Licensee Licensed Know-How, and Licensee
Data, regulatory materials and other information related to the
Product solely to manufacture clinical Materials or to make,
Develop, manufacture or Commercialize Products within the Cipher
Field.
(iv)
The license granted
to Licensee under Section 8.1 and any sublicenses that have been
granted to a Sublicensee with respect to Cipher IP shall
terminate.
(v)
Except as otherwise
provided under this Agreement or otherwise agreed by the Parties,
all activities underway at the time of termination shall be
terminated as soon as possible except that all costs of continuing
studies or Clinical Trials or winding down activities shall
continue to be borne by the Parties 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 Licensee.
(b)
If either Party has
the right to terminate this Agreement under Section 13.2, it may at
its sole option, elect either to: (i) terminate this Agreement and
pursue any legal or equitable remedy available to it; or (ii)
maintain this Agreement in effect and pursue any legal or equitable
remedy available to it.
Any
undisputed 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, 5, 6.l(b), 7.5, 8.2, 9, 10,
11, 12, 13 and 14.
ARTICLE
14
MISCELLANEOUS
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, but not limited
to, embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other
labour disturbances, fire, floods, or other acts of God, or acts,
omissions or delays in acting by any governmental authority or the
other Party. The affected 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.
Neither
Party may assign its rights or obligations under this Agreement
without providing prior written notice to the other
Party.
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.
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 Cipher, to:
|
Cipher
Pharmaceuticals Inc.
|
|
Attn: Shawn Patrick
O'Brien, President & CEO
|
|
2345 Argentia Road,
Suite lO0A
|
|
Mississauga,
Ontario
|
|
L5N
8K4
|
|
Email:
|
with a copy (which
shall not constitute notice) to:
|
Torys
LLP
|
|
79
Wellington Street West
|
|
Box 270, TD
Centre
|
|
Toronto,
ON
|
|
Attn: Cheryl
Reicin, Esq.
|
|
Email: creicin@torys.com
|
|
|
if
to Licensee, to:
|
Edesa Biotech
Inc.
|
|
Attn: Pardeep
Nijhawan, Director
|
|
l00 Spy
Court
|
|
Markham,
Ontario
|
|
L3R5H6
|
|
Email: par@exzell.com
|
|
|
with a copy (which
shall not constitute notice) to:
|
Borden Ladner
Gervais LLP
|
|
Scotia Plaza, 40
King Street W.
|
|
Toronto,
ON
|
|
M5H3Y4
|
|
Attn: Lydia
Wakulowsky
|
|
Email: lwakulowsky@blg.com
|
or to
such other address as the Party to whom notice is to be given may
have furnished to the other Party in writing in accordance
herewith. Any such notice shall be deemed to have been given: (a)
when delivered if personally delivered or sent by email on a
business day; (b) on the business day after dispatch if sent by
nationally-recognized overnight courier; or (c) on the fifth
business day following the date of mailing if sent by
mail.
14.5.
Applicable
Law and Litigation.
This
Agreement shall be governed by and construed in accordance with the
laws of the Province of Ontario and the laws of Canada applicable
therein, without reference to any rules of conflict of laws. For
controversies, claims and disputes not covered by the arbitration
provisions pursuant to Section 14.16, 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 the Province of Ontario,
Canada for any action, suit or proceeding and relating to
injunctive or other equitable relief, and agree not to commence any
action, suit or proceeding related thereto except in such courts;
and (b) waive any objection to the laying of venue of any action,
suit or proceeding in the courts of the Province of Ontario, Canada
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.
14.6.
Entire
Agreement; Amendments.
This
Agreement contains the entire understanding of the Parties with
respect to the subject matter hereof. All express or implied
agreements and understandings, either oral or written, with regard
to the subject matter hereof are superseded by the terms of this
Agreement. On the Effective Date, the confidentiality agreement
between the Parties effective November 25, 2015 shall terminate and
all Confidential Information exchanged thereunder shall be deemed
Confidential Information of the Party disclosing such information
and protected under this Agreement. This Agreement may be amended,
or any term hereof
modified, only by a written instrument duly executed by authorized
representatives of both Parties.
14.7.
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.
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.
14.9.
Cumulative
Remedies.
No
remedy referred to in this Agreement is intended to be exclusive,
but each shall be cumulative and in addition to any other remedy
referred to in this Agreement or otherwise available under
law.
14.10.
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.
The
Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument. Each Party shall be
entitled to rely on the delivery of executed facsimile copies of
counterpart execution pages of this Agreement and such facsimile
copies shall be legally effective to create a valid and binding
agreement among the parties.
14.12.
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.
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.
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.
14.15.
Use
of Third Parties.
It is understood that when a Party engages
any Third Patty to manufacture the Product, that engagement may
require a limited license or limited sublicense of rights obtained
from the other Party under this Agreement. The Party engaging such
Third Party (or non-licensed Affiliate) may disclose Confidential
Information of the other Party solely as necessary to fulfill the
business purposes of the engagement, and then only pursuant to
terms and conditions that are substantially as protective of that
Confidential Information as the terms and conditions of this
Agreement. Notwithstanding any delegation of obligations under this
Agreement by a Party to its Affiliates or to a Third Party, whether
related to manufacturer of the Product or otherwise, the Party
shall remain primarily liable and responsible for the performance
of all of its obligations under this Agreement and for causing such
Affiliates or Third Parties to act in a manner consistent herewith.
In addition, such Party shall assure that any intellectual property
developed by its Affiliates or such Third Parties shall be
Controlled by that Party. The Party contracting with such Third
Party shall not agree to any term that would make it unable to
comply with its obligations under this Agreement. Cipher shall not
engage any Third Party manufacturer without the prior written
consent of Licensee, not to be unreasonably withheld.
14.16.
Dispute
Resolutions.
(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 14.16 is not intended to alter the rights of the
Parties as established by Article 2, Governance, herein. The
dispute shall be resolved by final and binding arbitration. The
place of arbitration shall be the City of Toronto, Ontario, Canada.
The arbitration shall be in accordance with the rules of
ADRChambers ("ADRC") except
as modified herein. The number of arbitrators shall be three. The
language of the arbitration shall be English.
(b)
The Patty wishing
to commence an arbitration ("Claimant") shall notify the other
party ("Respondent") in
writing of its decision to commence arbitration hereunder
(sometimes referred to in this Agreement as its "demand for arbitration"), setting out
briefly its claims in its notice, and with its notice, name the
arbitrator it is appointing.
(c)
The Respondent
shall, within thirty (30) days of receipt of a demand for
arbitration, notify the Claimant in writing of the name of the
arbitrator it is appointing.
(d)
The third
arbitrator shall be chosen by the first two arbitrators within
twenty (20) days after the second of such arbitrators was
appointed.
(e)
All arbitrators
shall be chosen taking into account the type of issues to be
addressed in the arbitration, whether legal, business, scientific,
or a combination thereof, and having regard to their availability
to conduct the arbitration within the times provided below. (The
date on which the third arbitrator is appointed is the "Arbitration Panel
Finalization").
(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.
(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 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.
14.17.
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.
14.18.
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.
14.19.
Time
of the Essence.
Time
shall be of the essence with respect to any payment owed or any
other obligation of a Party hereunder.
14.20.
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.
14.21.
Performance
by Affiliates.
To the
extent that this Agreement imposes obligations on Affiliates of a
Party, such Party shall cause its Affiliates to perform such
obligations. Either Party may use one or more of its Affiliates to
perform its obligations and duties hereunder; provided, however the
Parties shall remain liable hereunder for the prompt payment and
performance of all their respective obligations
hereunder.
[Remainder of the Page Intentionally Left Blank]
The
Parties have executed this Agreement as of the Effective
Date.
|
CIPHER PHARMACEUTICALS
INC.
|
|
|
|
|
|
|
By:
|
/s/ Shawn Patrick
O'Brien
|
|
|
|
Name: Shawn Patrick
O'Brien
|
|
|
|
Title:
President & CEO
|
|
|
|
|
|
|
By:
|
/s/
Norm Evans
|
|
|
|
Name:
Norm
Evans
|
|
|
|
Title:
CFO
|
|
|
EDESA BIOTECH INC.
|
|
|
|
|
|
|
By:
|
/s/ Pardeep
Nijhawan
|
|
|
|
Name: Pardeep
Nijhawan
|
|
|
|
Title:
Director
|
|
|
By:
|
/s/ Michael
Brooks
|
|
|
|
Name: Michael
Brooks
|
|
|
|
Title:
Vice President
|
|
Schedule
"A"
Country
|
Registration
No. or Application No.
|
Australia
|
2006233502
|
Belgium
|
1719507
|
Brazil
|
PI609361-2
|
Canada
|
2604758
|
China
|
ZL
2006800165347
|
EU
|
1719507
|
Israel
|
186491
|
Japan
|
5021621
|
South
Korea
|
10-1355422
|
Mexico
|
281857
|
Norway
|
331211
|
New
Zealand
|
562940
|
Poland
|
1719507
|
Russian
Federation
|
016082
|
Thailand
|
0601001702
|
Taiwan
|
1366457
|
USA
|
8,426,475
|
Blueprint
Exhibit
10.6
CERTAIN IDENTIFIED INFORMATION HAS BEEN
EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD
LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY
DISCLOSED.
LICENSE
AND DEVELOPMENT AGREEMENT
This
License and Development Agreement ("Agreement") is made effective
as of [date] ("Effective
Date") by and between Pendopharm, a division of Pharmascience Inc,
located at 6111 Royalmount, Suite 100, Montreal, Quebec, H4P 2T4,
Canada (hereinafter "Pendopharm"), and Edesa Biotech Inc., a
Canadian corporation having its principal place of business at 100
Spy Court Markham, Ontario, L3R 5H6, Canada (hereinafter
"Edesa").
RECITALS
WHEREAS, Edesa Controls the rights to
certain intellectual property rights and know-how with respect to
two novel agonists in specific formulations (EB02 Topical cream,
EB03 Suppository and EB04);
WHEREAS, Edesa is
planning to perform proof-of-concept clinical trials for EB02
and EB04;
WHEREAS, Pendopharm is
a specialty pharmaceutical company active in the
development
and marketing of specialty pharmaceutical products in
Canada;
WHEREAS, Pendopharm
desires to obtain from Edesa certain exclusive rights to use the US
Data Package (as hereinafter defined) and the New Drug Application
("NDA") created in respect of EB02, EB03 and EB04 to prepare a New
Drug Submission ("NDS") to the competent Regulatory Authority in
Canada, in order to obtain Marketing Authorization (as defined
below) in Canada for EB02, EB03 and EB04;
WHEREAS, Pendopharm
also desires to obtain certain exclusive rights with respect to
importation, distribution, marketing and sale of EB02, EB03 and
EB04 in the territory of Canada;
WHEREAS, Edesa is
willing to (i) grant such exclusive right to use the US Data
Package to Pendopharm and the NDA if Edesa owns or controls such
NDA for use in the preparation of an NDS in the territory of
Canada; and (ii) grant Pendopharm certain exclusive rights under
its intellectual property rights and know-how with respect to
importation, distribution, marketing and sale of EB02, EB03 and
EB04 in the territory of Canada;
WHEREAS, Pendopharm is
entering into this Agreement knowing that a complete US Data
Package and NDA meeting the requirements of the FDA in order to
obtain a Marketing Authorization for use of the Licensed Products
will be available if and only if the proof of concept clinical
trials are successful and Edesa can continue to raise further funds
in future rounds of financing, otherwise Pendopharm acknowledges
that a US Data Package and NDA may never be completed or
available.
NOW, THEREFORE, Edesa
and Pendopharm, intending to be legally bound, hereby agree as
follows:
ARTICLE
1
DEFINITIONS
In this
Agreement, the below terms and expressions shall have the following
meanings, and such meanings shall apply equally to both the
singular and plural forms of the terms defined:
1.1.
Definitions.
(a)
"Acceptance to Proceed" shall
have the meaning set forth in Section 2.3.
(b)
"Affiliate" shall mean any
corporation or other entity, which directly or indirectly controls,
is controlled by or is under common control with a Party to this
Agreement. A corporation or other entity shall be regarded as in
control of another corporation or entity if it owns or directly or
indirectly controls more than fifty percent (50%) of the voting
stock or other ownership interest of the other corporation or
entity, or if it possesses, directly or indirectly, the power to
direct or cause the direction of the management and policies of the
corporation or other entity or the power to elect or appoint more
than fifty percent (50%) of the members of the governing body of
the corporation or other entity.
(c)
"Agreement" shall mean this
License and Development Agreement and its Exhibits.
(d)
"Alliance Manager" shall mean a
representative appointed by each of the Parties responsible for the
tasks set forth in Section 4.2(c).
(e)
"Applicable Law" shall mean all
applicable law, rules and regulations, including any rules,
regulations, guidelines or other requirements of any Regulatory
Authority that may be in effect from time to time.
(f)
"Business Day" shall mean a day
other than a Saturday or Sunday or any public holiday on which
banking institutions in Toronto or Montreal, Canada, are closed for
business.
(g)
"Calendar Quarter" shall mean
each successive period of three (3) calendar months commencing on
January 1, April 1, July 1 and October 1.
(h)
"Calendar Year" shall mean each
successive period of twelve (12) calendar months commencing on
January 1 and ending on December 31.
(i)
"Cipher Agreement" shall mean
the exclusive license agreement between the Cipher Pharmaceuticals Inc and Edesa
dated as of June 15th 2016.
(j)
"Claim" has the meaning set
forth in Section 7.3(b).
(k)
"Confidential Information" shall
have the meaning set forth in Section 12.l(a).
(l)
"Control" shall mean, with
respect to any item of Information, Regulatory Documentation,
Patent, Licensed Technology or Intellectual Property Right,
possession of the right, whether directly or indirectly, and
whether by ownership, license or otherwise (other than by operation
of the assignments, license and other grants of rights in this
Agreement) to assign or grant a license, sublicense or other right
to or under, such Information, Regulatory Documentation, Patent,
Licensed Technology or Intellectual Property Right as provided for
in this Agreement without violating the terms of any agreement or
other arrangement with any Third Party.
(m)
"Development" shall mean all
activities related to preclinical and other non-clinical testing,
test method development and stability testing, toxicology,
formulation, process development, manufacturing scale-up,
qualification and validation, quality assurance and quality control
related to the foregoing manufacturing activities, clinical studies
and post-approval studies, including manufacturing in support
thereof, statistical analysis and report writing, the preparation
and submission of drug approval applications, regulatory affairs
with respect to the foregoing and all other activities otherwise
requested or required by a Regulatory Authority as a condition or
in support of obtaining or maintaining marketing authorization.
When used as a verb, "Develop" shall mean to engage in
Development.
(n)
"Drug Master File" shall mean
the drug master file filed with a Regulatory Authority with respect
to the Licensed Products that will be created as development of the
products occurs.
(o)
"Edesa" shall have the meaning
set forth in the first and opening paragraph of this
Agreement.
(p)
"Edesa License" shall have the
meaning set forth in Section 5.1.
(q)
"Edesa IP Improvements" shall
have the meaning set forth in Section 7.l(b).
(r)
"Effective Date" shall have the
meaning set forth in the first and opening paragraph of this
Agreement.
(s)
"EMA" shall mean the European
Medicines Agency.
(t)
"Existing Edesa IP" shall have
the meaning set forth in Section 7.l(a).
(u)
"FDA" means the United States
Food and Drug Administration and any successor agency
thereto.
(v)
"Field" shall mean human
therapeutic use in the conditions of hemorrhoids and anal
fissures.
(w)
"First Commercial Sale" shall
mean, with respect to a Licensed Products in the Territory, the
first commercial sale of such product after Marketing Authorization
for such product has been granted by Health Canada.
(x)
"Health Canada" means the
Canadian Federal Department
known as
Health Canada and any
successor agency thereto.
(y)
"Indemnified Party" shall have
the meaning set forth in Section 9.5.
(z)
"Information" shall mean all
technical, scientific and other know-how and information, trade
secrets, knowledge, technology, means, methods, processes,
practices, formulae, instructions, skills, techniques, procedures,
experiences, ideas, technical assistance, designs, drawings,
assembly procedures, computer programs, apparatuses,
specifications, data, results and other material, including
biological, chemical, pharmacological, toxicological,
pharmaceutical, physical and analytical, pre-clinical, clinical,
safety, manufacturing and quality control data and information
including study designs and protocols; assays and biological
methodology; whether or not confidential, proprietary, patented or
patentable, in written, electronic or any other form now known or
hereafter developed, including the Regulatory
Documentation.
(aa)
"Intellectual Property Rights"
shall mean all rights in and to ideas, inventions, discoveries,
know-how, data, databases, documentation, reports, materials,
writings, designs, computer software, processes, principles,
methods, techniques and other information in whatever form,
including patents, utility patents, copyrights and any rights or
property similar to any of the foregoing in any part of the world,
whether registered or not, provided that such rights or property
are considered as intellectual property according to the Applicable
Law ("Intellectual Property").
(bb)
"Knowledge" and/or "known" shall mean, with respect
to any representation or warranty or other statement in this
Agreement qualified by knowledge of a Party, the actual knowledge
of the members of the management board of such Party.
(cc)
"Licensed Know-How" shall mean
all Information not generally known to the public and not covered
or claimed by published Licensed Patents, which Edesa owns, has
under license, or otherwise Controls on the Effective Date and at
all times during the Term necessary for Pendopharm to exploit the
Licensed Products and Licensed Patents.
(dd)
"Licensed Patents" shall mean
all existing or future regular, continuation, divisional,
continuation-in-part, re-exam, reissue, term extended patent and
patent applications ("Patents") in the Territory directly or
indirectly claiming priority to or immediately derived from the
patent applications licensed to Edesa under the Yissum Agreement
and/or Cipher Agreement, as listed in Exhibit 1.37.
(ee)
"Licensed Products(s)" shall
mean EB02, a topical anorectal formulation of Hyaluronic Acid (HA)
conjugated with dipalmitoyl phosphotidyl-ethanolamine (DPPE), EB03,
an anorectal suppository formulation of Hyaluronic Acid (HA)
conjugated with dipalmitoyl phosphotidyl-ethanolamine (DPPE)
licensed pursuant to the Yissum
Agreement and EB04, a topical
anorectal formulation of Levo-salbutamol licensed pursuant to the Cipher
Agreement.
(ff)
"Licensed Technology" shall mean
the Licensed Patents and the Licensed Know-How.
(gg)
"Losses" shall have the meaning
set forth in Section 9.1.
(hh)
"Marketing Authorization" shall
mean, with respect to the Territory, authorization from the
Regulatory Authority necessary to commercially distribute, sell or
market the Licensed Products in the Territory.
(ii)
"NDA" shall mean a New Drug
Application, and which consists of at least a complete registration
file in Common Technical Document (CTD) format.
jj)
"NDS" shall mean a New Drug
Submission which consists of at least a complete registration file
in Common Technical Document (CTD) format.
(kk)
"Net Sales" shall mean with
respect to the Licensed Products for any period, means the gross
amount invoiced and billed by Pendopharm or its Affiliates to
unrelated Third Parties (excluding any Sublicensee) for the Product
in the Territory, less:
(i)
Trade, quantity and
cash discounts actually allowed or paid;
(ii)
Commissions,
discounts, refunds, rebates (including wholesaler fees),
chargebacks, retroactive price adjustments, and any other
allowances actually allowed or paid which effectively reduce the
net selling price;
(iii)
Actual Product
returns and allowances;
(iv)
Any sales, use,
excise, value added taxes or similar taxes measured by the billing
amount, when included in billing;
(v)
Any freight,
postage, shipping, and insurance charges related to delivery of the
Product from an applicable warehouse, all to the extent included in
the third party invoices; and
(vi)
Custom, import and
export duties actually paid.
Any
refund or reimbursement of any of the foregoing amounts previously
deducted from Net Sales shall be appropriately credited to Net
Sales, or adjusted through allowances, upon receipt
thereof.
For
greater certainty "Net Sales" shall not include (i) sales or
transfers between members of the group comprised of Pendopharm,
Sublicensees, and their Affiliates; (ii) provision of Product for
the purpose of conducting Clinical Trials in order to obtain
Regulatory Approvals; (iii) disposal of reasonable quantities of
Licensed Products for promotional or advertising purposes or
regulatory or governmental purposes, but not to exceed 5% of Gross
Sales ; and (iv) transfers or dispositions of reasonable quantities
of Licensed Products to patients unable to purchase the Licensed
Products, but not to exceed 5% of Gross Sales.
Such
amounts shall be determined from the books and records of
Pendopharm or its Affiliates or Sublicensees, as applicable,
maintained in accordance with IFRS, consistently applied, except where
IFRS is not the standard, in which case whatever the accounting
standard is in effect will be applied.
Once
the Licensed Products are approved for sale in the Territory by the
applicable Regulatory Authority, if the Licensed Products are sold
as part of a bundled transaction and there is no individual price
for the Licensed Products in the transaction documentation
(agreement, invoice etc.), the amount to be included in Net Sales
shall be determined based on the pro rata allocation of the amount
invoiced for all products included in such bundled transaction,
based on the average per unit net sales price (calculated for the
Calendar Quarter being reported) for such Licensed Products and the
average per unit net sales price (calculated for the Calendar
Quarter being reported) for every other product included in such
bundled transaction and the number of units of Licensed Products
and every other product included in such bundled
transaction.
(11)
"Pendopharm License" has the
meaning ascribed to it in Section 5.2.
(mm)
"Pendopharm IP" shall have the
meaning ascribed to it in Section 7.l(c).
(nn)
"Pendopharm IP Improvements"
shall have the meaning ascribed to it in Section
7.1(d).
(oo)
"Parties" shall mean Pendopharm
and Edesa and " " shall mean either one of them.
(pp)
"Payment" shall have the meaning
set forth in Section 6.2(d).
(qq)
"Regulatory Approval" shall mean
any and all approvals, licenses, registrations or authorizations of
any Regulatory Authority necessary to commercially distribute, sell
or market a Licensed Products, including, where applicable, (i)
pricing or reimbursement approval, (ii) pre- and post-approval
marketing authorizations, (iii) labeling approval, (iv) technical,
medical and scientific data.
(rr)
"Regulatory Authority" shall
mean any applicable supra-national, federal, national, regional,
state, provincial or local regulatory agencies, departments,
bureaus, commissions, councils or other government entities
regulating or otherwise exercising authority with respect to the
Development and exploitation of the Licensed Products.
(ss)
"Regulatory Documentation" shall
mean all applications, registrations, licenses, authorizations and
approvals, including all Regulatory Approvals, the US Data Package,
all correspondence submitted to or received from Regulatory
Authorities and all supporting documents and all clinical studies
and tests relating to the Licensed Products and all data contained
in any of the foregoing, including, if applicable, all
investigational new drug applications, marketing authorization
applications, regulatory drug lists, advertising and promotion
documents, clinical data, adverse event files and complaint
files.
(tt)
"Rest of the World" shall mean
any country of the world other than the Territory.
(uu)
"Sublicensee" shall mean any
Affiliate of Pendopharm or Third Party to whom Pendopharm has
sublicensed its rights to the Licensed Products in accordance with
Section 5.3.
(vv)
"Territory" shall mean Canada,
including all provinces and territories.
(ww)
"Term" shall have the meaning
set forth in Section 10.1.
(xx)
"Third Party" shall mean any
person or entity other than Edesa or Pendopharm and their
respective Affiliates.
(yy)
"Trademarks" shall have the
meaning ascribed to it in Section 7.4.
(zz)
"US Data Package" shall mean all
clinical and non-clinical data (including without limitation all
Development, formulation and manufacturing information (including
the open part of the Drug Master File), Information and Regulatory
Documentation owned or Controlled by Edesa, to be used for the
submission of an NDA to the U.S. Food and Drug Administration
("FDA") for obtaining Marketing Authorization for sale of the
Licensed Products in the USA.
(aaa)
"Yissum Agreement" shall mean
the exclusive license agreement between the Yissum Research
Development Company and Edesa dated as of June 29,
2016.
ARTICLE
2
DEVELOPMENT
AND DATA SHARING
Edesa
shall use reasonable commercial efforts to Develop the Licensed
Products in the indications of hemorrhoids (with respect to EB02)
and anal fissures (with respect to EB04) for the purposes of
obtaining Regulatory Approval with the FDA.
2.2.
Provision
of US Data Package.
On a
Licensed Product by Licensed Product basis, Edesa agrees to provide
Pendopharm with the US Data Package within sixty (60) Business Days
of submission of the NDA to the FDA in the United States. Within
the ninety (90) day period following the provision of the US Data
Package to Pendopharm, Edesa will use reasonable efforts to answer
potential questions Pendopharm may have and, upon Pendopharm' s
request, provide any additional documents relating to the US Data
Package that Edesa may have in its possession or
Control.
2.3.
Acceptance
to Proceed.
Within
ninety (90) days of its receipt of the US Data Package , Pendopharm
will, on a Licensed Product by Licensed Product basis, inform Edesa
in writing if Pendopharm would like to proceed with the preparation
and submission of a Marketing Authorization application for the
Licensed Products to the competent Canadian Regulatory Authority
("Acceptance to Proceed").
2.4.
Failure
to provide Acceptance to Proceed.
If
Pendopharm does not provide Edesa with the Acceptance to Proceed
within the period provided for in Section 2.3, Edesa will be
entitled to, for the Licensed Product for which Pendopharm has not
provided its Acceptance to Proceed, remove the Licensed Product
from the scope of the license granted in this Agreement with
immediate effect by giving written notice to Pendopharm, whereby
all rights to that specific Licensed Product in the Territory
granted to Pendopharm under this Agreement shall revert back to
Edesa and Section 10.7(a) shall apply.
2.5.
Development
Responsibility.
If
Pendopharm declares Acceptance to Proceed, Pendopharm will be
responsible for obtaining Marketing Authorization and any other
Regulatory Approvals which may be required in the Territory for the
sale and marketing of the Licensed Product in the Field and for
generating any additional data which may be required for obtaining
Marketing Authorization in the Territory at its own
cost.
2.6.
Marketing
Authorization Application.
Pendopharm shall,
at the earliest possible time after receipt of the US Data Package
from Edesa, discuss with the competent Canadian Regulatory
Authority whether Marketing Authorization in the Territory can be
obtained on the basis of the US Data Package or whether additional
clinical studies have to be performed in the Territory.
If
no further clinical studies should be required, Pendopharm will,
subject to Section 2.3, use reasonable efforts to submit a
Marketing Authorization application for the Licensed Products to
the competent Regulatory Authority in the Territory.
2.7.
Additional
Clinical Studies and further Development.
(a)
Scope. If after
discussions with the competent Regulatory Authorities in the
Territory, Pendopharm is required to conduct further clinical
studies or further Development, Pendopharm shall establish the
scope and the design of any studies required in the Territory in
order to obtain the Marketing Authorization for the Licensed
Products, and shall seek Edesa prior written approval of the
clinical studies or further Development, such consent shall not be
unreasonably withheld or delayed.
(b)
Regulatory
Approval. Subject to Section 2.9, Pendopharm shall use reasonable
commercial efforts to initiate the clinical studies or further
Development without delay.
(c)
Ownership of Data
from Additional Clinical Studies. As between Pendopharm and Edesa,
Pendopharm shall own all data arising from the additional clinical
studies conducted or Development done by Pendopharm in the
Territory and Pendopharm hereby agrees to assign all right, title
and interest therein to Edesa at Termination in accordance with
Section 10.7(a).
2.8.
Clinical
Trial Material.
If
Pendopharm determines that clinical studies shall be performed in
the Territory, Edesa will supply the required clinical supply of
the Licensed Products to Pendopharm at actual cost. Detailed
supply
terms and responsibilities of the Parties regarding quality will be
agreed in a separate supply agreement prior to the commencement of
the supply of Licensed Products to Pendopharm, with the proviso
that such additional terms must reasonably enable Edesa to meet the
terms agreed with Edesa's contract manufacturer.
The
Parties will establish a shared website for the exchange of the
information in relation to the Licensed Products to be exchanged
between the Parties pursuant to the terms of this Agreement. Edesa
will commence providing information pertaining to the US Data
Package to Pendopharm after completion of the proof of concept
clinical trials for each of the products and as such information
becomes available. Each Party shall provide to the other Party
copies of all clinical and non-clinical data and other results and
analyses with respect to any Development activities with respect to
the Licensed Products in the Field, for each of the Licensed
Products and when and as such data, results and analyses become
available and as soon as reasonably practicable. Subject to
Applicable Law in the relevant territory, the aforesaid obligation
shall also include data generated by Edesa's licensees and/or
Pendopharm's Sublicensees, but shall, for purposes of clarity,
exclude any commercial information. Such clinical and non-clinical
data shall be prepared in the English language and in a format
generally accepted by Regulatory Authorities, such as the FDA,
Health Canada and/or the EMA. Further, any clinical studies
undertaken by or on behalf of a Party shall include consents and
authorizations which allow release of all protected health
information of the study participants to the other Party and its
licensees to the extent permitted by the Applicable Law and such
releases and/or authorizations shall contain language which makes
it clear to the study participant that any information related to
the Licensed Products shall be kept confidential. Each Party shall
furnish to the other Party regularly, at least every half a year,
reports including the clinical and non-clinical data generated by
it in the preceding half a year. For the avoidance of doubt, both
Parties agree to only enter into any agreements with Sublicensees
and/or Third Parties if the Sublicensee/Third Party undertakes the
same obligations regarding disclosure and access to clinical and
non-clinical data as Pendopharm undertakes pursuant to this
Agreement, in particular pursuant to the foregoing
sentences.
2.10.
Pricing
and Reimbursement Approvals.
Pendopharm shall be
responsible for all pricing and reimbursement approval proceedings
relating to the Licensed Products in the Territory.
2.11.
Regulatory
Records.
Pendopharm and
Edesa each shall maintain, or cause to be maintained, records of
their respective Development activities with respect to the
Licensed Products in the Field in sufficient detail and in good
scientific manner appropriate for patent and regulatory purposes,
which shall be complete and accurate and shall fully and properly
reflect all work done and results achieved in the performance of
their respective Development activities, and which shall be
retained by such Party for at least three (3) years after the
termination of this Agreement, or for such longer period as may be
required by Applicable Law. Not more than once in a Calendar Year,
each Party shall have the right, during normal business hours and
upon reasonable notice, to inspect and copy any such records of the
other Party. A Party shall provide the other Party with such
additional information regarding the Development activities in
relation to this Agreement as such Party may reasonably request
from time to time.
2.12.
Alliance
Management pre-Commercialization.
After
execution of this Agreement, Pendopharm and Edesa shall appoint one
representative of each organization who will meet by teleconference
at least two (2) times per year until the end of Phase III clinical
trials in order to update each other on medical affairs and
regulatory affairs and other relevant matters related to the
Licensed Products in the Territory. Each party will use reasonable
efforts to satisfy the requests of the other representative for
access to specific information and documentation.
ARTICLE
3
REGULATORY
3.1.
Adverse
Event Reporting.
Subject
to the terms of this Agreement, no later than three (3) months
before market launch in the Territory, Edesa and Pendopharm shall
discuss and develop mutually acceptable guidelines and procedures
for (a) the investigation, exchange, receipt, recordation,
communication (as between the Parties) and exchange of Adverse
Event Experience information and all other information required by
either Party in order to meet its pharmacovigilance
responsibilities and (b) for the handling of any oral or written
communication of dissatisfaction regarding the identity, quality,
durability, reliability or performance of the Licensed Products,
including appearance, low fills, foreign materials, foreign
product, defective packaging or defective labeling. "Adverse Event
Experience" shall mean (i) any finding from tests in laboratory
animals or in vitro that suggests a significant risk for human
subjects including reports of mutagenicity, teratogenicity or
carcinogenicity and (ii) any undesirable, untoward or noxious event
or experience associated with the clinical, commercial or other use
or occurring following administration, of the Licensed Products in
humans, occurring at any dose, whether expected or unexpected and
whether or not considered related to or caused by the Licensed
Products, including such an event or experience as occurs in the
course of the use of the Licensed Products in professional
practice, in a clinical trial, from overdose, whether accidental or
intentional, from abuse, from withdrawal or from a failure of
expected pharmacological or biological therapeutic action of the
Licensed Products, and including those events or experiences that
are required to be reported to any Regulatory Authority in the
Territory.
3.2.
Recall
of Licensed Products.
(a)
In the event that
any Regulatory Authority issues or requests a recall or takes
similar action in connection with the Licensed Products or in the
event either Party determines that an event, incident or
circumstance has occurred that may result in the need for a recall
or market withdrawal, the Party notified of or desiring such recall
or similar action shall, within twenty-four (24) hours, advise the
other Party thereof by telephone (and confirm by email or
facsimile), email or facsimile.
(b)
Pendopharm will use
best efforts to withdraw the Licensed Products from the market
without delay, if Edesa or any Regulatory Authority demands a
recall of the Licensed Products in the Territory.
(c)
Pendopharm shall
bear all reasonable costs of recall of the Licensed Products in the
Territory except if such recall is due to Edesa's negligence or
willful misconduct, in which event Edesa
shall bear the costs of said recall. For the purpose of this
Agreement, costs of a recall shall not include loss of profit of
either Party.
ARTICLE
4
SUPPLY
AND COMMERCIALIZATION
4.1.
Supply
of Licensed Products.
Edesa
will supply the Licensed Products to Pendopharm subject to the
terms of a separate supply agreement, the terms of which shall be
agreed by the parties in good faith, with the proviso that such
additional terms must reasonably enable Edesa to meet the terms
agreed with Edesa's contract manufacturer. On a product by product
basis, the parties will enter into good faith negotiations within
thirty (30) days of Edesa's receipt of Pendopharm's Acceptance to
Proceed.
(a)
General. Pendopharm
shall have sole responsibility for the commercialization of the
Licensed Products in the Territory, and all costs and expenses
associated with its commercialization of the Licensed Products in
the Territory shall be borne by Pendopharm. Pendopharm may, in its
sole discretion, choose whether to commercialize the Licensed
Products itself or, subject to Section 5.3, to collaborate with
Affiliates, Sublicensees or distributors.
(b)
Compliance with
Laws. Pendopharm shall comply in all material respects with all
Applicable Law with respect to the commercialization of the
Licensed Products in the Territory. In this regard, Edesa shall
provide Pendopharm with all information required in order for
Pendopharm to comply with the Patented Medicines Price Review Board
(PMPRB) Regulations.
(c)
Alliance
Management. After completion of a positive phase III clinical trial
of at least one of the Licensed Products, Pendopharm and Edesa
shall appoint one representative of each organization ("Alliance
Manager") who will meet by teleconference at least two (2) times
per year during the Term in order to update each other on
commercial activities (including, but not limited to, marketing and
reimbursement, sales performance, key market information,
forecasts), medical affairs, regulatory affairs, and supply chain
activities, changes, and plans relevant to the Licensed Products in
the Territory. Each party will use reasonable efforts to satisfy
the requests of the other Party's Alliance Manager for access to
specific information and documentation.
(d)
Marketing and
Promotion. Once Market Authorization has been granted for each of
the Licensed Products, Pendopharm shall be responsible
for:
(A)
the marketing and
promoting the Licensed Products in the Territory, which shall
include sales and marketing activities, managing tender processes
and submissions (public, hospitals and federal programs),
reimbursement activities, information exchange with Regulatory
Authorities and customers.
(B)
communicating with
customers, hospitals, pharmacies, payers and other health care
professionals.
(C)
using commercially
reasonable efforts for the commercialization of the Licensed
Products.
(D)
the provision of
all customer service, query handling, maintenance and development
of customer data in the Territory.
(e)
Ownership of
Customer Data. All customer data remains at all times the property
of Pendopharm. Notwithstanding the foregoing, if this Agreement is
terminated pursuant to Section 10.3 by Edesa, Pendopharm shall
transfer customer data to Edesa.
(f)
Training. Edesa
shall have the right, at its own cost, to provide trainings to
Pendopharm's sales representatives or product trainings, if Edesa
considers this necessary or useful, the frequency and location of
such trainings to be agreed on by the parties.
(g)
Marketing Material.
Edesa will provide international marketing materials, to Pendopharm
in electronic form. Pendopharm will be responsible for ensuring
that said marketing materials comply with Applicable Law prior to
using them in the Territory.
(h)
Conditions of Sale
by Pendopharm. Pendopharm has sole responsibility for the terms and
conditions of sale of the Licensed Products to customers in the
Territory.
ARTICLE
5
GRANT
OF LICENSE
5.1.
Grant
of License Rights to Pendopharm.
During
the Term of this Agreement, Edesa hereby grants to Pendopharm the
following licenses:
(a)
an exclusive,
royalty-bearing, non-sublicensable, non-transferable license to use
the US Data Package and, to the extent referenced in the US Data
Package, the Licensed Technology, for the sole purpose of preparing
the Canadian data package to obtain Market Authorization for the
Licensed Products to allow Pendopharm to distribute, market and
sell Licensed Products in the Field in the Territory;
and
(b)
the event
Pendopharm obtains Market Authorization for such Licensed Products
in the Territory, an exclusive, royalty-bearing, sublicensable,
non-transferable license to distribute, market and sell the
Licensed Products in the Field in the Territory.
(collectively, the
"Edesa License").
5.2.
Grant
of License Rights to Edesa.
During
the term of this Agreement, Pendopharm hereby grants to Edesa, an
exclusive, royalty-free, sub-licensable:
(a)
right to use the
clinical trial data, if Development is required pursuant to Section
2.7; and
(b)
right to use and
reproduce and amend the NDS, outside of the Territory.
(collectively, the "Pendopharm License").
5.3.
Pendopharm
Sublicenses.
(a)
Pendopharm shall
have the right to sublicense its rights granted pursuant to Section
5.1(b),
provided that the sublicense shall be at arm's length, conform to
the terms hereof, and (A) if granted to Affiliates of Pendopharm,
be notified to Edesa promptly after the grant of such sublicense
and (B) if granted to any Third Parties, be subject to the prior
written consent of Edesa, which consent shall not be unreasonably
withheld, conditioned or delayed (C) each sublicense agreement will
contain terms and conditions:
(i)
specifying that
such written agreement terminates upon termination of this
Agreement;
(ii)
consistent with the
relevant terms and conditions of this Agreement protecting the
rights of Edesa under this Agreement including imposing obligations
of confidentiality on each such sublicensee;
(iii)
that assign and
transfer all right, title and interest in and to any and all
inventions or work product developed by such Sublicensee relating
to the Licensed Products in the course of performing activities
under such sublicense to Edesa;
(iv)
that do not impose
any payment obligations or liability on Edesa without the prior
written consent of Edesa;
(v)
that Pendopharm
shall require each Sublicensee to provide it with regular written
royalty reports that include at least the detail that Pendopharm is
required to provide to Edesa pursuant to this Agreement which
reports, Pendopharm shall have the right to provide to Edesa upon
request;
(vi)
that Pendopharm
shall provide Edesa with an executed copy of each sublicense
agreement within five (5) Business Days of its
execution.
Except
as expressly provided herein, the parties grant no other right or
license to the other party, including any rights or licenses to the
Licensed Patents, the Licensed Know-How, any other Patents or other
Intellectual Property Rights, or any improvements to any of the
foregoing.
ARTICLE
6
PAYMENTS
6.1.
Royalty
Payments Pendopharm.
(a)
General. In
consideration of the Edesa License provided hereunder, Pendopharm
shall pay to Edesa a tiered royalty in the amounts set forth in
Section (c) below on all Net Sales by Pendopharm or its
Sublicensees of all Licensed Products in the
Territory.
(b)
Royalty Term.
Pendopharm's obligation to pay royalties shall expire, on a
Licensed Product-by-Licensed Product basis, on the later to occur
of:
(i)
13th anniversary of the
First Commercial Sale of the Licensed Product in the
Territory,
(ii)
the expiration date
in the Territory of the last-to-expire Patent of the Licensed
Patents relating to the Licensed Product,
(iii)
the expiration date
of the applicable regulatory or data exclusivity covering the
Licensed Product in the Territory,
(as
applicable, the "Royalty Term").
(c)
Tiered Royalty
Rate. Pendopharm will pay to Edesa royalties, on a Licensed Product
by Licensed Product basis, at the following rates:
Annual Net Sales (Canadian dollars)
|
Royalty Rate
|
Aggregate annual
Net Sales for each Licensed Product less than or equal to [ ]
million Canadian dollars ($[ ])
|
[
]% of Net Sales
|
Aggregate annual
Net Sales for each Licensed Product greater than [ ] million
Canadian dollars ($[ ]) and less than or equal
to
$[
]
|
[
]% of Net Sales
|
Aggregate annual
Net Sales for each Licensed Product greater than [ ] million
Canadian dollars ($[ ])
|
[ ]% of Net
Sales
|
(d)
Royalty Payment
Reports, Exchange Rates. From the date of First Commercial Sale of
the Licensed Products until the expiration of the Term, Pendopharm
shall within [thirty (30)
days] after each Calendar Quarter pay to Edesa the royalties
due under this Agreement for such Calendar Quarter and furnish to
Edesa a written quarterly report showing: (i) the Net Sales of the
Licensed Products sold by Pendopharm and its Sublicensees during
the reporting period; and (ii) the royalties due
thereon.
(e)
Generic
Competition. At such time as a generic equivalent is available for
sale in the Territory by a Third Party, Edesa authorizes Pendopharm
and its Affiliates to market a generic [equivalent to be supplied] by Edesa
("Authorized Generic") in the Territory. The royalties payable by
Pendopharm to Edesa for Authorized Generic will be
equal to [ ] percent ([ ]%) of the Royalty Rates
referred to in Section 6.l(c).
(i)
General. Any taxes,
levies or other duties ("Taxes") paid or required to be withheld
under the appropriate local tax laws by any one of the Parties
("Withholding Party") on account of monies payable to the other
Party under this Agreement shall, be deducted from the amount of
monies otherwise payable to the other Party under this Agreement
and shall be paid or remitted to the applicable governmental
authority within the time required by Applicable Law. The
Withholding Party shall secure and send to the other Party within a
reasonable period of time proof that any such Taxes required to be
withheld by the Withholding Party have been duly paid or remitted
for the benefit of the other Party.
6.2.
Audits,
Audit Disputes.
(a)
Audits. Upon
advance notice of not less than thirty (30) days, Pendopharm,
following the First Commercial Sale of the Licensed Products, shall
permit Edesa or an independent auditor designated by Edesa (each a
"Representative") to have access during normal business hours to
such books and records of Pendopharm as may be reasonably necessary
to verify the accuracy of the royalty reports and other Payments
described herein. Such audit will not be conducted more often that
once in a calendar year.
(b)
Auditor's Fees. The
fees charged by such auditor shall be paid by Edesa unless the
audit discloses that the royalties or other Payments payable by
Pendopharm for the audited period are underpaid by more than five
percent (5%), in which case Pendopharm shall pay the reasonable
fees and expenses charged by such auditor and, as the case may be,
a further amount equal to the amount of the underpaid royalty or
Payments plus interest. Any overpayment will be refundable or
credited against future royalties. Pendopharm shall include in each
sublicense granted by it pursuant to this Agreement a provision
requiring the Sublicensees to make reports to Pendopharm, to keep
and maintain books and records of sales made pursuant to such
sublicense and to grant access to such books and records to Edesa's
Representative to the same extent required of Pendopharm under this
Agreement. Edesa agrees that all information subject to review
under this Section 6.2 or under any sublicense agreement will be
confidential and that Edesa will cause its Representative to retain
all such information in confidence in accordance with the
confidentiality provisions of Article 12.
(c)
Audit Dispute. In
the event of a dispute regarding such books and records, including
the amount of royalties and other Payments owed to Edesa hereunder,
Edesa and Pendopharm shall work in good faith to resolve the
disagreement. If the Parties are unable to reach a mutually
acceptable resolution of any such dispute within thirty (30) days,
the dispute shall be submitted for decision to a certified public
accounting firm mutually selected by each Party's certified public
accountants or to such other Third Party as the Parties shall
mutually agree ("Expert"). The
decision of the Expert shall be final and the costs of such
decision as well as the initial audit shall be borne between the
Parties in such manner as the Expert shall determine. Not later
than ten (10) days after such decision and in accordance with such
decision, Pendopharm shall pay the underpaid royalties and other
Payments or Edesa shall reimburse such excess payments, as
applicable.
(d)
Payment. All
Payments to be made under this Agreement shall be made in CAD.
Pendopharm shall pay interest to Edesa on the aggregate amount of
any payments that are not paid on or before the date such payments
are due under this Agreement at a rate per annum equal to one
percent (I%) per month, calculated on the number of days such
payments are paid after the date such payments are due and
compounded monthly.
ARTICLE
7
INTELLECTUAL
PROPERTY
7.1.
Ownership
of Existing IP, Inventions and Joint Inventions.
Licenses.
(a)
Existing Edesa IP.
As between the Parties, Edesa shall own or Control, all
Information, Licensed Technology, Licensed Products and the US Data
Package and any Intellectual Property Rights therein, existing on
the Effective Date ("Existing IP").
(b)
Edesa IP
Improvements All modifications or improvements to the Existing IP,
conceived, prepared, developed or created either solely by Edesa,
or jointly with Pendopharm, shall be the exclusive property of
Edesa (the "Edesa IP Improvements"). Any Improvement shall be
included within the definition of Licensed Know-How and shall
become subject to the terms of this Agreement.
(c)
Pendopharm IP. As
between the Parties, Pendopharm shall own or Control, the right to
use the clinical trial data, if Development is required pursuant to
Section 2.7, the Trademarks and any Intellectual Property Rights
therein ("Pendopharm IP").
(d)
Pendopharm IP
Improvements All modifications or improvements to the Pendopharm
IP, conceived, prepared, developed or created either solely by
Pendopharm, or jointly with Edesa, shall be the exclusive property
of Pendopharm (the "Pendopharm IP Improvements"). Any Pendopharm IP
Improvements shall be included within the definition of the
Pendopharm License and shall become subject to the terms of this
Agreement.
(e)
Ownership of
Regulatory Approvals. As between Pendopharm and Edesa, Pendopharm
shall own all right, title and interest in and to all Regulatory
Approvals with respect to the Licensed Products in the
Territory.
7.2.
Maintenance
and Prosecution of Licensed Patents.
Edesa
or its licensees, through patent attorneys or agents of its or
their choice and at its or their sole cost and expense, shall have
the right, but not the obligation, to file, obtain, prosecute and
maintain the Licensed Patents and all foreign counterparts thereof
owned or Controlled by Edesa on the Effective Date and at all times
during the Term. With respect to the Territory, Edesa shall not,
and shall perform reasonable endeavours to procure that its
licensees other than Pendopharm, do not, abandon or cease the
prosecution of any such application for a Licensed Patents or
permit any registration of a Licensed Patents issuing therefrom to
lapse without first notifying Pendopharm and permitting Pendopharm
to continue the preparation, filing, prosecution and maintenance of
such applications or registrations or pay any required fees in the
name of Edesa, at Pendopharm's expense and through patent attorneys
of its choice. Pendopharm shall not become an assignee of any
Licensed Patent as a result of its continuing the prosecution or
registration of a Patent or paying any fees according to this
Section 0. If Pendopharm makes such expenses, Pendopharm shall have
the right to deduct such expenses from any royalty payment to be
made to Edesa pursuant to Section 6.1.
7.3.
Enforcement
and Third Party Infringement
Claims.
(a)
Rights and
Procedures. A party shall notify the other party of any
infringement, misappropriate or other violation of the Intellectual
Property Rights of the other party of which it becomes aware. The
other party may, at its sole discretion, bring proceedings or take
such action as it may deem appropriate to stop any such
infringement, misappropriate or other violation. If the other party does take
any such action or proceedings, the parties shall cooperate at
their own expense, in such action. The parties shall not be
permitted to bring proceedings or take other actions in respect of
infringement, misappropriation or violation of the other parties
Intellectual Property Rights without the prior written consent of
the other party.
(b)
Claims.
If any third
party commences an action or proceeding claiming the infringement,
misappropriation or other violation of its Intellectual Property
Rights by a party (a "Claim"), the parties shall immediately notify
each other party once they become aware of the Claim. Each party
shall, at its sole discretion, either defend any such Claim on its
own, permit the other party to participate in the defence of any
Claim, or permit the other party to defend such Claim on its own.
Neither party shall settle any Claim without the prior written
consent of the party. The parties shall cooperate at their own
expense, in any such defence of a Claim.
Subject
to Sections 10.4 and 10.5, Pendopharm shall be authorized to select
the trademark(s) for the Licensed Products(s) in the Territory in
accordance with Applicable Law and the requirements of the
Regulatory Authority (the "Trademarks"). Pendopharm shall own the
Trademarks and shall be solely responsible for the prosecution,
registration and maintenance of the Trademarks.
Pendopharm shall
have the first right to commence and control any application under
the Patented Medicines (Notice of Compliance) Regulations
("PM(NOC)") in connection with the Licensed Products in the
Territory. Accordingly, Edesa shall advise Pendopharm within thirty
(30) days of any grant of any of its patents and/or patent
applications with respect to the Licensed Products, subject to
Edesa having learnt of said grant. In such case, Pendopharm shall
be responsible for all legal costs it
incurs in pursuing any such application, and Pendopharm shall be
entitled to retain any award of costs granted in its favor. The
Party who commenced and controlled such an application shall also
have the sole obligation to defend any proceeding under Article 8
of the PM(NOC) in respect of a withdrawn, dismissed or discontinued
application commenced by that Party under the PMNOC, including the
obligations to pay all legal costs incurred in defending such
proceeding and all awards of damages and costs made by the court.
Edesa, at the request of Pendopharm, shall cooperate in all
reasonable respects with Pendopharm in the pursuit or defense of
such claims including, but not limited to, Edesa accepting to be
added as a party to said application or claim where
necessary.
Edesa
shall consult and cooperate with Pendopharm with a view to
obtaining issued Licensed Patents that meet the criteria for
listing on the Patent Register of Health Canada pursuant to the
Patented Medicines (Notice of Compliance) Regulations ("Patent
List"). Edesa consents to Pendopharm including any such issued
Licensed Patents on the Patent List for the Licensed Products and
will provide any necessary assistance to Pendopharm in order to
list the issued Licensed Patents in a timely manner.
ARTICLE
8
REPRESENTATIONS
AND WARRANTIES
8.1.
Representation
and warranties of Edesa.
Edesa
hereby represents and warrants to Pendopharm that, as of the
Effective Date and unless otherwise set forth below, at all times
during the Term:
(a)
Edesa has the full
right, power and authority to enter into this Agreement, to perform
its obligations under this Agreement and the fulfillment of its
obligations and performance of its activities hereunder do not
materially conflict with, violate, or breach or constitute a
default under any material contractual obligation, including the
Yissum Agreement or the Cipher Agreement, or a court or
administrative order by which Edesa is bound.
(b)
all necessary
consents, approvals and authorizations of all government
authorities and other persons required to be obtained by Edesa as
of the Effective Date in connection with the execution, delivery
and performance of this Agreement have been obtained.
(c)
Edesa does not have
any current knowledge that would cause any of its representations
or warranties to Pendopharm to be incorrect or untrue.
(d)
to the knowledge of
Edesa, neither Edesa nor any of its Affiliates, nor any of its
employees or agents (i) is debarred, excluded, suspended, proposed
for debarment or otherwise ineligible for participation in any
federal, state or provincial health care program; (ii) has been
convicted of or had a civil judgment rendered against it for
commission of fraud or a criminal offense; and (iii) is presently
indicted for or otherwise criminally or civilly charged by a
governmental entity or agency with commission of any of the offenses set
out in this paragraph.
(e)
Edesa shall, and
shall cause its Affiliates and agents to, comply with laws, rules,
regulations and guidelines and related to the performance of its
obligations hereunder and applicable including the
Food and Drugs Act (Canada) and
its regulations promulgated thereunder.
(f)
Edesa has, and
shall maintain during the Term, facilities, personnel, experience
and expertise sufficient in quality and quantity to perform its
obligations hereunder and it shall so perform with reasonable due
care and in conformity with current generally accepted industry
standards and procedures applicable in the Territory.
(g)
Edesa shall comply
during the Term of this Agreement, at its sole cost and expense,
with all Applicable Law in force in the Territory pertaining to and
in relation to Edesa's activities with regard to the Licensed
Products and the performance of its obligations under this
Agreement.
(h)
to Edesa Knowledge,
as of the Effective Date, there is no civil, criminal or
administrative judgment, action, suit, demand, claim, hearing,
notice of violation or investigation proceeding, pending or
threatened against Edesa that could materially and adversely affect
the ability of Edesa to carry out its obligations under this
Agreement.
(i)
Edesa shall
immediately notify Pendopharm if, at any time during the Term of
this Agreement, Edesa becomes aware that it, or any of its
Affiliates is convicted of an offense that would subject Pendopharm
or Edesa to exclusion, suspension or debarment from any program in
relation to the activities contemplated under this
Agreement.
(j)
Edesa takes all
commercially reasonable precautions, in line with industry norms,
to protect its confidential information and intellectual property
from unauthorized disclosure.
8.2.
Representation
and warranties of Pendopharm.
Pendopharm hereby
represents and warrants to Edesa that as of the Effective Date and,
unless otherwise set forth below, at all times during the
Term:
(a)
Pendopharm has the
full right, power and authority to enter into this Agreement, to
perform its obligations under this Agreement and the fulfillment of
its obligations and performance of its activities
hereunder.
(b)
all necessary
consents, approvals and authorizations of all government
authorities and other persons required to be obtained by Pendopharm
as of the Effective Date in connection with the execution, delivery
and performance of this Agreement have been obtained.
(c)
Pendopharm does not
have any current knowledge that would cause any of its
representations or warranties to Edessa to be incorrect or
untrue.
(d)
to the knowledge of
Pendopharm, neither Pendopharm nor any of its Affiliates, nor any
of its employees or agents (i) is debarred, excluded, suspended,
proposed for debarment or otherwise ineligible for participation in
any federal, state or provincial health care program; (ii) has been
convicted of or had a civil judgment rendered against it for
commission of fraud or a criminal offense; and (iii) is presently
indicted for or otherwise criminally or civilly charged by a
governmental entity or agency with commission of any of the
offenses set out in this paragraph.
(e)
Pendopharm shall,
and shall cause its Affiliates and agents to, comply with laws,
rules, regulations and guidelines and related to the performance of
its obligations hereunder and applicable including the Food and Drugs Act
(Canada) and its regulations promulgated thereunder.
(f)
Pendopharm has, and
shall maintain during the Term, facilities, personnel, experience
and expertise sufficient in quality and quantity to perform its
obligations hereunder and it shall so perform with reasonable due
care and in conformity with current generally accepted industry
standards and procedures applicable in the Territory.
(g)
Pendopharm shall
comply during the Term of this Agreement, at its sole cost and
expense, with all Applicable Law in force in the Territory
pertaining to and in relation to Pendopharm's activities with
regard to the Licensed Products and the performance of its
obligations under this Agreement.
(h)
to Pendopharm's
Knowledge, as of the Effective Date, there is no civil, criminal or
administrative judgment, action, suit, demand, claim, hearing,
notice of violation or investigation proceeding, pending or
threatened against Pendopharm that could materially and adversely
affect the ability of Pendopharm to carry out its obligations under
this Agreement.
(i)
Pendopharm shall
immediately notify Edessa if, at any time during the Term of this
Agreement, Pendopharm becomes aware that it, or any of its
Affiliates is convicted of an offense that would subject Edesa or
Pendopharm to exclusion, suspension or debarment from any program
in relation to the activities contemplated under this
Agreement.
(j)
Pendopharm takes
all commercially reasonable precautions, in line with industry
norms, to protect its confidential information and intellectual
property from unauthorized disclosure.
(k)
Pendopharm shall
only use Confidential Information, Information and Regulatory
Documentation within the Territory in accordance with the terms and
conditions of this Agreement.
8.3.
No
Reliance by Third Parties.
The
representations and warranties of each Party set forth in this
Agreement are intended for the sole and exclusive benefit of the
other Party hereto, and may not be relied upon by any Third
Party.
ARTICLE
9
INDEMNIFICATION
9.1.
Pendopharm
Indemnity Obligations.
PendopharmPendopharm
agrees to defend, indemnify and hold Edesa, its Affiliates, its
sub-contractors and its licensees and their respective directors,
officers, employees and agents (each a "Edesa Indemnity Party")
harmless against any and all claims, suits, judgments, losses,
liabilities, damages, costs, fees and expenses (including
reasonable attorneys' fees) (collectively, "Losses") resulting from
or arising out of (i) the negligence or willful misconduct on the
part of PendopharmPendopharm, its Affiliates, sub-contractors and
Sublicensees and their respective directors, officers, employees
and agents (each a "PendopharmPendopharm Indemnity Party") in
relation to the carrying out of this Agreement, (ii) the negligent
or willful breach by a Pendopharm Indemnity Party of any terms of
this Agreement, or (iii) the breach,
whether negligent or not, of any of Pendopharm's representations
and warranties in Article 8 of this Agreement by a
PendopharmPendopharm Indemnity Party, except for those Losses which
Edesa has an obligation to indemnify a PendopharmPendopharm
Indemnity Party pursuant to Section 9.2 hereof, as to which Losses
each Party shall indemnify the other to the extent of their
respective liability, and provided further that Pendopharm shall
not be obligated to indemnify any Edesa Indemnity Party for any
Losses to the extent such Losses arise as a result of negligence or
willful misconduct on the part of such Edesa Indemnity
Party.
9.2.
Edesa
Indemnity Obligations.
Edesa
agrees to defend, indemnify and hold Pendopharm, its Affiliates,
its sub-contractors and its Sublicensees and their respective
directors, officers, employees and agents harmless against any and
all Losses resulting from or arising out of (i) the negligence or
willful misconduct on the part of any Edesa indemnity Party in
relation to the carrying out of this Agreement, (ii) the negligent
or willful breach by a Edesa Indemnity Party of any terms of this
Agreement, or (iii) the breach, whether negligent or not, of any of
Edesa's representations and warranties in Article 8 of this
Agreement by an Edesa Indemnity Party, except for those Losses
which Pendopharm has an obligation to indemnify a Edesa Indemnity
Party pursuant to Section 9.1 hereof, as to which Losses each Party
shall indemnify the other to the extent of their respective
liability, and provided further that Edesa shall not be obligated
to indemnify any Pendopharm Indemnity Party for any Losses to the
extent such Losses arise as a result of negligence or willful
misconduct on the part of such Pendopharm Indemnity
Party.
The
indemnification obligations set forth in this Article 9 shall
survive the termination or expiration of this Agreement and remain
in full force and effect for a term ending three (3) years after
the end of the shelf life of the last Licensed Products sold by
Pendopharm, its Affiliates or a Sublicensee in relation to any
claim based on events which occur during the Term
hereof.
9.4.
Limitation
of Liability.
TO THE
FULL EXTENT ALLOWED BY LAW THE PARTIES EXCLUDE ANY LIABILITY,
WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY
OTHER LEGAL THEORY, FOR CONSEQUENTIAL, SPECIAL, INDIRECT,
INCIDENTAL, PUNITIVE OR EXEMPLARY DAMAGES OR OTHER SIMILAR OR LIKE
DAMAGES OR DAMAGES FOR LOSS OF
PROFITS, REVENUES OR DATA, ARISING OUT OF OR IN CONNECTION WITH
THIS AGREEMENT OR THE PERFORMANCE OR BREACH HEREOF, EVEN IF THE
PARTY HAS BEEN ADVISED OF THE POSSIBILITY THEREOF.
9.5.
Indemnification
Claims
(a)
Notice of Claim.
All indemnification claims in respect of a Party, its Affiliates
and Sublicensees and their respective directors, officers,
employees and agents shall be made solely by such Party to this
Agreement ("Indemnified Party"). The Indemnified Party shall give
the indemnifying Party prompt written notice ("Indemnification
Claim Notice") of any Losses or discovery of fact upon which such
Indemnified Party intends to base a request for indemnification
under Section 9.1 or 9.2, as applicable. In no event shall the
indemnifying Party be liable for any Losses that result from any
delay in providing such notice. Each Indemnification Claim Notice
must contain a description of the claim and the nature and amount
of such Loss (to the extent that the nature and amount of such Loss
is known at such time). The Indemnified Party shall furnish
promptly to the indemnifying Party copies of all notices and
documents received in respect of any Losses and claims asserted by
Third Parties ("Third Party Claims").
(b)
Control of Defense.
At its option, the indemnifying Party may assume the defense of any
Third Party Claim by giving written notice to the Indemnified Party
within thirty (30) days after the indemnifying Party's receipt of
an Indemnification Claim Notice or such shorter delay as may be
required in order to ensure a timely response to any Third Party
Claims. The assumption of the defense of a Third Party Claim by the
indemnifying Party shall not be construed as an acknowledgment that
the indemnifying Party is liable to indemnify the Indemnified Party
in respect of the Third Party Claim, and nothing shall constitute a
waiver by the indemnifying Party of any defenses it may assert
against the Indemnified Party's claim for indemnification. Upon
assuming the defense of a Third Party Claim, the indemnifying Party
may appoint as lead counsel in the defense of the Third Party Claim
any legal counsel selected by the indemnifying Party. In the event
the indemnifying Party assumes the defense of a Third Party Claim,
the Indemnified Party shall immediately deliver to the indemnifying
Party all original notices and documents (including court papers)
received by the Indemnified Party in connection with the Third
Party Claim. Should the indemnifying Party assume the defense of a
Third Party Claim, except as provided in Section 9.S(c), the
indemnifying Party shall not be liable to the Indemnified Party for
any legal expenses subsequently incurred by such Indemnified Party
in connection with the analysis, defense or settlement of the Third
Party Claim. In the event that it is ultimately determined that the
indemnifying Party is not obligated to indemnify, defend or hold
harmless the Indemnified Party from and against the Third Party
Claim, the Indemnified Party shall reimburse the indemnifying Party
for any and all costs and expenses (including reasonable attorneys'
fees and costs of suit) and any Third Party Claims incurred by the
indemnifying Party in its defense of the Third Party
Claim.
(c)
Right to
Participate in Defense. Without limiting Section 9.S(b) above, any
Indemnified Party shall be entitled to participate in, but not
control, the defense of such Third Party
Claim and to employ counsel of its choice for such purpose;
provided, however, that such employment shall be at the Indemnified
Party's own expense unless, subject to any potentially required
consent of an insurer, if applicable, (i) the employment thereof
has been specifically authorized by the indemnifying Party in
writing, (ii) the indemnifying Party has failed to assume the
defense and employ counsel in accordance with Section 9.5(b) or has
assumed defence and then failed to diligently defend the Third
Party Claim (in which case the Indemnified Party shall control the
defense) or (iii) the interests of the Indemnified Party and the
indemnifying Party with respect to such Third Party Claim are
sufficiently adverse to prohibit the representation by the same
counsel of both parties under Applicable Law, ethical rules or
equitable principles.
(d)
Settlement. With
respect to any Third Party Claims relating solely to the payment of
money damages in connection with a Third Party Claim and that shall
not result in the Indemnified Party becoming subject to injunctive
or other relief or otherwise adversely affecting the business of
the Indemnified Party in any manner, and as to which the
indemnifying Party shall have acknowledged in writing the
obligation to indemnify the Indemnified Party hereunder, the
indemnifying Party shall have the sole right to consent to the
entry of any judgment, enter into any settlement or otherwise
dispose of such Loss, on such terms as the indemnifying Party, in
its sole discretion, shall deem appropriate. Notwithstanding the
foregoing, in such a case the indemnifying Party agrees to consult
with the Indemnified Party in good faith in relation to any
settlement. With respect to all other Losses in connection with
Third Party Claims, where the indemnifying Party has assumed the
defense of the Third Party Claim in accordance with Section 9.5(b),
the indemnifying Party shall have authority to consent to the entry
of any judgment, enter into any settlement or otherwise dispose of
such Loss provided it obtains the prior written consent of the
Indemnified Party, which consent shall not be unreasonably withheld
or delayed. The indemnifying Party shall not be liable for any
settlement or other disposition of a Loss by an Indemnified Party
that is reached without the written consent of the indemnifying
Party. Regardless of whether the indemnifying Party chooses to
defend or prosecute any Third Party Claim, no Indemnified Party
shall admit any liability with respect to or settle, compromise or
discharge, any Third Party Claim without the prior written consent
of the indemnifying Party, such consent not to be unreasonably
withheld, conditioned or delayed.
(e)
Cooperation.
Regardless of whether the indemnifying Party chooses to defend or
prosecute any Third Party Claim, the Indemnified Party shall, and
shall cause each Indemnified Party to, cooperate in the defense or
prosecution thereof and shall furnish such records, information and
testimony, provide such witnesses and attend such conferences,
discovery proceedings, hearings, trials and appeals as may be
reasonably requested in connection therewith. Such cooperation
shall include access during normal business hours afforded to
indemnifying Party to, and reasonable retention by the Indemnified
Party of, records and information that are reasonably relevant to
such Third Party Claim, and making the indemnified Parties and
other employees and agents available on a mutually convenient basis
to provide additional information and explanation of any material
provided hereunder, and the
indemnifying Party shall reimburse the Indemnified Party for all
its reasonable and documented out-of-pocket expenses in connection
therewith.
ARTICLE
10
TERM
AND TERMINATION
This
Agreement will enter into effect on the Effective Date and remain
in effect until expiration as described in Section 6.1(b) or until
termination in accordance with Sections 10.2 to 10.6
hereof.
10.2.
Termination
by Pendopharm.
Pendopharm shall
have the right to terminate this Agreement upon one-hundred and
twenty (120) days prior
written notice to Edesa.
10.3.
Termination
by Edesa
Edesa
shall have the right to terminate this Agreement upon thirty (30)
days written notice to Pendopharm, in the event Edesa (i) is unable
to recruit the requisite number of participants in the proof of
concept clinical study or (ii)
the proof of concept clinical study is unable to be completed due
to a failure of obtaining the required approval (e.g. ethics board
approval) or has been terminated due to concerns regarding the
safety of participants following the use of the Licensed
Products.
10.4.
Termination
for Material Breach.
If
either Party commits a material breach of this Agreement, the other
Party shall have the right to terminate this Agreement by giving
written notice to the breaching Party in sufficient detail to
ascertain and respond to the alleged breach. Termination shall take
effect sixty (60) days after receipt of such notice by the
breaching Party unless within the same time period the breach has
been cured.
10.5.
Liquidation,
Bankruptcy, Insolvency.
To the
extent permitted under Applicable Law, if one of the Parties shall
go into liquidation, other than for the purpose of a bona fide
reorganization, or a receiver or trustee be appointed for its
property or estate, or if such Party files for a voluntary petition
in bankruptcy or application for insolvency or is adjudged bankrupt
or insolvent, and whether or not any of the aforesaid acts be the
outcome of a voluntary act of that Party, the other Party shall be
entitled to terminate this Agreement forthwith by written notice to
the first Party.
10.6.
Termination
of the Yissum or the Cipher Agreement
a)
In the event that
the Yissum Agreement is terminated and Edesa no longer controls the
Licensed Products identified as EB02 and EB03, this Agreement will
immediately terminate in respect ofEB02 and EB03 upon receipt of
written notice from Edesa to Pendopharm.
b)
In the event that
the Cipher Agreement is terminated and Edesa no longer controls the
Licensed Product identified as EB04, this Agreement will
immediately terminate in respect 0£ EB04 upon receipt of written
notice from Edesa to Pendopharm of such termination.
10.7.
Effects
oi Termination.
(a)
With the exception
of termination pursuant to Section 10.4 where Pendopharm is the
breaching party, the following shall occur in the event of
termination pursuant to Sections 10.2 to 10.6:
(i)
the Edesa License
and the Pendopharm License shall terminate
immediately;
(ii)
Pendopharm shall
cease all sales of the Licensed Products within 90 days from the
date of termination;
(iii)
Pendopharm shall
assign and set over to Edesa, all right, title and interest in the
Pendopharm IP, the Pendopharm IP Improvements and the Regulatory
Approvals in the Territory;
(iv)
Pendopharm shall
provide to Edesa, at its own expense, any and all documents,
Information, data files, records, and other materials, relevant for
the Development, manufacture and commercialization of the Licensed
Products in the Territory in its possession, and all Confidential
Information and other data, files, records and other materials
received from Edesa, provided, however, that Pendopharm shall be
permitted to retain one (1)
copy of such
Confidential Information and other materials for the sole purpose
of performing any continuing obligations hereunder or for archival
purposes. All retained Confidential Information shall continue to
be subject to the terms of this Agreement for the period set forth
in Section 12.l(a).
(b)
In the event of
termination pursuant to Section 10.4 where Edesa is the breaching
party, the following shall occur at Termination:
(i)
the Edesa License
and the Pendopharm License shall terminate
immediately;
(ii)
each Party shall
return all Confidential Information and all other Information,
data, files, records and other materials received from the other
Party required to commercialize the Licensed Products in the
Territory, in accordance with Section 12.3 hereof.
(c)
In the event of
termination pursuant to Section 10.6 (a), the provisions of this
Agreement shall remain in full force and effect in respect of the
Licensed Product identified as EB04. Similarly, in the event of
termination pursuant to Section 10.6 (b), the provisions of this
Agreement shall remain in full force and effect in respect of the
Licensed Products identified as EB02 and EB03.
(d)
Surviving
Provisions. In any event, any termination or expiration of this
Agreement, shall be without prejudice to:
(i)
the confidentiality
rights and obligations under Article 12 that survive termination or
expiration;
(ii)
any other rights or
remedies which either Party may then or thereafter have hereunder;
and
(iii)
either Party's
obligation to make any payments due pursuant to this Agreement
which accrue prior to termination or expiration, and at the time of
termination or expiration, all such payments due shall be made in
full within forty-five (45) days unless the Parties agree
otherwise.
ARTICLE
11
FORCE
MAJEURE
Neither
Party shall be held liable or responsible to the other Party or be
deemed to have defaulted under or be in breach of this Agreement
for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from
causes beyond the reasonable control of the affected Party,
including fire, floods, earthquakes, embargoes, epidemics, war,
acts of war, terrorist acts, insurrections, riots, civil
commotions, strikes, lockouts or other labor disturbances, act of
God or acts, omissions or delays in acting by any Regulatory
Authority or the other Party; provided, however, that the Party so
affected shall use reasonable commercial efforts to avoid or remove
such causes of non-performance, and shall continue performance
hereunder with reasonable dispatch whenever such causes are
removed. The affected Party shall provide the other Party with
prompt written notice of any delay or failure to perform that
occurs by reason of force majeure, stating the nature of the event,
its anticipated duration, and any action being taken to avoid or
minimize its effects. In the event that such force majeure
event (i) lasts for more
than one hundred eighty (180) days and (ii) has a material adverse
effect on the performance of the obligations of the affected Party,
the non-affected Party shall have the right to terminate this
Agreement upon written notice to the affected Party.
ARTICLE
12
CONFIDENTIALITY
12.1.
Nondisclosure
Obligations.
(a)
General. At all
times during the term of this Agreement and for a period of ten
(10) years thereafter, either Party ("Receiving Party") shall, and
shall cause its officers, directors, employees and agents to, keep
strictly confidential, and not publish or otherwise disclose, and
not use for any purpose, any Confidential Information furnished or
otherwise made known to it, directly or indirectly, by the other
Party ("Disclosing Party"), except to the extent such disclosure or
use is expressly permitted by the terms of this Agreement or is
reasonably necessary for the performance of the Receiving Party's
obligations hereunder and provided that such disclosure is made on
a need-to-know basis on conditions that the party to which such
disclosure is made, prior to the disclosure of the Confidential
Information, signed a written confidentiality agreement under which
it undertakes to keep the Confidential Information
confidential for the same time periods and to the same extent as
provided for under this Agreement. "Confidential Information" shall
mean any information provided by one Party to the other Party
relating to the terms of this Agreement and the collaboration of
the Parties hereunder, including any Information relating to the
Licensed Technology, the Development or commercialization of the
Licensed Products, the Marketing Authorizations and other
Regulatory Approvals, or the scientific, regulatory or business
affairs or other activities of either Party to the extent,
permitted under Applicable Law. The US Data Package and all other
data and information resulting from clinical studies shall be the
Confidential Information of the Party that owns such data and
information.
(b)
Limitations. The
obligation not to use and disclose Confidential Information shall
not apply to any part of such Confidential Information that can be
shown by written documents:
(i)
is, at the time of
disclosure by the Disclosing Party to the Receiving Party or
thereafter becomes part of the public domain other than by
unauthorized acts of the Receiving Party;
(ii)
has been disclosed
to the Receiving Party by a Third Party, provided such Third Party
was in lawful possession of the Confidential Information and was
under no confidentiality obligation vis-a-vis the Disclosing
Party;
(iii)
prior to disclosure
by the Disclosing Party, was already in the legal possession of the
Receiving Party; provided such Confidential Information was not
obtained directly or indirectly from the Disclosing Party pursuant
to another confidentiality agreement between the
Parties;
(iv)
has been
independently developed by the Receiving Party without any
reference to the Disclosing Party's Confidential
Information;
(c)
In addition to the
foregoing limitations, Confidential Information can be
disclosed:
(i)
to government or
other Regulatory Authorities to the extent that such disclosure is
reasonably necessary to obtain an issuance of a Licensed Patent or
Regulatory Approvals and Marketing Authorizations for and to
Commercialize the Licensed Products, provided that the Receiving
Party notifies the Disclosing Party reasonably in advance of such
disclosure; or
(ii)
pursuant to
interrogatories, requests for information or documents, subpoena,
court order, civil investigative demand issued by a court or
governmental agency or as otherwise required by Applicable Law,
provided that, to the extent reasonably practicable, the Receiving
Party notifies the Disclosing Party immediately upon receipt
thereof and grants the Disclosing Party the possibility to seek
legal protection against such disclosure and limits the scope of
disclosure to that portion of the Confidential Information that is
legally required to be disclosed.
12.2.
Terms.
Publications. Press Release.
(a)
Terms of this
Agreement, Press Release.
(i)
Edesa and
Pendopharm each agree not to disclose any terms or conditions of
this Agreement or the Agreement as such to any Third Party without
the prior written consent of the other Party, such consent not to
be unreasonably withheld, except as required by Applicable
Law.
(ii)
Neither Party shall
originate any publicity, news release or public announcement,
written or oral relating to this Agreement, including its existence
or the negotiations without the prior written approval of the other
Party, which approval shall not be unreasonably withheld, except as
required by Applicable Law or the rules of a stock
exchange.
12.3.
Return
oi Confidential Information.
Upon the effective date of expiration or
termination of this Agreement for any reason, either Party may
request in writing, and the other Party shall either, with respect
to Confidential Information to which such other Party does not
retain rights hereunder: (i) promptly destroy all copies of such
Confidential Information in the possession of the other Party and
confirm such destruction in writing to the requesting Party; or
(ii) promptly deliver to the requesting Party, at the other Party's
expense, all copies of such Confidential Information in the
possession of the other Party; provided, however, the other Party
shall be permitted to retain one (1) copy of such Confidential
Information for the sole purpose of performing any continuing
obligations hereunder or for archival purposes as well as
electronic copies which are automatically generated by computer
systems during back up procedures. All retained Confidential
Information shall continue to be subject to the terms of this
Agreement for the period set forth in Section 12.1.
ARTICLE
13
MISCELLANEOUS
This
Agreement together with the Exhibits hereto contains the entire
understanding of the Parties with respect to the subject matter
hereof. All prior express or implied agreements and understandings,
either oral or written, are superseded by this Agreement. This
Agreement may be amended and the written form requirement set forth
herein may be waived only by a written instrument duly executed by
all Parties hereto.
This
Agreement shall be binding upon and inure to the benefit of the
Parties hereto and their respective successors and permitted
assigns.
(a)
Assignment. Neither
Party may assign any of its rights or benefits under this
Agreement, or transfer any of its duties or obligations, in whole
or in part, except with the prior written consent of the other
Party. Notwithstanding the foregoing, either Party may assign this
Agreement to an Affiliate without the consent of the other Party,
provided that such assigning Party shall at all times remain liable
for the assignee's compliance with the terms of this
Agreement.
(b)
Effects. Any
assignment or transfer by a Party other than in accordance with the
terms hereof shall be null and void and shall entitle the other
Party to terminate this Agreement with immediate
effect.
Any
notice required or permitted hereunder shall be in writing, shall
refer specifically to this Agreement, and shall be delivered
personally by hand, by an overnight courier service or by facsimile
transmission, and shall be addressed to the Party to whom it is to
be given at the address or facsimile number shown
below:
If to
Pendopharm:
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Pendopharm, a
division of Pharmascience Inc.
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6111 Royalmount
Avenue, Suite 100
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Montreal, Quebec,
H4P 2T4
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Attention:
Vice-President,
Pendopharm
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Fax No.:
514-807-9483
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with a copy to:
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General Counsel and
Corporate Secretary
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Fax No.: (514)
342-3654
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If to Edesa:
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Edesa Biotech
Inc.
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100 Spy Court,
Markham, Ontario, L3R 5H6
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Attention:
CEO
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Fax No.:
905-475-9962
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with a copy to:
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●
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Fax No.:
●
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Each
Party may, at any time, substitute for its previous record address
any other address by giving prior written notice of the
substitution in accordance with this Section 13.3. Any such notice
shall be deemed to have been given and received on the date of
delivery, if received prior to 5:00 p.m. local time, on a Business
Day. If the notice is received after 5:00 p.m., local time on a
Business Day, or is received on a day which is not a Business Day,
then such notice shall be deemed to have been given and received on
the first Business Day thereafter.
The
failure of either Party to insist upon the strict performance of
any provisions hereof or to exercise any right or remedy shall not
be deemed a waiver of any right or remedy with respect to any
existing or subsequent breach or default; the election by either
Party of any particular right or remedy shall not be deemed to
exclude any other; and all rights and remedies shall be
cumulative.
In the
event any provisions of this Agreement are or become invalid or
unenforceable the remaining provisions of this Agreement shall
remain in effect. The invalid or unenforceable provisions shall be
replaced by a valid or enforceable one which most closely reflects
the original commercial intent of the Parties.
13.6.
Governing
Law and Dispute Resolution.
(a)
Laws. This
Agreement shall be governed by and construed in accordance with the
laws of the Province of Quebec and the laws of Canada which apply
therein, without regards to any conflict of law
provisions.
(b)
Dispute Resolution.
Any dispute, disagreement, controversy or claim arising out of or
relating to this Agreement, shall be exclusively submitted to the
courts of the Province of Quebec, Canada.
During
the Term and for a period of two (2) years thereafter, neither
Party shall actively recruit or solicit any employee of the other
Party or its Affiliates. For the avoidance of doubt, nothing shall
limit a Party from engaging in general recruitment efforts through
advertisements so long as the employees of the other Party and its
Affiliates are not specifically targeted in such recruitment
effort.
13.8.
Independent
Contractors.
It is
expressly agreed that Edesa and Pendopharm shall be independent
contractors and that the relationship between the two Parties shall
not constitute a partnership, joint venture or agency. Neither
Edesa nor Pendopharm shall have the authority to make any
statements, representations or commitments of any kind, or to take
any action, which shall be binding on the other, without the prior
consent of the other Party to do so.
13.9.
Mutual
Cooperation.
Each of
the Parties shall use all reasonable efforts to take, or cause to
be taken, all action or do or cause to be done, and to assist and
cooperate with each other Party in doing, all things necessary,
proper or advisable to consummate and make effective, in the most
expeditious manner practicable, the transactions contemplated by
this Agreement (in each case, to the extent that the same is within
the control of such Party).
13.10.
Further
Assurances.
Each
Party shall promptly do, execute, deliver or cause to be done,
executed and delivered all further acts, documents and things in
connection with this Agreement that the other Party may reasonably
require for the purposes of giving effect to this
Agreement.
The
parties have expressly required that this Agreement and all
documents and notices relating hereto be drafted
in English. Les parties aux
presentes ont expressement exige que la presente convention et tous
les documents et avis qui y sont afferents soient rediges en
anglais.
This
Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
[Signature page follows.]
IN
WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first set forth above.
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For
and on behalf of
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PENDOPHARM, A DIVISION OF PHARMASCIENCE INC.
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By:
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/s/ David
Goodman
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Name: David
Goodman
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Title: CEO
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For
and on behalf of
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EDESA
BIOTECH INC.
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By:
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/s/ Pardeep Nijhawan
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Name: Pardeep
Nijhawan |
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Title:
CEO |
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EXHIBIT 1.37
Edesa Licensed Patents (as of July 31, 2017)
CA
2,558,416
CA
2,834,918
CA
2,761,590
CA
2,604,758