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
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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.
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