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.
Exhibit 10.2
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Execution
Copy
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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.
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dated
April 17, 2020
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between
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NovImmune SA
Xxxxxx
xxx Xxxx 00, 0000 Xxxx-xxx-Xxxxxx, Xxxxxxxxxxx
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(hereinafter
NI)
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and
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Edesa Biotech Research, Inc.
000 Xxx
Xxxxx, Xxxxxxx, Xxxxxxx, Xxxxxx, X0X 0X0
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(hereinafter
Edesa)
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1.
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Definitions and Interpretation |
4 |
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2.
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Purchase of the Product |
4 |
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2.1 General |
4 |
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2.2 Compliance with
Specifications |
4 |
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2.3 Possession Instruction and Passing of
Risk |
4 |
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3.
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Purchase Price and other Fees |
4 |
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3.1 General |
4 |
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3.2 Payment Terms |
5 |
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3.3 Taxation |
5 |
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4.
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Representations, Warranties, and
Liability |
5 |
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4.1 Representations and
Warranties |
5 |
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4.2 Edesa's Obligation to Inspect;
Remedies |
6 |
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5.
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Exclusion of Liability
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6 |
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6.
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General |
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6.1 Written Form |
6 |
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6.2 Assignment |
6 |
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6.3 Independent Contractor |
6 |
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6.4 Notices |
7 |
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6.5 Force Majeure |
7 |
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6.6 Waiver |
7 |
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6.7 Governing Law |
7 |
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6.8 Dispute Resolution |
7 |
List of Annexes
Number
of Annex
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Name of
Annex
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Annex 1
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Definitions
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Annex
2.1
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Product
and Purchase Price
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Annex
2.2(a)
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Specifications
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Annex
2.2(b)
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Quality
Assistance Report No. B802533/1
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Annex
2.2(c)
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Lonza
Certificate of Analysis
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WHEREAS, NI is a company active in the development,
generation and manufacturing of monoclonal and bi-specific
antibodies, and NI owns IP (as defined) in such
antibodies;
WHEREAS, Edesa is interested in the further development and
commercialization of the NI monoclonal antibodies known as [___]
(Anti-TLR4) ([___]) and [___] (Anti-CXCL10) ([___]); [Nature of constructs omitted
as competitively sensitive information.]
WHEREAS, by entry into a license
agreement as of today, NI has granted Edesa an exclusive license
rights necessary to further develop and commercialize [___] and
[___];[Nature of constructs omitted
as competitively sensitive information.]
WHEREAS, NI owns an inventory of
approximately 3.9 Kgs of GMP manufactured [___] drug substance (the
Product), and Edesa wishes
to purchase the Product. The Parties have a mutual understanding
that payment of the Purchase Price (as defined) shall be made in
two instalments contingent upon successfully progressing to Phase
II and Phase III trials of therapies or drugs making use of
[___];[Nature of products omitted as
competitively sensitive information.]
WHEREAS, on NI's behalf, the Product is stored at and in
possession of [___]. [Place of Product storage
omitted as competitively sensitive information.]
WHEREAS, the Parties wish to set forth the terms of purchase
of the Product in this present purchase agreement (the Agreement);
NOW, THEREFORE, in consideration of the mutual covenants and
obligations contained herein and intending to be legally bound
hereby, the Parties agree as follows:
Edesa
hereby agrees to purchase the Product in accordance with
Annex 2.1, and NI agrees to change of
ownership of the Product to Edesa accordingly.
NI
shall deliver the Product and quality assurance documentation,
including certificates of analysis and GMP compliance, in
compliance with the Specifications (as defined) set forth in
Annexes 2.2(a) to 2.2(c).
(a)
Within thirty (30)
days of execution of this Agreement, NI shall instruct [___] to
store and possess the Product on Edesa's instead of NI's behalf at
the Place of Storage (as defined) without delivery (Besitzanweisung) (the Possession Instruction). For the
avoidance of doubt, as a result of the Possession Instruction,
Edesa will acquire ownership of the Product.[Place of Product storage
omitted as competitively sensitive information.]
(b)
Within thirty (30)
days after the time of Possession Instruction given by NI (the
Possession Instruction
Date), with effect as of the Possession Instruction Date,
Edesa shall enter into a new storage agreement with [____]
pertaining to the storage of the Product by [____]. [Place of Product storage
omitted as competitively sensitive information.]
(c)
Notwithstanding
relevant provisions of the New Storage Agreement, the risk of the
Product shall pass to Edesa as of the Possession Instruction
Date.
(b)
For the avoidance
of doubt, as of the Possession Instruction Date, Edesa shall pay
all fees to be paid under the New Storage Agreement.
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8
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(i)
[__] % of the
Purchase Price upon Edesa's notification to NI of being ready to
initiate a Phase II Trial of any therapy or drug making use of
[___], however no later than [____];
(ii)
[__] % of the
Purchase Price upon Edesa's notification to NI of being ready to
initiate a Phase III Trial of any therapy or drug making use of
[___], however no later than [____].
[Information relating to timing
and amount of payments and nature of constructs omitted
as competitively sensitive information.]
(a)
Upon an installment
becoming due, NI will provide Edesa with a correct and duly
detailed invoice. Edesa shall effect payment by bank transfer
within thirty (30) days of invoice's receipt.
(b)
In the event that
any payment hereunder is not made in time, the payment shall accrue
interest from the agreed date of payment at the rate of five
percent (5%) per annum. The payment of such interest shall not
limit NI from exercising any other rights it may have in case of
non-payment or late payment.
(a)
To the extent the
supply of the Product is subject to taxation in any jurisdiction,
Edesa agrees to bear such taxes, thus the Product Price being
understood and agreed as net of taxes such as VAT (as defined) or
other levies.
(b)
If and to the
extent Swiss VAT is applicable, NI shall specify on its invoices
the applicable rate (%) and amount of VAT owed, and such amount
shall be added to the Product Price and Edesa shall pay the Product
Price and such Swiss VAT. Edesa shall provide NI with all relevant
information and documentation required to issue such invoice in
accordance with applicable Swiss VAT law.
(c)
For any import
levies, VAT or other levies applicable in the county of delivery of
the Products shall, it shall be the sole responsibility and
liability of Edesa to correctly account for, declare and pay such
taxes.
(d)
The Parties shall
cooperate with each other using their reasonable best efforts to
obtain, to the extent possible under applicable laws and
regulations, a recovery of any VAT or other tax paid.
(a)
NI represents and
warrants to Edesa that, at the Possession Instruction Date at the
Place of Storage:
(i)
the Product will
meet and conform to the Specifications, and will be free from
material defects;
(ii)
NI has complied
with all laws and regulations applicable at its place (Switzerland)
relating to the Product;
(iii)
to NI's best
knowledge, the Product does not infringe any IP rights of any Third
Party (as defined);
(iv)
no Third Party has
any right or lien to deprive Edesa entirely, or partially, of the
intended use of the Product;
(b)
Other than the
representations and warranties given in this Section 4.1, NI
does not make any representations or give any warranties of any
kind, express or implied. In particular, NI does not warrant the
fitness of the Product for Edesa’s use or
application.
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(a)
No later than
thirty (30) calendar days after the date of notifications set forth
in section 3.2, Edesa or, if appointed, a third-party
representative shall inspect the Product at the Place of Storage
for any defects and deviations from the Specifications and shall
immediately notify NI of such defects or deviations, if any, in
writing or by e-mail.
(b)
If Edesa fails to
inspect the Product or to notify NI pursuant to
Section 4.2(a), claims arising out of such defects or
deviations shall be deemed waived by Edesa.
(e)
Remedies other than
those expressly set forth in paragraph (c) and (d), whether
statutory or otherwise and whether express or implied, are
excluded. For the avoidance of doubt, NI will not become liable for
direct, indirect or consequential damage whatsoever in case of
defects.
(a)
Unless expressly
provided for to the contrary, neither Party shall become liable to
the other Party for any direct, indirect, special, punitive or
consequential damage for any cause of action. Any such liability,
whether by contract, tort or any statute, is hereby
excluded.
(b)
No provision of
this Agreement shall be understood, however, to exclude or limit
the liability of a Party to the other for damage caused by
(i) gross negligence, willful misconduct, fraud or fraudulent
misrepresentation by such Party, or (ii) any other liability
that may not be limited or excluded by applicable law.
This
Agreement shall become effective upon its due execution by both
Parties. Changes or amendments of this Agreement are effective only
if made in writing. This also applies to a waiver of this form
requirement.
Other
than to an Affiliate or to a Party's successor to part or all of
the business to which this Agreement relates (including in
connection with any company merger, company trade sale, sale of
stock, sale of assets or other similar transaction), neither this
Agreement nor any interest therein shall be assigned or otherwise
transferred by a Party without the other Party’s prior
written consent.
The
relationship of the Parties is that of independent contractors. In
no event shall either Party hold itself out to others or allow
itself to be considered the agent, employee, or representative of
the other Party.
(a)
All notices
hereunder shall be in writing and shall be delivered personally,
mailed by overnight delivery, registered or certified mail, postage
prepaid, mailed by express mail service or given by facsimile, to
the following addresses of the respective Parties:
If
to NI:
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NovImmune
SA
Xxxxxx
xxx Xxxx 00
0000
Xxxx-xxx-Xxxxxx
Xxxxxxxxxxx
Attn:
Xxxxxx Xxxxxxxxx
Fax
No.:
Email:
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If
to Edesa:
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Edesa Biotech
Research Inc
000
Xxx Xxxxx,
Xxxxxxx,
Xxxxxxx, X0X0X0
Xxxxxx
Attn:
Xxxxxxx Xxxxxx
Fax
No.:
Email:
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[Personal information
omitted.]
(b)
Notices shall be
effective upon receipt if personally delivered, on the third
Business Day (as defined) following the date of mailing if sent by
certified or registered mail, and on the second Business Day
following the date of delivery to the express mail service if sent
by express mail, or the date of transmission if sent by facsimile.
A Party may change its address listed above by written notice to
the other Party.
Any
delay in the performance of any of the duties or obligations of
either Party under this Agreement caused by an event outside the
affected Party's reasonable control shall not be considered a
breach of this Agreement. Such events shall include acts of God;
acts of terrorism; riots; embargoes; sanctions; labour strikes;
fires; explosions; earthquakes; floods; shortages of material or
energy; or other unforeseeable causes beyond the reasonable control
of the Party so affected, including events related to the ongoing
COVID-19 pandemic, such as emergency proclamations by national
governments, quarantines and travel restrictions. The Party so
affected shall give prompt notice to the other Party of such cause
and shall take whatever reasonable steps are necessary to relieve
the effect of such cause as rapidly as possible.
No
waiver of any of the terms of this Agreement shall be valid unless
in writing and signed by an authorized representative of the
Parties. Failure by either Party to enforce any rights under this
Agreement shall not be construed as a waiver of such rights, nor
shall a waiver by either Party in one or more instances be
construed as constituting a continuing waiver or as a waiver in
other instances.
This
Agreement has been construed in accordance with and shall be
governed by the substantive laws of Switzerland with the exclusion
of the UN Convention on International Sales of Goods (Vienna
Convention).
All
disputes arising out of or in connection with this Agreement,
including disputes on its conclusion, binding effect, amendment and
termination, shall be resolved, to the exclusion of the ordinary
courts, by arbitration in accordance with the Rules of Arbitration
of the International Chamber of Commerce in force on the date when
the notice of arbitration is submitted in accordance with these
Rules. The number of arbitrators shall be three (3), and they shall
be appointed in accordance with the Rules of Arbitration. The seat
of the arbitration shall be in London. The arbitral proceedings
shall be conducted in English.
[Signature Page to follow]
IN WITNESS WHEREOF, each Party has caused this Agreement to
be executed on its behalf by its duly authorized representatives as
of the Effective Date.
Place
and Date: _Switzerland April 17, 2020
NovImmune SA
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/s/
Xxxxxxx Xxxxxxx
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/s/
Xxxxxx Eckelmann_
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Name:
Xxxxxxx Xxxxxxx
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Name:
Xxxxxx Xxxxxxxxx
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Place
and Date: _Canada April 17, 2020___
Edesa Biotech Research Inc.
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/s/
Xxxxxxx Xxxxxxxx
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/s/
Xxxxxxx Xxxxxx
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Name:
Xxxxxxx Xxxxxxxx
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Name:
Xxxxxxx Xxxxxx
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Affiliate shall mean any individual, corporation,
association or other business entity that directly or indirectly
controls, is controlled by, or is under common control with the
Party in question. As used in this definition, the term control
shall mean the direct or indirect ownership of more than fifty
percent (>50%) of the stock having the right to vote for
directors thereof or the ability to otherwise control the
management of the corporation or other business entity whether
through the ownership of voting securities, by contract,
resolution, regulation or otherwise.
Agreement shall mean this purchase agreement including its
Annexes.
Annex shall mean any of the numbered Annexes to this
Agreement.
Edesa shall meen Edesa Biotech Research, Inc. shown as a
Party on the cover page of this Agreement.
GMP shall mean current Good Manufacturing Practices as
applied to active pharmaceutical ingredients in accordance with
International Council for Harmonisation.
IP stands for Intellectual Property and shall mean patents
along with all applications, reissues, continuations,
continuations-in-part, revisions, divisions, extensions and
re-examinations, supplementary protection certificates, any other
rights to inventions, copyright and related rights as well as, to
the extent required in the context, trademarks, trade names and
domain names, rights in get-up, rights in goodwill or rights to xxx
for passing off, rights in designs, rights in computer software and
database and any other intellectual property rights, in each case
whether registered or unregistered and including all applications
(and rights to apply) for and all similar or equivalent rights or
forms of protection which subsist in any part of the
world.
New Storage Agreement shall have the meaning set forth in
section 2.3(b).
NI shall mean NovImmune SA shown as a Party on the cover
page of this Agreement.
[___]
shall have the meaning set forth in the second
whereas-clause.
[___]
shall have the meaning set forth in the second
whereas-clause.
[Nature of
constructs omitted as competitively sensitive
information.]
Parties shall mean both NI and Edesa.
Party shall mean either NI or Edesa.
Phase II Trial shall mean a human clinical trial in any
country that would satisfy the requirements of applicable
regulations and aims at testing efficacy and side effects of a
certain drug.
Phase III Trial shall mean a human clinical trial in any
country that would satisfy the requirements of applicable
regulations and aims at testing efficacy, effectiveness and safety
of a certain drug evidencing to be sufficient to obtain regulatory
approval to market such drug for patients having the disease or
condition being studied.
Place of Storage shall mean the place where the Product is
stored at the date of execution of this Agreement as specified in
Annex 2.1.
Possession Instruction shall have the meaning set forth in
section 2.3(a).
Possession Instruction Date shall have the meaning set forth
in section 2.3(b).
Product shall have the meaning set forth in the fourth
whereas-clause.
Purchase Price shall have the meaning set forth in section
3.1(a).
Specifications shall mean, with respect to the Product, all
applicable specifications set forth and analyzed and tested as
evidenced in Annexes 2.2(a) to 2.2(c), respectively.
[___] shall have the meaning set forth in the fifth
whereas-clause. [Place of product
storage omitted as competitively sensitive
information.]
Third Party shall mean a
natural person, corporation, partnership, joint venture, trust, any
governmental authority or other business entity or organization,
and any other recognized organization other than the Parties and/or
their Affiliates.
Annex
2.1 to Purchase Agreement
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1 | 2
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Annex 2.1 – Product and Purchase Price
Quantity
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Intended
Possession Instruction Date
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Place
of Storage
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Purchase
Price
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Approximately 3.9 Kgs with an accepted range of inaccuracy of
10%
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Within 30 days of execution of this Agreement
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[Place
of product storage omitted as competitively sensitive
information.]
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USD
5,000,000
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