Portions of this exhibit marked as “[***]” have been excluded because they are both not material and would likely cause competitive harm to the registrant if publicly disclosed. AMENDMENT TO THE LICENSE AGREEMENT OF SEPTEMBER 20, 2013
Exhibit 10.1
Portions of this exhibit marked as “[***]” have been
excluded because they are both not material and would likely cause
competitive harm to the registrant if publicly
disclosed.
AMENDMENT
TO
THE LICENSE AGREEMENT OF SEPTEMBER 20, 2013
This
amendment agreement (hereinafter referred to as the
“Amendment”) is made and
executed as of this 9th day of October,
2020 (“Effective
Date of Amendment”) by and between:
Orion Corporation, Business Identity Code 1999212-6, a
company registered under the laws of Finland and having its
principal office at Xxxxxxxxxx 0, 00000 Xxxxx, Xxxxxxx (hereinafter
referred to as “Orion”); and
Tenax Therapeutics, Inc., Business Identity Code 00-0000000,
a company registered under the laws of the State of Delaware, and
having its principal office at XXX Xxxxxx Xxxxxxx, Xxxxx 000,
Xxxxxxxxxxx, XX 00000, XXX (hereinafter referred to as
“Licensee”).
Orion
and Licensee are collectively referred to herein as the
“Parties” and each
individually as a “Party”.
WHEREAS,
this Amendment
pertains to that certain agreement titled “License
Agreement” and existing between the Parties and dated
September 20, 2013 (hereinafter referred to as the
“Agreement”);
and
WHEREAS,
it is the intention
of the Parties to amend the Agreement by, inter alia, adding a
certain orally administered Levosimendan product as well as a
subcutaneously administered Levosimendan product (as both having
been defined in more detail herein) to the scope of the Agreement
and to modify the term of the Agreement on the terms and conditions
set out hereinafter.
NOW,
THEREFORE, the Parties, in consideration of the premises and of the
mutual agreement, covenants and conditions hereinafter set forth,
hereby agree and convene as follows:
1
TERMS
USED IN THIS AMENDMENT
1.1
Unless otherwise
explicitly agreed herein, all capitalized terms used herein shall
have the same meaning as given to them under the
Agreement.
2
AMENDMENTS
AND CLARIFICATIONS TO THE AGREEMENT
2.1
The following
pharmaceutical product shall be referred to as the
“Oral
Product” under this Amendment and the
Agreement:
o
The orally
administered pharmaceutical product in capsule formulation,
containing Levosimendan as an active pharmaceutical ingredient and
having a strength of 1mg/capsule, the composition of which has been
described in Schedule 1 to this Amendment (attached
hereto).
2.2
The following
pharmaceutical product shall be referred to as the
“Modified Oral
Product” under this Amendment and the
Agreement:
o
An orally
administered pharmaceutical product in solid dosage form,
containing Levosimendan as an active pharmaceutical ingredient,
which deviates from the Oral Product solely in terms of its
excipients and/or strength of the active pharmaceutical
ingredient.
1
2.3
The following
pharmaceutical product shall be referred to as the
“Subcutaneously
Administered Product” under this Amendment and the
Agreement:
o
A subcutaneously
administered injectable pharmaceutical product containing
Levosimendan as an active pharmaceutical ingredient.
2.4
The definition of
“Development” under the Agreement shall be replaced
with the following:
o
“Development” means any
and all technical formulation development, as well as any and all
pre-clinical and clinical development activities reasonably related
to the submission of information to a Regulatory Authority and
other activities related to obtaining Regulatory Approval for the
Product in the Field in the Territory, but excluding
Commercialization activities. When used as a verb,
“Develop” means to engage
in Development.
2.5
The Oral Product,
the Modified Oral Product and the Subcutaneously Administered
Product shall be added to the definition of the
“Product” under the Agreement. However, notwithstanding
the foregoing, no manufacturing or supply obligations of Orion with
respect to the Product under the Agreement shall be applicable to
the Modified Oral Product or the Subcutaneously Administered
Product, unless the Parties separately agree
otherwise.
2.6
For purposes of
this Amendment and the Agreement, the “Phase III Study” shall
mean the phase III study to be conducted by Licensee in respect of
the Product and initiated before the end of 2022 and completed
before the end of 2026.
2.7
Solely with respect
to the Oral Product, the Modified Oral Product and the
Subcutaneously Administered Product, the “Field” shall be
restricted to mean:
o
The use of the Oral
Product, the Modified Oral Product and the Subcutaneously
Administered Product solely for Type 2 pulmonary hypertension in
heart failure patients with preserved ejection fraction (PH-HFpEF),
or other pulmonary hypertension or heart failure related
indications, or any other human indication for which the Oral
Product, the Modified Oral Product or the Subcutaneously
Administered Product (as applicable) has been registered in the
Territory by Licensee on the basis of the results of the Phase III
Study.
2.8
Solely with respect
to the Oral Product, Orion undertakes to provide to Licensee any
relevant CMC (chemistry, manufacture and controls) and safety data
relating to the Oral Product generated by or for Orion that are in
Orion’s possession or control. For clarity, Orion shall be
under no obligation to generate any additional data or
documentation for the purposes of the Agreement and the rights and
licenses granted to Licensee thereunder. Moreover, upon
Licensee’s request, Orion may, at Orion’s sole
discretion, provide to Licensee scientific support and advice in
relation to the Oral Product to a reasonable extent, in which case
Licensee shall reimburse Orion for any out-of-pocket expenses paid
to third parties and incurred by Orion in connection therewith. The
practicalities relating to such possible provision of scientific
support and advice shall be separately agreed upon by the
Parties.
2.9
Solely with respect
to the Oral Product, the Modified Oral Product and the
Subcutaneously Administered Product, Section 7.8 and Section 8.9 of
the Agreement shall not be applicable. Instead, the provisions
under Exhibit D (Key Terms For The Supply Agreement –
Development) and Exhibit E (Key Terms For The Supply Agreement
– Commercial) shall as such apply to the deliveries of the
Oral Product (but not, for clarity, of the Modified Oral Product or
the Subcutaneously Administered Product) by Orion to Licensee;
however, subject to the
following amendments to the Agreement:
i.
Orion shall have
the right and the obligation to supply the required amounts of the
Oral Product as well as the respective Placebo-Product to Licensee
for the Phase III Study. Orion shall charge a transfer price from
Licensee in respect of such supplies of the Oral Product and the
Placebo-Product corresponding to [***], respectively.
2
ii.
Orion shall have
the right but not the obligation to supply the Oral Product to
Licensee for Commercialization in the Territory (the
“Supply
Option”). In the event Orion uses the Supply Option,
the Parties shall separately negotiate on such supply of the Oral
Product, it being agreed that Orion may not require a higher
transfer price for the Oral Product than [***]. In the event Orion
has chosen not to supply the Oral Product to Licensee for
Commercialization in the Territory, Orion undertakes to arrange the
transfer of the relevant manufacturing information and know-how in
respect of the Oral Product existing in Orion’s possession to
Licensee, or a Third Party manufacturer appointed by Licensee for
such purpose (the “Technical Transfer”). The
costs and expenses of such Technical Transfer incurred by Orion
shall be borne by the Parties in equal shares. Following such
Technical Transfer, Orion may, at Licensee’s sole discretion,
supply Levosimendan to Licensee (or a Third Party manufacturer
appointed by Licensee) at a supply price mutually agreed upon. In
the event Orion chooses not to use the Supply Option, Orion shall
notify Licensee thereof in writing at the latest before the end of
2021. Further, if Orion does use the Supply Option, Orion shall
provide a minimum of twenty-four (24) months advance notice to
Licensee if Orion intends to terminate its supplies of the Oral
Product to Licensee. For the avoidance of doubt, in the event of
Orion not having used the Supply Option or Orion having terminated
its supplies of the Oral Product to Licensee, Licensee may source
the Oral Product from a Third Party manufacturer. For clarity, the
Modified Oral Product and the Subcutaneously Administered Product
are not covered by the Supply Option, and, Licensee is entitled to
source the Modified Oral Product and the Subcutaneously
Administered Product from a Third Party manufacturer
accordingly.
2.10
Subsection 4.1.1 of
the Agreement, pertaining to the royalty payments on Net Sales in
Territory, shall be replaced with the following:
4.1.1
During the
Term:
(a)
[***] of Annual Net
Sales of the Product in the Territory during the relevant Calendar
Year [***]; and
(b)
[***] of Annual Net
Sales of the Product in the Territory during the relevant Calendar
Year [***].
2.11
Solely with respect
to the Oral Product, the Modified Oral Product and the
Subcutaneously Administered Product, the Product Trademark shall be
defined to mean the following:
o
A trademark other
than Simdax®
selected by the Parties, to be registered and owned by Orion to be
used for the Oral Product, the Modified Oral Product or the
Subcutaneously Administered Product (as applicable) in the
Territory.
2.12
Section 16.1 (Term)
of the Agreement shall be replaced with the following:
o
16.1 Term. This Agreement shall
become binding upon the Effective Date and shall continue
thereafter in full force and effect, unless terminated sooner
pursuant to this Section 16, for ten (10) years after the launch of
the Product in the Territory; provided, however, that, to the
extent any of the Orion Patent Rights continue in existence in any
country in the Territory at the end of such ten (10) year period,
this Agreement shall continue in full force and effect on a
country-by-country basis until the expiration of such Orion Patent
Rights (the “Term”). For purposes of
this Agreement, the Product shall be considered launched upon the
occurrence of the first commercial sale of the Product by Licensee
to a Third Party in an arm’s length transaction following the
grant of the Regulatory Approval for the Product in the United
States of America by the FDA or in Canada by the relevant
Regulatory Authority. However, notwithstanding the foregoing, in
the event no Regulatory Approval for the Product has been granted
in the United States of America on or before September 20, 2028,
either Party shall have the right to terminate this Agreement with
immediate effect by notifying the other Party thereof in
writing.
2.13
For the avoidance
of doubt, any product containing the proprietary chemical entity of
Orion, which has been previously known as [***] and is currently
identified by Orion by [***], and whose chemical composition is
[***] shall not constitute a Product or a Line Extension Product
under the Agreement.
3
EFFECTIVE
DATE
3.1
The amendments to
the Agreement agreed upon herein shall become effective as of the
Effective Date of Amendment.
4
OTHER
PROVISIONS
4.1
For the avoidance
of doubt it is stated that except for what has been stipulated
herein above, all other terms and conditions of the Agreement will
remain unchanged.
4.2
The terms and
conditions of the Agreement with regard to the choice of law and
dispute resolution will apply to this Amendment.
***Balance of page left blank. Signature page
follows.***
3
IN WITNESS WHEREOF, the Parties, through their authorized
representatives, have executed two (2) identical counterparts of
this Amendment.
|
Orion
Corporation
|
|
|
|
|
By:
|
/s/
Satu Ahomäki
|
By:
|
/s/
Xxxxx Xxxxxxx
|
|
Name:
|
Satu
Ahomäki
|
Name:
|
Xxxxx
Xxxxxxx
|
|
Title:
|
Senior
Vice President, Commercial Operations
|
Title:
|
Director
/ Global Business Development and Alliance Management
|
|
|
|
|
|
|
By:
|
/s/
Xxxxxxx XxXxxxx
|
By:
|
/s/
Xxxxxxx Xxxxxx
|
|
Name:
|
Xxxxxxx
Xxxxxxx
|
Name:
|
Xxxxxxx
Xxxxxx
|
|
Title:
|
CEO
|
Title:
|
CFO/President
|
4
SCHEDULE 1
to the Amendment to the License Agreement of September 20,
2013
Description of the composition of the
Oral Product:
|
Component
|
Quantity
(mg/capsule)
|
|
Levosimendan
|
1.0
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]capsule[***]
|
1
capsule
|
5
