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 Orionintie 1, 02200
Espoo, Finland (hereinafter referred to as “Orion”); and
 
Tenax Therapeutics, Inc., Business Identity Code 26-2593535, a company
registered under the laws of the State of Delaware, and having its principal
office at ONE Copley Parkway, Suite 490, Morrisville, NC 27560, USA (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/ Jukka Muhonen
 
Name:
Satu Ahomäki
Name:
Jukka Muhonen
Title:
 
Senior Vice President, Commercial Operations
 
Title:
 
Director / Global Business Development and Alliance Management
 
 
 
 
Tenax Therapeutics, Inc.
 
 
 
By:
 
/s/ Anthony DiTonno
 
By:
 
/s/ Michael Jebsen
 
Name:
Anthony Ditonno
Name:
Michael Jebsen
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

 
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