Document:

tenx_ex101

 

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

 

5Exhibit 4.1

 

NUMBER UNITS

U-

 

SEE REVERSE FOR CERTAIN
DEFINITIONS

CUSIP [●]

 

RICE ACQUISITION CORP.

 

UNITS CONSISTING OF ONE SHARE OF CLASS A
COMMON STOCK AND

ONE-HALF OF ONE REDEEMABLE WARRANT TO PURCHASE ONE SHARE OF CLASS A COMMON STOCK

 

	THIS CERTIFIES THAT	is the owner of	Units.

 

Each Unit (“Unit”)
consists of one (1) share of Class A common stock, par value $0.0001 per share (“Common Stock”), of Rice
Acquisition Corp., a Delaware corporation (the “Company”), and one-half of one redeemable warrant (each
whole warrant, a “Warrant”). Each Warrant entitles the holder to purchase one (1) share (subject to adjustment)
of Common Stock for $11.50 per share (subject to adjustment). Each Warrant will become exercisable on the later of (i) thirty (30)
days after the Company’s completion of a merger, capital stock exchange, asset acquisition, stock purchase, reorganization
or other similar business combination with one or more businesses (each a “Business Combination”), or
(ii) twelve (12) months from the closing of the Company’s initial public offering, and will expire unless exercised before
5:00 p.m., New York City Time, on the date that is five (5) years after the date on which the Company completes its initial Business
Combination, or earlier upon redemption or liquidation (the “Expiration Date”). The Common Stock and
Warrants comprising the Units represented by this certificate are not transferable separately prior to [●], 2020, unless
Barclays Capital Inc. elects to allow earlier separate trading, subject to the Company’s filing of a Current Report on Form
8-K with the Securities and Exchange Commission containing an audited balance sheet reflecting the Company’s receipt of the
gross proceeds of the offering and issuing a press release announcing when separate trading will begin. The terms of the Warrants
are governed by a Warrant Agreement, dated as of [●], 2020, between the Company, Rice Acquisition Holdings LLC (“Opco”)
and Continental Stock Transfer & Trust Company, as Warrant Agent, and are subject to the terms and provisions contained therein,
all of which terms and provisions the holder of this certificate consents to by acceptance hereof. Copies of the Warrant Agreement
are on file at the office of the Warrant Agent at 1 State Street, 30th Floor, New York, New York 10004, and are available
to any Warrant holder on written request and without cost.

 

This certificate is not valid
unless countersigned by the Transfer Agent and Registrar of the Company.

 

This certificate shall
be governed by and construed in accordance with the internal laws of the State of New York.

 

Witness the facsimile signature
of its duly authorized officers.

 

	 	 
	Secretary	 
	 	 
	 	 
	Chief Executive Officer 	 

 

     

     

    

 

Rice Acquisition Corp.

 

The Company will furnish
without charge to each unitholder who so requests, a statement of the powers, designations, preferences and relative, participating,
optional or other special rights of each class of stock or series thereof of the Company and the qualifications, limitations, or
restrictions of such preferences and/or rights.

 

The following abbreviations,
when used in the inscription on the face of this certificate, shall be construed as though they were written out in full according
to applicable laws or regulations:

 

	TEN COM	–	as tenants in common	 	UNIF GIFT MIN ACT	–	
         

                     Custodian
                     

	TEN ENT	–	as tenants by the entireties	 	 	 	(Cust)                         (Minor)
	 	 	 	 	 	 	 
	JT TEN	–	as joint tenants with right of survivorship and not as tenants in common	 	 	 	
        under Uniform Gifts to Minors Act

        _________________________

        (State)

 

Additional abbreviations may also be used though
not in the above list.

 

    2

     

    

 

For value received,              
hereby sells, assigns and transfers unto                                             

 

PLEASE INSERT SOCIAL SECURITY OR OTHER IDENTIFYING
NUMBER OF ASSIGNEE

 

 

(PLEASE PRINT OR TYPEWRITE NAME AND ADDRESS, INCLUDING
ZIP CODE, OF ASSIGNEE)

 

 

 

 

 

 

 

 

Units represented by the within Certificate,
and do hereby irrevocably constitute and appoint Attorney to transfer the said Units on the books of the within named Company with
full power of substitution in the premises.

	Dated:	 	 

 

	 	 	 
	 	Notice:	The signature to this assignment must correspond with the name as written upon the face of the certificate in every particular, without alteration or enlargement or any change whatever.
	 	 	 
	Signature(s) Guaranteed:	 	 
	 	 	 
	THE SIGNATURE(S) MUST BE GUARANTEED BY AN ELIGIBLE GUARANTOR INSTITUTION (BANKS, STOCKBROKERS, SAVINGS AND LOAN ASSOCIATIONS AND CREDIT UNIONS WITH MEMBERSHIP IN AN APPROVED SIGNATURE GUARANTEE MEDALLION PROGRAM, PURSUANT TO RULE 17Ad-15 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED (OR ANY SUCCESSOR RULE)).	 	 

 

    3

     

    

 

In each case, as more fully
described in the Company’s final prospectus dated [●], 2020, the holder(s) of this certificate shall be entitled to
receive a pro-rata portion of certain funds held in the trust account established in connection with the Company’s initial
public offering only in the event that (i) the outstanding shares of Common Stock of the Company and Class A Units of Opco (other
than those held by the Company) are redeemed and the Company liquidates because it does not consummate an initial business combination
by [●], 2022, (ii) the shares of Common Stock sold
in its initial public offering are redeemed in connection with a stockholder vote to approve an amendment to the Company’s
amended and restated certificate of incorporation that would affect the substance or timing of the Company’s obligation to
redeem 100% of the Common Stock if it does not consummate an initial
business combination by [●], 2022, or (iii) if the
holder(s) seek(s) to redeem for cash his, her or its respective shares of Common Stock in connection with a tender offer (or proxy
solicitation, solely in the event the Company seeks stockholder approval of the proposed initial business combination) setting
forth the details of a proposed initial business combination. In no other circumstances shall the holder(s) have any right or interest
of any kind in or to the trust account.

 

4

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00315-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00315-of-00352.parquet"}]]