Document:

EX-10.3

 Exhibit 10.3 

Execution Version 

LIMITED WAIVER AND SECOND AMENDMENT TO AMENDED 

AND RESTATED BUSINESS LOAN AGREEMENT 

This LIMITED WAIVER AND SECOND AMENDMENT TO AMENDED AND RESTATED BUSINESS LOAN AGREEMENT (this “Amendment”), dated as
November 19, 2018 (“Second Amendment Effective Date”), is made and entered into by and among Zions Bancorporation, N.A. dba Amegy Bank (together with its successors and assigns, “Lender”), Fuse Medical, Inc.
(“Fuse”) and CPM Medical Consultants, LLC (“CPM”, together with Fuse, collectively, the “Borrowers” and each a “Borrower”). 

RECITALS 

A.    Lender and Borrowers are parties to that certain Amended and Restated Business Loan Agreement dated as of
December 31, 2017 (as amended by the Limited Wavier and First Amendment, dated as of September 21, 2018, and as may be further amended and restated, supplemented or otherwise modified from time to time, the “Loan
Agreement”). 
 B.    Borrowers have requested that Lender amend the Loan Agreement to extend the maturity date
of the Loans, to reduce the amount of the Revolving Facility Limit and to amend certain financial covenants, among other matters. 

C.    Lender is willing to amend the Loan Agreement on the terms and subject to the conditions set forth below. 

NOW, THEREFORE, in consideration of the premises herein contained and other good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the parties hereto hereby agree as follows: 
 ARTICLE I 

Definitions 

Section 1.1    Definitions. Capitalized terms used in this Amendment, to the extent not otherwise defined
herein, shall have the same definitions assigned to such terms in the Loan Agreement, as amended hereby. 
 ARTICLE II 

Limited Waiver 

Section 2.1    Limited Waiver. An Event of Default has occurred and currently exists under the Loan Agreement
as a result of Borrowers’ failure to achieve quarterly net income of at least $700,000 or more for the fiscal quarter ended September 31, 2018 as required by Section 10.1(q) (the “Specified
Default”). Borrowers represent and warrant that the Specified Default is the only Default or Event of Default that exists, or is anticipated to occur, under the Loan Agreement and the other Loan Documents as of the Second Amendment
Effective Date. Subject to the satisfaction of the conditions precedent set forth in Section 4.1 hereof, Lender hereby waives the Specified Default. In no event shall such waiver be deemed to constitute a waiver of
(a) any Default or Event of Default other than the Specified Default or (b) Borrowers’ obligation to comply with all of the terms and conditions of the Loan Agreement and the other Loan Documents from and after the Second Amendment
Effective Date. Notwithstanding any prior, temporary mutual disregard of the terms of any contracts between the parties, Borrowers hereby agree that they shall be required strictly to comply with all of the terms of the Loan Documents on and after
the Second Amendment Effective Date. 

 ARTICLE III 

Amendments to the Loan Agreement 

In reliance upon the representations and warranties of the Lender and Borrowers set forth in the Loan Documents and in this Amendment, the
Loan Agreement is hereby amended, effective as of the Second Amendment Effective Date, as follows: 

Section 3.1    Definitions. 

(a)    The following definitions in Section 1.1 of the Loan Agreement are hereby amended and
restated in their entirety as follows: 
 “Borrowing Base” means, as of any date of determination, an amount
equal to the sum of: 
 (a)    Eighty percent (80%) advance rate multiplied by Net Amount of Eligible
Accounts; plus 
 (b)    Fifty percent (50%) advance rate multiplied by Net Amount of Eligible Inventory
(provided that Eligible Inventory shall not constitute more than fifty percent (50%) of the Borrowing Base); minus 

(c)    Without limiting Lender’s discretion to implement other reserves or to increase the amount of
the dilution reserve, a dilution reserve in an amount of not less than $600,000 established by Lender in its sole and absolute discretion from time to relating to all receivables not specifically attributed to any one account or class of accounts;
minus 
 (d)    the sum of all other Reserves 

“Revolving Facility Limit” means $4,000,000. 

“Termination Date” means the earliest to occur of (a) November 4, 2019 and (b) the date on
which Lender’s commitment to make Loans is terminated pursuant to Section 10.2. 

(b)    Section 3.1(a) of the Loan Agreement is hereby amended and restated to read in its entirety as follows: 

“(a) Rate. Subject to the provisions of Section 3.1(b), the Loans shall bear interest at
the LIBOR Index Rate plus four percent (4.00%) per annum. All interest due hereunder shall be payable monthly in arrears on the first day of each calendar month and on the Termination Date.” 

(c)    Section 8.1(e) of the Loan Agreement is hereby amended and restated to read in its entirety as follows: 

“(e) Guarantor Tax Returns. As soon as available, but in no event later than thirty (30) days after the
applicable filing date for the tax reporting period ended, each Guarantor’s Federal and other governmental tax returns; provided, however, the applicable due date for Mr. Brooks’ tax returns related to the year ended December 31,
2016 shall be no later than June 30, 2019.” 

  
 2 

 (d)    Section 9.1 of the Loan Agreement is hereby amended and
restated to read in its entirety as follows: 
 “Section 9.1 Financial Covenants. Borrowers shall maintain
and keep in full force and effect each of the financial covenants set forth below: 
 (a)    Minimum
Fixed Charge Coverage Ratio. Borrowers shall not permit the Fixed Charge Coverage Ratio as of any calendar quarter end from and after the quarter ending June 30, 2019 to be less than 1.25 to 1.00. 

(b)    Minimum EBITDA. Borrowers shall not permit EBITDA to be less than (i) $700,000 for the fiscal
quarter ending December 31, 2018 and (ii) $100,000 for the fiscal quarter ending March 31, 2019.” 

(e)    Section 10.1(q) of the Loan Agreement is hereby amended and restated to read in its entirety as follows:

 “(q) from and after the quarter ending June 30, 2019 incur any consecutive quarterly losses.” 

ARTICLE IV 
 Conditions
Precedent 
 Section 4.1    Conditions Precedent. The effectiveness of this Amendment is subject to the
satisfaction of the following conditions precedent, unless specifically waived in writing by Lender, upon which this Amendment shall be effective as of the Second Amendment Effective Date: 

(a)    Lender shall have received a counterpart of this Amendment duly executed by Borrowers and the Consent and
Reaffirmation duly executed by Guarantors; 
 (b)    the representations and warranties contained herein and in all
other Loan Documents shall be true and correct as of the Second Amendment Effective Date as if made on the Second Amendment Effective Date; 

(c)    no Default or Event of Default shall have occurred and be continuing; and 

(d)    Borrowers shall have paid all reasonable costs and expenses incurred by Lender in connection with the preparation,
negotiation and execution of this Amendment and the other Loan Documents executed pursuant hereto, including, without limitation, the costs and fees of Lender’s legal counsel and such counsel’s outstanding invoices related to the
preparation of the Loan Documents and amendments thereto. 
 ARTICLE V 

Ratifications, Representations, Warranties, Acknowledgments and Covenants 

Section 5.1    Ratifications by Borrowers. The terms and provisions set forth in this Amendment shall modify
and supersede all inconsistent terms and provisions set forth in the Loan Agreement and, except as expressly modified and superseded by this Amendment, the terms and provisions of the Loan Agreement are ratified and confirmed and shall continue in
full force and effect. The Loan Agreement as amended by this Amendment shall continue to be legal, valid, binding and enforceable in accordance with its terms. 

  
 3 

 Section 5.2    Renewal and Extension of Security Interests and
Liens. Each Borrower hereby (a) renews and affirms the Liens created and granted in the Loan Documents, and (b) agrees that this Amendment shall in no manner affect or impair the Liens securing the Obligations, and that such Liens
shall not in any manner be waived, the purposes of this Amendment being to modify the Loan Agreement as herein provided, and to carry forward all Liens securing the same, which are acknowledged by such Borrower to be valid and subsisting. 

Section 5.3    Representations and Warranties. Each Borrower represents and warrants to Lender that
(a) the execution, delivery and performance of this Amendment and any and all Loan Documents executed and/or delivered in connection herewith have been authorized by all requisite entity action on the part of such Borrower and will not violate
the organizational documents of such Borrower or any agreement to which such Borrower is a party, (b) the representations and warranties contained in the Loan Agreement and in each of the other Loan Documents are true and correct on and as of
the Second Amendment Effective Date as though made on the Second Amendment Effective Date, (c) no Default or Event of Default under the Loan Agreement has occurred and is continuing, and (d) such Borrower is in full compliance with all
covenants and agreements contained in the Loan Agreement, as amended hereby. 
 ARTICLE VI 

Miscellaneous 

Section 6.1    Survival of Representations and Warranties. All representations and warranties made in the Loan
Agreement or any other Loan Document, including without limitation, any Loan Document furnished in connection with this Amendment, shall survive the execution and delivery of this Amendment and the other Loan Documents, and no investigation by
Lender or any closing shall affect such representations and warranties or the right of Lender to rely thereon. 

Section 6.2    Reference to Loan Agreement. Each of the Loan Documents and any and all other agreements,
documents or instruments now or hereafter executed and delivered pursuant to the terms hereof or pursuant to the terms of the Loan Agreement as amended hereby, are hereby amended so that any reference in such Loan Documents to the Loan Agreement
shall mean a reference to the Loan Agreement as amended hereby. 
 Section 6.3    Expenses of Lender.
Borrowers agree to pay on demand all reasonable costs and expenses incurred by Lender directly in connection with any and all amendments, modifications, and supplements to this Amendment and the other Loan Documents executed pursuant hereto,
including, without limitation, the costs and fees of Lender’s legal counsel, and all costs and expenses incurred by Lender in connection with the enforcement or preservation of any rights under the Loan Agreement, as amended hereby, or any
other Loan Document, including, without limitation, the reasonable costs and fees of Lender’s legal counsel. 

Section 6.4    Severability. Any provision of this Amendment held by a court of competent jurisdiction to be
invalid or unenforceable shall not impair or invalidate the remainder of this Amendment and the effect thereof shall be confined to the provision so held to be invalid or unenforceable. 

Section 6.5    APPLICABLE LAW. THIS AMENDMENT SHALL BE DEEMED TO HAVE BEEN MADE AND TO BE PERFORMABLE IN AND
SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF TEXAS NOT INCLUDING CONFLICTS OF LAW RULES. 

  
 4 

 Section 6.6    Waiver of Jury Trial. TO THE FULLEST EXTENT
PERMITTED BY APPLICABLE LAW, THE PARTIES HERETO EACH HEREBY WAIVES THE RIGHT TO TRIAL BY JURY IN ANY ACTION, SUIT, COUNTERCLAIM, OR PROCEEDING ARISING OUT OF OR RELATED TO THIS AMENDMENT. 

Section 6.7    RELEASE OF CLAIMS. TO INDUCE LENDER TO ENTER INTO THIS AMENDMENT, EACH BORROWER, AND BY
GUARANTORS’ SIGNATURES TO THE CONSENT AND REAFFIRMATION, EACH GUARANTOR VOLUNTARILY, KNOWINGLY AND UNCONDITIONALLY RELEASES, ACQUITS, AND FOREVER DISCHARGES LENDER AND ITS OFFICERS, DIRECTORS, AGENTS, EMPLOYEES, SUCCESSORS, AND ASSIGNS
(COLLECTIVELY, THE “RELEASED PARTIES”), FROM ANY AND ALL LIABILITIES, CLAIMS, DEMANDS, DAMAGES, EXPENSES, ACTIONS, OR CAUSES OF ACTION OF ANY KIND OR NATURE (IF THERE BE ANY), WHETHER ABSOLUTE OR CONTINGENT, DISPUTED OR UNDISPUTED,
AT LAW OR IN EQUITY, OR KNOWN OR UNKNOWN, THAT SUCH BORROWER NOW HAS OR EVER HAD AGAINST ANY OF THE RELEASED PARTIES ARISING UNDER OR IN CONNECTION WITH ANY OF THE LOAN DOCUMENTS OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY SUCH LIABILITIES,
CLAIMS, DEMANDS, DAMAGES, EXPENSES, ACTIONS, OR CAUSES OF ACTION ARISING OUT OF OR RELATING TO A CLAIM OF BREACH OF CONTRACT, FRAUD, LENDER LIABILITY OR MISCONDUCT, BREACH OF FIDUCIARY DUTY, USURY, UNFAIR BARGAINING POSITION, UNCONSCIONABILITY,
VIOLATION OF LAW, NEGLIGENCE, ERROR OR OMISSION IN ACCOUNTING OR CALCULATIONS, MISAPPROPRIATION OF FUNDS, TORTIOUS CONDUCT OR RECKLESS OR WILLFUL MISCONDUCT. EACH BORROWER AND EACH GUARANTOR REPRESENTS AND WARRANTS TO LENDER THAT IT HAS NOT
TRANSFERRED OR ASSIGNED TO ANY PERSON ANY CLAIM THAT IT HAS EVER HAD OR CLAIMED TO HAVE AGAINST ANY RELEASED PARTY. 

Section 6.8    Successors and Assigns. This Amendment is binding upon and shall inure to the benefit of the
parties hereto and their respective successors, assigns, heirs, executors, and legal representatives, except that none of the parties hereto other than Lender may assign or transfer any of its rights or obligations hereunder without the prior
written consent of Lender. 
 Section 6.9    Counterparts. This Amendment may be executed in one or more
counterparts, each of which when so executed shall be deemed to be an original, but all of which when taken together shall constitute one and the same instrument. Any signature delivered by a party by facsimile or other electronic transmission shall
be deemed to be an original signature hereto. 
 Section 6.10    Effect of Waiver. No consent or waiver,
express or implied, by Lender to or for any breach of or deviation from any covenant, condition or duty by any Borrower, shall be deemed a consent to or waiver of any other breach of the same or any other covenant, condition or duty. 

Section 6.11    Headings. The headings, captions, and arrangements used in this Amendment are for convenience
only and shall not affect the interpretation of this Amendment. 
 Section 6.12    Conflicting Provision. If
any provision of the Loan Agreement as amended hereby conflicts with any provision of any other Loan Document, the provision in the Loan Agreement shall control. 

Section 6.13    ENTIRE AGREEMENT. THIS AMENDMENT, THE LOAN AGREEMENT AND ALL OTHER LOAN DOCUMENTS EXECUTED AND
DELIVERED IN CONNECTION WITH AND PURSUANT TO THIS AMENDMENT AND THE LOAN AGREEMENT REPRESENT THE 

  
 5 

 
FINAL AGREEMENT BETWEEN THE PARTIES AND MAY NOT BE CONTRADICTED BY EVIDENCE OF PRIOR, CONTEMPORANEOUS, OR SUBSEQUENT ORAL AGREEMENTS OF THE PARTIES. THERE ARE NO UNWRITTEN ORAL AGREEMENTS BETWEEN
THE PARTIES. 
 [Signature Page Follows] 

  
 6 

 IN WITNESS WHEREOF, the parties hereto have caused this Limited Waiver and Second Amendment
to be duly executed and delivered as of the date first written above. 
  

			
	BORROWER:
	
	FUSE MEDICAL, INC.
		
	By:	 	 /s/ Christopher C. Reeg

	Name:	 	Christopher C. Reeg
	Title:	 	Chief Executive Officer
	
	BORROWER:
	
	CPM MEDICAL CONSULTANTS, LLC
		
	By:	 	 /s/ Christopher C. Reeg

	Name:	 	Christopher C. Reeg
	Title:	 	Chief Executive Officer
	
	LENDER:
	
	ZIONS BANCORPORATION, N.A. dba AMEGY BANK
		
	By:	 	 /s/ Olga Santiago

	Name:	 	Olga Santiago
	Title:	 	Vice President

 (Signature Page to Limited Waiver and Second Amendment) 

 
			
	GUARANTORS:
	
	NC143 FAMILY HOLDINGS LP
		
	By:	 	NC 143 Family Holdings GP LLC,
		 	General Partner of NC 143 Family
		 	Holdings LP
		
	By:	 	NC 143 Family Trust, Dated October 1,
		 	2014, as last amended, Manager of NC
		 	143 Family Holdings GP LLC
		
	By:	 	 /s/ Mark W. Brooks

	Name:	 	Mark W. Brooks
	Title:	 	Trustee of NC 143 Family Trust
		
	By:	 	 /s/ Penelope A. Brooks

	Name:	 	Penelope A. Brooks
	Title:	 	Trustee of NC 143 Family Trust
	
	MARK W. BROOKS
		
	By:	 	 /s/ Mark W. Brooks

 (Signature Page to Limited Waiver and Second Amendment)Exhibit 10.32

 

NOMINEE AGREEMENT

 

dated March 27, 2018

 

made by and among

 

CYTOVIA INTERNATIONAL LLC

 

and

 

NOVENTIA PHARMA SRL

 

regarding the

the European market authorizations
of Ceplene® and other products of Cytovia

 

     

     

    

 

Table of Contents

 

	1.	INTERPRETATION	1
	 	 	 
	2.	ENGAGEMENT	3
	 	 	 
	3.	PAYMENT	3
	 	 	 
	4.	CONFIDENTIALITY	4
	 	 	 
	5.	WARRANTIES	5
	 	 	 
	6.	LIABILITY AND INSURANCE	5
	 	 	 
	7.	COMPLIANCE WITH THE LAW	5
	 	 	 
	8.	FORCE MAJEURE	7
	 	 	 
	9.	ASSIGNMENT AND OTHER DEALINGS	7
	 	 	 
	10.	TERM	7
	 	 	 
	11.	TERMINATION	7
	 	 	 
	12.	NOTICES	9
	 	 	 
	13.	GOVERNING LAW AND ARBITRATION	9
	 	 	 
	14.	GENERAL PROVISIONS	10

 

     

     

    

 

This
nominee agreement ("Agreement") is as of the date mentioned on the first page but with retroactive effect as
of January 1, 2018, (“Effective Date”) and entered into by and among:

 

		(1)	Cytovia International LLC, a limited liability company validly existing and incorporated
under the laws of Switzerland, duly recorded with the register of commerce of the canton of Vaud under nr CHE-205.849.883, and
whose registered office is at route de Chenaux 9, 1091 Grandvaux, Switzerland (“Cytovia”)

 

and 

 

		(2)	Noventia Pharma SRL, a
                                         company validly existing and incorporated under the laws of Italy, duly recorded with
                                         the Camera di Commercio Industria Artigianato e Agricoltura di FORLI' - CESENA
                                         under nr FO - 317496, whose registered office is at Via Carlo Pisacane 31, 47121 Forli,
                                         Italy (“Service Provider”)

 

(Cytovia
and Nominee collectively “Parties” and individually each a “Party”)

 

 

 

RECITALS

 

		A.	Cytovia, a wholly owned subsidiary of Cytovia, Inc. (the “Parent”), has the
right to market and distribute the Products (as defined below) worldwide, being the owner or licensee of the Patents used in the
Products.

 

		B.	Cytovia through its Parent instructed the Nominee, who agreed, to acquire and register and accept
delivery in the name of the Nominee but in trust and on behalf of Cytovia and at the latter’s risk the Market Authorizations
(as defined below).

 

		C.	The Parties intend to transfer the Market Authorization to an Italian Affiliate of Cytovia to be
incorporated and to have the Nominee acting as nominee for Cytovia until such Affiliate is incorporated and until the Market Authorization
is transferred to said entity.

 

OPERATIVE
PROVISIONS

 

		1.	INTERPRETATION

 

		1.1.	In this Agreement:

 

“Affiliate” means
any person that directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control
with any other person. “Control” and, with correlative meanings, the terms “controlled by” and
“under common control with” shall mean ownership of at least 50% of voting securities together with the power
to direct or cause the direction of the management or policies of a person whether through the ownership of such voting securities,
by contract, resolution, regulation or otherwise;

 

    	 	1

    	 

    

 

“Business Day”
means any day other than a Saturday, Sunday or a public holiday in Forli (Italy) or Lausanne (Switzerland), on which the banks
in Forli and Lausanne are open for general business;

 

“Confidential Information”
means any information disclosed by or on behalf of one of the Parties to the other Party, its Affiliates or its or their Representatives
pursuant to or in connection with this Agreement (whether by oral, written, electronic or other form, and whether or not such information
is expressly stated to be confidential or marked as such);

 

“Effective Date”
means the date when Nominee was recoded as the holder of the Marketing Authorizations;

 

“FCPA” means
the US Foreign Corruption Practices Act 1977, the UK Proceeds of Crime Act 2000, the UK Bribery Act 2010 or any similar legislation
anywhere in the world, or the equivalent legislation in the Territory, each as amended from time to time;

 

“Field” means,
in relation to each Product, the treatment in humans of the field as set out in Schedule 1;

 

“Force Majeure”
means in relation to either Party any circumstances beyond the reasonable control of that Party;

 

“Intellectual Property
Rights” means patents, trademarks, service marks, trade names, internet domain names, rights in designs, copyright (including
rights in computer software and databases), database rights, moral rights, rights in know-how, utility models and other intellectual
property rights, in each case whether registered or unregistered and including any applications for the grant of any such rights
and all rights and forms of protection having an equivalent or similar effect anywhere in the world;

 

“Marketing Authorization(s)”
means, in relation to each Product, the authorization(s) from the relevant Regulatory Authority, required for the commercial marketing
and sale of that Product, in particular the so-called Autorizzazione all'lmmissione in Commercio or AIC received from the
Italian Regulatory Authority as further described in Schedule 1;

 

“Product(s)”
means the finished pharmaceutical product or products set out in Schedule 1 packaged and marketed under the relevant Trade Marks;

 

“Regulatory Authority”
means any competent government agency, regulatory authority or other administrative body responsible for granting any Marketing
Authorization in the Territory;

 

“Representatives”
means each of the parties or their Affiliates’ directors, officers, employees, agents or advisors;

 

“Territory”
means Italy and the other European Countries in which the Market Authorization has been recognized; and

 

“Trade Marks”
means, in relation to each Product, the trade mark registrations and applications of Cytovia and/or any of its Affiliates.

 

    	 	2

    	 

    

 

		1.2.	In this Agreement, unless the context otherwise requires:

 

		(a)	references to “persons” includes individuals,
bodies corporate (wherever incorporated), unincorporated associations and partnerships;

 

		(b)	the headings are inserted for convenience only and do not affect the construction of the Agreement;

 

		(c)	words denoting the singular shall include the plural and
vice versa;

 

		(d)	a “Party” includes a reference to that Party’s
successors and permitted assigns; and

 

		(e)	any reference to an enactment or statutory provision is a reference to it as it may have been, or may from time to time be
amended, modified, consolidated or re-enacted.

 

		1.3.	The Schedules comprise part of and shall be construed in accordance with the terms of this Agreement.
In the event of any inconsistency between the Schedules and the terms of this Agreement, the terms of this Agreement shall prevail.

 

		2.	ENGAGEMENT

 

		2.1.	Nominee acknowledges and agrees that it has acquired and has registered and has accepted delivery
in the name of the Nominee but in trust and on behalf of Cytovia and at the latter’s risk the Market Authorizations that
are listed in Schedule 1.

 

		2.2.	The beneficial ownership of the said Market Authorizations held by the Nominee and registered under
its name in its capacity as nominee of Cytovia shall belong to Cytovia.

 

		2.3.	Upon first request of Cytovia, the Nominee shall assign to Cytovia or to any other person designated
by Cytovia, including to any Affiliate, the Market Authorizations listed in Schedule 1 and all rights appertaining thereto.

 

		3.	PAYMENT.

 

		3.1.	At signing, Cytovia shall pay a one-time startup fee of EUR 4,000.-. Cytovia shall then pay to
the Nominee a quarterly fee in the amount of 4,000 (four thousand) EUR as of the Effective Date. Cytovia shall also pay to the
Nominee any and all reasonable out-of-pocket costs and expenses of Nominee incurred in connection with providing services hereunder
provided that appropriate documentation is provided to verify such expenses.

 

		3.2.	All sums payable under this Agreement are exclusive of Italian Value Added Tax and any other duty
or tax, which shall (if and to the extent applicable) be payable in addition by Cytovia. All invoices and payments hereunder shall
be denominated in EUR. Payments hereunder shall be made by such means as is agreed between the Parties, but in any event within
30 days from receipt of the invoice.

 

    	 	3

    	 

    

 

		4.	CONFIDENTIALITY

 

		4.1.	Each Party agrees and undertakes that it will treat and
keep confidential all Confidential Information of the other party which may become known to that party.

 

		4.2.	Each Party shall:

 

		(a)	not disclose any Confidential Information of the other Party to any person other than any of its
Representatives who need to know such information in order to implement the provisions of this Agreement;

 

		(b)	not use any Confidential Information of the other Party other than for the purpose of complying
with its obligations under, or to enjoy the benefits of, this Agreement; and

 

		(c)	procure that any person to whom any Confidential Information of the other Party is disclosed by
it complies with the restrictions contained in this clause 4.

 

		4.3.	The confidentiality obligations contained in this Agreement
shall not apply to the extent that such Confidential Information is:

 

		(a)	at the time of disclosure by one Party to the other in the public domain or otherwise publicly
known;

 

		(b)	after disclosure by one Party to the other becomes part of the public domain, other than by breach
of any obligation of confidentiality; or

 

		(c)	information which the receiving Party can establish by documentary evidence was already in its
possession at the time of receipt and was independently developed by the receiving Party without use of the Confidential Information
of the disclosing party.

 

		4.4.	Notwithstanding clause 4.1, the Party receiving Confidential
Information may disclose such Confidential Information:

 

		(a)	to Regulatory Authorities or other government agencies to gain approval to conduct clinical trials
in relation to the Product or to file, prosecute and maintain any Approval, provided that the disclosure is limited to the extent
reasonably necessary to obtain such;

 

		(b)	to the extent that such disclosure is required by any applicable law, regulation, court of competent
jurisdiction or governmental authority, provided that the Confidential Information is disclosed only to the extent required and
the Party to which such Confidential Information relates has been given sufficient prior written notice to enable it to seek protection
or confidential treatment of such Confidential Information.

 

		4.5.	The restrictions contained in this clause 4 shall continue
to apply after termination of this Agreement without limit in time.

 

    	 	4

    	 

    

 

		5.	WARRANTIES

 

		5.1.	Cytovia and the Nominee each represent, warrant and undertake
that:

 

		(a)	it is a validly existing corporation, in good standing under the laws of the jurisdiction of its
incorporation and has the corporate power and authority to enter into and perform its obligations under this Agreement;

 

		(b)	it has obtained all necessary corporate authorizations required to enter into and perform its obligations
under this Agreement;

 

		(c)	it is not under any obligation to any person, contractual or otherwise, that conflicts with
the terms of this Agreement: and

 

		(d)	this Agreement constitutes a legal, valid and binding obligation on it and is enforceable against
it in accordance with its terms.

 

		5.2.	The Nominee represents, warrants and undertakes to maintain in its employment, or will otherwise
arrange that such resources will be available to it, personnel, equipment and facilities sufficient in number and adequate in ability
to perform the services hereunder to Cytovia.

 

		6.	LIABILITY AND INSURANCE

 

		6.1.	Cytovia is entitled to compensation for the damage resulting from the Nominee’s breach of
any of its obligations under this Agreement provided that the Nominee could reasonably have foreseen such damage as a possible
consequence of the breach, unless the Nominee proves that the breach was due to an impediment beyond its control.

 

		6.2.	The Nominee shall maintain, at its own cost, comprehensive civil liability insurance and general
commercial liability insurance with respect to the Services - which include clinical trial insurance and clinical insurance - in
such amount as the Nominee customarily maintains with respect to its other services and which is reasonable and customary in the
pharmaceutical industry for companies of comparable size and activities, but in any event not less than USD 2 million to USD 5
million per occurrence or series of related occurrences. The Nominee shall maintain such insurance policy for not less than 6 years
following the expiry or termination of this Agreement. The Nominee shall provide Cytovia with a copy of such certificate promptly
on request.

 

		7.	COMPLIANCE WITH THE LAW

 

		7.1.	The Nominee represents, warrants and undertakes that:

 

		(a)	it is in compliance with the laws, rules and regulations of the Territory applicable to the performance
of its obligations under this Agreement as well as the laws of any other country that are applicable to the performance of such
obligations;

 

    	 	5

    	 

    

 

		(b)	in the course of performance of its obligations and performance of the Services, it shall continue
to comply in full (and shall ensure that all Affiliates and Representatives shall comply in full) with all applicable legislation,
rules and regulations (including tax and exchange control laws) of the Territory in which such performance takes place;

 

		(c)	it is not, and will not become, a party to any other agreement or under any obligation to, or restriction
by, any third party which would prevent the Nominee from entering into this Agreement or which would adversely affect this Agreement,
the performance of the services or any of the undertakings set out herein in any manner;

 

		(d)	it has not directly or indirectly made, and will not directly or indirectly make, any payment of,
or authorization or offer to pay, any money or anything of value to a foreign official, political party or candidate for the purpose
of securing an improper advantage. For the avoidance of doubt, doctors, hospital administrators and other persons at government-run,
government-owned or government-controlled hospitals are public officials;

 

		(e)	neither the Nominee nor any owner, partner, officer, director or employee of Nominee (or of any
Affiliate) is or will become a public official during the term of this Agreement without the prior written consent of Cytovia.
The Nominee shall upon Cytovia’s request, provide Cytovia with a list of all shareholders, and shall inform Cytovia immediately
in the event of any change of ownership or transfer of control of the Nominee takes place during the term of this Agreement; and

 

		(f)	in the course of performance of its obligations hereunder and performance of the transactions contemplated
hereunder, it complies with the Cytovia ethics standards.

 

		7.2.	Cytovia shall not be obligated under this Agreement to take any action or omit to take any action
that it believes, in good faith, would cause it to be in violation of any laws of the Territory or any other applicable jurisdiction.

 

		7.3.	The Nominee agrees from time to time, upon reasonable request, to provide Cytovia with information
on Nominee's business, its company structure, statutory accounts, shareholders and similar such information.

 

		7.4.	For the purposes of ensuring compliance
                                         with the FCPA, the Nominee agrees that, upon request by Cytovia during the Term of this
                                         Agreement the Nominee shall make available for an audit to be performed by a recognized
                                         Chartered Public Accountant (“CPA”) designated by Cytovia, the Nominee's
                                         books, records and other documentation relevant to its business activities conducted
                                         pursuant to this Agreement. The CPA firm shall provide to Cytovia information obtained
                                         from such review that relates to a possible violation of the FCPA or of the above representations,
                                         warranties and undertakings. Cytovia shall pay all costs of any such requested audit,
                                         unless such review uncovers any violation of the FCPA or of the above representations,
                                         warranties and undertakings, in which case, Nominee shall pay all costs of such audit.

 

		7.5.	The Nominee shall comply with, and shall procure compliance with, all applicable national and local
laws, rules, regulations, industry standards, codes of practice and best practice including, without limitation the requirements
of any Market Authorization in the Territory.

 

    	 	6

    	 

    

 

		8.	FORCE MAJEURE

 

		8.1.	Subject to clause 8.2, neither Party shall be liable to the other under this Agreement for any
loss or damages attributable to an event of Force Majeure, provided the Party affected shall give prompt notice thereof to the
other Party and the nature and extent of the circumstances giving rise to the event of Force Majeure. Subject to clause 8.2, the
Party giving such notice shall be excused from such of its obligations hereunder for so long as it continues to be affected by
Force Majeure.

 

		8.2.	If such event of Force Majeure continues unabated for a period of 90 days, the Parties will meet
to discuss in good faith what actions to take or what modifications should be made to this Agreement as a consequence of such event
of Force Majeure in order to alleviate its consequences on the affected Party. If the event of Force Majeure in question prevails
for a continuous period in excess of 120 days after the date on which the event of Force Majeure begins, the non-claiming Party
shall be entitled to give notice to terminate this Agreement. The notice to terminate must specify the termination date, which
must be not less than 30 clear days after the date on which the notice to terminate is given. Once a notice to terminate has been
validly given, the Agreement will terminate on the termination date set out in the notice. Neither Party shall have any liability
to the other in respect of termination of this Agreement due to Force Majeure, but rights and liabilities which have accrued prior
to termination shall subsist.

 

		9.	ASSIGNMENT AND OTHER DEALINGS

 

		9.1.	The Nominee shall not, nor shall it purport to, assign, transfer or charge any of its rights or
obligations under this Agreement.

 

		9.2.	Cytovia shall be entitled at any time to assign, transfer or charge all or any of its rights or
obligations under this Agreement to an Affiliate or any third party.

 

		10.	TERM

 

		10.1.	This Agreement shall enter into force as of the Effective Date and shall remain in force until
and as long the Nominee holds the Marketing Authorizations in trust and for the account of Cytovia or any of its Affiliates. It
shall automatically expire when the Nominee transfer the Market Authorization to Cytovia or any of its Affiliate pursuant to clause
2.3.

 

		11.	TERMINATION

 

		11.1.	Notwithstanding any other term of this Agreement, either Party shall be entitled to terminate this
Agreement on the date specified in any notice to the other if:

 

		(a)	the other Party commits a material or persistent breach
of any obligation under this Agreement and, in the case of a breach which is capable of remedy, fails to remedy it within 30 days
of receipt of notice from the first Party of such breach and of its intention to exercise its rights under this clause;

 

    	 	7

    	 

    

 

		(b)	a petition is presented, or a meeting is convened for the purpose of considering a resolution,
or other steps are taken, for making an administration order against or for the winding up of the other party or an administration
order or a winding up order is made against or a provisional liquidator is appointed with respect to the other party;

 

		(c)	an encumbrancer takes possession of, or a trustee or administrative receiver or similar officer
is appointed in respect of, all or any material part of the business or assets of the other Party, or distress or any form of execution
is levied or enforced upon or sued out against any such assets and is not discharged within 14 Business Days of being levied, enforced
or sued out;

 

		(d)	the other Party is unable to pay its debts or becomes unable to pay its debts as they fall due
or suspends or threatens to suspend making payments with respect to all or any class of its debts;

 

		(e)	the other Party proposes or makes any composition or arrangement or composition with, or any assignment
for the benefit of, its creditors;

 

		(f)	anything analogous to any of the events described in clauses 11.1(b) - 11.1 (e), inclusive, occurs
under the laws of any applicable jurisdiction; or

 

		(g)	the other Party ceases or threatens to cease to carry on the whole or any material part of its
business.

 

		11.2.	Cytovia shall be entitled to terminate this Agreement with immediate effect on the date specified
in any notice if:

 

		(a)	there is at any time, a material change in the management, ownership or control of the Nominee;

 

		(b)	the Nominee or any Affiliate or any third party directly or indirectly challenges or disputes the
validity or enforceability of any Intellectual Property Rights relating to any Product (or assists any third party to challenge
or dispute the validity or enforceability of such Intellectual Property Rights);

 

		(c)	in the event that any Regulatory Authority requires a change to any Product Specification, Cytovia,
in its absolute discretion, determines such change would result in a change to the manufacturing process for the relevant Product;

 

		(d)	for any reason any Approval lapses or is revoked by any Regulatory Authority in the Territory;

 

    	 	8

    	 

    

 

		(e)	the Nominee or any of its Affiliates
                                         or their respective Representatives (“Nominee Parties”) is or Cytovia
                                         becomes aware of any activity by any Nominee Party that involves or relates to or is
                                         accused of fraud, dealing with the proceeds of crime, bribery, corruption or any other
                                         similar matter or circumstance (including an accusation or investigation under the FCPA).

 

		11.3.	The termination or expiry of this Agreement shall not release either of the Parties from any liability
which at the time of termination or expiry has already accrued to the other Party, nor affect in any way the survival of any other
right, duty or obligation of the Parties which is expressly stated elsewhere in this Agreement to survive such termination or expiry.

 

		12.	NOTICES

 

		12.1.	Any notice given under this Agreement shall be in writing and hand delivered or sent by registered
or recorded delivery post or fax (fax notice to be confirmed by letter posted within 12 hours of transmission) to the address of
the other party as set out below (or such other address as may have been notified in writing to the other party), and any such
notice shall be deemed to have been served at the time of deliveiy (if delivered by hand) or upon the expiration of 48 hours after
posting (if sent by post) or upon the expiration of 5 Business Days after posting (if sent by post to an overseas address) or upon
receipt of confirmation of successful transmission by the senders fax (if sent by fax).

 

	To Cytovia	To the Nominee
	 	 
	Address:	Address:
	 	 
	route de Chenaux 9	Via Carlo Pisacane 31
	1091 Grandvaux	47121 Forli
	Switzerland	Italy
	 	 
	Fax/Email	Fax/Email
	 	 
	Attention:	Attention:

 

		12.2.	All notices under or in connection with this Agreement shall be in the English language or, if
in any other language, accompanied
by a translation into English. In the event of any conflict between the English text and the text in any other language, the English
text shall prevail.

 

		13.	GOVERNING LAW AND ARBITRATION

 

		13.1.	This Agreement shall in all respects be governed by and construed in accordance with material Swiss
law.

 

    	 	9

    	 

    

 

		13.2.	Any dispute, controversy or claim arising out of or in connection with this Agreement, including
its conclusion, existence, validity, binding effect, amendment, breach, termination or rescission shall be resolved by arbitration
in accordance with the Arbitration Rules of the International Chamber of Commerce in force on the date when the Notice of Arbitration
is submitted in accordance with these Rules. The seat of arbitration shall be Geneva and the arbitral proceedings shall be conducted
in English. The arbitration shall be conducted by one or more arbitrators who must be experienced in the pharmaceutical business.

 

		14.	GENERAL PROVISIONS

 

		14.1.	No variation to this Agreement shall be valid unless in writing and signed on behalf of each Party
by a director or other authorized person.

 

		14.2.	If at any time any provision of this Agreement or any part thereof is or becomes invalid or unenforceable,
then neither the validity nor the enforceability of the remaining provisions or the remaining part of the provision shall in any
way be affected or impaired thereby. The Parties agree to replace the invalid or unenforceable provision or part thereof by a valid
or enforceable provision which shall best reflect the Parties' original intention and shall to the extent possible achieve the
same economic result.

 

		14.3.	Failure by either Party on one or more occasions to avail itself of a right conferred by this Agreement
shall not be construed as a waiver of such Party’s right to enforce such right or any other right.

 

		14.4.	This Agreement contains the entire agreement and understanding between the Parties and supersedes
all previous agreements and understandings between the parties with respect to the subject matter of this Agreement. Each Party
acknowledges that, in entering into this Agreement, it does not do so on the basis of and does not rely on any representation or
warranty (whether made orally or in writing) except as expressly provided in this Agreement.

 

		14.5.	Nothing in this Agreement is deemed to constitute a partnership between the Parties nor constitute
any Party the agent of the other Party for any purpose.

 

		14.6.	The rights and remedies of each of the Parties under or pursuant to this Agreement are cumulative,
may be exercised as often as such Party considers appropriate and are in addition to its rights and remedies under general law.

 

		14.7.	Each of the Parties shall do execute and perform and shall procure to be done executed and performed
all such further acts deeds documents and things as the other Party may reasonably require from time to time to give full effect
to the terms of this Agreement.

 

		14.8.	This Agreement may be executed in any number of counterparts and by the Parties to it on separate
counterparts, each of which is an original but all of which together constitute one and the same instrument. Signatures to this
Agreement transmitted by fax, email in “portable document format” or by any other electronic means, intended to preserve
the original graphic or pictorial appearance of the Agreement, shall have the same effect as the physical delivery of the paper
Agreement bearing the original signatures.

 

    	 	10

    	 

    

 

IN WITNESS WHEREOF, the Parties have signed this Agreement
on the date first written above

 

	For Cytovia International LLC:	For Noventia Pharma SRL:

 

	By:	/s/ Olivier Cherpillod	 	By:	/s/ Massimo Radaelli
	Names:	Olivier Cherpillod	 	Names:	Massimo Radaelli
	Names:	Attorney	 	Names:	President & CEO

 

    	 	11

    	 

    

 

SCHEDULE 1

 

Products, Field, Market Authorization references

 

	PRODUCT	 	FIELD	 	MARKET AUTHORIZATION
	Ceplene® (histamine dihydrochloride)	 	Oncology	 	
        Italian AIC #: 040656011

         

        European Drugs Community Register 

No.: EU/1/08/477/001

 

    	 	12

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00289-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00289-of-00352.parquet"}]]