Exhibit 10.1


 


CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD
BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.


 


Second
AMENDMENT TO

License AGREEMENT


 


THIS
Second AMENDMENT (this “Second Amendment”) to the License Agreement
dated April 6, 2018, by and between Novartis Pharma AG, a Swiss corporation (“Novartis”), and Allarity Therapeutics
Europe ApS (formerly known as Oncology Venture ApS), a company organized under the laws of Denmark, with headquarters at Venlighedsvej
1, DK-2970 Hoersholm, Denmark, and a wholly-owned subsidiary of Allarity Therapeutics, Inc. (Delaware, U.S.A.) (“Allarity”)
as amended by that certain First Amendment to License Agreement effective as of March 30, 2022 (such agreement as amended, the “Agreement”),
is entered into by and between Novartis and Allarity as of September 27, 2022 (the “Second Amendment Execution Date”)
and shall be effective on the Second Amendment Effective Date (as defined below). In this Second Amendment, Novartis and Allarity each
may be referred to individually as a “Party” and together as the “Parties.”


 


WHEREAS,
Allarity has achieved the Milestone Event for submission of the first NDA with the FDA for a Licensed Product in the United States which
triggers a [***] Dollars (US$[***]) Milestone Payment to Novartis (the “Outstanding Milestone Payment”);


 


Whereas,
Novartis submitted Invoice No. 90465316 to Allarity on January 31, 2022 (the “Invoice Date”) for payment of the Outstanding
Milestone Payment, which payment has not yet been made by Allarity;


 


Whereas,
from the Invoice Date to the the Second Amendment Execution Date, the Parties have been in continuous negotiations regarding restructuring
of the Outstanding Milestone Payment to Novartis;


 


Whereas,
the Parties desire to amend the terms of the Agreement and that certain Promissory Note dated April 6, 2018, issued by OV-SPV2 ApS (now
Allarity Therapeutics Denmark ApS), a company organized under the laws of Denmark in favor of Novartis, in order to alter the terms and
timing of the Outstanding Milestone Payment;


 


WHEREAS,
the Parties therefore desire to amend the Agreement as set forth herein.


 


NOW,
THEREFORE, for good and valuable consideration, the receipt and consideration is hereby acknowledged, and intending to be legally
bound hereby, the Parties agree as follows:


 


		1.	Defined
                                            Terms. All capitalized terms used but not defined herein shall have the same meaning
                                            as set forth in the Agreement.



  


		2.	Effectiveness.
                                            This Second Amendment shall become effective only upon receipt by Novartis of the First Portion
                                            of Outstanding Milestone Payment (as defined below) from Allarity (such date, the “Second
                                            Amendment Effective Date”). If Novartis has not received the First Portion of Outstanding
                                            Milestone Payment within three (3) Business Days of the Second Amendment Execution Date
                                            then this Second Amendment shall be automatically be deemed to have been terminated and shall
                                            have no force or effect.



  






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		3.	Definitions.
                                            Clause 1.1 of the Agreement is hereby amended to include the following definitions:



  


“Financing
Transaction” means the incurrence by Allarity or any of its Affiliates of any indebtedness to, or any investment, financing,
or funding arrangement with, any Third Party, or the issuance, sale, pledge, or encumbrance of any capital stock or other debt or equity
securities (or rights to acquire any capital stock or other debt or equity securities) to any Third Party”.  Provided that,
a Financing Transaction shall not include any restructuring of Allarity’s existing investment financing agreements with 3i, LLP
(New York, NY).


 


“Phase
1 Clinical Trial” means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect
of a product or that would otherwise satisfy the requirements of 21 C.F.R. 312.21(a) or an equivalent clinical trial in a country other
than the United States.


 


“Phase
1b/2 Clinical Trial” means a human clinical trial of a product as a single agent or in combination for any indication that
(a) is intended for dose exploration, examination of pharmacological or clinical activity (including dose response, dose escalation,
duration of effect or kinetic/dynamic relationship assessments) and preliminary determination of efficacy and safety in the target patient
population, and (b) contains a sufficient number of well characterized and clinically uniform subjects for the applicable indication
using a pre-specified and uniform dose, or, if in combination, a fixed combination regimen, to assess the response rate and safety of
the investigational agent(s). The distinction between the Phase 1b and Phase 2 portion of the trial will be designated in the protocol
(examples including, but not exclusive of, the time when ineffective doses are dropped, a standard or care/comparator group is introduced
or the sample size of the responding cohorts is increased as a result of the observed response rate from the Phase 1b portion to confirm
the robustness of the result and/or further characterize safety.


  


		4.	Sublicensing.
                                            Clause 2.2(a) of the Agreement is hereby amended to add the following sentence to
                                            the end of such Clause:



  


“For
the avoidance of doubt, Allarity shall not be permitted to sublicense any rights granted to it under Clause 2.1 of this License Agreement
prior to completion of such Phase II Clinical Trial without the prior written consent of Novartis.”


  






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		5.	Milestone
                                            Payments. Clause 7.2 of the Agreement is hereby superseded and replaced in its
                                            entirety with the following:



 


7.2
Milestone Payments. In further consideration for the licenses and rights granted to Allarity hereunder, Allarity shall pay to
Novartis the following Milestones upon achievement of the respective Milestones events as set forth below, in each case related to
the Development of the Compound in the Field in the Territory, by Allarity or on behalf of Allarity, itself or through any of its
Affiliates or sublicensees, the corresponding one-time, non-refundable, non-creditable payments (“Milestone
Payments”):


 


	 	Milestone
    Event	Milestone
    Payment (US$)
	1	Upon
    the earlier of (i) enrollment of half of the patients required in the planned Phase 2 portion of a first Phase 1b/2 Clinical
    Trial for a Licensed Product; (ii) 2 years following start of First Patient First Visit of the first planned Phase 1b/2 Clinical
    Trial for the Licensed Product; or (iii) the conversion of any first Phase 1b/2 Clinical Trial to a Phase 2 Clinical Trial.	[***]
    United States Dollars (US$[***])

     

	2	Upon
    dosing of the first patient in the first Phase III Clinical Trial for a Licensed Product.	[***]
    United States Dollars (US$[***])
	3	Upon
    submission of the first NDA with the FDA for a Licensed Product in the United States.	[***]
    United States Dollars (US$[***]) (the “Outstanding Milestone Amount”) to be paid as follows:

                                                                                                                                                                    

    ●     [***]
    United States Dollars (US$[***]) on the Second Amendment Execution Date (the “First Portion of Outstanding Milestone Payment”)

    ●     [***]
    United States Dollars (US$[***]) by December 31, 2022 (the “Second Portion of Outstanding Milestone Payment”)

    ●     [***]
    United States Dollars (US$[***]) by April 1, 2023 (the “Third Portion of Outstanding Milestone Payment”)

    ●     [***]
    United States Dollars (US$[***]) by July 15, 2023 (the “Fourth Portion of Outstanding Milestone Payment”)

	4	Submission
    of a first MAA to the EMA or any other Regulatory Authority for a Licensed Product in the Main European Countries	[***]
    United States Dollars (US$[***])
	5	Upon
    receipt of the first authorization for a Licensed Product by the FDA in the United States to market and sell such Licensed Product
    (but explicitly excluding any pricing or reimbursement approvals).	[***]
    United States Dollars (US$[***])
	6	Upon
    receipt of a first MAA (including a respective pricing and reimbursement approval) for a Licensed Product in one or more countries
    belonging to the Main European Countries	[***]
    United States Dollars (US$[***])


 






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If
Milestone Events 4 or 5 in the foregoing table occur before (or without) the occurrence of a Milestone Event higher in the foregoing
table (i.e., Milestone Events 1 or 2, as the case may be), then all payments corresponding to Milestone Events 1 or 2 above and not yet
paid shall be paid simultaneously with the Milestone Payment for Milestone Events 4 or 5.


 


		6.	Payment
                                            of Milestones. Clause 7.3 of the Agreement is hereby superseded and replaced in
                                            its entirety with the following:



  


7.3
Payment of Milestones.


 


(a)
Each Milestone shall be deemed earned as of the first achievement of the respective Milestone event, and, except with respect to
Milestone Event 3, is payable one time only regardless of the number of Licensed Products (provided that, Milestone Event 3 is also
only payable for the first Licensed Product). Subject to this Clause 7.3, from and after the date of any notice of termination by
Novartis according to Clause 14.3(a) is received by Allarity, no further milestones with respect to the Licensed Product shall be
payable by Allarity to Novartis, except to the extent those Milestone Payments relate to Milestones that have been achieved prior to
Allarity’s receipt of the termination notice which are unpaid.


 


(b)
Notwithstanding anything in this Agreement to the contrary, upon Allarity or any of its Affiliates entering into a Financing
Transaction, the Milestone Payment for Milestone Event 3 shall be accelerated as follows:


     


(i) if the Financing
Transaction is less than [***] United States Dollars (US$[***]) then [***] percent ([***]%) of the gross amount raised in such Financing
Transaction shall be immediately due and payable to Novartis;


 


(ii) if
the Financing Transaction is greater than or equal to [***] United States Dollars (US$[***]) but less than [***] United States Dollars
(US$[***]) then the Second Portion of Outstanding Milestone Payment and the Third Portion of Outstanding Milestone Payment, if not
already paid, shall be immediately due and payable to Novartis;


 


(iii) if
the Financing Transaction is greater than [***] Million United States Dollars (US$[***]) then the Second Portion of Outstanding Milestone
Payment, Third Portion of Outstanding Milestone Payment and Fourth Portion of Outstanding Milestone Amount, if not already paid, shall
be immediately due and payable to Novartis.


 


(c)
For the avoidance of doubt, in no event shall the sum of all payments in respect of Milestone Event 3 exceed the Outstanding
Milestone Amount.


  


		7.	Applicable
                                            Law. The interpretation and performance of this Second Amendment shall be governed by,
                                            construed and enforced in accordance with the laws of the State of New York without giving
                                            effect to any choice of law rules that would cause the application of laws in any jurisdiction
                                            other than those of the State of New York.



  


		8.	Other
                                            Terms. All other terms of the Agreement shall remain in full force and effect. To the
                                            extent any provision of the Agreement conflicts with any provision of this Second Amendment,
                                            this Second Amendment will control.



  


		9.	Counterparts.
                                            This Second Amendment may be executed in multiple counterparts, all of which shall be considered
                                            one and the same agreement. The Parties recognize the use of simple electronic signatures
                                            (e.g. DocuSign) as legally valid and binding for this Second Amendment, unless applicable
                                            laws mandates any other form of execution.



 


[Remainder
of Page Intentionally Left Blank]


  



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IN
WITNESS WHEREOF, the Parties have caused this Second Amendment to the Agreement to be executed by their duly authorized representatives.


 


	NOVARTIS
    Pharma AG	 	Allarity
    Therapeutics Europe
	 	 	ApS
    (f/k/a Oncology Ventures ApS)
	 	 	 
	Signature:	/s/ Guillaume Vignon
		Signature:	/s/ James G. Cullem, J.D.

	Name:	Guillaume Vignon
	 	Name: 	James G. Cullem, J.D.

	Title:	Global Head of BD&L Partnering
	 	Title:	Chief Executive Officer

	Date:	09/28/22
	 	Date:	September 27, 2022



  


	NOVARTIS
    PHARMA AG	 
	 	 
	Signature:	/s/ Sven Werner
	 
	Name:	Sven Werner
	 
	Title:	Gbl BD&L Exec Dir Divestment & Outlicensing
	 
	Date:	09/28/2022	 


  


[Signature
Page to Second Amendment to License Agreement]


 


 


 


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