Exhibit 10.4 


 


This DEVELOPMENT
COLLABORATION Agreement (the "Agreement") dated as of September
30, 2016 (the "Effective Date") is entered into by and between Moleculin Biotech, Inc. ("MBI"),
a Delaware corporation, having a business address of 2575 West Bellfort Dr., Suite 333, Houston, TX 77054 and Dennin
Sp. z o. o. a limited liability company having a principal place of business located at PL-00-116 Warszawa, ul. Switokrzyska 30/63,
Poland ("Dermin"). MBI and Dermin are sometimes referred to herein
individually as a "Party" and collectively as the "Parties."


  





RECITALS


 


WHEREAS,
Dermin and AnnaMed have entered into an
Original License Agreement, and;


 


WHEREAS,
MBI acquired from AnnaMed
all the rights and responsibilities of the Original License Agreement, and;


 


WHEREAS, Dermin
has rights to Annamycin API and Annamycin DP currently held at Symbiosis Facilities, and;


 


WHEREAS,
Dermin now wishes to engage MBI manage
the use of Annamycin API and Annamycin DP in order to conduct human Clinical Trials, and;


 


WHEREAS,
consistent with the Original License Agreement, the Parties wish to share rights to any and all Development Data that may result
from human Clinical Trials;


 


NOW,
THEREFORE, in consideration of the covenants, conditions and agreements hereinafter set forth,
and other valuable consideration, the receipt and sufficiency of which is hereby acknowledged,
MBI and Dermin hereby agree as follows:


 


ARTICLE
1 

DEFINITIONS


 


1.1       "Affiliate"
means with respect to a Party, any entity that, directly
or indirectly, through one or more intermediaries, controls,
is controlled by, or is under common control with, such Party. For purposes of this definition, "control"
of a business entity means the direct or indirect ownership of at least fifty (50%) ownership
interests in such entity.


 


1.2       "
Annamed" means Annamed, Inc, a former Texas corporation which has since merged
with and into MBI.


 


1.3       "Annamycin"
means the drug named Annamycin in the Original License Agreement.


 


 1.4        "Annamycin API" means the Annamycin active pharmaceutical ingredient.




 


1.5       "Annamycin
DP" means Annamycin API converted into a finished drug product for use in humans.




    1/7


     


    

  


1.6       "Assignment"
means the Assignment of the Original License Agreement dated April 20, 2016,
pursuant to which MBI assumed all of the rights, obligations and covenants of Annamed under the Original License Agreement.


 


1.7       "Clinical
Trials" means any investigation in human subjects
intended to discover or verify the clinical, pharmacological , and/or
other pharmacodynamic effects of Licensed Product, and/or to identify any adverse reactions to Licensed Product,
and/or to study absorption, distribution, metabolism,
and excretion of Licensed Drug Product with the object of ascertaining its safety and/or efficacy for purposes of obtaining regulatory
approval to commercialize and market the Licensed Drug Product.


 


1.8       "Commercially
Reasonable Efforts" means, with respect to the
applicable goal or objective hereunder, the efforts, consistent
with the practice of comparable pharmaceutical development companies with respect to a comparable pharmaceutical product owned
by it or to which it has rights of comparable market potential at a similar stage in its product life (taking into account the
competitiveness of the marketplace, the proprietary position of the applicable active ingredient, the regulatory structure involved),
that a reasonable person in the position of the obligor would use so as to achieve that goal
or objective as expeditiously as possible.


 


1.9       "Development
Data" shall be any data, information or know-how resulting from Clinical Trials in humans,
whether conducted by either MBI or
Dermin using Dermin ' s
Annamycin DP.


 


1.10       "Governmental
Authority " means within the Licensed Territory
any (i) federal, state or local government; (ii) court,
arbitral or other tribunal or governmental or quasi governmental authority of any nature (including
any governmental agency, political subdivision, instrumentality,
branch department, official, or
entity); or (iii) body exercising , or entitled to exercise,
any administrative, executive,
judicial, legislative,
police, regulatory, or
taxing authority or power of any nature pertaining to government.


 


1.11       ''New
Intellectual Property" means new patententable subject
matter relating to Annamycin (including but not limited to that which may result from the use of the activities undertaken pursuant
to this Agreement), which is not already covered by the Original License Agreement.


 


1.12       "Laws"
means all applicable laws, rules, regulations, judgments,
orders, subpoenas, decrees, statutes, ordinances and other
requirements of any Governmental Authority or instrumentality within the Licensed Territory.


 


 1.13        "MBI" is as defined in the Header of this Agreement.




 


1.14       ''New
Intellectual Property" means patent or technology
rights developed by MBI relating to the composition of matter, formulation, delivery
and use of Annamycin.


 


1.15       "Original
License Agreement" means the Patent and Technology Development and License Agreement dated June 28,
2012 by and between Annamed and
Dermin, which agreement
has been assigned by Annamed to MBI pursuant to the Assignment.




    2/7


     


    

 


 


1.16       "Symbiosis"
means Symbiosis Pharmaceutical Services, company existing under the Laws of Scotland, having
an address at Stirling Innovation Park, Stirling, FK9 4NF, Scotland, UK.


 


1.17       "Symbiosis
Facilities" means any facility holding Dermin's supply of Annamycin API and Annamycin DP in the custody of Symbiosis.


 


1.18
       "Term" us as defined in Section 5.1 of
this Agreement.




 


ARTICLE
2

 ENGAGEMENT


 


2.1       Subject
to the terms and conditions of this Agreement, Dermin and MBI hereby mutually agree that MBI shall manage the conversion of existing
Annamycin API into Annamycin DP and the use of Annamycin DP in Clinical Trials in humans.


 


2.2       Subject
to the terms and conditions of this Agreement and consistent with the Original License Agreement, the Parties hereby agree that
Development Data shall be shared upon advanced written notice of the requesting Party.


 


ARTICLE
3 

DEVELOPMENT OBLIGATIONS


 


3.1       MBI
shall be solely responsible for any and all costs and expenses related to the exercise of its rights under Article 2 of this Agreement,
including, without limitation, any and all costs and expenses associated with the conversion of the Annamycin API into Annamycin
DP and the development and design of and conducting Clinical Trials.


 


3.2       MBI
hereby agrees to use Commercially Reasonable Efforts to develop, design and conduct Clinical Trials of Annamycin DP with the intent
to obtain regulatory approval under applicable Laws to commercialize and market Annamycin in the United States and Europe.


 


3.3       Dennin
hereby agrees to contract Davos Pharma to convert Annamycin API into Annamycin DP in a manner consistent with the arrangements
and procedures currently


established between
Dennin and Davos Pharma and to direct Davos Pharma to provide Annamycin for use in Clinical Trials as directed by MBI.


 


ARTICLE 4


DATA
AND INTELLECTUAL PROPERTY


 


4.1       Any
and all data generated from the use of Annamycin API and Annamycin DP by a Party shall be the property of that Party, provided
however, the other Party shall have the right to use such data subject to the confidentiality provisions set forth in Article 7
of this Agreement.


 


4.2       Any
New Intellectual Property shall be the property of MBI, provided however, that Dermin shall have an option to license New Intellectual
Property under the terms and conditions
set forth in the Original License Agreement. Dermin shall exercise its option under this Section 4.2 by written notice to MBI.




    3/7


     


    

  


ARTICLE
5 

TERMINATION


 


5.1       This
Agreement will become effective as of the Effective Date and will continue until 7 years, unless this Agreement is terminated earlier
pursuant to this Article 4 (the "Term").


 


5.2       If
either Party is in material breach of any of its obligations contained in this Agreement, the other Party, if it is not
also in material breach hereunder, will be entitled to give to the Party in material breach written notice specifying the nature
of such breach and requiring it to cure such breach, to the extent such breach is curable. If such breach is not cured within sixty
(60) Business Days after the receipt of such notice, or at the time of such notice is delivered if such breach is not curable,
the notifying Party will be entitled, without prejudice to any of its other rights conferred on it by this Agreement, and in addition
to any other remedies available to it at law or in equity, to terminate this Agreement by giving written notice, to take effect
immediately upon delivery of such notice.


 


5.3       This
Agreement may be terminated, prior to the expiration of the Term, immediately by either Party upon written notice to the other
Party in the event that the other Party hereto (i) applies for, consents to, becomes the subject of the appointment of, or the
taking of possession by a receiver, custodian, trustee or liquidator of itself or of all or a substantial part of its property;
(ii) makes a general assignment for the benefit of its creditors; (iii) commences a voluntary case under the bankruptcy code of
the applicable Laws in which it is organized; or


(iv) becomes
the subject of an involuntary case under the applicable Laws or similar insolvency proceeding, which case or proceeding has not
been dismissed or otherwise stayed within ninety


(90) days.


 


5.4       Termination
of this Agreement for any reason will be without prejudice to any rights that will have accrued to the benefit of either Party
prior to such termination, and such termination will not relive either Party from obligations which are expressly indicated to
survive termination of this Agreement.


 


5.5       Expiration
or termination of this Agreement will not relive the Parties of any obligation accruing prior to such expiration or termination.
Article 1 (Definitions); Article 2 (Rights); Article 4 (Termination); Article 5 (Representations, Warranties and Covenants); Article
6 (Confidentiality); and Article 7 (Miscellaneous) shall survive expiration of the Term or termination of this Agreement.


 


ARTICLE
6


REPRESENTATIONS,
WARRANTIES AND COVENANTS


 


6.1       Each
Party represents and warrants to the other Party that as of the Effective Date:




    4/7


     


    

 


 


 





 6.1.1        Each
Party is organized and validly existing under the laws of its state of formation.




 


 


6.1.2        Each Party
has all requisite corporate or company power and authority to execute and deliver this Agreement and to perform all of its
obligations hereunder. The execution and delivery of this Agreement and the performance by the Parties of their respective
obligations hereunder have been authorized by all requisite corporate or company action, as applicable, on their respective
parts. Each Party shall be liable for (i) any breach of this Agreement by any of its Affiliates and (ii) any failure by such
Party to cause its Affiliate to comply with this Agreement as if they were parties.


 


6.2       Dermin
represents and warrants to MBI that as of the Effective Date:


 


6.2.1       Dennin
owns and possess all rights, title and interest in,
to the Annamycin API and existing Annamycin DP;


 


6.2.2       Neither
the execution and delivery of this Agreement nor the performance of Dermin' s
obligations under this Agreement will conflict in any material respect with or result in a material breach of, or constitute a
material default under, any contract, agreement or instrument
to which Dennin is bound;


 


6.3       EXCEPT
AS EXPRESSLY SET FORTH IN THIS AGREEMENT NEITHER PARTY NOR THEIR AFFILIATES MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES
OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY EXPRESS
OR IMPLIED WARRANTIES OF MERCHANTABILTIY OR FITNESS FOR A PARTICULAR PURPOSE.


 


ARTICLE
7 

CONFIDENTIALITY


 


7.1       MBI
and Dermin each agree that Confidential Information of the other Party (i) shall be received in strict confidence, (ii) shall be
used only for the purposes of this Agreement, and (iii)
will not be disclosed by the Receiving Party (except as required by law, court
order or regulation), its agents or employees without the
prior written consent of the Disclosing Party


 


7.2       Subject
to full compliance with this Article 7, each Party may
disclose the other party' s Confidential Information in
confidence to its employees, consultants, Affiliates and
potential or actual,
investors or other commercial partners, research
collaborators and in connection with the performance of its obligations and the exercise of its rights under this Agreement and
the procurement of grant funding; provided, however
, that (i) the Receiving Party first advises recipients
of such disclosure of the confidential nature thereof and (ii) Receiving Party shall be responsible for any breaches of this Agreement
by any of such disclosure. Notwithstanding the foregoing, the
Receiving Party shall not disclose any Confidential Information of the Disclosing Party to any Third Party who does not have a
need to know such Confidential Information.




    5/7


     


    

 


7.3       Each
party's obligation of confidence hereunder will be fulfilled by using at least the same degree of care with the disclosing party's
Confidential Information as it uses to protect its own confidential information, but always at least a reasonable degree of care.


 


7.4       Except
as otherwise set forth in this Agreement, the Receiving Party will promptly return all of the Disclosing Party'
s Confidential Information, including
all reproductions and copies thereof in any medium, except
that the Receiving Party may retain a single archival copy as may be required by applicable Laws or its standard procedures.


 


ARTICLE
8

 MISCELLANEOUS


 


8.1       The
Parties shall execute and deliver any and all additional papers, documents,
and other instruments and shall do any and all further acts and things reasonably necessary,
if any, in connection
with the performance of its obligation hereunder to carry out the intent of this Agreement.


 


8.2       This
Agreement contains the entire understanding of the Parties. This Agreement may be amended only by a written instrument signed by
the Parties.


 


8.3       In
the event an ambiguity or question of intent or interpretation arises, this
Agreement will be construed as if drafted jointly by the Parties and no presumption or burden of proof will arise in favoring or
disfavoring any Party by virtue of the authorship of any provision of this Agreement.


 


8.4       The
waiver by any Party of any terms or condition of this Agreement, or
any part hereof, shall not be deemed a waiver of any other
term or condition of this Termination Agreement, or of
any later breach of this Agreement.


 


8.5       Any
notice required by this Agreement will be given by personal delivery (including delivery by reputable messenger services such as
Federal Express) or by prepaid, first class, certified
mail, return receipt requested,
addressed to:


 





	 	If to Dermin:	lf
    to MBI:
	 	 	 
	 	Dermin Sp. z o. o. 	Moleculin Biotech, Inc.
	 	Attention: Prezes Zarzadu	Attention: CEO
	 	PL-00-116 Warzawa,	2575 West Bellfort Dr., Suite 333
	 	 ul. Swietokrzyska 30/63,	Houston, TX 77054
	 	Poland	USA
	 	 	 







 


8.6       The
Article and Section captions in this Agreement have been inserted as a matter of convenience and are not part of this Termination
Agreement.


 


8.7       This
Agreement may be executed in counterparts, all of which together shall constitute a single agreement.


 


8.8       This
Agreement will be governed by, construed and enforced in accordance with the laws of the State of Texas,
United States.




    6/7


     


    

 


 


IN WITNESS
WHEREOF, the Parties hereto have executed this Agreement by their duly authorized representatives with full right, power and
authority to enter into and perform under this Agreement.


 





	Moleculin Biotech, Inc..	 	Dennin Sp. z o. o.	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	By	 /s/ Walter Klemp	 	By	 /s/ JERZY REPETA 	 
	 	[Printed Name and title]	 	 	PRESIDENT.	 
	 	 	 	 	[Printed Name]	 
	 	 	 	 	 	 




 


 






    7/7