Exhibit 10.4


CONFIDENTIAL-- EXECUTION COPY


 


CONFIDENTIAL TREATMENT REQUESTED


[***] – THE CONFIDENTIAL PORTION
OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY
WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.


 


THIRD AMENDMENT TO LICENSE AGREEMENT


 


THIS THIRD AMENDMENT
TO THE LICENSE AGREEMENT (the "Third Amendment"), is executed as of the 1st day of December 2012, and
is effective as of the 17th day of September, 2012 (the "Effective Date of Third Amendment") by and
between SmithKline Beecham (Cork) Limited, a company organized under the laws of the country of Ireland with a place of business
at Curraghbinny, Carrigaline, Country Cork, Ireland, on behalf of itself and its Affiliates (hereinafter "GSK") and Flamel
Technologies S.A., a corporation organized and existing under the laws of France, with its principal place of business at Parc
Club du Moulin a Vent, 33 Avenue du Docteur Georges Levy 69693 Venissieux Cedex, France (hereinafter, "Flamel").


 


GSK and Flamel Technologies
are sometimes collectively referred to herein as the "Parties" and separate as "Party".


 


Capitalized terms used
in this Third Amendment which are not defined herein will have the meanings ascribed to such terms in the Agreement (as defined
below).


 


WITNESSETH:


 


WHEREAS, GSK
and Flame' are parties to a License Agreement dated March 26, 2003, as amended by the First Amendment of License Agreement dated
October 18, 2004 and by the Second Amendment of License Agreement dated March 16, 2007 (all together the "Agreement");
and,


 


WHEREAS, Flamel
desires to amend the list of patent applications and patents encompassed within Flame! Patents Rights as set forth in Schedule
1.14 of the Agreement; and,


 


WHEREAS, in
consideration for the amendment of the list of patent applications and patents encompassed within the Flamel Patent Rights as provided
in this Third Amendment, GSK has requested, and Flamel has agreed, to certain parameters with respect to Flamers activities with
respect to the Removed Patents (as defined in paragraph 1 of this Third Amendment).


 


NOW, THEREFORE,
in consideration of the premises, the mutual covenants contained herein and other valuable consideration, the receipt and sufficient
of which are hereby acknowledged, the Parties hereby agree as follows:


 


		1.	As per the provisions of Section 1.14(1), the following
patents shall not be considered as Flamel Patent Rights and are removed from Schedule 1.14 (the following patents are collectively
referred to as the "Removed Patents"):



 


		(a)	"Microencapsulated Aspirin" i.e. FR9304560,
US5603957, US5846566, EP0624371 and 0104799/93; and,



 




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CONFIDENTIAL-- EXECUTION COPY


 


CONFIDENTIAL TREATMENT REQUESTED


[***] – THE CONFIDENTIAL PORTION
OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY
WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.


 


		(b)	"Micropump II" now named "Systèmes
Gonflant" i.e. FR2811571 and W002/03964;



		(c)	"Metformin multimicrocapsulaire" i.e FR2811571;
and,



		(d)	"Metformin bitherapie" i.e. FR 01 06854 and
W002/094285; and,



		(e)	"Micropump surenrobè pour compression"
i.e. FR0203336 and W003/077888.



 


		2.	As per the provisions of paragraph 2 of this Third Amendment,
Schedule 1.14 of the Agreement is replaced in its entirety by "Schedule 1.14 (NEW)", which is attached as Appendix
A of this Third Amendment.



 


		3.	During the Term, Flamel agrees not to, and shall cause
its Affiliates not to, directly or indirectly make, have made, use, sell, offer for sale or import In the Territory any presentation
or presentations of Carvedilol, alone or in combination with other therapeutically active compounds, that fall within the scope
of or are covered under a claim of one or more of the Removed Patents.



 


		4.	A facsimile or a portable document format (PDF) copy
of this Third Amendment, including the signature page, will be deemed an original. This Third Amendment may be executed in any
number of counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same
instrument.



 


		5.	This Third Amendment shall be deemed to have been made
in the United States, and its form, execution, validity, construction and effect shall be determined in accordance with, and any
dispute arising from the performance or breach hereof shall be governed by and construed in accordance with, the laws of the State
of New York, without reference to conflicts of laws principles.



 


		6.	Except as amended in this Third Amendment, all other
terms and conditions in the Agreement shall remain unchanged and in full force and effect. All references to the "Agreement"
in the Agreement shall mean the Agreement as amended by this Third Amendment.



 


[Signature Page Follows]


 




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CONFIDENTIAL-- EXECUTION COPY


 


CONFIDENTIAL TREATMENT REQUESTED


[***] – THE CONFIDENTIAL PORTION
OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY
WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.


 


[Signature Page to the Third Amendment]


 


IN WITNESS WHEREOF,
this Third Amendment has been executed by the Parties hereto.


 


	FLAMEL TECHNOLOGIES S.A.	 	SMITHKLINE BEECHAM (CORK) LIMITED
	 	 	 
	By:	 	 	By:	 
	 	 	 
	Name:  Michael S. Anderson	 	Name:
	 	 	 
	Title:  Chief Executive Officer	 	Director


 




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CONFIDENTIAL-- EXECUTION COPY


 


CONFIDENTIAL TREATMENT REQUESTED


[***] – THE CONFIDENTIAL PORTION
OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY
WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.


 


		Appendix A.	Schedule 1.14 (NEW) Updated List of Flamel Patent
Rights (as of the Effective Date of the Third Amendment)



 


		—	Flamel Reference # 19 Medicinal and/or nutritional microcapsules for oral administration



 





	Application Number	 	Application

Filing Date	 	Country	 	Status	 	Patent 

Number	 	Expiry

Date
	[***]	 	[***]	 	Argentina	 	Granted	 	[***]	 	17/10/15
	[***]	 	[***]	 	Argentina	 	Granted	 	[***]	 	17/10/15
	[***]	 	[***]	 	Brazil	 	Granted	 	[***]	 	22/05/17
	[***]	 	[***]	 	Canada	 	Granted	 	[***]	 	17/10/15
	[***]	 	[***]	 	France	 	Granted	 	[***]	 	18/10/14
	[***]	 	[***]	 	France	 	Granted	 	[***]	 	18/10/15
	[***]	 	[***]	 	Germany	 	Granted	 	[***]	 	18/10/15
	[***]	 	[***]	 	India	 	Granted	 	[***]	 	18/10/15
	[***]	 	[***]	 	Israel	 	Granted	 	[***]	 	17/10/15
	[***]	 	[***]	 	Italy	 	Granted	 	[***]	 	18/10/15
	[***]	 	[***]	 	Japan	 	Granted	 	[***]	 	18/10/15
	[***]	 	[***]	 	South Africa	 	Granted	 	[***]	 	17/10/15
	[***]	 	[***]	 	Spain	 	Granted	 	[***]	 	18/10/15
	[***]	 	[***]	 	United Kingdom	 	Granted	 	[***]	 	18/10/15
	[***]	 	[***]	 	USA	 	Granted	 	[***]	 	17/10/15







 


		—	Flamel Reference #69 Galenic microparticulate oral formulation for delayed and controlled release
of pharmaceutical active principles [1]



 





	Application Number	 	Application

Filing Date	 	Country	 	Status	 	Patent Number	 	Expiry

Date
	[***]	 	[***]	 	Brazil	 	Pending	 	[***]	 	NA
	[***]	 	[***]	 	Canada	 	Granted	 	[***]	 	09/10/2022
	[***]	 	[***]	 	China	 	Granted	 	[***]	 	09/10/2022
	[***]	 	[***]	 	Europe	 	Pending	 	[***]	 	NA
	[***]	 	[***]	 	France	 	Granted	 	[***]	 	09/10/2021
	[***]	 	[***]	 	Hong-Kong	 	Granted	 	[***]	 	09/10/2022
	[***]	 	[***]	 	India	 	Granted	 	[***]	 	09/10/2022
	[***]	 	[***]	 	Israel	 	Granted	 	[***]	 	09/10/2022
	[***]	 	[***]	 	Japan	 	Granted	 	[***]	 	09/10/2022
	[***]	 	[***]	 	Mexico	 	Pending	 	[***]	 	 
	[***]	 	[***]	 	Singapore	 	Granted	 	[***]	 	09/10/2022
	[***]	 	[***]	 	South Africa	 	Granted	 	[***]	 	09/10/2022
	[***]	 	[***]	 	South Korea	 	Granted	 	[***]	 	09/10/2022
	[***]	 	[***]	 	USA	 	Granted	 	[***]	 	11/09/2025







 




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CONFIDENTIAL-- EXECUTION COPY


 


CONFIDENTIAL TREATMENT REQUESTED


[***] – THE CONFIDENTIAL PORTION
OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY
WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.


 


		[1]	Previously listed as "Microcapsules "delayed release"' i.e. FR0112999 in Schedule
1.14 of the Agreement.



 


NA: Not Applicable; TBD: To be Determined.


 




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