Service Agreement – A


Formulation development of RHB-105 in oral solid dosage form and manufacture
of clinical supplies


Amendment 3







 


Exhibit 4.19


 


THE SYMBOL “[****]” DENOTES PLACES WHERE
PORTIONS OF THIS DOCUMENT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. SUCH MATERIAL HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.


 


Amendment 3 to The service
Agreement A is made and entered in April 19th, 2012 (the “Amendment”).


 


	1.		DESCRIPTION OF THE EXTRA WORK



			



The
Client requested that the GMP Omeprazole magnesium API and GMP Amoxicillin API and GMP Rifabutin API would be analyzed by Corealis
at their reception at the Corealis] facility for full testing and not only ID testing.



 


	a.		GMP Omeprazole magnesium API analytical release testing



 


	ITEM	Cost (USD$)	 
	 	 	 
	ID testing	 	 
	IR-Method qualification, set-up and analysis*	0$	 
	[****]	200$	 
	 	 	 
	Assay	 	 
	Method qualification	2,000$	 
	Set-up	605$	 
	Analysis	575$	 
	 	 	 
	Related substances	 	 
	Method qualification	2,500$	 
	Set-up**	0$	 
	Analysis	795$	 
	 	 	 
	Residual solvents	 	 
	Method A: [****]	 	 
	[****]	14,000$	 
	Analysis	1,200$	 
	 	 	 
	Water - Karl Fisher Titration (USP <921>)	 	 
	Analysis	165$	 
	 	 	 
	Appearance	 	 
	Analysis	85$	 
	 	 	 
	[****]	 	 
	 	 	Analysis	75$	 





















 


 


	Corealis	Page 1 of 5	 
	Date: April 19th, 2012	 	 





















     


     

    




Service Agreement – A


Formulation development of RHB-105 in oral solid dosage form and manufacture
of clinical supplies


Amendment 3







 


 


	[****]	Analysis	170$	 
	 	 	 
	[****]	 	 
	Analysis	550$	 
			 
	Report****	688$	 
		_______
			 
	Sub total for section 1. a.	23,608$	 
	 	 	 
	b. GMP Amoxicillin trihydrate API analytical release testing
			 
	ITEM	Cost (USD$)	 
			 
	ID testing	 	 
	IR-Method qualification,
set-up and analysis*	0$	 
		 	 
	Assay		 
	Method qualification	2,000$	 
	Set-up	605$	 
	Analysis	575$	 
			 
	Related substances	 	 
	Method qualification	2,500$	 
	Set-up**	0$	 
	Analysis	795$	 
		 	 
	pH	 	 
	Analysis	85$	 
	 	 	 
	Residual solvents	 	 
	[****]	 	 
	[****]	 	 
	[****]	 	 
	[****]	30,000$	 
	[****]	1,800$	 
	 	 	 
	Water - Karl Fisher Titration (USP <921>)	 	 
	Analysis	165$	 
	 	 	 
	Appearance	 	 
	Analysis	85$	 
	 	 	 
	Crystallinity	 	 
	Analysis	550$	 
	 	 	 
	Report****	1,175$	 
	 	_______	 
	 	 	 
	Sub total for section 1. b.	40,335$	 
	 	 			 














 





	Corealis	Page 2 of 5	 
	Date: April 19th, 2012	 	 






     


     

    







Service Agreement – A


Formulation development of RHB-105 in oral solid dosage form and manufacture
of clinical supplies


Amendment 3







 


 c. GMP Rifabutin API analytical release testing 




 





	ITEM	Cost (USD$)		 
	 	 	 
	ID testing	 	 
	IR-Method qualification,
set-up and analysis*	0$	 
	[****]	575$	 
		 	 
	Assay		 
	Method qualification	2,000$	 
	Set-up	605$	 
	Analysis	575$	 
		 	 
	Related substances		 
	Method qualification	2,500$	 
	Set-up**	0$ 
	Analysis	795$	 
		 	 
	Water - Karl Fisher Titration (USP <921>)	165$	 
	Analysis		 
			 
	Limit of N-Iso Butylpiperidone (TLC)	 	 
	Qualification,
set-up and analysis	1,650$	 
			 
	Residual solvents	 	 
	[****].	 	 
	[****].		 
	[****]	24,000$	 
	Analysis	1,800$	 
	Qualification
[****]***	2,000$	 
	 	 	 
	Appearance	 	 
	Analysis	85$	 
	 	 	 
	Report****	1,103$	 
	 	_______	 
	 	 	 
	Sub total for section 1. c.	37,853$	 
	 	_______	 
	 	 	 
	Total cost of the amendment	101,795$	 
	* Already included in Service Agreement A.	 	 
	 	 			 

















 





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	Date: April 19th, 2012	 	 








 









     


     

    




Service Agreement – A


Formulation development of RHB-105 in oral solid dosage form and manufacture
of clinical supplies


Amendment 3




 





** Included in the set-up cost of the Assay.


***Analysis to be outsourced to a Corealis qualified vendor.
[****] in Toronto using the validated analytical methods of [****].


**** Cost for the documentation and the CofA- 3% of the total cost of the analysis.


 


		2.	COST AND PAYMENTS



		2.1	The cost of the Services for the Extra Work detailed in section
1 is:



		2.1.1	$101,795 if the following installments are:



		·	50% at the signature of this Agreement; and



		·	the balance at the completion of the release testing.



OR


		2.1.2	$89,783 if $89,783 is paid within 7 days from the signature of this
Agreement.



 


		2.2	The Client shall pay to Corealis the following installments in
United-States currency ($USD):



 


		3.	TIMELINES FOR AMENDMENT 3



[****]


 


 


 


 


 


 


IN WITNESS THEREOF, the Parties have executed this Amendment
as of the Date written above, by their authorised representatives, who by signing confirm their authority and intention to bind
the Parties they represent. 


 





	Corealis	Page 4 of 5	 
	Date: April 19th, 2012	 	 






     


     

    




Service Agreement – A


Formulation development of RHB-105 in oral solid dosage form and manufacture
of clinical supplies


Amendment 3







 


 


	Corealis Pharma Inc.	 	7810962	 
	Canada Inc.	 	 
	 	 	 
	Per: /s/___________________	 	Per: /s/ Alain Guimond PhD
	 	 	 	 
	Name: Yves Roy, Ph.D.	 	Name: Alain Guimond PhD
	 	 	 
	Title: President	 	Title: Senior director of Research







 


 


 


 


 


 


 


 


 





	Corealis	Page 5 of 5	 
	Date: April 19th, 2012