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.
Formulation development of RHB-105 in oral solid dosage form and manufacture of clinical supplies
Amendment 3
AMENDMENT 3 TO THE SERVICE AGREEMENT A is made and entered in April 19th, 2012 (the “Amendment”).
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1.
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DESCRIPTION OF THE EXTRA WORK
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The Client requested that the GMP Omeprazole magnesium API and GMP Amoxicillin API and GMP Rifabutin API would be analyzed by [****] at their reception at the [****] facility for full testing and not only ID testing.
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a.
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GMP Omeprazole magnesium API analytical release testing
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ITEM
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Cost (USD$)
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ID testing
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IR-Method qualification, set-up and analysis*
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0$
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[****]
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200$
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Assay
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Method qualification
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2,000$
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Set-up
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605$
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Analysis
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575$
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Related substances
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Method qualification
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2,500$
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Set-up**
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0$
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Analysis
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795$
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Residual solvents
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Method A: [****]
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[****]
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14,000$
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Analysis
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1,200$
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Water - Xxxx Xxxxxx Titration (USP <921>)
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Analysis
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165$
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Appearance
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Analysis
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85$
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[****]
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Analysis
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75$
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[****]
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Analysis
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170$
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[****]
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Analysis
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550$
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Report****
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688$ | |
| Sub total for section 1. a. | 23,608$ | |
Page 1 of 5
Formulation development of RHB-105 in oral solid dosage form and manufacture of clinical supplies
Amendment 3
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b.
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GMP Amoxicillin trihydrate API analytical release testing
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ITEM
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Cost (USD$)
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ID testing
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IR-Method qualification, set-up and analysis*
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0$
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Assay
|
||
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Method qualification
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2,000$
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Set-up
|
605$
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Analysis
|
575$
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Related substances
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||
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Method qualification
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2,500$
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Set-up**
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0$
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Analysis
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795$
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pH
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Analysis
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85$
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Residual solvents
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[****]
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[****]
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[****]
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[****]
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30,000$
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[****]
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1,800$
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Water - Xxxx Xxxxxx Titration (USP <921>)
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Analysis
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165$
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Appearance
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||
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Analysis
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85$
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Crystallinity
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Analysis
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550$
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Report****
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1,175$
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Sub total for section 1. b.
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40,335$
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Page 2 of 5
Formulation development of RHB-105 in oral solid dosage form and manufacture of clinical supplies
Amendment 3
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c.
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GMP Rifabutin API analytical release testing
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ITEM
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Cost (USD$)
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ID testing
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IR-Method qualification, set-up and analysis*
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0$
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[****]
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575$
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Assay
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||
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Method qualification
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2,000$
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|
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Set-up
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605$
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|
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Analysis
|
575$
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Related substances
|
||
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Method qualification
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2,500$
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Set-up**
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0$
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Analysis
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795$
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Water - Xxxx Xxxxxx Titration (USP <921>)
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||
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Analysis
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165$
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Limit of N-Iso Butylpiperidone (TLC)
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Qualification, set-up and analysis
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1,650$
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Residual solvents
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[****]
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[****]
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[****]
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24,000$
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Analysis
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1,800$
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Qualification [****] ***
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2,000$
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Appearance
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Analysis
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85$
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Report****
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1,103$
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Sub total for section 1. c.
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37,853$
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Total cost of the amendment
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101,795$
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*
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Already included in Service Agreement A.
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**
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Included in the set-up cost of the Assay.
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***
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Analysis to be outsourced to a [****] qualified vendor. [****] in Toronto using the validated analytical methods of [****].
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****
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Cost for the documentation and the CofA- 3% of the total cost of the analysis.
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Page 3 of 5
Formulation development of RHB-105 in oral solid dosage form and manufacture of clinical supplies
Amendment 3
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2.
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COST AND PAYMENTS
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2.1
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The cost of the Services for the Extra Work detailed in section 1 is:
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2.1.1
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$101,795 if the following installments are:
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·
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50% at the signature of this Agreement; and
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·
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the balance at the completion of the release testing.
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OR
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2.1.2
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$89,783 if $89,783 is paid within 7 days from the signature of this Agreement.
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2.2
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The Client shall pay to [****] the following installments in United-States currency ($USD):
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3.
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TIMELINES FOR AMENDMENT 3
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[****]
Page 4 of 5
Formulation development of RHB-105 in oral solid dosage form and manufacture of clinical supplies
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.
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[****]
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7810962 Canada Inc. | ||||
| Per: |
/s/
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Per: |
/s/ Xxxxx Xxxxxxx PhD
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| Name: [****] | Name: Xxxxx Xxxxxxx PhD | ||||
| Title: President | Title: Senior director of Research | ||||
Page 5 of 5
