Document:

Exhibit 4.11

 

 

		 	 	 	   200 Armand-Frappier
	 	CONFIDENTIAL	 	   Laval, Quebec, Canada H7V 4A6 

   Tel (450) 973-7505
	 	 	 	   www.corealispharma.com

 

 

 

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.

 

Service Agreement
- Y

Manufacture of
resupply of Clinical Trial Material of

[****] RHB-104
capsules

 

THIS SERVICE AGREEMENT Y is made and entered
into this ___________ day of October, 2014 (the “Service Agreement”).

 

	BETWEEN:

COREALIS Pharma, Inc., a corporation duly incorporated under the laws of
Canada and having its principal place of business at 200 Armand-Frappier, Laval, Québec, Canada, H7V 4A6;

 

	 	
        (hereinafter referred to as “Corealis”)

 

	AND	RedHill Biopharma Ltd., a company duly incorporated under the laws of Israel, and having its principal place of business at 21 Ha’arba’a St., Tel-Aviv, 64739 Israel;

 

	 	(hereinafter referred to as the “Client”)

 

	 	
        (Corealis and the Client are at times referred
        to individually as the “Party” and collectively the “Parties”)

 

RECITALS

 

	A.  	
        The Client and Corealis entered into a Master
        Service Agreement dated on the 7th day of August, 2012 (the “MSA”).

 

	B.  	The Parties hereto wish to describe the services to be performed in connection with the MSA, subject to the terms and conditions set forth herein and in the MSA.

 

	C.  	Unless the context otherwise requires, all capitalized terms used in this Service Agreement shall have the meanings attributed to them in the MSA.

 

	1.  	INTERPRETATION

The recitals of this Service Agreement
as well as all of its Appendices form an integral part of this Service Agreement.

 

    	 	Page 1 of 13	 

    
CONFIDENTIAL
Service Agreement - Y
RedHill Biopharma Ltd. – COREALIS Pharma Inc.
Manufacture of resupply of Clinical Trial Material of 
[****] RHB-104 capsules

    

 

	2.  	DESCRIPTION AND DELIVERABLES

The objective of this Agreement is to GMP manufacture,
the warehousing, the analytical release testing and the stability storage and testing of the RHB-104 CTM resupply.

 

	2.1-	API, excipients and packaging components reception and storage

	2.1 a)	API sourcing

It is estimated that sufficient quantities of fully released
GMP clarithromycin API and GMP clofazimine API are available at Corealis and the Client at its own cost will ship to Corealis sufficient
quantities of GMP rifabutin API (collectively the clarithromycin API, the clofazimine API and the rifabutin API are called “APIs”
and individually “API”). Upon reception of the GMP rifabutin API Corealis will execute a full release testing of the
material according to GMP requirements. Should additional APIs be required, the sourcing will be the exclusive responsibility of
the Client. Upon request by the Client, Corealis could characterize and analyze the APIs which will be considered Extra Work.

 

	Cost:	[****]
	*	It is estimated that sufficient
    quantities of each of GMP clarithromycin API and GMP clofazimine API are available at Corealis to execute the manufacture
    of the CTM. However the Client will source and ship to Corealis sufficient quantities of GMP rifabutin API for the manufacture
    of the Drug product included in this Agreement. 
	 	The cost includes:
	 	 •	the reception of one lot of GMP rifabutin API (i.e.,
    documentation review, material registration in Corealis inventory, and material sampling following GMP requirements) (If API
    lot is in more than one container then the sampling and ID testing of each of the additional containers will be considered
    Extra Work at 200$/additional container), 
	 	 •	the full testing for the release of one lot of GMP rifabutin
    API using validated method. (Client will ship the GMP rifabutin API to Corealis with the complete certificate of analysis
    and related documentation to assure API conformity to the appropriate regulatory authorities),
	 	 •	the GMP warehousing of the Client’s Materials (e.g., API,
    raw material, objects, inactive ingredients) for the period where the Project is active and for a volume not exceeding 1 m3.
    If the material need to be stored for a longer period of time or the volume of the material is more than 1 m3 then
    the storage cost will be considered Extra Work or the material shipped at Client.
	 	The cost does not include:
	 	• 	The purchase of the analytical reference materials to be used
    as a standard, if needed, reference impurities (synthesis by-products, Related Substances, metabolites) of known purity, HPLC
    columns, and any dedicated peripherals (e.g., guard column) and reagents.
	 	 •	The release testing of any additional material (i.e., additional
    API) should the Client change the drug product material specifications or API source or any decision taken by the Client that
    requires additional analytical testing.
	 	 •	The repackaging of material (if required) as well as the shipping
    cost and custom fees, if any.
	 	 •	The destruction fees of any material after being pre-authorized
    by the Client.
	 	 •	Documentation fees for the shipment or reception of GMP API or
    GMP drug products at 200$/ event (i.e., reception or reception).
	 	 •	Sampling fees of 200$/ containers.
	 	 •	The shipping document preparation and shipment of material. 

 

 

    	 	Page 2 of 13	 

    
CONFIDENTIAL
Service Agreement - Y
RedHill Biopharma Ltd. – COREALIS Pharma Inc.
Manufacture of resupply of Clinical Trial Material of 
[****] RHB-104 capsules

    

 

 

	2.1 b)	GMP Materials (excipients and packaging components) storage and handling-

Corealis will handle the reception, the full release
testing, the shipping and the storage of GMP Materials (i.e., excipients and packaging materials) in its cGMP warehouse. All material
handling operations and storage conditions will respect the ICH GMP requirements.

 

	 	Cost:	[****]
	 	*	The cost includes:
	 	 	 •	The reception of 10 lots
    of excipients and packaging components (i.e., documentation review, material registration in Corealis inventory, and material
    sampling following GMP requirements) as well as their full release testing as per the [****]
    (The cost is based on the hypothesis that all GMP material will be received in one single shipment at 200$/ shipment and the
    full release testing of 10 GMP materials at an average cost of [****] of GMP material received. Any additional shipment or
    reception of GMP material will be considered as Extra Work at [****] or reception. Any additional sampling and testing of
    GMP material received will be considered Extra Work at [****] of GMP material received.). 
	 	 	 •	The
    GMP warehousing of the APIs and the drug product until completion of the study. If the material needs to be stored for a longer
    period of time then the storage cost will be [****]/ month.
	 	 	 •	All the GMP Materials, APIs and RHB-104
    drug products must have a volume of less than 1 m3. 
	 	 	The cost does not include:
	 	 	 •	The cost of APIs.
	 	 	 •	The purchase cost of the reference materials
    to be used as a standards and reference impurities (synthesis by-products, degradation products, metabolites) of known purity,
    if required.
	 	 	 •	Additional packaging or repackaging of
    APIs, Drug Products or any GMP material will be considered Extra Work.

 

	2.2-	Manufacturing of the Clinical Trial Material (CTM)

The CTM manufacturing process, manufacturing, packaging,
equipment calibration and validation, will be done by Corealis GMP laboratory. All the manufacturing, packaging and analytical
equipments that will be used for the CTM will be calibrated, validated and released for their cleanliness prior to their utilization.

 

	2.2 a)	Manufacturing and bulk packaging

Corealis will manufacture and package the single dose
strength of RHB-104 capsule as per the optimized formulation developed in the execution of Service Agreement N (document 004-140225rev4).

 

Specifically with respect to manufacturing, packaging
and bulk labeling, the followings items will be provided by Corealis:

 

	a)	Recommendation and justification of specific finished product release specifications,

	b)	Redaction of Master Manufacturing File (MMF)

 

    	 	Page 3 of 13	 

    
CONFIDENTIAL
Service Agreement - Y
RedHill Biopharma Ltd. – COREALIS Pharma Inc.
Manufacture of resupply of Clinical Trial Material of 
[****] RHB-104 capsules

    

 

	c)	The CTM will be manufactured and packaged in labeled* double lined sealed LDPE bags inserted in hard shell sealed barrels:

	 	•	RHB-104 capsule               –[****] units

 

	 	Cost:                                                145,000$**
	 	*	The labelling on the bags
    and barrels will include the basic information for GMP drug products (i.e., Name of sponsor, date of manufacturing, Lot number
    and storage conditions). This Agreement does not include preparation of special packaging and labelling which would require
    randomization, patient kits preparation of special shipments of clinical supplies. 
	 	**	The cost is based on the assumption that
    one batch of RHB-104 capsules will be manufactured and packaged within the same manufacturing campaign. The cost includes
    the GMP excipients, the GMP packaging materials, the manufacturing, the bulk packaging, the labelling, the cleaning verification
    of the manufacturing suites and the equipments for one manufacturing campaign. The cost does not include the transportation
    cost of the clinical supplies, the broker and custom fees, the cost of the APIs. No manufacturing engineering batch of the
    drug product will have been executed using the new RHB-104 capsule formulation developed by Corealis in the execution of Service
    Agreement N prior to the execution of this GMP manufacturing campaign and thus, Corealis could not be held responsible for
    batch failure unless the failure is du to a Corealis negligence or wilful misconduct. Furthermore, the manufacturing campaign
    will last 10 working days. The manufacturing campaign will start when the APIs are brought in the GMP manufacturing suites
    and will be terminated when the GMP manufacturing suites will have been released for their cleanliness. Should the manufacturing
    campaign be delayed by the Client, the Client’s suppliers, the Client’s APIs or any other factors outside the
    control of Corealis, every additional day to the GMP manufacturing campaign will be considered Extra Work at [****]/
    day for GMP suite rental and labour cost may also apply in addition to the suite rental. 

 

	2.2 b)	Packaging and labeling of the Clinical
Trial Material (CTM) (optional)

Specifically with respect to packaging and labeling,
the followings items will be provided by Corealis:

	a)	Redaction of Master Manufacturing File (MMF); and

	b)	
        The RHB-104 capsules of the [****] units batch
        will be packaged in induction sealed HDPE bottle containing [****]; and

	c)	
        Labeling of bottles in a ratio of two RHB-104 bottles to one RHB-104 placebo bottle
        (i.e., [****]) using the labels to be provided by the Client.

 

The followings items will be provided by the Client
to Corealis:

	a)	
        About [****]; and

	b)	The randomization list; and

	c)	The labels.

 

 

    	 	Page 4 of 13	 

    
CONFIDENTIAL
Service Agreement - Y
RedHill Biopharma Ltd. – COREALIS Pharma Inc.
Manufacture of resupply of Clinical Trial Material of 
[****] RHB-104 capsules

    

 

	 	Cost:                                                [****]
	 	*	This cost is not included in
    the total cost of the study in section 7 and should Services included in this section required by the Client it will be considered
    Extra Work and invoiced monthly. The cost is based on the assumption that [****]
    RHB-104 capsules will be bottled AND [****] will be labelled with labels to be provided by the Client AND all the bottling
    and the labelling will be executed within the same manufacturing campaign. The cost includes the GMP packaging materials,
    the packaging, the labelling, the cleaning verification of the packaging suites and the equipments. The cost does not include
    the transportation cost of the clinical supplies, the broker and custom fees, the preparation of Patient Kits. If the Services
    included in this Agreement is executed within the same manufacturing campaign as of the manufacturing of the RHB-104 capsule
    (Section 2.2 a)) and the bulk packaging is not required then $[****] will be subtracted from the discounted cost above. 

 

	2.2 c)	Release testing of CTM and cleaning verification

The validation of the analytical methods for the
release testing of the CTM and for the cleaning verification has already been validated. All analysis will be performed using the
validated methods. Except for the cleaning verification all of the analyses are outsourced to a Corealis qualified third Party laboratory.

 

Analyses to be performed on CTM are:

	 	 •	appearance,
	 	 •	Identification,
	 	 •	water content (KF),
	 	 •	assay* and degradation products*,
	 	 •	microbiology,
	 	 •	content uniformity,
	 	 •	dissolution** and disintegration time.

 

	 	Cost:                                                10,965$***
	 	*	Assay and Related Substances for the three APIs
    for RHB-104. 
	 	**	[****].
	 	***	The cost is not discounted as all of the CTM analyses are
    outsourced to a Third Party qualified laboratory. The cost includes the analysis of [****]
    (i.e., RHB-104 capsules), the analysis of [****] for cleaning verification for one GMP manufacturing campaign. Except for
    the cleaning verification all the analytical methods for release testing have been validated by a third Party Corealis qualified laboratory. 

 

	2.2	d) Stability study of CTM and cleaning verification

The validation of the analytical methods for the
analysis of the CTM has already been validated by a qualified third Party laboratory. All analysis will be performed using the
validated methods.

 

The CTM will be stored in cGMP stability chambers at
[****], and the samples analyzed using the Client’s validated methods. The single strength
RHB-104 capsule will be characterized for appearance, assay, related substances, dissolution*, disintegration and water content
using the schedule below.

 

    	 	Page 5 of 13	 

    
CONFIDENTIAL
Service Agreement - Y
RedHill Biopharma Ltd. – COREALIS Pharma Inc.
Manufacture of resupply of Clinical Trial Material of 
[****] RHB-104 capsules

    

 

 

The following stability testing schedule
will be used and modified per mutual agreement:

 

	Storage 

Condition	Time point (Month)
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]

	
        [****]
	-	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]

	
        [****]
	-	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]
	
        [****]

	
        [****]
	-	
        [****]
	
        [****]
	
        [****]
	-	-	-	-	-	-

X: Sample to be analyzed.

Y: Sample removed from chamber and analyzed only
at the request of Client.

 

	 	Cost:                                                74,120$**
	 	*	A dissolution test is [****].
	 	**	The cost is not discounted as all of the
    CTM analyses are outsourced to a Third Party qualified laboratory. The cost is based on the analysis of [****]. 

 

	2.3-	Reports and submission documentation

		·	Telephone meetings, Corealis facility and quality audit by Client’s or Client’s
representative will be held on an as needed basis.

		·	Client or Client’s representative meeting in Corealis facility will be held at Client’s
request.

		·	Progress reports will be provided on a Monthly basis or as needed.

		·	Item reports will be provided as they are completed.

		·	A final manufacturing report will be provided at the end of the study. It will include all
the necessary regulatory submission documents related to manufacturing and packaging which include (but not limited to):

		o	The finished products release & stability certificate of analysis.

		o	In process testing results.

		o	QA Reviewed and audited Manufacturing and Packaging/labeling Documents.

		o	Certificate of cGMP compliance.

		o	Certificate of analysis of raw materials and packaging components.

		o	Any atypical report or Out-of-Specification reports.

 

	 	Cost:                                              0$*
	 	*	Included in the costs of the
    previous sections. 

 

 

    	 	Page 6 of 13	 

    
CONFIDENTIAL
Service Agreement - Y
RedHill Biopharma Ltd. – COREALIS Pharma Inc.
Manufacture of resupply of Clinical Trial Material of 
[****] RHB-104 capsules

    

 

	3.  	GENERAL PROJECT TIMELINES

 

 

 

    	 	Page 7 of 13	 

    
CONFIDENTIAL
Service Agreement - Y
RedHill Biopharma Ltd. – COREALIS Pharma Inc.
Manufacture of resupply of Clinical Trial Material of 
[****] RHB-104 capsules

    

 

 

	4.	STARTING DATE AND COMPLETION

 

		4.1	Notwithstanding the date of signature of this Service Agreement,
Corealis shall start the performance of the Services within ten (10) business days after Corealis satisfaction of the following:

 

		4.1.1	signature by the Client of this Service Agreement; and

 

		4.1.2	complete delivery by the Client of all of the items mentioned
at sub-section 6.1 of section 6 hereof entitled “REQUIREMENTS”. 

 

		4.2	This Service Agreement shall be deemed completed upon full delivery
of the Services by Corealis and receipt by Corealis of the final and last payment for the Services.

 

	5.	ASSUMPTIONS

 

		5.1	The RHB-104 optimized formulation containing 95 mg Clarithromycin,
45 mg Rifabutin, and 10 mg Clofazimine will be manufactured for clinical supplies.

 

		5.2	Any subcontractor that will used within this project will need
to satisfy the Corealis quality audit. Otherwise Extra Work may be required to support subcontractors and/or take actions not to
delay the project (e.g., Corealis to purchase and release material after approval by the Client). Use of subcontractors must be
approved in advance by the Client.

 

		5.3	Corealis is not responsible for the qualification of any API
manufacturer, any delays in the manufacturing of the APIs, the delivery of the APIs, and for the quality of the APIs purchased
by the Client.

 

		5.4	If different lots of APIs are utilized in the execution of the
Project and the physical and chemical properties of the different lots are different or, if the physical and chemical properties
of the API intended to be utilized in the execution of this Projects differs from the expected API properties when this Agreement
was signed by both Parties, then additional formulation development and/or manufacturing process adjustments and/or additional
manufacturing time and/or additional sample analysis may be needed and if needed, they will be considered Extra Work and the Project’s
time lines adjusted accordingly. 

 

		5.5	When a decision is required to move the project forward, the
Client will provide its decision in writing to Corealis within a period of 5 days, or the project may be delayed. Corealis will
develop a final timeline for this project and all deviations will be immediately reported to the Client. Corealis will make its
best efforts to correct all deviations in order to maintain the project timeline. 

 

    	 	Page 8 of 13	 

    
CONFIDENTIAL
Service Agreement - Y
RedHill Biopharma Ltd. – COREALIS Pharma Inc.
Manufacture of resupply of Clinical Trial Material of 
[****] RHB-104 capsules

    

 

 

		5.6	Any analytical reference materials (e.g., standards and impurities)
and dedicated materials (e.g., HPLC columns, speciality reagents) purchased by Corealis and utilized solely for the execution of
the Client’s Project and any other equipments or materials that are damaged by the Client’s API or APIs (e.g., corrosion,
unusual ware, staining, contamination, loss of operational functions) or becomes dedicated to the Client’s Project or requires
unusual cleaning efforts and resources due to the nature of the Client’s APIs will be considered Extra Work and invoiced
at cost to the Client.

 

		5.7	The Client decided not to execute a stability study of the CTM.

 

		5.8	All shipments from Corealis to the Client or to a designated
location specified by the Client will be invoiced at cost as per the EXW (200 Armand-Frappier
boulevard, Laval, Quebec, Canada, H7V 4A6) Incoterms® 2010. All shipments
from Clients or from a designated supplier of the Client to Corealis will be invoiced at cost as per the DDP
(200 Armand-Frappier boulevard, Laval, Quebec, Canada, H7V 4A6) Incoterms®
2010. 

 

		5.9	The Client is responsible to verify that the Services and deliverables
provided in the execution of this Service Agreement do not violate or infringe any patent, trade secret or other proprietary or
intellectual property right of any third Party.

 

		5.10	During an audit, Corealis will allow the Client's representatives
to examine the batch records, technical reports, methods and protocols pertaining to the Services. The assistance provided by Corealis
to the Client during an audit will, under no circumstances, give rise to the payment of additional expenses unless the audit last
more than three working days (a working day consist of an 8 hour shift). Should additional time is required for the audit it will
be considered Extra Work.

 

		5.11	Corealis will allow the Client’s representatives to assist
to the execution of the Services for a maximum period of one day per manufacturing campaign. Should the Client’s representative
need additional time and/or if the normal execution of the Services is disturbed by the presence of the Client’s representative
then Corealis may consider it Extra Work. 

 

		5.12	If different lots of APIs are utilized in the execution of the
Project and the physical and chemical properties of the different lots are different or, if the physical and chemical properties
of the API intended to be utilized in the execution of this Project differs from the expected API properties when this Agreement
was signed by both Parties, then additional formulation development and/or manufacturing process adjustments may be needed and
if needed, they will be considered Extra Work and the Project’s time lines adjusted accordingly. 

 

    	 	Page 9 of 13	 

    
CONFIDENTIAL
Service Agreement - Y
RedHill Biopharma Ltd. – COREALIS Pharma Inc.
Manufacture of resupply of Clinical Trial Material of 
[****] RHB-104 capsules

    

 

 

		5.13	The costs included in this Agreement for GMP manufacturing are
based on the premises that all of the GMP manufacturing operations will be executed within the same manufacturing campaign, unless
explicitly specified in section 2. Should the GMP manufacturing campaign be delayed or split in several manufacturing campaigns
and where the delays or the split is not caused by Corealis or by Corealis qualified suppliers, the additional cost that may apply
will be considered Extra Work. 

 

		5.14	All of the Client’s Materials (e.g., API, raw material,
objects, inactive ingredients) stored in Corealis warehouse will not exceed a volume of 1 m3. Exceeding storage volume
will be considered Extra Work.

 

		6.	REQUIREMENTS

 

The Client shall provide to Corealis, at no cost to Corealis, the
following:

 

		6.1	If the Client send additional APIs to Corealis for the manufacture
of the RHB-104, the GMP APIs, reference materials to be used as a standard, reference impurities (synthesis by-products, degradation
products, metabolites) of known purity, the certificate of analysis, the BSE & TSE statements, the APIs manufacturer GMP certification.

 

		7.	COST AND PAYMENTS

 

		7.1	The cost of the Services is 247,701.00 $USD [****].
Any amount exceeding a total of 247,701$ requires a pre-approval in writing by the Client. 

 

		7.2	The Client shall pay to Corealis the following installments in
US currency ($USD):

 

		7.2.1	[****] upon signature of this Agreement; and 

 

		7.2.2	[****] at the completion of the CTM manufacturing; and

 

		7.2.3	[****] at the acceptance of the final CTM manufacturing report;
and 

 

		7.2.4	Stability study of CTM invoiced monthly. 

 

		7.3	Each of the above payments is subject to receipt of a non-disputed
invoice from Corealis and subject to the payment terms detailed in the Master Service Agreement.

 

    	 	Page 10 of 13	 

    
CONFIDENTIAL
Service Agreement - Y
RedHill Biopharma Ltd. – COREALIS Pharma Inc.
Manufacture of resupply of Clinical Trial Material of 
[****] RHB-104 capsules

    

 

		7.4	Notwithstanding section 7.1, for any extra work not covered by
this Service Agreement and agreed upon in writing between the Parties (the “Extra Work”), the Client shall pay to Corealis
the relevant sum as agreed in writing. For any such Extra Work Corealis will apply the hourly rates and other fees indicated in
this Appendix I attached hereto for the performance of the Services (The costs of the Services for the Extra Work and described
in section 7.1 are collectively, the “Fees”).

 

		7.5	Notwithstanding section 7.2 hereof, Corealis will invoice the
Client for the Extra Work, on a monthly basis for the Services that (i) have been pre-approved in writing by the Client, and; (ii)
that have been delivered or rendered by Corealis.

 

		8.	CONFIDENTIALITY

 

		8.1	Confidentiality issues are covered per the Non Disclosure Agreement
and the MSA.

 

		9.	REPRESENTATIONS AND WARRANTIES

 

		9.1	Corealis hereby represents and warrants to the Client that: 

 

		9.1.1	it is a duly organized and validly existing corporation under
the laws of the jurisdiction in which it is incorporated; 

 

		9.1.2	it has the necessary corporate power, authority, skills, and
capacity and is properly authorized to enter into this Service Agreement and to perform its obligations as per the terms and conditions
of this Service Agreement. The execution and delivery of this Service Agreement and the performance of the transactions contemplated
hereby have been duly authorized.

 

		9.2	The Client hereby represents and warrants to Corealis that: 

 

		9.2.1	it is a duly organized and validly existing corporation under
the laws of the jurisdiction in which it is incorporated; 

 

		9.2.2	it has the necessary corporate power, authority, skills, and
capacity and is properly authorized to enter into this Service Agreement and to perform its obligations as per the terms and conditions
of this Service Agreement. The execution and delivery of this Service Agreement and the performance of the transactions contemplated
hereby have been duly authorized; 

 

		10.	TERMS AND CONDITIONS

 

		10.1	This Service Agreement shall be governed, construed and interpreted
according to the laws in force in the Province of Quebec and the applicable laws of Canada therein, and the courts of the legal
district of Montreal, province of Quebec (Canada) shall have exclusive jurisdiction to hear any and all disputes arising hereunder.

 

 

    	 	Page 11 of 13	 

    
CONFIDENTIAL
Service Agreement - Y
RedHill Biopharma Ltd. – COREALIS Pharma Inc.
Manufacture of resupply of Clinical Trial Material of 
[****] RHB-104 capsules

    

 

	10.2  	This Service Agreement is subject to the terms and conditions provided in the MSA and bind the parties as well as their respective successors, permitted assigns and legal representatives.

 

	10.3  	This Service Agreement may be executed in counterparts, each of which shall be deemed to be an original and which together shall constitute one and the same agreement. This Service Agreement may also be executed between the Parties by exchange of facsimile transmissions or electronic transmissions in legible form, including without limitation in a tagged image format file (TIFF) or portable document format (PDF).

 

	10.4  	The Parties hereto have requested that this Service Agreement be drafted in the English language.  Les Parties ont exigé que ce contrat de services soit rédigé en anglais.

 

 

IN WITNESS THEREOF, the Parties have executed
this Service Agreement 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 Pharma Inc.
	 	RedHill Biopharma Ltd.
	Per: 	/s/	 	Per:	/s/ Dror Ben-Asher	 
	Name: 	Yves Roy, Ph.D.

	 	Name: Dror Ben-Asher
	Title: 	President	Title: CEO	 
	 	 	 	 	 	 
	 	 	 	Per: 	/s/ Ori Shilo	 
	 	 	 	Name: Ori Shilo	 
	 	 	 	Title: VP Finance and Operation

 

 

 

    	 	Page 12 of 13	 

    
CONFIDENTIAL
Service Agreement - Y
RedHill Biopharma Ltd. – COREALIS Pharma Inc.
Manufacture of resupply of Clinical Trial Material of 
[****] RHB-104 capsules

    

 

Appendix I 

Professional
Consultation Rates

	Professional

        (Chemist or Engineer)
	Hourly Rate*,
        **

        ($USD)

	Senior scientist	[****]
	Scientist	[****]
	Technician	[****]
	
        R&D laboratory overhead

        ( Equipment and supplies)
	[****]

 

 

Analytical Services

	Analyses

         
	Cost / Sample *

        ($USD)

	[****]	[****]
	[****]	[****]
	[****]	[****]
	[****]	[****]
	[****]	[****]
	[****] ****	[****]
	[****] ****	[****]
	[****] ****	[****]
	[****]	[****]
	[****]	[****]
	[****]	[****]
	[****]	[****]
	[****]	[****]
	[****]	[****]
	[****]	[****]
	[****]	[****]

	*	Prices
    can be changed by Corealis without any prior notice. Prices apply only
    for non GMP work and analysis. GMP prices will be supplied on demand.
	**	All expenses will be
    charged at cost.
	***	Will be invoiced in
    addition to the professional fees when laboratory work is required.
	****	A set-up charge of
    [****] method will be invoiced in addition to the sample cost.

 

Page 13 of 13Exhibit 4.16

 

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.

 

 

Dror Ben-Asher

CEO

RedHill Biopharma ltd.

21 Ha’arba’a Street

Tel Aviv 64739

Israel

 

July, 5th 2011

Dear Mr Ben-Asher,

 

Reference is made to Master Service Agreement executed between 7810962
Canada Inc. and Redhill Biopharma Ltd on 28 April 2011 in relation to RedHill’s RHB-104 program.

 

This letter is to confirm that 7810962 Canada Inc agree to extend
our undertakings and obligations to the development of RHB-105. The extension of our obligations does not oblige 7810962 Canada
Inc. to perform particular studies or services for the development of RHB-105 and any studies or services that we perform for Redhill
Biopharma Ltd will be following our written approval.

 

This letter agreement shall be construed and enforced in accordance
with, and the rights of the parties shall be exclusively governed by, the laws of the United Kingdom. Any disputes arising out
of this agreement shall be submitted to the exclusive jurisdiction of the courts of London, England and all proceedings shall be
drafted and conducted using only the English language.

 

Yours sincerely,

 

/s/ Alain Guimond________

Name: Alain Guimond PhD

Function: Senior Director of Research

Date: July 5th, 2011

 

For acknowledgement and agreement:

 

Name: Dror Ben-Asher

Function: CEO, RedHill Biopharma Ltd.

Date: July 5, 2011

 

Exhibit 1: Letter Agreement dated 28 April 2011

 

     

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

 

Exhibit 1 – Terms
of Service Agreement with 7810962 Canada Inc 

 

 

		BETWEEN:	7810962 Canada Inc., a
corporation duly incorporated under the laws of Canada and having its principal place of business at 5320 13e Avenue,
Montréal, Québec, H1X 2X8;

 

			(hereinafter referred to as “7810962”)

 

		AND:	RedHill Biopharma Ltd., a corporation duly incorporated under the laws of Israel and having its
principal place of business at 21 Ha’arba’a Street, Tel Aviv 64739, Israel;

 

(hereinafter referred to as the “Client”)

 

When signed by both parties, this Exhibit will form an integral
part of the Master Agreement executed between them on the date hereof and will set forth the specific services, details and schedule
as well as the specific payment terms and conditions under which the Client agrees that 7810962 will provide manufacturing development
services for the Client’s RHB-105 product.

 

Terms:

 

The Client agrees that 7810962 enters into a subcontract with Corealis
Pharma Inc. on the terms set out in the Proposal to be executed between 7810962 and Corealis Inc. as shown below in Exhibits 2.
For further clarity, the Client agrees with the cost described in Exhibit 2 and agrees to the payment schedule as described in
Exhibit 2.

 

IN WITNESS WHEREOF, this Proposal has been executed by the parties
hereto through their duly authorized officers on the date(s) set forth below.

 

For the Client:

 

Name: Dror Ben-Asher

Title: CEO

Date: July 5, 2011

 

 

For 7810962:

/s/ Alain Guimond PhD

Name: Alain Guimond PhD

Title: Senior Director of Research

Date: July 5, 2011

 

 

    	 	2	 

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

Exhibit 2

 

Service Agreement - A

Formulation development of RHB-105
in oral solid dosage form 

and manufacture of Phase III Clinical Trial Supplies

 

This service Agreement
is made and entered into this 5th day of July, 2011 (the “Service Agreement”).

 

		BETWEEN:	COREALIS Pharma, Inc., a corporation duly incorporated under the laws of Canada and having
its principal place of business at 200 Armand-Frappier, Laval, Québec, Canada, H7V 4A6;

 

			(hereinafter referred to as “Corealis”)

 

		AND:	7810962 Canada Inc., a
corporation duly incorporated under the laws of Canada and having its principal place of business at 5320 13e
Avenue, Montréal, Québec, H1X 2X8;

 

			(hereinafter referred to as the “Client”)

 

			(Corealis and the Client are at times referred to individually as the “Party” and collectively
the “Parties”)

 

RECITALS

 

		A.	The Client and Corealis entered into a Master Service Agreement dated July 5, 2011 (the “MSA”).

 

		B.	The Parties hereto wish to describe the
services to be performed in connection with the MSA, subject to the terms and conditions set forth herein and in the MSA.

 

		C.	Unless the context otherwise requires,
all capitalized terms used in this Service Agreement shall have the meanings attributed to them in the MSA.

 

		1.	INTERPRETATION

 

The recitals of this Service Agreement as well as all
of its Appendices form an integral part of this Service Agreement.

 

		2.	DESCRIPTION AND DELIVERABLES

 

		2.1-	[****] study 

The Drug-Drug compatibility study will be limited to
[****] and [****] since [****]
these molecules have [****] (i.e. [****] and [****]
respectively) and thus it is highly probable that they will [****] the [****]
moleculewhich is very [****] in an [****] environment.
The [****] and [****] will be [****]
under [****] and [****] conditions and stored in [****]
and [****] containers under the following conditions of temperature and humidity: The mixture
will be and for their (and) at each time points

 

 

    	 	1	 

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

	Storage 

Condition	
        Time point

        (Day)

	Initial	[****]	[****]
	[****]	[****]	[****]	[****]
	[****]	[****]	[****]

X: Sample to be
analyzed.

Y:
Sample removed from chamber and analyzed only at the request of Client if the [****] sample fails in stability.

 

		Cost:	[****]

*
Cost based on the analysis of the two APIs (i.e., [****] and [****]) for [****] samples ([****] X 4 conditions ([****] [****]
[****] and [****]) X 3 time points) at $ [****]/sample AND [****] analytical set-ups ([****] time points [****]/ time point) at
$[****]/ set-up.

 

		2.2-	Formulation development

Three drug products will be developed:

		·	[****] ([****] [****]
and [****]), and;

		·	[****] ([****] [****] and
[****]), and;

		·	[****] ([****] [****]
and [****]).

The following processes will be considered: [****]
followed by [****]. [****] will be [****].
[****] will be assessed by [****] and [****]
profile with [****].The formulation should be [****]
in capsule [****]. [****] will be considered.

 

Cost:                                  [****]

 

		2.3-	Analytical method development and analysis

Corealis will perform the development and optimization
of the analytical methods based on [****] The methods are [****],
[****], [****], [****],
[****] as well as all necessary methods including, but not limited to, [****] and [****]
method for the manufacturing of the Phase III CTM (as required by the FDA). Also in support of the formulation development activities
(i.e., section 2.2) the Corealis analytical group will support the formulators by executing the analyses required for rapid development
of the Drug Product.

 

Cost:                                    [****]

		2.4-	Stability of prototype formulations

Corealis will provide the following:

		·	Justification of up to [****] for non-GMP stability study;

		·	Manufacturing and packaging of up to [****];

 

    	 	2	 

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

		·	Sample incubation under the following conditions of temperature and humidity: [****];

		·	Justification of finished product specifications;

		·	Physico-chemical characterization at each of the following conditions (Includes: Appearance, Assay*,
Degradation Products*, Dissolution* and Water content).

 

The samples will be placed in Corealis'
stability chambers and the following stability testing schedule will be used:

 

	Storage 

Condition	Time point ([****])
	Initial	[****]	[****]	[****]	[****]	[****]	[****]
	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]
	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]
	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]

X: Sample to be
analyzed.

Y: Sample removed
from chamber and analyzed only at the request of Client.

 

		Cost:	$32,016**

* On
the [****] APIs.

**
The decision of testing the highest and lowest strength only and extrapolating the stability results to the middle dosage strength
(bracketing) will be taken by the Client.

***
Based on [****]/ sample using a bracketing study design.

 

 

 

 

    	 	3	 

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

		2.5-	Manufacturing of the Phase III Clinical Trial Material (CTM) 

The CTM manufacturing, packaging, equipment calibration
and validation, cleaning and raw material release will be done by Corealis GMP laboratory. All the manufacturing, packaging and
analytical equipments that will be used for this CTM manufacturing project will be calibrated, validated and released for their
cleanliness prior to their utilization.

 

		2.5	a)   GMP material storage and handling

Corealis will handle the reception, the shipping and
the storage of GMP materials in its cGMP warehouse. All material handling operations and storage conditions will respect the ICH
GMP requirements.

 

		Cost:	$1,455*

*
The cost includes:

		·	the
                                         reception of one lot of each of the three GMP APIs (i.e., documentation review, material
                                         registration in Corealis inventory, and material sampling following GMP requirements)
                                         (If API lot is in more than one container then the sampling and ID testing of each of
                                         the additional containers will be considered Extra Work at [****]/additional container),

		·	the
                                         ID testing for the release of the three lots of APIs (one for each API) using validated
                                         methods. (Client will ship the GMP APIs to Corealis with the complete certificate of
                                         analysis otherwise Extra Work may be required to release the GMP APIs.),

		·	the
                                         GMP warehousing of the API and the drug product until completion of the study. If the
                                         material needs to be stored for a longer period of time then the storage cost will be
                                         [****].

		·	the
                                         shipping document preparation and shipment of material.

The
cost does not include: 

		·	The
                                         purchase of the analytical reference materials to be used as a standard, if needed, reference
                                         impurities (synthesis by-products, degradation products, metabolites) of known purity
                                         estimated cost is [****]. Subject to pre-approval in writing by the Client of the purchasing
                                         of the materials, Corealis will order the materials. The cost of the materials and any
                                         related costs (e.g. transportation or custom fees) will be charged at cost to Client
                                         and will not exceed a cap of [****].

		·	Subject
                                         to pre-approval in writing by the Client, repackaging of material (if required) as well
                                         as the shipping cost and custom fees, if any, provided not exceeding a cap of [****].

 

		2.5	b)  GMP Manufacturing, packaging and labelling

Corealis will manufacture and package the CTM from the
selected Drug product formulation. The three dose strengths ([****], [****],
and [****] or [****], [****],and
[****]) of the selected solid dosage form and its matching placebo will be manufactured using
the cGMP APIs supplied by Client. The placebo blend will be similar to the active blend except for the APIs. In addition to the
CTM manufacture, Corealis will perform all necessary receipt and release of required excipients, packaging components, and labels.

 

Specifically with respect to manufacturing, packaging
and labeling, the followings items will be provided by Corealis:

		a)	Recommendation and justification of specific finished product release, in process testing, stability
as well as excipients and packaging components specifications,

 

    	 	4	 

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

		b)	Formulation and process information for the redaction of Master Manufacturing File (MMF)

		c)	The CTM will be manufactured and packaged/labeled in [****] bottles
with induction seal at [****] units per bottle:

·        
[****] – [****] units*;

·        
[****] – [****] units*;

·        
[****] – [****] units*;

·        
RHB-105 placebo – [****] units*.

		d)	Monitoring and supervision of the manufacturing, packaging and analytical operations.

 

		Cost:	$136,875**, ***

*
Includes [****] capsules of [****] for the CTM [****] study: [****] bottles of [****] capsules/ time point/ condition and [****]
bottles of [****] capsules for [****] (to be done [****]). It includes also [****] of placebo.

**Based
on the hypothesis that the [****]. If the [****] then, subject to pre-approval in writing by the Client, the following CTM will
be [****] at an additional cost of [****].

		·	[****]
                                         - [****] units;

		·	[****]
                                         - [****] units;

		·	[****]
                                         - [****] units;

		·	RHB-105
                                         Placebo [****] units.

This
same additional cost of [****] will apply in case the decision is taken to [****] detailed in [****].

***If
the manufacture of the placebo units is not needed then cost will be reduced by [****].

 

		2.5	c)   Analytical method validation

The analytical methods for the three strengths dosages
developed by Corealis will be validated in its GMP laboratory. The method will be validated according to ICH guidelines. The method
for cleaning verification will also require complete validation.

 

		Cost:	$75,100*

* Includes
analytical method validation of assay and content uniformity, related substances, and dissolution for the three strengths as well
as for cleaning. If required and pre-approved in writing by the Client, the analytical method validation for the microbial limit
will be done at an additional cost of [****].

 

    	 	5	 

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

		2.5	d)  Release testing and cleaning verification

The release of the CTM will be performed by the Corealis
GMP laboratory as well as the cleaning verification samples (swabs).

 

The placebo will also be tested for the absence of active.

 

Analyses to be performed are:

 

	 •	[****]*,	 	 •	[****]**,
	 •	[****]*,	 	 •	[****]***,
	 •	[****],** [****]**,	 	 •	[****]****.

 

		Cost:	$23,383*****

*
Analyse done also on placebo.

**
For the [****] APIs.

***
A dissolution test is [****].

****
Done only if requested by the Client.

*****
Cost includes the release of one lot of each of the three strengths as well as one lot of placebo. If required and pre-approved
in writing by the Client, the analysis of microbiolgy will be done at an extra cost of [****].

 

		2.5	e)   Stability of the CTM

The CTM will be stored in a cGMP stability chamber at
[****]. Two strengths of the finished product (highest and lowest dose strengths)** will be
characterized for appearance, assay, related substances, dissolution* and water content using the schedule below. Placebo will
be placed at [****] for appearance, water content and used for degradation products background
subtraction and will be analyzed only if needed.

 

The samples will be placed in cGMP stability chambers
and analyzed using validated methods. The following stability testing schedule will be used and modified per mutual agreement:

	Storage Condition	Time point [****]
	Initial	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]
	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]
	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]
	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]	[****]

X:
Sample to be analyzed for appearance, assay, related substances, dissolution* and water content.

Y: Sample removed
from chamber and analyzed only at the request of Client.

 

		Cost:	$88,800***

*
A dissolution test is a single time point and six vessels/ time point.

**
The decision of testing only the highest and lowest dose strength and extrapolating the stability results to the [****] will be
taken by the Client.

***
Based on the analysis of [****] using a bracketing study design. The analyses of placebos [****] will be done only if requested
and pre-approved in writing by the Client and they are not included in the cost above. 

 

    	 	6	 

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

 

		2.6-	Reports and submission documentation

	 •	Telephone meetings will be held on a weekly basis on a specific day of the week and at a specific time agreed to by the Parties.
	 •	Client or Client’s representative meeting in Corealis facility will be held at Client’s request.
	 •	Corealis facility and quality audit by Client’s or Client’s representative will be held at Client’s request.
	 •	Progress reports will be provided on a weekly basis.
	 •	Item reports will be provided as they are completed.
	 	 	 
	 •	The final development report(s) will include the followings:
	 	o	  The methodology and the results;
	 	o	The
finished products release & stability specifications, in process specifications and specific APIs, excipients and packaging
specifications. Specifications will be provided, for US submissions;
	 	o	The
final formulation and manufacturing process.
	 •	A final manufacturing process report will be provided at the end of the study. It will include all the necessary submission documents related to manufacturing and packaging which include (but are not limited to): 
	 	o	The finished products release & stability certificate of analysis. 
	 	o	In process results. 
	 	o	QA Reviewed and audited Manufacturing and Packaging Documents.
	 	o	Certificate of cGMP compliance.
	 	o	Certificate of analysis of raw materials and packaging components. 
	 	o	Any atypical report or Out-of-Specification reports.

 

Cost:                   $[****]*

*
Based on a value of [****] of the sub-total of all invoices before taxes. If [****], [****] and [****] are selected for the manufacturing
of the CTM, then the cost for section 2.6 will be $[****].

 

		3.	GENERAL PROJECT TIMELINES

 

[****]

 [****]

 

 

 

 

		4.	STARTING DATE AND COMPLETION

 

		4.1	Notwithstanding the date of signature of this Service Agreement,
Corealis shall start the performance of the Services within ten (10) business days after Corealis'
satisfaction of the following: 

 

		4.1.1	signature by the Client of this Service Agreement; and

 

    	 	7	 

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

 

		4.1.2	complete delivery by the Client of all of the items mentioned
at sub-sections 6.1 to 6.3 inclusive of section 6 hereof entitled “REQUIREMENTS”. 

 

		4.2	This Service Agreement shall be deemed completed upon full delivery
of the Services by Corealis and receipt by Corealis of the final and last payment for the Services.

 

		5.	ASSUMPTIONS

 

		5.1	The target formulation of RHB-105 will be the following drug
products with the three actives (The ‘APIs’) combined with pharmacopeia excipients and compressed or encapsulated:

 

		·	[****] with [****], [****], and [****]

		·	[****] with [****], [****], and [****]

		·	[****] with [****], [****], and [****]

 

In
the event that [****] the [****] will be considered
[****]:

 

		·	[****] with [****], [****], and [****]

		·	[****] with [****], [****], and [****]

		·	[****] with [****],[****], and [****]

 

		5.2	The best efforts will be made by Corealis to select excipients
and processes that will comply with the anticipated cGMP manufacturing site.

 

		5.3	The best efforts will be made by Corealis to reduce the project
timelines. 

 

		5.4	When decisions need to be taken to move forward in the project
at the decision time point, the Client will provide its decision in writing to Corealis within a period of 5 days. Otherwise the
project may be delayed. Corealis will develop a final timeline for this project and all deviations will be immediately reported
to the Client. Corealis will make its best efforts to correct all deviations in order to maintain the project timelines. 

 

		5.5	All APIs will be sourced by Client. Non-GMP material can be used
in the development phase however it should be of identical quality as the GMP material that would be use in the GMP manufacturing.

 

		6.	REQUIREMENTS

 

The Client shall provide to Corealis, at no cost to Corealis, the
following:

 

		6.1	All the available information on APIs (e.g.: interactions, stability,
impurities). 

 

		6.2	The APIs, reference materials to be used as a standard, reference
impurities (synthesis by-products, degradation products, metabolites) of known purity, certificate of analysis and APIs’
MSDS. 

 

    	 	8	 

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

		6.3	For the formulation development, a minimum quantity of [****]
of [****] [****] of [****] and [****] of [****] as well as sufficient quantities of related substances (standards, references,
impurities) for each APIs. 

 

		6.4	For cGMP manufacturing of CTM, a minimum quantity of [****] of
[****] [****] of [****] and [****] of [****] will be required. 

 

		7.	COST AND PAYMENTS

 

		7.1	The cost of the Services is up to $[****] ($[****] with a rebate
of $[****])or up to $[****] if the placebo manufacture are not required (section 2.5 b)). Any amount exceeding a total of $[****]
requires a pre-approval in writing by the Client.

 

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

 

		7.2.1	$[****] upon signature of this formulation development project Agreement;
and 

 

		7.2.2	$[****] at the initiation of the stability study for the prototypes;
and 

 

		7.2.3	$[****] ($[****] if placebo manufacture are not required) at the
initiation of the CTM manufacturing; and 

 

		7.2.4	$[****] ($[****] if placebo manufacture are not required) at the
completion of the CTM manufacturing report issued by Corealis; and

 

		7.2.5	$[****] at the acceptance of the final CTM manufacturing process
report by the Client in writing as a final report; and

 

		7.2.6	Stability studies (prototypes [****]
(as per section 2.4) and CTM [****] as per section 2.5 e) to be invoiced as per the following
schedule of payment.

 

Installments for the stability of prototype formulations

 

	Expected date that material will be introduced in stability chamber	[****]
	 	Time Point [****]
	0	1
	Date of pull out	[****]	[****]
	Date Results available	[****]	[****]
	Month of invoice	[****]	[****]
	Amount to be invoiced	[****]	[****]
	 	 	 	 

 

    	 	9	 

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

Installments for the CTM stability study 

 

	Expected date that material will be introduced in stability chamber	[****]
	 	Time Point [****]
	1	2
	Date of pull out	[****]	[****]
	Date Results available	[****]	[****]
	Month of invoice	[****]	[****]
	Amount to be invoiced	[****]	[****]
	 	Time Point [****]
	[****]	[****]
	Date of pull out	[****]	[****]
	Date Results available	[****]	[****]
	Month of invoice	[****]	[****]
	Amount to be invoiced	[****]	[****]
	 	Time Point [****]
	[****]	[****]
	Date of pull out	[****]	[****]
	Date Results available	[****]	[****]
	Month of invoice	[****]2	[****]
	Amount to be invoiced	[****]	[****]
	 	Time Point [****]
	[****]	[****]
	Date of pull out	[****]	[****]
	Date Results available	[****]	[****]
	Month of invoice	[****]	[****]
	Amount to be invoiced	[****]	[****]
	 	 	 	 

 

		7.3	Notwithstanding section 7.1, for any extra work not covered by
this Service Agreement and agreed upon in writing between the Parties (the “Extra Work”), the Client shall pay to Corealis
the hourly rates and other fees indicated in this Appendix I attached hereto for the performance of the Services (The costs of
the Services for the Extra Work and described in section 7.1 are collectively, the “Fees”).

 

		7.4	Notwithstanding section 7.2 hereof, Corealis will invoice the
Client for the Extra Work, on a monthly basis for the Services that have been delivered or rendered by Corealis. The Client shall
pay Corealis for these Services to the extent their performance has been pre-approved in writing by the Client.

 

		8.	CONFIDENTIALITY

 

		8.1	Confidentiality issues are covered per the Non Disclosure Agreement
and the MSA.

 

		9.	REPRESENTATIONS AND WARRANTIES

 

		9.1	Corealis hereby represents and warrants to the Client that: 

 

		9.1.1	it is a duly organized and validly existing corporation under
the laws of the jurisdiction in which it is incorporated; 

 

		9.1.2	it has the necessary corporate power, authority, skills, and
capacity and is properly authorized to enter into this Service Agreement and to perform its obligations as per the terms and conditions
of this Service Agreement. The execution and delivery of this Service Agreement and the performance of the transactions contemplated
hereby have been duly authorized.

 

    	 	10	 

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

		9.2	The Client hereby represents and warrants to Corealis that: 

 

		9.2.1	it is a duly organized and validly existing corporation under
the laws of the jurisdiction in which it is incorporated; 

 

		9.2.2	it has the necessary corporate power, authority, skills, and
capacity and is properly authorized to enter into this Service Agreement and to perform its obligations as per the terms and conditions
of this Service Agreement. The execution and delivery of this Service Agreement and the performance of the transactions contemplated
hereby have been duly authorized; 

 

		10.	TERMS AND CONDITIONS

 

		10.1	This Service Agreement shall be governed, construed and interpreted
according to the laws in force in the Province of Quebec and the applicable laws of Canada therein, and the courts of the legal
district of Montreal, province of Quebec (Canada) shall have exclusive jurisdiction to hear any and all disputes arising hereunder.

 

		10.2	This Service Agreement is subject to the terms and conditions
provided in the MSA and bind the parties as well as their respective successors, permitted assigns and legal representatives.

 

		10.3	This Service Agreement may be executed in counterparts, each
of which shall be deemed to be an original and which together shall constitute one and the same agreement. This Service Agreement
may also be executed between the Parties by exchange of facsimile transmissions or electronic transmissions in legible form, including
without limitation in a tagged image format file (TIFF) or portable document format (PDF).

 

		10.4	The Parties hereto have requested that this Service Agreement
be drafted in the English language. Les Parties ont exigé que ce contrat de services soit rédigé en anglais.

 

IN WITNESS THEREOF, the Parties have executed this Service Agreement
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 Pharma Inc.

	 	

7810962 Canada Inc.

	 	 	 
	Per: 	
/s/

	 	
Per:

	/s/ Alain Guimond PhD	 
	Name: 	
[****]

	 	

Name: Alain Guimond PhD

	Title: 	

VP Pharmaceutical R&D

	

Title: Senior Director of Research

 

    	 	11	 

    

Service Agreement - A
7810962 Canada Inc. – COREALIS Pharma Inc.
Formulation development of RHB-105 in oral solid dosage form 
 and manufacture of clinical supplies

    

 

APPENDIX
I

 

	[****]Contract Formulation and Process 

Development

 

Professional
Consultation Rates

	
        Professional
        

        (Chemist
        or Engineer)
	
        Hourly
        Rate*, **

        ($USD)

	Senior scientist 	$240.00
	Scientist 	$200.00
	Technician	$110.00
	
        R&D
        laboratory overhead 

        ( Equipment
        and supplies)
	$ 75.00***

 

 

Analytical
Services

	
        Analyses

         
	
        Cost
        / Sample *

        ($USD)

	XRPD 	[****]
	SEM	[****]
	TGA	[****]
	DSC	[****]
	Water Content (Karl Fisher)	[****]
	Single point dissolution test/ vessel ****	[****]
	Assay****	[****]
	Related Substances****	[****]
	Disintegration	[****]
	Hygroscopicity (5 conditions)	[****]
	Solubility in water at pH 2, 4.5 and 7	[****]
	Flow, Grinding and Compressibility	[****]
	Particle Size and Distribution	[****]
	Bulk and Tap Density	[****]
	Organoleptic (texture, color, appearance)  	[****]

 

*
Prices can be changed by Corealis without any prior notice. Prices apply only for non GMP work and analysis. GMP prices will be
supplied on demand.

**All expenses
will be charged at cost.

***Will
be invoiced in addition to the professional fees when laboratory work is required.

****A set-up
charge of $[****]/ HPLC method will be invoiced in addition
to the sample cost.

 

12

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