UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 20-F/A
(Amendment No. 1)

¨
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
 
OR
 
x
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2013
 
 OR
 
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
OR
 
o
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of event requiring this shell company report ________________
 
Commission file number 001-35773
 
RedHill Biopharma Ltd.
(Exact name of Registrant as specified in its charter)
 
N/A
(Translation of Registrant’s name into English)
 
Israel
(Jurisdiction of incorporation or organization)
 
21 Ha’arba’a Street, Tel Aviv 64739, Israel
(Address of principal executive offices)
 
Ori Shilo, Deputy Chief Executive Officer Finance and Operations
21 Ha’arba’a Street, Tel Aviv 64739, Israel
Tel: 972-3-541-3131; Fax: 972-3-541-3144
 (Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
 
Securities registered or to be registered pursuant to Section 12(b) of the Act.
 
Title of class
 
Name of each exchange on which registered
     
American Depositary Shares, each representing ten Ordinary Shares (1)
 
Nasdaq Capital Market
     
Ordinary Shares, par value NIS 0.01 per share (2)
 
Nasdaq Capital Market
 
(1)
Evidenced by American Depositary Receipts.
(2)
Not for trading, but only in connection with the listing of the American Depositary Shares.
 
Securities registered or to be registered pursuant to Section 12(g) of the Act:
None
 
(Title of Class)
 
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
 
None
(Title of Class)
 
 
 
 
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: 64,399,692
 
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
 
Yes    No   ý
 
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act 1934.
 
Yes    No   ý

                Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
 
ý Yes    No
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
 
 Yes o    No o
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
 
Large Accelerated filer o Accelerated filer o Non-accelerated filer ý
 
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP o

International Financing Reporting Standards as issued by the International Accounting
Standards Board ý
Other o

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

Item 17 [  ]   Item 18  [  ]
 
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
 
Yes  o    No   ý
 
We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and, as such, may elect to comply with certain reduced public company reporting requirements.

 
 
 
EXPLANATORY NOTE

This Amendment No. 1 on Form 20-F/A (“Amendment”) to Annual Report on Form 20-F for the year ended December 31, 2013 (the “Original Form 20-F”) of RedHill Biopharma Ltd. (the "Company"), as originally filed with the Securities and Exchange Commission (the “Commission”) on February 25, 2014 (the “Original Filing Date”), is being filed solely to amend Exhibit 4.13 (the “Exhibit”) filed with the Original Form 20-F. The Company had sought confidential treatment under Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and 17 C.F.R. Section 200.80(b)(4), for portions of the Exhibit and, following correspondence and conversations with the Staff of the Commission’s Division of Corporate Finance (the “Staff”), is re-filing the Exhibit to address comments the Company received from the Staff in response to its request for confidential treatment.

The Exhibit filed herewith supersedes the Exhibit filed with the Original Form 20-F. Except for the revised Exhibit, this Amendment does not reflect any events that may have occurred subsequent to the Original Filing Date and does not modify or update any disclosures made in the Original Form 20-F. Additionally, in connection with the filing of this Amendment, the Company is including new certifications of the Company’s Chief Executive Officer and Deputy Chief Executive Officer Finance and Operations pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act. The Company is not including certifications pursuant to Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C.1350) as no financial statements are being filed with this Amendment No. 1.


 
 
 
 

 
 
 
 
EXHIBIT INDEX

The exhibits filed with or incorporated into this Registration Statement are listed in the index of exhibits below
 
Exhibit
Number
Exhibit Description
   
1.1
Articles of Association of the Registrant, as amended (unofficial English translation) (incorporated by reference to Exhibit 1.1 of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on February 25, 2014).
   
2.1
Form of Deposit Agreement among the Registrant, the Bank of New York Mellon, as Depositary, and all Owners and Holders from time to time of American Depositary Shares issued hereunder (incorporated by reference to Exhibit 1 to the Registration Statement on Form F-6 filed by The Bank of New York Mellon with the Securities and Exchange Commission on December 6, 2012).
   
2.2
Form of American Depositary Receipt (incorporated by reference to Exhibit 1 to the Registration Statement on Form F-6 filed by The Bank of New York Mellon with the Securities and Exchange Commission on December 6, 2012).
   
4.1†
 Exclusive License Agreement, dated November 18, 2009, by and between the Registrant and Egalet a/s (RHB-101) (incorporated by reference to Exhibit 4.1 to Draft Registration Statement on Form DRS disseminated with the Securities and Exchange Commission, dated December 3, 2012).
   
4.2
 Exclusive License Agreement, dated May 2, 2010, by and between the Registrant and SCOLR Pharma Inc. (RHB-102) (incorporated by reference to Exhibit 4.2 to Draft Registration Statement on Form DRS disseminated with the Securities and Exchange Commission, dated October 26, 2012).
   
4.3†
Co- Development and Commercialization Agreement, dated August 26, 2010, by and between the Registrant and IntelGenx Corp. (incorporated by reference to Exhibit 4.3 to Draft Registration Statement on Form DRS disseminated with the Securities and Exchange Commission, dated December 3, 2012).
   
4.4†
 Side Letter Agreement, dated January 31, 2013, by and between the Registrant and IntelGenx Corp. (incorporated by reference to Exhibit 4.4 of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on February 25, 2014).
   
4.5†
Asset Purchase Agreement, dated August 11, 2010, by and between the Registrant and Giaconda Limited (RHB-104, 105, 106) (incorporated by reference to Exhibit 4.4 to Draft Registration Statement on Form DRS disseminated with the Securities and Exchange Commission, dated December 3, 2012).
   
4.6†
License Agreement, dated September 15, 2011, by and between the Registrant and University of Central Florida Research Foundation (incorporated by reference to Exhibit 4.5 to Draft Registration Statement on Form DRS disseminated with the Securities and Exchange Commission, dated October 26, 2012).
   
4.7
Independent Consulting Agreement, dated as of August 23, 2010, by and between the Registrant and R.E. Investments (incorporated by reference to Exhibit 4.8 to Draft Registration Statement on Form DRS disseminated with the Securities and Exchange Commission, dated October 26, 2012).
   
4.8†
Master Service Agreement, dated April 28, 2011, by and between the Registrant and 7810962 Canada Inc. and amendment (incorporated by reference to Exhibit 4.12 to Draft Registration Statement on Form DRS disseminated with the Securities and Exchange Commission, dated October 26, 2012).
   
4.9†
Second Amendment to Master Services Agreement, dated May 29, 2013 by and between the Registrant and 7810962 Canada Inc. (incorporated by reference to Exhibit 4.9 of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on February 25, 2014).
 
 
 
 
 
4.10†
Manufacturing Agreement, dated April 28, 2011, by and between 7810962 Canada Inc. and the Registrant (regarding RHB-104) and amendments (incorporated by reference to Exhibit 4.13 to Draft Registration Statement on Form DRS disseminated with the Securities and Exchange Commission, dated December 3, 2012).
   
4.11†
Manufacturing Agreement, dated October 21, 2012, by and between 7810962 Canada Inc. and the Registrant (regarding RHB-104) (incorporated by reference to Exhibit 4.14 to Draft Registration Statement on Form DRS disseminated with the Securities and Exchange Commission, dated October 26, 2012).
   
4.12†
Clinical Services Agreement, dated June 15, 2011, by and between RedHill and 7810962 Canada Inc. and amendment (regarding RHB-104) (incorporated by reference to Exhibit 4.15 to Draft Registration Statement on Form DRS disseminated with the Securities and Exchange Commission, dated December 3, 2012).
   
4.13†
Second Amendment to Clinical Services Agreement, dated January 19, 2014, by and between the Registrant and 7810962 Canada Inc.
   
4.14
Form of Letter of Exemption and Indemnity adopted on July 2013 (unofficial English translation) (incorporated by reference to Exhibit B to Exhibit 99.1 to Form 6-K disseminated with the Securities and Exchange Commission, dated June 26, 2013).
   
4.15
2010 Stock Option Plan, as amended (incorporated by reference to Exhibit 4.15 of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on February 25, 2014).
   
4.16
Form of Share Purchase Agreement, dated November 26, 2012 by and between the Registrant and each of the investors (incorporated by reference to Exhibit 4.19 to Draft Registration Statement on Form DRS disseminated with the Securities and Exchange Commission, dated December 18, 2012).
   
4.17
Securities Purchase Agreement, dated December 30, 2013 by and between the Registrant and OrbiMed Israel Partners Limited Partnership (together with Form of Warrant attached as Exhibit A) (incorporated by reference to Exhibit 4.17 of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on February 25, 2014).
   
4.18
Securities Purchase Agreement, dated December 31, 2013 by and between the Registrant and Broadfin Healthcare Master Fund, LTD (together with Form of Warrant attached as Exhibit A) (incorporated by reference to Exhibit 4.18 of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on February 25, 2014).
   
4.19
Form of Share Purchase Agreement, dated January 13, 2014 by and between the Registrant and each of the investors (together with Form of Warrant attached as Exhibit A) (unofficial English translation) (incorporated by reference to Exhibit 4.19 of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on February 25, 2014).
   
12.1
Certification by Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
   
12.2
Certification by Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
   
13*
Certification by Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
   
15.1*
Consent of Independent Registered Public Accounting Firm.
 
*
Previously filed with the Annual Report on Form 20-F filed with the Securities and Exchange Commission on February 25, 2014.
 
†
Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.
 
 
 
 
SIGNATURE
 
 The Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.
 
 
 
 REDHILL BIOPHARMA LTD.
 
     
     
 
By:
/s/ Dror Ben-Asher
 
   
Name:
Dror Ben-Asher
 
   
Title:
Chief Executive Officer and Chairman of 
the Board of Directors
 
       
       
 
By:
/s/ Ori Shilo
 
   
Name:
Ori Shilo
 
   
Title:
Deputy Chief Executive Officer Finance
and Operations
 
 
Date:  July 7, 2014
 
Exhibit 4.13
 
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 2 to Clinical Services Agreement

Sponsor’s study drug RHB-104


THIS AMENDMENT #2 (“ Amendment ”) to the Clinical Services Agreement signed 15 June 2011 (“ Clinical Services Agreement ”), is by and among:
 
 
(1) (1) RedHill Biopharma Ltd., having its principle place of business at 21 Ha’arba’a St., Tel Aviv 64739, Israel (hereafter “ SPONSOR ”);
 
     
 
(2) 7810962 Canada Inc., a Canadian corporation, having its principal office at 245 Victoria Ave, Suite 100, Montreal, Quebec, H3Z 2M6, Canada (hereinafter " MANAGER ");
 

 
Is hereby made effective as of December 11, 2013 (“ Effective Date ”) and the parties hereby agree as follows:
 
 
1.
Amendment 2 to Clinical Services Agreement.

This Change Order constitutes an amendment to the Clinical Services Agreement pursuant to section 3.0 therein.  As such, this Change Order is subject in all respects to the terms and provisions of the Clinical Services Agreement.

 
2.
Scope of Work

In addition to the Services to be provided in the above-referenced Clinical Services Agreement, Manager will cause inVentiv Health Clinical to perform additional Services for Sponsor’s study drug RHB-104, in accordance with the Summary of Changes attached hereto and incorporated herein as Exhibit A. The EU trial is removed from the contract in this amendment to the trial agreement.
 
 
3.
Compensation

Under this Change Order, inVentiv Health Clinical’s Professional Fees have decreased by the discounted amount of USD [****], the pass-through costs have increased by USD [****] and the investigator’s grants costs have Increased by USD [****]. The total cost of the Clinical Services Agreement have increased to USD 10,540,751.

 
 
 
Exhibit 4.13
 
Payment due to Manager for the Services provided under this Change Order shall be made pursuant to the Agreement and the revised unit Payment Schedule attached hereto and incorporated herein as Exhibit B.

 
4.
Project Period

The term of this Change Order shall commence on the date of its execution and shall continue until the Services as described in the Clinical Services Agreement are completed, unless this Change Order or corresponding Clinical Services Agreement are terminated early in accordance with the Clinical Services Agreement.


By their signatures below, the parties hereto agree to the terms of this Change Order and represent that they are authorized to enter into this Change Order on behalf of their respective companies.


ACCEPTED AND AGREED TO:

RedHill Biopharma Ltd.
For 7810962 Canada Inc
       
       
/s/ Dror Ben-Asher
  /s/ Alain Guimond  
    Name: Alain Guimond
Name: Dror Ben-Asher Title: Sr Director of R&D
       
Title: CEO      
    Date: January 10, 2014
       
Date: January 19, 2014
   
       
       
       
RedHill Biopharma Ltd.    
       
/s/ Ori Shilo      
Name: Ori Shilo      
       
       
Title: Deputy CEO Finance and Operations    
       
       
Date: January 19, 2014
   
 
 
 
 
Exhibit 4.13
 
Exhibit A: Summary of Changes
 
Study Assumption Changes
 
Changes to the parameters and assumptions for the study are defined below. Unless otherwise noted, activities will be performed according to the original contract. EU trial is removed from the study agreement
 
Amendment #2 RedHill Biopharma
 
Overview of major level changes

Category
Contract
Change Order –
NA Project
Rationale for change
Study Start- Up period
[****]
[****]
Work on global project began mid-July2011, with kick-off meeting August 10, 2011. Final protocol for NA expected early September, and then delayed until December 2011. [****]. On Mar. 1, 2012, the project was put on hold with an agreed upon charge of $[****]K/month; a contract amendment was put in place. The hold lasted [****] months, at which time inVentiv Health Clinical was instructed to restart start-up activities in full. Start-up activities continue.
Enrolment period
[****]
[****]
Per client
Stats Timeline
[****]
[****]
 
# of countries
[****]
[****]
EU sites are removed from the study agreement. [****] .
# of sites
[****]
[****]
Per client
# of subjects
[****]
[****]
Per client
# of CRF pages/book
[****]
[****]
Number of visits in NA study has [****] [****]
# of unique CRF pages
[****]
[****]
CRFs are complete [****] .
# RMVs per site
[****]
[****]
Calculated based on total number of CRF pages. [****]
# of PSVs
[****]
[****]
Additional sites, therefore additional PSVs
# of SIVs
[****]
[****]
Additional sites, therefore additional SIVs
# of RMVs
[****]
[****]
Additional CRF pages to be monitored (as detailed above), therefore additional RMVs required
# of COVs
[****]
[****]
Additional sites, therefore additional COVs
# of internal meetings
[****]
[****]
Dependent upon duration of trial: meetings typically held weekly during start-up and enrolment, then monthly thereafter
# of client telecons
[****]
[****]
Dependent upon duration of trial: meetings typically held weekly during start-up and enrolment, then monthly thereafter
 
 
3
 
 
Category
Contract
Change Order –
NA Project
Rationale for change
Investigator Meeting
[****]
[****]
Per client
# of vendors
[****]
[****]
[****]
# of edit checks
[****]
[****]
[****] : have 2 unique databases now, and larger CRF for each
# of imports
[****]
[****]
[****] : imports occur monthly from FPI to LPO plus one month, plus 1 test and 1 final
# of SAEs
[****]
[****]
Increased because # of subjects has increased. Assume 5% SAE rate in each study.
# of SAE Narratives
[****]
[****]
As above. Require 1 narrative for each SAE.
IVRS
[****]
[****]
Client request to include IVRS for randomization with 1 drug assignment/site, and unblinding capability
eCRF Changes
[****]
[****]
Amended protocol required changes to the previously finalized eCRF


 
 
 
 
 
 
4
 
Confidential
 
 
1.1
Revised Costs
 
Costs for this study are presented below in two categories, pass-through costs and professional fees.
 
1.1.1
Pass-Through Costs
 
Pass-through costs are in US dollars and include, but are not limited to, those expenses listed below. Manager will invoice Sponsor for actual costs in these areas. Actual costs will be kept to reasonable levels through adherence to inVentiv Health Clinical’s travel policy and prudent negotiation with outside providers. Pass-through costs are presented in the table below:
 
Task
Original
(USD)
New NA
(USD)
Assumption
Changes
influencing the
change in the
budget
Additional
comments
         
Site Visit Travel
[****]
[****]
Original contract has a total of [****] site visits. [****]
 
Investigators' Meeting Organisation
[****]
[****]
WebEx costs included in original budget. Investigator meetings have been changed to F2F.
 
Kick-off Meeting Travel/Attendance
[****]
[****]
Originally assumed [****] cover study globally, as studies and timelines were the same. Now assume [****] for each study, since timelines are vastly different and study teams not identical.
 
Shipping/Photocopying
[****]
[****]
Original contract assumes [****] . New NA budget assumes [****] .
 
Translation
[****]
[****]
Original contract [****] . New NA budget [****] ;
Costs for translating patient recruitment materials have been removed as this service is not included in updated budgets.
Regulatory Fees
[****]
[****]
assumed [****] .
Current costing tool separates out
 
 
 
 
Confidential
 
 
Task
Original
(USD)
New NA
(USD)
Assumption
Changes
influencing the
change in the
budget
Additional
comments
[****] (& Regulatory) Fees
[****]
[****] New NA costing assumes [****] . Regulatory Fees and [****] fees, as seen in EU costing. For original costing and new NA costing, these fees remain combined.
EDC Studies/3G Cards
[****]
[****]
[****]
 
[****]
[****]
[****]
 
[****]
EDC Fees ([****])
[****]
[****]
 
EDC Fees were included in Professional Fees in initial bid
 Pass Through Costs
[****]
[****]
   

 
 
 
 

 
 
 
 
Confidential
 
 
1.1.2
Investigator Grants Costs
 
Investigator
Grants
Original
(USD)
NA
(USD)
Assumption Changes
influencing the
change in the budget
Additional
Comments
 
[****]
$4,800,000
Original contract assumed [****] patients. New NA costing assumed [****] patients
Estimate only. Will be paid based on actual costs as approved by the Client.
 
 
 
1.1.3
Professional Fees
 
Based on the parameters and assumptions outlined in the original proposal, inVentiv Health Clinical fees are categorised by major activity in the table below and in USD:
 
 
Task
Original
(US Dollars)
New NA
(US Dollars)
Assumption Changes
influencing the change in
the budget
Additional comments
Pre-study Activities
       
Case Report Form Preparation/Review
[****]
[****]
[****]
Original costs were to prepare one CRF that would be utilized by both studies; with different study designs now we are preparing two different CRFs but are able to take efficiencies on pages that will be the same in both studies. Additionally, number of visits in NA study has [****] since details provided in protocol synopsis in April 2011
Data Management Plan Preparation/Review
[****]
[****]
[****]
Originally cost allocation was to prepare one plan to be utilized by both studies; with different study designs now we are preparing two different DM plans.  We are able to copy some aspects/pages of the DM plan from the NA study to the EU study, and where there are not similarities we have allocated cost for new pages/edit specs.
Informed Consent Preparation/Review
 
[****]
[****]
[****]
 
[****]
 
[****]
[****]
[****]
 
Investigators' Meetings
 
[****]
[****]
[****]
 
 
 
 
 
 
Confidential
 
 
Task
Original
(US Dollars)
New NA
(US Dollars)
Assumption Changes
influencing the change in
the budget
Additional comments
Investigator Site Contract
 
[****]
[****]
[****]
 
Investigator Recruitment
 
[****]
[****]
[****]
[****]
Project Plan Preparation/Review
[****]
[****]
[****]
[****] Assumed that there are efficiencies in the preparation of the EU plan based on finalization of the plan in NA due to similar process where applicable.  EU IPP plan will be different based on countries included outside NA and Israeli.
Protocol Preparation/Review
[****]
[****]
[****]
Assumes a separate CRA team is reviewing/reading protocol due to countries not being the same.  With the start of the EU study subsequent to the NA, there is also a separate team in many functional areas, i.e., separate DM team, biostats, medical writing, and safety.
Randomization Schedule Preparation
[****]
[****]
Originally allocated cost for
[****] and now doing [****]
 
Study-Specific Form Preparation
[****]
[****]
Originally allocated cost for [****] Now [****]
Efficiencies will be applied in EU study: assume use NA forms modified to suit EU study
Training - Project-Specific
[****]
[****]
Originally allocated cost for [****]
Training two separate teams w larger EU team.  Assumed NA training would be modified for EU training, but protocol designs are different so training different.
Translations
[****]
[****]
[****]
Fewer languages in NA study than EU
PROMIS
[****]
[****]
[****]
Two separate databases; one for each study.
Monitoring/Site Management
       
Data Clean-up
[****]
[****]
 
Increased number of eCRF pages.
Investigator Grant Administration
 
[****]
[****]
[****]
[****]
Laboratory Report Review
[****]
[****]
Decrease in total number of patients
Originally allocated cost for [****]
Serious/Significant Adverse Event Management
[****]
[****]
Decreased number of SAEs due to decreased number of subjects
Originally allocated cost for [****]
 
 
 
 
 
Confidential
 
Task Original
(US Dollars)
New NA
(US Dollars)
Assumption Changes
influencing the change in
the budget
Additional comments
Site Management
[****]
[****]
Decreased number of sites and  increased months
Originally allocated cost for the management   [****]
Site Visits - Pre-study Visits
[****]
[****]
Decreased number of sites
Originally cost allocation was for [****]
Site Visits - Initiation Visits
[****]
[****]
Decreased number of sites
Originally cost allocation was for [****]
Site Visits - Routine Visits
[****]
[****]
Increased number of visits due to increased number of CRF pages to monitor
Originally cost allocation was for [****]
Site Visits - Close-out Visits
[****]
[****]
Decreased number of sites
Originally cost allocation was for [****]
Study Master File/Project File Set-up and Maintenance
[****]
[****]
Decreased number of sites and  increased months
Originally allocated cost for the management   [****]
Patient/Site Recruitment
[****]
[****]
   
Regulatory
       
Regulatory Documentation Preparation/Review
[****]
[****]
Decreased number of sites
Originally cost allocation was   [****]
Project Management/Project Tracking
       
Financial Project Management
[****]
[****]
Increased study durations; 2 separate studies vs. 1
Originally cost allocation was   [****]
Project Management
[****]
[****]
Increased study durations; 2 separate studies vs. 1
Originally cost allocation was   [****]
Project Tracking/Communications
[****]
[****]
Increased study durations; 2 separate studies vs. 1
Originally cost allocation was   [****]
Vendor Management
[****]
[****]
Added [****] contract payment management
[****]
Data Management
       
Database Archiving
[****]
[****]
   
Data Cleanup (DM)
[****]
[****]
[****] .
 
Data Management: Database Quality Control Inspection
[****]
[****]
[****]
 
Database Design
[****]
[****]
[****]
Assume NA DB designed first with efficiencies taken for similar eCRF pages/edit specs in both studies.  We will reconsider upon receipt of synopsis with final assumptions. Assumed one data base originally and now two
Dictionary Coding
[****]
[****]
Increased number of subjects, therefore increased number of terms overall
 
 
 
 
 
 
Confidential
 
Task Original
(US Dollars)
New NA
(US Dollars)
Assumption Changes
influencing the change in
the budget
Additional comments
Edit Check Programming
[****]
[****]
Increased number of edit checks due to increased CRF size
Assume NA DB designed first with efficiencies taken for similar eCRF pages/edit specs in both studies.  We will reconsider upon receipt of synopsis with final assumptions.
Electronic Data Import
[****]
[****]
 
[****]
Case Report Form Data/Document Transfers
[****]
[****]
 
[****]
EDC Fees
[****]
[****]
 
[****]
Statistical Analysis and Table Generation
       
Electronic Data Transfer
[****]
[****]
[****]
 
Interim Analysis/Report Preparation and Review
[****]
[****]
[****]
 
Statistical Analysis Plan Preparation/Review
[****]
[****]
[****]
Originally cost allocation was to [****]
Table Generation
[****]
[****]
[****]
Originally preparing [****]
Table/Listings Review
[****]
[****]
[****]
Reviewing [****] separate sets of T&Ls.
Clinical Study Report
       
Clinical Study Report Preparation/Review
[****]
[****]
 
Assumes [****] separate study reports, originally assumed one.
Team Meetings
       
Project Team Meetings - Internal Meetings
[****]
[****]
[****]
 
Project Team Meetings - Client Teleconferences
[****]
[****]
[****]
 
Project Team Meetings - Kick-off Meeting
[****]
[****]
[****]
 
Total Direct Costs
[****]
[****]
   

 
Total Costs
 
 
Total Costs($)
Category
Current Contract
Change in Scope #1
Revised Total
 
(USD)
(USD)
(USD)
[****]
[****]
[****]
[****]
Investigator Grants Costs
[****]
[****]
$4,800,000
[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]
 
 
 
 
 
Confidential
 
 
 
Total Costs($)
Category
Current Contract
Change in Scope #1
Revised Total
 
(USD)
(USD)
(USD)
Revised Professional Fees
[****]
[****]
$4,995,243
Grand Total
$8,142,331
$2,398,420
$10,540,751
 
 
 
 
 
 

 
 
 
 
Confidential
 
Exhibit B Payment Schedule
 
 
 
Milestone Payment Schedule
7810962 Canada Inc (11ISB001)

 
Milestone
Total
(USD)
[****]
CO#1 [****]
Total
(USD)
[****]
[****]
[****]
[****]
[****]
[****]
 
[****]
[****]
[****]
[****]
[****]
   
[****]
     
[****]
   
[****]
     
[****]
   
[****]
     
[****]
   
[****]
     
[****]
[****]
[****]
[****]
     
[****]
[****]
[****]
[****]
     
[****]
[****]
[****]
[****]
     
[****]
[****]
[****]
[****]
     
[****]
 
[****]
[****]
[****]
[****]
 
[****]
 
[****]
[****]
     
 
[****]
[****]
[****]
     
[****]
   
[****]
     
[****]
 
[****]
[****]
     
[****]
   
[****]
     
[****]
   
[****]
     
[****]
   
[****]
     
[****]
[****]
[****]
[****]
     
[****]
[****]
[****]
[****]
     
 
[****]
[****]
[****]
     
[****]
   
[****]
     
[****]
 
[****]
[****]
     
[****]
   
[****]
     
[****]
   
[****]
     
[****]
[****]
[****]
[****]
     
[****]
[****]
[****]
       
[****]
 
[****]
[****]
     
[****]
   
[****]
     
[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]
     
 
[****]
[****]
[****]
     
Total Milestones
3,987,715
-1,708,011,
2,279,866
 
[****]
[****]
 
 
 
Page 12 of 14
 
Confidential
 
 
Milestone
Total
(USD)
[****]
CO#1 [****]
Total
(USD)
[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]
 
[****]
[****]
[****]
[****]
[****]
[****]
 
[****]
[****]
     
             
Total Milestone Payments [****]
[****]
[****]
4,995,243
 
[****]
[****]
             
[****]
           
             
             
[****]
           
[****]
     
[****]
[****]
[****]
[****]
     
[****]
[****]
[****]
[****]
     
[****]
[****]
[****]
             
[****]
     
[****]
[****]
[****]
[****]
     
[****]
[****]
[****]
[****]
     
[****]
[****]
[****]
[****]
     
[****]
[****]
[****]
         
[****]
[****]

 
Pass Through Costs:
 
 
(a)
[****] percent ([****]%) of the average estimated pass through costs equaling $[****] (exclusive of funds for investigator grants); will be due and payable upon execution of this Agreement. These funds will be drawn down as necessary to pay incurred pass through costs and will be replenished to the full [****]% once the amounts held are [****]% depleted.  This process to continue until the end of the study.
 
 
(b)
The pass-through costs above will be as provided in the expenses estimate and any additional costs will be pre-approved by the Company. The pass-through costs will be billed as incurred by inVentiv Health Clinical.
 
 
(c)
Any unused funds held for pass through costs will be returned within ninety (90) days from the date of the final reconciliation.
 
 
3.
Investigator Grants:
 
 
(a)
[****] percent ([****]%) of the estimated grant payments for the study, equaling $[****], will be invoiced upon commencement of services. These funds will be drawn down as the Investigator Grants are paid and the full [****]% will be replenished once the amounts held are [****]% depleted). This process to continue until the end of the study.
 
 
Page 13 of 14
 
Confidential
 
 
(b)
inVentiv Health Clinical will submit invoices for the amounts paid to investigators during the previous month. Any amount exceeding the estimate investigator grant payments will be pre-approved by the Company.
 
 
(c)
inVentiv Health Clinical will not make payments to investigators without having sufficient funds available in advance.
 
 
(d)
Any unused funds will be returned within ninety (90) days from the date of the final reconciliation
 
 
4.
Payment Conditions:

 
(a)
For all Services, pass through expenses and investigator grants invoiced, payments are due net thirty (30) days from invoice date as set forth in Terms, Item 2 of the Agreement.  In the event of a dispute, all undisputed portions of the invoice(s) are due within the above stated terms
 
 
(b)
Payments shall be made in the currency identified above and shall be made free of any applicable local withholding taxes, charges or remittance fees.  Invoices will be inclusive of applicable taxes as determined by local laws and regulations
 
 
(c)
InVentiv Health Clinical reserves the right to charge interest against any unpaid overdue balance at the rate of [****] percent ( [****] %) per month
 
 
(d)
All services and pass-through payments should be sent via wire or ACH
 
 
 
 
Page 14 of 14
 
Exhibit 12.1

CERTIFICATION BY CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
 
I, Dror Ben-Asher, certify that:
 
 
1.
I have reviewed this annual report on Form 20-F/A of RedHill Biopharma Ltd.; 
     
 
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     
 
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
     
 
4.
The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
     
 
a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
 
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
 
c)
Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
 
d)
Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting;
     
 
5.
The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
     
 
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
     
 
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
 
Date: July 7, 2014
 
/s/ Dror Ben-Asher  
Dror Ben-Asher
Chief Executive Officer
 
Exhibit 12.2

CERTIFICATION BY CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Ori Shilo certify that:
 
 
1.
I have reviewed this annual report on Form 20-F/A of RedHill Biopharma Ltd..;
     
 
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     
 
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
     
 
4.
The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
     
 
a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
 
 
b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
 
c)
Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
 
d)
Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting;
     
 
5.
The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
     
 
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
     
 
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
 
Date: July 7, 2014
 
/s/ Ori Shilo  
Ori Shilo
 
Deputy Chief Executive Officer Finance and Operations