Document:

exhibit_10-22.htm

Exhibit 10.22

 

**CONFIDENTIAL PORTIONS HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL 

TREATMENT AND HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE 

COMMISSION (THE “COMMISSION”).**

 

TASK ORDER

 

MEDPACE Task Order Number: 1

 

MEDPACE Project Number: ORINS07

 

This Task Order, dated 27 September 2012,  is between Medpace, Inc. (“MEDPACE”), and Oramed Ltd., (“SPONSOR”).

 

RECITALS:

 

WHEREAS, MEDPACE and SPONSOR have entered into that certain Master Services Agreement dated  27 September 2012  (the “Master Services Agreement”); and

 

WHEREAS, pursuant to the Master Services Agreement, MEDPACE has agreed to perform certain Services in accordance with Task Orders from time to time entered into by the Parties and SPONSOR and MEDPACE now desire to enter into such a Task Order; and

 

WHEREAS, MEDPACE and SPONSOR desire that MEDPACE provide certain services with respect to  a protocol entitled, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Multiple Oral Bedtime Doses of ORMD-0801 (Insulin Capsules) in Adult Patients with Type 2 Diabetes Mellitus who are Inadequately Controlled with Diet and Metformin (the  “Study”) for the study of the product ORMD-0801 (“Study Product”) as set out in the Protocol Number: ORA-D-007, which is incorporated herein by reference;

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, the Parties hereby agree as follows:

 

	
  

	
1.

	
Scope of Work:  MEDPACE shall perform the services described in the Scope of Work, attached hereto as Appendix 1, in accordance with the Project Schedule, attached hereto as Appendix 2, and protocol version dated 14 August 2012.

	
  

	
2.

	
Compensation:  For performance of these Services, SPONSOR shall pay to MEDPACE an amount equal to the Project Budget set forth in Appendix 3, which amount shall be payable pursuant to the Payment Schedule set forth in Appendix 4.  The Project Budget is provided for cost analysis purposes.  It is agreed that all fees are fixed prices unless the underlying assumptions as written in Appendix # 1 SCOPE OF WORK, and Appendix #2, PROJECT SCHEDULE are changed, and all such changes shall be documented in a Contract Amendment.  After staff is assigned, costs are incurred based upon allocation of staff capacity.

 

  

  

  

 

 

	
  

	
3.

	
Third Parties/Vendors: MEDPACE is responsible for coordinating with the vendors which will be selected and approved by SPONSOR.  SPONSOR will review and comment on all Third Parties/Vendors contracts prior to MEDPACE’s execution of such contracts.

 

	
  

	
4.

	
Transfer of Obligations:  Sponsor Obligations transferred to MEDPACE by SPONSOR (consistent with the regulations set forth in 21 C.F.R. Section 312, Subpart D) are identified in Appendix 5.

 

	
  

	
5.

	
MSA. The provisions of the Master Services Agreement are hereby expressly incorporated by reference into and made a part of this Task Order.

 

IN WITNESS WHEREOF, the Parties have hereunto signed this Task Order effective as of the day and year first written above.

 

MEDPACE, INC.

 

	
Signature: 

	
/s/ John Wynne

	
By: 

	
John Wynne

	
Title: 

	
Executive Director

Business Development Support

                            

Oramed Ltd.

 

	
Signature: 

	
/s/ Nadav Kidron

	
By: 

	
Nadav Kidron

	
Title: 

	
CEO

 

List of Appendices:

 

Appendix 1:  Scope of Work

Appendix 2:  Project Schedule

Appendix 3:  Project Budget

Appendix 4:  Payment Schedule

Appendix 5:  Transfer of Obligations

 

  

Page 2 of 15

  

 

 

APPENDIX 1: SCOPE OF WORK

 

Project Specifications

 

	
Item

	
Description

	
Number of investigators per country

	
10 sites + 5 Back-up sites (United States)

	
Number of screened patients

	
294 patients

	
Number of randomized patients

	
147 patients

	
Duration of enrollment period (first patient in–last patient in)

	
4 months

	
Duration of screening/treatment/follow-up period

	
~7.5 weeks

	
Duration of Investigator Meeting

	
1 meeting (12-hour duration); location TBD

	
Location and duration of Kickoff Meeting

	
1 meeting at Medpace (8-hour duration)

	
Teleconferences

	
26 calls ( approx. 2 per month; one hour each)

	
Number of qualification visits

	
1 visit

	
Number of initiation visits

	
10 visits

	
Number of routine monitoring visits (RMV)

	
40 visits

	
Monitoring frequency

	
On average, every 5-6 weeks as needed

	
Number of close-out visits

	
Assumed part of final RMV

	
Number of serious adverse events (SAEs)

	
8 SAEs

	
Total CRFs

	
5880 CRFs

	
CRFs per patient

	
40 CRFs

	
Unique CRFs

	
18 CRFs

	
Average data points per CRF

	
12 data points

	
Number of raw listings

	
23 raw listings

	
Number of unique TFLs

	
25 unique TFLs

	
Number of version TFLs

	
25 version TFLs

	
Study conducted in compliance with SOPs and Policies

	
Medpace SOPs and Policies

 

 

  

Page 3 of 15

  

 

 

 

Roles and Responsibilities

 

	
1.1

	
PROJECT START-UP

 

	
Oramed

	
Medpace

	
N/A

	
Item

	
Description

	
X

	  	  	
Write protocol

	  
	  	
X

	  	
Review protocol

	
Includes comment from Medpace team

	
X

	  	  	
Submit protocol amendments

	  
	  	
X

	  	
Develop ICF template

	
Using Medpace template

	
X

	  	  	
Review ICF template

	  
	  	
X

	  	
ICF amendments

	
1 amendment

	  	
X

	  	
ICF local customization

	
Negotiate changes with each site

	  	
X

	  	
CRF design

	
Design of CRFs and completion guidelines

	
X

	
X

	  	
Site identification

	
Medpace to identify qualified Investigators; Oramed to select/approve sites; assumes 15 sites selected (10 main sites + 5 back-up sites)

	  	
X

	  	
Investigator Meeting Planning

	
Arrange meeting

	  	
X

	  	
Preparation of Investigator Meeting(s)

	
Preparation and distribution of binders and meeting materials; includes presentation by Medpace associates

	  	
X

	  	
Investigator Meeting Attendees

	
CTM, Medical Expert, Project Coordinator, Data Manager, Statistical Analyst, Safety Manager, IVRS Manager and 3 CRAs; Assumes 1 day meeting

	
X

	
X

	  	
Investigator Meeting Planner Contract Negotiation and Payment Management

	
Medpace will negotiate the contract on behalf of Sponsor;  Sponsor will sign the contract and make payments to the meeting planner

	  	
X

	  	
Kickoff Meeting Attendees

	
CTM, Medical Expert, Project Coordinator, Project Assistant, Regulatory Submissions Manager, Data Manager, Statistical Analyst, Safety Manager, Safety Specialist and Lead CRA; Assumes 8 hrs. meeting at Medpace office

	  	
X

	  	
Submit essential documents to US central IRB

	
13 sites using central IRB (9 main + 4 back-up sites)

	  	
X

	  	
Support sites to submit essential documents to US local IRB

	
2 site using local IRB (1 main + 1 back-up sites)

	  	
X

	  	
Trial Master File set-up and maintenance

	
Set up and maintain file for all study sites according to Medpace SOPs

 

	
1.2

	
CLINICAL OPERATIONS

 

	
Oramed

	
Medpace

	
N/A

	
Item

	
Description

	  	
X

	  	
Clinical trial management

	
Provide overall study management for 10 sites

	  	
X

	  	
Project website

	
Medpace to develop secure, project-specific website containing relevant information and tools

	  	
X

	  	
Newsletters

	
6 monthly electronic newsletters

	  	
X

	  	
Ongoing essential document collection

	
Ongoing collection and maintenance of site-specific documents

	  	
X

	  	
Tracking of study medication shipments

	
Assumes 2 shipments per site for 10 sites

	  	
X

	  	
Supply, packaging, and labeling of study  medication

	
Assumes Medpace will contract and manage packaging, labeling and drug depot vendor

	  	
X

	  	
Storage and distribution of

Study medication

	
Assumes Medpace will contract and manage vendor to perform packaging, labeling and drug depot services

	
X

	
X

	  	
Destruction of study medication

	
Assumes Medpace will contract and manage drug depot vendor who will destroy drug upon Sponsor approval

	  	
X

	  	
Study medication accountability procedures

	
Follow Medpace SOPs and approved by Sponsor

	  	
X

	  	
Site contract negotiation

	
Negotiate site contract and budget for 15 sites

	  	
X

	  	
Investigator payments management

	
Make 2 quarterly payments per site for 10 sites

	
X

	
X

	  	
External vendors contract negotiation and management

	
Assumes Medpace will contract and manage drug depot vendor; Medpace will coordinate the purchase and distribution of  CGM devices and study supplies upon sponsor approval

	  	
X

	  	
Central lab selection

	
Please reference MRL budget

	  	
X

	  	
Central lab contract negotiation and management

	
 MRL

	  	
X

	  	
Central IRB payment management

	
Assumes 1 central IRB and 2 quarterly payments

 

  

Page 4 of 15

  

 

 

	
1.3

	
CLINICAL MONITORING

 

	
Oramed

	
Medpace

	
N/A

	
Item

	
Description

	  	
X

	  	
Clinical Research Associates (CRAs)

	
3 CRAs

	  	
X

	  	
Qualification visits

	
1 visit, 4 hrs. on-site; Cost of $2,347 shall be charged for each additional visit

	  	
X

	  	
Monitoring plan

	
Ongoing updates

Includes monthly meetings

	  	
X

	  	
Site initiation visits

	
10 visits, 4 hrs. on-site; Cost of $2,347 shall be charged for each additional visit

	  	
X

	  	
Routine monitoring visits (RMVs)

	
40 visits

	  	
X

	  	
Frequency of RMVs

	
On average, every 5-6 weeks, as needed

	  	
X

	  	
Estimated on-site time

	
16 hours

	  	
X

	  	
Close-out visits

	
Assumed combined with final RMV

	  	
X

	  	
In-house monitoring coordination

	
Medpace CRA contact sites to discuss project-specific issues; records maintained in ClinTrak

 

  

Page 5 of 15

  

 

 

	
1.4

	
CLINICAL SAFETY

 

	
Oramed

	
Medpace

	
N/A

	
Item

	
Description

	  	
X

	  	
Medical monitoring

	
Medical Expert on-call 24/7 during recruitment and treatment periods for 10 sites

	  	
X

	  	
Develop Safety Monitoring Plan

	
Includes one final version and one revision. Assumes utilization of Medpace SOPs

	  	
X

	  	
SAE reporting

	
All SAEs will be reported by sites to Medpace. Includes one initial and two follow-up reports per case; Assumes 8 SAEs; Cost of $1,339 shall be charged for each additional unit

	  	
X

	  	
Development of safety database

	
ARGUS will be used; Medpace to hold database

	  	
X

	  	
Enter SAEs into safety database

	
8 SAEs

	  	
X

	  	
Medical monitor review of SAE reports

	
Includes assessment of expectedness and company causality

	  	
X

	  	
Receive, query, and follow-up on reported SAEs

	  
	  	
X

	  	
Generate SAE narratives

	
Narratives written Clinical Study Report ready. Assumes final approval by Medpace Medical Monitor prior to distribution to sponsor.

	  	
X

	  	
Generate expedited SAE reports safety report

	
Assumes 1 expedited report, if additional events occur, a unit cost of $1,636 per report  shall be charged.

	
X

	
X

	  	
Distribute expedited SAE reports to FDA

	
Oramed to review and approve prior to submission

	  	
X

	  	
Distribute expedited SAE reports to central IRB

	
Compile and submit documents

	  	
X

	  	
Preparation of safety notification letters

	
Sponsor to review and approve prior to submission

	  	
X

	  	
Distribute safety notification letter for this protocol to sites

	
10 sites

	  	  	
 

X

 

	
Prepare periodic reports for regulatory authorities

	  
	
X

	
X

	  	
Prepare  Annual Safety Report

	
Medpace to prepare safety line listings to be included in IND Annual Report;  Oramed will be responsible for IND Annual Report filing

	  	  	
X

	
Distribute periodic reports to regulatory authorities/ECs

	  
	  	  	
X

	
Distribute  Annual Safety Report to regulatory authorities/ECs

	
Assumes Oramed will be responsible for IND Annual Report

	  	
X

	  	
Ongoing reconciliation between clinical and safety database

	
A final reconciliation is completed prior to database lock

	  	
 

 

 

X

 

	  	
Ongoing clinical trial AE data review including signal detection and trend analysis

	
Required per FDA guidance

	  	
X

	  	
Write narratives for withdrawals due to AE and/or abnormal lab values for inclusion in clinical study report

	
Assumes 1 withdrawal due to AE. If additional events occur, a unit cost of $915 shall be charged.

 

	
1.5

	
IVR/IWR SYSTEM

 

	
Oramed

	
Medpace

	
N/A

	
Item

	
Description

	  	
X

	  	
Randomization/Drug Supply Management

	
Provide study-specific system for randomization, patient visit tracking, and customized reports, drug management (via web or phone 24/7), including maintenance and Help Desk. Assumes English language only.

 

  

Page 6 of 15

  

 

 

 

	
1.6

	
DATA MANAGEMENT

 

	
Oramed

	
Medpace

	
N/A

	
Item

	
Description

	  	
 

 

 

 

X

	  	
Develop data management (DM) documents

	
DM documents include:

- Database specifications;

- Guidelines for the tracking of CRFs and data queries;

- Guidelines for entry of the CRF data; and

- Database edit check specifications

	  	
X

	  	
Database development

	
EDC system,  ClinTrak EDC

	  	
X

	  	
Database validation

	
Medpace SOPs

	  	
X

	  	
EDC Help Desk

	
Medpace provide support via phone/email

	  	
X

	  	
DM coordination and status reporting

	
Medpace coordination includes:

- CRF tracking

- Data cleaning/editing

- Query tracking

Medpace monthly DM status reports provided via secure website include:

- CRF status by site

- Patient status by site

- Query status by site

	  	
X

	  	
Query tracking/resolution

	  
	  	
X

	  	
Coding of AE/concomitant medications/medical histories

	
Assumed that Sponsor holds a valid agreement with the Maintenance and Support Services Organization (MSSO) for the MedDRA dictionary and Uppsala Monitoring Centre (UMC) for the WHODrug dictionary

	  	
X

	  	
Number of AE codes

	
5 AE codes per patient

	  	
X

	  	
Number of concomitant medications

	
5 concomitant medications per patient

	  	  	
X

	
Number of medical histories/conditions

	  
	  	
X

	  	
Number of external data sources

	
Assumes MRL

	  	
X

	  	
Data transfers from external data sources

	
2 quarterly transfers from MRL

	  	
X

	  	
Data transfers to Sponsor

	
2 transfers (1 test, 1 final)

	  	
X

	  	
Deliver data

	
CDISC SDTM

	  	
X

	  	
Database document

	
Medpace submission-ready

 

	
1.7

	
STATISTICAL ANALYSIS

 

	
Oramed

	
Medpace

	
N/A

	
Item

	
Description

	  	
X

	  	
Develop Statistical Analysis Plan (SAP)

	
Medpace format and template; Medpace to prepare the SAP to be included in the IND filing. The SAP will be revised (if needed) and finalized prior to the Database Lock.  

	  	
X

	  	
Programming, validation, and generation of Tables, Figures, Listings (TFLs)

	
23 raw listings

25 unique TFLs

25 version TFLs

2 derived datasets

	  	
X

	  	
Results review meeting

	
One meeting via teleconference after delivery of analysis results

 

 

  

Page 7 of 15

  

 

 

	
1.8

	
MEDICAL WRITING

 

	
Oramed

	
Medpace

	
N/A

	
Item

	
Description

	  	
X

	  	
Study report shell (SRS)

	
SRS incorporates protocol-related and statistical methodology information and in-text table shells in the results sections

	
X

	  	  	
SRS review

	  
	  	
X

	  	
Pre-final study report (PFSR)

	
PFSR is a complete version of the report, including results, but without the appendices

	
X

	  	  	
PFSR review

	  
	  	
X

	  	
Final study report (FSR)

	
FSR is a complete version of the report including appendices.

	  	
X

 

	  	
Publishing FSR

	
FSR file is converted to an Adobe PDF file and published by setting applicable document attributes.

	  	
X

	  	
Bookmarking/

hyperlinking FSR

	
Apply internal and external navigation via bookmarking/hyper linking from the FSR to any corresponding appendices

 

  

Page 8 of 15

  

 

 

APPENDIX 2: PROJECT SCHEDULE

 

	
Task

	
Date

	
Medpace Begins Work*

	
SEP-2012

	
Final Protocol

	
SEP-2012

	
Statistical Analysis Plan (Final Draft for IND Filing)**

	
15-NOV-2012

	
First Patient, First Visit

	
31-JAN-2013

	
Last Patient, First Visit

	
02-JUN-2013

	
Last Patient, Last Visit

	
25-JUL-2013

	
Final Database Lock

	
+ 6 weeks

	
Final Tables, Figures, and Listings available

	
+4 weeks

	
Delivery of Final Clinical Study Report

	
+ 8 weeks

	
Medpace Ends Work

	
NOV-2013

 

* Assumes Medpace receives final protocol and Investigator Brochure (IB) at start date.

 

** SAP date (Nov. 15, 2012) will depend on the Task Order signing and Final Protocol date.  Medpace requires 6 weeks from these dates (whichever is later) to provide the SAP.   

 

  

Page 9 of 15

  

 

 

APPENDIX 3: PROJECT BUDGET

 

	
Medpace Fees

	
Fee Details

	
Unit Desc

	
# Unit

	
Unit Cost

	
Fee

	
Start-up Services                Review Protocol

	
Protocol

	
1

	
**THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.**

	
  CRF Review/Development

	
CRF Book

	
1

	
  Investigator Meeting

	
Meeting

	
1

	
  Kick-Off Meeting

	
Meeting

	
1

	
  Project Specific Training

	
Study

	
1

	
  Vendor Contract Negotiation

	
Vendor

	
1

	
  Investigator Contract Negotiation

	
Site

	
1

	
  Site Identification/Selection

	
Site

	
15

	
  Investigator File Set-up

	
Study

	
1

	
  Initial Essential Document Collection

  Total

	
Site

	
15

	  	  
	
Meetings                                 Conference Calls

  Total

	
Call

	
26

	  	  
	
Interactive Voice Response  IVRS Development

System (IVRS) 

	
System

	
1

	
  IVRS Maintenance and Help Desk

	
Months

	
5.8

	
  IVRS System Utilization and Hosting

  Total

	
Months

	
5.8

	  	  
	
Project Management          Project Management

	
Months

	
5.8

	
  Vendor Management

	
Months

	
5.8

	
  Newsletters

	
Edition

	
6

	
  Ongoing Essential Document Collection and Review

	
Months

	
5.8

	
  ICF Amendment

	
Amendments

	
1

	
  Vendor Payment Administration

	
Payment

	
6

	
  Investigator Grants Management Total

	
Site Payments

	
20

	  	  
	
Clinical Safety                     Medical Monitoring

	
Months

	
5.8

	
  Safety Plan Development

	
Plan

	
1

	
  SAE Reporting

	
Events

	
8

	
  Processing Expedited SAE Reports

	
Events

	
1

	
  Other Narrative Preparation Total

	
Events

	
1

	  	  
	
Clinical Monitoring                Monitoring Plan Development

  and Ongoing Maintenance

	
Months

	
5.8

	
  Pre-Study Visits

	
Visits

	
1

	
  Study Initiation Visits

	
Visits

	
10

	
  Site Management

	
Site Month

	
58.1

	
  Routine Monitoring Visits Total

	
Visits

	
40

	  	  

 

  

Page 10 of 15

  

 

	
Medpace Fees

	
Fee Details

	
Unit Desc

	
# Unit

	
Unit Cost

	
Fee

	
Data Management                   Data Management Manual

	
Study

	
1

	
**THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.**

	
Database Development

	
Database

	
1

	
Database Conversion (CDISC)

	
Database

	
1

	
EDC User Acceptance Testing

	
UAT

	
1

	
Data Entry and Cleaning

	
CRF Book

	
5880

	
EDC Help Desk

	
Site Months

	
58.1

	
DM Coordination and Status Reports

	
Months

	
5.8

	
    EDC System Utilization and Hosting

    Total

	
Months

	
5.8

	  	  
	
Biostatistics                          Analysis Plan

	
Ran

	
1

	
Analysis Programming and Generation

	
Analysis

	
1

	
Raw Data Listings

	
Raw Listings

	
23

	
Unique TLFs

	
Unique TFL

	
25

	
Version TLFs Total

	
Version TFL

	
25

	  	  
	
Medical Writing                       Clinical Study Report

    Total

	
Study Report

	
1

	  	  
	
Total Direct Fees

	  	  	  	
$1,267,246.18

 

	  	
Fee Details

	
Unit Desc

	
# Unit

	
Unit Cost

	
Fee

	
Pre-Funded Expenses          Investigator Payments

	
Randomized Patients

	
147

	
**THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.**

	
    Drug Packaging, labeling and Depot Fees

	
Study

	
1

	
    Central Laboratory Fees (MRL)

	
Study

	
1

	
    Study Specific Supplies (CGM & Supplies)

	
Study

	
1

	
    CGM Data Management Software (SweetSpot)

	
System

	
1

	
Total Pre-Funded Expenses:

	  	  	  	
$1,686,001.56

	
Pass-Through Costs           Monitoring Tray el

	
Visit

	
51

	
**THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.**

	
   Central IRB Fees

	
Study

	
1

	
   Telecommunication Fees

	
Calls

	
26

	
   Misc. Printing/Copying/Shipping

	
Sites

	
10

	
   Meeting Expense

	
Study

	
1

	
Total Pass Through Costs:

	  	  	  	
$80,201.00

	
Sponsor Directly Paid Vendor   Investigator Meeting Planner

Fee

	
Meetings

	
1

	
**THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.**

	
Total Sponsor Directly Paid Vendor Fee

	  	  	  	
$83,450.00

 

  

Page 11 of 15

  

 

 

APPENDIX 4: PAYMENT SCHEDULE

 

Payment Schedule

 

	
Payment Schedule

Project                 Ph II Study of ORMD-0801 in Patients w/ T2DM Total Direct Fees: $ 1,267,246

Sponsor:              Oramed Pharmaceuticals, Ltd.

	
Payment Number

	
Milestones

	
Approximate

Date

	
Amount to

Pay

	
Percentage

	
1

	
Task Order Signed

	
Sep-12

	
$           63,362

	
5.0%

	
2

	
Kick-Off Meeting

	
11/5/2012

	
$        139,397

	
11.0%

	
3

	
Investigator  Meeting

	
1/3/2013

	
$          76,035

	
6.0%

	
4

	
First Patient Screened

	
1/31/2013

	
$        190,087

	
15.0%

	
5

	
25% Patients Enrolled

	
3/16/2013

	
$        190,087

	
15.0%

	
6

	
50% Patients Enrolled

	
4/18/2013

	
$        190,087

	
15.0%

	
7

	
Last Patient Screened

	
6/2/2013

	
$        164,742

	
13.0%

	
8

	
Last Patient Complete

	
7/25/2013

	
$        126,725

	
10.0%

	
9

	
Submission of Clinical Study Report to Sponsor for Final Approval

	
11/30/2013

	
$        126,725

	
10.0%

	
     Total Payments:

	
 $  1,267,246

	
100%

 

**THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.** of the total Pre-funded Expenses and $8,020 (10%) of total Pass-through Costs will be invoiced and due upon completion of the Kick-Off Meeting. Medpace will invoice Sponsor as needed for actual Pre-funded Expenses incurred. Sponsor shall pay such invoice within twenty (20 days) of receipt. If sufficient funds are not received from Sponsor, payments to Pre-funded Vendors may be delayed. 

 

Medpace shall apply the initial **THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.** Pre-funded amount paid upon completion of the Kick-Off Meeting, against the last invoice of actual-Pre-funded Expenses, and reconcile the balance. Pass-through Costs will be billed to Sponsor on a monthly basis or as incurred.

 

  

Page 12 of 15

  

 

 

Payment Information and General Conditions

 

Pass-through Costs and Pre-funded Expenses

 

Any sums quoted with respect to pass-through costs and pre-funded expenses are provisional, pending discussion with third parties and are not necessarily exhaustive.  While Medpace will endeavor to negotiate favorable rates for pass-through costs and pre-funded expenses, final costs may be dependent upon factors that are outside the control of Medpace.   Payments made to third parties are not subject to mark-up charges.

 

Pass-through costs may include, but are not limited to, project-specific printing, shipping, copying and binding costs, telecommunication and data costs, travel costs, including subsistence and accommodation costs in compliance with the Medpace travel policy, literature search and article retrieval costs, translation costs, central IRB fees, EC/regulatory fees, and pharmacy fees.   Costs associated with, project-specific printing, copying and binding are as detailed in the table below.

 

	
Item

	
Cost*

	
Description

	
b/w print, 20-24 lb.

	
0.15

	
total sheets, includes all impressions, sizes, or cuts

	
color print, 20-24 lb.

	
0.20

	
total sheets, includes all impressions, sizes, or cuts

	
b/w print, 28-60 lb.

	
0.20

	
total sheets, includes all impressions, sizes, or cuts

	
color print, 28-60 lb.

	
0.25

	
total sheets, includes all impressions, sizes, or cuts

	
b/w waterproof

	
1.05

	
total sheets, includes all impressions, sizes, or cuts

	
color waterproof

	
1.10

	
total sheets, includes all impressions, sizes, or cuts

	
tabs 5-bank

	
3.00

	  
	
laminating pouches

	
0.95+

	
Plus cost of color or b/w print

	
card/cover stock

	
0.30

	
color only

	
folder

	
0.50

	
2-pocket, usually includes label

	
binder 1"

	
8.00

	
includes front cover and spine

	
binder 1.5"

	
10.00

	
includes front cover and spine

	
binder 3"

	
15.00

	
includes front cover and spine

	
plastic coil binding 1/4"

	
0.75

	  
	
plastic coil binding 3/8"

	
1.10

	  
	
plastic coil binding 1/2"

	
1.50

	  
	
plastic coil binding 1"

	
3.00

	  
	
CDs

	
0.28

	
per CD

	
CD labels

	
0.18

	
per label

 

*Currency is Euros for Europe, Israel, and South Africa; US dollars for remaining regions. Costs are subject to change based on fluctuations in supplier prices.

 

  

Page 13 of 15

  

 

 

Medpace will pass-through mobile communication and data charges up to $25 per travel day.  This will include a standard daily rate and other internet charges (e.g. hotel, airline)

 

	
Item

	
Cost

	
Description

	
Mobile communication and data standard daily rate

	
$10/8€*

	
cost per day while CRA is traveling

	
Other internet charges by use (receipt required)

	
Up to $15

	  

 

*Currency is Euros for Europe, Israel, and South Africa; US dollars for remaining regions

 

Pre-funded Expenses

 

Pre-funded expenses may include, but are not limited to, Investigator Meeting planner fees, Investigator fees, drug packaging and labeling, EDC vendor fees, and laboratory fees.  Investigator fees are an estimate generated on Medpace’s initial feasibility and prior experience in this therapeutic area.  The investigator fee amount is subject to changes of +/- 20% of the total amount after completion of a full feasibility and final site selection.  The laboratory fee amount is subject to change after finalization of the laboratory services agreement.

 

Additional Costs

 

This is a fixed-price Task Order for direct fees, based upon the project specifications and assumptions detailed herein.  The project budget and the unit costs upon which it was generated is provided for cost analysis purposes.

 

All direct fees are fixed costs unless the underlying assumptions change, including but not limited to, protocol, trial duration, number of investigative sites, number of patients, and services provided by Medpace. All such changes shall be documented in a contract amendment.  After staff are assigned, costs are incurred based upon allocation of staff capacity.

 

Inflation

 

The fees stipulated in the fee estimate include inflation for the duration of the study as specified in this Task Order. Any significant shift in timelines will require a revision to the fees.

 

Currency

 

The currency of the Task Order is Unites States Dollars (USD).

 

Applicable Taxes

 

All direct fees, pass-through costs, and pre-funded expenses are quoted excluding any applicable taxes, which include but are not limited to Value Added Tax (VAT), Harmonized Sales Tax (HST), Goods and Services Tax (GST), which may be payable to Medpace by Sponsor.

 

  

Page 14 of 15

  

 

 

Appendix 5: Transfer of Obligations

 

CONFIDENTIAL

 

Directions:  Complete a form for each clinical study where Sponsor obligations have been transferred in accordance with 21 CFR Part 312, Subpart D (Responsibilities of Sponsors).  Forward the completed form to Sponsor’s Regulatory Affairs Department for submission to the applicable regulatory agencies.

 

	
Drug:

	
ORMD-0801

	
Study ID:

	
 ORINS07

	
Study Title:

	
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Multiple Oral Bedtime Doses of ORMD-0801 (Insulin Capsules) in Adult Patients with Type 2 Diabetes Mellitus who are Inadequately Controlled with Diet and Metformin

	
CRO Name:

	
Medpace, Inc.

	
CRO Address:

	
5375 Medpace Way, Cincinnati, OH 45227

	
Obligations Transferred to Medpace: R the Appropriate Box(es).

 o All obligations in 21 CFR 312, Subpart D (Responsibilities of Sponsors) have been transferred to Medpace.

 x The following obligations have been transferred to Medpace:

	
Sec. 312.32:  IND Safety Reports

x Promptly review safety information.

o Notify all participating investigators in a written IND safety report of any AE associated with the drug that is both serious and unexpected.

o Notify the FDA in a written IND safety report of any AE associated with the drug that is both serious and unexpected.

Sec. 312.53:  Selecting investigators and monitors

x(a) Select qualified investigators

o(b) Control investigational drug shipment

x(c) Obtain information from investigators

x    (1) Signed Form FDA-1572

x    (2) CV or other qualification statement

x    (3) Clinical protocol outline

x (4) Financial disclosure information

(d) Select qualified monitors

Sec. 312.54:  Emergency research

o (a) Monitor the progress of all studies involving an exception from informed consent.

o (b) Monitor such studies to identify when an IRB determines that it can’t approve the research.

Sec. 312.55:  Informing investigators

x (a) Provide sites with the current Inv. Brochure.

x (b) Inform investigators of new observations on the drug, particularly with respect to AEs and safe use.

Sec. 312.56:  Review of ongoing investigations

o (a) Monitor the progress of all IND studies.

x (b) Secure compliance from noncompliant investigators or discontinue drug shipments and end the investigator’s participation in the study.

x (c)Review and evaluate the safety and efficacy results as it is obtained from the  investigator.

x (d) Discontinue use of the investigational drug if it is determined to present an unreasonable and significant risk to subjects, notify all IRBs and investigators, and assure the return or alternate disposition of the drug from the investigators.

 

	
Sec. 312.57:  Record keeping and record retention

x (a) Maintain adequate records showing investigational drug receipt, shipment, or other disposition.

o (b) Maintain complete and accurate records showing any financial interests of the investigator subject to 21 CFR 54.

o (c) Retain the records and reports required by the regulations for 2 years after the marketing application is approved, or if not approved, until 2 years after investigational drug shipment is discontinued and FDA has been notified.

o (d) Retain reserve samples of any test article and reference standard identified and used in bioequivalence or bioavailability studies.

Sec. 312.58:  Inspection of sponsor’s records and reports

x (a) Permit FDA personnel to have access to and copy and verify any records and reports related to the clinical investigation.

o (b) Permit DEA personnel to have access to and copy records related to the shipment, delivery, receipt and disposition of any investigational controlled substance.  Assure adequate storage precautions are taken for investigational new drug substances listed in any schedule of the Controlled Substances Act.

Sec. 312.59:  Disposition of unused supply of investigational drug

o Assure the return (or alternate disposition) of all unused supplies of the investigational drug from each discontinued/terminated investigator; maintain written records of any disposition of the investigational drug.

(a)   Other

o Please describe any other applicable transfers below:

 

 

 

Page 15 of 15exhibit_10-23.htm

Exhibit 10.23

 

Executed Version

SECURITIES PURCHASE AGREEMENT

 

This Securities Purchase Agreement (this "Agreement") is dated as of October 30, 2012, among Oramed Pharmaceuticals Inc., a Delaware corporation (the "Company"), and D.N.A Biomedical Solutions Ltd., an Israeli company (referred to herein as "D.N.A" or an "Investor").

 

WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to the Securities Act of 1933, as amended (the “Securities Act”) and Regulation S promulgated thereunder, the Company desires to issue and sell to the Investor, and the Investor, desires to purchase from the Company certain securities of the Company, and the Investor desires to issue and sell to the Company, and the Company, desires to purchase from the Investor certain securities of the Investor, all as more fully described in this Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, and for other good and valuable consideration the receipt and adequacy of which are hereby acknowledged, the Company and the Investor agree as follows:

 

ARTICLE I.

DEFINITIONS

 

1.1           Definitions.  In addition to the terms defined elsewhere in this Agreement, for all purposes of this Agreement, the following terms shall have the meanings indicated in this Section 1.1:

 

"Affiliate" means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 144.

 

“Closing” means the closing of the purchase and sale of the Securities pursuant to Section 2.1.

 

"Closing Date" means the Trading Day when all of the conditions precedent to (A) the Investor's obligations to issue the Option to the Company and (B) the Company’s obligations to deliver the Oramed Shares have been satisfied or waived.

 

"Common Stock" means the common stock of the Company, par value $0.001 per share, and any other class of securities into which such common stock may hereafter be reclassified or changed into.

 

"D.N.A Ordinary Shares" means the ordinary shares of D.N.A, no par value, and any other class of securities into which such ordinary shares may hereafter be reclassified or changed into.

 

  

  

  

 

“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

“Liens” means a lien, charge, security interest, encumbrance, right of first refusal, preemptive right or other restriction.

 

"Oramed Shares" means the 2,390,057 shares of Common Stock issued or issuable to the Investor pursuant to this Agreement.

 

"Option" means the option to purchase 21,637,611 D.N.A Ordinary Shares in the form attached hereto as Exhibit A.

 

"Option Shares" means the D.N.A Ordinary Shares issuable upon exercise of the Option.

 

"Person" means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.

 

"Rule 144" means Rule 144 promulgated by the SEC pursuant to the Securities Act, as such Rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the SEC having substantially the same effect as such Rule.

 

"SEC" means the U.S. Securities and Exchange Commission.

 

"Securities" means the Oramed Shares, the Option and the Option Shares.

 

"Short Sales" means, without limitation, all "short sales" as defined in Rule 200 of Regulation SHO promulgated under the Exchange Act.

 

"Trading Day" means any day other than Friday, Saturday, Sunday or other day on which commercial banks in The City of New York or Israel are authorized or required by law to remain closed.

 

"Transaction Documents" means this Agreement, the Option and any other documents or agreements executed in connection with the transactions contemplated hereunder.

 

ARTICLE II.

PURCHASE AND SALE

 

2.1           Closing.  On the Closing Date, subject to the terms and conditions set forth in this Agreement, the Company shall issue and sell to the Investor, and the Investor, shall purchase from the Company, the Oramed Shares set forth opposite the Investor’s name on Schedule 1. Upon satisfaction of the conditions set forth in Sections 2.2 and 2.3, the Closing shall occur at such location as the parties shall mutually agree.

 

  

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2.2           Deliveries.

 

(a)      On the date hereof, the Company and the Investor shall deliver or cause to be delivered to the other, this Agreement, together with all exhibits and schedules attached thereto, duly executed by an authorized representative.

 

(b)      On the Closing Date, the Company shall deliver to the Investor irrevocable instructions to its transfer agent authorizing the transfer agent to issue to the Investor a certificate evidencing the Oramed Shares, and to register such shares in the name of the Investor.

 

(c)      On the Closing Date, the Investor shall deliver or cause to be delivered to the Company:

 

(i)             the Option, in full payment for the Oramed Shares, and

 

(ii)            A copy of the application of DNA for the approval of the TASE Board of Directors to list the Option Shares.

 

2.3           Closing Conditions.

 

(a)      The obligations of the Company hereunder in connection with the Closing are subject to the following conditions having been met:

 

(i)             the accuracy in all material respects when made and on the Closing Date of the representations and warranties of the Investor contained herein;

 

(ii)            all obligations, covenants and agreements of the Investor contained herein required to be performed at or prior to the Closing Date shall have been performed; and

 

(iii)           the delivery by the Investor of the items set forth in Section 2.2(c) of this Agreement.

 

(b)      The respective obligations of the Investor hereunder in connection with the Closing is subject to the following conditions having been met:

 

(i)             the accuracy in all material respects when made and on the Closing Date of the representations and warranties of the Company contained herein;

 

(ii)            all obligations, covenants and agreements of the Company contained herein required to be performed at or prior to the Closing Date shall have been performed;

 

  

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(iii)           the delivery by the Company of the items set forth in Section 2.2(b) of this Agreement;

 

(iv)           from the date hereof to the Closing Date, trading in the Common Stock shall not have been suspended by the SEC or the National Association of Securities Dealers over-the-counter electronic bulletin board (the “OTCBB”).

 

ARTICLE III.

REPRESENTATIONS AND WARRANTIES

 

3.1           Representations and Warranties of the Company.  The Company hereby represents and warrants to the Investor as follows on the date hereof and as of the Closing Date:

 

(a)      Organization, Good Standing and Qualification of the Company.  The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware.  The Company has all requisite corporate power and authority to own and operate its properties and to carry on its business as now being conducted and as proposed to be conducted.  The Company is duly qualified to do business as a foreign corporation and is in good standing in each jurisdiction in which failure to so qualify would materially and adversely affect the business, properties, operations, prospects or condition, financial or otherwise, of the Company.  The resolutions adopted by the directors of the Company on October  29, 2012 authorizing the transactions contemplated by the Transaction Documents have not been amended or modified in any way, have not been rescinded and are in full force and effect on the date hereof.

 

(b)      Corporate Authority; Enforceability.  The Company has full right, power and authority to issue and sell the Oramed Shares as herein contemplated and the Company has full power and authority to enter into and perform its obligations under the Transaction Documents.  The execution and delivery of the Transaction Documents and the consummation of the transactions contemplated herein and therein have been duly authorized and approved by all requisite corporate action, and each of the Transaction Documents are a valid and legally binding obligation of the Company.

 

(c)      Conflicts.  Neither the authorization, execution and delivery of the Transaction Documents nor the consummation of the transactions herein and therein contemplated, will (i) conflict with or result in a breach of any of the terms of the Company’s Certificate of Incorporation or By-Laws, (ii) violate any judgment, order, injunction, decree or award of any court or governmental body, having jurisdiction over the Company, against or binding on the Company or to which its property is subject, (iii) violate any material law or regulation of any jurisdiction which is applicable to the Company, (iv) violate, conflict with or result in the breach or termination of, or constitute a default under, the terms of any material agreement to which the Company is a party, except for such violations or defaults which do not materially and adversely affect the business, assets, operations, prospects or condition, financial or otherwise of the Company, or (v) violate or conflict with the rules and regulations of the OTCBB applicable to the Company.

 

  

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(d)      Capitalization. The authorized capital of the Company as of the date hereof consists of 200,000,000 shares of Common Stock, of which there were (i) 80,548,989 issued and outstanding as of the date hereof as fully paid and non-assessable shares; (ii) options and/or warrants to purchase 15,118,310 shares of Common Stock; and (iii) employee and directors options to purchase 7,824,000 shares of Common Stock. As of the date hereof, the Company has not issued any capital stock since its most recently filed periodic report under the Exchange Act, other than pursuant to the exercise of employee stock options under the Company’s stock option plans and the issuance of shares of Common Stock to employees pursuant to the Company’s employee stock purchase plan outstanding as of the date of the most recently filed periodic report under the Exchange Act.  All of the outstanding shares of capital stock of the Company are validly issued, fully paid and nonassessable.  No further approval or authorization of any stockholder or the Board of Directors of the Company is required for the issuance and sale of the Oramed Shares.  The issuance of the Oramed Shares pursuant to the provisions of this Agreement will not violate any preemptive rights or rights of first refusal granted by the Company that will not be validly waived or complied with, and will be free of any liens or encumbrances, other than any liens or encumbrances created by or imposed upon the Investor through no action of the Company.  There are no stockholders agreements, voting agreements or other similar agreements with respect to the Company’s capital stock to which the Company is a party or, to the knowledge of the Company, between or among any of the Company’s stockholders.

 

(e)      Litigation.  There are no actions, suits or proceedings at law or in equity or by or before any governmental instrumentality or other agency or regulatory authority now pending, or, to the best knowledge of the Company, threatened against the Company which, if adversely determined, could materially and adversely affect the business, assets, operations, prospects or condition, financial or otherwise, of the Company. There is no action, suit or proceeding by the Company currently pending or that the Company currently intends to initiate.

 

(f)       Compliance with Laws.  The Company is not in violation of any statute, law, rule or regulation, or in default with respect to any judgment, writ, injunction, decree, rule or regulation of any court or governmental agency or instrumentality, except for such violations or defaults which do not materially and adversely affect the business, assets, operations, prospects or condition, financial or otherwise, of the Company.

 

(g)      Governmental Consents.  Subject to the accuracy of the representations and warranties of the Investor set forth herein, no registration or filing with, or consent or approval of or other action by, any Federal, state or other government agency under laws and regulations thereof as now in effect is or will be necessary for the valid execution, delivery and performance by the Company of the Transaction Documents, and the issuance, sale and delivery of the Oramed Shares, other than the the filings required by state securities law.

 

  

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(h)      Regulatory Matters.  The clinical, pre-clinical and other trials, studies and tests conducted by or on behalf of or sponsored by the Company relating to its pharmaceutical product candidates were and, if still pending, are being conducted in all material respects in accordance with medical and scientific protocols and research procedures that the Company reasonably believes are appropriate.  The descriptions of the results of such trials, studies and tests as set forth in the SEC Documents (as defined in Section 3(i) of this Agreement), provided to the Investor are accurate in all material respects and fairly present the data derived from such trials, studies and tests.  All clinical trials conducted by the Company have been in compliance in all material respects with applicable laws and regulations.  The Company has not received any warning letters or written correspondence from the FDA and/or any other governmental entity or agency requiring the termination, suspension or modification of any clinical, pre-clinical and other trials, studies or tests that are material to the Company.   None of the clinical trials that the Company is currently conducting or sponsoring is subject to any temporary or permanent clinical hold by the FDA or any other governmental entity or agency, and the Company has no reason to believe that such clinical trials will be subject to any such action.

 

(i)       SEC Documents; Financial Statements.  For the past twelve (12) months, the Company has filed all reports, schedules, forms, statements and other documents required to be filed by it with the SEC pursuant to the reporting requirements of the Exchange Act (all of the foregoing filed prior to the date hereof and all exhibits included therein and financial statements, notes and schedules thereto and documents incorporated by reference therein being hereinafter referred to as the “SEC Documents”).  The Company has delivered to the Investor or their respective representatives true, correct and complete copies of each of the SEC Documents not available on the Electronic Data Gathering, Analysis, and Retrieval system of the SEC that have been requested by Investor.  As of their respective dates, the SEC Documents complied as to form in all material respects with the requirements of the Exchange Act and the rules and regulations of the SEC promulgated thereunder applicable to the SEC Documents, and none of the SEC Documents, at the time they were filed with the SEC, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading.  As of their respective dates, the financial statements of the Company included in the SEC Documents complied as to form in all material respects with applicable accounting requirements and the published rules and regulations of the SEC with respect thereto as in effect as of the time of filing.  Such financial statements have been prepared in accordance with generally accepted accounting principles (“GAAP”), consistently applied, during the periods involved (except (i) as may be otherwise indicated in such financial statements or the notes thereto, or (ii) in the case of unaudited interim statements, to the extent they may exclude footnotes or may be condensed or summary statements) and fairly present in all material respects the financial position of the Company as of the dates thereof and the results of its operations and cash flows for the periods then ended (subject, in the case of unaudited statements, to normal year-end audit adjustments).  The Company has no liabilities or obligations required to be disclosed in the SEC Documents that are not so disclosed in the SEC Documents, other than those incurred in the ordinary course of the Company’s business.

 

  

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(j)       Sarbanes-Oxley; Internal Accounting Controls. Each SEC Document containing financial statements that has been filed with or submitted to the SEC was accompanied by the certifications required to be filed or submitted by the Company’s chief executive officer and chief financial officer pursuant to the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”); at the time of filing or submission of each such certification, such certification was true and accurate and complied with the Sarbanes-Oxley Act and the rules and regulations promulgated thereunder; such certifications contain no qualifications or exceptions to the matters certified therein and have not been modified or withdrawn; and neither the Company nor any of its officers has received notice from any governmental entity questioning or challenging the accuracy, completeness, form or manner of filing or submission of such certification;

 

(k)      Absence of Changes.  The Common Stock is quoted for trading on the OTCBB.  No order ceasing, halting or suspending trading in the Common Stock nor prohibiting the sale of the Common Stock has been issued to and is outstanding against the Company or its directors, officers or promoters, and, to the best of the Company’s knowledge, no investigations or proceedings for such purposes are pending or threatened.  The Company has not taken any action which would be reasonably expected to result in the delisting or suspension of quotation of the Common Stock on or from the OTCBB and the Company has complied in all material respects with the rules and regulations of eligibility on the OTCBB.  The Company has not taken any steps to seek protection pursuant to any bankruptcy law nor does the Company have any knowledge or reason to believe that its creditors intend to initiate involuntary bankruptcy proceedings or any actual knowledge of any fact which would reasonably lead any creditor or creditors to do so.  Based on the financial condition of the Company as of the date hereof, after giving effect to the receipt by the Company of the proceeds from the transactions contemplated hereby, the Company reasonably believes that (i) the fair saleable value of the Company’s assets exceeds the amount that will be required to be paid on or in respect of the Company’s existing debts and other liabilities as they mature; (ii) the Company’s assets do not constitute unreasonably small capital to carry on its business as now conducted and as proposed to be conducted including its capital needs taking into account the particular capital requirements of the business conducted by the Company, and projected capital requirements and capital availability thereof; and (iii) the current cash flow of the Company, together with the proceeds the Company would receive, were it to liquidate all of its assets, after taking into account all anticipated uses of the cash, would be sufficient to pay all amounts on or in respect of its liabilities when such amounts are required to be paid.  The Company does not intend to incur debts beyond its ability to pay such debts as they mature (taking into account the timing and amounts of cash to be payable on or in respect of its debt).  The SEC Documents set forth as of the dates thereof all outstanding secured and unsecured Company Indebtedness, or for which the Company or any subsidiary has commitments. For the purposes of this Agreement, “Company Indebtedness” shall mean with respect to the Company and any subsidiary (a) any liabilities for borrowed money or amounts owed (other than trade accounts payable incurred in the ordinary course of business), (b) all guaranties, endorsements and other contingent obligations in respect of Company Indebtedness of others, whether or not the same are or should be reflected in the Company’s balance sheet (or the notes thereto), except guaranties by endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of business; and (c) the present value of any lease payments due under leases required to be capitalized in accordance with GAAP. Neither the Company nor any subsidiary is in default with respect to any Company Indebtedness.

 

  

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(l)      Patents and Trademarks. The Company has rights to use all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual property rights and similar rights necessary or material for use in connection with its business as described in the SEC Documents and which the failure to so have would have a material adverse effect on the results of operations, assets, business, prospects, or condition, financial or otherwise, of the Company (collectively, the “Company Intellectual Property Rights”). The Company has not received any notice (written or otherwise) that the Company Intellectual Property Rights used by the Company violate or infringe upon the rights of any other person or entity. To the knowledge of the Company, all such Company Intellectual Property Rights are enforceable and there is no existing infringement by another person or entity of any of the Company Intellectual Property Rights. The Company has taken reasonable security measures to protect the secrecy, confidentiality and value of all of its Company Intellectual Property Rights.

 

(m)     Offering.  Assuming the accuracy of the representations and warranties of the Investor contained in Section 3.2 of this Agreement, the offer, issue, and sale of the Oramed Shares are exempt from the registration and prospectus delivery requirements of the Securities Act and the registration or qualification requirements of all applicable state securities laws.  Neither the Company nor any authorized agent acting on its behalf will knowingly take any action hereafter that would cause the loss of such exemptions.

 

(n)      No General Solicitation; Placement Agent’s Fees.  Neither the Company, nor any of its Affiliates, nor any person acting on its or their behalf, has engaged in any form of general solicitation or general advertising (within the meaning of Regulation D of the Securities Act) in connection with the offer or sale of the Oramed Shares.  The Company shall be responsible for the payment of any placement agent’s fees, financial advisory fees, or brokers’ commissions (other than for persons engaged by any Investor or its investment advisor) relating to or arising out of the issuance of the Oramed Shares.

 

  

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(o)      No Integrated Offering.  Neither the Company nor any person acting on its behalf has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security, under circumstances that would require registration of any of the Oramed Shares under the Securities Act or cause this offering of the Oramed Shares to be integrated with prior offerings by the Company for purposes of the Securities Act or any applicable shareholder approval provisions, including, without limitation, under the rules and regulations of the OTCBB or any other exchange or automated quotation system on which any of the securities of the Company are listed or designated.

 

(p)      Manipulation of Price.  The Company has not, and to its knowledge no one acting on its behalf has, (i) taken, directly or indirectly, any action designed to cause or to result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of any of the Oramed Shares, (ii) sold, bid for, purchased, or paid any compensation for soliciting purchases of, any of the Oramed Shares, or (iii) paid or agreed to pay to any person any compensation for soliciting another to purchase any other securities of the Company.

 

(q)      But for the representations actually made in this Agreement, the Company represents that it is aware that the Option Shares are allocated "AS IS" without any further representations by the Investor and/or its directors and/or its shareholders.

 

(r)      The Company represents that it is capable of evaluating the merits and risks of the transactions contemplated hereunder, and that it shall solely bear all such economic risks.

 

(s)      The Company recognizes that its investment in DNA involves a high degree of risk, and has required knowledge and experience in financial and business matters as to be capable of evaluating the merits and risks of its investment and has the ability to bear the economic risks of its investment and the potential loss of its entire investment.

 

(t)      The Company further warrants that it has considered and shall solely bear the tax implications which apply to it in connection of the execution of its investment and that the Investor has not presented it with any representation in accordance with such tax implications.

 

(u)      The Company is, and will be, acquiring the Option and the Option Shares as principal for its own account for investment purposes only and not with a view to or for distributing or reselling such Option and the Option Shares or any part thereof, without prejudice, however, to the Company's right, to sell or otherwise dispose of all or any part of such Option and the Option Shares in compliance with applicable securities laws.  The Company hereby acknowledges that the Option Shares are subject to a resale restriction pursuant to applicable Israeli law and regulations.

 

(v)      The Company's wholly owned Israeli subsidiary, currently holds 8,404,667 D.N.A Ordinary Shares.  The Company is aware of the Investor's obligation to file an immediate report with the Israel Securities Authority (the "ISA") regarding this Agreement.  The Company is aware of the obligations under Israeli law of an “interested party” to promptly report to the Investor any changes in its ownership of D.N.A Ordinary Shares.

 

  

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(w)     Disclosure.  All disclosure provided to the Investor with regard to the representations and warranties contained in this Section 3.1 regarding the Company, its business and the transactions contemplated hereby, furnished in writing by the Company is true and correct in all material respects and does not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, together with the disclosure in the SEC Documents, not misleading.

 

(x)       Investor Reliance.  The Company expressly acknowledges and agrees that the Investor is relying upon the Company’s representations contained in this Agreement.

 

3.2      Representations and Warranties of the Investor.  The Investor, hereby represents and warrants to the Company as follows:

 

(a)      Organization, Validity and Qualification of the Investor.  The Investor is a company duly organized and validly existing under the laws of the State of Israel. .  The Investor has all requisite corporate power and authority to own and operate its properties and to carry on its business as now being conducted and as proposed to be conducted.  The Investor is duly qualified to do business as a foreign corporation and is in good standing in each jurisdiction in which failure to so qualify would materially and adversely affect the business, properties, operations, prospects or condition, financial or otherwise, of the Investor.  The resolutions adopted by the directors of the Investor on September 9, 2012 authorizing the transactions contemplated by the Transaction Documents have not been amended or modified in any way, have not been rescinded and are in full force and effect on the date hereof.

 

(b)      Corporate Authority; Enforceability.  The Investor has full right, power and authority to issue the Option and the Option Shares as herein contemplated and the Investor has full power and authority to enter into and perform its obligations under the Transaction Documents.  The execution and delivery of the Transaction Documents and the consummation of the transactions contemplated herein and therein have been duly authorized and approved by all requisite corporate action, and each of the Transaction Documents are a valid and legally binding obligation of the Investor.  The Transaction Documents have been duly executed by the Investor and, when delivered in accordance with the terms thereof, will constitute the valid and binding obligation of the Investor enforceable against them in accordance with its terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors. Subject to the resale restrictions under the relevant securities laws, the Options and the Option Shares, when issued by the Investor, will be duly and validly issued, fully paid and nonassessable, and free and clear of all liens.

 

  

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(c)      Conflicts.  Neither the authorization, execution and delivery of the Transaction Documents nor the consummation of the transactions herein and therein contemplated, will (i) conflict with or result in a breach of any of the terms of the Investor’s Memorandum of Association or Articles of Association, (ii) violate any judgment, order, injunction, decree or award of any court or governmental body, having jurisdiction over the Investor, against or binding on the Investor or to which its property is subject, (iii) violate any material law or regulation of any jurisdiction which is applicable to the Investor, (iv) violate, conflict with or result in the breach or termination of, or constitute a default under, the terms of any material agreement to which the Investor is a party, except for such violations or defaults which do not materially and adversely affect the business, assets, operations, prospects or condition, financial or otherwise of the Investor, or (v) violate or conflict with the rules and regulations of the Tel Aviv Stock Exchange (the "TASE").

 

(d)      Capitalization. The authorized capital of the Investor as of the date hereof consists of 1,000,000,000 ordinary shares, of which there were a total of (i) 186,112,740 ordinary shares issued and outstanding as of the date hereof as fully paid and nonassessable shares; (ii) options (including employee stock options) and/or warrants to purchase 16,111,810 ordinary shares; and (iii) 4,154,868 Series B bonds convertible into 692,478 ordinary shares.  All of the outstanding shares of share capital of the Investor are validly issued, fully paid and nonassessable.  The issuance of the Option and the Option Shares pursuant to the provisions of the Transaction Documents will not violate any preemptive rights or rights of first refusal granted by the Investor that will not be validly waived or complied with, and will be free of any liens or encumbrances. Other than a verbal understanding between Mr. Zeev Bronfeld and Mr. Meni Mor, each a controlling shareholder of the Investor, to act in concert with respect to the ordinary shares of the Investor held by each of them, there are no shareholders agreements, voting agreements or other similar agreements with respect to the Investor’s share capital to which the Investor is a party or, to the knowledge of the Investor, between or among any of the Investor's shareholders, including the Company. No further approval or authorization of any stockholder or the Board of Directors of the Investor is required for the issuance and sale of the Option or the Option Shares.

 

(e)      Litigation.  There are no actions, suits or proceedings at law or in equity or by or before any governmental instrumentality or other agency or regulatory authority now pending, or, to the best knowledge of the Investor, threatened against the Investor which, if adversely determined, could materially and adversely affect the business, assets, operations, prospects or condition, financial or otherwise, of the Investor. There is no action, suit or proceeding by the Investor currently pending or that the Investor currently intends to initiate.

 

(f)       Compliance with Laws.  Except as set forth in the letter attached hereto as Exhibit B, the Investor is not in violation of any statute, law, rule or regulation, or in default with respect to any judgment, writ, injunction, decree, rule or regulation of any court or governmental agency or instrumentality, except for such violations or defaults which do not materially and adversely affect the business, assets, operations, prospects or condition, financial or otherwise, of the Investor.

 

  

11

  

 

(g)      Filings, Consents and Approvals.  Except for the requisite approval of the TASE, no registration or filing with, or consent or approval of or other action by, any government agency under laws and regulations thereof as now in effect is or will be necessary for the valid execution, delivery and performance by the Investor of the Transaction Documents, and the issuance, sale and delivery of the Option and the Option Shares.  The ISA has the right to comment on private placements in Israel.  All reports delivered by the Investor in accordance with applicable TASE and ISA regulations were true and correct and did not contain any misleading information as such term is defined in the Israeli Securities Law, 5728-1968.

 

(h)      Intentionally Left Blank.

 

(i)       SEC Documents; Financial Statements. Except as set forth in the letter attached hereto as Exhibit B, for the past twelve (12) months, the Investor has filed all reports, schedules, forms, statements and other documents required to be filed by it with the ISA pursuant to the reporting requirements of applicable law (all of the foregoing filed prior to the date hereof and all exhibits included therein and financial statements, notes and schedules thereto and documents incorporated by reference therein being hereinafter referred to as the “ISA Documents”).  The Investor has delivered to the Company or their respective representatives true, correct and complete copies of each of the ISA Documents not available on MAGNA that have been requested by the Company.  As of their respective dates, the ISA Documents complied as to form in all material respects with the requirements of applicable law, and none of the ISA Documents, at the time they were filed with the ISA, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. Except as set forth in the letter attached hereto as Exhibit F, as of their respective dates, the financial statements of the Investor included in the ISA Documents complied as to form in all material respects with applicable accounting requirements and the published rules and regulations of the ISA with respect thereto as in effect as of the time of filing.  Such financial statements have been prepared in accordance with GAAP, consistently applied, during the periods involved (except (i) as may be otherwise indicated in such financial statements or the notes thereto, or (ii) in the case of unaudited interim statements, to the extent they may exclude footnotes or may be condensed or summary statements) and fairly present in all material respects the financial position of the Investor as of the dates thereof and the results of its operations and cash flows for the periods then ended (subject, in the case of unaudited statements, to normal year-end audit adjustments).  The Investor has no liabilities or obligations required to be disclosed in the ISA Documents that are not so disclosed in the ISA Documents, other than those incurred in the ordinary course of the Investor’s business.

 

  

12

  

 

(j)       Absence of Changes.  The ordinary shares of the Investor are listed on the TASE.  No order ceasing, halting or suspending trading in the ordinary shares or prohibiting the sale of the ordinary shares has been issued to and is outstanding against the Investor or its directors, officers or promoters, and, to the best of the Investor’s knowledge, no investigations or proceedings for such purposes are pending or threatened.  The Investor has not, received notice (written or oral) from the TASE to the effect that the Investor is not in compliance with the listing or maintenance requirements of the TASE.  The Investor is not, and has no reason to believe that it will not in the foreseeable future continue to be, in compliance with all such listing and maintenance requirements.  The Investor has not taken any action which would be reasonably expected to result in the delisting or suspension of quotation of the ordinary shares on or from the TASE and the Investor has complied in all material respects with the rules and regulations of eligibility on the TASE.  The Investor has not taken any steps to seek protection pursuant to any bankruptcy law nor does the Investor have any knowledge or reason to believe that its creditors intend to initiate involuntary bankruptcy proceedings or any actual knowledge of any fact which would reasonably lead any creditor or creditors to do so.  The Investor does not intend to incur debts beyond its ability to pay such debts as they mature (taking into account the timing and amounts of cash to be payable on or in respect of its debt).  The ISA Documents set forth as of the dates thereof all outstanding secured and unsecured Investor Indebtedness of the Investor or any subsidiary, or for which the Investor or any subsidiary has commitments.  For the purposes of this Agreement, “Investor Indebtedness” shall mean with respect to the Investor and any subsidiary (a) any liabilities for borrowed money or amounts owed (other than trade accounts payable incurred in the ordinary course of business), (b) all guaranties, endorsements and other contingent obligations in respect of Investor Indebtedness of others, whether or not the same are or should be reflected in the Investor’s balance sheet (or the notes thereto), except guaranties by endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of business; and (c) the present value of any lease payments due under leases required to be capitalized in accordance with GAAP. Neither the Investor nor any subsidiary is in default with respect to any Investor Indebtedness.

 

(k)      Patents and Trademarks. The Investor has rights to use all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual property rights and similar rights necessary or material for use in connection with its business as described in the ISA Documents and which the failure to so have would have a material adverse effect on the results of operations, assets, business, prospects, or condition, financial or otherwise, of the Investor (collectively, the “InvestorIntellectual Property Rights”). The Investor has not received any notice (written or otherwise) that the Investor Intellectual Property Rights used by the Investor violate or infringe upon the rights of any other person or entity. To the knowledge of the Investor, all such Investor Intellectual Property Rights are enforceable and there is no existing infringement by another person or entity of any of the Investor Intellectual Property Rights. The Investor has taken reasonable security measures to protect the secrecy, confidentiality and value of all of its Investor Intellectual Property Rights.

 

  

13

  

 

(l)       Offering.  The offer, issue, and sale of the Option and the Option Shares contemplated hereby are exempt from the prospectus requirements of under the Israeli Securities Law, 5728-1968.  Neither the Investor nor any authorized agent acting on its behalf will knowingly take any action hereafter that would cause the loss of such exemptions. The Investor has not offered or sold its ordinary shares or related derivative securities to more than 35 investors (excluding qualified institutional investors) during the past 12 months.

 

(m)     No General Solicitation; Placement Agent’s Fees.  Neither the Investor, nor any of its Affiliates, nor any person acting on its or their behalf, has engaged in any form of general solicitation or general advertising in connection with the offer or sale of the Option or the Option Shares.  The Investor shall be responsible for the payment of any placement agent’s fees, financial advisory fees, or brokers’ commissions (other than for persons engaged by any Investor or its investment advisor) relating to or arising out of the issuance of the Option and the Option Shares.

 

(n)      Authorization; Enforcement.  The Investor represents and warrants that it is an entity duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization with the requisite corporate or partnership power and authority to enter into and to consummate the transactions contemplated by the applicable this Agreement and otherwise to carry out its obligations hereunder.  This Agreement has been duly executed by the Investor, and when delivered by the Investor in accordance with terms hereof, will constitute the valid and legally binding obligation of the Investor, enforceable against it in accordance with its terms.

 

(o)      Investment Intent.  The Investor is acquiring the Oramed Shares as principal for its own account for investment purposes only and not with a view to or for distributing or reselling such Oramed Shares or any part thereof, without prejudice, however, to the Investor's right at all times to sell or otherwise dispose of all or any part of such Oramed Shares in compliance with applicable securities laws and this Agreement.  The Investor is acquiring the Oramed Shares hereunder in the ordinary course of its business. The Investor does not have any agreement or understanding, directly or indirectly, with any Person to distribute any of the Oramed Shares.

 

(p)      Investor Status.  At the time the Investor was offered the Oramed Shares, it was, and at the date hereof it is, an "accredited investor" as defined in Rule 501(a) under the Securities Act and a non-"U.S. person" within the meaning of Rule 902(k) promulgated under the Securities Act (and the Investor is not purchasing for the account or benefit of a U.S. Person).  At the time of the offer and sale of the Oramed Shares, the Investor was not located in the United States.  The Investor is not required to be registered as a broker-dealer under Section 15 of the Securities Exchange Act of 1934, as amended.

 

(q)      General Solicitation.  The Investor is not purchasing the Oramed Shares as a result of any advertisement, article, notice or other communication regarding the Oramed Shares published in any newspaper, magazine or similar media or broadcast over television or radio or presented at any seminar or any other general solicitation or general advertisement.

 

  

14

  

 

(r)       Access to Information.  The Investor acknowledges that it has been afforded (i) the opportunity to ask such questions as it has deemed necessary of, and to receive answers from, representatives of the Company concerning the terms and conditions of the offering of the Oramed Shares and the merits and risks of investing in the Oramed Shares; (ii) access to information about the Company and its financial condition, results of operations, business, properties, management and prospects sufficient to enable it to evaluate its investment; and (iii) the opportunity to obtain such additional information that the Company possesses or can acquire without unreasonable effort or expense that is necessary to make an informed investment decision with respect to the investment. The Investor understands that a purchase of the Oramed Shares is a speculative investment involving a high degree of risk.  The Investor is aware that there is no guarantee that the Investor will realize any gain from this investment, and that the Investor could lose the total amount of this investment. The Investor acknowledges that it has received no representations or warranties from the Company or its employees or agents in making this investment decision other than as set forth in this Agreement.

 

(s)      Independent Investment Decision.  The Investor has independently evaluated the merits of its decision to purchase Oramed Shares pursuant to this Agreement, such decision has been independently made by the Investor and the Investor confirms that it has only relied on the advice of its own business and/or legal counsel and not on the advice of any other Investor’s business and/or legal counsel in making such decision.

 

(t)       Short Sales.  The Investor has not directly or indirectly, nor has any Person acting on behalf of or pursuant to any understanding with the Investor, executed any Short Sales in the securities of the Company since the date that the Investor was first contacted regarding an investment in the Company.

 

(u)      Limitations on Transfers. The Investor acknowledges that the Oramed Shares must be held indefinitely unless subsequently registered under the Securities Act or unless an exemption from such registration is available.  The Investor is aware of the provisions of Rule 144 promulgated under the Securities Act which permit limited resale of securities purchased in a private placement subject to the satisfaction of certain conditions, which may include, among other things, the existence of a public market for the securities, the availability of certain current public information about the Company, the resale occurring not less than six months after a party has purchased and paid for the security to be sold, the sale being effected through a “broker’s transaction” or in transactions directly with a “market maker” and the number of securities being sold during any three month period not exceeding specified limitations.

 

(v)      But for the representations actually made in this Agreement, the Investor represents that it is aware that the Oramed Shares are allocated "AS IS" without any further representations by the Company and/or its directors and/or its shareholders.

 

  

15

  

 

(w)     Disclosure.  All disclosure provided to the Company with regard to the representations and warranties contained in this Section 3.2 regarding the Investor, its business and the transactions contemplated hereby, furnished in writing by the Investor is true and correct in all material respects and does not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, together with the disclosure in the ISA Documents, not misleading.

 

(x)      Company Reliance.  The Investor expressly acknowledges and agrees that the Company is relying upon the Investor’s representations contained in this Agreement.

 

ARTICLE IV.

MISCELLANEOUS

 

4.1           Certificates; Resales.

 

(a)      The Oramed Shares may only be disposed of in compliance with state and federal securities laws.  In connection with any transfer of the Oramed Shares other than pursuant to an effective registration statement or Rule 144(b)(1) to the Company or to an Affiliate of an Investor, the Company may require the transferor thereof to provide to the Company an opinion of counsel selected by the transferor, reasonably acceptable to the Company, the form and substance of which opinion shall be reasonably satisfactory to the Company, to the effect that such transfer does not require registration of such transferred Oramed Shares under the Securities Act.

 

(b)      Certificates evidencing the Oramed Shares will contain the following legend, until such time as they are not required:

 

THESE SECURITIES HAVE NOT BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE "SECURITIES ACT"), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS AS EVIDENCED BY A LEGAL OPINION OF COUNSEL TO THE TRANSFEROR TO SUCH EFFECT, THE SUBSTANCE OF WHICH SHALL BE REASONABLY ACCEPTABLE TO THE COMPANY.  THESE SECURITIES MAY BE PLEDGED IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT SECURED BY SUCH SECURITIES.

 

  

16

  

 

(c)      Certificates evidencing the Oramed Shares shall not contain any legend (including the legend set forth in Section 5.1(b) of this Agreement), (i) following a sale of such securities pursuant to an effective registration statement, or (ii) following any sale of such Shares pursuant to Rule 144 (assuming the transferor was not an Affiliate of the Company), or (iii) if such legend is not required under applicable requirements of the Securities Act (including judicial interpretations and pronouncements issued by the staff of the SEC).  The Company may not make any notation on its records or give instructions to any transfer agent of the Company that enlarge the restrictions on transfer set forth in this Section 5.1(c) except in the case of an Investor or its permitted transferee becoming an Affiliate.  Certificates for Oramed Shares subject to legend removal hereunder shall be transmitted by the transfer agent of the Company to the Investor by crediting the account of the Investor’s prime broker with the Depository Trust Company System.

 

(d)      The Option Shares are subject to a resale restriction pursuant to applicable Israeli law and regulations.

 

4.2           Indemnification.

 

(a)      The Investor acknowledges that he, she or it understands the meaning and legal consequences of the representations and warranties that are contained herein and hereby agrees, severally and not jointly, to indemnify, save and hold harmless the Company and its directors, officers, employees and counsel, from and against any and all claims or actions arising out of a breach of any representation, warranty or acknowledgment of the Investor contained in this Agreement.  Such indemnification shall be deemed to include not only the specific liabilities or obligations with respect to which such indemnity is provided, but also all reasonable costs, expenses, counsel fees and expenses of settlement relating thereto, whether or not any such liability or obligation shall have been reduced to judgment.  In addition, the Investor’s representations, warranties and indemnification contained herein shall survive the Investor’s purchase of the Oramed Shares hereunder for a period of one year following the date hereof.

 

(b)      The Company acknowledges it understands the meaning and legal consequences of the representations and warranties that are contained herein and hereby agrees to indemnify, save and hold harmless the Investor and its directors, officers, employees and counsel, from and against any and all claims or actions arising out of a breach of any representation, warranty or acknowledgment of the Company contained in this Agreement.  Such indemnification shall be deemed to include not only the specific liabilities or obligations with respect to which such indemnity is provided, but also all reasonable costs, expenses, counsel fees and expenses of settlement relating thereto, whether or not any such liability or obligation shall have been reduced to judgment.  In addition, the Company’s representations, warranties and indemnification contained herein shall survive the purchase of the Oramed Shares hereunder for a period of one year following the date hereof.

 

  

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4.3           Abstention from Trading. From the date hereof until the Closing Date, (i) the Investor will not engage in any financial market transactions (whether long, short or other hedging transactions) with respect to the Company’s Common Stock or with respect to the Investor's ordinary shares, and (ii) the Company will not, and the Company shall cause its directors and officers and each of its and their respective Affiliates to not, engage in any financial market transactions (whether long, short or other hedging transactions) with respect to the Company’s Common Stock or with respect to the Investor's ordinary shares.

 

4.4           Entire Agreement; Amendment.  The parties have not made any representations or warranties with respect to the subject matter hereof not set forth herein.  This Agreement, together with the Option and any other instruments executed simultaneously herewith, constitute the entire agreement between the parties with respect to the subject matter hereof.  All understandings and agreements heretofore between the parties with respect to the subject matter hereof are merged in this Agreement and any such instruments, which alone fully and completely expresses their agreement.  This Agreement may not be changed, modified, extended, terminated or discharged orally, but only by an agreement in writing, which is signed by all of the parties to this Agreement.

 

4.5           Notices.  Any notice required or permitted to be given to a party pursuant to the provisions of this Agreement will be in writing and will be effective on (i) the date of transmission, if such notice or communication is delivered via facsimile at the facsimile number set forth in this Agreement prior to 5:30 p.m. (in the time zone of the recipient of such notice) on a Trading Day, (ii) the next Trading Day after the date of transmission, if such notice or communication is delivered via facsimile at the facsimile number set forth in this Agreement on a day that is not a Trading Day or later than 5:30 p.m. (in the time zone of the recipient of such notice) on any Trading Day, (iii) the 2nd Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service, including Express Mail, for United States deliveries or (iii) five (5) Trading Days after deposit in the United States mail by registered or certified mail for United States deliveries.  All notices not delivered personally or by facsimile will be sent with postage and other charges prepaid and properly addressed to the party to be notified at the address set forth below such party’s signature of this Agreement or at such other address as such party may designate by ten (10) days advance written notice to the other parties hereto. The address for such notices and communications shall be as follows:

 

  

18

  

 

	
  

	
If to the Company:

	
Oramed Pharmaceuticals Inc.

	
  

	
Hi-Tech Park 2/5

	
  

	
Givat-Ram

	
  

	
PO Box 39098

	
  

	
Jerusalem 91390 Israel

	
  

	
Attn: Nadav Kidron

	
  

	
Facsimile:  +972-2-566-0004

With a copy to:

Goldfarb Seligman & Co., Law Offices

Electra Tower, 98 Yigal Alon Street

Tel Aviv 67891, Israel

Attn:  Adam M. Klein, Adv.

Facsimile:  +972-3-608-9855

 

	
  

	
If to an Investor:

	
To the address set forth under the Investor's name

	
  

	
on the signature pages hereof.

 

4.6           Delays or Omissions.  Except as otherwise specifically provided for hereunder, no party shall be deemed to have waived any of his or her or its rights hereunder or under any other agreement, instrument or document signed by any of them with respect to the subject matter hereof unless such waiver is in writing and signed by the party waiving said right.  Except as otherwise specifically provided for hereunder, no delay or omission by any party in exercising any right with respect to the subject matter hereof shall operate as a waiver of such right or of any such other right.  A waiver on any one occasion with respect to the subject matter hereof shall not be construed as a bar to, or waiver of, any right or remedy on any future occasion.  All rights and remedies with respect to the subject matter hereof, whether evidenced hereby or by any other agreement, instrument or document, will be cumulative, and may be exercised separately or concurrently.

 

4.7           Severability.  If any provision of this Agreement is held to be unenforceable under applicable law, then such provision shall be excluded from this Agreement, and the balance of this Agreement shall be interpreted as if such provision was so excluded and shall be enforceable in accordance with its terms.

 

4.8           Successors and Assigns.  Except as otherwise expressly provided herein, the provisions hereof shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors and administrators of the parties hereto.

 

4.9           Counterparts; Signatures.  This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, and all of which together shall constitute one instrument.  Signatures transmitted by facsimile or scanned and transmitted by electronic mail shall be considered valid and binding signatures.

 

  

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4.10         Survival of Warranties.  The representations, warranties, covenants and agreements of the Company and the Investor contained in or made pursuant to this Agreement shall survive the execution and delivery of this Agreement and shall in no way be affected by any investigation made by an Investor or the Company.

 

4.11         Further Action.  The parties agree to execute any and all such other and further instruments and documents, and to take any and all such further actions reasonably required to effectuate this Agreement and the intent and purposes hereof.

 

4.12         Construction.  The headings herein are for convenience only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof.  The language used in this Agreement will be deemed to be the language chosen by the parties to express their mutual intent, and no rules of strict construction will be applied against any party.  This Agreement shall be construed as if drafted jointly by the parties, and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Agreement.

 

4.13         Publicity.  Each of the parties hereto shall coordinate with each other all publicity relating to the transactions contemplated by this Agreement, and shall not issue any press release, immediate report or other filing with the ISA relating to this Agreement or the transactions contemplated by this Agreement without first obtaining the prior consent of the other or its representative, except that neither party shall be precluded from making such filings or giving such notices as may be required by law or the rules of any stock exchange. Each of the parties hereto shall cooperate and shall use their reasonable efforts to agree on the form and substance of the report to be filed by the Investor with the ISA relating to the transactions contemplated by this Agreement.

 

4.14         TASE Listing.  For so long the Option is outstanding or the Company holds any of the D.N.A Ordinary Shares, the Investor shall use its best efforts to maintain its listing on the TASE and shall comply with all reporting requirements under applicable law.

 

4.15         No Third-Party Beneficiaries.  This Agreement is intended for the benefit of the parties hereto and their respective successors and permitted assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other Person.

 

4.16         Governing Law; Venue and Waiver of Jury Trial.  This Agreement is to be construed in accordance with and governed  by the  internal  laws of the State of Delaware without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction to the rights and duties of the  parties.  The Company and the Investor agree that any suit, action, or proceeding arising out of or relating to this Agreement shall be brought to any court of competent jurisdiction sitting in Wilmington, Delaware and that the parties shall submit to the jurisdiction of such court. The parties irrevocably waive, to the fullest extent permitted by law, any objection the party may have to the laying of venue for any such suit, action or proceeding brought in such court.  THE PARTIES ALSO EXPRESSLY WAIVE ANY RIGHT THEY HAVE OR MAY HAVE TO A JURY TRIAL OF ANY SUCH SUIT, ACTION OR PROCEEDING.  If any one or more provisions of this Section 4.14 shall for any reason be held invalid or unenforceable, it is the specific  intent of the parties that such provisions shall be modified to the minimum extent necessary to make it or its application valid and enforceable.

 

  

20

  

 

4.17         Replacement of Securities.  If any certificate or instrument evidencing any Securities is mutilated, lost, stolen or destroyed, the Company or the Investor, as applicable, shall issue or cause to be issued in exchange and substitution for and upon cancellation thereof, or in lieu of and substitution therefor, a new certificate or instrument, but only upon receipt of evidence reasonably satisfactory to the Company or the Investor, as applicable, of such loss, theft or destruction and customary and reasonable indemnity, if requested.  The applicants for a new certificate or instrument under such circumstances shall also pay any reasonable third-party costs associated with the issuance of such replacement Securities.  If a replacement certificate or instrument evidencing any Securities is requested due to a mutilation thereof, the Company or the Investor, as applicable, may require delivery of such mutilated certificate or instrument as a condition precedent to any issuance of a replacement.

 

[SIGNATURE PAGES FOLLOW]

 

  

21

  

 

IN WITNESS WHEREOF, THE PARTIES HERETO HAVE CAUSED THIS SECURITIES PURCHASE AGREEMENT TO BE DULY EXECUTED BY THEIR RESPECTIVE AUTHORIZED SIGNATORIES AS OF THE DATE FIRST INDICATED ABOVE.

 

	 	
ORAMED PHARMACEUTICALS INC.

 

	 
	 	
By:

	
 

	 
	 	
Name:

	
Nadav Kidron

	 
	 	
Title:

	
Chief Executive Officer

	 

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK

SIGNATURE PAGES FOR INVESTORS FOLLOW]

 

  

22

  

 

IN WITNESS WHEREOF, the parties hereto have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.

 

Name of Investor: D.N.A Biomedical Solutions Ltd.

Signature of Authorized Signatory of Investor: /s/ Zeev Bronfeld      /s/ Meni Mor

 

Name of Authorized Signatory: Zeev Bronfeld and Meni Mor

Title of Authorized Signatory: Director and Director

Email Address of Investor:____________________________

Social Security or Taxpayer Identification Number _______________________________

Address for Notice of Investor:

Shimon Hatarasi 43, Tel Aviv 62492, Israel

Facsimile:  [_______________]

Address for Delivery of Securities for Investor (if not same as above):

____________________________________________

____________________________________________

____________________________________________

____________________________________________

  

23

  

 

SCHEDULE 1

 

	
Investor

	 	
Number of Shares

	 
	
D.N.A Biomedical Solutions Ltd.

	 	 	2,390,057	 

24

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