Document:

Exhibit 10.19

    

    

    

    

    

    

    

    

    

    

    COOPERATION AGREEMENT

    

    

    

    

    Between

    

    

    

    

    HYGO ENERGY TRANSITION LTD.

    

    

    

    

    And

    

    

    

    

    GOLAR LNG PARTNERS LP

    

    

    

    

    

    

    

    

    

    

    
      

      
        

      

    

    
    This Cooperation Agreement (the "Agreement") is entered into this 31 day of August 2020 by and between:

    

    

    	(1)	
            HYGO ENERGY TRANSITION LTD. (name changed from Golar Power Limited by resolution of the Shareholders dated August
                  13, 2020), a company incorporated under the laws of Bermuda with registered address 2nd floor S.E. Pearman Building, Hamilton HM11 Bermuda (hereinafter referred to as "Hygo Energy"
              which expression shall where the context so admits include its successors-in-title and assigns); and

          

    

    

    	(2)	
            GOLAR LNG PARTNERS LP, a master limited partnership formed under the laws of the Marshall Islands having its registered office at Trust Company
              Complex, Ajeltake Road, Ajeltake Island, MH96960(hereinafter referred to as "GMLP", which expression shall where the context so admits include its, successors-in-title and assigns).

          

    

    

    Hygo Energy and GMLP are each referred to as a "Party" and together as the "Parties".

    

    

    WHEREAS

    

    

    	A.	
            Hygo Energy develops, owns and operates integrated LNG-based transportation and downstream solutions including LNG carriers, a floating storage and regasification unit ("FSRU") and associated terminal and power generation infrastructure which will operate under long-term contracts with utility-grade offtakers.

          

    

    

    	B.	
            GMLP are a leading independent owner and operator of LNG carriers FSRUs and FLNG assets.

          

    

    

    	C.	
            The Parties now intend to cooperate to develop hub-spoke LNG terminal solutions which shall utilise GMLP's existing and future available asset portfolio , including utilising GMLP's
              assets for LNG terminal developments where GMLP's assets are technically suitable (the "Cooperation"). The terms and structure of the commercial cooperation will be worked on a project by project basis
              given the customized nature of each potential terminal. .

          

    

    

    NOW THEREFORE the Parties agree:

    

    

    	1.	
            INTERPRETATION

          

    

    

    	1.1	
            In this Agreement, including the Recitals, the following definitions are used:

          

    

    

    "Affiliate" means any company or legal entity which (a) controls either directly or indirectly a Party, or (b) is
      controlled directly or indirectly by such Party, or (c) is directly or indirectly controlled by a company or entity which directly or indirectly controls such Party. For the purpose of this Agreement, "control" means the direct or indirect ownership
      of fifty percent (50%) or more of the voting shares of such entity, the right to decide, directly or indirectly, the manner of exercising more than fifty percent (50%) of the votes in a general meeting of an entity or more than fifty percent (50%) of
      the votes in a meeting of the executive body of an entity or the right to appoint a majority of the board of directors or other governing body of such entity.

    

    

    
      

      2

      
        

      

    

    "Cooperation" shall have the meaning given to it in Recital C;

    

    

    "Intellectual Property" means any patent, registered design, copyright, database right, design right, topography
      right, trade mark, service mark, application to register any of the aforementioned rights, trade secret, rights in unpatented know-how and information, right of confidence and any other intellectual or industrial property right of any nature
      whatsoever in any part of the world, whether registered or unregistered;

    

    

    "Person" means any person, company, firm, partnership, entity, association or body corporate;

    

    

    "Personnel" means a Party or Person's directors, employees, servants, agents, representatives and invitees;

    

    

    "Opportunity" means a commercial opportunity for the Cooperation where GMLP's assets may be used.

    

    

    "Project Contract" means the contract Heads of Terms or preliminary agreements which shall contain all the terms
      applicable to the implementation of an Opportunity, which defines the respective roles, rights and obligations of the Parties;

    

    

    "Transaction Documents" means the documents to be entered into by the Parties in respect of an Opportunity,
      including agreements in respect of the project and any financing arrangements relating to the Opportunity.

    

    

    	1.2	
            In this Agreement, unless the context otherwise requires:

          

    

    

    	

          	1.2.1	
            references to recitals, clauses or paragraphs shall be references to recitals, clauses or paragraphs of this Agreement;

          

    

    

    	

          	1.2.2	
            the Schedules to this Agreement are an integral part of it;

          

    

    

    	

          	1.2.3	
            "including" means including without limitation;

          

    

    

    	

          	1.2.4	
            words importing the singular shall include the plural and vice versa; 1.2.5 words importing one gender shall include the other gender;

          

    

    

    	

          	1.2.6	
            all references to Persons include reference to their successors in title and permitted assigns; and

          

    

    

    	

          	1.2.7	
            clause numbers and headings are for ease of reference only and shall not be taken into account in construing this Agreement.

          

    

    

    
      

      3

      
        

      

    

    2.          PURPOSE

    

    

    	2.1	
            The Parties wish to further establish the basis on which they will evaluate their collaboration arrangement for the purposes of each potential Opportunity with the intent that the
              Parties will jointly participate in the Opportunities. The Parties shall:

          

    

    

    	

          	2.1.1	
            cooperate and engage in good faith to identify one or more potential Opportunities,

          

    

    

    	

          	2.1.2	
            if a potential Opportunity is identified, undertake Opportunity specific project visits to further explore project requirements, and

          

    

    

    	

          	2.1.3	
            subject to agreement to develop a specific Opportunity, engage in good faith to negotiate and enter into legally binding agreements to develop that Opportunity.

          

    

    

    	2.2	
            Any Project Contract and Transaction Documents will contain all the binding terms applicable to an opportunity which is progressed and will fully define the respective roles, rights and
              obligations of the Parties.

          

    

    

    	2.3	
            The Parties agree that if any Party identifies an Opportunity, it shall bring such opportunity to the attention of the other Party.

          

    

    

    3.          TERM

    

    

    	3.1.1	
            Any Party may terminate this Agreement by written notice, upon the occurrence and during the continuation of one of the following events:

          

    

    

    	

          	(a)	
            the other Party is in material breach of this Agreement, including but not limited to a breach of Clause 6 (Business Conduct), in which case such termination shall be without prejudice
              to the other rights of the affected Party, and take immediate effect at no cost, liability or penalty to the notifying Party; or

          

    

    

    	

          	(b)	
            the other Party enters into any deed of arrangement or commits an act of bankruptcy or compounds with its creditors, has a receiving order made against it or an order or resolution is
              passed for its winding up or dissolution otherwise than for the purposes of a bona fide amalgamation or reconstruction which has previously been approved by the notifying Party or otherwise becomes unable to pay its debts as they fall due, is
              insolvent within the meaning of any applicable law or if the notifying Party reasonably apprehends that any of the above events is likely to occur.

          

    

    

    	3.2	
            No rights or obligations shall survive the termination of this Agreement except those:

          

    

    

    
      	

            	3.2.1	
              expressly stated to so survive; or

            

    

    

    

    
      	

            	3.2.2	
              arising out of a pre-termination breach of this Agreement.

            

    

    

    

    
      

      4

      
        

      

    

    4.          PROCESSES

    

    

    	4.1	
            Subject to any contractual and legal restrictions, each Party shall, from time to time following the execution of this Agreement:

          

    

    

    	

          	4.1.1	
            make available to each other existing data and information relevant for the purposes of each Opportunity evaluation; and

          

    

    

    	

          	4.1.2	
            obtain and make available to each other any new data reasonably required for the Parties to undertake a complete asset evaluation and assessment of the feasibility of any Opportunity.

          

    

    

    	4.2	
            In negotiating any agreement with any person or entity that may relate to an Opportunity, each Party shall use commercially reasonable efforts to cause that agreement to permit the data
              and information contemplated by Section 4.1 to be shared with the other Party.

          

    

    

    5.          BUSINESS CONDUCT

    

    

    	5.1	
            No Party, nor its respective Personnel, have engaged, and each Party shall not, and shall procure (insofar as it lawfully can) that any of its respective Personnel do not, engage in any
              activity or conduct that has resulted or will result in a violation of:

          

    

    

    	

          	5.1.1	
            any Anti-Corruption Laws; and

          

    

    

    	

          	5.1.2	
            any applicable laws relating to economic or trade sanctions, including the laws or regulations implemented by the Office of Foreign Assets Controls of the United States Department of
              Treasury and any similar laws or regulations in other jurisdictions.

          

    

    

    	5.2	
            Each Party has and shall maintain in place adequate procedures to prevent bribery within the meaning of Section 7(2) of the Bribery Act 2010 by any of its Personnel.

          

    

    

    	5.3	
            For the purpose of this Clause 6, "Anti-Corruption Laws" means:

          

    

    

    	

          	5.3.1	
            the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions, 1997 ("OECD Convention");

          

    

    

    	

          	5.3.2	
            the Foreign Corrupt Practices Act of 1977 of the United States of America, as amended by the Foreign Corrupt Practices Act Amendments of 1988 and 1998, and as may be further amended and
              supplemented from time to time ("FCPA");

          

    

    

    	

          	5.3.3	
            the UK Bribery Act 2010; and

          

    

    

    
      

      5

      
        

      

    

    	

          	5.3.4	
            any other applicable law (including any (a) statute, ordinance, rule or regulation; (b) order of any court, tribunal or any other judicial body; and (c) rule, regulation, guideline or
              order of any public body, or any other administrative requirement) which:

          

    

    

    	

          	(a)	
            prohibits the conferring of any gift, payment or other benefit on any person or any officer, employee, agent or adviser of such person; and/or

          

    

    

    	

          	(b)	
            is broadly equivalent to the FCPA and/or the above United Kingdom laws or was intended to enact the provisions of the OECD Convention or which has as its objective the prevention of
              corruption.

          

    

    

    6.          MISCELLANEOUS PROVISIONS

    

    

    	6.1	
            Law and Jurisdiction - This Agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation
              (including non-contractual disputes or claims) shall be governed by and construed in accordance with the laws of England.

          

    

    

    Any dispute arising out of or in connection with this Agreement, including any question regarding its existence, validity or termination, shall be
      referred to and finally resolved by arbitration under the London Courts of International Arbitration (LCIA) Rules. The tribunal shall be made up of one arbitrator to be agreed by the Parties. Where Parties fail to agree on an arbitrator within thirty
      (30) days from the date the issue arises, an arbitrator shall be appointed as prescribed by the LCIA Rules. The place of arbitration shall be London, England and the language of the arbitration shall be English. The resulting award shall be final and
      binding on the Parties and shall be in lieu of any other remedy. Each Party shall bear its costs in respect of any disputes arising under this Agreement.

    

    

    Each Party acknowledges that the breach of this Agreement would be likely to cause the non-breaching Party considerable loss for which damages would be
      an inadequate remedy. Accordingly, each Party agrees that in addition to all other remedies available at law or in equity a Party shall be entitled to seek equitable relief including injunctive relief and specific performance from any court of
      competent jurisdiction upon any breach of this Agreement.

    

    

    	6.2	
            Assignment - No Party can assign to any third party or in any way dispose of its rights or obligations under this Agreement without the prior
              written consent of the other Parties which shall not be unreasonably withheld. The Parties shall be entitled to transfer or assign any and all of their rights and/or obligations to an Affiliate, provided that (i) notice of such assignment or
              transfer shall be promptly given to the other Parties (ii) such Affiliate has the resources and capacities to carry out such obligations, and (iii) unless the other Party otherwise agrees, the Party transferring or assigning shall remain
              jointly liable with such assignee for the performance of its obligations under this Agreement.

          

    

    

    
      

      6

      
        

      

    

    	6.3	
            Amendments - No amendments, changes or modifications to this Agreement shall be valid except if the same are in writing and signed by a duly
              authorised representative of each of the Parties.

          

    

    

    	6.4	
            Waiver - The rights of the Parties (whether arising under this Agreement or under the general law) shall not be waived or varied otherwise than
              by an express waiver or variation in writing. Any failure to exercise or any delay in exercising any of such rights shall not operate as a waiver or variation of that or any other such right; any defective or partial exercise of any such
              rights shall not preclude any other or further exercise of that or any other such right and no act or course of conduct or negotiation on their part or on their behalf shall in any way preclude them from exercising any such right or
              constitute a suspension or any variation of any such right.

          

    

    

    	6.5	
            Entire Agreement - This Agreement comprise the full and complete agreement of the Parties to date with regard to its subject matter and
              supersedes and cancels all prior communications, understandings and agreements between the Parties with respect to the subject matter hereof, whether written or oral.

          

    

    

    	6.6	
            Counterparts - This Agreement may be executed in one or more counterparts, each of which shall be deemed an original.

          

    

    

    	6.7	
            Severability - If any provision of this Agreement shall be found by any court or administrative body of competent jurisdiction to be invalid or
              unenforceable, the invalidity or unenforceability of such provision shall not affect the other provisions of this Agreement and all provisions not affected by such invalidity or unenforceability shall remain in full force and effect. The
              Parties agree to attempt to substitute, for any invalid or unenforceable provision, a valid or enforceable provision that achieves to the greatest possible extent, the economic, legal and commercial objectives of the invalid or unenforceable
              provision.

          

    

    

    	6.8	
            Rights of Third Parties — The Parties agree that:

          

    

    

    	

          	6.8.1	
            No provision of this Agreement shall by virtue of the Contracts (Rights of Third Parties) Act 1999 confer any benefit on, nor be enforceable by any person who is not a party to this
              Agreement. The Parties' rights to terminate, rescind or agree any variation, waiver or settlement under this Agreement are not subject to the consent of any person that is not a party to it.

          

    

    

    6.9          Nature of this Agreement - This
        Agreement does not:

    

    

    	

          	6.9.1	
            commit any Party to enter into a Project Contract or Transaction Document;

          

    

    

    	

          	6.9.2	
            contain all matters on which the Parties must agree before committing to undertake an Opportunity; or

          

    

    

    
      

      7

      
        

      

    

    	

          	6.9.3	
            create a partnership or joint venture or establish a relationship of principal and agent between the Parties or otherwise authorise any Party to represent, act on behalf of, or bind the
              other for any purpose.

          

    

    

    Subject to the other express obligations in this Agreement, including the obligation to act in good faith in certain circumstances, no Party shall have
      any obligation to incur material costs or liabilities in connection with any Opportunity unless and until the terms of the Project Contract and relevant Transaction Documents have been agreed and approved by the management of such Party and the
      Project Contract and Transaction Documents have been duly executed by all Parties and/or any applicable counterparties..

    

    

    6.10          No Public Announcements

    

    

    6.10.1 No Party shall publish or give permission for publication of any information relating to this Agreement or the discussions
      contemplated by it that includes the name, brand or logos or would imply the name, brand or logos of any of the Parties without the prior written approval of such other Party.

    

    

    Such approval shall be given separately in relation to each specific application for publication and shall apply only to that application. The accuracy
      of any information released is the responsibility of the Party making or permitting the publication. If such information is published or publicized not in compliance with such approval or is wrong in any material respect the other Party shall:

    

    

    	

          	(a)	
            publish an approved or corrected version at the expense of the Party making or permitting the original publication; and

          

    

    

    	

          	(b)	
            oblige the Party making or permitting the original publication to publish a correction and apology.

          

    

    

    6.10.2 If a Party is required by applicable law or the applicable rules or regulations of any governmental body or stock exchange to
      disclose information relating to this Agreement or the discussions contemplated by this Agreement, the Party required to make the announcement shall promptly notify the other Party in writing, and the other Party shall have the right to review and
      comment on the contents of the announcement before such announcement or publication is made. The Party required to make the announcement shall use good faith efforts to incorporate all comments received from the other Party.

    

    

    	6.11	
            Each Party is solely responsible for all of its costs associated with this Agreement, the discussions, analysis, negotiations and documentation covered hereby.

          

    

    

    
      

      8

      
        

      

    

    7.          INTELLECTUAL PROPERTY

    

    

    	7.1	
            Each Party will remain the owner of its Intellectual Property that is related to or used in connection with this Agreement. Nothing herein shall be construed as granting or transferring
              any ownership or right to use of whatever kind of any Intellectual Property which may be provided by one Party to the others in connection with this Agreement.

          

    

    

    	7.2	
            In the course of assisting the other Parties in evaluating an Opportunity, a Party may develop additional Intellectual Property. This Intellectual Property shall be that Party's
              exclusive property which it may freely use in providing services for its other customers. Except where expressly and specifically agreed in writing in a separate development agreement and in consideration of appropriate payment, a Party
              hereto shall not develop any Intellectual Property for ownership by any of the other Parties hereto and the developing Party retains sole ownership of any Intellectual Property created in connection with this Agreement and/or during the
              course of evaluation and execution of the Opportunity.

          

    

    

    8.          NOTICES

    

    

    	8.1	
            All notices and other communications provided for in this Agreement may be delivered in person, by courier, or by registered or certified mail to the relevant Party at its address shown
              below or to any other place designated in writing by such Party addressed as follows:

          

    

    

    If to Hygo Energy:

    

    

    Attention: CFO

    c/o Golar Management Ltd

    6th floor the Zig Zag

    70 Victoria Street

    London, United Kingdom

    

    

    If to GMLP:

    

    

    Attention: CEO

    c/o Golar Management Ltd

    6th floor the Zig Zag

    70 Victoria Street

    London, United Kingdom

    

    

    	8.2	
            Any such notice shall be deemed received upon delivery, if delivered personally, the next business day after delivery by a courier or on the date of acknowledgment of receipt, if
              delivered by courier, and five (5) days after dispatch if delivered by registered or certified mail.

          

    

    

    
      

      9

      
        

      

    

    IN WITNESS WHEREOF, the Parties have this Agreement by their duly authorized representatives as follows:

    

    

    	
            Signed for and on behalf of

          	
            Signed for and on behalf of

          
	
            Hygo Energy Transition Ltd.

          	
            Golar LNG Partners LP

          
	 	 
	
            Signature: /s/ Eduardo Maranhao

          	
            Signature: /s/ Karl Fredrik Staubo

          
	 	 
	
            Name:  Eduardo Maranhao

          	
            Name: Karl Fredrik Staubo

          
	 	 
	
            Title:  CFO

          	
            Title:  CEO

          
	 	 
	
            Date:  31/8/2020

          	
            Date:  31/8/2020

          

    

    

  

  10Exhibit
10.1

 

CERTAIN
IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE
HARM TO ORAMED PHARMACEUTICALS INC. IF PUBLICLY DISCLOSED. OMISSIONS ARE DENOTED IN BRACKETS WITH ASTERISKS THROUGHOUT THIS EXHIBIT.

 

CLINICAL
RESEARCH ORGANIZATION SERVICES AGREEMENT

 

By
and Between

 

Oramed
Ltd.

 

and

 

Integrium,
LLC

 

Effective
Date: January 15, 2020

 

    

     

    

 

	Integrium, LLC.	 	Confidential

 

CRO
Agreement

 

EFFECTIVE
DATE: January 15, 2020

 

Name
and Address of the Contact for Integrium, LLC

 

	Name:	Jessica
    Coutu
	 	 
	Title:	Sr.
    V.P. of Clinical Operations
	 	 
	Address:	100
    East Hanover Avenue, Suite 401
	 	Cedar
    Knolls, NJ 07927
	 	 
	Telephone:	(908)
    357-2010
	 	 
	Cell
    Phone:	(908)
    458-3058
	 	 
	e-mail:	jessica.coutu@integrium.com
	 	 
	Name and Address of the Contact for Oramed Ltd.
	 	 
	Name:	Dr.
    Miriam Kidron
	 	 
	Title:	Chief
    Medical and Technology Officer
	 	 
	Address:	Hi-Tech
    Park 2/4 Givat-Ram,
	 	P.O.
    Box 39098
	 	Jerusalem,
    91390, Israel
	 	 
	Telephone:	972
    2 566001
	 	 
	Facsimile:	972
    2 566004
	 	 
	e-mail:	miriam@oramed.com

 

    

     

    

 

	Integrium, LLC.	 	Confidential

 

INDEX

 

	1.	Term	1
	 	 	 
	2.	Scope
    of Work	1
	 	 	 
	3.	Conditions
    of Work/Sponsor Responsibilities	1
	 	 	 
	4.	Compensation	2
	 	 	 
	5.	Representations
    of CRO	3
	 	 	 
	6.	Confidentiality	4
	 	 	 
	7.	Conflicts
    of Interest	5
	 	 	 
	8.	Independent
    Contractor	6
	 	 	 
	9.	Tax
    Reporting and Payment	6
	 	 	 
	10.	Ownership,
    Disclosure and Transfer of Developments and Study Data	7
	 	 	 
	11.	Relationship
    with Investigators	8
	 	 	 
	12.	Indemnification	9
	 	 	 
	13.	Limitation
    of Liability	10
	 	 	 
	14.	Insurance	11
	 	 	 
	15.	Termination	11
	 	 	 
	16.	Personnel
    Recruitment	12
	 	 	 
	17.	Equal
    Opportunity / Affirmative Action	 
	 	 	 
	18.	Miscellaneous
    Provision	12

 

	Exhibit
    1	Protocol
	Exhibit
    2	Study
    Specifications: Assumptions, Timeline and Task Ownership Matrix
	Exhibit
    3	Study
    Budget
	Exhibit
    4	Payment
    Schedule
	Exhibit
    5	Transfer
    of Obligations

 

    Page i

     

    

 

	Integrium, LLC.	 	Confidential

 

Oramed
Ltd. (“Sponsor”), an Israeli company, with principal offices at Hi-Tech Park 2/4 Givat-Ram, P.O. Box 39098,
Jerusalem, 91390, Israel and Integrium, LLC, (“Integrium”), a California limited liability company, located
at 14351 Myford Road, Suite A, Tustin, California, 92780, hereby agree as follows:

 

		1.	Term

 

		1.1	The
                                         term of this Agreement shall be for the period beginning January 15, 2020 and ending
                                         upon the satisfactory performance of all the Services (as defined herein) unless terminated
                                         sooner as provided herein. The initial term of this Agreement was for the period beginning
                                         as of January 15, 2020 and ending on April 24, 2020 (the “Initial Term”)
                                         during which Start-up activities for the Project were initiated. This Agreement now represents
                                         the study in its entirety. Any previous payments for the ORA-D-013 Start-up are incorporated
                                         and reconciled herein and represented in the payment schedule.

 

		2.	Scope
of Work

 

		2.1	Sponsor
                                         is conducting a Study pursuant to Protocol No. ORA-D-013-1, (“Protocol”)
                                         entitled “A Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized,
                                         Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type
                                         2 Diabetes Mellitus with Inadequate Glycemic Control on One, Two or Three Oral Glucose-lowering
                                         Agents” (the “Study”).

 

		2.2	Integrium
                                         shall perform services (“Services”) as required for the execution
                                         of the Protocol according to the Study Specifications (Study Assumptions, Timeline and
                                         Task Ownership Matrix), Exhibit 2, attached hereto and made fully a part hereof.
                                         The designation of personnel to perform the services,
                                         shall be within Integrium’s discretion, but Sponsor reserves the right, at its
                                         sole discretion, to reject any personnel so designated by Integrium, and require replacement
                                         of such personnel. Prior to performing the Services under this Agreement, Integrium will
                                         inform Sponsor of the identity of the personnel designated and Integrium shall make reasonable
                                         efforts to assure that the personnel designated to perform the Services shall not be
                                         changed until the Services are completed; provided, however, that where any such
                                         personnel ceases to be employed by Integrium, Integrium shall promptly notify Sponsor
                                         of such cessation and use its best efforts to locate replacement personnel acceptable
                                         to Sponsor.

 

		3.	Conditions
of Work/Sponsor Responsibilities

 

		3.1	In
                                         order for Integrium to perform the Services properly and timely, unless otherwise agreed
                                         in writing, Sponsor shall provide Integrium with those materials and take those actions
                                         as described in the Study Specifications, set out in Exhibit 2 attached hereto
                                         and made a part hereof. In addition, Sponsor shall cause all Sponsor contracted designees
                                         to (i) reasonably cooperate with Integrium, and (ii) perform their services and supply
                                         to Integrium their study materials and deliverables in a timely manner. Any failure under
                                         this Section 3.1 shall not constitute a breach of this Agreement by Sponsor but may require
                                         changes in the budget/compensation and/or timelines for the Services in accordance with
                                         Section 4.3.

 

    Page 1

     

    

 

	Integrium, LLC.	 	Confidential

 

		3.2	Sponsor
                                         and/or its representatives may, during the Term, visit Integrium’s facilities (and
                                         those of Integrium’s approved contractors) at reasonable times and with reasonable
                                         frequency during normal business hours to (i) observe the progress of the Study at Integrium’s
                                         facilities and all Study sites (it being clarified that Integrium shall ensure that Sponsor
                                         has such rights viz-a-viz each Study site), (ii) monitor the accuracy and completeness
                                         of the Services, including, but not limited to, quality control and assurance, and/or
                                         (iii) review the responsibilities and/or performance obligations of Integrium personnel.
                                         Integrium will assist Sponsor in scheduling such visits and will make records and any
                                         other relevant information available to Sponsor and/or its representatives.

 

		3.3	Both
                                         Sponsor and Integrium enter into the Agreement for the express purpose of transferring
                                         from Sponsor to Integrium the responsibilities and obligations of a Sponsor to conduct,
                                         coordinate, manage, and/or develop the Study in accordance with United States Food and
                                         Drug Administration (“FDA”) regulations set forth in 21 CFR Section
                                         312, Subpart D, as such may be amended from time to time. Accordingly, if Sponsor is
                                         transferring to Integrium the responsibility for various regulatory responsibilities
                                         under the U.S. laws and regulations as set forth in Exhibit 5 (sample form), a
                                         Transfer of Regulatory Obligations Form will be completed. Any regulatory responsibilities
                                         not specifically stated as transferred to Integrium shall remain the regulatory responsibility
                                         of Sponsor. Sponsor shall file the Transfer of Regulatory Obligations with the FDA or
                                         as otherwise required by law or regulation. If an amendment to this Agreement affects
                                         the scope of regulatory obligations that have been transferred to Integrium, Integrium
                                         and Sponsor shall execute a corresponding amendment. Such amendment shall be filed by
                                         Sponsor with the appropriate government bodies.

 

		4.	Compensation

 

		4.1	In
                                         consideration for Integrium’s satisfactory performance of any and all of the Services,
                                         Sponsor shall pay Integrium a fee in the amount and on the terms specified in Exhibit
                                         3 (the “Study Budget and Payment Schedule”) attached hereto and
                                         made fully a part hereof. All fees will be invoiced by Integrium and Sponsor shall pay
                                         each invoice within thirty (30) days of receipt. If any portion of an invoice is disputed,
                                         then Sponsor shall pay the undisputed amounts as provided above and the parties will
                                         use good faith efforts to reconcile the disputed amount as soon as practicable. If any
                                         undisputed invoice is not paid within forty-five (45) days Sponsor will be considered
                                         in material breach. If the breach is not cured within ten (10) days of written notice
                                         thereof provided by Integrium, Integrium will suspend all activity until the breach is
                                         cured. If any breach extends beyond forty-five (45) days Integrium will terminate this
                                         Agreement. Any 3rd Party Vendor late fee charges resulting from Sponsor delays
                                         in providing payment to Integrium will be passed on to Sponsor.

 

    Page 2

     

    

 

	Integrium, LLC.	 	Confidential

 

		4.2	Any
                                         statement or invoice for services or expenses shall be stated with sufficient specificity
                                         for Sponsor to be able to determine the services performed, the work done, the related
                                         charges, and summary of pass through expenses.

 

		4.3	Any
                                         material change in the Services, or the Assumptions set out in Exhibit 2 (including,
                                         but not limited to, changes in an agreed starting date or suspension of the Study by
                                         the Sponsor) may require changes in the budget/compensation and/or timelines and shall
                                         require a written amendment to this Agreement. Each amendment shall detail the changes
                                         to the Services, Conditions, Compensation, Timeline or other matter. Sponsor agrees that
                                         it will not unreasonably withhold approval of an amendment even if it involves a fixed
                                         price contract if the proposed changes in compensation or timelines result from, among
                                         other appropriate reasons, changes in the assumptions upon which current compensation
                                         or timelines were based. Integrium shall not implement any change in the Project scope
                                         without Sponsor’s prior written approval. Integrium reserves the right to postpone
                                         effecting material changes in the Project’s scope until such time as the parties
                                         agree to and execute the corresponding Change Order.

 

		5.	Representations
of CRO

 

		5.1	Integrium
                                         represents that it has the requisite facilities, equipment, and personnel with the requisite
                                         expertise, experience and skill, to render the desired Services, and it shall render
                                         the Services, in a timely, competent and efficient manner. Integrium further represents
                                         that the Services to be provided pursuant to this Agreement will represent Integrium’s
                                         best efforts and will be of the highest professional standards and quality. Integrium
                                         further represents that it shall abide by all laws, rules and regulations including,
                                         but not limited to, GCP Guidelines issued by the FDA that apply to the performance of
                                         the Services at the time they are provided, including applicable requirements regarding
                                         equal employment opportunity and, when on Sponsor’s premises, Integrium’s
                                         employees shall comply with Sponsor’s policies with respect to conduct of visitors.

 

		5.2	Integrium
                                         certifies that neither Integrium nor any person employed by Integrium has been debarred
                                         under Section 335a of Title 22 of the United States Code, and that no debarred person
                                         will in future be employed or utilized to perform any Services. Integrium certifies that,
                                         to the best of its knowledge, no person performing any Services, including any investigator,
                                         has a conviction which could lead to debarment under Section 335a. Furthermore, Integrium
                                         agrees to notify Sponsor immediately of any action toward conviction or debarment of
                                         any person performing any Services. Integrium understands that Sponsor shall have the
                                         right to terminate this Agreement immediately upon receipt of notice that any employee
                                         or agent of Integrium has been debarred or is subject to any action toward conviction
                                         or debarment.

 

		5.3	Integrium
                                         shall maintain accurate and complete records specifically relating to the Services provided
                                         hereunder in accordance with generally accepted accounting principles and practices,
                                         consistently applied. To the extent that such records may be relevant in Sponsor’s
                                         reasonable opinion in determining whether Integrium is complying with its obligations
                                         pursuant to this Agreement, Sponsor, or Sponsor’s authorized representative, may
                                         audit such records during Integrium’s normal working hours and at Sponsor’s
                                         expense, upon providing five (5) working days’ written notice to Integrium. Integrium
                                         shall retain such records for a period of three (3) years from the date of final payment
                                         by Sponsor pursuant to the Agreement.

 

    Page 3

     

    

 

	Integrium, LLC.	 	Confidential

 

		5.4	Integrium
                                         represents and warrants that in any and all contracts between Integrium and a third party
                                         with respect to the performance by such third party of clinical trials or tests and services
                                         associated with any such clinical trials or tests (a “Third Party Contractor”),
                                         and in which Integrium acts as an agent or general contractor for Sponsor and to which
                                         such contract Sponsor is not a party, Integrium will include a third party beneficiary
                                         provision naming Sponsor as the third party beneficiary under such agreement. Notwithstanding
                                         anything to the contrary in this Agreement, prior to entering into any contract or arrangement
                                         with any Third Party Contractor or with any subcontractor with respect to the performance
                                         by such subcontractor of any of Integrium’s obligations under this Agreement, Integrium
                                         shall notify Sponsor thereof and be required to obtain the written consent of Sponsor
                                         to any such contract or arrangement (such consent not to be unreasonably withheld, delayed
                                         or conditioned).

 

		6.	Confidentiality

 

		6.1	It
                                         is understood by the parties hereto that during the performance of the Services, Integrium
                                         may receive from Sponsor, or otherwise acquire, certain Confidential, Proprietary, and/or
                                         Trade Secret Information which is the property of Sponsor (“Confidential Information”).
                                         Confidential Information shall include without limitation the Investigator’s brochure,
                                         the Protocol, the data recorded during the Study and data, formulae and information on
                                         the Study drug. For purposes of this Agreement, Confidential Information shall be understood
                                         to include all written or electronically transferred information received from Sponsor
                                         by Integrium, and unless expressly described in this section 6.1 such written material
                                         shall be marked “Confidential.” Confidential Information which is disclosed
                                         orally shall be deemed confidential if it is confirmed to be confidential by a writing
                                         provided to Integrium by Sponsor within a reasonable amount of time following oral disclosure
                                         or if such information is known or reasonably should be known by Integrium to be deemed
                                         to be Confidential Information (even without such written confirmation). Integrium hereby
                                         warrants and affirms that it shall neither use nor disclose Confidential Information
                                         for any purpose other than as is specifically allowed by this Agreement.

 

		6.2	Integrium
                                         shall disclose Confidential Information only to such of its employees or third parties
                                         (approved by Sponsor in writing) as may reasonably be required to assist Integrium in
                                         the performance of this Agreement and who have agreed to be bound by confidentiality
                                         and non-use terms and conditions similar to those in this Agreement. In the event of
                                         such disclosure, Integrium shall advise its employees, of the confidential nature of
                                         the information and shall instruct them to take all necessary and reasonable precautions
                                         to prevent the unauthorized use or disclosure thereof at least consistent with those
                                         precautions undertaken by Integrium hereunder.

 

    Page 4

     

    

 

	Integrium, LLC.	 	Confidential

 

		6.3	Upon
                                         the expiration or termination of this Agreement, Integrium shall either destroy or return
                                         to Sponsor all tangible and electronic forms of Confidential Information, including any
                                         and all copies and/or derivatives of Confidential Information made by Integrium (or Integrium’s
                                         employees or agents), as well as any writings, drawings, specifications, manuals or other
                                         printed material made by Integrium (or Integrium’s employees or agents) and based
                                         on, or derived from, Confidential Information; provided, however, that Integrium
                                         shall retain all information it is required by law to retain. Such information shall
                                         be retained for the amount of time required by law using the same amount of care and
                                         diligence to protect Sponsor’s information as it uses to protect its own confidential
                                         information but in any case not less than reasonable care and diligence.

 

		6.4	The
                                         foregoing obligations shall not apply to Confidential Information to the extent
                                         that it: (a) is or becomes generally available to the public other than as a result of
                                         a disclosure by the receiving party; (b) becomes available to the receiving party on
                                         a non-confidential basis from a source which is not prohibited from disclosing such information;
                                         (c) was developed independently of any disclosure by the disclosing party or was known
                                         to the receiving party prior to its receipt from the disclosing party, as shown by contemporaneous
                                         written evidence; or (d) is required by law or regulation to be disclosed (in which case
                                         notice of such disclosure shall be given promptly to Sponsor and Integrium shall reasonably
                                         cooperate with Sponsor in seeking to obtain assurances that any such information will
                                         be treated confidentially).

 

		6.5	Integrium
                                         shall not disclose, or otherwise make public, the terms of this Agreement, except as
                                         may be necessary to secure enforcement of the terms of this Agreement or in response
                                         to a lawful subpoena or to comply with applicable regulations.

 

		6.6	All
                                         of Integrium’s obligations set forth in this Article 6, including the obligations
                                         of confidentiality and non-use, shall continue through the term of this Agreement and
                                         shall survive for a period of ten (10) years following the expiration or termination
                                         of this Agreement.

 

		7.	Conflicts
of Interest

 

		7.1	Integrium
                                         hereby warrants and represents that it has advised Sponsor, prior to the date of signing
                                         of this Agreement, of any relationship with any third parties, including competitors
                                         of Sponsor, which would prevent Integrium from performing the Services contemplated by
                                         this Agreement in accordance with the legal and ethical standards set out herein or as
                                         otherwise mandated by applicable law.

 

		7.2	Integrium
                                         undertakes to advise Sponsor of any such relationships that might arise during the Term
                                         of this Agreement. In the event such a relationship arises, the parties will discuss
                                         in good faith options to minimize or eliminate possible effects of such conflicts of
                                         interest.

 

    Page 5

     

    

 

	Integrium, LLC.	 	Confidential

 

		8.	Independent
Contractor

 

		8.1	The
                                         parties hereto agree that Integrium is being retained and shall perform as an “Independent
                                         Contractor”. Neither Integrium nor any of its employees performing Service’s,
                                         shall be employees of Sponsor, it being understood and agreed that Integrium is an independent
                                         contractor for all purposes and at all times. All matters of compensation and benefits
                                         and terms of employment for Integrium’s employees shall be solely a matter between
                                         Integrium and its employees. Nothing contained herein shall be deemed or construed to
                                         create between the parties hereto a partnership or joint venture or employment relationship.
                                         No party shall have the authority to act on behalf of any other party, or to commit any
                                         other party in any manner or cause whatsoever or to use any other party’s name
                                         in any way not expressly authorized by this Agreement. No party shall be liable for any
                                         act, omission, representation, obligation or debt of any other party, even if informed
                                         of such act, omission, representation, obligation or debt.

 

		8.2	It
                                         is further understood that all Integrium services will be performed in accordance with
                                         Integrium’s SOPs; provided, however, that in the event that the performance
                                         of such services according to such SOPs conflict with the terms of this Agreement, performance
                                         of such services shall follow the terms of this Agreement.

 

		8.3	Integrium
                                         acknowledges and agrees that its employees are not eligible to participate in any benefits
                                         programs offered by Sponsor to its employees, or in any pension plans, profit sharing
                                         plans, insurance plans (including but not limited to, worker’s compensation insurance),
                                         or any other employee benefit or perquisite plans offered from time to time by Sponsor
                                         to its employees or to receive Sponsor stock directly from Sponsor or its officers, directors,
                                         or employees.

 

		8.4	Nothing
                                         contained in this Agreement shall be construed as making the parties joint venturers
                                         or as granting to either party the authority to bind or contract any obligations in the
                                         name of or on the account of the other party or to make any representations, guarantees
                                         or warranties on behalf of the other party except to the extent such authority is expressly
                                         provided in writing and agreed by the parties.

 

		9.	Tax
Reporting and Payment

 

		9.1	Integrium
                                         acknowledges and agrees that it shall be solely responsible for paying the appropriate
                                         amount of all federal, state and local taxes with respect to all compensation paid to
                                         Integrium pursuant to this Agreement, and that Sponsor shall have no responsibility whatsoever
                                         for withholding or paying any such taxes for or on behalf of Integrium.

 

		9.2	Integrium
                                         further agrees to indemnify and hold Sponsor harmless from and against any and all damages,
                                         losses, expenses, or penalties arising from or in connection with any claim brought by
                                         any federal, state or local taxing authority with regard to Integrium’s failure
                                         to pay required taxes or failure to file required forms with regard to compensation paid
                                         to Integrium by Sponsor pursuant to this Agreement.

 

    Page 6

     

    

 

	Integrium, LLC.	 	Confidential

 

		10.	Ownership,
Disclosure and Transfer of Developments and Study Data

 

		10.1	Sponsor
                                         acknowledges that Integrium possesses certain computer technical expertise, software
                                         and methodologies for administration of clinical trials, data collection, data management
                                         and statistical analyses methods which have been independently developed by Integrium
                                         without the benefit of any information provided by Sponsor. Sponsor and Integrium agree
                                         that any computer software programs, methodologies or other formulae or analyses or methodologies
                                         developed by Integrium in the administration and the conduct of clinical trials used
                                         by Integrium under or during the term of this Agreement are the product of Integrium’s
                                         technical expertise possessed and developed by Integrium prior to the date of this Agreement
                                         and remain the sole property of Integrium and Sponsor agrees that such technology is
                                         commercially valuable to Integrium and Sponsor agrees not to disclose such technology
                                         to any other party without Integrium’s prior written consent.

 

		10.2	All
                                         written materials and other works which may be subject to copyright and all patentable
                                         and un-patentable inventions, discoveries, data, and ideas (including but not limited
                                         to any computer software) which are made, conceived or reduced to practice or written
                                         by Integrium or Integrium’s employees or third party contractors authorized by
                                         Integrium pursuant to the terms hereof and which are based upon or arise from
                                         the Services performed by Integrium specifically for Sponsor (“Developments”)
                                         shall become Sponsor’s exclusive property, and may be used by Sponsor as Sponsor
                                         deems appropriate in its sole discretion without any obligation of any nature (including
                                         financial, reporting, accounting or otherwise) to Integrium. Integrium, by signing this
                                         Agreement, expressly agrees to Sponsor’s ownership of all Developments, and represents
                                         and warrants that it has appropriate provisions in its agreements with third party contractors
                                         approved to provide services hereunder that would enable Integrium to meet the obligations
                                         set out in this Article 10.

 

		10.3	Integrium
                                         agrees to hold all Developments in strict confidence in accordance with Article 6 of
                                         this Agreement.

 

		10.4	Integrium
                                         shall disclose promptly to Sponsor each Development and, upon Sponsor’s request
                                         and at Sponsor’s expense, Integrium shall assist Sponsor, or its designees, in
                                         filing patent or copyright applications in any country in the world. Each copyrightable
                                         work, to the extent permitted by law, shall be considered a work made for hire and the
                                         authorship and copyright of the work shall be in Sponsor’s name and, if not so
                                         considered, Integrium hereby assigns to Sponsor all of Integrium’s rights, title,
                                         and interests in such works, and agrees to the waiver of all moral rights therein - to
                                         the extent that same may exist. Integrium shall execute or cause to be executed by the
                                         inventor(s) or a duly authorized agent of Integrium, as the case may be, all papers and
                                         do all things which may be necessary or advisable, in the opinion of Sponsor, to prosecute
                                         such applications and to vest in Sponsor, or its designee, all the right, title and interest
                                         in and to the Developments.

 

		10.5	To
                                         avoid doubt, Integrium acknowledges and agrees that Sponsor and its licensors retain
                                         all right, title and interest in and to the Confidential Information, the Investigator’s
                                         brochure, the Protocol, and all rights and information underlying and related to the
                                         Study drug, and that no license (whether express or implied) to any of the foregoing
                                         is granted to Integrium under this Agreement.

 

    Page 7

     

    

 

	Integrium, LLC.	 	Confidential

 

		10.6	Upon
                                         the expiration or termination of this Agreement, Integrium shall transfer to Sponsor
                                         all Developments including any and all copies and/or derivatives hereof, made by Integrium
                                         (or Integrium employees) as well as any writings, drawings, specifications, manuals or
                                         other printed material made by Integrium (or Integrium employees or contractors), to
                                         the extent such Development is not already transferred prior to expiration or termination.
                                         Notwithstanding the reason for expiration or termination of this Agreement, Integrium
                                         shall under no circumstances be entitled to retain Confidential Information.

 

		10.7	All
                                         data developed relating to the Study shall be the sole and exclusive property of Sponsor,
                                         and Sponsor may use all data relating to the Study for any lawful purpose, including
                                         but not limited to submission to the FDA or other regulatory agencies. All agreements
                                         with Investigators and/or Trial Sites shall provide for the foregoing rights of Sponsor.

 

		10.8	Sponsor’s
                                         authorised representative(s) and, to the extent permitted by law, regulatory authorities
                                         may, during regular business hours, arrange in advance with Integrium and/or the respective
                                         Principal Investigator(s) and/or Trial Site(s) to inspect all data and work products
                                         relating to the respective Study and to examine Integrium’s facilities required
                                         for performance of this Agreement.

 

		11.	Relationship
with Investigators and Third Party Contractors

 

		11.1	If
                                         this Agreement requires Integrium to contract with investigators or investigative sites
                                         (collectively, “Investigators”), then any such contract shall be in
                                         a form mutually acceptable to Integrium and Sponsor. If an Investigator requests any
                                         material changes to such form effecting Sponsor’s rights, Integrium shall submit
                                         the proposed change to Sponsor, and Sponsor shall promptly review, comment on and/or
                                         approve such proposed change(s). The parties acknowledge and agree that Investigators
                                         shall not be considered the employees, agents, or subcontractors of Integrium or Sponsor,
                                         and that Investigators shall exercise their own independent medical judgement. Integrium’s
                                         responsibilities with respect to Investigators shall be limited to those responsibilities
                                         specifically set forth in this Agreement and any amendments hereto.

 

		11.2	It
                                         is hereby agreed that Exhibit 3 (the “Study Budget and Payment Schedule”)
                                         represents the entire consideration that will be paid by Sponsor to Integrium on behalf
                                         of the Study, and that the Sponsor will not pay directly or indirectly to any third party,
                                         including Investigators, and/or any other third party vendors (IRBs, labs, meeting planners,
                                         subcontracting CROs, IVRS, etc.), any amount that is not included in Exhibit 3.
                                         Sponsor acknowledges that Integrium shall not be responsible for any Study timeline delays
                                         as a result of site enrollment delays due to lack of payment or late payment from Sponsor.
                                         Integrium warrants that all up-front and advance payment or any monies made by Sponsor
                                         to Integrium will be allocated only to the Sponsor study specified on the invoice and
                                         will not be used for any other purposes. Integrium will provide Sponsor with a monthly
                                         pass-through reconciliation report indicating the status of these funds. Notwithstanding
                                         anything contained herein to the contrary, Sponsor agrees to indemnify and hold Integrium
                                         harmless for any and all claims from any sites and 3rd Party Vendors for unpaid
                                         invoices submitted to Sponsor.

 

    Page 8

     

    

 

	Integrium, LLC.	 	Confidential

 

		11.3	Sponsor
                                         agrees that, although Integrium will assume responsibility for disbursing fees and/or
                                         expenses to Investigators, and Third Party Contractors, Integrium is not liable for payment
                                         to Investigators and Third Party Contractors until Sponsor has pre-paid Integrium in
                                         advance for these fees and expenses. Upon contract execution of this Agreement, Sponsor
                                         agrees to provide the start-up and vendor advance requirements in accordance with Exhibit
                                         4, Payment Schedule.

 

		11.4	Reserved

 

		11.5	Sponsor
                                         acknowledges and agrees that Integrium will not be responsible for delays in a
                                         Study or Project to the extent that such delays are caused by Sponsor’s failure
                                         to make adequate pre-payment for Investigators’ services. Sponsor further acknowledges
                                         and agrees that payments for Investigator’s/vendors’ services are pass-through
                                         payments at actual costs to Third Party Contractors and are separate from payments for
                                         Integrium’s Services. Sponsor agrees that it will not withhold Investigator payments
                                         except to the extent that it has reasonable questions about the services performed by
                                         a particular Investigator.

 

		12.	Indemnification

 

		12.1	Sponsor
                                         hereby agrees to indemnify, defend, and hold Integrium, and its respective agents, servants,
                                         employees, officers, and directors (“Integrium Indemnities”) harmless
                                         from and against any and all losses, costs, damages, expenses, claims, actions, liability,
                                         and/or suits (including court costs and reasonable attorney fees) (“Liabilities”)
                                         suffered or incurred by Integrium or any of the foregoing as a result of personal injury
                                         to or death of a participant in any Study, and such personal injury or death arises from
                                         or is, by unappealable judgment or binding settlement between the parties, attributed
                                         to: (a) a claim of product liability or claim arising from the design, production, manufacture,
                                         or instructions for use of any Study Product; (b) a claim of strict liability in tort;
                                         (c) the design of the Study; and (d) Sponsor’s negligence with respect to performance
                                         of its obligations under this Agreement; provided, however, that if a claim with
                                         respect to the matters set forth in this Section 12.1 hereof arises in whole or in part
                                         from Integrium’s negligence or intentional misconduct or fraud, then the amount
                                         of Claim that Sponsor shall indemnify Integrium pursuant to this Section 12.1 shall be
                                         reduced by an amount in proportion to the percentage of Integrium’s responsibilities
                                         for such Claim as determined by a court of competent jurisdiction in a final and non-appealable
                                         decision or in a binding settlement between the parties. Under no circumstances shall
                                         Integrium be liable for any Third Party Contractor’s (i) adherence to the Study
                                         Protocol, (ii) adherence to project specifications or the Study timeline, (iii) breach
                                         of contract, (iv) the negligence or willful misconduct, or (v) any infringement, misappropriation
                                         or violation by Third Party Contractors of any right of any other party.

 

    Page 9

     

    

 

	Integrium, LLC.	 	Confidential

 

		12.2	Integrium
                                         hereby agrees to indemnify, defend, and hold Sponsor and its respective affiliates, employees,
                                         directors, agents, approved subcontractors and consultants (“Sponsor Indemnitees”)
                                         harmless from and against any and all Liabilities suffered or incurred by and Sponsor
                                         Indemnitee arising out of (a) any Integrium Indemnitee’s error, omission, gross
                                         negligence or willful misconduct, or (b) any breach of any covenant or warranty, or the
                                         inaccuracy of any representation of Integrium in this Agreement, or (c) Integrium’s
                                         failure to comply with the terms of this Agreement.

 

		12.3	Integrium
                                         Indemnitees agree: (a) to promptly notify Sponsor of any such Liability or Liabilities;
                                         (b) to cooperate fully in the handling of such Liability or Liabilities and, in the event
                                         of litigation, to attend hearings and trials and assist in securing and giving evidence,
                                         and obtaining the attendance of necessary and proper witnesses, and (c) to Sponsor’s
                                         control of the defense and settlement, with Integrium’s consent which shall not
                                         be unreasonably withheld, of all Liability or Liabilities by Sponsor. Sponsor will reimburse
                                         Integrium for all reasonable expenses incurred at Sponsor’s request in connection
                                         with this Section 12.2 (b) except to the extent and in the proportion that Integrium
                                         is responsible under 12.1 Sponsor shall carry out the management and defense of such
                                         claims or suits at their own expense.

 

		12.4	In
                                         the event that a patient participating in a Study suffers an illness or injury that the
                                         Investigator(s) and Sponsor determine to be directly associated with Study participation,
                                         and for which Sponsor would be obligated to indemnify Integrium under section 12.1, then
                                         – provided such illness or injury is not excluded by Sponsor’s insurance
                                         policy -Sponsor shall pay all medical and hospital expenses directly associated with
                                         the medical treatment of such adverse reaction which are in excess of that portion covered
                                         by the patient’s own insurance. In the event diagnostic procedures are required
                                         to determine the etiology of the patient’s symptoms, Sponsor shall pay the reasonable
                                         expense of such diagnostic workup without regard to the final diagnosis, but up to the
                                         amount covered by the Sponsor’s insurance policy and in accordance with its terms.

 

		13.	Limitation
                                         of Liability; Damages

 

		13.1	Except
                                         in the case of gross negligence, willful misconduct, fraud or non-adherence to the Protocol,
                                         neither Integrium, nor its affiliates, nor any of its or their respective directors,
                                         officers, employees or agents shall have any liability of any type (including, but not
                                         limited, to contract, negligence, and tort liability), for any special, incidental, indirect
                                         or consequential damages, including, but not limited to the loss of opportunity, loss
                                         of use, or loss of revenue or profit, in connection with or arising out of this Agreement,
                                         or any service order, even if such damages may have been foreseeable to Integrium. In
                                         addition, except in the case of gross negligence, willful misconduct, fraud or non-adherence
                                         to the Protocol, in no event shall the collective, aggregate liability (including, but
                                         not limited to, contract, negligence and tort liability) of Integrium and its affiliates
                                         and its and their respective directors, officers, employees and agents under this Agreement
                                         or any service order hereunder exceed the CRO Service Fees Grand Total amount set out
                                         in the Study Budget.

 

    Page 10

     

    

 

	Integrium, LLC.	 	Confidential

 

		13.2	For
                                         Failure to Perform. In the event that the Services provided hereunder (or any portion
                                         thereof) do not meet the specifications or other performance criteria agreed to by Integrium
                                         and Sponsor in writing, then Integrium will, at Sponsor’s option, promptly (i)
                                         re-perform such Services at Integrium’s cost, or (ii) refund to Sponsor all amounts
                                         paid by Sponsor to Integrium in connection with such Services.

 

		13.3	Except
                                         in the case of gross negligence, willful misconduct or fraud, neither Sponsor, nor its
                                         affiliates, nor any of its or their respective directors, officers, employees or agents
                                         shall have any liability of any type (including, but not limited, to contract, negligence,
                                         and tort liability), for any special, incidental, indirect or consequential damages,
                                         including, but not limited to the loss of opportunity, loss of use, or loss of revenue
                                         or profit, in connection with or arising out of this Agreement, or any service order,
                                         even if such damages may have been foreseeable to Sponsor.

 

		14.	Insurance

 

		14.1	Each
                                         party will maintain, for the duration of this Agreement, insurance in an amount reasonably
                                         adequate to cover its obligations under this Agreement and any and all Service Orders
                                         then in effect, and, upon request, each party will provide to the other party a certificate
                                         of insurance showing that such insurance is in place.

 

		14.2	Sponsor
                                         will supply Integrium with the Clinical Trial Insurance Certificate for each Study covered
                                         under a Service Order prior to commencement of subject screening for each Service Order.
                                         Integrium will not be responsible for enrollment delays due to Sponsor’s delay
                                         in providing said Certificate.

 

		15.	Termination

 

		15.1	In
                                         the event that a party hereto shall commit a material breach of this Agreement, the other
                                         party hereto shall have the right to terminate this Agreement immediately unless the
                                         breaching party can cure its breach and provide full performance within thirty (30) days
                                         of notice to it that a material breach has been declared. Upon termination of this Agreement,
                                         the non-breaching party shall have no further obligation to the breaching party, other
                                         than for Sponsor to pay for Services performed by Integrium as of the date of such termination
                                         and any rights and duties which the parties expressly stated herein as surviving termination.

 

		15.2	Sponsor
                                         may terminate this Agreement at any time by giving Integrium thirty (30) days written
                                         notice of such termination. If Sponsor should terminate pursuant to this Article 15.2,
                                         Sponsor will pay for all Service units performed up to the point of termination in accordance
                                         with the Budget, as well as costs reasonably incurred for the Services and which Integrium
                                         is unable to cancel (for the avoidance of doubt, Sponsor shall be responsible for any
                                         and all 3rd Party Vendor cancellation fees due upon Study cancellation), and all administrative
                                         costs incurred in the conduct of this Agreement up to the point of termination for those
                                         Services which are necessary to be performed for patient safety, government requirement
                                         compliance and/or expressly requested by Sponsor; provided, however, that no amounts
                                         shall be required to be paid which are in excess of the corresponding amounts set forth
                                         for such activities in this Agreement. Integrium shall use its best efforts to minimize
                                         the costs incurred following its receipt of notice of such termination.

 

    Page 11

     

    

 

	Integrium, LLC.	 	Confidential

 

		15.3	Either
                                         party may terminate this Agreement upon receipt of written notice to the other party
                                         and regard the other party as in breach of this Agreement, if the other party becomes
                                         insolvent, makes a general assignment for the benefit of creditors, files a voluntary
                                         petition of bankruptcy, suffers or permits the appointment of a voluntary petition of
                                         bankruptcy, suffers or permits the appointment of a receiver for its business or assets,
                                         or becomes subject to any proceeding under any bankruptcy or insolvency law, whether
                                         domestic or foreign, or has wound up or liquidated, voluntary or otherwise. In the event
                                         that any of the above events occur, that party shall immediately notify the other, in
                                         writing, of its occurrence.

 

		15.4	Upon
                                         receipt of notice of termination of this Agreement by either party: (i) Integrium will,
                                         as soon as reasonably practicable discontinue providing the applicable Services, except
                                         to the extent reasonably required to safely close out a Study or to transfer the remaining
                                         Services to another Service Provider selected by Sponsor, and (ii) Integrium will terminate
                                         or, if requested by Sponsor, assign existing 3rd Party obligations to the extent cancelable
                                         or assignable, as applicable. Any amounts paid by Sponsor which exceed the amounts owed
                                         to Integrium as of expiration or termination of this Agreement shall be refunded to Sponsor
                                         within thirty (30) days after expiration or termination. Any amounts owed by Sponsor,
                                         including 3rd Party Vendor cancellation fees, shall be paid to Integrium within
                                         thirty (30) days after expiration or termination.

 

		16.	Personnel
                                         Recruitment

 

		16.1	Neither
                                         Sponsor nor Integrium will solicit or make offers of employment to or enter into consultant
                                         relationships with employees or consultants of the other party if such person was involved,
                                         directly or indirectly, in the performance of this Agreement, at any time during the
                                         term of this Agreement; provided, however, that nothing contained herein will
                                         prevent a party from hiring any such employee or consultant who responds to a general
                                         hiring program conducted in the ordinary course of business or who approaches such party
                                         on a wholly unsolicited basis.

 

		17.	Reserved

 

		18.	Miscellaneous
                                         Provision

 

		18.1	Assignment.
                                         This Agreement may not be assigned by either party without the prior written consent
                                         of the other party, except that either of the parties may assign this Agreement to a
                                         successor in connection with the merger, consolidation or sale of all or substantially
                                         all of its assets. No assignment whether consensual or permissive shall relieve either
                                         party of its responsibility for performance of its obligations under this Agreement.

 

    Page 12

     

    

 

	Integrium, LLC.	 	Confidential

 

		18.2	Complete
                                         Agreement. This Agreement, together with its exhibits and Change Orders then in effect,
                                         supersedes all prior Agreements and understandings between the parties related to the
                                         subject matter of this Agreement.

 

		18.3	Waiver.
                                         No waiver by Sponsor with respect to any breach or default or of any right or remedy,
                                         and no course of dealing by Sponsor shall be deemed to constitute a continuing waiver
                                         of any other breach or default or of any other right or remedy, unless such waiver be
                                         expressed in writing, signed by Sponsor. No payment made by Sponsor shall be considered
                                         as acceptance of satisfactory performance of the Services, or as in any way relieving
                                         Integrium from its full responsibility pursuant to this Agreement.

 

		18.4	Amendment.
                                         This Agreement may not be altered, changed or amended except in writing signed by each
                                         of the parties hereto.

 

		18.5	Survival.
                                         The provisions of this Agreement dealing with confidentiality, independent contractor,
                                         ownership of developments, indemnification, limitations of liability, termination, governing
                                         law and survival shall survive the expiration and/or termination of this Agreement.

 

		18.6	Severability.
                                         In the event that any provision of this Agreement is held illegal or invalid for any
                                         reason, such provision shall not affect the remaining parts of this Agreement, but this
                                         Agreement shall be construed and enforced as if that illegal and invalid provision had
                                         never been inserted herein.

 

		18.7	Extraordinary
                                         Relief. In the event of the actual or threatened breach by Integrium of any of the
                                         terms of the Articles 6, 7, and 11 hereof, Sponsor shall have the right to specific performance
                                         and injunctive relief. The remedies in this paragraph are in addition to all other remedies
                                         and rights available at law or in equity.

 

		18.8	Force
                                         Majeure. Performance of this Agreement by each party shall be pursued with
                                         due diligence in all requirements hereof; however, neither party shall be liable for
                                         any loss or damage for delay or nonperformance due to causes not reasonably within its
                                         control. In the event of any delay resulting from such causes, the time for performance
                                         and payment hereunder shall be extended for a period of time necessary to overcome the
                                         effect of such delays. In the event of any delay or nonperformance caused by such uncontrollable
                                         forces, the party affected shall promptly notify the other in writing of the nature,
                                         cause, date of commencement thereof, and the anticipated extent of such delay, and shall
                                         indicate whether it is anticipated that the completion date of the Agreement would be
                                         affected thereby.

 

		18.9	Captions
                                         and Headings. The captions, numbering and headings in this Agreement are for convenience
                                         and reference only, and they shall in no way be held to explain, modify, or construe
                                         the meaning of the terms of this Agreement.

 

		18.10	Counterpart
                                         Originals. This Agreement may be executed in any number of counterparts, each of
                                         which, when executed, shall be deemed to be an original and all of which together shall
                                         constitute one and the same document.

 

    Page 13

     

    

 

	Integrium, LLC.	 	Confidential

 

		18.11	Governing
                                         Law. It is understood and agreed that this Agreement shall be governed by the laws
                                         of the State of Delaware in all respects of validity, construction and performance without
                                         regard to its conflict of laws rules.

 

		18.12	Arbitration.
                                         Any controversy or claim arising out of or relating to this Agreement, or the breach
                                         thereof, may be submitted to binding arbitration under the auspices of, and in accordance
                                         with, the then existing rules of JAMS, in a forum selected by the party to whom a request
                                         for arbitration is directed. Notwithstanding the foregoing, either party may seek injunctive
                                         or equitable relief from any court of competent jurisdiction.

 

		18.13	Notices.
                                         Except as otherwise provided, all communications and notices concerning payments required
                                         under this Agreement shall be mailed by certified mail, return receipt requested postage
                                         prepaid, or sent by Federal Express or telecopy to the addresses set forth below, or
                                         to such other addresses as the parties from time to time specify in writing

 

If
to Integrium for contractual matters:

 

Integrium,
LLC

100
East Hanover Ave., Suite 401

Cedar
Knolls, NJ 07927

Attn:
Jessica Coutu, Sr. VP Clinical Operations

 

If
to Integrium for financial matters:

 

Integrium,
LLC

14351
Myford Road, Suite A

Tustin,
CA 92780

Attn:
David Hyman, Financial Controller

 

		If to
Sponsor:	 Oramed Ltd.

Hi-Tech
Park 2/5 Givat-Ram

P.O.
Box 39098

Jerusalem
91390, Israel

Attn:
Dr. Miram Kidron

 

(Remainder
of Page Intentionally Left Blank)

 

    Page 14

     

    

 

	Integrium, LLC.	 	Confidential

 

IN
WITNESS WHEREOF, the parties hereto have executed, or have caused their duly authorized representatives to execute, this Agreement
as of its initial effective date.

 

	For
    and on behalf of	 	For and on behalf of	 	 
	Integrium,
    LLC	 	Oramed Ltd. 	 	 
	 	 	 	 	 	 
	/s/
    Jessica Coutu	 	/s/ Nadav Kidron	 	/s/
    Josh Hexter
	By: 	Jessica Coutu	 	By:	Nadav
    Kidron	 	Josh
    Hexter
	Title: 	 Sr. Vice President, 

Clinical Operations	 	Title:	CEO	 	COO
	 	 	 	 	 	 	 
	Date: 	September 2, 2020	 	Date:	September
    2, 2020	 	 

 

    Page 15

     

    

 

	Integrium, LLC.	 	Confidential

 

Integrium/
Oramed

 

Exhibit
1

 

Protocol
Number: ORA-D-013-1

Version:
1 

Date:
29 JUL 2020

 

 

 

 

 

 

 

 

(Remainder
of Page Intentionally Left Blank)

 

    Page 16

     

    

 

	Integrium, LLC.	 	Confidential

 

Integrium/Oramed

 

Exhibit
2

 

Study
Specifications

 

 

 

 

 

 

 

(Remainder
of Page Intentionally Left Blank)

 

    Page 17

     

    

 

	Integrium, LLC.	 	Confidential

 

	Project
    Identifiers	 
	Sponsor
    Company	Oramed
    Ltd.
	Protocol
    Number	ORA-D-013-1
	Protocol
    Title	A
    Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety
    of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on One, Two or Three Oral Glucose-lowering
    Agents
	Investigational
    Product(s)	ORMD-0801
	Indication	Type
    2 Diabetes Mellitus 
	Therapeutic
    Area	Metabolic
	Study
    Phase	III
	Sponsor
    Country	Israel
	Country
    Locations	US
	 	 
	Study
    Assumptions	 
	Subjects	 
	#
    Subjects Screened	1250
	%
    Screen Failure Rate	46%
	#
    Screen Failures 	575
	#
    Subjects Entering Treatment Phase	675
	%
    Early Termination Rate	25%
	#
    Early Terminations 	169
	#
    Subjects Complete	506
	Sites	 
	#
    Sites Identified	80
	Total
    Sites 	75
	#
    Central IRB Sites	73
	#
    Local IRB Sites	2
	Enrollment	 
	#
    Screened/site	16.67
	#
    Screened/site/week	0.43
	#
    Randomized/site	9.00
	#
    Randomization Rate (per site/ month)	1.00
	Third
    Party Vendors	 
	Meeting
    Planner	1
	Central
    IRB	1
	Central
    Lab	1
	CGM/Glucometer
    Vendor	1
    - Contracted by Sponsor
	Product
    Packaging & Distribution	1
    - Contracted by Sponsor
	IWRS	1
    - Contracted by Sponsor

 

    Page 18

     

    

 

	Integrium, LLC.	 	Confidential

 

	Project
    Meetings	#
    Meetings	Assumptions
	Investigators’
    Webcast Meeting	3	Assumes
    three 3-hour Investigators’ WebEx meetings
	Launch
    Meeting 	1	Assumes
    6-hour launch Meeting
	Sponsor
    Team Teleconferences	81	Assumes
    calls will be every other week for the duration of the study
	Internal
    Team Teleconferences	6	Monthly
    for the first months
	CRA
    Training Teleconferences	1	Assumes
    a 3-hour CRA training teleconference.
	CRA
    Teleconferences	12	Assumes
    monthly from FPFV to Database Lock
	 	 
	Monitoring
    Assumptions	 
	#
    CRAs	12
	#
    Pre-Study Selection Visits	56
	#
    Initiation Visits	75
	#
    In Person Site Initiation Visits	70
	#
    Remote Site Initiation Visits	5
	#
    Interim Monitoring Visits	 
	Monitoring
    Interval (Maximum - weeks)	Assumed
    every 6-8 weeks dependent upon enrollment
	#
    Interim Monitoring Visits/site 	12
	#
    Additional Days on-site/site	1
	#
    1-day Interim Monitoring Visits	900
	#
    Additional Days 	75
	#
    Close-out Visits	75
	 	 
	Safety
    Assumptions	 
	SAE
    rate (%)	6%
	Estimated
    # SAEs	40
	 	 
	Data
    Management	 
	CRF
    pgs per randomized patient	115
	Unique
    CRFs/Subject	53
	Standard	24
	Non-Standard	29
	Non-Unique
    CRFs/Subject 	62
	Standard	53
	Non-Standard	9
	CRF
    pgs per early term	86
	CRF
    pgs per screen failure	29
	Total
    CRF Pages	89399
	Complete
    subjects	58190
	Early
    Terms	14534

 

    Page 19

     

    

 

	Integrium, LLC.	 	Confidential

 

	Screen
    Failures	16675
	Total
    DM Datasets	20
	Total
    Edit Checks	300
	Estimated
    # Total Queries	17880
	Estimated
    # Queries/Patient (1/5 pages)	26.49
	Manual
    Coding	 
	#
    Medical History/Subject	2
	#
    ConMeds/Subject	2
	#
    AEs/Subject	2
	Data
    Transfers	 
	#
    Sponsor Transfers	2
	 	test,  final
	#  Lab
    Transfers	23
	 	test,
    monthly, final
	#
    Central CGM Reader Transfers	9
	 	test,
    quarterly, final
	#
    IWRS Transfers	2
	 	prior
    to primary lock and final lock
	 	 
	Statistical
    Analysis	The
    following assumptions are estimates. The total number of TLGs will be defined upon the finalization of the Statistical Analysis
    Plan. An amendment to the budget will be issued at that time, if applicable.
	#
    SAS Datasets	22
	Estimated
    Tables	 
	#
    Standard and Non-Standard Repeat	70
	#
    Non-Standard Unique	0
	Estimated
    Listings	 
	#
    Standard and Non-Standard Repeat	40
	#
    Non-Standard Unique	0
	Estimated
    Graphs	 
	#
    Standard and Non-Standard Repeat	20
	#
    Non-Standard Unique	0
	Exploratory
    Output	 
	#
    Exploratory Tables	0
	#
    Exploratory Listings	0
	#
    Exploratory Graphs	0
	pK
    Parameters	0
	Post-hoc
    Analysis	200
	EDC
    - ClinPlus	 
	Number
    of Screens	 
	Unique
    Screens	53
	Redundant
    Screens	62
	Site
    Patient Activity Duration (Months)	13.1
	Enrollment
    Duration (Months)	9
	Server
    Activity Duration (Months)	15
	Usage
    Fee/Help Desk Fees	 	 	 	 	 
	Product
    Usage Fee/Month	$2,800
	Integrium
    Archiving Pricing	 
	CD/DVD
    per site	$100
	Clinical
    Study Report	The
    budget is based on one draft and one final version of the CSR, assuming there will be no hyperlinking. If hyperlinking and/or
    additional versions of the CSR are requested, they will be provided at the study hourly rate for the actual additional hours.

 

    Page 20

     

    

 

	Integrium, LLC.	 	Confidential

 

	Project Timeline	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 
	Project
    Activity	 	Date	 	Month
    #	 	 	Week
    #	 
	Study Start Date	 	January 15, 2020	 	 	0.0	 	 	 	0.0	 
	Create Site Feasibility Questionnaire	 	January 17, 2020	 	 	0.1	 	 	 	0.3	 
	Draft Protocol Date	 	April 27, 2020	 	 	3.4	 	 	 	14.7	 
	Identify 75 sites	 	May 25, 2020	 	 	4.3	 	 	 	18.7	 
	Final Protocol Date	 	June 29, 2020	 	 	5.5	 	 	 	23.7	 
	Submission of Protocol to FDA	 	May 4, 2020	 	 	3.6	 	 	 	15.7	 
	Pre-study Visits Complete	 	July 23, 2020	 	 	6.3	 	 	 	27.1	 
	Response from FDA	 	June 24, 2020	 	 	5.3	 	 	 	23.0	 
	Submission of Revised Protocol to FDA	 	July 31, 2020	 	 	6.5	 	 	 	28.3	 
	Response from FDA	 	September 29, 2020	 	 	8.5	 	 	 	36.9	 
	Initial Paper Representation of eCRF	 	August 14, 2020	 	 	7.0	 	 	 	30.3	 
	Final Paper Representation of eCRF	 	August 21, 2020	 	 	7.2	 	 	 	31.3	 
	Programming of Database Complete	 	October 5, 2020	 	 	8.7	 	 	 	37.7	 
	UAT/Pre-production Audit of Database Complete	 	October 19, 2020	 	 	9.1	 	 	 	39.7	 
	Investigators’ Webcast Meeting	 	October 19, 2020	 	 	9.1	 	 	 	39.7	 
	Drug Available at Sites	 	November 2, 2020	 	 	9.6	 	 	 	41.7	 
	First Patient Screened	 	November 3, 2020	 	 	9.6	 	 	 	41.9	 
	First Patient Randomized to 26w Treatment Phase	 	November 24, 2020	 	 	10.3	 	 	 	44.9	 
	First Patient Enters 26w Extension Phase	 	May 25, 2021	 	 	16.3	 	 	 	70.9	 
	First Patient Last Visit	 	December 7, 2021	 	 	22.8	 	 	 	98.9	 
	Last Patient Screened	 	August 3, 2021	 	 	18.6	 	 	 	80.9	 
	Last Patient Randomized to 26w Treatment Phase	 	August 24, 2021	 	 	19.3	 	 	 	83.9	 
	Last Patient Completes 26w Treatment Phase	 	February 22, 2022	 	 	25.3	 	 	 	109.9	 
	Last IMV 26w Treatment Phase	 	March 22, 2022	 	 	26.2	 	 	 	113.9	 
	Primary Database Lock	 	May 17, 2022	 	 	28.1	 	 	 	121.9	 
	Last Patient Enters 26w Extension Phase	 	February 22, 2022	 	 	25.3	 	 	 	109.9	 
	Last Patient Last Visit	 	September 6, 2022	 	 	31.8	 	 	 	137.9	 
	Last IMV	 	October 4, 2022	 	 	32.7	 	 	 	141.9	 
	Final Database Lock	 	November 29, 2022	 	 	34.5	 	 	 	149.9	 
	Draft Final TLGs	 	December 6, 2022	 	 	34.8	 	 	 	150.9	 
	Final TLGs	 	December 20, 2022	 	 	35.2	 	 	 	152.9	 
	Draft CSR	 	January 17, 2023	 	 	36.1	 	 	 	156.9	 
	Final CSR	 	February 14, 2023	 	 	37.1	 	 	 	160.9	 
	CRO End Date	 	February 24, 2023	 	 	37.4	 	 	 	162.4	 
	Total Project Duration (Months)	 	37.4	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 	 	Months	 	 	Weeks	 	 	 	Phase	 
	Start-up	 	9.6	 	 	14.3	 	 	 	I	 
	Enrollment	 	9.0	 	 	39.1	 	 	 	II	 
	Treatment	 	13.1	 	 	57.0	 	 	 	III	 
	LPLV-DBL	 	2.8	 	 	12.0	 	 	 	IV	 
	DBL-CRO End	 	2.9	 	 	12.4	 	 	 	V	 
	 	 	37.4	 	 	134.8	 	 	 	 	 

 

    Page 21

     

    

 

	Integrium, LLC.	 	Confidential

 

 Integrium/Oramed

 

EXHIBIT
3 

 

Study
Budget

 

	 	 	STUDY START-UP	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	1	 	Project Management (Start Up)	 	[**]	 	9.6	 	Month	 	[**]
	2	 	Develop/Finalize Project Management Plan	 	[**]	 	1	 	Plan	 	[**]
	3	 	Project Launch Webcast Meeting/Training	 	[**]	 	1	 	Meeting	 	[**]
	4	 	Study Materials Management	 	[**]	 	75	 	Site	 	[**]
	5	 	Source Documentation Development	 	[**]	 	1	 	Total	 	[**]
	6	 	Site Identification	 	[**]	 	81	 	Site	 	[**]
	7	 	Pre-study Site Evaluation Visit	 	[**]	 	56	 	Visit	 	[**]
	8	 	Develop/Finalize CRA Monitoring Plan	 	[**]	 	2	 	Plan	 	[**]
	 	 	Data Management Plan (“DMP”)	 	[**]	 	1	 	Total	 	[**]
	9	 	Regulatory Document Collection - Start Up	 	[**]	 	75	 	Site	 	[**]
	10	 	Investigator Budget/Contract Negotiations	 	[**]	 	75	 	Site	 	[**]
	11	 	Webcast Investigators’ Meeting/Preparation	 	[**]	 	3	 	Meeting	 	[**]
	12	 	CRA Training Teleconference	 	[**]	 	1	 	Telecon	 	[**]
	13	 	Clinical System Set-Up Configuration & Maintenance	 	[**]	 	81	 	Site	 	[**]
	 	 	STUDY START-UP FEES TOTAL	 	 	 	 	 	 	 	 [**]
	 	 	EDC STUDY START-UP	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	14	 	eCRF Development	 	[**]	 	1	 	Total	 	[**]
	15	 	eCRF Completion Instructions	 	[**]	 	1	 	Total	 	[**]
	16	 	Edits Specifications and Programming	 	[**]	 	1	 	Total	 	[**]
	17	 	Validate/Test Data Entry Screens (UAT)	 	[**]	 	1	 	Total	 	[**]
	18	 	Annotate CRF	 	[**]	 	1	 	Total	 	[**]
	19	 	Clinical Database Development-SDTM Dataset Creation/Documentation	 	[**]	 	1	 	Total	 	[**]
	20	 	Database Design/Validation Specifications	 	[**]	 	1	 	Database	 	[**]
	21	 	EDC Kick-Off Meeting	 	[**]	 	1	 	Meeting	 	[**]
	22	 	Set-up Standard Data Entry Screens	 	[**]	 	1	 	Total	 	[**]
	23	 	Training Session	 	[**]	 	1	 	Study	 	[**]
	24	 	Project Manage all aspects of EDC start-up	 	[**]	 	1	 	Start-up	 	[**]
	25	 	Create Enrollment Screen	 	[**]	 	1	 	Total	 	[**]
	26	 	Data Export Programming	 	[**]	 	20	 	Dataset	 	[**]
	27	 	Register users/maintain passwords for life of study (per user (4 per site; 6 for sponsor))	 	[**]	 	306	 	Per User	 	[**]
	 	 	EDC START-UP FEES TOTAL	 	 	 	 	 	 	 	[**]

 

    Page 22

     

    

 

	Integrium, LLC.	 	Confidential

 

	 	 	CLINICAL MONITORING	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	28	 	Project Management (enrollment phase)	 	[**]	 	9.0	 	Month	 	[**]
	29	 	Project Management (treatment phase)	 	[**]	 	13.1	 	Month	 	[**]
	30	 	Project Management Study (LPLV to DBL)	 	[**]	 	2.8	 	Month	 	[**]
	31	 	Project Management Study (DBL - CRO end)	 	[**]	 	2.9	 	Month	 	[**]
	32	 	Sponsor Team Teleconferences	 	[**]	 	81	 	Telecon	 	[**]
	33	 	Internal Team Teleconferences	 	[**]	 	6	 	Telecon	 	[**]
	34	 	CRA Teleconferences	 	[**]	 	24	 	Telecon	 	[**]
	35	 	Trial Master File	 	[**]	 	76	 	Site	 	[**]
	36	 	Regulatory Document Maintenance	 	[**]	 	1950	 	Site*Month	 	[**]
	37	 	Reg. Doc. Collection - Protocol Amendments	 	[**]	 	75	 	Amendment	 	[**]
	38	 	Site Initiation Visits	 	[**]	 	75	 	Site	 	[**]
	39	 	Remote Site Initiation Visits	 	[**]	 	5	 	Visit	 	[**]
	40	 	Site Management, Patient Review, Query Resolution	 	[**]	 	1950	 	Site*Month	 	[**]
	41	 	Interim Monitoring Visits - One Day	 	[**]	 	900	 	Visit	 	[**]
	42	 	Interim Monitoring Visits – Add’l Day On-site	 	[**]	 	75	 	Day	 	[**]
	43	 	Close-out Visits	 	[**]	 	75	 	Visit	 	[**]
	44	 	Site Grant Administration	 	[**]	 	1725	 	Site*Month	 	[**]
	 	 	CLINICAL MONITORING/LOGISTICS SERVICES SUBTOTAL	 	 	 	 	 	 	 	[**]
	 	 	MEDICAL/SAE MANAGEMENT	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	45	 	Medical Management	 	[**]	 	25	 	Month	 	[**]
	46	 	Create Safety Plan	 	[**]	 	1	 	Plan	 	[**]
	47	 	Review Protocol Deviation Log	 	[**]	 	25	 	Month	 	[**]
	48	 	Tracking Protocol Waivers	 	[**]	 	25	 	Month	 	[**]
	49	 	Lab Alert/Patient Review	 	[**]	 	25	 	Month	 	[**]
	50	 	Monthly Review of AE Data Listings	 	[**]	 	25	 	Month	 	[**]
	51	 	Create Safety Database	 	[**]	 	2	 	Database	 	[**]
	52	 	SAE Management	 	[**]	 	40	 	SAE	 	[**]
	 	 	MEDICAL/SAE MANAGEMENT SERVICES SUBTOTAL	 	 	 	 	 	 	 	[**]
	 	 	DATA MANAGEMENT	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	53	 	Data Entry Activities	 	[**]	 	89,399	 	CRF Pg	 	[**]
	54	 	Generate/Track/Resolve Queries	 	[**]	 	17,880	 	Query	 	[**]
	55	 	Data Cleaning/Manual Listing Review	 	[**]	 	675	 	Patient	 	[**]
	56	 	Import Other Data	 	[**]	 	34	 	Transfer	 	[**]
	57	 	Export Data to Sponsor	 	[**]	 	2	 	Transfer	 	[**]
	58	 	Manual Coding	 	[**]	 	4,050	 	Manual Code	 	[**]
	59	 	Archive Study Records, Database	 	[**]	 	1	 	Database	 	[**]
	60	 	Data Base Lock Activities	 	[**]	 	2	 	Total	 	[**]
	 	 	DATA MANAGEMENT FEES SUBTOTAL	 	 	 	 	 	 	 	[**]

 

    Page 23

     

    

 

	Integrium, LLC.	 	Confidential

 

	 	 	EDC SYSTEM MAINTAINANCE	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	61	 	Coding System Set-up [WHO/MEDRA]	 	[**]	 	1	 	User	 	[**]
	62	 	Third Party Data Integrations	 	[**]	 	39	 	Transfer	 	[**]
	63	 	SAS Platform (months)	 	[**]	 	37	 	Month	 	[**]
	64	 	Ongoing Support Project Management	 	[**]	 	15	 	Month	 	[**]
	65	 	CRF Export Programming (Site Archives, Submission eCRFs)	 	[**]	 	1	 	Total	 	[**]
	66	 	Provide End of Study Archives to All Sites; 2 Copies to Sponsor	 	[**]	 	1	 	Total	 	[**]
	 	 	EDC SYSTEM SET-UP AND MAINTAINANCE SUBTOTAL	 	 	 	 	 	 	 	[**]
	 	 	BIOSTATISTICAL ANALYSIS	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	67	 	Draft & Final Statistical Analysis Plan (SAP)	 	[**]	 	1	 	SAP	 	[**]
	68	 	Analysis DataSets	 	[**]	 	22	 	Dataset	 	[**]
	69	 	Create/Document ADaM (Submission Ready) Datasets	 	[**]	 	22	 	Dataset	 	[**]
	70	 	Statistical Programming Deliverables (TLGs)	 	[**]	 	130	 	T/L/G	 	[**]
	71	 	Generate/QC TLFs	 	[**]	 	152	 	Appendix	 	[**]
	72	 	Output Review/Dry Runs	 	[**]	 	3	 	Dry Run	 	[**]
	73	 	Post-hoc Analysis Hours	 	[**]	 	200	 	Hour	 	[**]
	74	 	Annual IND Listings	 	[**]	 	2	 	Annual IND	 	[**]
	 	 	BIOSTATISTICAL ANALYSIS SUBTOTAL	 	 	 	 	 	 	 	[**]
	 	 	MEDICAL WRITING	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	75	 	Finalize Protocol	 	[**]	 	1	 	Protocol	 	[**]
	76	 	Develop/Finalize  ICF	 	[**]	 	1	 	Total	 	[**]
	77	 	Final CSR	 	[**]	 	1	 	Total	 	[**]
	 	 	MEDICAL WRITNG SUBTOTAL	 	 	 	 	 	 	 	[**]
	 	 	CRO SERVICE FEES GRAND TOTAL	 	 	 	 	 	 	 	[**]
	 	 	PASS THROUGH COSTS	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	1	 	Pre-study Site Evaluation Visit	 	[**]	 	56	 	Visit	 	[**]
	2a	 	Site Initiation Visit	 	[**]	 	70	 	Visit	 	[**]
	2b	 	Remote Site Initiation Visits	 	[**]	 	5	 	Visit	 	[**]
	3a	 	Interim Monitoring Visits - One Day	 	[**]	 	900	 	Visit	 	[**]
	3b	 	Interim Monitoring Visits – Add’l Day On-site	 	[**]	 	75	 	Day	 	[**]
	4	 	Close-out Visits	 	[**]	 	75	 	Visit	 	[**]
	5	 	WebEx Investigators’ Meeting Planner	 	[**]	 	1	 	Meeting	 	[**]
	6	 	Investigator Grants	 	 	 	 	 	 	 	 
	6a	 	# Patients Completed	 	[**]	 	506	 	Patient	 	[**]
	6b	 	# Screen Failures	 	[**]	 	575	 	Patient	 	[**]
	6c	 	# Early Terminations	 	[**]	 	169	 	Patient	 	[**]

 

    Page 24

     

    

 

	Integrium, LLC.	 	Confidential

 

	 	 	PASS THROUGH COSTS	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	6d	 	# Rescue Visits	 	[**]	 	34	 	Visit	 	[**]
	6e	 	# Unscheduled visits	 	[**]	 	34	 	Visit	 	[**]
	7	 	Site: Advertising/Patient Recruitment	 	[**]	 	75	 	Site	 	[**]
	8	 	Site: Archive Fees	 	[**]	 	75	 	Site	 	[**]
	9	 	Site: Database Review Fee	 	[**]	 	75	 	Site	 	[**]
	10	 	Site: Start-up Costs	 	[**]	 	75	 	Site	 	[**]
	11	 	Site: Regulatory Fee	 	[**]	 	0	 	Site	 	[**]
	12	 	Site: Pharmacy Start-up Fee	 	[**]	 	75	 	Site	 	[**]
	13	 	Site: IRB Fees	 	[**]	 	2	 	Total	 	[**]
	14a	 	Central IRB - Protocol Submission	 	[**]	 	1	 	Protocol	 	[**]
	14b	 	Central IRB - Site Submissions	 	[**]	 	73	 	Protocol	 	[**]
	14c	 	Central IRB annual renewal	 	[**]	 	73	 	Amend.	 	[**]
	14d	 	Central IRB - Site Specific Translations	 	[**]	 	20	 	Site	 	[**]
	14e	 	Central IRB annual renewal	 	[**]	 	73	 	Site	 	[**]
	14f	 	Central IRB Closeout Fee	 	[**]	 	73	 	Site	 	[**]
	14g	 	Central IRB - Advertising Approval	 	[**]	 	73	 	Site	 	[**]
	15	 	Estimated Central Laboratory Fees	 	[**]	 	1	 	Total	 	[**]
	16	 	Estimated IWRS Fees	 	[**]	 	0	 	Total	 	[**]
	17	 	Estimated CGM/Glucometer Fees	 	[**]	 	0	 	Total	 	[**]
	18	 	EDC Platform Product Usage	 	[**]	 	28	 	Total	 	[**]
	19	 	EDC Coding System Integration Fee [WHO/MEDRA]	 	[**]	 	1	 	Total	 	[**]
	20	 	End of study archive CDs to sites; 2 to Sponsor	 	[**]	 	77	 	Total	 	[**]
	21	 	Regulatory Binders	 	[**]	 	76	 	Binder	 	[**]
	22	 	Copying/ Printing	 	[**]	 	1	 	Total	 	[**]
	23	 	Postal & Shipping Fees	 	[**]	 	1	 	Total	 	[**]
	 	 	PASS-THROUGH COSTS TOTAL	 	 	 	 	 	 	 	[**]
	 	 	PROJECT’S OVER-ALL TOTAL COST	 	 	 	 	 	 	  $	21,589,332.07

 

    Page 25

     

    

 

	Integrium, LLC.	 	Confidential

 

 Integrium/Oramed

 

EXHIBIT
4 

 

Study
Payment Schedule

 

	Payment Schedule
	 	 	 	 	 	 	 	 	 
	Monthly Management Fees	 	Month	 	 	$ Amount	 	 	Verification of Milestone Completion/Deliverables
	Project Management Fees	 	January 2020	 	 	[**]	 	 	Paid (ORA-D-013 Start-up)
	Project Management Fees	 	February 2020	 	 	[**]	 	 	Paid (ORA-D-013 Start-up)
	Project Management Fees	 	March 2020	 	 	[**]	 	 	Paid (ORA-D-013 Start-up)
	Project Management Fees	 	April 2020	 	 	[**]	 	 	Paid (ORA-D-013 Start-up)
	Project Management Fees	 	May 2020	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	June 2020	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	July 2020	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	August 2020	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	September 2020	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	October 2020	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	November 2020	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	December 2020	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	January 2021	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	February 2021	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	March 2021	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	April 2021	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	May 2021	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	June 2021	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	July 2021	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	August 2021	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	September 2021	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	October 2021	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	November 2021	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	December 2021	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	January 2022	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	February 2022	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	March 2022	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	April 2022	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	May 2022	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	June 2022	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	July 2022	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	August 2022	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	September 2022	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	October 2022	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	November 2022	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	December 2022	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	January 2023	 	 	[**]	 	 	Invoiced Monthly
	Project Management Fees	 	February 2023	 	 	[**]	 	 	Invoiced Monthly
	Total Monthly Management Fees:	 	 	[**]	 	 	 

 

    Page 26

     

    

 

	Integrium, LLC.	 	Confidential

 

	Monthly Service Fees	 	Date	 	% Total Service Budget	 	 	% Milestone Service Budget	 	 	$ Amount	 	 	Verification of Milestone Completion/Deliverables
	Contract Execution	 	8/31/2020	 	 	5.00	%	 	 	10.13	%	 	 	[**]	 	 	Contract Execution
	EDC System Complete	 	10/19/2020	 	 	0.50	%	 	 	1.01	%	 	 	[**]	 	 	UAT complete
	1st Subject Randomized	 	11/24/2020	 	 	2.50	%	 	 	5.07	%	 	 	[**]	 	 	Enrollment log
	25% Subjects Randomized	 	1/26/2021	 	 	4.38	%	 	 	8.87	%	 	 	[**]	 	 	Enrollment log
	50% Subjects Randomized	 	3/30/2021	 	 	4.38	%	 	 	8.87	%	 	 	[**]	 	 	Enrollment log
	75% Subjects Randomized	 	6/1/2021	 	 	4.38	%	 	 	8.87	%	 	 	[**]	 	 	Enrollment log
	100% Subjects Randomized	 	8/24/2021	 	 	4.38	%	 	 	8.87	%	 	 	[**]	 	 	Enrollment log
	1st Subject Last Visit	 	12/7/2021	 	 	3.13	%	 	 	6.33	%	 	 	[**]	 	 	Enrollment log
	25% Subjects Last Visit	 	2/8/2022	 	 	3.13	%	 	 	6.33	%	 	 	[**]	 	 	Enrollment log
	50% Subjects Last Visit	 	4/12/2022	 	 	3.13	%	 	 	6.33	%	 	 	[**]	 	 	Enrollment log
	Primary Database Lock	 	5/17/2022	 	 	4.38	%	 	 	8.87	%	 	 	[**]	 	 	Database Lock
	75% Subjects Last Visit	 	6/14/2022	 	 	3.13	%	 	 	6.33	%	 	 	[**]	 	 	Enrollment log
	100% Subjects Last Visit	 	9/6/2022	 	 	3.13	%	 	 	6.33	%	 	 	[**]	 	 	Enrollment log
	Final Database Lock	 	11/29/2022	 	 	3.13	%	 	 	6.33	%	 	 	[**]	 	 	Database Lock
	Draft Final TLGs	 	12/6/2022	 	 	0.29	%	 	 	0.58	%	 	 	[**]	 	 	Draft Final TLGs
	Final CSR	 	12/20/2022	 	 	0.44	%	 	 	0.89	%	 	 	[**]	 	 	Draft Final TLGs
	Total Milestone Based Services:	 	 	 	 	49.39	%	 	 	100.00	%	 	 	[**]	 	 	 

 

	Unit Based Payments: 
 Actual Units Invoiced Monthly	 	% Total Services Budget	 	 	# Units	 	 	Unit Cost	 	 	$ Amount	 	 	Verification of Milestone Completion/Deliverables
	SAE Management	 	 	1.22	%	 	 	40	 	 	 	[**]	 	 	 	[**]	 	 	Invoiced monthly as occurred
	Total Unit Based Services:	 	 	 	[**]	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Total Services:	 	 	 	[**]	 	 	 

 

	Pass-through expenses	 	$ Amount	 	 	Verification of Milestone Completion/Deliverables
	Monitoring Visit Travel Expenses	 	 	[**]	 	 	Invoiced as Actuals Monthly
	Investigator Grants	 	 	[**]	 	 	Invoiced and Paid in Advance of Payment to Vendor
	Site Start-up Costs	 	 	[**]	 	 	Invoiced and Paid in Advance of Payment to Sites
	Site Pharmacy Start-up Costs	 	 	[**]	 	 	Invoiced and Paid in Advance of Payment to Sites
	Site Advertising	 	 	[**]	 	 	Invoiced as Actuals Monthly
	Site Archiving Fees	 	 	[**]	 	 	Invoiced as Actuals Monthly
	Central IRB Fees	 	 	[**]	 	 	Invoiced as Actuals Monthly
	Meeting Planner	 	 	[**]	 	 	Invoiced and Paid in Advance of Payment to Vendor
	Central Lab Vendor	 	 	[**]	 	 	Invoiced and Paid in Advance of Payment to Vendor
	EDC Platform Fees	 	 	 [**]	 	 	Invoiced as Actuals Monthly
	Copying/Printing/Supplies/Other	 	 	[**]	 	 	Invoiced as Actuals Monthly
	Postal & Shipping Fees	 	 	[**]	 	 	Invoiced as Actuals Monthly
	Total Pass-through Budget:	 	 	[**]	 	 	 
	 	 	 	 	 	 	 
	Grand Total Budget:	 	$	21,589,332.07	 	 	 

 

    Page 27

     

    

 

	Integrium, LLC.	 	Confidential

 

Pass
Through Advance Payment Schedule

 

	 	 	 	Contract Execution 	 	 	 	TBD
	 	 	 	Study
Total 	 
	Investigators’ Meeting Planner:

                                                                                80%
                                         invoiced start-up payment

                                                                                20%
                                         paid upon final reconciliation
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	Site Start-up Costs:

                                                                                [**]/site
                                         x 75 sites
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	Site Grant Payments:  

                                                                                Advance
                                         Payment = [**]/site X 65 sites
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	Site Pharmacy Start-up Costs:  

                                                                                [**]/site
                                         X 75 sites
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	Central Lab Vendor:

                                                                                Start-up
                                         payment
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	Pass-Through Advance Payment	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 

 

    Page 28

     

    

 

	Integrium, LLC.	 	Confidential

 

EXHIBIT
5 

 

Transfer
of Regulatory Obligations

 

	TRANSFER
OF US FDA REGULATORY OBLIGATIONS FOR INVESTIGATIONAL PHARMACEUTICAL AND BIOLOGIC PRODUCTS UNDER AN INVESTIGATIONAL NEW DRUG (IND)
APPLICATION (21 CFR 312.52 and ICH E6)

         
	 	 

 

Study
Drug:  ORMD-0801

IND
#:     

Protocol
Title: A Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy
and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on One, Two or Three Oral Glucose-lowering
Agents.

 

Pursuant
to 21 CFR 312.52 and ICH E6, the following obligation(s) of the Sponsor, Oramed Ltd. have been transferred to:

 

	CRO Name:	Integrium, LLC
	CRO Address:	14351 Myford Road
	 	Tustin, CA 92780

 

	 	 	 	 	 	 	 	Obligation Assigned to:1
	Responsibility	 	Reference	 	Integrium	 	Oramed
	 	Third Party Vendor
	A.	 	1.	Preparation
    of all or part of an IND application	 	312.23
    21CFR	 	N/A	 	N/A	 	N/A
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	2.	Submission
    of IND application to FDA, submit all Amendments to FDA 	 	 	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	B.
    	 	Maintain an IND with the following amendments, as necessary: 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	1.	Preparation
    of Protocol amendments (includes new protocols, changes in protocols, adding new investigators)	 	312.30
21CFR
	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	2.	Preparation
    of Chemistry, Manufacturing, and Control amendments	 	312.31
    21CFR	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	3.	Preparation
    of Pharmacology and Toxicology amendments	 	312.31
    21CFR	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	4.	Preparation
    of Clinical amendments	 	312.31
    21CFR	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	5. 	Safety
        Reports

        (a) Preparation
        of initial report

        (b) Preparation
        of follow-up reports

        (c) Notifications
        to FDA (phone/fax or written)

        (d) Notifications
        to investigators
	 	312.32
    21CFR	 	 

                                                                                    ☒

                                                                                    ☒

                                                                                    ☐

                                                                                    ☒
	 	 

                                                                                    ☐

                                                                                    ☐

                                                                                    ☐

                                                                                    ☐
	 	 

        ☐

        ☐

        ☒

        ☐

	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	6.	Preparation
    of Annual Reports	 	312.33
    21CFR	 	☐	 	☐	 	☒
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	7.	Preparation
    of response to request for information or clinical hold	 	312.41,
    312.42 CFR	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	8. 	Preparation
of letter to withdraw an IND
	 	312.38
    CFR	 	☐	 	☒	 	☐

 

    Page 29

     

    

 

	Integrium, LLC.	 	Confidential

 

	 	 	 	 	 	 	 	Obligation
    Assigned to:1
	Responsibility	 	Reference	 	Integrium	 	Oramed	 	Third
    Party Vendor
	C. 	 	Preparation
    and Update Investigative Brochure	 	21
        CFR 312.55 (a)

        ICH
        E6 5.12, 7.3
	 	☐	 	☒	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	D. 	 	Selecting
    investigators and monitors 	 	21 CFR 312.53	 	☒	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	1. 	Select
        qualified investigators

        (a)
        Identify qualified investigators/sites

        (b)
        Approve investigators/sites for participation
	 	 

21 CFR 312.53
    (a); 

    ICH E6 5.6.1	 	☒

        ☒
	 	☒

        ☒
	 	☐

        ☐

	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	2. 	Control of
    drug	 	 	 	 	 	 	 	 
	 	 	 	(a) Obtain
    required information from investigator (including signed Form FDA 1572, CV)	 	21 CFR 312.53
    (c); 

    ICH E6 5.14.2, 8.2	 	☒	 	☐	 	☐
	 	 	 	(b) Approved
    investigators for receipt of drug shipment	 	21
        CFR 312.53 (b); 

        ICH E6 5.14.2
	 	☒	 	☐	 	☐
	 	 	 	(c) Ship
    drug to approved investigators	 	21
        CFR 312.53 (b); 

        ICH E6 5.14.1, 5.14.4(a)
	 	☒	 	☐	 	☒
	 	 	 	(d) Maintain
    shipment records	 	21
        CFR 312.57 (a); 

        ICH E6 5.14.4(b)
	 	☒	 	☐	 	☒
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	3.	Provide qualified
    monitors 	 	21 CFR 312.53
    (d); 

    ICH E6 5.18.2	 	☒	 	☐	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	4. 	Informing
    investigators	 	 	 	 	 	 	 	 
	 	 	 	(a) Review
    with investigators their regulatory responsibilities	 	Guideline
    for the Monitoring of Clinical Investigations; ICH E6 5.18.4 (f)(g)	 	☒	 	☐	 	☐
	 	 	 	(b) Deliver
    investigator’s brochure	 	21 CFR 312.55
    (a); 

    ICH E6 5.6.2	 	☒	 	☐	 	☐
	 	 	 	(c) Inform
    participating investigators of new safety information about the study drug	 	21 CFR 312.55
    (b); 

    ICH E6 5.16.2	 	☒	 	☐	 	☐
	 	 	 	(d) Notify
    participating investigators of all serious unexpected adverse drug reactions	 	21 CFR 312.32
    (c); 

    ICH E6 5.17.1	 	☒	 	☐	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	E. 	 	Review
    of ongoing investigations	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	1.	Monitoring
    the investigation	 	21
        CFR 312.56

        21
        CFR 312.56 (a); 

        ICH E6 5.18.4
	 	☒	 	☐
	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	2. 	Discontinue
        investigator participation if not compliant

        (a) Notify
        FDA

        (b) Assure
        disposal or return of investigational drug
	 	21 CFR 312.56
    (b); 

    ICH E6 5.20	 	☒

        ☒

        ☒

         
	 	☒

        ☐

        ☐
	 	☐

        ☐

        ☐

         

	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	3.	Provide medical
    expertise to evaluate safety information	 	21 CFR 312.56
    (c); 

    ICH E6 5.16.1	 	☒	 	☐	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	4. 	Upon premature
    termination or suspension of a trial:	 	21 CFR 312.56
    (d);	 	 	 	 	 	 
	 	 	 	(a) Notify
    IRBs or notify investigators of their responsibility to notify IRBs	 	ICH E6 5.21	 	☒	 	☐	 	☐
	 	 	 	(b) Notify
    investigators	 	 	 	☒	 	☐	 	☐
	 	 	 	(c) Assure
    disposition of drug from sites to sponsor	 	 	 	☒	 	☐	 	☐
	 	 	 	(d) Notify
    FDA	 	 	 	☐	 	☐	 	☒

 

    Page 30

     

    

 

	Integrium, LLC.	 	Confidential

 

	 	 	 	 	 	 	 	Obligation Assigned to:1
	Responsibility	 	Reference	 	Integrium	 	Oramed	 	Third Party Vendor
	F. 	 	Trial Data Handling and Reporting	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	
        (a) Manage an independent
        date safety monitoring committee

        (b) Data Management

        (c) Statistical plan
        and/or analysis

        (d) Final study report
	 	
        ICH E6 5.5.2

        ICH E6 5.5.1

        ICH E6 5.5.1

        ICH E6 5.5.1
	 	
        NA

        

        ☒

        ☒

        ☒
	 	
        NA

        ☐

        ☐

        ☒
	 	
        NA

        ☐

        ☐

        ☐

        

	 	 	 	 	 	 	 	 	 	 	 	 
	G.	 	Recordkeeping and record retention	 	21 CFR 312.57	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 	 	1. 	Maintain sponsor records and reports, other than shipment records (see C.2.d), during the course of the investigation	 	21 CFR 312.57 (b), 312.58 (a); ICH E6 5.5.6, 5.5.7, 8	 	☒	 	☐	 	☐
	 	 	
        2. 

         
	Archive sponsor records and reports according to applicable regulatory requirements.	 	
        21 CFR 312.57 (a)(b)(c), 312.58 (a); ICH E6 5.5.8, 5.5.11, 8

         
	 	☐	 	☒	 	☐
	 	 	3. 	Retain reserve samples of the test articles and reference standards used in bioequivalence or bioavailability studies	 	21 CFR 312.57 (d); 

ICH E6 5.14.5(b)	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	H. 	 	Disposition of unused supply of investigational drug	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 	 	1.  	Assure return of drug from site to sponsor	 	
        21 CFR 312.59; ICH

         
	 	☒	 	☐	 	☒
	 	 	2.  	Conduct final disposition or destruction of drug	 	
        E6 5.14.4 (c)(d), 5.18.4

        (c)(iv)(v)
	 	☐	 	☐	 	☒
	I. 	 	Application for FDA approval to export investigational drug

(a) Content

(b) Format

	 	21 CFR 312.110; 

ICH E6 5.14.2	 	☐

                                                               ☐

                                                                
	 	☒

                                                               ☒

                                                                
	 	☐

                                                               ☐

                                                                

	 	 	 	 	 	 	 	 	 	 	 	 
	J.	 	Obtain
investigator financial disclosure information

	 	
        21 CFR 312.53 (c)(4)
	 	 	 	 	 	 
	 	 	1.  	Initial collection prior to study participation	 	 	 	☒	 	☐	 	☐
	 	 	2.  	Responsibility for the one year follow-up financial disclosure collection shall remain with the Sponsor (one year following the completion of the study)	 	 	 	☐	 	☒	 	☐

 

		1	If responsibility for an item is shared between Oramed
and Integrium, both boxes will be checked.

 

According
to 21 CFR 312.52(b), “A contract research organization that assumes any obligation of a sponsor shall comply with the specific
regulations in this chapter applicable to this obligation and shall be subject to the same regulatory action as a sponsor for
failure to comply with any obligation assumed under these regulations.” The assignment of responsibility does not preclude
either the sponsor or the CRO from participating in the requirements of the CFR.

 

Oramed
Ltd.

 

	 	 	/s/
    Miriam Kidron	 	September
2, 2020
	 	 	Name:  	Miriam Kidron	 	Date
	 	 	Title: 	CSO	 	 
	Integrium
    LLC.	 	 	 	 
	 	 	 	 	 
	 	 	/s/
    Jessica Coutu	 	September
    2, 2020
	 	 	Name:	 Jessica Coutu	 	Date
	 	 	Title: 	Sr. V.P. of Clinical Operations	 	 

 

 

Page 31

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00313-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00313-of-00352.parquet"}]]