Exhibit
10.1


 


**Confidential
portions have been omitted pursuant to a request for confidential treatment and 

have been filed separately with the Securities
and Exchange Commission (the “Commission”)**


 


 


 


 


 


CLINICAL
RESEARCH ORGANIZATION SERVICES AGREEMENT


 


 


 


 


By
and Between


 


 


 


Oramed
Ltd.


 


and


 


Integrium,
LLC


 


 


 


 


 


 


 


 


Effective
Date: November 1, 2017


 




     


     


    

 


	Integrium,
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CRO
Agreement





 


EFFECTIVE
DATE: November 1, 2017 





 


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




 







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INDEX


 





	1.	Term	1
	 	 	 
	2.	Scope of Work	1
	 	 	 
	3.	Conditions of Work/Sponsor Responsibilities	1
	 	 	 
	4.	Compensation	5
	 	 	 
	5.	Representations of CRO	6
	 	 	 
	6.	Confidentiality	7
	 	 	 
	7.	Conflicts of Interest	8
	 	 	 
	8.	Independent Contractor	8
	 	 	 
	9.	Tax Reporting and Payment	9
	 	 	 
	10.	Ownership, Disclosure and Transfer of Developments and Study Data	9
	 	 	 
	11.	Relationship with Investigators	11
	 	 	 
	12.	Indemnification	12
	 	 	 
	13.	Limitation of Liability	13
	 	 	 
	14.	Insurance	14
	 	 	 
	15.	Termination	14
	 	 	 
	16.	Personnel Recruitment	15
	 	 	 
	17.	Equal Opportunity / Affirmative Action	15
	 	 	 
	18.	Miscellaneous Provision	15
	 	 	 
	Exhibit 1	Protocol	19
	Exhibit 2	Study Specifications: Assumptions, Timeline and Task Ownership Matrix	20
	Exhibit 3	Study Budget	26
	Exhibit 4	Payment Schedule	33
	Exhibit 5	Transfer of Regulatory Obligation	35




 







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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 as of November 1, 2017 and ending
                                         upon the satisfactory performance of all the Services (as hereinafter defined) unless
                                         terminated sooner as provided for herein.



 


		2.	Scope
                                         of Work



 


		2.1	Sponsor
                                         is conducting a Study pursuant to Protocol No. ORA-D-015, (“Protocol”)
                                         entitled “A Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate
                                         the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients with Inadequate
                                         Glycemic Control on Oral Therapy” (the “Study”). The Protocol
                                         was submitted by Sponsor to the FDA in December, 2017, such Protocol being set out in
                                         Exhibit 1 attached hereto.
	 	 	 
		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.



 






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		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.



 


		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.



 






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		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.



 






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		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.



 


		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.



 






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		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.



 


		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.



 






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		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.



 


		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.



 






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		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.



 


		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.



 






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		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.



 


		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



 






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		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.



 


		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.



 






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		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.



 


		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.



 






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		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.



 


		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.



 






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		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.



 


		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.



 






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                                LLC.	Confidential




 


		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.



 


		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.



 




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                                LLC.	Confidential




 


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


100
East Hanover Ave., Suite 401


Cedar
Knolls, NJ 07927


Attn:
Ewa Olesiak-Deptuch, Sr. VP Finance & Accounting


 


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)


 




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	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/
    Joshua Hexter
	By: Jessica Coutu	 	By: Nadav Kidron	 	Joshua Hexter
	Title: Sr. Vice President, Clinical Operations	 	Title: CEO	 	COO
	Date: January 23, 2018	 	January 23, 2018	 	 




 







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Integrium/
Oramed


 


Exhibit
1


 


Protocol
Number: ORA-D-015


Version:
Original 1.0


Date:
27 October 2017





 


 


 


 


 


 


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of Page Intentionally Left Blank)





 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




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Integrium/
Oramed


 



Exhibit
2


 


Study
Specifications


 


 


 


 


 


 


 


(Remainder
of Page Intentionally Left Blank)


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 






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	Project
    Identifiers	 
	Sponsor
    Company	Oramed
    Ltd.
	Protocol
    Number	ORA-D-015
	Protocol
    Title	A
    Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes
    Mellitus Patients with Inadequate Glycemic Control on Oral Therapy
	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	445
	%
    Screen Failure Rate	40%
	#
    Screen Failures 	178
	#
    Subjects Entering Run-In Phase	267
	%
    Run-In Failure Rate	10%
	#
    Run-In Failures 	27
	#
    Subjects Entering Treatment Phase	240
	%
    Early Termination Rate	12%
	#
    Early Terminations 	29
	#
    Subjects Complete	211
	Sites	 
	#
    Sites Identified	40
	Total
    Sites	40
	#
    Central IRB Sites	40
	#
    Local IRB Sites	0
	Enrollment	 
	#
    Screened/site	11.13
	#
    Screened/site/week	0.43
	#
    Enrolled/site	6.68
	#
    Enrollment Rate (per site/per month)	1.12
	#
    Randomized/site	6.00
	#
    Randomization Rate (per site/ month)	1.01
	Third
    Party Vendors	 
	Meeting
    Planner	1
	Central
    IRB	1
	Central
    Lab	1
	CGM
    Monitors/Supply Vendor	1
    - Contracted by Sponsor




 






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	Centralized
    CGM Reader Vendor	1
    - Contracted by Sponsor
	eDiary/Glucometer
    Vendor	1
    - Contracted by Sponsor
	Product
    Packaging & Distribution	1
    - Contracted by Sponsor
	IWRS	1
    – Contracted by Sponsor
	 	 
	Project
    Meetings	#
    Meetings	Assumptions
	Investigator/CRA
    Training Meeting	1	Assumes
    1-day Investigators' Webex, a 0.5 day CRA/EDC training meeting at the same venue
	Launch
    Meeting 	1	Assumes
    6-hour launch Meeting
	Sponsor
    Team Teleconferences	39	Assumes
    calls will be every other week for the duration of the study
	Internal
    Team Teleconferences	6	Monthly
    for the first six months
	CRA
    Teleconferences	12	Assumes
    monthly from FPFV to Database Lock
	 	 
	Monitoring
    Assumptions	 
	#
    CRAs	6
	#
    Pre-Study Selection Visits	40
	#
    Initiation Visits	8
	 	For
    sites where PI and Study Coordinator do not attend Invest. Meeting
	#
    Interim Monitoring Visits	 
	Monitoring
    Interval (Maximum - weeks)	Assumed
    every 6-8 weeks dependent upon enrollment
	#
    Interim Monitoring Visits/site 	7.5
	#
    Additional Days on-site/site	4
	#
    1-day Interim Monitoring Visits	300
	#
    Additional Days 	160
	#
    Close-out Visits	40
	 	 
	Safety
    Assumptions	 
	SAE
    rate (%)	5%
	Estimated
    # SAEs	13
	Estimated
    # Expedited SAEs	0
	Data
    Management	 
	CRF
    pgs per randomized patient	106
	Unique
    CRFs/Subject	22
	Non-Unique
    CRFs/Subject 	84
	CRF
    pgs per early term	80
	CRF
    pgs per screen failure	27
	Total
    CRF Pages	31652
	Complete
    subjects	22366
	Early
    Terms	4480
	Screen
    Failures	4806
	Total
    DM Datasets	23
	Total
    Edit Checks	440




 






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	Estimated
    # Total Queries	6330
	Estimated
    # Queries/Patient (1/5 pages)	23.71
	Manual
    Coding	 
	#
    Medical History/Subject	5
	#
    ConMeds/Subject	3
	#
    AEs/Subject	2
	Data
    Transfers	 
	#
    Sponsor Transfers	2
	 	test,
    final
	#  Lab
    Transfers	18
	 	test,
    monthly, final
	#
    PK Transfers	N/A
	 	 
	#
    Electronic Diary Lab Transfers	7
	 	test,
    quarterly, final
	#
    Central CGM Reader Transfers	7
	 	test,
    quarterly, final
	#
    IWRS Transfers	No
    charge, integrated with EDC
	 	 
	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	10
	Estimated
    Tables	 
	#
    Standard and Non-Standard Repeat	80
	#
    Non-Standard Unique	20
	Estimated
    Listings	 
	#
    Standard and Non-Standard Repeat	30
	#
    Non-Standard Unique	10
	Estimated
    Graphs	 
	#
    Standard and Non-Standard Repeat	20
	#
    Non-Standard Unique	12
	Exploratory
    Output	 
	#
    Exploratory Tables	20
	#
    Exploratory Listings	20
	#
    Exploratory Graphs	0
	pK
    Parameters	0
	Post-hoc
    Analysis	120
	 	 
	EDC
    - DSG	 
	Number
    of Screens	 
	Unique
    Screens	22
	Redundant
    Screens	84
	Site
    Patient Activity Duration (Months)	4.4
	Enrollment
    Duration (Months)	6




 






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	Server
    Activity Duration (Months)	15
	Usage
    Fee/Help Desk Fees	 
	Product
    Usage Fee/Month	$2,500
	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.




 






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	Project
    Timeline	 	 	 
	 	 	 	 
	Project
    Activity	Date	Month
    #	Week
    #
	Study
    Start Date	November
    1, 2017	0.0	0.0
	Final
    Protocol Date	November
    22, 2017	0.7	3.0
	First
    Patient enrolled at OCRC	December
    18, 2017	 	 
	EDC
    Set-Up Complete	January
    24, 2018	2.8	12.0
	Investigators'
    Meeting	January
    26, 2018	 	 
	First
    Patient Screened For Other Sites	January
    29, 2018	2.9	12.7
	First
    Patient Enter Run-In Period	February
    19, 2018	3.6	15.7
	First
    Patient Enter Part 1 Titration	March
    5, 2018	4.1	17.7
	First
    Patient Enter Part 2 Maintenance	March
    19, 2018	4.5	19.7
	First
    Patient Last Visit	June
    11, 2018	7.3	31.7
	Last
    Patient Screened	July
    29, 2018	8.9	38.6
	Last
    Patient Enter Run-In Period	August
    19, 2018	9.6	41.6
	Last
    Patient Enter Part 1	September
    2, 2018	10.0	43.6
	Last
    Patient Enter Part 2	September
    16, 2018	10.5	45.6
	Last
    Patient Last Visit	December
    9, 2018	13.3	57.6
	Last
    IMV	January
    6, 2019	14.2	61.6
	Database
    Lock 	February
    3, 2019	15.1	65.6
	Draft
    Final TLGs	February
    10, 2019	15.3	66.6
	Final
    TLGs	February
    24, 2019	15.8	68.6
	Draft
    CSR	March
    24, 2019	16.7	72.6
	Final
    CSR	April
    21, 2019	17.6	76.6
	CRO
    End Date	May
    1, 2019	18.0	78.0
	Total
    Project Duration (Months)	18.0	 	 
	 	 	 	 
	 	Months	Weeks	Phase
	Start-up	2.9	12.7	I
	Enrollment	6.0	25.9	II
	Treatment	4.4	19.0	III
	LPLV-DBL	1.8	8.0	IV
	DBL-CRO
    End	2.9	12.4	V
	 	18.0	78.0	 







 






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                                LLC.	Confidential




 


Integrium/Oramed


 


EXHIBIT 3 


 


Study Budget 


 


 


 


 


 


 


 


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Study
Budget


 








	 	STUDY
    START-UP	UNIT
    COST	UNITS	MEASURE
    OF UNIT	 TOTAL
    
	1	Project
    Management (Start Up)	[THE CONFIDENTIAL

    PORTION HAS BEEN SO OMITTED

    PURSUANT TO A
 REQUEST FOR

    CONFIDENTIAL
 TREATMENT AND
    HAS BEEN FILED
 SEPARATELY WITH
    THE COMMISSION]	2.9	Month	[THE CONFIDENTIAL

                                         PORTION HAS BEEN

                                         SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

                                         SEPARATELY WITH

                                         THE COMMISSION]

	2	Develop/Finalize
    Project Management Plan	1	Plan
	3	Project
    Launch Webcast Meeting/Training	1	Meeting
	41	Study
    Materials Management	40	Site
	42	Source
    Documentation Development 	1	Total
	43	Site
    Identification	40	Site
	44	Pre-study
    Site Evaluation Visit	40	Visit
	45	Develop/Finalize
    CRA Monitoring Plan	1	Plan
	46	Study
    Manual/Quality Plan	1	Total
	47	Data
    Management Plan (“DMP”)	1	Total
	48	Regulatory
    Document Collection - Start Up	40	Site
    
	49	Investigator
    Budget/Contract Negotiations	40	Site
    
	50	Investigator
    Meeting and Preparation	1	Meeting
	51	Clinical
    System Set-Up Configuration & Maintenance 	40	Total
	52	Generate
    Randomization Codes	1	Randomization
	 	STUDY
    START-UP FEES TOTAL	 	 	 	[THE CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]
	 	EDC
    STUDY START-UP	UNIT
    COST	UNITS	MEASURE
    OF UNIT	TOTAL
    
	17	eCRF
    Development	[THE CONFIDENTIAL

                                         PORTION HAS BEEN 

                                         SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND 

                                         HAS BEEN FILED

                                         SEPARATELY WITH 

                                         THE COMMISSION]
	1	Total	[THE CONFIDENTIAL

                                         PORTION HAS BEEN

                                         SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

                                         SEPARATELY WITH

                                         THE COMMISSION]

	18	eCRF
    Completion Instructions	1	Total
	19	Edits
    Specifications and Programming	1	Total
	20	Validate/Test
    Data Entry Screens (UAT)	1	Total
	21	Annotate
    CRF	1	Total
	22	Clinical
    Database Development-SDTM Dataset Creation/Documentation	1	Total
	23	Platform
    Study Set-up Fee	1	Total
	24	Database
    Design and Validation Specifications	1
    	Database
	25	EDC
    Kick-Off Meeting	1
    	Meeting
	26	Set-up
    Standard Data Entry Screens	1
    	Total
	27	Training
    Session	1
    	Study
	28	Project
    Manage all aspects of EDC start-up	1
    	Start-up
	29	Create
    Enrollment Screen	1
    	Total
	30	Integrating
    EDC System with IWRS System	1
    	Total
	31	Data
    Export Programming	23
    	Dataset
	32	Create
    Custom Reports	1
    	Report
	33	Register
    users and maintain passwords for life of study (per user (4 per site + 6 for sponsor))	166
    	Per
    User
	 	EDC
    START-UP FEES TOTAL	 	 	 	[THE CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]



 






    	 	Page 27	 



     


    

 





	Integrium,
    LLC.	Confidential


 


	 	CLINICAL
    MONITORING	UNIT
    COST	UNITS	MEASURE
    OF UNIT	 TOTAL
    
	34	Project
    Management (enrollment phase) 	[THE CONFIDENTIAL

    PORTION HAS BEEN 

    SO OMITTED
 PURSUANT TO A

    REQUEST FOR
 CONFIDENTIAL

    TREATMENT AND 
 HAS BEEN FILED
    
 SEPARATELY WITH 

    THE COMMISSION]	6.0	Month	[THE CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]
	35	Project
    Management (treatment phase) 	4.4	Month
	36	Project
    Management Study (LPLV to DBL)	1.8	Month
	37	Project
    Management Study (DBL to CRO end)	2.9	Month
	38	Sponsor
    Team Teleconferences 	39
    	Telecon
	39	Internal
    Team Teleconferences 	6
    	Telecon
	40	CRA
    Teleconferences	12
    	Telecon
	41	Trial
    Master File 	41	Site
	42	Regulatory
    Document Maintenance	527	Month
	43	Site
    Initiation Visits	8	Site
    
	44	Site
    Management/Patient Review/Query Resolution 	520	Site*Month
	45	Interim
    Monitoring Visits - One Day	300	Visit
	46	Interim
    Monitoring Visits - Additional Day On-site	160	Day
	47	Close-out
    Visits	40	Visit
	48	Site
    Grant Administration	10	Month
	 	CLINICAL
    MONITORING/LOGISTICS SERVICES SUBTOTAL	 	 	 	[THE
    CONFIDENTIAL
 PORTION HAS BEEN
    

    SO OMITTED
 PURSUANT
    TO A
 REQUEST FOR

    CONFIDENTIAL
 TREATMENT
    AND
 HAS BEEN FILED

    SEPARATELY WITH
 THE
    COMMISSION]
	 	MEDICAL/SAE
    MANAGEMENT	UNIT
    COST	UNITS	MEASURE
    OF UNIT	 TOTAL
    
	49	Medical
    Management	[THE CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND 

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]	12	Month	[THE
                                         CONFIDENTIAL

                                         PORTION HAS BEEN

                                         SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

                                         SEPARATELY WITH

                                         THE COMMISSION]

	50	Create
    Safety Plan	1	Plan
	51	Review
    Protocol Deviation Log	12	Month
	52	Tracking
    Protocol Waivers	12	Month
	53	Lab
    Alert/Patient Review	12	Month
	54	Review
    of AE Data Listings on a Monthly basis	12	Month
	55	Create
    Safety Database	1	Database
	62	SAE
    Management	13	SAE
	 	MEDICAL/SAE
    MANAGEMENT SERVICES SUBTOTAL	 	 	 	[THE
    CONFIDENTIAL
 PORTION HAS BEEN
    

    SO OMITTED
 PURSUANT
    TO A
 REQUEST FOR

    CONFIDENTIAL
 TREATMENT
    AND
 HAS BEEN FILED

    SEPARATELY WITH
 THE
    COMMISSION]



 






    	 	Page 28	 



     


    

 





	Integrium,
    LLC.	Confidential


 


	 	DATA
    MANAGEMENT	UNIT
    COST	UNITS	MEASURE
    OF UNIT	 TOTAL
    
	56	Data
    Entry Activities	[THE CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND 

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]	31,652
    	CRF
    Pg	[THE CONFIDENTIAL

                                         PORTION HAS BEEN

                                         SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

                                         SEPARATELY WITH

                                         THE COMMISSION]

	57	Generate/Track/Resolve
    Queries	6,330
    	Query
	58	Data
    Cleaning/Manual Listing Review	267
    	Patient
	59	Import
    Other Data	25
    	Transfer
	60	Export
    Data to Sponsor	2
    	Transfer
	61	Manual
    Coding	2,670
    	Manual
    Code
	63	Archive
    Study Records, Database	1
    	Database
	64	Data
    Base Lock Activities	1
    	Total
	 	DATA
    MANAGEMENT FEES SUBTOTAL	 	 	 	[THE CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]
	 	EDC
    SYSTEM MAINTAINANCE	UNIT
    COST	UNITS	MEASURE
    OF UNIT	 TOTAL
    
	65	Coding
    System (Set-up Cost) [WHO/MEDRA]	[THE CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND 

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]	1
    	Access
    User	 [THE CONFIDENTIAL

                                         PORTION HAS BEEN

                                         SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

                                         SEPARATELY WITH

                                         THE COMMISSION]

	66	Third
    Party Data Integrations	32
    	Transfer
	67	SAS
    Platform (months)	18
    	Month
	68	Help
    Desk Support 	12
    	Month
	 	EDC
    SYSTEM MAINTAINANCE	UNIT
    COST	UNITS	MEASURE
    OF UNIT	 TOTAL
    
	69	Ongoing
    Support Project Management	[THE CONFIDENTIAL

                                         PORTION HAS BEEN

                                         SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

                                         SEPARATELY WITH

                                         THE COMMISSION]
	15
    	Month	[THE
                                         CONFIDENTIAL

                                         PORTION HAS BEEN

                                         SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

        SEPARATELY WITH

        THE COMMISSION]

	70	CRF
    Export Programming (Site Archives, eCRFs for Submission)	1
    	Total
	71	Provide
    End of Study Archives to All Sites and 2 Copies to Sponsor	1
    	Total
	 	EDC
    SYSTEM SET-UP AND MAINTAINANCE SUBTOTAL	 	 	 	[THE
    CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]



 






    	 	Page 29	 



     


    

 





	Integrium,
    LLC.	Confidential


 


	 	BIOSTATISTICAL
    ANALYSIS	UNIT
    COST	UNITS	MEASURE
    OF UNIT	 TOTAL
    
	72	Draft
    & Final Statistical Analysis Plan (SAP)	[THE CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND 

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]	1
    	SAP	[THE CONFIDENTIAL

                                         PORTION HAS BEEN

                                         SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

                                         SEPARATELY WITH

                                         THE COMMISSION]

	73	Analysis
    DataSets	10
    	Dataset
	74	Create/Document
    ADaM (Submission Ready) Datasets	10
    	Dataset
	75	Statistical
    Programming Deliverables (TLGs)	172
    	T/L/G
	76	Generate/QC
    TLFs	182
    	Appendix
	77	Output
    Review/Dry Runs	3
    	Dry
    Run
	78	Post-hoc
    Analysis Hours	120
    	Hour
	 	BIOSTATISTICAL
    ANALYSIS SUBTOTAL	 	 	 	[THE
    CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]
	 	MEDICAL
    WRITING	UNIT
    COST	UNITS	MEASURE
    OF UNIT	 TOTAL
    
	79	Finalize
    Protocol	[THE CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND 

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]	1	Protocol	[THE
    CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]
	80	Develop/Finalize
    ICF 	1	Total
	81	Final
    CSR	1
    	Total
	 	MEDICAL
    WRITNG SUBTOTAL	 	 	 	[THE
    CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]
	 	CRO
    SERVICE FEES GRAND TOTAL	 	 	 



 






    	 	Page 30	 



     


    

 





	Integrium,
    LLC.	Confidential


 


	 	PASS
    THROUGH COSTS	UNIT
    COST	UNITS	MEASURE
    OF UNIT	 TOTAL
    
	1	Pre-study
    Site Evaluation Visit	 [THE CONFIDENTIAL

                                         PORTION HAS BEEN

                                         SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

                                         SEPARATELY WITH

                                         THE COMMISSION]
	40
    	Visit	 [THE CONFIDENTIAL

                                         PORTION HAS BEEN

                                         SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

                                         SEPARATELY WITH

                                         THE COMMISSION]

	2	Site
    Initiation Visit	8
    	Visit
	3a	Interim
    Monitoring Visits - One Day	300
    	Visit
	3b	Interim
    Monitoring Visits - Additional Day On-site	160
    	Day
	4	Close-out
    Visits	40
    	Visit
	5	Investigators'
    Meeting Planner	1	Meeting
	6	Investigator
    Grants	 	 
	6a	#
    Patients Completed	211	Patient
	6b	#
    Screen Failures 	178	Patient
	6c	#
    Run-In Failures 	27	Patient
	6d	#
    Early Terminations	29	Patient
	6e	#
    Rescue Visits	1	Visit
	6f	#
    Unscheduled visits	1	Visit
	7	Site:
    Advertising/Patient Recruitment	40	Site
	8	Site:
    Archive Fees	40	Site
	9	Site:
    Start-up Costs 	40	Site
	10	Site:
    Estimated Rescue Meds	40	Site
	11	Site:
    Regulatory Fee	1	Site
	12	Site:
    Pharmacy Fee	1	Total
	13	Central
    Laboratory Fees	1	Total
	14	IWRS
    Fees	1	Total
	15a	Central
    IRB - Protocol & Advertising Submission	1	Protocol
	15b	Central
    IRB - Site Submissions	40	Protocol
	16	Mixed
    Meal Tolerance Test Supplies: Ensure 	40	Site
	17a	EDC
    Platform Product Usage 	15	Total
	17b	EDC
    Coding System Integration Fee [WHO/MEDRA]	1	Total
	18	End
    of study archive CDs to sites; 2 copies to Sponsor	42	Total
	19	Launch
    Binders 	41	Binder
	20	Regulatory
    Binders	40	Binder
	21	Copying/
    Printing	1	Total
	22	Postal
    & Shipping Fees	1	Total
	23	Sponsor/Internal
    - Teleconferences	1	Total
	 	PASS-THROUGH
    COSTS TOTAL   	 	 	 	[THE
    CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]
	 	PROJECT'S
    OVER-ALL TOTAL COST	 	 	 	 $
    7,030,303.09 





 






    	 	Page 31	 



     


    

 





	Integrium,
    LLC.	Confidential


 


Pass Through Advance Payment Schedule


 


	 	 Contract
    Execution 	Feb-18	 TBD
    	 Study
    Total 
	Investigators'
    Meeting Planner:

    40% invoiced start-up payment

    40% payment 1 month prior to meeting

    20% paid upon final reconciliation	 

        [THE CONFIDENTIAL

        PORTION HAS BEEN

        SO OMITTED

        PURSUANT TO A

        REQUEST FOR

        CONFIDENTIAL

        TREATMENT AND

        HAS BEEN FILED

        SEPARATELY WITH

        THE COMMISSION]
	 

        [THE CONFIDENTIAL

        PORTION HAS BEEN

        SO OMITTED

        PURSUANT TO A

        REQUEST FOR

        CONFIDENTIAL

        TREATMENT AND

        HAS BEEN FILED

        SEPARATELY WITH

        THE COMMISSION]
	 

        [THE CONFIDENTIAL

        PORTION HAS

        BEEN SO OMITTED

        PURSUANT TO A

        REQUEST FOR

        CONFIDENTIAL

        TREATMENT AND

        HAS BEEN FILED

        SEPARATELY WITH

        THE COMMISSION]
	 

        [THE CONFIDENTIAL

        PORTION HAS

        BEEN SO OMITTED

        PURSUANT TO A

        REQUEST FOR

        CONFIDENTIAL

        TREATMENT AND

        HAS BEEN FILED

        SEPARATELY WITH

        THE COMMISSION]

	Site
    Start-up Costs:

    [THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED
    PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION]/site x 30 sites
	Site
    Grant Payments: 

    Advance Payment = [THE CONFIDENTIAL PORTION HAS
    BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION]/site
    X 30 sites
	Central
    Lab Vendor:

    Start-up payment
	Pass-Through
    Advance Payment


 






    	 	Page 32	 



     


    

 





	Integrium,
    LLC.	Confidential


 


Exhibit 4


Study Payment Schedule


 


	Monthly
    Management Fees	Month	$
    Amount	Verification
    of Milestone Completion/Deliverables
	Project Management Fees	November
    2017	[THE CONFIDENTIAL

                                         PORTION HAS BEEN SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

                                         SEPARATELY WITH

                                         THE COMMISSION] 
	Invoiced
    Monthly
	Project
    Management Fees	December
    2017	Invoiced
    Monthly
	Project
    Management Fees	January
    2018	Invoiced
    Monthly
	Project
    Management Fees	February
    2018	Invoiced
    Monthly
	Project
    Management Fees	March
    2018	Invoiced
    Monthly
	Project
    Management Fees	April
    2018	Invoiced
    Monthly
	Project
    Management Fees	May
    2018	Invoiced
    Monthly
	Project
    Management Fees	June
    2018	Invoiced
    Monthly
	Project
    Management Fees	July
    2018	Invoiced
    Monthly
	Project
    Management Fees	August
    2018	Invoiced
    Monthly
	Project
    Management Fees	September
    2018	Invoiced
    Monthly
	Project
    Management Fees	October
    2018	Invoiced
    Monthly
	Project
    Management Fees	November
    2018	Invoiced
    Monthly
	Project
    Management Fees	December
    2018	Invoiced
    Monthly
	Project
    Management Fees	January
    2019	Invoiced
    Monthly
	Project
    Management Fees	February
    2019	Invoiced
    Monthly
	Project
    Management Fees	March
    2019	Invoiced
    Monthly
	Project
    Management Fees	April
    2019	Invoiced
    Monthly
	Project
    Management Fees	May
    2019	Invoiced
    Monthly
	Total
    Monthly Management Fees:	 
	 	 	 	 	 	 
	Monthly
    Service Fees	Date	%
    Total Service Budget	%
    Milestone Service Budget	$
    Amount	Verification
    of Milestone Completion/Deliverables
	Contract
    Execution	12/1/2017	6.88%	10.48%	[THE CONFIDENTIAL

                                         PORTION HAS BEEN SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

                                         SEPARATELY WITH

                                         THE COMMISSION]
	Contract
    Execution
	1
    Subject Entered	12/27/2017	3.04%	6.07%	Enrollment
    log
	25% Subjects Randomized	2/10/2018	4.05%	8.10%	Enrollment
    log
	50%
    Subjects Randomized	3/27/2018	4.05%	8.10%	Enrollment
    log
	75%
    Subjects Randomized	5/11/2018	4.05%	8.10%	Enrollment
    log
	100% Subjects Randomized	7/29/2018	4.05%	8.10%	Enrollment
    log
	1st
    Subject Last Visit	4/30/2018	3.04%	6.07%	Enrollment
    log
	25%
    Subjects Last Visit	6/23/2018	3.04%	6.07%	Enrollment
    log
	50%
    Subjects Last Visit	8/7/2018	3.04%	6.07%	Enrollment
    log
	75%
    Subjects Last Visit	9/21/2018	3.04%	6.07%	Enrollment
    log
	100%
    Subjects Last Visit	12/9/2018	3.04%	6.07%	Enrollment
    log
	Database
    Lock	2/3/2019	6.07%	12.15%	Database
    Lock
	Draft
    Final TLGs	2/24/2019	2.63%	5.26%	Draft
    Final TLGs
	Total
    Milestone Based Services:	50.00%	100.00%	 
	







 



    	 	Page 33	 



     


    

 





	Integrium,
    LLC.	Confidential


 





	Unit
    Based Payments: 

    Actual Units Invoiced Monthly	%
    Total Services Budget	#
    Units	Unit
    Cost	$
    Amount	Verification
    of Milestone Completion/Deliverables
	SAE
    Management	0.79%	13	[THE CONFIDENTIAL

                                         PORTION HAS BEEN

                                         SO OMITTED

                                         PURSUANT TO A

                                         REQUEST FOR

                                         CONFIDENTIAL

                                         TREATMENT AND

                                         HAS BEEN FILED

                                         SEPARATELY WITH

                                         THE COMMISSION]
	[THE CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]	Invoiced
    monthly as occurred
	Total
    Unit Based Services:	 
	 	 	 	 	 
	Total
    Services:	 


 





	Pass-through
    expenses	$
    Amount	Verification
    of Milestone Completion/Deliverables
	Monitoring
    Visit Travel Expenses	[THE CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]	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
    Advertising	Invoiced
    as Actuals Monthly
	Site
    Archiving Fees	Invoiced
    as Actuals Monthly
	IRB
    Fees	Invoiced
    as Actuals Monthly
	Meeting
    Planner	[THE CONFIDENTIAL

    PORTION HAS BEEN

    SO OMITTED

    PURSUANT TO A

    REQUEST FOR

    CONFIDENTIAL

    TREATMENT AND

    HAS BEEN FILED

    SEPARATELY WITH

    THE COMMISSION]	Invoiced
    and Paid in Advance of Payment to Vendor
	Central
    Lab Vendor	Invoiced
    and Paid in Advance of Payment to Vendor
	EDC
    Platform Usage Fees	Invoiced
    as Actuals Monthly
	Copying/Printing/Supplies	Invoiced
    as Actuals Monthly
	Postal
    & Shipping Fees	Invoiced
    as Actuals Monthly
	Sponsor/Internal
    - Teleconference System	Invoiced
    as Actuals Monthly
	Total
    Pass-through Budget:	 
	 	 	 
	Grand
    Total Budget:	 $7,030,303.09
    	 







 


Any changes to the timeline and/or budget
will result in an amendment to the contract and payment schedule.







    	 	Page 34	 



     


    

 





	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 Placebo-controlled, Multi-center,
Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients with Inadequate
Glycemic Control on Oral Therapy.


 


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







 





	Responsibility	Reference
	 Obligation
                                         Assigned to:1

	 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	312.32 21CFR	 	 	 
	 	 	(a)	Preparation of initial
    report	 	☒	☐	☐
	 	 	(b)	Preparation of follow-up
    reports	 	☒	☐	☐
	 	 	(c)	Notifications to FDA
    (phone/fax or written)	 	☐	☐	☒
	 	 	(d)	Notifications to investigators	 	☒	☐	☐
	 	 	 	 	 	 	 	 
	 	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 35	 



     


    

 





	Integrium,
    LLC.	Confidential


 


	Responsibility	Reference
	 Obligation
                                         Assigned to:1

	 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
	21
    CFR 312.53 (a); 	☒	☒	☐
	 	 	(a)	Identify
    qualified investigators/sites	ICH
    E6 5.6.1	☒	☒	☐
	 	 	 	 	 	 	 	 
	 	 	(b)	Approve
    investigators/sites for participation	 	 	 	 
	 	 	 	 	 	 	 	 
	 	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

        
	21
    CFR 312.56 (b); 	☒	☒	☐
	 	 	(a)	Notify
    FDA	ICH
    E6 5.20	☒	☐	☐
	 	 	(b)	Assure
    disposal or return of investigational drug	 	☒	☐	☐
	 	 	 	 	 	 	 	 
	 	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 36	 



     


    

 





	Integrium,
    LLC.	Confidential


 


	Responsibility	Reference
	 Obligation
                                         Assigned to:1

	 Integrium
	 Oramed
	Third Party

        Vendor

	F. 	Trial Data Handling and Reporting	 	 	 	 
	 	 	(a)	Manage an independent date safety monitoring
    committee	ICH
    E6 5.5.2	NA	NA	NA
	 	 	(b)	Data Management	ICH
    E6 5.5.1	☒	☐	☐
	 	 	(c)	Statistical plan and/or analysis	ICH
    E6 5.5.1	☒	☐	☐
	 	 	(d)	Final study report	ICH
    E6 5.5.1	☒	☒	☐
	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 
	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
	21
    CFR 312.110;  ICH 	 	 	 
	 	 	 	 	 	 
	 	 	(a)	Content	E6
    5.14.2	☐	☒	☐ 
	 	 	(b)	Format	 	☐	☒	☐ 
	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 
	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	 	14-Feb-2018
		 	Name:	 	Date
	 	 	Title:	 	 


 


	Integrium
    LLC.	 	 	 	 
	 	 	 	 	 
	 	 	/s/
    Jessica Coutu 	 	23-JAN-2018
		 	Name:
    Jessica Coutu	 	Date
		 	Title:
    Sr. V.P. Clinical Operations	 	 


 


 


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