Document:

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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		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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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

 

 

 

 

 

 

(Remainder
of Page Intentionally Left Blank)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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	Integrium,
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Integrium/
Oramed

 

Exhibit
2

 

Study
Specifications

 

 

 

 

 

 

 

(Remainder
of Page Intentionally Left Blank)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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    LLC.	Confidential

 

	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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Integrium/Oramed

 

EXHIBIT 3 

 

Study Budget 

 

 

 

 

 

 

 

(Remainder
of Page Intentionally Left Blank)

 

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	Integrium,
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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	 	 

 

 

Page
37Exhibit 10.4

 

INDEMNIFICATION AGREEMENT

 

This Indemnification Agreement (this “Agreement”) is made and entered into, effective        , by and between Pivotal Software, Inc., a Delaware corporation (the “Company”), and (“Indemnitee”).

 

Recitals

 

A.           Competent and experienced persons are reluctant to serve or to continue to serve as directors or officers of corporations unless they are provided with adequate protection through insurance or indemnification (or both) against claims against them arising out of their service and activities as directors. 

 

B.           Uncertainties relating to the availability of adequate insurance for directors and officers have increased the difficulty for corporations to attract and retain competent and experienced persons to serve as directors or officers. 

 

C.           The Board of Directors of the Company (the “Board”) has determined that the continuation of present trends in litigation will make it more difficult to attract and retain competent and experienced persons to serve as directors or officers of the Company and, in some cases, of its subsidiaries, that this situation is detrimental to the best interests of the Company’s stockholders and that the Company should act to assure its directors and officers that there will be increased certainty of adequate protection in the future. 

 

D.           It is reasonable, prudent and necessary for the Company to obligate itself contractually to indemnify its directors and officers to the fullest extent permitted by applicable law in order to induce them to serve or continue to serve as directors or officers of the Company or its subsidiaries. 

 

E.            Indemnitee’s willingness to continue to serve in his or her current capacity is predicated, in substantial part, upon the Company’s willingness to indemnify him or her to the fullest extent permitted by the laws of the State of Delaware and upon the other undertakings set forth in this Agreement. 

 

F.             In recognition of the need to provide Indemnitee with substantial protection against personal liability, in order to procure Indemnitee’s continued service, and to enhance Indemnitee’s ability to serve the Company in an effective manner, and in order to provide such protection pursuant to express contract rights (intended to be enforceable irrespective of any amendment to the Company’s Certificate of Incorporation or Bylaws (collectively, the “Constituent Documents”), any Change of Control (as defined in Section 1(a)) or any change in the composition of the Board), the Company wishes to provide in this Agreement for the indemnification of and the advancement of Expenses (as defined in Section 1(e)) to Indemnitee as set forth in this Agreement. 

 

 

Now, therefore, for and in consideration of the foregoing premises, Indemnitee’s agreement to continue to serve the Company in his or her current capacity and the mutual covenants and agreements contained herein, the parties hereby agree as follows:

 

1.             Certain Definitions — In addition to terms defined elsewhere herein, the following terms shall have the respective meanings indicated below when used in this Agreement: 

 

(a)          “Change of Control” shall mean the occurrence of any of the following events: 

 

                                               (i)                  The acquisition after the date of this Agreement by any individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) (a “Person”), of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Exchange Act) of 15% or more of either the then outstanding shares of common stock of the Company (the “Outstanding Company Common Stock”) or the combined voting power of the then outstanding voting securities of the Company entitled to vote generally in the election of directors (the “Outstanding Company Voting Securities”); provided, however, that for purposes of this paragraph (i), the following acquisitions shall not constitute a Change of Control: 

 

                                                                               (A)     any acquisition directly from the Company or any Controlled Affiliate of the Company; 

 

                                                                               (B)     any acquisition by the Company or any Controlled Affiliate of the Company; 

 

                                                                               (C)     any acquisition by any employee benefit plan (or related trust) sponsored or maintained by the Company or any Controlled Affiliate of the Company; 

 

                                                                              (D)      any acquisition by Mr. Michael S. Dell, his Affiliates or Associates (as such terms are defined in Rule 12b-2 promulgated under the Exchange Act), his heirs or any trust or foundation to which he has transferred or may transfer Outstanding Company Common Stock or Outstanding Company Voting Securities; or 

 

                                                                               (E)      any acquisition by any entity or its security holders pursuant to a transaction that complies with clauses (A), (B), and (C) of paragraph (iii) below; 

 

                                               (ii)                Individuals who, as of the date of this Agreement, constitute the Board (collectively, the “Incumbent Directors”) cease for any reason to constitute at least a majority of the Board; provided, however, that any individual who becomes a director of the Company subsequent to the date of this Agreement and whose election or appointment by the Board or 

 

2

 

nomination for election by the Company’s stockholders was approved by a vote of at least a majority of the then Incumbent Directors, shall be considered as an Incumbent Director, unless such individual’s initial assumption of office occurs as a result of an actual or threatened election contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies or consents by or on behalf of a Person other than the Board; 

 

                                               (iii)             Consummation of a reorganization, merger, consolidation, sale or other disposition of all or substantially all the assets of the Company or an acquisition of assets of another corporation (a “Business Combination”), unless, in each case, following such Business Combination (A) all or substantially all of the individuals and entities who were the beneficial owners, respectively, of the Outstanding Company Common Stock and Outstanding Company Voting Securities immediately prior to such Business Combination beneficially own, directly or indirectly, more than 50% of, respectively, the then outstanding shares of common stock and the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors, as the case may be, of the corporation resulting from such Business Combination (including a corporation that as a result of such transaction owns the Company or all or substantially all of the Company’s assets either directly or through one or more subsidiaries) in substantially the same proportions as their ownership, immediately prior to such Business Combination, of the Outstanding Company Common Stock and Outstanding Company Voting Securities, as the case may be, (B) no Person (excluding any employee benefit plan (or related trust) of the Company or the corporation resulting from such Business Combination and any Person referred to in clause (D) of paragraph (i) above) beneficially owns, directly or indirectly, 15% or more of, respectively, the then outstanding shares of common stock of the corporation resulting from such Business Combination or the combined voting power of the then outstanding voting securities of such corporation except to the extent that such ownership of the Company existed prior to the Business Combination and (C) at least a majority of the members of the board of directors of the corporation resulting from such Business Combination were Incumbent Directors at the time of the execution of the initial agreement, or of the action of the Board, providing for such Business Combination; 

 

                                               (iv)            Approval by the stockholders of the Company of a complete liquidation or dissolution of the Company; or 

 

                                               (v)               The occurrence of any other event of a nature that would be required to be reported in response to Item 6(e) of Schedule 14A of Regulation 14A (or a response to any similar item on any similar schedule or form) under the Exchange Act, whether or not the Company is then subject to such reporting requirement. 

 

3

Notwithstanding the foregoing, in no event shall a Change in Control be deemed to have occurred if, after the occurrence of any of the events described in Sections 1(a)(i), 1(a)(ii), 1(a)(iii), 1(a)(iv) or 1(a)(v), Denali Holding Inc., a Delaware corporation, directly or indirectly through a Controlled Affiliate, beneficially owns a majority of the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors.

 

(b)             “Claim” shall mean (i) any threatened, asserted, pending or completed claim, demand, action, suit or proceeding (including any cross claim or counterclaim in any action, suit or proceeding), whether civil, criminal, administrative, arbitrative, investigative or other and whether made pursuant to federal, state or other law (including securities laws); and (ii) any inquiry or investigation (including discovery), whether made, instituted or conducted by the Company or any other party, including any federal, state or other governmental entity, that Indemnitee in good faith believes might lead to the institution of any such claim, demand, action, suit or proceeding. 

 

(c)               “Controlled Affiliate” shall mean any corporation, limited liability company, partnership, joint venture, trust or other entity or enterprise, whether or not for profit, that is directly or indirectly controlled by the Company. For purposes of this definition, the term “control” shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of an entity or enterprise, whether through the ownership of voting securities, through other voting rights, by contract or otherwise; provided, however, that direct or indirect beneficial ownership of capital stock or other interests in an entity or enterprise entitling the holder to cast 20% or more of the total number of votes generally entitled to be cast in the election of directors (or persons performing comparable functions) of such entity or enterprise shall be deemed to constitute “control” for purposes of this definition. 

 

(d)             “Disinterested  Director” shall mean a director of the Company who is not and was not a party to the Claim with respect to which indemnification is sought by Indemnitee. 

 

(e)              “Expenses” shall mean all costs and expenses (including attorneys’ and experts’ fees and expenses) actually and reasonably incurred in connection with investigating, defending (including affirmative defenses and counterclaims), being a witness in or participating in (including on appeal), or preparing to investigate, defend, be a witness in or participate in (including on appeal), any Claim relating to an Indemnifiable Claim. 

 

(f)              “Indemnifiable Claim” shall mean any Claim based upon, arising out of or resulting from any of the following: 

 

4

 

(i)             Any actual, alleged or suspected act or failure to act by Indemnitee in his or her capacity as a director or officer of the Company or as a director, officer, employee, member, manager, trustee, fiduciary or agent (collectively, a “Representative”) of any Controlled Affiliate or other corporation, limited liability company, partnership, joint venture, employee benefit plan, trust or other entity or enterprise, whether or not for profit, as to which Indemnitee is or was serving at the request of the Company as a Representative; 

 

(ii)          Any actual, alleged or suspected act or failure to act by Indemnitee with respect to any business, transaction, communication, filing, disclosure or other activity of the Company or any other entity or enterprise referred to in clause (i) of this Section 1(f); or 

 

(iii)       Indemnitee’s status as a current or former director or officer of the Company or as a current or former Representative of the Company or any other entity or enterprise referred to in clause (i) of this Section 1(f) or any actual, alleged or suspected act or failure to act by Indemnitee in connection with any obligation or restriction imposed upon Indemnitee by reason of such status. 

 

In addition to any service at the actual request of the Company, for purposes of this Agreement, Indemnitee shall be deemed to be serving or to have served at the request of the Company as a Representative of another entity or enterprise if Indemnitee is or was serving as a director, officer, employee, member, manager, trustee, fiduciary or agent of such entity or enterprise and (A) such entity or enterprise is or at the time of such service was a Controlled Affiliate, (B) such entity or enterprise is or at the time of such service was an employee benefit plan (or related trust) sponsored or maintained by the Company or a Controlled Affiliate or (C) the Company or a Controlled Affiliate directly or indirectly caused Indemnitee to be nominated, elected, appointed, designated, employed, engaged or selected to serve in such capacity.

 

(g)             “Indemnifiable Losses” shall mean any and all Losses relating to, arising out of or resulting from any Indemnifiable Claim. 

 

(h)            “Independent Counsel” shall mean a law firm, or a member of a law firm, that is experienced in matters of corporation law and, as of the time of selection with respect to any Indemnifiable Claim, is not nor in the past five years has been retained to represent (i) the Company or Indemnitee in any matter material to either such party (other than with respect to matters concerning Indemnitee under this Agreement or other indemnitees under similar indemnification agreements) or (ii) any other party to the Indemnifiable Claim giving rise to a claim for indemnification hereunder. Notwithstanding the foregoing, the term “Independent Counsel” shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or Indemnitee in an action to determine Indemnitee’s rights under this Agreement. 

 

5

 

                      (i)             “Losses” means any and all Expenses, damages (including punitive, exemplary and the multiplied portion of any damages), losses, liabilities, judgments, payments, fines, penalties (whether civil, criminal or other), awards and amounts paid in settlement (including all interest, assessments and other charges paid or incurred in connection with or with respect to any of the foregoing). 

 

2.             Indemnification Obligation — Subject to Section 9, the Company shall indemnify, defend and hold harmless Indemnitee, to the fullest extent permitted by the laws of the State of Delaware in effect on the date hereof or as such laws may from time to time hereafter be amended to increase the scope of such permitted indemnification, against any and all Indemnifiable Claims and Indemnifiable Losses, in either case to the extent actually and reasonably incurred by or on behalf of Indemnitee. 

 

3.             Exclusions — Notwithstanding any provision in this Agreement, the Company shall not be obligated under this Agreement to make any indemnification payment in connection with any Claim involving Indemnitee: 

 

                        (a)       for which payment has actually been made to or on behalf of Indemnitee under any insurance policy or other indemnity provision, except with respect to any excess Losses beyond the amount paid under any insurance policy or other indemnity provision; or 

 

                       (b)        for (i) an accounting of profits made from the purchase and sale (or sale and purchase) by Indemnitee of securities of the Company within the meaning of Section 16(b) of the Exchange Act or similar provisions of state statutory law or common law, (ii) any reimbursement of the Company by Indemnitee of any bonus or other incentive-based or equity-based compensation or of any profits realized by Indemnitee from the sale of securities of the Company, as required in each case under the Exchange Act (including any such reimbursements that arise from an accounting restatement of the Company pursuant to Section 304 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), or the payment to the Company of profits arising from the purchase and sale by Indemnitee of securities in violation of Section 306 of the Sarbanes-Oxley Act) or (iii) any reimbursement of the Company by Indemnitee of any compensation pursuant to any compensation recoupment or clawback policy adopted by the Board or the compensation committee of the Board, including but not limited to any such policy adopted to comply with stock exchange listing requirements implementing Section 10D of the Exchange Act; or 

 

                       (c)         except as provided in Sections 5 and 23 of this Agreement, in connection with any Claim initiated by Indemnitee, including any Claim initiated by Indemnitee against the Company or its directors, officers, employees or other indemnitees, unless (i) the Board authorized the Claim prior to its initiation or (ii) the Company provides the indemnification, in its sole discretion, pursuant to the powers vested in the Company under applicable law. 

 

6

 

4.             Advancement of Expenses — Indemnitee shall have the right to advancement by the Company prior to the final disposition of any Indemnifiable Claim of any and all Expenses relating to, arising out of or resulting from any Indemnifiable Claim paid or incurred by Indemnitee and as to which Indemnitee provides supporting documentation. Indemnitee’s right to such advancement is not subject to the satisfaction of any standard of conduct. Without limiting the generality or effect of the foregoing, within 15 calendar days after any request by Indemnitee, the Company shall, in accordance with such request (but without duplication), (a) pay such Expenses on behalf of Indemnitee, (b) advance to Indemnitee funds in an amount sufficient to pay such Expenses or (c) reimburse Indemnitee for such Expenses; provided, however, that Indemnitee shall repay, without interest, any amounts actually advanced to Indemnitee that, at the final disposition of the Indemnifiable Claim to which the advance related, were in excess of amounts paid or incurred by Indemnitee with respect to Expenses relating to, arising out of or resulting from such Indemnifiable Claim. Indemnitee shall qualify for advances upon the execution and delivery to the Company of this Agreement, which shall constitute an undertaking providing that Indemnitee undertakes to repay the amounts advanced (without interest) to the extent that it ultimately is determined that Indemnitee is not entitled to be indemnified by the Company. No other form of undertaking shall be required other than the execution of this Agreement. This Section 4 shall not apply to any claim made by Indemnitee for which indemnity is excluded pursuant to Section 3. 

 

5.             Indemnification for Additional Expenses — Without limiting the generality or effect of the foregoing, the Company shall indemnify and hold harmless Indemnitee against and, if requested by Indemnitee, shall reimburse Indemnitee for, or advance to Indemnitee, within 15 calendar days of such request accompanied by supporting documentation for specific Expenses to be reimbursed or advanced, any and all Expenses incurred by Indemnitee in connection with any Claim made, instituted or conducted by Indemnitee for (a) indemnification or reimbursement or advance payment of Expenses by the Company under any provision of this Agreement or under any other agreement or provision of the Constituent Documents now or hereafter in effect relating to Indemnifiable Claims or (b) recovery under any directors’ and officers’ liability insurance policies maintained by the Company, regardless in each case of whether Indemnitee ultimately is determined to be entitled to such indemnification, reimbursement, advance or insurance recovery, as the case may be; provided, however, that Indemnitee shall return, without interest, any such advance of Expenses (or portion thereof) that remains unspent at the final disposition of the Claim to which the advance related. 

 

6.             Indemnification For Expenses of a Witness — Notwithstanding any other provision of this Agreement, to the fullest extent permitted by applicable law and to the extent that Indemnitee is, by reason of an Indemnifiable Claim, a witness or otherwise asked to participate in any Claim to which Indemnitee is not a party, Indemnitee shall be indemnified against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection therewith. 

 

7

 

7.             Partial Indemnity — If Indemnitee is entitled under any provision of this Agreement to indemnification by the Company for some or a portion of any Indemnifiable Loss but not for all of the total amount thereof, the Company shall nevertheless indemnify Indemnitee for the portion thereof to which Indemnitee is entitled. 

 

8.             Procedure for Notification — To obtain indemnification under this Agreement with respect to an Indemnifiable Claim or Indemnifiable Loss, Indemnitee shall submit to the Company a written request therefor, including a brief description (based upon information then available to Indemnitee) of such Indemnifiable Claim or Indemnifiable Loss. If, at the time of the receipt of such request, the Company has directors’ and officers’ liability insurance in effect under which coverage for such Indemnifiable Claim or Indemnifiable Loss is potentially available, the Company shall give prompt written notice of such Indemnifiable Claim or Indemnifiable Loss to the applicable insurers in accordance with the procedures set forth in the applicable policies. The Company shall provide to Indemnitee a copy of such notice delivered to the applicable insurers and copies of all subsequent correspondence between the Company and such insurers regarding the Indemnifiable Claim or Indemnifiable Loss, in each case substantially concurrently with the delivery or receipt thereof by the Company. The failure by Indemnitee to timely notify the Company of any Indemnifiable Claim or Indemnifiable Loss shall not relieve the Company from any liability hereunder unless, and only to the extent that, the Company did not otherwise learn of such Indemnifiable Claim or Indemnifiable Loss and such failure results in forfeiture by the Company of substantial defenses, rights or insurance coverage. 

 

9.             Determination of Right to Indemnification — 

 

(a)        To the extent that Indemnitee shall have been successful on the merits or otherwise in defense of any Indemnifiable Claim or any portion thereof or in defense of any issue or matter therein, including dismissal without prejudice, Indemnitee shall be indemnified against all Indemnifiable Losses relating to, arising out of or resulting from such Indemnifiable Claim in accordance with Section 2 and no Standard of Conduct Determination (as defined in paragraph (b) below) shall be required. 

 

(b)        To the extent that the provisions of Section 9(a) are inapplicable to an Indemnifiable Claim that shall have been finally disposed of, any determination of whether Indemnitee has satisfied any applicable standard of conduct under Delaware law that is a legally required condition precedent to indemnification of Indemnitee hereunder against Indemnifiable Losses relating to, arising out of or resulting from such Indemnifiable Claim (a “Standard of Conduct Determination”) shall be made as follows: 

 

(i)                                     If a Change of Control has not occurred, or if a Change of Control has occurred but Indemnitee has requested that the Standard of Conduct Determination be made pursuant to this clause (i): 

 

(A)                               By a majority vote of the Disinterested Directors, even if less than a quorum of the Board; 

 

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(B)                               If such Disinterested Directors so direct, by a majority vote of a committee of Disinterested Directors designated by a majority vote of all Disinterested Directors; or 

 

(C)                               If there are no such Disinterested Directors, by Independent Counsel in a written opinion addressed to the Board, a copy of which shall be delivered to Indemnitee; and 

 

(ii)                                  If a Change of Control has occurred and Indemnitee has not requested that the Standard of Conduct Determination be made pursuant to clause (i) above, by Independent Counsel in a written opinion addressed to the Board, a copy of which shall be delivered to Indemnitee. 

 

Indemnitee will cooperate with the person or persons making such Standard of Conduct Determination, including providing to such person or persons, upon reasonable advance request, any documentation or information which is not privileged or otherwise protected from disclosure and which is reasonably available to Indemnitee and reasonably necessary to such determination. The Company shall indemnify and hold harmless Indemnitee against and, if requested by Indemnitee, shall reimburse Indemnitee for, or advance to Indemnitee, within 15 calendar days of such request, accompanied by supporting documentation for specific expenses to be reimbursed or advanced, any and all costs and expenses (including attorneys’ and experts’ fees and expenses) incurred by Indemnitee in so cooperating with the person making such Standard of Conduct Determination.

 

(c)         The Company shall use its reasonable best efforts to cause any Standard of Conduct Determination required under Section 9(b) to be made as promptly as practicable. If (i) the person or persons empowered or selected under Section 9(b) to make the Standard of Conduct Determination shall not have made a determination within 30 days after the later of (A) receipt by the Company of written notice from Indemnitee advising the Company of the final disposition of the applicable Indemnifiable Claim (the date of such receipt being the “Notification Date”) and (B) the selection of an Independent Counsel, if such determination is to be made by Independent Counsel, that is permitted under the provisions of Section 9(e) to make such determination and (ii) Indemnitee shall have fulfilled his or her obligations set forth in the second sentence of Section 9(b), then Indemnitee shall be deemed to have satisfied the applicable standard of conduct; provided, however, that such 30-day period may be extended for a reasonable time, not to exceed an additional 30 days, if the person making such determination in good faith requires such additional time to obtain or evaluate documentation or information relating thereto. 

 

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(d)        If (i) Indemnitee shall be entitled to indemnification hereunder against any Indemnifiable Losses pursuant to Section 9(a), (ii) no determination of whether Indemnitee has satisfied any applicable standard of conduct under Delaware law is a legally required condition precedent to indemnification of Indemnitee hereunder against any Indemnifiable Losses or (iii) Indemnitee has been determined or deemed pursuant to Section 9(b) or (c) to have satisfied any applicable standard of conduct under Delaware law that is a legally required condition precedent to indemnification of Indemnitee hereunder against any Indemnifiable Losses, then the Company shall pay to Indemnitee, within 15 calendar days after the later of (x) the Notification Date with respect to the Indemnifiable Claim or portion thereof to which such Indemnifiable Losses are related, out of which such Indemnifiable Losses arose or from which such Indemnifiable Losses resulted and (y) the earliest date on which the applicable criterion specified in clause (i), (ii) or (iii) above shall have been satisfied, an amount equal to the amount of such Indemnifiable Losses. 

 

(e)         If a Standard of Conduct Determination is to be made by Independent Counsel pursuant to Section 9(b)(i), the Independent Counsel shall be selected by the Board and the Company shall give written notice to Indemnitee advising him or her of the identity of the Independent Counsel so selected. If a Standard of Conduct Determination is to be made by Independent Counsel pursuant to Section 9(b)(ii), the Independent Counsel shall be selected by Indemnitee and Indemnitee shall give written notice to the Company advising it of the identity of the Independent Counsel so selected. In either case, Indemnitee or the Company, as applicable, may, within five business days after receiving written notice of selection from the other, deliver to the other a written objection to such selection; provided, however, that such objection may be asserted only on the ground that the Independent Counsel so selected does not satisfy the criteria set forth in the definition of “Independent Counsel” in Section 1(h) and the objection shall set forth with particularity the factual basis of such assertion. Absent a proper and timely objection, the person or firm so selected shall act as Independent Counsel. If such written objection is properly and timely made and substantiated, (i) the Independent Counsel so selected may not serve as Independent Counsel unless and until such objection is withdrawn or a court of competent jurisdiction has determined that such objection is without merit and (ii) the non-objecting party may, at its option, select an alternative Independent Counsel and give written notice to the other party advising such other party of the identity of the alternative Independent Counsel so selected, in which case the provisions of the two immediately preceding sentences and clause (i) of this sentence shall apply to such subsequent selection and notice. If applicable, the provisions of clause (ii) of the immediately preceding sentence shall apply to successive alternative selections. If no Independent Counsel that is permitted under the foregoing provisions of this Section 9(e) to make the Standard of Conduct Determination shall have been selected within 30 days after the Company gives its initial notice pursuant to the first sentence of this Section 9(e) or Indemnitee gives its initial notice pursuant to the second sentence of this Section 9(e), as the case may be, either the Company 

 

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or Indemnitee may petition the Court of Chancery of the State of Delaware for resolution of any objection that has been made by the Company or Indemnitee to the other’s selection of Independent Counsel or for the appointment as Independent Counsel of a person selected by the Court or by such other person as the Court shall designate, and the person or firm with respect to whom all objections are so resolved or the person or firm so appointed will act as Independent Counsel. In all events, the Company shall pay all of the reasonable fees and expenses of the Independent Counsel incurred in connection with the Independent Counsel’s determination pursuant to Section 9(b). 

 

(f)          For purposes of any Standard of Conduct Determination, Indemnitee shall be deemed to have acted in good faith if Indemnitee’s action is in good faith reliance on the records or books of account of the Company or any Controlled Affiliate or other corporation, limited liability company, partnership, joint venture, employee benefit plan, trust or other entity or enterprise, whether or not for profit, as to which Indemnitee is or was serving at the request of the Company as a Representative, including financial statements, or on information supplied to Indemnitee by the officers of the Company or such other entity in the course of their duties, or on the advice of legal counsel for the Company or such other entity or on information or records given or reports made to the Company or such other entity by an independent certified public accountant or by an appraiser or other expert selected by the Company or such other entity.

 

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10.      Presumption of Entitlement — In making any Standard of Conduct Determination, the person or persons making such determination shall presume that Indemnitee has satisfied the applicable standard of conduct, and the Company shall, to the fullest extent not prohibited by law, have the burden of proof to overcome that presumption in connection with the making by any person, persons or entity of any determination contrary to that presumption. Any Standard of Conduct Determination that is adverse to Indemnitee may be challenged by Indemnitee in the Court of Chancery of the State of Delaware. No determination by the Company (including by its directors or any Independent Counsel) that Indemnitee has not satisfied any applicable standard of conduct shall be a defense to any Claim by Indemnitee for indemnification by the Company hereunder or create a presumption that Indemnitee has not met any applicable standard of conduct. 

 

11.      No Other Presumption — For purposes of this Agreement, the termination of any Claim by judgment, order, settlement (whether with or without court approval) or conviction, or upon a plea of nolo contendere or its equivalent, or an entry of an order of probation prior to judgment, shall not create a presumption that Indemnitee did not meet any applicable standard of conduct or that indemnification hereunder is otherwise not permitted. 

 

12.      Non-Exclusivity — The rights of Indemnitee hereunder shall be in addition to any other rights Indemnitee may have under the Constituent Documents, the substantive laws of the State of Delaware, any other contract or otherwise (collectively, “Other Indemnity Provisions”). No amendment, alteration or repeal of this Agreement or of any provision hereof shall limit or restrict any right of Indemnitee under this Agreement in respect of any action taken or omitted by Indemnitee prior to such amendment, alteration or repeal. To the extent that a change in Delaware law, whether by statute or judicial decision, permits greater indemnification or advancement of Expenses than would be afforded currently under the Constituent Documents and this Agreement, it is the intent of the parties hereto that Indemnitee shall enjoy by this Agreement the greater benefits so afforded by such change. No right or remedy herein conferred is intended to be exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in addition to every other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. Subject to Section 15, the assertion or employment of any right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other right or remedy. 

 

13.      Liability Insurance and Funding — For the duration of Indemnitee’s service as a director or officer of the Company and thereafter for so long as Indemnitee shall be subject to any pending or possible Indemnifiable Claim, to the extent the Company maintains policies of directors’ and officers’ liability insurance providing coverage for directors and officers of the Company, Indemnitee shall be covered by such policies, in accordance with their terms, to the maximum extent of the coverage available for any other director or officer of the Company. Upon request of Indemnitee, the Company shall provide Indemnitee with a copy of all directors’ and officers’ liability insurance applications, binders, policies, declarations, endorsements and other related materials and shall provide Indemnitee with a reasonable opportunity to review and comment on the 

 

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same. Without limiting the generality or effect   of the two immediately preceding sentences, no discontinuation or significant   reduction in the scope or amount of coverage from one policy period to the   next shall be effective (a) without the prior approval thereof by a   majority vote of the Incumbent Directors, even if less than a quorum, or   (b) if at the time that any such discontinuation or significant   reduction in the scope or amount of coverage is proposed there are no   Incumbent Directors, without the prior written consent of Indemnitee (which   consent shall not be unreasonably withheld or delayed). In all policies of   directors’ and officers’ liability insurance obtained by the   Company, Indemnitee shall be named as an insured in such a manner as to   provide Indemnitee the same rights and benefits, subject to the same   limitations, as are accorded to the Company’s directors and officers most   favorably insured by such policy. The Company may, but shall not be required   to, create a trust fund, grant a security interest or use other means,   including a letter of credit, to ensure the payment of such amounts as may be   necessary to satisfy its obligations to indemnify and advance expenses   pursuant to this Agreement.
    
	
 
    	
 
    
	
14.
    	
Subrogation — The Company hereby   acknowledges that Indemnitee may have certain rights to indemnification,   advancement of expenses and/or insurance provided by an Indemnitee-Related   Entity (as defined herein). The Company hereby agrees that (i) it is the   indemnitor of first resort (i.e., its obligations to Indemnitee are primary   and any obligation of the Indemnitee-Related Entity to advance expenses or to   provide indemnification for the same expenses or liabilities incurred by   Indemnitee are secondary), (ii) it shall be required to advance the full   amount of Expenses incurred by Indemnitee and shall be liable for the full   amount of all Expenses, judgments, penalties, fines and amounts paid in   settlement to the extent legally permitted and as required by the Certificate   of Incorporation or By-laws (or any agreement between the Company and   Indemnitee), without regard to any rights Indemnitee may have against the   Indemnitee-Related Entity, and (iii) it irrevocably waives, relinquishes   and releases the Indemnitee-Related Entity from any and all claims against   the Indemnitee-Related Entity for contribution, subrogation or any other   recovery of any kind in respect thereof. The Company further agrees that no   advancement or payment by the Indemnitee-Related Entity on behalf of   Indemnitee with respect to any claim for which Indemnitee has sought   indemnification from the Company shall affect the foregoing and the   Indemnitee-Related Entity shall have a right of contribution and/or be   subrogated to the extent of such advancement or payment to all of the rights   of recovery of Indemnitee against the Company. The term “Indemnitee-Related Entity” means any   company, corporation, limited liability company, partnership, joint venture,   trust, employee benefit plan or other enterprise (other than the Company or   the insurer under and pursuant to an insurance policy of the Company) from   whom an Indemnitee may be entitled to indemnification or advancement of   Expenses with respect to which the Company may also have an indemnification   or advancement obligation.
    
	
 
    	
 
    
	
15.
    	
No Duplication   of Payments — Subject to the provisions of Section 14 of this   Agreement, the Company shall not be liable under this Agreement to make any   payment to Indemnitee with respect to any Indemnifiable Losses to the extent   Indemnitee has otherwise actually received payment (net of Expenses incurred   in connection therewith)
    

 

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under any insurance policy, the Constituent   Documents or Other Indemnity Provisions or otherwise (including from any   entity or enterprise referred to in clause (i) of the definition of   “Indemnifiable Claim” in Section 1(f)) with respect to such   Indemnifiable Losses otherwise indemnifiable hereunder.
    
	
 
    	
 
    
	
16.
    	
Defense of   Claims — The Company shall be entitled to participate in the   defense of any Indemnifiable Claim or to assume the defense thereof, with   counsel reasonably satisfactory to Indemnitee; provided, however, that if   Indemnitee believes, after consultation with counsel selected by Indemnitee,   that (a) the use of counsel chosen by the Company to represent   Indemnitee would present such counsel with an actual or potential conflict,   (b) the named parties in any such Indemnifiable Claim (including any   impleaded parties) include both the Company and Indemnitee and Indemnitee   shall conclude that there may be one or more legal defenses available to him   or her that are different from or in addition to those available to the   Company or (c) any such representation by such counsel would be   precluded under the applicable standards of professional conduct then   prevailing, then Indemnitee shall be entitled to retain separate counsel (but   not more than one law firm plus, if applicable, local counsel with respect to   any particular Indemnifiable Claim) at the Company’s expense. The Company   shall not be liable to Indemnitee under this Agreement for any amounts paid   in settlement of any threatened or pending Indemnifiable Claim effected   without the Company’s prior written consent. The Company shall not, without   the prior written consent of Indemnitee, effect any settlement of any   threatened or pending Indemnifiable Claim that Indemnitee is or could have   been a party unless such settlement solely involves the payment of money and   includes a complete and unconditional release of Indemnitee from all   liability on any claims that are the subject matter of such Indemnifiable   Claim. Neither the Company nor Indemnitee shall unreasonably withhold its   consent to any proposed settlement; provided, however, that Indemnitee may   withhold consent to any settlement that does not provide a complete and   unconditional release of Indemnitee.
    
	
 
    	
 
    
	
17.
    	
Successors and   Binding Agreement —
    
	
 
    	
 
    
	
 
    	
(a) The Company shall   require any successor (whether direct or indirect, by purchase, merger,   consolidation, reorganization or otherwise) to all or substantially all the   business or assets of the Company, by agreement in form and substance   satisfactory to Indemnitee and his or her counsel, expressly to assume and   agree to perform this Agreement in the same manner and to the same extent the   Company would be required to perform if no such succession had taken place.   This Agreement shall be binding upon and inure to the benefit of the Company   and any successor to the Company, including any person acquiring directly or   indirectly all or substantially all the business or assets of the Company   whether by purchase, merger, consolidation, reorganization or otherwise (and   such successor will thereafter be deemed the “Company” for purposes of this   Agreement), but shall not otherwise be assignable or delegatable by the   Company.
    

 

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(b) This Agreement shall   inure to the benefit of and be enforceable by Indemnitee’s personal or legal   representatives, executors, administrators, successors, heirs, distributees,   legatees and other successors.
    
	
 
    	
 
    
	
 
    	
(c) This Agreement is   personal in nature and neither of the parties hereto shall, without the   consent of the other, assign or delegate this Agreement or any rights or   obligations hereunder except as expressly provided in Sections 17(a) and   17(b). Without limiting the generality or effect of the   foregoing, Indemnitee’s right to receive payments hereunder shall not be   assignable, whether by pledge, creation of a security interest or otherwise,   other than by a transfer by Indemnitee’s will or by the laws of descent and   distribution, and in the event of any attempted assignment or transfer   contrary to this Section 17(c), the Company shall have no liability to   pay any amount so attempted to be assigned or transferred.
    
	
 
    	
 
    
	
18.
    	
Notices — For all purposes of   this Agreement, all communications, including notices, consents, requests or   approvals, required or permitted to be given hereunder shall be in writing   and shall be deemed to have been duly given when hand delivered or dispatched   by electronic facsimile transmission (with receipt thereof orally confirmed),   or five business days after having been mailed by United States registered or   certified mail, return receipt requested, postage prepaid or one business day   after having been sent for next-day delivery by a nationally recognized   overnight courier service, addressed to the Company (to the attention of the   Secretary of the Company) and to Indemnitee at the addresses shown on the   signature page hereto, or to such other address as any party may have   furnished to the other in writing and in accordance herewith, except that   notices of changes of address will be effective only upon receipt.
    
	
 
    	
 
    
	
19.
    	
Governing Law   — The validity, interpretation, construction and performance of this   Agreement shall be governed by and construed in accordance with the   substantive laws of the State of Delaware, without giving effect to the   principles of conflict of laws of such State. The Company and Indemnitee each   hereby irrevocably consent to the jurisdiction of the Chancery Court of the   State of Delaware for all purposes in connection with any action or   proceeding that arises out of or relates to this Agreement and agree that any   action instituted under this Agreement shall be brought only in the Chancery   Court of the State of Delaware.
    
	
 
    	
 
    
	
20.
    	
Validity — If any provision of   this Agreement or the application of any provision hereof to any person or   circumstance is held invalid, unenforceable or otherwise illegal, the   remainder of this Agreement and the application of such provision to any   other person or circumstance shall not be affected, and the provision so held   to be invalid, unenforceable or otherwise illegal shall be reformed to the   extent, and only to the extent, necessary to make it enforceable, valid or legal.   In the event that any court or other adjudicative body shall decline to   reform any provision of this Agreement held to be invalid, unenforceable or   otherwise illegal as contemplated by the immediately preceding sentence, the   parties thereto shall take all such action as may be necessary or appropriate   to replace the provision so held to be invalid, unenforceable or otherwise   illegal with one or more alternative provisions that effectuate the purpose   and intent of the original provisions of this Agreement as fully as possible   without being invalid, unenforceable or otherwise illegal.
    

 

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21.
    	
Amendments;   Waivers — No provision of this Agreement may be amended,   modified, waived or discharged unless such amendment, modification, waiver or   discharge is agreed to in writing signed by Indemnitee and the Company. No   waiver by either party hereto at any time of any breach by the other party   hereto or compliance with any condition or provision of this Agreement to be   performed by such other party shall be deemed a waiver of similar or   dissimilar provisions or conditions at the same or at any prior or subsequent   time.
    
	
 
    	
 
    
	
22.
    	
Complete   Agreement — No agreements or representations, oral or otherwise,   expressed or implied with respect to the subject matter hereof have been made   by either party that are not set forth expressly in this Agreement.
    
	
 
    	
 
    
	
23.
    	
Legal Fees and   Expenses — It is the intent of the Company that Indemnitee not be   required to incur legal fees or other Expenses associated with the   interpretation, enforcement or defense of Indemnitee’s rights under this   Agreement by litigation or otherwise because the cost and expense thereof   would substantially detract from the benefits intended to be extended to   Indemnitee hereunder. Accordingly, without limiting the generality or effect   of any other provision hereof, if it should appear to Indemnitee that the   Company has failed to comply with any of its obligations under this Agreement   or in the event that the Company or any other person takes or threatens to   take any action to declare this Agreement void or unenforceable or institutes   any litigation or other action or proceeding designed to deny, or to recover   from, Indemnitee the benefits provided or intended to be provided to   Indemnitee hereunder, the Company irrevocably authorizes Indemnitee from time   to time to retain counsel of Indemnitee’s choice, at the expense of the Company   as hereafter provided, to advise and represent Indemnitee in connection with   any such interpretation, enforcement or defense, including the initiation or   defense of any litigation or other legal action, whether by or against the   Company or any director, officer, stockholder or other person affiliated with   the Company, in any jurisdiction. Notwithstanding any existing or prior   attorney-client relationship between the Company and such counsel, the   Company irrevocably consents to Indemnitee’s entering into an attorney-client   relationship with such counsel, and in that connection the Company and   Indemnitee agree that a confidential relationship shall exist between   Indemnitee and such counsel. Without respect to whether Indemnitee prevails,   in whole or in part, in connection with any of the foregoing, the Company   will pay and be solely financially responsible for any and all attorneys’ and   related fees and expenses actually and reasonably incurred by Indemnitee in   connection with any of the foregoing.
    
	
 
    	
 
    
	
24.
    	
Certain   Interpretive Matters —
    
	
 
    	
 
    
	
 
    	
(a) No provision of this   Agreement shall be interpreted in favor of, or against, either of the parties   hereto by reason of the extent to which any such party or its counsel   participated in the drafting thereof or by reason of the extent to which any   such provision is inconsistent with any prior draft hereof or thereof.
    

 

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(b) It is the Company’s   intention and desire that the provisions of this Agreement be construed   liberally, subject to their express terms, to maximize the protections to be   provided to Indemnitee hereunder.
    
	
 
    	
 
    
	
 
    	
(c) All references in this   Agreement to Sections, paragraphs, clauses and other subdivisions refer to   the corresponding Sections, paragraphs, clauses and other subdivisions of   this Agreement unless expressly provided otherwise. Titles appearing at the   beginning of any Sections, subsections or other subdivisions of this   Agreement are for convenience only, do not constitute any part of such   Sections, subsections or other subdivisions and shall be disregarded in   construing the language contained in such subdivisions. The words “this Agreement,” “herein,” “hereby,” “hereunder,” and “hereof,” and words   of similar import, refer to this Agreement as a whole and not to any   particular subdivision unless expressly so limited. The word “or” is not   exclusive, and the word “including”   (in its various forms) means “including without limitation.” Pronouns in   masculine, feminine or neuter genders shall be construed to state and include   any other gender, and words, terms and titles (including terms defined   herein) in the singular form shall be construed to include the plural and   vice versa, unless the context otherwise expressly requires.
    
	
 
    	
 
    
	
25.
    	
Counterparts — This Agreement may   be executed in one or more counterparts, each of which will be deemed to be   an original but all of which together shall constitute one and the same   agreement.
    

 

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In witness whereof, Indemnitee has executed, and the Company has caused its duly authorized representative to execute, this Agreement as of the date first above written.

 

	
 
    	
 
    
	
PIVOTAL SOFTWARE, INC.
    	
INDEMNITEE
    
	
 
    	
 
    
	
Address:
    	
Address:
    
	
 
    	
 
    
	
By:
    	
 
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    	
 
    
	
Title:

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