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Exhibit 10.21
 
Master Services Agreement
 
Medpace, Inc.

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This Master Services Agreement (the “Agreement”), dated as of 27 September, 2012
(the “Effective Date”), is between Medpace, Inc., an Ohio Corporation with a
principal place of business at 5375 Medpace Way, Cincinnati, OH 45227
(“MEDPACE”) and Oramed, Ltd., a company established pursuant to the laws of the
State of Israel, with a principal place of business at Hi-Tech Park 2/5 Givat
Ram, PO Box 39098, Jerusalem, 91390, Israel, (“SPONSOR”).  MEDPACE and SPONSOR
are sometimes referred to herein individually as a “Party” and together as the
“Parties”.

RECITALS:

WHEREAS, SPONSOR is in the business of developing and obtaining regulatory
approval of the marketing and sale of pharmaceutical products and or biological
products, and or medical devices; and
 
WHEREAS, MEDPACE is engaged in the business of providing services related to the
design and execution of clinical development programs involving drugs,
biologics, and medical devices through engagement by its clients, the sponsors
of clinical development programs, to perform such services; and
 
WHEREAS, SPONSOR desires to engage MEDPACE to perform certain services
(“Services”) as set forth hereinafter in connection with certain clinical
trials, all in accordance with and subject to the terms of this Agreement;
 
NOW, THEREFORE, in consideration of the premises and the mutual covenants and
conditions hereinafter set forth, the Parties agree as follows:

1.             PROJECT SPECIFICATIONS
 
 
A.
MEDPACE hereby agrees to perform Services for SPONSOR from time to time.  The
precise Services to be performed by MEDPACE shall be mutually agreed upon by the
Parties and set forth in one or more task orders (each a “Task Order”), a form
of which is attached hereto as Exhibit A.  Each Task Order shall be signed by an
authorized representative of each Party and shall include detailed information
concerning a given project, including a description of the specific services to
be provided (“Scope of Work”), project milestones and target completion dates
(“Project Schedule”), the applicable protocol, a detailed budget (“Project
Budget”), and a schedule of payments related to the Project Schedule and the
Project Budget (“Payment Schedule”).  Each Task Order shall contain a Transfer
of Obligations list (“Transfer of Obligations”) in conjunction with the relevant
Task Order and consistent with the regulations set forth in 21 C.F.R. Section
312, Subpart D (Responsibilities of Sponsors and Investigators).  Any
responsibilities not specifically transferred in the Transfer of Obligations
shall remain the regulatory responsibility of SPONSOR.

 
 
 

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B.
Unless otherwise stated in the applicable Task Order, the Services will be
conducted in compliance with MEDPACE SOPs and Policies, copies of which have
been or will be provided to SPONSOR during the negotiation of the relevant Task
Order.
 

 
C.
From time to time, SPONSOR may wish to enter into a Task Order with a MEDPACE
Affiliate for Services under this Agreement (“Affiliate Task Order”), and such
MEDPACE Affiliate may wish enter into the Affiliate Task Order with SPONSOR. Any
such Affiliate Task Order must be in writing and signed by the parties to the
Affiliate Task Order, and each signatory to an Affiliate Task Order is solely
responsible for all obligations it undertakes under the Affiliate Task Order.
For the purposes of a particular Affiliate Task Order, the Affiliate signing
such Affiliate Task Order will be substituted for MEDPACE everywhere it appears
in this Agreement, and the term “Affiliate Task Order” will be substituted for
Task Order everywhere it appears in this Agreement.
 

 
D.
As used herein, “Affiliate” means in relation to a Party, any entity, directly
or indirectly, controlling such Party, controlled by such Party, or under common
control with such Party.  For purposes of this definition, “control” shall mean
the possession, directly or indirectly, of the power to direct or cause the
direction of the activities, management or policies of such party, whether
through the ownership of voting securities, by contract or otherwise.  Without
limiting the foregoing, control shall be presumed to exist when a person,
organization or entity (i) owns or directly controls fifty percent (50%) or more
of the outstanding voting stock or other ownership interest of the other
organization or entity, or (ii) possesses, directly or indirectly, the power to
elect or appoint fifty percent (50%) or more of the members of the governing
body of the organization or other entity.
 

 
E.
To avoid any doubt, the Parties agree that any and all regulatory filings and
submissions that may be made with respect to the Services provided under this
Agreement shall be (i) coordinated with and approved by SPONSOR in advance at
all times, (ii) made solely in SPONSOR’s name, (iii) owned solely by
SPONSOR.  The extent of MEDPACE’s responsibility for such filings and
submissions shall be set out in the applicable Task Order.

 
 
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F.
As part of the Services and as an accommodation to SPONSOR, MEDPACE may contract
with third parties for the provision of services not customarily performed or
provided by MEDPACE (“Pre-funded Vendors”).  While MEDPACE may contract with
and/or facilitate the activities of such Pre-funded Vendors, MEDPACE does not
undertake by virtue of this Agreement, the relevant Task Order or such third
party contract, responsibility for the Pre-funded Vendor’s business,
professional conduct, performance, or breaches by such Pre-funded
Vendors.  MEDPACE’s responsibility with respect to such Pre-funded Vendors shall
be to coordinate the services of such Pre-funded Vendors and to make payments
after receipt of sufficient funds from SPONSOR (“Pre-funded Expenses”).   Pre -
funded Expenses may include but are not limited to third party advance payments
for investigator meetings, vendors, Study Site payments (“Study Site” shall mean
the physical location at which a particular investigator conducts a study), and
any payments to investigators, institutions, and site maintenance organizations
for services performed that relate to a study.  In the event a Pre-funded Vendor
requests indemnification with respect to the services performed under such
Pre-funded Vendor’s contract, MEDPACE shall notify SPONSOR and SPONSOR enter
into an indemnification agreement directly with such Pre-funded
Vendors.  MEDPACE shall have no obligation with respect to the indemnity of a
Pre-funded Vendors. The Parties acknowledge and agree that any Pre-funded
Vendors (including but not limited to investigators, institutions or site
management organizations) paid with Pre-funded Expenses in connection with the
performance of Services under this Agreement or any Task Order shall not be
considered the agent, employee or subcontractor of MEDPACE.
 

 
G.
Except as otherwise agreed by the Parties in writing, SPONSOR is and at all
times remains, in all geographical regions where the Study is being performed,
the “Sponsor” or “Legal Representative” of the Study pursuant to or applicable
law.

 
2.             PROJECT SCHEDULE
 
 
A.
Each Task Order shall contain project timelines, milestones and/or target dates
for completion of a project or a portion thereof, and all such schedules shall
be reasonable for the Services to be provided.  The Parties shall, at all times,
use their reasonable best efforts to comply with and perform their obligations
in accordance with each Task Order.
 

 
B.
If at any time either Party anticipates a delay in meeting the timelines for a
given Task Order as set forth in its Project Schedule, either due to changes to
the Services requested by SPONSOR, or other causes beyond the control of such
Party (such as FDA approval of a competitor’s NDA for the same drug, which may
adversely affect patient enrollment), then the anticipating Party shall promptly
notify the other Party in writing, specifying the reason for the delay and the
anticipated effect upon the timelines, milestones or other deliverables.

3.             CONTRACT AMENDMENTS
 
Any change in the details of a Task Order or the assumptions upon which the Task
Order is based may require changes in the Project Budget, Payment Schedule or
Project Schedule.  Every such change shall require a written amendment to the
Task Order (a “Contract Amendment”).  Each Contract Amendment shall detail the
requested changes to the applicable task, responsibility, duty, budget, timeline
or other matter.  The Contract Amendment will become effective upon the
execution of the Contract Amendment by both Parties, and if applicable, will
specify the period of time within which MEDPACE must implement the
changes.  Both Parties agree to act in good faith and promptly when considering
a Contract Amendment requested by the other party but neither party is obligated
to execute a Contract Amendment.  No Contract Amendment shall become effective
unless and until it is signed by both Parties.  Any such changes that result in
additional charges shall be reflected in the Contract Amendment to the affected
Task Order, Project Budget or Payment Schedule.
 
 
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4.             PROJECT BUDGET, PAYMENT SCHEDULE, AND TERMS
 
 
A.
Service Fees:
 

The SPONSOR agrees to pay MEDPACE for Services rendered pursuant to the Project
Budget and Payment Schedules included in each Task Order.
 
 
B.
Pass Through Costs:
 

The SPONSOR agrees to reimburse MEDPACE for reasonable pass-through costs
identified in the Task Order and incurred by MEDPACE in providing the Services
in accordance with the relevant Task Order.  All expenses billed to SPONSOR by
MEDPACE must be accompanied by appropriate documentary evidence, such as
receipts or other documentation reasonably acceptable to SPONSOR.
 
 
C.
Pre - funded Expenses:
 

The Parties will work to establish a process for payment of Pre-funded Expenses
in the applicable Task Order which allows for timely payment of such funds to
Pre-funded Vendors.
 
 
D.
Payment Terms:
 

SPONSOR shall mail payments to MEDPACE within 30 days after receipt of a written
invoice and required supporting documentation as applicable.  An annual interest
rate of 14% will be applied to outstanding invoices greater than 45 days. The
Parties will work in good faith to establish a payment schedule in the
applicable Task Order to ensure that MEDPACE is kept in a cash neutral position
and to avoid a negative cash flow at any time during the term of the applicable
Task Order.
 
 
E.
Security:
 

If at any time and from time to time during the term of the Agreement or any
Task Order, (1) SPONSOR is more than 90 days late on any single invoice, or (2)
45 days late on three consecutive invoices, or (3) SPONSOR is unable to provide
evidence of credit worthiness, MEDPACE shall have the right to require SPONSOR
to provide security in such amount and form and at such time as MEDPACE deems
necessary.  SPONSOR shall provide such security within fifteen (15) business
days of MEDPACE’s request.  As a public company, SPONSOR’s quarterly financial
statements are available to the public, on-line at www.oramed.com.

 
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5.            WARRANTIES AND REPRESENTATIONS:
 
 
A.
Acknowledgements:
 

MEDPACE acknowledges that the Services to be provided hereunder are for the
benefit of, and are subject to the direction of SPONSOR.  MEDPACE acknowledges
that SPONSOR is the beneficiary under the terms of this Agreement and each Task
Order, and that SPONSOR is entitled to enforce the provisions thereof.
 
 
B.
Representations and Warranties of MEDPACE:
 

 
i.
MEDPACE represents and warrants that it is duly organized, validly existing and
in good standing in its jurisdiction of organization, and is in good standing
and duly qualified to carrying on business including as contemplated by this
Agreement.

 
ii.
MEDPACE represents and warrants that the execution, delivery and performance of
this Agreement and each Task Order has been (and will be at the relevant time)
validly authorized by all necessary corporate action and this Agreement and each
Task Order represents (and will represent) the valid binding agreement of
MEDPACE enforceable in accordance with its terms.  MEDPACE represents and
warrants that the execution, delivery and performance of this Agreement and each
Task Order does not and will not violate any organizational document governing
MEDPACE, any agreement to which MEDPACE is a party, or any law or court or
governmental order, holding or writ by which MEDPACE is bound.  MEDPACE further
represents and warrants that it shall, and undertakes to, render the Services
requested by SPONSOR in accordance with high professional standards, consistent
with Good Clinical Practices and with the standard of care customary in the
contract research organization industry.

 
iii.
MEDPACE represents and warrants that the personnel assigned to perform services
rendered under this Agreement shall be qualified and professionally capable of
performing the Services, shall be adequate to effectively perform the Services
on the agreed upon schedule and shall devote such time as is necessary to
perform the Services on such agreed upon schedule.  Upon request of SPONSOR,
MEDPACE will provide SPONSOR with the credentials of all study personnel.

 
iv.
MEDPACE further represents, warrants and undertakes that it shall perform the
Services in compliance with all applicable laws and regulations in the
jurisdiction(s) in which the Services are performed, including, without
limitation, the US Food, Drug and Cosmetic Act and the regulations promulgated
pursuant thereto, and all future amendments thereto during the term.  In
addition, MEDPACE undertakes to ensure that any materials provided by SPONSOR
for the purpose of the performance of the Services pursuant to any Task Order
shall be handled, transported, stored, used and disposed of in accordance with
the laws and regulations.

 
v.
MEDPACE represents and warrants that there is no litigation, regulatory
investigation or proceeding, administrative hearing or any other similar
proceeding pending or to the best of its knowledge threatened against MEDPACE
which could adversely affect MEDPACE’s ability to perform the Services.

 
 
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C.
Representations and Warranties of SPONSOR
 

 
i.
SPONSOR represents and warrants that it is a corporation with its principal
office and place of business at Hi-Tech Park 2/5 Givat Ram, PO Box 39098,
Jerusalem, 91390, Israel, duly organized, validly existing and in good standing
in its place of organization, and is in good standing in and duly qualified to
do business.

 
ii.
SPONSOR represents and warrants that the execution, delivery and performance of
this Agreement and each Task Order has been and will be validly authorized by
all corporate action and this Agreement and each Task Order represents and will
represent the valid binding agreement of SPONSOR enforceable in accordance with
its terms.  The execution, delivery and performance of this Agreement and each
Task Order does not and will not violate any organizational document governing
SPONSOR, any agreement to which SPONSOR is a party, or any law or court or
governmental order, holding or writ by which SPONSOR is bound.

 
iii.
SPONSOR represents and warrants that there is no litigation, regulatory
investigation or proceeding, administrative hearing or any other similar
proceeding pending or to the best of its knowledge threatened against SPONSOR
which could adversely affect SPONSOR’s ability to perform under this Agreement
or any Task Order.

6.             TERMINATION
 
 
A.
SPONSOR may terminate this Agreement without cause immediately upon giving the
other Party notice of such termination, provided such termination shall not in
and of itself affect any then uncompleted Task Order.
 

 
B.
SPONSOR may terminate any Task Order without cause immediately upon giving
MEDPACE notice of such termination.  As soon as practicable, after receipt of
such notice, the Parties shall cooperate in good faith to agree on a plan to
expeditiously conclude activities with respect to such matter.  MEDPACE shall
transfer to SPONSOR all case report forms, study files, and other data and
information in any and all formats available, including electronic format and
computer files and programs, in MEDPACE’s possession.

 
 
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C.
MEDPACE may terminate a Task Order only if SPONSOR has defaulted on its
obligations thereunder and has not cured such default within fifteen (15) days
after receipt of written notice if the default is the failure to pay MEDPACE any
amount due thereunder or within thirty (30) days after receipt of written notice
in the event of any other default, provided, however, that where SPONSOR is
making diligent, good faith efforts to cure such default but requires additional
time to complete such cure, SPONSOR will notify MEDPACE in writing of its
request for additional time and the parties will negotiate in good faith an
appropriate extension to such period, provided, further, that SPONSOR shall be
entitled to an extension of at least fifteen (15) days if the parties fail to
reach agreement in respect of an appropriate extension.  As soon as practicable,
after receipt of such notice, the Parties shall cooperate in good faith to agree
on a plan to expeditiously conclude activities with respect to such
matter.  MEDPACE shall transfer to SPONSOR all case report forms, study files,
and other data and information in any and all formats available, including
electronic format and computer files and programs, in MEDPACE’s possession.
 

 
D.
In the event of any termination of a Task Order before completion, SPONSOR
agrees to pay MEDPACE for all Services rendered pursuant to the unfinished Task
Order prior to such termination and any non-cancelable expenses incurred in
connection with MEDPACE’s performance of Services thereunder to the extent such
expenses cannot be reasonably mitigated.  As soon as reasonably practicable
following receipt of a termination notice, MEDPACE shall submit an itemized
accounting of Services performed, expenses incurred pursuant to performance of
the Services, non-cancelable expenses incurred by MEDPACE relating to any
unfinished Task Order, and payments received in order to determine a balance to
be paid by either Party to the other.  Such balance shall be paid within 30 days
of receipt of such an itemized accounting by SPONSOR.
 

 
E.
The following sections shall survive any expiration of termination of this
Agreement: 8 [Confidentiality], 9 [Rights in Property], 10 [Patent Rights], 11
[Publicity], 14 [Indemnification], 15 [Limitation of Liability and Insurance],
16 [Inspections and Audit] and 18 [Non-Solicitation].

 
 
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7.            COMMUNICATIONS
 
Any notice required or permitted under this Agreement shall be in writing and
shall be deemed properly received as follows (i) upon receipt, if delivered
personally, (ii) 5 business days after delivery to the postal authorities by the
party serving notice if mailed by prepaid, first class, certified mail, return
receipt requested, (iii) 2 business days after delivery to the courier service
by the party serving notice if sent by express courier service, (iv) by
facsimile, one business day after transmission or dispatch, or (v) by e-mail, 24
hours after the e-mail was sent, unless the party sending the e-mail knows or
ought reasonably to suspect that the e-mail was not delivered to the addressee's
domain specified in the e-mail address; in each case to the Party to be notified
at the addresses and/or coordinates set forth below (or such other address as
shall be designated by written notice):

If to MEDPACE:
Medpace, Inc.
5375 Medpace Way
Cincinnati, Ohio  45227
Attn:  August J. Troendle
Telephone:  (513) 579-9911 x2278
Facsimile:               1.513.579.0444
Email:                      j.wynne@medpace.com

If to SPONSOR:
Oramed Pharmaceuticals, Inc.
Hi-Tech Park 2/5 Givat Ram
PO Box 39098
Jerusalem, 91390 Israel

8.             CONFIDENTIALITY
 
 
A.
SPONSOR, may provide confidential information to MEDPACE during the course of
this Agreement.  All information provided by SPONSOR or its clients, and any and
all data collected and/or generated by MEDPACE during the course of performance
of the Services is deemed to be the confidential information of SPONSOR
(“SPONSOR Confidential Information”).  MEDPACE shall not disclose SPONSOR
Confidential Information to any third party, or use SPONSOR Confidential
Information for any purpose other than for the benefit of SPONSOR pursuant to
the terms of this Agreement, without the prior written consent of SPONSOR.
 

 
i.
MEDPACE shall ensure by binding written agreement that its employees, agents,
and independent contractors (approved in advance and in writing by SPONSOR) who
are involved in the provision of the Services (herein “MEDPACE Representatives”)
shall comply with the provisions of Article 8 of this Agreement.  MEDPACE shall
disclose SPONSOR Confidential Information only to those MEDPACE Representatives
who reasonably need to know SPONSOR Confidential Information to enable MEDPACE
to perform its obligations under this Agreement.  MEDPACE shall remain
responsible to SPONSOR for all acts and omissions of MEDPACE Representatives
with respect to their use of the SPONSOR Confidential Information.

 
 
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ii.
MEDPACE shall exercise due care, but no less than a reasonable degree of care,
to prevent the unauthorized disclosure and use of SPONSOR Confidential
Information associated with the Services.  In the event that MEDPACE learns of
any such unauthorized disclosure and use, it shall immediately (a) notify
SPONSOR thereof, and (b) take all necessary actions to ensure that such
disclosure and use is terminated.
 

 
B.
MEDPACE may provide confidential information to SPONSOR during the course of
this Agreement (“MEDPACE Confidential Information”).  MEDPACE Confidential
Information shall include but is not limited to standard operating procedures,
pricing, and financial information provided by MEDPACE or its Affiliates to
SPONSOR during the course of performance of the Services, and any non-public
information pertaining to MEDPACE’s business practices or other proprietary
information.  SPONSOR shall not disclose MEDPACE Confidential Information to any
third party, or use MEDPACE Confidential Information for any purpose other than
for those set forth under this Agreement or a Task Order, without the prior
written consent of MEDPACE.
 

 
i.
SPONSOR shall ensure by binding written agreement that its employees, agents,
and approved independent contractors involved in the Services shall comply with
the provisions of Article 8 of this Agreement.  SPONSOR shall disclose MEDPACE
Confidential Information only to those of its employees, agents, and independent
contractors who reasonably need to know MEDPACE Confidential Information.

 
ii.
SPONSOR shall exercise due care, but no less than a reasonable degree of care,
to prevent the unauthorized disclosure and use of confidential information
associated with the Services.
 

 
C.
This confidentiality and non-disclosure provision shall not apply to:
 

 
i.
Information which was known by the Party receiving such information (the
“Receiving Party”) before the date hereof or which is independently discovered,
after the date hereof, without the aid, application or use of the confidential
information, as evidenced by written records;

 
ii.
Information which is in the public domain on the date hereof or subsequently
becomes publicly available through no fault or action of the Receiving Party; or

 
iii.
Information, which is disclosed to the Receiving Party by a third party,
authorized to disclose it.
 

 
D.
If the Receiving Party is requested to disclose the Confidential Information of
the other Party (the “Disclosing Party”) or the substance of this Agreement in
connection with a legal or administrative proceeding or otherwise to comply with
a requirement under applicable law, the Receiving Party will give the Disclosing
Party prompt notice of such request so that the Disclosing Party may seek an
appropriate protective order or other remedy, or waive compliance with the
relevant provisions of this Agreement.  The Disclosing Party must notify the
Receiving Party within 10 days that it intends to take action in response to the
request for disclosure.  If the Disclosing Party seeks a protective order or
other remedy, the Receiving Party, at the Disclosing Party’s expense, will
cooperate with and assist the Disclosing Party in such efforts.  Failure of the
Disclosing Party to intervene shall not relieve the obligations to maintain
confidentiality except in so far as the Receiving Party must comply with the
terms of such process compelling disclosure.
 

 
E.
Each Party acknowledges that any violation or threatened violation of the
foregoing provisions may cause irreparable injury to the other Party, entitling
the other Party to seek injunctive relief in addition to all other legal
remedies.

 
 
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9.             RIGHTS IN PROPERTY
 
 
A.
All materials, documents, data, laboratory samples, medical imaging data,
software and information of every kind and description supplied to MEDPACE by
SPONSOR or any of SPONSOR’s clients, or prepared, developed, or generated by
MEDPACE or the MEDPACE Representatives pursuant to this Agreement (collectively,
the “Results”), (except for the pre-existing MEDPACE procedural manuals,
personal data, methods, procedures, and policies) are and shall be the sole and
exclusive property of SPONSOR.  Further, all Results, and all rights subsisting
therein and related thereto, shall be and remain the exclusive property of
SPONSOR.  SPONSOR shall have the sole right to make whatever use SPONSOR deems
desirable of the Results.  MEDPACE shall not, without the prior written consent
of SPONSOR, publish, disseminate, or otherwise disclose to any third party any
Results (except such disclosure as may be required by law, in which event
MEDPACE shall notify SPONSOR thereof in advance), or use any Results for any
purpose other than the performance of this Agreement.  Any inventions or other
intellectual property, including without limitation patent rights, trade
secrets, protectable copyrights and trademarks, that may evolve from the Results
shall belong solely to SPONSOR, and MEDPACE agrees to assign its rights in all
such inventions and/or other intellectual property to SPONSOR consistent with
the obligations set forth in Article 10 below.  MEDPACE further agrees to
perform such further acts and execute such further documents as may be
reasonably necessary to carry out and give full effect to the foregoing
arrangements.
 

 
B.
SPONSOR acknowledges that all computer programs, software, applications,
databases, proposals and other documentation generally used by MEDPACE and not
directly related to, derived from or developed solely for SPONSOR are the
exclusive and confidential property of MEDPACE or the third parties from whom
MEDPACE has secured the right of use.  SPONSOR agrees that any improvement,
alteration or enhancement to MEDPACE systems, software, applications or
processes which are developed or implemented during the course of any Services
performed hereunder, without the use of any SPONSOR data, information, materials
or Confidential Information (or derivatives thereof) or Results, shall be the
property of MEDPACE.

 
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10.           PATENT RIGHTS
 
MEDPACE shall disclose promptly to SPONSOR any and all patentable and
unpatentable inventions, discoveries and improvements conceived or made by
MEDPACE while providing Services to SPONSOR pursuant to the Agreement and any
Task Order and constituting a modification, improvement, derivative or extension
of use relating to SPONSOR’s proprietary rights, and agrees to assign all its
interest therein to SPONSOR or its nominee; whenever requested to do so by
SPONSOR, MEDPACE shall execute any and all applications, assignments, or other
instruments and give testimony which SPONSOR shall deem necessary to apply for
and obtain a patent in the United States of America and/or other applicable
jurisdiction or of any foreign country or to protect otherwise SPONSOR’s
interests and shall compensate MEDPACE for the time devoted to said activities
at an hourly rate agreed to by SPONSOR and MEDPACE, and reimburse MEDPACE for
expenses reasonably incurred in respect to such activities.

11.           PUBLICITY
 
 
A.
MEDPACE shall not make any public announcements, presentations, disclosures
and/or publications concerning this Agreement or the subject matter hereof
without the prior written consent of SPONSOR, unless required by applicable law
or government agency.
 

 
B.
SPONSOR may not use MEDPACE’s name, logo or trademark in any public
communication, release, notice or other publication without the express prior
written consent of MEDPACE; provided, however, that SPONSOR may do so in order
to comply with applicable laws, regulations and filing obligations of stock
exchanges.

12.
RECORDS, SECURITY AND DISPOSITION OF STUDY FILES

 
 
A.
MEDPACE shall make available to SPONSOR relevant records, programs and data
which is the subject of a Task Order in accordance with the arrangements to be
agreed in the relevant Task Order.
 

 
B.
SPONSOR shall have the right to monitor the operations of MEDPACE hereunder, and
SPONSOR and or its designated representatives shall have the right to visit any
of the facilities, upon reasonable advance written notice, where MEDPACE is
performing any of the Services and during such visits to inspect the work being
done and materials used, to observe the procedures being followed, and to
examine the books, records and other data relevant to the Services.  If any
regulatory agency requests to inspect any books, records, data of MEDPACE
relating to the Services, MEDPACE shall immediately notify SPONSOR.

 
 
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C.
MEDPACE shall use industry-standard commercially reasonable efforts, including,
but not limited to, periodic backup of computer files (in accordance with
MEDPACE’s SOPs), to prevent the loss or alteration of SPONSOR’s study data,
Confidential Information, documentation, and correspondence, including secure,
off-site redundancy storage.  MEDPACE shall in all respects comply with any Food
and Drug Administration regulations concerning the maintenance, creation and
storage of records, including electronic records.
 

 
D.
MEDPACE shall transfer study materials, documents and correspondence to SPONSOR
in accordance with the arrangements (which shall include frequency of such
transfer) set out in the applicable Task Order.  MEDPACE shall have the right to
retain one copy of any study materials, documentation, and correspondence
necessary solely to meet regulatory or MEDPACE’s own internal audit
requirements, so long as it continues to maintain the confidentiality
requirements of Article 8.

13.           SPONSOR OBLIGATIONS
 
SPONSOR acknowledges that performance of the Services by MEDPACE will require
the co-operative involvement of both Parties, and SPONSOR hereby agrees to
provide such assistance as may be reasonably necessary to enable MEDPACE to
perform the Services.

14.           INDEMNIFICATION
 
 
A.
SPONSOR shall indemnify, defend and hold harmless MEDPACE from and against any
and all damages, losses, liabilities, costs or expenses (collectively
“Damages”), resulting or arising from any third-party claims, demands,
assessments, actions, suits, investigations or proceedings (collectively
“Claims”), relating to or arising from or in connection with this Agreement or
the Services under any Task Order (including but not limited to any Damages
arising from or in connection with any study, test, device, product or potential
product to which this Agreement relates), to the extent such Claims or Damages
have not resulted from MEDPACE’s negligence, willful misconduct, or breach of
any applicable law or material breach of this Agreement or any Task Order by
MEDPACE.
 

 
B.
MEDPACE agrees to indemnify, defend and hold harmless SPONSOR from and against
any and all Damages resulting or arising from third-party Claims relating to or
arising from or in connection with the Services under any Task Order to the
extent that such Claims or Damages are determined to have resulted from the
negligence, , or willful misconduct of MEDPACE or a breach of any applicable
federal, state or local law or a material breach of this Agreement or any Task
Order by MEDPACE.
 

 
C.
Any party providing indemnification under this Agreement shall have the right to
control the defense and settlement of any Claims or Damages.  The indemnified
party shall have the right to obtain separate legal counsel at its own expense
if it so chooses.  The indemnifying party shall not unreasonably withhold
consent for settlement and the indemnified party shall reasonably cooperate in
the defense of any Claims or Damages and provide prompt notice to the
indemnifying party of any Claims or Damages for which indemnification is sought.

 
 
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15.           LIMITATION OF LIABILITY AND INSURANCE
 
A.           Notwithstanding the terms of Article 14 above in no event shall
SPONSOR or MEDPACE be liable for any indirect, incidental, special, or
consequential damages or lost profits arising out of the provision of services
hereunder, even if the breaching party has been advised of the possibility of
such damages. For clarity, other types of damages may be a possible remedy in
any suit between the parties (including but not limited to punitive damages).
 
B.           Upon request, each Party shall provide a copy of a certificate
evidencing its insurance coverage to the other Party.

16.           INSPECTIONS AND AUDITS
 
 
A.
SPONSOR shall have the right, upon at least ten (10) days’ prior written notice
to MEDPACE, to examine the standard operating procedures, facilities, books,
records, papers, files and documentation, including computer files, data bases
and records, at MEDPACE’s facilities and the facilities of clinical
investigators contracted by MEDPACE to determine the adequacy of such records,
to ensure the Services are being performed in accordance with the approved Task
Orders and applicable regulations and/or to examine the financial records of
MEDPACE as may be reasonably necessary to verify out-of-pocket expenses incurred
during the performance of the Services.  Such inspections and audits shall be
conducted during normal business hours.
 

 
B.
MEDPACE shall provide reasonable assistance, including making available members
of its staff and providing access to all requested records, to facilitate such
inspections and audits.
 

 
C.
MEDPACE shall take all reasonable steps required by SPONSOR to cure any
deficiencies found in any audit, inspection or investigation.
 

 
D.
The obligations herein shall survive termination for a period of 7 years.

17.           DEBARMENT
 
 
A.
MEDPACE hereby represents, warrants, and certifies that neither it nor any of
its officers, directors, owners, principals or employees has been or will be at
any relevant time hereunder debarred under Section 306 of the Federal Food, Drug
and Cosmetic Act, 21 U.S.C. §335a(a) or (b), or similar local law.  In the event
that any such party becomes debarred, MEDPACE shall notify SPONSOR in writing
immediately, and upon SPONSOR’s request, such individual shall cease to be
involved in the provision of the Services.

 
 
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B.
MEDPACE hereby represents, warrants, and certifies that it has not and shall not
use in any capacity the services of any individual, corporation, partnership, or
association which has been debarred under Section 306 of the Federal Food, Drug
and Cosmetic Act, 21 U.S.C. §335a(a) or (b), or similar local law.  In the event
MEDPACE becomes aware of or receives notice of the debarment of any individual,
corporation, partnership, or association providing services to MEDPACE, which
relate to the Services being provided under this Agreement, MEDPACE shall notify
SPONSOR in writing immediately, and upon SPONSOR’s request, such individual
shall cease to be involved in the provision of the Services.

18.           NON-SOLICITATION
 
Neither Party nor its Affiliates shall, during the term of this Agreement and
for a period of twelve (12) months following its expiration or termination,
either directly or indirectly, hire any employee of the other Party with whom
its comes into contact as a result of providing the Services, or recruit,
solicit, or entice any such person to become employed by it or any Affiliate and
shall not approach any such employee for such purpose or encourage, authorize or
approve the taking of such action by any other person.  The Parties agree that
any breach of this provision would cause irreparable harm and that in addition
to any and all other available remedies injunctive relief, without the necessity
of a bond or other security, shall be appropriate and available.

19.           ENTIRE AGREEMENT
 
This Agreement, including the attachments hereto, contains the full
understanding of the Parties with respect to the subject matter hereof and
supersedes all existing agreements and all other oral, written or other
communications between the Parties concerning the subject matter hereof.  This
Agreement shall not be amended, modified or supplemented in any way except in
writing and signed by a duly authorized representative of SPONSOR and MEDPACE.

20.           GOVERNING LAW
 
This Agreement and the performance hereof shall be governed, interpreted and
construed in all respects by the internal laws of the State of New York.  All
disputes and claims arising under this Agreement or any Task Order shall be
resolved exclusively in a court of applicable jurisdiction located in New York,
New York, and each party consents to the venue of any such action; provided,
however, that injunctive relief may be sought in any court of competent
jurisdiction.
 
 
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21.           NO WAIVER
 
No waiver of any term, provision, or condition of this Agreement whether by
conduct or otherwise in any one or more instances shall be deemed to be or
construed as a further or continuing waiver of any such term, provisions, or
conditions, or of any other term, provision, or condition of this
Agreement.  Any waiver must be in writing and signed by the party so waiving the
term, provision, or condition.

22.           INDEPENDENT CONTRACTOR
 
In fulfilling its obligations pursuant to this Agreement, each Party shall be
acting as an independent contractor.  Neither Party is granted any right or
authority to assume or to create any obligation or responsibility, expressed or
implied, on behalf of or in the name of the other Party.

23.           FORCE MAJEURE
 
Neither Party shall be liable or deemed to be in default for any delay due to
causes beyond the reasonable control of the Party, such as: war, acts or threats
of terrorism, civil disorders, acts of God, or government action; provided, that
the affected Party promptly notifies the other of the cause and its effects on
the Services to be performed hereunder.  Financial difficulty shall never be
deemed a force majeure event.

24.           SEVERABILITY
 
In the event any provision of this Agreement shall be determined to be void or
unenforceable, the remaining provisions shall remain in full force and effect.

25.           ASSIGNMENT
 
 
A.
Except as set forth herein, neither Party shall assign this Agreement or any
Task Order except with the express prior written consent of the other Party.
 

 
B.
Notwithstanding anything contained herein, a Party may assign this Agreement
and/or any Task Order to an Affiliate, and SPONSOR may assign this Agreement
and/or any Task Order to a successor in interest to such Party or in the event
of a merger or acquisition; in any such event, the Party so assigning shall
notify the other Party in writing thereof.

26.           SUBCONTRACTING
 
 
A.
MEDPACE may subcontract any portion of the Services hereunder to an Affiliate
without the prior written consent of SPONSOR provided MEDPACE remains liable for
the performance of any such Affiliate, such subcontracting shall not derogate
from MEDPACE’s obligations under this Agreement, and MEDPACE provides prompt
written notice of such arrangement to MEDPACE.

 
 
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27.           CONFLICTS BETWEEN AGREEMENTS
 
In the event that there is any conflict between the provisions of this Agreement
and any duly executed Task Order, this Agreement shall control unless the
applicable provision in the Task Order clearly states that it shall take
precedence over the related provision in this Agreement.

[SIGNATURE PAGE FOLLOWS]
 
 
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date
first set forth above.

MEDPACE, INC.

Signature: 
/s/ John Wynne

By: 
John Wynne

Title: 
Executive Director
Business Development Support

                    

ORAMED, LTD.

Signature: 
/s/ Nadav Kidron

By: 
Nadav Kidron

Title: 
CEO

 
 
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EXHIBIT A

FORM OF TASK ORDER

MEDPACE Task Order Number: ______________

MEDPACE Project Number: ______________

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

RECITALS:
 
WHEREAS, MEDPACE and SPONSOR have entered into that certain Master Services
Agreement dated __________________  (the “Master Services Agreement”); and
 
WHEREAS, pursuant to the Master Services Agreement, MEDPACE has agreed to
perform certain Services in accordance with Task Orders from time to time
entered into by the Parties and SPONSOR and MEDPACE now desire to enter into
such a Task Order; and
 
WHEREAS, MEDPACE and SPONSOR desire that MEDPACE provide certain services with
respect to ______ (the  “Study”) for the study of the product ________ (“Study
Product”) as set out in the Protocol Number: ____________, which is incorporated
herein by reference;
 
        NOW, THEREFORE, in consideration of the mutual covenants contained
herein, the Parties hereby agree as follows:

 
1.
Scope of Work.  MEDPACE shall perform the services described in the Scope of
Work, attached hereto as Appendix 1, in accordance with the Project Schedule,
attached hereto as Appendix 2 and any other documents attached to and
specifically referenced in this Task Order (“Services”).

 
2.
Compensation.  For performance of these Services, SPONSOR shall pay to MEDPACE
an amount equal to the Project Budget set forth in Appendix 3, which amount
shall be payable pursuant to the Payment Schedule set forth in Appendix 4.  The
Project Budget is provided for cost analysis purposes.  It is agreed that all
fees are fixed prices unless the underlying assumptions (including, but not
limited to, trial duration, number of sites/patients, services provided) change
and all such changes shall be documented in a Contract Amendment.  After staff
are assigned, costs are incurred based upon allocation of staff capacity.

 
3.
Transfer of Obligations.  Sponsor Obligations transferred to MEDPACE by SPONSOR
(consistent with the regulations set forth in 21 C.F.R. Section 312, Subpart D)
are identified in Appendix 5.

 
 
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4.
MSA. The provisions of the Master Services Agreement are hereby expressly
incorporated by reference into and made a part of this Task Order.

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

MEDPACE, INC.

Signature:__________________________

By:________________________________

Title: ______________________________

ORAMED, LTD.

Signature:__________________________

By:________________________________
(Print Name)
Title: ______________________________
 
List of Appendices:

Appendix 1:  Scope of Work
Appendix 2:  Project Schedule
Appendix 3:  Project Budget
Appendix 4:  Payment Schedule
Appendix 5:  Transfer of Obligations
 
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