CONSULTING SERVICES AGREEMENT
THIS CONSULTING SERVICES AGREEMENT is
made and entered into as of April 21, 2009 (the “Effective Date”), by and
between ADRES Advanced Regulatory Services Ltd., an Israeli company #514239045,
with its principal office and place of business at Hacramim 2, Xxxx Xxxxx
(“Consultant”) and
Oramed Ltd., an Israeli company #513076712, with its principal office and place
of business at Givat Ram, Jerusalem,
Israel ("Company") (each
a “Party” and
collectively the “Parties”).
Consultant
provides consulting services relating to quality assurance and regulatory
processes and procedures. Company desires to engage the services of
Consultant and Consultant desires to accept such engagement to perform the
Consulting Services described herein upon the terms and conditions set forth
herein.
NOW, THEREFORE, in consideration of the
mutual promises set forth herein, Company and Consultant hereby agree as
follows:
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1
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Services and Scope of
Work
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1.1
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Services and Scope of
Work. Consultant agrees to provide to Company consulting services
as described on Schedule
1 attached hereto (“Consulting Services” or
"Services"). The
parties may amend the Services and Scope of Work to increase, decrease,
redefine or clarify the Services and/or the Scope of Work at anytime
during the term of this Agreement. However, the amendment must be provided
in writing and signed by both Consultant and Company prior to
implementation of the change.
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1.2
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Performance of
Services. Consultant has the right to (i) control and direct the
means, manner and method by which the Consulting Services are performed,
in particular, Company acknowledges and agrees to the use of
subcontractors by Consultant for performance of the Consulting Services or
portions thereof, including, CBR International Corp., and (ii) perform the
Consulting Services at any place or location and at such time as
Consultant may reasonably determine. Unless otherwise agreed to by the
Parties in writing or on a Schedule, Consultant shall (i) observe the work
rules and policies of Company while working on Company’s premises, (ii)
furnish all equipment and materials used to perform the Consulting
Services, including but not limited to telephone lines, personal computers
and modems, and (iii) comply with Company’s policies, guidelines, and
specifications with respect to computer security, network connectivity,
and acceptable use, which have been provided to Consultant in
writing.
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1.3
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Other Work.
Consultant has the right to perform services for others during the term of
this Agreement as long as such other engagement or performance does not
interfere with the timely performance of the Consulting Services to be
performed hereunder or compromise Company’s Confidential Information, as
defined herein.
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2
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Independent
Contractor
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2.1
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Independent
Contractor; No Agency. Consultant is an independent
contractor. Consultant shall not be deemed for any purpose to
be an employee of Company. Company shall not be responsible to
Consultant or any governing body for any payroll-related taxes related to
the performance of services hereunder, including but not limited to,
withholding or other taxes related to income tax, social security benefits
or unemployment compensation. Neither Party is an agent, representative or
partner of the other Party. Neither Party shall have any right,
power or authority to enter into any agreement for or on behalf of, or
incur any obligation or liability on behalf of, or to otherwise bind, the
other Party. This Agreement shall not be interpreted or
construed to create an employment relationship, an association, agency,
joint venture or partnership between the Parties or to impose any
liability attributable to such a relationship upon either
Party.
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2.2
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Consultant’s Employees
and Assistants. From time to time, Consultant may,
subject to the terms and conditions set forth in this Agreement engage
independent contractors or consultants (collectively, “Assistants”) to aid
Consultant in performing Consultant’s duties under this
Agreement. Company has no relationship with or to Consultant’s
employees or such Assistants and all such parties are not employees,
agents, consultants, representatives, assistants or independent
contractors of Company. Consultant, at its sole expense and
without additional charges to the Company, shall be fully and solely
responsible for the supervision and payment of its employees and such
Assistants and for all work performed by its employees and such Assistants
and any third party subcontractors approved by Company as provided in this
Agreement.
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3
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Fees, Expenses,
Records, and Taxes
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3.1
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Fees. Schedule 2 sets forth
the fee due for the Consulting Services and Consultant agrees to invoice
Company as set forth in Schedule
2.
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3.2
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Budget. The
budget provided in Schedule 2 is a “Not to
Exceed” (NTE) Budget. Any increase in the costs above the Budget in Schedule 2 requires
written pre-approval by Company subject to a presentation by Consultant of
an updated Budget.
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3.3
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Expenses.
Company shall reimburse Consultant for any travel expenses incurred in
carrying out the services under this Agreement, provided that such
expenses were pre-approved by Company in writing. Consultant
shall invoice for expenses once per month. Payment is due 30
days after receipt of the expenses
invoice.
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3.4
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Consultant
shall be entitled to reimbursement of the categories of expenses set forth
on Schedule
2. Consultant shall invoice Company on a monthly basis
for expenses incurred as a result of performing Consulting Services in
accordance with Schedule 2.
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3.5
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Payment Terms.
The charges and/or expenses invoiced in accordance with this Section 4
shall be payable in US$ by Company within thirty (30) days of Company’s
receipt of each invoice.
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3.6
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Taxes. Consultant
shall clearly and separately state Value Added Tax (VAT) on Consultant’s
invoice to Company for corresponding Consulting Services. Company shall
pay VAT on the invoice or, in lieu of the payment of VAT, Company may
provide Consultant with a certificate acceptable to the taxing authorities
exempting Company from payment of
VAT.
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4
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Term and
Termination
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4.1
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Term. This
Agreement shall commence on the Effective Date and shall continue in full
force and effect thereafter until the completion of the Consulting
Services, unless it is terminated or expires sooner in accordance with the
provisions of this Agreement.
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4.2
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Termination at
will. This Agreement may be terminated in its entirety without
cause by either Party on thirty (30) days’ prior written notice to the
other Party.
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4.3
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Termination For
Breach. Either Party may terminate this Agreement at any
time in the event of a material breach by the other Party that remains
uncured after thirty (30) days written notice thereof (or such shorter
period as may be specified in this Agreement or in any applicable
Schedule).
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4.4
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Termination for
Bankruptcy/Insolvency. Either Party may terminate this
Agreement immediately following written notice to the other Party if the
other Party (i) ceases to do business in the normal course, (ii) becomes
or is declared insolvent or bankrupt, (iii) is the subject of any
proceeding related to its liquidation or insolvency (whether voluntary or
involuntary) which is not dismissed within ninety (90) calendar days or
(iv) makes an assignment for the benefit of
creditors.
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4.5
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Payment Upon
Termination. If either Party terminates the Agreement,
Company agrees to pay Consultant for all fees and expenses incurred by the
Consultant up to the effective date of
termination
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4.6
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Survival.
Sections 5 and 6 shall survive expiration or termination of this
Agreement.
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5
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Confidentiality
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The
parties shall be bound by obligations of confidentiality regarding confidential
information received by either party. Such obligations are set forth in the
Company's standard Nondisclosure Agreement attached hereto as Schedule
C (the "NDA"),
the terms of which are incorporated herein by reference and shall apply to any
Confidential Information (as defined therein) disclosed or acquired by either
party during the term of this Agreement.
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6
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Ownership
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Consultant
agrees that all data, know-how, inventions and discoveries (whether or not
patentable), that are developed, generated, conceived or first reduced to
practice by or on behalf of either Party as a result of performing the services
pursuant to this Agreement (collectively, “Inventions”) shall be the sole
and exclusive property of Company. Consultant shall promptly disclose any and
all Inventions and, if and when requested by Company, deliver to Company any
tangible embodiments thereof, and Consultant hereby assigns and agrees to assign
to Company all of its right, title and interest in, to and under the Inventions,
and to execute any documents or undertake any further actions if requested by
Company to evidence such transfer of title thereto and to assist in securing
legal protection therefore. Company shall reimburse Consultant for any expenses
incurred at Company’s request to secure title or legal protection for any such
Inventions. Nothing in this Agreement shall be deemed to grant
Consultant or any of its Subcontractors any license or similar right to use or
practice any of the Inventions, or any intellectual property of Company not
resulting from the performance of the services. Consultant shall also continue
to own the copyright to all forms previously created by Consultant, including
those modified for use by Company. It is further agreed by Consultant, that any
improvements to existing inventions owned by Company resulting from the trials
will be reassigned to Company at the end of the clinical study, regardless of
any future business relationship.
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7
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Reports
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7.1
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Reports. The Company shall
be entitled to full transparency insofar such data pertains to the
Services, including performance thereof by the
Consultant.
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8
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Representations
and Warranties
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8.1
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Consultant
represents and warrants that:
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8.1.1
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it
has full corporate power and authority to enter into and carry out its
obligations under this Agreement;
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8.1.2
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this
Agreement has been duly executed and delivered by Consultant and
constitutes the legal, valid and binding obligation of Consultant
enforceable against it in accordance with its terms;
and
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8.1.3
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it
has never been and, to the best of its knowledge, none of its employees or
contractors assigned to perform the Services has ever been (i) debarred or
threatened to be debarred or (ii) indicted for a crime or otherwise
engaged in conduct for which a person can be debarred under 21 U.S.C.
335a, as amended.
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8.2
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Consultant
warrants that it will perform the Services in a (i) good faith, timely,
professional, cost effective, and diligent manner; (ii) in accordance with
the project requirements set forth in Schedule A; (iii) in compliance with
all applicable domestic and international laws and regulations; and (iv)
in compliance with acceptable scientific standards and practices and (v)
in accordance with the purpose of this Agreement as set forth in Schedule
1. Consultant further warrants that it will negotiate all third
party vender agreements in a cost effective manner and make all reasonable
efforts to ensure fair and reasonable
pricing.
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8.3
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Disclaimer.
Except as otherwise stated in the Agreement or its Schedules, each party
makes no representations or warranties and hereby expressly disclaims all
implied warranties (including the warranties of merchantability and
fitness for a particular purpose).
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9
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Limitation of
Liability
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NEITHER
PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY INCIDENTAL, INDIRECT,
CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES OF ANY KIND OR NATURE, INCLUDING
WITHOUT LIMITATION LOST REVENUES OR LOST PROFITS, WHETHER SUCH LIABILITY IS
ASSERTED ON THE BASIS OF CONTRACT (INCLUDING, WITHOUT LIMITATION, THE BREACH OF
THIS AGREEMENT OR ANY TERMINATION OF THIS AGREEMENT), TORT (INCLUDING NEGLIGENCE
OR STRICT LIABILITY), OR OTHERWISE, EVEN IF THE OTHER PARTY HAS BEEN WARNED IN
ADVANCE OF THE POSSIBILITY OF ANY SUCH LOSS OR DAMAGE.
IN NO
EVENT SHALL CONSULTANT’S MAXIMUM LIABILITY TO COMPANY UNDER THIS AGREEMENT
EXCEED THE AMOUNTS ACCTUALY PAID BY COMPANY TO CONSULTANT PURSUANT TO THIS
AGREEMENT.
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10
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Indemnification
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Consultant
shall, at all times indemnify, hold harmless, and defend Company, its officers,
directors, insurers, Affiliates, agents and employees (collectively, the “Indemnified Parties”) from and
against any and all loss, cost, liability or expense (including costs and
reasonable fees of attorneys and other professionals) arising out of or in
connection with the performance of the Services hereunder. The Company will
provide prompt written notice to Consultant of any claim or the assertion of a
claim by a third party giving rise to indemnification, provided, however, that
any failure to do so shall not limit any of the rights of the Company (except
and only to the extent such failure materially prejudices the defence of such
legal proceeding). Upon such notice, Consultant shall have the right
to defend against any such claims or actions filed against the Company, and to
select counsel for such defence reasonably acceptable to the Company, and
Consultant, at its expense, shall pay all costs and expenses associated
therewith. The Company shall cooperate reasonably with Consultant, in
supporting the defense against the claim or assertion. Consultant shall have no
obligation to indemnify any of the Indemnified Parties under this Section 10 to
the extent any such loss, cost, liability or expense is caused by and/or
resulting from (i) the use of any materials provided to Consultant by the
Company; (ii) performing the Services in accordance with the information,
instructions and/or guidelines provided to Consultant by the Company; or (iii)
the Company’s failure to substantially comply with Consultant’s reasonable
instructions which if implemented would have prevented such loss, cost,
liability or expense.
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11
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General
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11.1
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Notice. Any
notice, approval, request, authorization, direction or other communication
under this Agreement will be given in writing and will be deemed to have
been delivered and given for all purposes (i) on the delivery date if
delivered by confirmed facsimile; (ii) on the delivery date if delivered
personally to the party to whom the same is directed; (iii) one business
day after deposit with a commercial overnight carrier, with written
verification of receipt; or (iv) five business days after the mailing
date, whether or not actually received, if return receipt requested,
postage and charges prepaid, or any other means of rapid mail delivery for
which a receipt is available. The notice address shall be the
address for the Party set forth in the first paragraph of this Agreement,
with the other relevant notice
information.
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11.2
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No
Waiver. No waiver under this Agreement shall be valid or
binding unless set forth in writing and duly executed by the Party against
whom enforcement of such waiver is sought. The failure of
either Party to insist upon or enforce strict performance by the other
Party of any provision of this Agreement or to exercise any right under
this Agreement shall not be construed as a waiver or relinquishment to any
extent of such Party's right to assert or rely upon any such provision or
right in that or any other instance; rather, the same shall be and remain
in full force and effect.
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11.3
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Entire
Agreement. This Agreement sets forth the entire
agreement and supersedes any and all prior agreements of the Parties with
respect to the transactions set forth herein. Neither Party
shall be bound by, and each Party specifically objects to, any term,
condition or other provision which is different from or in addition to the
provisions of this Agreement (whether or not it would materially alter
this Agreement) and which is proffered by the other Party in any
correspondence or other document, unless the Party to be bound thereby
specifically agrees to such provision in
writing.
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11.4
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Amendment. No
change, amendment or modification of any provision of this Agreement shall
be valid unless set forth in a written instrument signed by the Party
subject to enforcement of such
amendment.
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11.5
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Assignment.
Neither Party shall assign or transfer this Agreement or any of its rights
and obligations hereunder whether in whole or in part without the prior
written consent of the other Party. Company hereby consents to the use by
Consultant of sub-contractors, at its choice, including CBR International
Corp. Notwithstanding the foregoing, neither Party need obtain the consent
of the other Party prior to assigning this Agreement (a) to an affiliate
of the assigning Party, or (b) to any third party acquiring all or
substantially all of the assets relating to this Agreement or a
controlling interest in the voting stock or voting interest of the
assigning party or any controlling affiliate of the assigning
party. Except as permitted by the foregoing, any attempted
assignment or delegation shall be null, void, and of no
effect. Subject to the foregoing, this Agreement shall be fully
binding upon, inure to the benefit of and be enforceable by the Parties
hereto and their respective successors and
assigns.
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11.6
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Force Majeure.
Neither Party shall be responsible for failure to perform the terms of
this Agreement and/or Schedule thereto, when performance is prevented by
force majeure. The term force majeure shall mean acts of God,
earthquakes, flood, or any other cause whatsoever, whether similar or
dissimilar to the causes herein enumerated, not within the reasonable
control of either party which through the exercise of due diligence, a
party is unable to foresee or overcome but specifically excluding
financial distress. In no event shall the term force majeure
include normal or reasonable foreseeable or reasonably avoidable
operational delays.
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11.7
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Construction;
Severability. In the event that any provision of this
Agreement conflicts with the law under which this Agreement is to be
construed or if any such provision is held invalid by a court with
jurisdiction over the Parties to this Agreement, (i) such provision shall
be deemed to be restated to reflect as nearly as possible the original
intentions of the Parties in accordance with applicable law, and (ii) the
remaining terms, provisions, covenants and restrictions of this Agreement
shall remain in full force and
effect.
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11.8
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Applicable Law;
Jurisdiction. This Agreement shall be interpreted, construed and
enforced in all respects in accordance with the laws of the State of
Israel, except for its conflicts of laws principles. Each Party
irrevocably consents and submits to the exclusive jurisdiction of the
courts of State of Israel situated in Tel-Aviv-Jaffa, in connection with
any action to enforce the provisions of this Agreement, to recover damages
or other relief for breach or default under this Agreement, or otherwise
arising under or by reason of this
Agreement.
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11.9
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Headings;
Interpretations. The captions and headings used in this Agreement
are inserted for convenience only and shall not affect the meaning or
interpretation of this Agreement. This Agreement shall be
construed fairly according to its terms, without regard to the drafter of
any provision hereof.
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11.10
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Counterparts;
Facsimile. This Agreement may be executed in
counterparts, each of which shall be deemed an original and all of which
together shall constitute one and the same document. Delivery of an
executed signature page to this Agreement by facsimile shall be effective
to the same extent as if such Party had delivered a manually executed
counterpart.
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IN
WITNESS WHEREOF, the Parties hereto, each acting under due and proper authority,
have executed this Agreement as of the date first written above.
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ADRES
Advanced Regulatory Services Ltd.
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COMPANY
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By:
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/s/
Xxxxx Xxxxxx
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By:
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/s/
Xxxxx Xxxxxx
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Print
Name:
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Xxxxx
Xxxxxx
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Print
Name:
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Xxxxx
Xxxxxx
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Title:
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CEO
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Title:
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CEO
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Date:
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April
21, 2009
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Date:
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April
21,
2009
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Schedule
1
The
Services
The
Services and Scope of Work is outlined in the following table. Consultant is
responsible for all regulatory document preparation and appropriate strategic
development to support pre-IND activities, and the submission of a U.S. IND
according to FDA regulations. The consultant is responsible to guide the company
to act according to FDA recommendations resulting from the pre-IND meeting. The
following outlines the Scope and Timelines for this effort.
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Tasks
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Timelines
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1.
Prepare Pre-IND Type B Meeting Request Letter
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Six
working weeks from the Effective Date
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2.
Submit Pre-IND Type B Request Letter
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60
days prior to pre-IND meeting
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3.
Prepare Strategic Development Plan
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Throughout
the term of the Agreement
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4.
Prepare Pre-IND Meeting Package
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For
the first 60-90 days
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5.
Submit Pre-IND Meeting Package
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30
days prior to the pre-IND meeting
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6.
Attend/Conduct Pre-IND Meeting with FDA
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August
1, 2009
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7.
Prepare CMC Technical Writing, Review and Revision for the IND
submission
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November
1, 2009
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8.
Preparation of the Clinical Development Plan (CDP)
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Throughout
the term of the Agreement
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9.
Prepare Clinical Protocol (CTO ready for the pre-IND package)
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Prior
to IND
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10.
Draft and ensure completeness and compliance of the IND application with
all FDA requirements*
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November
1, 2009 provided tox study results available
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11.
Serve as U.S. Representative to the FDA (CBR)
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Throughout
the term of the Agreement
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12.
Prepare any response and correspondence required to the U.S. FDA including
any IND amendments
required until
the IND approval **
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Throughout
the term of the Agreement
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13.
Quality Assurance Services (ADRES)
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Throughout
the term of the
Agreement
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*
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This
includes but is not limited to the following sections of the IND
application and any parts of complementary U.S. FDA
requirements:
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a.
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Introductory
Statement and General Investigational
Plan
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b.
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Investigator
Brochure
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c.
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Protocols
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d.
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Chemistry,
Manufacturing, Control information
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e.
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Pharmacology
and Toxicity Information
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f.
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Previous
Human Experience with the IND
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**
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Limited
to 20 hours, starting 30 days after IND submission; additional working
hours will be charged as per CBR and ADRES hourly
rates.
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Schedule
2
Budget
and Payment Milestones
The consulting NTE
Budget for this program is $211,000 (US). The type of agreement is both fixed
fee (retainer) and milestone based.
Costs
All
supplies, postage and photocopy charges will be billed as direct pass through
costs in addition to the Consulting Costs provided that, any single expense or
cost exceeding the amount of $1000 shall require the prior written consent of
the Company.
Milestones
and Retainer Payments
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Milestone
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Estimated
Timeline
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Milestone
$
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Monthly
Retainer
(11
Months)
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1.
Pre-IND Meeting Letter Submitted
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June
1, 2009
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$10,000
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$10,000/Month
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2.
Pre-IND Meeting Package Submitted
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July
1, 2009
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$10,000
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3.
Pre-IND Meeting Conducted
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August
1, 2009
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$10,000
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4.
IND Submitted
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November
1, 2009
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$71,000
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Total
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$101,000
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$110,000
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A.
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Milestones
payments will be invoiced upon completion of each milestone indicated.
Payment of each milestone invoices is due Net 30 days. Payment
of milestone invoices must be received before the deliverable of the next
milestone
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B.
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Payment
of monthly retainer is due at the beginning of each month in the 11 month
period.
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C.
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A
delay in a completion of any milestone of more then 60 days of dates
above, will enable Company to withhold the monthly retainer payment, until
such time when such milestone will be
completed.
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D.
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The
last monthly payment will be invoiced 30 days after IND submission. If IND
submission is done before the elapse of 12 months, the entire balance of
the retainer will be due and payable upon the IND
submission
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E.
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If
cost of work performed is less than the milestone budget, the difference
will be credited to Company at the end of the
project.
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Schedule
3
NDA
