Wagner Regulatory Associates, Inc. Agreement for Services
Exhibit
10.17
Xxxxxx
Regulatory Associates, Inc.
Agreement
for Services
Client’s
Name:
Pimi Xxxxxx Holdings Ltd.
Contact
person: r. Xxxxxx Xxxx and/or Mr.
Nimrod Xxx Xxxxxx
Contact person’s email and
telephone: 972-72-211-6144
Client’s
physical
address:
Kibutz Alonim, XXXxx 000
00000 Xxxxxx Xxxxxx, Xxxxxx
1.
Description of services to be provided to PIMI XXXXXX: Xxxxxx
Regulatory Associates, Inc. (“WRA”) a Delaware corporation, located at 0000
Xxxxxxxxx Xxxx, Xxxxx #0, Xxxxxxxxx, Xxxxxxxx 00000, will provide
technical and regulatory services for projects and tasks as assigned by PIMI
XXXXXX.
2. Term
of Agreement. It is agreed that
WRA will provide technical and regulatory services to PIMI XXXXXX from the date
of execution of this agreement and shall continue thereafter until terminated by
either party upon thirty days prior written notice to the other
party. If PIMI XXXXXX elects to terminate this Agreement, PIMI XXXXXX
shall pay WRA for all work performed to date unless such decision to terminate
is founded upon WRA negligence, willful misconduct or material breach of this
Agreement.
3. Compensation and
Expenses:
(a) WRA
agrees to provide technical and regulatory services to PIMI
XXXXXX. In return for such services PIMI XXXXXX agrees to compensate
WRA on a project fee basis. The fee basis and amount of fees are as
provided in the Addendum no. 1 to this agreement.
(b) WRA
fees and rates do not include reimbursable expenses. When business travel is
authorized by PIMI XXXXXX, reimbursable travel expenses shall include reasonable
coach class airline, train, and car rental costs, reasonable hotel and meal
costs, and such other reasonable and necessary travel expenses. For
other incidental expenses, such as long distance telephone, mailing costs,
photocopying costs, and fee-based internet database searches, PIMI XXXXXX shall
reimburse WRA at its cost, upon submission to PIMI XXXXXX of receipts evidencing
such expenditures.
(c) WRA
fees and rates do not include governmental licensing fees. When
licensing fees are required to carry out PIMI XXXXXX registration projects, WRA
will notify PIMI XXXXXX of such fees in advance so that the required monetary
funds can be deposited by bank wire transfer into the WRA bank
account. Upon receipt of these funds WRA will then pay the required
governmental licensing fees as required by government authorities and as
authorized by PIMI XXXXXX.
4. Work-Product Ownership
and Use.
All
written work, research and other written materials generated pursuant to this
Agreement shall be the sole and exclusive property of PIMI XXXXXX, and WRA shall
not use or disclose nor enable the use or disclosure of such materials for any
purpose without the specific, written preauthorization of PIMI
XXXXXX.
5.
Payment terms:
WRA shall
provide invoices to PIMI XXXXXX which describe in detail the services provided
with the associated fees and expenditures as provided for in Addendum no. 1 to
this agreement. PIMI XXXXXX agrees to pay WRA 50% of the total
project fees described in Addendum no. 1 to this agreement at the initiation of
the project which is authorized by PIMI XXXXXX. The remainder of the
fees will be invoiced to PIMI XXXXXX at completion of each task and PIMI XXXXXX
will submit payment to WRA with terms net 30 days. WRA invoices will
be delivered to PIMI XXXXXX in electronic format by email. All
payments to WRA will be by bank wire transfer to WRA’s designated bank account
in US dollars ($). WRA will confirm receipt of all payments by PIMI
XXXXXX.
Xxxxxx
Regulatory Associates, Inc.
Agreement
for Services
6. Additional
terms and conditions:
(a) Independent Firm.
It is understood that WRA is an independent firm, and is not an agent, employee,
legal representative, or partner of PIMI XXXXXX. As an independent firm, WRA is
solely responsible for determining the means and methods for performing the work
under this Agreement in accordance with the terms of this agreement. WRA will
determine the time, place, and manner of performance of the work in accordance
with the terms of this Agreement.
(b) Hold Harmless. It
is agreed that PIMI XXXXXX shall hold WRA harmless against any liability for
personal injury, property damage, or monetary losses arising from WRA’s work
under this Agreement, except to the extent that any such injury, damage, or
losses is due to the negligence or willful misconduct of WRA.
7. Miscellaneous.
This Agreement and all duly executed Addendums represents the entire agreement
on this subject between the parties to it. There are no oral or written
promises, terms, conditions, or obligations other than those contained in this
Agreement. This Agreement supersedes all previous communications,
representations or agreements, either oral or written, between the parties to it
on the subject matter of this Agreement. This agreement may be amended only by a
written addendum signed by WRA and PIMI XXXXXX. This Agreement may be
executed in multiple counterparts, which together shall constitute but one
original.
For: PIMI XXXXXX HOLDINGS,
LTD.
By: /s/ Eitan Shmuli, Director
Signed: Eitan Shmuli, Director
Title:Director
Title:Director
Date: 9th Sptember 2009
For: XXXXXX
REGULATORY ASSOCIATES, INC.
By: Xxxxx X. Xxxxxx
Regulatory Director
Addendum No.
1
This
document represents an addendum to the Agreement for Services contract between
WRA and PIMI XXXXXX and covers all work initiated during the period of September
2008 through September 2009.
Scope
of Work:
The Pimi
Xxxxxx product contains hydrogen peroxide active ingredient. It also
contains silver nitrate and phosphoric acid co-formulants
(inerts). This product will be produced using an EPA registered
source of hydrogen peroxide. This product’s label will specify those
uses and claims to include treatment of potatoes in storage to inhibit sprouting
and for treatment of fruits and vegetables post-harvest to provide bactericide
and fungicide effects. Pimi Xxxxxx seeks EPA FIFRA Section 3 'me-too'
registration of the product. Silver nitrate is not currently approved
by US EPA for use as an inert ingredient applied post-harvest to
food. A separate clearance must be obtained from EPA for silver
nitrate.
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1.
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WRA
to arrange pre-registration conference with US EPA, in Washington, DC to
(a) confirm data requirements for the Pimi Xxxxxx product containing
hydrogen peroxide (b) what data is needed (if any) for silver nitrate and
(c) EPA timelines.
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WRA
charges: $1200 plus travel expenses of approximately
$500.
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2.
|
WRA
to prepare registration dossier and submit to US EPA to obtain approval
for Pimi Xxxxxx product containing hydrogen peroxide as active ingredient
and silver and phosphoric acid as co-formulants
(inerts). Product will use registered source of hydrogen
peroxide. Product will be labeled for inhibition of sprouting
in stored potatoes and bactericide/fungicide for post-harvest treatment of
fruits and vegetables. Pimi Xxxxxx to provide WRA with reports
of data required by EPA, generated to GLP and acceptable to EPA, for acute
toxicity, physical & chemical properties of the product and non-GLP
description of the manufacturing process and formulation process of the
product. If required by EPA, PIMI XXXXXX will provide WRA with
reports of efficacy data acceptable to
EPA.
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WRA charges:
$5,250
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3.
|
WRA
to prepare and submit a petition for exemption of silver nitrate from the
requirement of a tolerance for residues which may occur on potatoes,
fruits, and vegetables. WRA will obtain and use toxicity data
for silver nitrate obtained from publicly available sources of scientific
literature to support this petition. Pimi Xxxxxx will provide
to WRA report(s) of data, acceptable to EPA, showing the residue
concentration of silver nitrate remaining on potatoes, fruits and
vegetables after treatment with this
product.
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WRA
charges: $8,250
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4.
|
WRA
to prepare and submit registration dossiers in all states including
California.
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WRA
charges: $2,750
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5.
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WRA
to prepare and submit registration dossiers in all states except for
California.
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WRA
charges: $2,250
The
terms of Addendum No. 1 accepted and approved:
For: PIMI XXXXXX HOLDINGS,
LTD.
By: /s/ Eitan Shmuli, Director
Signed: Eitan Shmuli, Director
Title:Director
Title:Director
Date: 9th Sptember
2009
