AGREEMENT
EXHIBIT 10.29
AGREEMENT
THIS AGREEMENT, made and
entered into as of May 1, 2010, is by and between Hadasit Medical Research
Services & Development Co. Ltd. (“Hadasit”), X.X. Xxx 00000,
Xxxxxxxxx Xxxxxx 00000 and Medgenics Medical Israel, Ltd., a company with an
address at Xxxxxxxx Xxxxxxxx Xxxx, Xxxxxx Xxxxxx 00000 (the “Company”).
WITNESSETH
WHEREAS, Hadassah Medical
Organization (“HMO”) owns and operates
the Hadassah National Facility at the Ein Kerem Hospital (the “LAB”) according to GMP Standards,
and
WHEREAS, Hadasit is authorized
to promote the services of the LAB and HMO’s employees and to enter into
agreements to provide the services of the LAB by HMO employees to researchers
and developers of Bio-Technologies, and
WHEREAS, Company engages in
research and development in the field of tissue and genetic engineering and has
developed a Process as defined herein (“the Process”); and
WHEREAS, as part of the
development of the Product (as hereinafter defined) for the purpose of
conducting clinical trials, the Company is interested to execute, in
coordination with Hadasit in the LAB the Work Plan annexed as Schedule
A hereto by
conducting the Process and using the Materials at the LAB (all of which shall
jointly be referred to herein as “the Work”)
WHEREAS, Hadasit is interested
in providing the Company with the services of the LAB and HMO employees under
the terms and conditions set forth herein;
WHEREAS, the parties herein
are willing and able to perform their respective obligations with respect to the
Work (as further described herein) under the terms set forth
below.
NOW, THEREFORE, it is hereby
agreed between the parties as follows:
1. Preamble,
Schedules and interpretation:
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1.1
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The
preamble to this Agreement and the Schedules thereto form an integral part
thereof. In the event of a contradiction between the provisions of this
Agreement and the Schedules, the provisions of this Agreement shall
prevail.
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1.2
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Headings
of clauses of this Agreement are intended for orientation only and shall
not be used for the purpose of
interpretation.
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1.3
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The
capitalized terms specified below shall have the following
meaning:
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1.3.1
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The “Work Sheet” shall
mean a detailed sheet specifying the precise manner in which the Work
shall be performed at the LAB, which shall include, among others, the
Company’s SOPs. Such Work Sheet and any amendment thereto shall be subject
to the prior approval of the SOG with respect to the GMP related aspects.
Such approval shall not be
construed
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so as to
derogate from the Company’s responsibilities hereunder. The current Work Sheet
is attached hereto as Schedule
B to this
Agreement.
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1.3.2
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The “Company’s Supervisor”
shall mean Xx. Xxxxxx Xxxxx and other Company employees trained
according to section 4.4 herein, or such other person designated by the
Company [and reasonably acceptable to Hadasit], with sufficient background
in the Company’s technology.
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1.3.3
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The “Company’s Contact Person”
shall mean Xx. Xxxxxx Xxxxx and Dr. Avi Xxxxxx, or another person
which may be designated by the Company subject to Hadasit’s prior
approval, not to be unreasonably
withheld.
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1.3.4
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The “Common Areas of the LAB”
shall mean those areas of the LAB that are intended for the use of
all the users of the LAB, including the Company, as set forth herein. Such
areas are rooms no. 2, 3, 6, 7, 8, 10, 11, 12, 15, 17, 18, 19, 20, 24, 26
and 27 in the drawing attached as Schedule
D
hereto.
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1.3.5
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The “Dedicated Lab”
shall mean a class 10,000 laboratory within the LAB, which includes
a class 100 biohazard hood. The Dedicated Laboratory shall be designated
upon commencement of the Work as in the drawing of the LAB attached as
Schedule
D hereto. The
equipment included in the Dedicated Lab is as specified in Schedule
D-1 attached
hereto.
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1.3.6
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“GMP Standards” shall
mean the Good Manufacturing Practice regulations determined by the U.S
Food and Drugs Association as shall be updated from time to time and
applied by the Supervisor of
GMP.
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1.3.7
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The “LAB” shall mean the Hadassah National
Facility operated according to GMP
Standards.
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1.3.8
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The “LAB Assistant”
shall mean Xxxxx Xxxxxxx & Xxxx Xxxxxx or another employee
designated by Hadasit.
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1.3.9
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The “Product” shall mean
EPODURE (Biopump/hEPO).
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1.3.10
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The
“Process” shall
mean: tissue manipulations for producing
EPODURE.
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1.3.11
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“Supervisor of GMP” or “SOG”
shall mean the person in charge of the operation of the LAB to be
designated from time to time by HMO. On the date hereof, Xx. Xxxxx Xxxxxxx
is the Supervisor of GMP.
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1.3.12
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“SOPs” shall mean the LAB’s standard
operation procedures that are set forth in Schedule
E hereto.
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1.3.13
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“Company’s
SOPs” shall mean the
Company’s standard operational procedures that were prepared by the
Company and approved by the SOG with respect to GMP related aspects and
are set forth in Schedule
F hereto.
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Any
change in the Company's SOPs shall be subject to the prior approval of the SOG,
which shall not be unreasonably withheld. The SOG's approvals under this section
shall not be construed so as to derogate from the Company's responsibilities. In
any contradiction between the Company's SOPs and the SOPs, the SOPs shall
govern.
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1.3.14
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The “HMO
Employees”:
jointly, shall mean those employees assigned to the conduct of the
Work, who may include the LAB Assistant, the SOG (as set forth in Section
1.3.11 hereto) or additional employees required in the opinion of the SOG
for the conduct of the Work.
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1.3.15
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The “Work”
shall mean the production of the Product by the execution of the
Work Plan set forth in Schedule A
hereto, by conducting the Process at the LAB in accordance with the
GMP Standards, the SOPs, the Work Plan and the Work
Sheet.
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1.3.16
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The “Work
Plan”
- shall mean the plan that specifies the timetables and the
different stages of Work (including specification of the dates in which
the Company's Supervisor attends at the Dedicated Lab), which was prepared
by the Company and approved by Hadasit and which is specified in Schedule
A
attached hereto, which shall not be amended without Hadasit's prior
written approval, which approval shall not be unreasonably withheld. The
timetables may be changed according to the specific needs of the Work via
mutual agreement. Any delay caused by the Company shall automatically
extend the timetables.
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1.3.17
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“The Work
Period”
shall mean the term as defined herein and any Extended
Term.
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2. Substance
of this Agreement:
2.1 The
Work will be carried out by the Company employees and LAB Assistant subject to
their availability, under the supervision of the Company's Supervisor at the
Dedicated Lab and under the supervision of the SOG during the Work Period
according to the GMP Standards, the SOPs, the Work Sheet and the Work Plan at
the LAB, and as is further described in Section 4 hereto. The SOG's contribution
to the project shall be as set forth in Section 4.2 hereto.
2.2 The
Company's Supervisor shall participate in the Work as set forth in Section 4.4
hereto, provided he or she has completed the Training as set forth in Section
4.4 hereto.
2.3 A
prior condition for the Work to commence shall be the completion of the
Company's Training for the SOG and the LAB Assistant (or other HMO Employees) as
set forth in Section 4.3 hereto.
2.4 Hadasit
shall provide the Dedicated Lab and the Common Areas of the LAB according to the
terms specified herein for purpose of the Work.
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2.5 The
Company shall be responsible for the sterility of any materials brought by the
Company into the LAB for purposes of the Work prior to their insertion thereto
and shall examine such materials and any tissues provided to it after the
completion of the Work prior to any further use thereof at its own
responsibility. The aforementioned notwithstanding, the Company does not warrant
that Tissues brought to the LAB will be sterile at the time of insertion to the
LAB
2.6 The
Company shall pay to Hadasit the Payment specified in Section 12 hereto and
shall be the sole owner of the Propriety Data as set forth in Section
13.
3. Parties
Representations
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3.1
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Each
of the Parties hereby represents and warrants as to itself as
follows:
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3.1.1
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It
has the legal capacity and authority to execute and deliver this
Agreement, to perform hereunder and to consummate the transactions
contemplated hereby without the necessity of any act or consent of any
other person or authority
whomsoever.
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3.1.2
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Neither
the execution or the delivery of this Agreement by it nor the closing of
the transactions contemplated hereby is prohibited by or violates any
provision of, and will not result in a breach of, any law, rule or
regulation applicable to it or any undertaking towards a third
party.
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3.2
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The
Company hereby also represents and warrants to Hadasit
that:
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3.2.1
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It
has all the necessary expertise and knowledge to perform all its
obligations pursuant to this
Agreement.
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3.2.2
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That
the Work, the Product and the execution or production thereof according to
the work procedures set forth herein, conform to every law, rule,
regulation, code of conduct, and common practice that may be applicable
and that any such law, rule, regulation, code of conduct or common
practice will be communicated to Hadasit, generally and on a case by case
basis.
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3.2.3
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That
it has reviewed the LAB's procedures and SOPs and found them adequate and
satisfactory for the purpose of the Work and this
Agreement.
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3.2.4
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That
the conduct of the Work hereinunder shall not create any interruption with
the regular course of the operation of the LAB nor shall it cause any
hazard to HMO's and/or Hadasit's premises, equipment, personnel, other
materials or other products.
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3.2.5
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That
the Company retains all intellectual property rights in the Process, the
Work and the Product; that to the Company's knowledge the Company is not
in breach of the intellectual property rights of any third party; that in
performing its obligations under this Agreement, the Company is not
breaching the provisions of any law and/or the rights of any third
party;
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and that
the Company is not aware of any outstanding claim(s) of infringement of any
intellectual property rights including without limitation any patent, copyright,
or trade secret related to the Process, the Product or the Work made or pending
against the Company.
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3.3
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Hadasit
hereby also represents and warrants to the Company
that:
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3.3.1
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It
has all the necessary expertise and knowledge to perform all of its
obligations
pursuant to this Agreement and that its actions hereunder will conform to
every law, rule, regulation, code of conduct, and common practice that may
be applicable including, without limitation, GMP Standards, SOPs, the Work
Sheet, the Company's SOPs and the Work Plan, the provisions of this
Agreement and HMO's procedures and
regulations.
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4. Scope of
Work
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4.1
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The
SOG, the LAB Assistant or other HMO Employees as defined below and the
Company's Supervisor(s) and/or the Company's employees shall execute the
Work Plan in compliance with the SOPs, the Work Sheet and the Work Plan,
the GMP Standards, the provisions of this Agreement and HMO's procedures
and regulations. Unless otherwise expressly specified, each party shall be
liable for the performance of its own personnel, as well as for breaches
of the Work Sheet, the SOPs, the Work Plan or this Agreement or to the
negligence or intentional misconduct
thereof.
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4.2
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The
Work shall be conducted by the Company's employees headed by the Company's
Contact Person and with the assistance of the LAB Assistant under
supervision of the SOG. In addition, the SOG may approve that the
Company's Supervisor(s) participates in the Work, as set forth herein in
section 4.5, such approval not to be unreasonably withheld. The SOG's
contribution to the conduct of the Work (other than supervision) shall be
based on the actual needs of the Work as shall be determined by the SOG at
her discretion. The SOG may assign to the Work other HMO Employees if in
her opinion they are required for the Work, and provided they are
qualified under the Company's Training as set forth
below.
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4.3
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Company's
Training: The Company shall train the SOG and the LAB Assistant
(and such other HMO Employees as the SOG deems fit) in order to qualify
them to conduct whatever portions of the Work is agreed between the
Company and the SOG from time to time. After the Company's Training is
completed, the Company shall test the HMO Employees' knowledge of such
materials and approve the commencement of said Work by such persons.
Hadasit shall not involve in said Work any of HMO employees that are not
trained by the Company as aforementioned. Hadasit, HMO, the SOG and any of
HMO's Employees who were trained by the Company shall not be held liable
for any act or omission that was done by them in compliance with said Work
and the Training.
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4.4
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4.5
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As
part of the Work, the Company shall provide the LAB with human body
tissues (“Tissues”) that need to be manipulated at
the LAB. The SOG may refuse to work with any such Tissues if in her
professional opinion they are hazardous to the LAB. It is clarified that
Hadasit does not undertake that any of the Tissues to be provided by the
Company shall be found suitable for use in the LAB, without derogating
from Hadasit's rights
hereunder.
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4.6
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4.7
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case of
lack of availability of the SOG, will review the results of the release criteria
testing and will sign on the release of the Product if all tests meet the
specified release criteria.
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4.8
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4.9
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4.10
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4.11
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5.
Coordination and
communication.
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5.1
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5.2
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5.2.1
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The
Work shall be conducted by the Company's Employees during the LAB's
normal business days and hours (Sunday through Thursday from 8:00am until
16:00pm) (“Standard
Working Hours”), unless the Work requires
other days (Friday or Saturday) or hours, in which case the Company must
adequately coordinate with the SOG said non-Standard Working Hours. Such
extra effort and the consideration in respect thereof are agreed to by the
parties. The Company is aware that the LAB Assistant is commonly present
during Standard Working Hours only and that the availability may vary,
pending other LAB Assistant's
obligations.
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5.2.2
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Company's
Supervisor(s) shall be allowed access to the Dedicated Lab during the
times in which the Company's Employees conduct the Work as set forth in
Section 5.2.1 above. Request will be made for at least two keys to the
outer main entrance of the LAB, to be given to the Company's Supervisor(s)
upon availability.
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5.2.3
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At
any given time, not more than 3 qualified persons on behalf of Hadasit and
the Company will be present at the Dedicated Lab with priority to the
required HMO Employee(s).
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5.2.4
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5.3
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Access to the
LAB: The Company's Supervisor(s)'s access to the Common
Areas
of the LAB shall be governed by the SOPs during such times as set forth in
Section 5.2.1 above. The Company's Supervisor(s) shall not enter off-limit
areas without first obtaining the written approval of the SOG, which shall
not be unreasonably withheld.
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6. Maintenance
of the LAB:
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6.1
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Hadasit
represents that on the date hereof, the LAB and the Dedicated Lab are in
good condition and that during the Work it shall remain in such good
condition, suitable for the purpose of this
Agreement.
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6.2
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Nothing
contained herein shall cast upon Hadasit or HMO any liability to purchase
any additional equipment or to upgrade any existing
equipment.
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6.3
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As
specified in the LAB SOPs, the Dedicated Lab will be cleaned by HMO
Employees on each day of Work activity. In addition, in the case of Work
activity for multiple patients on a single day, the Dedicated Lab will be
cleaned by a Company's designee after the Work on each patient. In such
cases, the Company will coordinate at least one day in advance with the
SOG and shall incur all associated costs of the cleaning. Company's
cleaning designee shall be guided by the SOG prior to entering the
LAB.
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6.4
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To
the extent possible under the circumstances, Hadasit shall use its best
efforts to coordinate with the Company any maintenance that may materially
interfere with the regular course of the
Work.
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6.5
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The
Company shall be liable for any damage caused to Hadasit's equipment by
the Company's Supervisor(s) or due to the breach of the provisions of this
Agreement by the Company.
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6.6
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The
Company Employees shall be responsible for the Dedicated Lab cleaning at
the end of a working day that ends off-Standard Working
Hours.
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7. Amendments and
changes:
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7.1
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Hadasit
shall be entitled to amend the SOPs and the Company shall adjust the Work
to any such amendment(s). However, prior to any such change, Hadasit shall
inform the Company thereof, and as to the Effective Date at which time it
shall be effectuated, and grant to the Company a review period of at least
30 days. At the end of such review period, the Company may either (i)
notify Hadasit of the termination of the Agreement as of the Effective
Date or (ii) inform Hadasit of its acceptance of the change, in which case
the SOG shall train the Company's Supervisor if needed and this Agreement
shall apply mutatis
mutandis. If the Company does not respond to Hadasit's notice of
the anticipated amendment, it shall be deemed to have accepted
it.
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7.2
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At
its discretion, Hadasit may require the Company to amend the Company's
documents (including without limitation: the Work plan, the Work Sheet,
the Company's SOPs or other documents related to the Work) in order to
ensure that they comply with the SOPs or with the GMP Standards. In such
event, the procedures set forth in Section 7.1 shall apply, mutatis mutandis.
However, for as long as the Company's documents and/or procedures
are not amended as aforementioned, Hadasit shall be entitled to freeze the
Work until such amendment is effectuated. The aforementioned is not
designed to cast on Hadasit any further liabilities under this
Agreement.
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7.3
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The
Company may from time to time change the Work Plan, the Company's SOPs and
the Work Sheet, provided however that such change is coordinated with the
SOG and approved by Hadasit and the SOG prior to any implementation
thereof, which approval shall not be unreasonably
withheld.
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8. Records
and Reports:
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8.1
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The
Company's and HMO's employees shall keep such records, manage such
documentation and report to the SOG or to the Company, all as set forth in
the SOPs and the Work Sheet.
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8.2
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Without
derogating from the Company's undertakings hereunder, during the entire
Work Period, including any extension thereof, the Company shall promptly
notify the SOG of the occurrence of any of the
following:
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8.2.1
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Any
event that requires notification of the SOG under the SOPs or the
Company's SOPs.
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8.2.2
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Any
other event that is significant or is not in the regular course of events
or might cause any hazard or damage or contamination or interruption to
the LAB and its users.
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8.3
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The
Company shall fill in and file any form and report required under the
SOPs.
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8.4
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Hadasit
shall promptly inform the Company of any event within its knowledge
which
reflects problems, errors and deviations associated with the conduct of
the Work at the LAB.
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8.5
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The
Company shall not be charged for Agreement periods during which it
is impossible
to use the LAB if such impossibility was directly caused by conditions in
Hadasit's or HMO's control or within their responsibility (such as
strikes, construction works, failure of the LAB systems, etc.). Under the
above circumstances, The Company shall in good faith use its best efforts
to take the required actions for it to renew the
Work.
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9. Quality
Control and Efficacy of the Product, Use of Work Products:
The
Company is solely responsible for quality control and for the efficacy of the
Product. In addition and notwithstanding anything to the contrary herein, the
Company shall be solely liable and responsible for any use of the Work's
products (including the Tissues) provided to it by Hadasit according to this
Agreement.
10. Materials
and Items:
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10.1
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Hadasit
and the Company shall be responsible for providing those items and
materials listed in Schedule
H hereto opposite
their name (the “Materials”).
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10.2
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The
Company hereby warrants that any of the Materials provided or to be
provided by it hereunder is suitable for use under GMP
Standards.
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10.3
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The
Materials supplied by the Company shall be stored in the LAB, according to
Hadasit's SOPs at no additional charge, and according to the
manufacturer's recommendations, should there be any. For Materials
supplied by the Company which need refrigerated storage or frozen storage,
dedicated storage space in a refrigerator/freezer shall be provided for
use by the Company.
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11. No
Employer-Employee Relations
Nothing
contained in this Agreement shall be construed as employee-employer relations
between the Company's Supervisor(s) (or other representatives of the Company)
and Hadasit and/or HMO and/or Hadasit's or HMO's personnel and the Company or
vise versa.
12. Consideration
In
consideration of the fulfillment of Hadasit's obligations pursuant to this
Agreement, the Company agrees to pay to Hadasit the total sum indicated in Schedule
I hereto on such dates and
manner as set forth therein (the “Payment”).
13. Proprietary Data, Company
Confidential Information, Confidentiality
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13.1
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Subject
to sections 13.2 and 13.3 hereto, the Product, the Process and all data
obtained in the performance of the Work and all results derived therefrom
and
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including,
without limitation, ideas, inventions, techniques, improvements, know-how or
other technology or associated intellectual property relating to the Work,
whether or not patentable (the “Proprietary
Data”) including any right to use it shall
be the exclusive property of the Company.
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13.2
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Hadasit
and its employees hereby assign and transfer to the Company any and
all right,
title and interest in such Proprietary Data and agree to take all further
acts reasonably
required, at the Company's expense, to convey title in such
property to
the Company and/or to assist the Company to perfect and protect such
rights.
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13.3
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In
the event that Hadasit's reasonable assistance is required in order to
enable the Company to perfect or protect the Company's rights in the
Proprietary Data, Hadasit and the SOG shall, at the Company's expense,
reasonably provide the Company with such assistance provided, however,
that such assistance does not cause the disclosure or infringement of the
LAB's confidential methods/procedures, proprietary information and/or
other intellectual property
rights.
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13.4
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For
purpose of this Section 13.4, the Company's Confidential Information shall
mean all Proprietary Data, information, and Materials furnished to Hadasit
by the Company whether in writing or orally or in any other media for
purposes of the Work.
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Hadasit
shall maintain in strict confidence any and all of the Company's Confidential
Information and shall use it solely for the purpose of this Agreement. The
foregoing confidentiality obligations shall not apply to Information that: (i)
is at the time of disclosure in the public domain, or (ii) becomes part of the
public domain thereafter other than through a violation by Hadasit or its
employees of this obligation of confidentiality or (iii) is disclosed to Hadasit
and/or the SOG and/or the LAB Assistant by a third party through no violation of
any confidential obligation to the Company.
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13.5
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The
Company shall maintain in strict confidence any and all
information disclosed
to its employees, agents and other personnel including the Company’s Supervisor(s)
whether in writing or orally or in any other media with respect
to the
LAB's methods, procedures, know-how, equipment and/or any other
business secrets
or information that are confidential in their nature (“Hadasit Information”). The foregoing confidentiality
obligations shall not apply to Information
that: (i) is at the time of disclosure in the public domain, or
(ii) becomes
part of the public domain thereafter other than through a violation by
the
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Company
or its employees of this obligation of confidentiality or (iii) is disclosed to
the Company or the Company's employees by a third party through no violation of
any confidential obligation to Hadasit.
14. Publications
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14.1
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Any
publication by Hadasit with respect to the Work, Product or Process shall
require prior written approval of the Company, which approval shall not be
unreasonably withheld. In any such publication, Hadasit shall include
appropriate acknowledgement of the
Company.
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14.2
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Subject
to Section 14.3 hereto, the Company shall include appropriate
acknowledgement and credit to HMO, the LAB and the SOG in any publication
relating to the Work in whichever media it is
utilized.
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14.3
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Notwithstanding
anything to the contrary herein, the Company shall not use the names of
Hadasit, HMO or the SOG without Hadasit's prior written
approval.
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15. Liability,
Indemnification and Insurance
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15.1
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The
Company warrants and confirms that it has prepared the Work Plan and the
Work Sheet including without limitation the manufacturing instructions,
the Company's SOPs and the Product Specifications and that it is solely
and exclusively responsible for the
same.
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15.2
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The
sole responsibility of Hadasit and the HMO Employees shall be to conduct
the Work in compliance with the SOPs and the Work Sheet and this
Agreement. Except as expressly set forth herein, Hadasit and/or HMO shall
not have any liability or responsibility whatsoever with respect to the
Product, the Work, any accompanying materials or any use thereof. Without
derogating from the foregoing, Hadasit and/or HMO and/or the SOG shall not
bear any responsibility for the use or failure of the Work's products and
results and shall not be liable for any act and/or omission on the part of
the Company and/or Company's Supervisor(s) in carrying out the
Work.
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15.3
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Disclaimer
of Warranty. Without derogating from the aforementioned, Hadasit
disclaims all warranties, either express or implied, with respect to the
Work and the Product, including without limitation implied warranties of
merchantability, efficacy and fitness for a particular purpose. The entire
risk arising out of the performance of the Work and the Product and the
use of the results and products of the Work and any accompanying materials
remains solely with the Company, and the Company shall be solely
responsible for any use of the Work and/or the
Product.
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15.4
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Exclusion
of consequential damages.
Neither party shall be liable (whether under contract, tort (including
negligence) or otherwise) to the other party, or any third party for any
indirect, special or consequential damages, including, without limitation,
any loss or damage to business earnings, lost profits or goodwill and lost
or damaged data or documentation, suffered by any person, arising
from
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and/or
related to this agreement, even if such party is advised of the possibility of
such damages.
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15.5
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Limitation
of Liability.
Without derogating from the above, if Hadasit is found liable
(whether under contract, tort (including negligence) or otherwise), the
cumulative liability of Hadasit for all claims whatsoever related to the
Work or the Product or otherwise arising out of this Agreement, shall not
exceed the amounts actually paid to Hadasit under this
Agreement.
|
|
15.6
|
Indemnification;
legal defense.
The Company shall indemnify, defend and hold harmless HMO, Hadasit,
the SOG, the HMO Employees engaged in the Work (each, an “Indemnitee”), promptly upon their first
demand, from and against any loss, damage, liability and expense
(including legal costs) in connection with any third party arising out of
or resulting from the performance or production of the Work or the Product
or any accompanying materials or the use of the Product or the Work or the
results or products thereof or of any accompanying materials, including
damages suffered by Hadasit's or HMO's employees as a result of their
exposure to the Process or Product or Materials introduced by the Company
for the purpose of the Work. The indemnification undertaking under this
Section 15.6 shall be subject to the
following:
|
|
15.6.1
|
That
the respective damage was not caused by the negligence or intentional
misconduct of an Indemnitee. In the event of mutual responsibility, the
indemnification shall be proportionally
reduced.
|
|
15.6.2
|
That
the Company is notified in writing as soon as practicable under the
circumstances of any complaint or claim potentially subject to
indemnification and that the Indemnitees cooperate with the Company, at
its expense, with respect to such
claims.
|
|
15.7
|
A
condition precedent for this Agreement to become effective shall be that
the Company
purchases an insurance policy with such coverage satisfactory
to Hadasit
(the “Policy”).
The Company undertakes to maintain such insurance during
the term of this Agreement and for such relevant periods under
the applicable
statute of limitations. With respect to the insurance Policy, the
parties have
agreed as follows: (i) the types of insurance coverage under the Policy
and the
amounts thereof shall be as detailed in Schedule
J hereto. (ii) HMO
and Hadasit
will be included as co-insured in such insurance Policy. (iii) for as
long as
the Company maintains such Policy, the Company's liability towards
Hadasit, HMO
and the Indemnitees (collectively), with respect to the performance of
this Agreement,
shall be limited to US$ 3,000,000. On the date hereof, the
insurance policy
maintained by the Company is as detailed in Schedule
J hereto.
|
16. Term and
Termination
|
16.1
|
This
Agreement shall commence on the date hereof and shall continue for a
period of up to four (4) months after the commencement of the Work at the
LAB, unless earlier terminated in accordance with the provisions of this
Section 16 (the “Term”). The Company shall be entitled
to extend this Agreement on a monthly basis (the “Extended
Term”) upon written notice to Hadasit
of at least 30 days
|
13 of
26
prior to
the end of the Term and upon at least 25 days prior written notice during the
Extended Term, provided however that such Extended Term shall not exceed 5
months in the aggregate.
|
16.2
|
This
Agreement shall terminate upon the completion of the Term or the Extended
Term (as applicable). Notwithstanding the foregoing, each party may
terminate this Agreement at any time, at its sole discretion, upon 30 days
prior written notice to the terminated
party.
|
|
16.3
|
Either
party may terminate this Agreement upon the occurrence of any of the
following: (a) the filing of a petition for the winding-up or liquidation
of the other party or for an appointment of a receiver, and such petition
has not been withdrawn, dismissed or struck out within 21 days of its
filing (b) the breach by a party of this Agreement that is not cured
within fifteen (15) days of delivery of a written notice from the
non-defaulting party to the defaulting party calling upon it to cure such
breach. In addition, Hadasit may terminate the Agreement upon a delay of
more than 10 days in the Payment, provided 10 day prior notice has been
given to the Company regarding any failure to make such payments. The
aforementioned shall not derogate from any other remedy that the parties
are entitled to under law.
|
|
16.4
|
As
it receives all the payments due under this agreement, Hadasit shall
forward to the Company the Proprietary Data in its possession. However,
Hadasit shall be entitled to retain copies of all documents and data
relating to the functioning of the LAB, including, without limitation,
batch records, microbiological testing, total particle counts, printouts
from the computerized control system, and such other documents and data to
be determined by the SOG at its sole
discretion.
|
|
16.5
|
Within
five (5) days from the termination of the Agreement, the Company shall
vacate Hadasit's or HMO's premises, including without limitation the LAB
and its surroundings, and any failure to do so shall cast upon the Company
the obligation to continue paying the Payments for any such time until
complete evacuation. In the event the Company breaches its undertaking
hereunder, Hadasit shall be entitled at its sole discretion and without
derogating from its other remedies under law to vacate the Company's
belongings from the LAB by itself, and the Company shall reimburse Hadasit
for its costs in this regard.
|
|
16.6
|
The
undertakings contained in Sections 3, 6.8, 9, 11, 13, 14 and 15 shall
survive the termination of this
Agreement.
|
17. Miscellaneous
|
17.1
|
Neither
party may assign in whole or in part any of its rights or obligations
under this Agreement, without the prior written consent of the Company.
However, Hadasit may assign its rights for the Payment to any third party
whatsoever without obtaining such
approval.
|
|
17.2
|
This
Agreement is the entire agreement between the parties as to the subject
matter contained herein and supersedes all other agreements, oral and
written,
|
14 of
26
heretofore
made between the parties. Any amendment hereto must be in writing and signed
both parties.
|
17.3
|
Neither
party is authorized to represent the other party or act as its agent or
undertake obligations on its
behalf.
|
|
17.4
|
The
waiver by either party of any breach or alleged breach of any provision
hereunder shall not be construed to be a waiver of any concurrent, prior
or succeeding breach of said provision or any other provision
herein.
|
|
17.5
|
If
any provision of this Agreement is held to be void, the remaining
provisions shall remain valid and shall be construed as to achieve their
original purposes in full compliance with the applicable
laws.
|
|
17.6
|
This
Agreement and its interpretation, execution and termination shall be
governed by the laws of the State of Israel, and the competent courts in
the District of Jerusalem shall have exclusive jurisdiction with respect
to this Agreement and everything connected thereto and/or stemming
therefrom.
|
|
17.7
|
Force Majeure.
Neither party shall be liable for any delay or failure to perform
hereunder due to floods, riots, strikes (in which case Section 8.5 shall
apply), freight embargoes, acts of God, acts of war or hostilities of any
nature, laws or regulations of any government (whether foreign or
domestic, federal, state, county or municipal) or any other similar cause
beyond the reasonable control of the party affected. A party relying on
such an event to excuse its performance hereunder shall immediately notify
the other party in writing of the nature of that event and the prospects
for that party's future performance and shall thereafter, while that event
continues, respond promptly and fully in writing to all requests for
information from the other party relating to that event and those
prospects. If performance by either party is delayed more than thirty (30)
days due to such event or series of events, the other party may terminate
this Agreement, effective immediately, without
liability.
|
18.
Notices
All
notices and communications provided for hereunder shall be in writing and shall
be delivered by registered mail or facsimile or delivered by hand to the
addresses listed in the caption to this Agreement or to such other address or
facsimile number as either party shall designate in writing to the other party.
Notices and communications sent by registered mail shall be deemed to have been
received by the addressee on the date of delivery or 4 days after dispatch,
whichever is the earlier. Notices and communications delivered by hand or sent
by facsimile shall be deemed delivered within 1 business day of delivery or
transmission.
15 of
26
IN
WITNESS WHEREOF the parties have signed this Agreement on the date first
hereinbefore written.
| /s/ Xxxxxx X. Xxxxxxxx | /s/ ILLEGIBLE | |
|
Company
|
Hadasit
|
|
|
By: XXXXXX X. XXXXXXXX
|
By: ILLEGIBLE
|
|
|
Title: CEO
|
Title:
|
16 of
26
Schedule A
The Work
Plan
Timetables
and stages of the Work:
For each
patient, the work flow for the duration of the ex-vivo processing is specified
completely by the SOPs. Estimated durations for each step are shown in the table
below.
|
Day
number
|
GMP
room
use
|
Procedure
description
|
Working
time at GMP
|
|
0
(Harvest
day)
|
+
|
Fat
tissue and stratum cornea removal from micro organs that were harvest in
operation room.
Introduce
micro organs into culture in 24 well plates.
|
120
minutes
|
|
1
|
+
|
Transduce
micro organs with helper dependent Adeno EPO vector.
|
60
minutes
|
|
2
|
+
|
Viral
vector removal
|
150
minutes
|
|
3
|
+
|
Transduce
micro organs with helper dependent Adeno EPO vector.
|
60
minutes
|
|
4
|
+
|
Viral
vector removal
|
150
minutes
|
|
5
|
-
|
||
|
6
|
-
|
||
|
7
|
+
|
Media
change:
Sampling
of the collect medium for sterility
and secretion and viability analysis.
|
120
minutes
|
|
8
|
-
|
||
|
9
|
-
|
||
|
10
|
+
|
Media
change:
Sampling
of the collect medium for secretion
and viability analysis.
|
120
minutes
|
|
11
(Implantation
day)
|
+
|
Media
collect and micro organ wash:
Sampling
of the collect medium for sterility and viability analysis, and micro
organ
|
120
minutes
|
Details
as to the start of ex-vivo treatment for each patient will be given at least two
days prior to the start of ex-vivo processing.
17 of
26
Schedule
B
Work
Sheet
Company
SOPs can be found in Schedule F.
18 of
26
Schedule
C
Company's Contact
Person:
|
Name:
|
Xx.
Xxxxxx Xxxxx
|
|
Phone:
|
(000)
000-0000
|
|
E-mail:
|
xxxxxx@xxxxxxxxx.xxx
|
|
Name:
|
Avi
Xxxxxx
|
|
Phone:
|
(000)
000-0000
|
|
E-mail:
|
xxx@xxxxxxxxx.xxx
|
|
Company's
Supervisor
|
|
|
Name:
|
Xx.
Xxxxxx Xxxxx
|
|
Phone:
|
(000)
000-0000
|
|
E-mail:
|
xxxxxx@xxxxxxxxx.xxx
|
19 of
26
Schedule
D
Medgenics’ Dedicated Lab is
Room 23 and 25 shown below.
20 of
26
Schedule
D-l
Equipment
Within
Class 10,000 GMP Lab
1. Laminar
flow hood
2. Water
bath
3. Refrigerator/Freezer
(-20 frost free)
4. Laser
particle counter, type Lasair - dedicated unit and backup
5. Biotest
Air Sampler + extra battery and charger - dedicated unit and
backup
Within
Class 100,000
6. Validated
autoclave
Within
analytic Lab
7. Vortex
8. Shaker
for ELISA reader
9.
ELISA
Reader (540 nm filter) - need for recalibration within analytic lab before start
of Work
10.
Computer connected to ELISA reader and
internet
11.
Refrigerator/Freezer (-20 frost
free)
12.
Freezer (-20 frost free)
13.
-80 freezer
14.
Bacteria incubator
21 of
26
Schedule E and Schedule
F
The
SOP’s
Company
SOPs:
|
Protocol
number
|
Protocol
name
|
|
060001
|
Protocol
For Production Medium Preparation
|
|
060003
|
Protocol
for Sterilization
|
|
060009
|
Protocol
for Glucose Assay
|
|
060010
|
Protocol
for Micoplasma Assay
|
|
060011
|
Protocol
for Dermal core Biopump production
|
|
060013
|
Protocol
For Label Preparation
|
|
060015
|
Release
Criteria SOP for Dermal Core
|
|
060017
|
Protocol
for hEPO ELISA of Dermal Core BPs
|
|
060019
|
AminoLab
Pickup Verification Protocol
|
|
060403
|
Antibiotics
and Serum Aliquots preparation
|
|
060404
|
Protocol
for viral vector HD-EPO Aliquots
preparation
|
Hadasit
SOPs:
22 of
26
Schedule
G
Within
Class 10,000 GMP LAB
1. Shaker
for viral transduction x2
2. Electric
Pipette -aid (x2) + chargers
3. Heating
plate
4. Pipettors
- P-5000, P-1000, P-200, P-20, P-10
5.
Tissue
culture incubators (5% C02) x2 - Hadasit to connect to their general GMP alarm
system and be responsible for periodic calibration.
6. Eppendorf
centrifuge
Within
analytic Lab
7. Elisa
washer
8. Multi
8-channel pipettes - 2x 5-50ul
9.
Multi 8-channel pipettes - 2x 50-300ul
10.
Electric Pipette-aid + charger
11.
Xxxxxxxxx - X-0000, X-000, X-00, X-00
00.
Glucometer
13.
Stopwatch
23 of
26
Schedule H
Materials
Materials
to be provided by the Company:
|
Material
|
Vendor
|
Catalog
no.
|
|
Medium
|
|
|
|
Serum
|
||
|
Saline
|
||
|
Antibiotics
|
||
|
Sterile
Pipettor tips (l0ul, 20ul, 200ul, l000ul, 5000ul)
|
||
|
Cryo-tubes
|
||
|
Xxxxx
(24-xxxxx, 6-xxxxx)
|
||
|
Xxxxx
(96-xxxxx) - for XXXXX
|
||
|
Xxxxx
dishes (140mm)
|
||
|
Syringes
(5ml, 10ml, 50ml)
|
||
|
Scalpels
|
||
|
Glucose
test strips
|
||
|
EPO
ELISA kits
|
||
|
Non-sterile
pipettor tips (l0ul, 20ul, 200ul, 1000ul)
|
||
|
50
ml reagent reservoir
|
||
|
Pipettes
(5ml, 10ml, 25ml)
|
||
|
Test
tubes (15ml, 50ml)
|
||
|
Petri
dishes (90mm)
|
||
|
Eppendorf
tubes
|
||
|
Material
to be provided by Hadasit:
|
||
|
Material
|
Vendor
|
Catalog
no.
|
|
Ethanol
70%
|
||
|
Sterile
Gloves (different sizes)
|
||
|
Sterile
Gowns (different sizes)
|
||
|
Biotest
strips (bacteria and fungus)
|
||
|
Contact
plates
|
||
|
Masks
|
||
|
Hats
and foot covers
|
||
|
Sterile
water (for water bath and incubators)
|
||
|
Sterile
non-woven wipes
|
24 of
26
Schedule I
Payment
Schedule
|
1.
|
In
consideration for the performance of the Work at the LAB by HMO's
Employees, the Company shall pay to Hadasit the total amount of NIS
125,000 (one hundred and twenty-five thousand New Israeli Shekels) plus
VAT (the “Payment”) per month during the entire
Work Period including any extension thereof and for as long as the Company
has not completely evacuated Hadasit's or HMO's premises (including
storage of Materials) (the “Term”).
|
|
2.
|
Advance
payments totaling NIS 260,000 has been made in advance: NIS 10,000 check
dated March 3, 2010 non-refundable), and wire transfer of NIS 250,000 on
March 22, 2010.
|
|
3.
|
In the
event the Company cannot perform any of the Work for 30 or more
consecutive days during the Term because of regulatory issues (lack of
approval from the Israeli Ministry of Health for the commencement of the
Study (as defined in the Clinical Trial Agreement)), the Company shall be
entitled to suspend this Agreement for a maximum consecutive period of
four (4) months and shall not have to pay Hadasit any Payment for any of
those days during which it could not perform the Work, provided that the
Company made an advance fourteen (14) days written notice to Hadasit and
vacated the Dedicated Lab and the LAB and its
surroundings.
|
|
4.
|
The
period of suspension shall not last more than four (4) consecutive months.
The Company may end the suspension period by notifying Hadasit in writing
thirty (30) days in advance that it wishes to return and operate the
Dedicated Lab. At the end of the suspension period, Hadasit shall provide
the Company either the Dedicated Lab or another compatible Dedicated Lab
within the LAB, as may be assigned to the Company by the SOG with the
reasonable consent of the Company. Beyond the four (4) months consecutive
suspension period, Hadasit will work to facilitate, but has no obligation
to provide, the Dedicated Lab or a compatible Dedicated Lab to the
Company.
|
|
5.
|
The
monthly payment of NIS125,000 plus VAT shall be made on a monthly basis
upon receipt of a tax invoice and by the 5th
of the month in which the work is performed. The advanced payment will be
deducted from the payment due for the last two months of
work.
|
|
6.
|
Any
payment pursuant to this Agreement shall be paid, along with applicable
V.A.T under Israeli law, as against Hadasit's issuance of a lawful tax
invoice therefore.
|
|
7.
|
With
respect to the Company's Training, the Company shall bear any travel and
overnight expenses of the HMO Employees, if caused by the
Company.
|
25 of
26
Schedule
J
26 of
26
