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Exhibit 10.12
SUPPLY AND DISTRIBUTION AGREEMENT: COMMERCIAL PHASE
THIS AGREEMENT (the "AGREEMENT") is entered into by and between
OMRIX
BIOPHARMACEUTICALS, LTD., an Israeli company (hereinafter,
"OMRIX"), and FFF
ENTERPRISES, INC., a United States ("US") corporation organized and
existing
under the laws of California (hereinafter, "FFF"), together with
Omrix, the
"PARTIES" and each individually a "PARTY."
WHEREAS:
A. Omrix
manufactures Omrigam NF, a proprietary immune globulin
intravenous
("IGIV") for use in patients with primary immune deficiency, and
wishes to
obtain FDA approval of a Biologics License Application ("BLA") to
market
Omrigam NF in the US;
B. FFF is a
wholesale distributor of pharmaceutical products, including
IGIV
products, in North America and wishes to be the exclusive
distributor of
Omrigam NF in the United States of America ("US") subsequent to
FDA
approval of the BLA for Omrigam;
C. The Parties
have agreed to enter into a Supply and Distribution Agreement:
Investigational Phase (the "INVESTIGATIONAL AGREEMENT"), attached
hereto as
Exhibit A;
D. Under the
Investigational Agreement, FFF will assume sponsorship of the
Investigational New Drug Application for Omrigam NF and will
take
responsibility for conducting clinical trials and distributing
Omrigam NF
under a treatment protocol;
E. The term of
the Investigational Agreement ends upon FDA approval of the BLA
to
market Omrigam NF in the US; and
F. Omrix wishes
to designate FFF as its exclusive authorized distributor to
market Omrigam NF in the US, and FFF wishes to accept such
designation, all
under the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the mutual promises and
covenants contained
herein, effective upon the Effective Date, the Parties agree as
follows:
1. EFFECTIVE
DATE
This
Agreement shall be effective immediately upon execution by the
Parties, except Sections 3.4, 4, 5, 6, 11 and 12, which shall
become
effective on the date the FDA issues written notice (which will be
attached
hereto as Exhibit B and incorporated as part of this Agreement upon
its
issuance) that it has
approved a Biologics License to market Omrigam NF in
the
US for use in humans with primary immune deficiency (hereafter
the
"APPROVAL DATE").
2.
DEFINITIONS
As
used in this Agreement the following definitions shall apply in
each
case
where the defined term appears in capitalized form:
2.1
"AFFILIATE" - means
any entity controlled by, controlling, or under
common control with a Party to this Agreement, through ownership
or
control of more than 50% of the voting power of the shares or
other
means of ownership or control, provided that such control continues
to
exist.
2.2
"BATCH" - means all
material intended to have uniform character and
quality that is produced from a single manufacturing procedure
in
accordance with established parameters and according to a
single
manufacturing order during that same cycle of manufacture.
FFF - Omrix Agreement: Commercial Phase CONFIDENTIAL
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PORTIONS OF THIS EXHIBIT MARKED BY AN *** HAVE BEEN OMITTED
PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION.
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2.3
"BLA" - means a
Biologics License Application, as defined in 21 CFR
Section 601.2, to market Omrigam NF in the US for use in patients
with
primary immune deficiency.
2.4
"CALENDAR YEAR" -
means the period beginning on January 1 and ending
on December 31 of each year.
2.5
"CFR" - means the US
Code of Federal Regulations, as may be amended
from time to time, and any successor thereto.
2.6
"CGMP" - means current
Good Manufacturing Practice and General
Biological Products Standards as defined in 21 CFR Parts 210, 211,
600
and 606.
2.7
"COMMERCIAL PHASE" -
means the phase of a relationship between the
Parties after FDA approval of a BLA of Omrigam NF has been
obtained
and Omrigam NF may be marketed in the US for use in humans with
primary immune deficiency.
2.8
"DCI CONTRACT" - means
the Plasma Supply Agreement between Omrix and
DCI Management Group, LLC, attached hereto as Exhibit C, execution
of
which is a condition precedent to this Agreement.
2.9
"FDA" - means the US
Food and Drug Administration.
2.10
"HANDLING SPECIFICATIONS" - means the specifications for the
handling,
the storage, the use, the transport and the general possession of
the
Product by FFF as agreed upon by the Parties in consideration of
the
specifications and standards defined and specified in an approved
BLA
for the Product, as more fully described in Exhibit D hereto.
The
Handling Specifications may be amended from time to time by the
Parties as provided under this Agreement.
2.11
"IGIV" - means immune globulin intravenous.
2.12
"INVESTIGATIONAL PHASE" - means the phase of relationship between
the
Parties described in the Investigational Agreement, which
covers
exclusive use by FFF and its agents of Omrigam NF in clinical
trials
and exclusive distribution by FFF of Omrigam NF under a
treatment
protocol (as defined in 21 CFR Section 312.34), provided that a
treatment protocol is approved by the FDA.
2.13
"MASTER BATCH RECORD" - means the criteria, methodology,
manufacturing
Process, Specifications and formulae for the Product, which
includes
the
identity and quantities of the Raw Materials and other
components,
as such may be amended by mutual agreement of the Parties from time
to
time.
2.14
"OMRIGAM NF" - means Omrix's proprietary polyvalent IGIV, as
further
described in Exhibit E hereto.
2.15
"OTHER TAXES" - means all taxes, other than US Taxes, associated
with
the marketing, distribution, sale and delivery of the Product,
including but not limited to all sales and export taxes imposed by
the
Israeli government.
2.16
"PROCESSING," "PROCESS," and "PROCESSED" - have comparable
meanings
and mean the act of manufacturing and inspecting the Product in
accordance with the Master Batch Record and specified
procedures.
FFF - Omrix Agreement: Commercial Phase CONFIDENTIAL
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2.17
"PRODUCT" - means Omrigam NF approved by the FDA for commercial
distribution for use in humans with primary immune deficiency only
by
means of a Biologics License as defined in 21 CFR Part 601.
2.18
"QUALIFIED PERSON" - means any person who possesses the skills,
experience, education, and authority to perform a task or job
described in this Agreement.
2.19
"RAW MATERIALS" - means the plasma, excipients and associated
manufacturing components, all of which are utilized in Processing.
The
plasma used to manufacture the Product or any component thereof
shall
at all times be obtained from US licensed collection centers.
2.20
"REGULATORY FILINGS" - means any document or report required to
be
filed for an FDA approved biological product under the US
Federal
Food, Drug and Cosmetics Act and associated regulations in Title 21
of
the CFR, including without limitation any supplement to an
approved
BLA and any postmarketing report for the biological product.
2.21
"SPECIFICATIONS" - means, with respect to the Product, the
Specifications for Processing the Product as agreed upon by the
Parties in consideration of the specifications and standards
defined
and specified in an approved BLA for the Product, as more fully
described in Exhibit F hereto. The Specifications may be amended
from
time to time by the Parties as provided under this Agreement.
2.22
"TECHNOLOGY" - means all the technical information, whether
tangible
or intangible, including (without limitation) any and all data,
techniques, discoveries, inventions, Processes, formulations,
know-how, patents (including any divisional, continuation,
extension,
reissue, reexamination certificate, or renewal patents), patent
applications, inventor certificates, trade secrets, method of
production and other proprietary information, that Omrix has rights
to
(as either owner, licensee or sublicense), or may hereafter
obtain
rights to, relating to the Product.
2.23
"TERM" - as defined in Section 7.1, below.
2.24
"US TAXES" - means all taxes associated with the marketing,
distribution, sale and delivery of the Product that are due,
payable
and/or collectable under the laws of US federal, state, and/or
local
government, including but not limited to sales, use, excise,
withholding, value-added and similar taxes and all customs, duties
or
other US governmental impositions, but excluding taxes calculated
on
Omrix's income.
3. GRANT OF
RIGHTS
3.1
FFF Rights. Omrix owns
certain Technology and facilities to
manufacture the Product. Omrix agrees to use the Technology to
manufacture the Product for FFF subject to the terms and
conditions
set forth in this Agreement. Except as otherwise provided in
section
5.2.d and 5.2.e, FFF shall have and Omrix hereby grants to FFF
the
exclusive right (exclusive even as to Omrix and its Affiliates)
to
distribute, market, offer for sale, sell, import and promote
the
Product in the US.
3.2
Omrix Obligations.
Omrix agrees that:
a. Omrix shall
use reasonable commercial efforts to reply to
technical and commercial queries received from FFF in the
course
of the performance of its obligations hereunder and shall
provide
FFF with such technical assistance and technical, professional,
and clinical data and information as Omrix and
FFF - Omrix Agreement: Commercial Phase CONFIDENTIAL
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FFF, working together, determine are reasonably necessary for
the
promotion and solicitation of sale of the Product in the US;
b. Omrix and its
Affiliates shall not engage in any marketing,
promotion, advertisement, sale or distribution of the Product
within the US including placing resale and export restrictions
in
all contracts for the sale of the Product to third parties
other
than FFF; and;
c. Omrix shall
not use its Technology, or allow any of its
Affiliates or any third party to use its Technology (e.g., by
grant of a license), for the purpose of competing with FFF,
directly or indirectly, in the US.
3.3
Omrix Rights. Except
as provided in Section 3.2 above, Omrix shall
retain all rights to develop, distribute, market, offer for
sale,
sell, import and promote the Product outside the US.
3.4
FFF Obligations. FFF
agrees that:
a. FFF shall use
commercially reasonable efforts to sell, market,
and distribute the Product in the US, faithfully and diligently
perform its obligations as Omrix's distributor, and
professionally promote and develop the sale and use of the
Product in the US;
b. FFF shall
perform all marketing and sales activities for the
Product in the US, including, but not limited to, promotion of
the Product by way of meetings, seminars, advertisement in
magazines, participation in exhibitions, sales of the Product
and
after sales support;
c. FFF shall
make written periodic reports, at least quarterly,
commencing in the quarter in which the BLA is approved by the
FDA, specifying: (i) the promotional activities carried out by
FFF in the reported quarter; and (ii) complaints and requests
of
customers of which FFF is aware. FFF shall promptly report to
Omrix any significant developments that could be reasonably
foreseen
to have an immediate material adverse impact on its
marketing activities in the US;
d. FFF shall
conduct business in a manner that reflects favorably at
all times on the Product, goodwill and reputation of Omrix and
avoid deceptive, misleading or unethical practices, and refrain
from making any representations, warranties or guarantees with
respect to the Product that are known by FFF to be inconsistent
with those made by Omrix in its published or provided
literature
for the Product. FFF shall submit to Omrix for its prompt
review
and approval all promotional material intended by FFF for use
in
the promotion of the Product;
e. FFF shall
appoint a Qualified Person as a product manager to
serve as a liaison and chief point of contact between FFF and
Omrix for all marketing, sales, and technical issues related to
the Product;
f. FFF shall
employ a professional sales and technical support
organization to provide sales and technical support for Product
to its customers;
g. FFF shall
keep Omrix informed as to problems encountered and
resolutions proposed in relation to the Product and communicate
promptly to Omrix all modifications, design changes, or
improvement of the Product suggested by
FFF - Omrix Agreement: Commercial Phase CONFIDENTIAL
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any customers, or any employee of FFF, provided that Omrix
shall be and remain the exclusive owner of such information in
connection with the Product;
h. FFF shall
refrain from incurring any liability on behalf of Omrix
except as expressly authorized by this Agreement; and
i. FFF shall not
sell, market, offer for sale, sell, import and
promote the Product outside the US.
4. REGULATORY
MATTERS
4.1
General. In connection
with performing their obligations pursuant to
this Agreement, FFF and Omrix shall use all commercially
reasonable
efforts to perform such responsibilities diligently, with the
objective of maximizing the sales potential of the Product and
promoting the therapeutic profile and benefits of the Product in
the
most commercially beneficial manner. Without limiting the
generality
of the foregoing, each Party shall, at its own expense, except
as
otherwise specifically provided in this Agreement:
a. Collaborate
and cooperate in the preparation and filing of all
Regulatory Filings as defined in Section 2.20, above and all
other aspects necessary to implement this Agreement;
b. Use
commercially reasonable efforts to perform the work set out
for such Party to perform in this Agreement;
c. Conduct all
work pursuant to this Agreement in compliance in all
material aspects with all requirements of applicable laws,
rules
and regulations, and all other requirements of any applicable
cGMP to
achieve the objectives of this Agreement efficiently and
expeditiously; and
d. Maintain
records in sufficient detail, which shall be complete
and accurate and shall fully and properly reflect all work done
and results achieved in connection with the Product in the form
required under all applicable laws and regulations.
4.2
Ownership. Omrix shall
own the Biologics License for the Product, and
any reissuance or reinstatement thereof. Omrix shall also own
all
Regulatory Filings in connection with the Product.
4.3
Duties.
a. As the owner
of the Biologics License for the Product, Omrix
shall be primarily responsible for preparing and filing all
Regulatory Filings, including any supplemental applications and
postmarketing reports as required by 21 CFR Parts 314, 600 and
601. Omrix shall consult with FFF in preparing all Regulatory
Filings and FFF shall provide Omrix with timely assistance and
information necessary to prepare Regulatory Fillings as
required.
b. Omrix shall
be responsible for conducting all communications with
the FDA
regarding the Product. Omrix shall provide FFF with
copies of all correspondence received from the FDA regarding
the
Product, including any FDA adverse product experience reports
as
defined in 21 CFR Section 600.80 or MEDWATCH reports forwarded
to
Omrix by the FDA. Additionally, Omrix shall discuss with FFF
any
commitments to the FDA prior to agreeing to them.
FFF - Omrix Agreement: Commercial Phase CONFIDENTIAL
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c. Omrix shall
be responsible for compliance of the manufacturing
and Processing procedures in accordance with the
Specifications.
4.4
Notices Regarding
Product. Omrix and FFF shall each give the other
prompt notice of any information either of them receives regarding
the
safety of the Raw Materials or the Product, including any confirmed
or
unconfirmed information on adverse experience or unexpected
adverse
experience, as defined in 21 CFR Part 600, associated with the use
of
the Product. For serious adverse experience or unexpected
adverse
experience, as defined in 21 CFR Part 600, notice must be given
by
telephone within one (1) business day after receipt of the
information
and followed by written notice not less than one (1) week
thereafter.
Omrix shall be responsible for all responses due and cost for
filing
any report with the FDA concerning such adverse reactions
associated
with the use of the Product, as required by applicable laws and
regulations (including 21 CFR Section 600.80).
5. PRODUCT
SUPPLY
5.1
Commercial Supply.
Subject to the terms and conditions of this Section
5, Omrix shall supply FFF with FFF's requirements for Product
for
commercial use in the US pursuant to this Agreement. Product shall
be
ordered and supplied at the Purchase Price (as defined below),
according to the procedures outlined in this Section 5. Omrix
will
make reasonable commercial efforts to negotiate favorable pricing
(at
least fair market pricing) for the purchase by Omrix of US
sourced
recovered plasma.
5.2
Annual Supply and
Purchase Amounts.
a. In the
Calendar Year that a BLA for the Product is approved by
the FDA for use in humans with primary immune deficiency, Omrix
agrees to sell to FFF and FFF shall purchase all Product
produced
by Omrix from US sourced recovered plasma, provided, however,
that under no circumstances shall FFF be responsible for
purchasing more than the pro rata share of *** grams of the
Product
based on the actual number of days from when the BLA is
approved by the FDA until the end of the year in which the
approval is received, unless Omrix has obtained FFF's prior
written agreement that FFF will purchase any such excess
Product.
b. Except as
provided in Section 5.2.d below, each Calendar Year
thereafter, Omrix agrees to sell to FFF and FFF shall purchase
all Product produced by Omrix from US sourced recovered plasma,
provided, however, that under no circumstances shall FFF be
responsible for purchasing more than *** grams of the Product
in
a Calendar Year, unless Omrix has obtained FFF's prior written
agreement that FFF will purchase any such excess Product.
c. In the
Calendar Year that this Agreement is terminated or
expired, Omrix agrees to sell to FFF and FFF shall purchase all
Product produced by Omrix from US sourced recovered plasma
purchased, provided, however, that under no circumstances shall
FFF be responsible for purchasing more than the Pro Rata share
of
*** grams of the Product based on the actual number of days
from
January 1 of the year until the date on which this Agreement is
terminated or expired, unless Omrix has obtained FFF's prior
written agreement that FFF will purchase any such excess
Product.
d. In the event
that more than *** liters of recovered plasma
sourced in the US is available to Omrix during a Calendar Year,
then FFF will have the option to purchase the Product
manufactured by Omrix from such excess recovered
FFF - Omrix Agreement: Commercial Phase CONFIDENTIAL
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plasma (the "Excess Product"). provided that Omrix will provide
FFF with at least six (6) months prior written notice of the
availability and Purchase Price applicable to the Excess
Product.
Omrix will provide FFF with evidence of the price to be paid by
Omrix for the recovered plasma sufficient for FFF to verify the
applicable Purchase Price for the Product. If within sixty (60)
days of receipt of such written notice from Omrix of the
quantity
and price of the Excess Product FFF does not agree in writing
to
purchase such Excess Product, then the exclusivity granted to
FFF
under this Agreement shall not apply to such Excess Product.
e.
Notwithstanding anything to the contrary in this Agreement, and
in addition to any right to which Omrix may be entitled under
this Agreement, in the event that FFF shall fail to order and
purchase from Omrix the quantity of Product as required under
this section 5 (i.e., *** grams, plus any higher amounts agreed
to by FFF, including the Excess Product, if the purchase option
is exercised by FFF), then Omrix shall have the right at its
sole
discretion to terminate FFF's exclusivity rights granted
hereunder. Omrix shall exercise such right by issuing written
notice to FFF; provided, however, such termination of
exclusivity
rights shall not affect the continued validity of those
reasonably applicable remaining provisions of this Agreement
and
shall not preclude Omrix from the exercise of any other remedy
available to Omrix under this Agreement or applicable law.
5.3
Processing. Omrix, as
the owner of the Technology and any improvements
thereof, shall be responsible for Processing the Product, whether
by
itself or by third parties, subsidiaries or Affiliates, in
accordance
with the Specifications. Said Processing shall include, without
limitation, all product labeling and other package inserts and
materials required by the FDA. Omrix shall ensure that all
services,
facilities and goods used in connection with such manufacture
comply
with the applicable cGMPs in effect.
5.4
Change in Processing.
Omrix shall not implement any changes relating
to the Product without providing FFF with 20-day prior written
notice
of such changes. A change is defined as any variation in the
written
procedures currently in place that: (a) impacts the regulatory
commitments for the Product, (b) may require revalidation, (c)
may
materially affect the quality, purity, identity or strength of the
Raw
Materials
or the Product, or (d) would necessarily result in changing,
altering or modifying the Specifications, Handling
Specifications,
Testing Methods (defined below), sampling procedures,
validation
procedures or Master Batch Record relating to the Product. In
the
event that Omrix intends at any time to implement such a change,
Omrix
shall complete and bear all costs associated with implementing
said
change and performing the studies necessary to meet any and all
requirements from the FDA (including, without limitation, the
requirements of 21 CFR Sections 600.14 and 601.12) needed to
approve
such change, except that FFF may, at its sole discretion, complete
and
bear the costs of any clinical trials necessary to implement
said
change. Omrix shall supply at its expense all the Product required
for
such clinical trials.
5.5
Forecasts. During the
Term of this Agreement, Omrix shall, by November
30th of each Calendar Year, provide FFF with a non-binding good
faith
forecast for the following Calendar Year, broken down into months,
for
the quantity of the Product that Omrix anticipates producing from
US
sourced recovered plasma. The forecast will be updated every
other
month, or more frequently, as otherwise updated by Omrix. The
Parties
acknowledge that the actual supply of the Product that Omrix is
obligated to provide is subject to volumes provided under the
DCI
Contract.
5.6
Orders for the
Product. All FFF's orders for the Product shall be made
pursuant to written purchase orders. Subject to the limitations
set
forth in Sections 5.2.a, 5.2.b,
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5.2.c and 5.2.d above, FFF shall issue purchase orders (or if
not
issued, will be deemed to be issued) each calendar quarter, based
upon
Omrix's forecast provided in Section 5.5 above. All purchase
orders
must be faxed to Omrix at +972-3-535-0265. Any additional or
different
terms on FFF's purchase orders shall have no force or effect and
shall
be
superseded by the terms of this Agreement. Purchase orders shall
be
signed by an authorized official of FFF and shall specify: (a)
the
purchase order number; (b) quantities; (c) requested delivery
schedule; (d) preferred shipping method; and (e) exact "Ship
to"
address. Any additional or different terms on Omrix's written
acceptance shall have no force or effect and shall be superseded
by
the terms of this Agreement. Once accepted by Omrix, FFF's
purchase
orders, including those for any excess Product as provided in
Section
5.2.d, shall be binding on Omrix to supply to FFF the quantities
of
the Product provided in the purchase orders. Omrix reserves the
right
to cancel, suspend, refuse, or delay any orders if FFF fails to
make
payment when due as required in Section 6.2 below or otherwise
fails
to comply with the terms and conditions of this Agreement.
5.7
Delivery. Omrix shall
ship the quantity of the Product ordered on the
schedule set forth in Omrix's forecasts. Omrix shall be
responsible
for payment of the costs of shipping and insurance associated with
the
delivery of the Product to FFF. Omrix shall ship all Products
F.O.B.
FFF's designated facility in the US or at any alternative
receiving
location if agreed in writing by the Parties. For purposes of
this
Agreement, risk of loss in the Product shall pass to FFF at the
time
the Product is received by FFF.
5.8
Title. Title to the
Product to be delivered to FFF shall remain in
Omrix until delivery of the Product to FFF as described in
Section
5.7. Thereafter title to the Product shall transfer to FFF.
5.9
Conformity;
Specifications; Quality Control.
a. All
quantities of the Product supplied by Omrix pursuant to this
Agreement will comply in all material respects with the
Specifications and shall adhere in all material respects to all
applicable governmental laws and regulations relating to the
manufacture, packaging, sale, storage, and shipment of each
shipment of the Product at the time it is shipped by Omrix
hereunder.
b. Omrix shall
conduct, or cause to be conducted, quality control
testing of the Product prior to shipment, in accordance with
the
Specifications as are in effect and such other quality control
testing procedures adopted by Omrix from time to time
(collectively, the "TESTING METHODS"). The Testing Methods
shall
include all FDA required release testing and Omrix shall
undertake all such tests. Omrix shall retain records pertaining
to such testing. Each shipment of the Product hereunder shall
be
accompanied by a certified quality control protocol and
certificate of analysis for each Batch of the Product therein
as
well as such customs and other documentation as is necessary or
appropriate.
5.10
Acceptance/Rejection. After receipt of a shipment of the
Product,
including documentation as provided in Section 5.9 above, FFF
shall
have ten (10) days to accept or reject the Product. Any such
rejection
should be based on a documented deviation from the Master Batch
Record
and shall be handled as hereafter set forth in Section 5.11.
5.11
Rejection Procedures.
a. Should FFF
reject any Batch pursuant to Section 5.10, and Omrix
agrees that such rejection was justified, Omrix shall promptly
credit FFF's account if the
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invoice with respect to the Batch so rejected will have been
paid
by that time by FFF by virtue of Section 6.
b. Should FFF
reject any Batch pursuant to Section 5.10, and should
Omrix, after good faith negotiation, fail to agree that such
rejection was justified, the Parties shall jointly appoint an
independent third party to test samples of such Batch and to
review any pertinent record and information developed by both
Parties relating thereto to ascertain the validity of the
rejection. The findings of such third party shall be binding
upon
both Parties. If the Product is found to meet the
Specifications
in all material respects, FFF shall pay the costs of such tests
and shall be deemed to have accepted the Product as of the date
such findings are published. If the Product is found not to
meet
Specifications in any material respect, Omrix shall pay the
costs
of such tests and shall promptly credit FFF's account.
c. Upon Omrix's
receipt of a claim that a shipment or Batch thereof
of the Product does not meet the Specifications, and Omrix
agrees
that such claim is justified, Omrix shall use commercially
reasonable efforts to replace such shipment or Batch thereof
with
an additional shipment of the Product that does conform to such
Specifications as soon as practicable.
5.12
Inventory Management. Omrix shall maintain an inventory of the
Product
in accordance with Omrix's usual and customary inventory
management
practices that Omrix applies to its other therapeutic products,
but
sufficient to satisfy the requirements of this Section 5.
5.13
Shortage of Supply.
a. Omrix shall
notify FFF: (a) as promptly as possible, but in no
event more than ten (10) days after Omrix's receipt of a
purchase
order from FFF as provided in Section 5.6, or (b) immediately
upon becoming aware of Omrix's inability to supply the quantity
of the Product to FFF that Omrix is required to supply
hereunder,
Omrix's inability to supply such quantities of the Product. In
such event, Omrix shall implement all commercially reasonable
efforts to remedy such shortage.
b. In the event
of Omrix's inability to supply both FFF's
requirements of the Product and Omrix's other requirements,
including any third party requirements as of the date of this
Agreement, for the Product due to force majeure or otherwise,
Omrix shall first allocate the Product that Omrix has in
inventory and that Omrix is able to produce among the
quantities
of all such requirements, so that FFF receives all of its
required annual supply of Product, as determined from purchase
orders and where purchase orders are not in place, from the
forecasts, for the
Product.
6. PAYMENT
6.1
Purchase Price. The
purchase price for the Product supplied by Omrix
to FFF pursuant to this Agreement is listed in Exhibit G
("PURCHASE
PRICE"). The Purchase Price does not include any applicable taxes.
FFF
shall pay all US Taxes associated with the sale and delivery of
Omrix's Product to FFF. The Purchase Price represents the net
amount
to be received by Omrix. If FFF shall be required to deduct,
collect,
withhold or pay such US Taxes, the sum payable to Omrix shall
be
increased as may be necessary so that after making all required
deductions
