Supply and Marketing
Agreement
ARISTOS PHARMACEUTICALS, INC. and
SOVEREIGN PHARMACEUTICALS, LTD
agree as follows:
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1.0
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As
used throughout this Agreement, the initially capitalized terms
shall have the meanings ascribed to them in Sections 1.1
through 1.42.
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1.1
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“Act” shall mean
collectively the Federal Food, Drug, and Cosmetic Act of 1938,
including any amendments thereto, and all regulations promulgated
thereunder, and the Federal Controlled Substances Act, including
all amendments thereto, and any regulations promulgated
thereunder.
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1.2
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“Affiliate” shall mean:
(a) any corporation or business entity fifty percent (50%) or
more of the voting stock or voting equity interests of which are
owned directly or indirectly by a Party; or (b) any
corporation or business entity which directly or indirectly owns
fifty percent (50%) or more of the voting stock or voting equity
interests of a Party; or (c) any corporation or business
entity directly or indirectly controlling or under common control
of a corporation or business entity as described in (a) or
(b).
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1.3
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“Agreement” shall mean
this Supply and Marketing Agreement entered into by and between the
Parties as of the Effective Date.
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1.4
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“ARISTOS” means ARISTOS
PHARMACEUTICALS, INC, a Delaware corporation having a place of
business at 2000 Regency Parkway, Suite 255, Cary, NC,
27518.
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1.5
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“Business Day” shall
mean any day, other than a Saturday or Sunday, on which commercial
banks are not authorized by law to close in the State of North
Carolina.
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1.6
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“cGMP” shall mean the
quality systems and current good manufacturing practices set forth
in 21 C.F.R. (Parts 210 and 211), as amended from time to time and
in effect during the Term of this Agreement.
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1.7
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“Change of Control”
shall have the meaning ascribed to it in
Section 6.4.
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1.8
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“DESI” means any drug
approved between 1938 and 1962 that was permitted to stay on the
market while evidence of their effectiveness was
reviewed.
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1.9
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“Distribution Cost”
means the amount, in respect of any calendar month, which is equal
to the actual cost of shipping of the Product from the Distributor
for such calendar month.
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1.10
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“Distributor” means any
wholesaler, food/drug/mass merchandising chain, or other company
that purchase Product from ARISTOS.
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[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
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1.11
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“Effective Date” shall
mean May 1, 2008.
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1.12
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“Facility(ies)” shall
mean a production facility which has been validated and approved by
the Regulatory Authority of the country in which the Product
produced in such Facility is to be Marketed, and which complies
with the requirements of the Regulatory Authority of the country in
which the production facility is located. Initially the Facility
shall be SOVEREIGN Pharmaceuticals at 7590 Sand Street, Fort Worth,
TX, 76118 which has been inspected and approved.
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1.13
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“FDA” shall mean the
United States Food and Drag Administration or any successor
thereof.
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1.14
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“Initial Commercial
Delivery” shall mean the receipt by ARISTOS of the initial
batch quantities of each SKU of the Product set forth in the
“Per Batch Forecast” contained in the Initial Forecast
attached hereto as Exhibit C and to be delivered hereunder as
provided for in Section 2.4.
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1.15
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“Initial Forecast” shall
have the meaning ascribed to it in Section 2.1 (a).
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1.16
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“Initial Order” shall
have the meaning ascribed to it in Section 2.1 (b).
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1.17
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“Losses” shall mean
judgments, losses, liabilities, costs or expenses (including
reasonable attorney’s fees).
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1.18
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“Manufacturer” shall
mean SOVEREIGN if it Manufactures Product, or the Third Party
engaged through agreement of ARISTOS and SOVEREIGN to Manufacture
at a Facility if SOVEREIGN does not Manufacture.
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1.19
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“Manufacturing” or
“Manufacture” shall mean the activities associated with
producing a finished dosage form of the Product including Materials
acquisition, manufacturing, packaging, testing and labeling of
finished dosage form of the Product.
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1.20
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“Market”,
“Marketing”, or ‘Marketed” shall mean the
advertising, marketing sale, selling, marketing, and/or
distribution of Product.
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1.21
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“Materials” means all
ingredients, packaging supplies, printed materials and all other
components used to Manufacture the Product.
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1.22
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“Net Profit Share” means
the amount equal to a [***]% of Net Receipts (as defined in Section
1.23) between ARISTOS and SOVEREIGN, attached hereto as
Exhibit A.
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1.23
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“Net Receipts” means
with respect to a calendar month, the Net Sales for such calendar
month less the sum of: (i) the Distribution Cost,
(ii) the shipping cost from the Facility to ARISTOS’S
designated site, (iii) the shipping cost from the
ARISTOS’S designated site to Distributors and (iv) the
Purchase Price for the Units of Product sold during such calendar
month.
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[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
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1.24
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“Net Sales” means the
total gross invoices for Units of Product sold during a calendar
month to Third Party customers in the Territory in bona fide arms
length transactions, less: (a) quantity and/or cash discounts
actually allowed or taken, (b) customs duties and taxes, if
any, directly related to the sale of the Product and paid by
ARISTOS, (c) amounts allowed or credited by reason of
rejections, return of goods, and any retroactive price reductions
specifically identifiable as relating to the Product, within limits
which are customary in the pharmaceutical industry with respect to
the marketing of generic products, (d) amounts incurred
resulting from mandated rebate programs of the government of the
Territory (or any agency thereof), (e) third party rebates and
chargebacks related to the sale of the Product, to the extent
allowed, and (f) floor stocks.
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1.25
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“Party” or
“Parties’ shall mean ARISTOS or SOVEREIGN or both of
them, depending on the context.
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1.26
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“Person” means any
individual, corporation, partnership, joint venture, limited
liability company, trust or unincorporated organization or
government or any agency or political subdivision
thereof.
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1.27
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“Product” shall mean one
or more DESI products in the forms and strengths identified in
Exhibit D, in finished form, packaged and labeled as set forth
in Exhibit E (each such package being referred to herein as a
“Unit” and each strength and bottle size collectively
referred to herein as a “SKU”).
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1.28
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“Product Specifications”
shall mean those product, process, Manufacturing, packaging and
labeling specifications required in the Manufacture and delivery to
ARISTOS of Products in compliance with all applicable Regulatory
Requirements, including the Product formula and materials required
for the Manufacture of the Product that are to be purchased and
supplied under this Agreement, as such are in effect as of the
Effective Date and as such may be modified by SOVEREIGN after the
Effective Date.
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1.29
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“Purchase Order” shall
have the meaning set forth in Section 2.3.
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1.30
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“Purchase Price” shall
mean with respect to each Unit of Product, the prices to be paid by
ARISTOS to SOVEREIGN per Unit during the Term and which are set
forth in Exhibit B.
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1.31
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“Quality Agreement”
shall mean the agreement that shall be entered into by and between
the Parties within thirty (30) days of the Effective Date and
which shall govern all quality and regulatory issues arising out of
the transactions contemplated by this Agreement.
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1.32
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“Registration” shall
mean all permits, licenses, approvals and authorizations granted by
any Regulatory Authority with regard to the Product.
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1.33
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“Regulatory Authority”
shall mean any federal, state or local regulatory agency,
department, bureau or other governmental entity, including, without
limitation, the FDA and the U.S. Drug Enforcement Administration,
which is responsible for issuing
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approvals, licenses, registrations
(including the Registrations), permits or authorizations necessary
for, or otherwise governs, the Manufacture, handling, use, storage,
import, transport, distribution or sale of the Product in the
Territory.
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1.34
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“Regulatory
Requirements” shall mean all applicable approvals, licenses,
registrations (including the Registrations), cGMPs, and
authorizations and all other requirements of each applicable
Regulatory Authority in relation to the Product, including each of
the foregoing which is necessary for, or otherwise governs, the
Manufacture, handling, use, storage, import, transport,
distribution or sale of the Product.
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1.35
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“SKU” shall have the
meaning ascribed to it in Section 1.27.
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1.36
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“SOVEREIGN” shall mean
SOVEREIGN Pharmaceuticals Ltd, a Texas limited partner, located at
7590 Sand Street, Fort Worth, TX, 76118
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1.37
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“Standard Manufacturing
Batch” shall mean, with respect to each Product, the standard
finished lot size as set forth on Exhibit G attached
hereto.
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1.38
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“Subsequent Forecast”
shall have the meaning ascribed to it in
Section 2.2.
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1.39
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“Term” shall have the
meaning ascribed to it in Section 6.0.
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1.40
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“Territory” shall mean
the United States of America, its territories and possessions,
including Puerto Rico.
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1.41
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“Third Party” shall mean
any Person other than ARISTOS or SOVEREIGN.
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1.42
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“Unit” shall have the
meaning ascribed to it in Section 1.27.
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Article 2 —
Manufacture. Orders, Pricing, Payment and
Conformance
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2.0
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Manufacture and Sale of
Product .
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(a)
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SOVEREIGN hereby grants to ARISTOS
the exclusive right during the Term to Market in the
Territory.
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(b)
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During the Term, SOVEREIGN shall not
grant to any Third Party in the Territory the right to Market the
Product, as listed in Exhibit D
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(c)
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SOVEREIGN shall Manufacture, sell
and deliver the Product hereunder in accordance with (i) the
Product Specifications; (ii) cGMP; and (iii) the Act and
all other applicable Regulatory Requirements.
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(d)
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Product shall be Manufactured at the
SOVEREIGN Facility at 7590 Sand Street, Fort Worth, TX, 76118 or at
a Third Party Manufacturer’s Facility.
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2.1
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Initial Forecast: Initial
Order .
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(a)
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ARISTOS shall within fifteen
(15) Business Days of the Effective Date, provide a forecast
of the monthly requirements of Product to be manufactured and
supplied by the Manufacturer hereunder for the first twelve
(12) full calendar months of this Agreement (the
“Initial Forecast”).
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(b)
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The
first three (3) full calendar month portion of the Initial
Forecast shall be deemed a firm order (the “Initial
Order”).
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(c)
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A
Purchase Order for the Initial Order shall be submitted on or
before the twentieth (20th) Business Day after the Effective
Date.
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(d)
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The
production and supply requirements specified in and for the
remaining period of such Initial Forecast shall constitute
ARISTOS’S best estimate forecast of its Product production
and supply requirements.
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2.2
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Rolling Forecast
. On or before the first
(1st) calendar day of the last month of any calendar quarter
(excluding only the first such date following the Effective Date),
ARISTOS shall provide SOVEREIGN with an updated twelve
(12) month forecast for the Product (each, a “Subsequent
Forecast”).
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(a)
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Accompanying each Subsequent
Forecast will be a Purchase Order for the first three
(3) months of such Subsequent Forecast;
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(b)
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SOVEREIGN will confirm its
acceptance of the Subsequent Forecast no later than the 15th
calendar day of the calendar month preceding the forecast period
covered by such Subsequent Forecast at which time such Subsequent
Forecast shall become a firm order; provided, however, that if
SOVEREIGN is not able to commit to supply the forecasted amount in
such Subsequent Forecast, it shall inform ARISTOS of the amount it
can supply and the Parties shall meet and discuss the
discrepancy.
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(c)
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Forecasts (both the Initial Forecast
and Subsequent Forecasts) and Purchase Orders shall be in full
Standard Manufacturing Batches.
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(1)
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If
a particular strength of Product is sold in SKU’s of varying
bottle sizes, then the composite of the forecasted SKUs with
respect to such strength of Product must equate to a Standard
Manufacturing Batch.
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(2)
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If
a generically equivalent product to a Product launches, the
Forecast will be adjusted within thirty (30) days of
notification of the generically equivalent product’s
launch.
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(d)
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All
Product batches shall be made to order. ARISTOS will provide firm
Purchase Orders at least twelve (12) weeks prior to the
expected delivery date.
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(e)
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SOVEREIGN will use reasonable
efforts to maintain adequate active pharmaceutical ingredient and
other components to meet the requirements of the forecast provided
by ARISTOS.
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2.3
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Orders . Each purchase order or any
acknowledgment thereof, whether printed, stamped, typed or written,
shall be governed by the terms of this Agreement and none of the
provisions of such purchase order or acknowledgment shall be
applicable, except those specifying quantity ordered and required
delivery dates which shall be as specified in the relevant Initial
Forecast or the Subsequent Forecast, as the case may be (each, a
“Purchase Order”).
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2.4
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Delivery : Risk of Loss.
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(a)
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SOVEREIGN shall complete the Initial
Commercial Delivery on or before dates as set forth in
Exhibit H.
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(b)
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SOVEREIGN shall complete all other
deliveries of Product hereunder in accordance with the terms as set
forth in 2.2(d).
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(c)
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Shipment of Product shall be to the
ARISTOS location designated in the Purchase Order and shall be FOB
ARISTOS PHARMACEUTICALS, INC.’s distribution center in
Memphis, TN or such other site as ARISTOS may designate during the
Term.
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(d)
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Title and risk of loss to Product
supplied hereunder shall pass to ARISTOS upon delivery of the
Product to the designated carrier at the SOVEREIGN’S
warehouse specified in Section 2.6(c).
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2.5
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Inventory . Upon the expiration or termination
of this Agreement:
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(a)
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ARISTOS may elect to submit a
Purchase Order for and if so submitted, SOVEREIGN shall sell to
ARISTOS, in accordance with all Regulatory Requirements, the amount
of Product in the current Subsequent Forecast or Subsequent
Forecast for next calendar quarter for which ARISTOS has not
already placed a Purchase Order.
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(b)
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SOVEREIGN agrees that,
notwithstanding the expiration or termination of this Agreement,
ARISTOS may continue to sell Product in its inventory, including
Product purchased under this Section 2.5, until such inventory
is exhausted.
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(c)
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This Section 2.5 shall survive
expiration or termination of this Agreement.
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2.6
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Shipment: Payment Terms
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(a)
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SOVEREIGN shall invoice ARISTOS,
upon shipment for the Purchase Price
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corresponding
to the quantities and types of Product delivered pursuant to the
applicable Purchase Order consistent with the terms of this
agreement.
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(b)
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ARISTOS shall make payment in U.S.
dollars net ninety (90) days following receipt of each invoice
unless a longer period is agreed between ARISTOS PHARMACEUTICALS,
INC. and SOVEREIGN.
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(c)
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SOVEREIGN’S designated
warehouse is located in Fort Worth, TX.
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(d)
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The
Purchase Price set forth in Exhibit B shall be applicable
throughout the Term.
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2.7
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Non-Availability of
Product .
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(a)
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At
Fault. In the event that SOVEREIGN fails to deliver batch
quantities of Product consistent with the Initial Forecast or any
Subsequent Forecast and such delivery failures result in stock
outages through fault of SOVEREIGN that result in penalties from
Distributors, SOVEREIGN will reimburse all fines associated with
said penalties to ARISTOS.
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(b)
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No
Fault. In the event that SOVEREIGN fails to deliver batch
quantities of Product consistent with the Initial Forecast or any
Subsequent Forecast and such delivery failures result in stock
outages through no fault of SOVEREIGN that are not resolved through
good faith discussions, then ARISTOS may elect to purchase Product
from Third Parties for the period that SOVEREIGN is unable to
deliver Product hereunder.
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2.8
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Reports . On the thirtieth (30th) day of
each calendar month, ARISTOS shall provide to SOVEREIGN a report
setting forth, by SKU, the number of Units sold and the gross sales
dollars for the previous calendar month. If the market price for
Product listed on Exhibit D decrease(s) by more than ten
percent (10%), ARISTOS shall so notify SOVEREIGN within seven (7)
Business Days of ARISTOS’s receipt of such
information.
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2.9
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Payment to SOVEREIGN
. ARISTOS shall within
ninety (90) days after the end of each calendar
month:
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(a)
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provide SOVEREIGN with a written
statement detailing the computation of the Net Profit Share for
each Product for such month, and
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(b)
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pay
to SOVEREIGN such Net Profit Share. See Exhibit A.
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2.10
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SOVEREIGN’S Audit
Rights .
ARISTOS shall maintain and shall require its Affiliates to
maintain, at their respective offices, accurate and complete books
and records relating to the Products in such form and in such
reasonable detail as to enable SOVEREIGN and its Affiliates to
verify such information. Upon the written request of SOVEREIGN, but
not more than once each Contract Year, ARISTOS shall permit an
independent certified public accounting firm or consultants to have
access during normal business hours to such of the records of
ARISTOS as shall be necessary to verify the accuracy of
ARISTOS’s payments to SOVEREIGN. If such accounting firm or
consultant concludes that there are discrepancies in the reporting
or calculation of the Product sales such accounting firm shall
recalculate such amounts and (a) ARISTOS shall pay any additional
sums underpaid to SOVEREIGN within thirty (30) calendar days
of such redetermination; or (b) SOVEREIGN shall credit ARISTOS
for any overpaid amounts. The fees and expenses charged by such
accounting firm shall be paid by SOVEREIGN.
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Article 3 —
Warranties, Covenants and Indemnification
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3.0
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By SOVEREIGN . SOVEREIGN hereby represents,
warrants and covenants to ARISTOS that:
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(a)
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all
of the Product supplied and delivered by SOVEREIGN to ARISTOS under
and pursuant to this Agreement shall:
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(1)
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conform in all respects to the
Product Specifications;
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(2)
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comply with all of the requirements
under the Act and any Regulatory Requirements
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(3)
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at
the time of delivery, not be (A) adulterated or misbranded
within the meaning of the Act, or (B) be an article which may
not, under the provisions of the Act, be introduced into interstate
commerce;
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(4)
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be
free from all liens, encumbrances and defects in title other than
those that arise directly as a result of actions taken by
ARISTOS;
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(5)
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not, to its knowledge, infringe any
patents, trademarks or copyrights or misappropriate any trade
secrets of any Third Party in the Territory;
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(b)
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it
shall not, directly or indirectly, during the Term and for so long
as ARISTOS’s rights are exclusive, Market other than through
ARISTOS;
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(c)
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it
will, on or before May 1, 2008, exclusively own all the right,
title and interest in any intellectual property associated with the
Product in Exhibit D
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(d)
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it
has the exclusive right to purchase Product from
SOVEREIGN;
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(f)
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it
has the right to have ARISTOS order Product directly from
SOVEREIGN;
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(g)
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that SOVEREIGN will fill
ARISTOS’ s orders for Product at the Purchase
Price;
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(h)
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has
the right to license the rights set forth in (d), (e) and
(f) to ARISTOS; and
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(i)
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it
will, in carrying out the terms of this Agreement, act in a
reasonable commercial manner.
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3.1
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By ARISTOS . ARISTOS hereby represents,
warrants and covenants to SOVEREIGN that:
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(a)
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the
Marketing shall comply with all of the requirements under the Act
and any Regulatory Requirements;
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(b)
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it
will not sell or promote Product in the Territory for any
application other than the indications) approved by the applicable
Regulatory Authorities in the Territory as determined by
SOVEREIGN;
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(c)
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it
will not sell Product at a loss in order to obtain sales of another
ARISTOS product.
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(a)
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SOVEREIGN agrees to defend,
indemnify and hold ARISTOS, its Affiliates and all of their
respective parents, Affiliates, subsidiaries, officers, directors,
employees, agents, assignees and successors harmless from and
against any and all Losses resulting or arising from any claims,
demands, actions, causes of action, liabilities, suits,
proceedings, investigations, inquiries, injunctions or regulatory
actions by a Third Party to the extent such Losses arise from a
material breach by SOVEREIGN of any of its representations,
warranties, agreements, covenants or obligations contained in or
made pursuant to this Agreement; provided, however, SOVEREIGN shall
not be required to indemnify ARISTOS to the extent such Losses
arise from the (i) negligence or willful misconduct of ARISTOS
or its Affiliates, or (ii) a material breach of this Agreement
by ARISTOS.
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(b)
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ARISTOS agrees to defend, indemnify
and hold SOVEREIGN., its Affiliates and all of their respective
parents, Affiliates, subsidiaries, officers, directors, employees,
agents, assignees and successors harmless from and against any and
all Losses resulting from any claims, demands, actions, causes of
action, liabilities, suits, proceedings, investigations, inquiries,
injunctions or regulatory actions by a Third Party to the extent
such Losses arise from a material breach by ARISTOS of any of its
representations, agreements, covenants or obligations contained in
or made pursuant to this Agreement; provided, however, ARISTOS
shall not be required to indemnify SOVEREIGN to the extent such
Losses arise from the (i) negligence or willful misconduct of
SOVEREIGN or its Affiliates, or (ii) a material breach of this
Agreement by SOVEREIGN.
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(c)
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No
Party against whom a claim of indemnification is made under this
Agreement shall be liable hereunder with respect to an
indemnification claim relating to a Third Party claim or cause of
action unless the indemnified Party making such claim
shall:
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(1)
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notify the indemnifying Party of
such claim in accordance with Section 8.10 promptly upon
becoming aware of the existence or threatened existence of any such
claim giving rise to or that may give rise to a claim of
indemnification hereunder, and
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(2)
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allow the indemnifying Party full
control over the defense of such claim,
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(3)
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cooperate in the defense of such
claim at the indemnifying Party’s expense;
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(d)
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Notwithstanding the provisions of
Section 3.2(c):
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(1)
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the
failure to so notify, provide information and assistance will only
relieve the indemnifying Party of its obligations to the
indemnified Party hereunder if and to the extent that the
indemnifying Party is materially prejudiced thereby.
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(2)
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if
the indemnifying Party does not acknowledge its indemnification
obligation hereunder with respect to such claim and/or elects not
to defend such claim, the indemnified Party shall have the right,
but not the obligation, to defend and settle such claim until such
time as the indemnifying Party acknowledges in writing its
indemnification obligation hereunder with respect to such claim
and/or elects in writing to defend and settle such claim in
accordance with the indemnification provisions herein.
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(3)
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the
indemnified Party shall, at its own cost, have the right to
participate in any legal proceeding, settlement negotiation or
other like event and to contes
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