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EXHIBIT 10.20
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AMENDED AND RESTATED SUPPLY AGREEMENT
By and Among
NOVARTIS PHARMACEUTICALS CORPORATION,
and
NOVEN PHARMACEUTICALS, INC.
Dated as of April 1, 1999
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Securities and Exchange Commission. Asterisks denote omissions.
AMENDED AND RESTATED SUPPLY AGREEMENT
This AMENDED AND RESTATED SUPPLY AGREEMENT (the "Agreement")
is entered into as of April 1, 1999 (the "Effective Date"), by and between
Novartis Pharmaceuticals Corporation, a Delaware corporation ("Novartis") and
Noven Pharmaceuticals, Inc., a Delaware corporation ("Noven") (with each of
Noven and Novartis referred to individually as a "Party" or collectively as the
"Parties").
W I T N E S S E T H :
WHEREAS, Noven and Novartis, as the successor-in-interest to
the Pharmaceuticals Division of Ciba-Geigy Corporation, a New York corporation
("Ciba"), are parties to a certain Restated License Agreement (as defined
herein) covering the development, manufacture, and sale of the Finished Products
and a certain Supply Agreement (as defined herein) pursuant to which Noven
manufactured and supplied the Finished Products to Novartis; and
WHEREAS, Novartis and Noven have formed Vivelle Ventures LLC
pursuant to that certain Formation Agreement (the "Formation Agreement") dated
as of May 1, 1998 (the "LLC") for the purpose of creating a platform to maintain
and grow a franchise in women's health, focusing initially on the manufacture
and sale of the Finished Products; and
WHEREAS, Novartis as its contribution to LLC, among other
things, granted an exclusive sublicense to LLC of Novartis' rights under the
Restated License Agreement and made a limited assignment to LLC of Novartis'
rights and obligations under the Supply Agreement; and
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WHEREAS, Novartis desires Noven to supply it or the LLC, as
the case may be, with the Finished Products and Noven has the capability and is
desirous of supplying Finished Products to Novartis or the LLC pursuant to the
terms and conditions specified herein.
NOW, THEREFORE, in consideration of the premises and the
mutual covenants and conditions contained herein, the Parties agree to amend and
restate the Supply Agreement as follows, to more particularly set forth each
Party's rights and obligations thereunder:
ARTICLE 1. DEFINITIONS
The following terms, as used in the Agreement, shall have the
meanings set forth in this Article 1:
1.1 Except as otherwise provided herein, all capitalized terms
not defined herein shall have the same meaning ascribed to them in the Restated
License Agreement.
1.2 "GMP" shall mean the Current Good Manufacturing Practices
as that term is defined by the FDA which are in force or hereafter adopted by
the FDA in (a) its applicable regulations promulgated or issued thereunder, (b)
guidelines or directives that Noven and Novartis may mutually agree are
applicable, as amended from time to time and (c) good manufacturing practice as
required by GRB regulations.
1.3 "GRB" means the U.S. Food and Drug Administration or any
other government regulatory body of a country where the Finished Products are to
be sold or distributed which has authority over clinical testing, manufacturing,
marketing or sale of pharmaceutical products.
1.4 "Finished Products" shall mean the 17(beta)-estradiol
single active ingredient in a matrix currently being marketed by LLC under the
trademark "Vivelle" ("Vivelle") and the
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Securities and Exchange Commission. Asterisks denote omissions.
17(beta)-estradiol single active ingredient in a dot matrix currently being
marketed by Novartis (or the LLC as the case may be) under the trademark
"Vivelle-Dot" ("Vivelle-Dot") pursuant to the Restated License Agreement,
manufactured by Noven in accordance with the Specifications (as defined herein)
and supplied to Novartis by Noven in finished packaged form ready for retail
sale and distribution.
1.5 "Materials" shall mean all active ingredients and
excipients used in the manufacture of the Finished Products, as well as the
primary and printed packaging materials, collectively.
1.6 "Plant" shall mean (a) the Noven facility located at 00000
X.X. 000xx Xxxxxx, Xxxxx, Xxxxxxx 00000, and (b) any other Noven facility agreed
to by Novartis pursuant to paragraph 2.7 which has been qualified by a GRB for
manufacture of the Finished Products.
1.7 "Product Application" means a formal application seeking
approval to manufacture, market and sell the Finished Products within a
particular country or jurisdiction submitted by a Party to the appropriate GRB
under applicable laws, or such application owned by a Party including any
Abbreviated New Drug Application (ANDA) or New Drug Application (NDA), as
defined in the U.S. Federal Food, Drug and Cosmetic Act and applicable
regulations promulgated thereunder, as such are from time to time amended.
1.8 "Project Facilities" shall mean the Plant and all
facilities and equipment used by Noven to carry out the manufacture, storage,
disposal and transportation of the Finished Products, or any component thereof,
including those of any Noven contractor or subcontractor of any rank (including,
without limitation, environmental or health and safety consultant or waste
management firm).
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1.9 "Restated License Agreement" shall mean the Restated
License Agreement entered into between Noven and Novartis, dated November 15,
1991, pursuant to which Noven has granted Novartis an exclusive license under
the Patent Rights and Know-How (as defined therein), to manufacture, have
manufactured, use and sell the Finished Products and which has been exclusively
sublicensed to LLC pursuant to that certain Sublicense Agreement dated May 1,
1998.
1.10 "Specifications" shall mean, collectively, the Noven
manufacturing, packaging and standard testing procedures for the Finished
Products, including all applicable control procedures and analytical test
methods contained therein, as described in Exhibit A attached hereto, as may be
amended from time to time.
1.11 "Supply Agreement" shall mean that certain Supply
Agreement dated as of August 31, 1995 by and between Noven and Novartis assigned
in part to LLC pursuant to a Limited Assignment Agreement dated May 1, 1998 and
which has been amended and restated pursuant to this Agreement.
1.12 "Waste" shall mean all materials, except any Finished
Products or component thereof, present at the Plant and produced or generated in
connection with the manufacture of the Finished Products. Waste shall include
Finished Products or any component thereof which does not meet the
Specifications; waste water, recovered solvents, and other remainders and
materials; and components of the Finished Products, that are not used in the
manufacture by Noven of the Finished Products, or non-compliant Finished
Products which are returned to Noven pursuant to this Agreement.
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ARTICLE 2. MANUFACTURING
2.1 Noven shall manufacture the Finished Products in
accordance with the Specifications and all applicable laws and regulations
relating to the manufacture and packaging thereof, including but not limited to,
Sections 501, 502 and 505 of Federal Food, Drug and Cosmetic Act, as amended
from time to time. Upon Novartis' written request, Noven, at Novartis' expense,
shall provide Novartis with copies of any permits required by state and local
governing authorities having jurisdiction over any Plant for the operation of
any Plant or for the manufacture of the Finished Products.
2.2 The Specifications may be amended by mutual agreement of
Noven and Novartis. In the event that such changes result in increased
production costs to Noven, Noven and Novartis shall mutually agree as to the
allocation of such costs between the Parties. Additionally, Novartis shall
reimburse Noven for the costs of implementing any changes requested by Novartis
in labeling, packaging and preprinting of backing or pouch materials, and of
discontinuing stock of same due to such changes, provided, however, that
Novartis' obligation to reimburse Noven under this Section 2.2 shall be limited
to such quantities of stock as would be necessary for Noven to fill Novartis'
next Order (as defined in Section 4.3 herein) and for active drug substance,
such quantities sufficient to fill Novartis' requirements for a four-month
period. Notwithstanding the foregoing, Novartis, upon prior written notice to
Noven, shall have the right to change unilaterally the Specifications if
required by a GRB. In the event that change(s) required by a GRB result in
increased costs to Noven, all cost increases due to such change(s) shall be
shared equally between Noven and Novartis.
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2.3 Without the prior written approval of Novartis, which
approval shall not be unreasonably withheld, Noven shall not rework or reprocess
any Waste.
2.4 Noven acknowledges that it is familiar with and shall
abide by GMPs.
2.5 Noven shall keep accessible all books (including
laboratory books) and records maintained in connection with the testing of the
Finished Products, including those books and records relating to cross-over
cleaning, for a period of seven (7) years for purposes of United States
requirements and eleven (11) years in order to comply with Canadian requirements
from the date of generation of such documents.
2.6 Noven shall not change the manufacturing site for the
Finished Products from the Plant without the prior written approval of Novartis,
which approval shall not be unreasonably withheld.
2.7 Noven shall inform Novartis of any change in production
equipment used to manufacture the Finished Products prior to implementation, and
Novartis shall review each change in equipment within thirty (30) days after
notification in writing by Noven. All changes must be reviewed and approved in
writing by Novartis prior to being implemented, such approval not to be
unreasonably withheld, and Noven shall validate the production equipment where
required before production is initiated.
2.8 Noven shall package the Finished Products in accordance
with the Specifications and GMP, including identifying and labeling each
shipping unit as appropriate.
2.9 Notwithstanding anything contained herein to the contrary,
any Finished Products supplied by Noven for resale in Canada shall conform with
the standards, specifications, and all laws and regulations applicable with
respect to Canada, including but not
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limited to preprinting and labeling requirements, and shall be manufactured in a
facility approved for that purpose by the proper authorities of Canada, to the
extent that Novartis (a) assists Noven in determining of the applicable
standards, specifications, laws, and regulations of Canada and (b) agrees to an
appropriate increase in the per unit price for Finished Products in an amount
representing any increase in Noven's per unit cost for compliance therewith or
as a result of any Specification changes required by such standards,
specifications, laws and regulations.
2.10 ***.
ARTICLE 3. TERM
3.1 The term of this Agreement and the Parties' obligations
hereunder shall be deemed to have commenced on the earlier of the termination of
the Supply Agreement or the Effective Date and shall continue for three (3)
periods of twelve (12) months (each an "Agreement Year") with the first
Agreement Year commencing on the date this Agreement is executed by all Parties
(the "Term").
3.2 Six (6) months prior to the expiration of the Term the
Parties may negotiate to extend this Agreement for an additional twelve (12)
months (the "Extension Period").
ARTICLE 4. SUPPLY/PURCHASES
4.1 In each Agreement Year, Novartis agrees that it will
purchase from Noven and make payment for a minimum of *** ("Annual Purchase
Minimum"). For the time period representing the earlier of the termination of
the Supply Agreement or the Effective Date through the execution of this
Agreement by both parties (with such period herein referred to as the "Partial
Year"), Novartis agrees that it will purchase from Noven and make payment for a
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minimum amount of Finished Product equal to the pro rata share of the Annual
Purchase Minimum. For purposes of clarification, the Annual Purchase Minimum may
be comprised of any number of Vivelle and Vivelle-Dot individually prepackaged
dosage forms (each a "Unit") totaling, in the aggregate, *** of Finished
Products based upon the prices set forth on Exhibit B (as the same may be
adjusted in accordance with this Agreement). In the event that the actual
purchases of Finished Products are less than the Annual Purchase Minimum in any
Agreement Year, Noven may xxxx Novartis for the difference within thirty (30)
days following each Agreement Year. All amounts paid by Novartis (or by the LLC
as the case may be) to Noven for samples of Vivelle and Vivelle-Dot will be
credited in full against the Annual Purchase Minimum for the relevant Agreement
Year, Partial Year or portion thereof.
4.2 Noven represents and warrants that it possesses, and
covenants that during the Term and any Extension Period it will possess, the
capability of supplying Novartis, and that it shall supply Novartis pursuant to
Novartis' purchase orders, with *** Units of Finished Products ("Annual Supply
Minimum") during an Agreement Year. Noven further represents and warrants that
it possesses, and covenants that for the Partial Year it will possess, the
capability of supplying Novartis, and that it shall supply Novartis pursuant to
Novartis' purchase orders, with a minimum amount of Finished Product equal to
the pro rata share of the Annual Supply Minimum for said Partial Year. Noven's
failure to meet the Annual Supply Minimum shall be deemed a material breach of
the Agreement.
4.3 Within sixty (60) days after the execution of this
Agreement by both Parties, Novartis shall provide Noven with written forecasts
broken down monthly indicating each of the quantities of Vivelle and Vivelle-Dot
that Novartis estimates it will purchase during
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*** shall constitute a firm order ("Order"). Thereafter, at quarterly intervals,
Novartis shall provide Noven with an Order for one quarter plus an additional
one quarter's forecast, ***.
4.4 Orders will be placed within *** of each of the quantities
of Vivelle and Vivelle-Dot previously forecasted by Novartis ***; provided,
however, that Noven will use commercially reasonable efforts to produce
quantities in excess of *** of such Orders if requested by Novartis. Orders
shall indicate the quantities to be delivered and specific delivery dates which
shall be no sooner than ninety (90) days after receipt of an Order by Noven.
4.5 All Finished Products supplied by Noven pursuant to an
Order shall have been manufactured (a) no earlier than ninety (90) days prior to
the agreed upon delivery date of the Order, and (b) from a full lot of either
the Vivelle or Vivelle-Dot Unit dedicated to be delivered only to Novartis, so
that no portion of the lot from which either the Vivelle or Vivelle-Dot Unit
were manufactured shall have been delivered or planned to be delivered to a
third party. Noven shall complete the manufacturing process, including packaging
the Finished Product for retail sale, no later than six (6) months after the
manufacture of pouched system by Noven at the Plant.
4.6 Delivery of Finished Products shall be ***, title to
shipments of the Finished Products *** to ensure that the viability of the
Finished Product is maintained in accordance with the Specifications, ***.
4.7 The Parties agree that the provisions of this Agreement,
together with any amendments hereto, shall prevail over any inconsistent or
additional statements or provisions contained in any other documents passing
between the parties, including but not limited to, any Order, acknowledgment,
confirmation or notice.
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4.8 The license granted in Article 2 of the Restated License
Agreement shall not limit Noven's right to manufacture in the Territory
transdermal patch products containing estrogen and to export the same outside of
the Territory for resale by third parties outside the Territory, provided that:
(a) Noven shall not manufacture transdermal patch products
containing estrogen as the single active ingredient for any third party
for sale within the Territory without the prior written consent of
Novartis;
(b) All transdermal patch products containing estrogen as the
single active ingredient manufactured in the United States for export
by Noven or exported by Noven shall comply with all applicable laws and
regulations in the United States relating thereto, including without
limitation, GMPs;
(c) Noven will provide Novartis with (i) adverse drug
experience data required to be disclosed by Novartis under 21 C.F.R.
ss. 314.80 and/or 21 C.F.R. ss. 314.81 within five (5) business days of
receipt by Noven of the same as well as (ii) any additional information
required to be submitted by Novartis under 21 C.F.R. ss. 314.81, to the
extent that such additional information relates to transdermal patch
products containing estrogen as a single active ingredient, provided
that Noven now or hereafter has the right to disclose the same under
the terms of existing agreements with third parties, in a timely
manner;
(d) Except as required by law for export, Novartis labels or
labeling identifying Novartis shall not accompany or be placed on
transdermal patch products
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containing estrogen manufactured by Noven other than those manufactured
for Novartis; and
(e) Except for the right to manufacture for export granted
above, nothing in this Agreement confers any other rights upon Noven
under the NDA's or ANDA's transferred or required to be transferred to
Novartis pursuant to Article 7.2 of the Restated License Agreement. The
Restated License Agreement fully sets forth the rights of the parties
with respect to the NDA's and ANDA's transferred or required to be
transferred to Novartis.
ARTICLE 5. QUALITY CONTROL AND QUALITY ASSURANCE
5.1 Each lot of Finished Products manufactured by Noven in
accordance with Article 2 herein shall meet the applicable release standards as
set forth in the Specifications to assure the Finished Products meet regulatory
specifications at all times through the expiration date of that lot as defined
in the applicable Product Application. Noven shall employ appropriate change
control procedures to ensure that the applicable release standards remain
congruent with the applicable Product Application. Control procedures and
analytical test methods referenced in a given Product Application may not be
modified or superseded without the express written or verbal consent of Novartis
and only, if necessary, after approval by the appropriate GRB.
5.2 Noven shall be responsible for procuring all Materials and
shall ensure, through applicable GMP testing, that at all times all Materials
used in the manufacture of the Finished Products are in compliance with their
specifications and, as appropriate, are within the expiration dates printed on
their labels or packaging. Noven shall ensure that all Materials are stored
according to the precise storage conditions provided by their manufacturer or
supplier.
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Noven shall carry out all Materials testing in accordance with GMP and all
laboratory testing failures shall be promptly investigated and documented in
reasonable detail. Noven may release Materials for processing only upon receipt
of satisfactory test results. Noven shall employ appropriate change control
procedures to ensure the control procedures remain congruent with the applicable
Product Application and shall notify Novartis promptly of any changes to control
procedures.
5.3 Noven shall ensure that all Materials released for
processing are tested in accordance with agreed specifications and the filed
Product Application. Noven will confirm that all batches of Materials correspond
to the applicable specifications and GMP and are approved by Noven for
incorporation into the Finished Product. Noven shall retain samples of all
Materials used to prepare a lot of a Finished Product (except for water and
volatile solvents) for a period of at least one year beyond the expiration date
of the last lot of Finished Product containing said component. Packaging
components are represented by Noven's retention of samples of finished dosage
forms. The amount of retained sample shall be sufficient for at least three
complete and full testing analyses in accordance with the control procedures for
that component.
5.4 Noven shall investigate, in accordance with GMP, and
promptly notify Novartis in writing of any extraordinary event occurring during
the manufacture or packaging of a lot of Finished Product that is shipped to
Novartis. An "extraordinary event" is defined as any deviation from the
manufacturing and/or packaging procedures contained in the Specifications or
from GMP which may have the potential to result in a Finished Product outside
the established
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test specifications. Novartis reserves the right to review and evaluate all such
investigations prior to acceptance of a given lot of the Finished Product.
5.5 In-process testing shall be performed by Noven as required
by Noven's standard operating procedures but at all times consistent with the
applicable Product Application. Representative samples from each lot of a
Finished Product shall be tested by Noven for conformance with the requirements
of the applicable Product Application prior to shipment of the full lot unless
shipment prior to testing is agreed to in writing by Novartis. Any lot which
fails to conform to release standards shall be rejected. All laboratory testing
failures must be investigated and documented by the testing laboratory. Product
Specification failures resulting in batch rejections, in-process production and
environmental control specification failures, and critical equipment operating
parameter failures, must be fully investigated by Noven in a timely manner, to
determine the possible root cause, and necessary follow-up actions must be
conducted promptly. Noven shall notify Novartis in writing of each such failure
in the annual product review referred to in Section 5.8.
5.6 Noven shall complete a batch manufacturing record for each
lot of each Finished Product manufactured, retain it for at least seven (7)
years, and upon request shall provide a copy to Novartis. Records for all
Materials used in the manufacture of a particular lot of Finished Products as
well as supporting documentation for the validation of equipment and processes,
shall be retained for a period of one year beyond the expiration date of that
lot.
5.7 Noven shall store retained samples of each lot of Finished
Product as required by the applicable GRB. The amount retained shall be
sufficient for at least three complete and full testing analyses in accordance
with the control procedure.
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5.8 Noven shall perform follow-up stability testing and annual
product review in accordance with its standard operating procedures and
consistent with all applicable GRB regulations for each lot of Finished Product.
5.9 Noven shall be responsible for validating all
manufacturing and control procedures, including all applicable cleaning
procedures. Noven will allow Novartis to audit all relevant documents, as well
as the documentation concerning the qualification and calibration of equipment,
upon reasonable request.
5.10 Noven shall reject any lot which fails to meet the
applicable release standards as set forth in the Specifications or which does
not comply with the specifications set forth in the applicable Product
Application.
5.11 Noven shall provide test data and other information as
requested by Novartis to enable Novartis to evaluate and respond to customer
service and complaint handling operations relating to the Finished Products. In
the case of customer complaints or reports of adverse incidents relating to the
Finished Products, Noven shall provide Novartis, as promptly as possible, but in
all cases within fifteen (15) days from Noven becoming aware of said complaint
or incident, a written evaluation setting forth all relevant details applicable
to the complaint and, to the extent applicable, a copy of each customer or
regulatory complaint it receives concerning a Finished Product.
5.12 Each Party shall inform the other immediately upon
becoming aware of an upcoming or underway inspections by regulatory authorities
relating in any way to a Finished Product manufactured by Noven. Noven also
shall inform Novartis promptly upon becoming
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aware of any serious violation uncovered as a result of an inspection of its
facilities or its procedures which may impact the Finished Products or Novartis'
rights under this Agreement.
5.13 Re-use or issue by Noven of any returned Finished Product
bearing the Novartis tradename or any trademark owned by or licensed to Novartis
requires the express written approval of Novartis. Mis-shipments are not
classified as returned goods and can be placed back in distribution.
5.14 Upon reasonable notice and during normal business hours,
Novartis may inspect, on a confidential basis, Noven's facilities, batch records
and testing records to assure that the manufacturing and control processes were
carried out in accordance with GMP, the Specifications and all applicable GRB
regulations.
5.15 Any changes which may have a quality or regulatory impact
must be submitted to Novartis for approval prior to implementation. These
changes include but are not limited to changes or modifications to the existing:
manufacturing process, equipment, formulation, batch size, Material, suppliers,
processing of Materials, analytical methods, Specifications, storage conditions,
or transport conditions.
5.16 No later than two (2) months prior to the due date of
the annual report required to be filed with any GRB, for each of Vivelle and
Vivelle-Dot, Noven will furnish to Novartis information in reasonable detail
relating to stability data and any changes to the Specifications made in
accordance with this Agreement and any chemistry-related data. The Parties
acknowledge that the due date for the annual report required to be filed with
the U.S. Food and Drug Administration for each calendar year is October for
Vivelle and July for Vivelle-Dot.
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5.17 That certain Quality Assurance Agreement (the "QA
Agreement") by and between the Parties entered into on February 5, 1999,
attached as Exhibit C hereto, as amended from time to time, shall further define
the Parties obligations under this Article 5.
ARTICLE 6. PRICE
6.1 The price of each Unit of Vivelle and Vivelle-Dot
manufactured during the Term of the Agreement is set forth in Exhibit B attached
hereto.
6.2 The price of Finished Product, to be manufactured during
the Extension Period shall be negotiated by the Parties in good faith at least
six (6) months prior to the expiration of the Term of the Agreement.
6.3 The prices described in Section 6.1 shall be adjusted
thirty (30) days prior to each Agreement Year (except for the first Agreement
Year for which there is no adjustment) in accordance with any increases during
the previous Agreement Year in Noven's aggregate costs for materials and labor
used in manufacturing the Finished Products; provided, however, that no
adjustment shall exceed, on a percentage basis, the percentage increase in the
"Producer Price Index" published by the U.S. Department of Labor, Bureau of
Labor Statistics (the "Index") with 1998 as the base year or ***, whichever is
greater. If the cost of (a) either Estradiol, backing material or release liner
increases by *** or (b) any other raw material or combination of raw materials
increases by more than ***, Noven may, upon prior written notice to Novartis,
increase the prices for Finished Products by an amount which does not exceed
such increase in cost. Price increases under the preceding sentence shall be
effective solely during the period the cost increase is in effect and the
materials causing the increase are actually used in Finished Products.
Notwithstanding the prior two sentences, upon receipt of notice from Noven of a
price increase
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described in the prior two sentences, if Novartis is able to purchase the raw
material or materials subject to the cost increase at a lower cost than that
available to Noven, Novartis shall have the option of purchasing such raw
material or materials and providing them to Noven, in which case the price
increase described in the prior two sentences shall not take effect ***. Should
the publication of said Index be discontinued by said Bureau of Labor
Statistics, then such other indexes as may be published by said Bureau most
nearly approaching said discontinued Index shall be used in determining the
adjustment hereunder. Should said Bureau discontinue the publication of any such
index, then such indexes as may be published by another United States
governmental agency, as most nearly approximating the Index, shall govern and be
substituted as the Index hereunder.
6.4 During the Term of the Agreement or the Extension Period,
Novartis may propose making process improvements to manufacturing in order to
maximize the efficiency of the manufacturing processes. Noven shall act in good
faith to review any such proposal and, if implemented by Noven, the Parties
shall negotiate a reduction in the pricing of the Finished Products based upon
the improvement, taking into account each Party's costs incurred in realizing
such benefits, to ensure that the Parties share such benefits equally.
ARTICLE 7. RESPONSIBILITY
7.1 Noven shall use best efforts to manufacture and deliver
Finished Products to Novartis which meet the Specifications. Novartis shall use
best efforts to properly store, handle and care for the Finished Products while
in Novartis' possession or control. Novartis shall, within sixty (60) days after
Novartis receives delivery of each shipment of Finished Products, notify Noven
in the event of the non-compliance of the Specifications of all or any part
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of said shipment to the extent such non-compliance is not due to the fault of
Novartis, and shall immediately provide Noven with samples of the Finished
Products upon Noven's request. Failure to provide such notification to Noven
shall constitute acceptance by Novartis of the shipment, except for latent
defects caused by the gross negligence or willful misconduct of Noven.
7.2 In the event of notification by Novartis of any
non-compliance with the Specifications of the shipment to the extent such
non-compliance is not due to the fault of Novartis, the particular shipment
shall be set aside and held intact by Novartis until all questions relating to
the non-compliance of the shipment have been resolved, corrected, or remedied to
Novartis' satisfaction.
7.3 With respect to the purchase price and cost of
transportation and disposal of Finished Products that are not in compliance with
the Specifications, to the extent such non-compliance is not due to the fault of
Novartis, Noven's liability to Novartis shall be (a) at Novartis' option, (i)
replacement of the Finished Products, (ii) reimbursement of the purchase price
of the Finished Products, or (iii) credit to Novartis for future orders of
Finished Products; and (b) payment for the reasonable cost of transportation and
disposal of any non-compliant Finished Products.
7.4 Noven agrees and warrants to indemnify, defend, and hold
harmless Novartis from and against any and all claims, damages, expenses,
attorneys' fees, settlements, and judgments arising out of any injury or damage
to a third party alleged to be caused by the Finished Products supplied by Noven
to Novartis whether manufactured for or by Noven; provided, however, that
Novartis notifies Noven within twenty (20) days of receipt of a claim or
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action, fully cooperates with Noven in the defense of such claim or action, and
permits Noven to control the defense and settlement of such claim or action.
Notwithstanding the above, Noven does not warrant and shall not be liable to
indemnify Novartis from and against any claims, damages, expenses, attorneys'
fees, settlements and judgments to the extent arising out of any injury or
damage to a third party caused by the negligence or willful misconduct on the
part of Novartis or breach by Novartis of this Agreement, for which Novartis
shall have the right to control the defense and settle such claim or action.
Novartis agrees and warrants to indemnify and hold harmless Noven from and
against any and all claims, damages, expenses, attorneys' fees, settlements and
judgments for personal injury to a third party to the extent caused by the
negligence or willful misconduct of Novartis or breach by Novartis of this
Agreement. This provision shall survive expiration or termination of this
Agreement.
7.5 If an authorized government agency of the United States or
any country or territory shall seize any Finished Products or if Novartis in its
sole judgment deems it necessary to initiate a voluntary recall for any
commercially reasonable reason, Novartis shall immediately notify Noven of such
seizure or recall and shall consult with Noven regarding the timely compliance
with all pertinent state or federal regulations pertaining thereto. Notification
of the applicable GRB authorities shall be coordinated. Furthermore, each Party
shall make a permanent and complete record of all costs incurred thereby, a copy
of which shall be delivered to the other Party as soon after the completion of
such recall or seizure as practically may be done. When the cause or reason of
said recall or seizure resides in the negligent failure of Noven to manufacture
in accordance with the Specifications or applicable government rules and
regulations, or in the failure of said product to maintain stability for the
period described in the
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product labeling, Noven shall reimburse Novartis for all reasonable costs
incurred by Novartis in effecting such recall or seizure, including all
reasonable credits extended to Novartis' customers as a result thereof. When the
cause or reason for said recall or seizure is anything other than that set forth
in the preceding sentence, including, but not limited to, failure by others than
Noven or its agents to properly store or transport the Finished Products,
Novartis shall bear all costs of such recall or seizure and indemnify Noven
therefrom including reimbursement for all reasonable costs incurred by Noven at
Novartis' request in effecting such recall or seizure.
ARTICLE 8. PAYMENT
Payment for the Finished Products furnished to Novartis shall
be made by Novartis no later than thirty (30) days after Novartis' receipt of
the invoice from Noven or delivery of the Finished Products to Novartis,
whichever is later. In the event Novartis shall, with respect to any delivery of
the Finished Products complying with Specifications, fail to make payment of
undisputed amounts when due and payable, and shall fail to remedy such failure
within thirty (30) days after Novartis' receipt of written notice of such
failure from Noven, Noven may suspend its obligation (a) to meet the Annual
Supply Minimum and (b) deliver Finished Products pursuant to an Order, until
such undisputed amount has been paid in full. In addition to the foregoing, upon
written notice to Novartis, interest shall accrue on any undisputed amount due
and payable to Noven at the prime rate plus *** until such amount is paid. The
prime rate shall be the rate specified as the prime rate in the Wall Street
Journal on the date such undisputed amount was due and payable.
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ARTICLE 9. AUDIT AND INSPECTION RIGHTS
9.1 During the term of this Agreement and the Extension
Period, Novartis and its authorized representatives shall have the right, at
Novartis' expense, to audit, inspect and observe the manufacture, storage,
disposal and transportation of the Finished Products or Waste during normal
business hours upon five (5) days prior notice. All employees and
representatives of Novartis (a) shall comply with and observe all applicable
rules and regulations governing their conduct while performing their audit,
inspection, or observation, and (b) shall have no authority to manage,
supervise, or control, any of Noven's employees. Noven agrees to respond to
Novartis' audit findings within thirty (30) days of receipt of the audit report
and to be responsive to the recommendations contained therein.
9.2 Noven shall make available all records and reports
relating to the manufacture, storage, disposal and transportation of Finished
Products and/or Waste to Novartis, as well as those documents relating to
analytical and stability data, for Novartis' review during normal business hours
and upon reasonable prior notice to Noven, and Novartis shall have the right to
copy these documents as required. In the event that Novartis supplies materials
to be used by Noven, Novartis shall have the right to conduct inventory
reconciliation audits and other audits as reasonably required for its internal
control.
9.3 Noven agrees to fully respond within forty-five (45) days
of receipt, to an annual questionnaire provided by Novartis concerning Noven's
safety, health and environmental practices and any changes thereto.
9.4 Noven shall promptly give Novartis advance notice, to the
extent that advance notice is given to Noven, of any site visit to the Plant
regarding the manufacture,
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storage, disposal or transportation of the Finished Products or Waste by any
governmental or regulatory agency; provided, however, that Noven shall notify
Novartis within eight (8) hours of notification to Noven of any site visits by
the FDA or other GRB. Novartis shall have the option of attending any such site
visit by any governmental or regulatory agency, if the site visit relates
directly or indirectly to the manufacturing, storage, disposal and
transportation of the Finished Products. Should Novartis not participate in the
site visit, Noven shall fully report in writing the substance and results of the
visit to Novartis within seven (7) days of the occurrence thereof. In the event
that any such governmental or regulatory agency finds that a Plant is deficient
or unsatisfactory in any respect, Novartis shall have the option to (a) assist
Noven, at Noven's expense in correcting the deficiency, or (b) terminate this
Agreement provided the violations materially impair Noven's capability to
continue to produce Finished Products in accordance with this Agreement.
ARTICLE 10. WASTE DISPOSAL
Noven shall assume responsibility for disposing of all Waste
in accordance with all applicable laws and regulations, and in accordance with
all Novartis requirements, standards and procedures provided in writing to
Noven. Novartis shall provide to Noven a list of disposal sites previously
approved by Novartis. If Novartis and Noven cannot mutually agree upon a
disposal method or site, Novartis shall have the option of assuming the
responsibility to dispose of such Waste itself at Noven's expense, such expense
not to exceed that which would otherwise be incurred or expended by Noven if
lawfully disposed of by Noven. Copies of all documentation evidencing disposal
by Noven shall be made available to Novartis upon Novartis' request and expense.
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ARTICLE 11. SAFETY
Noven shall comply with all applicable health and safety
regulations policies and procedures relating to the manufacture and packaging of
the Finished Products including the transmission by Noven to its employees of
health and safety information relating to the Finished Products, and their
manufacture, storage, disposal and transportation.
ARTICLE 12. ENVIRONMENTAL, HEALTH AND SAFETY WARRANTY INDEMNIFICATION
Noven represents and warrants that all Project Facilities
shall be in full compliance with all applicable health, safety and
environmental, laws, statutes, ordinances, regulations, rules and
pronouncements. Noven agrees and warrants to indemnify, defend and hold harmless
Novartis, its officers and employees, from any and all liability (including
strict and joint and several liability) or loss arising from or related to
(including liability for threatened harm) Project Facilities and Waste disposal.
Novartis agrees and warrants to indemnify, defend and hold harmless Noven, its
officers and employees, from any and all liability (including strict and joint
and several liability) or loss arising from or related to Waste disposal for
which Novartis has assumed responsibility.
ARTICLE 13. CONFIDENTIALITY
(a) Each Party acknowledges that the information disclosed in
connection with the activities contemplated hereunder may contain confidential
information of the disclosing Party ("CONFIDENTIAL INFORMATION"), and that any
such Confidential Information shall remain the property of the disclosing Party
(such Party hereinafter referred to as the "DISCLOSING PARTY"). Each Party
agrees, covenants and acknowledges that, except to the extent expressly
permitted by
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this Agreement or as otherwise agreed to by the Parties in writing, from and
after the Effective Date of this Agreement, it will not disclose, give, sell,
use or otherwise divulge any Confidential Information received from the
Disclosing Party (whether written or oral) which is marked as CONFIDENTIAL or
orally indicated to be confidential and subsequently confirmed in writing as
confidential within thirty (30) days after its disclosure.
(b) Each Party agrees, covenants and acknowledges that from
and after the Effective Date of this Agreement, it will exercise the same degree
of care with respect to protecting the Confidential Information of the
Disclosing Party as the care it exercises with respect to its own Confidential
Information.
(c) In the event a Party or its respective employees,
officers, directors or advisors, who have received Confidential Information
(hereafter the "RECIPIENT"), become legally compelled to disclose any
Confidential Information, such Recipient shall provide the Disclosing Party with
prompt written notice of such requirement so that such Disclosing Party may seek
a protective order or other remedy or waive compliance with this Article 13. In
the event that such protective order or other remedy is not obtained, or such
Disclosing Party waives compliance with this Article 13, then the Recipient
shall furnish only that portion of Confidential Information which is legally
required to be provided and exercise its best efforts to obtain assurances that
appropriate confidential treatment will be accorded the Confidential
Information.
(d) The confidentiality and restrictive use obligations under
this Article 13 shall not apply to (i) any information that, at the time of
disclosure, is or subsequently becomes available publicly; PROVIDED, HOWEVER,
that such information was not disclosed in breach of this Agreement by the
Recipient or any of its Affiliates or their respective employees, officers,
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directors or advisors, or (ii) is hereafter made available to the Recipient from
a source other than the Disclosing Party, which source did not obtain same from
the Disclosing Party and did not impose an obligation of confidentiality on the
Recipient.
(e) The Parties recognize that the performance of the
obligations under this Article 13 are special, unique and extraordinary in
character, and that in the event of the breach by either Party or their
Affiliates or their respective employees, officers, directors or advisors of the
terms and conditions of this Article 13, the Disclosing Party shall be entitled,
if it so elects, to institute and prosecute proceedings in any court of
competent jurisdiction, either at law or in equity, to enforce the specific
performance thereof by such Party or to enjoin such Party or their Affiliates or
their respective employees, officers, directors or advisors from violating the
provisions of this Article 13.
ARTICLE 14. INTELLECTUAL PROPERTY
All inventions, whether patentable or not, conceived and
reduced to practice by Novartis alone shall be owned by Novartis. All
inventions, whether patentable or not, conceived and reduced to practice by
Noven alone shall be owned by Noven. All inventions, whether patentable or not,
conceived and reduced to practice jointly by Novartis and Noven shall be owned
jointly by Novartis and Noven.
ARTICLE 15. TERMINATION AND DEFAULT
15.1 TERMINATION
15.1.1 Novartis may terminate this Agreement during the Term
without cause upon ninety (90) days' written notice; provided, however, that
Novartis shall be obligated to pay
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the Annual Purchase Minimum in accordance with the provisions of Section 4.1
herein for the remainder of the Term, but excluding the Extension Period.
15.1.2 Noven may not terminate this Agreement except as
otherwise provided herein.
15.1.3 The right of, either Party to terminate this Agreement,
as herein provided, shall not be affected in any way by its waiver of or failure
to take action with respect to any previous defaults.
15.1.4 This Agreement and the obligations of the parties
hereunder shall immediately terminate upon termination of the Restated License
Agreement.
15.2 DEFAULT
15.2.1 If Noven shall be in default with respect to any
material obligation hereunder and fail to cure such default within thirty (30)
days after notice thereof, then Novartis may terminate this Agreement during the
Term or the Extension Period by giving thirty (30) days' prior written notice to
that effect.
15.2.2 Notwithstanding Section 15.2.1 above, any intentional
violation by Noven of Article 10, 11 or 12 shall be grounds for immediate
termination by Novartis of this Agreement during the Term or the Extension
Period.
15.2.3 Notwithstanding Section 15.2.1 above, Novartis shall
have the right to immediately terminate this Agreement during the Term or the
Extension Period in the event of (a) a Change of Control event with respect to
Noven as defined in that certain Limited Liability Company Operating Agreement
(the "Operating Agreement") dated as of May 1, 1998 by and between the Parties
that, at such time, would permit Novartis to dissolve the LLC pursuant to the
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terms of such Operating Agreement or (b) an assignment or delegation of this
Agreement by Noven without the prior written consent of Novartis.
15.2.4 In the event that Noven is not able to supply any
portion of the Finished Products pursuant to an Order, then Novartis shall have
the right to manufacture, or have a third party manufacture on its behalf, that
portion of Novartis' requirements of the Finished Products which Noven is not
able to supply. If Noven is not able to supply any portion of the Finished
Products pursuant to an Order for more than one hundred and twenty (120) days,
then Novartis shall have the right (a) to source from another manufacturer, (b)
void the terms of Articles 4 in whole or in part, and (c) terminate this
Agreement.
15.2.5 Either party shall have the right to terminate this
Agreement in the event that any proceeding under a Bankruptcy Act or an
insolvency, receivership or dissolution proceeding is filed by or against the
other party and such proceeding is not dismissed within sixty (60) days after
the filing thereof.
15.2.6 Noven shall also have the right to terminate this
Agreement if Novartis fails to make payment(s) (i) upon undisputed amounts
exceeding *** or (ii) upon any amounts exceeding *** due hereunder within the
time provided therefor and continues in default for more than ninety (90) days
after receiving notice from Noven, such termination to be effective upon further
notice to Novartis after failure by Novartis to cure such default.
ARTICLE 16. OBLIGATIONS UPON TERMINATION
Except as otherwise agreed by the parties, within thirty (30)
days of the effective date of the expiration or any termination of this
Agreement, Novartis and any Supplier in possession of Know-How shall cease to
use and deliver to Noven, upon written request all
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Know-How, to the extent that such use is not permitted by the Restated License
Agreement except for any documents or records which either Novartis or the
Supplier is required to retain by law, and Noven shall do the same with respect
to any Novartis Know-How in its possession. Noven shall deliver to Novartis, at
Novartis' request and expense, all Finished Products and preprinted packaging,
labeling and stock materials which are in the possession of Noven, for which
Novartis shall be obligated to make payment upon delivery.
ARTICLE 17. INSURANCE
Noven shall maintain the types and amounts of insurance set
forth in Exhibit D, attached hereto.
ARTICLE 18. PUBLICITY
Without the prior written consent of Novartis as to the text,
intended date and time (EST time) of publication, Noven agrees not to issue any
press release or other public statement disclosing the existence of or relating
to this Agreement; provided, however, that Noven shall not be prevented from
complying with any duty of disclosure it may have pursuant to law or applicable
stock exchange rules.
ARTICLE 19. ASSIGNMENT
Neither Party shall assign its rights or obligations hereunder
to a third party without the prior written consent of the other Party, such
consent not to be unreasonably withheld, and any attempt to make such assignment
without such consent shall render this Agreement null and void.
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ARTICLE 20. GOVERNING LAW
This Agreement shall be governed by and construed in
accordance with the laws of the State of New York without regard to
choice-of-law principles of the State of New York.
ARTICLE 21. SEVERABILITY
If any one or more of the provisions of this Agreement shall
be held to be invalid, illegal or unenforceable, the validity, legality or
enforceability of the remaining provisions hereof shall not in any way be
affected or impaired thereby. In the event any provisions shall be held invalid,
illegal or unenforceable, the parties shall use best efforts to substitute a
valid, legal and enforceable provision, which, insofar as practical, implements
the purposes hereof.
ARTICLE 22. NOTICES
22.1 All notices, requests, demands and other communications
hereunder shall be given in writing and shall be: (a) personally delivered; (b)
sent by telecopier, facsimile transmission or other electronic means of
transmitting written documents; or (c) sent to the Parties at their respective
addresses indicated herein by registered or certified U.S. mail, return receipt
requested and postage prepaid, or by private overnight mail courier service. The
respective addresses to be used for all such notices, demands or requests are as
follows:
(a) If to Noven, to:
Noven Pharmaceuticals, Inc.
00000 X.X. 000xx Xxxxxx
Xxxxx, XX 00000
Attention: Xx. Xxxxxx X. Xxxxxxx, President and
Chief Executive Officer
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
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with a copy to:
Noven Pharmaceuticals, Inc.
00000 X.X. 000xx Xxxxxx
Xxxxx, XX 00000
Attention: General Counsel
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
or to such other person or address as Noven shall furnish to
Novartis in writing.
(b) If to Novartis, to:
Novartis Pharmaceuticals Corporation
00 Xxxxx 00
Xxxx Xxxxxxx, XX 00000
Attention: Office of the CEO
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with copies to:
Novartis Pharmaceuticals Corporation
00 Xxxxx 00
Xxxx Xxxxxxx, XX 00000
Attention: General Counsel
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
and
White & Case LLP
0000 Xxxxxx xx xxx Xxxxxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxxxx X. Xxxxx, Xx., Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
or to such other person or address as Novartis shall furnish
to Noven in writing.
If personally delivered, such communication shall be deemed
delivered upon actual receipt; if electronically transmitted pursuant to this
paragraph, such communication shall be deemed delivered on the day transmitted
unless it is received after 5:00 p.m., New York time,
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or on a day which is not a business day, in which case it shall be deemed
delivered on the next business day after transmission (and sender shall bear the
burden of proof of delivery); if sent by overnight courier pursuant to this
paragraph, such communication shall be deemed delivered upon receipt; and if
sent by U.S. mail pursuant to this paragraph, such communication shall be deemed
delivered as of the date of delivery indicated on the receipt issued by the
relevant postal service, or, if the addressee fails or refuses to accept
delivery, as of the date of such failure or refusal. Either Member may change
its address for the purposes of this Agreement by giving notice thereof in
accordance with this Section.
ARTICLE 23. FORCE MAJEURE
Neither Party shall be responsible or liable to the other
hereunder for failure or delay in performance of this Agreement due to any war,
fire, accident or other casualty, any governmental action, any labor
disturbance, any act of God or the public enemy, or any other cause beyond such
Party's reasonable control. In the event of the application of this Article, the
party affected by such force majeure shall use its best efforts to eliminate,
cure and overcome any of such causes and resume performance of its obligations;
provided, however, that either Party shall have the right to terminate this
Agreement if performance of this Agreement is prevented for a continuous period
of one hundred twenty (120) days.
ARTICLE 24. COST
Unless otherwise specified, each Party shall bear the full
cost of its compliance with the terms of this Agreement and its respective
obligations hereunder. For purposes of this Agreement, the term "costs" when
used herein shall mean the fully allocated costs including but not limited to
the fully allocated cost of goods and services and manufacturing overhead
directly
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related to Finished Products, and allocation of all administrative and general
expenses directly related to Finished Products. Costs shall be determined by
generally accepted accounting principles, applied on a consistent basis.
ARTICLE 25. LICENSE AGREEMENT AND OTHER AGREEMENTS
Unless otherwise specified herein and the Exhibits attached
hereto, nothing contained in this Agreement shall affect the rights and
obligations of the Parties under the Restated License Agreement, the Formation
Agreement or any other agreement by and between the Parties and the terms and
conditions of all such agreements shall remain in full force and effect.
ARTICLE 26. ENTIRE AGREEMENT
This Agreement and the Exhibits attached hereto constitute the
entire understanding between the Parties relating to the subject matter hereof,
and no amendment or modification to this Agreement shall be valid or binding
upon the Parties unless designated as such, made in writing and signed by the
representatives of such Parties.
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IN WITNESS WHEREOF, this Agreement has been duly executed by
the Parties to be effective as of the day and year first written above.
NOVEN PHARMACEUTICALS, INC.
By /s/ Xxxxxx X. Xxxxxxx
--------------------------------------
Name: Xxxxxx X. Xxxxxxx
Title: President and Chief Executive Officer
Date: January 18, 2000
NOVARTIS PHARMACEUTICALS
CORPORATION
By /s/ Xxxxx Xxxxx
--------------------------------------
Name: Xxxxx Xxxxx
Title: President and Chief Executive Officer
Date: January 11, 2000
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EXHIBIT A
FINISHED PRODUCT SPECIFICATION
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EXHIBIT B
FINISHED PRODUCT PRICE SCHEDULE
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EXHIBIT C
QUALITY ASSURANCE AGREEMENT
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EXHIBIT D
INSURANCE
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