Confidential
MANUFACTURING AGREEMENT
This MANUFACTURING AGREEMENT ("Agreement"), having an effective date of the
1st day of March, 2004, (the "Effective Date"), is made and entered into by
and between AstraZeneca LP, having a principal place of business at 00 Xxxx
Xxxxxx, Xxxxxxxxxxx, XX 00000("XX") and the Dentsply Anesthetics Division of
Maillefer Instruments Trading S.a.r.L., having a place of business at Xxxxxx
xx Xxxxxx 0, XX-0000 Xxxxxxxxxx, Xxxxxxxxxxx ("Dentsply").
RECITALS
WHEREAS, as of the date last written below (the "Execution Date"), AZ is
manufacturing certain Products (as defined in Article 1 below) for sale
by Dentsply pursuant to the AZLAD Products Manufacturing Agreement
between AstraZeneca AB and Maillefer Instruments Holding S.A. ("MIH")
(the respective parent companies of AZ and Dentsply) dated January 18,
2001 (the "2001 Agreement"); and
WHEREAS, AZ's obligations to manufacture and Dentsply's obligations to
purchase the Products under the 2001 Agreement terminate on February 29,
2004; and
WHEREAS, AZ and Dentsply desire to enter into an arrangement for the
manufacturing of the Products as of the Effective Date, which Products
will be manufactured by AZ for sale by Dentsply, on the terms and
conditions set forth in this Agreement; and
WHEREAS, in order to allow AZ to take into account such manufacturing
obligations for its strategic planning purposes, AZ and Dentsply have
agreed to enter into this Agreement on the Execution Date.
NOW, THEREFORE, the parties hereto, intending to be legally bound, agree
to the following:
1. DEFINITIONS
The following terms for the purpose of this Agreement shall have the
following respective meanings:
1.1 "Active Ingredient" means, with respect to any Product, the active
pharmaceutical ingredient in a Product.
1.2 "Affiliate" means, with respect to any Person, another Person that
directly, or indirectly through one or more intermediaries,
controls, is controlled by or is under common control with such
Person. "Control," and with correlative meanings, the terms
"controlled by" and "under common control with" means the power to
direct or cause the direction of the management or policies of a
Person, whether through the ownership of voting securities, by
contract, resolution, regulation or otherwise. With respect to AZ,
"Affiliate" shall also mean any corporation or other business
entity that controls, is controlled by or under common control with
AstraZeneca PLC. With respect to Dentsply, "Affiliate" shall also
mean any corporation or other business entity that controls, is
controlled by, or is under common control with MIH.
1.3 "Annual Period" means a calendar year, provided, however, that the first
Annual Period shall run from the Effective Date through December 31
of such year and is therefore less than a calendar year.
1.4 "Batch" means a quantity of 3,750 Sales Units, and is equal to 375,000
individual dental cartridges of one Product
1.5 "CGMP Requirements" means the FDA's current Good Manufacturing Practice
requirements as promulgated under the FFDCA at 21 CFR (Parts 210
and 211), and as further defined by FDA guidance documents, as such
may be amended from time to time, applicable to the clinical
processing and bulk packaging of the Products.
1.6 "Components" means all containers, closures, packaging components,
labels and labeling necessary for the manufacture of the Product as
finished goods.
1.7 "Confidential Information" has the meaning set forth in Section 12.1 of
this Agreement.
1.8 "Effective Date" means the date written in the preamble of this
Agreement.
1.9 "Facility" means AZ's facility in Westborough, Massachusetts.
1.10 "FDA" means the United States Food and Drug Administration, or any such
successor agency of the Federal government.
1.11 "FFDCA" means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.ss.ss.301
et seq., as amended.
1.12 "Firm Order" has the meaning set forth in Section 2.3(b) of this
Agreement.
1.13 "Forecast" has the meaning set forth in Section 2.3(b) of this Agreement.
1.14 "Government and Regulatory Authority Approval" means any and all actions
of a Government or Regulatory Authority necessary for the
Manufacture and distribution of the Products.
1.15 "Government or Regulatory Authority" means any United States Federal,
state, or local government, governmental instrumentality or
governmental or other regulatory or administrative authority,
agency, department, board or court, tribunal or judicial,
administrative or arbitration tribunal, and any foreign counterpart
thereof.
1.16 "Law" means any Federal, state or local law, statute or ordinance, or
any rule, regulation, or published guidelines, or any statement
having the effect of law, promulgated by any Government or
Regulatory Authority.
1.17 "Materials" means, with respect to any Product, all inactive raw
materials used in the formulation of the Product necessary for the
manufacture of the Product as finished goods.
1.18 "Manufacture" and "Manufacturing" means the manufacturing, processing,
formulating, packaging and holding of such Product prior to
delivery to Dentsply and performing the in-process and other
testing of the Product required to be performed by AZ pursuant to
the Quality Agreement prior to delivery to Dentsply.
1.19 "Party" means each of AZ and Dentsply.
1.20 "Person" means any natural person, corporation, general partnership,
limited partnership, limited liability company, proprietorship,
other business organization, trust, union, association or
Government or Regulatory Authority.
1.21 "Product" means any of the products set forth in Exhibit A attached
hereto and made a part hereof.
1.22 "Quality Agreement" means the Agreement executed between the Parties on
the date hereof, in the form set forth in Exhibit B hereto, and any
similar successor agreement governing the same subject matter.
1.23 "Specifications" means, with respect to each Product, the Product
description and attributes set forth in Exhibit C attached hereto
and made a part hereof, and any changes thereto as mutually agreed
upon by the Parties in accordance with Section 2.1.
1.24 "Territory" means the United States of America, Canada and Puerto Rico.
1.25 "Sales Unit" means one hundred (100) dental cartridges of a Product
1.26 "Work in Process" shall mean, with respect to any Product, all Materials
and Active Ingredient from the time of pre-weighing for allocation
to a manufacturing lot until satisfactory completion of quality
testing for such manufacturing lot.
2. MANUFACTURE OF PRODUCTS
2.1 Manufacturing. AZ agrees to Manufacture the Products, subject to the
terms and conditions set forth in this Agreement, to meet
Dentsply's requirements for the Products. AZ shall Manufacture the
Products (a) in accordance with the Specifications, as may be
amended in writing from time to time, with written notice by
Dentsply and mutual agreement of the Parties and (b) in material
compliance with the Quality Agreement, this Agreement, the CGMP
Requirements and all other applicable legal requirements.
Notwithstanding the provisions of this Agreement or any of its
Exhibits, including but not limited to the Specifications, AZ shall
implement, as soon as possible, any change to the Manufacture of
Products that is required or recommended by the FDA or required by
CGMP Requirements or other applicable Law, and in such event, will
provide written notice to Dentsply of any such change as soon as is
reasonably practicable. Any and all direct costs (including but
not limited to documented internal administrative costs, costs of
external technical consultants engaged by AZ in effectuating such
changes, the lost value and disposal cost of obsolescent Work in
Process, Materials, Components and completed, packaged Products)
associated with any change in the Manufacture of the Products shall
be borne by Dentsply. If a change is made to the Specifications,
Dentsply shall first obtain any required Government and Regulatory
Authority approvals and shall make any necessary amendments to
regulatory filings.
2.2 Supply and Ownership of Materials. AZ shall arrange to have all Active
Ingredients necessary for the Manufacture of the Products shipped
to AZ unless otherwise mutually agreed by the Parties. AZ shall be
responsible for release of the Active Ingredients in accordance
with the Specifications. AZ shall supply the Components and
Materials necessary for the Manufacture of the Products listed in
Exhibit A. AZ shall retain title and ownership of all Products
until shipment in accordance with Section 2.5.
2.3 Forecasts and Orders
(a) Dentsply shall provide Forecasts and Firm Orders for Products
in whole Batches in accordance with the procedures set forth in
Section 2.3(b). AZ shall use commercially reasonable efforts to
deliver Product in accordance with timelines set forth in the
Firm Orders submitted by Dentsply as set forth in Section 2.3(b).
(b) Commencing on December 1, 2003 (the "Initial Forecast Date"),
Dentsply will provide AZ a forecast of Dentsply's requirements in
Batches for each Product for each month for a twelve (12) month
period (a "Forecast"); provided, however, that from the Initial
Forecast Date until the Effective Date, each Forecast shall
reflect Dentsply's requirements for the twelve-month period
beginning on the Effective Date. Such Forecast shall be revised
monthly for (i) a rolling twelve (12) month period, or (ii)
through the remaining period to termination of this Agreement,
with the first three (3) months' forecast in each twelve (12)
month period beginning on December 1, 2003 reflected in the form
of a firm, non-cancelable purchase order (a "Firm Order"). The
maximum monthly quantity specified in the Forecast or Firm Order
shall not exceed 17 Batches (63,750 Sales Units) per month as the
total for all Products. The minimum monthly quantity specified
in the Forecast or Firm Order shall not be less than 12 Batches
(45,000 Sales Units) per month as the total for all Products.
For the term of this Agreement, should Dentsply provide a Firm
Order that is below the minimum monthly quantity, AZ will invoice
Dentsply as if the minimum monthly quantity of Sales Units of the
highest priced Product had been Manufactured; provided, however,
that Dentsply may provide a Firm Order that is below the minimum
monthly quantity of Batches for the month during which AZ
conducts its annual shutdown of the Facility or for a month that
AstraZeneca determines it can not provide such minimum quantity
due to a decrease in available capacity such as equipment
maintenance or SAP software installation. AZ will notify
Dentsply in writing of the month that such shutdown is to occur
at least three (3) months prior to the first day of such month.
(c) AZ will respond within 10 business days of receiving from
Dentsply the monthly rolling Forecast and Firm Order and will
either (i) confirm acceptance by AZ of the Forecast and Firm
Order quantities or (ii) reject the requested quantities and
initiate a dialogue between the Parties to arrive at mutually
acceptable values for the Forecast and Firm Order. AZ will use
commercially reasonable efforts to accommodate any additional
quantity of Products requested by Dentsply after the Firm Order
has been sent to AZ, but AZ shall not be liable in any respect
for its inability to do so. Notwithstanding anything in this
Agreement to the contrary, AZ shall have no obligation to
Manufacture in any month more than 17 Batches in total for all
Products, and AZ shall have no obligation to Manufacture any
quantity of Products during the specified shutdown month. Firm
Orders may be amended only by mutual agreement of the Parties, in
writing.
2.4 Inability of AZ to meet Requirements. If during the term of this
Agreement AZ cannot meet substantially all of Dentsply's
requirements for the Product for any reason other than Dentsply's
failure to comply with Section 2.3, then AZ promptly shall so
advise Dentsply in writing, and, after a period of forty-five (45)
days with no deliveries, Dentsply shall be free to purchase
replacement Products from other sources for as long as AZ's
inability to supply Dentsply's requirements continues.
2.5 Delivery of Products. AZ agrees to arrange delivery of the Products to
Dentsply F.O.B. AZ's Facility in Westborough, Massachusetts.
Dentsply will select appropriate carriers. AZ agrees to provide
reasonable assistance in this selection. Products shall be shipped
in accordance with FDA regulations, and other applicable federal
and state regulations.
3. MANUFACTURING STANDARDS AND QUALITY ASSURANCE
3.1 Each Product will be Manufactured, controlled, tested, and released in
accordance with the Quality Agreement. If there is any
inconsistency between this Agreement and the Quality Agreement, the
terms of the Quality Agreement shall control with respect to
quality issues, and this Agreement shall control with respect to
all other issues.
3.2 AZ warrants that, as of the date of each delivery hereunder to Dentsply,
and until its date of expiration, each Product, whether for
intended sale in the United States or elsewhere, shall comply with
the provisions of the FFDCA, and such Product shall not, when
delivered to Dentsply, be adulterated or misbranded within the
meaning of the FFDCA. A material default by either Party of the
Quality Agreement shall be deemed a default under this Agreement.
3.3 Dentsply warrants that each Product shall have all necessary and
appropriate Government and Regulatory Approval for commercial sale
by Dentsply in the Territory and further warrants such Product
after delivery to Dentsply will not be adulterated or misbranded
within the meaning of the FFDCA.
4. REGULATORY SUBMISSIONS
4.1 Government and Regulatory Approval. Dentsply shall have responsibility
for making all filings and submissions with respect to the Products
to the FDA or other applicable Government and Regulatory
Authorities in the Territory and for obtaining all Government and
Regulatory Approvals required for the commercial sale of Product in
the Territory. AZ shall, at Dentsply's request, cooperate and
provide reasonable assistance with such filings and submissions,
including, the provision of appropriate data when necessary.
4.2 Government and Regulatory Contacts. Dentsply shall be responsible for
all Government and Regulatory contacts, meetings or filings with
the FDA or equivalent contacts with Government and Regulatory
Authorities in the Territory. AZ agrees to provide reasonable
assistance during this Agreement as required.
4.3 Adverse Experience Reporting. Dentsply and AZ shall report to the other
any information that they have knowledge of concerning any adverse
drug experience in connection with the use of the Products,
including the incidence or severity thereof, associated with
non-clinical toxicity studies, clinical uses, studies,
investigations or tests, whether or not determined to be
attributable to the Products, all as further outlined in the
Quality Agreement.
4.4 Recalls. All coordination of any recall or field correction activities
involving Products shall be handled by Dentsply whether or not such
action was requested by AZ.
4.5 Expenses. In the event that any Product is recalled as a result of (i)
the supply by AZ of Product that does not conform to the warranty
set forth in Section 3.2 or (ii) the negligent or intentionally
wrongful act of AZ or its representatives, then AZ shall bear all
of the reasonable, documented out-of-pocket costs and expenses of
such recall including without limitation expenses related to
communications and meetings with all required Government and
Regulatory Authorities, expenses of replacement stock, the cost of
notifying customers and costs associated with shipment of recalled
Product from customers and shipment of an equal amount of
replacement Product to those customers. In the event that any
Product is recalled as a result of any act other than as set forth
in the immediately preceding sentence, then Dentsply shall bear all
of the reasonable, documented costs and expenses of such recall,
including without limitation expenses related to communications and
meetings with all required Government and Regulatory Authorities,
expenses of replacement stock, the cost of notifying customers and
costs associated with shipment of recalled Product from customers
and shipment of an equal amount of replacement Product to those
customers. In the event that the reason for any recall of Product
hereunder is in part the responsibility of AZ as described in the
first sentence of this Section 4.5 and in part the responsibility
of Dentsply as described in the immediately preceding sentence,
then the expenses related to such recall shall be allocated in an
equitable manner between the Parties.
5. CONSIDERATION
5.1 Price. The price for the Products to be delivered by AZ during the term
of this Agreement, shall be as set forth in Exhibit D. AZ shall
invoice for the Products such amounts upon shipment of the Products
to Dentsply. The terms of payment shall be net thirty (30) days
from date of invoice provided that the invoice is promptly mailed,
sent via overnight courier, or telefaxed, to Dentsply.
5.2 Price Changes. AstraZeneca may increase its price for the Products to
absorb increased costs in the supply price to AstraZeneca of Active
Ingredients, Materials and Components used in the production of
Dentsply Products. AstraZeneca agrees to provide reasonable
documentation to substantiate any such increase.
5.3 Equipment. The Parties have mutually agreed that Exhibit E represents
equipment known to require repair or replacement during 2004.
Within 30 days of the Execution Date, the parties shall undertake
to schedule in a timely manner the repairs or replacement work. The
actual cost of performing these equipment repairs and replacements
will be borne by Dentsply.
5.4 Equipment Repair Costs. During the term of this Agreement, AstraZeneca
shall be responsible for the cost of maintenance, repair, and
replacement for the items of equipment owned by Dentsply and listed
in Exhibit F, with the exception of the maintenance, repairs and
replacements listed in Exhibit E as set forth in Section 5.3
above. Notwithstanding the foregoing, in the event that the cost
of any specific maintenance, repair or replacement, including all
equipment vendor support costs, AstraZeneca labor and materials,
exceeds $50,000, Dentsply shall, upon written notification thereof
by AstraZeneca, reimburse AstraZeneca for the entire cost of that
repair or replacement. AstraZeneca agrees, where reasonably
practicable, to provide Dentsply with written notice of its best
estimate of the cost of such repairs prior to beginning to make, or
have made, those repairs. In addition, in the event the estimated
cost of the repairs exceeds $75,000, Dentsply shall have 72 hours
from receipt of notice of the estimated repair cost and request for
approval to decide whether to give its approval to AstraZeneca
making those repairs, which approval may not be unreasonably
withheld. In the event Dentsply does not respond to AstraZeneca's
request for approval within that 72 hour period, Dentsply shall be
deemed to have given its approval to any such requested repairs.
AstraZeneca agrees to provide reasonable documentation to
substantiate any such maintenance event.
5.5 Equipment Removal and Facility Restoration. For the term of this
Agreement Dentsply will retain ownership of the equipment set forth
in Exhibit F and such Dentsply equipment shall remain at AZ's
Facility. Dentsply shall complete disassembly and removal of this
equipment as soon as reasonably practicable after termination of
this Agreement and as mutually agreed to by the Parties. The
removal of equipment from classified Manufacturing areas must be
scheduled with the annual Westborough site shutdown in order to
minimize disruption to other AstraZeneca activities. The cost of
disassembly, removal and transport of all such equipment, and any
repairs or modifications to the Facility that are necessary to
restore the Facility to working order and area classification, will
be Dentsply's responsibility.
5.6 Active Ingredients, Materials, Components. Upon termination of this
Agreement, all Active Ingredients, Materials and Components unique
to the Manufacture of the products, shall be either (i) destroyed
pursuant to Dentsply's written instructions and at Dentsply's loss
of inventory value and disposal expense, or (ii) sold to Dentsply
at cost FOB Westborough, MA.
6. TERM AND TERMINATION
6.1 Term. Except with respect to Dentsply's forecasting obligations
specified in Section 2.3, the obligations of the Parties hereunder
shall commence on the Effective Date and continue until February,
28, 2005 (the "Termination Date") unless this Agreement is extended
by Dentsply notifying AstraZeneca in writing, no later than
September 1, 2004, of its intention to extend the Agreement beyond
the "Termination Date" to a new date not to extend beyond December
31, 2005.
6.2 Termination for Breach. This Agreement may be terminated by either
Party if the other Party fails to remedy and make good any material
default in the performance of any condition or obligation under
this Agreement within ninety (90) days of the date a written notice
of such default and intention to terminate is sent to the
defaulting Party; provided that if a defaulting Party has promptly
from receipt of notice commenced to cure such default and can
demonstrate that it is diligently attempting to cure such default
at the lapse of such ninety (90) days, then such party shall have
such additional time to cure as may be reasonably required but not
to exceed an additional seventy-five (75) days.
6.3 Termination for Bankruptcy. This Agreement may be terminated by either
Party immediately, or at any time thereafter by notice to the other
if the other becomes bankrupt or insolvent, or enters into
liquidation whether compulsorily or voluntarily, or convenes a
meeting of its creditors, or has a receiver appointed over all or
part of its assets, or ceases for any reason to carry on business.
6.4 Termination for Force Majeure. This Agreement may be terminated by a
Party, upon thirty (30) days written prior notice in the event of
the other Party's inability to substantially perform its
obligations hereunder for more than one hundred eighty (180) days
due to an event of force majeure as defined in Section 11.1 herein,
provided that if the breaching Party reasonably expects that such
condition of force majeure will be remedied within ninety (90) days
from the date on which the breaching Party receives the
non-breaching Party's notice of termination, then the breaching
Party shall have ninety (90) days from the date of such notice to
remedy such breach before termination becomes effective.
6.5 No Waiver. The failure of either Party to terminate this Agreement by
reason of the breach of any of its provisions by the other Party
shall not be construed as a waiver of the rights or remedies
available for any subsequent breach of the terms and provisions of
this Agreement.
6.6 Accrued Liabilities. Termination of this Agreement for any reason shall
not discharge either Party's liability for obligations incurred
hereunder and amounts unpaid at the time of such termination.
Dentsply shall pay AZ for any finished Product ordered by Dentsply
prior to termination. Dentsply shall also pay AZ for any Work in
Process and Materials (supplied by AZ) that were to be used in the
Manufacture of Products hereunder and that are in AZ's possession
upon termination of the Agreement. All Materials, Work in Process
and finished goods of Products ordered by Dentsply in AZ's
possession shall be returned to Dentsply upon termination.
6.7 Property. Subject to the provisions of Section 5.5, in the event of
termination of this Agreement for whatever cause, in addition to
the other obligations of the Parties hereunder, each Party shall
return to the other Party or to the other Party's designee, at the
owner's sole cost and expense, no later than thirty (30) days after
the effective date of termination, all of such other Party's
property, including, but not limited to, all proprietary
information, in its possession, except to the extent required to be
retained by Law or to comply with such Party's continuing
obligations hereunder.
7. INDEPENDENT CONTRACTORS
The Parties acknowledge, agree and declare that the relationship hereby
established between them is solely that of provider and recipient of
manufacturing services and that each Party hereto is an independent
contractor with respect to the other. Nothing contained in this
Agreement shall be construed as creating a partnership, joint venture or
agency relationship between the Parties or, except as otherwise
expressly provided in this Agreement, as granting either Party the
authority to bind or contract any obligation in the name of or on the
account of the other Party or to make any statements, representations,
warranties or commitments on behalf of the other Party. All person
employed by a Party shall be employees of such Party and not of the
other Party and all costs and obligations incurred by reason of any such
employment shall be for the account and expense of such Party.
8. INDEMNIFICATION
8.1 Indemnification by AZ. AZ agrees to indemnify, defend and hold harmless
Dentsply, its Affiliates and their respective employees against any
and all third-party claims, including claims made against Dentsply
by any of its distributors; losses; damages and liabilities;
including reasonable attorney's fees, incurred by any of them
arising out of any material breach of any obligation by AZ
hereunder or any grossly negligent or intentionally wrongful act or
omission by AZ in connection with its Manufacturing services
hereunder.
8.2 Indemnification by Dentsply. Dentsply agrees to indemnify, defend and
hold harmless AZ, its Affiliates and their employees against any
and all third-party claims, losses, damages and liabilities,
including reasonable attorney's fees, incurred by any of them
arising out of any Manufacture of the Products in accordance with
the Specifications, including any claim of infringement of
intellectual property rights as further set forth in Section 14.7,
any breach of any obligation by Dentsply hereunder or any negligent
or intentionally wrongful act or omission of Dentsply in connection
with the marketing, distribution or sale of the Product in the
Territory.
8.3 Procedure. If Dentsply, its Affiliates or their respective employees,
or AZ, its Affiliates or their respective employees (in each case
an "Indemnified Party") receive any written claim which such
Indemnified Party believes is the subject of indemnity hereunder by
AZ or Dentsply as the case may be (in each case an "Indemnifying
Party"), the Indemnified Party shall, as soon as reasonably
practicable after forming such belief, give notice thereof to the
Indemnifying Party; provided, that the failure to give timely
notice to the Indemnifying Party as contemplated hereby shall not
release the Indemnifying Party from any liability to the
Indemnified Party unless the Indemnifying party demonstrates that
the defense of such claim is prejudiced by such failure. The
Indemnifying Party shall have the right, by prompt notice to the
Indemnified Party, to assume the defense of such claim, at its
cost, with counsel reasonably satisfactory to the Indemnified
Party. If the Indemnifying Party does not so assume the defense of
such claim or, having done so, does not diligently pursue such
defense, the Indemnified Party may assume such defense, with
counsel of its choice, but at the cost of the Indemnifying Party.
If the Indemnifying Party so assumes such defense, it shall have
absolute control of the conduct of the litigation; the Indemnified
Party may, nevertheless, participate therein through counsel of its
choice and at its cost. The party not assuming the defense of any
such claim shall render all reasonable assistance to the party
assuming such defense, and all out-of-pocket costs of such
assistance shall be for the account of the Indemnifying Party. No
such claim shall be settled other than by the party defending the
same, and then only with the consent of the other party, which
shall not be unreasonably withheld; provided, that the Indemnified
Party shall have no obligation to consent to any settlement of any
such claim which imposes on the Indemnified Party any liability or
obligation which cannot be assumed and performed in full by the
Indemnifying Party.
9. INSURANCE
9.1 Each Party shall obtain and keep in force during the term of this
Agreement, (a) worker's compensation insurance in compliance with
the worker's compensation laws of the state or states in which such
Party has employees performing work related to this Agreement and
employer's liability insurance with respect to such employees
written on a per occurrence basis with a minimum limit of One
Million Dollars ($1,000,000) per occurrence; and (b) commercial
general liability insurance, written on a per occurrence basis,
including, without limitation, premises, broad form property
damages, contractual and products liability/completed operations
coverage, which shall specifically cover such Party's
indemnification obligations under Section 8.1 or 8.2 hereof, as
applicable, with a combined single limit for bodily injury and
property damage of not less than Ten Million Dollars ($10,000,000).
9.2 Each Party shall furnish certificates of insurance for the policies of
such Party to the other Party within ten (10) days after the
Effective Date. Each Party shall immediately provide the other
with written notice of any cancellation, non-renewal, expiration or
material modification of any policy. Should either Party at any
time neglect or refuse to provide the insurance required herein, or
should such insurance be canceled or materially modified, the other
Party shall have the right to procure the same and the cost thereof
shall be deducted from any compensation then due or thereafter to
become due to the first Party.
10. LIMITATION OF LIABILITY
Limitation. Except in the event of (a) a claim pursuant to a Party's
indemnification obligations herein, (b) a Party's fraud or willful
misrepresentation or willful misconduct, or (c) a breach of a party's
confidentiality obligations herein, in no event shall either Party be
liable to the other for special, indirect, incidental or consequential
damages, including lost profits, in any way arising out of or relating
to this Agreement.
11. FORCE MAJEURE
Force Majeure. Neither Party shall be liable to the other for default
or delay in the performance of its obligations under this Agreement, if
such default or delay shall be caused directly or indirectly by
accident, fire, flood, riot, war, terrorism, act of God, embargo,
strike, failure or delay of normal source of supply of materials, or
delay of carriers, or complete or partial shutdown of plant by any of
the foregoing causes or other causes beyond its reasonable control,
provided same are not due to the fault or neglect of such Party and
provided further that any such delay or failure shall be remedied by
such Party as soon as possible after the cause of such failure or delay.
12. CONFIDENTIALITY
12.1 Any information or data (including but not limited to, any technical
information, experience or data) regarding either Party's
formulations, plans, programs, plants, processes, technical
materials, Product, production requirements, standard
specifications, costs, equipment, operations, procedures,
instructions or customers (all of which is herein referred to as
"Confidential Information") is the sole property of the respective
Party. Each Party shall treat the other Party's Confidential
Information in the same protective manner that it treats its own
Confidential Information. Parties shall not use, except for the
purpose of carrying out this Agreement, or disclose to others or
permit their employees, agents, consultants or subcontractors to
use, except for the purpose of carrying out this Agreement, or
disclose to others, during the term of this Agreement and for a
period of four (4) years from the date of termination or expiration
of this Agreement, Confidential Information which has heretofore
come or hereafter may come within the knowledge of, or which has
been or may hereafter be acquired or developed by the respective
party, its employees, agents, consultants or subcontractors, in the
performance of any services hereunder. This paragraph shall not
prevent either Party from using or disclosing to others information:
(a) which is known to the receiving Party at the time it is
disclosed by or obtained from the disclosing Party, which
knowledge can be established by competent evidence; or
(b) which is, or through no fault of the receiving Party becomes,
lawfully available to the public; or
(c) which lawfully becomes available to the receiving Party from a source
other than the disclosing Party; or
(d) which is independently developed by the Party without reliance upon or
reference to the Confidential Information which independent
development can be established by competent evidence; or
(e) which the receiving Party is required by applicable Law, a
court having jurisdiction, or Government or Regulatory Authority
to disclose.
12.2 Upon termination of this Agreement, if requested, the receiving Party
shall deliver to the disclosing party all notes, drawings,
blueprints, manuals, letters, notebooks, reports and other writings
of or pertaining to Confidential Information, including all copies
thereof, and all other Confidential Information which is in the
possession of or under the control of the receiving Party. Parties
shall restrict access to Confidential Information to as few as
practicable of their employees, agents, consultants and
subcontractors, and in all cases shall restrict such knowledge to
only those employees, agents, consultants and subcontractors who
are directly connected with the performance of the services
hereunder.
13. COMPLIANCE WITH LAW
Each Party shall comply with, and shall not be in material violation of,
all valid, applicable Laws of the Territory which materially affect the
Manufacture, processing, packaging, shipment, or storage of the Products.
14. TRADE NAMES AND TRADEMARKS
14.1 AZ's Rights. Dentsply hereby acknowledges that it does not have, and
shall not acquire by virtue of this Agreement, any rights to or
under any goodwill, trademark, tradename, copyright, patent of AZ,
nor in any of AZ's trademarks or tradenames appearing on the label
or packaging materials of the Products. Dentsply agrees to do
nothing by act or omission which would impair AZ's or its
Affiliates' rights, ownership and title in the aforementioned.
14.2 Dentsply's Rights. AZ hereby acknowledges that it does not have, and
shall not acquire by virtue of this Agreement, any rights to or
under any goodwill, trademark, tradename, copyright, patent or
other intellectual property of Dentsply, nor in any of Dentsply's
trademarks or tradenames appearing on the label or packaging
materials of the Products. AZ agrees to do nothing by act or
omission which would impair Dentsply's or its Affiliates' rights,
ownership and title in the aforementioned.
14.3 No Contest. Each Party further agrees not to contest, deny or dispute
the validity of any trademarks or tradenames owned by the other
Party appearing on the labels or packaging materials of the
Products or the title of such other Party thereto, and not to
assist others in doing so, and not to take action of any kind
inconsistent with the holding of all such trademark rights by such
other Party.
14.4 Use. Neither Party shall use the trademarks or tradenames owned by the
other Party under which the Products are Manufactured on any other
goods or products, except as provided hereunder.
14.5 Infringement. Each Party shall immediately report in writing to the
other Party upon being acquainted through any source whatsoever of
any and all infringements or threatened infringements of the
tradenames or trademarks owned by such other Party appearing on the
labels and packaging materials of the Products, and any attempt on
the part of anyone to register, copy, infringe upon or imitate such
trademarks or tradenames, and if required by such party, the
notifying Party will, at the other Party's sole expense, take such
steps as the other Party may deem advisable against the
infringement or otherwise for the protection of the other Party's
rights.
14.6 Survival. The obligations set forth in this Article 14 shall survive
the termination or expiration of this Agreement.
14.7 Intellectual Property Indemnification. Dentsply shall indemnify, defend
and hold AstraZeneca, its Affiliates, and their employees,
contractors and agents harmless from and against any and all
claims, demands, actions, suits, losses, damages, costs, expenses
(including reasonable attorney's fees), and liabilities which they
may incur, suffer or be required to pay by reason of any patent
infringement suit or other intellectual property suit brought
against them as a result of or in connection with AZ's Manufacture
of a Product provided such Product is manufactured in accordance
with all material Specifications.
15. NOTICES
Any notice or request expressly provided for or permitted under this
Agreement shall be in writing, delivered manually or by mail, telegram,
telefax or cable and shall be deemed sufficiently given if and when
received by the Party to be notified at its address first set forth
below, or if and when mailed by registered mail or certified mail,
postage prepaid, addressed to such party at such address. Either Party,
by notice to the other, may change its address for receiving such
notices.
To AZ: AstraZeneca LP
00 Xxxx Xxxxxx
Xxxxxxxxxxx, XX 00000
Attention: General Manager
With a copy to: General Counsel
AstraZeneca LP
0000 Xxxxxxx Xxxx
Xxxxxxxxxx, XX 00000
To Dentsply: Maillefer Instruments Trading S.a.r.L.
Dentsply Anesthetics Division
Xxxxxx xx Xxxxxx 0
XX-00000 Xxxxxxxxxx
Xxxxxxxxxxx
With a copy to: DENTSPLY Pharmaceutical Division
Concord Executive Center
0000 Xxxxxxx Xxxx
Xxxx, XX 00000
And to: Dentsply International Inc.
000 Xxxx Xxxxxxx Xxxxxx
Xxxx, XX 00000
Attention: Secretary
16. GOVERNING LAW
Other than claims for equitable or injunctive relief, any dispute or
claim under this Agreement or any amendment thereto (unless such
amendment provides otherwise), including without limitation as to their
existence, validity, enforceability, interpretation, performance,
breach, or damages, including claims in tort, whether arising before or
after the termination of this Agreement, shall be settled only by
binding arbitration pursuant to the rules of the American Arbitration
Association (the "Rules"); provided, however, that: (a) the arbitration
shall take place in Wilmington, Delaware; (b) there shall be three (3)
arbitrators, who shall be selected under the normal procedures
prescribed in the Rules, (c) at the arbitration hearing, each party may
make written and oral presentations to the arbitrators, present
testimony and written evidence, and examine witnesses; (d) the
arbitrators shall have the power to award as damages the expenses of the
arbitrators and of the administrator's fees for the arbitration; (e) the
arbitrators shall issue a written decision explaining the basis for such
decision; (f) such decision shall be final, binding, and enforceable in
any court having jurisdiction over either of the parties..
The parties hereby irrevocably and unconditionally consent to the
exclusive jurisdiction of the courts of the State of Delaware for any
action, suit, or proceeding for equitable or injunctive relief arising
out of or relating to this Agreement, and agree not to commence any such
action, suit, or proceeding related thereto except in such courts.
17. COMPLETE CONTRACT
This document, together with the exhibits thereto constitutes the
complete and exclusive statement of the terms of the Agreement between
the Parties hereto with reference to the subject matter hereof, and no
statement or agreements, oral or written, made prior to or at the
signing hereof shall vary or modify the written terms hereof, and
neither Party shall claim any modification or rescission from any
provision hereof unless such modification or rescission is in writing,
signed by the other Party.
18.
NONASSIGNABILITY
During the term of this Agreement the rights of either Party under this
Agreement shall not be assigned, nor shall the performance of either
Party's duties be delegated without the other Party's prior written
consent, except either Party may assign this agreement to an Affiliate
without obtaining the other Party's prior written consent. Notice of
assignment shall be given to other Party at least thirty (30) days prior
to the effective date of said assignment.
19. WAIVER
A Party's failure to enforce, at any time or for any period of time, any
provision of this Agreement, or to exercise any right or remedy, shall
not constitute a waiver of that provision, right or remedy or prevent
such Party from enforcing any or all provisions of this Agreement and
exercising any rights or remedies. All rights and remedies are
cumulative and do not exclude any other right or remedy provided by Law
or otherwise available.
20. COUNTERPARTS
This Agreement may be executed in any number of counterparts, each of
which shall be deemed an original and all of which taken together shall
be deemed to constitute one and the same instrument. An executed
signature page of this Agreement delivered by facsimile transmission
shall be as effective as an original executed signature page.
21. NO BENEFIT TO OTHERS
The provisions of this Agreement are for the sole benefit of the Parties
and their successors and permitted assigns, and they shall not be
construed as conferring any rights in any other persons except as
otherwise provided in this Agreement.
22. SEVERABILITY
If any provision of this Agreement is held to be invalid, illegal or
unenforceable, in nay respect, then, to the fullest extent permitted by
applicable Law and if the rights or obligations of any Party will not be
materially and adversely affected: (a) such provision will be given no
effect by the Parties and shall not form part of this Agreement, (b) all
other provisions of this Agreement shall remain in full force and effect
and (c) the Parties will use their best efforts to negotiate a provision
in replacement of the provision held invalid, illegal or unenforceable
that is consistent with applicable Law and achieves, as nearly as
possible, the original intention of the Parties. To the fullest extent
permitted by applicable Law, the Parties waive any provision of law that
would render any provision of this Agreement invalid, illegal or
unenforceable in any respect.
23. SURVIVAL
The respective rights and obligations of the Parties set forth in this
Agreement shall survive the expiration or termination of this Agreement
to the extent necessary to the intended preservation of such rights and
obligations.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their respective duly authorized representatives as of the Execution Date.
Maillefer Instruments Trading S.a.r.L. ASTRAZENECA LP
By: _________________________ By: ________________________
Name: _________________________ Name: ________________________
Title: _________________________ Title:________________________
Date: _________________________ Date: ___________________________
