EXECUTION COPY
EXHIBIT 4.33
TRANSITIONAL SUPPLY AGREEMENT
This Transitional Supply Agreement (this "AGREEMENT") is entered into
this 27th day of March, 2003 between Xxxxx (Chemicals) Limited, an Irish
corporation ("PURCHASER"), and Pfizer Inc., a Delaware corporation ("PFIZER").
RECITALS
WHEREAS, Pfizer, Purchaser and Xxxxx Holdings plc, a public limited
company organized under the Laws of Northern Ireland, have entered into the
Purchase and Sale Agreement (OCs), dated as of March 5, 2003 (the "PURCHASE
AGREEMENT"), pursuant to which certain Affiliates of Pfizer are selling the
Purchased Assets (as defined in the Purchase Agreement) to Purchaser;
WHEREAS, pursuant to the terms of the Purchase Agreement, Pfizer has
agreed to supply to Purchaser for a limited time the Products; and
WHEREAS, Pfizer and Purchaser desire to define their respective rights
and obligations with regard to the supply of the Products in this Agreement.
NOW, THEREFORE, for good and valuable consideration, the sufficiency
and receipt of which are hereby acknowledged, the Parties hereby agree as
follows:
ARTICLE 1
DEFINITIONS
1.1 Definitions. As used in this Agreement, the following terms
shall have the meanings set forth or as referenced below:
"ACTION" shall mean any action, suit, proceeding, arbitration or
Governmental Authority action, notification, investigation or audit.
"AFFILIATE" shall mean, with respect to any Person, any other Person
that directly or indirectly, through one or more intermediaries, controls, is
controlled by, or is under common control with, such Person at any time during
the period for which the determination of affiliation is being made.
"AGREEMENT" shall mean this Agreement, as the same may be amended or
supplemented from time to time in accordance with the terms hereof.
"BUSINESS DAY" shall mean any day other than a Saturday, a Sunday or a
day on which banks in New York, New York, United States of America are
authorized or obligated by Law or executive order to close.
"CERTIFICATE OF ANALYSIS" shall mean a written certification,
substantially in the form attached as Schedule F, delivered by Pfizer to
Purchaser with each shipment of Ordered Products.
"cGMPs" shall mean the current Good Manufacturing Practices applicable
to pharmaceutical products for human use in the United States of America and
similar regulations applicable to pharmaceutical products for human use in other
countries where a material amount of any of the Products are sold.
"CONFIDENTIAL PFIZER INFORMATION" shall have the meaning set forth in
Section 10.2.
"CONFIDENTIAL PURCHASER INFORMATION" shall have the meaning set forth
in Section 10.1.
"ESTROSTEP TARGET SHELF LIFE" shall have the meaning set forth in
Section 3.6(a).
"FAJARDO PLANT" shall mean the manufacturing and packaging facility and
equipment located in Fajardo, Puerto Rico used to manufacture the Products.
"FCA" shall mean FCA as defined in the International Chamber of
Commerce Incoterms 2000.
"FDA" shall mean the United States Food and Drug Administration.
"FIRM ORDER" shall mean a written irrevocable firm purchase order for
the Products, which order shall include a delivery schedule specifying the
delivery date for each Product ordered and the location to which shipment of the
Product is to be delivered.
"GOVERNMENTAL AUTHORITY" shall mean any supranational, national,
federal, state, provincial or local judicial, legislative, executive or
regulatory authority.
"INDEMNIFIABLE CLAIM" shall have the meaning set forth in Section 9.4.
"INDEMNIFIED PARTY" shall have the meaning set forth in Section 9.3.
"INDEMNIFYING PARTY" shall have the meaning set forth in Section 9.3.
"INDEPENDENT LABORATORY" shall have the meaning set forth in Section
5.1(c).
"LABELING" shall mean any and all printed labels, labeling and package
inserts for the Products.
"LAWS" shall mean all laws, statutes, rules, regulations, ordinances
and other pronouncements having the effect of law of any Governmental Authority.
"LESS THAN TARGET SHELF LIFE PRODUCTS" shall have the meaning set forth
in Section 3.6(b).
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"LOESTRIN TARGET SHELF LIFE" shall have the meaning set forth in
Section 3.6(a).
"LOSS" or "LOSSES" shall mean any and all damages, fines, fees,
penalties, deficiencies, losses and expenses (including interest, court costs,
reasonable fees of attorneys, accountants and other experts or other expenses of
litigation or other proceedings or of any claim, default or assessment).
"NDA" shall mean a New Drug Application filed with the FDA relating
solely to any of the Products requesting permission to place a drug on the
market in accordance with 21 C.F.R. Part 314 and all supplements filed pursuant
to the requirements of the FDA, including all documents, data and other
information concerning any such Product that are necessary for FDA approval to
market any such Product in the United States of America.
"NEGOTIATION PERIOD" shall have the meaning set forth in the Purchase
Agreement.
"NON-SERIOUS ADVERSE EVENT" for the Products shall mean an untoward
medical occurrence at any dose for any of the Products that is not a Serious
Adverse Event.
"ORDERED PRODUCTS" shall mean the Products ordered pursuant to a Firm
Order.
"PARTY" shall mean Pfizer or Purchaser and, when used in the plural,
means Pfizer and Purchaser.
"PERSON" shall mean any individual, firm, corporation, partnership,
limited liability company, trust, joint venture or other entity or organization.
"PPI" shall have the meaning set forth in Section 4.2(a).
"PRODUCT CLAIM" shall mean a claim from a Third Party for money or
other compensation (beyond the cost of a particular Product) in respect of
potential or actual injury or harm allegedly due and owing as a result of the
use, application or defect of any of the Products or labeling of any of the
Products, in each case irrespective of the legal theory of liability.
"PRODUCT QUALITY COMPLAINT" shall have the meaning set forth in Section
6.1(a).
"PRODUCT REGISTRATION" shall mean the licenses, permits, certificates,
approvals, registrations or other authorizations for each Product under the
applicable Laws of any Governmental Authority, including any NDAs.
"PRODUCTS" shall mean the certain products set forth on Schedule A.
"PROCEEDING" shall have the meaning set forth in Section 11.5.
"PURCHASE AGREEMENT" shall have the meaning set forth in the Recitals
above.
"RECALL" shall have the meaning set forth in Section 6.2.
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"SERIOUS ADVERSE EVENT" for the Products shall have the meaning set
forth in 21 C.F.R. Section 314.80(a), as amended, or the ICH guidelines, as
applicable.
"SPECIFICATIONS" shall mean the specifications for each of the Products
as set forth on Schedule B.
"STANDARD COST" shall mean, in respect of the period commencing on the
date hereof and ending on December 31, 2003, Pfizer's standard cost for calendar
year 2002 as set forth on Schedule C and, in respect of subsequent calendar
years, shall mean the standard cost in effect for the preceding calendar year,
as adjusted pursuant to Section 4.2.
"TARGET SHELF LIFE" shall have the meaning set forth in Section 3.6(a).
"TERM" shall have the meaning set forth in Section 8.1.
"THIRD PARTY" shall mean any Person who or which is neither a Party nor
an Affiliate of a Party.
1.2 Other Definitional Provisions.
(a) The words "HEREOF", "HEREIN", "HERETO" and "HEREUNDER" and words of
similar import, when used in this Agreement, shall refer to this Agreement as a
whole and not to any particular provision of this Agreement.
(b) The terms defined in the singular shall have a comparable meaning
when used in the plural, and vice versa.
(c) The term "INCLUDING" shall mean "INCLUDING, WITHOUT LIMITATION".
(d) When a reference is made in this Agreement to an Article, a Section
or Schedule, such reference shall be to an Article of, a Section of or a
Schedule to, this Agreement unless otherwise indicated.
ARTICLE 2
SUPPLY OF PRODUCTS; FORECASTS AND PURCHASE ORDERS
2.1 Products to be Supplied. Purchaser agrees to purchase from
Pfizer, and Pfizer agrees to sell to Purchaser, except as otherwise provided
herein, all of Purchaser's requirements for the Products, ordered during the
Term as provided herein. Pfizer shall solely and exclusively supply the Products
to Purchaser and its designees, and neither Pfizer nor any of its Affiliates
shall have the right to manufacture or supply any Product or any generic version
thereof for or to any other Person.
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2.2 Forecasts.
(a) Purchaser shall provide Pfizer with a Firm Order for the
period from the date hereof up to and including June 30, 2003, which Firm Order
shall be attached as Schedule E. Pfizer shall supply the quantities set forth on
Schedule E for each Product in accordance with the delivery schedule set forth
therein, and to the extent such Firm Order is not sufficient to meet Purchaser's
actual requirements for any Product for such period, Pfizer shall use its
commercially reasonable efforts to supply Purchaser with its requirements beyond
the amounts set forth on Schedule E. For periods after June 30, 2003, Firm
Orders shall be filled by Pfizer in accordance with the Firm Orders placed by
Purchaser pursuant to Section 2.2(b).
(b) Except as provided in Section 2.2(a), within 10 days after the
beginning of each calendar quarter, Purchaser shall give to Pfizer a forecast of
Purchaser's estimated quarterly requirements of the Products for the 24 month
period commencing with the next succeeding calendar quarter. The 24 month
forecast delivered to Pfizer pursuant to the preceding sentence shall represent
Purchaser's reasonable estimates of the quantity of the Products that Purchaser
will require during such 24 month period to which such forecast applies, and the
forecast of its requirements of the Products during the first quarter of such 24
month period shall be reflected in a Firm Order accompanying such forecast.
(c) Notwithstanding the foregoing, any Firm Order for any Product
placed for a calendar quarter in accordance with Section 2.2(b) shall be between
75% and 125% of the most recent forecast estimated quantity for such Product for
such calendar quarter provided by Purchaser to Pfizer in accordance with this
Section 2.2 prior to the Firm Order being placed by Purchaser. If requested by
Purchaser, Pfizer shall use its commercially reasonable efforts to supply an
amount over 125% of the most recent forecast estimated quantity for a Product.
(d) Pfizer shall promptly notify Purchaser in writing if at any
time Pfizer has reason to believe that Pfizer will not be able to fill a Firm
Order for any Product in all material respects in accordance with the delivery
schedule specified therein by Purchaser and pursuant to the terms and conditions
of this Agreement.
(e) All forecasts to be provided or delivered by Purchaser to
Pfizer pursuant to this Section 2.2 shall be in writing.
2.3 Capacity. Any forecasts delivered by Purchaser to Pfizer
pursuant to Section 2.2 and the aggregate of all Firm Orders must be within
Pfizer's capacity as set forth on Schedule D.
2.4 Acceptance of Firm Order. Pfizer agrees to accept all Firm
Orders submitted in accordance with and on the terms set forth in this
Agreement. No terms and conditions contained in any Firm Order, acknowledgment,
invoice, xxxx of lading, acceptance or other preprinted form issued by either
Party shall be effective to the extent they are inconsistent with or modify the
terms and conditions contained herein.
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2.5 Delivery. All Products sold pursuant to this Agreement shall
be delivered FCA FAJARDO (Pfizer's place of manufacture). Purchaser shall bear
the cost of shipping and insurance.
ARTICLE 3
SUPPLY AND SERVICES CRITERIA
3.1 General. Subject to the terms of this Agreement, Pfizer shall
produce the Products following the same practices and procedures in effect as of
the date of this Agreement.
3.2 Compliance with Specifications. All Products supplied
hereunder shall be in finished dosage form, filled, labeled and packaged for
commercial sale or distribution as samples, as the case may be, by Pfizer in
accordance with the terms and conditions of this Agreement, the Specifications
and applicable Laws. Pfizer shall be responsible for the purchase of all raw
materials in accordance with the NDAs and other regulatory filings for the
Products as necessary to supply finished Products to Purchaser under this
Agreement. Purchaser shall promptly notify Pfizer of any changes to the
Specifications that are required by changes in applicable Laws or are otherwise
desired by Purchaser, including changes to the packaging or Labeling of the
Products. Any such changes shall be subject to the prior approval of Pfizer
(which approval shall not be unreasonably withheld), and Pfizer shall use its
commercially reasonable efforts to accommodate such changes. If any such change
would cause an increase or decrease in the Standard Costs of the Products,
Pfizer shall promptly notify Purchaser of the change in the Standard Costs of
the Products, and Purchaser shall bear the cost of such change. Purchaser shall
also bear any one-time costs required to implement any such change. With respect
to any regulatory filings and approvals made or sought by Purchaser under this
Section 3.2, Pfizer shall, and shall cause its relevant Affiliates to, provide
reasonable cooperation to Purchaser in connection therewith. If a change
proposed to be made to the Specifications or the manufacture of the Products
under this Section 3.2 requires prior approval by any applicable Governmental
Authority before implementation, such change shall not be implemented in respect
of a Product until such change has been so approved.
3.3 Practices. Pfizer shall adhere in all material respects to
cGMPs as they apply to the manufacturing, handling and control of the Products.
3.4 Labeling. For up to 180 days after the date hereof, Pfizer
shall continue to use Pfizer's Labeling on the Products manufactured for
Purchaser. After such time, each such Product shall be manufactured with
Labeling and packaging identifying Purchaser (or Purchaser's designee) as the
distributor thereof and, only if required by applicable Law, Pfizer or its
applicable Affiliate as the manufacturer thereof. Purchaser shall provide Pfizer
with its Labeling as soon as practicable from the date Purchaser completes the
related registration process, but in no event later than 90 days thereafter. In
the event that inventories of Pfizer's Labeling have been depleted and Purchaser
has not provided Pfizer with Purchaser's Labeling, Pfizer shall procure
additional Pfizer's Labeling until such time
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Purchaser provides Pfizer with Purchaser's Labeling in accordance with this
Section 3.4. Should Purchaser wish to substitute its Labeling prior to the date
that is 180 days after the date hereof, Purchaser shall reimburse Pfizer for its
out-of-pocket cost for the unused Labeling that would otherwise have been used
through the end of such 180 day period. As between Pfizer and Purchaser, with
respect to the Products sold after the date hereof, Purchaser shall be solely
responsible for ensuring that the Labeling and other printed materials, if any,
comply with all applicable Laws; provided, however, that Pfizer warrants to
Purchaser that the Products supplied hereunder prior to the conversion of the
Labeling from Pfizer's Labeling to Purchaser's Labeling in accordance with this
Section 3.4 shall comply with the FDA-approved Labeling as it exists on the date
hereof.
3.5 Capital Investments. Pfizer shall not be required to make any
capital investment for the purpose of expanding the capacity or modification of
the manufacturing facility for the Products. Pfizer shall seek to minimize any
investment required for compliance with changes in Law during the Term, but if
any such investments are required, the cost of these capital investments shall
be borne by Purchaser. Pfizer agrees to review such investments with Purchaser
and to obtain its approval prior to initiating the investments, such approval
not to be unreasonably withheld. If Purchaser does not approve of these
investments, Pfizer may immediately terminate the manufacture of all Products
from the manufacturing facility requiring these investments if it is unable to
obtain the required approvals of the relevant Governmental Authority to continue
to operate the facility without investment and without penalty.
3.6 Shelf Life.
(a) Pfizer shall have as its objective to deliver to Purchaser (i)
Ordered Products, which correspond to the Products set forth on Schedule A with
the Estrostep(R) trademark, with a shelf life of not less than 12 months from
the date of delivery to Purchaser ("ESTROSTEP TARGET SHELF LIFE") and (ii)
Ordered Products, which correspond to the Products set forth on Schedule A with
the Loestrin(R) trademark, with a shelf life of not less than 18 months from the
date of delivery to Purchaser ("LOESTRIN TARGET SHELF LIFE" and, together with
the Estrostep Target Shelf Life, the "TARGET SHELF LIFE").
(b) If any Ordered Products are delivered to Purchaser with a
shelf life of less than the applicable Target Shelf Life (the "LESS THAN TARGET
SHELF LIFE PRODUCTS"), and any Less than Target Shelf Life Products are returned
to Purchaser by any Third Party customer as a result of such Less than Target
Shelf Life Products having been delivered to Purchaser with less than the
applicable Target Shelf Life, then Pfizer shall provide replacement Products to
Purchaser, at no cost to Purchaser, and shall make arrangements for the return,
reworking or disposal, at Pfizer's option and expense, of such returned Less
than Target Shelf Life Products.
(c) Notwithstanding anything herein to the contrary, Pfizer's sole
liability and obligation to Purchaser in respect of any failures by Pfizer to
deliver Ordered Products to Purchaser with the applicable Target Shelf Life
shall be as provided in Section 3.6(b).
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ARTICLE 4
CONSIDERATION
4.1 Pricing. Subject to Section 4.2, the Parties agree that the
price for each of the Products during the Term shall be the Standard Cost of
such Product in effect at the time of delivery of the applicable Firm Order in
accordance with Sections 2.2(a) and (b) to Pfizer.
4.2 Standard Cost Adjustments.
(a) The Standard Cost of each Product shall be adjusted effective
as of each January 1st during the Term by such percentage increase in the
Producer Price Index as published by the United State Department of Labor,
Bureau of Labor Statistics (the "PPI") over the immediately preceding 12 month
period, except to the extent that Pfizer has elected to adjust the Standard Cost
as set forth in Section 4.2(c) for such year. The Standard Cost adjustment under
this Section 4.2(a) shall be notified to Purchaser not later than June 30th of
each year and shall be retroactively effective to January 1st of that same year
and shall apply to all Firm Orders received on or after said January 1st. In the
event that Pfizer fails to provide notice of any PPI increase by June 30th of a
given year, any such increase shall only be effective as of the date such notice
is actually given and shall only apply to Firm Orders received on or after such
date. If the PPI is not available for any period, the most similar available
index shall be used.
(b) In the event that Purchaser's Firm Orders for all Products in
the aggregate for three consecutive quarters in a calendar year are at least 20%
lower than aggregate quantities estimated in the forecast for the corresponding
periods provided 12 months prior to the submission of such Firm Orders, Pfizer
may elect in its sole discretion to adjust that portion of the Standard Cost of
the Products that represent Pfizer's allocation of overhead solely relating to
the dedicated hormone facility at the Fajardo Plant by the change in the
allocation for such overhead to be incurred by Pfizer in the following year.
Schedule G sets forth the applicable overhead allocations for the dedicated
hormone facility for each Product as of the date hereof. All other components of
the Standard Cost of such Product for such year shall be adjusted by the index
set forth in Section 4.2(a) or the change in cost set forth in Section 4.2(c),
as the case may be. Pfizer shall act in good faith in connection with the
Standard Cost adjustment set forth in this Section 4.2(b). Any Standard Cost
adjustment made pursuant to this Section 4.2(b) shall be notified to Purchaser
not later than June 30th of each year and shall be retroactively effective to
January 1st of that same year and shall apply to all Firm Orders received on or
after said January 1st. In the event that Pfizer fails to provide notice of any
overhead allocation increase by June 30th of a given year, any such increase
shall only be effective as of the date such notice is actually given and shall
only apply to Firm Orders received on or after such date.
(c) In the event that during any given calendar year during the
Term, a change of more than 20% (above or below the amount included in the
applicable Standard Cost of a Product) in the price to Pfizer of any material,
service or utility used in the manufacture of a Product results in an increase
or decrease in the total Standard Cost of such Product of 5% or
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more, Pfizer may elect in its sole discretion to adjust the Standard Cost for
such Product for the following calendar year to reflect the increase or decrease
in cost above or below that included in the then prevailing Standard Cost for
such Product. Pfizer shall act in good faith in connection with the Standard
Cost adjustment set forth in this Section 4.2(c). Any Standard Cost adjustment
made pursuant to this Section 4.2(c) shall be notified to Purchaser not later
than June 30th of each year and shall be retroactively effective to January 1st
of that same year and shall apply to all Firm Orders received on or after said
January 1st. In the event that Pfizer fails to provide notice of any such
increase or decrease by June 30th of a given year, any such increase or decrease
shall only be effective as of the date such notice is actually given and shall
only apply to Firm Orders received on or after such date.
4.3 Payment of Obligations. Invoices for Firm Orders shall be
submitted to Purchaser upon delivery by Pfizer of the Ordered Products and such
invoices shall be payable in full within 30 days from the date of receipt of the
invoice. Payment shall be made by Purchaser by check delivered to Pfizer's
address as designated in such invoice or by wire transfer to an account
designated by Pfizer. Any required payment hereunder not made by Purchaser on or
before the date specified in this Section 4.3 shall bear interest from the date
such payment is due until the date it is actually received by Pfizer at an
annual rate equal to 12%.
4.4 Audit Right. Purchaser shall have the right to have a
nationally recognized independent public accounting firm audit, within 60 days
of delivery by Pfizer to Purchaser of a notice of Standard Cost adjustment
pursuant to Section 4.2(b) or (c), Pfizer's books and records relating to the
manufacture of the Products, for the sole purpose of verifying Pfizer's
determination of the adjustment to the Standard Cost undertaken pursuant to
Section 4.2(b) or (c). Such audit shall be at reasonable times during normal
business hours and upon reasonable notice to Pfizer. A copy of such auditing
firm's conclusions of its audit shall be furnished to Pfizer at least ten
Business Days prior to disclosure to Purchaser to allow Pfizer an opportunity to
review the accuracy of the auditing firm's conclusions. The conclusions of such
audit firm shall be final and binding on the Parties. Purchaser shall bear the
full cost of such audit (including reimbursement to Pfizer for administrative
costs it incurs in connection with the audit), unless such audit discloses a
variance of more than 5% from the increase in Standard Cost imposed by Pfizer,
in which event, Pfizer shall bear the full cost of such audit. Any amounts that
are determined to be due and owing by Pfizer to Purchaser following such audit
shall be paid within 30 Business Days thereafter, together with any interest due
thereon from the date of overpayment by Purchaser at the rate of 12% per annum.
The payment of such interest shall not limit Purchaser from exercising any other
legal rights it may have as a consequence of the lateness of any payment.
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ARTICLE 5
ACCEPTANCE OF PRODUCTS BY PURCHASER
5.1 Receipt of Product; Acceptance; Product Returns.
(a) Purchaser shall be entitled to reject any portion or all of
any shipment of Products that does not conform to the Certificate of Analysis or
otherwise fails to comply with the warranties set forth in Article 7 (unless
such non-conformity was attributable to an act or omission of Purchaser or the
common carrier once the Product was delivered by Pfizer to such common carrier),
provided that (i) Purchaser shall notify Pfizer within 30 days after receipt of
such shipment if it is rejecting a shipment due to obvious physical damage,
obvious packaging defect or quantity discrepancies that are evident upon visual
inspection of the packaged Products as shipped by Pfizer and (ii) in the case of
Products having defects other than those obvious defects, Purchaser shall notify
Pfizer within 90 days after receipt of such Product. Notwithstanding anything
contained herein, Purchaser shall have no obligation to inspect the Products
beyond a visual inspection of each shipment for obvious physical damage or
quantity discrepancies that are evident upon visual inspection of the packaged
Products as shipped by Pfizer. Without in any way limiting Pfizer's indemnity
obligation as set forth in Section 9.1, if no notice is provided by Purchaser
within such time periods, then Purchaser shall be deemed to have accepted the
shipment. Any notice of rejection by Purchaser shall be accompanied by a
reasonably detailed statement of its reasons for rejection and a report of any
pertinent analysis performed by Purchaser on the allegedly nonconforming
Product, together with the methods and procedures used. Pfizer shall notify
Purchaser as promptly as reasonably possible, but in any event within ten
Business Days after receipt of such notice of rejection, whether it accepts
Purchaser's assertions of nonconformity.
(b) Whether or not Pfizer accepts Purchaser's assertion of
nonconformity, promptly upon receipt of a notice of rejection, unless otherwise
specified by Purchaser, Pfizer shall use its commercially reasonable efforts to
provide replacement Products for those rejected by Purchaser in the original
shipment. If the Product rejected by Purchaser from such original shipment
ultimately is found to be nonconforming (whether pursuant to Section 5.1(c) or
if Pfizer so acknowledges in writing), Pfizer shall bear all expenses for such
replacement Product (including all transportation and/or disposal charges and
cost of manufacture for such nonconforming Product) to the extent Purchaser
previously paid for any corresponding nonconforming Product. If it is determined
subsequently that such Product was in fact conforming (whether pursuant to
Section 5.1(c) or if Purchaser so acknowledges in writing), then Purchaser shall
be responsible not only for the purchase price of the allegedly nonconforming
Product (including all transportation charges), but also, upon receipt and
acceptance by Purchaser in accordance with the procedures (and at the same price
charged in the original shipment) set forth above, the replacement Product.
Replacement shipments shall also be subject to the procedures contained in
Section 5.1(a).
(c) If Pfizer disagrees with any alleged nonconformity, then an
independent laboratory (or other expert) of recognized repute reasonably
acceptable to both Parties (the
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"INDEPENDENT LABORATORY") shall analyze an aliquot sample or such other portions
of a shipment, furnished by Purchaser from the shipment received by Purchaser,
as may be necessary to substantiate whether the shipment rejected by Purchaser
conformed in all material respects to the Certificate of Analysis and any other
pertinent Specifications or otherwise failed to comply with the warranties set
forth in Article 7 at the time of delivery to the common carrier. At the same
time Purchaser furnishes to the Independent Laboratory an aliquot sample or such
other portion of such shipment, Purchaser shall also furnish to Pfizer a split
sample of such aliquot sample or such other portion of such shipment. In
conducting its analysis hereunder, the Independent Laboratory shall use the same
analytical methodology used by Pfizer. Pfizer shall provide a reasonably
detailed description of such analytical methodology to the Independent
Laboratory. Both Parties agree to cooperate with the Independent Laboratory's
reasonable requests for assistance in connection with its analysis hereunder.
Both Parties shall be bound by the Independent Laboratory's results of analysis,
which, absent manifest error, shall be deemed final as to any dispute over
compliance of the Product in all material respects with the Certificate of
Analysis and/or any other pertinent Specifications and/or the warranties set
forth in Article 7. If the analysis of the Independent Laboratory shows that the
Products do not conform in all material respects to the Certificate of Analysis
or any other pertinent Specifications or the warranties set forth in Article 7
at the time of delivery to the common carrier, the costs of such analysis shall
be paid by Pfizer. If the analysis of the Independent Laboratory shows that the
Products do conform in all material respects to the Certificate of Analysis and
any other pertinent Specifications and the warranties set forth in Article 7 at
the time of delivery to the common carrier, the costs of such analysis shall be
paid by Purchaser.
(d) If Pfizer acknowledges an alleged nonconformity (or if the
Independent Laboratory concludes that the Product was nonconforming in
accordance with Section 5.1(c)), Pfizer promptly (and in any case within 30 days
thereafter) shall make arrangements for the return, reworking or disposal, at
Pfizer's option, of the nonconforming Product. If Pfizer requests that Purchaser
dispose of such nonconforming Product, Pfizer shall give Purchaser written
instructions as to how Purchaser or its agent shall, at Pfizer's expense and
liability, lawfully dispose of any non-conforming Products, and Purchaser shall
provide Pfizer with written certification of such destruction. Pfizer shall pay,
or reimburse Purchaser, for any reasonable return shipping charges or
out-of-pocket costs incurred by Purchaser for such return shipment or lawful
disposal of such nonconforming Product in accordance with Pfizer's instructions.
5.2 Quality Control. Pfizer shall conduct all quality control
testing of the Products prior to shipment in accordance with the applicable
Product Registrations and Laws. Pfizer shall retain records and samples of
Products relating to such testing as required by applicable Law. If Purchaser
conducts quality control testing of Products after delivery thereof to
Purchaser, Purchaser shall use the same analytical methodology as used by
Pfizer. Upon written request from Purchaser, Pfizer shall provide a reasonably
detailed description of the analytical methodology used by Pfizer for quality
control testing of the Products.
5.3 Inspections. Pfizer shall afford Purchaser or Purchaser's
representatives reasonable access, but no more than two times per year, to
inspect, review and audit the
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premises where the Products are being tested and/or manufactured for the sole
purpose of confirming that all Products tested and/or manufactured at such
facility are tested and/or manufactured in accordance with cGMPs, the applicable
Product Registration and other requirements of this Agreement and of applicable
Law. In connection with such inspection, review or audit, Pfizer shall allow
Purchaser to review and inspect the applicable testing and/or manufacturing
facility and records, to meet with Pfizer's personnel and to obtain copies from
Pfizer of any such records solely for the purpose of confirming that Pfizer's
manufacturing and record-keeping is compliant with the applicable Product
Registration, this Agreement and applicable Laws. Such inspections, reviews and
audits shall occur upon not less than ten days' prior written notice to Pfizer,
such inspections, reviews and audits shall only be conducted during normal
business hours and such inspections, reviews and audits shall not unreasonably
disrupt the normal operations of Pfizer. Purchaser's exercise of its inspection
rights hereunder shall in no way waive, modify or diminish Pfizer's obligations
under this Agreement.
5.4 Notification, Etc. of Certain Matters. In the event that
representatives of any relevant Governmental Authority inspect or notify Pfizer
of their intention to inspect the Xxxxxxx Plant in connection with the
manufacturing or supply of the Products, Pfizer shall notify Purchaser promptly
upon learning of such inspection, and shall supply Purchaser with copies of all
correspondence and other documentation received from the Governmental Authority
relating thereto. Pfizer shall provide promptly to Purchaser copies of any
letter, comments or inquiry from any relevant Governmental Authority in
connection with the manufacturing or supply of the Products that requires a
response or action by Pfizer including, but not limited to, an FDA Form 483 or a
Warning Letter. Pfizer shall permit Purchaser to review and comment on the
content of any written response relating to an inspection of the Xxxxxxx Plant
that relates in any way to the Products before Pfizer submits that response to
the Governmental Authority. If such comments are provided promptly (within one
week unless the circumstances require greater expedition), Pfizer shall consider
the comments before submission of the response.
5.5 Restart Matters. In the event that any relevant Governmental
Authority determines that Pfizer must cease manufacturing the Products as well
as other products in the Xxxxxxx Plant due to Pfizer's failure to adhere to
cGMPs relating to manufacturing, handling or controlling of any product made in
the Xxxxxxx Plant, Pfizer shall use reasonable best efforts to obtain approval
from the relevant Governmental Authority to begin manufacturing the Products as
soon as practicable thereafter. In the event of a Xxxxxxx Plant shutdown
described herein, should the relevant Governmental Authority allow Pfizer to
begin manufacturing products in the Xxxxxxx Plant on an incremental
product-by-product basis, Pfizer shall not discriminate against the Products
during Pfizer's efforts to obtain approval to restart manufacturing.
12
ARTICLE 6
PRODUCT QUALITY COMPLAINTS; PRODUCT RECALLS; ADVERSE EVENTS
6.1 Product Quality Complaints.
(a) Subject to Sections 6.1(b) through (d), Purchaser shall be
responsible for responding to all Product Quality Complaints with respect to the
Products. Both Parties shall cooperate to effect any resolutions with respect to
any Product Quality Complaint. "PRODUCT QUALITY COMPLAINT" shall mean any
complaint that questions the purity, identity, potency or quality of any
Product, its packaging or labeling, any complaint that concerns any incident
that causes any Product or its labeling to be mistaken for, or applied to,
another article, any bacteriological contamination, any significant chemical,
physical or other change or deterioration in any distributed Product or any
failure of any Product to meet its applicable Specifications. Where the subject
matter of the Product Quality Complaint relates in any way to the
responsibilities of a Party under this Agreement or the duties performed by a
Party hereunder, such Party shall, within three Business Days but not more than
five days from receipt of written notice by such Party from the other Party or
receipt by such Party of any other information from a Third Party constituting a
Product Quality Complaint, initiate a complaint investigation at such Party's
expense. Such Party shall conduct such investigation expeditiously. The
investigating Party shall report its findings to the other Party's contact
listed below in Section 6.1(b) or (c), as the case may be.
(b) Pfizer shall inform Purchaser's contact of any Product Quality
Complaint received by it within three Business Days but no more than five days
from the receipt date by Pfizer. Such information shall be sent to the contact
set forth below:
Xxxxxx Xxxxxxxx Inc.
000 Xxxxxxxxxx Xxxxx
Xxxxxxxx, Xxx Xxxxxx 00000
Attention: Vice President - Regulatory Affairs
Facsimile No.: (000) 000-0000
Telephone No.: (000) 000-0000
(c) Purchaser shall inform Pfizer's contact of any Product Quality
Complaint received by it within three Business Days but no more than five days
from the receipt date by Purchaser. Such information shall be sent to Pfizer as
set forth below:
Pfizer Inc.
Product Complaints
000 Xxxxx Xxxx
Xxxxxx Xxxxxx, Xxx Xxxxxx 00000-0000
Attention: Director of Product Complaints
Facsimile No.: (000) 000-0000
Telephone No.: (000) 000-0000
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(d) Nothing in this Section 6.1 is intended to limit, alter or
restrict a Party's reporting obligations under applicable Law.
6.2 Product Recalls.
(a) In the event that either Party obtains information that a
Product or any portion thereof should be alleged or proven not to meet the
Specifications, the Labeling or the Product Registration for such Product or to
be otherwise defective, such Party shall notify the other Party immediately and
both Parties shall cooperate fully regarding the investigation and disposition
of any such matter. Pfizer and Purchaser shall each maintain such traceability
records as are sufficient and as may be necessary to permit a recall, product
withdrawal or field correction of any of the Products. In the event (i) any
applicable Governmental Authority should issue a request, directive or order
that a Product be recalled or withdrawn or (ii) Purchaser determines that any
Product already in interstate or international commerce presents a risk of
injury or gross deception or is otherwise defective and that a recall of such
Product is appropriate (each of (i) and (ii), a "RECALL"), each Party shall give
telephonic notice (to be confirmed in writing) to the other within 24 hours of
the occurrence of such event.
(b) Purchaser shall have sole responsibility for carrying out any
Recalls. Pfizer shall provide full cooperation and assistance to Purchaser in
connection therewith as may be reasonably requested by Purchaser. Purchaser
shall be responsible for all expenses of effecting any such Recall (including
any out-of-pocket expenses incurred by Pfizer in connection with such
cooperation), except to the extent such Recall is attributable to a breach by
Pfizer of its obligations hereunder (in which case Pfizer shall be responsible
for the expenses associated with any such Recall attributable to such breach).
6.3 Adverse Events.
(a) Within one month after the date hereof, the Parties shall
discuss and develop mutually acceptable guidelines and procedures for the
surveillance, receipt, evaluation, reporting and communication (as between the
Parties), exchange of Serious Adverse Event and Non-Serious Adverse Event
information, and the migration of such data, in accordance with the terms of
this Agreement in order to permit both Parties to comply with their respective
obligations under all applicable Laws until such time as all Product
Registrations and other Governmental Authorizations, including clinical trial
applications, are transferred to Purchaser or its designee. The Parties shall
bear their respective costs incurred in connection with receiving, recording,
reviewing, reporting, communicating and exchanging with each other regarding
and, as applicable, reporting and responding to any Serious Adverse Events or
Non-Serious Adverse Events.
(b) Until the earlier of (i) nine months after the Closing and
(ii) the date upon which all Product Registrations are transferred to Purchaser,
Pfizer shall maintain systems for global pharmacovigilance for the Products.
Until such time as guidelines and procedures are developed in accordance with
Section 6.3(a), each Party shall promptly notify the other Party of any
significant adverse event(s) that affect the marketing of such Products or are
required
14
to be reported in accordance with FDA regulations, including adverse drug
experiences and governmental inquiries. Purchaser shall have the reporting
responsibility for such events as provided under applicable Law to applicable
Governmental Authorities. Each of Pfizer and Purchaser shall cooperate with the
other Party in connection therewith as reasonably requested by the other Party
and as follows:
(i) Serious Adverse Events for the Products of which one
Party becomes aware shall be submitted to the other Party within the
time frames specified in the applicable regulations or guidelines.
Non-Serious Adverse Events for the Products that are reported to one
Party shall be submitted to the other Party no more than one month from
the date received by the first-mentioned Party; provided, however, that
medical and scientific judgment should be exercised in deciding whether
expedited reporting is appropriate in other situations, such as
important medical events that may not be immediately life-threatening
or result in death or hospitalization, but may jeopardize the patient
or may require intervention to prevent a Serious Adverse Event outcome.
(ii) All Serious Adverse Events and Non-Serious Adverse
Events shall be submitted by one Party to the other Party pursuant to
this Section 6.3 in accordance with the current contact information for
the non-reporting Party. Each Party shall provide the other with
current contact information in writing promptly after the date hereof,
but in no event later than 15 Business Days after such date, and, in
the event of any changes, promptly shall update such information in
writing to the other Party.
6.4 Medical Inquiries. Purchaser shall have sole responsibility,
at its expense, for handling all medical inquiries concerning the Products.
Pfizer shall, and shall cause its relevant Affiliate to, refer all routine
medical information requests in writing to Purchaser as set forth in Section
6.3(b)(ii). Urgent medical information requests shall be referred by Pfizer to
Purchaser by telephone.
ARTICLE 7
WARRANTIES; CERTAIN COVENANTS
7.1 Pfizer hereby warrants to Purchaser, for the benefit of
Purchaser, that (a) Ordered Products supplied pursuant to this Agreement shall
in all material respects be (i) in compliance with the Specifications, cGMPs and
all other requirements and conditions contained in this Agreement and (ii)
warranted to be free of defects in material and workmanship and (b) Pfizer shall
either (i) at its option, repair or replace, within a reasonable period of time,
or (ii) if Pfizer is unable after using its commercially reasonable efforts to
effectively perform such repair or replacement within a reasonable amount of
time, refund the price of any Ordered Products that fail to conform with the
warranties in this Section 7.1.
7.2 To the extent permissible by Law, the warranties contained in
Section 7.1(a) are exclusive and in lieu of all other warranties, express or
implied, and Pfizer expressly
15
disclaims and excludes any implied warranty of merchantability or implied
warranty of fitness for a particular purpose.
7.3 Except as provided in Section 9.1(b) in respect of Pfizer's
maximum annual indemnification liability in respect of third party claims, in
the event of any breach of this Agreement, the parties hereto shall be entitled
to all remedies available at Law or equity.
ARTICLE 8
TERM AND TERMINATION
8.1 Term. Subject to the other provisions of this Article 8, this
Agreement shall have a term ("TERM") beginning on the date hereof and ending on
the later of (a) five years from the date hereof and (b) four years from the
expiration of the Negotiation Period and shall not be renewable. Notwithstanding
the foregoing, this Agreement shall terminate on the date on which Pfizer
completes the sale of the Xxxxxxx Plant to Purchaser.
8.2 Termination Upon Obtainment of Alternate Source of Supply.
Purchaser agrees to proceed as promptly as practicable after the date of this
Agreement to obtain an alternate source of supply for the Products. As soon as
Purchaser shall obtain an alternate source of supply for the Products, Purchaser
shall promptly notify Pfizer, and Pfizer may, at its sole discretion and at any
time during the remaining Term, terminate the supply of the Products under this
Agreement upon 30 days prior written notice to Purchaser. Pfizer shall provide
Purchaser (or Purchaser's designee) with the assistance of its employees and
access to its other internal resources to provide Purchaser with a reasonable
level of technical assistance and consultation in connection with the regulatory
qualification of an alternate supplier for the Products, provided that Purchaser
shall reimburse Pfizer for the fully-burdened cost of such technical assistance
and consultation to the extent that Pfizer provides in excess of 120 man-hours
of such assistance and consultation, provided further that Purchaser shall
reimburse Pfizer for all reasonable out-of-pocket costs incurred in connection
with such assistance and consultation.
8.3 Termination by Pfizer.
(a) This Agreement may be terminated by Pfizer, at its option,
upon the commencement against Purchaser of a voluntary or involuntary proceeding
under any bankruptcy, insolvency, liquidation or similar Law, or upon the
appointment with respect to Purchaser of a successor, trustee, custodian,
sequestrator or similar official.
(b) This Agreement may be terminated by Pfizer in the event of a
material breach by Purchaser of Purchaser's obligations of performance under
this Agreement if such breach is not cured within 60 days following receipt of
notice of such material breach from Pfizer.
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8.4 Termination by Purchaser.
(a) This Agreement may be terminated by Purchaser, at its option,
upon the commencement against Pfizer of a voluntary or involuntary proceeding
under any bankruptcy, insolvency, liquidation or similar Law, or upon the
appointment with respect to Pfizer of a successor, trustee, custodian,
sequestrator or similar official.
(b) This Agreement may be terminated by Purchaser in the event of
a material breach by Pfizer of Pfizer's obligations of performance under this
Agreement if such breach is not cured within 60 days following receipt of notice
of such material breach from Purchaser.
8.5 Effect of Termination or Expiration. Indemnification and
confidentiality obligations that accrue prior to the effective date of such
termination or the expiration of this Agreement shall survive the termination or
expiration of this Agreement. If this Agreement is terminated by Pfizer pursuant
to Section 8.3(b), then Purchaser shall purchase all merchantable inventory,
including work in process, raw materials and packaging materials, at Pfizer's
full cost. This Section 8.5 shall survive the termination or expiration of this
Agreement.
ARTICLE 9
INDEMNIFICATION
9.1 Indemnification by Pfizer.
(a) Pfizer agrees to indemnify, protect, defend and hold Purchaser
and its directors, officers, employees and agents harmless from and against any
Losses that they may incur at any time by reason of any Action brought by any
Governmental Authority or other Third Party arising out of (i) Pfizer's breach
of this Agreement or of any warranty made by Pfizer to Purchaser under this
Agreement or (ii) Pfizer's supply of damaged or defective Product that does not
meet the Specifications.
(b) In no event shall Pfizer's liability pursuant to Section
9.1(a) for any and all Losses to Purchaser, other than any Losses arising out of
any Product Claims (but only if such Product Claims are indemnifiable pursuant
to Section 9.1(a)), exceed $10,000,000 in the aggregate for any given calendar
year during the Term.
9.2 Indemnification by Purchaser. Purchaser agrees to indemnify,
protect, defend and hold Pfizer and its directors, officers, employees and
agents harmless from and against any Losses that the may incur at any time by
reason of any Action brought by any Governmental Authority or other Third Party
arising out of (i) Purchaser's breach of this Agreement or of any warranty made
by Purchaser to Pfizer under this Agreement or (ii) the manufacture, sale,
marketing, use or distribution of the Products, except to the extent that Pfizer
is obligated to indemnify, protect and defend Purchaser and its directors,
officers, employees and agents for such Losses under Section 9.1.
17
9.3 Notice of Claims. If any of the Persons to be indemnified
under this Article 9 (the "INDEMNIFIED PARTY") has suffered or incurred any
Loss, the Indemnified Party shall so notify the party from whom indemnification
is sought (the "INDEMNIFYING PARTY") promptly in writing describing such Loss,
the amount or estimated amount thereof, if known or reasonably capable of
estimation, and the method of computation of such Loss, all with reasonable
particularity and containing a reference to the provisions of this Agreement or
any other agreement or instrument delivered pursuant hereto in respect of which
such Loss shall have occurred. If any action at law or suit in equity is
instituted by or against a Third Party with respect to which the Indemnified
Party intends to claim any liability as a Loss under this Article 9, the
Indemnified Party shall promptly notify the Indemnifying Party of such action or
suit and tender to the Indemnifying Party the defense of such action or suit. A
failure by the Indemnified Party to give notice and to tender the defense of the
action or suit in a timely manner pursuant to this Section 9.3 shall not limit
the obligation of the Indemnifying Party under this Article 9, except (i) to the
extent such Indemnifying Party is materially prejudiced thereby and (ii) to the
extent expenses that are incurred during the period in which notice was not
provided shall not be deemed a Loss.
9.4 Control of Claims.
(a) The Indemnifying Party under this Article 9 shall have the
right, but not the obligation, to conduct and control, through counsel of its
choosing, any claim, action, suit or proceeding for which indemnification is
sought pursuant to this Article 9 ("INDEMNIFIABLE CLAIM"), and the Indemnifying
Party may compromise or settle the same, provided that the Indemnifying Party
shall give the Indemnified Party advance notice of any proposed compromise or
settlement, provided further that the Indemnifying Party shall not compromise or
settle any Indemnifiable Claim without the approval of the Indemnified Party if
such compromise or settlement imposes any obligations on the Indemnified Party,
such approval not to be unreasonably withheld. No Indemnified Party may
compromise or settle any Indemnifiable Claim without the consent of the
Indemnifying Party. The Indemnifying Party shall permit the Indemnified Party to
participate in, but not control, the defense of any such Indemnifiable Claim
through counsel chosen by the Indemnified Party, provided that the fees and
expenses of such counsel shall be borne by the Indemnified Party. If the
Indemnifying Party elects not to control or conduct the defense or prosecution
of an Indemnifiable Claim, the Indemnifying Party nevertheless shall have the
right to participate in the defense or prosecution of any Indemnifiable Claim
and, at its own expense, to employ counsel of its own choosing for such purpose.
(b) The parties hereto shall cooperate in the defense or
prosecution of any Indemnifiable Claim, with such cooperation to include (i) the
retention of and the provision to the Indemnifying Party of records and
information that are reasonably relevant to such Indemnifiable Claim and (ii)
the making available of employees on a mutually convenient basis for providing
additional information and explanation of any material provided hereunder.
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ARTICLE 10
CONFIDENTIALITY
10.1 Pfizer's Obligation. Except for the proper exercise of any
rights granted or reserved under other provisions of this Agreement, Pfizer
agrees that it shall keep confidential, and shall cause its officers, employees,
directors and counsel to keep confidential and shall not publish or otherwise
divulge to a Third Party, other than any agents of Pfizer, or use for itself,
unless Purchaser shall have given its prior written approval, during the Term
and for a period of ten years after the end of the Term, any information of a
proprietary nature relating to Purchaser's business or operations, including
non-public information concerning Purchaser's products, processes, customers and
suppliers and the products and processes of Purchaser's customers and suppliers
furnished to Pfizer by Purchaser in connection with this Agreement (any of the
foregoing, "CONFIDENTIAL PURCHASER INFORMATION"); provided, however, that Pfizer
shall have the right to disclose any Confidential Purchaser Information provided
hereunder if, in the reasonable opinion of Pfizer's legal counsel, such
disclosure is necessary (a) in connection with the securing of any governmental
approval necessary for the performance by Pfizer of any of its obligations
hereunder or under any other agreement with Purchaser or (b) for the purpose of
complying with governmental regulations. Pfizer shall notify Purchaser of
Pfizer's intent to make such disclosure of Confidential Purchaser Information
pursuant to the proviso of the preceding sentence sufficiently prior to making
such disclosure so as to allow Purchaser adequate time to take whatever action
Purchaser may deem to be appropriate to protect the confidentiality of
Confidential Purchaser Information.
10.2 Purchaser's Obligation. Except for the proper exercise of any
rights granted or reserved under other provisions of this Agreement, Purchaser
agrees that it shall keep confidential, and shall cause its officers, employees,
directors and counsel to keep confidential and shall not publish or otherwise
divulge to a Third Party, other than any agents of Purchaser, or use for itself,
unless Pfizer shall have given its prior written approval, during the Term and
for a period of ten years after the end of the Term, any information of a
proprietary nature relating to Pfizer's business or operations, including
non-public information concerning Pfizer's products, processes, customers and
suppliers and the products and processes of Pfizer's customers and suppliers,
furnished to Purchaser by Pfizer in connection with this Agreement (any of the
foregoing, "CONFIDENTIAL PFIZER INFORMATION"); provided, however, that Purchaser
shall have the right to disclose any Confidential Pfizer Information provided
hereunder if, in the reasonable opinion of Purchaser's legal counsel, such
disclosure is necessary (a) in connection with the securing of any governmental
approval necessary for the performance by Purchaser of any of its obligations
hereunder or under any other agreement with Pfizer or (b) for the purpose of
complying with government regulations. Purchaser shall notify Pfizer of
Purchaser's intent to make such disclosure of Confidential Pfizer Information
pursuant to the proviso of the preceding sentence sufficiently prior to making
such disclosure so as to allow Pfizer adequate time to take whatever action
Pfizer may deem to be appropriate to protect the confidentiality of Confidential
Pfizer Information.
19
10.3 Permitted Disclosure or Use of Information. Nothing in this
Article 10 shall prevent disclosure or use of Confidential Purchaser Information
or Confidential Pfizer Information, as the case may be, that (a) is or has
become known to the public other than through a breach of this Agreement or (b)
lawfully was disclosed to the disclosing Party by a Third Party having the right
to disclose it.
10.4 Use of Information to Perform Obligations Under this
Agreement. Within the limits set forth in this Article 10, each Party shall be
entitled at all times to use all Confidential Purchaser Information or
Confidential Pfizer Information, as the case may be, provided by the other Party
in order to perform its obligations under this Agreement.
ARTICLE 11
MISCELLANEOUS
11.1 Force Majeure. No Party shall be liable to another for its
failure to perform any of its obligations hereunder caused by contingencies
beyond its control, including acts of God, fire, flood, wars, acts of terrorism,
sabotage, strike and government actions (other than actions prohibiting the sale
of the Products resulting from Pfizer's failure to supply Products in compliance
with the Specifications or cGMPs (i.e., failure to comply with 21 C.F.R. Parts
210 and 211) or otherwise resulting from Pfizer's failure to comply with any
applicable requirement of Law). Any Party asserting its inability to perform any
obligation hereunder for any such contingency shall promptly notify the other
Party of the existence of any such contingency and shall use its reasonably
diligent efforts to re-commence its performance of such obligation as soon as
commercially practicable.
11.2 Assignment. None of the Parties may assign any of its rights
or obligations hereunder without the written approval of the other Party, such
approval not to be unreasonably withheld; provided, however, that the Parties
may assign any of their respective rights or obligations under this Agreement to
any of their respective Affiliates without the approval of the other Party, and
Pfizer may assign any of its rights and obligations under this Agreement to any
Third Party that purchases the Xxxxxxx Plant without Purchaser's approval. This
Agreement shall be binding upon and inure to the benefit of the successors and
assigns of each of the Parties.
11.3 Independent Contractor. The Parties shall each be an
independent contractor in the performance of their respective obligations
hereunder. No Third Party, including any employee of any Party, shall have, or
acquire, any rights by reason of this Agreement.
11.4 Notices. All notices or other communications hereunder shall
be deemed to have been duly given and made if in writing and if served by
personal delivery upon the Party for whom it is intended, if delivered by
registered or certified mail, return receipt requested, or by a national courier
service, or if sent by facsimile, provided that the facsimile is promptly
confirmed by telephone confirmation thereof, to the Person at the address set
forth below, or such other address as may be designated in writing hereafter, in
the same manner, by such Person.
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If to Pfizer:
Pfizer Inc.
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: President, Pfizer Global Manufacturing
Facsimile No. (000) 000-0000
with a copy to:
Pfizer Inc.
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxxxx Xxxxxxx, Esq.
Senior Vice President and General Counsel
Telephone No. (000) 000-0000
Facsimile No. (000) 000-0000
If to Purchaser:
Xxxxx (Chemicals) Limited
0 Xxxxxxxx Xxxxxx
Xxx Xxxxxxxxx, Xx. Xxxxxx
Attention: Senior Vice President, Finance
Telephone Xx. 000 000 0 000 0000
Xxxxxxxxx No. 011 353 1 214 8477
with a copy to:
Xxxxx Holdings PLC
000 Xxxxxxxxxx Xxxxx
Xxxxxxxx, Xxx Xxxxxx 00000
Attention: Senior Vice President, Corporate Development,
General Counsel and Corporate Secretary
Telephone No. (000) 000-0000
Facsimile No. (000) 000-0000
11.5 Governing Law. This Agreement shall be governed by and
construed in accordance with the Laws of the State of New York, regardless of
the Laws that might otherwise govern applicable principles of conflicts of Laws
thereof. With respect to any suit, action or proceeding relating to this
Agreement (each, a "PROCEEDING"), each Party irrevocably (i) agrees and consents
to be subject to the jurisdiction of the United States District Court for the
Southern District of New York or any New York State court sitting in New York
City and (ii) waives any objection which it may have at any time to the laying
of venue of any Proceeding brought in any such court, waives any claim that such
Proceeding
21
has been brought in an inconvenient forum and further waives the right to
object, with respect to such Proceeding, that such court does not have any
jurisdiction over such Party.
11.6 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, and all of which shall
constitute one and the same agreement.
11.7 Headings. The heading references herein are for convenience
purposes only, do not constitute a part of this Agreement and shall not be
deemed to limit or affect any of the provisions hereof.
11.8 Modifications. This Agreement contains the entire
understanding and agreement between the Parties as to the supply of the Products
hereunder. It may not be amended or modified, except by a written instrument
executed by the Parties.
11.9 Cumulative Effect. The rights and obligations of the Parties
under this Agreement shall be cumulative to and not exclusive of the rights and
obligations of the Parties contained in the Purchase Agreement.
11.10 Sales and Use Taxes. Purchaser shall be responsible for the
payment of any sales and use taxes on the Products delivered by Pfizer to
Purchaser.
11.11 Severability. In the event that any one or more of the
provisions contained herein, or the application thereof in any circumstances, is
held invalid, illegal or unenforceable in any respect for any reason, the
Parties shall negotiate in good faith with a view to the substitution therefor
of a suitable and equitable solution in order to carry out, so far as may be
valid and enforceable, the intent and purpose of such invalid provision;
provided, however, that the validity, legality and enforceability of any such
provision in every other respect and of the remaining provisions contained
herein shall not be in any way impaired thereby, it being intended that all of
the rights and privileges of the Parties shall be enforceable to the fullest
extent permitted by Law.
22
IN WITNESS WHEREOF, the Parties have duly executed this Agreement as of
the day and year first above written.
PFIZER INC.,
By:______________________________________________
Name:
Title:
XXXXX (CHEMICALS) LIMITED,
By:______________________________________________
Name:
Title:
23
