[EXHIBIT 99.3]
INTERNATIONAL COLLABORATION AGREEMENT
This Agreement, effective as of June 28, 1996, is made by and between
XXXXXX-XXXXXXX COMPANY, a Delaware corporation (hereinafter
"XXXXXX-XXXXXXX"), with primary offices located at 000 Xxxxx Xxxx, Xxxxxx
Xxxxxx, Xxx Xxxxxx 00000, by and through its Xxxxx-Xxxxx Division, and
PFIZER INC., a Delaware corporation (hereinafter "PFIZER"), with primary
offices located at 000 Xxxx 00xx Xxxxxx, Xxx Xxxx, XX 00000-0000.
WHEREAS, XXXXXX-XXXXXXX and its Affiliates own all rights, title and
interest in and to various patents relating to the Products (as hereinafter
defined); and
WHEREAS, XXXXXX-XXXXXXX and PFIZER believe that the Products
represent an improvement upon existing pharmaceutical treatments for the
lowering of cholesterol levels in humans, and further believe that the
Products may prove beneficial in the treatment of cardiovascular disease;
and
WHEREAS, XXXXXX-XXXXXXX believes that current sellers of
pharmaceutical products which are competitive with the Products are large,
powerful and well entrenched in the License Territory and the Co-Promotion
Territory (each as hereinafter defined) and as a consequence believes that
XXXXXX-XXXXXXX alone would be limited in its ability to realize the
commercial potential for the Product; and
WHEREAS, PFIZER and its Affiliates have significant experience and
expertise in the marketing and promotion of pharmaceutical products, and
PFIZER does not market or sell a pharmaceutical product which is
competitive with the Products; and
WHEREAS, PFIZER believes it can make significant contributions to the
successful market development and commercialization of Products in the
License Territory and the Co-Promotion Territory; and
WHEREAS, XXXXXX-XXXXXXX and PFIZER believe that the co-promotion or
licensing of the Products on the terms set forth herein will best enable
the medical profession and patients to recognize and benefit from the
Products, and XXXXXX-XXXXXXX and PFIZER desire to bring those benefits to
the marketplace by co-promoting or licensing the Products pursuant to the
International Agreements.
NOW THEREFORE, for and in consideration of the foregoing and the
representations, covenants and agreements contained herein, XXXXXX-XXXXXXX
and PFIZER, intending to be legally bound, hereby agree
as follows:
ARTICLE I - DEFINITIONS
Section 1.01 Definitions. The following capitalized terms shall have
the following meanings:
"Affiliate" means any Person that directly or indirectly controls or
is controlled by or is under common control with XXXXXX-XXXXXXX or PFIZER,
as the case may be, but only for so long as said control shall continue. As
used herein the term "control" means possession of the power to direct or
cause the direction of the management and policies of a Person whether by
contract or otherwise.
"Agreement Year" has the meaning ascribed to it in the International
License Agreement.
"Atorvastatin" means the chemical compound ([R-(R*,R*)]-2-(4-
fluorophenyl)-B, d-dihydroxy-5-(l-methylethyl)-3-phenyl-4-[(phenylamino)
carbonyl]-lH-pyrrole-l-heptanoic acid, calcium salt (2:1) and hydrates
thereof.
"Bulk" has the meaning ascribed to it in the International License
Agreement.
"Co-Promotion Territory" means Australia, Austria, Belgium, Canada,
Finland, Germany, Greece, Luxembourg, Mexico, Netherlands, Portugal, Puerto
Rico, Republic of Ireland, South Africa, Sweden, Switzerland and United
Kingdom.
"Country" means any country in the Co-Promotion Territory or the
License Territory.
"Designated Marketing Authorization" means the authorization to sell
the Product in the applicable Country as granted by the relevant
Governmental or Regulatory Authority, which authorization includes
indications, warnings, etc. materially equivalent to those provided in
Exhibit A.
"Governmental or Regulatory Authority" means any court, tribunal,
arbitrator, agency, commission, official or other instrumentality of any
government or of any federal, state, county, city or other political
subdivision thereof.
"International Agreements" means this Agreement, the International
Co-Promotion Agreement and the International License Agreement.
"International Co-Promotion Agreement" means the International
Co-Promotion Agreement between XXXXXX-XXXXXXX and PFIZER of even date
herewith.
"International License Agreement" means the International License
Agreement between XXXXXX-XXXXXXX and PFIZER of even date herewith.
"Laws" means all laws, statutes, rules, regulations, ordinances and other
pronouncements having the effect of law of any government or Governmental or
Regulatory Authority.
"License Territory" means Brazil, Chile, China, Denmark, Iceland, Italy
(including San Marino and Vatican City) , Korea, Norway, Russia - C. I. S.
Republics, Spain and Turkey.
"Losses" means any and all damages, fines, fees, penalties,
judgments, deficiencies, losses and expenses (including without limitation
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).
"Marketing Authorization" means the authorization to sell the Product in
the applicable Country as granted by the relevant Governmental or Regulatory
Authority.
"Milestone Countries" means Australia, Brazil, Canada, Germany, Italy,
First Nordic Country (as set forth in Section 3.01(iii)), Netherlands, Spain,
Turkey and the United Kingdom.
"Net Sales" has the meaning ascribed to it in the International License
Agreement.
"Person" means any natural person, corporation, general partnership,
limited partnership, joint venture, proprietorship or other business
organization.
"Price Approval" means, in Countries where Governmental or Regulatory
Authorities approve or determine pricing for pharmaceutical products for
reimbursement or otherwise, such approval or determination, which approval
or determination shall be acceptable to the party applying therefor.
"Products" means all finished pharmaceutical formulations that (i)
contain Atorvastatin as the sole active ingredient, or (ii) contain
Atorvastatin together with one or more other active ingredients where such
combination products have indications for (a) lipid lowering and the
treatment or prevention of atherosclerosis or (b) the treatment or
prevention of vascular disease.
ARTICLE II - CO-PROMOTION AND LICENSE RIGHTS
Section 2.01 Co-Promotion. XXXXXX-XXXXXXX hereby agrees to grant to
PFIZER rights to co-promote the Products in the Co-Promotion Territory
pursuant to the terms of the International Co-Promotion Agreement which is
being executed simultaneously with the execution of this Agreement.
Section 2.02 License. XXXXXX-XXXXXXX hereby agrees to grant to PFIZER
license rights to the Products in the License Territory pursuant to the
terms of the International License Agreement which is being executed
simultaneously with the execution of this Agreement.
Section 2.03 Other Countries. XXXXXX-XXXXXXX and PFIZER shall discuss
the merits of including additional countries in the arrangements
contemplated by this Agreement, and if the parties agree, the International
License Agreement or the International Co- Promotion Agreement, as the case
may be, shall be amended to include such additional countries. The parties
shall discuss as soon as practicable after the execution of this Agreement
the inclusion of Argentina, Colombia and Venezuela in the License Territory
(under the terms of the International License Agreement) and the granting
to PFIZER of semi-exclusive rights to those countries pursuant to Section
2.01(b) or (c) of the International License Agreement.
ARTICLE III - PFIZER PAYMENTS
Section 3.01 PFIZER Payments. In consideration for the rights granted
to PFIZER under this Agreement, the International Co-Promotion Agreement
and the International License Agreement, PFIZER shall make the following
payments to XXXXXX-XXXXXXX:
(i) Five Million Dollars (US$5,000,000) upon signing of this Agreement;
(ii) Subject to this Section 3.01 and Section 3.02, Thirty Million
Dollars (US$30,000,000) within five business days of the receipt by
PFIZER of notice from XXXXXX-XXXXXXX of the issuance of a Designated
Marketing Authorization and Price Approval (if applicable) for the
Product in either Germany or the United Kingdom, whichever occurs
first; and
(iii) Subject to this Section 3.01 and Section 3.02, the amounts
indicated below within five business days of receipt by PFIZER of
notice from (A) XXXXXX-XXXXXXX, in the case of (x) Milestone
Countries for which XXXXXX-XXXXXXX has the responsibility of
obtaining a Marketing Authorization and Price Approval (if
applicable) pursuant to the terms of the International License
Agreement; or (y) Milestone Countries in the Co-Promotion
Territory, or (B) the applicable Governmental or Regulatory
Authority, in the case of Milestone Countries in the License
Territory for which PFIZER has the responsibility of obtaining a
Marketing Authorization and Price Approval (if applicable)
pursuant to the terms of the International License Agreement, in
each case, of the issuance of a Designated Marketing
Authorization and Price Approval (if applicable) for the Product
in each of the following countries:
Australia US$ 2,000,000
Brazil 2,000,000
Canada 7,500,000
First Nordic Country
(Denmark, Norway,
Sweden, Finland) 2,000,000
Netherlands 2,000,000
Turkey 2,000,000
(iv) In the event that a Marketing Authorization in any Milestone
Country does not constitute a Designated Marketing Authorization
within thirty (30) days after the receipt of such Marketing
Authorization, XXXXXX-XXXXXXX shall notify PFIZER whether
XXXXXX-XXXXXXX is agreeable or not to undertaking, at
XXXXXX-XXXXXXX'x sole expense, such additional studies as may be
necessary in order to obtain a Designated Marketing
Authorization; provided, that XXXXXX-XXXXXXX shall have the right
at any time, upon notice to PFIZER, to cease any further activity
with respect to such additional studies.
(v) In the event that a Designated Marketing Authorization and
Price Approval (if applicable) are not received by PFIZER or
XXXXXX-XXXXXXX, as the case may be, on or prior to July 1, 1999
covering Australia, Canada, the first Nordic Country, the
Netherlands, Brazil or Turkey, the following shall apply:
(A) In the Milestone Countries where XXXXXX-XXXXXXX has the
responsibility of obtaining a Marketing Authorization and Price
Approval (if applicable), XXXXXX-XXXXXXX shall deliver a notice to
PFIZER indicating whether or not XXXXXX-XXXXXXX will continue to seek
a Designated Marketing Authorization and Price Approval (if
applicable) in the relevant Country.
(1) In the event that XXXXXX-XXXXXXX notifies PFIZER that
XXXXXX-XXXXXXX will permanently not seek or will withdraw its
application for a Designated Marketing Authorization
and/or Price Approval (if applicable), PFIZER shall relinquish
all of its co-promotion and licensing rights with respect to
such Country and the affected Country shall be removed from the
Co-Promotion Territory or License Territory and the
International Co-Promotion Agreement or International License
Agreement shall be modified accordingly; provided, however, in
the event at any time thereafter XXXXXX-XXXXXXX determines that
it or its Affiliate or licensee will launch a Product under a
Marketing Authorization that is not a Designated Marketing
Authorization, XXXXXX-XXXXXXX will deliver a notice thereof to
PFIZER, and PFIZER will have ninety days following the receipt
of such notice to request that its license or co-promotion
rights be reinstated. If Price Approval for such Product is not
required or has been obtained, such request will be accompanied
by a payment to XXXXXX-XXXXXXX of the amount set forth in
Section 3.01(iii); otherwise, PFIZER shall pay the amount set
forth in Section 3.01(iii) within five business days after
receipt by PFIZER of notice of Price Approval from the relevant
Governmental or Regulatory Authority, or in the event that
XXXXXX-XXXXXXX is responsible for obtaining Price Approval,
within five business days of notice from XXXXXX-XXXXXXX of the
issuance of a Price Approval.
(2) In the event that XXXXXX-XXXXXXX notifies PFIZER that
XXXXXX-XXXXXXX will continue to seek a Designated Marketing
Authorization and Price Approval (if applicable), PFIZER shall
have the right, for a period of ninety days after receipt of
such notice, to request that such Country be removed from the
Co-Promotion Territory or License Territory, as the case may
be. In the event that PFIZER makes such a request, PFIZER shall
relinquish all of its co-promotion and licensing rights with
respect to such Country and the affected Country shall be
removed from the Co-Promotion Territory or License Territory
and the International Co-Promotion Agreement or International
License Agreement shall be modified accordingly. In the event
that PFIZER does not make such a request within ninety days
after receipt of notice from XXXXXX-XXXXXXX, the amounts set
forth in Section 3.01(iii) shall be payable in accordance with
the terms thereof.
(B) In the Milestone Countries where PFIZER has the
responsibility of obtaining a Marketing Authorization and
Price Approval (if applicable), PFIZER shall deliver a
notice to XXXXXX-XXXXXXX indicating whether or not PFIZER
will continue to seek a Designated Marketing Authorization
and Price Approval (if applicable) in the relevant Milestone
Country.
(1) In the event that PFIZER notifies XXXXXX-XXXXXXX that
PFIZER will permanently not seek or will withdraw its
application for a Designated Marketing Authorization and Price
Approval (if applicable), PFIZER shall relinquish all of its
co-promotion and licensing rights with respect to such Country
and the affected Country shall be removed from the Co-Promotion
Territory or License Territory and the International
Co-Promotion Agreement or International License Agreement shall
be modified accordingly.
(2) In the event that PFIZER notifies XXXXXX-XXXXXXX that
PFIZER will continue to seek a Designated Marketing
Authorization and/or Price Approval (if applicable), PFIZER
shall use its reasonable efforts to obtain such Designated
Marketing Authorization and/or Price Approval (if applicable)
within twelve months after such notice is given. If PFIZER is
unable after twelve months to obtain such Designated Marketing
Authorization and/or Price Approval (if applicable), PFIZER
shall (unless good faith negotiations are continuing with the
relevant Governmental or Regulatory Authority) relinquish all
of its co-promotion and licensing rights with respect to such
Country and the affected Country shall be removed from the
Co-Promotion Territory or License Territory and the
International Co-Promotion Agreement or International License
Agreement shall be modified accordingly.
Section 3.02 Adjustments. The following adjustments shall be made to
the payments specified in Section 3.01:
(i) If PFIZER shall have made the payment under Section 3.01(ii)
based on the receipt of a Designated Marketing Authorization and
Price Approval (if applicable) for Germany and a Designated Marketing
Authorization and Price Approval (if applicable) for the United
Kingdom are received on or prior to July 1, 1999, then PFIZER shall
pay to XXXXXX-XXXXXXX US$7,500,000 within five business days of the
receipt by PFIZER of notice from XXXXXX-XXXXXXX of the issuance of a
Designated Marketing Authorization and Price Approval (if applicable)
for the Product in the United Kingdom.
(ii) In the event that PFIZER shall have made the payment under
Section 3.01(ii) based on the receipt of a Designated Marketing
Authorization and Price Approval (if applicable) for Germany and if
no Designated Marketing Authorization and Price Approval (if
applicable) for the United Kingdom are received on or prior to July
1, 1999, then the following shall apply:
XXXXXX-XXXXXXX shall deliver a notice to PFIZER indicating whether or
not it will continue to seek a Designated Marketing Authorization and Price
Approval (if applicable) in the United Kingdom.
(1) In the event that XXXXXX-XXXXXXX notifies PFIZER that
XXXXXX-XXXXXXX will permanently not seek or will withdraw its
application for a Designated Marketing Authorization and Price
Approval (if applicable), PFIZER shall relinquish all of its
co-promotion rights with respect to the United Kingdom and the
United Kingdom shall be removed from the Co-Promotion Territory
and the International Co-Promotion Agreement shall be modified
accordingly; provided, however, in the event at any time
thereafter XXXXXX-XXXXXXX determines that it or its Affiliate
or licensee will launch a Product under a Marketing
Authorization that is not a Designated Marketing Authorization,
XXXXXX-XXXXXXX will deliver a notice thereof to PFIZER and
PFIZER will have ninety days following the receipt of such
notice to request that its co-promotion rights be reinstated.
If Price Approval for such Product is not required or has been
obtained, such request will be accompanied by a payment to
XXXXXX-XXXXXXX of US$7,500,000, otherwise, PFIZER shall pay to
XXXXXX-XXXXXXX US$7,500,000 within five business days after
receipt by PFIZER of notice from XXXXXX-XXXXXXX of the issuance
of a Price Approval.
(2) In the event that XXXXXX-XXXXXXX notifies PFIZER that
XXXXXX-XXXXXXX will continue to seek a Designated Marketing
Authorization and Price Approval (if applicable), PFIZER shall
have the right, for a period of ninety days after receipt of
such notice, to request that the United Kingdom be removed from
the Co-Promotion Territory. In the event that PFIZER makes such
a request, PFIZER shall relinquish all of its co-promotion
rights with respect to the United Kingdom, the United Kingdom
shall be removed from the Co-Promotion Territory and the
International Co-Promotion Agreement shall be modified
accordingly. In the event that PFIZER does not make such a
request within ninety days after receipt of notice from
XXXXXX-XXXXXXX, PFIZER shall pay U.S.$7,500,000 within
five business days of the receipt by PFIZER of notice from
XXXXXX-XXXXXXX of the issuance of a Designated Marketing
Authorization and Price Approval (if applicable) for the
Product in the United Kingdom.
(iii) If PFIZER shall have made the payment under Section 3.01(ii)
based on receipt of a Designated Marketing Authorization and Price
Approval (if applicable) for the United Kingdom and a Designated
Marketing Authorization and Price Approval (if applicable) for
Germany are received prior to July 1, 1999, then PFIZER shall pay to
XXXXXX-XXXXXXX US$7,500,000 within five business days of the receipt
by PFIZER of notice from XXXXXX-XXXXXXX of the issuance of a
Designated Marketing Authorization and Price Approval (if applicable)
for the Product in Germany.
(iv) If PFIZER shall have made the payment under Section 3.01(ii)
based on receipt of a Designated Marketing Authorization and Price
Approval (if applicable) for the United Kingdom and if no Designated
Marketing Authorization and Price Approval (if applicable) for
Germany are received prior to July 1, 1999, the following shall
apply:
XXXXXX-XXXXXXX shall deliver a notice to PFIZER indicating whether or
not it will continue to seek a Designated Marketing Authorization and
Price Approval (if applicable) in Germany.
(1) In the event that XXXXXX-XXXXXXX notifies PFIZER that
XXXXXX-XXXXXXX will permanently not seek or will withdraw its
application for a Designated Marketing Authorization and Price
Approval (if applicable), PFIZER shall relinquish all of its
co-promotion rights with respect to Germany and Germany shall
be removed from the Co-Promotion Territory and the
International Co-Promotion Agreement shall be modified
accordingly and PFIZER shall be entitled to a credit of
US$2,500,000 against payments due under Sections 3.01 or 3.02;
provided, however, in the event at any time thereafter
XXXXXX-XXXXXXX determines that it or its Affiliate or licensee
will launch a Product under a Marketing Authorization that is
not a Designated Marketing Authorization, XXXXXX-XXXXXXX will
deliver a notice thereof to PFIZER and PFIZER will have ninety
days following the receipt of such notice to request that its
co-promotion rights be reinstated. If Price Approval for such
Product is not required or has been obtained, such request will
be accompanied by a payment to XXXXXX-XXXXXXX of US$10,000,000;
otherwise PFIZER shall pay US$10,000,000 within five business
days after receipt by PFIZER of notice from XXXXXX-XXXXXXX
of the issuance of a Price Approval.
(2) In the event that XXXXXX-XXXXXXX notifies PFIZER that
XXXXXX-XXXXXXX will continue to seek a Designated Marketing
Authorization and Price Approval (if applicable), PFIZER shall
have the right, for a period of ninety days after receipt of
such notice, to request that Germany be removed from the
Co-Promotion Territory. In the event that PFIZER makes such a
request, PFIZER shall relinquish all of its co-promotion rights
with respect to Germany, Germany shall be removed from the
Co-Promotion Territory and the International Co-Promotion
Agreement shall be modified accordingly and PFIZER shall be
entitled to a credit of US$2,500,000 against payments due under
Sections 3.01 or 3.02. In the event that PFIZER does not make
such a request within ninety days after receipt of notice from
XXXXXX-XXXXXXX, PFIZER shall pay US$7,500,000 within five
business days of the receipt by PFIZER of notice from
XXXXXX-XXXXXXX of the issuance of a Designated Marketing
Authorization and Price Approval (if applicable) for the
Product in Germany.
(v) (A) If PFIZER shall have made the payment under Section
3.01(ii) and no Designated Marketing Authorization and Price Approval (if
applicable) for Spain or Italy has been received prior to July 1, 1999,
then the following shall apply with respect to each such Country:
XXXXXX-XXXXXXX shall deliver a notice to PFIZER indicating whether or
not it will continue to seek a Designated Marketing Authorization and Price
Approval (if applicable) in such Country.
(1) In the event that XXXXXX-XXXXXXX notifies PFIZER that
XXXXXX-XXXXXXX will permanently not seek or will withdraw its
application for a Designated Marketing Authorization and Price
Approval (if applicable), PFIZER shall relinquish all of its
license rights with respect to such Country and such Country
shall be removed from the License Territory and the
International License Agreement shall be modified accordingly
and PFIZER shall be entitled to a credit of US$10,000,000
against payments due under Sections 3.01 or 3.02. It is
understood that such credit shall be US$10,000,000 for each
such Country where PFIZER has relinquished its licensing rights
in accordance with this subclause (1); provided, however, that
in the event at any time thereafter XXXXXX-XXXXXXX determines
that it or its Affiliate or licensee will launch a Product
under a Marketing Authorization that is not a Designated
Marketing Authorization, XXXXXX-XXXXXXX will deliver a
notice thereof to PFIZER and PFIZER will have ninety days
following the receipt of such notice to request that its
license rights be reinstated. If Price Approval for such
Product is not required or has been obtained, such request
will be accompanied by a payment to XXXXXX-XXXXXXX of
US$10,000,000, otherwise PFIZER shall pay US$10,000,000
within five business days after receipt by PFIZER of notice
from XXXXXX-XXXXXXX of the issuance of a Price Approval.
(2) In the event that XXXXXX-XXXXXXX notifies PFIZER that
XXXXXX-XXXXXXX will continue to seek a Designated Marketing
Authorization and Price Approval (if applicable), PFIZER shall
have the right, at any time after receipt of such notice, to
request that such Country be removed from the License
Territory. In the event that PFIZER makes such a request,
PFIZER shall relinquish all of its license rights with respect
to such Country, such country shall be removed from the License
Territory and the International License Agreement shall be
modified accordingly and PFIZER shall be entitled to a credit
of US$10,000,000 against payments due under Sections 3.01 or
3.02. It is understood that such credit shall be US$10,000,000
for each such Country where PFIZER has relinquished its
licensing rights in accordance with this subclause (2). In the
event that PFIZER does not make such a request, PFIZER shall
not be entitled to such credit.
(B) If PFIZER shall have made the payment under Section
3.01(ii) and no Designated Marketing Authorization and Price Approval
(if applicable) for either Italy or Spain has been received by PFIZER
prior to July 1, 1999, but the corresponding Designated Marketing
Authorization and Price Approval has been received by XXXXXX-XXXXXXX,
then, provided that PFIZER has not received a credit or refund
pursuant to subclause (A) of this Section 3.02(v), PFIZER shall have
the-right to request that Italy or Spain, as the case may be, be
removed from the License Territory. In the event that PFIZER makes
such a request, PFIZER shall relinquish all of its licensing rights
with respect to Italy or Spain, as the case may be, and such Country
shall be removed from the License Territory and the International
License Agreement shall be modified accordingly and PFIZER shall be
entitled to a credit of US$10,000,000 against payments due under
Sections 3.01 or 3.02. It is understood that such credit shall be
US$10,000,000 for each such Country where PFIZER has relinquished its
licensing rights in accordance with this subclause (B).
(vi) All PFIZER credits as specified in this Section 3.02 shall first
be applied by PFIZER against payment of any amounts payable under
Sections 3.01 or 3.02, as PFIZER may elect. To the extent that
amounts hereafter payable under Sections 3.01 and 3.02 are less than
the full amount of said credits, then XXXXXX-XXXXXXX shall pay to
PFIZER the shortfall on the earlier of July 1, 1999 or the date
PFIZER has made all payments contemplated under Sections 3.01 and
3.02. Notwithstanding the foregoing, all amounts paid by PFIZER
pursuant to Section 3.01(i) and all Product Expenses (as defined in
the International Co-Promotion Agreement) paid by PFIZER prior to
such notification or PFIZER's relinquishment of such rights shall be
nonrefundable.
Section 3.03 Manner of Payments. All sums payable under Section 3.01
shall be payable in United States Dollars by bank wire transfer in
immediately available funds to such bank account as XXXXXX-XXXXXXX shall
designate. PFIZER shall notify XXXXXX-XXXXXXX'x Assistant Treasurer,
International by facsimile transmission (at 000-000-0000 or such other
number as may be communicated to PFIZER by XXXXXX-XXXXXXX) as to the date
and amount of any such wire transfer to XXXXXX-XXXXXXX one business day
prior to such transfer. XXXXXX-XXXXXXX shall notify PFIZER's Treasurer by
facsimile transmission (at 000-000-0000 or such other number as may be
communicated to XXXXXX-XXXXXXX by PFIZER) as to the date and amount of any
such wire transfer to PFIZER one business day prior to such transfer. Any
taxes imposed on and required to be paid or withheld by PFIZER on account
of amounts payable to XXXXXX-XXXXXXX under this Agreement shall be deducted
from the amount of payment due hereunder at the rates specified by
applicable Law or treaty. In cases where a tax treaty is applicable and
XXXXXX-XXXXXXX desires to benefit thereby, XXXXXX-XXXXXXX shall provide
PFIZER with appropriate documentation necessary to receive benefits
thereunder. In addition, PFIZER shall provide promptly to XXXXXX-XXXXXXX
receipts from the relevant government or taxing authority evidencing
payment of such taxes.
Section 3.04 Interest. Subject to applicable Law and Section 3.05(d),
if (a) either PFIZER or XXXXXX -XXXXXXX fails to make a timely payment
pursuant to this Article III, (b) or XXXXXX-XXXXXXX issues credits pursuant
to this Article III, interest shall accrue on such amount from the day on
which the credit is established until the day on which such credit is
extinguished, interest shall accrue on the past due amount or the amount of
such credit at a rate equal to the rate of interest for 30 day high-grade
commercial paper issued by major corporations effective for the first date
on which the payment was delinquent, calculated on an actual/360 basis, as
quoted in The Wall Street Journal.
Section 3.05 XXXXXX-XXXXXXX Payments in Respect of License
Territories.
(a) In consideration for its participation in the marketing,
promotion and sale of the Products in each Country in the License
Territory, for each Agreement Year and separately calculated for each
Country in the License Territory, until the expiration or earlier
termination of the International License Agreement, XXXXXX-XXXXXXX agrees
to pay PFIZER an amount, calculated in the currency of the Country of sale,
equal to the difference between (i) the aggregate amount paid by PFIZER to
XXXXXX-XXXXXXX for Bulk with respect to such Country under the
International License Agreement during such Agreement Year and (ii) 28% of
Net Sales in such Country during such Agreement Year. Such payment shall be
adjusted simultaneously with any adjustments made pursuant to Section
4.01(d)(v) of the International License Agreement. Notwithstanding anything
contained in this Section 3.05, in the event that any adjustment is made
for a Country pursuant to the proviso contained in Section 4.01(d)(i) of
the International License Agreement, PFIZER shall not be entitled to the
payments set forth in this Section 3.05 for such Country.
(b) XXXXXX-XXXXXXX shall make payments to PFIZER arising under
Section 3.05(a) on a quarterly basis by Country based upon the estimated
prices determined in accordance with Section 4.01(d)(ii) of the
International License Agreement. The aggregate amount of all such payments
made with respect to each Country for each Agreement Year shall be adjusted
simultaneously with any adjustments made pursuant to Section 4.01(d)(v) of
the International License Agreement and the adjusted amount shall be paid
by one party to the other as appropriate.
(c) All sums due to either party shall be payable in the currency
applicable to the respective Country for which the calculation is made
under Sections 3.05(a) and (b) by bank wire transfer in immediately
available funds to such bank account(s) as each of PFIZER and
XXXXXX-XXXXXXX shall designate. PFIZER shall notify XXXXXX-XXXXXXX'x
Assistant Treasurer, International by facsimile transmission (at
000-000-0000 or such other number as may be communicated to PFIZER by
XXXXXX-XXXXXXX) as to the date and amount of any such wire transfer to
XXXXXX-XXXXXXX one business day prior to such transfer. XXXXXX-XXXXXXX
shall notify PFIZER's Treasurer by facsimile transmission (at 000-000-0000
or such other number as may be communicated to XXXXXX-XXXXXXX by PFIZER) as
to the date and amount of any such wire transfer to PFIZER one business day
prior to such transfer. Any taxes imposed on and required to be paid or
withheld by PFIZER on account of amounts payable to XXXXXX-XXXXXXX under
this Agreement shall be deducted from the amount of payment due hereunder
at the rates specified by applicable Law or treaty. In cases where a tax
treaty is applicable and XXXXXX-XXXXXXX desires to benefit thereby,
XXXXXX-XXXXXXX shall provided PFIZER with appropriate documentation
necessary to receive benefits thereunder. In addition, PFIZER shall provide
promptly to XXXXXX-XXXXXXX receipts from the relevant government or taxing
authority evidencing payment of such taxes.
(d) If either XXXXXX-XXXXXXX or PFIZER shall fail to make a timely
payment pursuant to this Section 3.05, interest shall accrue on the past
due amount at a rate equal to the 30 day local interbank rate applicable
for the currency of payment, effective for the first date on which payment
was delinquent, as published in The Financial Times or, if such rate is not
regularly published in The Financial Times, as published in such source as
the parties may mutually agree.
ARTICLE IV - REPRESENTATIONS,
WARRANTIES AND INDEMNIFICATION
Section 4.01XXXXXX-XXXXXXX Representations and Warranties.
XXXXXX-XXXXXXX hereby represents, warrants and covenants to
PFIZER as follows:
(a) As of the date hereof, XXXXXX-XXXXXXX has the corporate power and
authority to execute and deliver the International Agreements and to
perform its obligations thereunder, and the execution, delivery and
performance of the International Agreements by XXXXXX-XXXXXXX have been
duly and validly authorized and approved by proper corporate action on the
part of XXXXXX-XXXXXXX, and XXXXXX-XXXXXXX has taken all other action
required by Law, its certificate of incorporation, by-laws or any agreement
to which it is a party or to which it may be subject that is required to
authorize such execution, delivery and performance. Assuming due
authorization, execution and delivery on the part of PFIZER, the
International Agreements constitute legal, valid and binding obligations of
XXXXXX-XXXXXXX, enforceable against XXXXXX-XXXXXXX in accordance with their
terms, except as the enforceability thereof may be limited by applicable
bankruptcy, insolvency, reorganization or other similar laws of general
application relating to creditors' rights.
(b) As of the date hereof, the execution and delivery of the
International Agreements by XXXXXX-XXXXXXX and the performance by
XXXXXX-XXXXXXX contemplated hereunder and thereunder will not violate any
Laws or any order of any court or other Governmental or Regulatory
Authority.
(c) As of the date hereof, the execution and delivery of the
International Agreements by XXXXXX-XXXXXXX does not require XXXXXX-XXXXXXX
to obtain any permits, authorizations or consents from any
Governmental or Regulatory Authority. In addition, the execution, delivery
and performance of the International Agreements by XXXXXX-XXXXXXX does not
require XXXXXX-XXXXXXX to obtain any permits, authorizations or consents
from any other Person. Except as set forth in Exhibit B, the execution,
delivery and performance of the International Agreements by XXXXXX-XXXXXXX
will not result in the breach of or give rise to any termination of any
agreement or contract to which XXXXXX-XXXXXXX may be a party and which
relates to the Products.
(d) As of the date hereof, Exhibit C contains a correct and complete
list of all patents and patent applications issued or pending in the
Countries relating to Atorvastatin which are owned by XXXXXX-XXXXXXX or its
Affiliates (collectively, the "Patents"). All of the Patents issued as of
the date hereof (i) are held of record by XXXXXX-XXXXXXX, (ii) are free and
clear of all liens, encumbrances and other claims, and (iii) are not
subject in any Country to any pending cancellation, opposition or
reexamination proceeding or any other proceeding challenging their extent
or validity. To the best of XXXXXX-XXXXXXX'x knowledge, all of the Patents
issued as of the date hereof are valid and in full force. XXXXXX-XXXXXXX is
the owner of record of all applications listed on Exhibit C. To the best of
XXXXXX-XXXXXXX'x knowledge, the claims included in such applications relate
to patentable subject matter, and XXXXXX-XXXXXXX is not aware of any reason
that such claims would not be allowed to issue, other than with respect to
European Patent Application 90113986.5, which was filed on July 20, 1990,
has been rejected in the Official Actions issued by the EPO, and is
continuing to be prosecuted by XXXXXX-XXXXXXX.
(e) As of the date hereof, to the best of XXXXXX-XXXXXXX'x knowledge,
the manufacture, use or sale of the Products does not infringe any patents
of third parties, and, to the best knowledge of XXXXXX-XXXXXXX, no third
party is infringing in the Countries any of the issued Patents or any of
the claims of the patent applications listed in Exhibit C.
(f) As of the date hereof, here are no actions, suits, proceedings or
claims, pending against XXXXXX-XXXXXXX or any of its Affiliates, or, to the
knowledge of XXXXXX-XXXXXXX, threatened against XXXXXX-XXXXXXX or any of
its Affiliates, at law or in equity, or before or by any court or
Governmental or Regulatory Authority relating to the Products or any of the
matters contemplated under the International Agreements. To the knowledge
of XXXXXX-XXXXXXX, there are no investigations, pending or threatened
against XXXXXX-XXXXXXX or any of its Affiliates, at law or in equity, or
before or by any Governmental or Regulatory Authority relating to the
Products or any of the matters contemplated under the International
Agreements.
(g) As of the date hereof, XXXXXX-XXXXXXX has exercised reasonable
diligence to ensure that the applications for Marketing Authorization and,
Price Approval (if applicable) filed with the applicable Governmental or
Regulatory Authorities in each Country and all amendments thereto have been
prepared in accordance with all applicable Laws.
(h) As of the date hereof, XXXXXX-XXXXXXX has heretofore disclosed to
PFIZER all material information known to XXXXXX-XXXXXXX with respect to the
safety and effectiveness of the Products or human risk factors relating
thereto.
(i) XXXXXX-XXXXXXX will exercise reasonable diligence to ensure that
the applications for Marketing Authorization and Price Approval (if
applicable) to be filed with the applicable Governmental or Regulatory
Authorities in each country, and all amendments thereto, will be prepared
in accordance with all applicable Laws.
(j) XXXXXX-XXXXXXX acknowledges that PFIZER is relying, and is
entitled to rely, on the foregoing representations, warranties
and covenants.
Section 4.02 PFIZER Representations and Warranties. PFIZER
hereby represents and warrants to XXXXXX-XXXXXXX as of the date hereof as
follows:
(a) As of the date hereof, PFIZER has the corporate power and
authority to execute and deliver the International Agreements and to
perform its obligations thereunder, and the execution, delivery and
performance of the International Agreements by PFIZER have been duly and
validly authorized and approved by proper corporate action on the part of
PFIZER, and PFIZER has taken all other action required by law, its
certificate of incorporation, by-laws or any agreement to which it is a
party or to which it may be subject that is required to authorize such
execution, delivery and performance. Assuming due authorization, execution
and delivery on the part of XXXXXX-XXXXXXX, the International Agreements
constitute legal, valid and binding obligations of PFIZER, enforceable
against PFIZER in accordance with their terms, except as the enforceability
thereof may be limited by applicable bankruptcy, insolvency, reorganization
or other similar laws of general application relating to creditors' rights.
(b) As of the date hereof, the execution and delivery of the
International Agreements by PFIZER and the performance by PFIZER
contemplated thereunder will not violate any Laws or any order of any court
or other Governmental or Regulatory Authority.
(c) As of the date hereof, the execution and delivery of the
International Agreements by PFIZER does not require PFIZER to obtain any
permits, authorizations or consents from any Governmental or Regulatory
Authority. In addition, the execution, delivery and performance of the
International Agreements by PFIZER does not require PFIZER to obtain any
permits, authorizations or consents from any other Person. The execution,
delivery and performance of the International Agreements by PFIZER will not
result in the breach of or give rise to any termination of any agreement or
contract to which PFIZER may be a party.
(d) As of the date hereof, there are no actions, suits, proceedings
or claims pending against PFIZER or any of its Affiliates, or, to the
knowledge of PFIZER, threatened against PFIZER or any of its Affiliates, at
law or in equity, or before or by any court or Governmental or Regulatory
Authority relating to any of the matters contemplated under the
International Agreements. To the knowledge of PFIZER, there are no
investigations, pending or threatened against PFIZER or any of its
Affiliates, at law or in equity, or before or by any Governmental or
Regulatory Authority relating to the matters contemplated under the
International Agreements or which would otherwise materially adversely
affect PFIZER's ability to perform its obligations under the International
Agreements.
(e) PFIZER will exercise reasonable diligence to ensure that the
applications for Marketing Authorization and Price Approval (if applicable)
to be filed with the applicable Governmental or Regulatory Authorities in
each Country, and all amendments thereto, will be prepared in accordance
with all applicable Laws.
(f) PFIZER acknowledges that XXXXXX-XXXXXXX is relying, and is
entitled to rely, on the foregoing representations, warranties
and covenants.
Section 4.03 Indemnification of PFIZER.
(a) XXXXXX-XXXXXXX shall indemnify, defend and hold PFIZER PARTIES
(as hereinafter defined) harmless from and against any and all Losses
incurred, suffered or sustained by PFIZER PARTIES or to which PFIZER
PARTIES become subject, arising out of or resulting from (i) any third
party claims, actions, suits, proceedings, liabilities or obligations
arising from (a) any misrepresentation or breach of any representation,
warranty or agreement made by XXXXXX-XXXXXXX in the International
Agreements, (b) any act or omission of negligence, recklessness or willful
misconduct of XXXXXX-XXXXXXX or (c) the testing, manufacture, use or sale
of the Products (including, without limitation, any claim for death or
bodily injury or patent or trademark infringement), except to the extent
that the foregoing is directly attributable to the Packaging by PFIZER
pursuant to the International License Agreement; and (ii) any claim for
indemnification by PFIZER which is wrongfully disputed by XXXXXX-XXXXXXX.
For purposes of this Section 4.03 PFIZER PARTIES means PFIZER and its
Affiliates and their respective agents, directors, officers and employees.
(b) The indemnity in Section 4.03(a) shall not apply to the extent
that any Loss is primarily the result of any breach of the International
Agreements by PFIZER or of any act or omission of negligence, recklessness
or willful misconduct of PFIZER PARTIES.
Section 4.04 Indemnification of XXXXXX-XXXXXXX.
(a) PFIZER shall indemnify, defend and hold XXXXXX-XXXXXXX PARTIES
(as hereinafter defined) harmless from and against any and all Losses
incurred, suffered or sustained by XXXXXX-XXXXXXX PARTIES or to which
XXXXXX-XXXXXXX PARTIES become subject, arising out of or resulting from:
(i) any third party claims, actions, suits, proceedings, liabilities or
obligations arising from (a) any misrepresentation or breach of any
representation, warranty or agreement made by PFIZER in the International
Agreements, (b) any act or omission of negligence, recklessness or willful
misconduct of PFIZER or (c) PFIZER's Packaging pursuant to the
International License Agreement; and (ii) any claim for indemnification by
XXXXXX-XXXXXXX which is wrongfully disputed by PFIZER. For purposes of this
Section 4.04 XXXXXX-XXXXXXX PARTIES means XXXXXX-XXXXXXX and its Affiliates
and their respective agents, directors, officers and employees.
(b) The indemnity in Section 4.04(a) shall not apply to the extent
that any Loss is primarily the result of any breach of the International
Agreements by XXXXXX-XXXXXXX or of any act or omission of negligence,
recklessness or willful misconduct of XXXXXX-XXXXXXX PARTIES.
Section 4.05Procedures. In the event any third party asserts any
claim with respect to any matter to which the indemnification in Sections
4.03 or 4.04 relates, the party against whom the claim is asserted (the
"Indemnified Party") shall not make any admission concerning such claim,
but shall promptly notify the other party (the "Indemnifying Party"), of
the claim, and the Indemnifying Party shall be entitled, but not obliged,
to manage and control, at its sole expense, the defense of the claim and
its settlement. The benefit of any indemnity by the Indemnifying Party
under this Agreement in respect of any claim shall not apply to the
Indemnified Party if any admission made by such party or any failure by
such party to notify the Indemnifying Party of the claim materially
prejudices the defense of such claim. If the Indemnifying Party elects to
defend such claim, it shall give prompt notice to the Indemnified Party. If
the Indemnifying Party does not give such notice and does not proceed
diligently to defend the Indemnified Party within twenty (20) days after
receipt of notice of the claim, the Indemnifying Party shall be bound by
any defense or settlement made by the Indemnified Party and shall reimburse
the Indemnified Party for its Losses and expenses related to the defense or
settlement of the third party claim. If the Indemnifying Party elects to
defend the claim and gives notice to the Indemnified Party and proceeds
diligently to defend the Indemnified Party, then the Indemnified Party
shall not settle any claim for which it is seeking indemnification without
the prior consent of the Indemnifying Party. The Indemnified Party shall,
if requested by the Indemnifying Party, cooperate in all reasonable
respects in the defense of such a third party claim which is being managed
and controlled by the Indemnifying Party. The Indemnified Party may, at its
option and expense, be represented by counsel of its own choice in any
action or proceeding arising out of such claim; provided, however, the
Indemnifying Party shall not be liable for any litigation costs or expenses
incurred, without its consent, by the Indemnified Party where such action
or proceeding is under the control and management of the Indemnifying
Party.
Section 4.06 Insurance Proceeds. Any indemnification hereunder shall
be made net of any insurance proceeds recovered by the Indemnified Party;
provided, however, that if, following the payment to the Indemnified Party
of any amount under this Article IV, such Indemnified Party recovers any
insurance proceeds in respect of the claim for which such indemnification
payment was made, the Indemnified Party shall promptly pay an amount equal
to the amount of such proceeds (but not exceeding the amount of such
indemnification payment) to the Indemnifying Party.
Section 4.07 Survival. The provisions of this Article IV shall survive
the expiration or termination of this Agreement.
ARTICLE V - MISCELLANEOUS
Section 5.01 Confidentiality; Public Announcements.
(a) Each party shall keep the terms of this Agreement confidential
and shall not disclose the same to any third party other than (i) by
agreement of the parties hereto, or (ii) as required by Law or stock
exchange regulation or an order of a competent court; provided that prior
to disclosure pursuant to (ii) above, the disclosing party shall notify the
nondisclosing party sufficiently prior to making such disclosure so as to
allow the nondisclosing party adequate time to take whatever action it may
deem to be appropriate to protect the confidentiality of the information.
(b) Neither party shall make any press release or other public
announcement or other disclosure to third parties relating to this
Agreement without the prior consent of the other party, which consent shall
not be unreasonably withheld, except where required by applicable Law;
provided that prior to disclosure, the disclosing party shall notify the
nondisclosing party sufficiently prior to making such disclosure so as to
allow the nondisclosing party adequate time to take whatever action it may
deem to be appropriate to protect the confidentiality of the information.
Section 5.02 Choice of Law: Submission to Jurisdiction. This Agreement
shall be governed by and construed in accordance with the law of the State
of New York other than those provisions governing conflicts of law. Each
party hereby irrevocably and unconditionally submits for itself and its
property in any legal action or proceeding relating to or arising out of
this Agreement, or any of the transactions contemplated hereby, to the
nonexclusive general jurisdiction of the Courts of the State of New York,
the courts of the United States of America for the Southern District of New
York, and appellate courts from any thereof, and agrees that any such
action or proceeding may be brought in such courts.
Section 5.03 Assignment. This Agreement may not be assigned by either
party without the prior consent of the other party; provided that each
party shall have the right to assign its rights and obligations under this
Agreement to (a) any third party successor to all or substantially all of
(i) its entire business or (ii) its pharmaceutical business or (b) in whole
or in part to its Affiliate or Affiliates who shall be substituted directly
in whole or in part for it hereunder; provided, however, that the assignor
shall be responsible for the performance of its Affiliate assignee(s)
hereunder. This Agreement shall be binding upon, and subject to the terms
of the foregoing sentence, inure to the benefit of the parties hereto,
their successors, legal representatives and assigns.
Section 5.04 Notices. All demands, notices, consents, approvals,
reports, requests and other communications hereunder must be in writing and
will be deemed to have been duly given only if delivered personally or by
facsimile transmission or by mail (first class, postage prepaid) to the
parties at the following addresses or facsimile numbers:
XXXXXX-XXXXXXX:
Xxxxxx-Xxxxxxx Company
000 Xxxxx Xxxx
Xxxxxx Xxxxxx, Xxx Xxxxxx 00000
Attention: President, Pharmaceutical Sector
Facsimile No. 000-000-0000
with a copy to: Vice President and General Counsel
Facsimile No. (000) 000-0000
PFIZER:
Pfizer Inc.
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000-0000
Attention: President, International Pharmaceuticals Group
Facsimile No. (000) 000-0000
with a copy to: Senior Vice President and General Counsel
Facsimile No. (000) 000-0000
or to such other address as the addressee shall have last furnished in
writing in accord with this provision to the addressor.
Section 5.05 Invalid Provisions. If any provision of this Agreement is
held to be illegal, invalid or unenforceable under any applicable present
or future Law, and if the rights or obligations of either party hereto
under this Agreement will not be materially and adversely affected thereby,
(i) such provision will be fully severable, (ii) this Agreement will be
construed and enforced as if such illegal, invalid or unenforceable
provision had never comprised a part hereof, (iii) the remaining provisions
of this Agreement will remain in full force and effect and will not be
affected by the illegal, invalid or unenforceable provision or by its
severance herefrom and (iv) in lieu of such illegal, invalid or
unenforceable provision, there will be added automatically as a part of
this Agreement, a legal, valid and enforceable provision as similar in
terms to such illegal, invalid or unenforceable provision as may be
possible.
Section 5.06 Headings. The headings used in this Agreement have been
inserted for convenience of reference only and do not define or limit the
provisions hereof.
Section 5.07 Waiver. Any term or condition of this Agreement may be
waived at any time by the party that is entitled to the benefit thereof,
but no such waiver shall be effective unless set forth in a written
instrument duly executed by or on behalf of the party or parties waiving
such term or condition. No waiver by any party of any term or condition of
this Agreement, in any one or more instances, shall be deemed to be or
construed as a waiver of the same or any other term or condition of this
Agreement on any future occasion. All remedies, either under this Agreement
or by Law or otherwise afforded, will be cumulative and not alternative.
Section 5.07 Entire Agreement. This Agreement (including Exhibits A to
C hereto), together with the Confidential Disclosure Agreement, dated March
4, 1996 between XXXXXX-XXXXXXX and PFIZER, the International Co-Promotion
Agreement and the International License Agreement, constitutes the
entire agreement between the parties hereto with respect to the within
subject matter and supersedes all previous agreements, whether written or
oral. This Agreement may be altered, amended or changed only by a writing
making specific reference to this Agreement and signed by duly authorized
representatives of XXXXXX-XXXXXXX and PFIZER.
Section 5.09 Third Party Beneficiaries. None of the provisions of this
Agreement shall be for the benefit of or enforceable by any third party,
including, without limitation, any creditor of either party hereto. No such
third party shall obtain any right under any provision of this Agreement or
shall by reasons of any such provision make any claim in respect of any
debt, liability or obligation (or otherwise) against any party thereto.
Section 5.10 Independent Agreements. XXXXXX-XXXXXXX and PFIZER have,
as of the date hereof, entered into an Option Agreement (the "Option
Agreement") under which PFIZER grants to XXXXXX-XXXXXXX an option to
negotiate and possibly to acquire in the future certain co-promotion and
other rights to a PFIZER compound. The Option Agreement contemplates that
the parties will in the future negotiate and, if such negotiations are
successful, enter into additional agreements regarding such PFIZER
compound. It is recognized that the parties may fail to reach any future
agreement or agreements contemplated under the Option Agreement, or the
Option Agreement may terminate, or disputes may arise under the Option
Agreement or in connection with any transactions contemplated thereunder,
or XXXXXX-XXXXXXX may not acquire or be granted any rights to any PFIZER
compound under the option Agreement. XXXXXX-XXXXXXX acknowledges under any
of the foregoing circumstances it shall have no claim whatsoever against
PFIZER under the International Agreements which shall remain in full force
and effect according to their terms.
Section 5.11 EC Commission Notification. The parties hereby agree to
notify jointly in due course, the International Agreements to the
Commission of the European Communities (the "Commission") for the purpose
of obtaining negative clearance or, if the Commission deems the
International Agreements to come within Article 85(l) of the Treaty of
Rome, an exemption under Article 85(3) of the Treaty of Rome therefor. It
is further agreed as follows:
(1) The parties shall cooperate jointly towards the preparation
and submission of forms and materials required to notify the
International Agreements, including such materials as are
reasonably required or requested by the Commission pursuant to
such notification;
(2) The parties shall use all reasonable endeavors to obtain
from the Commission confirmation in the form of a comfort
letter or, if this is not forthcoming, a formal decision, to
the effect that the International Agreements merit a
negative clearance as aforesaid or an exemption under
Article 85 (3);
(3) If, arising out of such notification, the Commission
requires the International Agreements to be changed in any
respect, the parties shall negotiate in good faith such changes
so as to reflect as nearly as possible the original intentions
of the parties; and
(4) Each party will be responsible for its own legal and other
external costs associated with the notification contemplated
herein.
Section 5.12 Limitation of Liability. Notwithstanding anything to the
contrary contained elsewhere in the International Agreements (but subject
to this Section 5.12), neither party shall be liable to the other for
Losses constituting incidental, indirect or consequential damages under the
International Agreements for a cumulative aggregate amount in excess of
US$20,000,000; provided, however, notwithstanding the foregoing, each party
shall have the right to recover (and the foregoing limitations contained in
this Section 5.12 shall not apply to): (i) all amounts for which the other
party is obligated to pay pursuant to Article III of this Agreement,
Article III or Section 14.04 of the International Co-Promotion Agreement or
Sections 4.01(d) and 7.02 of the International License Agreement in the
event of (x) a breach by XXXXXX-XXXXXXX of its obligations to make payments
pursuant to Section 14.04 of the International Co-Promotion Agreement or
Section 7.02 of the International License Agreement, or (y) a breach by the
other party of its respective obligations to make payments pursuant to
Article III of this Agreement, Article III of the International
Co-Promotion Agreement, or Section 4.01(d) of the International License
Agreement; or (ii) all Losses relating to a breach by the other party of
its respective obligations under Section 4.03 (in the case of
XXXXXX-XXXXXXX) or Section 4.04 (in the case of PFIZER) under this
Agreement involving, in any case, the commencement of or assertion of any
claim, action, suit or proceeding by a third party in respect of which
indemnity may be sought under Section 4.03 or Section 4.04, as applicable,
of this Agreement. It is agreed that in the event of a breach of the
International Agreements by XXXXXX-XXXXXXX, the difference (in no event
less than zero), if any, between (I) amounts previously paid to
XXXXXX-XXXXXXX by PFIZER pursuant to Article III of this Agreement,
expenses for which PFIZER is responsible pursuant to Section 3.01 of the
International Co-Promotion Agreement, together with all internal costs and
expenses incurred by PFIZER in connection with, or in support of, its
performance of its obligations under the International Agreements (such as,
for example, clinical, marketing, promotional and field force costs and
expenses) and (II) amounts previously paid or credited to PFIZER pursuant
to Section 3.02 of this Agreement, Sections 3.02 and 14.04 of the
International Co-Promotion Agreement or Section 7.02 of the International
License Agreement, will not be considered as constituting incidental,
indirect or consequential damages.
Section 5.13 Counterparts. This Agreement may be executed in any two
or more counterparts, each of which, when executed, shall be deemed to be
an original and all of which together shall constitute one and the same
document.
IN WITNESS WHEREOF, XXXXXX-XXXXXXX and PFIZER, by their duly
authorized officers, have executed this Agreement as of the date first
written above.
XXXXXX-XXXXXXX COMPANY PFIZER INC.
/s/ Xxxxxxxx X.X. xx Xxxx /s/ Xxxxxx Xxxxxxx
--------------------------------- ---------------------------
Xxxxxxxx X.X. xx Xxxx Xxxxxx Xxxxxxx
President and Chief Operating Executive Vice President
Officer
