[EXHIBIT 99.5]
INTERNATIONAL LICENSE 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. Capitalized terms not
otherwise defined herein have the meanings set forth in Section 1.01.
WHEREAS, XXXXXX-XXXXXXX holds rights in the Territory under Patents,
Technical Information and Trademarks pertaining to Atorvastatin;
WHEREAS, PFIZER has significant experience in the development,
marketing, promotion and sale of pharmaceutical products and believes it
can make significant contributions to the successful development and
commercialization of Atorvastatin outside the United States;
WHEREAS, XXXXXX-XXXXXXX believes that the arrangements with PFIZER
pursuant to this Agreement for the commercialization and market development
of Atorvastatin outside the United States are desirable and fully
compatible with XXXXXX-XXXXXXX'x business objectives;
WHEREAS, XXXXXX-XXXXXXX and PFIZER are simultaneously with the
execution of this International License Agreement executing the
International Collaboration Agreement dated as of the date hereof
(hereinafter, the "International Collaboration Agreement"); and
WHEREAS, pursuant to the International Collaboration Agreement,
XXXXXX-XXXXXXX has agreed to enter into this Agreement.
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:
"Adverse Drug Experience Report" means any oral, written or
electronically transmitted report of any "adverse drug experience" as
defined or contemplated by 21 C.F.R. 314.80 or 312.32 or their local
equivalents, associated with the use of Atorvastatin or any Product.
"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 Years" for each Country means the period commencing on the
Launch Date and ending on the last day of Agreement Year Ten.
"Agreement Year One" with respect to each Country means the period
commencing on the Launch Date and ending on the last day of the fourth
complete calendar quarter following the Launch Date; "Agreement Year Two"
with respect to each Country means the twelve-month period commencing on
the first day following the expiration of Agreement Year One; references to
Agreement Year Three through Agreement Year Nine mean the successive
twelve-month periods thereafter; and Agreement Year Ten means the period
commencing on the first day following the expiration of Agreement Year Nine
and expiring on the tenth anniversary of the Launch Date.
"Atorvastatin" means the chemical compound [R-(R*,R*)]-2-(4-
fluorophenyl)-b, d-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)
carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) and hydrates
thereof.
"Bulk" has the meaning ascribed to it in Section 5.01(a).
"Category 1 Country" means a Country set forth under Category 1 on
Exhibit A.
"Category 2 Country" means a Country set forth under Category 2 on
Exhibit A.
"Category 3 Country" means a Country set forth under Category 3 on
Exhibit A.
"Competing Products" means any prescription pharmaceutical product
other than the Products (i) where a significant pharmacological action of
such product is direct inhibition of HMG-CoA reductase (as demonstrated by
at least 50% inhibition of the enzyme activity of HMG-CoA reductase, at a
product concentration of 1 micromolar in an in vitro, cell-free HMG-CoA
reductase activity assay system) and (ii) with indications for lipid
lowering and treatment or prevention of atherosclerosis.
"Confidential Information" means (i) for XXXXXX-XXXXXXX, all PFIZER
Confidential Information and (ii) for PFIZER, all XXXXXX-XXXXXXX
Confidential Information.
"Country" means a country listed in Exhibit A.
"FDA" means the United States Food and Drug Administration.
"Good Manufacturing Practices" means the regulatory standards and the
principles and guidelines of good manufacturing practice, as in effect from
time to time, relating to the manufacture of medicinal products including,
but not limited to, standards for equipment, facilities, production and
quality control established by the applicable Governmental or Regulatory
Authority.
"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 Co-Promotion Agreement" means the International
Co-Promotion Agreement between PFIZER and XXXXXX-XXXXXXX dated of even date
herewith.
"Launch Date" for each Country means the date on which the first
Product is first shipped in commercial quantities from the distribution
centers of PFIZER or an Affiliate of PFIZER for commercial sale to
unaffiliated third parties in such Country, as promptly notified in writing
to XXXXXX-XXXXXXX by PFIZER.
"Laws" means all laws, statutes, rules, regulations, ordinances and
other pronouncements having the effect of law of any government or
Governmental or Regulatory Authority.
"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).
"Manufacturing Authorization" means the authorization necessary to
Package the Products as granted by the relevant Governmental or Regulatory
Authorities.
"Marketing Authorization" means the authorization necessary to sell
the Product in the applicable Country as granted by the relevant
Governmental or Regulatory Authorities.
"Net Sales" for each Country means the aggregate sales of PFIZER and
its Affiliates of Products to unaffiliated third parties in the relevant
Country (but not including sales between Pfizer and its Affiliates), less
(i) bad debts related to the Products, and (ii) sales returns and
allowances, including, without limitation, trade, quantity and cash
discounts and any other adjustments, including, but not limited to, those
granted on account of price adjustments, billing errors, rejected goods,
damaged goods, recalls, returns, rebates, chargeback rebates, fees,
reimbursements or similar payments given or granted to wholesalers or other
distributors, buying groups, health care insurance carriers or other
institutions, freight and insurance charges billed to the customers,
customs or excise duties, sales tax and other taxes (except income taxes)
or duties relating to sales, and any payment in respect of sales to any
Governmental or Regulatory Authority, all as determined in accordance with
generally accepted accounting principles on a basis consistent with
PFIZER's audited financial statements, except for such items that may be
reclassified to comply with the foregoing definition.
"Packaging" means activities relating to filling/blistering, labeling,
packaging, and finishing the Products, including, but not limited to,
purchasing packaging materials, quality control, release and storage and
the tests and analyses conducted in connection therewith.
"Patents" means those patents identified in, and the patents issuing
from the applications listed in, Exhibit C to the International
Collaboration Agreement.
"Person" means any natural person, corporation, general partnership,
limited partnership, joint venture, proprietorship or other business
organization.
"PFIZER Confidential Information" means information which has prior to
the date hereof been or which at any time hereafter is disclosed in writing
and marked "Confidential" (or if disclosed orally, is reduced to writing
within thirty (30) days of disclosure) directly or indirectly by PFIZER or
by any of its Affiliates or agents or agents of its Affiliates to XXXXXX-
XXXXXXX or any of its Affiliates or agents or agents of its Affiliates in
connection with this Agreement and which relates to the business of PFIZER.
"Post-Agreement Year One" with respect to each Country means the
twelve month period commencing on the day following either (i) the last day
of Agreement Year Ten, or (ii) if earlier terminated pursuant to Section
11.02, the date of termination; "Post Agreement Year Two" and "Post
Agreement Year Three" mean the successive twelve month periods thereafter.
"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.
"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, in each case, to be marketed by PFIZER in
the Territory during the Agreement Years.
"Serious Adverse Drug Experience Report" means any Adverse Drug
Experience Report that involves an adverse drug experience that is fatal or
life-threatening, is permanently disabling, requires in-patient
hospitalization, or is a congenital anomaly, cancer or overdose, or any
other event which would constitute a "serious" adverse drug experience
pursuant to the terms of 21 C.F.R. 314.80 or 312.32 or their local
equivalents.
"Technical Information" means (a) all information and data which is
now, or at any time hereafter during the Term of this Agreement shall
become, owned or possessed by XXXXXX-XXXXXXX and its Affiliates for the
Products which are necessary to apply for Marketing Authorization or Price
Approval of the Products in the relevant Country, including, but not
limited to, information and data concerning the manufacture, stability,
pharmacology, toxicology and clinical use of the Product, (b) any other
material medical, clinical, toxicological or other scientific or medical
information or data pertaining to the Products which is now, or at any
time hereafter during the Term of this Agreement shall become, owned or
possessed by XXXXXX-XXXXXXX and its Affiliates, and (c) such other
information or data as XXXXXX-XXXXXXX may xxxx appropriate.
"Term of this Agreement" for each Country means the period from the
date hereof until the expiration of this Agreement in accordance with
Section 11.01 or earlier termination of this Agreement in accordance with
Section 11.02.
"Territory" means all of the Countries.
"Trademark" has the meaning ascribed to it in Section 2.03.
"XXXXXX-XXXXXXX Confidential Information" means information which has
prior to the date hereof been or which at any time hereafter is disclosed
in writing and marked "Confidential" (or if disclosed orally, is reduced to
writing within thirty (30) days of disclosure) directly or indirectly by
XXXXXX-XXXXXXX or by any of its Affiliates or agents or agents of its
Affiliates to PFIZER or any of its Affiliates or agents or agents of its
Affiliates in connection with this Agreement and which relates to the
business of XXXXXX-XXXXXXX, including, without limitation, any information
concerning Atorvastatin or any of its intermediates or the Products.
ARTICLE II - LICENSES
SECTION 2.01. Grant of Licenses. XXXXXX-XXXXXXX grants to PFIZER
under the Patents, Technical Information and Trademarks, the following:
(a) An exclusive license to use and sell Products in each Category 1
Country. For purposes of this sub-clause, "exclusive" means to the
exclusion of all other parties in a Country including XXXXXX-XXXXXXX
and its Affiliates.
(b) An exclusive license under the Trademark and a semi-exclusive
license under the Patents and Technical Information to use and sell
Products in each Category 2 Country. For purposes of this sub-clause,
"semi-exclusive" means to the exclusion of all other parties in a
Country except XXXXXX-XXXXXXX or an Affiliate of XXXXXX-XXXXXXX.
(c) An exclusive license under the Trademark and a semi-exclusive
license under the Patents and Technical Information to use and sell
Products in each Category 3 Country. For purposes of this sub-clause,
"semi-exclusive" means to the exclusion of all other parties except
XXXXXX-XXXXXXX or an Affiliate of XXXXXX-XXXXXXX (except in Italy
where two of XXXXXX-XXXXXXX and its Affiliates may sell the Products)
and one additional local licensee which, as of the date hereof, are
as follows: (i) in Brazil, AchE LaboratOrios FarmacEuticos S/A, (ii)
in Korea, Je Il Pharmaceutical Co., Ltd., (iii) in Italy, one of the
companies of the A. Menarini group and (iv) in Spain, Laboratorios
Almirall, S.A.
SECTION 2.02. Sublicenses. The licenses granted to PFIZER in Section
2.01 shall include the right to grant sublicenses to its Affiliates, in
whole or in part; provided however, that PFIZER shall be responsible for
the performance of its Affiliate sublicensee(s) hereunder. The licenses
granted to PFIZER in Section 2.01 shall not include the right to grant
sublicenses to third parties without the prior consent of XXXXXX-XXXXXXX.
SECTION 2.03. Trademarks. (a) Subject to clause (d) below, PFIZER
shall in each Country sell Products under trademarks searched for
availability, designated and owned by XXXXXX-XXXXXXX, and which are
reasonably acceptable to PFIZER, for use by PFIZER in such Country (the
"Trademarks"); provided, however, that in the event XXXXXX-XXXXXXX has not
by December 31, 1996 obtained and designated a Trademark in any Country,
then PFIZER shall have the right to obtain a Trademark which is reasonably
acceptable to XXXXXX-XXXXXXX in such Country, but shall be required to
assign such Trademark to XXXXXX-XXXXXXX.
(b) XXXXXX-XXXXXXX shall maintain the Trademarks in each Country at
its own cost and expense throughout the term of this Agreement. All
goodwill deriving from the use by PFIZER of Trademarks will accrue solely
and exclusively to XXXXXX-XXXXXXX.
(c) PFIZER shall use the Trademarks only in accordance with
reasonable standards and guidelines communicated by XXXXXX-XXXXXXX from
time to time during the Term of this Agreement. PFIZER agrees that its use
of the Trademark shall be in a commercially acceptable and responsible
manner.
(d) In Countries where XXXXXX-XXXXXXX sells Products, it shall do so
under a single Trademark, except in Italy where it may sell Products under
two separate Trademarks. PFIZER shall sell Products in each Country under
a single Trademark, except in Category 1 Countries where PFIZER may sell
Products under one or more Trademarks; such Trademark may be a XXXXXX-
XXXXXXX owned Trademark from a major market outside of such Country,
provided that such Trademark is available and that XXXXXX-XXXXXXX shall
have consented to such use, such consent not to be unreasonably withheld.
(e) Immediately upon expiration or termination of this Agreement with
respect to any Country, all rights granted to PFIZER hereunder to use the
Trademark in such Country shall cease immediately and shall forthwith
revert to XXXXXX-XXXXXXX, and PFIZER will discontinue forthwith all use of
the Trademark in such Country and shall not thereafter directly or
indirectly sell or distribute any products bearing trademarks, names or
designs confusingly similar to the Trademark or otherwise use trade names,
names or designs confusingly similar to the Trademark (provided, however,
that, at XXXXXX-XXXXXXX'x option, PFIZER either shall continue customer
sales of existing inventories or shall sell such existing inventories back
to XXXXXX-XXXXXXX at cost); and will not represent itself in such Country
as having been associated with, or a licensee of, XXXXXX-XXXXXXX upon
expiration or termination of this Agreement.
SECTION 2.04. Technical Information. XXXXXX-XXXXXXX shall forthwith
upon execution of this Agreement and periodically thereafter promptly
disclose to PFIZER all Technical Information which it can legally
disclose. Upon expiration or earlier termination of this Agreement PFIZER,
its successors, assigns and legal representatives shall use reasonable
efforts to collect and return to XXXXXX-XXXXXXX or destroy, at
XXXXXX-XXXXXXX'x request, all Technical Information obtained by PFIZER
pursuant to this Agreement in whatever form it may exist; and shall use
its reasonable efforts to prevent the further use of any and all Technical
Information without XXXXXX-XXXXXXX'x express written consent.
SECTION 2.05. Cooperation. (a) Subject to the other provisions of
this Agreement, the parties agree that the principal objectives of the
parties hereunder with respect to Products in each Country in the
Territory are to use reasonable efforts to maximize Net Sales and
operating income to the parties hereunder and to develop and sponsor
various local clinical studies for the Product during the Term of this
Agreement.
(b) In all Countries other than Countries in which XXXXXX-XXXXXXX or
its Affiliates sell Products, PFIZER shall seek to produce an operating
plan each year that will include product strategy, positioning, research
and development expenses, advertising and promotion expenses and detail
position by cycle. Each operating plan shall be submitted to the Global
Business Subcommittee (as defined in the International Co-Promotion
Agreement). PFIZER shall provide XXXXXX-XXXXXXX such other information as
XXXXXX-XXXXXXX reasonably may request. The operating plans shall not
address sales force incentives or compensation, and each party shall have
sole authority and responsibility for designing and executing any such
program for its sales force.
SECTION 2.06. Information Exchange. With respect to all Countries
other than Countries in which XXXXXX-XXXXXXX or its Affiliates sell
Products, each party shall forthwith upon the execution of this Agreement
and thereafter at all times during the Agreement Years promptly disclose
to the other party all significant information of which it becomes aware,
which it can legally disclose and which it reasonably believes will be
important in planning and effecting the detailing, promotion, marketing
and sale of the Products in the Territory.
SECTION 2.07. Product Launch. In Category 2 and Category 3 Countries,
XXXXXX-XXXXXXX shall render reasonable assistance to PFIZER to enable
PFIZER to launch the Product simultaneously with XXXXXX-XXXXXXX. If, based
upon the reasonable opinion of the parties, in such Countries, PFIZER and
XXXXXX-XXXXXXX and the third party co-marketer, if any, are unable to all
launch the Product within a ten day period, the launch of the Product by
the party or parties that are ready to launch earlier will be postponed
for a maximum of forty-five days from the date such party or parties were
prepared to launch the Product unless all are able to launch within a ten
day period prior to the expiration of such forty-five day period.
ARTICLE III - REGULATORY AND OTHER MATTERS
SECTION 3.01. Regulatory Approvals. (a) In all Category 1 Countries
and in Brazil and Korea, PFIZER shall exercise reasonable efforts to
obtain, as soon as reasonably practicable, the approval by the relevant
Governmental or Regulatory Authority of a Marketing Authorization for a
Product which includes labeling (consistent with guidelines established by
the Operating Committee in accordance with the procedures set forth in
Section 4.01 of the International Co-Promotion Agreement), indications,
warnings, etc. materially equivalent to the provisions of Exhibit C and a
Price Approval. In all Category 2 and Category 3 Countries (other than
Brazil and Korea), XXXXXX-XXXXXXX shall exercise reasonable efforts to
obtain, as soon as reasonably practicable, the approval by the relevant
Governmental or Regulatory Authority of a Marketing Authorization for a
Product which includes labeling (consistent with guidelines established by
the Operating Committee in accordance with the procedures set forth in
Section 4.01(d) of the International Co-Promotion Agreement), indications,
warnings, etc. materially equivalent to the provisions of Exhibit C and a
Price Approval; provided, however, that in all Category 2 and Category 3
Countries where the Law mandates that the licensee must obtain the
Marketing Authorization and Price Approval, PFIZER will exercise such
efforts. The party obtaining such approvals shall bear its own costs in
obtaining such Marketing Authorization and Price Approval. Each party
shall give the other party reasonable assistance in obtaining such
approvals, including without limitation XXXXXX-XXXXXXX'x requesting the
assessment report and other relevant documentation from the relevant
German Governmental or Regulatory Authority for filing with an application
for Marketing Authorization in Norway. Each party shall keep the other
party informed of negotiations with Governmental or Regulatory Authorities
with respect to Price Approvals that it seeks pursuant to this Section
3.01 and shall notify the other party of the price the filing party
intends to accept for Price Approval prior to finalization of such price.
(b) In any Country where PFIZER is required to obtain the approval by
the relevant Governmental or Regulatory Authority of a Marketing
Authorization and Price Approval (if applicable) pursuant to clause (a)
above or otherwise by agreement with XXXXXX-XXXXXXX, in the event that
PFIZER fails to submit an application or file for such approvals as soon
as reasonably practicable, but no later than twelve (12) months after
receiving all necessary Technical Information from XXXXXX-XXXXXXX, XXXXXX-
XXXXXXX shall have the right to terminate this Agreement with respect to
such Country.
(c) PFIZER shall, upon notice and consultation with XXXXXX-XXXXXXX,
be entitled at any time to cease permanently the sale of any Product in
any Country if continued sale of such Product would be in violation of
Laws or if PFIZER in good faith believes that it has an ethically valid
reason therefor based on medical or scientific problems concerning such
Product.
(d) XXXXXX-XXXXXXX shall, upon notice and consultation with PFIZER,
be entitled at any time to cease permanently the sale of Bulk to PFIZER in
any Country if continued sale of the Bulk by XXXXXX-XXXXXXX or Product by
PFIZER would be in violation of Laws or if XXXXXX-XXXXXXX in good faith
believes that it has an ethically valid reason therefor based on medical
or scientific problems concerning such Product.
(e) XXXXXX-XXXXXXX may terminate this Agreement with respect to any
Country upon notice to PFIZER if PFIZER fails to Launch a Product in such
Country within twenty-four (24) months after Marketing Authorization,
including the indications, warnings etc. materially equivalent to the
provisions of Exhibit C, unless Pfizer shall be diligently pursuing a
Price Approval (if applicable).
(f) Subject to the provisions of the International Collaboration
Agreement, neither party shall be under any liability whatsoever to
compensate the other or make any other payment to the other if (i)
Marketing Authorization or Price Approval is not received, (ii) the
Marketing Authorization for the first Product in a Country does not
include indications, warnings, etc. materially equivalent to the
provisions of Exhibit C, or (iii) either party determines to take any of
the steps that it is permitted to take pursuant to this Section 3.01;
provided, in the case of (i), (ii) and (iii) above, such failure to obtain
such Marketing Authorization or Price Approval or indications warnings,
etc. in the Marketing Authorization materially equivalent to the
provisions of Exhibit C or such cessation of sale shall not be the result
of any breach of this Agreement by such party.
SECTION 3.02. Advertising and Promotion. (a) PFIZER shall bear all of
its own costs and expenses of advertising and promoting the Product in
each Country. PFIZER shall promote the Product and provide information
about the Product to the medical profession through the distribution of
advertising and promotional materials, samples of which shall be submitted
to XXXXXX- XXXXXXX to enable XXXXXX-XXXXXXX to monitor the medical and
technical content of such materials.
(b) PFIZER shall exercise reasonable efforts in each Country to
market, create a demand for and continuously develop sales of the Product,
in order to maximize Net Sales and operating income throughout the term of
this Agreement.
SECTION 3.03. Studies. PFIZER shall be free to undertake clinical and
other research studies with the Products in the Territory at its own
expense, for registration or other purposes, provided that PFIZER shall
first submit to XXXXXX-XXXXXXX the protocols relating thereto and allow
XXXXXX-XXXXXXX not less than thirty (30) days within which to review and
approve such protocols as to their scientific and medical content, which
approval shall not be unreasonably withheld. If XXXXXX-XXXXXXX does not
respond to PFIZER within such period, approval shall be deemed to have
been given. PFIZER shall promptly disclose to XXXXXX-XXXXXXX a copy of
reports relating to such approved activities. PFIZER will xxxxx
XXXXXX-XXXXXXX a royalty-free, non-exclusive license (without further
compensation) to use all results of any such studies with respect to the
manufacture, use or sale of the Product.
SECTION 3.04. Communication with Regulatory Authorities. PFIZER
shall, immediately upon receipt of any communication from any Governmental
or Regulatory Authority relating to Atorvastatin or any Product, forward a
copy or description of the same to XXXXXX-XXXXXXX and respond to all
inquiries by XXXXXX-XXXXXXX relating thereto. If PFIZER is advised by its
counsel that it must communicate with any Governmental or Regulatory
Authority, then PFIZER shall so advise XXXXXX-XXXXXXX immediately and,
unless the Law prohibits, provide XXXXXX-XXXXXXX in advance with a copy of
any proposed written communication with any Governmental or Regulatory
Authority and comply with any and all reasonable direction of XXXXXX-
XXXXXXX concerning any meeting or written or oral communication with any
Governmental or Regulatory Authority.
SECTION 3.05. Regulatory Information. Subject to the terms of Section
3.04, each party agrees to provide the other with all reasonable
assistance and take all actions reasonably requested by the other party
that are necessary or desirable to enable the other party to comply with
any Law applicable to Atorvastatin or any Product, including, but not
limited to, XXXXXX-XXXXXXX or PFIZER meeting its reporting and other
obligations to (i) maintain and update any Marketing Authorizations for
the Products and (ii) report Adverse Drug Experience Reports and Serious
Adverse Drug Experience Reports to any Governmental or Regulatory
Authorities. Such assistance and actions shall include, among other
things, keeping the other party informed, commencing within forty-eight
hours of notification of any action by, or notification or other
information which it receives (directly or indirectly) from, any
Governmental or Regulatory Authority, which (a) raises any material
concerns regarding the safety or efficacy of any Product, (b) which
indicates or suggests a potential material liability for either party to
third parties arising in connection with any Product, or (c) which is
reasonably likely to lead to a recall or market withdrawal of any Product,
provided that neither party shall be obliged to disclose information in
breach of any contractual restriction which it could not reasonably have
avoided. For purposes of this Section 3.05, each of the events set forth
in (a), (b) and (c) of this Section 3.05 shall be defined as a "Material
Event". Information that shall be disclosed pursuant to this Section 3.05
shall include, but not be limited to:
(1) Governmental or Regulatory Authority inspections of manufacturing
(including packaging facilities), distribution or other related
facilities; inquiries by Governmental or Regulatory Authorities concerning
clinical investigation activities (including inquiries of investigators,
clinical monitoring organizations and other related parties); any
communication from Governmental or Regulatory Authorities involving the
manufacture, sale, promotion or distribution of Products or any other
Governmental or Regulatory Authority reviews or inquiries relating to
Atorvastatin or any of the Products which, in each case, constitute a
Material Event; and
(2) an initiation of any Governmental or Regulatory Authority
investigation, detention, seizure or injunction concerning any Product.
SECTION 3.06. Adverse Drug Experience Reports. (a) Subject to
applicable Law, PFIZER shall:
(i) notify XXXXXX-XXXXXXX of all Serious Adverse Drug Experience
Reports (including Serious Adverse Drug Experience Reports occurring
in any post-marketing study conducted, sponsored or monitored by
PFIZER or XXXXXX-XXXXXXX) within ninety-six hours of the time such
Serious Adverse Drug Experience Report becomes known to PFIZER or any
of its Affiliates or any employee or agent of PFIZER or any of its
Affiliates (the "PFIZER Group"); and
(ii) notify XXXXXX-XXXXXXX of all Adverse Drug Experience Reports
(except for Adverse Drug Experience Reports occurring in a post-
marketing study conducted, sponsored or monitored by PFIZER or
XXXXXX- XXXXXXX) within thirty days of the time such Adverse Drug
Experience Report becomes known to any member of the PFIZER Group;
and
(iii) notwithstanding any other provision of this Section 3.06, use
its best efforts to notify XXXXXX-XXXXXXX of all unexpected fatal or
life-threatening experiences occurring in connection with an IND
study conducted, sponsored or monitored by PFIZER, as defined in 21
C.F.R. 312.32, within twenty-four (but, in no event, later than
thirty-six) hours of the time any such experience becomes known to
any member of the PFIZER Group; and
(iv) notwithstanding any other provision in this Section 3.06,
notify XXXXXX-XXXXXXX of all other serious and unexpected adverse
experiences occurring in connection with an IND study conducted,
sponsored or monitored by PFIZER, as defined in 21 C.F.R 312.32,
within seventy-two hours of the time any such experience becomes
known to any member of the PFIZER Group.
(b) PFIZER shall notify XXXXXX-XXXXXXX of all Adverse Drug Experience
Reports occurring in any post-marketing study conducted, sponsored or
monitored by PFIZER when such study is completed in a study report issued
to XXXXXX-XXXXXXX in connection therewith. Each such final study report
shall be provided to XXXXXX-XXXXXXX within fifteen days of its completion.
Except for Adverse Drug Experience Reports occurring in any post-marketing
study conducted, sponsored or monitored by PFIZER, notification under this
Section 3.06 shall be by facsimile and overnight courier and in accordance
with instructions to be mutually agreed upon by PFIZER and XXXXXX-XXXXXXX.
All follow-up investigations concerning Adverse Drug Experience Reports
and Serious Adverse Drug Experience Reports occurring during
post-marketing studies shall be conducted by the party initiating,
sponsoring or monitoring such study; provided that the results of such
follow-up investigations conducted by PFIZER shall be delivered to
XXXXXX-XXXXXXX within ninety-six hours of the time such follow-up
information is obtained by any member of the PFIZER Group. All other
follow-up investigations concerning Adverse Drug Experience Reports and
Serious Adverse Drug Experience Reports shall be conducted by
XXXXXX-XXXXXXX. PFIZER shall provide all reasonable cooperation with any
investigation of any such spontaneous Adverse Drug Experience Report or
Serious Adverse Drug Experience Report conducted by XXXXXX-XXXXXXX.
(c) Subject to Section 3.04, (i) PFIZER shall not disclose any
information concerning Adverse Drug Experience Reports or Serious Adverse
Drug Experience Reports to any Person or Governmental or Regulatory
Authority without the prior consent of XXXXXX-XXXXXXX, and (ii) XXXXXX-
XXXXXXX shall have the sole discretion to determine whether any complaint,
Adverse Drug Experience Report or Serious Adverse Drug Experience Report
must be reported to the FDA or any other Governmental or Regulatory
Authority.
SECTION 3.07. Return of Marketing Authorization Upon Termination or
Expiration. Upon expiration or termination of PFIZER's rights in any
Country, PFIZER will promptly transfer to XXXXXX-XXXXXXX, a XXXXXX-XXXXXXX
Affiliate or a third party designated by XXXXXX-XXXXXXX, all Marketing
Authorizations and approvals relating to the Product in the applicable
Country as may be required by XXXXXX-XXXXXXX or such party to market the
Product in such Country. The transfer fees and any government fees for
such transfer will be borne by XXXXXX-XXXXXXX.
SECTION 3.08. Compliance with Laws. PFIZER hereby covenants to
XXXXXX-XXXXXXX as follows:
(a) During the Term of this Agreement PFIZER shall carry out the
packaging and labeling, detailing, storage, distribution, promotion,
marketing and sale of the Products and its other obligations or activities
hereunder in accordance with (i) the terms of this Agreement, (ii)
acceptable pharmaceutical industry practices and (iii) all applicable
Laws.
(b) During the Term of this Agreement PFIZER shall refrain from
infringing any patent of any third party in connection with PFIZER's
Packaging of the Product in accordance with ARTICLE V hereof.
ARTICLE IV - SUPPLY OF PRODUCTS
SECTION 4.01. (a) Supply Obligations. Subject to the provisions of
this Agreement, XXXXXX-XXXXXXX hereby undertakes to supply the Products to
PFIZER and PFIZER undertakes to purchase or to procure the purchase from
XXXXXX-XXXXXXX all of PFIZER's requirements of Products in bulk tablet
form (hereinafter "Bulk") in each Country or, subject to agreement between
the parties on terms and conditions to be agreed, in trade packaged form.
The parties covenant and agree to comply in all respects with the
requirements of EU Directive 91/356 for the Countries in the European
Union and to take all necessary and appropriate action in furtherance
thereof.
(b) Specifications. The Bulk shall be manufactured, packaged and
supplied hereunder in accordance with all applicable laws and according to
the specifications which shall be provided by XXXXXX-XXXXXXX to PFIZER and
shall be in accordance with XXXXXX-XXXXXXX'x specifications for
corresponding Bulk in countries within and outside the Territory. XXXXXX-
XXXXXXX shall be entitled at any time to change such specifications in
line with changes made with respect to XXXXXX-XXXXXXX'x corresponding Bulk
in countries within and outside the Territory, provided that any such
changes shall not materially adversely affect the quality or efficacy of
the Bulk, and provided that XXXXXX-XXXXXXX shall give to PFIZER prior
notice of any proposed change in time to allow PFIZER to arrange any
necessary modifications to its Marketing Authorizations in the applicable
Countries for the affected Bulk.
(c) Forecasts and Orders. At least three months prior to the
commencement of each calendar quarter, PFIZER shall give to XXXXXX-XXXXXXX
a forecast of PFIZER's estimated requirements in each Country for rolling
twenty-four (24) month periods commencing with such calendar quarter. The
twenty-four (24) month forecasts delivered to XXXXXX-XXXXXXX pursuant to
the preceding sentence shall represent PFIZER's reasonable provisional
estimates of the quantity of the Products that PFIZER will require in each
such Country during the twenty-four (24) month period to which such
forecast applies and the quantities shown in the forecast for the first
three months shall be automatically considered a firm order deliverable at
any time during each month, so that no separate purchase orders will be
sent by PFIZER. PFIZER may adjust any firm order hereunder at any time
prior to the day that is sixty (60) days prior to the first day of the
period to which such firm order applies, provided that such adjusted firm
order is between eighty percent (80%) and one hundred twenty percent
(120%) of the most recent firm order provided to XXXXXX-XXXXXXX pursuant
to this Section 4.01(c). XXXXXX-XXXXXXX shall use its reasonable efforts
to deliver PFIZER's firm order requirements. Minimum order quantities for
Bulk shall be agreed between the parties.
(d) Prices and Payment
(i) XXXXXX-XXXXXXX agrees to sell to PFIZER its requirements of
Bulk at prices in each Country which will be agreed between the
parties from time to time, but which will not, unless otherwise
agreed, (i) be greater than the price which would give PFIZER
Gross Profit in the applicable Country of less than sixty
percent (60%) of Net Sales or (ii) be less than the price which
would give PFIZER Gross Profit of greater than seventy-two
percent (72%) of Net Sales, calculated in the currency of the
Country of sale. For purposes of this sub-clause, "Gross
Profit" means Net Sales less the price paid by PFIZER for the
Bulk; provided, however, that in no event will XXXXXX-XXXXXXX
be required hereunder to sell to PFIZER its requirements of
Bulk at a price which is less than XXXXXX-XXXXXXX'x actual
manufacturing cost plus the costs of freight, insurance, duty
and other delivery terms (in each case on a currency adjusted
basis), and all applicable taxes paid by XXXXXX-XXXXXXX
thereon, except income taxes and recoverable value added taxes.
(ii) The parties shall calculate and agree on estimated prices of
the Bulk (A) in or prior to Agreement Year One based on the
projected Net Sales in each Country for such Agreement Year and
(B) thereafter, based on the Net Sales in each Country during
the preceding Agreement Year.
(iii) The prices for the Bulk agreed between the parties pursuant to
subclause (i) above contemplate shipment by XXXXXX-XXXXXXX
Delivered Duty Paid (Incoterms 1990) to a PFIZER plant or
location designated by PFIZER in each Country, but excluding
VAT or other applicable taxes, which will be payable by PFIZER.
Unless otherwise agreed, prices shall be stated and payable in
local currency. Should any events unforeseen by and beyond the
control of the parties occur that alter XXXXXX- XXXXXXX'x costs
hereunder relating to delivery terms, and materially and
detrimentally affect its economic return on the sale of Bulk to
Pfizer as contemplated on the date hereof, the parties shall
consult together in order to revise the applicable prices and
delivery terms on a fair basis so that neither party is unduly
prejudiced.
(iv) Payment will be made to XXXXXX-XXXXXXX within forty-five (45)
days of the relevant invoice date or PFIZER's receipt of the
Bulk, whichever shall occur later.
(v) Within sixty (60) days after the end of each Agreement Year,
the actual price for the Bulk shall be calculated based upon
PFIZER's Net Sales in each Country, and an adjustment of the
differences between such actual price and the estimated price
for the Bulk originally charged for the Products in each such
Country shall be paid by one party to the other as appropriate
with respect to all Bulk invoiced to PFIZER during such
Agreement Year.
(vi) XXXXXX-XXXXXXX shall supply PFIZER's reasonable requirements of
Bulk in each Country in the Territory (x) for use in
promotional samples of Products and studies other than clinical
studies specified in subparagraph (y) below at a price per pill
of ten percent (10%) of the quotient of (1) Net Sales in the
current Agreement Year over (2) the total number of pills of
Product sold to unaffiliated third parties in the Territory in
such Agreement Year (such procedure for arriving at such price
to be analogous to the procedure with respect to price of the
Bulk as set forth in Section 4.01(d)(ii)-(v)) and (y) at no
cost for use in Products for clinical studies required by
appropriate Governmental or Regulatory Authorities for
marketing approval, new indications and labeling changes, and
approved pursuant to Section 3.03. PFIZER shall use and
distribute samples in full compliance with all applicable Laws.
(e) Failure of Supply. In the event for any reason, including Force
Majeure (as hereinafter defined), XXXXXX-XXXXXXX shall be unable in any
Country to supply Bulk on a timely basis (in accordance with XXXXXX-
XXXXXXX'x normal and customary practice), such that as a result, PFIZER is
unable to supply on a timely basis (in accordance with PFIZER's normal and
customary practice) at least ninety percent (90%) of the orders for
Products in such Country, provided that such orders are not materially
greater than the corresponding forecast for Bulk given to XXXXXX-XXXXXXX
at least nine (9) months prior to such time pursuant to Section 4.01(c),
then the following adjustments shall be made to the terms otherwise
provided herein:
(i) If such failure to supply continues for two consecutive months
or less, the Agreement Year for such Country in which such
failure to supply occurred shall be extended by a length of
time equal to two times the number of days during which
XXXXXX-XXXXXXX failed to supply Bulk as provided for above.
(ii) If such failure to supply continues longer than two consecutive
months, the Agreement Year for such Country in which such
failure to supply occurred shall be extended by a length of
time equal to four times the number of days during which
XXXXXX-XXXXXXX failed to supply Bulk as provided for above.
(iii) Provided XXXXXX-XXXXXXX'x failure to meet its supply
obligations shall not be the result of XXXXXX-XXXXXXX'x
material breach of its obligations under this Agreement, then
sub-clauses 4.01 (e)(i) and 4.01(e)(ii) set forth PFIZER's sole
remedy in the event XXXXXX-XXXXXXX fails to meet the supply
obligations set forth in this Article IV.
(iv) In the event for any reason, including Force Majeure, XXXXXX-
XXXXXXX shall be unable to supply Bulk on a timely basis,
XXXXXX- XXXXXXX shall use reasonable efforts to ensure that it
supplies Bulk to all of its licensees, distributors,
co-promoters, etc. on a ratably equitable basis.
ARTICLE V - PACKAGING BY PFIZER
SECTION 5.01. Information for Submission. In those Countries where
XXXXXX-XXXXXXX holds or will apply for the Marketing Authorization, PFIZER
shall promptly provide to XXXXXX-XXXXXXX all information and data
necessary to enable XXXXXX-XXXXXXX, when required, to make the submissions
to the relevant Governmental or Regulatory Authorities to reflect in the
applicable Marketing Authorization the identity of the Person Packaging
the Product. PFIZER shall not make any changes or take any actions which
will require an amendment to any Marketing Authorization, including but
not limited to transfer of any Product to alternative manufacturing
facilities or changes in or replacement of equipment, without the prior
written consent of XXXXXX-XXXXXXX.
SECTION 5.02. Compliance with Laws. PFIZER shall Package each Product
in accordance with Good Manufacturing Practices and shall comply in all
respects with all applicable Laws with respect to the Packaging of each
Product.
SECTION 5.03. Approval of Product Labels, Printed Packaging Materials
and Inserts. In each Country, PFIZER shall sell the Product only with
labels, printed packaging materials and product inserts whose format and
type, including the appearance of the relevant Trademark, has been
approved in writing by XXXXXX-XXXXXXX, which approval will not be
unreasonably withheld or delayed and shall be deemed to have been given if
XXXXXX- XXXXXXX shall not have responded within thirty (30) days of having
received samples of said material from PFIZER. Such approval shall be
deemed continuing so long as there is no material modification to the
prior approved use of the Trademark as used in connection with such
labels, printed packaging materials and product inserts.
SECTION 5.04. Quality Audit. PFIZER shall make that portion of its
manufacturing facilities where Products are Packaged and/or stored,
including all records and reference samples related to Products, available
for inspection by XXXXXX-XXXXXXX during business hours. Records made
available for inspection hereunder shall include records relevant to
assessing the quality of a Product in the event of a complaint or a
suspected defect. Inspections by XXXXXX-XXXXXXX shall be conducted only by
qualified personnel of XXXXXX-XXXXXXX or the relevant Governmental or
Regulatory Authority and shall be limited to determining whether there is
compliance with Good Manufacturing Practices and other requirements of
applicable Law.
SECTION 5.05. Storage. PFIZER shall store all Bulk, work-in-process
and finished Products under such conditions that the quality of such
materials are not affected and in accordance with instructions provided by
XXXXXX-XXXXXXX.
SECTION 5.06. Regulatory Licenses, Approvals and Consents. PFIZER
shall obtain all licenses, consents and authorizations of applicable
Governmental or Regulatory Authorities or third parties necessary or
desirable in connection with its Packaging activities and shall comply in
all material respects with all conditions applicable to any such license,
consent, permit or authority.
ARTICLE VI - INFORMATION CONCERNING THE PRODUCT
SECTION 6.01. Public Statements. PFIZER and XXXXXX-XXXXXXX shall use
reasonable efforts to ensure that no claims or representations in respect
of the Products or Atorvastatin or the characteristics thereof are made by
or on behalf of it (by members of its sales force or otherwise) that are
inconsistent with the Marketing Authorization.
SECTION 6.02. Ownership. PFIZER shall not represent to any third
party that it has any proprietary or property right or interest in the
Products, Atorvastatin or in the Patents, the Technical Information or the
Trademarks, except for such rights specifically granted to PFIZER under
Section 2.01. Furthermore, PFIZER acknowledges that it does not have any
right, title or interest in the Patents.
SECTION 6.03. Medical Inquiries. PFIZER shall comply with the
directions and policies which XXXXXX-XXXXXXX may reasonably formulate
concerning responses to be made to medical questions or inquiries from
members of the medical and paramedical professions and consumers regarding
the Products and shall, if so requested by XXXXXX-XXXXXXX, provide XXXXXX-
XXXXXXX with details of inquiries received and responses given.
SECTION 6.04. XXXXXX-XXXXXXX Information. (a) XXXXXX-XXXXXXX shall
provide PFIZER with information, known to XXXXXX-XXXXXXX, which is
relevant or appropriate to enable PFIZER to respond promptly to medical
questions or inquiries from members of the medical and paramedical
professions and consumers relating to the Products.
(b) PFIZER will refer all questions and inquiries to which it is
unable to respond, using the materials provided by XXXXXX-XXXXXXX pursuant
to clause (a) above, to XXXXXX-XXXXXXX.
ARTICLE VII - PAYMENTS
SECTION 7.01. PFIZER Payments. In consideration for the rights
granted to PFIZER under this Agreement (including, without limitation, the
licenses to use and sell the Products under Section 2.01 and the rights
set forth in this Agreement to use the Patents, Trademark, Technical
Information and other intangible rights granted hereunder), PFIZER has
paid and will pay to XXXXXX-XXXXXXX certain amounts as provided in the
International Collaboration Agreement.
SECTION 7.02. XXXXXX-XXXXXXX Payments. In each Country where
termination or expiration of this Agreement has occurred pursuant to
Section 11.01 or Section 11.02 (for any reason other than PFIZER's
material breach) and for so long as XXXXXX-XXXXXXX, its Affiliates or
licensees continue to sell the Product in such Country, in each of
Post-Agreement Year One, Post-Agreement Year Two and Post-Agreement Year
Three, XXXXXX- XXXXXXX shall, as consideration for PFIZER's efforts
hereunder, pay to PFIZER an annual amount equal to ten per cent (10%) of
the average of Net Sales made in such Country in each of the two complete
Agreement Years immediately preceding such expiration or termination
payable in four equal quarterly installments on the first day of each
calendar quarter; provided, however, that if XXXXXX-XXXXXXX shall cease to
sell Product in any such Country during any Post-Agreement Year, the
payment related to such year shall be pro-rated and XXXXXX-XXXXXXX shall
have no obligation to make further payments pursuant to this Section 7.02
in any subsequent Post- Agreement Year. The parties shall bear equally the
cost of hedging any currency risk relating to the payments contemplated in
Section 7.02.
ARTICLE VIII - CONFIDENTIAL INFORMATION
SECTION 8.01. Confidential Information. Each of PFIZER and XXXXXX-
XXXXXXX shall keep the other's Confidential Information with the same
degree of care it maintains the confidentiality of its own confidential
information. Each party shall not use such Confidential Information for
any purpose other than in performance of this Agreement or disclose the
same to any other Person other than to such of its employees, agents,
advisers, representatives, consultants and counsel who have a need to know
such Confidential Information to implement the terms of this Agreement;
provided, however, any such consultants shall be subject to
confidentiality obligations consistent with those provided herein. The
party receiving the Confidential Information (the "Receiving Party") shall
advise any employee, agent, adviser, representative, consultant or counsel
who receives such Confidential Information of the confidential nature
thereof and of the obligations contained in this Agreement relating
thereto, and the Receiving Party shall ensure that all such employees,
agents, advisers, representatives, consultants and counsel comply with
such obligations as if they had been a party hereto. Upon termination of
this Agreement, or earlier if so requested in writing by the party
disclosing the Confidential Information (the "Disclosing Party"), the
Receiving Party shall use reasonable efforts to return or destroy all
documents, tapes or other media containing Confidential Information in its
possession, except that the Receiving Party may keep one copy of
Confidential Information in the Legal Department files of the Receiving
Party, solely for archival purposes. Such archival copy shall be deemed to
be the property of the Disclosing Party, and shall not be copied or
distributed in any manner without the express prior written permission of
the Disclosing Party; provided, however, that the Receiving Party shall
have the right to disclose any Confidential Information provided hereunder
if, in the reasonable opinion of the Receiving Party's legal counsel, such
disclosure is necessary to comply with the terms of this Agreement, or the
requirements of any Law. The Receiving Party shall notify the Disclosing
Party of the Receiving Party's intent to make such disclosure of
Confidential Information pursuant to the proviso of the preceding sentence
sufficiently prior to making such disclosure so as to allow the Disclosing
Party adequate time to take whatever action the Disclosing Party may deem
to be appropriate to protect the confidentiality of the information.
SECTION 8.02. Exceptions. Each of PFIZER and XXXXXX-XXXXXXX shall be
relieved of any and all of the obligations of Section 8.01 with respect to
a specific item of Confidential Information if:
(a) such Confidential Information is in the public domain at the time
of disclosure hereunder or subsequently comes within the public
domain through no fault or action of the Receiving Party or any of
its Affiliates; or
(b) such Confidential Information is in the possession or control of
the Receiving Party or any of its Affiliates at the time of
disclosure by or on behalf of the Disclosing Party or is
independently discovered, after the date of disclosure, by the
Receiving Party or any of its Affiliates without the aid, application
or use of the Confidential Information, in each such case as
evidenced by written records; or
(c) such Confidential Information is obtained by the Receiving Party
from any third party not in violation of any confidentiality
obligation to the Disclosing Party.
SECTION 8.03. Survival. The obligations and prohibitions contained in
this Article VIII shall survive the expiration or termination of this
Agreement for a period of five (5) years.
ARTICLE IX - INDEMNIFICATION
SECTION 9.01. Indemnification of PFIZER. XXXXXX-XXXXXXX shall
indemnify PFIZER in accordance with Section 4.03 of the International
Collaboration Agreement.
SECTION 9.02. Indemnification of XXXXXX-XXXXXXX. PFIZER shall
indemnify XXXXXX-XXXXXXX in accordance with Section 4.04 of the
International Collaboration Agreement.
SECTION 9.03. Survival. The provisions of this Article IX shall
survive the expiration or termination of this Agreement.
ARTICLE X - PATENTS AND TRADEMARKS
SECTION 10.01. Prosecution and Maintenance of Patents. XXXXXX-XXXXXXX
shall make adequate filings for, and prosecute and maintain, all Patents
and related applications in the Territory unless XXXXXX-XXXXXXX reasonably
believes that any such Patent or related application is not material to
the matters contemplated in this Agreement. XXXXXX-XXXXXXX shall consult
with PFIZER prior to abandoning any Patents or related applications that
are material to the matters contemplated in this Agreement. At PFIZER's
reasonable request XXXXXX-XXXXXXX shall advise PFIZER of the status of
pending applications, shall provide PFIZER with copies of documentation
concerning such applications and shall consult with PFIZER before taking
any action materially affecting the scope of patent coverage relating to
Products in the Territory. XXXXXX-XXXXXXX shall file all applications and
take any other actions necessary to obtain patent extensions and
supplementary protection certificates for Patents where available in the
Territory unless XXXXXX-XXXXXXX reasonably believes that any such Patent
or application is not material to the matters contemplated in this
Agreement.
SECTION 10.02. Patent Infringement. (a) In the event any infringement
action shall be brought in any Country against PFIZER or any of its
Affiliates because of their use or sale of Products, PFIZER shall promptly
notify XXXXXX-XXXXXXX. XXXXXX-XXXXXXX shall, at its sole expense, assume
the defense of such action, and PFIZER shall be fully indemnified on
account of such action subject to the terms of Section 9.01; provided,
however, that such defense and indemnity shall be inapplicable to the
extent it relates to a claim which arises from PFIZER's Packaging of the
Product in accordance with ARTICLE V hereof.
(b) If any third party shall, in the reasonable opinion of either
party, infringe any of the Patents, such party shall promptly notify the
other party.
(c) If any third party shall infringe any of the Patents in
connection with either the manufacture, use or sale of a product in a
Country or Countries that has a Material Adverse Effect (as hereinafter
defined) on the Products, XXXXXX-XXXXXXX shall bring suit and take such
other action as it may determine is reasonably necessary to enjoin,
prohibit, or retard such infringement. XXXXXX-XXXXXXX and PFIZER will
share the costs and expenses of such suit or action equally. PFIZER shall,
at XXXXXX-XXXXXXX'x request, cooperate in such suits or actions. Any
monetary recovery in connection with such infringement action shall first
be applied to reimburse XXXXXX-XXXXXXX and, to the extent PFIZER's
assistance or cooperation has been requested by XXXXXX-XXXXXXX, PFIZER,
for their out-of- pocket expenses (including reasonable attorneys' fees)
in prosecuting such infringement, and XXXXXX-XXXXXXX and PFIZER shall
share the balance of such recovery equally. If such recovery is less than
such out-of-pocket expenses, reimbursement shall be on a pro-rata basis.
In the event of such a Material Adverse Effect, the Agreement Year with
respect to the affected Country or Countries in which such infringement
occurred shall be extended by the number of days during which such
infringement resulted in a Material Adverse Effect on Net Sales in such
Country or Countries. For purposes of this Section 10.02(c), "Material
Adverse Effect" shall be deemed to occur if sales in a Country of
infringing products by such infringing party equal to at least ten percent
(10%) of Net Sales in such Agreement Year in such Country. If
XXXXXX-XXXXXXX fails to obtain a discontinuance of said infringement
and/or elects not to bring suit against such third party infringer,
XXXXXX-XXXXXXX will give notice to PFIZER of its election not to bring
suit within ten days of such election. PFIZER may, at its option, (i)
obtain a discontinuance of the alleged infringement or (ii) bring suit
against such third party within six months of the date of receipt by
PFIZER of the aforesaid notice. Any suit by PFIZER will be either in the
name of PFIZER or in the name of XXXXXX-XXXXXXX, or jointly by
XXXXXX-XXXXXXX and PFIZER, as may be required by Law. For this purpose,
XXXXXX-XXXXXXX will execute such legal papers necessary for the
prosecution of such suit as may be reasonably requested by PFIZER. If
PFIZER does bring such a suit or action, it shall bear all costs and
expenses associated therewith and will be entitled to keep any and all
recoveries.
(d) If any third party shall infringe any of the Patents and such
infringement does not result in a Material Adverse Effect, XXXXXX-XXXXXXX
shall have sole discretion whether or not to bring suit to enjoin,
prohibit, or retard such infringement. XXXXXX-XXXXXXX shall be solely
responsible for all out-of-pocket expenses incurred in connection with
such infringement suits and shall have sole rights to any recoveries made
thereunder. PFIZER shall, at XXXXXX-XXXXXXX'x request, cooperate in such
suits or actions.
SECTION 10.03. Trademark Infringement. (a) XXXXXX-XXXXXXX and PFIZER
shall each advise the other promptly upon its becoming aware of any
infringement by a third party of the Trademark. XXXXXX-XXXXXXX and its
Affiliates shall have sole discretion to decide what if any action should
be taken in relation to such infringement. PFIZER shall cooperate fully
with, and as reasonably requested by, XXXXXX-XXXXXXX, at XXXXXX-XXXXXXX'x
expense, in any investigation or action taken by XXXXXX-XXXXXXX or any of
its Affiliates in respect of such infringement. Any sums obtained as a
result of any such suit or proceeding, whether by judgment, award, decree
or settlement, shall be the property of XXXXXX-XXXXXXX or its Affiliate
and PFIZER shall not under any circumstances be entitled to any share of
the same. If XXXXXX-XXXXXXX fails to obtain a discontinuance of said
infringement and/or elects not to bring suit against such third party
infringer, XXXXXX-XXXXXXX will give notice to PFIZER of its election not
to bring suit within ten days of such election. PFIZER may, at its option,
(i) obtain a discontinuance of the alleged infringement or (ii) bring suit
against such third party within six months of the date of receipt by
PFIZER of the aforesaid notice. Any suit by PFIZER will be either in the
name of PFIZER or in the name of XXXXXX-XXXXXXX, or jointly by
XXXXXX-XXXXXXX and PFIZER, as may be required by Law. For this purpose,
XXXXXX-XXXXXXX will execute such legal papers necessary for the
prosecution of such suit as may be reasonably requested by PFIZER. If
PFIZER does bring such a suit or action, it shall bear all costs and
expenses associated therewith and will be entitled to keep any and all
recoveries.
(b) In the event any trademark infringement action shall be brought
in any Country against PFIZER or any of its Affiliates because of their
use or sale of Products, PFIZER shall promptly notify XXXXXX-XXXXXXX.
XXXXXX- XXXXXXX shall, at its sole expense, assume the defense of such
action, and PFIZER shall be fully indemnified on account of such action
subject to the terms of Section 9.01; provided, however, that such defense
and indemnity shall be inapplicable to the extent it relates to a claim
which arises from PFIZER's Packaging of the Product in violation of
ARTICLE V hereof.
ARTICLE XI - TERM AND TERMINATION
SECTION 11.01. Term. Unless otherwise mutually agreed to by the
parties, this Agreement shall, with respect to each Country, expire on the
last day of Agreement Year Ten.
SECTION 11.02. Termination. (a) If either XXXXXX-XXXXXXX or PFIZER
materially breaches or defaults in the performance of any of the
provisions of this Agreement with respect to any Country, and such
material breach or default is not cured within sixty (60) days after the
giving of notice by the other party specifying such breach or default, the
other party shall have the right to terminate this Agreement forthwith
with respect to that Country. For the purposes of this Section 11.02, a
material breach or default in the performance of any of the provisions of
this Agreement shall include a material inaccuracy in any representation,
warranty or covenant contained herein.
(b) To the extent permitted by Law, if either XXXXXX-XXXXXXX or
PFIZER shall become insolvent, or shall make or seek to make or arrange an
assignment for the benefit of creditors, or if proceedings in voluntary or
involuntary bankruptcy shall be initiated by, on behalf of or against such
party (and, in the case of any such involuntary proceeding, not dismissed
within ninety (90) days), or if a receiver or trustee of such party's
property shall be appointed and not discharged within ninety (90) days,
the other party shall have the right to terminate this Agreement
forthwith.
SECTION 11.03. PFIZER Right to Terminate. At any time, upon twelve
(12) months' notice to XXXXXX-XXXXXXX, PFIZER shall have the right on a
Country-by-Country basis, at PFIZER's sole discretion, to terminate this
Agreement and upon such termination, subject to Section 11.04, PFIZER
shall have no further rights to any payments or compensation from
XXXXXX-XXXXXXX. In addition, in the event that PFIZER ceases permanently
the sale of any Product in any Country in accordance with Section 3.01(c)
this Agreement shall automatically terminate with respect to such Country.
SECTION 11.04. XXXXXX-XXXXXXX Right to Terminate. XXXXXX-XXXXXXX
shall have the right to terminate this Agreement with respect to certain
Products in accordance with Sections 3.01(b) and 3.01(e). In addition, in
the event that XXXXXX-XXXXXXX ceases permanently the sale of Bulk to
PFIZER pursuant to Section 3.01(d) this Agreement shall automatically
terminate with respect to such Country.
SECTION 11.05. No Prejudice to Rights. Termination of this Agreement
shall be without prejudice to:
(a) The rights of the parties to any payments due under Article IV to
the date of termination; and
(b) Any remedies which either party may then have hereunder or at
law; and
(c) Either party's right to obtain performance of any obligations
provided for in this Agreement which survive termination by their
express terms.
ARTICLE XII - MISCELLANEOUS
SECTION 12.01. Non-Compete. During the Term of this Agreement and for
two (2) years thereafter, neither PFIZER nor XXXXXX-XXXXXXX (nor their
respective Affiliates or licensees (other than AchE LaboratOrios
FarmacEuticos S/A and the companies of the Menarini group)) shall,
directly or indirectly, market, sell, detail, promote or distribute any
Competing Products in any part of the Territory.
SECTION 12.02. Manner of Payments. All sums due to either party shall
be payable in local currency or such other currency as shall be agreed
between the parties 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.
SECTION 12.03. Interest on Late Payments. If either XXXXXX-XXXXXXX or
PFIZER shall fail to make a timely payment pursuant to this Agreement,
interest shall accrue on the past due amount 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 12.04. Relationship of the Parties. Each party shall bear its
own costs incurred in the performance of its obligations hereunder without
charge or expense to the other except as expressly provided in this
Agreement. Neither party shall have any responsibility for the hiring,
termination or compensation of the other party's employees or for any
employee benefits of such employee. No employee or representative of a
party shall have any authority to bind or obligate the other party to this
Agreement for any sum or in any manner whatsoever, or to create or impose
any contractual or other liability on the other party without said party's
approval. For all purposes, and notwithstanding any other provision of
this Agreement to the contrary, PFIZER's legal relationship under this
Agreement to XXXXXX-XXXXXXX shall be that of independent contractor.
Nothing in this Agreement shall be construed to establish a relationship
of co-partners or joint venturers between the parties.
SECTION 12.05. No Solicitation. The parties agree that during the
Term of this Agreement neither party to this Agreement shall solicit any
employee of the other party, with whom it has come in contact or
interacted for the purposes of the performance of this Agreement, to leave
the employment of the other party and accept employment with the first
party.
SECTION 12.06. Force Majeure. The occurrence of an event which
materially interferes with the ability of a party to perform its
obligations or duties hereunder which is not within the reasonable control
of the party affected, not due to malfeasance, and which could not with
the exercise of due diligence have been avoided ("Force Majeure"),
including, but not limited to, fire, accident, labor difficulty, strike,
riot, civil commotion, act of God, delay or errors by shipping companies
or change in Law, shall not excuse such party from the performance of its
obligations or duties under this Agreement, but shall merely suspend such
performance during the continuation of Force Majeure. The party prevented
from performing its obligations or duties because of Force Majeure shall
promptly notify the other party hereto (the "Other Party") of the
occurrence and particulars of such Force Majeure and shall provide the
Other Party, from time to time, with its best estimate of the duration of
such Force Majeure and with notice of the termination thereof. The party
so affected shall use reasonable efforts to avoid or remove such causes of
nonperformance. Upon termination of Force Majeure, the performance of any
suspended obligation or duty shall promptly recommence. Neither party
shall be liable to the Other Party for any direct, indirect,
consequential, incidental, special, punitive, exemplary or other damages
arising out of or relating to the suspension or termination of any of its
obligations or duties under this Agreement by reason of the occurrence of
Force Majeure.
SECTION 12.07. 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 12.08. 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 non-exclusive 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 12.09. Assignment. This Agreement may not be assigned by
either party without the prior written 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. It is further
understood and agreed that each party may assign, or otherwise cause to be
performed, its obligations under this Agreement to or by, as the case may
be, one or more of its Affiliates to the extent necessary or appropriate
in order to ensure that such obligations are fulfilled in accordance with
the terms and intent of this Agreement. 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 12.10. 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 12.11. 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 12.12. 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 12.13. 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 12.14. Entire Agreement. This Agreement (including Exhibits A
through C hereto), together with the International Collaboration Agreement
and the Confidential Disclosure Agreement, dated March 4, 1996 (the
"Confidential Disclosure Agreement"), each between XXXXXX-XXXXXXX and
PFIZER, constitutes the entire agreement between the parties hereto with
respect to the within subject matter and supersedes all previous
agreements, whether written or oral. It is agreed that (i) Article VIII of
this Agreement shall govern the protection of Confidential Information
disclosed prior to or pursuant to this Agreement and (ii) the matters
referred to in Paragraph 8 and Attachment A of the Confidential Disclosure
Agreement shall remain in full force and effect pursuant to the terms
thereof. 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 12.15. No License. Nothing in this Agreement shall be deemed
to constitute the grant of any license or other right in either party to
or in respect of any product, patent, trademark, Confidential Information,
trade secret or other data or any other intellectual property of the other
party except as expressly set forth herein.
SECTION 12.16. 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 reason of any such provision make any claim in
respect of any debt, liability or obligation (or otherwise) against any
party thereto.
SECTION 12.17. 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 that,
under any of the foregoing circumstances, it shall have no claim
whatsoever against PFIZER under this Agreement, which shall remain in full
force and effect according to its terms.
SECTION 12.18. 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.
By: /s/ Xxxxxxxx X.X. xx Xxxx By: /s/ X. Xxxxxxx
----------------------------- ----------------------------
Name: Xxxxxxxx X.X. xx Xxxx Name: Xxxxxx Xxxxxxx
Title: President and Chief Title: Executive Vice President
Operating Officer
