[EXHIBIT 99.4]
INTERNATIONAL CO-PROMOTION 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 Co-Promotion Territory (as
hereinafter defined) under Patents, Technical Information (as defined in
the International License Agreement) and Trademarks pertaining to
Atorvastatin;
WHEREAS, PFIZER has significant experience in the market development,
marketing, promotion and sale of pharmaceutical products and believes it
can make significant contributions to the successful market 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 Co-Promotion 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 Quarters" means for each Agreement Year, each of the three
month periods ending March 31, June 30, September 30 and December 31;
provided, however, that the first Agreement Quarter for Agreement Year One
shall extend from the Launch Date to the end of the first complete calendar
quarter thereafter and the last Agreement Quarter for Agreement Year Ten
shall end on the tenth anniversary of the Launch Date.
"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 .
"Agreement Years" for each Country means the period commencing on the
Launch Date and ending on the last day of Agreement Year Ten.
"Atorvastatin" means the chemical compound [R-(R*,R*)]-2-(4-
fluorophenyl)-ss,d-dihydroxy-5-(1-methylethyl)-3-phenyl-4-
[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) and
hydrates thereof.
"Category 1 Countries" means the Countries set forth under Category 1
on Exhibit A.
"Category 2 Countries" means the Countries set forth under Category 2
on Exhibit A.
"Category 3 Countries" means the Countries set forth under Category 3
on Exhibit A.
"Change in Control" means an event where:
(A) any Person(s) acquire beneficial ownership of capital stock of
XXXXXX-XXXXXXX entitling the holder(s) thereof to at least fifty-one
percent (51%) of the voting power of the then outstanding capital
stock of XXXXXX-XXXXXXX with respect to the election of directors of
XXXXXX-XXXXXXX, or
(B) XXXXXX-XXXXXXX enters into a merger, consolidation or similar
transaction with another Person (the "Acquiring Corporation") in which
(i) XXXXXX-XXXXXXX is not the surviving corporation in such
transaction, (ii) the members of the Board of Directors of XXXXXX-
XXXXXXX prior to such transaction constitute less than one half of the
members of the Board of Directors of the Acquiring Corporation
following such transaction, and (iii) at least fifty-one percent (51%)
of the voting power of the outstanding capital stock of the Acquiring
Corporation with respect to the election of directors following such
transaction is held by Persons who were shareholders of the Acquiring
Corporation prior to such transaction, or
(C) XXXXXX-XXXXXXX sells to any Person(s) in one or more related
transactions properties or assets representing at least fifty-one
percent (51%) of (i) XXXXXX-XXXXXXX'x consolidated total assets as
reflected on its most recent Annual Report on Form 10-K or Quarterly
Report on Form 10-Q, provided that all or substantially all of the
properties and assets used in connection with XXXXXX-XXXXXXX'x
pharmaceutical business are included in such transaction(s) and (ii)
XXXXXX-XXXXXXX'x consolidated operating income for the most recent
fiscal year as reflected on its most recent Annual Report on Form 10-
K.
"Clinical Plan" means the clinical plan and budget for each Country as
determined or varied in accordance with the provisions of Section 4.01.
"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.
"Co-Promotion Territory" means all of the Countries.
"Country" means any of the countries set forth on Exhibit A.
"Designated Market" for each Country means the HMG-CoA Reductase
Inhibitors ("Statins") identified in the IMS nomenclature as of the date
hereof as B4A1, as such nomenclature may be modified from time to time
consistent with such designation.
"Detail" means a face-to-face contact (including a live video
presentation) of either a XXXXXX-XXXXXXX or PFIZER sales representative (or
their respective designees in accordance with Section 2.02(d)), as the case
may be, with (i) a medical professional with prescribing authority or (ii)
such other groups as may be mutually agreed between the parties that
involves either a Primary or Secondary Product Presentation, in each case
as measured by each party's internal recording of such activity; provided
that during the first six (6) months after the Launch Date in each Country,
only a Primary Product Presentation shall constitute a Detail in such
Country.
"FDA" means the United States Food and Drug Administration.
"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.
"IMS" means Intercontinental Medical Statistics Ltd. or such other
market share data publication as may be mutually agreed between the
parties.
"International Collaboration Agreement" means the International
Collaboration Agreement, dated the date hereof, between XXXXXX-XXXXXXX and
PFIZER which covers, in addition to the Co-Promotion Territories, certain
additional countries.
"International License Agreement" means the International License
Agreement, dated the date hereof, between XXXXXX-XXXXXXX and PFIZER.
"Launch Date" for each Country means the date on which the first
Product is first shipped by XXXXXX-XXXXXXX in commercial quantities from
its distribution centers for commercial sale to unaffiliated third parties
in such Country, as promptly notified to PFIZER by XXXXXX-XXXXXXX.
"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).
"Market Share" for each Country, means the share (expressed as a
percentage) of the Designated Market that is achieved by Products (based
on tablets sold, which number of tablets shall be derived by converting
total number of packs into total number of tablets sold by XXXXXX-XXXXXXX
and its Affiliates during the twelve full calendar months comprising the
applicable Agreement Year, or, in the event that this Agreement is
terminated in accordance with Section 14.03, during the twelve full
calendar months ending on or prior to the termination date), as audited and
published by IMS or its affiliate in its pharmaceutical sales audit
publication. The parties may, by mutual agreement, choose an alternative
auditor-publisher and publication or unit of measure. Notwithstanding the
foregoing definition, for purposes of the definition of Net Sales
Multiplier, Market Share means the share (expressed as a percentage) of the
Designated Market that is achieved by Products (based on tablets as set
forth above) sold by XXXXXX-XXXXXXX and its Affiliates during the fourth
Agreement Quarter of the immediately preceding Agreement Year. Market
Share shall be calculated to the nearest tenth of a percent.
"Marketing Authorization" means the authorization to sell the Product
in the applicable Country as granted by the relevant Governmental or
Regulatory Authorities.
"Marketing Plan" means an annual plan and budget for the promotion and
marketing of the Products in each Country as developed under Section 4.01.
"Net Sales" for each Country means (a) the aggregate sales of XXXXXX-
XXXXXXX and its Affiliates of Products to unaffiliated third parties in the
relevant Country (but not including sales between XXXXXX-XXXXXXX 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 granted or given 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 in respect of any government-
subsidized program, all as determined in accordance with generally accepted
accounting principles on a basis consistent with XXXXXX-XXXXXXX'x audited
financial statements and (b) any monetary recovery in connection with an
infringement action brought pursuant to Section 12.02.
"Net Sales Multiplier" means the applicable percentage of Net Sales
(based upon the Category into which each Country falls) which percentage
shall be based on Market Share achieved as set forth in Exhibit E.
"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.
"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.
"Primary Product Presentation" means a promotional message involving a
Product where such Product is given an important emphasis (but not an
emphasis that is significantly less important than the emphasis given to
other products) during a sales call.
"Product Expenses" for each Country means all (a) out-of-pocket costs
and expenses incurred (i.e. paid or accrued) to third parties (other than
expenses incurred for the services of a contract sales force), whether
incurred by XXXXXX-XXXXXXX or PFIZER, for each Country on or after April
15, 1996 in connection with (i) marketing, advertising, sampling and
promoting (including, without limitation, educational expenses, speakers'
programs and symposia) Atorvastatin and the Products, (ii) training and
communications materials, (iii) clinical, preclinical, epidemiological
modeling and pharmacoeconomic studies that are designed to support local
marketing and commercialization of the Products consistent with the
Clinical Plan, (iv) supplementary submissions to Governmental or Regulatory
Authorities, including, without limitation, consultant fees and advisory
committee meetings relating to such submissions and (v) prosecution of
patent infringement pursuant to Section 12.02; provided, however, such out-
of-pocket expenses from April 15, 1996 through June 30, 1996 for the Co-
Promotion Territory shall not be in excess of $5 million, (b) all costs and
direct expenses of PFIZER and XXXXXX-XXXXXXX relating to the supply of
Samples (as determined in accordance with Section 5.02(b)) and the
distribution of Samples and (c) all costs and expenses incurred centrally
by XXXXXX-XXXXXXX or PFIZER implementing Global Marketing programs agreed
by the Global Business Subcommittee and relating to or benefiting the
activities of the parties pursuant to this Agreement in such Country.
"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 XXXXXX-
XXXXXXX in the Co-Promotion Territory during the Agreement Years.
"Secondary Product Presentation" means a promotional message during a
sales call that involves a Product and that is neither a Primary Product
Presentation nor a reminder sales call.
"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.
"Term of this Agreement" for each Country means the period from the
date hereof until the expiration of this Agreement in accordance with
Section 14.01 or earlier termination of this Agreement in accordance with
Section 14.03.
"Trademark" has the meaning ascribed to it in Section 2.05(a).
"U.S. Agreement" means the Collaboration Agreement dated June 28, 1996
between the parties covering the United States.
"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.
SECTION 1.02. Interpretation. Unless the context of this Agreement
otherwise requires, (i) words of one gender include the other gender; (ii)
words using the singular or plural number also include the plural or
singular number, respectively; (iii) the terms "hereof," "herein,"
"hereby," and derivative or similar words refer to this entire Agreement;
and (iv) the terms "Article" and "Section" refer to the specified Article
and Section of this Agreement. Whenever this Agreement refers to a number
of days, unless otherwise specified, such number shall refer to calendar
days.
ARTICLE II - CERTAIN RIGHTS AND OBLIGATIONS
SECTION 2.01. Co-Promotion Rights. Subject to the terms of this
Agreement, XXXXXX-XXXXXXX grants to PFIZER the exclusive right, together
with XXXXXX-XXXXXXX, to promote and detail Products in the Co-Promotion
Territory pursuant to the terms of this Agreement. Subject to the
provisions of Section 2.02(d), so long as PFIZER's rights of co-promotion
under this Section 2.01 shall remain in effect, XXXXXX-XXXXXXX shall not
grant any rights to, or permit or authorize any third party (other than a
XXXXXX-XXXXXXX Affiliate) to sell Products in any Country (other than
wholesalers and other third parties in the chain of distribution), or to
promote or detail Products in the Co-Promotion Territory in a manner
similar to the detailing and promotion of Products by PFIZER pursuant to
this Agreement.
SECTION 2.02. Detailing and Promotional Efforts.
(a) Both PFIZER and XXXXXX-XXXXXXX shall deploy such of their
respective sales forces in an effort to promote effectively and detail the
Products in the Co-Promotion Territory in accordance with the terms of this
Agreement and the relevant Marketing Plan. In conducting such promotion
and detailing both PFIZER and XXXXXX-XXXXXXX shall use reasonable
commercial efforts consistent with accepted pharmaceutical industry
business practices. No party shall be required to undertake any activity
under this Agreement which it believes, in good faith, may violate any Laws
or codes of practice.
(b) Each party shall diligently work to fulfill all responsibilities
assigned to it under this Agreement and each Marketing Plan and shall
comply with all applicable Laws in the Co-Promotion Territory. It is the
intention of the parties that during each Agreement Year with respect to
each Category 1 Country each of XXXXXX-XXXXXXX and PFIZER will devote
substantially equal efforts and internal resources to the marketing,
promotion and detailing of the Products and the other activities
contemplated under this Agreement; provided, however, (i) with respect to
each Category 2 Country such efforts and resources shall be 33% for PFIZER
and 67% for XXXXXX-XXXXXXX and (ii) with respect to each Category 3 Country
such efforts and resources shall be 67% for PFIZER and 33% for XXXXXX-
XXXXXXX. The Marketing Plans developed under Section 4.01 shall reflect
the foregoing. If the parties agree that additional detailing or other
internal resources are necessary beyond those contemplated in this
Agreement, or if one party is requested to devote its resources in excess
of its appropriate share, the parties shall first determine fair
compensation to such party for its additional efforts. Furthermore, no
party hereto shall be required, without its consent, to devote any
employees or other internal resources of a type, scope or nature which are
materially different from those provided by the other party.
(c) During each Agreement Year in each Category 1 Country, each of
PFIZER and XXXXXX-XXXXXXX shall be responsible for performing a number of
Details equal to fifty percent (50%) of the Details designated for such
Agreement Year in the Marketing Plan then in effect; provided, however, (i)
with respect to each Category 2 Country PFIZER shall be responsible for
performing a number of Details equal to 33% of the Details called for in
the Marketing Plan then in effect for such Agreement Year, and XXXXXX-
XXXXXXX shall be responsible for performing 67% of the Details called for
in such Marketing Plan and (ii) with respect to each Category 3 Country
PFIZER shall be responsible for performing a number of Details equal to 67%
of the Details called for in the Marketing Plan then in effect for such
Agreement Year, and XXXXXX-XXXXXXX shall be responsible for performing 33%
of the Details called for in such Marketing Plan.
(d) Upon written notice to the other party, XXXXXX-XXXXXXX and PFIZER
shall each have the right to use the services of a contract sales force
(i.e. a third party whose primary business is devoted to detailing third
party products) to assist such party in satisfying its obligations
hereunder; provided, however, that during Agreement Years One and Two in
each Country, PFIZER and XXXXXX-XXXXXXX will promote the Product solely
through their respective existing experienced sales forces and will not
rely upon contract sales forces (other than the United Kingdom, where
PFIZER shall have the right during Agreement Years One and Two to
supplement its existing sales force with contract sales forces in a manner
consistent with its past practices); provided, further, that after such
time as XXXXXX-XXXXXXX terminates PFIZER's co-promotion rights under
Sections 14.02(a) or 14.02(b), in no event shall XXXXXX-XXXXXXX be
permitted to use in any Country a contract sales force (without PFIZER's
prior consent) to perform a number of Details greater than such number of
Details performed in such Country by a contract sales force for XXXXXX-
XXXXXXX prior to such termination of PFIZER's co-promotion rights.
Furthermore, in no event shall XXXXXX-XXXXXXX increase in any Country its
use of such a contract sales force (without PFIZER's prior consent) to
perform a greater number of Details in anticipation of its decision to
terminate PFIZER's co-promotion rights in such Country pursuant to Sections
14.02(a) or 14.02(b).
SECTION 2.03. Detailing Reports. Each party shall provide to the
other party a report of the number of Details carried out by its
representatives during each Agreement Quarter. Reports shall be delivered
to the other party within six weeks of the end of the applicable Agreement
Quarter.
SECTION 2.04. Development of Products; Regulatory Approvals.
(a) XXXXXX-XXXXXXX shall exercise reasonable efforts to obtain, as
soon as reasonably practicable, the Marketing Authorization, and, where
relevant, Price Approval, for a Product with a package insert or, in the
case of Canada, a Product monograph, that is materially equivalent to the
provisions of Exhibit C.
(b) XXXXXX-XXXXXXX shall 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 XXXXXX-XXXXXXX in good faith believes
that it has an ethically valid reason therefor based on medical or
scientific problems concerning such Product.
(c) Except as otherwise provided in Sections 3.01 and 3.02 of the
International Collaboration Agreement, XXXXXX-XXXXXXX shall be under no
liability whatsoever to compensate PFIZER or make any other payment to
PFIZER if (i) Marketing Authorization or Price Approval is not received,
(ii) the approved package insert or, in the case of Canada, the Product
monograph for the first Product is not materially equivalent to the
provisions of Exhibit C, or (iii) if XXXXXX-XXXXXXX determines to take any
of the steps that it is permitted to take pursuant to this Section 2.04,
provided, in the case of (i), (ii) and (iii) above, such failure to obtain
such Marketing Authorization or Price Approval or, in the case of (b)
above, such cessation of sale shall not be the result of any breach of this
Agreement by XXXXXX-XXXXXXX.
SECTION 2.05. Trademarks, etc.
(a) The Products shall be promoted and sold under trademark(s)
selected by XXXXXX-XXXXXXX in its sole discretion and owned by XXXXXX-
XXXXXXX or by any of its Affiliates (the "Trademark"). PFIZER shall have
no rights under this Agreement in or to the Trademark or the goodwill
pertaining thereto except as specifically provided herein. PFIZER shall
utilize the Trademark only for the purposes contemplated herein. PFIZER
agrees that upon termination or expiration of this Agreement (or upon
PFIZER no longer retaining co-promotion rights under Section 2.01 if such
date occurs first), it will discontinue forthwith all use of the Trademark.
(b) Except as specifically set forth in this Agreement, PFIZER shall
not enjoy or exercise any proprietary or property right or other interest
in the Trademark, the Patents or in any copyright owned by XXXXXX-XXXXXXX
or any of its Affiliates and relating to any Product.
(c) PFIZER is the owner of the PFIZER logo set forth on Exhibit D
(the "PFIZER Logo"). PFIZER grants XXXXXX-XXXXXXX the right to use the
PFIZER Logo on labeling, package inserts, Product monographs and packaging
materials for Products, all Promotional Materials (as hereinafter defined),
Samples (as hereinafter defined) and any other materials used in connection
with the performance of this Agreement during the Term of this Agreement
(or the period of time in which PFIZER retains co-promotion rights under
Section 2.01 if shorter) and for the period of six (6) months thereafter
for all Products, Promotional Materials, Samples, labeling, inserts and
Product monographs containing the PFIZER Logo; provided, however, such use
shall be consistent with the uses approved by PFIZER's representatives on
the Operating Committee (or the applicable Country Marketing Team).
XXXXXX-XXXXXXX shall have no rights under this Agreement in or to the
PFIZER Logo or the goodwill pertaining thereto except as specifically
provided for herein. Except as provided for in this Section 2.05(c),
XXXXXX-XXXXXXX agrees that upon termination or expiration of this Agreement
(or upon PFIZER no longer retaining co-promotion rights under Section 2.01
if such date occurs first), it will discontinue forthwith all use of the
PFIZER Logo.
SECTION 2.06. 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) shall, directly or indirectly, market,
sell, detail, promote or distribute any Competing Products in any part of
the Co-Promotion Territory.
ARTICLE III - PAYMENTS
SECTION 3.01. PFIZER Payments.
(a) In consideration for the rights granted to PFIZER under this
Agreement (including, without limitation, the exclusive right to co-promote
the Products under Section 2.01 and the rights set forth in this Agreement
to use the governmental approvals, data, inventions, discoveries, patents,
trademark, manufacturing rights, know-how and other intangible rights
granted hereunder), PFIZER has paid to XXXXXX-XXXXXXX certain amounts as
provided in the International Collaboration Agreement.
(b) For as long as PFIZER shall enjoy co-promotion rights under
Section 2.01, subject to the terms of Section 14.04(b), PFIZER shall be
responsible (i) with respect to each Category 1 Country for fifty percent
(50%) of all Product Expenses, (ii) with respect to each Category 2 Country
for thirty-three percent (33%) of all Product Expenses and (iii) with
respect to each Category 3 Country for sixty-seven percent (67%) of all
Product Expenses. PFIZER shall pay its share of Product Expenses in
accordance with the terms set forth in Sections 3.03 and 3.04.
SECTION 3.02. XXXXXX-XXXXXXX Payments. Subject to the other
provisions of this Agreement, XXXXXX-XXXXXXX agrees that:
(a) XXXXXX-XXXXXXX shall be responsible (i) with respect to each
Category 1 Country for fifty percent (50%) of all Product Expenses, (ii)
with respect to each Category 2 Country for sixty-seven percent (67%) of
all Product Expenses and (iii) with respect to each Category 3 Country for
thirty-three percent (33%) of all Product Expenses. Xxxxxx-Xxxxxxx shall
pay its share of Product Expenses in accordance with the terms set forth in
Sections 3.03 and 3.04.
(b) For each Agreement Year and separately calculated for each
Category 1 Country, XXXXXX-XXXXXXX shall pay to PFIZER, in the local
currency for each such Category 1 Country, a percentage of Net Sales, which
percentage shall be based on Market Share achieved as set forth in Exhibit
E, with such calculation of the XXXXXX-XXXXXXX payment to PFIZER to be made
in accordance with the sample methodology set forth in Exhibit B hereto.
(c) For each Agreement Year and separately calculated for each
Category 2 Country, XXXXXX-XXXXXXX shall pay to PFIZER, in the local
currency for each such Category 2 Country, a percentage of Net Sales, which
percentage shall be based on Market Share achieved as set forth in Exhibit
E, with such calculation of the XXXXXX-XXXXXXX payment to PFIZER to be made
in accordance with the sample methodology set forth in Exhibit B hereto
(provided, however, that such methodology shall assume and use the
multiplier designated under Category 2 of Exhibit E).
(d) For each Agreement Year and separately calculated for each
Category 3 Country, XXXXXX-XXXXXXX shall pay to PFIZER, in the local
currency for each such Category 3 Country, a percentage of Net Sales which
percentage shall be based on Market Share achieved as set forth in Exhibit
E, with such calculation of the XXXXXX-XXXXXXX payment to PFIZER to be made
in accordance with the sample methodology set forth in Exhibit B hereto
(provided, however, that such methodology shall assume and use the
multiplier designated under Category 3 of Exhibit E).
(e) For purposes of Sections 3.02(b), 3.02(c) and 3.02(d), in no
event shall Xxxxxx-Xxxxxxx be obligated to pay Pfizer an amount that is
greater than forty-four percent (44%), twenty-nine and four one hundredths
of one percent (29.04%) and fifty-eight and ninety-six one hundredths of
one percent (58.96%), respectively, of the Net Sales in any Country in any
Agreement Year.
SECTION 3.03. Payments; Payment Reports.
(a) XXXXXX-XXXXXXX shall make payments to PFIZER arising under
Sections 3.02(b), 3.02(c) or 3.02(d), as the case may be, on a quarterly
basis by Country as follows: (i) for the first three Agreement Quarters in
Agreement Year One, payment shall be calculated in accordance with Sections
3.02(b), 3.02(c) and 3.02(d) applying (x) for Category 1 Countries, 26.40%
of Net Sales for such period in such Countries, (y) for Category 2
Countries, 17.42% of Net Sales for such period in such Countries and (z)
for Category 3 Countries, 35.38% of Net Sales for such period in such
Countries, and (ii) for the first three Agreement Quarters in each
Agreement Year after Agreement Year One, payments shall be calculated for
each Country by applying to Net Sales for such Agreement Quarters the Net
Sales Multiplier for the fourth Agreement Quarter of the prior Agreement
Year. Within ninety (90) days after the expiration of the fourth Agreement
Quarter in each Agreement Year for each Country, XXXXXX-XXXXXXX shall (i)
determine the Net Sales for such fourth Agreement Quarter and the entire
Agreement Year, (ii) calculate the actual amount due PFIZER for such
Agreement Year pursuant to the terms of Sections 3.02(b), 3.02(c) or
3.02(d), as the case may be, and (iii) pay PFIZER the difference between
(x) what was paid to PFIZER for the first three Agreement Quarters in such
Agreement Year and (y) the amount actually due to PFIZER under Sections
3.02(b), 3.02(c) or 3.02(d), as the case may be, for such Agreement Year;
provided that if the amount paid to PFIZER for the first three Agreement
Quarters in any Agreement Year exceeds what was actually due to PFIZER for
the entire Agreement Year pursuant to the applicable subsection, PFIZER
shall repay such excess amount to XXXXXX-XXXXXXX.
(b) PFIZER shall, within thirty (30) days of (i) the end of each
Agreement Quarter, or, (ii) prior to the Launch Date, the end of each
calendar quarter or (iii) in the event that this Agreement is terminated
pursuant to Section 14.03, such termination date, notify XXXXXX-XXXXXXX in
writing of the total amount of Product Expenses by Country incurred by
PFIZER during such Agreement Quarter, calendar quarter or shorter period,
as the case may be. Furthermore, within thirty (30) days of the Launch
Date in each Country, PFIZER shall notify XXXXXX-XXXXXXX of the total
amount of Product Expenses incurred by PFIZER and its Affiliates in the
period of time between the end of the last complete calendar quarter prior
to the Launch Date and the Launch Date in such Country.
(c) Provided PFIZER has complied with Section 3.03(b), XXXXXX-XXXXXXX
shall, for the first three Agreement Quarters in each Agreement Year
(except for any Agreement Quarter that is the last Agreement Quarter with
respect to any Country) within forty-five (45) days of the receipt of
PFIZER's notice under Section 3.03(b), notify PFIZER of the calculation of
the total amount of Product Expenses for such Agreement Quarter by Country,
the amounts paid or accrued by each of XXXXXX-XXXXXXX or PFIZER, and the
amounts, if any, payable by either party to the other in accordance with
Sections 3.01(b), 3.02(a) and 3.03(a).
(d) Provided PFIZER has complied with Section 3.03(b), XXXXXX-XXXXXXX
shall, within ninety (90) days of the end of each Agreement Year, or in the
event that this Agreement is terminated with respect to any Country
pursuant to Section 14.03, ninety (90) days after the termination date,
notify PFIZER by Country of the calculation of the total amount of Product
Expenses for the fourth or last Agreement Quarter, by Country, the amounts
paid or accrued by each of XXXXXX-XXXXXXX or PFIZER, and the amount payable
to PFIZER or XXXXXX-XXXXXXX, as the case may be, in accordance with
Sections 3.01(b), 3.02(a) and Section 3.03(a).
(e) Any amount payable by either party pursuant to the notification
under Sections 3.03(c) and 3.03(d) shall be offset against any amounts due
such party and the net amount shall be paid by XXXXXX-XXXXXXX or PFIZER, as
the case may be, within ten (10) business days after notification by
XXXXXX-XXXXXXX pursuant to Section 3.03(c) or Section 3.03(d).
(f) For the period of time from April 15, 1996 to the expiration of
the last complete calendar quarter prior to the Launch Date in each
Country, XXXXXX-XXXXXXX shall, within sixty (60) days after the end of each
calendar quarter, notify PFIZER of the calculation of XXXXXX-XXXXXXX'x and
PFIZER's share of Product Expenses in respect of such calendar quarter in
accordance with Sections 3.01(b) and 3.02(a), and PFIZER or XXXXXX-XXXXXXX,
as the case may be, shall pay such amount to the other within ten (10)
business days after such notification. In addition, within sixty (60) days
of the Launch Date, XXXXXX-XXXXXXX shall notify PFIZER of the calculation
of XXXXXX-XXXXXXX'x and PFIZER's share of Product Expenses in respect of
the period of time from the end of the last complete calendar quarter prior
to the Launch Date to the Launch Date, and PFIZER or XXXXXX-XXXXXXX, as the
case may be, shall pay such amount to the other within ten (10) business
days after such notification.
SECTION 3.04. Manner of Payments. All sums due to either party shall
be payable in such 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 two business days 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 two business days prior to such transfer.
SECTION 3.05. Interest on Late Payments. If either XXXXXX-XXXXXXX or
PFIZER shall fail to make a timely payment pursuant to this Article III,
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 mutually agree.
ARTICLE IV - COOPERATION; MARKETING PLANS;
CLINICAL DEVELOPMENT PLANS
SECTION 4.01. Cooperation.
(a) Subject to the other provisions of this Agreement, the parties
agree that the principal objectives of the parties hereunder in jointly
promoting and detailing Products in the Co-Promotion 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 period of time XXXXXX-XXXXXXX and PFIZER shall
be co-promoting the Products under this Agreement. The parties agree that
they shall establish a formal framework within which they will discuss
strategies for the development, marketing and detailing of the Products in
the Co-Promotion Territory.
(b) The formal framework referred to in Section 4.01(a) shall
initially be comprised of the following:
(i) An Operating Committee, which shall operate by consensus between
the parties, shall meet at least quarterly and shall have as its
overall purpose the development and implementation of commercial
planning activities and research and development programs, each
consistent with the other. The Operating Committee shall have
subcommittees as set forth below. The Operating Committee shall
consist of an equal number of representatives of each party,
chaired by a senior sales and marketing manager of XXXXXX-
XXXXXXX, shall review the activities of the U.S. Marketing
Subcommittee (established under the U.S. Agreement), the Global
Business Subcommittee, the Research Subcommittee (established
under the U.S. Agreement) and any other subcommittees formed from
time to time, and seek to resolve any matter upon which any such
subcommittee is unable to agree.
(ii) A Global Business Subcommittee, which shall operate by consensus
between the parties, comprising an equal number of
representatives of each party, chaired by a senior marketing
manager of XXXXXX-XXXXXXX, which shall meet at least quarterly
to: (a) develop and discuss global strategies for marketing of
the Product, including allocation of responsibility for global
marketing activities, (b) develop and review global marketing
plans (including the budget for advertising, promotional
strategies) and Clinical Plans, (c) review progress against the
current global marketing plans, (d) review progress of marketing
expenditures in each Agreement Year against the budget for such
activities in such Agreement Year, (e) review potential
amendments to the current global marketing plans (including the
budget for advertising and promotional strategies), (f) make
presentations to the Executive Committee and (g) undertake all
other responsibilities deemed necessary in connection with the
management of the promotion and marketing of the Product in the
Co-Promotion Territory. The Global Business Subcommittee also
shall have responsibility for reviewing the operating plans of
all Countries in the Territory (as such term is defined in the
International License Agreement) other than those countries in
which XXXXXX-XXXXXXX or its Affiliates sell a Product.
(iii) A Country Marketing Team for each Country which shall
operate by consensus between the parties to accomplish the
objectives and intent of Sections 4.01(a) and (c) through
(f) for each such Country, comprising an equal number of
representatives of each party.
(iv) An Executive Committee, which shall operate by consensus between
the parties, comprising an equal number of senior executives of
each party, chaired by a senior executive of XXXXXX-XXXXXXX,
which shall review the activities of the Operating Committee,
including the Global Business Subcommittee thereof and the
Research Subcommittee, and seek to resolve any matter upon which
any such committee or subcommittee is unable to agree.
(c) The parties may, upon mutual agreement, supplement or vary the
formal framework specified in Section 4.01(b) from time to time.
(d) If for any reason the Executive Committee cannot reach agreement
on any appropriate matter, the matter shall be referred to the Chief
Executive Officers of each party for good faith resolution. It is, however,
expressly agreed that the XXXXXX-XXXXXXX Chief Executive Officer, after
consultation with the PFIZER Chief Executive Officer, shall have the final
decision making authority with respect to the matters appropriately
referred to him and such decision shall be binding on the parties, subject
to the provisions of this Agreement. Pursuant to the foregoing, it is
acknowledged that the Chief Executive Officers of XXXXXX-XXXXXXX and PFIZER
may reasonably disagree on matters relating to strategies to market, detail
and/or promote the Products in the Co-Promotion Territory. The decisions
of the XXXXXX-XXXXXXX Chief Executive Officer on such matters shall be
binding on the parties, provided such decisions are made in good faith and
have a reasonable basis therefor. In particular, it is agreed that such
decisions cannot be challenged on the basis of being inconsistent with the
first two sentences of Section 2.02(a) or the first sentence of Section
4.01(a), provided such decision shall not be in conflict with other
specific provisions of this Agreement.
(e) Each Country Marketing Team shall seek to produce a pre-launch
activities plan and a draft Marketing Plan for Agreement Year One by or
before December 31, 1996. At least six months prior to anticipated
approval of a Marketing Authorization the Country Marketing Team shall
finalize the Marketing Plan for Agreement Year One and for each ensuing
Agreement Year on or before October 31 of the prior Agreement Year or such
other date as may be determined in accordance with this Section 4.01;
provided, however, that the Country Marketing Team for each of Germany and
the United Kingdom shall seek to produce a Marketing Plan for Agreement
Year One by or before October 31, 1996. Each Country Marketing Team shall
also produce a Clinical Plan.
(f) Subject to the provisions of this Agreement, each Marketing Plan
shall stipulate the way in which the Products are to be promoted and
detailed during the period to which the Marketing Plan relates and shall
include, inter alia: (i) the number, type and priority of Details to be
performed and strategies relating to such detailing activity, (ii) other
advertising and promotional activity to be undertaken, (iii) any training
and/or sampling programs to be conducted, (iv) budgets, (v) medical
education programs to be conducted, (vi) public relations activities and
(vii) such other activities as may be agreed on by the Global Business
Subcommittee, the applicable Country Marketing Team, the Operating
Committee, the Executive Committee or determined or varied pursuant to the
provisions of Section 4.01(d). The Marketing 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. Neither party shall make any material change in any Marketing
Plan or Clinical Plan without the prior approval of the Global Business
Subcommittee.
(g) All of the committees and subcommittees contemplated hereunder
shall be established as soon as reasonably practicable after the date of
this Agreement. Each party shall bear its own costs associated with its
participation on the various committees and subcommittees.
SECTION 4.02. Information Exchange. 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 Co-
Promotion Territory.
ARTICLE V - PROMOTIONAL MATERIALS AND SAMPLES
SECTION 5.01. Promotional and Educational Materials.
(a) Subject to the terms of clause (b) below and applicable Law,
during the Term of this Agreement (or the period of time in which PFIZER
retains co-promotion rights under Section 2.01 if shorter) XXXXXX-XXXXXXX
and PFIZER shall create and develop advertising, promotional, educational
and communication materials for marketing, advertising and promotion of the
Products for distribution to independent third parties (including medical
professionals) and to XXXXXX-XXXXXXX'x and PFIZER's respective sales forces
in accordance with the terms of the Marketing Plans (the "Promotional
Materials") and which shall be subject to XXXXXX-XXXXXXX'x prior approval
pursuant to Section 8.03. Subject to the terms of Section 2.05(c) and this
Section 5.01, XXXXXX-XXXXXXX shall own all right, title and interest in and
to any such Promotional Materials which are specifically directed to the
Products including applicable copyrights and trademarks and PFIZER shall
execute all documents and take all actions as are reasonably requested by
XXXXXX-XXXXXXX to vest title to such Promotional Materials, copyrights and
trademarks in XXXXXX-XXXXXXX. Promotional Materials shall be paid for by
the parties as set forth in Sections 3.01(b) and 3.02(a).
(b) PFIZER and XXXXXX-XXXXXXX shall retain all rights, including,
without limitation, copyrights and trademarks, to all of their respective
existing programs and materials in all formats (print, video, audio,
digital, computer, etc.) regarding sales training, patient education and
disease management programs presently owned by each, as well as any
modifications of such programs each may develop in the future which are not
specific to the Products. PFIZER and XXXXXX-XXXXXXX shall, from time to
time, each notify the other as to the identity of such proprietary
programs. In the event that XXXXXX-XXXXXXX desires after the expiration or
termination of this Agreement, to use any PFIZER program which has been
specifically adapted for, or directed to, any of the Products, the parties
shall negotiate in good faith to conclude, if possible, an appropriate
agreement (including the amount of compensation to be paid to PFIZER for
such use). In addition, all such new programs hereafter jointly developed
by PFIZER and XXXXXX-XXXXXXX pursuant to this Agreement shall be jointly
owned by PFIZER and XXXXXX-XXXXXXX, and each party shall have the right to
use such jointly developed programs free of charge after the Term of this
Agreement.
(c) PFIZER shall not produce (other than as concepts for
consideration by XXXXXX-XXXXXXX), distribute or otherwise use any
promotional or communications material relating to the Products which has
not been approved in accordance with the management framework established
in Section 4.01 and by XXXXXX-XXXXXXX pursuant to Section 5.01(a).
(d) Each party shall during each Agreement Year provide the other
party with such quantities of Promotional Materials consistent with the
applicable Marketing Plan and the provisions of this Agreement to meet such
party's reasonable requirements for use in accordance with the then current
Marketing Plan.
SECTION 5.02. Samples.
(a) XXXXXX-XXXXXXX shall during each Agreement Year provide PFIZER
with such quantities of samples of the Products ("Samples") consistent with
the applicable Marketing Plan and the provisions of this Agreement to meet
PFIZER's reasonable requirements for use in accordance with the then
current Marketing Plan. For each Agreement Year Samples shall be allocated
fairly between the parties based on the number of Details each is required
to undertake. PFIZER and XXXXXX-XXXXXXX shall use Samples strictly in
accordance with the then current Marketing Plan and shall distribute
Samples in full compliance with all applicable Laws.
(b) The cost per Sample distributed in each Agreement Quarter shall
be calculated as twelve percent (12%) of the quotient of (i) Net Sales in
such Agreement Quarter over (ii) the total number of pills of Product sold
to unaffiliated third parties in each Country in such Agreement Quarter.
(c) Within thirty (30) days after the end of the Term of this
Agreement (or, if earlier, the termination of PFIZER's co-promotion
rights), PFIZER shall return, or otherwise dispose of in accordance with
instructions from XXXXXX-XXXXXXX, all remaining Samples provided by XXXXXX-
XXXXXXX and will provide XXXXXX-XXXXXXX with a certified statement that all
remaining Samples have been returned or otherwise properly disposed of and
that PFIZER is no longer in possession or control of any such Samples in
any form or fashion.
SECTION 5.03. Labeling. The parties agree that, subject to the
requirements of applicable Law, XXXXXX-XXXXXXX and PFIZER shall be given
equal exposure and prominence on all Product package inserts, Product
monographs, packaging, Samples and all Promotional Materials used or
distributed in the Co-Promotion Territory in connection with the Products
under this Agreement; provided such equal exposure shall not be required
where PFIZER has prohibited the use of the PFIZER Logo in accordance with
the terms of Section 2.05(c).
ARTICLE VI - INFORMATION CONCERNING THE PRODUCT
SECTION 6.01. Public Statements. PFIZER and XXXXXX-XXXXXXX shall
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 have not been approved by
XXXXXX-XXXXXXX or which do not represent an accurate summary or explanation
of the labeling of the Product or a portion thereof.
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 or the Trademark, except for such
rights 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 shall refer all questions and inquiries to which PFIZER is
unable to respond, using the materials provided by XXXXXX-XXXXXXX pursuant
to Section 6.04(a), to XXXXXX-XXXXXXX.
ARTICLE VII - TRAINING
SECTION 7.01. Training Plans. PFIZER and XXXXXX-XXXXXXX shall, each
at its own expense, comply with any reasonable training plan contained in
any Marketing Plan which is otherwise consistent with provisions of this
Agreement.
SECTION 7.02. Assistance. During the Term of this Agreement (or the
period of time in which PFIZER retains co-promotion rights under Section
2.01 if shorter), each party shall make available to the other, to the
extent reasonable:
(a) Reasonable services of such party's sales training personnel to
assist the other party's sales training personnel in training its detailing
force; and
(b) Reasonable quantities of training and communications materials
created and developed for marketing and promoting the Products.
ARTICLE VIII - REGULATORY MATTERS
SECTION 8.01. Communication with Regulatory Authorities. PFIZER
shall not without the consent of XXXXXX-XXXXXXX or unless so required by
Law (and then only pursuant to the terms of this Section 8.01), correspond
or communicate with any Governmental or Regulatory Authority, whether
within the Co-Promotion Territory or otherwise, concerning the Products or
Atorvastatin or otherwise take any action concerning any authorization or
permission under which the Products are sold or any application for the
same. Furthermore, 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 8.02. Filings with Governmental or Regulatory Authorities.
Subject to the terms of Section 2.04, upon receipt of the initial Marketing
Authorization for a Product in each Country, XXXXXX-XXXXXXX shall have
exclusive authority and responsibility to maintain and seek revisions of
the conditions of each such Marketing Authorization for the Products and
shall keep PFIZER informed of any such actions, provided any such revisions
are not inconsistent with the decisions of the parties as determined in
accordance with Section 4.01. Within twenty (20) days after submission to
the applicable Governmental or Regulatory Authority, XXXXXX-XXXXXXX shall
provide PFIZER with copies of all final submissions that are intended to
change or modify the label or labeling for, or the indications of,
Atorvastatin or any of the Products. Subject to the terms of Section 8.01,
PFIZER will not file any document with any Governmental or Regulatory
Authority relating to any Product or Atorvastatin without the prior consent
of XXXXXX-XXXXXXX.
SECTION 8.03. Labeling and Promotional Materials. XXXXXX-XXXXXXX
shall have sole authority and responsibility to seek and/or obtain any
necessary Governmental or Regulatory Authority approvals of any label,
labeling, package inserts, Product monographs and packaging, and
Promotional Materials used in connection with the Products, and for
determining whether the same requires Governmental or Regulatory Authority
approval. No Product label, labeling or Promotional Materials may be used
or distributed by PFIZER unless such label, labeling or Promotional
Materials have been approved in advance by the Country Marketing Team and,
for purposes of determining compliance with applicable Laws, XXXXXX-
XXXXXXX, pursuant to XXXXXX-XXXXXXX'x internal procedures.
SECTION 8.04. Complaints. Subject to the terms of Section 8.06, and
except as otherwise agreed on a Country by Country basis, PFIZER shall
refer any complaints (including medical complaints) which it receives
concerning any Product or Atorvastatin to XXXXXX-XXXXXXX within ninety-six
hours of PFIZER's receipt of the same; provided that all complaints
concerning suspected or actual Product tampering, contamination or mix-up
(e.g. wrong ingredients) shall be delivered within twenty-four hours of any
member of the PFIZER Group's (as hereinafter defined) receipt of the same.
PFIZER shall not take any other action in respect of any such complaint
without the consent of XXXXXX-XXXXXXX unless otherwise required by Law.
SECTION 8.05. Regulatory Information. Subject to the terms of
Section 8.01, 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 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 8.05, each of the
events set forth in (a), (b) and (c) of this Section 8.05 shall be defined
as a "Material Event". Information that shall be disclosed pursuant to
this Section 8.05 shall include, but not be limited to:
(1) Governmental or Regulatory inspections of manufacturing,
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 8.06. 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 8.06, 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 8.06, 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 8.06 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 8.01, (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 8.07. Recalls Or Other Corrective Action. XXXXXX-XXXXXXX
shall have sole responsibility for and shall make all decisions with
respect to any recall, market withdrawals or any other corrective action
related to the Products. XXXXXX-XXXXXXX shall promptly notify PFIZER of
any such actions taken by XXXXXX-XXXXXXX which are reasonably likely to
result in a material adverse effect on the marketability of any Product in
any Country. At XXXXXX-XXXXXXX'x request, PFIZER shall provide reasonable
assistance to XXXXXX-XXXXXXX in conducting such recall, market withdrawal
or other corrective action and any documented, direct, out-of-pocket costs
incurred by PFIZER with respect to participating in such recall, market
withdrawal or other corrective action shall be reimbursed by XXXXXX-
XXXXXXX. XXXXXX-XXXXXXX shall be under no liability whatsoever to
compensate PFIZER or make any other payment to PFIZER for any decision to
recall, initiate a market withdrawal or take any other corrective action
with respect to the Products contemplated in this Section 8.07, unless such
action results from XXXXXX-XXXXXXX'x failure to comply with the terms of
this Agreement.
SECTION 8.08. Survival of Obligations. The obligations of the
parties set forth in Sections 8.01, 8.04, 8.05 and 8.06 shall survive the
termination of this Agreement (or the period of time in which PFIZER
retains co-promotion rights under Section 2.01 if shorter) for the shelf
life of the Products containing the PFIZER Logo in accordance with Section
2.05(c).
ARTICLE IX - ORDERS AND SUPPLY OF PRODUCTS
SECTION 9.01. Orders and Terms of Sale. XXXXXX-XXXXXXX shall have
the sole right to (i) receive, accept and fill orders for Products, (ii)
control invoicing, order processing and collection of accounts receivable
for Product sales, (iii) record Product sales in its books of account, and
(iv) establish and modify the commercial terms and conditions with respect
to the sale and distribution of Products, including matters such as the
price at which the Products will be sold and whether any discounts, rebates
or other deductions should be made, paid or allowed. It is understood that
certain of the matters set forth in clause (iv) above shall be incorporated
in the Marketing Plans developed pursuant to Section 4.01.
SECTION 9.02. Misdirected Orders. If, for any reason, PFIZER
receives orders for Products, PFIZER shall forward such orders to
XXXXXX-XXXXXXX (or if directed by XXXXXX-XXXXXXX to XXXXXX-XXXXXXX'x
wholesalers) as soon as practicable.
SECTION 9.03. Product Returns. If any quantities of the Products are
returned to PFIZER, PFIZER shall immediately notify XXXXXX-XXXXXXX and ship
them to the facility designated by XXXXXX-XXXXXXX, with any reasonable or
authorized shipping or other documented direct cost to be paid by
XXXXXX-XXXXXXX. PFIZER, at its option, may advise the customer who made
the return that the Products have been returned to XXXXXX-XXXXXXX, but
shall take no other steps in respect of any return without the consent of
XXXXXX-XXXXXXX. All returns of Samples used by the PFIZER field force
shall first be returned to PFIZER which shall ship them to XXXXXX-XXXXXXX,
at XXXXXX-XXXXXXX'x expense.
SECTION 9.04. Supply. XXXXXX-XXXXXXX shall use reasonable efforts to
supply Products (both for trade purposes and Samples) during the Term of
this Agreement in a consistent fashion and in sufficient quantities to meet
the forecasted amounts of Products in accordance with the then current
Marketing Plan. With respect to the foregoing, XXXXXX-XXXXXXX shall
maintain inventory of Products (a) for the first two Agreement Quarters of
Agreement Year One for each Country, equal to six (6) months requirement
(based on the then current Marketing Plan) and (b) for the final two
Agreement Quarters of Agreement Year One and the remaining Agreement Years,
equal to three (3) months requirement (based on the then current Marketing
Plan). XXXXXX-XXXXXXX may establish appropriate back-up manufacturing
facilities and, in such event, shall be responsible for obtaining all
Governmental or Regulatory Authority approvals for such facilities on a
timely basis as required to prevent any interruption, discontinuity or
other impediment to continued supply of the Products.
SECTION 9.05. PFIZER Back-Up Manufacturing Facilities. If, after
approval of a Marketing Authorization for a Product, additional back-up
manufacturing facilities are required, PFIZER shall have the option, at its
sole cost and expense, to request XXXXXX-XXXXXXX to file a supplement to
have one or more of PFIZER's or any of its Affiliate's manufacturing
facilities (the "PFIZER Facilities") qualified and approved as back-up
manufacturing facilities. If PFIZER desires to have any of its facilities
so qualified, PFIZER shall notify XXXXXX-XXXXXXX of the identity of such
PFIZER Facilities and the back-up manufacturing services to be provided
promptly after PFIZER has made this determination. XXXXXX-XXXXXXX shall
have the right to visit and audit such PFIZER Facilities and review all
other appropriate technical information to determine whether such PFIZER
Facilities are acceptable, such consent not to be unreasonably withheld.
If approved by XXXXXX-XXXXXXX, XXXXXX-XXXXXXX shall have the right to
provide reasonable technical assistance in the qualification and approval
of such PFIZER Facilities at the cost and expense of PFIZER. XXXXXX-
XXXXXXX shall be solely responsible for filing all submissions or other
correspondence with the applicable Governmental or Regulatory Authorities
in connection with any decision to seek approval of a PFIZER Facility as an
additional back-up manufacturing facility. XXXXXX-XXXXXXX shall also be
responsible for determining technical and other conditions set forth in any
supplement filed with reference to this Section. XXXXXX-XXXXXXX shall have
the sole right to determine whether or not to use the PFIZER Facilities in
the event of an interruption or depletion in supply of Product and, under
such circumstances, a separate manufacturing agreement will be entered into
between the parties.
SECTION 9.06. Failure of Supply. In the event for any reason,
including Force Majeure (as hereinafter defined) (but excluding the failure
of PFIZER to perform its obligations as a back-up manufacturer pursuant to
the terms of Section 9.05, if applicable), XXXXXX-XXXXXXX shall be unable
in any Country to supply on a timely basis (in accordance with XXXXXX-
XXXXXXX'x normal and customary practice) at least ninety percent (90%) of
the orders for Product in such Country and provided that such orders are
not materially greater than the forecasted Product requirements included in
the then current Marketing Plan for such Country, then the following
adjustments shall be made to the terms otherwise provided herein:
(a) 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 Product as
provided for above.
(b) 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 Product as
provided for above.
(c) 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 Sections 9.06(a) and 9.06(b) set
forth PFIZER's sole remedy in the event XXXXXX-XXXXXXX fails to meet the
supply obligations set forth in this Article IX.
ARTICLE X - CONFIDENTIAL INFORMATION
SECTION 10.01. Confidential Information. Each of PFIZER and XXXXXX-
XXXXXXX shall keep all Confidential Information received from the other
with the same degree of care it maintains the confidentiality of its own
confidential information. Neither party shall 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 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 10.02. Exceptions. Each of PFIZER and XXXXXX-XXXXXXX shall be
relieved of any and all of the obligations of Section 10.01 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 10.03. Survival. The obligations and prohibitions contained
in this Article X shall survive the expiration or termination of this
Agreement for a period of five (5) years.
ARTICLE XI - COVENANTS
SECTION 11.01. XXXXXX-XXXXXXX Covenants. XXXXXX-XXXXXXX hereby
covenants and agrees as follows:
(a) During the Term of this Agreement XXXXXX-XXXXXXX shall carry out
the detailing, promotion, marketing and sale of the Products and its other
obligations or activities hereunder in accordance with (i) the terms of
this Agreement, (ii) accepted pharmaceutical industry practices and (iii)
all applicable Laws.
(b) Products to be distributed by XXXXXX-XXXXXXX during the Term of
this Agreement will, at the time of shipment by or on behalf of XXXXXX-
XXXXXXX, not be misbranded or adulterated under the terms of applicable
Laws.
(c) XXXXXX-XXXXXXX acknowledges that PFIZER is relying, and is
entitled to rely, on the foregoing covenants.
SECTION 11.02. PFIZER Covenant. PFIZER hereby covenants as follows:
(a) During the Term of this Agreement PFIZER shall carry out the
detailing, promotion and marketing of the Products and its other
obligations or activities hereunder in accordance with (i) the terms of
this Agreement, (ii) accepted pharmaceutical industry practices and (iii)
all applicable Laws.
(b) PFIZER acknowledges that XXXXXX-XXXXXXX is relying, and is
entitled to rely, on the foregoing covenants.
SECTION 11.03. Indemnification of PFIZER. XXXXXX-XXXXXXX shall
indemnify PFIZER in accordance with Section 4.03 of the International
Collaboration Agreement.
SECTION 11.04. Indemnification of XXXXXX-XXXXXXX. PFIZER shall
indemnify XXXXXX-XXXXXXX in accordance with Section 4.04 of the
International Collaboration Agreement.
SECTION 11.05. Survival. The provisions of this Article XI shall
survive the expiration or termination of this Agreement.
ARTICLE XII - PATENT AND TRADEMARK INFRINGEMENT
SECTION 12.01. Prosecution and Maintenance of Patents. XXXXXX-
XXXXXXX shall make adequate filings for, and prosecute and maintain, all
Patents and related applications in the Co-Promotion 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. 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
Co-Promotion Territory unless XXXXXX-XXXXXXX reasonably believes that any
such Patent or application is not material to the matters contemplated in
this Agreement.
SECTION 12.02. Patent Infringement.
(a) In the event any infringement action shall be brought within the
Co-Promotion Territory against PFIZER or any of its Affiliates because of
the manufacture, 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 Article XI.
(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 any
Country that has a Material Adverse Effect (as hereinafter defined) on the
Products in such Country, XXXXXX-XXXXXXX shall bring suit and take such
other action as it may determine is reasonably necessary to enjoin,
prohibit, or retard such infringement. PFIZER shall cooperate in such
suits or actions. In the event of such a Material Adverse Effect, the
Agreement Year with respect to the Country involved 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. For purposes of this Section 12.02(c), "Material Adverse
Effect" shall be deemed to occur if sales in such Country of infringing
products by such infringing party equal at least ten percent (10%) of Net
Sales in such Country in such Agreement Year.
(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.
SECTION 12.03. Trademarks.
(a) XXXXXX-XXXXXXX agrees to pursue and maintain the Trademark and
all of its relevant copyrights relating to the Products in the Co-Promotion
Territory. XXXXXX-XXXXXXX and PFIZER shall each advise the other promptly
upon its becoming aware of any infringement by a third party of the
Trademark.
(b) 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.
(c) In the event any trademark infringement action shall be brought
within the Co-Promotion Territory against PFIZER or any of its Affiliates
because of the manufacture, 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 Article XI.
ARTICLE XIII - RECORDS
SECTION 13.01. Detail Records. Both parties shall keep accurate and
complete records of each Detail carried out by it under this Agreement and
shall make such records available for inspection, review and audit by an
independent certified public accountant or the local equivalent appointed
by the other party and reasonably acceptable to such party for the purpose
of verifying the number of Details made by such party. All costs and
expenses incurred in connection with performing any such audit shall be
paid by the party performing such audit. Such accountants shall not reveal
to the party seeking verification the details of its review, except for
such information as is required to be disclosed under this Agreement, and
shall be subject to confidentiality obligations consistent with the
provisions of Article X.
SECTION 13.02. Financial Records. XXXXXX-XXXXXXX shall keep such
records of Net Sales and Product Expenses as are necessary to determine
accurately under United States generally accepted accounting principles the
sums due to PFIZER and XXXXXX-XXXXXXX under this Agreement. PFIZER shall
keep such records of its Product Expenses as are necessary to determine
accurately under United States generally accepted accounting principles the
sums due to PFIZER and XXXXXX-XXXXXXX under this Agreement. Such records
shall be retained by each party (in such capacity, the "Recording Party")
and shall be made available for inspection, review and audit, at any time
during the applicable Agreement Year and for three (3) years thereafter, at
the request and expense of the other party, by an independent certified
public accountant or the local equivalent appointed by such other party and
reasonably acceptable to the Recording Party for the sole purpose of
verifying the Recording Party's accounting reports and payments made or to
be made pursuant to this Agreement, provided that such audits may not be
performed by either party more than once per Agreement Year. Such
accountants shall not reveal to the party seeking verification the details
of its review, except for such information as is required to be disclosed
under this Agreement, and shall be subject to confidentiality obligations
consistent with the provisions of Article X.
SECTION 13.03. Retaining of Records. The documents from which were
calculated (i) the sums due under Article III and (ii) the number of
Details as set forth in the written reports delivered in accordance with
Section 2.02 shall be retained by XXXXXX-XXXXXXX or PFIZER (whichever is
relevant) during the Term of this Agreement and for three (3) years
thereafter.
ARTICLE XIV - TERM AND TERMINATION
SECTION 14.01. 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 14.02. Termination of Co-Promotion Rights. XXXXXX-XXXXXXX
shall have the right to terminate PFIZER's co-promotion rights, granted
under Section 2.01, as follows:
(a) If at any time from the date of this Agreement through the end of
Agreement Year Five a Change of Control of XXXXXX-XXXXXXX shall occur,
XXXXXX-XXXXXXX shall have the right to terminate PFIZER's co-promotion
rights under Section 2.01 on a Country-by-Country basis as follows: (i)
XXXXXX-XXXXXXX shall give to PFIZER notice of XXXXXX-XXXXXXX'x intent to
terminate such co-promotion rights ("Termination Notice A"), (ii)
Termination Notice A shall specify for each affected Country a date for
such termination of co-promotion rights which date shall be not less than
twelve (12) months after the date of Termination Notice A, (iii) in no
event shall the date for termination of such co-promotion rights be earlier
than the first day of Agreement Year Four in the affected Country, and (iv)
in all cases the date for termination of such co-promotion rights shall be
on the first day of an Agreement Quarter in the affected Country; and
(b) XXXXXX-XXXXXXX shall have the right, at its sole discretion, to
terminate PFIZER's co-promotion rights under Section 2.01 on a Country-by-
Country basis as follows: (i) XXXXXX-XXXXXXX shall give to PFIZER notice of
XXXXXX-XXXXXXX'x intent to terminate such co-promotion rights ("Termination
Notice B"), (ii) Termination Notice B shall specify for each affected
Country a date for such termination of co-promotion rights which date shall
be not less than twelve (12) months after the date of Termination Notice B,
(iii) in no event shall the date for termination of such co-promotion
rights be earlier than the first day of Agreement Year Six in the affected
Country, and (iv) in all cases the date for termination of such co-
promotion rights shall be on the first day of an Agreement Quarter in the
affected Country.
SECTION 14.03. Termination of Agreement.
(a) 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 (provided the date for termination
shall be on the first day of an Agreement Quarter), and upon such
termination, subject to Section 14.05, PFIZER shall have no further rights
to any payments or compensation from XXXXXX-XXXXXXX.
(b) If either XXXXXX-XXXXXXX or PFIZER materially breaches or
defaults in the performance of any of the provisions of this Agreement, 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.
For the purposes of this Section 14.03(b), 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.
(c) 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 14.04. Effects of Termination of Co-Promotion Rights.
(a) Termination by XXXXXX-XXXXXXX under Section 14.02 shall not
release either party from any obligation to pay to the other party any sums
due under Article III in connection with activities completed on or before
the effective date of such termination, but no further sums shall be
payable under Article III except as provided in Sections 14.04 or 14.05.
(b) If PFIZER's co-promotion rights for any Country are terminated by
XXXXXX-XXXXXXX pursuant to Sections 14.02(a) or 14.02(b), XXXXXX-XXXXXXX
shall pay to PFIZER seventy-five percent (75%) of the payment(s) PFIZER
would have received pursuant to Article III through the end of Agreement
Year Ten for such Country. In computing such amounts there shall be
deducted the amounts PFIZER would have owed XXXXXX-XXXXXXX pursuant to
Section 3.01(b) with respect to the remaining Agreement Years had PFIZER's
co-promotion rights not been terminated; provided that PFIZER shall have no
obligations under Section 3.01(b) to actually pay or incur any Product
Expenses after PFIZER's co-promotion rights are terminated under Sections
14.02(a) or 14.02(b). It is understood that payments for each such
remaining Agreement Year shall be based on the actual Net Sales and Product
Expenses, in each case for such Agreement Year as provided in this
Agreement. Moneys shall be payable in the manner and at such times as set
forth in Sections 3.03 and 3.04 for each Agreement Quarter during such
remaining Agreement Years. In addition, XXXXXX-XXXXXXX shall continue to
comply with all its marketing, detailing, promotional and clinical
obligations under this Agreement as if PFIZER had retained its co-promotion
rights. In addition, XXXXXX-XXXXXXX (or such other co-promotion partner as
XXXXXX-XXXXXXX shall appoint) shall assume the marketing, detailing and
promotional obligations that PFIZER would have been responsible for
pursuant to this Agreement had the Agreement not been terminated, and
PFIZER shall have no responsibility therefor.
SECTION 14.05. 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 III
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.
SECTION 14.06. Return of Confidential Information. (a) Subject to
the terms of Section 10.01 and 14.06(b), upon the termination of this
Agreement (or, if earlier, the termination of PFIZER's co-promotion
rights), (i) PFIZER shall within thirty (30) days return to XXXXXX-XXXXXXX
all Samples, Promotional Materials, communications materials, marketing
plans and reports and other tangible XXXXXX-XXXXXXX Confidential
Information provided to PFIZER by or on behalf of XXXXXX-XXXXXXX pursuant
to the terms and intent of this Agreement, and (ii) XXXXXX-XXXXXXX shall
within thirty (30) days return to PFIZER all tangible PFIZER Confidential
Information provided to XXXXXX-XXXXXXX by or on behalf of PFIZER pursuant
to this Agreement.
(b) If PFIZER's co-promotion rights are terminated by XXXXXX-XXXXXXX
pursuant to Section 14.02, then, XXXXXX-XXXXXXX shall reimburse PFIZER for
the Product Expenses incurred by PFIZER pursuant to Section 3.01(b) with
respect to the Samples and Promotional Materials returned to XXXXXX-XXXXXXX
pursuant to Section 14.06(a). This payment shall be made by XXXXXX-XXXXXXX
within sixty (60) days of PFIZER's return of such Samples in accordance
with the terms of Section 14.06(a).
ARTICLE XV - MISCELLANEOUS
SECTION 15.01. 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 15.02. No Solicitation. The parties agree that during the
Term of this Agreement neither party 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 15.03. 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 15.04. 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 15.05. 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 15.06. 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. It is further understood and agreed that each party
shall assign, or otherwise cause to be performed, its obligations under
this Agreement (including, without limitation, obligations of
confidentiality, detailing, payment and promotion) 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 15.07. 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 15.08. 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 15.09. 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 15.10. 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 15.11. Entire Agreement. This Agreement (including Exhibits
A through E hereto), together with the Confidential Disclosure Agreement,
dated March 4, 1996, between XXXXXX-XXXXXXX and PFIZER (the "Confidential
Disclosure Agreement") and the International Collaboration 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. It is agreed that (i) Article X 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 15.12. 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 15.13. 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 this Agreement which shall remain in full force and effect
according to its terms.
SECTION 15.14. 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 either
party hereto.
SECTION 15.15. 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/ Xxxxxx Xxxxxxx
-------------------------- -------------------------------
Name: Xxxxxxxx X.X. xx Xxxx Name: Xxxxxx Xxxxxxx
Title: President and Chief Title: Executive Vice President
