SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
November 16, 1999
Date of Report (Date of earliest event reported)
WARNER-LAMBERT COMPANY
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
1-3608 22-1598912
(Commission File Number) (IRS Employer Identification No.)
201 Tabor Road, Morris Plains, New Jersey 07950-2693
(Address of principal executive offices) (Zip Code)
(973) 540-2895
(Registrant's telephone number, including area code)
Item 5. Other Events.
Pursuant to an understanding between Warner-Lambert Company
("Warner-Lambert") and Pfizer Inc. ("Pfizer") reached on November 15, 1999,
the companies have agreed to release the terms of the following agreements,
each of which is filed as an exhibit to this Form 8-K and each of which is
incorporated herein by reference: (1) Collaboration Agreement, effective as
of June 28, 1996, by and between Warner-Lambert and Pfizer, together with
the following amendments and related agreements: (a) First Amendment to
Collaboration Agreement, dated as of February 28, 1997, by and between
Warner-Lambert and Pfizer; (b) Letter Agreement, dated as of May 22, 1997,
by and between Warner-Lambert and Pfizer; (c) Letter Agreement, dated as of
May 14, 1998, by and between Warner-Lambert and Pfizer; (d) Second
Amendment to Collaboration Agreement, dated as of June 30, 1999, by and
between Warner-Lambert and Pfizer; and (e) Confidential Disclosure
Agreement, dated as of March 4, 1996, by and between Warner-Lambert and
Pfizer; (2) Option Agreement, effective as of June 28, 1996, by and between
Warner-Lambert and Pfizer; (3) International Collaboration Agreement,
effective as of June 28, 1996, by and between Warner-Lambert and Pfizer,
together with the following amendments: (a) Amendment, dated as of May 27,
1997, by and between Warner-Lambert Export Limited ("W-L Export") and
Pfizer Overseas, Inc. ("Pfizer Overseas") and (b) Amendment, dated as of
January 16, 1998, by and between W-L Export and Pfizer Overseas; (4)
International Co-Promotion Agreement, effective as of June 28, 1996, by and
between Warner-Lambert and Pfizer, together with the following amendments
and waivers: (a) Amendment and Waiver, dated as of December 4, 1997, by and
between W-L Export and Pfizer Overseas; (b) Amendment, dated as of January
16, 1998, by and between W-L Export and Pfizer Overseas; (c) Waiver and
Consent, dated as of May 13, 1998, by and between W-L Export and Pfizer
Overseas; and (d) Amendment, dated as of December 1, 1998, by and between
W-L Export and Pfizer Overseas; and (5) International License Agreement,
effective as of June 28, 1996, by and between Warner-Lambert and Pfizer,
together with the following amendments: (a) Amendment, dated as of May 27,
1997, by and between W-L Export and Pfizer Overseas; (b) Amendment, dated
as of April 22, 1998, by and between W-L Export and Pfizer Overseas; and
(c) Amendment and Waiver, dated as of December 1, 1998, by and between W-L
Export and Pfizer Overseas.
Item 7. Financial Statements and Exhibits.
(c) The following exhibits are filed with this report:
(99.1) Collaboration Agreement, effective as of June 28, 1996,
by and between Warner-Lambert Company and Pfizer Inc.
(99.1.1) First Amendment to Collaboration Agreement, dated as of
February 28, 1997, by and between Warner-Lambert Company and
Pfizer Inc.
(99.1.2) Letter Agreement, dated as of May 22, 1997, by and between
Warner-Lambert Company and Pfizer Inc.
(99.1.3) Letter Agreement, dated as of May 14, 1998, by and between
Warner-Lambert Company and Pfizer Inc.
(99.1.4) Second Amendment to Collaboration Agreement, dated as of
June 30, 1999, by and between Warner-Lambert Company and
Pfizer Inc.
(99.1.5) Confidential Disclosure Agreement, dated as of March 4,
1996, by and between Warner-Lambert Company and Pfizer Inc.
(99.2) Option Agreement, effective as of June 28, 1996, by and
between Warner-Lambert Company and Pfizer Inc.
(99.3) International Collaboration Agreement, effective as of
June 28, 1996, by and between Warner-Lambert Company
and Pfizer Inc.
(99.3.1) Amendment, dated as of May 27, 1997, by and between
Warner-Lambert Export Limited and Pfizer Overseas, Inc.
(99.3.2) Amendment, dated as of January 16, 1998, by and between
Warner-Lambert Export Limited and Pfizer Overseas, Inc.
(99.4) International Co-Promotion Agreement, effective as of
June 28, 1996, by and between Warner-Lambert Company
and Pfizer Inc.
(99.4.1) Amendment and Waiver, dated as of December 4, 1997, by and
between Warner-Lambert Export Limited and Pfizer Overseas
Inc.
(99.4.2) Amendment, dated as of January 16, 1998, by and between
Warner-Lambert Export Limited and Pfizer Overseas Inc.
(99.4.3) Waiver and Consent, dated as of May 13, 1998, by and between
Warner-Lambert Export Limited and Pfizer Overseas Inc.
(99.4.4) Amendment, dated as of December 1, 1998, by and between
Warner-Lambert Export Limited and Pfizer Overseas Inc.
(99.5) International License Agreement, effective as of June
28, 1996, by and between Warner-Lambert Company and
Pfizer Inc.
(99.5.1) Amendment, dated as of May 27, 1997, by and between
Warner-Lambert Export Limited and Pfizer Overseas Inc.
(99.5.2) Amendment, dated as of April 22, 1998, by and between
Warner-Lambert Export Limited and Pfizer Overseas Inc.
(99.5.3) Amendment and Waiver, dated as of December 1, 1998, by and
between Warner-Lambert Export Limited and Pfizer Overseas
Inc.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
WARNER-LAMBERT COMPANY
By: /s/ Rae G. Paltiel
---------------------------------
Name: Rae G. Paltiel
Title: Secretary
Dated: November 16, 1999
EXHIBIT INDEX
(99.1) Collaboration Agreement, effective as of June 28, 1996,
by and between Warner-Lambert Company and Pfizer Inc.
(99.1.1) First Amendment to Collaboration Agreement, dated as of
February 28, 1997, by and between Warner-Lambert Company and
Pfizer Inc.
(99.1.2) Letter Agreement, dated as of May 22, 1997, by and between
Warner-Lambert Company and Pfizer Inc.
(99.1.3) Letter Agreement, dated as of May 14, 1998, by and between
Warner-Lambert Company and Pfizer Inc.
(99.1.4) Second Amendment to Collaboration Agreement, dated as of
June 30, 1999, by and between Warner-Lambert Company and
Pfizer Inc.
(99.1.5) Confidential Disclosure Agreement, dated as of March 4,
1996, by and between Warner-Lambert Company and Pfizer Inc.
(99.2) Option Agreement, effective as of June 28, 1996, by and
between Warner-Lambert Company and Pfizer Inc.
(99.3) International Collaboration Agreement, effective as of
June 28, 1996, by and between Warner-Lambert Company
and Pfizer Inc.
(99.3.1) Amendment, dated as of May 27, 1997, by and between
Warner-Lambert Export Limited and Pfizer Overseas Inc.
(99.3.2) Amendment, dated as of January 16, 1998, by and between
Warner-Lambert Export Limited and Pfizer Overseas Inc.
(99.4) International Co-Promotion Agreement, effective as of
June 28, 1996, by and between Warner-Lambert Company
and Pfizer Inc.
(99.4.1) Amendment and Waiver, dated as of December 4, 1997, by
and between Warner-Lambert Export Limited and Pfizer
Overseas Inc.
(99.4.2) Amendment, dated as of January 16, 1998, by and between
Warner-Lambert Export Limited and Pfizer Overseas Inc.
(99.4.3) Waiver and Consent, dated as of May 13, 1998, by and between
Warner-Lambert Export Limited and Pfizer Overseas Inc.
(99.4.4) Amendment, dated as of December 1, 1998, by and between
Warner-Lambert Export Limited and Pfizer Overseas Inc.
(99.5) International License Agreement, effective as of June
28, 1996, by and between Warner-Lambert Company and
Pfizer Inc.
(99.5.1) Amendment, dated as of May 27, 1997, by and between
Warner-Lambert Export Limited and Pfizer Overseas Inc.
(99.5.2) Amendment, dated as of April 22, 1998, by and between
Warner-Lambert Export Limited and Pfizer Overseas Inc.
(99.5.3) Amendment and Waiver, dated as of December 1, 1998, by and
between Warner-Lambert Export Limited and Pfizer Overseas
Inc.
[EXHIBIT 99.1]
COLLABORATION AGREEMENT
This Agreement, effective as of June 28, 1996, is made by and
between WARNER-LAMBERT COMPANY, a Delaware corporation (hereinafter
"WARNER-LAMBERT"), with primary offices located at 201 Tabor Road, Morris
Plains, New Jersey 07950, by and through its Parke-Davis Division, and
PFIZER INC., a Delaware corporation (hereinafter "PFIZER"), with primary
offices located at 235 East 42nd Street, New York, NY 10017-5755.
WHEREAS, WARNER-LAMBERT and its Affiliates (as hereinafter
defined) own all right, title and interest in and to the Patents (as
hereinafter defined); and
WHEREAS, WARNER-LAMBERT intends to file with the United States
Food and Drug Administration (hereinafter "FDA") a New Drug Application
(hereinafter "NDA") which will permit WARNER-LAMBERT to market, distribute
and sell a Product (as hereinafter defined) in the United States; and
WHEREAS, WARNER-LAMBERT believes that a collaboration arrangement
with PFIZER regarding the Products under the terms set forth in this
Agreement would be desirable and fully compatible with WARNER-LAMBERT's
marketing and business objectives; and
WHEREAS, PFIZER has significant experience in the development,
marketing and promotion of pharmaceutical products and believes it can make
significant contributions to the successful development and
commercialization of the Products; and
WHEREAS, WARNER-LAMBERT and PFIZER each desire to collaborate
with the other in the development and marketing of the Products in the
United States pursuant to the terms set forth in this Agreement.
NOW, THEREFORE, for and in consideration of the foregoing and the
representations, covenants and agreements contained herein, WARNER-LAMBERT
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" shall mean 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, associated with the
use of Atorvastatin or any Product.
"Affiliate" shall mean any Person that directly or indirectly
controls or is controlled by or is under common control with WARNER-LAMBERT
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" shall mean 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 last day of Agreement Year Ten.
"Agreement Year One" shall mean 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" shall mean 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 shall mean the successive twelve-month periods thereafter; and
"Agreement Year Ten" shall mean the period commencing on the first day
following the expiration of Agreement Year Nine and expiring on the day
which is twelve months from the end of Agreement Year Nine less the number
of days equal to one-half of the Stub Period (as defined in Section 3.06).
"Agreement Years" shall mean the period commencing on the Launch
Date and ending on the last day of Agreement Year Ten.
"Atorvastatin" shall mean the chemical compound [R-(R*,R*)]-2-(4-
fluorophenyl)-b, d-dihydroxy-5-(l-methylethyl)-3-phenyl-4-[(phenylamino)
carbonyl] 1 H-pyrrole-1-heptanoic acid, calcium salt (2:1) and hydrates
thereof.
"Baseline Sales" shall mean the amount per Agreement Year as set
forth on Exhibit A, as adjusted pursuant to Section 3.06.
"Change in Control" shall mean an event where:
(A) any Person(s) acquire beneficial ownership of capital stock
of WARNER-LAMBERT entitling the holder(s) thereof to at least
fifty-one percent (51%) of the voting power of the then outstanding
capital stock of WARNER-LAMBERT with respect to the election of
directors of WARNER-LAMBERT, or
(B) WARNER-LAMBERT enters into a merger, consolidation or
similar transaction with another Person (the "Acquiring Corporation")
in which (i) WARNER-LAMBERT is not the surviving corporation in such
transaction, (ii) the members of the Board of Directors of
WARNER-LAMBERT 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) WARNER-LAMBERT sells to any Person(s) in one or more related
transactions, properties or assets representing at least fifty-one
percent (51%) of (i) WARNER-LAMBERT's 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 WARNER-LAMBERT's
pharmaceutical business are included in such transaction(s) and (ii)
WARNER-LAMBERT's consolidated operating income for the most recent
fiscal year as reflected on its most recent Annual Report on Form
10-K.
"Clinical Development Plan" shall mean an annual clinical
development plan and budget for the Product Lifecycle Plan Studies, as
provided in Exhibit D and as determined or varied in accordance with the
provisions of Section 4.01.
"Competing Products" shall mean 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" shall mean (i) for WARNER-LAMBERT, all
PFIZER Confidential Information and (ii) for PFIZER, all WARNER-LAMBERT
Confidential Information.
"Detail" shall mean a face-to-face contact (including a live
video presentation) of either a WARNER-LAMBERT or PFIZER sales
representative (or their respective designees in accordance with Section
2.02(f)), as the case may be, with (i) a medical professional with
prescribing authority or (ii) an office nurse with influence over the
pharmaceutical treatment of a patient 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 in the case of (ii)
above, such contacts are prearranged with the applicable office nurses and
such contacts do not exceed five percent (5%) of the Details performed by
the applicable party during any Agreement Year; provided, further, that
during the first six (6) months after the Launch Date, only a Primary
Product Presentation shall constitute a Detail. With respect to certain
group or institutional Product presentations, Exhibit B sets forth how such
presentations will be counted for determination of the number of Details.
"FD&C Act" shall mean the Federal Food, Drug and Cosmetic Act, as
amended, and all applicable regulations thereunder.
"Governmental or Regulatory Authority" shall mean any court,
tribunal, arbitrator, agency, commission, official or other instrumentality
of any federal, state, county, city or other political subdivision,
domestic or foreign.
"Launch Date" shall mean the date on which the first Product is
first shipped in commercial quantities from WARNER-LAMBERT's distribution
centers for commercial sale to unaffiliated third parties in the Territory,
as promptly notified to PFIZER by WARNER-LAMBERT.
"Laws" shall mean all laws, statutes, rules, regulations,
ordinances and other pronouncements having the effect of law of any
government or Governmental or Regulatory Authority.
"Losses" shall mean any and all damages, fines, fees, penalties,
judgments, deficiencies, losses and expenses (including without limitation
interest, court costs, reasonable fees of attorneys, accountants and other
experts or other expenses of litigation or other proceedings or of any
claim, default or assessment).
"Marketing Plan" shall mean an annual plan and budget for the
promotion and marketing of the Products consistent with the provisions of
Articles II, IV and V and as may be determined or varied in accordance with
the provisions of Section 4.01.
"Net Sales" shall mean the aggregate sales of WARNER-LAMBERT and
its Affiliates of Products to unaffiliated third parties in the Territory
(but not including sales between WARNER-LAMBERT 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 Federal or state
Medicaid, Medicare or similar program, all as determined in accordance with
generally accepted accounting principles on a basis consistent with
WARNER-LAMBERT's audited financial statements.
"Patents" shall mean those patents identified in, and the patents
issuing from the applications listed in, Exhibit C.
"Person" shall mean any natural person, corporation, general
partnership, limited partnership, joint venture, proprietorship or other
business organization.
"PFIZER Confidential Information" shall mean 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 WARNER-LAMBERT 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.
"Primary Product Presentation" shall mean 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" shall mean (a) all out-of-pocket costs and
expenses incurred (i.e. paid to third parties or accrued therefor) by
WARNER-LAMBERT or PFIZER (other than costs and expenses incurred for the
services of a contract sales force) 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) Product Lifecycle Plan Studies, including,
without limitation, those Product Lifecycle Plan Studies commencing prior
to April 15, 1996 (but only with respect to expenses incurred for such
studies after April 15, 1996) and any fees paid to clinical research
organizations in connection with any Product Lifecycle Plan Study, and (iv)
supplementary submissions to Governmental or Regulatory Authorities,
including, without limitation, consultant fees and advisory committee
meetings relating to such submissions, except as otherwise provided in
Section 14.03(e); provided, however, such out-of-pocket costs and expenses
from April 15, 1996 through June 30, 1996 shall not be in excess of
$6,000,000, and (b) all costs and direct expenses of WARNER-LAMBERT and
PFIZER relating to the supply of Samples (as determined in accordance with
Section 5.02(b)) and the distribution of Samples.
"Product Lifecycle Plan Studies" shall mean clinical,
preclinical, epidemiological modeling, and pharmacoeconomic studies that
are designed to support marketing, publications, future labeling changes or
new indications of Atorvastatin or the Products (in the case of combination
Products, relating to (a) lipid lowering and the treatment or prevention of
atherosclerosis or (b) the treatment or prevention of vascular disease)
and, in each case, which are not included with the primary filing of the
NDA to support initial registration of the first Product, as outlined in
Exhibit D.
"Products" shall mean 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
WARNER-LAMBERT in the Territory during the Agreement Years.
"Quarterly Baseline Sales" shall mean for each Agreement Quarter,
one-fourth of the Baseline Sales for the applicable Agreement Year.
"Secondary Product Presentation" shall mean 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" shall mean 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.
"Territory" shall mean the United States of America (including
its military bases and commissaries wherever located and excluding its
territories and possessions).
"Term of this Agreement" shall mean 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.
"WARNER-LAMBERT Confidential Information" shall mean 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 WARNER-LAMBERT 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 WARNER-LAMBERT, 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 any gender include each 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, WARNER- LAMBERT grants to PFIZER the exclusive right, together
with WARNER-LAMBERT, to promote and detail Products in the Territory
pursuant to the terms of this Agreement. Subject to the provisions of
Section 2.02(f), so long as PFIZER's rights of co-promotion under this
Section 2.01 shall remain in effect, WARNER-LAMBERT shall not grant any
rights to, or permit or authorize any third party (other than a
WARNER-LAMBERT Affiliate) to sell Products in the Territory (other than
wholesalers and other third parties in the chain of distribution), or to
promote or detail Products in the 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 WARNER-LAMBERT shall deploy such of
their respective sales forces in an effort to promote effectively and
detail the Products in the Territory in accordance with the terms of this
Agreement and the relevant Marketing Plan. In conducting such promotion and
detailing both PFIZER and WARNER-LAMBERT 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.
(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 Territory. It is the
intention of the parties that during the first seven (7) Agreement Years
each of WARNER- LAMBERT 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, and
during Agreement Years Eight through Agreement Year Ten such efforts and
resources shall be 35% for PFIZER and 65% for WARNER-LAMBERT. 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 of the first seven (7) Agreement Years,
each of PFIZER and WARNER-LAMBERT 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. With respect
to each of Agreement Years Eight through Ten, PFIZER shall be responsible
for performing a number of Details equal to thirty-five percent (35%) of
the Details called for in the Marketing Plan then in effect for such
Agreement Year, and WARNER-LAMBERT shall be responsible for performing
sixty-five percent (65%) of the Details called for in such Marketing Plan.
(d) Subject to the terms of Section 2.02(e), (i) the
Marketing Plans for Agreement Years One through Five shall obligate both
parties together to perform a total of one million (1,000,000) Details for
each such Agreement Year, and (ii) the Marketing Plans for Agreement Years
Six through Ten shall obligate both parties together to perform a total of
nine hundred thousand (900,000) Details for each such Agreement Year,
provided, if PFIZER's co-promotion rights have been terminated pursuant to
Sections 14.02(a) or 14.02(b), then the number of required Details to be
included in the Marketing Plans for each of the remaining Agreement Years
shall be the lesser of (i) the number of Details in the Marketing Plan for
the last Agreement Year in which PFIZER was co-promoting the Product
hereunder and (ii) 1,000,000 (for Agreement Years One through Five) or
900,000 (for Agreement Years Six through Ten).
(e) The number of Details set forth in Section 2.02(d) may
be adjusted by the Operating Committee, the Executive Committee or
WARNER-LAMBERT pursuant to the terms of Section 4.01; provided that
WARNER-LAMBERT shall not unilaterally increase or decrease such number of
Details during any Agreement Year by more than twenty-five percent (25%)
without the prior consent of PFIZER.
(f) Upon notice to the other party, WARNER-LAMBERT 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, after such time as WARNER-LAMBERT terminates
PFIZER's copromotion rights under Sections 14.02(a) or 14.02(b), in no
event shall WARNER-LAMBERT be permitted to use a contract sales force
(without PFIZER's prior consent) to perform a number of Details greater
than such number of Details performed by a contract sales force for
WARNER-LAMBERT prior to termination of PFIZER's copromotion rights.
Furthermore, in no event shall WARNER-LAMBERT increase 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 pursuant to Sections 14.02(a) or 14.02(b).
SECTION 2.03. Detailing Reports.
(a) During the first Agreement Quarter of Agreement Year
One, each party shall provide to the other both a preliminary and final
report of the number of Details carried out by its representatives during
each week in such Agreement Quarter. Preliminary reports shall be delivered
to the other party no later than two weeks after the end of the applicable
week in such Agreement Quarter and final reports shall be delivered no
later than six weeks after the end of the applicable week.
(b) Commencing with the second Agreement Quarter and
continuing until the expiration of Agreement Year Two, each party shall
provide to the other party both a preliminary and final report of the
number of Details carried out by its representatives during each month.
Preliminary reports shall be delivered to the other party no later than two
weeks after the end of the applicable calendar month and final reports
shall be delivered no later than six weeks after the end of the applicable
calendar month.
(c) Commencing with the first Agreement Quarter in
Agreement Year Three and continuing during the remaining Agreement Years,
each party shall provide to the other party a report of the number of
Details carried out by its representatives during each Agreement Quarter.
Preliminary reports shall be delivered to the other party within two weeks
of the end of the applicable Agreement Quarter and final reports shall be
delivered six weeks after the end of the applicable Agreement Quarter.
SECTION 2.04. Development of Products; Regulatory Approvals.
(a) WARNER-LAMBERT shall exercise reasonable efforts to
obtain, as soon as reasonably practicable, the approval by FDA of an NDA
for a Product with a package insert that is materially equivalent to the
provisions of Exhibit E-2.
(b) WARNER-LAMBERT shall be entitled at any time to cease
permanently the sale of any Product in the Territory if continued sale of
such Product would be in violation of Laws or if WARNER-LAMBERT in good
faith believes that it has an ethically valid reason therefor based on
medical or scientific problems concerning such Product.
(c) WARNER-LAMBERT shall be under no liability whatsoever
to compensate PFIZER or make any other payment to PFIZER if (i) the FDA,
for any reason, does not approve any NDA or supplement, (ii) the approved
package insert for the first Product is not materially equivalent to the
provisions of Exhibit E-2, or (iii) if WARNER-LAMBERT 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
approve by FDA or such cessation of sale shall not be the result of any
breach of this Agreement by WARNER-LAMBERT.
(d) Subject to the performance of, or compliance with,
their respective obligations as set forth in this Agreement, neither party
shall have any liability to the other party, whether in respect of any
amounts which might have been earned but are not earned by the other party
pursuant to this Agreement, or for any costs or expenses of any nature
incurred by the other party in anticipation of any amounts which might have
been earned by such other party pursuant to this Agreement but are not
earned, if for any reason, other than a breach of this Agreement, Net Sales
of the Products in the Territory during any of the Agreement Years do not
reach the Baseline Sales for such Agreement Year or any other level.
SECTION 2.05. Trademarks, etc.
(a) The Products shall be promoted and sold under
trademark(s) selected by WARNER-LAMBERT in its sole discretion and owned by
WARNER-LAMBERT 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
WARNER-LAMBERT or any of its Affiliates and relating to any Product.
(c) PFIZER is the owner of the PFIZER logo set forth on
Exhibit F (the "PFIZER Logo"). PFIZER grants WARNER-LAMBERT the right to
use the PFIZER Logo on labeling, package inserts 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 and inserts 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 U.S. Marketing Subcommittee thereof). WARNER-LAMBERT 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), WARNER-LAMBERT 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. Product Lifecycle Plan Studies. All data,
inventions and discoveries generated during the course of any Product
Lifecycle Plan Study, whether such study is sponsored and/or conducted by
PFIZER or WARNER-LAMBERT, shall be the joint property of WARNER-LAMBERT and
PFIZER, and each party shall have the right to use such data, inventions
and discoveries free of charge during and after the Term of this Agreement.
The parties agree to execute any documents or undertake any further actions
as may be reasonably necessary to effectuate the foregoing. Nothing in this
Section 2.06 shall be deemed to amend or modify the covenants and
agreements set forth in Sections 2.05(b), 2.08, 6.02 and 10.01.
SECTION 2.07. Joint Development Program. The parties will
undertake a joint development program (the "Program") to develop additional
indications and clinical information regarding the Products. The Program
will consist of the Product Lifecycle Plan Studies. The Program will be
managed by the Research Subcommittee pursuant to the provisions of Section
4.01. WARNER-LAMBERT and PFIZER shall be responsible for the expenses of
the Program pursuant to the applicable provisions of Sections 3.01 and
3.02(a). The parties shall have such rights regarding data, inventions and
discoveries generated from the Program as set forth in Section 2.06.
SECTION 2.08. Non-Compete. During the Term of this Agreement and
for two (2) years thereafter, neither PFIZER nor WARNER-LAMBERT (nor their
respective Affiliates or licensees) shall, directly or indirectly, market,
sell, detail, promote or distribute any Competing Products in any part of
the 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 shall pay to WARNER-LAMBERT One Hundred
Forty-five Million Dollars ($145,000,000) as follows: (i) Twenty Million
Dollars ($20,000,000) upon signing of this Agreement, (ii) Twenty Million
Dollars ($20,000,000) within three business days of PFIZER's receipt of
notice from WARNER-LAMBERT of the acceptance for filing by FDA of an NDA
for a Product which NDA provides for intended uses materially equivalent to
those provided for in Exhibit E-1, and (iii) One Hundred Five Million
Dollars ($105,000,000) within three business days of PFIZER's receipt of
notice from WARNER- LAMBERT of FDA approval of an NDA for the Product which
includes an approved package insert materially equivalent to that provided
in Exhibit E-2. Such payments shall be made in accordance with the terms of
Section 3.04.
(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 for (i) fifty percent (50%) of all Product Expenses until
the expiration of Agreement Year Seven and (ii) thirty-five percent (35%)
of all Product Expenses in Agreement Years Eight through the expiration of
Agreement Year Ten. 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. WARNER-LAMBERT Payments. Subject to the other
provisions of this Agreement, WARNER-LAMBERT agrees that:
(a) WARNER-LAMBERT shall be responsible for (i) fifty
percent (50%) of all Product Expenses until the expiration of Agreement
Year Seven and (ii) sixty five percent (65%) of all Product Expenses in
Agreement Years Eight through the expiration of Agreement Year Ten.
WARNER-LAMBERT shall pay its share of Product Expenses in accordance with
the terms set forth in Sections 3.03 and 3.04.
(b) For Agreement Years One through Agreement Year Seven,
WARNER-LAMBERT shall pay to PFIZER an amount equal to: (i) 13.35% of Net
Sales up to fifty percent (50%) of the Baseline Sales for the applicable
Agreement Year, (ii) 31.15% of Net Sales in excess of fifty percent (50%)
of the Baseline Sales for each such Agreement Year up to one hundred
percent (100%) of the applicable Baseline Sales, and (iii) 44.50% of Net
Sales in excess of the Baseline Sales for each such Agreement Year; and
(c) For Agreement Year Eight, WARNER-LAMBERT shall pay to
PFIZER an amount equal to: (i) 13.35% of Net Sales up to fifty percent
(50%) of the Baseline Sales for Agreement Year Eight, (ii) 22.25% of Net
Sales in excess of fifty percent (50%) of the Baseline Sales for Agreement
Year Eight up to one hundred percent (100%) of the Baseline Sales for
Agreement Year Eight, and (iii) 31.15% of Net Sales in excess of the
Baseline Sales for Agreement Year Eight; and
(d) For Agreement Year Nine, WARNER-LAMBERT shall pay to
PFIZER an amount equal to: (i) 13.35% of Net Sales up to one hundred
percent (100%) of the Baseline Sales for Agreement Year Nine, and (ii)
31.15% of Net Sales in excess of the Baseline Sales for Agreement Year
Nine; and
(e) For Agreement Year Ten, WARNER-LAMBERT shall pay to
PFIZER an amount equal to: (i) 8.90% of Net Sales up to one hundred percent
(100%) of the Baseline Sales for Agreement Year Ten, and (ii) 31.15% of Net
Sales in excess of the Baseline Sales for Agreement Year Ten.
(f) Solely by way of illustration, Exhibit G sets forth the
application of the above subsections (b) through (e).
(g) In the event that PFIZER obtains any co-promotion
rights to any combination Atorvastatin product included as a Product
pursuant to this Agreement, the parties shall meet to discuss in good faith
any appropriate amendments to the terms of subsections (b) through (e) to
reflect any increased manufacturing or other direct costs or third party
royalties associated with such new Product.
SECTION 3.03. Payments; Payment Reports.
(a) WARNER-LAMBERT shall make payments to PFIZER arising
under Section 3.02 (subsections (b) through (e)) on a quarterly basis as
follows: For the first three Agreement Quarters in any Agreement Year,
payment shall be calculated in accordance with the applicable formula set
forth in Section 3.02 (subsections (b) through (e)) by comparing Net Sales
in each such Agreement Quarter against the Quarterly Baseline Sales for
such Agreement Quarter. At the expiration of the fourth Agreement Quarter
in each Agreement Year, WARNER-LAMBERT 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 Section 3.02 (subsections (b) through (e)), and (iii) pay
PFIZER the difference between (x) what was paid to PFIZER pursuant to
Section 3.02 (subsections (b) through (e)) for the first three Agreement
Quarters in such Agreement Year and (y) the amount actually due to PFIZER
under Section 3.02 (subsections (b) through (e)) for such Agreement Year;
provided that if the amount paid to PFIZER pursuant to Section 3.02
(subsections (b) through (e)) 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 promptly
repay such excess amount to WARNER-LAMBERT.
(b) PFIZER shall, within thirty (30) days of the end of
each Agreement Quarter (or, prior to the Launch Date, each calendar
quarter), notify WARNER-LAMBERT of the total amount of Product Expenses
incurred by PFIZER and its Affiliates during such Agreement Quarter or
calendar quarter, as the case may be. Furthermore, within thirty (30) days
of the Launch Date, PFIZER shall notify WARNER-LAMBERT 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.
(c) Provided PFIZER has complied with Section 3.03(b),
WARNER-LAMBERT shall, 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, the
amounts paid or accrued by each of WARNER-LAMBERT or PFIZER, and the
amounts, if any, payable by either party to the other in accordance with
Sections 3.01(b) and 3.02(a).
(d) Provided PFIZER has complied with Section 3.03(b),
WARNER-LAMBERT shall, within forty-five (45) days of the receipt of
PFIZER's notice under Section 3.03(b), notify PFIZER of the calculation of
the amount payable to PFIZER or WARNER-LAMBERT, as the case may be,
pursuant to 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 WARNER-LAMBERT
or PFIZER, as the case may be, within ten (10) business days after
notification by WARNER-LAMBERT pursuant to Sections 3.03(c) and 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,
WARNER-LAMBERT shall, within sixty (60) days after the end of each calendar
quarter, notify PFIZER of the calculation of WARNER-LAMBERT's 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 WARNER-LAMBERT, 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, WARNER-LAMBERT shall notify PFIZER of the calculation of
WARNER-LAMBERT's 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 WARNER-LAMBERT, 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 United States dollars by bank wire transfer in
immediately available funds to such bank account in the Territory as each
of PFIZER and WARNER-LAMBERT shall designate. PFIZER shall notify
WARNER-LAMBERT's Assistant Treasurer, Domestic by facsimile transmission
(at 201-540-3930 or such other number as may be communicated to PFIZER by
WARNER-LAMBERT) as to the date and amount of any such wire transfer to
WARNER-LAMBERT one business day prior to such transfer. WARNER-LAMBERT
shall notify PFIZER's Treasurer by facsimile transmission (at 212-573-1133
or such other number as may be communicated to WARNER-LAMBERT by PFIZER) as
to the date and amount of any such wire transfer to PFIZER one business day
prior to such transfer.
SECTION 3.05. Interest on Late Payments. If either
WARNER-LAMBERT 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 rate of interest for 30 day high-grade commercial paper issued
by major corporations effective for the first date on which the payment was
delinquent, calculated on an actual/360 basis, as quoted in The Wall Street
Journal.
SECTION 3.06. Adjustments to Baseline Sales. Upon the
determination of the Launch Date, the parties shall meet to discuss in good
faith appropriate adjustments to the Quarterly Baseline Sales and Baseline
Sales for the Agreement Years to account for any extended stub period
included in the First Agreement Quarter of Agreement Year One as follows:
Upon determining the additional period added to Agreement Year One (the
"Stub Period"), a pro rata portion (based on the Stub Period) of Baseline
Sales for Agreement Year Two shall be subtracted from Baseline Sales for
Agreement Year Two and added to the Baseline Sales for Agreement Year One.
For Agreement Year Two and each succeeding Agreement Year, pro rata
portions (based on the Stub Period) of the Baseline Sales for the
succeeding Agreement Year shall be subtracted from such Agreement Year and
added to the Baseline Sales for the prior Agreement Year through Agreement
Year Nine. Baseline Sales for Agreement Year Ten shall be reduced by
one-half of the pro rata amount of such Baseline Sales that was added to
the Baseline Sales for Agreement Year Nine pursuant to the preceding
sentence. Quarterly Baseline Sales for each Agreement Quarter in the
Agreement Years shall be increased (or decreased for purposes of Agreement
Year Ten) by a pro rata amount of the increase (or decrease) in Baseline
Sales for the applicable Agreement Year.
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 Territory are to use
reasonable efforts to maximize Net Sales and the financial return to the
parties hereunder and to develop and sponsor Product Lifecycle Plan Studies
during the period of time WARNER-LAMBERT 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 Territory.
Exhibit K hereto sets forth a chart depicting the organization and
structure the parties have adopted to implement the cooperation between the
parties.
(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 and in
Exhibit K. The Operating Committee shall consist of an
equal number of senior sales and marketing managers and
senior research and development managers of each party,
chaired by a senior sales and marketing manager of
WARNER-LAMBERT, shall review the activities of the U.S.
Marketing Subcommittee, the Research Subcommittee 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 U.S. Marketing Subcommittee comprising an equal
number of senior sales and marketing managers of each
party and two senior research and development managers
of each party, chaired by a senior sales and marketing
manager of WARNER-LAMBERT, which shall operate by
consensus between the parties, and shall meet at least
quarterly to: (a) develop and discuss strategies for
the detailing and marketing of the Product in the
Territory, including allocation of responsibility for
marketing activities, (b) develop and agree upon
contracting strategies and procedures as provided in
Exhibit L, (c) prepare and review Marketing Plans
(including the budget for advertising, promotional and
detailing activities and sampling strategies)
consistent with the provisions of Exhibits H and I and
Articles II, IV and V, (d) review progress against the
current Marketing Plan, (e) review progress of
marketing expenditures in an Agreement Year against the
budget for such activities in the applicable Agreement
Year, (f) review progress of Product sales against the
forecast included in the current Marketing Plan, (g)
review potential amendments to the current Marketing
Plan (including the budget for advertising, promotional
and sampling strategies and the forecast of Product
sales), (h) establish working groups responsible for
the preparation and tactical implementation of the
Marketing Plan, (i) integrate PFIZER colleagues into
existing WARNER-LAMBERT Product teams, (j) make
presentations to the Executive Committee and (k)
undertake all other responsibilities deemed necessary
in connection with the management of the marketing and
sale of the Product in the Territory.
(iii) A Research Subcommittee comprising an equal number of
senior research and development managers of each party
and two senior sales and marketing managers of each
party, chaired by a senior research and development
manager of WARNER-LAMBERT, which shall operate by
consensus between the parties, and shall meet at least
quarterly to: (a) review progress of ongoing Product
Lifecycle Plan Studies, (b) review and approve annual
worldwide Clinical Development Plans (including
budgets) consistent with provisions of Exhibit D,
(c) review clinical expenditures in an Agreement Year
against the budget for such activities in the
applicable Clinical Development Plan, and (d) make
presentations to the Executive Committee.
(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 WARNER-LAMBERT, which shall review
the activities of the Operating Committee, including
the U.S. Marketing Subcommittee and the Research
Subcommittee thereof, 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 WARNER-LAMBERT 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 WARNER-LAMBERT and PFIZER
may reasonably disagree on matters relating to strategies to market, detail
and/or promote the Products in the Territory. The decisions of the
WARNER-LAMBERT 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 decisions shall not be in conflict with other specific
provisions of this Agreement.
(e) Attached hereto as Exhibit H is the Marketing Plan for
all pre-launch educational activities and the Marketing Plan for Agreement
Year One. The U.S. Marketing Subcommittee shall seek to produce Marketing
Plans 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.
(f) Attached hereto as Exhibit I are general parameters for
the annual Marketing Plans for Agreement Years Two through Ten. Each
Marketing Plan shall be consistent with the provisions of such Exhibit I;
provided such Marketing Plans may be adjusted by the Operating Committee
(or the U.S. Marketing Subcommittee thereof), the Executive Committee or
WARNER-LAMBERT pursuant to the terms of Section 4.01. WARNER-LAMBERT shall
not unilaterally increase or decrease any total annual budget amount or the
total annual Sample number included in Exhibit I for a Marketing Plan
without the prior consent of PFIZER (i) by more than twenty-five percent
(25%) for Agreement Years Two through Six, and (ii) by more than fifteen
percent (15%) for Agreement Years Seven through Ten. Subject to the
foregoing and the other provisions of this Agreement, each Marketing Plan
shall stipulate the way in which the Products are to be promoted and
detailed in the Territory during the period to which the Marketing Plan
relates and shall include, inter alia: (i) the number and type of Details
to be performed and strategies relating to such detailing activity, (ii)
contracting strategies and procedures as provided in Exhibit L, (iii) other
advertising and promotional activity to be undertaken, (iv) any training
and/or sampling programs to be conducted, (v) budgets, (vi) disease
management programs to be conducted, (vii) medical education programs to be
conducted, (viii) public relations activities and (ix) such other
activities as may be agreed on by the U.S. Marketing Subcommittee, 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 Development Plan without the prior
approval of the Operating Committee.
(g) All of the committees and subcommittees contemplated in
Exhibit K shall be established within thirty (30) days from 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
Territory.
ARTICLE V
PROMOTIONAL MATERIALS AND SAMPLES
SECTION 5.01. Promotional and Educational Materials.
(a) Subject to the terms of clause (b) below and Section
8.03, during the Term of this Agreement (or the period of time in which
PFIZER retains co-promotion rights under Section 2.01 if shorter) the
Operating Committee 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 WARNER-LAMBERT's and PFIZER's
respective sales forces in accordance with the terms of the Marketing Plans
(the "Promotional Materials") and which shall be subject to
WARNER-LAMBERT's prior approval pursuant to Section 8.03. Subject to the
terms of Section 2.05(c) and this Section 5.01, WARNER-LAMBERT 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 WARNER-LAMBERT to vest title to
such Promotional Materials, copyrights and trademarks in WARNERLAMBERT.
Promotional Materials shall be paid for by the parties as set forth in
Sections 3.01(b) and 3.02(a).
(b) PFIZER and WARNER-LAMBERT 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 WARNER-LAMBERT shall, from time to
time, each notify the other as to the identity of such proprietary
programs. In the event that WARNER-LAMBERT 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 WARNER-LAMBERT pursuant to this Agreement shall be jointly owned
by PFIZER and WARNER-LAMBERT, 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 WARNER-LAMBERT), 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 WARNER-LAMBERT pursuant to Section 8.03.
(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) WARNER-LAMBERT 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 WARNER-LAMBERT shall use Samples
strictly in accordance with the then current Marketing Plan and shall
distribute Samples in full compliance with all applicable Laws, including
the requirements of the Prescription Drug Marketing Act of 1987, as amended
(the "PDM Act"). PFIZER will maintain those records required by the PDM Act
and all other Laws and shall allow representatives of WARNER-LAMBERT to
inspect such records on request. WARNER-LAMBERT shall be solely responsible
for the filing of any necessary reports to FDA in connection with the PDM
Act.
(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 the Territory 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 WARNER-LAMBERT, all remaining Samples provided by
WARNER-LAMBERT and will provide WARNER-LAMBERT 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 the FD&C Act and approval of FDA, WARNER-LAMBERT and PFIZER
shall be given equal exposure and prominence on all Product package
inserts, packaging, Samples and all Promotional Materials used or
distributed 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).
Regarding the Physicians Desk Reference, reference to PFIZER shall be as
set forth in Exhibit J.
ARTICLE VI
INFORMATION CONCERNING THE PRODUCT
SECTION 6.01. Public Statements. PFIZER and WARNER-LAMBERT
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 WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT, provide
WARNER-LAMBERT with details of inquiries received and responses given.
SECTION 6.04. WARNER-LAMBERT Information.
(a) WARNER-LAMBERT shall provide PFIZER with information,
known to WARNER-LAMBERT, 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 WARNER-LAMBERT
pursuant to Section 6.04(a), to WARNER-LAMBERT.
ARTICLE VII
TRAINING
SECTION 7.01. Training Plans. PFIZER and WARNER-LAMBERT 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 WARNER-LAMBERT or unless so required by
Law (and then only pursuant to the terms of this Section 8.01), correspond
or communicate with the FDA or with any other Governmental or Regulatory
Authority, whether within the 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 the FDA or from any other Governmental or
Regulatory Authority relating to Atorvastatin or any Product, forward a
copy or description of the same to WARNER-LAMBERT and respond to all
inquiries by WARNER-LAMBERT relating thereto. If PFIZER is advised by its
counsel that it must communicate with the FDA or with any other
Governmental or Regulatory Authority, then PFIZER shall so advise
WARNER-LAMBERT immediately and, unless the Law prohibits, provide
WARNER-LAMBERT in advance with a copy of any proposed written communication
with the FDA or any other Governmental or Regulatory Authority and comply
with any and all reasonable direction of WARNER-LAMBERT concerning any
meeting or written or oral communication with the FDA or any other
Governmental or Regulatory Authority.
SECTION 8.02. FDA Filings. Subject to the terms of Section 2.04,
upon receipt of the initial NDA approval for a Product, WARNER-LAMBERT
shall have exclusive authority and responsibility to maintain and seek
revisions of the conditions of FDA marketing approval 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
FDA, WARNER-LAMBERT shall provide PFIZER with copies of all final
submissions to the NDA 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 FDA or any other Governmental or Regulatory Authority relating to any
Product or Atorvastatin without the prior consent of WARNER-LAMBERT.
SECTION 8.03. Labeling and Promotional Materials.
WARNER-LAMBERT shall have sole authority and responsibility to seek and/or
obtain any necessary FDA approvals of any label, labeling, package inserts
and packaging, and Promotional Materials used in connection with the
Products, and for determining whether the same requires FDA 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 Operating Committee (or the U.S. Marketing
Subcommittee thereof) and, for purposes of determining compliance with
applicable Laws, WARNER-LAMBERT, pursuant to WARNER-LAMBERT's internal
procedures.
SECTION 8.04. Complaints. Subject to the terms of Section 8.06,
PFIZER shall refer any complaints (including medical complaints) which it
receives concerning any Product or Atorvastatin to WARNER-LAMBERT 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 WARNER-LAMBERT 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, WARNER-LAMBERT meeting its reporting and other obligations to
(i) maintain and update any NDA's for the Products, (ii) report Adverse
Drug Experience Reports and Serious Adverse Drug Experience Reports to the
FDA and/or other Governmental or Regulatory Authorities and (iii) submit or
file Promotional Materials with the FDA. 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, the
FDA or any other 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) receipt of a Warning Letter relating to Atorvastatin or any
of the Products; and
(3) 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
the FD&C Act, PFIZER shall:
(i) notify WARNER-LAMBERT of all Serious Adverse Drug
Experience Reports (including Serious Adverse Drug
Experience Reports occurring in any Product Lifecycle
Plan Study conducted, sponsored or monitored by PFIZER
or WARNER-LAMBERT) 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 WARNER-LAMBERT of all Adverse Drug Experience
Reports (except for Adverse Drug Experience Reports
occurring in a Product Lifecycle Plan Study conducted,
sponsored or monitored by PFIZER or WARNER-LAMBERT)
within ten 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 WARNER-LAMBERT 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 hours (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 WARNER-LAMBERT 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 WARNER-LAMBERT of all Adverse Drug
Experience Reports occurring in any Product Lifecycle Plan Study conducted,
sponsored or monitored by PFIZER when such Product Lifecycle Plan Study is
completed in a study report issued to WARNER-LAMBERT in connection
therewith. Each such final study report shall be provided to WARNER-LAMBERT
within fifteen days of its completion. Except for Adverse Drug Experience
Reports occurring in any Product Lifecycle Plan 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 WARNER-LAMBERT. All follow-up
investigations concerning Adverse Drug Experience Reports and Serious
Adverse Drug Experience Reports occurring during Product Lifecycle Plan
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 WARNER-LAMBERT
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 WARNER-LAMBERT. 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 WARNER-LAMBERT.
(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 WARNER-LAMBERT, and (ii)
WARNER-LAMBERT 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.
(d) Within fourteen (14) days of submission, WARNER-LAMBERT
shall provide PFIZER with copies of all 15 day "Alert Reports" relating to
the Products and submitted to FDA in accordance with 21 C.F.R. 314.80(c)(1)
and all periodic adverse drug experience reports relating to the Products
and submitted in accordance with 21 C.F.R. 314.80(c)(2).
SECTION 8.07. Recalls Or Other Corrective Action.
WARNER-LAMBERT 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. WARNER-LAMBERT shall promptly
notify PFIZER of any such actions taken by WARNER-LAMBERT which are
reasonably likely to result in a material adverse effect on the
marketability of any Product in the Territory. At WARNER-LAMBERT's request,
PFIZER shall provide reasonable assistance to WARNER-LAMBERT 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 WARNER-LAMBERT. WARNER-LAMBERT 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 WARNER-LAMBERT's 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. WARNER-LAMBERT 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
WARNER-LAMBERT (or if directed by WARNER-LAMBERT to WARNER-LAMBERT's
wholesalers) as soon as practicable.
SECTION 9.03. Product Returns. If any quantities of the
Products are returned to PFIZER, PFIZER shall immediately notify
WARNER-LAMBERT and ship them to the facility designated by WARNER-LAMBERT,
with any reasonable or authorized shipping or other documented direct cost
to be paid by WARNER-LAMBERT. PFIZER, at its option, may advise the
customer who made the return that the Products have been returned to
WARNER-LAMBERT, but shall take no other steps in respect of any return
without the consent of WARNER-LAMBERT. All returns of Samples used by the
PFIZER field force shall first be returned to PFIZER which shall ship them
to WARNER-LAMBERT, at WARNER-LAMBERT's expense.
SECTION 9.04. Supply. WARNER-LAMBERT 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, WARNER-LAMBERT shall
maintain inventory of Products (a) for the first two Agreement Quarters of
Agreement Year One, equal to six (6) months (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
(based on the then current Marketing Plan). WARNER-LAMBERT shall establish
appropriate back-up manufacturing facilities and shall be responsible for
obtaining all FDA or other 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 an NDA for a Product, additional back-up manufacturing
facilities are required, PFIZER shall have the option, at its sole cost and
expense, to request WARNER-LAMBERT 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 WARNER-LAMBERT of the identity of such PFIZER Facilities and the
back-up manufacturing services to be provided promptly after PFIZER has
made this determination. WARNER-LAMBERT 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
WARNER-LAMBERT, WARNER-LAMBERT 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. WARNER-LAMBERT shall be
solely responsible for filing all submissions or other correspondence with
the FDA and/or other Governmental or Regulatory Authorities in connection
with any decision to seek approval of a PFIZER Facility as an additional
back-up manufacturing facility. WARNER-LAMBERT shall also be responsible
for determining technical and other conditions set forth in any supplement
filed with reference to this Section. WARNER-LAMBERT 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), WARNER-LAMBERT shall be unable
to supply on a timely basis (in accordance with WARNER-LAMBERT's normal and
customary practice) at least ninety-three percent (93%) of the orders for
Product in the Territory and provided that such orders are not materially
greater than the forecasted Product requirements included in the then
current Marketing Plan, 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 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 WARNER-LAMBERT failed to supply Product as provided for above.
(b) If such failure to supply continues longer than two
consecutive months, the Agreement Year 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 WARNER-LAMBERT failed to supply Product as
provided for above.
(c) Provided WARNER-LAMBERT's failure to meet its supply
obligations shall not be the result of WARNER-LAMBERT's material breach of
its obligations under this Agreement, then Sections 9.06(a) and (b) set
forth PFIZER's sole remedy in the event WARNER-LAMBERT 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
WARNER-LAMBERT shall keep all Confidential Information from the other with
the same degree of care it maintains the confidentiality of its own
confidential information. Each party shall not use such Confidential
Information for any purpose other than in performance of this Agreement or
disclose the same to any other Person other than to such of its employees,
agents, advisers, representatives, consultants and counsel who have a need
to know such Confidential Information to implement the terms of this
Agreement; provided, however, any such consultants shall be subject to
confidentiality obligations consistent with those provided herein. The
party receiving the Confidential Information (the "Receiving Party") shall
advise any employee, agent, adviser, representative, consultant or counsel
who receives such Confidential Information of the confidential nature
thereof and of the obligations contained in this Agreement relating
thereto, and the Receiving Party shall ensure that all such employees,
agents, advisers, representatives, consultants and counsel comply with such
obligations as if they had been a party hereto. Upon termination of this
Agreement, or earlier if so requested 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 WARNER-LAMBERT
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
REPRESENTATIONS, WARRANTIES, COVENANTS AND
INDEMNIFICATION
SECTION 11.01. WARNER-LAMBERT Representations, Warranties and
Covenants. WARNER-LAMBERT hereby represents, warrants, covenants and
agrees as follows:
(a) WARNER-LAMBERT has the corporate power and authority to
execute and deliver this Agreement and to perform its obligations
hereunder, and the execution, delivery and performance of this Agreement by
WARNER-LAMBERT has been duly and validly authorized and approved by proper
corporate action on the part of WARNER-LAMBERT, and WARNER-LAMBERT has
taken all other action required by law, its certificate of incorporation,
by-laws or any agreement to which it is a party or to which it may be
subject, required to authorize such execution, delivery and performance.
Assuming due authorization, execution and delivery on the part of PFIZER,
this Agreement constitutes a legal, valid and binding obligation of
WARNER-LAMBERT, enforceable against WARNER-LAMBERT in accordance with its
terms, except as the enforceability thereof may be limited by applicable
bankruptcy, insolvency, reorganization or other similar laws of general
application relating to creditors' rights.
(b) As of the date hereof, the execution and delivery of
this Agreement by WARNER-LAMBERT and the performance by WARNER-LAMBERT
contemplated hereunder will not violate any Laws or any order of any court
or other Governmental or Regulatory Authority.
(c) As of the date hereof, neither the execution and
delivery of this Agreement nor the performance hereof by WARNER-LAMBERT
requires WARNER-LAMBERT to obtain any permits, authorizations or consents
from any Governmental or Regulatory Authority (except for FDA approval of
the Products) or from any other Person, and such execution, delivery and
performance will not result in the breach of or give rise to any
termination of any agreement or contract to which WARNER-LAMBERT may be a
party and which relates to the Products.
(d) As of the date hereof, Exhibit C contains a correct and
complete list of all patents and patent applications issued or pending in
the Territory relating to Atorvastatin which are owned by WARNER-LAMBERT or
its Affiliates. All of the Patents issued as of the date hereof (i) are
held of record by WARNER-LAMBERT, (ii) are free and clear of all liens,
encumbrances and other claims, and (iii) are not subject anywhere in the
Territory to any pending cancellation, opposition or reexamination
proceeding or any other proceeding challenging their extent or validity. To
the best of WARNER-LAMBERT's knowledge, all of the Patents issued as of the
date hereof are valid and in full force. WARNER-LAMBERT is the owner of
record of all applications listed on Exhibit C. To the best of
WARNER-LAMBERT's knowledge, the claims included in such applications relate
to patentable subject matter, and WARNER-LAMBERT is not aware of any reason
that such claims would not be allowed to issue.
(e) As of the date hereof, to the best of WARNER-LAMBERT's
knowledge, the manufacture, use or sale of the Products does not infringe
any patents of third parties, and, to the best knowledge of WARNER-LAMBERT,
no third party is infringing in the Territory any of the issued Patents or
any of the claims of the patent applications listed in Exhibit C.
(f) As of the date hereof, there are no actions, suits,
proceedings or claims, pending against WARNER-LAMBERT or any of its
Affiliates, or, to the knowledge of WARNER-LAMBERT, threatened against
WARNER-LAMBERT or any of its Affiliates, at law or in equity, or before or
by any court or Governmental or Regulatory Authority relating to the
Products or any of the matters contemplated under this Agreement. To the
knowledge of WARNER-LAMBERT, there are no investigations, pending or
threatened against WARNER-LAMBERT or any of its Affiliates, at law or in
equity, or before or by any Governmental or Regulatory Authority relating
to the Products or any of the matters contemplated under this Agreement.
(g) WARNER-LAMBERT will exercise reasonable diligence to
ensure that the Product NDA to be filed with the FDA and all amendments
thereto will be prepared in accordance with all applicable requirements of
the FD&C Act.
(h) WARNER-LAMBERT has heretofore disclosed to PFIZER all
material information known to WARNER-LAMBERT with respect to the safety and
effectiveness of the Products or human risk factors relating thereto.
(i) WARNER-LAMBERT covenants that during the Term of this
Agreement it 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.
(j) WARNER-LAMBERT covenants that Products to be
distributed by WARNER-LAMBERT during the Term of this Agreement will, at
the time of shipment by or on behalf of WARNER-LAMBERT, not be misbranded
or adulterated under the terms of the FD&C Act.
(k) WARNER-LAMBERT acknowledges that PFIZER is relying, and
is entitled to rely, on the foregoing representations, warranties and
covenants.
SECTION 11.02. PFIZER Representations, Warranties and Covenants.
PFIZER hereby represents, warrants, covenants and agrees as follows:
(a) PFIZER has the corporate power and authority to execute
and deliver this Agreement and to perform its obligations hereunder, and
the execution, delivery and performance of this Agreement by PFIZER has
been duly and validly authorized and approved by proper corporate action on
the part of PFIZER, and PFIZER has taken all other action required by law,
its certificate of incorporation, by-laws or any agreement to which it is a
party or to which it may be subject, required to authorize such execution,
delivery and performance. Assuming due authorization, execution and
delivery on the part of WARNER-LAMBERT, this Agreement constitutes a legal,
valid and binding obligation of PFIZER, enforceable against PFIZER in
accordance with its terms, except as the enforceability thereof may be
limited by applicable bankruptcy, insolvency, reorganization or other
similar laws of general application relating to creditors' rights.
(b) As of the date hereof, the execution and delivery of
this Agreement by PFIZER and the performance by PFIZER contemplated
hereunder will not violate any Laws or any order of any court or other
Governmental or Regulatory Authority.
(c) As of the date hereof, neither the execution and
delivery of this Agreement nor the performance hereof by PFIZER requires
PFIZER to obtain any permits, authorizations or consents from any
Governmental or Regulatory Authority or from any other Person, and such
execution, delivery and performance will not result in the breach of or
give rise to any termination of any agreement or contract to which PFIZER
may be a party.
(d) As of the date hereof, there are no actions, suits,
proceedings or claims, pending against PFIZER or any of its Affiliates, or,
to the knowledge of PFIZER, threatened against PFIZER or any of its
Affiliates, at law or in equity, or before or by any court or Governmental
or Regulatory Authority relating to any of the matters contemplated under
this Agreement. To the knowledge of PFIZER, there are no investigations,
pending or threatened against PFIZER or any of its Affiliates, at law or in
equity, or before or by any Governmental or Regulatory Authority relating
to the matters contemplated under this Agreement or which would otherwise
materially adversely affect PFIZER's ability to perform its obligations
hereunder.
(e) PFIZER covenants that during the Term of this Agreement
it 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.
(f) PFIZER acknowledges that WARNER-LAMBERT is relying, and
is entitled to rely, on the foregoing representations, warranties and
covenants.
SECTION 11.03. Indemnification of PFIZER.
(a) WARNER-LAMBERT shall indemnify, defend and hold PFIZER
PARTIES (as hereinafter defined) harmless from and against any and all
Losses incurred, suffered or sustained by PFIZER PARTIES or to which PFIZER
PARTIES become subject, arising out of or resulting from: (i) any third
party claims, actions, suits, proceedings, liabilities or obligations
arising from (a) any misrepresentation or breach of any representation,
warranty or agreement made by WARNER-LAMBERT in this Agreement, (b) any act
or omission of negligence, recklessness or willful misconduct of
WARNER-LAMBERT (including, without limitation, any violation of the FD&C
Act) or (c) the testing, manufacture, distribution, use or sale of the
Products (including, without limitation, any claim for death or bodily
injury or patent or trademark infringement); and (ii) any claim for
indemnification by PFIZER which is wrongfully disputed by WARNER-LAMBERT.
For purposes of this Section 11.03 PFIZER PARTIES means PFIZER and its
Affiliates and their respective agents, directors, officers and employees.
(b) The indemnity in Section 11.03(a) shall not apply to
the extent that any Loss is primarily the result of any breach of this
Agreement by PFIZER or of any act or omission of negligence, recklessness
or willful misconduct of PFIZER PARTIES.
SECTION 11.04. Indemnification of WARNER-LAMBERT.
(a) PFIZER shall indemnify, defend and hold WARNER-LAMBERT
PARTIES (as hereinafter defined) harmless from and against any and all
Losses incurred, suffered or sustained by WARNER-LAMBERT PARTIES or to
which WARNER-LAMBERT PARTIES become subject, arising out of or resulting
from: (i) any third party claims, actions, suits, proceedings, liabilities
or obligations arising from (a) any misrepresentation or breach of any
representation, warranty or agreement made by PFIZER in this Agreement or
(b) any act or omission of negligence, recklessness or willful misconduct
of PFIZER (including, without limitation, any violation of the FD&C Act);
and (ii) any claim for indemnification by WARNER-LAMBERT which is
wrongfully disputed by PFIZER. For purposes of this Section 11.04
WARNER-LAMBERT PARTIES means WARNER-LAMBERT and its Affiliates and their
respective agents, directors, officers and employees.
(b) The indemnity in Section 11.04(a) shall not apply to
the extent that any Loss is primarily the result of any breach of this
Agreement by WARNER-LAMBERT or of any act or omission of negligence,
recklessness or willful misconduct of WARNER-LAMBERT PARTIES.
SECTION 11.05. Procedures. In the event any third party asserts
any claim in respect to any matter to which the indemnification in Sections
11.03 or 11.04 relates, the party against whom the claim is asserted (the
"Indemnified Party") shall not make any admission concerning such claim,
but shall promptly notify the other party (the "Indemnifying Party"), of
the claim, and the Indemnifying Party shall be entitled, but not obliged,
to manage and control, at its sole expense, the defense of the claim and
its settlement. The benefit of any indemnity by the Indemnifying Party
under this Agreement in respect of any claim shall not apply to the
Indemnified Party if any admission made by such party or any failure by
such party to notify the Indemnifying Party of the claim materially
prejudices the defense of such claim. If the Indemnifying Party elects to
defend such claim, it shall give prompt notice to the Indemnified Party. If
the Indemnifying Party does not give such notice and does not proceed
diligently to defend the Indemnified Party within twenty (20) days after
receipt of notice of the claim, the Indemnifying Party shall be bound by
any defense or settlement made by the Indemnified Party and shall reimburse
the Indemnified Party for its Losses and expenses related to the defense or
settlement of the third party claim. If the Indemnifying Party elects to
defend the claim and gives notice to the Indemnified Party and proceeds
diligently to defend the Indemnified Party, then the Indemnified Party
shall not settle any claim for which it is seeking indemnification without
the prior consent of the Indemnifying Party. The Indemnified Party shall,
if requested by the Indemnifying Party, cooperate in all reasonable
respects in the defense of such a third party claim which is being managed
and controlled by the Indemnifying Party. The Indemnified Party may, at its
option and expense, be represented by counsel of its own choice in any
action or proceeding arising out of such claim; provided, however, the
Indemnifying Party shall not be liable for any litigation costs or expenses
incurred, without its consent, by the Indemnified Party where such action
or proceeding is under the control and management of the Indemnifying
Party.
SECTION 11.06. Insurance Proceeds. Any indemnification
hereunder shall be made net of any insurance proceeds recovered by the
Indemnified Party; provided, however, that if, following the payment to the
Indemnified Party of any amount under this Article XI, such Indemnified
Party recovers any insurance proceeds in respect of the claim for which
such indemnification payment was made, the Indemnified Party shall promptly
pay an amount equal to the amount of such proceeds (but not exceeding the
amount of such indemnification payment) to the Indemnifying Party.
SECTION 11.07. 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.
WARNER-LAMBERT shall make adequate filings for, and prosecute and maintain,
all Patents and related applications in the Territory unless WARNER-LAMBERT
reasonably believes that any such Patent or related application is not
material to the matters contemplated in this Agreement. WARNER-LAMBERT
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 WARNER-LAMBERT 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. WARNER-LAMBERT shall file all applications
and take any other actions necessary to obtain patent extensions and
supplementary protection certificates for Patents where available in the
Territory unless WARNER-LAMBERT 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 Territory against PFIZER or any of its Affiliates because of the
manufacture, use or sale of Products, PFIZER shall promptly notify
WARNER-LAMBERT. WARNER-LAMBERT 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 the
Territory that has a Material Adverse Effect (as hereinafter defined) on
the Products, WARNER-LAMBERT shall bring suit and take such other action as
it may determine is reasonably necessary to enjoin, prohibit, or retard
such infringement. PFIZER shall, at WARNER-LAMBERT's request, cooperate in
such suits or actions. Any monetary recovery in connection with such
infringement action shall first be applied to reimburse WARNER-LAMBERT and
to the extent requested by WARNER-LAMBERT, PFIZER, for their out-of-pocket
expenses (including reasonable attorneys' fees) in prosecuting such
infringement, and WARNER-LAMBERT shall be entitled to the balance of such
recovery. If such recovery is less than such out-of-pocket expenses,
reimbursement shall be on a pro-rata basis. In the event of such a Material
Adverse Effect, the Agreement Year 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 the Territory. For
purposes of this Section 12.02(c), "Material Adverse Effect" shall be
deemed to occur if sales in the Territory of infringing products by such
infringing party equal at least ten percent (10%) of Net Sales in such
Agreement Year. If WARNER-LAMBERT fails to obtain a discontinuance of said
infringement and/or elects not to bring suit against such third party
infringer, WARNER-LAMBERT will give notice to PFIZER of its election not to
bring suit within ten (10) days of such election. PFIZER may, at its
option, (i) obtain a discontinuance of the alleged infringement or (ii)
bring suit against such third party within six (6) months of the date of
receipt by PFIZER of the aforesaid notice. Any suit by PFIZER will be
either in the name of PFIZER or in the name of WARNER-LAMBERT, or jointly
by WARNER-LAMBERT and PFIZER, as may be required by Law. For this purpose,
WARNER-LAMBERT will execute such legal papers necessary for the prosecution
of such suit as may be reasonably requested by PFIZER. If PFIZER does bring
such a suit or action, it shall bear all costs and expenses associated
therewith and will be entitled to keep any and all recoveries.
(d) If any third party shall infringe any of the Patents
and such infringement does not result in a Material Adverse Effect,
WARNER-LAMBERT shall have sole discretion whether or not to bring suit to
enjoin, prohibit, or retard such infringement. WARNER-LAMBERT shall be
solely responsible for all out-of-pocket expenses incurred in connection
with such infringement suits and shall have sole rights to any recoveries
made thereunder. PFIZER shall, at WARNER-LAMBERT's request, cooperate in
such suits or actions.
SECTION 12.03. Trademarks. (a) WARNER-LAMBERT agrees to pursue
and maintain the Trademark and all of its relevant copyrights relating to
the Products in the Territory. WARNER-LAMBERT and PFIZER shall each advise
the other promptly upon its becoming aware of any infringement by a third
party of the Trademark.
(b) WARNER-LAMBERT 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, WARNER-LAMBERT, at WARNER-LAMBERT's expense, in any
investigation or action taken by WARNER-LAMBERT 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 WARNER-LAMBERT or its Affiliate and PFIZER shall not
under any circumstances be entitled to any share of the same.
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 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. WARNER-LAMBERT shall keep
such records of Net Sales and Product Expenses as are necessary to
determine accurately under generally accepted accounting principles the
sums due to PFIZER and WARNER-LAMBERT under this Agreement. PFIZER shall
keep such records of its Product Expenses as are necessary to determine
accurately under generally accepted accounting principles the sums due to
PFIZER and WARNER-LAMBERT 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 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 WARNER-LAMBERT 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 expire on the last day of Agreement Year Ten.
SECTION 14.02. Termination of Co-Promotion Rights.
WARNER-LAMBERT 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 WARNER-LAMBERT shall
occur, WARNER-LAMBERT shall have the right to terminate PFIZER's
co-promotion rights under Section 2.01 as follows: (i) WARNER-LAMBERT shall
give to PFIZER notice of WARNER-LAMBERT's intent to terminate such
co-promotion rights ("Termination Notice A"), (ii) Termination Notice A
shall specify 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,
and (iv) in all cases the date for termination of such co-promotion rights
shall be on the first day of an Agreement Quarter; and
(b) WARNER-LAMBERT shall have the right, at its sole
discretion, to terminate PFIZER's co-promotion rights under Section 2.01 as
follows: (i) WARNER-LAMBERT shall give to PFIZER notice of WARNER-LAMBERT's
intent to terminate such co-promotion rights ("Termination Notice B"), (ii)
Termination Notice B shall specify 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, and (iv) in all cases the date for termination of
such co-promotion rights shall be on the first day of an Agreement Quarter;
and
(c) If Net Sales during Agreement Year Four are less than
sixty-five percent (65%) of the Baseline Sales for Agreement Year Four,
WARNER-LAMBERT shall have the right, at its sole discretion, to terminate
PFIZER's co-promotion rights under Section 2.01 as follows: (i)
WARNER-LAMBERT shall give to PFIZER notice of WARNER-LAMBERT's intent to
terminate such co-promotion rights ("Termination Notice C") which Notice
shall be given on or before the date which is the commencement of the third
Agreement Quarter of Agreement Year Five, and (ii) Termination Notice C
shall specify the last day of Agreement Year Five as the date for such
termination.
SECTION 14.03. Termination of Agreement.
(a) At any time, upon twelve (12) months' notice to
WARNER-LAMBERT, PFIZER shall have the right, 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 WARNER-LAMBERT.
(b) If either WARNER-LAMBERT 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
WARNER-LAMBERT 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.
(d) Between July 1, 1996 and August 31, 1996, PFIZER shall
have the right to review and audit the NDA submission relating to a
Product. WARNER-LAMBERT shall respond to all reasonable inquiries generated
therefrom. Within ten (10) days of completion of such audit, but no later
than September 10, 1996, PFIZER shall have the right, upon prior notice to
WARNER-LAMBERT, to terminate this Agreement if, as a result of such review
and audit, PFIZER determines that the package insert likely to be approved
by FDA will not be materially equivalent to that provided in Exhibit E-2;
provided that such termination notice shall be effective on or before
September 10, 1996; provided further that all amounts paid by PFIZER on or
before such termination date pursuant to Section 3.01(a)(i) and all Product
Expenses paid by PFIZER on or before such termination date shall be
nonrefundable. If PFIZER has paid the amount set forth in Section
3.01(a)(ii), such amount shall be refunded by WARNER-LAMBERT to PFIZER.
(e) If FDA does not approve an NDA for the Product which
includes a package insert materially equivalent to that provided in Exhibit
E-2, the following provisions shall apply:
(i) Within thirty (30) days after such FDA approval
WARNER-LAMBERT shall notify PFIZER whether
WARNER-LAMBERT is agreeable or not to undertaking, at
WARNER-LAMBERT's sole expense, such additional studies
as may be necessary in order to obtain FDA approval for
the Product with a package insert materially equivalent
to that provided in Exhibit E-2; provided that
WARNER-LAMBERT shall have the right at any time, upon
notice to PFIZER, to cease any further activity with
respect to such additional studies.
(ii) Within thirty (30) days of the giving of notice by
WARNER-LAMBERT pursuant to Section 14.03(e)(i) that it
shall undertake such additional studies, PFIZER shall
have the option, by notice to WARNER-LAMBERT, to either
(x) terminate this Agreement, effective the date of
such notice, or (y) to elect to continue this Agreement
to await the results of the additional studies to be
undertaken by WARNER-LAMBERT and the results of any
additional FDA action or approval regarding the
Product; provided the payment of the $105,000,000 by
PFIZER under Section 3.01(a)(iii) shall only be payable
at such time as FDA shall approve an NDA for a Product
which includes an approved package insert materially
equivalent to that provided in Exhibit E-2; provided
further that all amounts paid by PFIZER pursuant to
Section 3.01(a)(i) and 3.01(a)(ii) and all Product
Expenses paid by PFIZER prior to such notification or
PFIZER's termination of the Agreement shall be
nonrefundable. If WARNER-LAMBERT elects to sell a
Product while conducting further clinical studies in
accordance with Section 14.03(e)(i), PFIZER shall have
no co-promotion rights nor obligations with respect to
such Product until such time as it makes the payment of
$105,000,000 pursuant to Section 3.01(a)(iii). It is
understood that the Launch Date shall not be deemed to
have occurred with respect to a Product unless PFIZER
has exercised its rights to such Product as evidenced
by its payment of $105,000,000 pursuant to this Section
14.03(e).
(iii) Within ninety (90) days of the giving of notice by
WARNER-LAMBERT pursuant to Section 14.03(e)(i) that
(x) it shall not undertake such additional studies, or
(y) it shall permanently cease any further activity
with respect to such additional studies, PFIZER shall
either make the payment of $105,000,000 pursuant to
Section 3.01(a)(iii) or this Agreement shall terminate
forthwith; provided, however, that WARNER-LAMBERT shall
not undertake such additional studies or resume any
further activity with respect to such studies for
a fifteen (15) year period thereafter.
SECTION 14.04. Effects of Termination of Co-Promotion Rights.
(a) Termination by WARNER-LAMBERT 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 are terminated by
WARNER-LAMBERT pursuant to Sections 14.02(a) or 14.02(b), WARNER-LAMBERT
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. In computing such amounts there shall be deducted the amounts
PFIZER would have owed WARNER-LAMBERT 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, Product Expenses and the
Baseline Sales, 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, (i) WARNER-LAMBERT 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, and (ii) WARNER-LAMBERT (or such other co-promotion partner as
WARNER-LAMBERT shall appoint) shall assume the marketing, detailing,
promotional and clinical 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.
(c) If PFIZER's co-promotion rights are terminated by
WARNER-LAMBERT pursuant to Section 14.02(c), then, to the extent that the
aggregate payments made by PFIZER pursuant to Sections 3.01(a) and 3.01(b)
are in excess of the aggregate payments made by WARNER-LAMBERT to PFIZER
pursuant to Section 3.02, WARNER-LAMBERT shall pay to PFIZER an amount
equal to one hundred thirty-seven and one-half percent (137.5%) of such
difference. Such amount shall be paid in five (5) equal annual
installments, beginning with the first day of Agreement Year Six. In the
event PFIZER's co-promotion rights are terminated under Section 14.04(c),
neither party shall have continuing obligations regarding supplying,
marketing, promoting, detailing or clinical development of the Products.
Moreover, in no event shall either party have any further obligations under
Article III arising after PFIZER's co-promotion rights have been terminated
under Section 14.02(c).
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 WARNER-LAMBERT
all Samples, Promotional Materials, communications materials, marketing
plans and reports and other tangible WARNER-LAMBERT Confidential
Information provided to PFIZER by or on behalf of WARNER-LAMBERT pursuant
to the terms and intent of this Agreement, and (ii) WARNER-LAMBERT shall
within thirty (30) days return to PFIZER all tangible PFIZER Confidential
Information provided to WARNER-LAMBERT by or on behalf of PFIZER pursuant
to this Agreement.
(b) If PFIZER's co-promotion rights are terminated by
WARNER-LAMBERT pursuant to Section 14.02, then, WARNER-LAMBERT 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 WARNER-LAMBERT pursuant to Section 14.06(a). This payment shall
be made by WARNER-LAMBERT 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 WARNER-LAMBERT 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. Limitation on Liability. Notwithstanding
anything to the contrary contained elsewhere in this Agreement, (but
subject to this Section 15.05), neither party shall be liable to the other
for Losses constituting incidental, indirect or consequential damages for a
cumulative aggregate amount in excess of $50,000,000; provided, however,
notwithstanding the foregoing, each party shall have the right to recover
(and the foregoing limitations contained in this Section 15.05 shall not
apply to): (i) all amounts for which the other party is obligated to pay
pursuant to Article III or Section 14.04 in the event of (x) a breach by
WARNER-LAMBERT of its obligations to make payments pursuant to Section
14.04, or (y) a breach by the other party of its respective obligations to
make payments pursuant to Article III; or (ii) all Losses relating to a
breach by the other party of its respective obligations under Section 11.03
(in the case of WARNER-LAMBERT) or Section 11.04 (in the case of PFIZER)
involving, in any case, the commencement of or assertion of any claim,
action, suit or proceeding by a third party in respect of which indemnity
may be sought under Section 11.03 or Section 11.04, as applicable. It is
agreed that in the event of a breach of this Agreement by WARNER-LAMBERT,
the difference (in no event less than zero), if any between (I) amounts
previously paid to WARNER-LAMBERT by PFIZER pursuant to Section 3.01(a) and
expenses for which PFIZER is responsible pursuant to Section 3.01(b),
together with all internal costs and expenses incurred by PFIZER in
connection with, or in support of, its performance of its obligations under
this Agreement (such as, for example, clinical, marketing, promotional and
field force costs and expenses) and (II) amounts previously paid to PFIZER
pursuant to Sections 3.02 and 14.04, will not be considered as constituting
incidental, indirect or consequential damages.
SECTION 15.06. Choice of Law. 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 15.07. 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) its
Affiliate or Affiliates who shall be substituted directly in whole or in
part for it hereunder; provided however, that the assignor shall be
responsible for the performance of its Affiliate assignee(s) hereunder.
This Agreement shall be binding upon, and subject to the terms of the
foregoing sentence, inure to the benefit of the parties hereto, their
successors, legal representatives and assigns.
SECTION 15.08. 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:
WARNER-LAMBERT:
Warner-Lambert Company
201 Tabor Road
Morris Plains, New Jersey 07950
Attention: President, Pharmaceutical Sector
Facsimile No. 201-540-4009
with a copy to: Vice President and General Counsel
Facsimile No. (201) 540-3927
PFIZER:
Pfizer Inc.
235 East 42nd Street
New York, New York 10017-5755
Attention: President, U.S. Pharmaceutical Group
Facsimile No. (212) 808-8652
with a copy to: Senior Vice President and General Counsel
Facsimile No. (212) 808-8924
or to such other address as the addressee shall have last furnished in
writing in accord with this provision to the addressor.
SECTION 15.09. 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 15.10. 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 15.11. 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 15.12. Entire Agreement. This Agreement (including
Exhibits A through L hereto), together with the Confidential Disclosure
Agreement, dated March 4, 1996, between WARNER-LAMBERT and PFIZER (the
"Confidential Disclosure 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 WARNER-LAMBERT and PFIZER.
SECTION 15.13. 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 15.14. 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. Independent Agreements. WARNER-LAMBERT and
PFIZER have, as of the date hereof, entered into an option Agreement (the
"Option Agreement") under which PFIZER grants to WARNER-LAMBERT 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 WARNER-LAMBERT may not acquire or be granted any rights to any PFIZER
compound under the Option Agreement. WARNER-LAMBERT 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 15.16. 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, WARNER-LAMBERT and PFIZER, by their duly
authorized officers, have executed this Agreement as of the date first
written above.
WARNER-LAMBERT COMPANY PFIZER INC.
/s/ Lodewijk J.R. de Vink /s/ Karen L. Katen
----------------------------- --------------------------------
Lodewijk J.R. de Vink Karen L. Katen
President and Chief Operating Vice President
Officer
[EXHIBIT 99.1.1]
[Letterhead of Pfizer Inc.]
February 28, 1997
Warner-Lambert Company
201 Tabor Road
Morris Plains, New Jersey 07950
Attn: Maurice Renshaw
Corporate Vice President
President, Parke-Davis, U.S. and Mexico
Re: First Amendment to Collaboration Agreement
Dear Mr. Renshaw:
Warner-Lambert Company ("Warner-Lambert") and Pfizer Inc. ("Pfizer")
are parties to a Collaboration Agreement effective as of June 28, 1996 (the
"Collaboration Agreement"). The parties wish to amend the Collaboration
Agreement to reflect (1) certain changes to the definition of Product
Expenses regarding Product Lifecycle Plan Studies and (2) additional
detailing to be performed by Pfizer and Warner-Lambert and the compensation
to be paid to Pfizer in exchange for such additional detailing.
Accordingly, the Collaboration Agreement is hereby amended as follows:
1. The definition of "Product Expenses" is amended to include the
following:
"Product Expenses shall further include certain additional expenses
relating to certain Product Lifecycle Plan Studies identified by the
Operating Committee. With respect to each such agreed-upon Product
Lifecycle Plan Study, the amount to be included as Product Expenses
and thus shared by PFIZER and WARNER-LAMBERT in accordance with the
terms of the Collaboration Agreement shall be the total of (i) all
direct Grant Costs (as hereinafter defined) for such Product Lifecycle
Plan Study, plus (ii) seventy-five percent (75%) of such Grant Costs
("Overhead Costs"). Inclusion of Overhead Costs as Product Expenses
is intended to reimburse the party conducting such Product Lifecycle
Plan Study (the "Conducting Party") for its overhead and internal
resources employed in connection therewith. Notwithstanding the
foregoing, Overhead Costs shall not be included as Product Expenses
for any Product Lifecycle Plan Study from the date that a Conducting
Party initiates the use of a clinical research organization to perform
substantially all clinical monitoring and data management activities
on behalf of the Conducting Party in connection with such Product
Lifecycle Plan Study. With respect to Product Lifecycle Plan Studies
currently ongoing and identified below, Overhead Costs shall be
applied retroactively from April 15, 1996 where applicable, subject to
the $6,000,000 cap on total out-of-pocket expenses from April 15, 1996
through June 30, 1996, as set forth in the definition of Product
Expenses. For purposes of this definition, "Grant Costs" means
out-of-pocket costs related to investigators, investigator meetings
and laboratory grants, but shall not include the costs of clinical
monitoring, data management, programming, biostatistics or report
writing.
The initial Product Lifecycle Plan Studies that PFIZER and
WARNER-LAMBERT intend to be subject to this amendment are the
following:
Ongoing Studies Planned Trials
--------------- --------------
981-53 Usual Care 981-105 Unstable angina (MIRACLE)
981-68 AVERT 981-124 Cerebral Vascular Disease
981-71 NIDDM Intervention Trial
981-69 Pharmacoeconomic
981-70 Treat-to-Target Trials
981-72
2. Section 2.02 of the Collaboration Agreement is amended to insert the
following new subsections:
"(g) In addition to the Details to be performed by PFIZER pursuant to
Section 2.02(d), PFIZER shall perform an additional 500,000 Details
per year for a period of two (2) years commencing no later than May
1997. PFIZER shall use its Pratt sales force to satisfy this
additional detailing obligation. "Pratt Year One" shall mean the
twelve-month period commencing on May 1, 1997; references to Pratt
Years Two through Five shall mean the successive twelve-month periods
thereafter.
(h) In addition to the Details to be performed by WARNER-LAMBERT
pursuant to Section 2.02(d), WARNER-LAMBERT shall utilize an
additional sales force to perform an additional 250,000 Details per
year for each of Agreement Years One through Four."
3. Section 3.02 of the Collaboration Agreement is amended to insert the
following new subsection (h):
"(h) In consideration of the additional Details to be provided by
PFIZER pursuant to Section 2.02(g), PFIZER shall be compensated as
follows:
(i) Subject to any adjustments pursuant to Section 3.02(h)(iii)
and (iv) below, WARNER-LAMBERT shall pay to PFIZER for each of
Pratt Years One and Two an additional 3.5% (the "Pratt
Percentage"), resulting in a total of 48%, of Net Sales in excess
of the Agreement Year Baseline Sales.
(ii) Subject to any adjustments pursuant to Section 3.02(h)(iii)
and (iv) below, WARNER-LAMBERT shall pay to PFIZER for each of
Pratt Years Three, Four and Five an additional percentage of Net
Sales in excess of the Baseline Sales (the "Carryover
Percentage"). The Carryover Percentage shall be calculated as
follows:
Actual number of total additional PFIZER Details
performed during Pratt Years One and Two
------------------------------------------------- x 3.5%
1,000,000
(iii) PFIZER shall perform additional Details in both Pratt
Years One and Two, as set forth in Section 2.02(g), unless each
party, in its sole discretion, agrees in a writing signed by both
parties that PFIZER will not perform any additional Details in
Pratt Year Two. In the event of such an agreement, (a) PFIZER
shall be paid the Pratt Percentage (as defined in Section
3.02(h)(i) above) for Pratt Year One only and shall be paid the
Carryover Percentage (as defined in Section 3.02(h)(ii)
above) for Pratt Years Two, Three and Four only; and (b)
WARNER-LAMBERT shall be required to perform an additional 250,000
Details per year for Agreement Years One and Two only.
(iv) Adjustments to the Pratt Percentage and Carryover Percentage
to be paid with respect to any given Agreement Year shall be made
as follows:
(a) In the event that PFIZER performs less than 500,000 total
additional Details in either of Pratt Years One or Two, the Pratt
Percentage to be paid to PFIZER for the corresponding Agreement
Year shall be calculated as follows:
Actual number of total additional PFIZER Details
performed during the relevant Pratt Year
------------------------------------------------ x 3.5%
500,000
(b) In the event that WARNER-LAMBERT performs less than 250,000
total additional Details in any of Agreement Years One through
Four, the parties shall meet to discuss appropriate adjustments
to the compensation to be paid to PFIZER pursuant to this Section
3.02(h).
(v) For purposes of calculating the compensation to be paid to PFIZER
pursuant to this Section 3.02(h), the maximum number of additional
PFIZER Details to be credited to PFIZER in either Pratt Year One or
Pratt Year Two shall not exceed 500,000."
4. Section 3.03 of the Collaboration Agreement is amended to add the
following new subsections:
"(g) WARNER-LAMBERT shall make payments to PFIZER arising under
Section 3.02(h) at the end of Agreement Years One through Six in
accordance with this Section 3.03 as set forth below:
Year End Action if Pratt Details for Two Years
-------- -------------------------------------
Agreement Year One Pay PFIZER the Pratt Percentage of Net Sales
in excess of the Baseline Sales in Agreement
Year One, prorated for number of Pratt Year
Months in Agreement Year One
Agreement Year Two Pay PFIZER the Pratt Percentage of Net Sales
in excess of the Baseline Sales in Agreement
Year Two
Pratt Year Two Calculate Carryover Percentage
(occurring mid-year
in Agreement Year
Three)
Agreement Years Pay PFIZER Carryover Percentage for Net Sales
Three, Four and Five in excess of the Baseline Sales in Agreement
Years Three, Four and Five
Agreement Year Six Pay PFIZER Carryover Percentage for Net Sales
in excess of the Baseline Sales in Agreement
Year Six, prorated for number of Pratt Year
Months in Agreement Year Six
(h) All payments to be made pursuant to Section 3.03 (g) shall be
made at the end of Agreement Years One through Six, as applicable, in
accordance with the provisions of Article III."
5. The second sentence of Section 5.02(a) is deleted in its entirety.
In all other respects, the Collaboration Agreement remains in full
force and effect. Please indicate your agreement to this amendment by
signing in the space provided and returning an original to me.
Very truly yours,
PFIZER INC.
By: /s/ Karen L. Katen
---------------------------------
Name: Karen L. Katen
Title: Vice President;
Executive Vice President,
President, USPG
AGREED AND ACCEPTED:
WARNER-LAMBERT COMPANY
By: /s/ Maurice A. Renshaw
---------------------------
Maurice A. Renshaw
Title: Vice President;
President, Parke-Davis U.S. & Mexico
Date: 3/19/97
[EXHIBIT 99.1.2]
[Letterhead of Warner-Lambert Company]
May 22, 1997
Pfizer Inc.
235 East 42nd Street
New York, New York 10017-5755
Attention: President, U.S. Pharmaceutical Group
Re: Baseline Sales Adjustment
Dear Sirs:
Reference is hereby made to the Collaboration Agreement, effective as of
June 28, 1996 (the "Collaboration Agreement"), between Warner-Lambert
Company ("Warner-Lambert") and Pfizer Inc. ("Pfizer"). All capitalized
terms used and not otherwise defined herein shall have the meanings given
thereto under the Collaboration Agreement.
Warner-Lambert hereby notifies Pfizer that the Launch Date occurred on
January 28, 1997.
This represents a "stub period" of 63 days from January 28, 1997 through
March 31, 1997. In accordance with Section 3.06 of the Collaboration
Agreement, the adjusted Baseline Sales are as follows:
Agreement Year Adjusted Baseline Sales (in millions)
-------------- -------------------------------------
1 $263
2 $337
3 $457
4 $541
5 $588
6 $612
7 $651
8 $688
9 $763
10 $753
Please indicate your agreement with the foregoing by signing and returning
the enclosed copy of this letter.
Very truly yours,
WARNER-LAMBERT COMPANY
By: /s/ Richard B. Van Duyne
-------------------------
Richard B. Van Duyne
Vice President, Corporate
Development & Licensing
RBVD:jsc
cc: Pfizer Inc.
Attn: Senior Vice President and General Counsel
(fax: 212-808-8924)
Agreed:
PFIZER INC.
By: /s/ Karen L. Katen
-----------------------------
Name: Karen L. Katen
Title: Vice President
[EXHIBIT 99.1.3]
[Letterhead of Pfizer Inc.]
May 14, 1998
Izumi Hara, Esq.
Vice President and Associate General Counsel,
Corporate Affairs
Warner Lambert Co.
201 Tabor Road
Morris Plains, NJ 07950
Re: Treating to New Targets Study, protocol 981-117/258-102
Dear Ms. Hara:
It is my understanding that Pfizer and Warner-Lambert have agreed to
include the Pfizer logo in connection with the above-referenced clinical
trial, which is being conducted, in part, in France. Section 2.05(c) of
the Collaboration Agreement between Warner Lambert Co. and Pfizer Inc.
dated June 28, 1996 states as follows:
PFIZER grants WARNER-LAMBERT the right to use the PFIZER logo on
labeling, package inserts 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 . . . .
It is Pfizer's view that this Section 2.05(c) extends to Warner-Lambert the
right to use the Pfizer logo on all materials associated with the Treating
to New Targets ("TNT") Study, wherever those materials are used.
Consequently, we believe that Section 2.05(c) enables Warner-Lambert to
include the Pfizer logo on TNT Study materials to be used in France.
Please let me know if you require anything further.
Very truly yours,
/s/ Beth F. Levine
----------------------------
Beth F. Levine
[EXHIBIT 99.1.4]
June 30, 1999
Warner-Lambert Company
201 Tabor Road
Morris Plains, New Jersey 07950
Re: Second Amendment to Collaboration Agreement
Dear Sirs/Madam:
Pfizer Inc. ("Pfizer") and Warner-Lambert Company ("Warner-Lambert")
entered into a Collaboration Agreement, effective as of June 28, 1996, as
amended by a First Amendment to Collaboration Agreement, dated February 28,
1997 (as amended, the "Collaboration Agreement"). The parties wish to
further amend the Collaboration Agreement regarding detailing to be
performed by Pfizer. Accordingly, Section 2.02 of the Collaboration
Agreement is hereby amended to insert the following new subsection (i):
"(i) Commencing May 1, 1999 and continuing until the end of Agreement
Year Five, PFIZER agrees that in discharge of its detailing
obligations as specified in this Section 2.02, PFIZER shall
utilize its Pratt sales force."
Except as specifically amended herein, the Collaboration Agreement
shall remain in full force and effect according to its terms. Please
indicate your agreement to this Second Amendment by signing below and
returning an original to us.
Very truly yours,
PFIZER INC.
By: /s/ Gary N. Jortner
------------------------------------
Name: Gary N. Jortner
Title: Vice President, Pfizer Inc.;
Senior Vice President
Product Development,
Pfizer Pharmaceutical Group
AGREED AND ACCEPTED:
WARNER-LAMBERT COMPANY
By: /s/ Anthony Wild
-----------------------------
Name: ANTHONY WILD
Title: Executive Vice President
[EXHIBIT 99.1.5]
CONFIDENTIAL DISCLOSURE AGREEMENT
This CONFIDENTIAL DISCLOSURE AGREEMENT (the "Agreement"), dated as of
March 4, 1996, between Warner-Lambert Company, ("Warner-Lambert"), and
Pfizer Inc. (the "Receiving Party"),
WITNESSETH:
WHEREAS, Warner-Lambert possesses certain valuable and confidential
information relating to its pharmaceutical business, including, without
limitation, its product atorvastatin (the "Information"); and
WHEREAS, Warner-Lambert wishes to explore the possibility of entering
into certain commercial arrangements with the Receiving Party (the
"Program") and the Receiving Party wishes to have access to the Information
to aid the Receiving Party in reaching a decision concerning the Program;
NOW, THEREFORE, in consideration of the mutual promises contained
herein, Warner-Lambert and the Receiving Party hereby agree as follows:
1. Warner-Lambert shall disclose such of the Information as it deems
necessary to enable the Receiving Party to evaluate the Program and the
Receiving Party shall accept and hold the Information in confidence in
accordance with the provisions of Paragraph 2 hereof.
2. Without the prior written consent of Warner-Lambert, the Receiving
Party shall neither disclose to any third party (except its consultants
pursuant to the terms set forth below) any or all of the Information
disclosed by Warner-Lambert hereunder, nor permit any such third party
(except such consultants) to have access to such Information, nor use such
Information for any purpose other than to evaluate the Information as it
relates to the Program. In addition, the Receiving Party shall only
disclose the Information to those of its employees and consultants who
shall reasonably need to know the Information in order to evaluate such
Information or Program or to make decisions or render advice in connection
therewith and who shall be informed of the existence of this Agreement and
shall agree to be bound by the terms hereof. Each of the Receiving Party's
consultants shall be bound in writing by a confidential disclosure
agreement consistent with the terms hereof prior to its receipt of
Information. The Receiving Party undertakes to ensure strict compliance
with the terms of such confidential disclosure agreements, and shall
exercise all of its rights thereunder, including, without limitation, the
pursuit of injunctive relief, to ensure the same. Furthermore, upon
Warner-Lambert's request, the Receiving Party shall assign to
Warner-Lambert its rights under any such confidential disclosure agreement.
However, the aforesaid obligations assumed by the Receiving Party hereunder
shall not apply to any Information which falls within any of the following
categories:
(a) Information which is in the public domain at the time of
disclosure hereunder or which subsequently has come within the
public domain through no fault of or action by the Receiving
Party; and
(b) Information which is in the possession of the Receiving Party at
the time of disclosure by Warner-Lambert or which is
independently discovered, after the date hereof, by the Receiving
Party without the aid, application or use of the Information, in
each such case as evidenced by written records; and
(c) Information which is obtained, after the date hereof, by the
Receiving Party from any third party which is lawfully in
possession of such Information and not in violation of any
contractual or legal obligation with respect to such Information.
3. This Agreement, including the confidentiality and limited use
obligations hereunder, shall remain in effect for a period of seven (7)
years from the date of disclosure of the Information, provided that the
expiration of the term of this Agreement shall not release the Receiving
Party from any obligation of confidentiality or nonuse which may arise from
applicable law.
4. Each of the parties agrees that it shall not disclose to any third
party the existence or subject matter hereof to the maximum extent
permitted by law during the term described in Paragraph 3 hereof. The
Receiving Party shall return to Warner-Lambert, upon request, any and all
written documents and samples of any products provided by Warner-Lambert
hereunder.
5. No right of license, either express or implied, with respect to the
Information is granted hereunder by Warner-Lambert to the Receiving Party.
The disclosure of the Information by Warner-Lambert to the Receiving Party
shall not result in any obligation on the part of either party to enter
into any future agreement relating to the Information or to undertake any
other obligation not set forth in a written agreement signed by the parties
hereto.
6. The Receiving Party represents and warrants to Warner-Lambert that it
has the necessary corporate power to enter into and perform its obligations
under this Agreement and all necessary corporate action required to
authorize the execution and delivery of this Agreement and the performance
of the Receiving Party's obligations hereunder has been taken.
7. The Receiving Party acknowledges and agrees that any remedies at law
for a breach or threatened breach of any of the provisions of this
Agreement would be inadequate and, in recognition of that fact, agrees
that, in the event of a breach or threatened breach by it of the provisions
of this Agreement, in addition to any remedies at law, Warner-Lambert
without posting any bond shall be entitled to obtain equitable relief in
the form of specific performance, a temporary restraining order, a
temporary or permanent injunction or any other equitable remedy which may
then be available.
8. The Receiving Party hereby agrees to the terms set forth in Attachment
A to this Agreement, and such terms are hereby incorporated into and made a
part of this Agreement.
9. This Agreement contains all the representations and agreements between
the parties relating to the Information and any representation, promise or
condition concerning the same which is not contained herein or in a
superseding written agreement referring to this Agreement shall not be
binding on either party hereto.
10. 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 and any dispute arising out of or in connection with this
Agreement, including its existence, validity or termination, shall be
governed by and resolved in accordance with the laws of the State of New
York, other than those provisions governing conflicts of law.
IN WITNESS WHEREOF, the Receiving Party and Warner-Lambert have caused
this Agreement to be executed by their respective duly authorized
representatives as of the date first above written.
PFIZER INC. WARNER-LAMBERT COMPANY
By: /s/ John Niblack By: /s/ R. B. Van Duyne
---------------------------- --------------------------------
Title: Executive Vice President Title: Vice President, Business
Development and Licensing
ATTACHMENT A
1. Restriction on Acquisitions of Voting Securities. Except as provided
in Sections 4 and 5 below, the Receiving Party covenants and agrees with
Warner-Lambert that, from the date hereof until the date (the "Standstill
Termination Date") which is the later of:
(i) the last to occur of
(a) one (1) year after termination of discussions between
Warner-Lambert and the Receiving Party with respect to
atorvastatin, or
(b) the first to occur of (1) the date the United States New
Drug Application for atorvastatin submitted by Warner-Lambert is
granted final approval by the United States Food and Drug
Administration permitting the immediate commencement of
commercial distribution of the product or (2) two (2) years after
the date of this Agreement, or
(ii) in the event that Warner-Lambert and the Receiving Party enter
into an agreement with respect to atorvastatin, five years after the
termination of such agreement,
neither the Receiving Party nor any of its Affiliates (as defined below)
will, except with the express written consent of Warner-Lambert and then
only to the extent stated in such written consent, acquire or agree to
acquire or make any proposal to acquire, directly or indirectly, the
beneficial ownership of any common stock, equity securities or other
securities having voting power with respect to the election of directors of
Warner-Lambert ("Voting Equity"), or any other securities convertible into
Voting Equity or any options, warrants or other rights to acquire Voting
Equity (such convertible securities, options, warrants or other rights,
together with Voting Equities, being hereinafter called "Voting
Securities") of Warner-Lambert or its Affiliates. For purposes of this
Agreement, "Affiliates" shall mean any corporation or entity controlling,
controlled by, or under common control with the party in question. As used
herein the term control means possession of the power to direct, or cause
the direction of, the management and policies of a corporation or entity by
reason of any ownership interest therein.
2. Restrictions on Solicitations of Proxies. Except as provided in
Sections 4 and 5 below, the Receiving Party covenants and agrees that, from
the date hereof until the Standstill Termination Date, neither it nor any
of its Affiliates will, except with the express written consent of
Warner-Lambert and then only to the extent stated in such written consent,
make or in any way participate, directly or indirectly, in any
"solicitation" of "proxies" (as such terms are defined in Regulation 14A
under the Securities Exchange Act of 1934 (the "Exchange Act")) to vote or
seek to advise or influence any person with respect to the voting of any
Voting Securities of Warner-Lambert or its Affiliates.
3. Other Restrictions. Except as provided in Sections 4 and 5 below, the
Receiving Party covenants and agrees that, from the date hereof until the
Standstill Termination Date neither it nor any of its Affiliates shall (i)
seek to have Warner-Lambert waive, amend or modify any of the restrictions
contained in this Agreement or the Certificate of Incorporation or the
By-laws of Warner-Lambert, (ii) make any Acquisition Proposal (as defined
below) or proposal with respect to a Business Combination (as defined
below), joint venture, or any other extraordinary business arrangement,
including, but not limited to, a business arrangement which could result
in a change of control of Warner-Lambert, in each case in respect of
Warner-Lambert or any of its Affiliates, (iii) take any initiatives
involving Warner-Lambert that would otherwise require Warner-Lambert to
make a public announcement or make any public comment or proposal with
respect to any Acquisition Proposal or Business Combination, (iv) join a
partnership, limited partnership, syndicate or other group for the purpose
of acquiring, holding, voting or disposing of Voting Securities of
Warner-Lambert or otherwise become a "person" within the meaning of
Section 13(d)(3) of the Exchange Act with respect to any Voting Securities
of Warner-Lambert or its Affiliates, (v) enter into any discussions,
negotiations, arrangements or understandings with any third party with
respect to any of the foregoing, (vi) knowingly advise, assist or encourage
any third party in connection with any of the foregoing; or (vii) otherwise
seek to control or influence Warner-Lambert or its management or Board of
Directors.
"Acquisition Proposal" shall mean any tender offer or exchange offer
or proposal to Warner-Lambert (including, without limitation, any proposal
or offer to stockholders of Warner-Lambert) with respect to a Business
Combination or involving the purchase of 20% or more of the outstanding
Voting Securities of Warner-Lambert.
"Business Combination" shall mean (a) a merger, consolidation,
acquisition, scheme or other analogous arrangement in which Warner-Lambert
is a constituent corporation or party and pursuant to which Voting
Securities of Warner-Lambert are or may be exchanged for cash, securities
or other property or (b) a sale of all or substantially all of the assets
of Warner-Lambert and its Affiliates; provided that neither (i) a
transaction in which the beneficial ownership of the capital stock of
Warner-Lambert immediately after the consummation of such transaction is
substantially the same as the beneficial ownership of Warner-Lambert's
capital stock immediately prior to the consummation thereof nor (ii) a
merger, consolidation or other reorganization in which Warner-Lambert is
the surviving corporation, in which substantially all the shares of
Warner-Lambert capital stock outstanding immediately prior to the
consummation of such merger remain outstanding immediately after the
consummation thereof and the only change in the capital stock of
Warner-Lambert resulting from such merger is the issuance of shares of
capital stock pursuant thereto which, following such issuance, do not
represent more than 20% of Warner-Lambert's Voting Securities shall be
deemed a Business Combination.
4. Termination. If (a) a third party independently or in concert with
others commences or makes an Acquisition Proposal, and such third party is
the acquiring party, or if Warner-Lambert solicits a third party offer for
an Acquisition Proposal or a Business Combination, and such third party is
the acquiring party, or (b) Warner-Lambert enters into an agreement with a
third party with respect to an Acquisition Proposal or a Business
Combination, and such third party is the acquiring party, then
Warner-Lambert shall be deemed to have relinquished its right to enforce
the restrictions on the Receiving Party and its Affiliates set forth in
Sections 1, 2 and 3 herein and any claim for damages at law based on
actions of the Receiving Party or its Affiliates inconsistent with such
restrictions while such rights are relinquished; provided that, if any
tender offer or exchange offer or any Acquisition Proposal or Business
Combination made by the Receiving Party or any of its Affiliates (which,
but for the foregoing provisions of this Section 4, would have been
inconsistent with the restrictions set forth in Sections 1, 2 and 3 herein)
shall have lapsed or been terminated or withdrawn, Warner-Lambert's right
to enforce the restrictions on acquisitions set forth in Sections 1, 2 and
3 herein shall immediately be reinstated; and provided further that neither
the Receiving Party nor any Affiliate of the Receiving Party shall be
required to dispose of or be prevented from beneficially owning any Voting
Securities or any other property rights relating to Voting Securities of
Warner-Lambert which the Receiving Party or its Affiliate acquired or
contracted to acquire during the period of such relinquishment and prior to
such reinstatement.
5. Permitted Investment. Notwithstanding the foregoing, the
proscriptions set forth in this Agreement shall not apply to (i) passive
investments by the Receiving Party or any Affiliate solely for the purpose
of cash or money management or by an affiliated pension or employee benefit
plan or trust or to indirect interests in portfolio securities held by an
investment company registered under the Investment Company Act of 1940 or
to interests in securities comprising part of a broad based, publicly
traded market basket or index of stock approved for such a plan or trust in
which such plan or trust invests, so long as such interest does not, in the
aggregate, exceed 1/2 of 1% of Warner-Lambert's outstanding Voting
Securities.
6. Indemnification. The Receiving Party hereby agrees to indemnify and
hold harmless Warner-Lambert from and against any costs (including legal
fees) of whatsoever nature arising directly or indirectly out of a breach
of the obligations of the Receiving Party contained in this Attachment A.
[EXHIBIT 99.2]
OPTION AGREEMENT
This Agreement, effective as of June 28, 1996, is made by and between
WARNER-LAMBERT COMPANY, a Delaware corporation (hereinafter
"WARNER-LAMBERT"), with primary offices located at 201 Tabor Road, Morris
Plains, New Jersey 07950, and PFIZER INC., a Delaware corporation
(hereinafter "PFIZER"), with primary offices located at 235 East 42nd
Street, New York, NY 10017-5755.
WHEREAS, PFIZER and its Affiliates (as hereinafter defined) hold
certain rights to certain pharmaceutical compounds hereinafter described;
and
WHEREAS, PFIZER may further develop such pharmaceutical compounds into
pharmaceutical Products (as hereinafter defined) and may file at some
future date for regulatory approval in the United States and elsewhere to
market, distribute and sell some or all of the Products in the United
States and elsewhere; and
WHEREAS, simultaneously with the execution of this Agreement
WARNER-LAMBERT and PFIZER are signing (i) a Collaboration Agreement, dated
the date hereof (hereinafter "Collaboration Agreement"), under which
WARNER-LAMBERT grants to PFIZER certain co-promotion and other rights
regarding atorvastatin in the United States and (ii) an International
Collaboration Agreement, International Co-Promotion Agreement and
International License Agreement, each dated the date hereof (collectively
referred to herein as the "International Agreements"), under which
WARNER-LAMBERT grants to PFIZER certain co-promotion and other rights
regarding atorvastatin in countries outside the United States; and
WHEREAS, PFIZER and WARNER-LAMBERT have had discussions concerning the
possibility that the parties would enter into an agreement under which
PFIZER would grant to WARNER-LAMBERT certain co-promotion and other rights
regarding a Product, when and if such Product is ever marketed, but
WARNER-LAMBERT does not desire to negotiate the terms of such an agreement
at this time; and
WHEREAS, PFIZER is willing to grant to WARNER-LAMBERT and
WARNER-LAMBERT is interested in obtaining an option to negotiate an
agreement granting such co-promotion and other rights in the future under
the terms set forth in this Agreement.
NOW, THEREFORE, for and in consideration of the foregoing and the
covenants and agreements contained herein, WARNER-LAMBERT and PFIZER,
intending to be legally bound, hereby agree as follows:
ARTICLE I - DEFINITIONS
SECTION 1.01 Definitions. The following capitalized terms shall have
the following meanings:
"Affiliate" shall mean any Person that directly or indirectly controls
or is controlled by or is under common control with WARNER-LAMBERT 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.
"Change in Control" shall mean an event where:
(A) any Person(s) acquire beneficial ownership of capital stock of
WARNER-LAMBERT entitling the holder(s) thereof to at least fifty-one
percent (51%) of the voting power of the then outstanding capital
stock of WARNER-LAMBERT with respect to the election of directors of
WARNER-LAMBERT, or (B) WARNER-LAMBERT enters into a merger,
consolidation or similar transaction with another Person (the
"Acquiring Corporation") in which (i) WARNER-LAMBERT is not the
surviving corporation in such transaction, (ii) the members of the
Board of Directors of WARNER-LAMBERT 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) WARNER-LAMBERT sells to any Person(s) in one or more related
transactions properties or assets representing at least fifty-one
percent (51%) of (i) WARNER-LAMBERT's 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 WARNER-LAMBERT's
pharmaceutical business are included in such transaction(s) and (ii)
WARNER-LAMBERT's consolidated operating income for the most recent
fiscal year as reflected on its most recent Annual Report on Form
10-K.
"Confidential Information" shall mean (i)-for WARNER-LAMBERT, all
PFIZER Confidential Information and (ii) for PFIZER, all WARNER-LAMBERT
Confidential Information.
"Co-Promotion Agreement" shall mean an agreement or agreements whereby
PFIZER grants to WARNER-LAMBERT and its designated Affiliates co-promotion
and/or other rights to a Product upon such terms as the parties may agree
upon pursuant to the terms of this Agreement. While the parties acknowledge
that they cannot as of the date hereof determine the specific terms or
parameters for such agreement or agreements, the parties intend that, at
the time they negotiate such agreement or agreements, they will consider as
relevant factors: (a) market and competitive environment regarding the
Product, (b) the medical profile of the Product, (c) the patent situation
relevant to the Product, (d) the regulatory and cost containment
environment affecting the Product, (e) estimated sales and profit levels
for the Product, (f) the extent of the operations of each of the parties in
various countries, and (g) the terms of the Collaboration Agreement and the
International Agreements.
"Darifenacin" shall mean the chemical compound (S)-1[2-(2,
3-Dihydro-5-benzofuranyl)ethyl]-a, a-dipheny]-3-pyrrolidineacetamide.
"Droloxifene" shall mean the chemical compound phenol, 3-
1-[4-]2-(dimethylamino)ethoxy]phenyl]-2-phenyl-l-butenyl],-(E)-.
"Eletriptan" shall mean the chemical compound (R)-lH-Indole,
3-{(l-methyl-2-pyrrolidinyl)methyl)-5-(2-(phenysulfonyl)ethyl)-.
"Governmental or Regulatory Authority" means any court, tribunal,
arbitrator, agency, commission, official or other instrumentality of any
federal, state, county, city or other political subdivision, domestic or
foreign.
"Laws" shall mean all laws, statutes, rules, regulations, ordinances
and other pronouncements having the effect of law of any government or
Governmental or Regulatory Authority.
"Person" shall mean any natural person, corporation, general
partnership, limited partnership, joint venture, proprietorship or other
business organization.
"PFIZER Confidential Information" shall mean 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
WARNER-LAMBERT in connection with this Agreement and which relates to the
business of PFIZER, including, without limitation, any information
concerning any Pfizer pharmaceutical compound or any of their intermediates
or the Products.
"Products" shall mean all finished pharmaceutical compositions,
formulations and dosage forms containing as an active ingredient any one of
Darifenacin, Droloxifene, Eletriptan or such other chemical compound as may
be contained in an Additional Product designated by PFIZER pursuant to
Section 2.03.
"Term of this Agreement" shall mean the period from the date hereof
until the expiration of this Agreement in accordance with Section 5.01 or
earlier termination of this Agreement in accordance with Section 5.02.
"Transaction" shall mean one or more related transactions involving
(i) any sale or grant of any rights to a Product (including patent and
trademark licenses), or (ii) any joint venture, co-promotion or similar
relationship involving a Product.
"WARNER-LAMBERT Confidential Information" shall mean 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 WARNER-LAMBERT or by any of its Affiliates or agents or
agents of its Affiliates to PFIZER in connection with this Agreement and
which relates to the business of WARNER-LAMBERT.
ARTICLE II - OPTION RIGHTS AND RELATED OBLIGATIONS
SECTION 2.01 Option Rights. (a) Notice of Anticipated Regulatory
Filing. During the Term of this Agreement, PFIZER shall notify
WARNER-LAMBERT at least six months, but no more than nine months, prior to
the date on which PFIZER reasonably anticipates filing a New Drug
Application (hereinafter, "NDA") with the United States Food and Drug
Administration (or, if earlier, filing for regulatory registration in any
of United Kingdom, France, Germany, Italy, Spain or Japan) covering any
Product (such notice to be referred to hereinafter as a "Notice of
Anticipated Regulatory Filing"). At the same time Pfizer provides a Notice
of Anticipated Regulatory Filing PFIZER shall provide to WARNER-LAMBERT an
executive summary (hereinafter "Executive Summary") describing what PFIZER
reasonably believes to be pertinent safety and efficacy data for such
Product (which PFIZER may legally disclose) to assist WARNER-LAMBERT in
making a preliminary scientific assessment of the applicable Product. All
information included in the Executive Summary shall be considered PFIZER
Confidential Information subject to the provisions of Article IV.
(b) Option. PFIZER grants to WARNER-LAMBERT an option (hereinafter,
the "Option") to negotiate with PFIZER the terms and conditions of a
Co-Promotion Agreement relating to the Product that was the subject of a
Notice of Anticipated Regulatory Filing as follows:
(i) The Option may be exercised by WARNER-LAMBERT by notifying PFIZER
of its intent to exercise the Option at any time during the period
beginning with the date of the Notice of Anticipated Regulatory Filing and
ending thirty (30) days thereafter (hereinafter, the "Option Period");
(ii) If WARNER-LAMBERT exercises the Option during the Option Period,
a negotiation period (hereinafter, a "Negotiation Period") shall commence,
beginning on the date the Option is exercised and ending on the earliest of
(x) the date a Co-Promotion Agreement is entered into by the parties, (y)
the date the Negotiation Period is terminated by the mutual agreement of
the parties, or (z) ninety (90) days after the date of the Notice of
Anticipated Regulatory Filing. During the Negotiation Period, the parties
shall negotiate in good faith regarding the entering into of a Co-Promotion
Agreement.
(iii) If WARNER-LAMBERT does not exercise the Option during the
Option Period with respect to a given Product or no Co-Promotion Agreement
is entered into regarding such Product during the Negotiation Period
despite good faith negotiations by both parties, WARNER-LAMBERT shall have
no further rights, and PFIZER shall have no further obligations, with
respect to such Product pursuant to this Agreement, and PFIZER shall be
free to enter into any Transaction or take any other action with respect to
such Product as PFIZER may determine in its sole and absolute discretion.
(c) Notice of Transaction.
(i) During the Term of this Agreement at such time or times as
PFIZER, in its reasonable discretion, believes that there is a reasonable
likelihood that PFIZER will enter into a Transaction with any third party,
PFIZER shall notify WARNER-LAMBERT (such notice to be referred to
hereinafter as a "Notice of Transaction"). PFIZER in a Notice of
Transaction shall identify the Product involved, but shall not be required
to disclose any other details of the proposed Transaction. At the same time
of the giving of the Notice of Transaction, PFIZER shall provide to
WARNER-LAMBERT an Executive Summary regarding the Product identified in the
Notice of Transaction.
(ii) WARNER-LAMBERT shall notify PFIZER of its desire to negotiate a
Co-Promotion Agreement with respect to a Product that is the subject of a
Notice of Transaction within thirty (30) days of a Notice of Transaction.
If within such period WARNER-LAMBERT notifies PFIZER that it desires to
negotiate such a Co-Promotion Agreement, a Negotiation Period shall take
place as described in Section 2.01(c)(iii). If WARNER-LAMBERT does not
notify PFIZER that it desires to negotiate such a Co-Promotion Agreement or
no Co-Promotion Agreement is entered into regarding such Product during the
Negotiation Period, WARNER-LAMBERT shall have no further rights, and PFIZER
shall have no further obligations, with respect to such Product pursuant to
this Section 2.01, and PFIZER shall be free to enter into any Transaction
or take any other action with respect to such Product in PFIZER's sole and
absolute discretion; provided however that, if PFIZER shall not have
entered into the Transaction contemplated by the Notice of Transaction or
any other Transaction involving such Product within one (1) year following
the date of such Notice of Transaction and this Agreement is then still in
effect, WARNER-LAMBERT shall have all rights and PFIZER shall have all
obligations pursuant to Section 2.01 with respect to such Product.
(iii) The term of the Negotiation Period described in 2.01(c)(ii)
shall begin as of the date of the Notice of Transaction and end on the
earliest of (x) the date a definitive Co-Promotion Agreement is entered
into by the parties, (y) the date the Negotiation Period is terminated by
the mutual agreement of the parties, or (z) seventy-five (75) days after
the date of the Notice of Transaction. During such Negotiation Period, the
parties shall negotiate in good faith regarding the entering into of a
Co-Promotion Agreement.
(d) Notice of Interest.
(i) At any time during the Term of this Agreement WARNER-LAMBERT
shall have the right to notify PFIZER of its interest in negotiating a
Co-Promotion Agreement for a Product (such notice to be referred to
hereinafter as a "Notice of Interest"). WARNER-LAMBERT in a Notice of
Interest shall identify the Product. Within sixty (60) days of receipt of a
Notice of Interest, PFIZER shall provide to WARNER-LAMBERT an Executive
Summary for such Product.
(ii) Upon receipt of a Notice of Interest, a negotiation period
(hereinafter, a "Negotiation Period") shall take place as described in
Section 2.01(d)(iii). If no Co-Promotion Agreement is entered into
regarding such Product during the Negotiation Period, WARNER-LAMBERT shall
have no further rights, and PFIZER shall have no further obligations, with
respect to such Product under this Agreement, and PFIZER shall be free to
enter into any Transaction or take any other action with respect to such
Product as PFIZER may determine in its sole and absolute discretion.
(iii) The term of the Negotiation Period described in 2.01(d)(ii)
shall begin as of the date of the Notice of Interest and end on the
earliest of (x) the date a definitive Co-Promotion Agreement is entered
into by the parties, (y) the date the Negotiation Period is terminated by
the mutual agreement of the parties, or (z) sixty (60) days after
WARNER-LAMBERT's receipt of the Executive Summary for the applicable
Product. During such Negotiation Period, the parties shall negotiate in
good faith regarding the entering into of a Co-Promotion Agreement.
(e) Letter of Intent. If during a Negotiation Period under Section
2.01(b), 2.01(c) or 2.01(d), the parties enter into a non-binding letter of
intent containing financial or other business terms acceptable to the
parties regarding a contemplated Co-Promotion Agreement, PFIZER shall
provide to WARNER-LAMBERT reasonable access to all significant safety and
efficacy data regarding the relevant Product. All such data shall be
considered PFIZER Confidential Information subject to the provisions of
Article IV.
(f) Confidentiality of Negotiations. All discussions between the
parties pursuant to this Agreement, including but not limited to any terms
under discussion during any Negotiation Period, shall not be disclosed to
any third party.
SECTION 2.02 Negotiation Period Restriction. During a Negotiation
Period pursuant to Sections 2.01(b), 2.01(c) or 2.01(d), PFIZER shall not
discuss, negotiate or enter into any agreement with any third party to
effect any Transaction relating to a Product that is the subject of the
relevant Notice of Anticipated Regulatory Filing, Notice of Transaction or
Notice of Interest.
SECTION 2.03 Additional Product. In the event that, during the term
of this Agreement, WARNER-LAMBERT shall have no further rights pursuant to
Section 2.01 to any Products containing as an active ingredient
Darifenacin, Droloxifene or Eletriptan as a result of any of the following
circumstances or any combination thereof:
(a) Following a Notice of Anticipated Regulatory Filing, (i)
WARNER-LAMBERT does not, pursuant to Section 2.01(b), exercise an option
during an Option Period or (ii) no Co-Promotion Agreement is entered into
during the relevant Negotiation Period; or
(b) Following a Notice of Transaction, (i) WARNER-LAMBERT does not
pursuant to Section 2.01(c)(ii) notify PFIZER of its desire to negotiate a
Co-Promotion Agreement or (ii) PFIZER has entered into a Transaction with a
third party regarding the Product that was the subject of such Notice of
Transaction; or
(c) Following a Notice of Interest, no Co-Promotion Agreement is
entered into during the relevant Negotiation Period; or
(d) PFIZER has delivered a Product Notice pursuant to Section 2.05;
then, upon WARNER-LAMBERT's request to PFIZER, PFIZER shall, not less than
sixty days following such request, designate as an additional Product
(hereinafter, "Additional Product") a pharmaceutical product (selected in
PFIZER's sole and absolute discretion) currently under development and for
which PFIZER reasonably believes at such time that, subject to successful
development, will be an important product in major markets. Such
Additional Product shall be treated thereafter for all purposes of this
Agreement as a Product.
SECTION 2.04 No Obligation to Enter into Agreement. The parties
acknowledge and agree that they may fail for any reason whatsoever to enter
into a Co-Promotion Agreement for which they may commence negotiations
under this Agreement, and nothing herein shall obligate either party in any
way to enter into a Co-Promotion Agreement or any other agreement or
understanding relating to any Product. Any decision by a party to enter
into a Co-Promotion Agreement or any other agreement or understanding
relating to any Product shall be in the sole and absolute discretion of
such party. Provided the parties have complied with this Agreement, neither
party shall have any recourse against or liability to the other if the
parties fail to enter into a Co-Promotion Agreement or any other agreement
or understanding relating to any Product as contemplated herein, except for
the PFIZER Payments as set forth in Section 3.01.
SECTION 2.05 Future Development. Nothing herein shall obligate
PFIZER in any way to continue the development of, or to file for regulatory
approval for or to market any Product. Any decision regarding the
development, commercialization, marketing, or regulatory filing with
respect to any Product shall be in PFIZER's sole and absolute discretion.
Notwithstanding the foregoing, PFIZER shall send a notice to WARNER-LAMBERT
(a "Product Notice") after Pfizer has determined that it will not pursue
the active development of and/or regulatory filing for a Product.
SECTION 2.06 Time Periods. The parties acknowledge and agree that
the time periods set forth herein are to be strictly complied with and are
essential to the accomplishment of the objectives of the parties in
entering into this Agreement.
SECTION 2.07 Clinical Development Reports. During the Term of this
Agreement, PFIZER shall provide semi-annual reports to WARNER-LAMBERT
regarding the progress of clinical development programs for Products to
which WARNER-LAMBERT continues to have rights pursuant to Section 2.01.
ARTICLE III - PAYMENTS
SECTION 3.01 PFIZER Payments. In the event this Option Agreement is
still in effect and no Co-Promotion Agreement has been entered into between
the parties by the end of Agreement Year Five (as defined and determined
under the Collaboration Agreement), PFIZER shall pay to WARNER-LAMBERT up
to a total of thirty million dollars ($30,000,000) as follows: six million
dollars ($6,000,000) shall be payable on the first day of Agreement Year
Six and six million dollars ($6-1,000,000) shall be payable on the first
day of each of Agreement Years Seven, Eight, Nine and Ten, respectively,
provided that this Agreement is still in effect on the date such payment is
due. It is understood that any Co-Promotion Agreement which may be entered
into, at any time after any payments have been made under this Section
3.01, shall provide that such payments be refunded to PFIZER by
WARNER-LAMBERT as part of such Co-Promotion Agreement. Except as
specifically set forth in the preceding sentence, it is understood that all
payments made under this Section 3.01 shall be nonrefundable.
ARTICLE IV - CONFIDENTIAL INFORMATION
SECTION 4.01 Confidential Information. Each of PFIZER and
WARNER-LAMBERT shall keep all Confidential Information received from the
other with the same degree of care it maintains the confidentiality of its
own confidential information. Each party shall not use such Confidential
Information for any purpose other than in performance of this Agreement or
disclose the same to any other Person other than to such of its employees,
agents, advisers, representatives, consultants and counsel who have a need
to know such Confidential Information to implement the terms of this
Agreement; provided, however, any such consultants shall be subject to
confidentiality obligations consistent with those provided herein. The
party receiving the Confidential Information (the "Receiving Party") shall
advise any employee, agent, adviser, representative, consultant or counsel
who receives such Confidential Information of the confidential nature
thereof and of the obligations contained in this Agreement relating
thereto, and the Receiving Party shall ensure that all such employees,
agents, advisers, representatives, consultants and counsel comply with such
obligations as if they had been a party hereto. Upon termination of this
Agreement, or earlier if so requested in writing by the party disclosing
the Confidential Information (the "Disclosing Party") the Receiving Party
shall use reasonable efforts to return or destroy all documents, tapes or
other media containing Confidential Information in its possession, except
that the Receiving Party may keep one copy of Confidential Information in
the Legal Department files of the Receiving Party, solely for archival
purposes. Such archival copy shall be deemed to be the property of the
Disclosing Party, and shall not be copied or distributed in any manner
without the express prior written permission of the Disclosing Party;
provided, however, that the Receiving Party shall have the right to
disclose any Confidential Information provided hereunder if, in the
reasonable opinion of the Receiving Party's legal counsel, such disclosure
is necessary to comply with the terms of this Agreement, or the
requirements of any Law. The Receiving Party shall notify the Disclosing
Party of the Receiving Party's intent to make such disclosure of
Confidential Information pursuant to the proviso of the preceding sentence
sufficiently prior to making such disclosure so as to allow the Disclosing
Party adequate time to take whatever action the Disclosing Party may deem
to be appropriate to protect the confidentiality of the information.
SECTION 4.02 Exceptions. Each of PFIZER and WARNER-LAMBERT shall be
relieved of any and all of the obligations of Section 4.01 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 4.03 Survival. The obligations and prohibitions contained
in this Article IV shall survive the expiration or termination of this
Agreement for a period of five (5) years.
ARTICLE V - TERM AND TERMINATION
SECTION 5.01 Term. Unless earlier terminated pursuant to Section
5.02 or as otherwise mutually agreed to by the parties, this Agreement
shall expire at the end of Agreement Year Ten (as defined and determined
under the Collaboration Agreement).
SECTION 5.02 Termination of Agreement.
(a) This Agreement shall automatically terminate without any further
notice from either party if any of the following events has occurred:
(i) Any Co-Promotion Agreement contemplated hereunder is entered into
between the parties; or
(ii) PFIZER has paid to WARNER-LAMBERT thirty million dollars
($30,000,000) pursuant to Section 3.01; or
(iii) WARNER-LAMBERT has given notice to PFIZER of the termination
of PFIZER's co-promotion rights pursuant to Sections 14.02(a), 14.02(b) or
14.02(c) of the Collaboration Agreement; or
(iv) The Collaboration Agreement terminates for any reason, other than
PFIZER's material breach or PFIZER's termination pursuant to Section
14.03(a) of the Collaboration Agreement.
(b) If either WARNER-LAMBERT 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.
(c) Promptly after a change in Control WARNER-LAMBERT shall notify
PFIZER thereof, and PFIZER shall have the right, at PFIZER's discretion,
within thirty (30) days of said WARNER-LAMBERT notice to pay to
WARNER-LAMBERT thirty million dollars ($30,000,000) less all amounts
previously paid to WARNER-LAMBERT pursuant to Section 3.01 and to terminate
this Agreement immediately thereafter.
(d) If PFIZER terminates the Collaboration Agreement under Section
14.03(a) thereof, PFIZER shall have the right, at PFIZER's discretion,
within thirty (30) days after such termination of the Collaboration
Agreement to pay to WARNER-LAMBERT thirty million dollars ($30,000,000)
less all amounts previously paid to WARNER-LAMBERT pursuant to Section 3.01
and to terminate this Agreement immediately thereafter.
SECTION 5.03 No Prejudice to Rights. Termination of this Agreement
shall be without prejudice to either party's right to obtain performance of
any obligations provided for in this Agreement which survive termination by
their express terms. Unless any provisions herein expressly survive
termination, the parties understand and agree that all obligations
hereunder shall terminate upon termination of this Agreement without any
liability to the other party.
SECTION 5.04 Return of Confidential Information. Subject to the
terms of Section 4.01, upon termination of this Agreement, WARNER-LAMBERT
shall within thirty (30) days return to PFIZER all tangible PFIZER
Confidential Information provided to WARNER-LAMBERT by or on behalf of
PFIZER pursuant to this Agreement and PFIZER shall within thirty (30) days
return to WARNER-LAMBERT all tangible WARNER-LAMBERT Confidential
Information provided to PFIZER by or on behalf of WARNER-LAMBERT pursuant
to this Agreement.
ARTICLE VI - MISCELLANEOUS
SECTION 6.01 PFIZER Representations and Warranties.
(a) PFIZER has the corporate power and authority to execute and
deliver this Agreement and to perform its obligations hereunder, and the
execution, delivery and performance of this Agreement by PFIZER has been
duly and validly authorized and approved by proper corporate action on the
part of PFIZER, and PFIZER has taken all other action required by law, its
certificate of incorporation, by-laws or any agreement to which it is a
party or to which it may be subject, required to authorize such execution,
delivery and performance. Assuming due authorization, execution and
delivery on the part of PFIZER, this Agreement constitutes a legal, valid
and binding obligation of PFIZER, enforceable against PFIZER in accordance
with its terms, except as the enforceability
thereof may be limited by applicable bankruptcy, insolvency, reorganization
or other similar laws of general application relating to creditors' rights.
(b) As of the date hereof, the execution and delivery of this
Agreement by PFIZER and the performance by PFIZER contemplated hereunder
will not violate any Laws or any order of any court or other Governmental
or Regulatory Authority.
(c) Subject to Section 6.01A, as of the date hereof, neither the
execution and delivery of this Agreement nor the performance hereof by
PFIZER requires PFIZER to obtain any permits, authorizations or consents
from any Governmental or Regulatory Authority or from any other Person, and
such execution, delivery and performance will not result in the breach of
or give rise to any termination of any agreement or contract to which
PFIZER may be a party and which relates to the Products.
(d) As of the date hereof, there are no actions, suits, proceedings
or claims, pending against PFIZER or any of its Affiliates, or, to the
knowledge of PFIZER, threatened against PFIZER or any of its Affiliates, at
law or in equity, or before or by any court or Governmental or Regulatory
Authority relating to the Products or any of the matters contemplated under
this Agreement. To the knowledge of PFIZER, there are no investigations,
pending or threatened against PFIZER or any of its Affiliates, at law or in
equity, or before or by any Governmental or Regulatory Authority relating
to the Products or any of the matters contemplated under this Agreement.
(e) As of the date hereof, to the best of PFIZER's knowledge, based
solely upon the actual knowledge of Peter C. Richardson, PFIZER's chief
patent counsel (located in New York, New York), without due inquiry, the
manufacture, use or sale of Products containing Darifenacin, Droloxifene or
Eletriptan would not infringe any patents of third parties; provided,
however, the foregoing representation in the case of Droloxifene is limited
to clinical indications for osteoporosis and breast cancer.
(f) PFIZER acknowledges that WARNER-LAMBERT is relying, and is
entitled to rely, on the foregoing representations and warranties.
SECTION 6.01A Droloxifene. PFIZER has disclosed to WARNER-LAMBERT,
and WARNER-LAMBERT acknowledges, that PFIZER's rights to Droloxifene are
derived from, and are subject to, the terms of a license agreement with
Klinge Pharma GmbH and Klinge Pharma & Co. Said license agreement
provides, inter alia, that: (i) PFIZER has no rights to sell Droloxifene in
Austria, Ireland or Switzerland, (ii) PFIZER's rights to sell Droloxifene
in Germany are limited to certain indications, and (iii) the entry by
PFIZER into a Co-Promotion Agreement with respect to Droloxifene for
countries (other than the United States) may require prior consultation by
PFIZER with Klinge and for Germany may be restricted or prohibited.
SECTION 6.02 WARNER-LAMBERT Representations and Warranties.
(a) WARNER-LAMBERT has the corporate power and authority to execute
and deliver this Agreement and to perform its obligations hereunder, and
the execution, delivery and performance of this Agreement by WARNER-LAMBERT
has been duly and validly authorized and approved by proper corporate
action on the part of WARNER-LAMBERT, and WARNER-LAMBERT has taken all
other action required by law, its certificate of incorporation, by-laws or
any agreement to which it is a party or to which it may be subject,
required to authorize such execution, delivery and performance. Assuming
due authorization, execution and delivery on the part of PFIZER, this
Agreement constitutes a legal, valid and binding obligation of
WARNER-LAMBERT, enforceable against WARNER-LAMBERT in accordance with its
terms, except as the enforceability thereof may be limited by applicable
bankruptcy, insolvency, reorganization or other similar laws of general
application relating to creditors' rights.
(b) As of the date hereof, the execution and delivery of this
Agreement by WARNER-LAMBERT and the performance by WARNER-LAMBERT
contemplated hereunder will not violate any Laws or any order of any court
or other Governmental or Regulatory Authority.
(c) As of the date hereof, neither the execution and delivery of this
Agreement nor the performance hereof by WARNER-LAMBERT requires
WARNER-LAMBERT to obtain any permits, authorizations or consents from any
Governmental or Regulatory Authority or from any other Person, and such
execution, delivery and performance will not result in the breach of or
give rise to any termination of any agreement or contract to which
WARNER-LAMBERT may be a party and which relates to the Products.
(d) As of the date hereof, there are no actions, suits, proceedings
or claims, pending against WARNER-LAMBERT or any of its Affiliates, or, to
the knowledge of WARNER-LAMBERT, threatened against WARNER-LAMBERT or any
of its Affiliates, at law or in equity, or before or by any court or
Governmental or Regulatory Authority relating to any of the matters
contemplated under this Agreement. To the knowledge of WARNER-LAMBERT,
there are no investigations, pending or threatened against WARNER-LAMBERT
or any of its Affiliates, at law or in equity, or before or by any
Governmental or Regulatory Authority relating to any of the matters
contemplated under this Agreement.
(e) WARNER-LAMBERT acknowledges that PFIZER is relying, and is
entitled to rely, on the foregoing representations and warranties.
SECTION 6.03 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. 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 WARNER-LAMBERT 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 6.04 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.
SECTION 6.05 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 6.06 Choice of Law. 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.
SECTION 6.07 Assignment. This Agreement may not be assigned by
either party without the prior written consent of the other party; provided
that each party shall have the right to assign its rights and obligations
under this Agreement to (a) any third party successor to all or
substantially all of (i) its entire business or (ii) its pharmaceutical
business without the consent of the other party, subject however to
PFIZER's right to terminate this Agreement pursuant to Section 5.02(c), or
(b) its Affiliate or Affiliates who shall be substituted directly in whole
or in part for it hereunder; provided that the assignor shall be
responsible for the performance of its Affiliate(s) assignee(s) hereunder.
This Agreement shall be binding upon, and, subject to the terms of the
foregoing sentence, inure to the benefit of the parties hereto, their
successors, legal representatives and assigns.
SECTION 6.08 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:
WARNER-LAMBERT:
Warner-Lambert Company
201 Tabor Road
Morris Plains, New Jersey 07950
Attention: President, Pharmaceutical Sector
Facsimile No. (201) 540-4009
with a copy to: Vice President and General Counsel
Facsimile No. (201) 540-3927
PFIZER:
Pfizer Inc.
235 East 42nd Street
New York, New York 10017-5755
Attention: President, U.S. Pharmaceutical Group
Facsimile No. (212) 808-8652
with a copy to: Senior Vice President and General Counsel
Facsimile No. (212) 808-8924
or to such other address as the addressee shall have last furnished in
writing in accord with this provision to the addressor.
SECTION 6.9 Limitation of Liability. Notwithstanding anything to
the contrary in this Agreement, neither party shall be liable to the other
for any incidental, indirect or consequential damages.
SECTION 6.10 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 6.11 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 6.12 Entire Agreement. This Agreement together with the
Collaboration Agreement, the International Agreements and the Confidential
Disclosure Agreement, dated March 4, 1996, between WARNER-LAMBERT and
PFIZER (the "Confidential Disclosure 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 IV of this Agreement shall govern the protection
of Confidential Information disclosed 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 WARNER-LAMBERT and PFIZER.
SECTION 6.13 No License. Nothing in this Agreement shall be deemed
to constitute the grant to WARNER-LAMBERT of any license or other right to
or in respect of any Product except as expressly set forth herein.
SECTION 6.14 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 6.15 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, WARNER-LAMBERT and PFIZER, by their duly
authorized officers, have executed this Agreement as of the date first
written above.
WARNER-LAMBERT COMPANY PFIZER INC.
/s/ Lodewijk J.R. de Vink /s/ Karen L. Katen
------------------------------------ -------------------------------
Lodewijk J.R. de Vink Karen L. Katen
President and Chief Operating Officer Vice President
[EXHIBIT 99.3]
INTERNATIONAL COLLABORATION AGREEMENT
This Agreement, effective as of June 28, 1996, is made by and between
WARNER-LAMBERT COMPANY, a Delaware corporation (hereinafter
"WARNER-LAMBERT"), with primary offices located at 201 Tabor Road, Morris
Plains, New Jersey 07950, by and through its Parke-Davis Division, and
PFIZER INC., a Delaware corporation (hereinafter "PFIZER"), with primary
offices located at 235 East 42nd Street, New York, NY 10017-5755.
WHEREAS, WARNER-LAMBERT and its Affiliates own all rights, title and
interest in and to various patents relating to the Products (as hereinafter
defined); and
WHEREAS, WARNER-LAMBERT and PFIZER believe that the Products
represent an improvement upon existing pharmaceutical treatments for the
lowering of cholesterol levels in humans, and further believe that the
Products may prove beneficial in the treatment of cardiovascular disease;
and
WHEREAS, WARNER-LAMBERT believes that current sellers of
pharmaceutical products which are competitive with the Products are large,
powerful and well entrenched in the License Territory and the Co-Promotion
Territory (each as hereinafter defined) and as a consequence believes that
WARNER-LAMBERT alone would be limited in its ability to realize the
commercial potential for the Product; and
WHEREAS, PFIZER and its Affiliates have significant experience and
expertise in the marketing and promotion of pharmaceutical products, and
PFIZER does not market or sell a pharmaceutical product which is
competitive with the Products; and
WHEREAS, PFIZER believes it can make significant contributions to the
successful market development and commercialization of Products in the
License Territory and the Co-Promotion Territory; and
WHEREAS, WARNER-LAMBERT and PFIZER believe that the co-promotion or
licensing of the Products on the terms set forth herein will best enable
the medical profession and patients to recognize and benefit from the
Products, and WARNER-LAMBERT and PFIZER desire to bring those benefits to
the marketplace by co-promoting or licensing the Products pursuant to the
International Agreements.
NOW THEREFORE, for and in consideration of the foregoing and the
representations, covenants and agreements contained herein, WARNER-LAMBERT
and PFIZER, intending to be legally bound, hereby agree
as follows:
ARTICLE I - DEFINITIONS
Section 1.01 Definitions. The following capitalized terms shall have
the following meanings:
"Affiliate" means any Person that directly or indirectly controls or
is controlled by or is under common control with WARNER-LAMBERT or PFIZER,
as the case may be, but only for so long as said control shall continue. As
used herein the term "control" means possession of the power to direct or
cause the direction of the management and policies of a Person whether by
contract or otherwise.
"Agreement Year" has the meaning ascribed to it in the International
License Agreement.
"Atorvastatin" means the chemical compound ([R-(R*,R*)]-2-(4-
fluorophenyl)-B, d-dihydroxy-5-(l-methylethyl)-3-phenyl-4-[(phenylamino)
carbonyl]-lH-pyrrole-l-heptanoic acid, calcium salt (2:1) and hydrates
thereof.
"Bulk" has the meaning ascribed to it in the International License
Agreement.
"Co-Promotion Territory" means Australia, Austria, Belgium, Canada,
Finland, Germany, Greece, Luxembourg, Mexico, Netherlands, Portugal, Puerto
Rico, Republic of Ireland, South Africa, Sweden, Switzerland and United
Kingdom.
"Country" means any country in the Co-Promotion Territory or the
License Territory.
"Designated Marketing Authorization" means the authorization to sell
the Product in the applicable Country as granted by the relevant
Governmental or Regulatory Authority, which authorization includes
indications, warnings, etc. materially equivalent to those provided in
Exhibit A.
"Governmental or Regulatory Authority" means any court, tribunal,
arbitrator, agency, commission, official or other instrumentality of any
government or of any federal, state, county, city or other political
subdivision thereof.
"International Agreements" means this Agreement, the International
Co-Promotion Agreement and the International License Agreement.
"International Co-Promotion Agreement" means the International
Co-Promotion Agreement between WARNER-LAMBERT and PFIZER of even date
herewith.
"International License Agreement" means the International License
Agreement between WARNER-LAMBERT and PFIZER of even date herewith.
"Laws" means all laws, statutes, rules, regulations, ordinances and other
pronouncements having the effect of law of any government or Governmental or
Regulatory Authority.
"License Territory" means Brazil, Chile, China, Denmark, Iceland, Italy
(including San Marino and Vatican City) , Korea, Norway, Russia - C. I. S.
Republics, Spain and Turkey.
"Losses" means any and all damages, fines, fees, penalties,
judgments, deficiencies, losses and expenses (including without limitation
interest, court costs, reasonable fees of attorneys, accountants and other
experts or other expenses of litigation or other proceedings or of any
claim, default or assessment).
"Marketing Authorization" means the authorization to sell the Product in
the applicable Country as granted by the relevant Governmental or Regulatory
Authority.
"Milestone Countries" means Australia, Brazil, Canada, Germany, Italy,
First Nordic Country (as set forth in Section 3.01(iii)), Netherlands, Spain,
Turkey and the United Kingdom.
"Net Sales" has the meaning ascribed to it in the International License
Agreement.
"Person" means any natural person, corporation, general partnership,
limited partnership, joint venture, proprietorship or other business
organization.
"Price Approval" means, in Countries where Governmental or Regulatory
Authorities approve or determine pricing for pharmaceutical products for
reimbursement or otherwise, such approval or determination, which approval
or determination shall be acceptable to the party applying therefor.
"Products" means all finished pharmaceutical formulations that (i)
contain Atorvastatin as the sole active ingredient, or (ii) contain
Atorvastatin together with one or more other active ingredients where such
combination products have indications for (a) lipid lowering and the
treatment or prevention of atherosclerosis or (b) the treatment or
prevention of vascular disease.
ARTICLE II - CO-PROMOTION AND LICENSE RIGHTS
Section 2.01 Co-Promotion. WARNER-LAMBERT hereby agrees to grant to
PFIZER rights to co-promote the Products in the Co-Promotion Territory
pursuant to the terms of the International Co-Promotion Agreement which is
being executed simultaneously with the execution of this Agreement.
Section 2.02 License. WARNER-LAMBERT hereby agrees to grant to PFIZER
license rights to the Products in the License Territory pursuant to the
terms of the International License Agreement which is being executed
simultaneously with the execution of this Agreement.
Section 2.03 Other Countries. WARNER-LAMBERT and PFIZER shall discuss
the merits of including additional countries in the arrangements
contemplated by this Agreement, and if the parties agree, the International
License Agreement or the International Co- Promotion Agreement, as the case
may be, shall be amended to include such additional countries. The parties
shall discuss as soon as practicable after the execution of this Agreement
the inclusion of Argentina, Colombia and Venezuela in the License Territory
(under the terms of the International License Agreement) and the granting
to PFIZER of semi-exclusive rights to those countries pursuant to Section
2.01(b) or (c) of the International License Agreement.
ARTICLE III - PFIZER PAYMENTS
Section 3.01 PFIZER Payments. In consideration for the rights granted
to PFIZER under this Agreement, the International Co-Promotion Agreement
and the International License Agreement, PFIZER shall make the following
payments to WARNER-LAMBERT:
(i) Five Million Dollars (US$5,000,000) upon signing of this Agreement;
(ii) Subject to this Section 3.01 and Section 3.02, Thirty Million
Dollars (US$30,000,000) within five business days of the receipt by
PFIZER of notice from WARNER-LAMBERT of the issuance of a Designated
Marketing Authorization and Price Approval (if applicable) for the
Product in either Germany or the United Kingdom, whichever occurs
first; and
(iii) Subject to this Section 3.01 and Section 3.02, the amounts
indicated below within five business days of receipt by PFIZER of
notice from (A) WARNER-LAMBERT, in the case of (x) Milestone
Countries for which WARNER-LAMBERT has the responsibility of
obtaining a Marketing Authorization and Price Approval (if
applicable) pursuant to the terms of the International License
Agreement; or (y) Milestone Countries in the Co-Promotion
Territory, or (B) the applicable Governmental or Regulatory
Authority, in the case of Milestone Countries in the License
Territory for which PFIZER has the responsibility of obtaining a
Marketing Authorization and Price Approval (if applicable)
pursuant to the terms of the International License Agreement, in
each case, of the issuance of a Designated Marketing
Authorization and Price Approval (if applicable) for the Product
in each of the following countries:
Australia US$ 2,000,000
Brazil 2,000,000
Canada 7,500,000
First Nordic Country
(Denmark, Norway,
Sweden, Finland) 2,000,000
Netherlands 2,000,000
Turkey 2,000,000
(iv) In the event that a Marketing Authorization in any Milestone
Country does not constitute a Designated Marketing Authorization
within thirty (30) days after the receipt of such Marketing
Authorization, WARNER-LAMBERT shall notify PFIZER whether
WARNER-LAMBERT is agreeable or not to undertaking, at
WARNER-LAMBERT's sole expense, such additional studies as may be
necessary in order to obtain a Designated Marketing
Authorization; provided, that WARNER-LAMBERT shall have the right
at any time, upon notice to PFIZER, to cease any further activity
with respect to such additional studies.
(v) In the event that a Designated Marketing Authorization and
Price Approval (if applicable) are not received by PFIZER or
WARNER-LAMBERT, as the case may be, on or prior to July 1, 1999
covering Australia, Canada, the first Nordic Country, the
Netherlands, Brazil or Turkey, the following shall apply:
(A) In the Milestone Countries where WARNER-LAMBERT has the
responsibility of obtaining a Marketing Authorization and Price
Approval (if applicable), WARNER-LAMBERT shall deliver a notice to
PFIZER indicating whether or not WARNER-LAMBERT will continue to seek
a Designated Marketing Authorization and Price Approval (if
applicable) in the relevant Country.
(1) In the event that WARNER-LAMBERT notifies PFIZER that
WARNER-LAMBERT will permanently not seek or will withdraw its
application for a Designated Marketing Authorization
and/or Price Approval (if applicable), PFIZER shall relinquish
all of its co-promotion and licensing rights with respect to
such Country and the affected Country shall be removed from the
Co-Promotion Territory or License Territory and the
International Co-Promotion Agreement or International License
Agreement shall be modified accordingly; provided, however, in
the event at any time thereafter WARNER-LAMBERT determines that
it or its Affiliate or licensee will launch a Product under a
Marketing Authorization that is not a Designated Marketing
Authorization, WARNER-LAMBERT will deliver a notice thereof to
PFIZER, and PFIZER will have ninety days following the receipt
of such notice to request that its license or co-promotion
rights be reinstated. If Price Approval for such Product is not
required or has been obtained, such request will be accompanied
by a payment to WARNER-LAMBERT of the amount set forth in
Section 3.01(iii); otherwise, PFIZER shall pay the amount set
forth in Section 3.01(iii) within five business days after
receipt by PFIZER of notice of Price Approval from the relevant
Governmental or Regulatory Authority, or in the event that
WARNER-LAMBERT is responsible for obtaining Price Approval,
within five business days of notice from WARNER-LAMBERT of the
issuance of a Price Approval.
(2) In the event that WARNER-LAMBERT notifies PFIZER that
WARNER-LAMBERT will continue to seek a Designated Marketing
Authorization and Price Approval (if applicable), PFIZER shall
have the right, for a period of ninety days after receipt of
such notice, to request that such Country be removed from the
Co-Promotion Territory or License Territory, as the case may
be. In the event that PFIZER makes such a request, PFIZER shall
relinquish all of its co-promotion and licensing rights with
respect to such Country and the affected Country shall be
removed from the Co-Promotion Territory or License Territory
and the International Co-Promotion Agreement or International
License Agreement shall be modified accordingly. In the event
that PFIZER does not make such a request within ninety days
after receipt of notice from WARNER-LAMBERT, the amounts set
forth in Section 3.01(iii) shall be payable in accordance with
the terms thereof.
(B) In the Milestone Countries where PFIZER has the
responsibility of obtaining a Marketing Authorization and
Price Approval (if applicable), PFIZER shall deliver a
notice to WARNER-LAMBERT indicating whether or not PFIZER
will continue to seek a Designated Marketing Authorization
and Price Approval (if applicable) in the relevant Milestone
Country.
(1) In the event that PFIZER notifies WARNER-LAMBERT that
PFIZER will permanently not seek or will withdraw its
application for a Designated Marketing Authorization and Price
Approval (if applicable), PFIZER shall relinquish all of its
co-promotion and licensing rights with respect to such Country
and the affected Country shall be removed from the Co-Promotion
Territory or License Territory and the International
Co-Promotion Agreement or International License Agreement shall
be modified accordingly.
(2) In the event that PFIZER notifies WARNER-LAMBERT that
PFIZER will continue to seek a Designated Marketing
Authorization and/or Price Approval (if applicable), PFIZER
shall use its reasonable efforts to obtain such Designated
Marketing Authorization and/or Price Approval (if applicable)
within twelve months after such notice is given. If PFIZER is
unable after twelve months to obtain such Designated Marketing
Authorization and/or Price Approval (if applicable), PFIZER
shall (unless good faith negotiations are continuing with the
relevant Governmental or Regulatory Authority) relinquish all
of its co-promotion and licensing rights with respect to such
Country and the affected Country shall be removed from the
Co-Promotion Territory or License Territory and the
International Co-Promotion Agreement or International License
Agreement shall be modified accordingly.
Section 3.02 Adjustments. The following adjustments shall be made to
the payments specified in Section 3.01:
(i) If PFIZER shall have made the payment under Section 3.01(ii)
based on the receipt of a Designated Marketing Authorization and
Price Approval (if applicable) for Germany and a Designated Marketing
Authorization and Price Approval (if applicable) for the United
Kingdom are received on or prior to July 1, 1999, then PFIZER shall
pay to WARNER-LAMBERT US$7,500,000 within five business days of the
receipt by PFIZER of notice from WARNER-LAMBERT of the issuance of a
Designated Marketing Authorization and Price Approval (if applicable)
for the Product in the United Kingdom.
(ii) In the event that PFIZER shall have made the payment under
Section 3.01(ii) based on the receipt of a Designated Marketing
Authorization and Price Approval (if applicable) for Germany and if
no Designated Marketing Authorization and Price Approval (if
applicable) for the United Kingdom are received on or prior to July
1, 1999, then the following shall apply:
WARNER-LAMBERT shall deliver a notice to PFIZER indicating whether or
not it will continue to seek a Designated Marketing Authorization and Price
Approval (if applicable) in the United Kingdom.
(1) In the event that WARNER-LAMBERT notifies PFIZER that
WARNER-LAMBERT will permanently not seek or will withdraw its
application for a Designated Marketing Authorization and Price
Approval (if applicable), PFIZER shall relinquish all of its
co-promotion rights with respect to the United Kingdom and the
United Kingdom shall be removed from the Co-Promotion Territory
and the International Co-Promotion Agreement shall be modified
accordingly; provided, however, in the event at any time
thereafter WARNER-LAMBERT determines that it or its Affiliate
or licensee will launch a Product under a Marketing
Authorization that is not a Designated Marketing Authorization,
WARNER-LAMBERT will deliver a notice thereof to PFIZER and
PFIZER will have ninety days following the receipt of such
notice to request that its co-promotion rights be reinstated.
If Price Approval for such Product is not required or has been
obtained, such request will be accompanied by a payment to
WARNER-LAMBERT of US$7,500,000, otherwise, PFIZER shall pay to
WARNER-LAMBERT US$7,500,000 within five business days after
receipt by PFIZER of notice from WARNER-LAMBERT of the issuance
of a Price Approval.
(2) In the event that WARNER-LAMBERT notifies PFIZER that
WARNER-LAMBERT will continue to seek a Designated Marketing
Authorization and Price Approval (if applicable), PFIZER shall
have the right, for a period of ninety days after receipt of
such notice, to request that the United Kingdom be removed from
the Co-Promotion Territory. In the event that PFIZER makes such
a request, PFIZER shall relinquish all of its co-promotion
rights with respect to the United Kingdom, the United Kingdom
shall be removed from the Co-Promotion Territory and the
International Co-Promotion Agreement shall be modified
accordingly. In the event that PFIZER does not make such a
request within ninety days after receipt of notice from
WARNER-LAMBERT, PFIZER shall pay U.S.$7,500,000 within
five business days of the receipt by PFIZER of notice from
WARNER-LAMBERT of the issuance of a Designated Marketing
Authorization and Price Approval (if applicable) for the
Product in the United Kingdom.
(iii) If PFIZER shall have made the payment under Section 3.01(ii)
based on receipt of a Designated Marketing Authorization and Price
Approval (if applicable) for the United Kingdom and a Designated
Marketing Authorization and Price Approval (if applicable) for
Germany are received prior to July 1, 1999, then PFIZER shall pay to
WARNER-LAMBERT US$7,500,000 within five business days of the receipt
by PFIZER of notice from WARNER-LAMBERT of the issuance of a
Designated Marketing Authorization and Price Approval (if applicable)
for the Product in Germany.
(iv) If PFIZER shall have made the payment under Section 3.01(ii)
based on receipt of a Designated Marketing Authorization and Price
Approval (if applicable) for the United Kingdom and if no Designated
Marketing Authorization and Price Approval (if applicable) for
Germany are received prior to July 1, 1999, the following shall
apply:
WARNER-LAMBERT shall deliver a notice to PFIZER indicating whether or
not it will continue to seek a Designated Marketing Authorization and
Price Approval (if applicable) in Germany.
(1) In the event that WARNER-LAMBERT notifies PFIZER that
WARNER-LAMBERT will permanently not seek or will withdraw its
application for a Designated Marketing Authorization and Price
Approval (if applicable), PFIZER shall relinquish all of its
co-promotion rights with respect to Germany and Germany shall
be removed from the Co-Promotion Territory and the
International Co-Promotion Agreement shall be modified
accordingly and PFIZER shall be entitled to a credit of
US$2,500,000 against payments due under Sections 3.01 or 3.02;
provided, however, in the event at any time thereafter
WARNER-LAMBERT determines that it or its Affiliate or licensee
will launch a Product under a Marketing Authorization that is
not a Designated Marketing Authorization, WARNER-LAMBERT will
deliver a notice thereof to PFIZER and PFIZER will have ninety
days following the receipt of such notice to request that its
co-promotion rights be reinstated. If Price Approval for such
Product is not required or has been obtained, such request will
be accompanied by a payment to WARNER-LAMBERT of US$10,000,000;
otherwise PFIZER shall pay US$10,000,000 within five business
days after receipt by PFIZER of notice from WARNER-LAMBERT
of the issuance of a Price Approval.
(2) In the event that WARNER-LAMBERT notifies PFIZER that
WARNER-LAMBERT will continue to seek a Designated Marketing
Authorization and Price Approval (if applicable), PFIZER shall
have the right, for a period of ninety days after receipt of
such notice, to request that Germany be removed from the
Co-Promotion Territory. In the event that PFIZER makes such a
request, PFIZER shall relinquish all of its co-promotion rights
with respect to Germany, Germany shall be removed from the
Co-Promotion Territory and the International Co-Promotion
Agreement shall be modified accordingly and PFIZER shall be
entitled to a credit of US$2,500,000 against payments due under
Sections 3.01 or 3.02. In the event that PFIZER does not make
such a request within ninety days after receipt of notice from
WARNER-LAMBERT, PFIZER shall pay US$7,500,000 within five
business days of the receipt by PFIZER of notice from
WARNER-LAMBERT of the issuance of a Designated Marketing
Authorization and Price Approval (if applicable) for the
Product in Germany.
(v) (A) If PFIZER shall have made the payment under Section
3.01(ii) and no Designated Marketing Authorization and Price Approval (if
applicable) for Spain or Italy has been received prior to July 1, 1999,
then the following shall apply with respect to each such Country:
WARNER-LAMBERT shall deliver a notice to PFIZER indicating whether or
not it will continue to seek a Designated Marketing Authorization and Price
Approval (if applicable) in such Country.
(1) In the event that WARNER-LAMBERT notifies PFIZER that
WARNER-LAMBERT will permanently not seek or will withdraw its
application for a Designated Marketing Authorization and Price
Approval (if applicable), PFIZER shall relinquish all of its
license rights with respect to such Country and such Country
shall be removed from the License Territory and the
International License Agreement shall be modified accordingly
and PFIZER shall be entitled to a credit of US$10,000,000
against payments due under Sections 3.01 or 3.02. It is
understood that such credit shall be US$10,000,000 for each
such Country where PFIZER has relinquished its licensing rights
in accordance with this subclause (1); provided, however, that
in the event at any time thereafter WARNER-LAMBERT determines
that it or its Affiliate or licensee will launch a Product
under a Marketing Authorization that is not a Designated
Marketing Authorization, WARNER-LAMBERT will deliver a
notice thereof to PFIZER and PFIZER will have ninety days
following the receipt of such notice to request that its
license rights be reinstated. If Price Approval for such
Product is not required or has been obtained, such request
will be accompanied by a payment to WARNER-LAMBERT of
US$10,000,000, otherwise PFIZER shall pay US$10,000,000
within five business days after receipt by PFIZER of notice
from WARNER-LAMBERT of the issuance of a Price Approval.
(2) In the event that WARNER-LAMBERT notifies PFIZER that
WARNER-LAMBERT will continue to seek a Designated Marketing
Authorization and Price Approval (if applicable), PFIZER shall
have the right, at any time after receipt of such notice, to
request that such Country be removed from the License
Territory. In the event that PFIZER makes such a request,
PFIZER shall relinquish all of its license rights with respect
to such Country, such country shall be removed from the License
Territory and the International License Agreement shall be
modified accordingly and PFIZER shall be entitled to a credit
of US$10,000,000 against payments due under Sections 3.01 or
3.02. It is understood that such credit shall be US$10,000,000
for each such Country where PFIZER has relinquished its
licensing rights in accordance with this subclause (2). In the
event that PFIZER does not make such a request, PFIZER shall
not be entitled to such credit.
(B) If PFIZER shall have made the payment under Section
3.01(ii) and no Designated Marketing Authorization and Price Approval
(if applicable) for either Italy or Spain has been received by PFIZER
prior to July 1, 1999, but the corresponding Designated Marketing
Authorization and Price Approval has been received by WARNER-LAMBERT,
then, provided that PFIZER has not received a credit or refund
pursuant to subclause (A) of this Section 3.02(v), PFIZER shall have
the-right to request that Italy or Spain, as the case may be, be
removed from the License Territory. In the event that PFIZER makes
such a request, PFIZER shall relinquish all of its licensing rights
with respect to Italy or Spain, as the case may be, and such Country
shall be removed from the License Territory and the International
License Agreement shall be modified accordingly and PFIZER shall be
entitled to a credit of US$10,000,000 against payments due under
Sections 3.01 or 3.02. It is understood that such credit shall be
US$10,000,000 for each such Country where PFIZER has relinquished its
licensing rights in accordance with this subclause (B).
(vi) All PFIZER credits as specified in this Section 3.02 shall first
be applied by PFIZER against payment of any amounts payable under
Sections 3.01 or 3.02, as PFIZER may elect. To the extent that
amounts hereafter payable under Sections 3.01 and 3.02 are less than
the full amount of said credits, then WARNER-LAMBERT shall pay to
PFIZER the shortfall on the earlier of July 1, 1999 or the date
PFIZER has made all payments contemplated under Sections 3.01 and
3.02. Notwithstanding the foregoing, all amounts paid by PFIZER
pursuant to Section 3.01(i) and all Product Expenses (as defined in
the International Co-Promotion Agreement) paid by PFIZER prior to
such notification or PFIZER's relinquishment of such rights shall be
nonrefundable.
Section 3.03 Manner of Payments. All sums payable under Section 3.01
shall be payable in United States Dollars by bank wire transfer in
immediately available funds to such bank account as WARNER-LAMBERT shall
designate. PFIZER shall notify WARNER-LAMBERT's Assistant Treasurer,
International by facsimile transmission (at 201-540-7761 or such other
number as may be communicated to PFIZER by WARNER-LAMBERT) as to the date
and amount of any such wire transfer to WARNER-LAMBERT one business day
prior to such transfer. WARNER-LAMBERT shall notify PFIZER's Treasurer by
facsimile transmission (at 212-573-1133 or such other number as may be
communicated to WARNER-LAMBERT by PFIZER) as to the date and amount of any
such wire transfer to PFIZER one business day prior to such transfer. Any
taxes imposed on and required to be paid or withheld by PFIZER on account
of amounts payable to WARNER-LAMBERT under this Agreement shall be deducted
from the amount of payment due hereunder at the rates specified by
applicable Law or treaty. In cases where a tax treaty is applicable and
WARNER-LAMBERT desires to benefit thereby, WARNER-LAMBERT shall provide
PFIZER with appropriate documentation necessary to receive benefits
thereunder. In addition, PFIZER shall provide promptly to WARNER-LAMBERT
receipts from the relevant government or taxing authority evidencing
payment of such taxes.
Section 3.04 Interest. Subject to applicable Law and Section 3.05(d),
if (a) either PFIZER or WARNER -LAMBERT fails to make a timely payment
pursuant to this Article III, (b) or WARNER-LAMBERT issues credits pursuant
to this Article III, interest shall accrue on such amount from the day on
which the credit is established until the day on which such credit is
extinguished, interest shall accrue on the past due amount or the amount of
such credit at a rate equal to the rate of interest for 30 day high-grade
commercial paper issued by major corporations effective for the first date
on which the payment was delinquent, calculated on an actual/360 basis, as
quoted in The Wall Street Journal.
Section 3.05 WARNER-LAMBERT Payments in Respect of License
Territories.
(a) In consideration for its participation in the marketing,
promotion and sale of the Products in each Country in the License
Territory, for each Agreement Year and separately calculated for each
Country in the License Territory, until the expiration or earlier
termination of the International License Agreement, WARNER-LAMBERT agrees
to pay PFIZER an amount, calculated in the currency of the Country of sale,
equal to the difference between (i) the aggregate amount paid by PFIZER to
WARNER-LAMBERT for Bulk with respect to such Country under the
International License Agreement during such Agreement Year and (ii) 28% of
Net Sales in such Country during such Agreement Year. Such payment shall be
adjusted simultaneously with any adjustments made pursuant to Section
4.01(d)(v) of the International License Agreement. Notwithstanding anything
contained in this Section 3.05, in the event that any adjustment is made
for a Country pursuant to the proviso contained in Section 4.01(d)(i) of
the International License Agreement, PFIZER shall not be entitled to the
payments set forth in this Section 3.05 for such Country.
(b) WARNER-LAMBERT shall make payments to PFIZER arising under
Section 3.05(a) on a quarterly basis by Country based upon the estimated
prices determined in accordance with Section 4.01(d)(ii) of the
International License Agreement. The aggregate amount of all such payments
made with respect to each Country for each Agreement Year shall be adjusted
simultaneously with any adjustments made pursuant to Section 4.01(d)(v) of
the International License Agreement and the adjusted amount shall be paid
by one party to the other as appropriate.
(c) All sums due to either party shall be payable in the currency
applicable to the respective Country for which the calculation is made
under Sections 3.05(a) and (b) by bank wire transfer in immediately
available funds to such bank account(s) as each of PFIZER and
WARNER-LAMBERT shall designate. PFIZER shall notify WARNER-LAMBERT's
Assistant Treasurer, International by facsimile transmission (at
201-540-7761 or such other number as may be communicated to PFIZER by
WARNER-LAMBERT) as to the date and amount of any such wire transfer to
WARNER-LAMBERT one business day prior to such transfer. WARNER-LAMBERT
shall notify PFIZER's Treasurer by facsimile transmission (at 212-573-1133
or such other number as may be communicated to WARNER-LAMBERT by PFIZER) as
to the date and amount of any such wire transfer to PFIZER one business day
prior to such transfer. Any taxes imposed on and required to be paid or
withheld by PFIZER on account of amounts payable to WARNER-LAMBERT under
this Agreement shall be deducted from the amount of payment due hereunder
at the rates specified by applicable Law or treaty. In cases where a tax
treaty is applicable and WARNER-LAMBERT desires to benefit thereby,
WARNER-LAMBERT shall provided PFIZER with appropriate documentation
necessary to receive benefits thereunder. In addition, PFIZER shall provide
promptly to WARNER-LAMBERT receipts from the relevant government or taxing
authority evidencing payment of such taxes.
(d) If either WARNER-LAMBERT or PFIZER shall fail to make a timely
payment pursuant to this Section 3.05, interest shall accrue on the past
due amount at a rate equal to the 30 day local interbank rate applicable
for the currency of payment, effective for the first date on which payment
was delinquent, as published in The Financial Times or, if such rate is not
regularly published in The Financial Times, as published in such source as
the parties may mutually agree.
ARTICLE IV - REPRESENTATIONS,
WARRANTIES AND INDEMNIFICATION
Section 4.01WARNER-LAMBERT Representations and Warranties.
WARNER-LAMBERT hereby represents, warrants and covenants to
PFIZER as follows:
(a) As of the date hereof, WARNER-LAMBERT has the corporate power and
authority to execute and deliver the International Agreements and to
perform its obligations thereunder, and the execution, delivery and
performance of the International Agreements by WARNER-LAMBERT have been
duly and validly authorized and approved by proper corporate action on the
part of WARNER-LAMBERT, and WARNER-LAMBERT has taken all other action
required by Law, its certificate of incorporation, by-laws or any agreement
to which it is a party or to which it may be subject that is required to
authorize such execution, delivery and performance. Assuming due
authorization, execution and delivery on the part of PFIZER, the
International Agreements constitute legal, valid and binding obligations of
WARNER-LAMBERT, enforceable against WARNER-LAMBERT in accordance with their
terms, except as the enforceability thereof may be limited by applicable
bankruptcy, insolvency, reorganization or other similar laws of general
application relating to creditors' rights.
(b) As of the date hereof, the execution and delivery of the
International Agreements by WARNER-LAMBERT and the performance by
WARNER-LAMBERT contemplated hereunder and thereunder will not violate any
Laws or any order of any court or other Governmental or Regulatory
Authority.
(c) As of the date hereof, the execution and delivery of the
International Agreements by WARNER-LAMBERT does not require WARNER-LAMBERT
to obtain any permits, authorizations or consents from any
Governmental or Regulatory Authority. In addition, the execution, delivery
and performance of the International Agreements by WARNER-LAMBERT does not
require WARNER-LAMBERT to obtain any permits, authorizations or consents
from any other Person. Except as set forth in Exhibit B, the execution,
delivery and performance of the International Agreements by WARNER-LAMBERT
will not result in the breach of or give rise to any termination of any
agreement or contract to which WARNER-LAMBERT may be a party and which
relates to the Products.
(d) As of the date hereof, Exhibit C contains a correct and complete
list of all patents and patent applications issued or pending in the
Countries relating to Atorvastatin which are owned by WARNER-LAMBERT or its
Affiliates (collectively, the "Patents"). All of the Patents issued as of
the date hereof (i) are held of record by WARNER-LAMBERT, (ii) are free and
clear of all liens, encumbrances and other claims, and (iii) are not
subject in any Country to any pending cancellation, opposition or
reexamination proceeding or any other proceeding challenging their extent
or validity. To the best of WARNER-LAMBERT's knowledge, all of the Patents
issued as of the date hereof are valid and in full force. WARNER-LAMBERT is
the owner of record of all applications listed on Exhibit C. To the best of
WARNER-LAMBERT's knowledge, the claims included in such applications relate
to patentable subject matter, and WARNER-LAMBERT is not aware of any reason
that such claims would not be allowed to issue, other than with respect to
European Patent Application 90113986.5, which was filed on July 20, 1990,
has been rejected in the Official Actions issued by the EPO, and is
continuing to be prosecuted by WARNER-LAMBERT.
(e) As of the date hereof, to the best of WARNER-LAMBERT's knowledge,
the manufacture, use or sale of the Products does not infringe any patents
of third parties, and, to the best knowledge of WARNER-LAMBERT, no third
party is infringing in the Countries any of the issued Patents or any of
the claims of the patent applications listed in Exhibit C.
(f) As of the date hereof, here are no actions, suits, proceedings or
claims, pending against WARNER-LAMBERT or any of its Affiliates, or, to the
knowledge of WARNER-LAMBERT, threatened against WARNER-LAMBERT or any of
its Affiliates, at law or in equity, or before or by any court or
Governmental or Regulatory Authority relating to the Products or any of the
matters contemplated under the International Agreements. To the knowledge
of WARNER-LAMBERT, there are no investigations, pending or threatened
against WARNER-LAMBERT or any of its Affiliates, at law or in equity, or
before or by any Governmental or Regulatory Authority relating to the
Products or any of the matters contemplated under the International
Agreements.
(g) As of the date hereof, WARNER-LAMBERT has exercised reasonable
diligence to ensure that the applications for Marketing Authorization and,
Price Approval (if applicable) filed with the applicable Governmental or
Regulatory Authorities in each Country and all amendments thereto have been
prepared in accordance with all applicable Laws.
(h) As of the date hereof, WARNER-LAMBERT has heretofore disclosed to
PFIZER all material information known to WARNER-LAMBERT with respect to the
safety and effectiveness of the Products or human risk factors relating
thereto.
(i) WARNER-LAMBERT will exercise reasonable diligence to ensure that
the applications for Marketing Authorization and Price Approval (if
applicable) to be filed with the applicable Governmental or Regulatory
Authorities in each country, and all amendments thereto, will be prepared
in accordance with all applicable Laws.
(j) WARNER-LAMBERT acknowledges that PFIZER is relying, and is
entitled to rely, on the foregoing representations, warranties
and covenants.
Section 4.02 PFIZER Representations and Warranties. PFIZER
hereby represents and warrants to WARNER-LAMBERT as of the date hereof as
follows:
(a) As of the date hereof, PFIZER has the corporate power and
authority to execute and deliver the International Agreements and to
perform its obligations thereunder, and the execution, delivery and
performance of the International Agreements by PFIZER have been duly and
validly authorized and approved by proper corporate action on the part of
PFIZER, and PFIZER has taken all other action required by law, its
certificate of incorporation, by-laws or any agreement to which it is a
party or to which it may be subject that is required to authorize such
execution, delivery and performance. Assuming due authorization, execution
and delivery on the part of WARNER-LAMBERT, the International Agreements
constitute legal, valid and binding obligations of PFIZER, enforceable
against PFIZER in accordance with their terms, except as the enforceability
thereof may be limited by applicable bankruptcy, insolvency, reorganization
or other similar laws of general application relating to creditors' rights.
(b) As of the date hereof, the execution and delivery of the
International Agreements by PFIZER and the performance by PFIZER
contemplated thereunder will not violate any Laws or any order of any court
or other Governmental or Regulatory Authority.
(c) As of the date hereof, the execution and delivery of the
International Agreements by PFIZER does not require PFIZER to obtain any
permits, authorizations or consents from any Governmental or Regulatory
Authority. In addition, the execution, delivery and performance of the
International Agreements by PFIZER does not require PFIZER to obtain any
permits, authorizations or consents from any other Person. The execution,
delivery and performance of the International Agreements by PFIZER will not
result in the breach of or give rise to any termination of any agreement or
contract to which PFIZER may be a party.
(d) As of the date hereof, there are no actions, suits, proceedings
or claims pending against PFIZER or any of its Affiliates, or, to the
knowledge of PFIZER, threatened against PFIZER or any of its Affiliates, at
law or in equity, or before or by any court or Governmental or Regulatory
Authority relating to any of the matters contemplated under the
International Agreements. To the knowledge of PFIZER, there are no
investigations, pending or threatened against PFIZER or any of its
Affiliates, at law or in equity, or before or by any Governmental or
Regulatory Authority relating to the matters contemplated under the
International Agreements or which would otherwise materially adversely
affect PFIZER's ability to perform its obligations under the International
Agreements.
(e) PFIZER will exercise reasonable diligence to ensure that the
applications for Marketing Authorization and Price Approval (if applicable)
to be filed with the applicable Governmental or Regulatory Authorities in
each Country, and all amendments thereto, will be prepared in accordance
with all applicable Laws.
(f) PFIZER acknowledges that WARNER-LAMBERT is relying, and is
entitled to rely, on the foregoing representations, warranties
and covenants.
Section 4.03 Indemnification of PFIZER.
(a) WARNER-LAMBERT shall indemnify, defend and hold PFIZER PARTIES
(as hereinafter defined) harmless from and against any and all Losses
incurred, suffered or sustained by PFIZER PARTIES or to which PFIZER
PARTIES become subject, arising out of or resulting from (i) any third
party claims, actions, suits, proceedings, liabilities or obligations
arising from (a) any misrepresentation or breach of any representation,
warranty or agreement made by WARNER-LAMBERT in the International
Agreements, (b) any act or omission of negligence, recklessness or willful
misconduct of WARNER-LAMBERT or (c) the testing, manufacture, use or sale
of the Products (including, without limitation, any claim for death or
bodily injury or patent or trademark infringement), except to the extent
that the foregoing is directly attributable to the Packaging by PFIZER
pursuant to the International License Agreement; and (ii) any claim for
indemnification by PFIZER which is wrongfully disputed by WARNER-LAMBERT.
For purposes of this Section 4.03 PFIZER PARTIES means PFIZER and its
Affiliates and their respective agents, directors, officers and employees.
(b) The indemnity in Section 4.03(a) shall not apply to the extent
that any Loss is primarily the result of any breach of the International
Agreements by PFIZER or of any act or omission of negligence, recklessness
or willful misconduct of PFIZER PARTIES.
Section 4.04 Indemnification of WARNER-LAMBERT.
(a) PFIZER shall indemnify, defend and hold WARNER-LAMBERT PARTIES
(as hereinafter defined) harmless from and against any and all Losses
incurred, suffered or sustained by WARNER-LAMBERT PARTIES or to which
WARNER-LAMBERT PARTIES become subject, arising out of or resulting from:
(i) any third party claims, actions, suits, proceedings, liabilities or
obligations arising from (a) any misrepresentation or breach of any
representation, warranty or agreement made by PFIZER in the International
Agreements, (b) any act or omission of negligence, recklessness or willful
misconduct of PFIZER or (c) PFIZER's Packaging pursuant to the
International License Agreement; and (ii) any claim for indemnification by
WARNER-LAMBERT which is wrongfully disputed by PFIZER. For purposes of this
Section 4.04 WARNER-LAMBERT PARTIES means WARNER-LAMBERT and its Affiliates
and their respective agents, directors, officers and employees.
(b) The indemnity in Section 4.04(a) shall not apply to the extent
that any Loss is primarily the result of any breach of the International
Agreements by WARNER-LAMBERT or of any act or omission of negligence,
recklessness or willful misconduct of WARNER-LAMBERT PARTIES.
Section 4.05Procedures. In the event any third party asserts any
claim with respect to any matter to which the indemnification in Sections
4.03 or 4.04 relates, the party against whom the claim is asserted (the
"Indemnified Party") shall not make any admission concerning such claim,
but shall promptly notify the other party (the "Indemnifying Party"), of
the claim, and the Indemnifying Party shall be entitled, but not obliged,
to manage and control, at its sole expense, the defense of the claim and
its settlement. The benefit of any indemnity by the Indemnifying Party
under this Agreement in respect of any claim shall not apply to the
Indemnified Party if any admission made by such party or any failure by
such party to notify the Indemnifying Party of the claim materially
prejudices the defense of such claim. If the Indemnifying Party elects to
defend such claim, it shall give prompt notice to the Indemnified Party. If
the Indemnifying Party does not give such notice and does not proceed
diligently to defend the Indemnified Party within twenty (20) days after
receipt of notice of the claim, the Indemnifying Party shall be bound by
any defense or settlement made by the Indemnified Party and shall reimburse
the Indemnified Party for its Losses and expenses related to the defense or
settlement of the third party claim. If the Indemnifying Party elects to
defend the claim and gives notice to the Indemnified Party and proceeds
diligently to defend the Indemnified Party, then the Indemnified Party
shall not settle any claim for which it is seeking indemnification without
the prior consent of the Indemnifying Party. The Indemnified Party shall,
if requested by the Indemnifying Party, cooperate in all reasonable
respects in the defense of such a third party claim which is being managed
and controlled by the Indemnifying Party. The Indemnified Party may, at its
option and expense, be represented by counsel of its own choice in any
action or proceeding arising out of such claim; provided, however, the
Indemnifying Party shall not be liable for any litigation costs or expenses
incurred, without its consent, by the Indemnified Party where such action
or proceeding is under the control and management of the Indemnifying
Party.
Section 4.06 Insurance Proceeds. Any indemnification hereunder shall
be made net of any insurance proceeds recovered by the Indemnified Party;
provided, however, that if, following the payment to the Indemnified Party
of any amount under this Article IV, such Indemnified Party recovers any
insurance proceeds in respect of the claim for which such indemnification
payment was made, the Indemnified Party shall promptly pay an amount equal
to the amount of such proceeds (but not exceeding the amount of such
indemnification payment) to the Indemnifying Party.
Section 4.07 Survival. The provisions of this Article IV shall survive
the expiration or termination of this Agreement.
ARTICLE V - MISCELLANEOUS
Section 5.01 Confidentiality; Public Announcements.
(a) Each party shall keep the terms of this Agreement confidential
and shall not disclose the same to any third party other than (i) by
agreement of the parties hereto, or (ii) as required by Law or stock
exchange regulation or an order of a competent court; provided that prior
to disclosure pursuant to (ii) above, the disclosing party shall notify the
nondisclosing party sufficiently prior to making such disclosure so as to
allow the nondisclosing party adequate time to take whatever action it may
deem to be appropriate to protect the confidentiality of the information.
(b) Neither party shall make any press release or other public
announcement or other disclosure to third parties relating to this
Agreement without the prior consent of the other party, which consent shall
not be unreasonably withheld, except where required by applicable Law;
provided that prior to disclosure, the disclosing party shall notify the
nondisclosing party sufficiently prior to making such disclosure so as to
allow the nondisclosing party adequate time to take whatever action it may
deem to be appropriate to protect the confidentiality of the information.
Section 5.02 Choice of Law: Submission to Jurisdiction. This Agreement
shall be governed by and construed in accordance with the law of the State
of New York other than those provisions governing conflicts of law. Each
party hereby irrevocably and unconditionally submits for itself and its
property in any legal action or proceeding relating to or arising out of
this Agreement, or any of the transactions contemplated hereby, to the
nonexclusive general jurisdiction of the Courts of the State of New York,
the courts of the United States of America for the Southern District of New
York, and appellate courts from any thereof, and agrees that any such
action or proceeding may be brought in such courts.
Section 5.03 Assignment. This Agreement may not be assigned by either
party without the prior consent of the other party; provided that each
party shall have the right to assign its rights and obligations under this
Agreement to (a) any third party successor to all or substantially all of
(i) its entire business or (ii) its pharmaceutical business or (b) in whole
or in part to its Affiliate or Affiliates who shall be substituted directly
in whole or in part for it hereunder; provided, however, that the assignor
shall be responsible for the performance of its Affiliate assignee(s)
hereunder. This Agreement shall be binding upon, and subject to the terms
of the foregoing sentence, inure to the benefit of the parties hereto,
their successors, legal representatives and assigns.
Section 5.04 Notices. All demands, notices, consents, approvals,
reports, requests and other communications hereunder must be in writing and
will be deemed to have been duly given only if delivered personally or by
facsimile transmission or by mail (first class, postage prepaid) to the
parties at the following addresses or facsimile numbers:
WARNER-LAMBERT:
Warner-Lambert Company
201 Tabor Road
Morris Plains, New Jersey 07950
Attention: President, Pharmaceutical Sector
Facsimile No. 201-540-4009
with a copy to: Vice President and General Counsel
Facsimile No. (201) 540-3927
PFIZER:
Pfizer Inc.
235 East 42nd Street
New York, New York 10017-5755
Attention: President, International Pharmaceuticals Group
Facsimile No. (212) 573-1240
with a copy to: Senior Vice President and General Counsel
Facsimile No. (212) 808-8924
or to such other address as the addressee shall have last furnished in
writing in accord with this provision to the addressor.
Section 5.05 Invalid Provisions. If any provision of this Agreement is
held to be illegal, invalid or unenforceable under any applicable present
or future Law, and if the rights or obligations of either party hereto
under this Agreement will not be materially and adversely affected thereby,
(i) such provision will be fully severable, (ii) this Agreement will be
construed and enforced as if such illegal, invalid or unenforceable
provision had never comprised a part hereof, (iii) the remaining provisions
of this Agreement will remain in full force and effect and will not be
affected by the illegal, invalid or unenforceable provision or by its
severance herefrom and (iv) in lieu of such illegal, invalid or
unenforceable provision, there will be added automatically as a part of
this Agreement, a legal, valid and enforceable provision as similar in
terms to such illegal, invalid or unenforceable provision as may be
possible.
Section 5.06 Headings. The headings used in this Agreement have been
inserted for convenience of reference only and do not define or limit the
provisions hereof.
Section 5.07 Waiver. Any term or condition of this Agreement may be
waived at any time by the party that is entitled to the benefit thereof,
but no such waiver shall be effective unless set forth in a written
instrument duly executed by or on behalf of the party or parties waiving
such term or condition. No waiver by any party of any term or condition of
this Agreement, in any one or more instances, shall be deemed to be or
construed as a waiver of the same or any other term or condition of this
Agreement on any future occasion. All remedies, either under this Agreement
or by Law or otherwise afforded, will be cumulative and not alternative.
Section 5.07 Entire Agreement. This Agreement (including Exhibits A to
C hereto), together with the Confidential Disclosure Agreement, dated March
4, 1996 between WARNER-LAMBERT and PFIZER, the International Co-Promotion
Agreement and the International License Agreement, constitutes the
entire agreement between the parties hereto with respect to the within
subject matter and supersedes all previous agreements, whether written or
oral. This Agreement may be altered, amended or changed only by a writing
making specific reference to this Agreement and signed by duly authorized
representatives of WARNER-LAMBERT and PFIZER.
Section 5.09 Third Party Beneficiaries. None of the provisions of this
Agreement shall be for the benefit of or enforceable by any third party,
including, without limitation, any creditor of either party hereto. No such
third party shall obtain any right under any provision of this Agreement or
shall by reasons of any such provision make any claim in respect of any
debt, liability or obligation (or otherwise) against any party thereto.
Section 5.10 Independent Agreements. WARNER-LAMBERT and PFIZER have,
as of the date hereof, entered into an Option Agreement (the "Option
Agreement") under which PFIZER grants to WARNER-LAMBERT 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 WARNER-LAMBERT may not acquire or be granted any rights to any PFIZER
compound under the option Agreement. WARNER-LAMBERT acknowledges under any
of the foregoing circumstances it shall have no claim whatsoever against
PFIZER under the International Agreements which shall remain in full force
and effect according to their terms.
Section 5.11 EC Commission Notification. The parties hereby agree to
notify jointly in due course, the International Agreements to the
Commission of the European Communities (the "Commission") for the purpose
of obtaining negative clearance or, if the Commission deems the
International Agreements to come within Article 85(l) of the Treaty of
Rome, an exemption under Article 85(3) of the Treaty of Rome therefor. It
is further agreed as follows:
(1) The parties shall cooperate jointly towards the preparation
and submission of forms and materials required to notify the
International Agreements, including such materials as are
reasonably required or requested by the Commission pursuant to
such notification;
(2) The parties shall use all reasonable endeavors to obtain
from the Commission confirmation in the form of a comfort
letter or, if this is not forthcoming, a formal decision, to
the effect that the International Agreements merit a
negative clearance as aforesaid or an exemption under
Article 85 (3);
(3) If, arising out of such notification, the Commission
requires the International Agreements to be changed in any
respect, the parties shall negotiate in good faith such changes
so as to reflect as nearly as possible the original intentions
of the parties; and
(4) Each party will be responsible for its own legal and other
external costs associated with the notification contemplated
herein.
Section 5.12 Limitation of Liability. Notwithstanding anything to the
contrary contained elsewhere in the International Agreements (but subject
to this Section 5.12), neither party shall be liable to the other for
Losses constituting incidental, indirect or consequential damages under the
International Agreements for a cumulative aggregate amount in excess of
US$20,000,000; provided, however, notwithstanding the foregoing, each party
shall have the right to recover (and the foregoing limitations contained in
this Section 5.12 shall not apply to): (i) all amounts for which the other
party is obligated to pay pursuant to Article III of this Agreement,
Article III or Section 14.04 of the International Co-Promotion Agreement or
Sections 4.01(d) and 7.02 of the International License Agreement in the
event of (x) a breach by WARNER-LAMBERT of its obligations to make payments
pursuant to Section 14.04 of the International Co-Promotion Agreement or
Section 7.02 of the International License Agreement, or (y) a breach by the
other party of its respective obligations to make payments pursuant to
Article III of this Agreement, Article III of the International
Co-Promotion Agreement, or Section 4.01(d) of the International License
Agreement; or (ii) all Losses relating to a breach by the other party of
its respective obligations under Section 4.03 (in the case of
WARNER-LAMBERT) or Section 4.04 (in the case of PFIZER) under this
Agreement involving, in any case, the commencement of or assertion of any
claim, action, suit or proceeding by a third party in respect of which
indemnity may be sought under Section 4.03 or Section 4.04, as applicable,
of this Agreement. It is agreed that in the event of a breach of the
International Agreements by WARNER-LAMBERT, the difference (in no event
less than zero), if any, between (I) amounts previously paid to
WARNER-LAMBERT by PFIZER pursuant to Article III of this Agreement,
expenses for which PFIZER is responsible pursuant to Section 3.01 of the
International Co-Promotion Agreement, together with all internal costs and
expenses incurred by PFIZER in connection with, or in support of, its
performance of its obligations under the International Agreements (such as,
for example, clinical, marketing, promotional and field force costs and
expenses) and (II) amounts previously paid or credited to PFIZER pursuant
to Section 3.02 of this Agreement, Sections 3.02 and 14.04 of the
International Co-Promotion Agreement or Section 7.02 of the International
License Agreement, will not be considered as constituting incidental,
indirect or consequential damages.
Section 5.13 Counterparts. This Agreement may be executed in any two
or more counterparts, each of which, when executed, shall be deemed to be
an original and all of which together shall constitute one and the same
document.
IN WITNESS WHEREOF, WARNER-LAMBERT and PFIZER, by their duly
authorized officers, have executed this Agreement as of the date first
written above.
WARNER-LAMBERT COMPANY PFIZER INC.
/s/ Lodewijk J.R. de Vink /s/ Robert Neimeth
- --------------------------------- ---------------------------
Lodewijk J.R. de Vink Robert Neimeth
President and Chief Operating Executive Vice President
Officer
[EXHIBIT 99.3.1]
AMENDMENT
AMENDMENT, dated as of May 27, 1997 (this "Amendment"), to the
International Collaboration Agreement, effective as of June 28, 1996 (the
"Agreement") by and between Warner-Lambert Company, a Delaware corporation
("Warner-Lambert"), and Pfizer Inc., a Delaware corporation ("Pfizer").
Capitalized terms not otherwise defined herein have the meanings set forth
in the Agreement.
WHEREAS, Warner-Lambert has assigned certain of its rights and
obligations under the Agreement to Warner-Lambert Export Limited, a company
organized and existing under the laws of Ireland ("Export"), in accordance
with the Assignment and Assumption Agreement dated as of November 1, 1996;
and
WHEREAS, Pfizer has assigned certain of its rights and obligations
under the Agreement to Pfizer Overseas Inc., a corporation organized and
existing under the laws of Delaware ("Pfizer Overseas"); and
WHEREAS, upon this Amendment becoming effective, the parties have
agreed that certain provisions of the Agreement be amended in the manner
provided for in this Amendment;
NOW, THEREFORE, the parties hereto hereby agree as follows:
ARTICLE I - AMENDMENTS
Section 1.01 Amendments of Section 1.01.
(a) The definition of "Co-Promotion Territory" in Section 1.01 of the
Agreement is hereby amended by deleting from the second line thereof the
country "Greece,".
(b) The definition of "License Territory" in Section 1.01 of the
Agreement is hereby amended by inserting the countries "Egypt, Greece," in
the second line thereof before the country "Iceland."
Section 1.02 Amendment of Section 3.05(a). Section 3.05(a) is hereby
amended by inserting the following phrase after the words "Net Sales" in
the tenth line thereof: "or, to the extent that WARNER-LAMBERT packages the
Products for PFIZER 30% of Net Sales,".
ARTICLE II - MISCELLANEOUS
Section 2.01 No Other Amendments; Confirmation. Except as expressly
amended, waived, modified and supplemented hereby, the provisions of the
Agreement are and shall remain in full force and effect.
Section 2.02 Governing Law. This Amendment 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.
Section 2.03 Headings. The headings used in this Amendment have been
inserted for convenience of reference only and do not define or limit the
provisions hereof.
Section 2.04 Third Party Beneficiaries. None of the provisions of this
Amendment 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 Amendment or
shall by reason of any such provision make any claim in respect of any
debt, liability or obligation (or otherwise) against either party hereto.
IN WITNESS WHEREOF, the parties hereto, by their duly authorized
officers, have executed this Amendment as of the date first
written above.
WARNER-LAMBERT PFIZER OVERSEAS INC.
EXPORT LIMITED
By:/s/ Paul V. Breen By:/s/ Daniel P. Cronin
------------------------- ----------------------------
Name: Paul V. Breen Name: Daniel P. Cronin
Title: Managing Director Title: Vice President
[EXHIBIT 99.3.2]
AMENDMENT
AMENDMENT, dated as of January 16, 1998 (this "Amendment"), to the
International Collaboration Agreement, effective as of June 28, 1996 (the
"Agreement") by and between Warner-Lambert Company, a Delaware corporation,
and Pfizer Inc., a Delaware corporation. Capitalized terms not otherwise
defined herein have the meanings set forth in the Agreement.
WHEREAS, Warner-Lambert Company has assigned certain of its rights and
obligations under the Agreement to Warner-Lambert Export Limited, a company
organized and existing under the laws of Ireland ("Warner-Lambert"), in
accordance with the Assignment and Assumption Agreement dated as of
November 1, 1996; and
WHEREAS, Pfizer Inc. has assigned certain of its rights and obligations
under the Agreement to Pfizer Overseas Inc., a corporation organized and
existing under the laws of Delaware ("Pfizer") in accordance with an
Assignment effective as of June 28, 1996; and
WHEREAS, the Agreement has previously been amended by an Amendment
Agreement dated May 27, 1997; and
WHEREAS, upon this Amendment becoming effective, the parties have agreed
that certain provisions of the Agreement be amended in the manner provided for
in this Amendment;
NOW, THEREFORE, the parties hereto hereby agree as follows:
ARTICLE I -AMENDMENT
SECTION 1.01. Amendment of Section 1.01.
The definition of "Co-Promotion Territory" in Section 1.01 of the
Agreement is hereby amended by adding to the list of countries the
additional countries "Malaysia," "Singapore" and "Vietnam."
Article II - MISCELLANEOUS
Section 2.01. No Other Amendments; Confirmation. Except as
expressly amended, waived, modified and supplemented hereby, the provisions
of the Agreement, as amended to date, are and shall remain in full force
and effect.
Section 2.02. Governing Law. This Amendment 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.
Section 2.03. Headings. The headings used in this Amendment
have been inserted for convenience of reference only and do not define or
limit the provisions hereof.
Section 2.04. Third Party Beneficiaries. None of the provisions of this
Amendment 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 Amendment or
shall by reason of any such provision make any claim in respect of any
debt, liability or obligation (or otherwise) against either party hereto.
IN WITNESS WHEREOF, the parties hereto, by their duly authorized
officers, have executed this Amendment as of the date first
written above.
WARNER-LAMBERT PFIZER OVERSEAS INC.
EXPORT LIMITED
By: /s/ Paul V. Breen By: /s/ Mohand Sidi Said
----------------------------- ----------------------------
Name: Paul V. Breen Name: Mahand Sidi Said
Title: Managing Director Title: Vice President
[EXHIBIT 99.4]
INTERNATIONAL CO-PROMOTION AGREEMENT
This Agreement, effective as of June 28, 1996, is made by and between
WARNER-LAMBERT COMPANY, a Delaware corporation (hereinafter "WARNER-
LAMBERT"), with primary offices located at 201 Tabor Road, Morris Plains,
New Jersey 07950, by and through its Parke-Davis Division, and PFIZER INC.,
a Delaware corporation (hereinafter "PFIZER"), with primary offices located
at 235 East 42nd Street, New York, NY 10017-5755. Capitalized terms not
otherwise defined herein have the meanings set forth in Section 1.01.
WHEREAS, WARNER-LAMBERT 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, WARNER-LAMBERT 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 WARNER-LAMBERT's business objectives;
WHEREAS, WARNER-LAMBERT 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,
WARNER-LAMBERT has agreed to enter into this Agreement.
NOW, THEREFORE, for and in consideration of the foregoing and the
representations, covenants and agreements contained herein, WARNER-LAMBERT
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 WARNER-LAMBERT 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
WARNER-LAMBERT entitling the holder(s) thereof to at least fifty-one
percent (51%) of the voting power of the then outstanding capital
stock of WARNER-LAMBERT with respect to the election of directors of
WARNER-LAMBERT, or
(B) WARNER-LAMBERT enters into a merger, consolidation or similar
transaction with another Person (the "Acquiring Corporation") in which
(i) WARNER-LAMBERT is not the surviving corporation in such
transaction, (ii) the members of the Board of Directors of WARNER-
LAMBERT 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) WARNER-LAMBERT sells to any Person(s) in one or more related
transactions properties or assets representing at least fifty-one
percent (51%) of (i) WARNER-LAMBERT's 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 WARNER-LAMBERT's
pharmaceutical business are included in such transaction(s) and (ii)
WARNER-LAMBERT's 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 WARNER-LAMBERT, all PFIZER
Confidential Information and (ii) for PFIZER, all WARNER-LAMBERT
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 WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT and PFIZER.
"Launch Date" for each Country means the date on which the first
Product is first shipped by WARNER-LAMBERT in commercial quantities from
its distribution centers for commercial sale to unaffiliated third parties
in such Country, as promptly notified to PFIZER by WARNER-LAMBERT.
"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 WARNER-LAMBERT
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 WARNER-LAMBERT 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 WARNER-
LAMBERT and its Affiliates of Products to unaffiliated third parties in the
relevant Country (but not including sales between WARNER-LAMBERT 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 WARNER-LAMBERT's 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 WARNER-
LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-
LAMBERT 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.
"WARNER-LAMBERT 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
WARNER-LAMBERT 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 WARNER-LAMBERT, 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, WARNER-LAMBERT grants to PFIZER the exclusive right, together
with WARNER-LAMBERT, 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, WARNER-LAMBERT shall not
grant any rights to, or permit or authorize any third party (other than a
WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT and (ii) with respect to each Category 3 Country
such efforts and resources shall be 67% for PFIZER and 33% for WARNER-
LAMBERT. 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 WARNER-LAMBERT 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 WARNER-
LAMBERT 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 WARNER-LAMBERT shall be responsible for performing 33%
of the Details called for in such Marketing Plan.
(d) Upon written notice to the other party, WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT terminates PFIZER's co-promotion rights under
Sections 14.02(a) or 14.02(b), in no event shall WARNER-LAMBERT 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 WARNER-
LAMBERT prior to such termination of PFIZER's co-promotion rights.
Furthermore, in no event shall WARNER-LAMBERT 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) WARNER-LAMBERT 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) WARNER-LAMBERT 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 WARNER-LAMBERT 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, WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT.
SECTION 2.05. Trademarks, etc.
(a) The Products shall be promoted and sold under trademark(s)
selected by WARNER-LAMBERT in its sole discretion and owned by WARNER-
LAMBERT 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 WARNER-LAMBERT
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 WARNER-LAMBERT 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).
WARNER-LAMBERT 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),
WARNER-LAMBERT 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 WARNER-LAMBERT (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 WARNER-LAMBERT 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. WARNER-LAMBERT Payments. Subject to the other
provisions of this Agreement, WARNER-LAMBERT agrees that:
(a) WARNER-LAMBERT 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. Warner-Lambert 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, WARNER-LAMBERT 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 WARNER-LAMBERT 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, WARNER-LAMBERT 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 WARNER-LAMBERT 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, WARNER-LAMBERT 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 WARNER-LAMBERT 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 Warner-Lambert 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) WARNER-LAMBERT 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, WARNER-LAMBERT 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 WARNER-LAMBERT.
(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 WARNER-LAMBERT 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 WARNER-LAMBERT 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), WARNER-LAMBERT
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 WARNER-LAMBERT 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), WARNER-LAMBERT
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 WARNER-LAMBERT or PFIZER, and the amount payable
to PFIZER or WARNER-LAMBERT, 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 WARNER-LAMBERT or PFIZER, as
the case may be, within ten (10) business days after notification by
WARNER-LAMBERT 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, WARNER-LAMBERT shall, within sixty (60) days after the end of each
calendar quarter, notify PFIZER of the calculation of WARNER-LAMBERT's 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 WARNER-LAMBERT,
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, WARNER-LAMBERT shall notify PFIZER of the calculation
of WARNER-LAMBERT's 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 WARNER-LAMBERT, 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 WARNER-LAMBERT shall designate. PFIZER shall notify
WARNER-LAMBERT's Assistant Treasurer, International by facsimile
transmission (at 201-540-7761 or such other number as may be communicated
to PFIZER by WARNER-LAMBERT) as to the date and amount of any such wire
transfer to WARNER-LAMBERT two business days prior to such transfer.
WARNER-LAMBERT shall notify PFIZER's Treasurer by facsimile transmission
(at 212-573-1133 or such other number as may be communicated to WARNER-
LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-
LAMBERT, 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 WARNER-LAMBERT, 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 WARNER-LAMBERT 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 WARNER-LAMBERT,
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 WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT 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) WARNER-LAMBERT
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 WARNER-LAMBERT's and PFIZER's respective sales forces
in accordance with the terms of the Marketing Plans (the "Promotional
Materials") and which shall be subject to WARNER-LAMBERT's prior approval
pursuant to Section 8.03. Subject to the terms of Section 2.05(c) and this
Section 5.01, WARNER-LAMBERT 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
WARNER-LAMBERT to vest title to such Promotional Materials, copyrights and
trademarks in WARNER-LAMBERT. Promotional Materials shall be paid for by
the parties as set forth in Sections 3.01(b) and 3.02(a).
(b) PFIZER and WARNER-LAMBERT 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 WARNER-LAMBERT shall, from time to
time, each notify the other as to the identity of such proprietary
programs. In the event that WARNER-LAMBERT 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 WARNER-LAMBERT pursuant to this Agreement shall be jointly
owned by PFIZER and WARNER-LAMBERT, 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 WARNER-LAMBERT), 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 WARNER-LAMBERT 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) WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT, all remaining Samples provided by WARNER-
LAMBERT and will provide WARNER-LAMBERT 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, WARNER-LAMBERT 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 WARNER-LAMBERT 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
WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT, provide WARNER-
LAMBERT with details of inquiries received and responses given.
SECTION 6.04. WARNER-LAMBERT Information.
(a) WARNER-LAMBERT shall provide PFIZER with information, known to
WARNER-LAMBERT, 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 WARNER-LAMBERT pursuant
to Section 6.04(a), to WARNER-LAMBERT.
ARTICLE VII - TRAINING
SECTION 7.01. Training Plans. PFIZER and WARNER-LAMBERT 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 WARNER-LAMBERT 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
WARNER-LAMBERT and respond to all inquiries by WARNER-LAMBERT relating
thereto. If PFIZER is advised by its counsel that it must communicate with
any Governmental or Regulatory Authority, then PFIZER shall so advise
WARNER-LAMBERT immediately and, unless the Law prohibits, provide WARNER-
LAMBERT 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 WARNER-LAMBERT 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, WARNER-LAMBERT 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, WARNER-LAMBERT 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 WARNER-LAMBERT.
SECTION 8.03. Labeling and Promotional Materials. WARNER-LAMBERT
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, WARNER-
LAMBERT, pursuant to WARNER-LAMBERT's 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 WARNER-LAMBERT 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 WARNER-LAMBERT 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, WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT) 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 WARNER-LAMBERT 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
WARNER-LAMBERT) 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 WARNER-LAMBERT 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
WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT in connection therewith. Each such final study report
shall be provided to WARNER-LAMBERT 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 WARNER-LAMBERT.
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 WARNER-LAMBERT
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 WARNER-LAMBERT. 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 WARNER-LAMBERT.
(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 WARNER-LAMBERT, and (ii) WARNER-
LAMBERT 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. WARNER-LAMBERT
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. WARNER-LAMBERT shall promptly notify PFIZER of
any such actions taken by WARNER-LAMBERT which are reasonably likely to
result in a material adverse effect on the marketability of any Product in
any Country. At WARNER-LAMBERT's request, PFIZER shall provide reasonable
assistance to WARNER-LAMBERT 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 WARNER-
LAMBERT. WARNER-LAMBERT 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 WARNER-LAMBERT's 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. WARNER-LAMBERT 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
WARNER-LAMBERT (or if directed by WARNER-LAMBERT to WARNER-LAMBERT's
wholesalers) as soon as practicable.
SECTION 9.03. Product Returns. If any quantities of the Products are
returned to PFIZER, PFIZER shall immediately notify WARNER-LAMBERT and ship
them to the facility designated by WARNER-LAMBERT, with any reasonable or
authorized shipping or other documented direct cost to be paid by
WARNER-LAMBERT. PFIZER, at its option, may advise the customer who made
the return that the Products have been returned to WARNER-LAMBERT, but
shall take no other steps in respect of any return without the consent of
WARNER-LAMBERT. All returns of Samples used by the PFIZER field force
shall first be returned to PFIZER which shall ship them to WARNER-LAMBERT,
at WARNER-LAMBERT's expense.
SECTION 9.04. Supply. WARNER-LAMBERT 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, WARNER-LAMBERT 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). WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT of the identity of such
PFIZER Facilities and the back-up manufacturing services to be provided
promptly after PFIZER has made this determination. WARNER-LAMBERT 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 WARNER-LAMBERT, WARNER-LAMBERT 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. WARNER-
LAMBERT 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. WARNER-LAMBERT shall also be
responsible for determining technical and other conditions set forth in any
supplement filed with reference to this Section. WARNER-LAMBERT 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), WARNER-LAMBERT shall be unable
in any Country to supply on a timely basis (in accordance with WARNER-
LAMBERT's 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 WARNER-LAMBERT 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 WARNER-LAMBERT failed to supply Product as
provided for above.
(c) Provided WARNER-LAMBERT's failure to meet its supply obligations
shall not be the result of WARNER-LAMBERT's 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 WARNER-LAMBERT 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 WARNER-
LAMBERT 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 WARNER-LAMBERT 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. WARNER-LAMBERT Covenants. WARNER-LAMBERT hereby
covenants and agrees as follows:
(a) During the Term of this Agreement WARNER-LAMBERT 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 WARNER-LAMBERT during the Term of
this Agreement will, at the time of shipment by or on behalf of WARNER-
LAMBERT, not be misbranded or adulterated under the terms of applicable
Laws.
(c) WARNER-LAMBERT 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 WARNER-LAMBERT is relying, and is
entitled to rely, on the foregoing covenants.
SECTION 11.03. Indemnification of PFIZER. WARNER-LAMBERT shall
indemnify PFIZER in accordance with Section 4.03 of the International
Collaboration Agreement.
SECTION 11.04. Indemnification of WARNER-LAMBERT. PFIZER shall
indemnify WARNER-LAMBERT 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. WARNER-
LAMBERT shall make adequate filings for, and prosecute and maintain, all
Patents and related applications in the Co-Promotion Territory unless
WARNER-LAMBERT reasonably believes that any such Patent or related
application is not material to the matters contemplated in this Agreement.
WARNER-LAMBERT 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 WARNER-LAMBERT 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. WARNER-LAMBERT 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 WARNER-LAMBERT 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
WARNER-LAMBERT. WARNER-LAMBERT 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, WARNER-LAMBERT 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, WARNER-LAMBERT
shall have sole discretion whether or not to bring suit to enjoin,
prohibit, or retard such infringement.
SECTION 12.03. Trademarks.
(a) WARNER-LAMBERT agrees to pursue and maintain the Trademark and
all of its relevant copyrights relating to the Products in the Co-Promotion
Territory. WARNER-LAMBERT and PFIZER shall each advise the other promptly
upon its becoming aware of any infringement by a third party of the
Trademark.
(b) WARNER-LAMBERT 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, WARNER-
LAMBERT, at WARNER-LAMBERT's expense, in any investigation or action taken
by WARNER-LAMBERT 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 WARNER-
LAMBERT 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 WARNER-LAMBERT. WARNER-LAMBERT 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. WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT 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. WARNER-LAMBERT
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 WARNER-LAMBERT shall occur,
WARNER-LAMBERT shall have the right to terminate PFIZER's co-promotion
rights under Section 2.01 on a Country-by-Country basis as follows: (i)
WARNER-LAMBERT shall give to PFIZER notice of WARNER-LAMBERT's 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) WARNER-LAMBERT 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) WARNER-LAMBERT shall give to PFIZER notice of
WARNER-LAMBERT's 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 WARNER-LAMBERT,
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 WARNER-LAMBERT.
(b) If either WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT 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
WARNER-LAMBERT pursuant to Sections 14.02(a) or 14.02(b), WARNER-LAMBERT
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 WARNER-LAMBERT 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, WARNER-LAMBERT 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, WARNER-LAMBERT (or such other co-promotion partner as
WARNER-LAMBERT 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 WARNER-LAMBERT
all Samples, Promotional Materials, communications materials, marketing
plans and reports and other tangible WARNER-LAMBERT Confidential
Information provided to PFIZER by or on behalf of WARNER-LAMBERT pursuant
to the terms and intent of this Agreement, and (ii) WARNER-LAMBERT shall
within thirty (30) days return to PFIZER all tangible PFIZER Confidential
Information provided to WARNER-LAMBERT by or on behalf of PFIZER pursuant
to this Agreement.
(b) If PFIZER's co-promotion rights are terminated by WARNER-LAMBERT
pursuant to Section 14.02, then, WARNER-LAMBERT 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 WARNER-LAMBERT
pursuant to Section 14.06(a). This payment shall be made by WARNER-LAMBERT
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 WARNER-LAMBERT 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:
WARNER-LAMBERT:
Warner-Lambert Company
201 Tabor Road
Morris Plains, New Jersey 07950
Attention: President, Pharmaceutical Sector
Facsimile No. (201) 540-4009
with a copy to: Vice President and General Counsel
Facsimile No. (201) 540-3927
PFIZER:
Pfizer Inc.
235 East 42nd Street
New York, New York 10017-5755
Attention: President, International Pharmaceuticals Group
Facsimile No. (212) 573-1240
with a copy to: Senior Vice President and General Counsel
Facsimile No. (212) 808-8924
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 WARNER-LAMBERT 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 WARNER-
LAMBERT 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. WARNER-LAMBERT and PFIZER
have, as of the date hereof, entered into an Option Agreement (the "Option
Agreement") under which PFIZER grants to WARNER-LAMBERT 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 WARNER-LAMBERT may not acquire or be granted any rights to any PFIZER
compound under the Option Agreement. WARNER-LAMBERT 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, WARNER-LAMBERT and PFIZER, by their duly
authorized Officers, have executed this Agreement as of the date first
written above.
WARNER-LAMBERT COMPANY PFIZER INC.
By: /s/ Lodewijk J.R. de Vink By: /s/ Robert Neimeth
-------------------------- -------------------------------
Name: Lodewijk J.R. de Vink Name: Robert Neimeth
Title: President and Chief Title: Executive Vice President
[EXHIBIT 99.4.1]
AMENDMENT AND WAIVER
AMENDMENT AND WAIVER, dated as of December 4, 1997 (this "Amendment"),
to the International Co-Promotion Agreement, effective as of June 28, 1996
(the "Agreement") by and between Warner-Lambert Company, a Delaware
corporation ("Warner-Lambert"), and Pfizer Inc., a Delaware corporation
("Pfizer"). Capitalized terms not otherwise defined herein have the
meanings set forth in the Agreement.
WHEREAS, Warner-Lambert has assigned certain of its rights and
obligations under the Agreement to Warner-Lambert Export Limited, a company
organized and existing under the laws of Ireland ("Export"), in accordance
with the Assignment and Assumption Agreement dated as of November 1, 1996;
and
WHEREAS, Pfizer has assigned certain of its rights and obligations
under the Agreement to Pfizer Overseas Inc., a corporation organized and
existing under the laws of Delaware ("Pfizer Overseas"); and
WHEREAS, upon this Amendment becoming effective, the parties have
agreed that certain provisions of the Agreement be amended or waived in the
manner provided for in this Amendment;
NOW, THEREFORE, the parties hereto hereby agree as follows:
ARTICLE I - WAIVER
SECTION 1.01. Waiver of Section 2.02(d). Solely in the United
Kingdom, Export hereby waives compliance by Pfizer Overseas with the
provisions of Section 2.02(d) of the Agreement which require Pfizer
Overseas, to the extent it uses the services of a contract sales force, to
employ only "a third party whose primary business is devoted to detailing
third party products," but only if the quality of service provided by the
contract sales force(s) is in all material respects equal to (or better
than) that which would otherwise be provided by Pfizer Overseas, and
provided, further, that (a) Pfizer Overseas shall provide Export with 60
days' prior written notice before retaining any third party contract sales
force(s), and (b) Export consents to the use of such third party contract
sales force(s), which consent shall not be withheld except for a material
business reason.
ARTICLE II - AMENDMENTS
SECTION 2.01. Amendment of Article II. Article II of the Agreement
is hereby amended by inserting the following Section after Section 2.06
thereof:
"2.07 Inventions and Discoveries. All data, inventions and
discoveries generated during the course of any Clinical Plan, whether the
relevant study is sponsored and/or conducted by WARNER-LAMBERT or PFIZER,
shall be the joint property of WARNER-LAMBERT and PFIZER, and each party
shall have the right to use such data, inventions and discoveries free of
charge during and after the Term of this Agreement. The parties agree to
execute any documents or undertake any further actions as may be reasonably
necessary to effectuate the foregoing."
SECTION 2.02. Amendment of Exhibit A. Exhibit A of the Agreement is
hereby amended by (a) deleting the country "Greece" under Category 1, (b)
inserting the country "Portugal" below the country "Netherlands" and above
the territory "Puerto Rico" under Category 1 and (c) deleting the country
"Portugal" under Category 3.
ARTICLE III - MISCELLANEOUS
SECTION 3.01. No Other Amendments; Confirmation. Except as expressly
amended, waived, modified and supplemented hereby, the provisions of the
Agreement are and shall remain in full force and effect.
SECTION 3.02. Governing Law. This Amendment 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.
SECTION 3.03. Headings. The headings used in this Amendment have
been inserted for convenience of reference only and do not define or limit
the provisions hereof.
SECTION 3.04. Third Party Beneficiaries. None of the provisions of
this Amendment 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
Amendment or shall by reason of any such provision make any claim in
respect of any debt, liability or obligation (or otherwise) against either
party hereto.
IN WITNESS WHEREOF, the parties hereto, by their duly authorized
officers, have executed this Amendment as of the date first written above.
WARNER-LAMBERT PFIZER OVERSEAS INC.
EXPORT LIMITED
By: /s/ Paul V. Breen By: /s/ Daniel Cronin
------------------------- -----------------------------
Name: Paul V. Breen Name: Daniel Cronin
Title: Managing Director Title: Vice President
[EXHIBIT 99.4.2]
AMENDMENT
Amendment, dated as of January 16, 1998 (this "Amendment"), to the
International Co-Promotion Agreement, effective as of June 28, 1996 (the
"Agreement") by and between Warner-Lambert Company, a Delaware corporation,
and Pfizer Inc., a Delaware corporation. Capitalized terms not otherwise
defined herein have the meanings set forth in the Agreement.
WHEREAS, Warner-Lambert Company has assigned certain of its rights and
obligations under the Agreement to Warner-Lambert Export Limited, a company
organized and existing under the laws of Ireland ("Warner-Lambert"), in
accordance with the Assignment and Assumption Agreement dated as of
November 1, 1996; and
WHEREAS, Pfizer Inc. has assigned certain of its rights and
obligations under the Agreement to Pfizer Overseas Inc., a corporation
organized and existing under the laws of Delaware ("Pfizer") in accordance
with the Assignment effective as of June 28, 1996; and
WHEREAS, the Agreement has previously been amended by an Amendment and
Waiver dated as of December 4, 1997; and
WHEREAS, upon this Amendment becoming effective, the parties have
agreed that certain provisions of the Agreement be amended in the manner
provided for in this Amendment;
NOW, THEREFORE, the parties hereto hereby agree as follows:
ARTICLE I - AMENDMENTS
SECTION 1.01. Amendment of Section 1.01
Section 1.01 of the Agreement is hereby further amended by adding the
following new definition immediately before the definition of "FDA":
"'Distribution Expenses', for each of Malaysia, Singapore and Vietnam,
means, subject to the next sentence, the out-of-pocket costs actually
paid or credited, by WARNER-LAMBERT or its Affiliate, for the order
processing, handling, warehousing and physical distribution of the
Products in trade packaged form from (a) the point at which
WARNER-LAMBERT or its Affiliate in each such country (or if
WARNER-LAMBERT does not have an affiliate in such country, in a
neighboring country) takes title to the Products to (b) unaffiliated
third party customers of the Products which customers are not hired by
WARNER-LAMBERT or its Affiliate to distribute the Products (for
purposes of this definition, "Final Customers"). "Distribution
Expenses" shall include, without limitation, (i) fees and expenses of
third parties hired by WARNER-LAMBERT or its Affiliate to process
orders, handle, warehouse and physically distribute the Products, (ii)
costs related to the operation of distribution centers and warehouses,
(iii) freight, shipping and insurance costs to transport the Products
from the initial destination in each such country to Final Customers,
(iv) customer and collection services, and (v) order entry and
processing costs, but shall not include (i) any payments made by third
party distributors for sales force commissions or sales force
incentives, (ii) freight, shipping and insurance costs paid by
WARNER-LAMBERT or its Affiliate in each such country (or such
neighboring country) to transport the Products from the point of final
manufacture to the initial destination in each such country, and (iii)
any bad debt and accounts receivable carrying charges which are not
customary for such country."
SECTION 1.02 Amendment of Section 3.01
Section 3.01 (b) is hereby amended by inserting the words "and in the
case of Malaysia, Singapore and Vietnam, for fifty percent (50%) of all
Distribution Expenses," in the fourth line, immediately after the words
"Product Expenses," and by inserting the words "and Distribution Expenses"
in the eighth line, immediately after the words "Product Expenses."
SECTION 1.03 Amendments of Section 3.02
(a) Section 3.02(a) is hereby amended by inserting the words "and in
the case of Malaysia, Singapore and Vietnam, for fifty percent (50%) of all
Distribution Expenses," in the third line, immediately after the word
"Expenses," and by inserting the words "and Distribution Expenses" in the
seventh line, immediately after the words "Product Expenses."
(b) Section 3.02(b) is hereby amended by inserting the words "or, in
the case of Vietnam (subject to the next succeeding sentence), Malaysia and
Singapore, as set forth in Exhibit F," in the fifth line, immediately after
the words "Exhibit E."
(c) Section 3.02(b) is further amended by inserting a new closing
sentence as follows:
"Notwithstanding the immediately preceding sentence, in the case of
Vietnam, until such time as a Pharmaceutical Business Intelligence
Research Group ("PBIRG") vendor or supplier makes available a
validated audit having a data accuracy average (measuring accuracy,
completeness, timeliness and standardization) of at least 85%, the
percentage of Net Sales payable to Pfizer shall be fixed at forty five
percent (45%)."
(d) Section 3.02(e) is hereby amended by inserting the words ", or
forty-five percent (45%), in the case of Malaysia, Singapore and Vietnam,"
in the third line after the words "forty-four percent (44%)."
SECTION 1.04 Amendment of Section 3.03
(a) Section 3.03 (a) is hereby amended by inserting the words ", or,
with respect to Malaysia and Singapore, 27%, or, with respect to Vietnam,
but subject to Section 3.02(b) herein, 45%,", in the sixth line after the
words "Countries, 26.40%".
(b) Section 3.03 (c) is hereby amended by inserting the words "the
total amount of Distribution Expenses for each of Malaysia, Singapore and
Vietnam for such Agreement Quarter," in the seventh line after the words
"by Country,".
(c) Section 3.03 (d) is hereby amended by inserting the words "the
total amount of Distribution Expenses for each of Malaysia, Singapore and
Vietnam for the fourth or last Agreement Quarter," in the seventh line
after the words "by Country,".
(d) Section 3.03 (f) is hereby amended by inserting the words "and,
with respect to Malaysia, Singapore and Vietnam, Distribution Expenses," in
each of the sixth line and the twelfth line after the words "Product
Expenses".
SECTION 1.05 Replacement of Exhibit-A.
Exhibit A to the Agreement is hereby replaced by the attached
Exhibit A.
ARTICLE II - MISCELLANEOUS
SECTION 2.01. No Other Amendments; Confirmation. Except as expressly
amended, waived, modified and supplemented hereby, the provisions of the
Agreement, as amended to date, are and shall remain in full force and
effect.
SECTION 2.02. Governing Law. This Amendment 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.
SECTION 2.03 Headings. The headings used in this Amendment have been
inserted for convenience of reference only and do not define or limit the
provisions hereof.
SECTION 2.04 Third Party Beneficiaries. None of the provisions of
this Amendment 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
Amendment or shall by reason of any such provision make any claim in
respect of any debt, liability or obligation (or otherwise) against either
party hereto.
IN WITNESS WHEREOF, the parties hereto, by their duly authorized
officers, have executed this Amendment as of the date first written above.
WARNER-LAMBERT PFIZER OVERSEAS INC.
EXPORT LIMITED
By: /s/ Paul V. Breen By: /s/ Mohand Sidi Said
----------------------------- ------------------------------
Name: Paul V. Breen Name: Mohand Sidi Said
Title: Managing Director Title: Vice President
[EXHIBIT 99.4.3]
WAIVER AND CONSENT
WAIVER AND CONSENT, dated as of May 13, 1998 (this "Waiver"), to the
International Co-Promotion Agreement, effective as of June 28, 1996 (the
"Agreement") by and between Warner-Lambert Company, a Delaware corporation
("Warner-Lambert"), and Pfizer Inc., a Delaware corporation ("Pfizer").
Capitalized terms not otherwise defined herein have the meanings set forth
in the Agreement.
WHEREAS, Warner-Lambert has assigned certain of its rights and
obligations under the Agreement to Warner-Lambert Export Limited, a company
organized and existing under the laws of Ireland ("Export"), in accordance
with the Assignment and Assumption Agreement dated as of November 1, 1996;
and
WHEREAS, Pfizer has assigned certain of its rights and obligations
under the Agreement to Pfizer Overseas Inc., a corporation organized and
existing under the laws of Delaware ("Pfizer Overseas"); and
WHEREAS, upon this Waiver becoming effective, the parties have agreed
that certain provisions of the Agreement be waived and consented to in the
manner provided for in this Waiver;
NOW, THEREFORE, the parties hereto hereby agree as follows:
ARTICLE I - WAIVER AND CONSENT
SECTION 1.01. Waiver of Section 2.02(d) Use of Contract Sales
Force. Solely in Ireland, Pfizer Overseas and Export each hereby waives
compliance by the other party with the provisions of Section 2.02(d) of the
Agreement which require Pfizer Overseas and Export, during Agreement Years
One and Two, to each promote the Product solely through its existing sales
forces and not to rely upon any contract sales forces; provided, however,
such contract sales forces are used only to supplement the detailing
efforts each party's respective existing sales forces and not in lieu of
any existing sales forces.
SECTION 1.02. Waiver of Section 2.02(d) Nature of Contract Sales
Force. Solely in Ireland, Pfizer Overseas and Export each hereby waives
compliance by the other party with the provisions of Section 2.02(d) of the
Agreement which require each party, to the extent that it uses the services
of a contract sales force, to employ only "a third party whose primary
business is devoted to detailing third party products," but only if the
quality of service provided by the contract sales force(s) is in all
material respects equal to (or better than) that which would otherwise be
provided by the party employing such contract sales force.
SECTION 1.03. Consent to Third Party Sales Force. Solely in Ireland,
Pfizer Overseas and Export each hereby consents to the use by the other
party of a third party contract sales force, subject to the conditions set
forth herein.
ARTICLE II - MISCELLANEOUS
SECTION 2.01. No Other Waivers and Consents. Except as expressly
waived and consented to hereby, the provisions of the Agreement are and
shall remain in full force and effect.
SECTION 2.02. Governing Law. This Amendment 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.
SECTION 2.03. Headings. The headings used in this Amendment have
been inserted for convenience of reference only and do not define or limit
the provisions hereof.
SECTION 2.04. Third Party Beneficiaries. None of the provisions of
this Waiver 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 Waiver
or shall by reason of any such provision make any claim in respect of any
debt, liability or obligation (or otherwise) against either party hereto.
IN WITNESS WHEREOF, the parties hereto, by their duly authorized
officers, have executed this Waiver as of the date first written above.
WARNER-LAMBERT PFIZER OVERSEAS INC.
EXPORT LIMITED
By: /s/ Paul V. Breen By: /s/ Daniel P. Cronin
---------------------------- ------------------------------
Name: Paul V. Breen Name: Daniel P. Cronin
Title: Managing Director Title: Vice President
[EXHIBIT 99.4.4]
AMENDMENT
AMENDMENT, dated as of December 1, 1998 (this "Amendment"), to the
International Co-Promotion Agreement, effective as of June 28, 1996 (the
"Agreement") by and between Warner-Lambert Company, a Delaware corporation,
and Pfizer Inc., a Delaware corporation.
WHEREAS, Warner-Lambert Company has assigned certain of its rights and
obligations under the Agreement to Warner-Lambert Export Limited, a company
organized and existing under the laws of Ireland ("Warner-Lambert"), in
accordance with the Assignment and Assumption Agreement dated as of
November 1, 1996; and
WHEREAS, Pfizer Inc. has assigned certain of its rights and
obligations under the Agreement to Pfizer Overseas Inc., a corporation
organized and existing under the laws of Delaware ("Pfizer"), in accordance
with an Assignment effective as of June 28, 1996;
WHEREAS, the Agreement has previously been amended by an Amendment and
Waiver dated as of December 4, 1997 and an Amendment dated as of January
16, 1998;
WHEREAS, Warner-Lambert and Pfizer wish to clarify the terms of the
arrangement for the co-promotion of the Products in China (as hereinafter
defined) in the event that Warner-Lambert elects, in accordance with an
Amendment and Waiver dated December 1, 1998 (the "International License
Amendment") to the International License Agreement effective as of June 28,
1996 between Warner-Lambert and Pfizer (the "International License
Agreement"), to co-promote the Products with Pfizer in China (the
"Election"); and
WHEREAS, the parties have agreed that as of the effective date of the
Election certain provisions of the Agreement shall be amended in the manner
provided for in this Amendment and certain other agreements shall be
entered into;
NOW, THEREFORE, the parties hereto hereby agree as follows:
ARTICLE I - AMENDMENTS
SECTION 1.01. Amendment of Section 1.01.
Section 1.01 of the Agreement is hereby amended by:
(a) adding the following new definition immediately before the
definition of "Category 1 Countries":
"Bulk" means the bulk tablet form of Products."
(b) adding the following new definition immediately before the
definition of "Change in Control":
"Category 4 Country" means China."
(c) adding the following new definitions immediately before the
definition of "Clinical Plan":
"China" means the People's Republic of China (excluding the Special
Administrative Region of Hong Kong and Macao)."
"China Commencement Date" means the date on which Warner-Lambert shall
commence co-promotion of the Products pursuant to the Election."
"China Product Expenses" means, for any period, the total of Product
Expenses, (as that term is defined in the Agreement) incurred by Pfizer and
Warner-Lambert, in each case for China, during such period."
"China Co-Promotion Amount" means, for any period, the difference
between (i) ninety percent (90%) of Net Sales for China during such period
and (ii) the sum of China Product Expenses and Distribution Expenses for
China for such period."
(d) adding the following new definition immediately before the
definition of "FDA":
"Distribution Expenses" for China means, subject to the next sentence,
the out-of-pocket costs actually paid or credited, by Pfizer or its
Affiliate, for the order processing, handling, warehousing and physical
distribution of the Products from (a) Pfizer's or its Affiliate's plant in
China to (b) unaffiliated third party customers of the Products which
customers are not hired by Pfizer or its Affiliate to distribute the
Products (for purposes of this definition, "Final Customers").
"Distribution Expenses" shall include without limitation, (i) fees and
expenses of third parties hired by Pfizer or its Affiliate to process
orders, handle, warehouse and physically distribute the Products, (ii)
costs related to the operation of distribution centers and warehouses,
(iii) freight, shipping and insurance costs to transport the Products from
Pfizer's or its Affiliate's plant in China to Final Customers, (iv)
customer and collection services, and (v) order entry and processing costs,
but shall not include (i) any payments made by third party distributors for
sales force commissions or sales force incentives, or (ii) any bad debt or
accounts receivable carrying charges which are not customary in China."
(e) amending the definition of "Launch Date" by adding the words ";
provided, however, that for the purposes of this Agreement, "Launch Date"
for China means the China Commencement Date" at the end thereof.
(f) adding the following new definition immediately before the
definition of "Market Share":
"Manufacturing Authorization" means the authorization necessary to
Package the Products as granted by the relevant Governmental or Regulatory
Authorities in China."
(g) adding the following new definition immediately before the
definition of "Patents":
"Packaging" means activities relating to filling/blistering, labeling,
packaging, and finishing the Products, including but not limited to,
purchasing packaging materials, quality control, release and storage and
the tests and analyses conducted in connection therewith."
(h) amending the definition of "Net Sales" by:
(i) inserting the words "or, in the case of China, the aggregate
sales of Pfizer and its Affiliates," in the second line after the
words "Warner-Lambert and its Affiliates";
(ii) inserting the words "or sales between Pfizer and its Affiliates"
in the fourth line after the words "Warner-Lambert and its
Affiliates"; and
(iii) inserting the words "or, in the case of China, consistent with
PFIZER's audited financial statements," in the nineteenth line
after the words "Warner-Lambert's audited financial statements."
(i) amending the definition of "Term of this Agreement" by inserting
the words "(or, with respect to China, the China Commencement Date)" in the
second line after the words "date hereof".
SECTION 1.02. Amendment of Exhibit A.
Exhibit A of the Agreement is hereby amended by adding a Category 4
and by inserting the country China under such Category.
SECTION 1.03. Amendments of Section 3.01
(a) Section 3.01 (b) is hereby amended by inserting the words " and
(iv) with respect to China, a Category 4 Country, for fifty percent (50%)
of all Product Expenses and Distribution Expenses", in the eighth line,
immediately after the first appearance of the word "Expenses," and by
inserting the words "and Distribution Expenses" in the eighth line,
immediately after the second appearance of the word "Expenses."
(b) Section 3.01 is further amended by adding thereto new subsections
(c) and (d) providing as follows:
"(c) For each Agreement Year and separately calculated for China, a
Category 4 Country, PFIZER shall pay to WARNER-LAMBERT, in local currency,
fifty percent (50%) of the China Co-Promotion Amount.
(d) For purposes of Section 3.01(c), in no event shall PFIZER be
obligated to pay WARNER-LAMBERT an amount that is greater than forty-five
percent (45%) of Net Sales in China in any Agreement Year."
SECTION 1.04. Amendment of Section 3.02.
Section 3.02(a) is hereby amended by inserting the words "and (iv) in
the case of China, a Category 4 Country, for fifty percent (50%) of all
Product Expenses and Distribution Expenses in the sixth line, immediately
after the words "Expenses."
SECTION 1.05 General.
References to a "Section" or "Sections" herein shall mean the
relevant Section of this Amendment, unless otherwise noted as referring to
the relevant Section of the Agreement. Unless otherwise noted, capitalized
terms used herein shall have the meanings ascribed to them in the
Agreement.
ARTICLE II - ADDITIONAL AGREEMENTS
SECTION 2.01. Third Party Sales Force.
Notwithstanding the terms of Section 2.02 (d) of the Agreement
relating to the time at which the parties may employ a contract field
force, it is agreed that at any time after the China Commencement Date,
each party shall have the right to use the services of a contract sales
force to promote and detail Products in China, to assist such party in
satisfying its obligations hereunder or to discharge its promotion and
detailing obligations hereunder. In the event that either party grants
such rights, such party shall (i) exercise effective supervisory control
over the activities of said third party, and shall (ii) continue to be
responsible for the third party's performance consistent with the terms and
conditions of this Amendment and the Agreement.
SECTION 2.02. Detailing and Promotional Efforts.
(a) It is the intention of the parties that, during each Agreement
Year with respect to China, each of Warner-Lambert and Pfizer will devote
substantially equal efforts and internal resources to the marketing,
promotion and detailing of Products and the other activities contemplated
under the Agreement. The Marketing Plans developed for China under Section
4.01 of the Agreement shall reflect the foregoing. In accordance with
Section 2.02(b) of the Agreement, if one party is requested to devote its
resources in excess of its proportionate share, the sharing of the China
Co-Promotion Amount in accordance with Section 2.06 of this Amendment shall
take the unequal devotion of resources into account.
(b) During each Agreement Year with respect to China, each of Pfizer
and Warner-Lambert 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, that if one
party performs more than fifty (50%) of the Details, such efforts shall be
taken into account in computing the China Co-Promotion Amount to be shared
in accordance with Section 2.06 of this Amendment.
SECTION 2.03. Development of Products; Regulatory Approvals.
Notwithstanding the provisions of Section 2.04 of the Agreement, and
provided that Warner-Lambert has not elected to supply the Product in
accordance with Section 2.07 below, Pfizer shall exercise reasonable
efforts to obtain the Marketing Authorization and Price Approval in China
for a Product with a package insert that is materially equivalent to the
provisions of Exhibit C to the Agreement. With respect to China, Pfizer
shall have the same rights as are provided to Warner-Lambert under the
terms of Sections 2.04(b) and (c) of the Agreement, subject to conditions
equivalent to those contained therein.
SECTION 2.04. Pfizer Payments.
(a) For so long as Pfizer shall enjoy co-promotion rights in China
under Section 2.01 of the Agreement, and subject the terms of Section
14.04(b) of the Agreement, Pfizer shall be responsible for fifty percent
(50%) of all China Product Expenses and fifty percent (50%) of all
Distribution Expenses for China. Pfizer shall pay its share of China
Product Expenses in accordance with the terms set forth in Section 2.06 of
this Amendment.
(b) For each Agreement Year with respect to China, and separately
calculated for China based in part on Warner-Lambert's notification to
Pfizer of Warner-Lambert's share of China Product Expenses in accordance
with Section 2.06 of this Amendment, Pfizer shall pay to Warner-Lambert, an
amount equal to fifty percent (50%) of the China Co-Promotion Amount.
SECTION 2.05. Warner-Lambert Payments.
For so long as Pfizer shall enjoy co-promotion rights in China under
Section 2.01 of the Agreement, and subject the terms of Section 14.04(b) of
the Agreement, Warner-Lambert shall be responsible for fifty percent (50%)
of all China Product Expenses and fifty percent (50%) of all Distribution
Expenses for China. Warner-Lambert shall pay its share of China Product
Expenses and Distribution Expenses for China in accordance with the terms
set forth in Section 2.06 of this Amendment.
SECTION 2.06. Payments; Payment Reports.
(a) Notwithstanding the provisions of Section 3.03 of the Agreement,
Pfizer shall make payments to Warner-Lambert arising under Section 2.04 of
this Amendment on a quarterly basis as follows: for each Agreement Quarter
relating to China, Pfizer shall pay Warner-Lambert its share of the China
Co-Promotion Amount pursuant to the procedures set forth in subsections
(b), (c) and (d) of this Section 2.06.
(b) Warner-Lambert shall, within thirty (30) days of (i) the end of
each Agreement Quarter with respect to China, or (ii) in the event that the
Agreement is terminated with respect to China pursuant to Section 14.03,
such termination date, notify Pfizer in writing of the total amount of
China Product Expenses incurred by Warner-Lambert during such Agreement
Quarter or shorter period.
(c) Provided Warner-Lambert has complied with Section 2.06(b) of this
Amendment, Pfizer shall, for each Agreement Quarter in each Agreement Year
relating to China (except for any Agreement Quarter that is the last
Agreement Quarter with respect to China), within forty-five (45) days of
the receipt of Warner-Lambert's notice under Section 2.06(b) of this
Amendment, or, with respect to the last Agreement Quarter in each Agreement
Year, within ninety (90) days of such receipt, notify Warner-Lambert of the
calculation of the total amount of China Product Expenses, Distribution
Expenses for China and Net Sales for China for such Agreement Quarter, the
amounts paid or accrued by each of Warner-Lambert or Pfizer, and the
amounts, if any, payable to each of Pfizer and Warner-Lambert in accordance
with Sections 2.04, 2.05 and 2.06(a) of this Amendment.
(d) Any amount payable by either party with respect to China pursuant
to the notification under Section 2.06(c) of this Amendment shall be offset
against any amounts due such party and the net amount shall be paid by
Pfizer or Warner-Lambert, as the case may be, within ten (10) business days
after notification by Pfizer pursuant to Section 2.06(c).
SECTION 2.07. Manufacturing Authorization; Samples.
(a) It is the intention of the parties that during the Term of this
Agreement Pfizer shall (i) continue to Package the Product from Bulk
supplied by Warner-Lambert, shall (ii) continue to account for and book the
sales of the Product in China (except to the extent the parties otherwise
agree pursuant to Section 2.11 of this Amendment), and (iii)
notwithstanding the fact that Pfizer shall continue to so Package the
Product and account for and book sales of the Product in China, that the
basic economic relationship and legal obligations with respect to co-
promotion of the Products, as amended hereby, that are established under
the Agreement shall apply in China. Notwithstanding the foregoing,
however, it is agreed that within one (1) year from the date of Election
("Supply Election Term"), Warner-Lambert shall have the right, but not the
obligation, to assume responsibility for the supply of Products within
China and obtain the Manufacturing Authorization and all other necessary
related Governmental or Regulatory Approvals.
In the event that Warner-Lambert elects to assume responsibility for
the manufacture and sale of Products within China, the Agreement shall be
revised accordingly and the parties shall enter into such other appropriate
definitive agreements to effectuate the foregoing intention in accordance
with the basic economic relationships established in the Agreement and the
Laws of China.
In the event of expiration of the Supply Election Term or if Warner-
Lambert notifies Pfizer of its intention not to exercise the right to
supply Product as described herein (which it shall do as soon as
practicable but in any event not later than six (6) months from the
Election date), Pfizer shall automatically continue to Package and account
for the sales of the Products, subject to the other provisions of this
Agreement, for the Term of the Agreement.
(b) Until Warner-Lambert exercises its rights as contemplated in
subparagraph (a) above, if at all, Pfizer's Affiliate in China, Pfizer
Pharmaceuticals Limited ("Pfizer Dalian") shall have the exclusive right to
Package the Products based upon the purchase of Bulk from Warner-Lambert in
compliance with the Manufacturing Authorization, Articles III and V of the
International License Agreement and this Amendment, subject to Section 2.15
hereof.
(c) Until Warner-Lambert exercises its rights as contemplated in
subparagraph (a) above, if at all, Pfizer Dalian shall, during each
Agreement Year relating to China during which Pfizer Dalian Packages the
Products, provide Warner-Lambert with such quantities of Samples consistent
with the applicable Marketing Plan for China and the provisions of the
Agreement to meet Warner-Lambert's reasonable requirements for use in
accordance with the then current Marketing Plan.
(d) The cost per Sample distributed in each Agreement Quarter for
China shall be calculated as twelve percent (12%) of the quotient of (i)
Net Sales for China in such Agreement Quarter over (ii) the total number of
pills of Product sold to unaffiliated third parties in China in such
Agreement Quarter.
(e) Until Warner-Lambert exercises its rights as contemplated in
subparagraph (a) above, if at all, within thirty (30) days after the end of
the Term of the Agreement as it relates to China (or, if earlier, the
termination of Pfizer's co-promotion rights for China), Pfizer and Pfizer
Dalian shall return, or otherwise dispose of in accordance with
instructions from Warner-Lambert, all remaining Samples produced by Pfizer
or Pfizer Dalian for China, if any, and will provide Warner-Lambert with a
certified statement that all remaining Samples have been returned or
otherwise properly disposed of and that Pfizer and Pfizer Dalian are no
longer in possession or control of any such Samples in any form or fashion.
In addition to the reimbursements provided for under Section 14.06(b) of
the Agreement, Warner-Lambert shall reimburse Pfizer in respect of purchase
of Bulk and Packaging costs relating to such Samples.
(f) Until Warner-Lambert exercises its rights as contemplated in
subparagraph (a) above, if at all, Pfizer shall have rights with respect to
orders and terms of sale in China equivalent to the rights of Warner-
Lambert under Section 9.01 of the Agreement.
(g) If Warner-Lambert exercises its rights as contemplated in
subparagraph (a) above, at Warner-Lambert's option, Pfizer either shall
continue customer sales of existing inventories of Products or shall sell
such existing inventories back to Warner-Lambert at cost.
SECTION 2.08. Communication with Regulatory Authorities.
Warner-Lambert shall grant, pursuant to Section 8.01 of the Agreement,
Pfizer the right to correspond or communicate with Governmental and
Regulatory Authorities in China concerning the Products and Atorvastatin
and to take reasonable actions concerning any authorization or permission
under which Products are sold or with respect to any application for the
same; provided, however, that, unless the Law prohibits, Pfizer shall
provide drafts of any such written correspondence or communications to
Warner-Lambert for review prior to submission to such authorities.
SECTION 2.09. Filings with Governmental or Regulatory Authorities.
Notwithstanding the provisions of Section 8.02 of the Agreement,
Pfizer shall have authority and responsibility to maintain and seek
revisions of the conditions of the Marketing Authorization for the Products
in China; provided any such revisions are not inconsistent with the
decisions of the parties as determined in accordance with Section 4.01 of
the Agreement. Pfizer shall provide Warner-Lambert for its prior review
and approval, copies of all submissions to Governmental or Regulatory
Authorities in China that are intended to revise the conditions of the
Marketing Authorization, Price Approval or Manufacturing Authorization or
change or modify the label or labeling for, or the indications of,
Atorvastatin or any of the Products.
SECTION 2.10. Labeling and Promotional Materials.
Notwithstanding the provisions of Section 8.03 of the Agreement,
Pfizer shall have 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, on
Promotional Materials used in connection with the Products, and for
determining whether the same requires Governmental or Regulatory Authority
approval; provided, however, that no such labels, labeling, package
inserts, Product monographs and packaging, and Promotional Materials may
used or distributed by Pfizer unless the same shall be approved in advance
by the China Country Marketing Team and, for the purposes of determining
compliance with applicable laws, Warner-Lambert, pursuant to Warner-
Lambert's internal procedures.
SECTION 2.11. Joint Sales Company
The parties shall determine whether to establish a joint sales
company or other legal entity within and/or outside of China to accomplish
the terms and conditions of this Amendment, including with respect to the
sharing of the China Co-Promotion Amount under Section 2.06 of this
Amendment. If permitted under the Laws of China, such company or other
legal entities would have the sole right to (i) receive, accept and fill
orders of Products in China, (ii) control invoicing, order processing and
collection of accounts receivable for Product sales, and (iii) record
Product sales in its books of account. The parties agree to consider and
negotiate the proposals herein within six (6) months from the date of the
Election by Warner-Lambert and to prepare a joint recommendation together
with plans for the implementation of the project ( "Joint Recommendation").
In the event that, notwithstanding good faith negotiations and the
preparation of the Joint Recommendation, a party believes that it is
commercially unreasonable to implement the Joint Recommendation, then it
shall document the basis therefor (the "Objections") and the final decision
whether to implement the Joint Recommendation shall be conclusively decided
by the Global Business Subcommittee within thirty (30) days from the date
of receipt of the Joint Recommendation and the Objections. The decision of
the Global Business Subcommittee shall be binding upon each of the parties.
SECTION 2.12. Misdirected Orders.
If, either Pfizer or Warner-Lambert, for any reason, receives orders
for Products in China, each shall forward such orders to the company or
entity established in accordance with Section 2.11 of this Amendment (or to
Pfizer, if applicable) as soon as practicable.
SECTION 2.13. Product Returns
Returned Products in China shall be sent to Pfizer, on terms and
conditions equivalent to those provided for in Section 9.03 of the
Agreement. If a company or entity is established in accordance with
Section 2.11 of this Amendment, the parties shall agree upon the handling
of any quantities of Products which are returned to Pfizer or Warner-
Lambert in China.
SECTION 2.14. Supply.
Until Warner-Lambert exercises its rights as contemplated in Section
2.07(a), if at all, Pfizer shall use reasonable efforts to supply Products
(both for trade purposes and Samples) for China during the Term of this
Agreement as it relates to China 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, Pfizer
shall maintain inventory of Products for China equal to three (3) months
requirements (based on the then current Marketing Plan), so long as Warner-
Lambert supplies adequate quantities of Bulk for such purposes. The
provisions of Section 9.06 of the Agreement shall apply to China with
respect to Warner-Lambert's obligations to supply Bulk to enable Pfizer to
supply orders for Products on a timely basis.
SECTION 2.15. Pfizer Manufacturing.
Warner-Lambert shall have the right to visit and audit the facilities
of Pfizer Dalian during the Term of the Agreement on the same terms as are
provided in Section 5.04 of the International License Agreement. Pfizer
Dalian shall be responsible for filing all submissions or other
correspondence with the applicable Governmental or Regulatory Authorities
for China to obtain the Manufacturing Authorization, provided, however,
that Warner-Lambert shall have the right to review such submissions or
correspondence prior to filing.
SECTION 2.16. Failure of Supply
In the event that for any reason, including Force Majeure, Pfizer
shall be unable to supply on a timely basis orders for Product in China,
Warner-Lambert shall have the right to supply fully finished imported
Product to customers in China to the extent necessary, during the period in
which Pfizer is unable to so supply, to fill such orders that Pfizer is
unable to fill.
SECTION 2.17. Pfizer Covenant.
Pfizer hereby covenants and agrees that any Products to be distributed
in China during the Term of the Agreement as it relates to China which
Products have been Packaged in China will, at the time of shipment by or
on behalf of Pfizer, not be misbranded or adulterated under the terms of
applicable Laws as a result of actions or omissions of Pfizer.
SECTION 2.18. Other Agreements.
(a) Until such time, if at all, as Warner-Lambert exercises its
rights under Section 2.07(a) to manufacture and sell the Products in China,
Section 8.07 of the Agreement shall not apply to China, provided that
Pfizer shall obtain Warner-Lambert's prior written approval before carrying
out any recall, market withdrawal or other corrective action related to the
Products.
(b) Notwithstanding the terms of Section 8.04 of the Agreement,
Pfizer shall have the right to handle complaints with respect to the
Products in China.
(c) The provisions of Section 4.01(a) - (c) and (d)(ii) - (v) of the
International License Agreement shall apply to the supply of Bulk by
Warner-Lambert to Pfizer during effectiveness of this Amendment.
(d) With respect to activity in or affecting China, Pfizer and
Warner-Lambert shall each indemnify, defend and hold harmless the other as
provided in and subject to the terms of Sections 4.03 and 4.04 of the
International Collaboration Agreement dated June 28, 1996 between Warner-
Lambert Company and Pfizer Inc.
SECTION 2.19. Financial Records.
Pfizer shall keep such records of Net Sales, China Product Expenses
and Distribution Expenses for China, and Warner-Lambert shall keep such
records of China Product Expenses, in each case as are necessary to
determine accurately under United States generally accepted accounting
principles the China Co-Promotion Amount and the sums due to Pfizer and
Warner-Lambert under this Amendment.
The parties shall deduct from any payments required under this
Amendment those taxes which each of them may be required by the Laws to
withhold and pay, if at all, and each party shall promptly submit to the
other evidence of such payments. The parties agree to furnish each other
with such assistance as reasonably necessary to enable the parties to claim
corresponding tax exemptions or tax credits, as the case may be.
SECTION 2.20. Term.
The Agreement with respect to China shall expire on the last day of
Agreement Year Five. With respect to China, all references in the
Agreement to "Agreement Year Ten" shall mean Agreement Year Five.
SECTION 2.21. Termination of Co-Promotion Rights.
(a) Warner-Lambert shall have the right to terminate the Agreement
with respect to China pursuant to Section 14.02(b) at any time during the
Term of the Agreement as it relates to China, notwithstanding the
provisions of Section 14.02(b)(iii) of the Agreement. In the event that
Warner-Lambert exercises its right to terminate Pfizer's co-promotion
rights with respect to China pursuant to Section 14.02(b) of the Agreement,
Warner-Lambert shall pay to Pfizer (in lieu of the amount described in
Section 14.04(b) of the Agreement), for each Agreement Year for China which
would have been remaining had Warner-Lambert not exercised its right to
terminate, an amount equal to seventy-five (75%) of the difference between
(a) the China Co-Promotion Amount for such Agreement Year and (b) one-half
(1/2) of the total China Product Expenses for such Agreement Year. In
computing the amounts payable to Pfizer in accordance with the foregoing,
it shall be assumed that Pfizer shall have no obligation to actually pay or
incur any China Product Expenses after Pfizer's co-promotion rights are
terminated under Section 14.02(b). It is understood that payments for each
such remaining Agreement Year with respect to China shall be based on the
actual Net Sales for China and China Product Expenses, in each case for
such Agreement Year as provided in the Agreement. It is agreed that the
last three sentences of Section 14.04(b) of the Agreement shall apply in
the event that Warner-Lambert exercises its aforedescribed rights in this
Section 2.21.
(b) In the event that Warner-Lambert exercises its right to terminate
the Agreement with respect to China pursuant to Section 14.02(b) of the
Agreement and makes the payments as described above, Warner-Lambert shall,
in addition, continue to make the payments to Pfizer pursuant to Section
7.02 of the International License Agreement, as amended by the
International License Amendment in Section 2.11.
ARTICLE III - MISCELLANEOUS
SECTION 3.01. No Other Amendments; Confirmation. Except as expressly
amended, waived, modified and supplemented hereby, the provisions of the
Agreement, as amended to date, are and shall remain in full force and
effect.
SECTION 3.02. Governing Law. This Amendment shall be governed by and
construed in accordance with the law of the State of New York.
SECTION 3.03. Headings. The headings used in this Amendment have
been inserted for convenience of reference only and do not define or limit
the provisions hereof.
SECTION 3.04. Third Party Beneficiaries. None of the provisions of
this Amendment 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
Amendment or shall by reason of any such provision make any claim in
respect of any debt, liability or obligation (or otherwise) against either
party hereto.
IN WITNESS WHEREOF, the parties hereto, by their duly authorized
officers, have executed this Amendment as of the date first written above.
WARNER-LAMBERT PFIZER OVERSEAS INC.
EXPORT LIMITED
By: /s/ Paul V. Breen By: /s/ Mohand Sidi Said
-------------------------- ------------------------------
Name: Paul V. Breen Name: Mohand Sidi Said
Title: Managing Director Title: Vice President
[EXHIBIT 99.5]
INTERNATIONAL LICENSE AGREEMENT
This Agreement, effective as of June 28, 1996, is made by and between
WARNER-LAMBERT COMPANY, a Delaware corporation (hereinafter "WARNER-
LAMBERT"), with primary offices located at 201 Tabor Road, Morris Plains,
New Jersey 07950, by and through its Parke-Davis Division, and PFIZER INC.,
a Delaware corporation (hereinafter "PFIZER"), with primary offices located
at 235 East 42nd Street, New York, NY 10017-5755. Capitalized terms not
otherwise defined herein have the meanings set forth in Section 1.01.
WHEREAS, WARNER-LAMBERT holds rights in the Territory under Patents,
Technical Information and Trademarks pertaining to Atorvastatin;
WHEREAS, PFIZER has significant experience in the development,
marketing, promotion and sale of pharmaceutical products and believes it
can make significant contributions to the successful development and
commercialization of Atorvastatin outside the United States;
WHEREAS, WARNER-LAMBERT 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 WARNER-LAMBERT's business objectives;
WHEREAS, WARNER-LAMBERT and PFIZER are simultaneously with the
execution of this International License Agreement executing the
International Collaboration Agreement dated as of the date hereof
(hereinafter, the "International Collaboration Agreement"); and
WHEREAS, pursuant to the International Collaboration Agreement,
WARNER-LAMBERT has agreed to enter into this Agreement.
NOW, THEREFORE, for and in consideration of the foregoing and the
representations, covenants and agreements contained herein, WARNER-LAMBERT
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 WARNER-LAMBERT or PFIZER,
as the case may be, but only for so long as said control shall continue. As
used herein the term "control" means possession of the power to direct or
cause the direction of the management and policies of a Person whether by
contract or otherwise.
"Agreement Years" for each Country means the period commencing on the
Launch Date and ending on the last day of Agreement Year Ten.
"Agreement Year One" with respect to each Country means the period
commencing on the Launch Date and ending on the last day of the fourth
complete calendar quarter following the Launch Date; "Agreement Year Two"
with respect to each Country means the twelve-month period commencing on
the first day following the expiration of Agreement Year One; references to
Agreement Year Three through Agreement Year Nine mean the successive
twelve-month periods thereafter; and Agreement Year Ten means the period
commencing on the first day following the expiration of Agreement Year Nine
and expiring on the tenth anniversary of the Launch Date.
"Atorvastatin" means the chemical compound [R-(R*,R*)]-2-(4-
fluorophenyl)-b, d-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)
carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) and hydrates
thereof.
"Bulk" has the meaning ascribed to it in Section 5.01(a).
"Category 1 Country" means a Country set forth under Category 1 on
Exhibit A.
"Category 2 Country" means a Country set forth under Category 2 on
Exhibit A.
"Category 3 Country" means a Country set forth under Category 3 on
Exhibit A.
"Competing Products" means any prescription pharmaceutical product
other than the Products (i) where a significant pharmacological action of
such product is direct inhibition of HMG-CoA reductase (as demonstrated by
at least 50% inhibition of the enzyme activity of HMG-CoA reductase, at a
product concentration of 1 micromolar in an in vitro, cell-free HMG-CoA
reductase activity assay system) and (ii) with indications for lipid
lowering and treatment or prevention of atherosclerosis.
"Confidential Information" means (i) for WARNER-LAMBERT, all PFIZER
Confidential Information and (ii) for PFIZER, all WARNER-LAMBERT
Confidential Information.
"Country" means a country listed in Exhibit A.
"FDA" means the United States Food and Drug Administration.
"Good Manufacturing Practices" means the regulatory standards and the
principles and guidelines of good manufacturing practice, as in effect from
time to time, relating to the manufacture of medicinal products including,
but not limited to, standards for equipment, facilities, production and
quality control established by the applicable Governmental or Regulatory
Authority.
"Governmental or Regulatory Authority" means any court, tribunal,
arbitrator, agency, commission, official or other instrumentality of any
government or of any federal, state, county, city or other political
subdivision thereof.
"International Co-Promotion Agreement" means the International
Co-Promotion Agreement between PFIZER and WARNER-LAMBERT dated of even date
herewith.
"Launch Date" for each Country means the date on which the first
Product is first shipped in commercial quantities from the distribution
centers of PFIZER or an Affiliate of PFIZER for commercial sale to
unaffiliated third parties in such Country, as promptly notified in writing
to WARNER-LAMBERT by PFIZER.
"Laws" means all laws, statutes, rules, regulations, ordinances and
other pronouncements having the effect of law of any government or
Governmental or Regulatory Authority.
"Losses" means any and all damages, fines, fees, penalties, judgments,
deficiencies, losses and expenses (including without limitation interest,
court costs, reasonable fees of attorneys, accountants and other experts or
other expenses of litigation or other proceedings or of any claim, default
or assessment).
"Manufacturing Authorization" means the authorization necessary to
Package the Products as granted by the relevant Governmental or Regulatory
Authorities.
"Marketing Authorization" means the authorization necessary to sell
the Product in the applicable Country as granted by the relevant
Governmental or Regulatory Authorities.
"Net Sales" for each Country means the aggregate sales of PFIZER and
its Affiliates of Products to unaffiliated third parties in the relevant
Country (but not including sales between Pfizer and its Affiliates), less
(i) bad debts related to the Products, and (ii) sales returns and
allowances, including, without limitation, trade, quantity and cash
discounts and any other adjustments, including, but not limited to, those
granted on account of price adjustments, billing errors, rejected goods,
damaged goods, recalls, returns, rebates, chargeback rebates, fees,
reimbursements or similar payments given or granted to wholesalers or other
distributors, buying groups, health care insurance carriers or other
institutions, freight and insurance charges billed to the customers,
customs or excise duties, sales tax and other taxes (except income taxes)
or duties relating to sales, and any payment in respect of sales to any
Governmental or Regulatory Authority, all as determined in accordance with
generally accepted accounting principles on a basis consistent with
PFIZER's audited financial statements, except for such items that may be
reclassified to comply with the foregoing definition.
"Packaging" means activities relating to filling/blistering, labeling,
packaging, and finishing the Products, including, but not limited to,
purchasing packaging materials, quality control, release and storage and
the tests and analyses conducted in connection therewith.
"Patents" means those patents identified in, and the patents issuing
from the applications listed in, Exhibit C to the International
Collaboration Agreement.
"Person" means any natural person, corporation, general partnership,
limited partnership, joint venture, proprietorship or other business
organization.
"PFIZER Confidential Information" means information which has prior to
the date hereof been or which at any time hereafter is disclosed in writing
and marked "Confidential" (or if disclosed orally, is reduced to writing
within thirty (30) days of disclosure) directly or indirectly by PFIZER or
by any of its Affiliates or agents or agents of its Affiliates to WARNER-
LAMBERT or any of its Affiliates or agents or agents of its Affiliates in
connection with this Agreement and which relates to the business of PFIZER.
"Post-Agreement Year One" with respect to each Country means the
twelve month period commencing on the day following either (i) the last day
of Agreement Year Ten, or (ii) if earlier terminated pursuant to Section
11.02, the date of termination; "Post Agreement Year Two" and "Post
Agreement Year Three" mean the successive twelve month periods thereafter.
"Price Approval" means, in Countries where Governmental or Regulatory
Authorities approve or determine pricing for pharmaceutical products for
reimbursement or otherwise, such approval or determination.
"Products" means all finished pharmaceutical formulations that (i)
contain Atorvastatin as the sole active ingredient, or (ii) contain
Atorvastatin together with one or more other active ingredients where such
combination products have indications for (a) lipid lowering and the
treatment or prevention of atherosclerosis or (b) the treatment or
prevention of vascular disease, in each case, to be marketed by PFIZER in
the Territory during the Agreement Years.
"Serious Adverse Drug Experience Report" means any Adverse Drug
Experience Report that involves an adverse drug experience that is fatal or
life-threatening, is permanently disabling, requires in-patient
hospitalization, or is a congenital anomaly, cancer or overdose, or any
other event which would constitute a "serious" adverse drug experience
pursuant to the terms of 21 C.F.R. 314.80 or 312.32 or their local
equivalents.
"Technical Information" means (a) all information and data which is
now, or at any time hereafter during the Term of this Agreement shall
become, owned or possessed by WARNER-LAMBERT and its Affiliates for the
Products which are necessary to apply for Marketing Authorization or Price
Approval of the Products in the relevant Country, including, but not
limited to, information and data concerning the manufacture, stability,
pharmacology, toxicology and clinical use of the Product, (b) any other
material medical, clinical, toxicological or other scientific or medical
information or data pertaining to the Products which is now, or at any
time hereafter during the Term of this Agreement shall become, owned or
possessed by WARNER-LAMBERT and its Affiliates, and (c) such other
information or data as WARNER-LAMBERT may deem appropriate.
"Term of this Agreement" for each Country means the period from the
date hereof until the expiration of this Agreement in accordance with
Section 11.01 or earlier termination of this Agreement in accordance with
Section 11.02.
"Territory" means all of the Countries.
"Trademark" has the meaning ascribed to it in Section 2.03.
"WARNER-LAMBERT 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
WARNER-LAMBERT 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 WARNER-LAMBERT, including, without limitation, any information
concerning Atorvastatin or any of its intermediates or the Products.
ARTICLE II - LICENSES
SECTION 2.01. Grant of Licenses. WARNER-LAMBERT grants to PFIZER
under the Patents, Technical Information and Trademarks, the following:
(a) An exclusive license to use and sell Products in each Category 1
Country. For purposes of this sub-clause, "exclusive" means to the
exclusion of all other parties in a Country including WARNER-LAMBERT
and its Affiliates.
(b) An exclusive license under the Trademark and a semi-exclusive
license under the Patents and Technical Information to use and sell
Products in each Category 2 Country. For purposes of this sub-clause,
"semi-exclusive" means to the exclusion of all other parties in a
Country except WARNER-LAMBERT or an Affiliate of WARNER-LAMBERT.
(c) An exclusive license under the Trademark and a semi-exclusive
license under the Patents and Technical Information to use and sell
Products in each Category 3 Country. For purposes of this sub-clause,
"semi-exclusive" means to the exclusion of all other parties except
WARNER-LAMBERT or an Affiliate of WARNER-LAMBERT (except in Italy
where two of WARNER-LAMBERT and its Affiliates may sell the Products)
and one additional local licensee which, as of the date hereof, are
as follows: (i) in Brazil, AchE LaboratOrios FarmacEuticos S/A, (ii)
in Korea, Je Il Pharmaceutical Co., Ltd., (iii) in Italy, one of the
companies of the A. Menarini group and (iv) in Spain, Laboratorios
Almirall, S.A.
SECTION 2.02. Sublicenses. The licenses granted to PFIZER in Section
2.01 shall include the right to grant sublicenses to its Affiliates, in
whole or in part; provided however, that PFIZER shall be responsible for
the performance of its Affiliate sublicensee(s) hereunder. The licenses
granted to PFIZER in Section 2.01 shall not include the right to grant
sublicenses to third parties without the prior consent of WARNER-LAMBERT.
SECTION 2.03. Trademarks. (a) Subject to clause (d) below, PFIZER
shall in each Country sell Products under trademarks searched for
availability, designated and owned by WARNER-LAMBERT, and which are
reasonably acceptable to PFIZER, for use by PFIZER in such Country (the
"Trademarks"); provided, however, that in the event WARNER-LAMBERT has not
by December 31, 1996 obtained and designated a Trademark in any Country,
then PFIZER shall have the right to obtain a Trademark which is reasonably
acceptable to WARNER-LAMBERT in such Country, but shall be required to
assign such Trademark to WARNER-LAMBERT.
(b) WARNER-LAMBERT shall maintain the Trademarks in each Country at
its own cost and expense throughout the term of this Agreement. All
goodwill deriving from the use by PFIZER of Trademarks will accrue solely
and exclusively to WARNER-LAMBERT.
(c) PFIZER shall use the Trademarks only in accordance with
reasonable standards and guidelines communicated by WARNER-LAMBERT from
time to time during the Term of this Agreement. PFIZER agrees that its use
of the Trademark shall be in a commercially acceptable and responsible
manner.
(d) In Countries where WARNER-LAMBERT sells Products, it shall do so
under a single Trademark, except in Italy where it may sell Products under
two separate Trademarks. PFIZER shall sell Products in each Country under
a single Trademark, except in Category 1 Countries where PFIZER may sell
Products under one or more Trademarks; such Trademark may be a WARNER-
LAMBERT owned Trademark from a major market outside of such Country,
provided that such Trademark is available and that WARNER-LAMBERT shall
have consented to such use, such consent not to be unreasonably withheld.
(e) Immediately upon expiration or termination of this Agreement with
respect to any Country, all rights granted to PFIZER hereunder to use the
Trademark in such Country shall cease immediately and shall forthwith
revert to WARNER-LAMBERT, and PFIZER will discontinue forthwith all use of
the Trademark in such Country and shall not thereafter directly or
indirectly sell or distribute any products bearing trademarks, names or
designs confusingly similar to the Trademark or otherwise use trade names,
names or designs confusingly similar to the Trademark (provided, however,
that, at WARNER-LAMBERT's option, PFIZER either shall continue customer
sales of existing inventories or shall sell such existing inventories back
to WARNER-LAMBERT at cost); and will not represent itself in such Country
as having been associated with, or a licensee of, WARNER-LAMBERT upon
expiration or termination of this Agreement.
SECTION 2.04. Technical Information. WARNER-LAMBERT shall forthwith
upon execution of this Agreement and periodically thereafter promptly
disclose to PFIZER all Technical Information which it can legally
disclose. Upon expiration or earlier termination of this Agreement PFIZER,
its successors, assigns and legal representatives shall use reasonable
efforts to collect and return to WARNER-LAMBERT or destroy, at
WARNER-LAMBERT's request, all Technical Information obtained by PFIZER
pursuant to this Agreement in whatever form it may exist; and shall use
its reasonable efforts to prevent the further use of any and all Technical
Information without WARNER-LAMBERT's express written consent.
SECTION 2.05. Cooperation. (a) Subject to the other provisions of
this Agreement, the parties agree that the principal objectives of the
parties hereunder with respect to Products in each Country in the
Territory are to use reasonable efforts to maximize Net Sales and
operating income to the parties hereunder and to develop and sponsor
various local clinical studies for the Product during the Term of this
Agreement.
(b) In all Countries other than Countries in which WARNER-LAMBERT or
its Affiliates sell Products, PFIZER shall seek to produce an operating
plan each year that will include product strategy, positioning, research
and development expenses, advertising and promotion expenses and detail
position by cycle. Each operating plan shall be submitted to the Global
Business Subcommittee (as defined in the International Co-Promotion
Agreement). PFIZER shall provide WARNER-LAMBERT such other information as
WARNER-LAMBERT reasonably may request. The operating plans shall not
address sales force incentives or compensation, and each party shall have
sole authority and responsibility for designing and executing any such
program for its sales force.
SECTION 2.06. Information Exchange. With respect to all Countries
other than Countries in which WARNER-LAMBERT or its Affiliates sell
Products, each party shall forthwith upon the execution of this Agreement
and thereafter at all times during the Agreement Years promptly disclose
to the other party all significant information of which it becomes aware,
which it can legally disclose and which it reasonably believes will be
important in planning and effecting the detailing, promotion, marketing
and sale of the Products in the Territory.
SECTION 2.07. Product Launch. In Category 2 and Category 3 Countries,
WARNER-LAMBERT shall render reasonable assistance to PFIZER to enable
PFIZER to launch the Product simultaneously with WARNER-LAMBERT. If, based
upon the reasonable opinion of the parties, in such Countries, PFIZER and
WARNER-LAMBERT and the third party co-marketer, if any, are unable to all
launch the Product within a ten day period, the launch of the Product by
the party or parties that are ready to launch earlier will be postponed
for a maximum of forty-five days from the date such party or parties were
prepared to launch the Product unless all are able to launch within a ten
day period prior to the expiration of such forty-five day period.
ARTICLE III - REGULATORY AND OTHER MATTERS
SECTION 3.01. Regulatory Approvals. (a) In all Category 1 Countries
and in Brazil and Korea, PFIZER shall exercise reasonable efforts to
obtain, as soon as reasonably practicable, the approval by the relevant
Governmental or Regulatory Authority of a Marketing Authorization for a
Product which includes labeling (consistent with guidelines established by
the Operating Committee in accordance with the procedures set forth in
Section 4.01 of the International Co-Promotion Agreement), indications,
warnings, etc. materially equivalent to the provisions of Exhibit C and a
Price Approval. In all Category 2 and Category 3 Countries (other than
Brazil and Korea), WARNER-LAMBERT shall exercise reasonable efforts to
obtain, as soon as reasonably practicable, the approval by the relevant
Governmental or Regulatory Authority of a Marketing Authorization for a
Product which includes labeling (consistent with guidelines established by
the Operating Committee in accordance with the procedures set forth in
Section 4.01(d) of the International Co-Promotion Agreement), indications,
warnings, etc. materially equivalent to the provisions of Exhibit C and a
Price Approval; provided, however, that in all Category 2 and Category 3
Countries where the Law mandates that the licensee must obtain the
Marketing Authorization and Price Approval, PFIZER will exercise such
efforts. The party obtaining such approvals shall bear its own costs in
obtaining such Marketing Authorization and Price Approval. Each party
shall give the other party reasonable assistance in obtaining such
approvals, including without limitation WARNER-LAMBERT's requesting the
assessment report and other relevant documentation from the relevant
German Governmental or Regulatory Authority for filing with an application
for Marketing Authorization in Norway. Each party shall keep the other
party informed of negotiations with Governmental or Regulatory Authorities
with respect to Price Approvals that it seeks pursuant to this Section
3.01 and shall notify the other party of the price the filing party
intends to accept for Price Approval prior to finalization of such price.
(b) In any Country where PFIZER is required to obtain the approval by
the relevant Governmental or Regulatory Authority of a Marketing
Authorization and Price Approval (if applicable) pursuant to clause (a)
above or otherwise by agreement with WARNER-LAMBERT, in the event that
PFIZER fails to submit an application or file for such approvals as soon
as reasonably practicable, but no later than twelve (12) months after
receiving all necessary Technical Information from WARNER-LAMBERT, WARNER-
LAMBERT shall have the right to terminate this Agreement with respect to
such Country.
(c) PFIZER shall, upon notice and consultation with WARNER-LAMBERT,
be entitled at any time to cease permanently the sale of any Product in
any Country if continued sale of such Product would be in violation of
Laws or if PFIZER in good faith believes that it has an ethically valid
reason therefor based on medical or scientific problems concerning such
Product.
(d) WARNER-LAMBERT shall, upon notice and consultation with PFIZER,
be entitled at any time to cease permanently the sale of Bulk to PFIZER in
any Country if continued sale of the Bulk by WARNER-LAMBERT or Product by
PFIZER would be in violation of Laws or if WARNER-LAMBERT in good faith
believes that it has an ethically valid reason therefor based on medical
or scientific problems concerning such Product.
(e) WARNER-LAMBERT may terminate this Agreement with respect to any
Country upon notice to PFIZER if PFIZER fails to Launch a Product in such
Country within twenty-four (24) months after Marketing Authorization,
including the indications, warnings etc. materially equivalent to the
provisions of Exhibit C, unless Pfizer shall be diligently pursuing a
Price Approval (if applicable).
(f) Subject to the provisions of the International Collaboration
Agreement, neither party shall be under any liability whatsoever to
compensate the other or make any other payment to the other if (i)
Marketing Authorization or Price Approval is not received, (ii) the
Marketing Authorization for the first Product in a Country does not
include indications, warnings, etc. materially equivalent to the
provisions of Exhibit C, or (iii) either party determines to take any of
the steps that it is permitted to take pursuant to this Section 3.01;
provided, in the case of (i), (ii) and (iii) above, such failure to obtain
such Marketing Authorization or Price Approval or indications warnings,
etc. in the Marketing Authorization materially equivalent to the
provisions of Exhibit C or such cessation of sale shall not be the result
of any breach of this Agreement by such party.
SECTION 3.02. Advertising and Promotion. (a) PFIZER shall bear all of
its own costs and expenses of advertising and promoting the Product in
each Country. PFIZER shall promote the Product and provide information
about the Product to the medical profession through the distribution of
advertising and promotional materials, samples of which shall be submitted
to WARNER- LAMBERT to enable WARNER-LAMBERT to monitor the medical and
technical content of such materials.
(b) PFIZER shall exercise reasonable efforts in each Country to
market, create a demand for and continuously develop sales of the Product,
in order to maximize Net Sales and operating income throughout the term of
this Agreement.
SECTION 3.03. Studies. PFIZER shall be free to undertake clinical and
other research studies with the Products in the Territory at its own
expense, for registration or other purposes, provided that PFIZER shall
first submit to WARNER-LAMBERT the protocols relating thereto and allow
WARNER-LAMBERT not less than thirty (30) days within which to review and
approve such protocols as to their scientific and medical content, which
approval shall not be unreasonably withheld. If WARNER-LAMBERT does not
respond to PFIZER within such period, approval shall be deemed to have
been given. PFIZER shall promptly disclose to WARNER-LAMBERT a copy of
reports relating to such approved activities. PFIZER will grant
WARNER-LAMBERT a royalty-free, non-exclusive license (without further
compensation) to use all results of any such studies with respect to the
manufacture, use or sale of the Product.
SECTION 3.04. Communication with Regulatory Authorities. PFIZER
shall, immediately upon receipt of any communication from any Governmental
or Regulatory Authority relating to Atorvastatin or any Product, forward a
copy or description of the same to WARNER-LAMBERT and respond to all
inquiries by WARNER-LAMBERT relating thereto. If PFIZER is advised by its
counsel that it must communicate with any Governmental or Regulatory
Authority, then PFIZER shall so advise WARNER-LAMBERT immediately and,
unless the Law prohibits, provide WARNER-LAMBERT 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 WARNER-
LAMBERT concerning any meeting or written or oral communication with any
Governmental or Regulatory Authority.
SECTION 3.05. Regulatory Information. Subject to the terms of Section
3.04, each party agrees to provide the other with all reasonable
assistance and take all actions reasonably requested by the other party
that are necessary or desirable to enable the other party to comply with
any Law applicable to Atorvastatin or any Product, including, but not
limited to, WARNER-LAMBERT or PFIZER meeting its reporting and other
obligations to (i) maintain and update any Marketing Authorizations for
the Products and (ii) report Adverse Drug Experience Reports and Serious
Adverse Drug Experience Reports to any Governmental or Regulatory
Authorities. Such assistance and actions shall include, among other
things, keeping the other party informed, commencing within forty-eight
hours of notification of any action by, or notification or other
information which it receives (directly or indirectly) from, any
Governmental or Regulatory Authority, which (a) raises any material
concerns regarding the safety or efficacy of any Product, (b) which
indicates or suggests a potential material liability for either party to
third parties arising in connection with any Product, or (c) which is
reasonably likely to lead to a recall or market withdrawal of any Product,
provided that neither party shall be obliged to disclose information in
breach of any contractual restriction which it could not reasonably have
avoided. For purposes of this Section 3.05, each of the events set forth
in (a), (b) and (c) of this Section 3.05 shall be defined as a "Material
Event". Information that shall be disclosed pursuant to this Section 3.05
shall include, but not be limited to:
(1) Governmental or Regulatory Authority inspections of manufacturing
(including packaging facilities), distribution or other related
facilities; inquiries by Governmental or Regulatory Authorities concerning
clinical investigation activities (including inquiries of investigators,
clinical monitoring organizations and other related parties); any
communication from Governmental or Regulatory Authorities involving the
manufacture, sale, promotion or distribution of Products or any other
Governmental or Regulatory Authority reviews or inquiries relating to
Atorvastatin or any of the Products which, in each case, constitute a
Material Event; and
(2) an initiation of any Governmental or Regulatory Authority
investigation, detention, seizure or injunction concerning any Product.
SECTION 3.06. Adverse Drug Experience Reports. (a) Subject to
applicable Law, PFIZER shall:
(i) notify WARNER-LAMBERT 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 WARNER-LAMBERT) 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 WARNER-LAMBERT 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
WARNER- LAMBERT) within thirty days of the time such Adverse Drug
Experience Report becomes known to any member of the PFIZER Group;
and
(iii) notwithstanding any other provision of this Section 3.06, use
its best efforts to notify WARNER-LAMBERT of all unexpected fatal or
life-threatening experiences occurring in connection with an IND
study conducted, sponsored or monitored by PFIZER, as defined in 21
C.F.R. 312.32, within twenty-four (but, in no event, later than
thirty-six) hours of the time any such experience becomes known to
any member of the PFIZER Group; and
(iv) notwithstanding any other provision in this Section 3.06,
notify WARNER-LAMBERT 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 WARNER-LAMBERT 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 WARNER-LAMBERT in connection therewith. Each such final study report
shall be provided to WARNER-LAMBERT within fifteen days of its completion.
Except for Adverse Drug Experience Reports occurring in any post-marketing
study conducted, sponsored or monitored by PFIZER, notification under this
Section 3.06 shall be by facsimile and overnight courier and in accordance
with instructions to be mutually agreed upon by PFIZER and WARNER-LAMBERT.
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
WARNER-LAMBERT 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
WARNER-LAMBERT. 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 WARNER-LAMBERT.
(c) Subject to Section 3.04, (i) PFIZER shall not disclose any
information concerning Adverse Drug Experience Reports or Serious Adverse
Drug Experience Reports to any Person or Governmental or Regulatory
Authority without the prior consent of WARNER-LAMBERT, and (ii) WARNER-
LAMBERT shall have the sole discretion to determine whether any complaint,
Adverse Drug Experience Report or Serious Adverse Drug Experience Report
must be reported to the FDA or any other Governmental or Regulatory
Authority.
SECTION 3.07. Return of Marketing Authorization Upon Termination or
Expiration. Upon expiration or termination of PFIZER's rights in any
Country, PFIZER will promptly transfer to WARNER-LAMBERT, a WARNER-LAMBERT
Affiliate or a third party designated by WARNER-LAMBERT, all Marketing
Authorizations and approvals relating to the Product in the applicable
Country as may be required by WARNER-LAMBERT or such party to market the
Product in such Country. The transfer fees and any government fees for
such transfer will be borne by WARNER-LAMBERT.
SECTION 3.08. Compliance with Laws. PFIZER hereby covenants to
WARNER-LAMBERT as follows:
(a) During the Term of this Agreement PFIZER shall carry out the
packaging and labeling, detailing, storage, distribution, promotion,
marketing and sale of the Products and its other obligations or activities
hereunder in accordance with (i) the terms of this Agreement, (ii)
acceptable pharmaceutical industry practices and (iii) all applicable
Laws.
(b) During the Term of this Agreement PFIZER shall refrain from
infringing any patent of any third party in connection with PFIZER's
Packaging of the Product in accordance with ARTICLE V hereof.
ARTICLE IV - SUPPLY OF PRODUCTS
SECTION 4.01. (a) Supply Obligations. Subject to the provisions of
this Agreement, WARNER-LAMBERT hereby undertakes to supply the Products to
PFIZER and PFIZER undertakes to purchase or to procure the purchase from
WARNER-LAMBERT all of PFIZER's requirements of Products in bulk tablet
form (hereinafter "Bulk") in each Country or, subject to agreement between
the parties on terms and conditions to be agreed, in trade packaged form.
The parties covenant and agree to comply in all respects with the
requirements of EU Directive 91/356 for the Countries in the European
Union and to take all necessary and appropriate action in furtherance
thereof.
(b) Specifications. The Bulk shall be manufactured, packaged and
supplied hereunder in accordance with all applicable laws and according to
the specifications which shall be provided by WARNER-LAMBERT to PFIZER and
shall be in accordance with WARNER-LAMBERT's specifications for
corresponding Bulk in countries within and outside the Territory. WARNER-
LAMBERT shall be entitled at any time to change such specifications in
line with changes made with respect to WARNER-LAMBERT's corresponding Bulk
in countries within and outside the Territory, provided that any such
changes shall not materially adversely affect the quality or efficacy of
the Bulk, and provided that WARNER-LAMBERT shall give to PFIZER prior
notice of any proposed change in time to allow PFIZER to arrange any
necessary modifications to its Marketing Authorizations in the applicable
Countries for the affected Bulk.
(c) Forecasts and Orders. At least three months prior to the
commencement of each calendar quarter, PFIZER shall give to WARNER-LAMBERT
a forecast of PFIZER's estimated requirements in each Country for rolling
twenty-four (24) month periods commencing with such calendar quarter. The
twenty-four (24) month forecasts delivered to WARNER-LAMBERT pursuant to
the preceding sentence shall represent PFIZER's reasonable provisional
estimates of the quantity of the Products that PFIZER will require in each
such Country during the twenty-four (24) month period to which such
forecast applies and the quantities shown in the forecast for the first
three months shall be automatically considered a firm order deliverable at
any time during each month, so that no separate purchase orders will be
sent by PFIZER. PFIZER may adjust any firm order hereunder at any time
prior to the day that is sixty (60) days prior to the first day of the
period to which such firm order applies, provided that such adjusted firm
order is between eighty percent (80%) and one hundred twenty percent
(120%) of the most recent firm order provided to WARNER-LAMBERT pursuant
to this Section 4.01(c). WARNER-LAMBERT shall use its reasonable efforts
to deliver PFIZER's firm order requirements. Minimum order quantities for
Bulk shall be agreed between the parties.
(d) Prices and Payment
(i) WARNER-LAMBERT agrees to sell to PFIZER its requirements of
Bulk at prices in each Country which will be agreed between the
parties from time to time, but which will not, unless otherwise
agreed, (i) be greater than the price which would give PFIZER
Gross Profit in the applicable Country of less than sixty
percent (60%) of Net Sales or (ii) be less than the price which
would give PFIZER Gross Profit of greater than seventy-two
percent (72%) of Net Sales, calculated in the currency of the
Country of sale. For purposes of this sub-clause, "Gross
Profit" means Net Sales less the price paid by PFIZER for the
Bulk; provided, however, that in no event will WARNER-LAMBERT
be required hereunder to sell to PFIZER its requirements of
Bulk at a price which is less than WARNER-LAMBERT's actual
manufacturing cost plus the costs of freight, insurance, duty
and other delivery terms (in each case on a currency adjusted
basis), and all applicable taxes paid by WARNER-LAMBERT
thereon, except income taxes and recoverable value added taxes.
(ii) The parties shall calculate and agree on estimated prices of
the Bulk (A) in or prior to Agreement Year One based on the
projected Net Sales in each Country for such Agreement Year and
(B) thereafter, based on the Net Sales in each Country during
the preceding Agreement Year.
(iii) The prices for the Bulk agreed between the parties pursuant to
subclause (i) above contemplate shipment by WARNER-LAMBERT
Delivered Duty Paid (Incoterms 1990) to a PFIZER plant or
location designated by PFIZER in each Country, but excluding
VAT or other applicable taxes, which will be payable by PFIZER.
Unless otherwise agreed, prices shall be stated and payable in
local currency. Should any events unforeseen by and beyond the
control of the parties occur that alter WARNER- LAMBERT's costs
hereunder relating to delivery terms, and materially and
detrimentally affect its economic return on the sale of Bulk to
Pfizer as contemplated on the date hereof, the parties shall
consult together in order to revise the applicable prices and
delivery terms on a fair basis so that neither party is unduly
prejudiced.
(iv) Payment will be made to WARNER-LAMBERT within forty-five (45)
days of the relevant invoice date or PFIZER's receipt of the
Bulk, whichever shall occur later.
(v) Within sixty (60) days after the end of each Agreement Year,
the actual price for the Bulk shall be calculated based upon
PFIZER's Net Sales in each Country, and an adjustment of the
differences between such actual price and the estimated price
for the Bulk originally charged for the Products in each such
Country shall be paid by one party to the other as appropriate
with respect to all Bulk invoiced to PFIZER during such
Agreement Year.
(vi) WARNER-LAMBERT shall supply PFIZER's reasonable requirements of
Bulk in each Country in the Territory (x) for use in
promotional samples of Products and studies other than clinical
studies specified in subparagraph (y) below at a price per pill
of ten percent (10%) of the quotient of (1) Net Sales in the
current Agreement Year over (2) the total number of pills of
Product sold to unaffiliated third parties in the Territory in
such Agreement Year (such procedure for arriving at such price
to be analogous to the procedure with respect to price of the
Bulk as set forth in Section 4.01(d)(ii)-(v)) and (y) at no
cost for use in Products for clinical studies required by
appropriate Governmental or Regulatory Authorities for
marketing approval, new indications and labeling changes, and
approved pursuant to Section 3.03. PFIZER shall use and
distribute samples in full compliance with all applicable Laws.
(e) Failure of Supply. In the event for any reason, including Force
Majeure (as hereinafter defined), WARNER-LAMBERT shall be unable in any
Country to supply Bulk on a timely basis (in accordance with WARNER-
LAMBERT's normal and customary practice), such that as a result, PFIZER is
unable to supply on a timely basis (in accordance with PFIZER's normal and
customary practice) at least ninety percent (90%) of the orders for
Products in such Country, provided that such orders are not materially
greater than the corresponding forecast for Bulk given to WARNER-LAMBERT
at least nine (9) months prior to such time pursuant to Section 4.01(c),
then the following adjustments shall be made to the terms otherwise
provided herein:
(i) If such failure to supply continues for two consecutive months
or less, the Agreement Year for such Country in which such
failure to supply occurred shall be extended by a length of
time equal to two times the number of days during which
WARNER-LAMBERT failed to supply Bulk as provided for above.
(ii) If such failure to supply continues longer than two consecutive
months, the Agreement Year for such Country in which such
failure to supply occurred shall be extended by a length of
time equal to four times the number of days during which
WARNER-LAMBERT failed to supply Bulk as provided for above.
(iii) Provided WARNER-LAMBERT's failure to meet its supply
obligations shall not be the result of WARNER-LAMBERT's
material breach of its obligations under this Agreement, then
sub-clauses 4.01 (e)(i) and 4.01(e)(ii) set forth PFIZER's sole
remedy in the event WARNER-LAMBERT fails to meet the supply
obligations set forth in this Article IV.
(iv) In the event for any reason, including Force Majeure, WARNER-
LAMBERT shall be unable to supply Bulk on a timely basis,
WARNER- LAMBERT shall use reasonable efforts to ensure that it
supplies Bulk to all of its licensees, distributors,
co-promoters, etc. on a ratably equitable basis.
ARTICLE V - PACKAGING BY PFIZER
SECTION 5.01. Information for Submission. In those Countries where
WARNER-LAMBERT holds or will apply for the Marketing Authorization, PFIZER
shall promptly provide to WARNER-LAMBERT all information and data
necessary to enable WARNER-LAMBERT, when required, to make the submissions
to the relevant Governmental or Regulatory Authorities to reflect in the
applicable Marketing Authorization the identity of the Person Packaging
the Product. PFIZER shall not make any changes or take any actions which
will require an amendment to any Marketing Authorization, including but
not limited to transfer of any Product to alternative manufacturing
facilities or changes in or replacement of equipment, without the prior
written consent of WARNER-LAMBERT.
SECTION 5.02. Compliance with Laws. PFIZER shall Package each Product
in accordance with Good Manufacturing Practices and shall comply in all
respects with all applicable Laws with respect to the Packaging of each
Product.
SECTION 5.03. Approval of Product Labels, Printed Packaging Materials
and Inserts. In each Country, PFIZER shall sell the Product only with
labels, printed packaging materials and product inserts whose format and
type, including the appearance of the relevant Trademark, has been
approved in writing by WARNER-LAMBERT, which approval will not be
unreasonably withheld or delayed and shall be deemed to have been given if
WARNER- LAMBERT shall not have responded within thirty (30) days of having
received samples of said material from PFIZER. Such approval shall be
deemed continuing so long as there is no material modification to the
prior approved use of the Trademark as used in connection with such
labels, printed packaging materials and product inserts.
SECTION 5.04. Quality Audit. PFIZER shall make that portion of its
manufacturing facilities where Products are Packaged and/or stored,
including all records and reference samples related to Products, available
for inspection by WARNER-LAMBERT during business hours. Records made
available for inspection hereunder shall include records relevant to
assessing the quality of a Product in the event of a complaint or a
suspected defect. Inspections by WARNER-LAMBERT shall be conducted only by
qualified personnel of WARNER-LAMBERT or the relevant Governmental or
Regulatory Authority and shall be limited to determining whether there is
compliance with Good Manufacturing Practices and other requirements of
applicable Law.
SECTION 5.05. Storage. PFIZER shall store all Bulk, work-in-process
and finished Products under such conditions that the quality of such
materials are not affected and in accordance with instructions provided by
WARNER-LAMBERT.
SECTION 5.06. Regulatory Licenses, Approvals and Consents. PFIZER
shall obtain all licenses, consents and authorizations of applicable
Governmental or Regulatory Authorities or third parties necessary or
desirable in connection with its Packaging activities and shall comply in
all material respects with all conditions applicable to any such license,
consent, permit or authority.
ARTICLE VI - INFORMATION CONCERNING THE PRODUCT
SECTION 6.01. Public Statements. PFIZER and WARNER-LAMBERT shall use
reasonable efforts to ensure that no claims or representations in respect
of the Products or Atorvastatin or the characteristics thereof are made by
or on behalf of it (by members of its sales force or otherwise) that are
inconsistent with the Marketing Authorization.
SECTION 6.02. Ownership. PFIZER shall not represent to any third
party that it has any proprietary or property right or interest in the
Products, Atorvastatin or in the Patents, the Technical Information or the
Trademarks, except for such rights specifically granted to PFIZER under
Section 2.01. Furthermore, PFIZER acknowledges that it does not have any
right, title or interest in the Patents.
SECTION 6.03. Medical Inquiries. PFIZER shall comply with the
directions and policies which WARNER-LAMBERT 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 WARNER-LAMBERT, provide WARNER-
LAMBERT with details of inquiries received and responses given.
SECTION 6.04. WARNER-LAMBERT Information. (a) WARNER-LAMBERT shall
provide PFIZER with information, known to WARNER-LAMBERT, which is
relevant or appropriate to enable PFIZER to respond promptly to medical
questions or inquiries from members of the medical and paramedical
professions and consumers relating to the Products.
(b) PFIZER will refer all questions and inquiries to which it is
unable to respond, using the materials provided by WARNER-LAMBERT pursuant
to clause (a) above, to WARNER-LAMBERT.
ARTICLE VII - PAYMENTS
SECTION 7.01. PFIZER Payments. In consideration for the rights
granted to PFIZER under this Agreement (including, without limitation, the
licenses to use and sell the Products under Section 2.01 and the rights
set forth in this Agreement to use the Patents, Trademark, Technical
Information and other intangible rights granted hereunder), PFIZER has
paid and will pay to WARNER-LAMBERT certain amounts as provided in the
International Collaboration Agreement.
SECTION 7.02. WARNER-LAMBERT Payments. In each Country where
termination or expiration of this Agreement has occurred pursuant to
Section 11.01 or Section 11.02 (for any reason other than PFIZER's
material breach) and for so long as WARNER-LAMBERT, its Affiliates or
licensees continue to sell the Product in such Country, in each of
Post-Agreement Year One, Post-Agreement Year Two and Post-Agreement Year
Three, WARNER- LAMBERT shall, as consideration for PFIZER's efforts
hereunder, pay to PFIZER an annual amount equal to ten per cent (10%) of
the average of Net Sales made in such Country in each of the two complete
Agreement Years immediately preceding such expiration or termination
payable in four equal quarterly installments on the first day of each
calendar quarter; provided, however, that if WARNER-LAMBERT shall cease to
sell Product in any such Country during any Post-Agreement Year, the
payment related to such year shall be pro-rated and WARNER-LAMBERT shall
have no obligation to make further payments pursuant to this Section 7.02
in any subsequent Post- Agreement Year. The parties shall bear equally the
cost of hedging any currency risk relating to the payments contemplated in
Section 7.02.
ARTICLE VIII - CONFIDENTIAL INFORMATION
SECTION 8.01. Confidential Information. Each of PFIZER and WARNER-
LAMBERT shall keep the other's Confidential Information with the same
degree of care it maintains the confidentiality of its own confidential
information. Each party shall not use such Confidential Information for
any purpose other than in performance of this Agreement or disclose the
same to any other Person other than to such of its employees, agents,
advisers, representatives, consultants and counsel who have a need to know
such Confidential Information to implement the terms of this Agreement;
provided, however, any such consultants shall be subject to
confidentiality obligations consistent with those provided herein. The
party receiving the Confidential Information (the "Receiving Party") shall
advise any employee, agent, adviser, representative, consultant or counsel
who receives such Confidential Information of the confidential nature
thereof and of the obligations contained in this Agreement relating
thereto, and the Receiving Party shall ensure that all such employees,
agents, advisers, representatives, consultants and counsel comply with
such obligations as if they had been a party hereto. Upon termination of
this Agreement, or earlier if so requested in writing by the party
disclosing the Confidential Information (the "Disclosing Party"), the
Receiving Party shall use reasonable efforts to return or destroy all
documents, tapes or other media containing Confidential Information in its
possession, except that the Receiving Party may keep one copy of
Confidential Information in the Legal Department files of the Receiving
Party, solely for archival purposes. Such archival copy shall be deemed to
be the property of the Disclosing Party, and shall not be copied or
distributed in any manner without the express prior written permission of
the Disclosing Party; provided, however, that the Receiving Party shall
have the right to disclose any Confidential Information provided hereunder
if, in the reasonable opinion of the Receiving Party's legal counsel, such
disclosure is necessary to comply with the terms of this Agreement, or the
requirements of any Law. The Receiving Party shall notify the Disclosing
Party of the Receiving Party's intent to make such disclosure of
Confidential Information pursuant to the proviso of the preceding sentence
sufficiently prior to making such disclosure so as to allow the Disclosing
Party adequate time to take whatever action the Disclosing Party may deem
to be appropriate to protect the confidentiality of the information.
SECTION 8.02. Exceptions. Each of PFIZER and WARNER-LAMBERT shall be
relieved of any and all of the obligations of Section 8.01 with respect to
a specific item of Confidential Information if:
(a) such Confidential Information is in the public domain at the time
of disclosure hereunder or subsequently comes within the public
domain through no fault or action of the Receiving Party or any of
its Affiliates; or
(b) such Confidential Information is in the possession or control of
the Receiving Party or any of its Affiliates at the time of
disclosure by or on behalf of the Disclosing Party or is
independently discovered, after the date of disclosure, by the
Receiving Party or any of its Affiliates without the aid, application
or use of the Confidential Information, in each such case as
evidenced by written records; or
(c) such Confidential Information is obtained by the Receiving Party
from any third party not in violation of any confidentiality
obligation to the Disclosing Party.
SECTION 8.03. Survival. The obligations and prohibitions contained in
this Article VIII shall survive the expiration or termination of this
Agreement for a period of five (5) years.
ARTICLE IX - INDEMNIFICATION
SECTION 9.01. Indemnification of PFIZER. WARNER-LAMBERT shall
indemnify PFIZER in accordance with Section 4.03 of the International
Collaboration Agreement.
SECTION 9.02. Indemnification of WARNER-LAMBERT. PFIZER shall
indemnify WARNER-LAMBERT in accordance with Section 4.04 of the
International Collaboration Agreement.
SECTION 9.03. Survival. The provisions of this Article IX shall
survive the expiration or termination of this Agreement.
ARTICLE X - PATENTS AND TRADEMARKS
SECTION 10.01. Prosecution and Maintenance of Patents. WARNER-LAMBERT
shall make adequate filings for, and prosecute and maintain, all Patents
and related applications in the Territory unless WARNER-LAMBERT reasonably
believes that any such Patent or related application is not material to
the matters contemplated in this Agreement. WARNER-LAMBERT 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 WARNER-LAMBERT shall advise PFIZER of the status of
pending applications, shall provide PFIZER with copies of documentation
concerning such applications and shall consult with PFIZER before taking
any action materially affecting the scope of patent coverage relating to
Products in the Territory. WARNER-LAMBERT shall file all applications and
take any other actions necessary to obtain patent extensions and
supplementary protection certificates for Patents where available in the
Territory unless WARNER-LAMBERT reasonably believes that any such Patent
or application is not material to the matters contemplated in this
Agreement.
SECTION 10.02. Patent Infringement. (a) In the event any infringement
action shall be brought in any Country against PFIZER or any of its
Affiliates because of their use or sale of Products, PFIZER shall promptly
notify WARNER-LAMBERT. WARNER-LAMBERT shall, at its sole expense, assume
the defense of such action, and PFIZER shall be fully indemnified on
account of such action subject to the terms of Section 9.01; provided,
however, that such defense and indemnity shall be inapplicable to the
extent it relates to a claim which arises from PFIZER's Packaging of the
Product in accordance with ARTICLE V hereof.
(b) If any third party shall, in the reasonable opinion of either
party, infringe any of the Patents, such party shall promptly notify the
other party.
(c) If any third party shall infringe any of the Patents in
connection with either the manufacture, use or sale of a product in a
Country or Countries that has a Material Adverse Effect (as hereinafter
defined) on the Products, WARNER-LAMBERT shall bring suit and take such
other action as it may determine is reasonably necessary to enjoin,
prohibit, or retard such infringement. WARNER-LAMBERT and PFIZER will
share the costs and expenses of such suit or action equally. PFIZER shall,
at WARNER-LAMBERT's request, cooperate in such suits or actions. Any
monetary recovery in connection with such infringement action shall first
be applied to reimburse WARNER-LAMBERT and, to the extent PFIZER's
assistance or cooperation has been requested by WARNER-LAMBERT, PFIZER,
for their out-of- pocket expenses (including reasonable attorneys' fees)
in prosecuting such infringement, and WARNER-LAMBERT and PFIZER shall
share the balance of such recovery equally. If such recovery is less than
such out-of-pocket expenses, reimbursement shall be on a pro-rata basis.
In the event of such a Material Adverse Effect, the Agreement Year with
respect to the affected Country or Countries in which such infringement
occurred shall be extended by the number of days during which such
infringement resulted in a Material Adverse Effect on Net Sales in such
Country or Countries. For purposes of this Section 10.02(c), "Material
Adverse Effect" shall be deemed to occur if sales in a Country of
infringing products by such infringing party equal to at least ten percent
(10%) of Net Sales in such Agreement Year in such Country. If
WARNER-LAMBERT fails to obtain a discontinuance of said infringement
and/or elects not to bring suit against such third party infringer,
WARNER-LAMBERT will give notice to PFIZER of its election not to bring
suit within ten days of such election. PFIZER may, at its option, (i)
obtain a discontinuance of the alleged infringement or (ii) bring suit
against such third party within six months of the date of receipt by
PFIZER of the aforesaid notice. Any suit by PFIZER will be either in the
name of PFIZER or in the name of WARNER-LAMBERT, or jointly by
WARNER-LAMBERT and PFIZER, as may be required by Law. For this purpose,
WARNER-LAMBERT will execute such legal papers necessary for the
prosecution of such suit as may be reasonably requested by PFIZER. If
PFIZER does bring such a suit or action, it shall bear all costs and
expenses associated therewith and will be entitled to keep any and all
recoveries.
(d) If any third party shall infringe any of the Patents and such
infringement does not result in a Material Adverse Effect, WARNER-LAMBERT
shall have sole discretion whether or not to bring suit to enjoin,
prohibit, or retard such infringement. WARNER-LAMBERT shall be solely
responsible for all out-of-pocket expenses incurred in connection with
such infringement suits and shall have sole rights to any recoveries made
thereunder. PFIZER shall, at WARNER-LAMBERT's request, cooperate in such
suits or actions.
SECTION 10.03. Trademark Infringement. (a) WARNER-LAMBERT and PFIZER
shall each advise the other promptly upon its becoming aware of any
infringement by a third party of the Trademark. WARNER-LAMBERT 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, WARNER-LAMBERT, at WARNER-LAMBERT's
expense, in any investigation or action taken by WARNER-LAMBERT 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 WARNER-LAMBERT or its Affiliate
and PFIZER shall not under any circumstances be entitled to any share of
the same. If WARNER-LAMBERT fails to obtain a discontinuance of said
infringement and/or elects not to bring suit against such third party
infringer, WARNER-LAMBERT will give notice to PFIZER of its election not
to bring suit within ten days of such election. PFIZER may, at its option,
(i) obtain a discontinuance of the alleged infringement or (ii) bring suit
against such third party within six months of the date of receipt by
PFIZER of the aforesaid notice. Any suit by PFIZER will be either in the
name of PFIZER or in the name of WARNER-LAMBERT, or jointly by
WARNER-LAMBERT and PFIZER, as may be required by Law. For this purpose,
WARNER-LAMBERT will execute such legal papers necessary for the
prosecution of such suit as may be reasonably requested by PFIZER. If
PFIZER does bring such a suit or action, it shall bear all costs and
expenses associated therewith and will be entitled to keep any and all
recoveries.
(b) In the event any trademark infringement action shall be brought
in any Country against PFIZER or any of its Affiliates because of their
use or sale of Products, PFIZER shall promptly notify WARNER-LAMBERT.
WARNER- LAMBERT shall, at its sole expense, assume the defense of such
action, and PFIZER shall be fully indemnified on account of such action
subject to the terms of Section 9.01; provided, however, that such defense
and indemnity shall be inapplicable to the extent it relates to a claim
which arises from PFIZER's Packaging of the Product in violation of
ARTICLE V hereof.
ARTICLE XI - TERM AND TERMINATION
SECTION 11.01. Term. Unless otherwise mutually agreed to by the
parties, this Agreement shall, with respect to each Country, expire on the
last day of Agreement Year Ten.
SECTION 11.02. Termination. (a) If either WARNER-LAMBERT or PFIZER
materially breaches or defaults in the performance of any of the
provisions of this Agreement with respect to any Country, and such
material breach or default is not cured within sixty (60) days after the
giving of notice by the other party specifying such breach or default, the
other party shall have the right to terminate this Agreement forthwith
with respect to that Country. For the purposes of this Section 11.02, a
material breach or default in the performance of any of the provisions of
this Agreement shall include a material inaccuracy in any representation,
warranty or covenant contained herein.
(b) To the extent permitted by Law, if either WARNER-LAMBERT or
PFIZER shall become insolvent, or shall make or seek to make or arrange an
assignment for the benefit of creditors, or if proceedings in voluntary or
involuntary bankruptcy shall be initiated by, on behalf of or against such
party (and, in the case of any such involuntary proceeding, not dismissed
within ninety (90) days), or if a receiver or trustee of such party's
property shall be appointed and not discharged within ninety (90) days,
the other party shall have the right to terminate this Agreement
forthwith.
SECTION 11.03. PFIZER Right to Terminate. At any time, upon twelve
(12) months' notice to WARNER-LAMBERT, PFIZER shall have the right on a
Country-by-Country basis, at PFIZER's sole discretion, to terminate this
Agreement and upon such termination, subject to Section 11.04, PFIZER
shall have no further rights to any payments or compensation from
WARNER-LAMBERT. In addition, in the event that PFIZER ceases permanently
the sale of any Product in any Country in accordance with Section 3.01(c)
this Agreement shall automatically terminate with respect to such Country.
SECTION 11.04. WARNER-LAMBERT Right to Terminate. WARNER-LAMBERT
shall have the right to terminate this Agreement with respect to certain
Products in accordance with Sections 3.01(b) and 3.01(e). In addition, in
the event that WARNER-LAMBERT ceases permanently the sale of Bulk to
PFIZER pursuant to Section 3.01(d) this Agreement shall automatically
terminate with respect to such Country.
SECTION 11.05. No Prejudice to Rights. Termination of this Agreement
shall be without prejudice to:
(a) The rights of the parties to any payments due under Article IV to
the date of termination; and
(b) Any remedies which either party may then have hereunder or at
law; and
(c) Either party's right to obtain performance of any obligations
provided for in this Agreement which survive termination by their
express terms.
ARTICLE XII - MISCELLANEOUS
SECTION 12.01. Non-Compete. During the Term of this Agreement and for
two (2) years thereafter, neither PFIZER nor WARNER-LAMBERT (nor their
respective Affiliates or licensees (other than AchE LaboratOrios
FarmacEuticos S/A and the companies of the Menarini group)) shall,
directly or indirectly, market, sell, detail, promote or distribute any
Competing Products in any part of the Territory.
SECTION 12.02. Manner of Payments. All sums due to either party shall
be payable in local currency or such other currency as shall be agreed
between the parties by bank wire transfer in immediately available funds
to such bank account(s) as each of PFIZER and WARNER-LAMBERT shall
designate. PFIZER shall notify WARNER-LAMBERT's Assistant Treasurer,
International by facsimile transmission (at 201-540-7761 or such other
number as may be communicated to PFIZER by WARNER-LAMBERT) as to the date
and amount of any such wire transfer to WARNER-LAMBERT one business day
prior to such transfer. WARNER-LAMBERT shall notify PFIZER's Treasurer by
facsimile transmission (at 212-573-1133 or such other number as may be
communicated to WARNER-LAMBERT by PFIZER) as to the date and amount of any
such wire transfer to PFIZER one business day prior to such transfer.
SECTION 12.03. Interest on Late Payments. If either WARNER-LAMBERT or
PFIZER shall fail to make a timely payment pursuant to this Agreement,
interest shall accrue on the past due amount at a rate equal to the rate
of interest for 30 day high-grade commercial paper issued by major
corporations effective for the first date on which the payment was
delinquent, calculated on an actual/360 basis, as quoted in The Wall
Street Journal.
SECTION 12.04. Relationship of the Parties. Each party shall bear its
own costs incurred in the performance of its obligations hereunder without
charge or expense to the other except as expressly provided in this
Agreement. Neither party shall have any responsibility for the hiring,
termination or compensation of the other party's employees or for any
employee benefits of such employee. No employee or representative of a
party shall have any authority to bind or obligate the other party to this
Agreement for any sum or in any manner whatsoever, or to create or impose
any contractual or other liability on the other party without said party's
approval. For all purposes, and notwithstanding any other provision of
this Agreement to the contrary, PFIZER's legal relationship under this
Agreement to WARNER-LAMBERT shall be that of independent contractor.
Nothing in this Agreement shall be construed to establish a relationship
of co-partners or joint venturers between the parties.
SECTION 12.05. No Solicitation. The parties agree that during the
Term of this Agreement neither party to this Agreement shall solicit any
employee of the other party, with whom it has come in contact or
interacted for the purposes of the performance of this Agreement, to leave
the employment of the other party and accept employment with the first
party.
SECTION 12.06. Force Majeure. The occurrence of an event which
materially interferes with the ability of a party to perform its
obligations or duties hereunder which is not within the reasonable control
of the party affected, not due to malfeasance, and which could not with
the exercise of due diligence have been avoided ("Force Majeure"),
including, but not limited to, fire, accident, labor difficulty, strike,
riot, civil commotion, act of God, delay or errors by shipping companies
or change in Law, shall not excuse such party from the performance of its
obligations or duties under this Agreement, but shall merely suspend such
performance during the continuation of Force Majeure. The party prevented
from performing its obligations or duties because of Force Majeure shall
promptly notify the other party hereto (the "Other Party") of the
occurrence and particulars of such Force Majeure and shall provide the
Other Party, from time to time, with its best estimate of the duration of
such Force Majeure and with notice of the termination thereof. The party
so affected shall use reasonable efforts to avoid or remove such causes of
nonperformance. Upon termination of Force Majeure, the performance of any
suspended obligation or duty shall promptly recommence. Neither party
shall be liable to the Other Party for any direct, indirect,
consequential, incidental, special, punitive, exemplary or other damages
arising out of or relating to the suspension or termination of any of its
obligations or duties under this Agreement by reason of the occurrence of
Force Majeure.
SECTION 12.07. Confidentiality; Public Announcements.
(a) Each party shall keep the terms of this Agreement confidential
and shall not disclose the same to any third party other than (i) by
agreement of the parties hereto, or (ii) as required by Law or stock
exchange regulation or an order of a competent court; provided that prior
to disclosure pursuant to (ii) above, the disclosing party shall notify
the nondisclosing party sufficiently prior to making such disclosure so as
to allow the nondisclosing party adequate time to take whatever action it
may deem to be appropriate to protect the confidentiality of the
information.
(b) Neither party shall make any press release or other public
announcement or other disclosure to third parties relating to this
Agreement without the prior consent of the other party, which consent
shall not be unreasonably withheld, except where required by applicable
Law; provided that prior to disclosure, the disclosing party shall notify
the nondisclosing party sufficiently prior to making such disclosure so as
to allow the nondisclosing party adequate time to take whatever action it
may deem to be appropriate to protect the confidentiality of the
information.
SECTION 12.08. Choice of Law; Submission to Jurisdiction. This
Agreement shall be governed by and construed in accordance with the law of
the State of New York other than those provisions governing conflicts of
law. Each party hereby irrevocably and unconditionally submits for itself
and its property in any legal action or proceeding relating to or arising
out of this Agreement, or any of the transactions contemplated hereby, to
the non-exclusive general jurisdiction of the Courts of the State of New
York, the courts of the United States of America for the Southern District
of New York, and appellate courts from any thereof, and agrees that any
such action or proceeding may be brought in such courts.
SECTION 12.09. Assignment. This Agreement may not be assigned by
either party without the prior written consent of the other party;
provided that each party shall have the right to assign its rights and
obligations under this Agreement to (a) any third party successor to all
or substantially all of (i) its entire business or (ii) its pharmaceutical
business or (b) in whole or in part to its Affiliate or Affiliates who
shall be substituted directly in whole or in part for it hereunder;
provided, however, that the assignor shall be responsible for the
performance of its Affiliate assignee(s) hereunder. It is further
understood and agreed that each party may assign, or otherwise cause to be
performed, its obligations under this Agreement to or by, as the case may
be, one or more of its Affiliates to the extent necessary or appropriate
in order to ensure that such obligations are fulfilled in accordance with
the terms and intent of this Agreement. This Agreement shall be binding
upon, and subject to the terms of the foregoing sentence, inure to the
benefit of the parties hereto, their successors, legal representatives and
assigns.
SECTION 12.10. Notices. All demands, notices, consents, approvals,
reports, requests and other communications hereunder must be in writing
and will be deemed to have been duly given only if delivered personally or
by facsimile transmission or by mail (first class, postage prepaid) to the
parties at the following addresses or facsimile numbers:
WARNER-LAMBERT:
Warner-Lambert Company
201 Tabor Road
Morris Plains, New Jersey 07950
Attention: President, Pharmaceutical Sector
Facsimile No. (201) 540-4009
with a copy to: Vice President and General Counsel
Facsimile No. (201) 540-3927
PFIZER:
Pfizer Inc.
235 East 42nd Street
New York, New York 10017-5755
Attention: President, International Pharmaceuticals Group
Facsimile No. (212) 573-1240
with a copy to: Senior Vice President and General Counsel
Facsimile No. (212) 808-8924
or to such other address as the addressee shall have last furnished in
writing in accord with this provision to the addressor.
SECTION 12.11. Invalid Provisions. If any provision of this Agreement
is held to be illegal, invalid or unenforceable under any applicable
present or future Law, and if the rights or obligations of either party
hereto under this Agreement will not be materially and adversely affected
thereby, (i) such provision will be fully severable, (ii) this Agreement
will be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (iii) the
remaining provisions of this Agreement will remain in full force and
effect and will not be affected by the illegal, invalid or unenforceable
provision or by its severance herefrom and (iv) in lieu of such illegal,
invalid or unenforceable provision, there will be added automatically as a
part of this Agreement, a legal, valid and enforceable provision as
similar in terms to such illegal, invalid or unenforceable provision as
may be possible.
SECTION 12.12. Headings. The headings used in this Agreement have
been inserted for convenience of reference only and do not define or limit
the provisions hereof.
SECTION 12.13. Waiver. Any term or condition of this Agreement may be
waived at any time by the party that is entitled to the benefit thereof,
but no such waiver shall be effective unless set forth in a written
instrument duly executed by or on behalf of the party or parties waiving
such term or condition. No waiver by any party of any term or condition of
this Agreement, in any one or more instances, shall be deemed to be or
construed as a waiver of the same or any other term or condition of this
Agreement on any future occasion. All remedies, either under this
Agreement or by Law or otherwise afforded, will be cumulative and not
alternative.
SECTION 12.14. Entire Agreement. This Agreement (including Exhibits A
through C hereto), together with the International Collaboration Agreement
and the Confidential Disclosure Agreement, dated March 4, 1996 (the
"Confidential Disclosure Agreement"), each between WARNER-LAMBERT and
PFIZER, constitutes the entire agreement between the parties hereto with
respect to the within subject matter and supersedes all previous
agreements, whether written or oral. It is agreed that (i) Article VIII of
this Agreement shall govern the protection of Confidential Information
disclosed prior to or pursuant to this Agreement and (ii) the matters
referred to in Paragraph 8 and Attachment A of the Confidential Disclosure
Agreement shall remain in full force and effect pursuant to the terms
thereof. This Agreement may be altered, amended or changed only by a
writing making specific reference to this Agreement and signed by duly
authorized representatives of WARNER-LAMBERT and PFIZER.
SECTION 12.15. No License. Nothing in this Agreement shall be deemed
to constitute the grant of any license or other right in either party to
or in respect of any product, patent, trademark, Confidential Information,
trade secret or other data or any other intellectual property of the other
party except as expressly set forth herein.
SECTION 12.16. Third Party Beneficiaries. None of the provisions of
this Agreement shall be for the benefit of or enforceable by any third
party, including, without limitation, any creditor of either party hereto.
No such third party shall obtain any right under any provision of this
Agreement or shall by reason of any such provision make any claim in
respect of any debt, liability or obligation (or otherwise) against any
party thereto.
SECTION 12.17. Independent Agreements. WARNER-LAMBERT and PFIZER
have, as of the date hereof, entered into an Option Agreement (the "Option
Agreement") under which PFIZER grants to WARNER-LAMBERT 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 WARNER-LAMBERT may not acquire or be granted any rights to any PFIZER
compound under the Option Agreement. WARNER-LAMBERT acknowledges that,
under any of the foregoing circumstances, it shall have no claim
whatsoever against PFIZER under this Agreement, which shall remain in full
force and effect according to its terms.
SECTION 12.18. Counterparts. This Agreement may be executed in any
two or more counterparts, each of which, when executed, shall be deemed to
be an original and all of which together shall constitute one and the same
document.
IN WITNESS WHEREOF, WARNER-LAMBERT and PFIZER, by their duly authorized
Officers, have executed this Agreement as of the date first written above.
WARNER-LAMBERT COMPANY PFIZER INC.
By: /s/ Lodewijk J.R. de Vink By: /s/ R. Neimeth
----------------------------- ----------------------------
Name: Lodewijk J.R. de Vink Name: Robert Neimeth
Title: President and Chief Title: Executive Vice President
Operating Officer
[EXHIBIT 99.5.1]
AMENDMENT
AMENDMENT, dated as of May 27, 1997 (this "Amendment"), to the
International Collaboration Agreement, effective as of June 28, 1996 (the
"Agreement") by and between Warner-Lambert Company, a Delaware corporation
("Warner-Lambert"), and Pfizer Inc., a Delaware corporation ("Pfizer").
Capitalized terms not otherwise defined herein have the meanings set forth
in the Agreement.
WHEREAS, Warner-Lambert has assigned certain of its rights and
obligations under the Agreement to Warner-Lambert Export Limited, a company
organized and existing under the laws of Ireland ("Export"), in accordance
with the Assignment and Assumption Agreement dated as of November 1, 1996;
and
WHEREAS, Pfizer has assigned certain of its rights and obligations
under the Agreement to Pfizer Overseas Inc., a corporation organized and
existing under the laws of Delaware ("Pfizer Overseas"); and
WHEREAS, upon this Amendment becoming effective, the parties have
agreed that certain provisions of the Agreement be amended in the manner
provided for in this Amendment;
NOW, THEREFORE, the parties hereto hereby agree as follows:
ARTICLE I - AMENDMENTS
SECTION 1.01. Amendments of Section 1.01.
(a) The definition of "Co-Promotion Territory" in Section 1.01 of the
Agreement is hereby amended by deleting from the second line thereof the
country "Greece,".
(b) The definition of "License Territory" in Section 1.01 of the
Agreement is hereby amended by inserting the countries "Egypt, Greece," in
the second line thereof before the country "Iceland."
SECTION 1.02. Amendment of Section 3.05(a). Section 3.05(a) is
hereby amended by inserting the following phrase after the words "Net
Sales" in the tenth line thereof: "or, to the extent that WARNER-LAMBERT
packages the Products for PFIZER 30% of Net Sales,".
ARTICLE II - MISCELLANEOUS
SECTION 2.01. No Other Amendments; Confirmation. Except as expressly
amended, waived, modified and supplemented hereby, the provisions of the
Agreement are and shall remain in full force and effect.
SECTION 2.02. Governing Law. This Amendment 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.
SECTION 2.03. Headings. The headings used in this Amendment have
been inserted for convenience of reference only and do not define or limit
the provisions hereof.
SECTION 2.04. Third Party Beneficiaries. None of the provisions of
this Amendment 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
Amendment or shall by reason of any such provision make any claim in
respect of any debt, liability or obligation (or otherwise) against either
party hereto.
IN WITNESS WHEREOF, the parties hereto, by their duly authorized
officers, have executed this Amendment as of the date first written above.
WARNER-LAMBERT PFIZER OVERSEAS INC.
EXPORT LIMITED
By: /s/ Paul V. Breen By: /s/ Daniel P. Cronin
---------------------------- -----------------------------
Name: Paul V. Breen Name: Daniel P. Cronin
Title: Managing Director Title: Vice President
[EXHIBIT 99.5.2]
AMENDMENT
AMENDMENT, dated as of April 22, 1998 (this "Amendment"), to the
International License Agreement, effective as of June 28, 1996 (the
"Agreement") by and between Warner-Lambert Company, a Delaware corporation
("Warner-Lambert"), and Pfizer Inc., a Delaware corporation ("Pfizer").
Capitalized terms not otherwise defined herein have the meanings set forth
in the Agreement.
WHEREAS, Warner-Lambert has assigned certain of its rights and
obligations under the Agreement to Warner-Lambert Export Limited, a
company organized and existing under the laws of Ireland ("Export"), in
accordance with the Assignment and Assumption Agreement dated as of
November 1, 1996; and
WHEREAS, Pfizer has assigned certain of its rights and obligations
under the Agreement to Pfizer Overseas Inc., a corporation organized and
existing under the laws of Delaware ("Pfizer Overseas"); and
WHEREAS, upon this Amendment becoming effective, the parties have
agreed that certain provisions of the Agreement be amended in the manner
provided for in this Amendment;
NOW, THEREFORE, the parties hereto hereby agree as follows:
ARTICLE I - AMENDMENTS
SECTION 1.01. Amendment of Exhibit A. Exhibit A of the Agreement is
hereby amended by inserting the country "Morocco" below the country
"Iceland" and above the country "Norway" under Category 1.
ARTICLE II - ADDITIONAL AGREEMENTS
SECTION 2.01. Sales Minimums.
(a) Solely in Morocco, Pfizer Overseas agrees that aggregate
Net Sales in Morocco shall equal at least U.S.$71,429, U.S.$857,143
and U.S.$1,787,714, respectively, for each of the first three
Agreement Years for Morocco. In the event Pfizer Overseas or its
Affiliates does not achieve such sales minima during any of the first
three Agreement Years, Pfizer Overseas shall pay to Export, within 60
days after the end of such Agreement Year, an amount calculated as
follows: the difference between 14% of Net Sales for the Agreement
Year in which the shortfall occurred and (i) U.S.$10,000 in Agreement
Year One, (ii) U.S.$120,000 in Agreement Year Two, and (iii)
U.S.$250,000 in Agreement Year Three.
(b) For example, if Pfizer Overseas achieved Net Sales equal to
U.S.$60,000 in Agreement Year One, Pfizer Overseas would owe Export
an amount equal to $1,600 (i.e., $10,000 minus ($60,000 X 14%)).
SECTION 2.02. Termination of Exclusive License Rights.
(a) If Pfizer Overseas or its Affiliates, as the case may be,
does not achieve Net Sales in Morocco equal to at least
U.S.$2,000,000 during the period beginning 24 months and ending 36
months after the Launch Date for Morocco, and if applicable Laws or
Governmental or Regulatory Authority, as the case may be, do not
allow the transfer of the Manufacturing Authorization from Pfizer
Overseas to Export, or its Affiliate, at such time, Export may elect,
in its sole discretion, (i) to continue unchanged its relationship
with Pfizer Overseas for Morocco as provided in this Amendment and
any other applicable agreements or (ii) renegotiate such relationship
as further provided in this Section 2.02(a). In the event that Export
shall elect to renegotiate such relationship as provided in the
foregoing clause (ii), Export or its Affiliates shall have the right
to promote and detail the Product in Morocco on such commercially
reasonable terms and conditions (including as to exclusivity) as
shall be negotiated between the parties in good faith; provided that
under any such renegotiated relationship, Pfizer Overseas or its
Affiliates shall have the right to continue its current manufacturing
and/or packaging, distribution and sale of the Product in Morocco.
(b) If Pfizer Overseas or its Affiliates, as the case may be,
does not achieve Net Sales in Morocco equal to at least
U.S.$2,000,000 during the period beginning 24 months and ending 36
months after the Launch Date for Morocco, and if applicable Laws or
Governmental or Regulatory Authority, as the case may be, allow the
transfer of the Manufacturing Authorization from Pfizer Overseas to
Export, or its Affiliate, at such time, Export may elect, in its sole
discretion, (i) to terminate the exclusive license granted to Pfizer
Overseas in Morocco and retain all rights to promote, detail and
distribute the Product exclusively in Morocco; or (ii) to agree with
Pfizer to promote and detail the Product in Morocco in accordance
with the International Co-Promotion Agreement dated as of June 28,
1996, as amended. In the event Pfizer elects not to continue such
manufacturing and/or packaging and distribution activities, as the
case may be, Pfizer agrees to use its best efforts to transfer
promptly the Manufacturing Authorization to such party designated by
Export, in its sole discretion, so as to not materially disrupt
Export's or its designee's ability to distribute the Product in
Morocco.
(c) Export's rights under this Section 2.02 shall be in
addition to, and shall not be in limitation of, its rights under
Section 2.01.
(d) The parties shall agree to execute any other documents or
undertake any further actions as may be reasonably necessary to
effectuate the provisions of this Section 2.01.
SECTION 2.03. Methods of Calculation.
(a) For purposes of calculating Net Sales in Morocco under
Section 2.01 and 2.02 above, the parties agree as follows:
(i) the currency exchange rate shall be 9.36 Dirhams per
U.S.$1.00; and
(ii) the manufacturer selling price for the Product is equal to
8.90 Dirhams per 10 mg. tablet.
(b) In the event that the actual (1) currency exchange rate in
Morocco or (2) the manufacturer selling price of the 10 mg. tablet of
the Finished Product shall be greater than or less than by more than
15% the rate or price, as the case may be, set forth in Section
2.03(a) above, the parties agree to appropriately renegotiate, in
good faith, the sales minima set forth in Sections 2.01 and 2.02
above.
ARTICLE III - MISCELLANEOUS
SECTION 3.01. No Other Amendments; Confirmation. Except as expressly
amended, waived, modified and supplemented hereby, the provisions of the
Agreement are and shall remain in full force and effect.
SECTION 3.02. Governing Law. This Amendment 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.
SECTION 3.03. Headings. The headings used in this Amendment have been
inserted for convenience of reference only and do not define or limit the
provisions hereof.
SECTION 3.04. Third Party Beneficiaries. None of the provisions of
this Amendment 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
Amendment or shall by reason of any such provision make any claim in
respect of any debt, liability or obligation (or otherwise) against either
party hereto.
IN WITNESS WHEREOF, the parties hereto, by their duly authorized
officers, have executed this Amendment as of the date first written above.
WARNER-LAMBERT PFIZER OVERSEAS INC.
EXPORT LIMITED
By: /s/ Paul V. Breen By: /s/ Mohand Sidi Said
---------------------------- ----------------------------
Name: Paul V. Breen Name: Mohand Sidi Said
Title: Managing Director Title: Vice President
[EXHIBIT 99.5.3]
AMENDMENT AND WAIVER
AMENDMENT AND WAIVER, dated as of December 1, 1998 (this
"Amendment"), to the International License Agreement, effective as of June
28, 1996 (the "Agreement") by and between Warner-Lambert Company, a
Delaware corporation ("Warner-Lambert"), and Pfizer Inc., a Delaware
corporation ("Pfizer").
WHEREAS, Warner-Lambert has assigned certain of its rights and
obligations under the Agreement to Warner-Lambert Export Limited, a
company organized and existing under the laws of Ireland ("Export"), in
accordance with an Assignment and Assumption Agreement dated as of
November 1, 1996;
WHEREAS, Pfizer has assigned certain of its rights and obligations
under the Agreement to Pfizer Overseas Inc., a corporation organized and
existing under the laws of Delaware ("Pfizer Overseas") in accordance with
an Assignment effective as of June 28, 1996;
WHEREAS, the Agreement has previously been amended by an Amendment
dated May 27, 1997 and an Amendment dated April 22, 1998; and
WHEREAS, upon this Amendment becoming effective, the parties have
agreed that certain provisions of the Agreement be amended in the manner
provided for in this Amendment;
NOW, THEREFORE, the parties hereto hereby agree as follows:
ARTICLE I - AMENDMENT AND WAIVER
SECTION 1.01. Amendment of Section 1.01. Section 1.01 of the
Agreement is hereby amended by adding the following new definitions
immediately before the definition of "Competing Products":
"China" means the People's Republic of China (excluding The Special
Administrative Region of Hong Kong and Macao)."
"China Exclusive Termination Date" shall mean the earlier of (i) the
date on which the Agreement is terminated with respect to China and Export
commences co-promoting the Products in China, in accordance with Section
2.01 of this Amendment or (ii) the termination or expiration of the
Agreement as it relates to China in accordance with the terms thereof.
SECTION 1.02. Waiver of Rights.
Notwithstanding that China is a Category 2 Country under the
Agreement, Export hereby agrees, for a period of five (5) years from the
Launch Date in China, to waive the rights of Export to sell Products in
China, as described in Section 2.01 (b) of the Agreement, and to
manufacture Products in China.
SECTION 1.03. General.
References to a "Section" or "Sections" herein shall mean the
relevant Section of this Amendment, unless otherwise noted as referring to
the relevant Section of the Agreement. Unless otherwise noted, capitalized
terms used herein shall have the meanings ascribed to them in the
Agreement. References herein to Export or Pfizer Overseas shall be deemed
to include their respective Affiliates, as appropriate.
ARTICLE II - ADDITIONAL AGREEMENTS
SECTION 2.01. Co-Promotion Election.
Without limiting Export's right to terminate the Agreement in
accordance with the terms thereof, Export shall have the right with
respect to China, at any time on or after the last day of Agreement Year
Five, to terminate the Agreement as it relates to China and to co-promote
the Products in China with PFIZER pursuant to the terms of the
International Co-Promotion Agreement, dated as of June 28, 1996 between
WARNER-LAMBERT and PFIZER (the "International Co-Promotion Agreement"), as
amended by an Amendment dated the date hereof (the "International
Co-Promotion Amendment"), and assigned to Export. Export may exercise such
right by providing written notice to PFIZER at least six (6) months prior
to the date on which Export desires to commence co-promoting the Products,
which date shall not be earlier than the day after the last day of
Agreement Year Five for China, and this Agreement shall terminate on such
date.
SECTION 2.02. Agreement Year.
For the purposes of the Agreement as it relates to China, "Agreement
Years" means the period commencing on the Launch Date for China and ending
on the China Exclusive Termination Date.
SECTION 2.03. Post-Agreement Year One.
For the purposes of the Agreement as it relates to China, "Post-
Agreement Year One" means the twelve-month period commencing on the day
following the China Exclusive Termination Date; "Post-Agreement Year Two"
and "Post-Agreement Year Three" mean the successive twelve (12) month
periods thereafter.
SECTION 2.04. Term of Agreement.
For the purposes of the Agreement as it relates to China, "Term of
this Agreement" means the period from the date of the Agreement until the
China Exclusive Termination Date.
SECTION 2.05. Trademarks.
Notwithstanding the provisions of Section 2.03(e) of the Agreement,
in the event that Export elects, in accordance with Section 2.01 of this
Amendment, to co-promote the Products with PFIZER in China, PFIZER may
have the right to continue using the Trademark in China in accordance with
the International Co-Promotion Agreement, as amended by the International
Co- Promotion Amendment.
SECTION 2.06. Product Launch.
The provisions of Section 2.07 of the Agreement shall not apply with
respect to China.
SECTION 2.07. Regulatory Approvals.
Pfizer Overseas shall exercise reasonable efforts to obtain, as soon
as reasonably practicable (i) approval by the relevant Governmental or
Regulatory Authority of a Marketing Authorization for a Product which
includes labeling and Packaging (consistent with guidelines established by
the Operating Committee in accordance with the procedures set forth in
Section 4.01 of the International Co-Promotion Agreement), indications,
warnings, etc. materially equivalent to the provisions of Exhibit C of the
Agreement and a Price Approval, and such other licenses, consents and
authorizations as are required to initially import finished Product into
China, and to (ii) obtain the Manufacturing Authorization to Package the
Product in Dalian, China from bulk tablet form ("Bulk") supplied by
Export. Pfizer Overseas shall bear its own costs in obtaining such
Marketing Authorization, Price Approval and the Manufacturing
Authorization. Pfizer Overseas shall keep Export informed of negotiations
with Governmental or Regulatory Authorities in obtaining the Marketing
Authorization, Price Approval and the Manufacturing Authorization and
shall notify Export of the price it intends to accept for Price Approval
prior to finalization of such price all in accordance with the Agreement.
At the request of Pfizer Overseas, Export shall provide such reasonable
assistance as necessary in obtaining the foregoing approvals.
SECTION 2.08. License, Supply of Products, Bulk and Compliance with
Laws.
(a) Subject to Section 1.02 of this Amendment, during the Term of
this Agreement, Pfizer Overseas shall have, as provided in Section 2.01(b)
of the Agreement, an exclusive license under the Trademark and a semi-
exclusive license under the Patents and Technical Information to Package
the Products at its manufacturing facility in Dalian, China, and to use
and sell the Products in China. For purposes of this sub-clause, "semi-
exclusive" means to the exclusion of all other parties in China except
Export.
(b) Subject to the provisions of the Agreement, as amended, and until
the Manufacturing Authorization is issued by the Governmental or
Regulatory Authorities in China to Pfizer Overseas, Export shall supply
the Products to Pfizer Overseas, and Pfizer Overseas undertakes to
purchase the Products from Export to meet all of Pfizer Overseas's
requirements of Products for China. When the Manufacturing Authorization
is issued to Pfizer Overseas for the Products, Pfizer Overseas shall
procure the Bulk from Export and shall Package the Products all in
accordance with the Agreement and as specifically set forth in Article V
thereof.
(c) Pfizer Overseas shall Package the Products in accordance with (i)
the terms of the Agreement, (ii) acceptable pharmaceutical industry
practice and (iii) all applicable Laws and Good Manufacturing Practices.
(d) Pfizer Overseas shall refrain from infringing any patent of any
third party in connection with the Packaging of the Product.
(e) The parties agree to file with Governmental or Regulatory
Authorities in China a short form summary contract of the rights granted
by WARNER-LAMBERT to Pfizer Overseas to Package the Products in accordance
with this Amendment. The short form summary contract is intended solely
for WARNER-LAMBERT or its Affiliates to file for and obtain administrative
protection under the Laws in China for the Product and such summary
contract shall not, in any manner whatsoever, be relied upon by either of
the parties to interpret their respective rights and obligations under
this Amendment, or the International License Agreement, the International
Co- Promotion Agreement or the International Collaboration Agreement, as
each has been amended.
SECTION 2.09. Quality Audit.
Without limiting the provisions of Section 5.04 of the Agreement,
Pfizer Overseas shall make that portion of its manufacturing facilities
where Products are Packaged, including all records and reference samples
related to Products, available for inspection by Export during business
hours. Records made available for inspection hereunder shall include
records relevant to assessing the quality of a Product in the event of a
complaint or a suspected defect.
SECTION 2.10. Regulatory Licenses, Approvals and Consents.
Without limiting the provisions of Section 5.06 of the Agreement,
Pfizer Overseas shall obtain all licenses, consents and authorizations of
applicable Governmental or Regulatory Authorities or third parties
necessary or desirable in connection with the Product and such Packaging
activities and shall comply in all material respects with all conditions
applicable to any such license, consent, permit or authority.
SECTION 2.11. Warner-Lambert Payments.
In the event that Export elects, pursuant to Section 2.01 of this
Amendment, to terminate the Agreement with respect to China and to co-
promote the Products with Pfizer in China, Export shall make the payments
described in Section 7.02 of the Agreement based upon ten percent (10%) of
the average of Net Sales of Products in China generated in Agreement Year
Nine and Agreement Year Ten and not on the two (2) complete Agreement
Years immediately preceding the date of expiration or termination of the
Agreement. Such payments shall be made in addition to the amounts payable
pursuant to Section 2.21 of the International Co-Promotion Amendment.
Notwithstanding the terms of such Section 7.02, if Export exercises its
rights to co-promote under Section 2.01 of this Amendment, such payment
shall be payable by Export whether or not Export ceases the sale of
Products in China in any Post Agreement Year.
SECTION 2.12. Indemnification of Export.
With respect to activity in or affecting China, Pfizer Overseas and
Export shall each indemnify, defend and hold harmless the other as
provided in and subject to the terms of Sections 4.03 and 4.04 of the
International Collaboration Agreement dated June 28, 1996 between
Warner-Lambert and Pfizer.
ARTICLE III - MISCELLANEOUS
SECTION 3.01. No Other Amendments; Confirmation. Except as expressly
amended, waived, modified and supplemented hereby, the provisions of the
Agreement are and shall remain in full force and effect.
SECTION 3.02. Governing Law. This Amendment shall be governed by and
construed in accordance with the law of the State of New York.
SECTION 3.03. Headings. The headings used in this Amendment have been
inserted for convenience of reference only and do not define or limit the
provisions hereof.
SECTION 3.04. Third Party Beneficiaries. None of the provisions of
this Amendment 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
Amendment or shall by reason of any such provision make any claim in
respect of any debt, liability or obligation (or otherwise) against either
party hereto.
IN WITNESS WHEREOF, the parties hereto, by their duly authorized
officers, have executed this Amendment as of the date first written above.
WARNER-LAMBERT PFIZER OVERSEAS INC.
EXPORT LIMITED
By: /s/ Paul V. Breen By: /s/ Mohand Sidi Said
---------------------------- ----------------------------
Name: Paul V. Breen Name: Mohand Sidi Said
Title: Managing Director Title: Vice President
