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CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
EXHIBIT 10.8
COPROMOTION AGREEMENT
This COPROMOTION AGREEMENT is made as of the Effective Date
(defined below), by and between XXXXXXX-XXXXX SQUIBB U.S. PHARMACEUTICALS GROUP,
a division of X.X. XXXXXX & SONS, INC., a Delaware corporation, having a place
of business at 000 Xxxxxxxx Xxxx Xxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 ("BMS"), and
WOMEN FIRST HEALTHCARE, INC., a Delaware corporation, maintaining its principal
business offices at 00000 Xx Xxxxxx Xxxx, Xxxxx 000 Xxx Xxxxx, Xxxxxxxxxx
00000 ("WFHC").
W I T N E S S E T H:
WHEREAS, BMS markets and distributes pravastatin sodium tablets
under the trademark Pravachol(R) which has been approved by the U.S. Food and
Drug Administration ("FDA") for the treatment of cholesterol-lowering and other
indications (as more fully specified in the labeling for the product); and
WHEREAS, WFHC is engaged in the business of marketing
pharmaceutical products to physicians; and
WHEREAS, BMS wishes to expand the promotion of Pravachol(R) to
obstetricians and gynecologists (and to nurse practitioners and physician
assistants in those offices) and to those primary care physicians whose primary
practices are in the field of OB/GYN medical care and who are designated as an
OB/GYN on BMS' internal tracking databases, and WFHC desires to have the right
to copromote said product to such physicians, upon the terms specified herein;
and
WHEREAS, the parties wish to develop and implement an education
program for OB/GYNs and their patients.
NOW, THEREFORE, in consideration of the mutual covenants herein
set forth, and intending to be legally bound hereby, the parties hereto agree as
follows:
1. DEFINITIONS.
For purposes of this Agreement, the following terms shall have
the corresponding meanings set forth below:
"Affiliate" means, with respect to any Person, any other
Person which directly or indirectly controls, is controlled by, or is under
common control with, such Person. A Person shall be regarded as in control of
another Person if it/he/she owns, or directly or indirectly controls, more than
fifty percent (50%) of the voting securities (or comparable equity interests) or
other ownership interests of the other Person, or if it/he/she directly or
indirectly possesses the power to direct or cause the direction of the
management or policies of the other Person, whether through the ownership of
voting securities, by contract or any other means whatsoever.
"Agreement" means this agreement, together with all
appendices, exhibits and schedules hereto, and as the same may be amended or
supplemented from time to time hereafter by a written
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agreement duly executed by authorized representatives of each party hereto.
"Agreement Quarter" means each three-month period commencing
on the first day of January, April, July, or October, as the case may be, during
the Copromotion Term. The first Agreement Quarter shall commence on March 1,
1999 and end on June 30, 1999; thereafter, an Agreement Quarter shall cover a
calendar quarter.
"Agreement Year" means each 12-month period commencing on
April 1 and each anniversary thereof during the Copromotion Term; provided, that
the first Agreement Year shall commence on March 1, 1999 and end on March 31,
2000.
"Average Selling Price per Prescription" has the meaning set
forth in Section 11(b) hereof.
"Baseline Agreement Year Prescriptions" and "Baseline
Quarterly Prescriptions" have the meaning set forth in Section 11(b) hereof.
"Baseline Annual Sales Attributable to Covered Physicians"
has the meaning set forth in Section 11(b) hereof.
"Call Plan" has the meaning specified in Section 5(d)
hereof.
"Confidential and Proprietary Information" has the meaning
set forth in Section 15 hereof.
"Copromotion Term" has the meaning specified in Section
13(a) hereof.
"Costs" with respect to a Funded Activity has the meaning
specified in Section 6(d) hereof.
"Covered Physician" means any obstetrician or gynecologist
whose principal offices are located in the Territory (and including those nurse
practitioners and physician assistants who work with such physicians in those
offices) ) and to those primary care physicians whose primary practices are in
the field of OB/GYN medical care and who are designated as an OB/GYN on BMS'
internal tracking databases.
"Covered Physician Prescriptions" has the meaning set forth
in Section 11(b) hereof.
"Effective Date" of this Agreement means March 1, 1999 (as
to the CoPromotion Term), and January 1, 1999 (as to the Initial Education
Program).
"Funded Activities" has the meaning specified in Section
6(a) hereof.
"IMS America" means the International Marketing Services
Prescription Reporting
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Service, or such other prescription reporting service to which WFHC and BMS may
mutually agree to in writing.
"Initial Training Sessions" has the meaning in Section 7(a)
hereof.
"Net Sales" means for the applicable period the gross amount
invoiced for the Product by BMS or its licensees to unAffiliated Third Parties
in the Territory, less the following amounts to the extent deducted on such
invoice or absorbed by BMS: (i) quantity, trade, and/or cash discounts,
allowances, rebates, and price adjustments or reductions allowed or given; (ii)
freight, postage and shipping insurance expenses absorbed by BMS and not
reimbursed by the invoicee; (iii) credits, rebates, chargebacks, or refunds
allowed for rejected, outdated or returned Products; and (iv) sales and other
excise taxes and duties directly related to the sale, to the extent that such
items are included in the gross invoice price (but not including taxes assessed
against the income derived from such sale). If a Product is sold for
compensation other than cash, Net Sales shall be calculated based on the fair
market value of the Product in cash.
"Net Sales Attributable to Covered Physicians" has the
meaning set forth in Section 11(b) hereof.
"Person" shall mean an individual, corporation, partnership,
limited liability company, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, sole proprietorship, unincorporated
organization, governmental authority, or any other form of entity not
specifically listed herein.
"Product" means all product presentations (including all dosage
strengths) of Pravachol(R) (pravastatin sodium) tablets currently approved by
FDA, and any new tablets or other presentations of Pravachol(R), and any new
dosages or indications or uses (including all dosage strengths) of same that are
approved by FDA during the term of this Agreement.
"Sales/Marketing Committee" has the meaning specified in
Section 5 hereof.
"Serious adverse event" and "Non-serious adverse event" have
the meanings set forth in section 9(h) hereof.
"Territory" means the fifty states of the United States of
America, and specifically excluding Puerto Rico and any U.S. held territories
and possessions.
"Third Party" means any Person other than (i) BMS and any of
its Affiliates and (ii) WFHC and any of its Affiliates.
"Trademark" means the trademark Pravachol(R) and any other
trademark or trade name (whether registered or unregistered) used on or with the
Product or in any promotional material related to the Product in the Territory
during the Copromotion Term.
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2. GRANT OF RIGHTS TO WFHC.
(a) BMS hereby engages WFHC to promote the Product during
the Copromotion Term on an exclusive (except as provided in subsection (i)
below) basis to Covered Physicians, upon the terms and conditions set forth in
this Agreement. BMS reserves all rights not expressly granted hereunder.
Notwithstanding the foregoing, BMS reserves:
(i) the right to promote the Product through BMS and its
Affiliates to Covered Physicians during the Copromotion
Term within the Territory; provided, however, that BMS may
not grant any unAffiliated Third Party the right to
copromote the Product during the Copromotion Term within
the Territory to Covered Physicians without WFHC's prior
written consent; and
(ii) the right to promote the Product or to grant to one or
more Third Parties the right to promote the Product
outside the Territory to any physician or healthcare
provider; and
(iii) the right to promote the Product or to grant to one or
more Third Parties the right to promote the Product within
the Territory to physicians and health care providers,
other than Covered Physicians,
as and on such terms as BMS may elect and determine in its sole and absolute
discretion.
(b) Subject to the terms and conditions of this Agreement,
BMS hereby grants to WFHC a fully-paid up, nonexclusive right and license to use
the Trademark during the Copromotion Term solely in connection with the
promotion of the Product to Covered Physicians in the Territory in accordance
with this Agreement.
3. COPROMOTION BY WFHC.
(a) WFHC shall use reasonable commercial efforts to
diligently promote the Product in the Territory to Covered Physicians in
accordance with the terms of this Agreement during the Copromotion Term. WFHC
shall not be obligated to conduct any advertising of the Product except as
authorized by the Sales/Marketing Committee upon the unanimous approval of all
members of such Committee.
(b) Except as provided for in Section 6 of this Agreement or
otherwise agreed to by the parties and subject to the terms and conditions of
this Agreement, WFHC shall be solely responsible for the costs and expenses of
establishing and maintaining its sales force and conducting its other activities
under this Agreement and shall have sole authority to control its sales force
and direct the activities of its sales force. It is understood that the WFHC
sales force will not be composed, in any material part, of contract sales
personnel or telemarketers hired by WFHC without the prior written consent of
BMS.
(c) WFHC shall instruct its sales force not to, and shall
use commercially reasonable efforts to ensure that its sales force do not,
promote or detail the Product to any physician, osteopath or health care
professional who is not a Covered Physician. WFHC shall provide BMS, within five
(5) working days of transmission, complete copies and/or transcripts of all home
office generated (for example, those sent out by WFHC's Sales, Marketing and
Sales Training departments) communications
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(whether written, electronic or visual aids) to a majority of WFHC sales
representatives or detail personnel concerning the promotion of the Product. The
individual to which these shall be sent will be designated by BMS upon execution
of this Agreement. All such written, electronic and visual communications
provided to a majority of WFHC sales representatives regarding Product strategy,
positioning or selling messages shall be consistent in all respects with the
positioning strategy and selling messages then approved by the Sales/Marketing
Committee, shall comply with the product labeling, and shall be in accordance
with applicable law.
(d) BMS shall retain sole responsibility for contractual and
other relationships with managed care organizations, formularies, insurers, and
governmental agencies and instrumentalities (including without limitation
Medicare, Medicaid, the Veterans Administration, and military entities). If any
information derived from such relationships would be pertinent to the
development of the Covered Physician market by WFHC hereunder, BMS will, where
legally able to do so, share such pertinent information with WFHC under an
obligation of confidentiality.
(e) During the Copromotion Term and for one year (1) year
thereafter, WFHC shall not market, promote or otherwise sell any other statin or
other cholesterol-lowering drug product other than the Product; provided, that
the foregoing restriction shall not apply to hormonal therapy products that have
a primary or secondary effect of lowering cholesterol. Said one-year
post-Copromotion Term restriction shall not apply, however, if (1) BMS has
terminated this Agreement pursuant to Section 13(c)(ii) or Section 13(d), or (2)
WFHC has terminated this Agreement pursuant to section 13(b)(ii).
4. RESPONSIBILITIES OF BMS.
(a) Except as may be provided for in Section 6 of this
Agreement, BMS shall be solely responsible for the costs and expenses of
conducting its activities under this Agreement.
(b) BMS shall have the sole authority to determine the price
of the Product sold by BMS, including price increases or decreases and the
timing thereof as determined by BMS.
(c) BMS shall have the sole responsibility, at its cost and
expense, for Product manufacture, shipping, distribution and warehousing, for
the invoicing and billing of purchasers of the Product, for order confirmation
(if any) in accordance with BMS customary practices, and for the collection of
receivables resulting from Net Sales. BMS will book all sales of the Product
sold by BMS and its Affiliates. This Agreement shall not be construed as
creating or implying any obligation on BMS' part to supply WFHC with Product,
other than Product samples.
(d) BMS shall use commercially reasonable efforts, including
maintaining reasonable levels of inventory in light of customary industry
practice, to ensure that sufficient stock of the Product will be available in
its inventory to fill orders from the trade in accordance with normal industry
practices. In the event that there is not sufficient stock of the Product, BMS
shall equitably allocate same between Covered Physicians and Non-Covered
Physicians, and if such insufficient inventory proximately causes sales to
Covered Physicians in an Agreement Year to be materially less than they would
have been and WFHC is able to demonstrate same to BMS' reasonable satisfaction,
then BMS and WFHC shall mutually determine the amount of Net Sales, and the
Baseline Sales figure in Article 11 hereof shall be adjusted, for that Agreement
Year only, to reflect such number of lost Net Sales (and the Agreement Quarter
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targets for such Agreement Year shall also be adjusted to equitably and
appropriately reflect such lost Net Sales in the Agreement Quarter(s) in which
incurred).
(e) BMS shall use reasonable efforts consistent with
applicable legal requirements to maintain all necessary authorizations with the
FDA to market the Product in the Territory, provided that WFHC does not engage
in any act or omission inconsistent with such legal requirements.
(f) If BMS enters into a co-promotion agreement with a Third
Party for the promotion of the Product to persons or entities other than Covered
Physicians, then, subject to reimbursement by WFHC for a proportionate cost for
promotional materials as provided for in Article 6 hereof, BMS shall furnish
WFHC with copies of such promotional materials as BMS makes available to its or
such Third Party's sales force (including translations thereof, if available),
as the Sales/Marketing Committee may determine appropriate for release to WFHC.
(g) Promptly following the execution of this Agreement, BMS
shall furnish WFHC with the names and addresses of those Covered Physicians in
the Territory which BMS believes already prescribe sufficient quantities of the
Product as to lead BMS to believe that such individuals already fully appreciate
the healthcare risks of heart disease in women and are willing to prescribe
Pravastatin for the prevention or treatment of same. WFHC will use commercially
reasonable efforts to coordinate its promotional efforts on Covered Physicians
with the appropriate BMS sales representative.
(h) BMS reserves the right to assign to a Third Party all
rights to the Product (including the IND and NDA), as and upon such terms as BMS
may elect and determine in its sole and absolute discretion.
5. SALES/MARKETING COMMITTEE.
(a) A marketing committee for the Product in the Territory
to Covered Physicians will be established promptly by BMS and WFHC after
execution of this Agreement (such committee being referred to herein as the
"Sales/Marketing Committee"). WFHC shall be entitled to participate in the
activities of the Sales/Marketing Committee related to the development and
coordination of the marketing strategy and promotional plans for the Product in
the Territory to Covered Physicians, which activities shall include:
(i) developing and revising, subject to BMS' prior written
approval before use (with BMS to use commercially
reasonable efforts to review and provide its response
within 30 days after receipt of the material), existing
and new promotional materials for the Product for
in-person promotion to Covered Physicians and related
non-personal promotional activities, to the extent that
the same relate specifically to the marketing of the
Product to Covered Physicians;
(ii) developing promotional programs for the Product to Covered
Physicians;
(iii) reviewing and approving the Call Plan presented by WFHC
identifying the direct selling activity to be performed by
WFHC in any given period;
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(iv) establishing appropriate Product sampling scheduling;
(v) planning market research activities;
(vi) preparing any new materials directly related to the
Product that are to be used to train WFHC's sales force;
(vii) planning symposia, seminars and other professional
relations events of specific interest to Covered
Physicians; and
(viii) designing and implementing programs to encourage and
improve cooperation between BMS and WFHC with respect to
maximizing sales of the Product to Covered Physicians.
(b) The Sales/Marketing Committee shall be composed of two
(2) persons, with WFHC and BMS each being entitled to designate one (1)
individual. The initial members shall be designated by each party in writing
promptly following execution of this Agreement. Each party may change its
designated members at any time upon advance written notice to the other party
(for BMS, notice must be sent to its Senior Vice President, Cardiovascular and
Metabolic Diseases Marketing; for WFHC, notices must be sent to its President)
of any substitution of a member. Decisions and recommendations of the
Sales/Marketing Committee will be made by vote of WFHC and BMS, with each party
having two votes. Except where unanimous agreement of all representatives to the
Sales/Marketing Committee is expressly required under this Agreement, in the
event of a tie, BMS's Senior Vice President, Cardiovascular and Metabolic
Diseases Marketing shall have the deadlock breaking vote. In the event unanimous
agreement of the members of the Sales/Marketing Committee is required hereunder
and there is a tie, the matter for which approval was sought will be deemed to
have been rejected and the matter will not be implemented.
(c) The Sales/Marketing Committee shall meet not less than
once in each Agreement Quarter during the Copromotion Term or as otherwise
agreed by the parties in writing, at such locations as are designated by each
party alternatingly. Each party shall bear the costs and expenses of its
designated members that are incurred in connection with the Sales/Marketing
Committee meetings.
(d) WFHC shall present a Call Plan to the Sales/Marketing
Committee for review and approval not less frequently than annually covering a
period not to exceed one year. Each Call Plan shall identify the direct selling
and marketing activities to be conducted by WFHC in an Agreement Quarter
specifically targeting Covered Physicians shall be subject to the review and
unanimous written approval of all designated representatives of BMS and WFHC to
the Sales/Marketing Committee (the call plan so approved being referred to
herein as the "Call Plan"); provided that, subject to Sections 3(e), 3(f) and
4(h) hereof, WFHC shall have the discretion to determine the particular Covered
Physicians to whom it promotes, the frequency of presentation of, and the
presentation order as this relates to, the Product. Each Call Plan shall remain
in effect until a new Call Plan is again so approved by the Sales/Marketing
Committee.
Where a Call Plan has been approved by the Sales/Marketing
Committee and that Plan clearly and specifically identifies the advertising
programs and related costs to be incurred (and those that will be reimbursed by
BMS in accordance with section 6 hereof), WFHC may implement that Call Plan
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without further approval from the Sales/Marketing Committee. Any material
deviations from such approved Call Plan will require resubmission and unanimous
approval by all members of the Sales/Marketing Committee.
(e) Notwithstanding anything in this Section 5 or that
might otherwise imply to the contrary in this Agreement, BMS shall have
strategic responsibility and sole authority and responsibility for obtaining all
legal, regulatory and medical approvals related to the selling and use of
promotional materials prepared or approved by the Sales/Marketing Committee.
6. FUNDING OF PROMOTIONAL ACTIVITIES.
(a) Subject to Section 6(b) hereof, WFHC shall be solely
responsible during the Copromotion Term for the Costs incurred by it and by BMS
of the following activities related to the promotion of the Product in the
Territory to Covered Physicians (collectively, the "Funded Activities"):
(i) reasonable and customary selling and promotional materials
and advertisements that have been approved by the
Sales/Marketing Committee for use with Covered Physicians;
(ii) advertisements that have been unanimously approved by the
Sales/Marketing Committee primarily targeting Covered
Physicians;
(iii) the purchase by WFHC of Product samples from BMS, as set
forth in Article 8 hereof;
(iv) cost of promotional materials, as determined in accordance
with Section 7(c) hereof; and
(v) cost of training and training materials, as set forth in
Sections 7(a) and 7(b) below.
The incurrence of any Costs by either BMS or WFHC for Funded Activities shall
require the unanimous approval of all members of the Sales/Marketing Committee.
(b) BMS shall be under no obligation to conduct or develop
symposia, seminars, technical and scientific exhibits and other professional
relations events with respect to the Product or to conduct additional Phase I,
II, III or IV clinical trials with respect to the Product. WFHC may conduct or
develop symposia, seminars, technical and scientific exhibits and other
professional relations events with respect to the Product that specifically
target Covered Physicians, provided that a copy of all written materials to be
provided by WFHC at any such event is provided to BMS in advance in sufficient
time for BMS to have a reasonable opportunity to review and comment upon same
(it being understood that the content of the presentations by third party
presenters at such professional relations events and educational seminars shall
be the sole responsibility of such individuals in accordance with applicable law
and prevailing customary scientific practices). Such professional relations
event and educational materials shall be developed in cooperation with WFHC's
Health Advisory Board for Cardiovascular Risk Management and as part of the
Education Program. WFHC may conduct, subject to prior written approval by BMS
(which may be given or denied in BMS' sole and absolute discretion) and subject
to the overall direction and supervision of BMS, additional Phase IV clinical
trials with respect to the use of the Product. Except as
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provided in Article 17 hereof, WFHC shall be solely responsible for all costs or
expenses incurred by WFHC or BMS pursuant to this Section 6(b), and BMS shall
have no contribution or reimbursement obligation hereunder with respect to same.
(c) For purposes of Articles 6, 7 and 8 hereof, the term
"Costs" means, in the case of the Funded Activities (other than Product
samples), the direct, out-of-pocket costs and expenses paid by BMS or WFHC to an
unAffiliated Third Party in connection with such activities during the period in
question. The term "Costs" means, in the case of the Product samples described
in Section 6(a)(iii) above, the Cost of Manufacture of the Product samples.
(d) Each Party shall submit a statement to the other party
within twenty-one (21) days after the end of each Agreement Quarter, identifying
in reasonable detail the Funded Activities and related Costs incurred by it (as
determined in accordance with Section 6(c) above) that are WFHC's responsibility
under this Article 6. Each party shall promptly provide any supplementary
documentation as the other party may reasonably request to verify such Costs.
WFHC shall reimburse BMS for the Costs incurred by BMS for which WFHC is
required to reimburse BMS hereunder within 45 days after the end of each
Agreement Quarter. The calculation of such Costs and the reconciliation thereof
shall be subject to audit and inspection in accordance with Section 12 hereof.
(e) Except as provided in Section 6(a), any marketing and
promotional expenses related to the Product for the Non-Covered Physician
market, including all promotional materials, advertisements, symposia and other
promotional events therefor, shall be borne by BMS.
7. TRAINING OF WFHC SALES FORCE.
(a) The parties intend that BMS will provide WFHC's sales
force with the same or substantially similar training with respect to promotion
of the Product to Covered Physicians as has been given traditionally to BMS's
sales force in the Territory (it being understood that such training shall be
specific to the Product itself, as opposed to general sales training). BMS and
WFHC will hold two initial training sessions ("Initial Training Sessions"),
which shall be held on up to two mutually convenient dates within one (1) year
after the Effective Date of this Agreement, and which will be held at a location
mutually acceptable to BMS and WFHC. The Sales/Marketing Committee will
determine the content of each such Initial Training Session, and shall review
the Product-related training materials and make recommendations for any
revisions and updates thereto as the Committee may deem appropriate; provided,
however, BMS shall determine and be solely responsible for the content,
development, and associated cost of all training materials. Any subsequent
training programs for WFHC personnel following the two Initial Training Sessions
for which participation by BMS personnel will be required shall require the
prior unanimous agreement of all members of the Sales/Marketing Committee.
All members of the WFHC sales force (including detail
personnel, management, and sales representatives) shall attend a Product-related
training program, whether as part of an Initial Training Session or a subsequent
training program conducted by WFHC or BMS, with as many of such individuals as
practicable to attend the two Initial Training Sessions. WFHC shall bear the
full cost and expense of all of its sales force personnel (including management,
detail personnel, sales representatives, and contractors) who attend a
Product-related training programs, without contribution from BMS. BMS shall bear
the costs and expenses of its training personnel provided for the Initial
Training Session and for any
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subsequent training program that has received the prior unanimous approval of
the Sales/Marketing Committee.
(b) WFHC shall have the authority, and shall be responsible
at its cost and expense, for all training to be provided to its sales force
following the Initial Training Sessions; provided, however, that the contents
and strategic direction of any training provided by WFHC that relates to the
Product shall be coordinated and agreed to by WFHC and BMS. From time to time as
training materials for the Product may be revised by BMS (the timing and content
of which shall be determined by BMS in the exercise of its sole and absolute
discretion or as mandated by regulatory agencies or as directed by the
Sales/Marketing Committee), BMS will make such training materials available to
WFHC at BMS' out-of-pocket cost for development and production.
(c) Where BMS has granted to a Third Party the right to
co-promote the Product to Non-Covered Physicians, and where any promotional
materials, advertisements, symposia and other promotional events developed by
such Third Party for the Product in the Territory for Non-Covered Physicians
that will also directly benefit Covered Physicians (i.e., such materials and
activities, while not intended primarily for the benefit of the Covered
Physician market, will nonetheless have a direct benefit to same), then, such
activities and materials shall be discussed within the Sales/Marketing Committee
to determine whether WFHC should bear a portion of the Cost of same. If the
Sales/Marketing Committee approves by unanimous vote of all its members that
WFHC should bear a portion of the Cost of same, the Sales/Marketing Committee
will determine (again, by unanimous vote) an equitable allocation of the Cost of
such materials and activities as will be borne by WFHC, which amount shall be
reimbursed by WFHC to BMS (or which shall be subject to credit by WFHC against
BMS' contribution obligation under Section 6(b) below). WFHC shall have no right
to use such materials without BMS' prior written consent.
(d) Where any promotional and sales literature and
materials, advertisements, symposia and other promotional events have been
developed by BMS for the Product in the Territory for Non-Covered Physicians
that will also directly benefit Covered Physicians, BMS will make such materials
available to WFHC, provided that WFHC reimburses BMS for its out-of-pocket costs
incurred in developing, printing or duplicating such materials. BMS hereby
grants to WFHC a credit of Two Hundred Fifty Thousand Dollars ($250,000) during
each Agreement Year during the term hereof for the payment of such costs as WFHC
may incur under Sections 7(c) and 7(d) hereof.
(e) BMS reserves and retains title and all rights,
including copyright rights, in and to all written, visual and electronic works
and other materials provided by it to WFHC hereunder, as well as any adaptions
thereof or "derivative works" (as such term is defined in the U.S. Copyright
Code, 17 U.S.C. Section 101 et. seq.) derived or developed by WFHC from or with
such works and materials. Subject to the foregoing and to its obligations under
other terms and conditions of this Agreement, WFHC is granted the nonexclusive
right under this subsection to use, copy, modify, and distribute such materials
only in furtherance of this Agreement and the rights granted to it hereunder,
for the Copromotion Term of this Agreement. WFHC will ensure that all copyright
notices and this permission notice appear on all copies of the written materials
provided by BMS and all adaptations and derivative works thereof.
8. PRODUCT SAMPLES; ADDITIONAL CLINICAL STUDIES.
(a) BMS agrees to provide to WFHC reasonable quantities of
Product samples
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in accordance with Section 8(b) below, as requested by WFHC. Such samples shall
be used solely in making detail calls to Covered Physicians in the Territory.
Product samples will in all cases be shipped to WFHC's central distribution
facility. Shipments of Product samples shall require not less than thirty (30)
days advance written notice and shall be subject to the same shipping schedules
as that under which BMS customarily distributes Product samples to its own sales
representatives.
Product samples (and promotional and sales literature where
made available to WFHC under other provisions of this Agreement) will be shipped
to WFHC's central distribution facility. WFHC shall be responsible for the
further distribution of same to its sales representatives. All costs of such
distribution by WFHC shall be borne solely by WFHC. Once WFHC accepts shipment
of Product samples from BMS, WFHC shall be responsible for all Product samples
accountability and compliance with the Prescription Drug Marketing Act, as
amended, and other applicable federal, state and local laws relating to samples.
WFHC is further responsible for adherence by its sales representatives to such
laws.
Product samples shall have a shelf life of not less than
nine (9) months, unless otherwise agreed to by unanimous written consent of all
members of the Sales/Marketing Committee.
BMS shall bear the Product Sample Costs (as determined in
Section 8(b)) of the Product samples provided to WFHC up to the Sample Quantity
Maximum (as defined in Section 8(b) below) for a given Agreement Year, subject
to the following:
(i) BMS shall have no obligation to provide Product
samples in an Agreement Year if the aggregate
Product Sample Cost of the Product samples to be
provided by BMS would exceed *** for such Agreement
Year; and
(ii) Any Product samples requested by WFHC in excess of
the Sample Quantity Maximum for a given Agreement
Year shall require not less than sixty (60) days
advance written notice and shall be paid for by
WFHC at BMS' Cost therefor within thirty (30) days
after receipt of BMS' invoice therefor.
(b) BMS will make available to WFHC for distribution by its
sales representatives in the First Agreement Year up to *** Sleeves based on the
assumption that WFHC will have 100 sales representatives each capable of
sampling 250 key Covered Physicians that are different from those sampled by the
other WFHC sales reps, *** (the "Sample Quantity Maximum"). A Sleeve contains
six (6) 40mg tablets. For Agreement Years after the First Agreement Year, the
Sample Quantity Maximum shall be determined by the Sales & Marketing Committee.
The Product Sample Cost for the First Agreement Year shall
be ***. Said figure shall be adjusted as of the beginning of each Agreement Year
thereafter by the percentage increase or decrease in the Producers Price Index
as published by the Bureau of Statistics, U.S. Department of Labor (or successor
agency) from the first day of the previous Agreement Year through the end of
such previous Agreement Year.
(c) BMS shall have sole control over the design and conduct
of any Phase I
*** Certain information on this page has been omitted
and filed separately with the Commission. Confidential
treatment has been requested with respect to the
omitted portions.
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through V clinical studies relating to the Product, as well as sole and absolute
discretion as to whether to initiate any such studies. Where WFHC has requested
that BMS conduct a specific study (and BMS has agreed to conduct such study), or
where WFHC has agreed in writing with BMS to participate in the cost of
conducting a specific Study proposed by BMS (it being understood that WFHC has
no obligation to do so hereunder), then the cost of such studies shall be shared
as the parties may mutually agree; otherwise, BMS shall be responsible for the
cost of conducting any such studies. Any costs incurred by WFHC pursuant to this
section 8(b) shall not be subject to reimbursement out of the annual
contribution made by BMS under section 6(b) hereof.
BMS shall have the exclusive right to use for any purpose
the data resulting from clinical studies relating to the Product conducted by it
or WFHC, including, but not limited to, product registrations and product
licenses related to the Product, throughout the world.
9. CERTAIN REGULATORY MATTERS.
(a) All regulatory matters regarding the Product shall
remain under the exclusive control of BMS, subject to the participation by WFHC
in matters related to the marketing of the Product to Covered Physicians and in
certain clinical studies as more fully set forth in Sections 6(c)(ii) and 8(b)
above. BMS will have the sole responsibility, at its cost and expense, to
respond to Product and medical complaints and to handle all returns and recalls
of the Product.
(b) BMS shall furnish WFHC with efficacy and safety
information reasonably requested by WFHC to assist it in promoting the Product
to Covered Physicians, including, without limitation, relevant clinical and
safety data included in the New Drug Application for the Product and information
related to the efficacy and safety profile of the Product since its approval by
the FDA. Such information shall be treated as confidential information of BMS,
and shall not be disclosed to Third Parties without BMS' prior written approval.
(c) Beginning as of the Effective Date of this Agreement,
each party shall promptly notify the other party of any significant event(s)
that affect the marketing of the Product, including, but not limited to, adverse
drug reactions and governmental inquiries, whether within or outside the
Territory. BMS shall have the reporting responsibility for such events to
applicable regulatory health authorities anywhere in the world.
WFHC shall report all such adverse events involving the Product
learned by it to:
Vice President, Worldwide Safety & Surveillance
Xxxxxxx-Xxxxx Squibb Company
X.X. Xxx 0000
Mail Stop HW19-1.01
Xxxxxxxxx, Xxx Xxxxxx 00000-0000
X.X.X.
Facsimile No.:(000) 000-0000
Telephone No.:(000) 000-0000
A CIOMS-I form or a form that contains the data elements of a CIOMS-I form is
recommended.
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Serious adverse events concerning the Product learned by BMS
shall be reported by BMS to WFHC at the time that BMS reports such events to
FDA, and shall be sent to:
Vice President, Regulatory Affairs and Quality Systems
Women First HealthCare, Inc.
00000 Xx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, Xxxxxxxxxx 00000
Facsimile No.: (000) 000-0000
Telephone No.: (000) 000-0000
"Serious" adverse events for a Product (as defined in section 9(g) below)
learned by WFHC shall be submitted to BMS within three (3) working days but no
more than four (4) calendar days from the receipt date by WFHC.
"Non-serious" adverse events for a Product (as defined in
section 9(g) below) that are spontaneously reported to WFHC shall be submitted
to BMS no more than one (1) month from the date received by WFHC; provided,
however, that medical and scientific judgment should be exercised in deciding
whether expedited reporting is appropriate in other situations, such as
important medical events that may not be immediately life-threatening or result
in death or hospitalization but may jeopardize the patient or may require
intervention to prevent a serious adverse event outcome.
(d) Beginning as of the Effective Date of this Agreement,
each party shall promptly notify the other party in writing of any order,
request or directive of a court or other governmental authority to recall or
withdraw the Product in any jurisdiction. BMS shall be responsible, at its sole
cost and expense, for the costs of any recall or withdrawal of the Product.
(e) Upon being contacted by the Food and Drug
Administration (FDA) or any other federal, state or local agency for any
regulatory purpose pertaining to this Agreement or to the Product, WFHC shall,
if not prohibited by applicable law, immediately notify BMS and will not respond
to the agency until consulting with BMS, to the maximum feasible extent;
provided, however, that the foregoing shall not be construed to prevent WFHC in
any way from complying, and WFHC may permit unannounced FDA or similar
inspections authorized by law and respond to the extent necessary to comply,
with its obligation under applicable law.
(f) WFHC shall inform BMS' office of the Vice President,
Worldwide Safety & Surveillance of any Product Quality Complaint received within
three (3) working days but no more than four (4) calendar days from the receipt
date by WFHC. A Product Quality Complaint is defined as any complaint that
questions the purity, identity, potency or quality of the Product, its
packaging, or labeling, or any complaint that concerns any incident that causes
the drug product or its labeling to be mistaken for, or applied to, another
article or any bacteriological contamination, or any significant chemical,
physical, or other change or deterioration in the distributed drug product, or
any failure of one or more distributed batches of the drug product to meet the
specifications therefor in the NDA for the Product. Such information shall be
sent to the same address as set forth in Section 9(c) above
(g) A "serious" adverse event for a Product is defined as
any untoward
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medical occurrence that at any dose for the Product: (i) results in death; (ii)
is life-threatening (as defined below); (iii) requires inpatient hospitalization
or prolongation of existing hospitalization; (iv) results in persistent or
significant disability/incapacity; (v) is a congenital anomaly/birth defect;
(vi) results in drug dependency or drug abuse; (vii) is cancer, (viii) is a
serious medical event (as defined below), or (ix) is an overdose. A "nonserious"
adverse event is defined as that which is not serious.
A "life-threatening" adverse event is defined as an event
in which the patient or subject was at risk of death at the time of the event;
it does not refer to an event which hypothetically might have caused death if it
were more severe.
A "serious medical event" is defined as a medical event
that may not be immediately life-threatening or result in death or
hospitalization but, based on appropriate medical and scientific judgment, may
jeopardize the patient/subject or may require intervention (e.g., medical,
surgical) to prevent one of the other outcomes listed as a serious definition.
Examples of such events include, but are not limited to, intensive treatment in
an emergency room or at home for allergic bronchospasm; blood dyscrasia or
convulsions that do not result in hospitalization.
(h) BMS and WFHC will cooperate and establish a mutually
acceptable procedure designed to ensure access by BMS to samples forming the
basis of a Product complaint received by BMS. BMS will provide WFHC with samples
of return labels for this purpose.
(i) BMS Professional Services Department shall be
responsible for handling all medical inquiries concerning each Product within
the Territory, including without limitation responding to questions concerning
permitted and off-label uses of each Product, requests for journal articles, the
administration of and response to medical inquiries concerning the Products by
consumers, physicians, pharmacists and other health care professionals,
including those forwarded by sales representatives and field force personnel
promoting the Products. WFHC shall refer all routine medical information
requests in writing to:
Xxxxxxx-Xxxxx Squibb Company
Professional Services Department
X.X. Xxx 0000 X00-00
Xxxxxxxxx, XX 00000-0000
Urgent medical information requests shall be referred by
telephone to: Professional Services Department: (000) 000-0000.
10. COMPLIANCE WITH LAW AND LABELING.
(a) Each party shall maintain in full force and effect all
necessary licenses, permits and other authorizations required by law to carry
out its duties and obligations under this Agreement. Each party shall comply
with all laws, ordinances, rules and regulations (collectively, "Laws")
applicable to its activities under this Agreement, including without limitation,
any requirements of any product license applicable to the Product in the
Territory; provided, however, that WFHC shall be solely responsible for
compliance with those Laws pertaining to the activities conducted by it
hereunder (including, without limitation, those Laws that apply to documentation
and records retention pertaining to the distribution and
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use of Product samples by it under this Agreement), notwithstanding that FDA
may, as a matter of law, be entitled to hold BMS accountable or responsible
(whether primarily or secondarily) for failure of WFHC to comply with such Laws.
The parties will reasonably cooperate with one another with the goal of ensuring
full compliance with Laws. BMS shall be responsible for all labeling changes to
the Product
(b) WFHC shall make no representations or warranties
relative to the Product that conflict or are inconsistent with the NDA,
applicable law, and the FDA-approved label for the Product. WFHC shall be
responsible for any out-of-pocket costs incurred by BMS resulting from
statements made by its sales representatives that relate to the safety or
efficacy of the Product that are not in compliance with applicable law or have
not been authorized by BMS in advance in writing.
11. COPROMOTION COMPENSATION.
(a) As compensation for services rendered by WFHC during
the Copromotion Term and its agreements hereunder, BMS shall pay to WFHC a fee
("Performance Fee") with respect to each Agreement Year during the term hereof
*** of those Net Sales Attributable to Covered Physicians that are in excess of
the Baseline Annual Sales Attributable to Covered Physicians for such Agreement
Year.
(b) For purposes of this Agreement:
"Average Selling Price per Prescription" means, for any Agreement
Year (or any Agreement Quarter or six-month or nine-month period prior to the
end of an Agreement Year), the Total Net Sales of the Product in the Territory
for the applicable period from prescriptions written by all physicians of all
specialties and practices, divided by the total number of retail (TRX) and mail
order prescriptions (TRX) for the Product that are written or ordered in such
applicable period by Covered and Non-Covered Physicians. The number of retail
(TRX) prescriptions shall be determined by the National Prescriptions Audit
Plus: Prescriber Specialty Report as issued by IMS America. The number of mail
order prescriptions shall be determined by BMS using internal data in accordance
with its historical customary practices (with the Average Selling Price for mail
order prescriptions to be adjusted (i.e., trued up) to be equivalent with the
number of tablets per prescription on a retail basis).
"Baseline Annual Sales Attributable to Covered Physicians" for
each Agreement Year shall mean the product of: (i) the Baseline Agreement Year
Prescriptions for such Agreement Year, multiplied by (ii) the Average Selling
Price per Prescription for such Agreement Year;
"Baseline Agreement Year Prescriptions" for an Agreement Year
means the minimum number of Covered Physician Prescriptions for the Product
written for an Agreement Year that must be exceeded before WFHC shall realize
any compensation under this Article 11 for such Agreement. Said minimum numbers
are as follows:
(i) For the first Agreement Year, equal *** Covered
Physician Prescriptions.
(ii) For the second Agreement Year, equal the sum of: (1)
*** (2) a number that is the product of (A) *** (B) ***
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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*** that are marketed by all companies in the Territory
(such percentage increase to be determined by data
reported by IMS America); and
(iii) For the third Agreement Year, equal the sum of (1) the
number obtained in (ii) above, plus (2) a number that is
the product of (A) the number obtained in (ii) above,
multiplied by (B) the percentage increase during the
Second Agreement Year in the number of prescriptions
written by all physicians of all specialties and practices
in the Territory for pravastatin in the Territory (such
percentage increase to be determined by data reported by
IMS America).
"Baseline Quarterly Prescription" shall mean:
(i) For the first Agreement Year,
- *** Covered Physician Prescriptions
for 3/1/99-6/30/99;
- *** Covered Physician Prescriptions
for 7/1/99-9/30/99;
- *** Covered Physician Prescriptions
for 10/1/99-12/31/99;
- *** Covered Physician Prescriptions
for 1/1/00-3/31/00.
(ii) For the second and third Agreement Years, equal the
quotient of (1) the Baseline Agreement Year Prescriptions
for such Agreement Year, divided (2) by four.
"Covered Physician Prescriptions" shall equal the number of
retail prescriptions (TRX) for the Product that are written or ordered by
Covered Physicians as determined by the National Prescriptions Audit Plus:
Prescriber Specialty Report as issued by IMS America.
"Net Sales Attributable to Covered Physicians" means, for any
Agreement Year (or any Agreement Quarter or six-month or nine-month period prior
to the end of an Agreement Year), a number equal to the product of (i) the
number of Covered Physician Prescriptions for the applicable period (such
prescriptions to be determined by the National Prescriptions Audit Plus:
Prescriber Specialty Report as issued by IMS America), multiplied by (ii) the
Average Selling Price per Prescription for such applicable period.
(c) In order for WFHC to receive its Performance Fee on a
quarterly basis, as opposed to waiting until the end of the year and making a
lump sum (if applicable) of the amount that may be due it under Section 11(b),
BMS shall, subject to section 11(d) below, pay to WFHC, on a quarterly basis for
each of the first three Agreement Quarters in any Agreement Year, an amount
equal to the difference between:
(i) *** of the amount by which (A) Net Sales Attributable to
Covered Physicians for such Agreement Quarter and all
previous Agreement Quarters during such Agreement Year
exceeds (B) the product of (1) the sum of the Baseline
Quarterly Prescriptions for such applicable period times
(2) the Average Selling Price per Prescription for such
applicable period, less
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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(ii) all compensation previously paid to WFHC pursuant to this
Article 11 during such Agreement Year.
If (i) less (ii) is less than zero for a given Agreement Quarter, no payment
shall be made by BMS with respect to such Agreement Quarter.
No separate payment shall be made for the fourth Agreement
Quarter in any Agreement Year. Instead, at the end of each such Agreement Year,
a final reconciliation shall be conducted by comparing the amount to which WFHC
is otherwise entitled for such Agreement Year pursuant to Section 11(a) above
(based on the Average Selling Price per Prescription for the entire Agreement
Year) against the sum of all amounts (if any) previously paid to WFHC pursuant
to this Section 11(c) for prior Agreement Quarters during such Agreement Year.
If the calculation determines that WFHC is due further compensation (or has been
overcompensated by BMS) as a result of any quarterly payments made by BMS with
respect to the first three quarters of any Agreement Year, the balance due to
WFHC (or to be refunded by WFHC) shall be computed and paid by the applicable
party to the other within ninety (90) days after the end of such Agreement Year.
(d) Compensation due WFHC under this section 11 above
shall be calculated and paid within 60 days after the end of each Agreement
Quarter (ninety days after the fourth Agreement Quarter) during the Copromotion
Term, in accordance with Sections 11(a)-(c) and 12 hereof. Any payments not made
when due under Sections 11(a)-(c) shall bear interest at the rate of ten percent
(10%) per annum (or the highest rate permitted by applicable law, whichever is
the lower) on the unpaid balance from the date due until paid in full.
(e) In addition to compensation received during the
Copromotion Term, WFHC shall receive residual compensation ("Residual
Compensation") during the 24-month period following expiration or early
termination of the Copromotion Term (the "Residual Period") equal in the
*** of the compensation due by BMS to it for the Agreement Year immediately
preceding termination, but only where:
(A) (i) This Agreement has expired in accordance with its
terms at the end of the term provided for hereunder (or
such longer term as this Agreement may be extended by
mutual written consent);
(ii) WFHC has terminated this Agreement prior to
expiration in accordance with section 13(b)(ii) hereof; or
(iii) BMS has terminated this Agreement pursuant to
section 13(d) hereof; and
(B) WFHC complies with its obligations under Sections 3(e),
10, 14, 15, and 19 hereof.
Termination of this Agreement for any reason other than the above events shall
not trigger any Residual Compensation due WFHC. Such Residual Compensation
payment shall be made by BMS in eight (8) equal quarterly installments, each
installment to be made as of the end of each Agreement Quarter in the Residual
Period.
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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12. PAYMENTS AND REPORTING.
(a) BMS shall furnish WFHC, within 60 days after the end
of each Agreement Quarter (within 90 days at the end of each Agreement Year), a
report setting forth in reasonable detail the calculation of Net Sales
Attributable to Covered Physicians for such Agreement Quarter (and Agreement
Year), and the calculation of WFHC's compensation under Section 11 with respect
to such period (and, in addition to a report for the fourth Agreement Quarter,
with respect to the entire Agreement Year).
(b) All payments to a party under this Agreement shall be
made by wire transfer in immediately available funds in legal currency of the
United States and shall be delivered to the account of such party designated by
it in writing from time to time.
(c) The parties will maintain complete and accurate books
and records in sufficient detail to enable verification of the detail call
activity of WFHC, the Net Sales attributable to Covered Physicians and the basis
for calculating the compensation paid by BMS to WFHC hereunder. Either party may
demand an audit of the other party's relevant books and records in order to
verify the other's reports on the aforesaid matters. Upon reasonable prior
notice to the party to be audited, the independent public accountants of the
other party shall have access to the relevant books and records of the party to
be audited in order to conduct a review or audit thereof. Such access shall be
available during normal business hours not more than once each calendar year
during the Copromotion Term and only until two years after the relevant period
in question. The accountants shall be entitled to report its conclusions and
calculations to the party requesting the audit, except that in no event shall
the accountants disclose the names of customers of either party or the prices,
discounts, rebates, or other terms of sale charged by BMS for the Product.
The party requesting the audit shall bear the full cost of
the performance of any such audit except as hereinafter set forth. If, as a
result of any inspection of the books and records of BMS, it is shown that BMS'
payments to WFHC under this Agreement were less than the amount which should
have been paid, then BMS shall make all payments required to be made to
eliminate any discrepancy revealed by said inspection within 30 days after
WFHC's demand therefor. If, as a result of any inspection of the books and
records of WFHC, it is shown that BMS' reimbursements for costs associated with
Funded Activities to WFHC under this Agreement were more than the amount which
should have been paid, then WFHC shall reimburse BMS for the discrepancy
revealed by said inspection within 30 days after BMS' demand therefor.
Furthermore, if the payments were less than the amount which should have been
paid by an amount in excess of five percent (5%) of the payments actually made
during the period in question, the party responsible for the discrepancy shall
also reimburse the auditing party for its out-of-pocket costs of such
inspection.
13. COPROMOTION TERM AND TERMINATION.
(a) The Copromotion Term shall be for three (3) years and
shall begin effective March 1, 1999 and shall end on March 31, 2002, unless
terminated earlier in accordance with Section 13(b), 13(c) or 13(d) below or
unless extended by the parties' mutual agreement in accordance with Section
13(e) below (the "Copromotion Term").
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(b) WFHC may terminate the Copromotion Term:
(i) at any time, without cause, effective as of the end of an
Agreement Year, upon written notice to BMS given not less
than sixty (60) days' prior to the end of such Agreement
Year. During such notice period, WFHC shall continue to
fulfill its obligations under this Agreement; or
(ii) immediately upon written notice of termination given to
BMS, if BMS has breached a material obligation or duty
under this Agreement that is continuing thirty (30) days
after WFHC has advised BMS in writing of the nature of
said breach.
(c) BMS may terminate the Copromotion Term upon the
occurrence of any of the following:
(i) Upon sixty (60) days' prior written notice to WFHC, if:
(A) Covered Physician Prescriptions for the First
Agreement Year do not exceed *** Covered
Physician Prescriptions for such Agreement Year, or
if Covered Physician Prescriptions for the Second
Agreement Year do not exceed *** Covered
Physician Prescriptions for such Agreement Year, or
if Covered Physician Prescriptions for the Third
Agreement Year do not exceed *** Covered
Physician Prescriptions for such Agreement Year or
(B) Aggregate Covered Physician Prescriptions for each
Agreement Quarter during any two (2) consecutive
Agreement Quarters do not exceed twice the Baseline
Quarterly Prescriptions for such two Agreement
Quarters; or
(ii) Upon written notice to WFHC, if BMS has permanently ceased
manufacturing and marketing the Product because of a
significant safety problem related to the Product; or
(iii) BMS may terminate the Copromotion Term immediately upon
written notice of termination given to WFHC, if WFHC has
breached a material obligation or duty under this
Agreement that is continuing 30 days after BMS has advised
WFHC in writing of the nature of the breach or default.
(d) If during the Copromotion Term WFHC experiences a
"change in control", WFHC will promptly notify BMS in writing of same, and BMS
shall be entitled at any time within one hundred twenty (120) days after receipt
of such notification, in the exercise of its sole and absolute discretion, upon
90 days written notice to WFHC, to terminate the Copromotion Term. For purposes
of this Agreement, the term "change in control" shall mean any sale of voting
securities or sale of assets (whether by sale, merger, consolidation, share
exchange, or otherwise) which, directly or indirectly, (i) transfers over 50% of
the assets of WFHC relating to the Product to any Person other than an Affiliate
of WFHC, or (ii) results in any Person (other than an Affiliate of WFHC existing
as of the Effective Date or a financial institution or venture capital firm)
becoming the beneficial owner, directly or indirectly, of securities of
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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WFHC representing over: (A) if such Person is a "Pharmaceutical-related Person"
(as defined below), twenty percent (20%) of the combined voting power of WFHC's
then outstanding securities, or (B) if such Person is not a
"Pharmaceutical-related Person", fifty percent (50%) of the combined voting
power of WFHC's then outstanding securities. This termination right may be
exercised by BMS each time there is a change in control, whether or not
exercised with respect to an earlier change in control. Each party shall
continue to fulfill its duties hereunder during such 90-day notice period.
For purposes of this paragraph 13(d) only,
"Person" shall have the meaning used in section 13(d) and 14(d)
of the Securities Exchange Act of 1934, as amended, and
"beneficial ownership" shall be determined pursuant to Rule 13d-3
under the Securities Exchange Act of 1934, as amended; and
"Pharmaceutical-related Person" means a Person, or any Affiliate
of such a Person, for whom more than fifty percent (50%) of such
Person's gross revenues are derived, as applicable, from (i) the
sale, licensing and/or distribution of drug products (whether
prescription, generic or over-the counter), nutritional agents
and medical devices, and (ii) the provision of drug or device
management services (such as a Pharmaceutical Benefits Management
(PBM) entity).
(e) The Copromotion Term may be extended as the parties
may mutually agree, it being understood that neither party shall be under any
obligation, express or implied, to do so. In order to be binding upon either
party, any such extension, and the terms governing such extension, must be
evidenced by a written agreement executed by duly authorized representatives of
both parties.
(f) Neither the termination nor expiration of the
Copromotion Term shall release or operate to discharge either party from any
liability or obligation that may have accrued prior to such termination or
expiration. Any termination of the Copromotion Term by a party shall not be an
exclusive remedy, but shall be in addition to any legal or equitable remedies
that may be available to the terminating party.
(g) If the Copromotion Term is terminated by either party
prior to the completion of an Agreement Quarter, WFHC shall be entitled to
receive a pro rata portion of the compensation which it would have been entitled
to receive under Section 11 had the Copromotion Term been in effect for the
entire Agreement Quarter (based on the number of days that WFHC was responsible
for marketing the Product to Covered Physicians in the Territory during such
Agreement Quarter).
(h) Upon the termination or expiration of the Copromotion
Term, WFHC shall promptly cease all of its promotion activities pursuant to this
Agreement, discontinue any use of the Trademark, return to BMS all sales
training, promotional, marketing material, BMS call lists and computer files,
and any remaining Product samples (i.e., not already distributed or destroyed
with destruction certified by WFHC) that may have been supplied to WFHC by BMS
under this Agreement. BMS shall be entitled to promote the Product to all
Covered Physicians thereafter without compensation or obligation to WFHC, except
such compensation obligations as may apply as set forth in Section 11(e). It is
understood that the names and addresses of any Covered Physicians to whom WFHC
may have made calls are not considered Confidential Information.
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(i) Notwithstanding the expiration or termination of the
Copromotion Term, this Agreement shall be deemed to continue and shall not be
deemed terminated in its entirety and of no further force and effect unless and
until neither party has any further obligation to the other party in accordance
with the terms hereof.
14. INDEMNIFICATION AND INSURANCE.
(a) BMS shall defend, indemnify and hold WFHC and its
employees, agents, officers, directors and affiliates (a "WFHC Party") harmless
from and against any and all losses, liabilities, obligations, claims, fees
(including, without limitation, attorneys fees), expenses incurred by a WFHC
Party that are claimed by any Third Party and that result from or arise in
connection with (i) the breach of any covenant, representation or warranty of
BMS contained in this Agreement, (ii) the manufacturing, sale or distribution of
the Product by BMS or any licensee or affiliate thereof, including, without
limitation, any claim of patent infringement, (iii) any product liability claim
related to the Product, including, without limitation, the use by any person of
any Product that was manufactured, sold or distributed by BMS or any licensee or
affiliate thereof, (iv) any contamination of or defect in the Product; and (v)
breach by BMS of its obligations under Article 10 hereof. Notwithstanding
anything in this Section 14(a), BMS shall not be obligated to indemnify a WFHC
Party for any liability related to the Product for which WFHC has assumed an
indemnification obligation under Section 14(b) below.
(b) WFHC shall defend, indemnify and hold BMS and its
employees, agents, officers, directors and affiliates (a "BMS Party") harmless
from and against any and all losses, liabilities, obligations, claims, fees
(including, without limitation, attorneys fees), expenses and lawsuits brought
against or incurred by a BMS Party by a Third Party resulting from or arising in
connection with (i) the breach by WFHC of any covenant, representation or
warranty of WFHC contained in this Agreement, (ii) any contamination,
mislabeling, or adulteration of any Samples while such Samples are under the
control of WFHC, and/or (iii) breach by WFHC of its obligations under Article 10
hereof.
(c) To receive the benefits of the indemnity under clauses
(a) or (b) above, as applicable, an indemnified Party must (i) give the
indemnifying party written notice of any claim or potential claim promptly after
the indemnified party receives notice of any such claim; (ii) allow the
indemnifying party to assume the control of the defense and settlement
(including all decisions relating litigation, defense and appeal) of any such
claim (so long as it has confirmed its indemnification obligation responsibility
to such indemnified Party under this Article 14); and (iii) so long as such
cooperation does not vitiate any legal privilege to which it is entitled,
reasonably cooperate with the indemnifying party in its defense of the claim
(including, without limitation, making documents and records available for
review and copying and making persons within its/his/her control available for
pertinent testimony). If the indemnifying party defends the claim, an
indemnified Party may participate in, but not control, the defense of such claim
at its/his/her sole cost and expense. An indemnifying party shall have no
liability under this Article 14 as to any claim for which settlement or
compromise of such claim or an offer of settlement or compromise of such claim
is made by an indemnified Party without the prior consent of the indemnifying
party.
(d) WFHC acknowledges and agrees that any WFHC sales force
personnel (including contract sales personnel, telemarketers, detail personnel,
independent contractors, employees, and agents) used by WFHC to fulfill its
obligations under this Agreement are not, and are not intended to be or
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be treated as, employees of BMS or any of its Affiliates, and that such
individuals are not eligible to participate in any "employee benefit plans", as
such term is defined in section 3(3) of ERISA, that are sponsored by BMS or any
of its Affiliates. BMS shall not be responsible to WFHC, to any employees,
agents, contractors, telemarketers, or other personnel of WFHC used by it to
perform its obligations under this Agreement, or to any governmental entity for
any compensation or benefits (including, without limitation, vacation and
holiday remuneration, healthcare coverage or insurance, life insurance, pension
or profit-sharing benefits and disability benefits), payroll-related taxes or
withholdings, or any governmental charges or benefits (including without
limitation unemployment and disability insurance contributions or benefits and
workmen' compensation contributions or benefits) that may imposed upon or be
related to the performance by WFHC and any of its employees, agents,
contractors, telemarketers, detail or other personnel used by WFHC to discharge
its obligations under this Agreement, all of which shall be the sole
responsibility of WFHC, even if it is subsequently determined by any court, the
IRS or any other governmental agency that such individual may be a common law
employee of BMS or any of its Affiliates. All such matters of compensation,
benefits and other terms of employment for any employee, agent, contractor,
telemarketer, detail or other personnel used by WFHC to fulfill its obligations
hereunder shall be solely a matter between WFHC and such individual(s) or
entities.
WFHC will indemnify, defend, and hold harmless each BMS
Party from and against any damages, liability, loss and costs that may be paid
or payable by any such BMS Indemnitee resulting from or in connection with any
claim or other cause of action asserted by:
(i) any employees, agents, contractors, telemarketers, detail
personnel, or other personnel of WFHC used by it to
perform its obligations under this Agreement, or
(ii) by any Third Party (including federal, state or local
governmental authorities)
with respect to:
(iii) any payment or obligation to make a payment to any
employees, agents, contractors, telemarketers, or other
personnel used by WFHC to perform its obligations under
this Agreement with respect to any compensation, benefits
of any type under any employee benefit plan (as such term
is defined above), and any other bonus, stock option,
stock purchase, incentive, deferred compensation,
supplemental retirement, severance and other similar
fringe or employee benefit plans, programs or arrangements
that may be sponsored at any time by BMS or any of its
Affiliates or by WFHC or any of its Affiliates, even if it
is subsequently determined by any court, the IRS or any
other governmental agency that any such employee, agent,
contractor, telemarketer, detail and other personnel used
by WFHC to discharge its obligations hereunder may be a
common law employee of BMS or any of its Affiliates; and
(iv) the payment or withholding of any contributions, payroll
taxes, or any other payroll-related item by or on behalf
of WFHC or any of its employees, agents, contractors,
telemarketers, and other personnel with respect to which
BMS, WFHC or any of WFHC's employees, agents, contractors,
telemarketers, and other personnel may be responsible
hereunder or pursuant to applicable law to pay, make,
collect,
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withhold or contribute, even if it is subsequently
determined by any court, the IRS or by any other
governmental agency that any such employee, agent,
contractor, telemarketer, and other person used by WFHC to
discharge its obligations hereunder may be a common law
employee of BMS or any of its Affiliates.
Nothing contained in this Section 14(d) is intended to or will effect or limit
any compensation payable by BMS to WFHC for the services rendered by WFHC
pursuant to this Agreement.
(e) WFHC shall use commercially reasonable efforts to
maintain insurance against such risks (including product liability) and upon
such terms (including coverages, deductible limits and self-insured retentions)
as is customary for the activities to be conducted by it under this Agreement
and is appropriate to cover its indemnification obligations hereunder. Without
limiting the foregoing, WFHC shall carry, during the term of this Agreement and
for five years thereafter, comprehensive general liability insurance, including
product liability and contractual liability endorsements, in an amount of not
less than $5,000,000 per occurrence and $10,000,000 in the aggregate. Such
policy shall be endorsed to include the following: (a) the policies shall
provide for thirty (30) days notice to BMS of cancellation or material change in
the coverage before such cancellation or change takes effect. Such insurance
shall be with insurance companies having a Best's Insurance rating of A:X or
better. WFHC shall furnish to BMS evidence of such insurance, upon request. Such
insurance information shall be kept in confidence in the same manner as any
other confidential information disclosed by WFHC to BMS hereunder.
15. CONFIDENTIALITY.
(a) Each party acknowledges that it may receive
confidential or proprietary information of the other party in the performance of
this Agreement. Each party shall hold confidential and shall not, directly or
indirectly, disclose, publish or use for the benefit of any Third Party or
itself, except in carrying out its duties hereunder, any confidential or
proprietary information of the other party, without first having obtained the
furnishing party's written consent to such disclosure or use. "Confidential or
proprietary information" shall include, inter alia, know-how, scientific
information, clinical data, efficacy and safety data, adverse event information,
formulas, methods and processes, specifications, pricing information (including
discounts, rebates and other price adjustments) and other terms and conditions
of sales, customer information, business plans, and all other intellectual
property. This restriction shall not apply to any information within the
following categories:
(i) information that is known to the receiving party or its
Affiliates prior to the time of disclosure to it, to the
extent evidenced by written records or other competent
proof;
(ii) information that is independently developed by employees,
agents, or independent contractors of the receiving party
or its Affiliates without reference to or reliance upon
the information furnished by the disclosing party, as
evidenced by written records or other competent proof;
(iii) information disclosed to the receiving party or its
Affiliates by a Third Party that has a right to make such
disclosure;
(iv) information that is contained in any written promotional
material prepared by BMS
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for use in connection with the Product; or
(v) any other information that becomes part of the public
domain through no fault or negligence of the receiving
party.
The receiving party shall also be entitled to disclose the
other party's Confidential Information that is required to be disclosed in
compliance with applicable laws or regulations (including, without limitation,
to comply with SEC, NASDAQ or stock exchange disclosure requirements), or by
order of any governmental body or a court of competent jurisdiction; provided
that the party required to disclose such information shall use all reasonable
efforts to obtain confidential treatment of such information by the agency or
court.
(b) This obligation shall survive the termination or
expiration of this Agreement for five (5) years.
(c) The confidentiality obligations described above shall
supersede the Confidential Disclosure Agreement dated as of November 3, 1998
between the parties and shall govern any and all information disclosed by either
party to the other pursuant thereto, and shall be retroactively effective to the
date of such Confidential Disclosure Agreement.
(d) It is expressly understood and agreed that WFHC may
disclose confidential information to members of its board of directors who are
not employees of WFHC (and to consultants who have received BMS' prior written
approval), provided, that WFHC shall ensure that such directors and consultants
are bound by a written obligation of confidentiality to WFHC as regards
confidential information hereunder that is disclosed to them that is reasonably
satisfactory to BMS.
16. REPRESENTATIONS AND WARRANTIES.
(a) BMS represents and warrants to WFHC that (i) the
execution, delivery and performance of this Agreement by BMS does not conflict
with, or constitute a breach of or under, any order, judgment, agreement or
instrument to which BMS is a party; (ii) the execution, delivery and performance
of this Agreement by BMS does not require the consent of any person or the
authorization of (by notice or otherwise) any governmental or regulatory
authority; (iii) the rights granted by BMS to WFHC hereunder do not conflict
with any rights granted by BMS to any Third Party; and (iv) BMS owns the NDA for
the Product.
(b) WFHC represents and warrants to BMS that (i) the
execution, delivery and performance of this Agreement by WFHC does not conflict
with, or constitute a breach of or under, any order, judgment, agreement or
instrument to which WFHC is a party; and (ii) the execution, delivery and
performance of this Agreement by WFHC does not require the consent of any person
or the authorization of (by notice or otherwise) any governmental or regulatory
authority.
17. INITIAL EDUCATION PROGRAM.
(a) Initial Educational Program. In consideration of the
funding set forth in
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section 17(b) hereof, WFHC will work with (i) its existing Health Advisory Board
and (ii) a Medical Advisory Board on Cardiovascular Disease which it will create
to develop an initial educational program (the "Initial Educational Program")
containing those element; set forth in Exhibit A hereto and to implement such
Initial Education Program during the First Agreement Year. WFHC shall fully
consult with BMS with respect to all aspects relating to the development and
implementation of such Initial Educational Program and shall give due
consideration to all recommendations made by BMS. BMS shall have the right to
approve any materials, brochures, educational programs, and other features and
elements of the Initial Education Program that relate in any way to the use of
any statin or statins (whether individually or as a class) and other
cholesterol-lowering drugs to treat, manage, or prevent cardiovascular and
metabolic risks, diseases or conditions or to the importance of lowering
cholesterol; provided, that the content of an outside physician's presentation
at an educational seminar or similar program is the responsibility of such
individual without approval of BMS). WFHC shall consult with BMS regarding the
location, venue, participants, and timing of all speaker programs, mailings,
seminars, monographs, videotapes reports, lectures and lecture series kits,
newsletters and similar programs and materials. The Initial Education Program
shall be commence effective January 1, 1999 and run through March 31, 2000.
(b) Funding. Subject to the terms set forth in this
Article 17, in support of WFHC activities in developing and carrying out the
Initial Educational Program, BMS shall pay WFHC a development fee of ***, which
shall be paid out in equal quarterly installments on 4/1/1999, 7/1/1999,
10/1/1999, and 1/1/2000. Unless otherwise expressly provided for in this
Agreement, WFHC shall, except for such *** of funding, be responsible for all
costs and expenses incurred by it in developing and carrying out such Initial
Education Program.
(c) Ownership of Works. Subject to Section 7(e) hereof,
all educational materials, writings, videos, questionnaires, documentation and
other works (collectively, "Works") pertaining to the educational components and
patient risk assessment components of the Initial Education Program, and all
copyrights and other intellectual property rights pertaining thereto, shall (i)
if solely authored or developed by employees or contractors of a Party, be owned
by such Party, or (ii) if jointly authored or developed by employees or
contractors of both Parties, be jointly owned by the Parties (authorship to be
determined in accordance with the U.S. Copyright Law). If jointly authored or
developed, each party may use such Works as it deems appropriate, without
compensation or accounting to the other party, subject to the following:
(i) Neither party shall use any trademarks owned or
controlled by the other party or its Affiliates, except with the prior written
consent of the other Party (to be given or withheld in the other Party's sole
and absolute discretion), and provided that the other Party, even if such
permission is given, shall have the right to review and must approve in writing
in advance all uses of its Trademark on any materials or other works proposed to
be used by a Party. BMS recognizes that WFHC is the owner of certain trademarks
and trade names, which it may elect to use in the development of the Initial
Educational Program.
(ii) WFHC shall not use such Works to promote,
directly or indirectly, any statin or other cholesterol-lowering medicine (other
than hormonal therapy products) during the Term of this Agreement and for one
year thereafter.
Where any such Works are developed solely by or for WFHC during
the term of this
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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Agreement, WFHC hereby grants to BMS and its Affiliates a non-exclusive, fully
paid-up, irrevocable, perpetual, worldwide, and sublicensable right and license
under any copyrights or other intellectual property rights owned or controlled
by WFHC pertaining to same to use, adapt, copy, modify, make derivative works,
and distribute such Works for any purpose or use, subject to subparagraph (i)
above.
(d) Full Educational Program. Not less than sixty (60)
days prior to the end of the First Agreement Year, the parties will meet and
confer for the purpose of discussing whether BMS would be interested in funding
a Full Education Program during the remaining Term of this Agreement. Such
discussion will cover whether there is mutual interest in BMS funding and WFHC
developing and carrying out such a Full Education Program, and, if so, whether
mutually acceptable terms can be agreed upon. It is understood and agreed that
neither party shall have any obligation express or implied, to negotiate or
reach an agreement. WFHC agrees that it shall not participate in discussions
with or negotiate with any Third Party with respect to the development and/or
implementation of an Initial Education Program or Full Education Program with
respect to cardiovascular disease treatments, prevention, or risk management,
unless (i) the parties have not reached a written agreement for a Full Education
Program , if any, by December 31, 1999, or (ii) BMS has notified WFHC in writing
(which, to be valid, must be signed by a Vice President or higher of BMS) that
BMS has no interest in funding a Full Education Program.
18. NOTICES. Unless otherwise explicitly set forth herein,
any notice required or permitted to be given hereunder shall be in writing and
shall be delivered personally by hand, or sent by reputable overnight courier,
signature required, to the addresses of each party set forth below or to such
other address or addresses as shall be designated in writing in the same matter:
(a) If to BMS:
Xxxxxxx-Xxxxx Squibb U.S. Pharmaceutical Group
000 Xxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, XX 00000
Attention: Senior Vice President - Cardiovascular
and Metabolic Diseases Marketing
with a copy to the attention of the "Vice President and Senior Counsel - USPG"
at the same address.
(b) If to WFHC:
Women First HealthCare, Inc.
00000 Xx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: Xxxxx X. Xxxx, President
All notices shall be deemed given when received by the addressee.
19. NON-SOLICITATION. During the Copromotion Term and for
a period of six (6) months thereafter, neither party shall solicit, directly or
indirectly, any individual who was a member of the other party's sales force or
marketing group related to the Product in the Territory during the Copromotion
Term, without the written consent of the other party.
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20. MISCELLANEOUS PROVISIONS.
(a) Assignment. Neither party shall assign or otherwise
transfer this Agreement or any interest herein or right hereunder without the
prior written consent of the other party, and any such purported assignment,
transfer or attempt to assign or transfer any interest herein or right hereunder
shall be void and of no effect; except that each party (i) may assign its rights
and obligations hereunder to an Affiliate without the prior consent of the other
party (although, in such event, the assigning party shall remain primarily
responsible for all of its obligations and agreements set forth herein,
notwithstanding such assignment) and (ii) may assign its rights and obligations
to a successor (whether by merger, consolidation, reorganization or other
similar event) or purchaser of all or substantially all of its business assets
relating to the Product, provided, that such successor or purchaser has agreed
in writing to assume all of such party's rights and obligations hereunder and a
copy of such assumption is provided to the other party hereunder.
(b) Non-Waiver. Any failure on the part of a party to
enforce at any time or for any period of time any of the provisions of this
Agreement shall not be deemed or construed to be a waiver of such provisions or
of any right of such party thereafter to enforce each and every such provision
on any succeeding occasion or breach thereof.
(c) Dispute Resolution. (i) If any dispute arises under
this Agreement which cannot be resolved expeditiously by the Sales/Marketing
Committee after due consideration, the matter shall be submitted to the
President of WFHC and the President of the BMS U.S. Pharmaceuticals Group for
resolution. If such personnel are unable to resolve such dispute within thirty
(30) days of initiating such negotiations, then, subject to section 20(c)(iii)
below such dispute shall be finally resolved by binding arbitration under
Section 20(c)(ii) below.
(ii) Any such arbitration shall be held in New York,
New York, according to the Commercial Arbitration Rules (the "Rules") of the
American Arbitration Association. Any arbitration herewith shall be conducted in
the English language. The arbitration shall be conducted by one arbitrator who
is knowledgeable in the subject matter which is at issue in the dispute and who
is selected by mutual agreement of the parties or, failing such agreement, shall
be selected according to the AAA rules. The parties shall have such discovery
rights as the arbitrator may allow, but in no event broader than that discovery
permitted under the Federal Rules of Civil Procedure. In conducting the
arbitration, the arbitrator shall apply the New York Rules of Evidence, and
shall be able to decree any and all relief of an equitable nature, including but
not limited to such relief as a temporary restraining order, a preliminary
injunction, a permanent injunction, or replevin of property, as well as specific
performance. The arbitrator shall also be able to award direct, indirect and,
where permitted by this Agreement, consequential damages, but shall not award
any other form of damage (e.g., punitive or exemplary damages). The reasonable
fees and expenses, of the arbitrators, along with the reasonable legal fees and
expenses of the prevailing Party (including all expert witness fees and
expenses), the fees and expenses of a court reporter, and any expenses for a
hearing room, shall be paid as follows: If the arbitrators rule in favor of one
Party on all disputed issues in the arbitration, the losing Party shall pay 100%
of such fees and expenses; if the arbitrators rule in favor of one Party on some
issues and the other Party on other issues, the arbitrators shall issue with the
rulings a written determination as to how such fees and expenses shall be
allocated between the Parties. The arbitrators shall allocate fees and expenses
in a way that bears a reasonable relationship to the outcome of the arbitration,
with the Party prevailing on more issues, or on issues of greater value or
gravity, recovering a relatively
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larger share of its legal fees and expenses. The decision of the arbitrators
shall be final and may be entered, sued on or enforced by the Party in whose
favor it runs in any court of competent jurisdiction at the option of such
Party. Whether a claim, dispute or other matter in question would be barred by
the applicable statute of limitations, which statute of limitations also shall
apply to any claim or disputes subject to arbitration under this Section, shall
be determined by binding arbitration pursuant to this Section.
(iii) Notwithstanding anything to the contrary in
this section 20(c), either Party may seek immediate injunctive or other interim
relief or other equitable remedies without resort to arbitration from any court
of competent jurisdiction as necessary to enforce and prevent infringement of
the patent rights, copyright rights, trademarks, trade secrets, or other
intellectual property rights owned or controlled by a Party or its Affiliates or
to prevent breach of any of sections 3(e,) 15 or 19 hereof.
(d) Entirety of Agreement. This Agreement contains the
entire understanding of the parties with respect to the subject matter hereof
and thereof and supersedes all previous and contemporaneous verbal and written
agreements, representations and warranties with respect to such subject matter.
This Agreement (or any provision or term hereof) may be released, waived,
changed or supplemented only by a written agreement signed by an officer or
other authorized representative of the party against whom enforcement of any
release, waiver, change or supplement is sought. This Agreement shall not be
strictly construed against either party hereto.
(e) Public Announcements. The form and content of any
public announcement to be made by one party regarding this Agreement, or the
subject matter contained herein, shall be subject to the prior written consent
of the other party (which consent may not be unreasonably withheld), except as
may be required by applicable law (including, without limitation, disclosure
requirements of the SEC, NASDAQ, or any other stock exchange) in which event the
other party shall endeavor to give the other party reasonable advance notice and
review of any such disclosure.
(f) Governing Law. This Agreement shall be governed by and
construed in accordance with the internal laws of the State of Delaware, without
regard to its conflicts of law principles.
(g) Relationship of the Parties. In making and performing
this Agreement, the parties are acting, and intend to be treated, as independent
entities and nothing contained in this Agreement shall be construed or implied
to create an agency, partnership, joint venture, or employer and employee
relationship between BMS and WFHC. Except as otherwise provided herein, neither
party may make any representation, warranty or commitment, whether express or
implied, on behalf of or incur any charges or expenses for or in the name of the
other party. No party shall be liable for the act of any other party unless such
act is expressly authorized in writing by both parties hereto.
(h) Counterparts. This Agreement shall become binding when
any one or more counterparts hereof, individually or taken together, shall bear
the signatures of each of the parties hereto. This Agreement may be executed in
any number of counterparts, each of which shall be deemed an original as against
the party whose signature appears thereon, but all of which taken together shall
constitute but one and the same instrument.
(i) Force Majeure. Neither party shall be liable to the
other party for any failure to perform as required by this Agreement if the
failure to perform is due to circumstances reasonably
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beyond such party's control, including, without limitation, acts of God, civil
disorders or commotions, acts of aggression, fire, explosions, floods, drought,
war, sabotage, embargo, unexpected safety or efficacy results obtained with the
Product, utility failures, supplier failures, material shortages, labor
disturbances, a national health emergency, or appropriations of property. A
party whose performance is affected by a force majeure event shall take prompt
action using its reasonable best efforts to remedy the effects of the force
majeure event.
(j) No Implied Rights. Nothing in this Agreement is
intended to create or imply any right or license in the other Party under any
patent rights, copyrights, trademarks or other intellectual property rights
owned or controlled by a Party, except as expressly set forth herein.
*********************************
IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement
in multiple counterparts through their duly authorized representatives.
XXXXXXX-XXXXX SQUIBB U.S. WOMEN FIRST HEALTHCARE, INC.
PHARMACEUTICALS GROUP
By: /s/ Xxxxxxx X. Xxxx By: /s/ Xxxxx X. Xxxx
---------------------------------- ----------------------------------
Name: Xxxxxxx X. Xxxx Name: Xxxxx X. Xxxx
Title: President Title: President and Chief
Executive Officer
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EXHIBIT A
INITIAL EDUCATIONAL PROGRAM
The Initial Educational Program shall be developed by WFHC and shall
consist of the following elements and timelines:
CARDIOVASCULAR PROGRAM WITH OB/GYNS
TIME AND EVENT SCHEDULE
Event Timing Comment
----- ------ -------
Distinguished Professors' Conference Jan 8-10,1999 Attended by 125 of the leadership of
Program: Gateway to Midlife Health - A OB/GYNs. Segment from Xx. Xxxxx Xxxxxx
Better Way. was included on use of statins to lower
cholesterol with pravastatin as choice
based on event reduction.
Distinguished Professor Lecture Series Feb - yr. End 1999 Slide series and script will include
Program: Women First HealthCare - A section on the importance of lowering
Better Way. cholesterol using statins. A minimum of
50 of these lectures will be held with
OB/GYNs across the country. WFHC will
consult with BMS as to the selection of
the venues and lecturers.
Establishment of a Health Advisory Board Feb - April 1999 Health Advisory Board would include
for cardiovascular risk management in women. OB/GYNs and cardiologists who have a
Program: Managing Cardiovascular Risk - focus on cardiovascular disease in
A Better Way. women. WFHC will consult with BMS as to
the selection of the Board members.
Health Advisory Board Meeting April - June 1999 Development of guidelines for managing
Program: Managing Cardiovascular Risk - cardiovascular risk in women.
A Better Way.
Publication of monograph and videotape from April 1999 Monograph and videotape would mailed to
Distinguished Professors' Conference. 25,000 OB/GYNs. Would include section on
Program: Women First HealthCare - A importance of lowering cholesterol using
Better Way. statins from Distinguished Professors'
Conference.
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CARDIOVASCULAR PROGRAM WITH OB/GYNS
TIME AND EVENT SCHEDULE (CON'T)
Event Timing Comment
----- ------ -------
Development of pre-test on managing April 1999 Mailed to approximately 25,000 OB/GYNs.
cardiovascular risk in women. Would include detailed answers with
Program: Managing Cardiovascular Risk - references.
A Better Way.
Publication of Consensus Report from Health June-July 1999 Would include guidelines for the OB/GYNs in
Advisory Board. managing cardiovascular disease.
Program: :Managing Cardiovascular Risk -
A Better Way.
Development of Lecture Series Kit which June - July 1999 Designed to be used to present guidelines in
includes slides, monograph and Consensus Report to OB/GYNs across the
implementation elements. Program: country.
Managing Cardiovascular Risk -
A Better Way.
20 physician meetings July - Dec 1999 Use of Lecture Series materials with
Program: Managing Cardiovascular Risk - OB/GYNs. WFHC will consult with BMS as
A Better Way. to venues, timing, and speakers.
Case & Comment Newsletter on cardiovascular Q3 or Q4 1999 Will be mailed to 25,000 OB/GYNs.
disease in midlife women. Program: Gateway
to Midlife Health - A Better Way.
Women-to-Women Meetings Throughout 1999 Meetings will include information on
Program: Gateway to Midlife Health - cardiovascular risk in women at midlife.
A Better Way.
Support through WFHC Throughout 1999 Our Call Center nurses will support the doctor
Midlife HealthLine(TM) and patient regarding the use of statins to lower
Program: Gateway to Midlife Health - cholesterol.
A Better Way.
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