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EXHIBIT 10.21
*** Certain information (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.
COPROMOTION AGREEMENT
This COPROMOTION AGREEMENT is made as of the Effective Date
(defined below), by and between WOMEN FIRST HEALTHCARE, INC., a Delaware
corporation, having a place of business at ▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇ ▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("WFHC"), and ESSENTIA PHARMACEUTICALS B.V., a
corporation of the Netherlands, maintaining its principal business offices at
16690 ▇▇▇▇▇▇▇▇ Ridge Road, Suite 100, P.O. Box 679, Chesterfield, MO 63006-0679
("Essentia").
W I T N E S S E T H
WHEREAS, WFHC markets and distributes oral estrogen tablets under
the trademark "ORTHO-EST(R)" and estradiol transdermal systems under the
trademark "Esclim(TM)," both of which have been approved by the U.S. Food and
Drug Administration ("FDA") as hormonal replacement therapy products (as more
fully specified in the labeling for the product); and
WHEREAS, Essentia is engaged in the business of marketing
pharmaceutical products to physicians; and
WHEREAS, WFHC wishes to expand the promotion of ORTHO-EST(R) oral
estrogen tablets and Esclim(TM) transdermal estrogen patches to certain family
practitioners and general practitioners who are "Covered Physicians," as defined
below, and Essentia desires to have the right to copromote such products to such
physicians, upon the terms specified herein.
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 agreement duly executed by authorized
representatives of each party hereto.
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"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 April 6, 2001
and end on June 30, 2001.
"Agreement Year" means each 12-month period commencing on April 1
and each anniversary thereof during the Copromotion Term.
"Average Selling Price Per Esclim(TM) Prescription" has the
meaning set forth in Section 11(b) hereof.
"Average Selling Price Per ORTHO-EST(R) Prescription" has the
meaning set forth in Section 11(c) hereof.
"Baseline Agreement Year Esclim(TM) Prescriptions" and "Baseline
Quarterly Esclim(TM) Prescriptions" have the meanings set forth in Section 11(b)
hereof.
"Baseline Agreement Year ORTHO-EST(R) Prescriptions" and
"Baseline Quarterly ORTHO-EST(R) Prescriptions" have the meanings set forth in
Section 11(c) hereof.
"Baseline Annual Esclim(TM) Sales Attributable to Covered
Physicians" has the meaning set forth in Section 11(b) hereof.
"Baseline Annual ORTHO-EST(R) Sales Attributable to Covered
Physicians" has the meaning set forth in Section 11(c) hereof.
"Call Plan" has the meaning set forth in Section 5(d) hereof.
"Confidential or Proprietary Information" has the meaning set
forth in Section 15 hereof.
"Copromotion Term" has the meaning specified in Section 13(a)
hereof.
"Costs" has the meaning specified in Section 6(d) hereof.
"Covered Physician" means any of the family practitioners/general
practitioners listed on Exhibit A hereto.
"Covered Physician Esclim(TM) Prescriptions" has the meaning set
forth in Section 11(b) hereof.
"Covered Physician ORTHO-EST(R) Prescriptions" has the meaning
set forth in Section 11(c) hereof.
"Detail" or "Details" and "Detailing" means, with respect to the
Products, the activity undertaken by a sales representative during a
face-to-face sales call on physicians or other health care professionals with
prescribing authority to provide information on the use, safety, effectiveness,
contraindications, side effects, warnings and other relevant characteristics of
the Products, in a fair and balanced manner consistent with the requirements of
the Food,
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Drug and Cosmetic Act, including, but not limited to, the regulations
of 21 CFR Part 202, and using, as necessary or desirable, labeling or
promotional materials, in an effort to increase physician prescribing
preferences of the Products.
"Effective Date" of this Agreement means April 6, 2001.
"Esclim(TM) Product" means all product presentations (including
all dosage strengths) of Esclim(TM) estradiol transdermal systems currently
approved by FDA, 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.
"Esclim(TM) Trademark" means the trademark Esclim(TM) and any
other trademark or trade name (whether registered or unregistered) used on or
with the Esclim(TM) Product or in any promotional material related to the
Esclim(TM) Product in the Territory during the Copromotion Term.
"Essentia Funded Activities" has the meaning specified in Section
6(b) hereof.
"▇▇▇▇▇▇▇▇ Agreement" means the Distribution and License Agreement
between WFHC and Laboratoires ▇▇▇▇▇▇▇▇ ▇.▇. dated as of July 19, 1999, as
amended.
"IMS America" means the International Marketing Services
Prescription Reporting Service.
"Initial Training Session" has the meaning in Section 7(a)
hereof.
"License Cost per Esclim(TM) Prescription" has the meaning in
Section 11(b) hereof.
"Net Esclim(TM) Sales Attributable to Covered Physicians" has the
meaning set forth in Section 11(b) hereof.
"Net ORTHO-EST(R) Sales Attributable to Covered Physicians" has
the meaning set forth in Section 11(c) hereof.
"Net Sales" means for the applicable period the gross amount
invoiced for the Esclim(TM) Product or the ORTHO-EST(R) Product, as the case may
be, by WFHC or its licensees to Third Parties in the Territory, less the
following amounts to the extent deducted on such invoice or absorbed by WFHC:
(i) trade, quantity and cash discounts or rebates actually
and lawfully allowed and taken and any other similar adjustments, including,
without limitation, those granted on account of price adjustments, billing
errors, rejected goods, and damaged goods;
(ii) price reductions, credits, rebates, product returns,
charge-back and prime vendor rebates, fees, reimbursements or similar payments
or adjustments actually granted or given to wholesalers and other distributors,
buying groups, health care insurance carriers,
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pharmacy benefit management companies, health maintenance organizations or other
institutions or health care organizations;
(iii) any sales or use tax, customs duties, excise or other
duties or other governmental charge (other than an income tax) levied on the
sale, transportation or delivery of the Esclim(TM) Product or the ORTHO-EST(R)
Product, as the case may be;
(iv) price reductions, credits, rebates, charge-back and
prime vendor rebates, fees, reimbursements or similar payments or adjustments
actually granted or given in connection with sales of the Esclim(TM) Product or
the ORTHO-EST(R) Product, as the case may be, to any governmental or regulatory
authority in respect to any state or federal Medicare, Medicaid or similar
programs; and
(v) bad debts.
"ORTHO-EST(R) Agreement" means the ORTHO-EST(R) Asset Transfer &
Supply Agreement between WFHC and Ortho-▇▇▇▇▇▇ Pharmaceutical, Inc. effective as
of September 30, 2000.
"ORTHO-EST(R) Product" means all product presentations
(including all dosage strengths) of ORTHO-EST(R) tablets currently approved by
FDA, and any new tablets or other presentations of ORTHO-EST(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
"ORTHO-EST(R) Trademark" means the trademark ORTHO-EST(R) and any
other trademark or trade name (whether registered or unregistered) used on or
with the ORTHO-EST(R) Product or in any promotional material related to the
ORTHO-EST(R) Product in the Territory during the Copromotion Term.
"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.
"Products" means the ORTHO-EST(R) Product and the Esclim(TM)
Product.
"Sales/Marketing Committee" has the meaning specified in Section
5(a) hereof.
"Serious adverse event" and "Non-serious adverse event" have the
meanings set forth in section 9(g) hereof.
"Territory" means the fifty states of the United States of
America.
"Third Party" means any Person other than (i) WFHC and any of its
Affiliates and (ii) Essentia and any of its Affiliates.
"Trademarks" means the ORTHO-EST(R) Trademark and the Esclim(TM)
Trademark.
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"WFHC Funded Activities" has the meaning specified in Section
6(a) hereof.
2. GRANT OF RIGHTS TO ESSENTIA.
(a) WFHC hereby engages Essentia to promote the Products during
the Copromotion Term on an exclusive basis to Covered Physicians in the
Territory, upon the terms and conditions set forth to this Agreement. WFHC
reserves all rights not expressly granted hereunder. Notwithstanding the
foregoing, WFHC reserves the right to promote the Products or to grant to one or
more Third Parties the right to promote the Products within the Territory to
physicians and health care providers other than Covered Physicians on terms no
more favorable than those granted to Essentia.
(b) WFHC and Essentia agree to meet periodically, but no less
often than once per Agreement Year, to review and to consider in good faith
proposed revisions to the list of Covered Physicians. In addition, WFHC agrees
that if Essentia increases the number of its sales representatives Detailing the
Products to Covered Physicians to more than 50, WFHC will negotiate in good
faith an increase in the number of Covered Physicians. If the parties agree upon
an increase in the number of Covered Physicians, WFHC and Essentia shall confer
and consider in good faith making an equitable adjustments in the Baseline
Agreement Year Esclim(TM) Prescriptions, the Baseline Quarterly Esclim(TM)
Prescriptions, the Baseline Agreement Year ORTHO-EST(R) Prescriptions and the
Baseline Quarterly ORTHO-EST(R) Prescriptions.
(c) Subject to the terms and conditions of this Agreement, WFHC
hereby grants to Essentia the non-exclusive right to use the Trademarks during
the Copromotion Term solely in connection with the promotion of the Products to
Covered Physicians in the Territory in accordance with this Agreement. Essentia
shall comply with the terms of use of the Esclim(TM) Trademark set forth on
Exhibit B hereto and with the terms of use of the ORTHO-EST(R) Trademark set
forth on Exhibit C hereto.
3. COPROMOTION BY ESSENTIA.
(a) Essentia shall use reasonable commercial efforts to
diligently promote the Products in the Territory to Covered Physicians in
accordance with the terms of this Agreement during the Copromotion Term.
(b) During the Copromotion Term, Essentia shall deploy a sales
force comprised of at least 50 committed sales representatives to Detail the
Products to Covered Physicians in the Territory. On each Detail, Essentia agrees
to Detail the Esclim(TM) Product and the ORTHO-EST(R) Product together as one
product in a position no worse than the second product position during the
Detail. In addition, the Products will represent at least 30% of the time spent
by Essentia sales representatives during each Detail.
(c) During the Copromotion Term, Essentia shall cause its sales
force to call upon pharmacies as may be reasonably necessary to ensure product
"pull through" so that supplies of the Products are available to fill
prescriptions written by Covered Physicians.
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(d) Except as provided for in Section 6 of this Agreement and
subject to the terms and conditions of this Agreement, Essentia 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 Essentia sales force will not be composed, in
any material part, of contract sales personnel or telemarketers hired by
Essentia without the prior written consent of WFHC.
(e) Except as provided in Section 3(c), Essentia shall instruct
its sales force not to, and shall use commercially reasonable efforts to ensure
that its sales force does not, promote or detail the Products outside the
Territory or to any physician, osteopath or health care professional who is not
a Covered Physician. Essentia shall provide WFHC, within five (5) working days
of transmission, complete copies and/or transcripts of all home office generated
(for example, those sent out by Essentia's Sales, Marketing and Sales Training
departments) communications (whether written, electronic or visual aids) to a
majority of Essentia sales representatives or detail personnel concerning the
promotion of the Products. The individual to whom these shall be sent will be
designated by WFHC upon execution of this Agreement. All such written,
electronic and visual communications provided to a majority of Essentia 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.
(f) WFHC 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 Essentia hereunder, WFHC will,
where legally able to do so, share such pertinent information with Essentia
under an obligation of confidentiality.
(g) During the Copromotion Term and for one year (1) year
thereafter, Essentia shall not market, promote or otherwise sell any other
estrogen replacement therapy product other than the Products. Without limiting
the generality of the foregoing, Essentia shall not develop, manufacture, sell,
distribute or promote any transdermal patch containing estradiol as the sole
active ingredient. Said one-year post-Copromotion Term restriction shall not
apply, however, if (1) WFHC has terminated this Agreement pursuant to Section
13(c)(ii) or 13(c)(iii) or (2) Essentia has terminated this Agreement pursuant
to Section 13(b).
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4. RESPONSIBILITIES OF WFHC.
(a) Except as may be provided for in Section 6 of this
Agreement, WFHC shall be solely responsible for the costs and expenses of
conducting its activities under this Agreement.
(b) As between WFHC and Essentia, WFHC shall have the sole
authority to determine the price of the Products sold by WFHC, including price
increases or decreases and the timing thereof as determined by WFHC.
(c) As between WFHC and Essentia, WFHC shall have the sole
responsibility, at its cost and expense, for manufacturing or acquiring the
Products, as the case may be, and shipping, distribution and warehousing of the
Products, for the invoicing and billing of purchasers of the Products, for order
confirmation (if any) in accordance with WFHC customary practices, and for the
collection of receivables resulting from Net Sales. WFHC will book all sales of
the Products sold by WFHC and its Affiliates. This Agreement shall not be
construed as creating or implying any obligation on WFHC's part to supply
Essentia with the Products, other than samples of the Products.
(d) WFHC shall use commercially reasonable efforts, including
maintaining reasonable levels of inventory in light of customary industry
practice, to ensure that sufficient stock of the Products 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 inventory of the Products,
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 Essentia is able to demonstrate the same to WFHC's reasonable satisfaction,
then WFHC and Essentia shall mutually determine the amount of lost Net Sales,
and the Baseline Sales figure in Section 11 hereof relating to the affected
Product shall be adjusted, for that Agreement Year only, to reflect such number
of lost Net Sales (and the Agreement Quarter 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). Such adjustment shall be
Essentia's sole remedy for any lost sales to Covered Physicians caused by
inadequate supply of the Products.
(e) WFHC shall use reasonable efforts consistent with applicable
legal requirements to maintain all necessary authorizations with the FDA to
market the Products in the Territory, provided that Essentia does not engage in
any act or omission inconsistent with such legal requirements.
(f) If WFHC enters into a co-promotion agreement with a Third
Party for the promotion of either of the Products to persons or entities other
than Covered Physicians, then WFHC shall furnish Essentia (at Essentia's sole
cost and expense) with copies of the promotional materials WFHC 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 Essentia.
(g) WFHC reserves the right to assign to a Third Party all of
its rights to the Products (including the ANDA relating to the ORTHO-EST(R)
Product and the NDA relating to
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the Esclim(TM) Product) as and upon such terms as WFHC may elect and determine
in its sole and absolute discretion.
5. SALES/MARKETING COMMITTEE.
(a) A marketing committee will be established promptly by WFHC
and Essentia after execution of this Agreement (such committee being referred to
herein as the "Sales/Marketing Committee"). Essentia 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 Products in the Territory to Covered Physicians, which activities shall
include:
(i) developing and revising, subject to WFHC's prior
written approval before use (with WFHC 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 Products for in-person promotion
to Covered Physicians to the extent that the same relate specifically to the
marketing of the Products to Covered Physicians;
(ii) developing promotional programs for the Products to
Covered Physicians and pharmacies; and
(iii) establishing appropriate sampling scheduling for the
Products.
(b) The Sales/Marketing Committee shall be composed of four (4)
persons, with Essentia and WFHC each being entitled to designate two (2)
individuals. The initial members shall be designated by each party in writing
promptly following execution of this Agreement. Each party may change its
designated member at any time upon advance written notice to the other party
(for WFHC, notice must be sent to its Vice President, Pharmaceuticals Division;
for Essentia, notices must be sent to its President and COO) of any substitution
of a member. Decisions and recommendations of the Sales/Marketing Committee will
be made by vote of Essentia and WFHC, with each party having one vote. In the
event of a tie, WFHC's Vice President, Pharmaceuticals Division shall have the
deadlock breaking vote. Other than as provided herein, WFHC shall retain
ultimate authority with respect to all strategic matters involving or relating
to the Products.
(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
alternatively. Each party shall bear the costs and expenses of its designated
members that are incurred in connection with the Sales/Marketing Committee
meetings.
(d) Essentia shall present a Call Plan to the Sales/Marketing
Committee for review and discussion 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 Essentia in an Agreement Quarter
specifically targeting Covered Physicians and shall be subject to the review of
the Sales/Marketing Committee (the call plan so approved being referred to
herein as the "Call Plan"); provided that Essentia shall have the discretion to
determine the particular Covered Physicians to whom it promotes and the
frequency of presentation of the
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Products. Each Call Plan will reflect Essentia's proposed structure for Details
by Essentia sales representatives and will provide that sales representatives
will spend at least thirty percent (30%) of their time during each Detail on the
Products.
(e) Essentia shall present its sales force bonus plan to the
Sales/Marketing Committee for review and discussion not less frequently than
annually. Each sales force bonus plan shall describe the criteria for awarding
bonuses to sales representatives based on prescriptions written for the Products
and other products by physicians to whom such representatives have made Details.
Each sales force bonus plan will provide that at least thirty percent (30%) of a
sales representative's bonus opportunity will be directly related to sales of
the Products.
(f) Notwithstanding anything in this Section 5 or that might
otherwise imply to the contrary in this Agreement, WFHC 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) WFHC shall be solely responsible during the Copromotion Term
for the Costs incurred by it with respect to the following activities related to
the promotion of the Products in the Territory to Covered Physicians
(collectively, the "WFHC Funded Activities"):
(i) reasonable and customary selling and promotional
materials provided by WFHC to Essentia for use with Covered Physicians (except
as otherwise provided in Section 6(b) below);
(ii) the cost of samples of the Products up to the
Esclim(TM) Sample Quantity Maximum and the ORTHO-EST(R) Sample Quantity Maximum,
as set forth in Section 8 hereof; and
(iii) cost of product training and product training
materials, as set forth in Section 7(b) below.
(b) Essentia shall be solely responsible during the Copromotion
Term for the Costs incurred by it with respect to the following activities
related to the promotion of the Products in the Territory to Covered Physicians
(collectively, "Essentia Funded Activities"):
(i) expenses related to changes in selling and promotional
materials requested by Essentia and approved by the Sales/Marketing Committee;
(ii) the cost of samples of the Products requested by
Essentia in excess of the Esclim(TM) Sample Quantity Maximum and the
ORTHO-EST(R) Sample Quantity Maximum, as set forth in Section 8 hereof; and
(iii) cost of photocopying associated with making copies of
product training and product training materials for the Essentia sales force, as
set forth in Section 7(b) below.
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(c) WFHC shall be under no obligation to conduct or develop
symposia, seminars, technical and scientific exhibits and other professional
relations events with respect to the Products or to conduct additional clinical
trials with respect to the Products.
(d) For purposes of Sections 6, 7 and 10 hereof, the term
"Costs" means, in the case of the WFHC Funded Activities (other than samples of
Products) or Essentia Funded Activities, the direct, out-of-pocket costs and
expenses paid by WFHC or Essentia in connection with such activities during the
period in question. In the case of Product samples, the term "Costs" means
WFHC's direct out-of-pocket costs and expenses for manufacturing or acquiring
such samples during the period in question.
(e) Any marketing and promotional expenses related to the
Products for the Non-Covered Physician market, including all promotional
materials, advertisements, symposia and other promotional events therefor, shall
be borne by WFHC.
7. TRAINING OF ESSENTIA SALES FORCE.
(a) The parties intend that WFHC will provide representatives of
Essentia's sales force with the same or substantially similar training with
respect to promotion of the Products to Covered Physicians as has been given
traditionally to WFHC's sales force in the Territory (it being understood that
such training shall be specific to the Products themselves, as opposed to
general sales training). WFHC and Essentia will hold one initial training
session (the "Initial Training Session"), which shall be held on a mutually
convenient date within sixty (60) days after the Effective Date of this
Agreement, and which will be held at a location mutually acceptable to WFHC and
Essentia. WFHC shall determine and be solely responsible for the content,
development, and associated cost of all training materials used in the Initial
Training Session. Essentia shall designate a reasonable number of
representatives to attend the Initial Training Session who, in turn, will
provide product training on the Products to the balance of Essentia's sales
force.
All members of the Essentia sales force (including detail
personnel, management, and sales representatives) shall attend a training
program related to the Products, whether as part of the Initial Training Session
or a subsequent training program conducted by Essentia representatives who
attended the Initial Training Session. Essentia shall bear the full cost and
expense of all of its sales force personnel (including management, detail
personnel, sales representatives, and contractors) who attend training programs
related to the Products, without contribution from WFHC. WFHC shall bear the
costs and expenses of its training personnel provided for the Initial Training
Session.
(b) WFHC will provide sufficient copies of training materials
for Essentia's representatives who attend the Initial Training Session.
Essentia, however, will be responsible at its sole cost and expense for
photocopying such training materials and providing them to members of its sales
force at subsequent training programs conducted by Essentia. From time to time
as training materials for the Products may be revised by WFHC (the timing and
content of which shall be determined by WFHC in the exercise of its sole and
absolute discretion or as mandated by regulatory agencies or as directed by the
Sales/Marketing Committee), WFHC will
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make such training materials available to Essentia, and Essentia shall be
responsible for photocopying such training materials and providing them to
members of Essentia's sales force.
(c) Where any promotional and sales literature and materials,
advertisements, symposia and other promotional events have been developed by
WFHC for the Products in the Territory for Non-Covered Physicians that will also
directly benefit Covered Physicians, WFHC will make such materials available to
Essentia, provided that Essentia reimburses WFHC for its out-of-pocket costs
incurred in developing, printing or duplicating such materials.
(d) WFHC 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 Essentia hereunder, as well as any adaptations
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 Essentia from or
with such works and materials. Subject to the foregoing and to its obligations
under other terms and conditions of this Agreement, Essentia 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. Essentia will ensure
that all copyright notices and this permission notice appear on all copies of
the written materials provided by WFHC and all adaptations and derivative works
thereof.
8. PRODUCT SAMPLES; ADDITIONAL CLINICAL STUDIES.
(a) WFHC agrees to provide to Essentia reasonable quantities of
samples of Products in accordance with Section 8(b) below, as requested by
Essentia. Such samples shall be used solely in making Detail calls to Covered
Physicians in the Territory. 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 WFHC customarily distributes samples of
the Products to its own sales representatives.
Samples of Products (and promotional and sales literature
where made available to Essentia under other provisions of this Agreement) will
be shipped to Essentia's central distribution facility. Essentia shall be
responsible for the further distribution of same to its sales representatives.
All costs of such distribution by Essentia shall be borne solely by Essentia.
Once Essentia accepts shipment of samples of Products from WFHC, Essentia shall
be responsible for all accountability of samples of Products and compliance with
the Prescription Drug Marketing Act, as amended, and other applicable federal,
state and local laws relating to samples. Essentia is further responsible for
adherence by its sales representatives to such laws.
Product samples shall have a shelf life of not less than
twelve (12) months, unless otherwise approved by the Sales/Marketing Committee.
WFHC shall bear the Product sample costs (as determined in
Section 8(b)) of the Product samples provided to Essentia up to the Sample
Quantity Maximum (as defined in Section 8(b) below) for a given Agreement Year;
provided that any samples of Products requested by Essentia in excess of the
Sample Quantity Maximum for a Product in a given Agreement Year shall require
not less than sixty (60) days advance written notice and shall
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be paid for by Essentia at WFHC's Cost therefor within thirty (30) days after
receipt of WFHC's invoice therefor.
(b) WFHC will make available to Essentia for distribution by its
sales representatives in the first Agreement Year up to *** boxes of
Esclim(TM) samples (the "Esclim(TM) Sample Quantity Maximum"). Each box contains
two Esclim(TM) transdermal estrogen patches. For Agreement Years after the first
Agreement Year, the Esclim(TM) Sample Quantity Maximum shall be determined by
the Sales/Marketing Committee.
(c) WFHC will make available to Essentia for distribution by its
sales representatives in the first Agreement Year up to *** bottles of
ORTHO-EST(R) samples (the "ORTHO-EST(R) Sample Quantity Maximum"), with each
bottle currently containing a 30-day supply. WFHC reserves the right to change
the number of tablets contained in each ORTHO-EST(R) sample bottle; provided
that WFHC will not change the number of the ORTHO-EST(R) tablets in sample
bottles provided to Essentia unless it also changes the number of tablets per
bottle for ORTHO-EST(R) sample bottles provided by WFHC to Non-Covered
Physicians. For Agreement Years after the first Agreement Year, the ORTHO-EST(R)
Sample Quantity Maximum shall be determined by the Sales/Marketing Committee.
(d) Essentia will seek to allocate Product samples to the
highest prescribing Covered Physicians, as identified by Essentia based on data
obtained from IMS America or another prescription reporting service mutually
agreed upon by the parties and the experience of its sales force. In addition,
Essentia will actively seek to cause such Covered Physicians to provide Product
samples to their patients.
(e) WFHC shall have sole control over the design and conduct of
any Phase I through V clinical studies relating to the Products, as well as sole
and absolute discretion as to whether to initiate any such studies. As between
WFHC and Essentia, WFHC shall have the exclusive right to use for any purpose
the data resulting from any clinical studies relating to the Products conducted
by it or Essentia, including, but not limited to, product registrations and
product licenses related to the Products, throughout the world.
9. CERTAIN REGULATORY MATTERS.
(a) As between WFHC and Essentia, all regulatory matters
regarding the Products shall remain under the exclusive control of WFHC, subject
to the participation by Essentia in matters related to the marketing of the
Products to Covered Physicians. WFHC will have the sole responsibility, at its
cost and expense, to respond to complaints about the Products and to handle all
returns and recalls of the Products.
(b) WFHC shall furnish Essentia with efficacy and safety
information reasonably requested by Essentia to assist it in promoting the
Products to Covered Physicians. Such information shall be treated as
confidential information of WFHC, and shall not be disclosed to Third Parties
without WFHC's 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 Products, including, but not limited to, adverse
drug reactions and governmental inquiries,
*** Certain information (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.
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whether within or outside the Territory. WFHC shall have the responsibility for
evaluating such events and reporting such events to applicable regulatory health
authorities in the Territory.
Essentia shall report all such adverse events involving the
Products learned by it to:
Director of Regulatory Affairs
Women First HealthCare, Inc.
▇▇▇▇ ▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
A MedWatch form or a CIOMS-I form that contains the data elements required for
adverse event reporting is recommended.
Serious adverse events concerning the Products learned by WFHC
shall be reported by WFHC to Essentia by way of WFHC providing to Essentia any
quarterly or annual Adverse Drug Event reports submitted by WFHC to the FDA at
the time WFHC reports such events to the FDA, and shall be sent to:
President & COO
Essentia Pharmaceuticals B.V.
16690 ▇▇▇▇▇▇▇▇ Ridge Road, Suite 100
P.O. Box 679
Chesterfield, MO 63006-0679
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Telephone No. (▇▇▇) ▇▇▇-▇▇▇▇
Serious adverse events for either of the Products (as defined in Section 9(g)
below) learned by Essentia shall be submitted to WFHC within three (3) working
days but no more than four (4) calendar days from the receipt date by Essentia.
Non-serious adverse events for a Product (as defined in Section
9(g) below) that are spontaneously reported to Essentia shall be submitted to
WFHC no more than one (1) month from the date received by Essentia; 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 my 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
Products in any jurisdiction. As between WFHC and Essentia, WFHC shall be
responsible, at its sole cost and expense, for the costs of any recall or
withdrawal of the Products.
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(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 Products, Essentia shall, if not
prohibited by applicable law, immediately notify WFHC and will not respond to
the agency until consulting with WFHC, to the maximum feasible extent; provided,
however, that the foregoing shall not be construed to prevent Essentia in any
way from complying, and Essentia 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) Essentia shall inform WFHC's Director of Regulatory Affairs
of any Product Quality Complaint received within three (3) working days but no
more than five (5) calendar days from the receipt date by Essentia. A "Product
Quality Complaint" is defined as any complaint that questions the purity,
identity, potency or quality of either of the Products, 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 or ANDA, as applicable, for such 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 medical occurrence that at any dose for a 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 immediate 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 medial 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.
(h) WFHC and Essentia will cooperate and establish a mutually
acceptable procedure designed to ensure access by WFHC to samples forming the
basis of a complaint regarding either of the Products received by WFHC. WFHC
will provide Essentia with samples of return labels for this purpose.
(i) As between WFHC and Essentia, WFHC 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, request 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
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forwarded by sales representatives and field force personnel promoting the
Products. Essentia shall refer all routine medical information requests in
writing to:
Director of Regulatory Affairs
Women First HealthCare, Inc.
▇▇▇▇ ▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
Urgent medical information requests shall be referred by
telephone to:
Medical Director
Women First HealthCare, Inc.
▇▇▇▇ ▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
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, guidelines, rules and regulations (collectively,
"Laws") applicable to its activities under this Agreement, including without
limitation, any requirements of any product license applicable to the Products
in the Territory; provided, however, that Essentia 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 use of samples of
Products by it under this Agreement), notwithstanding that the FDA may, as a
matter of law, be entitled to hold WFHC accountable or responsible (whether
primarily or secondarily) for failure of Essentia to comply with such Laws. The
parties will reasonably cooperate with one another with the goal of ensuring
full compliance with Laws. WFHC shall be responsible for all labeling changes to
the Products.
(b) Essentia shall make no representations or warranties
relative to the Products that conflict or are inconsistent with the NDA or ANDA,
as applicable, applicable law, and the FDA-approved label for the Products.
Essentia shall be responsible for any Costs incurred by WFHC resulting from
statements made by Essentia's sales representatives that relate to the safety or
efficacy of the Products that are not in compliance with applicable law or have
not been authorized by WFHC in advance in writing.
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11. COPROMOTION COMPENSATION.
(a) As compensation for services rendered by Essentia with
respect to the Esclim(TM) Product during the Copromotion Term and its agreements
hereunder, WFHC shall pay to Essentia a fee (the "Esclim(TM) Performance Fee")
with respect to each Agreement Year during the term hereof equal to fifty
percent (50%) of those Net Esclim(TM) Sales Attributable to Covered Physicians
that are in excess of the Baseline Annual Esclim(TM) Sales Attributable to
Covered Physicians for such Agreement Year. As compensation for services
rendered by Essentia with respect to the ORTHO-EST(R) Product during the
Copromotion Term and its agreements hereunder, WFHC shall pay to Essentia a fee
(the "ORTHO-EST(R) Performance Fee") with respect to each Agreement Year during
the term hereof equal to fifty percent (50%) of those Net ORTHO-EST(R) Sales
Attributable to Covered Physicians that are in excess of the Baseline Annual
ORTHO-EST(R) Sales Attributable to Covered Physicians for such Agreement Year.
(b) For purposes of this Agreement:
"Average Selling Price per Esclim(TM) 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) for the Esclim(TM) Product, the total Net
Sales of the Esclim(TM) 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 and mail order prescriptions (TRx) for the
Esclim(TM) Product that are written or ordered in such applicable period by
Covered and Non-Covered Physicians. The number of retail and mail order
prescriptions (TRx) shall be determined by the National Prescriptions Audit as
issued by IMS America or another prescription reporting service mutually agreed
upon by the parties.
"Baseline Annual Esclim(TM) Sales Attributable to Covered
Physicians" for each Agreement Year shall mean the product of: (i) the Baseline
Agreement Year Esclim(TM) Prescriptions for such Agreement Year multiplied by
(ii) the Average Selling Price per Esclim(TM) Prescription for such Agreement
Year.
"Baseline Agreement Year Esclim(TM) Prescriptions" for an
Agreement Year means that number of Covered Physician Prescriptions for the
Esclim(TM) Product written and dispensed during an Agreement Year equal to the
actual number of Covered Physician Prescriptions for the Esclim(TM) Product
written and dispensed during 2000, as determined by the X-Ponent Data as issued
by IMS America or similar data provided by another prescription reporting
service mutually agreed upon by the parties.
"Baseline Quarterly Esclim(TM) Prescriptions" shall mean:
(i) For the first Agreement Year, that number of Covered
Physician Esclim(TM) Prescriptions for each calendar quarter
during the first Agreement Year determined by mutual
agreement of the parties based on the IMS America data for
2000 as soon as practicable after such date is available;
provided that in no event shall the sum of the Baseline
Quarterly Esclim(TM) Prescriptions for the first Agreement
Year be less than the Baseline Agreement Year
Esclim(TM) Prescriptions for such Agreement Year; and
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(ii) For the second Agreement Year and the third Agreement Year,
if applicable, the quotient of (1) the Baseline Agreement
Year Esclim(TM) Prescriptions for such Agreement Year
divided (2) by four.
"Covered Physician Esclim(TM) Prescriptions" shall equal the
number of retail and mail order prescriptions (TRx) for the Esclim(TM) Product
that are written or ordered by Covered Physicians and dispensed by pharmacies as
determined by the X-Ponent Data as issued by IMS America or similar data
provided by another prescription reporting service mutually agreed upon by the
parties.
"License Cost per Esclim(TM) Prescription" shall mean WFHC's
license royalty payable to Laboratoires ▇▇▇▇▇▇▇▇ ▇.▇. pursuant to Section 3.3(i)
of the ▇▇▇▇▇▇▇▇ Agreement calculated on a per prescription basis for the
applicable period, with such calculation to be made by WFHC in good faith.
"Net Esclim(TM) 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 Esclim(TM) Prescriptions for the applicable
period multiplied by (ii) the difference of (A) the Average Selling Price per
Esclim(TM) Prescription for such applicable period minus (B) the License Cost
per Esclim(TM) Prescription for such applicable period.
(c) For purposes of this Agreement:
"Average Selling Price per ORTHO-EST(R) 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) for the ORTHO-EST(R) Product, the total
Net Sales of the ORTHO-EST(R) 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 and mail order prescriptions (TRx) for the
ORTHO-EST(R) Product that are written or ordered in such applicable period by
Covered and Non-Covered Physicians. The number of retail and mail order
prescriptions (TRx) shall be determined by the National Prescriptions Audit as
issued by IMS America or another prescription reporting service agreed upon by
the parties.
"Baseline Annual ORTHO-EST(R) Sales Attributable to Covered
Physicians" for each Agreement Year shall mean the product of: (i) the Baseline
Agreement Year Esclim(TM) Prescriptions for such Agreement Year, multiplied by
(ii) the Average Selling Price per ORTHO-EST(R) Prescription for such Agreement
Year.
"Baseline Agreement Year ORTHO-EST(R) Prescriptions" for an
Agreement Year means that number of Covered Physician Prescriptions for the
ORTHO-EST(R) Product written and dispensed during an Agreement Year equal to the
actual number of Covered Physician Prescriptions for the ORTHO-EST(R) Product
written and dispensed during 2000, as determined by the X-Ponent Data as issued
by IMS America or similar data provided by another prescription reporting
service mutually agreed upon by the parties.
"Baseline Quarterly ORTHO-EST(R) Prescriptions" shall mean:
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(i) For the first Agreement Year, that number of Covered
Physician ORTHO-EST(R) Prescriptions for each calendar
quarter during the first Agreement Year determined by mutual
agreement of the parties based on the IMS America data for
2000 as soon as practicable after such data is available;
provided that in no event shall the sum of the Baseline
Quarterly ORTHO-EST(R) Prescriptions for the first Agreement
Year be less than the Baseline Agreement Year
ORTHO-EST(R) Prescriptions for such Agreement Year; and
(ii) For the second Agreement Year and the third Agreement Year,
if applicable, the quotient of (1) the Baseline Agreement
Year ORTHO-EST(R) Prescriptions for such Agreement Year
divided (2) by four.
"Covered Physician ORTHO-EST(R) Prescriptions" shall equal the
number of retail and mail order prescriptions (TRx) for the ORTHO-EST(R) Product
that are written or ordered by Covered Physicians and dispensed as determined by
X-Ponent Data as issued by IMS America or similar data provided by another
prescription reporting service mutually agreed upon by the parties.
"Net ORTHO-EST(R) 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 ORTHO-EST(R) Prescriptions for
the applicable period multiplied by (ii) the Average Selling Price per
ORTHO-EST(R) Prescription for such applicable period.
(d) In order for Essentia to receive its Esclim(TM) Performance
Fee on a quarterly basis, as opposed to WFHC waiting until the end of the year
and making a lump sum (if applicable) of the amount that may be due Essentia
under Section 11(g), WFHC shall, subject to Section 11(g) below, pay to
Essentia, 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 Esclim(TM) 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 Esclim(TM) Quarterly Prescriptions for such applicable
period times (2) the Average Selling Price per Esclim(TM) Prescription for such
applicable period, less
(ii) all compensation previously paid to Essentia pursuant
to this Section 11 with respect to Net Esclim(TM) Sales Attributable to Covered
Physicians during such Agreement Year.
If (i) less (ii) is less than zero for a given Agreement Quarter, no payment
shall be made by WFHC with respect to such Agreement Quarter.
(e) In order for Essentia to receive its ORTHO-EST(R)
Performance Fee on a quarterly basis, as opposed to WFHC waiting until the end
of the year and making a lump sum
*** Certain information (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.
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(if applicable) of the amount that may be due Essentia under Section 11(g), WFHC
shall, subject to section 11(g) below, pay to Essentia, 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 ORTHO-EST(R) 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 ORTHO-EST(R) Quarterly Prescriptions for such applicable
period times (2) the Average Selling Price per ORTHO-EST(R) Prescription for
such applicable period, less
(ii) all compensation previously paid to Essentia pursuant
to this Section 11 with respect to Net ORTHO-EST(R) Sales Attributable to
Covered Physicians during such Agreement Year.
If (i) less (ii) is less than zero for a given Agreement Quarter, no payment
shall be made by WFHC with respect to such Agreement Quarter.
(f) No separate payments 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
Essentia is otherwise entitled for such Agreement Year pursuant to Section 11(a)
above against the sum of all amounts (if any) previously paid to Essentia
pursuant to Sections 11(d) and 11(e) for prior Agreement Quarters during such
Agreement Year. If the calculation determines that Essentia is due further
compensation (or has been overcompensated by WFHC) as a result of any quarterly
payments made by WFHC with respect to the first three quarters of any Agreement
Year, the balance due to Essentia (or to be refunded by Essentia) shall be
computed and paid by the applicable party to the other within ninety (90) days
after the end of such Agreement Year.
(g) Compensation due Essentia under this Section 11 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)-(f) and 12 hereof. Any payments not made when due
under Sections 11(a)-(f) 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.
(h) WFHC shall bear the costs of obtaining the IMS data or
similar data provided by another prescription reporting service mutually agreed
upon by the parties required to calculate the Average Selling Price per
Esclim(TM) Prescription and the Average Selling Price per ORTHO-EST(R)
Prescription. Essentia shall obtain the IMS America data (or similar data
provided by another prescription reporting service mutually agreed upon by the
parties) necessary to calculate the actual number of Covered Physician
Prescriptions for the Esclim(TM) Product and the actual number of Covered
Physician Prescriptions for the ORTHO-EST(R) Product written and dispensed by
pharmacies during 2000, and WFHC shall reimburse Essentia for the actual cost of
obtaining such data; provided that WFHC's reimbursement obligation shall not
exceed ***. Essentia shall bear the costs of obtaining the IMS data or
similar data provided by another prescription reporting service mutually agreed
upon by the parties required to calculate the Covered Physician Esclim(TM)
Prescriptions and the Covered Physician
*** Certain information (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.
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ORTHO-EST(R) Prescriptions. Essentia shall make the data it obtains available to
WFHC or to an independent third party selected by the parties to make the
parties' calculations with respect to Covered Physician Prescriptions.
12. PAYMENTS AND REPORTING.
(a) WFHC shall furnish Essentia, 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 Esclim(TM)
Sales Attributable to Covered Physicians for such Agreement Quarter (and
Agreement Year) and the calculation of Net ORTHO-EST(R) Sales Attributable to
Covered Physicians for such Agreement Quarter (and Agreement Year), and the
calculation of Essentia'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 Net Esclim(TM) Sales
Attributable to Covered Physicians, the Net ORTHO-EST(R) Sales Attributable to
Covered Physicians and the basis for calculating the compensation paid by WFHC
to Essentia 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 and, in the case of the Esclim(TM) Product, the
independent accountants of Laboratoires ▇▇▇▇▇▇▇▇ ▇.▇. shall have access to the
books and records of Essentia 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
their 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 WFHC
for the Products.
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 either party, it is shown
that such party's payments to the other under this Agreement were less than the
amount which should have been paid, then the audited party shall make all
payments required to be made to eliminate any discrepancy revealed by said
inspection within 30 days after the other party's 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.
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13. COPROMOTION TERM AND TERMINATION.
(a) The Copromotion Term shall be for two (2) years and shall
begin effective April 6, 2001 and shall end on March 31, 2003, 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").
(b) Essentia 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 thirty (30) days
after Essentia has advised WFHC in writing of the nature of said breach.
(c) WFHC may terminate the Copromotion Term upon the occurrence
of any of the following:
(i) Upon sixty (60) days' prior written notice to Essentia,
if:
(A) Covered Physician Esclim(TM) Prescriptions for an
Agreement Year do not exceed the number of Covered
Physician Esclim(TM) Prescriptions for such Agreement
Year mutually agreed upon by the parties in good faith
within thirty (30) days after they receive the data
necessary to calculate the Baseline Agreement Year
Esclim(TM) Prescriptions ***; or
(B) Aggregate Covered Physician Esclim(TM) Prescriptions
for each Agreement Quarter during any two (2)
consecutive Agreement Quarters do not exceed the
Baseline Quarterly Esclim(TM) Prescriptions for such
two Agreement Quarters; or
(C) Covered Physician ORTHO-EST(R) Prescriptions for an
Agreement Year do not exceed the number of Covered
Physician ORTHO-EST(R) Prescriptions for such Agreement
Year mutually agreed upon by the parties in good faith
within thirty (30) days after they receive the data
necessary to calculate the Baseline Agreement Year
ORTHO-EST(R) Prescriptions (***
*** Certain information (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.
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***); or
(D) Aggregate Covered Physician ORTHO-EST(R) Prescriptions
for each Agreement Quarter during any two (2)
consecutive Agreement Quarters do not exceed the
Baseline Quarterly ORTHO-EST(R) Prescriptions for such
two Agreement Quarters.
(ii) Upon written notice to Essentia, if WFHC has
permanently ceased manufacturing or marketing either of the Products;
(iii) Immediately upon written notice of termination given
to Essentia, (A) if WFHC's rights to obtain supplies of the ORTHO-EST(R) Product
or to use the ORTHO-EST(R) Trademark under the ORTHO-EST(R) Agreement are
terminated for any reason or are limited in any material respect or (B) if
WFHC's rights to obtain supplies of the Esclim(TM) Product or to market, use,
distribute and sell the Esclim(TM) Product or to use the Esclim(TM) Trademark
under the ▇▇▇▇▇▇▇▇ Agreement are terminated for any reason or are limited in any
material respect; or
(iv) Immediately upon written notice of termination given to
Essentia, if Essentia has breached a material obligation or duty under this
Agreement that is continuing 30 days after WFHC has advised Essentia in writing
of the nature of the breach or default.
(d) If during the Copromotion Term Essentia experiences a
"change in control," Essentia will promptly notify WFHC in writing of same, and
WFHC 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 30 days written notice to Essentia, 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 Essentia to any Person other
than an Affiliate of Essentia or (ii) results in any Person becoming the
beneficial owner, directly or indirectly, of securities of Essentia representing
over fifty percent (50%) of the combined voting power of Essentia's then
outstanding securities. This termination right may be exercised by WFHC 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 30-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.
(e) The Copromotion Term may be extended one year upon the
mutual agreement of the parties, 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.
*** Certain information (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.
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(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, Essentia 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 Essentia 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,
Essentia shall promptly cease all of its promotion activities pursuant to this
Agreement, discontinue any use of the Trademarks, return to WFHC all sales
training, promotional, marketing material, WFHC call lists and computer files,
and any remaining samples of the Products (i.e., not already distributed or
destroyed with destruction certified by Essentia) that may have been supplied to
Essentia by WFHC under this Agreement. WFHC shall be entitled to promote the
Products to all Covered Physicians thereafter without compensation or obligation
to Essentia. It is understood that the names and addresses of any Covered
Physicians to whom Essentia may have made calls are not considered Confidential
Information.
(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) WFHC shall defend, indemnify and hold Essentia and its
employees, agents, officers, directors and affiliates (each an "Essentia Party")
harmless from and against any and all losses, liabilities, obligations, claims,
fees (including, without limitation, attorneys fees), expenses incurred by an
Essentia 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
WFHC contained in this Agreement, (ii) the sale or distribution of the Products
by WFHC or any licensee or affiliate thereof, including, without limitation, any
claim of patent infringement, (iii) any product liability claim related to the
Products, including, without limitation, the use by any person of any Product
that was manufactured, sold or distributed by WFHC or any licensee or affiliate
thereof, (iv) any contamination of or defect in a Product, and (v) breach by
WFHC of its obligations under Section 10 hereof. Notwithstanding anything in
this Section 14(a), WFHC shall not be obligated to indemnify an Essentia Party
for any liability related to a Product for which Essentia has assumed an
indemnification obligation under Section 14(b) below.
(b) Essentia shall defend, indemnify and hold WFHC and its
employees, agents, officers, directors and affiliates (each, a "WFHC Party")
harmless from and against any and all losses, liabilities, obligations, claims,
fees (including, without limitation, attorneys' fees),
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expenses and lawsuits brought against or incurred by a WFHC Party by a Third
Party resulting from or arising in connection with (i) the breach by Essentia of
any covenant, representation or warranty of Essentia contained in this
Agreement, (ii) any contamination, mislabeling, or adulteration of any samples
of Products while such samples are under the control of Essentia or breach by
Essentia of its obligations under Section 8 hereof and/or (iii) breach by
Essentia of its obligations under Section 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 Section 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
Section 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) Essentia acknowledges and agrees that any Essentia sales
force personnel (including contract sales personnel, telemarketers, detail
personnel, independent contractors, employees, and agents) used by Essentia to
fulfill its obligations under this Agreement are not, and are not intended to be
or be treated as, employees of WFHC 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 WFHC or any
of its Affiliates. WFHC shall not be responsible to Essentia, to any employees,
agents, contractors, telemarketers, or other personnel of Essentia 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 Essentia and any of its employees, agents,
contractors, telemarketers, detail or other personnel used by Essentia to
discharge its obligations under this Agreement, all of which shall be the sole
responsibility of Essentia, 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 WFHC 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 Essentia to fulfill its
obligations hereunder shall be solely a matter between Essentia and such
individual(s) or entities.
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Essentia will indemnify, defend, and hold harmless each WFHC
Party from and against any damages, liability, loss and costs that may be paid
or payable by any such WFHC Party 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 Essentia 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:
(A) any payment or obligation to make a payment to any
employees, agents, contractors, telemarketers, or other personnel used by
Essentia 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 WFHC or any of its Affiliates or by Essentia 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 Essentia to discharge its
obligations hereunder may be a common law employee of WFHC or any of its
Affiliates; and
(B) the payment or withholding of any contributions,
payroll taxes, or any other payroll-related item by or on behalf of Essentia or
any of its employees, agents, contractors, telemarketers, and other personnel
with respect to which WFHC, Essentia or any of Essentia's employees, agents,
contractors, telemarketers, and other personnel may be responsible hereunder or
pursuant to applicable law to pay, make, collect, 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 Essentia to discharge its obligations hereunder may be a
common law employee of WFHC or any of its Affiliates.
Nothing contained in this Section 14(d) is intended to or will effect or limit
any compensation payable by WFHC to Essentia for the services rendered by
Essentia pursuant to this Agreement.
(e) Essentia 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, Essentia 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 name WFHC as an additional insured party thereunder and shall
be endorsed to provide for thirty (30) days notice to WFHC 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. Essentia shall furnish to WFHC evidence of such
insurance, upon request. Such insurance
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information shall be kept in confidence in the same manner as any other
confidential information disclosed by Essentia to WFHC hereunder. WFHC shall
cause Essentia to be an additional insured party under WFHC's comprehensive
general liability insurance.
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 the 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 WFHC for use in connection with the Products;
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 Confidentiality Agreement dated as of February 1, 2001 between the
parties and shall govern any
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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 Essentia may
disclose confidential information to members of its board of directors who are
not employees of Essentia (and to consultants who have received WFHC's prior
written approval), provided that Essentia shall ensure that such directors and
consultants are bound by a written obligation of confidentiality to Essentia as
regards confidential information hereunder that is disclosed to them that is
reasonably satisfactory to WFHC.
16. REPRESENTATIONS AND WARRANTIES.
(a) WFHC represents and warrants to Essentia 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; (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; (iii) the rights granted by WFHC to Essentia hereunder do not
conflict with any rights granted by WFHC to any Third Party; and (iv) WFHC owns
the NDA for the Esclim(TM) Product and the ANDA for the ORTHO-EST(R) Product;
provided that in the case of the Esclim(TM) Product, WFHC may be required to
transfer the NDA to Laboratoires ▇▇▇▇▇▇▇▇ ▇.▇. following termination of the
▇▇▇▇▇▇▇▇ Agreement (as defined below) under certain circumstances.
(b) Essentia represents and warrants to WFHC that (i) the
execution, delivery and performance of this Agreement by Essentia does not
conflict with, or constitute a breach of or under, any order, judgment,
agreement or instrument to which Essentia is a party; and (ii) the execution,
delivery and performance of this Agreement by Essentia does not require the
consent of any person or the authorization of (by notice or otherwise) any
governmental or regulatory authority.
17. LIMITATION OF LIABILITY.
(a) EXCEPT WITH RESPECT TO THE PARTIES' RESPECTIVE
INDEMNIFICATION OBLIGATIONS FOR THIRD PARTY CLAIMS PURSUANT TO SECTION 14 AND
WITHOUT LIMITING THE PARTIES ABILITIES TO SEEK INJUNCTIVE RELIEF OR SPECIFIC
PERFORMANCE OF THIS AGREEMENT, THE PARTIES EXPRESSLY AGREE THAT, WITH RESPECT TO
ANY CLAIM BY EITHER WFHC OR ESSENTIA AGAINST THE OTHER ARISING OUT OF ANY BREACH
OF THIS AGREEMENT, THE LIABILITY OF THE BREACHING PARTY TO THE NON-BREACHING
PARTY FOR SUCH BREACH SHALL BE LIMITED UNDER THIS AGREEMENT OR OTHERWISE AT LAW
OR EQUITY TO DIRECT MONEY DAMAGES ONLY, AND IN NO EVENT SHALL A PARTY BE LIABLE
TO THE OTHER FOR INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL
DAMAGES, EVEN IF ADVISED OF THE POSSIBILITY OF THE SAME.
(b) Essentia acknowledges and agrees that WFHC shall not be
liable and shall have no responsibility to Essentia (except as contemplated by
Section 4(d) above) in the event (i)
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WFHC receives insufficient quantities of the Products from Laboratoires ▇▇▇▇▇▇▇▇
▇.▇., in the case of the Esclim(TM) Product, or Ortho-▇▇▇▇▇▇ Pharmaceutical,
Inc. or a replacement manufacturer selected by WFHC under the ORTHO-EST(R)
Agreement, in the case of the ORTHO-EST(R) Product, to meet demand for such
Products or (ii) WFHC's rights under the ORTHO-EST(R) Agreement or the ▇▇▇▇▇▇▇▇
Agreement are limited in any material respect or terminated for any reason.
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 WFHC:
Women First HealthCare, Inc.
▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: Senior Vice President,
Corporate Development
(b) If to Essentia:
Essentia Pharmaceuticals B.V.
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇
P.O. Box 679
Chesterfield, MO 63006-0679
Attention: President & COO
All notices shall be deemed given when received by the addressee.
19. NON-SOLICITATION. During the Copromotion Term and for a period of twelve
(12) 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 either of the Products in the Territory during the Copromotion Term,
without the written consent of the other party.
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 (i) each party 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) WFHC 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 Products, provided that such successor or purchaser has
agreed in writing to assume all of WFHC's rights and obligations hereunder and a
copy of such assumption is
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provided to Essentia 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 Essentia and the President of WFHC 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 San Diego, California, 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 California Evidence
Code, 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 reasonable fees and expenses of the arbitrator
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 arbitrator rules 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
arbitrator rules in favor of one Party on some issues and the other Party on
other issues, the arbitrator shall issue with the rulings a written
determination as to how such fees and expenses shall be allocated between the
Parties. The arbitrator 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 larger share of its legal fees and expenses. The decision of the
arbitrator 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
20(c), 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 2(c), 3(e), 3(g), 7(d), 10,
15 or 19 hereof.
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(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 California,
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 WFHC and Essentia. 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 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 a 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
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other intellectual property rights owned or controlled by a Party, except as
expressly set forth herein.
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IN WITNESS WHEREOF, the parties hereto have duly executed this
Agreement in multiple counterparts through their duly authorized
representatives.
ESSENTIA PHARMACEUTICALS B.V. WOMEN FIRST HEALTHCARE, INC.
By: ____________________________ By: ____________________________
Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇ Name: ▇▇▇▇▇ ▇. ▇▇▇▇
Title: President & COO Title: Senior Vice President,
Corporate Development
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EXHIBIT A
COVERED PHYSICIANS
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EXHIBIT B
TERMS OF USE OF ESCLIM(TM) TRADEMARK
Essentia shall sell, distribute and promote the Esclim(TM) Product under the
Esclim(TM) Trademark, to the exclusion of any other trademark (except Essentia's
own corporate name). Except as otherwise provided in this Agreement, under no
circumstances shall Essentia, as a result of this Agreement, obtain any
ownership interest or other right in the Esclim Trademark. Essentia shall
promptly notify WFHC in writing of any alleged or threatened infringement of the
Esclim(TM) Trademark in the Territory of which it becomes aware. As between WFHC
and Essentia, WFHC shall have the right to prosecute any infringement action
with respect to the Esclim(TM) Trademark.
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EXHIBIT C
TERMS OF USE OF ORTHO-EST(R) TRADEMARK
Essentia agrees that it shall not contest the validity of the ORTHO-EST(R)
Trademark or Ortho-▇▇▇▇▇▇ Pharmaceutical's ownership of the ORTHO-EST(R)
Trademark or any registrations relating thereto. Essentia acknowledges that this
Agreement does not constitute any form of assignment or transfer of ownership in
the ORTHO-EST(R) Trademark. Essentia agrees that nothing in this Agreement shall
give Essentia any proprietary or other interest or right in the ORTHO-EST(R)
Trademark, or the right to register it or trademarks similar to the ORTHO-EST(R)
Trademark in the Territory, other than pursuant to the license granted pursuant
to Section 2(c) of the Agreement. Essentia agrees that all use of the
ORTHO-EST(R) Trademark shall inure to the benefit of Ortho-▇▇▇▇▇▇
Pharmaceutical. Essentia agrees at the reasonable request of WFHC or
Ortho-▇▇▇▇▇▇ Pharmaceutical to execute any and all documents necessary or
appropriate to assist Ortho-▇▇▇▇▇▇ Pharmaceutical in maintaining Ortho-▇▇▇▇▇▇
Pharmaceutical's rights in and to the ORTHO-EST(R) Trademark, all at
Ortho-▇▇▇▇▇▇ Pharmaceutical's sole cost and expense.
Advertising and other promotional materials created by Essentia to promote sales
of the ORTHO-EST(R) Product, if any, and any use of the ORTHO-EST(R) Trademark
in such materials, will be submitted to WFHC to provide to Ortho-▇▇▇▇▇▇
Pharmaceutical for its prior written approval.
All advertising copy, promotional materials, press releases, labels, packaging
and other materials relating to the ORTHO-EST(R) Product and displaying the
ORTHO-EST(R) Trademark shall comply with the following guidelines:
A. The ORTHO-EST(R) Trademark shall be used only in a manner reasonably
intended to (i) promote the general goodwill and public acceptance of the
ORTHO-EST(R) Product, and (ii) maintain enforceability of the ORTHO-EST(R)
Trademark against misuse or infringement by others.
B. The ORTHO-EST(R) Trademark is to appear prominently, in a distinctive type
size and/or style, on all packaging and labels. The proper trademark symbol
(i.e., (R)) should follow the ORTHO-EST(R) Trademark in its most prominent
location on all packaging and labels. The ORTHO-EST(R) Trademark symbol
should follow the ▇▇▇▇ once in each piece of printed matter and preferably
where the ORTHO-EST(R) Trademark appears most prominently on the first page
of the piece.
C. The ORTHO-EST(R) Trademark shall always be used in a manner that will
distinguish it from the surrounding text. The ORTHO-EST(R) Trademark may be
distinguished in the following ways: In all capital letters: ORTHO-EST; in
italic print with an initial capital letter: Ortho-Est Tablets; and in
print that is larger and/or bolder than text: ORTHO-EST.
D. The ORTHO-EST(R) Trademark shall always be used as a proper adjective. The
ORTHO-EST(R) Trademark should, whenever possible, be followed by the
word(s) comprising the remainder of the Official Product Name, e.g.,
Tablets. This shall be done
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at least where the ORTHO-EST(R) Trademark appears most prominently and on
the first and last pages of a printed piece.
1. The official product names to be used with the ORTHO-EST(R) Trademark
shall have initial capital letters, e.g., ORTHO-EST Tablets.
2. If a promotional piece discusses more than one presentation of a
product, the ORTHO-EST(R) Trademark should be followed by the words
comprising the remainder of the official product names, e.g.,
ORTHO-EST Tablets and Caplets.
3. The ORTHO-EST(R) Trademark shall not be used in conjunction with a
non-descriptive noun, e.g., "ORTHO-EST studies" is an incorrect usage.
4. The word "brand" may also be used to reduce the possibility that the
ORTHO-EST(R) Trademark will be thought of as the generic name for the
product. When used, it should always appear in small print, e.g.,
ORTHO-EST brand tablets.
E. The ORTHO-EST(R) Trademark shall not be used in the possessive form.
Correct: ___mg size ORTHO-EST Tablets
Wrong: ORTHO-EST's 400 mg size
F. The ORTHO-EST(R) Trademark shall not be used in the plural form.
Correct: The doctor recommended ORTHO-EST Tablets
Wrong: The doctor recommended ORTHO-ESTS
G. The ORTHO-EST(R) Trademark shall not be hyphenated or divided to create a
new word from the ORTHO-EST(R) Trademark.
Correct: Patients treated with ORTHO-EST Tablets
Wrong: ORTHO-EST-treated patients
H. The ORTHO-EST(R) Trademark shall not be used as a verb.
I. The ORTHO-EST(R) Trademark shall not be equated with the active ingredient.
Correct: ORTHO-EST Tablets (estropipate)
Wrong: ORTHO-EST (estropipate)
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J. The ORTHO-EST(R) Trademark, wherever it is used with respect to ORTHO-EST
Rx products, shall utilize the same type style as currently used by ORTHO
for Ortho-Est products.
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