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EXHIBIT 10.1(B)
ORTHO-PREFEST(TM) CO-PROMOTION
AGREEMENT
BETWEEN
WOMEN FIRST HEALTH CARE
AND
ORTHO-XXXXXX PHARMACEUTICAL, INC.
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TABLE OF CONTENTS
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ARTICLE I. DEFINITIONS........................................................................................... 1
1.1 "Affiliate".................................................................................... 1
1.2 "Contraceptive Product"........................................................................ 1
1.3 "Co-Promotion"................................................................................. 1
1.4 "Detail" (or "Details" and "Detailing")........................................................ 2
1.5 "Detail Report"................................................................................ 2
1.6 "Effective Date"............................................................................... 2
1.7 "Executive Committee".......................................................................... 2
1.8 "HRT Product".................................................................................. 2
1.9 "Initial PREFEST Physicians"................................................................... 2
1.10 "Joint Marketing Committee" or "JMC"........................................................... 2
1.11 "Marketing Plan"............................................................................... 2
1.12 "Medical Education Program".................................................................... 2
1.13 "Net Sales".................................................................................... 2
1.14 "ORTHO-PREFEST(TM)"............................................................................ 3
1.15 "ORTHO Sales Force"............................................................................ 3
1.16 "Prescribing Physicians"....................................................................... 3
1.17 "Primary Position"............................................................................. 3
1.18 "Primary Presentation"......................................................................... 3
1.19 "Revised PREFEST Physicians"................................................................... 3
1.20 "Sales Message"................................................................................ 3
1.21 "Non-Targeted Prescribing Physicians".......................................................... 3
1.22 "Term"......................................................................................... 3
1.23 "Territory".................................................................................... 3
1.24 "Trademarks"................................................................................... 3
1.25 "WFHC Called-on Physicians".................................................................... 3
1.26 "WFHC Sales Force"............................................................................. 4
ARTICLE II. TERMINATION, GRANTS AND RESTRICTIONS................................................................. 4
2.1 Termination.................................................................................... 4
2.2 Grant.......................................................................................... 4
2.3 Retained Rights................................................................................ 4
2.4 Non Compete.................................................................................... 4
ARTICLE III. STRATEGY/COORDINATION OF ACTIVITIES................................................................. 5
3.1 Strategy....................................................................................... 5
3.2 Committees..................................................................................... 5
3.3 Joint Marketing Committee...................................................................... 5
3.4 Executive Committee............................................................................ 6
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ARTICLE IV. PROMOTION AND DETAILING.............................................................................. 6
4.1 Co-Promotion................................................................................... 6
4.2 WFHC's Details................................................................................. 7
4.3 Sales Force.................................................................................... 7
4.4 Detail Reports................................................................................. 7
4.5 Co-Promotion Audit of Performance.............................................................. 7
ARTICLE V. ROLES AND OBLIGATIONS OF THE PARTIES REGARDING ORTHO-PREFEST(TM)...................................... 7
5.1 ORTHO's Roles and Obligations.................................................................. 7
5.2 WFHC'S Roles and Obligations................................................................... 9
ARTICLE VI. COMPENSATION......................................................................................... 9
6.1 ORTHO-PREFEST(TM) Call Compensation 2000....................................................... 9
6.2 ORTHO-PREFEST(TM) Royalty...................................................................... 10
6.3 Incentive Plan................................................................................. 11
6.4 Launch Meeting Costs........................................................................... 11
6.5 Audit.......................................................................................... 11
6.6 Objections..................................................................................... 11
6.7 Overdue Payments............................................................................... 11
6.8 Netting........................................................................................ 12
ARTICLE VII. SAMPLING PROGRAM.................................................................................... 12
7.1 Samples........................................................................................ 12
7.2 Compliance with Law............................................................................ 12
ARTICLE VIII. MEDICAL EDUCATION.................................................................................. 12
8.1 New Programs................................................................................... 12
8.2 Indemnification................................................................................ 12
ARTICLE IX. REPRESENTATION, WARRANTIES AND COVENANTS............................................................. 13
9.1 FDA Approval................................................................................... 13
9.2 Labeling....................................................................................... 13
9.3 Manufacture.................................................................................... 13
9.4 WFHC Sales Force............................................................................... 13
ARTICLE X. INDEMNIFICATION....................................................................................... 13
10.1 ORTHO and WFHC................................................................................. 13
10.2 ORTHO.......................................................................................... 13
10.3 Procedure...................................................................................... 14
10.4 Insurance...................................................................................... 14
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ARTICLE XI. CONFIDENTIALITY...................................................................................... 14
11.1 Confidential Information....................................................................... 14
11.2 Retention of Confidential Information.......................................................... 15
11.3 Prior Notice................................................................................... 15
ARTICLE XII. TRADEDRESS AND PACKAGING............................................................................ 15
12.1 Trademark...................................................................................... 15
ARTICLE XIII. TERM-TERMINATION................................................................................... 16
13.1 Initial Term................................................................................... 16
13.2 Option to Terminate............................................................................ 16
13.3 Termination for Event of Default............................................................... 16
13.4 Effect of Termination.......................................................................... 17
ARTICLE XIV. INTELLECTUAL PROPERTY RIGHTS........................................................................ 17
14.1 Rights......................................................................................... 17
14.2 Infringement................................................................................... 17
ARTICLE XV. DISPUTE RESOLUTION................................................................................... 18
15.1 Initial Resolution............................................................................. 18
ARTICLE XVI. MISCELLANEOUS....................................................................................... 18
16.1 Independent Contractor......................................................................... 18
16.2 Notice......................................................................................... 18
16.3 Force Majeure.................................................................................. 19
16.4 Assignment..................................................................................... 19
16.5 Modification................................................................................... 19
16.6 Waivers........................................................................................ 19
16.7 Governing Law.................................................................................. 20
16.8 Public Disclosure.............................................................................. 20
16.9 Performance by Affiliates...................................................................... 20
16.10 Entire Agreement............................................................................... 20
16.11 Limitation of Liability........................................................................ 20
16.12 Binding Agreement.............................................................................. 20
16.13 Severability................................................................................... 20
16.14 Captions....................................................................................... 21
16.15 Survival....................................................................................... 21
16.16 Counterparts................................................................................... 21
16.17 Remedies Not Exclusive......................................................................... 21
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ORTHO-PREFEST(TM) CO-PROMOTION AGREEMENT
This ORTHO-PREFEST(TM) Co-Promotion Agreement ("Agreement"), by and
between ORTHO-XXXXXX PHARMACEUTICAL, INC., a Delaware corporation ("ORTHO"), and
WOMEN FIRST HEALTHCARE, INC., a Delaware corporation ("WFHC") is made effective
as of September 30, 2000.
RECITALS
WHEREAS, ORTHO and WFHC entered into a Co-Promotion Agreement dated
May 27, 1999 (the "Original Agreement") to co-promote ORTHO-PREFEST(TM), ORTHO
TRI-CYCLEN(R) and ORTHO-ELODOSE(TM);
WHEREAS, ORTHO and WFHC, entered into a First Amendment to
Co-Promotion Agreement dated May 27, 2000 ("First Amendment") eliminating from
the Original Agreement the right of WFHC to co-promote ORTHO Oral Contraceptive
Products, particularly ORTHO TRI-CYCLEN(R), and ORTHO-ELODOSE(TM);
WHEREAS, ORTHO and WFHC desire to terminate the Original Agreement
and the First Amendment, under the terms and conditions as recited herein.
NOW, THEREFORE, in consideration of the covenants and promises
contained in this Agreement ORTHO and WFHC agree as follows:
ARTICLE I.
DEFINITIONS
For the purpose of this Agreement, the following terms shall have
the following meanings:
1.1 "AFFILIATE" means, with respect to a Party, a trust, business, joint
venture, partnership, corporation, association or is an executive officer or
director of, or any other person or entity that, directly or indirectly, through
one or more intermediaries, controls or is controlled by, or is owned by or
under common ownership with a Party. For purposes of this definition, the term
"controls" (including its correlative meanings and the terms "owned by" and
"under common ownership with") means the direct or indirect ownership of more
than fifty percent (50%) of the outstanding voting securities of a corporation
or other entity or comparable equity interest in any other type of entity.
1.2 "CONTRACEPTIVE PRODUCT" means any prescription pharmaceutical
product useful in preventing contraception in a human female.
1.3 "CO-PROMOTION" means the promotion of a Product through ORTHO's and
WFHC's respective sales forces in the Territory under a single Trademark.
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1.4 "DETAIL" (OR "DETAILS" AND "DETAILING") means, with respect to
ORTHO-PREFEST(TM), 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
ORTHO-PREFEST(TM), in a fair and balanced manner consistent with the
requirements of the Food, 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 ORTHO-PREFEST(TM), but excluding sample drops,
mentions and incidental contacts.
1.5 "DETAIL REPORT" means the monthly report submitted by WFHC to ORTHO
described in Section 4.4.
1.6 "EFFECTIVE DATE" means September 30, 2000.
1.7 "EXECUTIVE COMMITTEE" the president of ORTHO and a Vice President of
Sales and Marketing for ORTHO and Xx. Xxxxxx Xxxxxx (currently chairman of
WFHC), with the responsibilities as described in Article 3.
1.8 "HRT PRODUCT" means any prescription estrogen or estrogen and
progestin combination product useful as hormone replacement therapy in a human
female.
1.9 "INITIAL PREFEST PHYSICIANS" means physicians on a list of 22,000
Prescribing Physicians targeted to be Detailed by WFHC during the first and
second calendar quarters of 2000.
1.10 "JOINT MARKETING COMMITTEE" OR "JMC" means the working group, as
described in Section 3.3, that is responsible for managing the day-to-day
administrative and operational activities related to the Co-Promotion of
ORTHO-PREFEST(TM).
1.11 "MARKETING PLAN" means the Marketing Plan that was in effect as of
the Effective Date under the Original Agreement.
1.12 "MEDICAL EDUCATION PROGRAM" means the medical education program
described in Section 8.1.
1.13 "NET SALES" means the amount invoiced by WFHC or its sublicensees
for sales of ORTHO-PREFEST(TM) to a third party in the Territory, less estimates
which will be adjusted to actual on a periodic basis of: (i) discounts,
including cash discounts, discounts to managed care or similar organizations or
government organizations, rebates paid, credit, accrued or actually taken,
including government rebates such as Medicaid chargebacks or rebates, and
retroactive price reductions or allowances actually allowed or granted from the
billed amount, and commercially reasonable and customary fees paid to
distributors (other than to a distributor that is an Affiliate of WFHC), (ii)
credits or allowances actually granted upon claims, rejections or returns of
such sales of ORTHO-PREFEST(TM), including recalls, regardless of WFHC
requesting such recalls and (iii) taxes, duties or other governmental charges
levied on or measured by the billing amount when included in billing, as
adjusted for rebates, charge-backs, and refunds.
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1.14 "ORTHO-PREFEST(TM)" means ORTHO's ORTHO-PREFEST(TM) brand, in all
dosage forms and package configurations.
1.15 "ORTHO SALES FORCE" means the sales force of ORTHO Detailing
ORTHO-PREFEST(TM).
1.16 "PRESCRIBING PHYSICIANS" means those physicians and nurse
practitioners in the field of women's health care, including, but not limited
to, OB/GYN physicians and primary care physicians with prescribing authority in
the Territory who appear on a target list to be determined as recited in
Sections 1.9 and 1.19.
1.17 "PRIMARY POSITION" means the presentation of ORTHO-PREFEST(TM) by
WFHC's Sales Force in the first position during the Detailing of Prescribing
Physicians.
1.18 "PRIMARY PRESENTATION" means a Detail during which a sales
representative delivers the Sales Message.
1.19 "REVISED PREFEST PHYSICIANS" means physicians on a list of 16,000
Prescribing Physicians targeted to be Detailed by WFHC during the 3rd and 4th
calendar quarters of 2000. The parties agree that this list was provided to Xxx
Xxxxxx of ORTHO in an electronic mail message dated September 7, 2000 sent by
Xxxxxx Xxxxxxxx of WFHC.
1.20 "SALES MESSAGE" means the sales presentation on a given Product in
which at least the core message providing the main features and benefits of
ORTHO-PREFEST(TM) is conveyed, which core message is the message that is agreed
upon by the JMC (as defined in the Original Agreement) for each sales
representative to use when making a sales presentation to a Prescribing
Physician.
1.21 "NON-TARGETED PRESCRIBING PHYSICIANS" means those physicians who
are other than the Initial PREFEST Physicians.
1.22 "TERM" means the period of time commencing September 30, 2000 and
ending December 31, 2000, unless terminated sooner hereunder.
1.23 "TERRITORY" shall mean the United States of America, the District
of Columbia and Puerto Rico.
1.24 "TRADEMARKS" means all trademarks, trade names, brand names, logos
and designs, whether registered or not, used during the Term in connection with
the identification, promotion, marketing or sale of ORTHO-PREFEST(TM).
1.25 "WFHC CALLED-ON PHYSICIANS" means those Initial PREFEST Physicians
and nurse practitioners identified in the WFHC called-on list by name and
Medical Education Number (ME number) to be Detailed by WFHC.
1.26 "WFHC SALES FORCE" means the sales force of WFHC Detailing
ORTHO-PREFEST(TM).
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ARTICLE II.
TERMINATION, GRANTS AND RESTRICTIONS
2.1 TERMINATION. The Parties agree that the Original Agreement and the
First Amendment are terminated as of the Effective Date of this Agreement and
shall be of no further force or effect, including without limitation any
restrictions contained in Section 2.3 of the Original Agreement (as amended by
the First Amendment) with respect to WFHC's competitive activities beyond the
Term (as defined and used in the Original Agreement and the First Amendment).
From and after the Effective Date until the end of the Term, the Co-Promotion of
ORTHO-PREFEST(TM) by WFHC and ORTHO shall be conducted under the terms of this
Agreement.
2.2 GRANT. Subject to the terms and conditions of this Agreement,
including but not limited to the rights reserved to ORTHO herein, ORTHO grants
to WFHC the right to Co-Promote and Detail ORTHO-PREFEST(TM) in the Territory to
Prescribing Physicians, as described in Article IV.
2.3 RETAINED RIGHTS.
(a) In addition to those rights that ORTHO retains under Section
4.1 with respect to Co-Promoting and Detailing the
ORTHO-PREFEST(TM) to Prescribing Physicians, ORTHO retains all
rights to the ORTHO-PREFEST(TM) not expressly granted herein.
(b) Except as specifically provided herein, nothing in this
Agreement shall be construed or implied as a grant, assignment
or transfer to either Party of a license or other right of any
kind under any patent, Trademark or other intellectual property
right owned or controlled by the other Party. ORTHO, as the
originator of ORTHO-PREFEST(TM), will retain full and sole
control and ownership over ORTHO-PREFEST(TM) and all existing
and future patents, Trademarks, regulatory approvals and other
rights connected with ORTHO-PREFEST(TM).
2.4 NON COMPETE. WFHC shall not market, promote, distribute or sell any
Contraceptive Product or HRT Product indicated and approved for human
consumption in the Territory, other than ORTHO-EST(R) and ORTHO-PREFEST(TM)
during the Term and for a period of three months immediately thereafter;
provided, however, that WFHC may promote an estrogen-only patch product or
another product that is other than a Contraceptive Product or HRT Product
through the WFHC Sales Force in only the second or third call position during a
Detail if such product(s) is defined in the call plan for its sales
representatives and such call plan is not changed more than four times per year,
and further provided that as of January 1, 2001, WFHC may promote ORTHO-EST(R)
and/or ESCLIM and/or any other non-competitive, non-Contraceptive Product and
non-HRT product in the first position. WFHC may, however, promote such estrogen
patch product or any Contraceptive Product through a sales force that is
independent from the WFHC Sales Force at anytime and in any position it so
desires. Notwithstanding the foregoing, in the event that this Agreement is
terminated by WFHC under Section 13.3, the restrictions set forth in this
Section 2.4 shall terminate and be of no further force or effect.
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ARTICLE III.
STRATEGY/COORDINATION OF ACTIVITIES
3.1 STRATEGY. The Parties agree that the most efficient strategy to
achieve the objectives of their cooperation is through the Co-Promotion of
ORTHO-PREFEST(TM), using a centrally coordinated marketing approach, a single
Trademark, and packaging and promotional literature as set forth in the
Marketing Plan.
Upon reasonable consultation with WFHC, the Joint Marketing
Committee, and the Executive Committee, ORTHO shall have sole discretion in
determining the marketing strategy for ORTHO-PREFEST(TM) in the Territory,
including but not limited to the budget for promoting ORTHO-PREFEST(TM), product
positioning, education programs, Sales Message and Phase IV studies. In
addition, ORTHO shall be responsible for the preparation of Marketing Plans for
ORTHO-PREFEST(TM).
3.2 COMMITTEES. For the purpose of implementing and coordinating the
Parties' promotional activities in the Territory and the related expenditures,
the Parties established a Joint Marketing Committee and an Executive Committee
under the Original Agreement, which committees are hereby established under this
Agreement. Each Party shall bear its own costs and expenses associated with its
participation in the JMC and Executive Committee.
3.3 JOINT MARKETING COMMITTEE.
(a) FORMATION. The JMC shall consist of 2-4 members from each
Party, with the members being representatives from the Parties'
respective sales and marketing departments. ORTHO shall select
one of its members to serve as chairperson of the JMC. Either
Party may appoint, substitute or replace members of the JMC upon
prior written notice to the other Party.
(b) DECISION MAKING. All decisions of the JMC shall be made by a
majority vote of the members. In the event the JMC cannot reach
a mutual decision and is deadlocked on any matter to be decided
by the JMC, the chairperson shall have the right to cast the
deciding vote and render a decision on the matter. Either Party,
however, may appeal any decision to the Executive Committee.
(c) FUNCTION. The JMC shall be responsible, among other things,
for:
(i) reviewing and commenting on the Marketing Plan;
(ii) implementing and supporting the Marketing Plan and
managing the day-to-day administrative and operational
activities related to the Co-Promotion of
ORTHO-PREFEST(TM);
(iii) coordinating the activities of each Party with
respect to the Co-Promotion of ORTHO-PREFEST(TM) in the
Territory; and
(iv) selecting vendors.
(d) MEETINGS. No meetings of the JMC will take place during the
Term of this Agreement, unless requested by ORTHO.
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3.4 EXECUTIVE COMMITTEE.
(a) FORMATION. The Executive Committee shall consist of those
people on the Committee under the CO-PROMOTION AGREEMENT as of
the Effective Date hereof. ORTHO and WFHC may substitute or
replace its members on the Executive Committee upon prior
written notice to the other. Any replacement or substitute
member shall be a person having a functionally equivalent
position within that Party to that of the person replaced or
substituted. WFHC may not substitute its member who is listed in
Section 1.7, except in the case of the death, disability, or
termination of employment, provided such is replaced with an
individual in a functionally equivalent position at WFHC, or
unless agreed to in advance in writing by ORTHO.
(b) FUNCTION. The Executive Committee is responsible for:
(i) providing the leadership required to ensure the
optimal performance of the JMC;
(ii) reviewing and commenting on the Marketing Plan; and
(iii) addressing and deciding all matters referred to it
by the JMC.
(c) MEETINGS. No meetings of the Executive Committee shall take
place during the term of this Agreement, unless requested by
ORTHO.
(d) DECISION MAKING. All decisions of the Executive Committee
shall be made by a majority vote of the members. If a majority
of the Executive Committee cannot reach a decision on a given
matter, the ORTHO representatives shall have the right to render
a decision on the matter. Other than as provided above, ORTHO
retains ultimate authority with respect to all strategic matters
involving or relating to ORTHO-PREFEST(TM).
ARTICLE IV.
PROMOTION AND DETAILING
4.1 CO-PROMOTION. ORTHO and WFHC agree to deploy their respective WFHC
Sales Force and ORTHO Sales Force in an effort to Co-Promote and Detail
ORTHO-PREFEST(TM) in accordance with the terms and conditions of this Agreement
and the Marketing Plan then in effect. In conducting such Co-Promotion and
Detailing, ORTHO and WFHC shall comply with all applicable laws and use
reasonable commercial efforts consistent with accepted pharmaceutical industry
business practices (including, but not limited to, the relevant American Medical
Association Guidelines). No Party shall be required to undertake any activity
under this Agreement which it believes, in good faith, may violate any
applicable law.
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4.2 WFHC'S DETAILS. During the Term, WFHC shall deploy the WFHC Sales
Force to Detail and Co-Promote ORTHO-PREFEST(TM) to Revised PREFEST Physicians
in the Territory as set forth in Section 4.3.
4.3 SALES FORCE. All Detailing required under Section 4.2 shall be (a)
done by regular, full-time members of WFHC's Sales Force, (b) of a quality
equivalent to that provided by WFHC to product lines it is currently promoting
and (c) directed exclusively to the total coverage of Prescribing Physicians
targeted in the Marketing Plan. WFHC shall be solely responsible for the cost
and expense of fulfilling its Detailing obligations including, but not limited
to salaries, travel, materials, training.
4.4 DETAIL REPORTS.WFHC, 30 days after each month, will provide to ORTHO
on an electronic tape a record of its Detailing activity by physician and
"rollable" to their territory, district and regional configuration. This file
will provide information on all calls to physicians, including the detail
position of ORTHO-PREFEST(TM) presented by WFHC and samples that were left. A
territory, zip code file of the WFHC alignment should be provided. Once
submitted to ORTHO the Detail Report may not be revised by WFHC and the payments
described in Section 6.1 shall be based on the information contained in the
Detail Report, subject, however, to revisions (if any) to the Detail Report from
an audit under Section 6.5.
4.5 CO-PROMOTION AUDIT OF PERFORMANCE.
(a) ORTHO shall have the right to review and audit WFHC's call
reporting records during regular business hours to confirm
satisfaction of the obligations set out in this Article IV where
there is a substantial difference between WFHC's call reporting
records and the records of the IMS auditing service or other
pharmaceutical industry call reporting service utilized by ORTHO
hereunder. If, after such review, the Parties are unable to
agree as to the results of ORTHO's audit, ORTHO may demand a
verification of any certification by audit of WFHC's call
reporting system to be conducted by a mutually agreed upon
auditor.
(b) In addition, ORTHO representatives may attend local and
national sales meetings and training meetings of WFHC. Moreover,
ORTHO representatives may accompany WFHC sales representatives
to monitor their performance. Furthermore, ORTHO may audit
WFHC's Detailing performance using Fast Tape or some other
commercially available service or product.
ARTICLE V.
ROLES AND OBLIGATIONS OF THE PARTIES
REGARDING ORTHO-PREFEST(TM)
5.1 ORTHO'S ROLES AND OBLIGATIONS.
(a) PRODUCT. As between the Parties, ORTHO shall have the sole
right and responsibility to manufacture, label, distribute and
sell the ORTHO-PREFEST(TM) and to establish and modify the terms
and conditions with respect to the sale of ORTHO-PREFEST(TM),
including, without limitation, the price at which ORTHO-
PREFEST(TM) will be sold, any discount applicable to payments or
receivables, and the like. All sales of Products will be booked
by ORTHO.
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(b) MEDICAL INQUIRIES. ORTHO shall respond to all medical
questions or inquiries relating to ORTHO-PREFEST(TM) directed to
each Party's respective sales force, unless such question or
inquiry can be answered by reference to the FDA approved
labeling and package insert. ORTHO shall designate a medical
liaison to whom WFHC shall instruct the WFHC Sales Forces to
direct medical questions or inquiries relating to
ORTHO-PREFEST(TM)
(c) GOVERNMENTAL CONTACT. WFHC shall notify ORTHO's regulatory
affairs department upon being contacted by the FDA or any state
drug regulatory agency or any comparable governmental agency in
the Territory with respect to any regulatory purpose pertaining
to the use of ORTHO-PREFEST(TM) by Prescribing Physicians. ORTHO
shall also be responsible for maintaining the registration of
ORTHO-PREFEST(TM), obtaining and maintaining the authorization
and/or ability to market ORTHO-PREFEST(TM) in the Territory, and
for initiating and/or responding to all contacts with the FDA
and other regulatory agencies in the Territory relating to
ORTHO-PREFEST(TM). ORTHO shall retain responsibility for
communicating with all government agencies and satisfying all
requirements regarding maintenance of approvals to market
ORTHO-PREFEST(TM) in the United States; provided, however, that
WFHC may respond to any agency's inquiry regarding
ORTHO-PREFEST(TM) if and only if (a) in the reasonable opinion
of WFHC's counsel, such response is necessary to comply with the
requirements of any law, governmental order or regulation, and
(b) WFHC has requested the agency to direct the inquiry to ORTHO
instead of WFHC, and such agency has refused such request; but
in any such event, unless in the considered opinion of WFHC's
counsel there is a legal prohibition against doing so, WFHC
shall immediately notify ORTHO of such agency's inquiry and of
WFHC's intention to make such response. ORTHO shall be permitted
to accompany WFHC to any meeting with such agency, take part in
any such communications and receive copies of all such
communications.
(d) REGULATORY DISPUTES/LAWSUITS. ORTHO shall retain exclusive
authority and responsibility for handling, in any manner it
deems appropriate, any disputes or lawsuits with any regulatory
agency regarding the regulatory status of ORTHO-PREFEST(TM).
(e) PROMOTIONAL MATERIALS. ORTHO shall provide WFHC with all
required sales and promotional materials in accordance with the
Marketing Plan then in effect. ORTHO shall provide WFHC with
prompt notice of, and copies of, any changes in the label or
labeling, or in the advertising, sales or promotional and
training materials relating to ORTHO-PREFEST(TM), or of any
significant programs that may affect the marketing, sale or
distribution of ORTHO-PREFEST(TM) to Prescribing Physicians.
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(f) ADVERSE REACTION REPORTING. ORTHO shall retain exclusive
authority and responsibility for the handling of any adverse
drug experience (as defined in 21 CFR 314.80) reported to ORTHO
involving ORTHO-PREFEST(TM), including the filing with the FDA
of any such reports that it receives directly from third parties
or WFHC. ORTHO shall provide WFHC's Regulatory Department with
copies of the periodic adverse drug experience reports,
submitted to the FDA pursuant to 21 CFR 314.80(c)(2), at about
the time of submission to the FDA. ORTHO shall promptly notify
WFHC of any adverse drug experience report or series of adverse
drug experiences that may affect the labeling of
ORTHO-PREFEST(TM) or the use thereof in the Field.
5.2 WFHC'S ROLES AND OBLIGATIONS.
(a) PROMOTION. WFHC shall, consistent with customary
pharmaceutical business practices and all applicable laws, rules
and regulations, train, deploy, motivate (through appropriate
incentives), and direct the WFHC Sales Force to Co-Promote and
Detail ORTHO-PREFEST(TM) to Prescribing Physicians using
promotional and sales materials supplied by ORTHO in accordance
with the Marketing Plan or as otherwise decided by the Executive
Committee and implemented by the JMC. WFHC may supplement the
ORTHO promotional and sales materials with its own, only if
approved in writing by ORTHO in advance. Moreover, any
information including but not limited to information
communicated via the Internet and scientific publications
mentioning ORTHO-PREFEST(TM) (i) by name, (ii) by describing
ORTHO-PREFEST(TM) or (iii) via an Internet link to
ORTHO-PREFEST(TM), which WFHC intends to publish, disclose or
otherwise distribute, must be approved in writing in advance by
ORTHO.
(b) ORDERS. WFHC is not authorized to solicit or accept sales
orders for ORTHO-PREFEST(TM). If, for any reason, WFHC should
receive sales orders for ORTHO-PREFEST(TM), WFHC shall promptly
forward such orders to ORTHO as soon as practicable.
ARTICLE VI.
COMPENSATION
6.1 ORTHO-PREFEST(TM) CALL COMPENSATION 2000. The Parties agree that no
compensation is due to WFHC under the Original Agreement. ORTHO shall compensate
WFHC for all activities under the Original Agreement and this Agreement as set
forth herein. For calendar year 2000, ORTHO will compensate WFHC as follows:
(a) for the 1st and 2nd calendar quarters of 2000, ORTHO will
pay WFHC $55 per Detail in the Primary Position of ORTHO-PREFEST
(TM) to Initial PREFEST Physicians,
(b) for the 3rd and 4th calendar quarters of 2000, ORTHO will
pay WFHC $55 per Detail in the Primary Position of
ORTHO-PREFEST(TM) to Revised PREFEST Physicians, provided that
the maximum Details for which WFHC will be
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compensated in the 3rd and 4th calendar quarters of 2000 will be
no more than 26,250 Details per calendar quarter over the Term;
and
(c) for the 1st and 2nd calendar quarters of 2000, ORTHO will
pay WFHC $40 per Detail of ORTHO-PREFEST(TM) in the Primary
Position to 50% of the Non-Targeted Prescribing Physicians
actually Detailed.
Payments under Sections 6.1(a) and (c) shall be made within 15 days
of the Effective Date. Payments under Section 6.1(b) will be made on a monthly
basis by ORTHO to WFHC 60 days after the end of the month or 30 days after
receiving the Detail Reports from WFHC, whichever is later. If ORTHO disputes a
Detail Report, no payment needs to be made with respect to the disputed Details
until the dispute is resolved pursuant to the audit provision in Section 4.5.
Payment will be made with respect to all undisputed Details.
6.2 ORTHO-PREFEST(TM) ROYALTY. The royalty for ORTHO-PREFEST(TM) for
calendar year 2000 shall be calculated as described herein. Forty-five days
after the end of each calendar quarter, ORTHO will determine the total number of
prescriptions written for ORTHO-PREFEST(TM) by Initial PREFEST Physicians (for
the 1st and 2nd calendar quarters of 2000) and by Revised PREFEST Physicians
(for the 3rd and 4th calendar quarters of 2000) during the preceding calendar
quarter by WFHC Called on Physicians using data from the IMS auditing service
("Total WFHC PREFEST Prescriptions or "P"). The ORTHO-PREFEST(TM) Net Sales
Price ("N") will be the forecasted net price per prescription as used in ORTHO's
annual business plan forecast. This Net Sales Price N may be adjusted in
periodic business plan adjustments during the year.
The following formula will be used to calculate the PREFEST Royalty
(T1) owed to WFHC for the preceding quarter.
T(1) = P X N X R
wherein
T(1) equals the total royalty due to WFHC for the quarter;
P equals the total PREFEST Prescriptions written by Initial PREFEST
Physicians (for the 1st and 2nd calendar quarters of 2000) and by Revised
PREFEST Physicians (for the 3rd and 4th calendar quarters of 2000) Detailed by
the WFHC Sales Force as defined above;
N equals the ORTHO-PREFEST(TM) Net Sales Price as defined above;
and
R equals the applicable royalty rate of 5%.
Payments under this Section 6.2 shall be made as follows:
For the 1st and 2nd calendar quarters of 2000, 15 days after the
Effective Date and;
For the 3rd and 4th calendar quarters of 2000, 45 days after the
end of the quarter.
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6.3 INCENTIVE PLAN. WFHC agrees to implement a bonus and incentive plan
for the 4th quarter of 2000 in accordance with Exhibit A, attached hereto.
6.4 LAUNCH MEETING COSTS. WFHC shall pay ORTHO the sum of $247,617 for
ORTHO-PREFEST(TM) Launch Meeting costs. The Parties agree that such payment is
in full satisfaction and settlement of all of WFHC's liabilities and obligations
in connection with such Launch Meeting costs. This amount shall be offset
against the payments due to WFHC from ORTHO hereunder.
6.5 AUDIT. The Parties shall keep accurate records of all data used for
the purpose of making the payments provided herein, which shall contain
sufficient detail to permit a determination of the accuracy of the reports.
Either Party, by and through its authorized third party representatives, shall
have the right, at its own expense and upon reasonable notice, to audit all of
the relevant books and records of the other Party that are directly related to
the promotion, Detailing and/or sale of ORTHO-PREFEST(TM) in order to determine
the accuracy of the quarterly reports and to verify the computation of amounts
due and owing, subject to the following, unless for good cause shown:
(a) Such audit will be limited to the period of three (3) years
following termination or expiration of this Agreement (or such
longer period as such records may be required to be available by
law or regulation);
(b) No period of time shall be audited more than once; and
(c) No audit shall be requested more than once in any twelve
(12) month period.
6.6 OBJECTIONS. All reports and all information contained therein
provided to a Party pursuant to this Article VI shall be deemed conclusive and
binding upon such Party unless written objection shall be lodged with the other
Party within one (1) year from the date of such report, except that objections
discoverable only upon audit shall be reserved for a period of three (3) months
after completion of an audit in which the facts giving rise to the objection are
discovered, regardless of when the audit is performed.
6.7 OVERDUE PAYMENTS. In the event any payment due hereunder is not made
when due, the payment shall accrue interest (beginning on the date such payment
is due) calculated at the rate of one percent (1.0%) per month and such payment
when made shall be accompanied by all interest so accrued.
6.8 NETTING. Any payments owed to WFHC by ORTHO under this Agreement, as
of the end of the 3rd calendar quarter of 2000 will be netted against amounts
owed ORTHO by WFHC under (i) the ORTHO-EST(R) Asset Transfer & Supply Agreement
between WFHC and ORTHO having the same effective date as this Agreement, and
(ii) the Distribution Agreement, as of the end of the 3rd calendar quarter of
2000.
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ARTICLE VII.
SAMPLING PROGRAM
7.1 SAMPLES. ORTHO shall provide WFHC with samples, in amounts
consistent with the amounts it provides to the ORTHO Sales Force promoting
ORTHO-PREFEST(TM) at no cost, according to the Marketing Plan, which will recite
how many samples will be distributed, when and where. At the end of the Term,
samples and sales aids will be returned to ORTHO in accordance with established
practices.
7.2 COMPLIANCE WITH LAW. All activities in connection with the
distribution of samples shall be conducted in a manner which conforms to (a) the
Marketing Plan and (b) the Prescription Drug Marketing Act of 1987, as may be
amended from time to time, and applicable state laws and regulations. Each Party
shall be responsible for compliance with the Prescription Drug Marketing Act of
1987, as may be amended from time to time.
ARTICLE VIII.
MEDICAL EDUCATION
8.1 NEW PROGRAMS. Under the Original Agreement, ORTHO agreed to pay WFHC
$6,800,000 plus up to 5% management fee to be used for Medical Education
Program(s) directed to ORTHO-PREFEST(TM) using providers selected by WFHC. This
financial commitment by ORTHO is hereby changed to $6,627,857, which as of the
Effective Date represents moneys already paid (including a management fee of
$125,000 already paid) or committed to be paid, plus an additional $1,000,000 to
be used by WFHC for the Medical Education Program set forth on Exhibit B. The
Medical Education Program shall be conducted as set forth in Exhibit B and must
be substantially completed during calendar year 2000. Programs not begun and
substantially completed in 2000 will not be reimbursed, thereby reducing the
$1,000,000 commitment accordingly.
The additional $1,000,000 shall be paid as follows:
1/3 upon the execution of the Agreement between WFHC and the
provider of the medical education program;
1/3 upon the start of the Medical Education Program; and
1/3 upon substantial completion of the Medical Education Program,
which must occur prior to December 31, 2000, or such 1/3 payment will not be
made.
8.2 INDEMNIFICATION. WFHC agrees to indemnify and hold harmless ORTHO
against any claims by the provider identified on Exhibit C relating to
non-payment of such provider's invoices to WFHC for services rendered under
prior medical education programs conducted in connection with ORTHO products.
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ARTICLE IX.
REPRESENTATION, WARRANTIES AND COVENANTS
9.1 FDA APPROVAL. ORTHO represents and warrants to WFHC that the data
submitted to the FDA in support of the approval of ORTHO-PREFEST(TM) in the
Territory is complete and accurate in all material respects.
9.2 LABELING. ORTHO covenants that ORTHO-PREFEST(TM) labeling and the
related sales, advertising, promotional and training materials provided to WFHC
by ORTHO (except for any such materials provided in accordance with
specifications provided by WFHC, with respect to which WFHC provides the same
covenant) shall conform to the FDA approved labeling for ORTHO-PREFEST(TM) and
will comply with all applicable laws and regulations.
9.3 MANUFACTURE. ORTHO covenants that it shall manufacture
ORTHO-PREFEST(TM) in accordance with the provisions of the Federal Food, Drug
and Cosmetic Act and the FDA's Current Good Manufacturing Practices and
regulations promulgated thereunder, relating to the manufacture of
pharmaceutical products.
9.4 WFHC SALES FORCE. WFHC covenants that it shall deploy the WFHC Sales
Force to Co-Promote ORTHO-PREFEST(TM) in the Primary Position.
ARTICLE X.
INDEMNIFICATION
10.1 ORTHO AND WFHC. ORTHO and WFHC shall each indemnify and hold
harmless the other Party and their officers, directors, agents, employees and
Affiliates against and from any and all claims, suits, judgments, expenses
(including reasonable attorney fees), losses, liabilities and damages
(collectively, "Indemnification Claims" or "Claims") which the other Party may
incur or suffer which arise out of or are based upon (i) the material default by
such Party in the performance of any obligation of or agreement made by such
Party in this Agreement or the material breach of any warranty, representation,
or agreement made by such Party in this Agreement, (ii) the acts or omissions to
act of the agents, servants or employees of such Party related to their
obligations under or actions taken pursuant to this Agreement, including,
without limitation, acts or omissions to act which are: (a) intentional
misconduct or negligent acts or omissions to act or (b) outside of the scope of
the permissible conduct of such agents, servants or employees as required in
view of the terms of this Agreement, FDA approval of ORTHO-PREFEST(TM), or any
rules or regulations of the FDA or any other governmental agency, authority or
entity, including, but not limited to, making claims for ORTHO-PREFEST(TM)
beyond the approved labeling, failing to provide the approved package insert as
may be required with ORTHO-PREFEST(TM) or recommending use in non-indicated
patients; and (iii) any and all actions, suits, proceedings, demands,
assessments, judgments, reasonable costs and legal and other expenses incident
to any of the foregoing.
10.2 ORTHO. ORTHO further agrees to defend, indemnify and hold harmless
WFHC, its officers, directors, agents, employees and Affiliates, from and
against (i) all claims, monetary judgments, assessed damages and reasonable
attorney fees incurred by or assessed against WFHC for activities prior to any
termination of this Agreement on account of any claim
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that the manufacture, use or sale of ORTHO-PREFEST(TM) in the Territory
infringes the patent, trademark or other intellectual property right of any
third party, or (ii) any Claims on account of personal injuries (including
death) or product liability claims or other loss or damage to third parties
resulting from or relating to the manufacture, labeling, sale or use of
ORTHO-PREFEST(TM), unless and to the extent such loss or damage was primarily
due to the negligence, recklessness or willful misconduct of WFHC (whether
committed by affirmative act or by omission).
10.3 PROCEDURE. The Party seeking indemnification (the "Indemnified
Party") shall inform the other Party promptly of any such Indemnifiable Claim
which is brought against it and shall, to the extent such Indemnifiable Claim is
brought by a third party, at the other Party's request, cooperate fully with the
other Party in defending such Indemnifiable Claim. The Indemnified Party, at its
expense, shall have the right to advise and consult on and participate in any
related suit or proceeding, subject to the ultimate control of the Indemnifying
Party. The other Party ("Indemnifying Party") shall have full control over the
suit or proceedings, including the right to settle, through counsel of its
choice who is reasonably acceptable to the Indemnified Party; provided, however,
the Indemnifying Party will not, absent the consent of the Indemnified Party
(which consent will not be unreasonably withheld), consent to the entry of any
judgement or enter into any settlement that (1) provides for any relief other
than the payment of monetary damages for which the Indemnifying Party shall be
solely liable and (2) where the claimant or plaintiff does not release the
Indemnified Party from all liability in respect thereof. If the Indemnifying
Party declines to accept control of the defense of such claim or action, the
Indemnified Party may retain counsel at the expense of the Indemnifying Party
and control the defense of the claim or action, provided that the claim or
action may not be settled by the Indemnified Party without the approval of the
Indemnifying Party, which approval shall not be unreasonably withheld or
delayed. If the Indemnifying Party elects to assume the defense of any claim or
action, such party shall not settle the same without the consent of the
Indemnified Party if such settlement would impose any monetary or other material
obligation or burden on the Indemnified Party or require the Indemnified Party
to submit to a temporary restraining order or an injunction or otherwise limit
the Indemnified Party's rights under this Agreement. Any payment made by the
Indemnifying Party to settle any such claim or action shall be at its own cost
and expense.
10.4 INSURANCE. WFHC agrees to maintain (a) workers' compensation
insurance for all of its employees, the limits of which shall be statutory, and
(b) commercial general liability and automobile insurance with limits of not
less than $5,000,000 and $1,000,000, per occurrence, respectively.
ARTICLE XI.
CONFIDENTIALITY
11.1 CONFIDENTIAL INFORMATION. Except to the extent expressly authorized
by this Agreement or otherwise agreed to by the Parties in writing, the Parties
agree that, during the Term and for five (5) years thereafter, the receiving
party shall keep strictly confidential and shall not publish or otherwise
disclose or use in any way or for any purpose other than as provided for in this
Agreement any information marked as confidential by the providing Party
("Confidential Information") furnished to it by the other Party pursuant to this
Agreement, except
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to the extent that the receiving party can establish by competent evidence that
such Confidential Information:
(a) is already lawfully known to the recipient at the time of
disclosure as documented by recipient; or
(b) is or becomes generally available to the public other than
through any act or omission of the recipient in breach of this
Agreement; or
(c) is acquired by the recipient from a third party having, to
recipient's best knowledge, the lawful right to disclose same;
or
(d) is required by law to be disclosed; or
(e) is required to be disclosed in order to exercise rights
granted or retained pursuant to this Agreement, provided that
any such disclosure will be subject to use and disclosure
restrictions similar to those provided herein.
Each Party shall use the same efforts to keep secret and prevent the disclosure
of such Confidential Information to parties, other than its agents, officers,
employees and representatives authorized to receive such Confidential
Information and who are bound by use and disclosure restrictions similar to
those provided herein, as it would use with respect to is own confidential and
proprietary information. Confidential Information shall remain the sole and
absolute property of the disclosing party, subject to the rights granted herein.
11.2 RETENTION OF CONFIDENTIAL INFORMATION. In the event this Agreement
is terminated for any reason by either Party, or expires, as provided herein,
each Party agrees to return to the other, and thereafter refrain from using, all
Confidential Information given to it by the other Party, provided that each
party may retain one copy of such information in its law department files solely
for evidentiary purposes. All provisions of this Section shall survive the
expiration or termination of this Agreement.
11.3 PRIOR NOTICE. If a receiving party is required by law or rules or
regulations of any governmental agency or authority or any stock exchange to
disclose Confidential Information of the disclosing party, the receiving party
shall, prior to making any such disclosure, give the disclosing party sufficient
advance written notice to permit the disclosing party to seek a protective order
or other similar protection with respect to such Confidential Information, and
thereafter shall disclose only the minimum information which, in the opinion of
its counsel, is required to be disclosed in order to comply with the legal
requirements imposed on such party, whether or not a protective order or other
similar protection is obtained, and to the extent possible, only under
conditions of confidentiality.
ARTICLE XII.
TRADEDRESS AND PACKAGING
12.1 TRADEMARK. Only ORTHO's Trademark and logo will appear on any
Product and packaging. Both ORTHO's and WFHC's Trademarks and logos will appear
on all jointly used printed promotional materials. Neither Party shall acquire
any rights in the other Party's
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name or logo on account of the use thereof pursuant to this Agreement. Neither
Party shall use the other Party's trademark or logo on any promotional,
educational and/or training materials without the consent of the other Party.
ARTICLE XIII.
TERM-TERMINATION
13.1 INITIAL TERM. This Agreement shall remain in effect until December
31, 2000, at which time it shall terminate, unless earlier terminated by either
Party in accordance with Sections 13.2 or Section 13.3.
13.2 OPTION TO TERMINATE.
(a) Notwithstanding any provision herein to the contrary, ORTHO
shall have the right, at its sole option, to terminate this
Agreement as follows:
(i) upon not less than thirty (30) days' advance written
notice to WFHC in the event there is a change of control
of WFHC (a "change of control" shall be deemed to have
occurred if any third party that is not an Affiliate of
WFHC (A) acquires a majority of the shares of WFHC or a
right to control the voting of a majority of WFHC
shares, or (B) acquires sufficient shares or the right
to control the votes of sufficient shares to enable such
third party to designate or elect a majority of WFHC's
Board of Directors); or
(ii) immediately if ORTHO loses applicable regulatory or
marketing approval for ORTHO-PREFEST(TM) in the
Territory ; or
(iii) upon 30 days advance written notice if Xx. Xxxxxx
Xxxxxx is no longer associated with WFHC (other than as
a result of death or disability).
(b) Notwithstanding any provision herein to the contrary, WFHC
shall have the right, at its sole option, to terminate this
Agreement if ORTHO loses applicable regulatory or marketing
approval for ORTHO-PREFEST(TM) in the Territory.
13.3 TERMINATION FOR EVENT OF DEFAULT. Notwithstanding Section 13.1,
either Party may, in addition to exercising any other available legal or
equitable rights or remedies, terminate this Agreement, effective immediately
upon the expiration of any applicable cure period, upon the occurrence of an
Event of Default (as defined below) with respect to the other Party. The term
"Event of Default" with respect to a Party means the occurrence of any of the
following events:
(a) Except as provided in Section 13.3(b) below, the failure of
a Party to comply with or perform any material non-monetary
provision of this Agreement, and such failure remains uncured
for sixty (60) days following written notice of such failure (if
such default is cured within the cure period, such written
notice
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shall be null and void), provided that, if the defaulting party
can establish to the reasonable satisfaction of the other party
that it is diligently and actively pursuing a cure at the
expiration of the cure period, and that the default is
reasonably capable of being cured, then the cure period shall be
extended for so long as a cure is being diligently and actively
pursued, not to exceed 120 days in the aggregate.
(b) The failure of a Party to comply with or perform any
material monetary provision of this Agreement, and such failure
remains uncured for thirty (30) days following written notice of
such failure (if such default is cured within such period, such
written notice shall be null and void).
(c) A Party (i) admits in writing its inability to pay its debts
as they mature, (ii) is the subject of a voluntary or
involuntary petition in bankruptcy or of any other proceeding
under bankruptcy, insolvency or similar laws which, if
involuntary, is not dismissed within sixty (60) days of the date
filed, (iii) makes an assignment for the benefit of creditors,
(iv) is named in, or its property is subject to, a suit for the
appointment of a receiver which is not dismissed within sixty
(60) days of the date filed, or (v) is dissolved or liquidated.
13.4 EFFECT OF TERMINATION.
(a) Upon termination or expiration of this Agreement, neither
WFHC nor its Affiliates shall thereafter have any further rights
to market, Detail, promote or sell ORTHO-PREFEST(TM), except as
otherwise specifically provided herein.
(b) Termination or expiration of this Agreement shall not
operate to release any Party from any obligation or liability
incurred under the terms of this Agreement prior to or upon
termination or expiration of this Agreement, including the
payment of any amounts due but unpaid by one Party to the other,
or from any obligations provided for in this Agreement which
survive termination of this Agreement.
ARTICLE XIV.
INTELLECTUAL PROPERTY RIGHTS
14.1 RIGHTS. WFHC acknowledges that ORTHO and/or its Affiliates owns and
retains all proprietary and property interests and rights in (a) all Trademarks,
patents, copyrights or other property rights regarding ORTHO-PREFEST(TM),
including, but not limited to, all regulatory filings and approvals relating to
ORTHO-PREFEST(TM), and (b) all supporting sales and promotional material. WFHC
also acknowledges that no right or license is granted to WFHC hereunder with
respect to (a) and (b) above, except for the right to use such materials in the
Detailing and promotion of ORTHO-PREFEST(TM) in accordance with the terms of
this Agreement.
14.2 INFRINGEMENT. WFHC shall advise ORTHO promptly upon its becoming
aware of any infringement by a third party of any patent or Trademark related to
ORTHO-PREFEST(TM). ORTHO may take such commercially reasonable action as may be
required to restrain or otherwise prevent such infringement. WFHC shall
reasonably cooperate with and as requested
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by ORTHO, at ORTHO's sole cost and expense, in ORTHO's attempt to restrain such
infringement.
ARTICLE XV.
DISPUTE RESOLUTION
15.1 INITIAL RESOLUTION. In the case of any disputes between the Parties
arising from this Agreement, and in case this Agreement does not provide a
solution for how to resolve such disputes, the Parties shall discuss and
negotiate in good faith a solution acceptable to both Parties and in the spirit
of this Agreement. If after negotiating in good faith pursuant to the foregoing
sentence, the Parties fail to reach agreement, then the President of ORTHO and
the President of WFHC shall discuss in good faith an appropriate resolution to
the dispute. If these executives fail, after good faith discussions, to reach an
amicable agreement, then either Party may pursue any remedies available to such
Party at law or in equity.
ARTICLE XVI.
MISCELLANEOUS
16.1 INDEPENDENT CONTRACTOR. The cooperation between the Parties as set
forth in this Agreement will not constitute, nor be construed as constituting, a
partnership or a relationship of agent and principal. Neither Party shall, under
any circumstance, act as, or represent itself to be, a partner, agent or a
representative of the other. Neither Party shall have any responsibility for the
firing, compensation, or employee benefits of the other Party's employees. No
employee or representative of either Party shall have any authority to bind or
obligate the other Party to this Agreement for any sum or in any manner
whatsoever, or to create or impose a contractual or other liability on the other
Party without said Party's prior authorized written approval. For all purposes,
and notwithstanding any other provision of this Agreement to the contrary, the
legal relationship of the Parties under this Agreement shall be that of
independent contractors.
16.2 NOTICE. Any notice required or permitted hereunder shall be in
writing and shall be sufficiently given when personally delivered,
telecommunicated (with confirmation), delivered by overnight courier or mailed
prepaid first class registered or certified mail and addressed to the Party for
whom it is intended at its record address, and such notice shall be effective
upon receipt, if delivered personally, telecommunicated, or by overnight
courier, or shall be effective five (5) days after it is deposited in the mail,
if mailed. The record addresses and facsimile number of the Parties are set
forth below:
If to WFHC: Women First HealthCare, Inc.
00000 Xx Xxxxxx Xxxx
Xxxxx 000
Xxx Xxxxx, XX. 00000
Attn: President
Facsimile No.: (000) 000-0000
Phone No.: (000) 000-0000
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If to ORTHO: Ortho-XxXxxx Pharmaceutical, Inc.
X.X. Xxxxx #000 Xxxxx
Xxxxxxx, XX 00000-0000
Attn: President
Facsimile No.: (000) 000-0000
with a copy: Xxxxxxx & Xxxxxxx
Xxx Xxxxxxx & Xxxxxxx Xxxxx
Xxx Xxxxxxxxx, XX 00000
Attn: Office of General Counsel
Facsimile No.: (000) 000-0000
Any Party, at any time, may change its previous record address or facsimile
number by giving written notice of the change to the other Party as herein
provided.
16.3 FORCE MAJEURE. Neither Party shall lose any rights hereunder or be
liable to the other Party for damages or losses on account of failure of
performance by the defaulting Party if the failure is occasioned by government
action, war, fire, explosion, flood, strike, lockout, embargo, act of God, or
any other similar cause beyond the control of the defaulting Party; provided,
however, that the Party claiming force majeure has exerted all reasonable
efforts to avoid such force majeure and has given prompt notice to the other
Party of any such force majeure. The Party giving such notice shall be excused
from such of its obligations hereunder as it is disabled from performing for so
long as it is so disabled; provided, however, that Party commences and continues
to take reasonable and diligent actions to cure or remedy such force majeure. In
the event of any such force majeure event, the Parties shall meet promptly to
determine an equitable solution to the effects of any such event. Force majeure
shall not include a Party's failure to perform any obligation under this
Agreement as a result of any Year 2000 Problem or any failure to meet its Detail
commitment. The Term shall not be extended by any force majeure event.
16.4 ASSIGNMENT. This Agreement shall not be assigned by either Party
without the written consent of the other Party, except that this Agreement may
be assigned in whole or in part to any Affiliate of a Party, provided that (i)
the assigning Party remains obligated for its Affiliate's performance of this
Agreement, and (ii) the assigning Party provides prior written notice to the
other Party of the anticipated assignment. Either Party may assign this
Agreement to any party succeeding (by sale, merger, reverse merger or otherwise)
to substantially all of the business and operations of such Party subject to the
other Party's right to terminate this Agreement pursuant to Article 13.
16.5 MODIFICATION. No modification or amendment hereof shall be valid or
binding upon the Parties hereto unless made in writing and duly executed on
behalf of both of the Parties.
16.6 WAIVERS. Failure of a Party to insist upon the strict performance
of any provision hereof or to exercise any right or remedy shall not be deemed a
waiver of any right or remedy with respect to any existing or subsequent breach
or default.
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16.7 GOVERNING LAW. This Agreement shall be construed and the legal
relations between the Parties hereto determined in accordance with the laws of
the State of New York without regard to what laws might otherwise govern under
applicable principles of conflict or choice of law.
16.8 PUBLIC DISCLOSURE. Neither Party shall originate any publicity,
news release or public announcements, written or oral, whether to the public or
press, stockholders or otherwise, relating to this Agreement, including its
existence, the subject matter to which it relates, performance under it or any
of its terms, to any amendment hereto or performances hereunder without the
prior written consent of the other Party, save only such announcements that are
required by law to be made or that are otherwise agreed by the Parties. Such
announcements shall be brief and factual. If a Party decides to make an
announcement required by law, it will give the other Party at least ten (10)
business days advance notice, where possible, of the text of the announcement so
that the other Party will have an opportunity to comment upon the announcement.
To the extent that the receiving Party reasonably requests that any information
in the materials proposed to be disclosed or deleted, the disclosing Party shall
request confidential treatment of such information pursuant to Rule 406 of the
Securities Act of 1933 or Rule 24b-2 of the Securities Exchange Act of 1934 as
amended, as applicable (or any other applicable regulation relating to the
confidential treatment of information) so that there be omitted from the
materials that are publicly filed any information that the receiving Party
reasonably requests to be deleted, unless in the opinion of the disclosing
Party's legal counsel such Confidential Information is legally required to be
fully disclosed. A Press Release approved by the Parties with respect to the
signing of this Agreement is attached hereto as Exhibit D.
16.9 PERFORMANCE BY AFFILIATES. Any Party hereto may satisfy any of its
obligation hereunder through any of its Affiliates; provided, however, that each
Party guarantees the performance at all times of any of such Party's obligations
so delegated pursuant to this Section.
16.10 ENTIRE AGREEMENT. This Agreement constitutes the entire agreement
between the Parties relating to the subject matter covered herein and supersedes
all prior oral or written agreements. No covenants, promises, agreements,
warranties, representations, conditions or understandings, either oral or
written, exist between the Parties other than as set forth herein.
16.11 LIMITATION OF LIABILITY. Except with respect to the Parties'
respective indemnification obligations for third party claims pursuant to
Sections 10.1 and 10.2, the Parties expressly agree that, with respect to any
claim by either ORTHO or WFHC 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.
16.12 BINDING AGREEMENT. This Agreement shall be binding upon, and shall
inure to the benefit of, the respective successors and permitted assigns of the
Parties hereto.
16.13 SEVERABILITY. If any provision of this Agreement is held to be
invalid or unenforceable, such invalid or unenforceable provision shall not
affect the validity of the
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remaining provisions. If any of the terms or provisions of this Agreement are in
conflict with any applicable statute or rule of law, then such terms or
provisions shall be deemed inoperative to the extent that they may conflict
therewith and shall be deemed to be modified to conform with such statute or
rule of law unless such modification would render such provision inconsistent
with the intent of the Parties.
16.14 CAPTIONS. All captions herein are for convenience only and shall
not be interpreted as having any substantive meaning.
16.15 SURVIVAL. The provisions of Sections 6.1, 6.2 (with respect to
unpaid amounts), 6.5 and Articles 10, 11 and 15 and the definitions of Article 1
of this Agreement shall survive the termination or expiration of this Agreement
for a period of five (5) years after such termination or expiration. The
provisions of this Agreement that do not survive termination or expiration
hereof (as the case may be) shall, nonetheless, be controlling on, and shall be
used in construing and interpreting, the rights and obligations of the Parties
hereto with regard to any dispute, controversy or claim that may arise in
connection with this Agreement.
16.16 COUNTERPARTS. This Agreement may be executed simultaneously in any
number of counterparts, and may be executed by facsimile. All counterparts shall
collectively constitute one and the same agreement.
16.17 REMEDIES NOT EXCLUSIVE. Except as specifically provided herein,
the remedies under this Agreement shall be cumulative and not alternative, and
the election of one remedy for a breach shall not preclude pursuit of other
remedies.
(NO FURTHER TEXT ON THIS PAGE)
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be
executed by their respective duly authorized officers or representatives as of
the Effective Date.
ORTHO-XXXXXX
PHARMACEUTICAL, INC. WOMEN FIRST HEALTHCARE, INC.
By: By:
President President: Xxxxxx X. Xxxxxx
Date: Date:
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