EXHIBIT 10.1
*** 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.
AGREEMENT
BETWEEN
WOMEN FIRST HEALTHCARE, INC.
AND
XXXXXXXX-XX XXXXX INC.
TABLE OF CONTENTS
DEFINITIONS PAGE
ARTICLE 1 - DEFINITIONS
1.1 Product 2
1.2 FDA 2
1.3 NDA 2
1.4 IND 2
1.5 Technical Information 2
1.6 Effective Date 3
1.7 Territory 3
1.8 Affiliate 3
1.9 Term 3
1.10 Singular/Plural 3
ARTICLE 2 - GRANT
2.1 NDA 4
2.2 Perfecting Rights 4
2.3 Trademarks 5
2.4 Housemarks 6
ARTICLE 3 - RESPONSIBILITIES AND COORDINATION
3.1 Product Approval Efforts 6
3.2 Marketing Efforts 7
3.3 Medical Questions 13
3.4 Discussions 13
3.5 Coordinators 14
3.6 Quality Control 15
ARTICLE 4 - SUPPLY OF PRODUCT
4.1 Product Supply 17
4.2 Supplies 18
4.3 Shipment 18
4.4 Recalls 18
ARTICLE 5 - PAYMENT REPORTS AND AUDITS
5.1 Amount 19
5.2 Payment 19
ARTICLE 6 - LIABILITY
6.1 Product Liability 19
6.2 Handling 20
6.3 Notice 20
6.4 Defense 21
ARTICLE 7 - WARRANTY
7.1 Authority 21
7.2 No Infringement 22
7.3 No Conflicts 22
7.4 Regulatory Approvals 22
7.5 Inventory 23
7.6 Litigation 24
7.7 Limited Warranty 24
7.8 Risks 24
ARTICLE 8 - TERMINATION
8.1 Termination 24
8.2 Bankruptcy 25
8.3 Termination Rights 26
ARTICLE 9 - MISCELLANEOUS
9.1 Force Majeure 26
9.2 Jurisdiction 27
9.3 Notices 27
9.4 Press Releases 27
9.5 Captions 28
9.6 Severability 28
9.7 Assignment 29
9.8 Entire Agreement 29
Exhibit 1 - List of Transfer Know-how 30
Exhibit 2 - List of Transfer Supplies 32
Exhibit 3 - Initial Press Release 33
AGREEMENT
This Agreement made as of the 12th day of October, 2001 by and between
Women First HealthCare, Inc., a corporation organized and existing under the
laws of the State of Delaware, having offices at 00000 Xx Xxxxxx Xxxx, Xxxxx
000, Xxx Xxxxx, Xxxxxxxxxx 00000 (hereinafter referred to as "WFH") and
Xxxxxxxx-Xx Xxxxx Inc., a corporation organized and existing under the laws of
the State of New Jersey, having offices at 000 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxx
Xxxxxx 00000 (hereinafter referred to as "ROCHE").
WHEREAS, ROCHE has marketed in the United States of America ("USA") a
human pharmaceutical product under the trademarks, Bactrim(TM)DS and
Bactrim(TM), having sulfamethoxazole and trimethoprim as its active ingredients;
WHEREAS, ROCHE and WFH have entered into a non-disclosure agreement,
dated May 1, 2001 ("Non-Disclosure Agreement") under which ROCHE and WFH shared
information with regard to the research, development, and commercialization of
the above product;
WHEREAS, ROCHE and its affiliates collectively have worldwide rights to
the above product, including the trademarks; and
WHEREAS, WFH desires to acquire rights to the above product in the USA
and ROCHE desires to divest itself, either via sale or license, of rights to
this product in the USA.
NOW, THEREFORE, for and in consideration of the mutual covenants set
forth herein, ROCHE and WFH agree as follows:
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ARTICLE 1 - DEFINITIONS
The following terms used in this Agreement shall have the meaning set
forth in this Article:
1.1 "Product" shall mean a product sold in connection with the Bactrim
trademark and having the active ingredients, sulfamethoxazole and
trimethoprim, in all formulations, including finished dosage tablet,
pediatric suspension or intravenous pharmaceutical form, for
distribution or sale to an ultimate user, distributor, prescriber, or
dispenser.
1.2 "FDA" shall mean the United States Food and Drug Administration.
1.3 "NDA" shall mean new drug application numbers 17-377, 17-560, and 18-374
covering the Products as well as all their supplements for which ROCHE
has received approval from the FDA to market the Products.
1.4 "IND" shall mean any investigational new drug application numbers
11,565, 24,941, 6,132, and 8,455 covering the Products for which ROCHE
has received approval from the FDA.
1.5 "Technical Information" shall mean any and all technical data,
information, drawings, manuals, notes, reports, programs and other
materials, including chemical manufacturing data, toxicological data and
pharmacological data, clinical data, medical uses, formulations,
specifications, quality control testing data, and submissions and
correspondence to and from the FDA, adverse event files, documents
related to drug efficacy study implementation, and IND safety
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reports and complaint files, in each case with regard to the Products, to the
extent owned or controlled by ROCHE.
1.6 "Effective Date" shall mean October 12, 2001.
1.7 "Territory" shall mean the USA, its territories, commonwealths and
possessions.
1.8 "Affiliate" shall mean: (i) an organization of which fifty percent (50%)
or more of the voting stock is controlled or owned, directly or
indirectly, by either party to this Agreement; (ii) an organization
which directly or indirectly owns or controls fifty percent (50%) or
more of the voting stock of either party to this Agreement; or (iii) an
organization, the majority ownership of which is directly or indirectly
common to the majority ownership of either party to this Agreement.
Anything to the contrary in this paragraph notwithstanding, Genentech,
Inc., a Delaware corporation, shall not be deemed an Affiliate of ROCHE
bound by the terms and obligations of this Agreement.
1.9 "Term" shall mean the period of time beginning on the Effective Date and
continuing until the later of (i) termination of the trademark license
granted under Article 2.3 or (ii) one (1) year after the Effective Date.
1.10 In the definitions, the singular shall include the plural and vice
versa.
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ARTICLE 2 - GRANT
2.1 NDA ROCHE hereby assigns and transfers to WFH all of ROCHE's right,
title and interest in and to (i) the NDAs and (ii) the INDs in the Territory.
ROCHE shall provide to WFH all Technical Information in ROCHE's possession that
is necessary for making, having made, using, importing, and selling Products in
the Territory.
2.2 Perfecting Rights (a) ROCHE, upon request of WFH, shall as soon as
reasonably practicable provide WFH with the Technical Information and shall
execute any document necessary to perfect in WFH the ownership rights in the
NDAs and INDs, as described in Article 2.1. WFH shall have the right to use such
Technical Information in any manner WFH deems appropriate to make, have made,
use, import and sell the Products in the Territory.
(b) In the interest of avoiding the possibility of a dispute, the
parties have prepared and agreed upon a list of Technical Information that is
attached as Exhibit 1 to this Agreement ("Transfer Know-how") and made a part
thereof. The list describes all the Technical Information that has been or shall
be provided by ROCHE to WFH. ROCHE represents that the Transfer Know-how has
sufficient Technical Information to permit ROCHE to make, use, and sell the
Products in the Territory. In no event shall ROCHE be obligated to conduct
research or generate Technical Information.
(c) (i) Subject to clause (ii) below, as of the Effective
Date, ROCHE hereby assigns to WFH all of its rights,
title, interests and claims in, and with respect to, its
rights under all contracts to which ROCHE is a party
related to the Products in the Territory to WFH,
including managed care contracts.
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(ii) Anything in this Agreement to the contrary
notwithstanding, this Agreement shall not constitute an
agreement to assign any such contract or any claim or
right or any benefit arising thereunder or resulting
therefrom if an attempted assignment thereof, without
the consent of a third party thereto, would constitute a
breach thereof or in any way materially adversely
affects the rights of WFH thereunder. If such consent is
not obtained, or if an attempted assignment thereof
would be ineffective or would affect the rights
thereunder so that WFH would not receive all such
rights, ROCHE will cooperate with WFH, in all reasonable
respects, to provide to WFH the benefits under any such
contract, claim or right including without limitation
enforcement for the benefit of WFH of any and all rights
of ROCHE against a third party thereto arising out of
the breach or cancellation by such third party or
otherwise.
2.3 Trademarks ROCHE grants to WFH a sole and exclusive, royalty-free
license to use the Bactrim(TM) DS and Bactrim(TM) trademarks in the Territory
for the sale of the currently existing forms of Products sold under the
Bactrim(TM) DS and Bactrim(TM) trademarks. WFH shall be able to extend this sole
and exclusive, royalty-free license to other Products in the Territory, such as
new delivery forms, reformulations, and other such modified forms of Bactrim
products, provided that (i) such other Products maintain the quality standards
and goodwill that have become associated with the Bactrim(TM) DS and Bactrim(TM)
trademarks and (ii) such other Products will not adversely impact upon the
Bactrim(TM) DS and Bactrim(TM) trademarks outside the Territory. ROCHE may, at
its
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sole option and discretion, terminate the trademark license and
contemporaneously assign the Bactrim(TM) DS and Bactrim(TM) trademarks in the
Territory to WFH.
2.4 Housemarks ROCHE grants to WFH for a period of two (2) years
beginning on the Effective Date permission for WFH to use ROCHE trademarks,
including the ROCHE hexagon, that appear on Bactrim(TM) DS and Bactrim(TM)
packaging materials in the inventory and related package inserts and marketing,
sales, instructional and other accompanying literature existing as of the
Effective Date ("ROCHE Housemarks") solely for the purpose of allowing WFH to
sell such inventory and distribute such literature during such two (2) year
period. WFH shall not copy, display, or otherwise use any ROCHE trademarks,
other than the licensed Bactrim(TM) DS and Bactrim(TM) trademarks, in any
advertising or promotional materials.
ARTICLE 3 - RESPONSIBILITIES AND COORDINATION
3.1 Product Approval Efforts Subject to Articles 3.4 and 3.5, WFH, at
its sole cost, shall be solely responsible for obtaining any approvals that may
be necessary for transferring the Products to WFH. Moreover, WFH as soon as
practicable (but not later than three (3) months after the Effective Date) shall
assume full responsibility for maintaining the NDA including without limitation
complying with FDA reporting requirements with respect to the Products. ROCHE
will continue to perform all required stability testing for the Products
manufactured by ROCHE prior to the Effective Date. ROCHE will provide to WFH all
necessary information in its possession for the first annual report, which will
be prepared and submitted by WFH.
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3.2 Marketing Efforts WFH, at its sole cost, shall be solely responsible
for the marketing, distribution and sale of the Products in the Territory.
Subject to the indemnification provisions in Article 6 below, as soon as
practicable (but not later than one (1) month after the Effective Date, in the
case of subsections (ii), (v) and (vi) below, and two (2) months after the
Effective Date, in the case of subsections (i), (iii) and (iv) below) WFH
assumes sole responsibility for the following actions with respect to the
Products in the Territory:
(i) responding to product and medical questions and
complaints relating to the Products. ROCHE agrees that
it shall refer any such complaints which it receives to
WFH, as soon as reasonably practicable.
(ii) handling all returns of the Products sold by or for WFH
or its Affiliates in the Territory. However, ROCHE shall
continue to handle and process all returns of the
Product according to ROCHE's normal policies and
procedures until April 30, 2003. Any returns received
directly by WFH prior to April 30, 2003 shall be
forwarded to ROCHE's designated facility at ROCHE's
expense for handling of the returned Product and
processing of customer credits, unless the Product is in
a condition that allows it, under current good
manufacturing practices of the FDA, as set forth in 21
C.F.R. Parts 210 and 211 ("GMP"), to be returned to
inventory for resale by WFH, in which case WFH shall
return the Product to its inventory. If the Product is
returned to inventory for resale by WFH
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or if the return is in any other way readily
identifiable as arising from a sale originally recorded
by WFH, then WFH will bear the cost of the return and
process the customer credit accordingly with no cost
chargeable to ROCHE. Beginning April 1, 2003, ROCHE's
liability for the cost of returns of the Product bearing
the NDC codes included in the Product supplied under
Article 4.1 shall be capped at an average of nine
thousand dollars ($9,000) per month. However, if WFH
were to introduce Product to market under new NDC codes
before April 1, 2003, then ROCHE's liability for the
cost of returns of the product bearing the transferred
NDC codes shall be limited to an average of nine
thousand dollars ($9,000) per month from that time
forward, applied on a quarterly basis with the remainder
chargeable by ROCHE to WFH. Beginning May 1, 2003 and
continuing thereafter, WFH shall handle all returns of
the Product and process customer credits according to
WFH's policies and procedures. WFH will charge ROCHE on
a quarterly basis for returns of Product bearing NDC
codes not included in the Product supplied to WFH under
Article 4.1. Any returns received directly by ROCHE
after April 30, 2003 shall be forwarded to WFH or WFH's
designated facility at WFH's expense for handling of the
returned Product and processing of customer credits. WFH
shall settle and xxxx XXXXX for XXXXX'x share of returns
activity on a calendar quarterly basis, subject to the
nine thousand dollar ($9,000)
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average monthly cap for transferred NDCs noted above.
WFH will continue to process and charge ROCHE for all
returns of the Product under all NDC codes not included
in the Product supplied under Article 4.1, until one
year after the expiration date of the Product, from
which date the returns will no longer be eligible for
return credit to customers and ROCHE shall bear no
further expense. In any event, WFH's charges to ROCHE
shall be limited to amount of return credits actually
processed and provided to customers for that period for
those NDCs for which ROCHE retains liability for
returns. Neither party shall take any action that would
encourage or delay the return of any Product.
(iii) subject to Article 4.4, handling all recalls of the
Products in the Territory; provided however, recalls of
any Products sold or otherwise distributed by ROCHE
other than to WFH shall be the responsibility of ROCHE
and not WFH.
(iv) communicating with any governmental agencies and
satisfying their requirements regarding the
authorization and/or continued authorization to market
the Products in commercial quantities in the Territory.
(v) handling distribution, inventory and receivables with
respect to the Products in the Territory, other than
receivables accrued prior to October 1, 2001.
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(vi) communicating with dispensers, distributors, end-users
unless WFH solicits and ROCHE agrees to participate in
such communication.
(b) From October 1, 2001 until the earlier of (i) such time as WFH
assumes responsibility for the actions enumerated above or (ii) one month from
the Effective Date, ROCHE shall continue to fill orders for Products and accept
returns. Any sales of Products by ROCHE pursuant to this Article 3.2(b) shall be
for the account of WFH, and ROCHE shall remain responsible for handling any
recalls or returns with respect to such sales. For amounts billed by ROCHE on
behalf of WFH on or after October 1, 2001, ROCHE shall remit the related Net
Receipts to WFH on a monthly basis as outlined below. "Net Receipts" means the
amount invoiced by ROCHE on behalf of WFH for sales of Product in the Territory
less (i) freight and insurance, or similar costs which are incurred by ROCHE on
behalf of WFH as customary terms offered to customers for the sale of Product,
(ii) cash discounts, or similar costs which are taken off invoice as customary
terms offered to customers for the sale of Product, and (iii) bad debt as
specifically incurred and agreed between ROCHE and WFH. The following is the
formula to be used in the Net Receipts calculation.
Net Receipts Calculation
--------------------------------------------------------------------------------
100.00% Gross amounts billed for Bactrim by ROCHE on behalf of WFH
-2.00% Minus: cash discounts
-.2% Minus: freight and insurance
-----
97.8% Net Receipts: Percent of xxxxxxxx due to WFH
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Note: Bad debt write-offs for uncollectible amounts billed by ROCHE on behalf of
WFH will be documented by ROCHE as incurred and settled between the parties on a
case-specific basis.
Wherever practical, ROCHE and WFH will work to transfer the processing
and payment of rebates related to sales of those NDCs of the Product supplied to
WFH under Article 4.1 to WFH as soon as possible after the Effective Date. Each
rebate related to the NDCs, including Medicaid rebates, shall be allocated
between the parties based upon a ratio for ROCHE and a ratio for WFH, determined
with reference to the reimbursement period for each rebate and administrative
fee (the "Period"). (Accordingly, there may be a different Period for
calculating rebates and administrative fees). The ROCHE ratio shall be the
number of days in the Period before October 1, 2001 divided by the total number
of days in the Period. The WFH ratio shall be the number of days in the Period
beginning October 1, 2001 divided by the total number of days in the Period. For
each rebate or administrative fee, (i) ROCHE shall be responsible for an amount
equal to the ROCHE ratio times each rebate or each administrative fee due for
the Period, and (ii) WFH shall be responsible for an amount equal to the WFH
ratio times each rebate or each administrative fee due for the Period.
For those sales of the Product bearing NDCs previously sold by ROCHE and
which NDCs were not included in the Product supplied under Article 4.1, ROCHE
shall retain responsibility for all rebates subsequently charged.
ROCHE shall notify all parties with purchase contracts covering the NDCs
of the Product supplied under Article 4.1 that the contract will terminate as to
those NDCs of
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the Product in accordance with its terms which in no case shall exceed sixty
(60) days. Each chargeback (including disputed chargebacks) that is received
before October 1, 2001 or during the six (6) week period immediately thereafter
(the "Chargeback Period") shall be the obligation of ROCHE. Should WFH have paid
any chargebacks during the Chargeback Period, ROCHE shall reimburse WFH for the
payment of such chargeback within fifteen (15) business days of receipt of a
request for payment, including reasonably sufficient supporting data, from WFH.
After this Chargeback Period, all chargebacks for the transferred NDCs shall be
the obligation of WFH. For one year after the Effective Date, unless agreed
otherwise by the parties, ROCHE agrees to process all chargebacks in the
ordinary course of business consistent with past practices, and pass those
charges along to WFH accordingly. For those sales of the Product bearing NDCs
previously sold by ROCHE and which NDCs were not included in the Product
supplied under Article 4.1, ROCHE shall retain responsibility for all
chargebacks subsequently charged. ROCHE shall provide WFH with all documentation
related to any rebates, administrative fees and chargebacks under assigned
contracts or assumed contractual obligations on a quarterly basis.
(i) Within fifteen (15) business days after the end of each month,
ROCHE shall send a report summarizing the calculation of Net
Receipts for such month. ROCHE shall remit to WFH payment for
Net Receipts by wire transfer within thirty (30) business days
after the end of such month. Payment for Net Receipts shall
continue so long as ROCHE continues to invoice customers for
sales of Product on behalf of ROCHE.
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(ii) Within fifteen (15) business days after the end of each quarter,
ROCHE shall send an invoice and a report summarizing all
rebates, Medicaid rebates, administrative fees, chargebacks,
credit for returned goods, to the extent such amounts are owed
by WFH and paid by ROCHE. WFH shall remit payment for such
invoice, within fifteen (15) business days after receipt of such
invoice.
(iii) Within fifteen (15) business days after the end of each quarter,
WFH shall send an invoice and a report summarizing all credit
for returned goods, if any, to the extent such amounts are owed
by ROCHE and paid by WFH. ROCHE shall remit payment for such
invoice, within fifteen (15) business days after receipt of such
invoice.
3.3 Medical Questions No later than fifteen (15) days after the
Effective Date, ROCHE shall provide WFH with such Transfer Know-how which would
enable WFH to respond properly and promptly to medical questions or complaints
with respect to the Products. For up to two (2) months after the Effective Date
both parties shall coordinate responses to questions and complaints regarding
the Products, with WFH assuming complete responsibility at the earliest possible
date. After such two (2) month period (or earlier assumption of responsibility
by WFH), WFH shall be solely responsible for responding to all medical questions
or complaints and ROCHE shall immediately refer any such medical questions or
complaints, including all notices of adverse findings, adverse event files and
safety reports, to WFH for handling.
3.4 Discussions (a) For the period of time beginning on the Effective
Date and continuing for one (1) year thereafter, ROCHE shall provide WFH with
all
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transitional services with respect to the Product and/or the Transfer Know-how
necessary to successfully transfer the Bactrim business to WFH. The first fifty
(50) person hours of transitional services will be provided in a manner
reasonably requested by WFH and at no cost to WFH. Thereafter, transitional
services will be provided in a manner reasonably requested by WFH and at the
rate of three hundred dollars per hour per person ($300/hr/person). Neither
party shall have an obligation to continue any discussions with the other party
with respect to the Products and/or the Technical Information after this one (1)
year period. In no event or at any time will ROCHE be obligated to conduct any
research or development activities or make any expenditures in time or money in
research or development whatsoever with respect to the Products.
3.5 Coordinators (a) To encourage a prompt and efficient transfer of
responsibility and for obtaining FDA approval, the parties shall each appoint
one (1) authorized representative with respect to regulatory matters and one (1)
authorized representative with respect to business and commercial matters,
between whom communications will be conducted ("Coordinator(s)"). Each party
will notify the other as to the name of the representatives so appointed. Either
party may appoint a new Coordinator at any time, upon written notice to the
other party. The Coordinators may confer and periodically meet to coordinate the
transfer of the Products from ROCHE to WFH, with the regulatory Coordinators and
business/commercial Coordinators meeting separately or together as a group. Each
party may identify additional representatives with specific expertise so as to
form a Transition Team headed by the Coordinators for transferring
responsibility to WFH.
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(b) Consistent with Article 3.1, the Coordinators shall establish a
time schedule, acceptable to both parties, for the transfer of the NDA to WFH.
Each party shall be responsible for its costs with respect to participation on
the Transition Team. Neither party may obligate the other party in any way,
financially or legally, with respect to the transfer of the manufacture of the
Products, obtaining or maintaining FDA approval of the Products or
commercialization of the Products.
3.6 Quality Control (a) WFH acknowledges the goodwill and reputation
that has been associated with the ROCHE Housemarks and the Bactrim(TM) DS and
Bactrim(TM) trademarks, over the years, and shall use these trademarks for which
rights are granted in this Agreement in a manner that maintains and promotes
such goodwill and reputation. WFH shall take all reasonable precautions and
actions to protect the goodwill and reputation that has inured to the ROCHE
Housemarks and the Bactrim(TM) DS and Bactrim(TM) trademarks, shall refrain from
doing any act that is reasonably likely to impair the reputation of the ROCHE
Housemarks and the Bactrim(TM) DS and Bactrim(TM) trademarks, and shall
cooperate fully with ROCHE to protect the ROCHE Housemarks and the Bactrim(TM)
DS and Bactrim(TM) trademarks. Full cooperation shall include WFH permitting
ROCHE, upon reasonable notice, to inspect manufacturing and packaging facilities
to the extent necessary to ensure that Product that maintains and promotes the
goodwill and reputation of the trademarks.
(b) WFH shall use commercially reasonable efforts to ensure that
Products will be manufactured in accordance with the applicable formulations
and/or product specifications used by or reasonably acceptable to ROCHE, and
that the packaging and promotional materials for the Products and samples of the
Products themselves
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(collectively these materials and samples are referred to as "Materials") will
be offered by WFH to ROCHE for approval to ensure a level a quality consistent
with the reputation of ROCHE.
(c) WFH shall not use the ROCHE Housemarks other than as they appear on
Bactrim(TM) DS and Bactrim(TM) Materials in the inventory existing as of the
Effective Date. WFH shall not use the Bactrim(TM) DS and Bactrim(TM) trademarks
in connection with any Materials without the prior written approval of ROCHE,
such approval not to be unreasonably delayed or withheld. Accordingly, WFH
agrees to furnish ROCHE for its inspection samples of all such Materials for
ROCHE's prior approval. ROCHE agrees to provide WFH with any written comments or
objections, or written approval, as soon as reasonably possible and within
fifteen (15) business days of its receipt of any such Materials. Any Materials
not disapproved in writing by ROCHE within such fifteen (15) business day period
shall be deemed to have been approved.
(d) If any Materials that are submitted to ROCHE are disapproved, then
ROCHE shall specify the reasons for disapproval in writing and help suggest a
solution. Upon its receipt of a notice of disapproval, WFH may proceed to cure
any causes for disapproval and may resubmit the Materials for approval. This
process shall continue until such Materials are approved by ROCHE.
(e) If quality standards or goodwill related to the Bactrim(TM)DS and
Bactrim(TM)trademarks is materially diminished by WFH, then ROCHE shall have the
right to revoke the trademark license; provided that ROCHE shall provide WFH
with advance notice of any such material diminution in standards or goodwill and
a reasonable opportunity (of not less than thirty (30) days) to cure such
diminution of standards and goodwill. If the
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cure of such diminution of standards and goodwill is not reasonably achievable
in such thirty (30) day period but WFH demonstrates that it has taken
substantial steps toward such cure during the initial thirty (30) day period,
then WFH shall be permitted to continue to pursue such cure for an additional
thirty (30) days provided such additional time shall not cause a material
diminution of the Bactrim(TM)trademark outside the Territory. The rights granted
under this Agreement are exclusive to the Territory. Accordingly, WFH shall
avoid making sales that would likely result in Product being shipped outside the
Territory.
(f) Notwithstanding the covenants with respect to goodwill and quality
standards set forth in this Article 3.6 or any other provision of this
Agreement, the parties acknowledge that WFH shall have no obligation to make,
have made, use, or sell the Product in the Territory or otherwise pursue the
Bactrim business.
ARTICLE 4 - SUPPLY OF PRODUCT
4.1 Product Supply As soon as practicable (but not more that fifteen
(15) days after the Effective Date), ROCHE shall provide to WFH half (1/2) of
the supply of Products designated for sale in the Territory then in the
possession and control of ROCHE which have thereon labeling prepared by ROCHE.
Between fifteen (15) days after the Effective Date and forty-five (45) days
after the Effective Date, ROCHE shall provide to WFH what remains of the other
half (1/2) of the supply of Products designated for sale in the Territory then
in the possession and control of ROCHE which have thereon labeling prepared by
ROCHE. Such total supply of Products as of the
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Effective Date shall consist of at least the number of Bactrim(TM) tablets
indicated on Exhibit 2.
4.2 Supplies ROCHE shall transfer to WFH within sixty (60) days after
the Effective Date its entire inventory of supplies related to the manufacture
of the Products. In the interest of avoiding the possibility of a dispute, the
parties have prepared and agreed upon a list of supplies that is attached as
Exhibit 2 to this Agreement ("Transfer Supplies") and made a part thereof. At
WFH's request, ROCHE will transfer less than the entire inventory of Transfer
Supplies and will dispose of the remaining Transfer Supplies.
4.3 Shipment All shipments of Products and Transfer Supplies under
Article 4, will be F.O.B. origin (for most Products this will be Joppa,
Maryland).
4.4 Recalls If either WFH or ROCHE believes a recall of a Product
provided to WFH under Article 4.1 is required or desirable, both parties shall
cooperate fully regarding the investigation and disposition of such matter. If
any recall of a Product is agreed by the parties or required by any governmental
authority, the cost of such recall shall be borne by the party(s) which has
caused the conditions causing such recall. The other party shall be entitled to
such credits, replacements, reimbursements and allowances from the causing party
as shall be necessary in order to assure that all cost reasonably incurred by
the other party to effect such recall are paid or reimbursed by the causing
party.
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ARTICLE 5 - PAYMENTS
5.1 Amount WFH shall pay to ROCHE six million dollars ($6,000,000) on
the Effective Date.
5.2 Payment The payment due hereunder shall be paid by wire transfer to:
Xxxxxxxx-Xx Xxxxx Inc.
Account No. 323839614 at
Chase Xxxxxxxxx Xxxx
Xxx Xxxx, Xxx Xxxx 00000
Chase ABA Routing No. 000000000
ARTICLE 6 - LIABILITY
6.1 Product Liability Without limiting any of the obligations of either
party under this Agreement, each party shall indemnify and hold harmless the
other party, the other party's past, present and future directors, officers,
employees and agents and all persons acting on their behalf, from and against
any and all losses, claims, obligations, liens, encumbrances, liabilities,
penalties, causes of action, costs and expenses, (including, without limitation,
costs and expenses of defense, orders, judgments, fines, amounts paid in
settlements and reasonable attorneys' fees and expenses), and damages,
including, without limitation, injury to or death of persons (including, without
limitation, employees or agents of either party) and/or damage to or loss
(including, without limitation, loss of use of or destruction of any property
(including without limitation, property of ROCHE or WFH, or their respective
employees or agents) whether the foregoing are based in contract, warranty,
negligence, strict liability, other tort, or any other legal theory, in
connection with any of the activities contemplated or
19
encompassed under this Agreement, arising out of, or incident to, (a), in the
case of ROCHE, the negligent act or omission of ROCHE, its past, present and
future directors, officers, employees and agents and all persons acting on their
behalf ("Related Parties"), with respect to the Products provided under Article
4.1, including the manufacture by ROCHE and its Related Parties of the Products
provided under Article 4.1, (b) also in the case of ROCHE, the research,
manufacture, use or sale of Products by ROCHE and its Related Parties before the
Effective Date, including the claims related to that certain litigation related
to Xxxxxx Xxxxxxxx, and (c), in the case of WFH, the research, manufacture, use
or sale of Products by WFH and its Related Parties on or after the Effective
Date.
6.2 Handling Subject to Article 6.1, each party assumes the
responsibility of any personal or property injury arising from its own handling
and own use of the Products.
6.3 Notice Whenever any claim shall arise for indemnification under
Article 6.1, the party being indemnified ("indemnitee") shall promptly notify
the indemnifying party ("indemnitor") of the claim and, when known, the facts
constituting the basis for such claim ("Notice"). The indemnitee shall not
settle or compromise any claim by a third party for which it is entitled to
indemnification hereunder without the prior written consent of the indemnitor
(which shall not be unreasonably withheld) unless suit shall have been
instituted against the indemnitee and the indemnitor shall not have taken
control of such suit after notification thereof as provided in Article 6.4. Any
and all obligations for indemnification under Article 6.1 shall expire if a
party does not receive Notice during the Term of the Agreement.
20
6.4 Defense In connection with any claim giving rise to indemnity
hereunder resulting from or arising out of any claim or legal proceeding by a
person who is not a party to this Agreement, the indemnitor at its sole cost and
expense, may, upon written notice to the indemnitee, assume the defense of any
such claim or legal proceeding if it acknowledges to the indemnitee in writing
its obligations to indemnify the indemnitee with respect to all elements of such
claim. Such acknowledgment shall be without prejudice to establishing that no
obligation to indemnify exists during such legal proceedings. The indemnitee
shall be entitled to participate in (but not control) the defense of any such
action, with its counsel and at its own expense. If the indemnitor does not
assume the defense of any such claim or litigation resulting therefrom, (a) the
indemnitee may defend against such claim or litigation, after giving notice of
the same to the indemnitor, on such terms as the party may deem appropriate, and
(b) the indemnitor shall be entitled to participate in (but not control) the
defense of such action, with its counsel and at its own expense. If the
indemnitor thereafter seeks to question the manner in which the indemnitee
defended such third party claim or the amount or nature of any such settlement,
the indemnitor shall have the burden to prove by clear and convincing evidence
that the indemnitee did not defend or settle such third party claim in a
reasonably prudent manner.
ARTICLE 7 - WARRANTY
7.1 Authority Each party warrants and represents that it has the
authority to enter into this Agreement and to carry out the terms and
obligations hereunder.
21
7.2 No Infringement Other than as described in that certain agreement
between ROCHE and Miles Laboratories, Inc. dated March 1, 1971 , ROCHE
represents that it has no knowledge of any outstanding and unresolved claim or
accusation that the Bactrim(TM) DS or Bactrim(TM) trademarks infringe or may
infringe any third-party marks or rights. As used in this Agreement, the term
"knowledge" means the cognition by a party of a fact after inquiry of an
employee in the area to which the fact pertains.
7.3 No Conflicts ROCHE represents that it has no knowledge of any
outstanding agreements or understandings of any kind, either written, oral or
implied, regarding the Products or the Bactrim(TM) DS and Bactrim(TM) trademarks
which are inconsistent or in conflict with any provision of this Agreement.
7.4 Regulatory Approvals (a) ROCHE represents that to its knowledge the
NDAs described in Article 1.3 are in full force and effect and ROCHE has
received no notice from the FDA that challenges and questions the status of the
NDAs. ROCHE further represents that to its knowledge ROCHE has made available
true and correct copies to WFH of all Regulatory Approvals (defined below)
related to the Product, including the NDAs described in Article 1.3, and has
obtained all of the necessary Regulatory Approvals relating to the manufacture
and sale of the Product in the Territory as currently conducted and has not
failed to obtain any such Regulatory Approval which could reasonably be expected
to have a material adverse effect on the ability of WFH to make, have made, use,
or sell the Product in the Territory.
(b) ROCHE represents that to its knowledge ROCHE has conducted and is
currently conducting (if applicable) the manufacturing, promotion, advertising,
marketing
22
and sale of the Product in compliance with all applicable laws, rules,
regulations and court or administrative orders and processes. ROCHE represents
that to its knowledge ROCHE has not received any written notice of violation of
any applicable law, regulation or requirement relating to the Product within the
past five (5) years.
(c) "Regulatory Approvals" means, to the extent they relate to the
Product and to the extent owned or licensed by ROCHE, the NDAs and INDs
described in Articles 1.3 and 1.4, all supplements thereto and all regulatory
files relating thereto, and any and all (i) regulatory filings and supporting
documents, clinical studies and tests (excluding DEA licenses, and wholesale,
distributor and pharmacy licenses) relating to the Product; and (ii) records
maintained under GMP, or other record keeping or reporting requirements of the
FDA, the Environmental Protection Agency, the Occupational Health and Safety
Administration or any other governmental or regulatory authorities, including
all investigational new drug applications, FDA warning letters, FDA notices of
adverse finding letters, FDA audit reports (including any responses to such
reports), all other correspondence and communications with governmental or
regulatory authorities in connection with the Product, adverse event files,
documents related to drug efficacy study implementation, and IND safety reports
and complaint files with respect to the Product.
7.5 Inventory ROCHE's inventory of Products designated for sale in the
Territory as of the Effective Date consists of the number of Bactrim(TM) and
Bactrim(TM) DS tablets indicated on Exhibit 2. Such inventory was acquired and
has been maintained in accordance with ROCHE's regular business practices and
consists of Products saleable in the ordinary course of the Bactrim business.
23
7.6 Litigation Except for that certain litigation related to Xxxxxx
Xxxxxxxx, which ROCHE will continue to be solely responsible for and indemnify
WFH against, ROCHE represents that to its knowledge (i) there are no actions,
suits, proceedings, investigations, arbitration proceedings or other proceedings
pending or threatened against or affecting the Products, and (ii) there is not
currently outstanding against ROCHE any judgment, decree, injunction, rule,
order or award of any governmental or regulatory authority or arbitrator
relating to the Products.
7.7 Limited Warranty Technical Information is being provided to WFH with
NO WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE. Products are being provided with NO
WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
7.8 Risks While ROCHE shall cooperate with WFH in accordance with
Article 3, ROCHE, inter alia, can not ensure WFH's ability to (i) obtain or
maintain FDA approval to commercialize any Products, (ii) successfully
manufacture any Products or (iii) market the Products to obtaining any level of
sales. WFH agrees that ROCHE does not assume any risks or responsibility for WFH
obtaining or not obtaining any sales of the Products for any reason other than
breach of the representations or warranties set forth in this Article 7.
ARTICLE 8 - TERMINATION
8.1 Termination During the Term of the Agreement, failure by either
party to comply with any of the respective material obligations and conditions
contained in this
24
Agreement shall entitle the other party to give the party in default written
notice requiring it to make good such default. If such default is not cured
within thirty (30) days after receipt of such notice, the notifying party shall
be entitled (without prejudice to any of its other rights conferred on it by
this Agreement) to terminate the entire Agreement to take effect immediately.
However, if the cure of such default is not reasonably achievable in such thirty
(30) day period but the defaulting party demonstrates that it has taken
substantial steps toward such cure during the initial thirty (30) day period,
such defaulting party shall be permitted to continue to pursue such cure for an
additional thirty (30) days. The right of either party to terminate this
Agreement shall not be affected in any way by its waiver of or failure to take
action with respect to any previous default.
8.2 Bankruptcy The trademark license provided for in Article 2.3 of this
Agreement, at ROCHE's option, shall terminate upon (i) an adjudication of WFH as
bankrupt or insolvent, or WFH's admission in writing of its inability to pay its
obligations as they mature; or (ii) an assignment by WFH for the benefit of
creditors; or (iii) WFH's applying for or consenting to the appointment of a
receiver, trustee or similar officer for any substantial part of its property or
such receiver, trustee or similar officers appointment without the application
or consent of WFH, if such appointment shall continue undischarged for a period
of ninety (90) days; or (iv) WFH's instituting (by petition, application,
answer, consent or otherwise) any bankruptcy, insolvency arrangement, or similar
proceeding relating to WFH under the laws of any jurisdiction; or (v) the
institution of any such proceeding (by petition, application or otherwise)
against WFH, if such proceeding shall remain undismissed for a period of ninety
(90) days or
25
the issuance or levy of any judgment, writ, warrant of attachment or execution
or similar process shall not be released, vacated or fully bonded within ninety
(90) days after its issue or levy.
8.3 Termination Rights (a) Termination of this Agreement for any reason
shall be without prejudice to:
(i) the rights and obligations hereunder that survive
termination; and
(ii) any other remedies which either party may then or
thereafter have hereunder.
(b) ROCHE's rights to the payments under Articles 4 and 5 shall
survive termination.
ARTICLE 9 - MISCELLANEOUS
9.1 Force Majeure The performance by either party of any covenant or
obligation on its part to be performed hereunder shall be excused if
contingencies beyond its control occur, such as strikes or other work stoppage,
lock-outs, riots, wars, whether war is declared or not, acts of God, invasion,
fire, explosions, floods, storms, delay of carrier, and acts of government or
governmental agencies or instrumentalities. Each party will notify the other
immediately should any contingency occur and of the period such inability to
perform is expected to continue. Both parties will be excused of their covenants
and obligations during the period in which such inability to perform exists.
26
9.2 Choice of Law Any dispute regarding this Agreement shall be governed
by and interpreted in accordance with the laws of the State of New Jersey.
9.3 Notices Any notice required or permitted to be given hereunder shall
be considered properly given if hand delivered or sent by certified return
receipt mail to the respective address of each party as follows:
Women First HealthCare, Inc.
00000 Xx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: President
and
Xxxxxxxx-Xx Xxxxx Inc.
000 Xxxxxxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Corporate Secretary
or to such other person or address as the addressee shall have last furnished in
writing to the addressor, with the notice to be effective upon receipt.
9.4 Press Releases (a) ROCHE, upon transfer of the Products and NDAs to
WFH, will issue a press release intended to reach pertinent audiences which
prescribe, dispense or distribute the Product. The press release shall be
subject to review and approval by WFH (which approval shall not be unreasonably
withheld) and advise of the transfer of the Products and the NDAs to WFH and the
availability of the Products from WFH.
(b) The parties will jointly issue the press release attached hereto as
Exhibit 3 on the first business day following the Effective Date (the "Initial
Release").
(c) Following the dissemination of the Initial Release, the parties will
jointly issue and agree upon any other press release and any other public
announcement
27
which refers to this Agreement or to the relationship of the parties. Each party
shall obtain the other party's prior written approval for such press releases
and public announcements, which approval will not be unreasonably withheld. Such
approval shall not be needed if a party reasonably believes the press release or
public announcement is required by force of law. In such instance the other
party shall have a reasonable opportunity to comment on the proposed disclosure.
Notwithstanding the foregoing or the provisions of the Non-Disclosure Agreement,
ROCHE acknowledges and agrees that WFH may publicly file a copy of this
Agreement as an exhibit to its reports with the U.S. Securities and Exchange
Commission (the "SEC") if WFH determines such filing to be necessary, provided
that (i) WFH shall supply to ROCHE an advance copy of the form of the Agreement
as proposed to be filed with the SEC, (ii) WFH shall give ROCHE the opportunity
to comment on such proposed filing, and (iii) WFH shall take all reasonable and
lawful actions to obtain confidential treatment with respect to the provisions
of this Agreement which WFH or ROCHE reasonably deem to be competitively
sensitive information.
9.5 Captions All titles and captions in this Agreement are for
convenience only and shall not be of any force or substance.
9.6 Severability In the event that a court of competent jurisdiction
holds that a particular provision or requirement of this Agreement is in
violation of any law, such provision or requirement shall not be enforced only
to the extent that it is in violation of such law and all other provisions and
requirements of this Agreement shall remain in full force and effect.
28
9.7 Assignment This Agreement shall be binding upon, and shall inure to
the benefit of the respective successors of the parties hereto, or to an
assignee of all of the good will and entire business and assets of a party
hereto, but shall not otherwise be assignable, except to an Affiliate as defined
herein, without the prior written consent of the other party, which consent will
not be unreasonably withheld.
9.8 Entire Agreement This Agreement constitutes the entire agreement
between the parties hereto with respect to the subject matter hereof and
supersedes all previous agreements whether written or oral except for the
Non-Disclosure Agreement. No modification or amendment hereof shall be of any
force or effect unless it is in writing signed by the parties to be bound
thereby.
IN WITNESS WHEREOF Women First HealthCare, Inc. and Xxxxxxxx-Xx Xxxxx
Inc. have caused this Agreement to be duly executed by their authorized
representatives on the dates written below.
WOMEN FIRST HEALTHCARE, INC. XXXXXXXX-XX XXXXX INC.
By: /s/ Xxxxxx X. Xxxxxx By: /s/ Xxxxxx X. Xxxxxxxxxxx
----------------------------- -------------------------
Name: Xxxxxx X. Xxxxxx Name: Xxxxxx X. Xxxxxxxxxxx
----------------------------- -------------------------
Title: Chairman, President & CEO Title: President and CEO
----------------------------- -------------------------
Date: October 15, 2001 Date: October 12, 2001
----------------------------- -------------------------
Approved As To Form
LAW DEPT.
By: /s/ JMP
29
EXHIBIT 1
BACTRIM DOCUMENTATION TRANSFER
NDA 17-377 - Bactrim(TM) (trimethoprim and sulfamethoxazole) DS (double
strength) Tablets and TableTS
NDA 17-560 - Bactrim(TM) (trimethoprim and sulfamethoxazole) Pediatric
Suspension
NDA 18-374 - Bactrim(TM) (trimethoprim and sulfamethoxazole) IV Infusion
IND 6132 - Bactrim (trimethoprim and sulfamethoxazole) Tablets (withdrawn
9/29/94)
IND 8455 - Bactrim (trimethoprim and sulfamethoxazole) Suspension (withdrawn
1/3/91)
IND 11,565 - Bactrim IV Infusion (withdrawn 7/13/87)
IND 24,941 - Bactrim IV Infusion Double Bag Delivery System (withdrawn 1/6/86)
All regulatory and clinical documentation associated with these applications.
The regulatory documentation includes the following general types of
information:
- Flysheets (detailed chronological listing of all submissions sent
to/received from FDA)
- Correspondence Folders
- FDA Submissions
- 15 Day Reports
- Promotional Folders
- Microfiche
The clinical documentation includes the following general types of information:
- Case Report Forms
- Investigator Data (e.g., curricula vitae)
- Shipping Labels
- IMR (Investigational Material Returned) Forms
Other documentation consists of:
- All business, financial, legal, trademark and other due diligence
materials made available to WFH for review in anticipation of the
execution of the Agreement to which this Exhibit 1 is attached
- All manufacturing documentation, standard operating procedures and
analytical information relating to finished product and APIs
(trimethoprim and sulfamethoxazole)
- All complaint files and investigations
30
- All stability files and investigations
- All adverse event files and investigations
- All quality control files and investigations
- All annual product reviews
31
EXHIBIT 2
BACTRIM(TM) DS TABLETS -- ***
BACTRIM(TM) TABLETS -- ***
TRANSFER SUPPLIES
Material Approximate Quantity
-------- --------------------
RAW MATERIALS
Med Antifoam C ***
Saccharin Sod ***
Rasp Fl 50.954/A ***
Glycerine ***
Calcium Chloride ***
PACKAGING MATERIALS
Bottle Glass Amb Shelf Saver NP ***
Insert Cut Bactrim & Bactrim DS ***
Plastic Seal-Logo ***
Tape Reinforced 3 ***
Shipper Misc. 24X10 Oz. Btl ***
Label PS Bactrim IV ***
Seal Plastic ***
Marlex ***
Cap Mtl/Plastic 38mm CRC ***
Break ***
*** 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.
32
EXHIBIT 3
INITIAL PRESS RELEASE
CONTACT:
Xxxxxxx X. Xxxxxxxx
Vice President/CFO
Women First HealthCare, Inc.
858.509.3806
xxxxxxxxx@xxxxxxxxxx.xxx
Xxxxx Xxxxxxx
Director, Public Relations
Women First HealthCare, Inc.
858.509.3860
xxxxxxxx@xxxxxxxxxx.xxx
WOMEN FIRST HEALTHCARE ACQUIRES THE BACTRIM(TM)FAMILY OF PRODUCTS FROM
XXXXXXXX-XX XXXXX; PROVIDES GUIDANCE THAT FOURTH QUARTER TO BE IN LINE WITH
EXPECTATIONS
SAN DIEGO, OCTOBER XX, 2001 - Women First HealthCare, Inc. (Nasdaq: WFHC) has
acquired exclusive U.S. rights to the Bactrim(TM) family of antibacterial
products from Xxxxxxxx-Xx Xxxxx Inc., the U.S. prescription drug unit of the
Roche Group (Roche), effective October xx, 2001. This is the fourth acquisition
for the Company in the last ten months. Indicated for a variety of usages
including the treatment of certain urinary tract infections, Bactrim(TM)
(trimethoprim and sulfamethoxazole) is the latest addition to Women First's
pharmaceutical portfolio, which also includes estrogen replenishment in oral and
transdermal patch form, a headache management product, and a development-stage
prenatal vitamin. Annual sales by Roche of the Bactrim(TM) products are in the
$2.5 million range.
Women First paid $6.0 million to acquire all existing U.S. inventory and rights
in the U.S. to the New Drug Applications (NDAs) for Bactrim(TM) DS (double
strength) Tablets, Bactrim(TM) Tablets, Pediatric Suspension, and Intravenous
(IV) Infusion. Additionally, Women First was granted a sole and exclusive
royalty-free license to use the Bactrim(TM) trademark in the U.S. Subject to
certain terms of the agreement, Women First will be able to extend this
royalty-free license in the U.S. to new delivery forms, reformulations and other
modified forms of Bactrim(TM) DS and Bactrim(TM). Women First will assume the
responsibility for finding a manufacturer for the products.
Women First will initially concentrate marketing efforts on sales leader
Bactrim(TM) DS, which has a proven track record in the treatment of certain
urinary tract infections (UTIs). Women are particularly prone to UTIs. According
to the National Institute of Diabetes & Digestive & Kidney Diseases, one woman
in five develops a UTI during her lifetime(1). The incidence of UTIs in women
increases linearly with age, making UTIs a common urogenital complaint of
menopausal and postmenopausal women seeking clinician consultation. According to
NDC Health, the total market for the Bactrim(TM) family of products and their
generic equivalents in 2000 was $265 million.
"We are pleased to announce the acquisition of the Bactrim(TM) brand of
products, which is well recognized and highly regarded throughout the physician
community," said Company chairman, president and CEO Xxxxxx X. Xxxxxx. "We have
been looking to expand Women First's specialty pharmaceutical portfolio to
include infection control for urinary tract infections, a major complaint of
women of all ages. Women First plans to evaluate the products' potential for
reformulation to maximize their potential in this significant market. The
Bactrim(TM) acquisition, a direct outgrowth of our recent $31.5 million private
placement, positions the Company to achieve sales and profitability expectations
for the fourth quarter 2001 and to meet our long-term goal of sustainable and
accelerating profitability."
33
-more-
WOMEN FIRST HEALTHCARE ACQUIRES THE BACTRIM(TM)FAMILY OF PRODUCTS FROM
XXXXXXXX-XX XXXXX; FOURTH ACQUISITION IN TEN MONTHS
2-2-2
About Bactrim(TM)(trimethoprim and sulfamethoxazole) DS (double strength)
Tablets
Bactrim(TM) (trimethoprim and sulfamethoxazole) Tablets and Suspensions are
indicated for a number of conditions including Urinary Tract Infections due to
certain susceptible strains of organisms, Acute Otitis Media in pediatric
patients and Acute Exacerbations of Chronic Bronchitis in Adults due to
susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae,
Shigellosis caused by susceptible strains of Shigella flexneri and Shigella
sonnei, Pneumocystis Carinii Pneumonia, and Traveler's Diarrhea in Adults due to
susceptible strains of enterotoxigenic E. coli. The most common adverse side
effects are gastrointestinal disturbances (nausea, vomiting, anorexia) and
allergic skin reactions (such as rash and urticaria). Fatalities associated with
the administration of sulfonamides, although rare, have occurred due to severe
reactions including Xxxxxxx-Xxxxxxx Syndrome, toxic epidermal necrolysis,
fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood
dyscrasias. Sulfonamide-containing products can produce, on rare occasions,
severe allergic hyperreactivity reactions, which can be fatal. Cough, shortness
of breath, and pulmonary infiltrates are hypersensitivity reactions of the
respiratory tract that have been reported in association with sulfonamide
treatment. Pseudomembranous colitis has been reported with nearly all
antibacterial agents and may range in severity from mild to life-threatening. It
is important to consider this diagnosis in patients who present with diarrhea.
Sulfonamide-containing products such as trimethoprim/sulfamethoxazole should be
discontinued at the first appearance of skin rash or any sign of adverse
reaction. For other important product information on Bactrim(TM), please see
Complete Prescribing Information.
(1) National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK).
Urinary Tract Infection in Adults. Information accessed from NIDDK website at
xxxx://xxx.xxxxx.xxx.xxx/xxxxxx/xxxxxx/xxxx/xxxxxxxx/xxxxxxxx.xxx. Accessed
9/24/01.
About Women First HealthCare, Inc.
Women First HealthCare, Inc. (Nasdaq: WFHC) is a San Diego-based specialty
pharmaceutical company. Founded in 1996, its mission is to help midlife women
make informed choices regarding their health care and to provide pharmaceutical
products--the Company's primary emphasis--and lifestyle products to meet their
needs. Women First HealthCare is specifically targeted to women age 40+ and
their clinicians. An internationally recognized Health Advisory Board of experts
in women's health guides Women First HealthCare in the development of
information and products for women and clinicians as women transition from
perimenopause through postmenopause. The Company operates in three segments:
Pharmaceuticals, Consumer Business, and Corporate Marketing. Product focus
currently includes estrogen replenishment, headache management,
antibacterial/urinary tract infection management, dietary supplementation, and
self-care/lifestyle. Further information about Women First HealthCare can be
found online at xxx.xxxxxxxxxx.xxx, About Us and Investor Relations. Information
about the Company's As We Change(R) national mail order catalog and Internet
retailer can also be found online at xxx.xxxxxxxxxx.xxx.
Safe Harbor Statement under the Private Securities Litigation Reform Act of
1995: This press release may contain certain "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements are subject to various risks, and Women First
HealthCare, Inc. cautions you that any forward-looking information is not a
guarantee of future performance. Women First HealthCare, Inc. disclaims any
34
intent or obligation to update these forward-looking statements. Actual results
could differ materially due to a number of factors, including (i) we have
incurred significant losses since we were founded in November 1996, and if
midlife women do not use, and their clinicians do not recommend, the products we
offer, we will continue to experience significant losses; (ii) there is a
limited market awareness of our Company and the products and services we offer;
(iii) we may not be able to identify appropriate licensing, co-promotion or
acquisition candidates in the future or to take advantage of the opportunities
we identify; (iv) we and our products face significant competition; (v) if we do
not successfully manage any growth we experience, we may experience increased
expenses without corresponding revenue increases; (vi) we are dependent on
single sources of supply for all of the products we offer; and (vii) additional
factors set forth in the Company's Securities and Exchange Commission filings
including its Annual Report on Form 10-K for the period ended December 31, 2000
and its Form 10-Q for the period ended June 30, 2001.
# # #
35