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EXHIBIT 10.1(A)
ORTHO-EST(R) ASSET TRANSFER
& SUPPLY AGREEMENT
BETWEEN
WOMEN FIRST HEALTH CARE
AND
ORTHO-▇▇▇▇▇▇ PHARMACEUTICAL, INC.
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TABLE OF CONTENTS
ORTHO-EST(R) ASSET TRANSFER & SUPPLY AGREEMENT
PAGE
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ARTICLE I. DEFINITIONS........................................................................................... 1
1.1 "Affiliate".................................................................................... 2
1.2 "Effective Date"............................................................................... 2
1.3 "Indemnifiable Claim".......................................................................... 2
1.4 "Manufacturing Know-How"....................................................................... 2
1.5 "Net Sales".................................................................................... 2
1.6 "Product"...................................................................................... 3
1.7 "Specifications"............................................................................... 3
1.8 "Territory".................................................................................... 3
1.9 "Trademark".................................................................................... 3
ARTICLE II. ORTHO-EST(R) TRANSFER OF OWNERSHIP AND TRADEMARK LICENSE............................................. 3
2.1 Ownership Transfer............................................................................. 3
2.2 Excluded Assets................................................................................ 4
2.3 Tax Liabilities................................................................................ 4
2.4 Trademark License.............................................................................. 4
2.5 Use of Trademarks.............................................................................. 5
2.6 Validity & Ownership of Trademark.............................................................. 5
2.7 Quality Control................................................................................ 6
2.8 Trademark Review............................................................................... 6
2.9 Term of Trademark License...................................................................... 7
2.10 Adverse Reaction Reporting..................................................................... 7
ARTICLE III. SOURCING............................................................................................ 8
3.1 Supply......................................................................................... 8
3.2 Replacement Manufacturer....................................................................... 8
3.3 Technology Transfer............................................................................ 8
3.4 Replacement Manufacturing Qualifications....................................................... 9
3.5 Cost of Supply................................................................................. 10
3.6 Inspection..................................................................................... 10
3.7 Release........................................................................................ 11
3.8 Continuing Assistance.......................................................................... 11
3.9 Product Responsibility......................................................................... 11
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ARTICLE IV. INDEMNIFICATION...................................................................................... 11
4.1 ORTHO Warranty For Product Supplied by ORTHO................................................... 12
4.2 WFHC Warranty.................................................................................. 13
4.3 ORTHO Indemnification.......................................................................... 13
4.4 WFHC Indemnification........................................................................... 14
4.5 Special Damages................................................................................ 14
4.6 Prior Sales of Products........................................................................ 14
4.7 Procedure...................................................................................... 14
4.8 Cooperation.................................................................................... 15
ARTICLE V. CONFIDENTIALITY....................................................................................... 16
5.1 Confidential Information....................................................................... 16
5.2 Return of Confidential Information............................................................. 17
5.3 Prior Notice................................................................................... 17
ARTICLE VI. TERM-TERMINATION..................................................................................... 18
6.1 Termination with Reason........................................................................ 18
6.2 Termination for Event of Default............................................................... 18
6.3 Effect of Termination.......................................................................... 19
ARTICLE VII. MISCELLANEOUS....................................................................................... 20
7.1 Independent Contractor......................................................................... 20
7.2 Notice......................................................................................... 20
7.3 Force Majeure.................................................................................. 21
7.4 Assignment..................................................................................... 22
7.5 Modification................................................................................... 22
7.6 Waivers........................................................................................ 22
7.7 Law............................................................................................ 22
7.8 Public Disclosure.............................................................................. 23
7.9 Performance by Affiliates...................................................................... 23
7.10 Entire Agreement............................................................................... 23
7.11 Limitation of Liability........................................................................ 24
7.12 Binding Agreement.............................................................................. 24
7.13 Severability................................................................................... 24
7.14 Captions....................................................................................... 24
7.15 Survival....................................................................................... 24
7.16 Counterparts................................................................................... 25
7.17 Remedies Not Exclusive......................................................................... 25
EXHIBIT B PRODUCTS-ORTHO-EST(ESTROPIPATE) DOSAGE
EXHIBIT C GUIDELINES FOR THE USE OF THE TRADEMARK ORTHO-EST(R)
EXHIBIT F MANUFACTURING AND SUPPLY COSTS
EXHIBIT G PRESS RELEASE
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ORTHO-EST(R) ASSET TRANSFER
& SUPPLY AGREEMENT
This ORTHO-EST(R) Asset Transfer & Supply Agreement ("Agreement"), is
entered into by and between ORTHO-▇▇▇▇▇▇ PHARMACEUTICAL, INC., a Delaware
corporation ("ORTHO"), and WOMEN FIRST HEALTHCARE, INC., a Delaware corporation
("WFHC") effective as of September 30, 2000.
RECITALS
WHEREAS, ORTHO and WFHC entered into a Distribution Agreement dated July
1, 1998 (the "Distribution Agreement") under which WFHC has the right to
distribute ORTHO-EST(R) in the United States (including Puerto Rico), which was
subsequently amended by Amendment No. 1 to Distribution Agreement dated November
25, 1998 (the "First Amendment");
WHEREAS, ORTHO and WFHC desire to terminate the Distribution Agreement
and the First Amendment and transfer the product ORTHO-EST(R) to WFHC 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:
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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, is an 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 "EFFECTIVE DATE" means September 30, 2000.
1.3 "INDEMNIFIABLE CLAIM" means any claim brought by a party against the other
Party pursuant to Article IV.
1.4 "MANUFACTURING KNOW-HOW" means all technical information, whether tangible
or intangible, including any method, procedure, process, assay, trade secret,
testing, packaging, specification for materials, regulatory information
(including information contained in registration dossiers, drug master files and
other documents filed with regulatory authorities), quality control, validation
and equipment necessary for the manufacture, production, and/or formulation of
ORTHO-EST(R).
1.5 "NET SALES" means the amount invoiced by WFHC or its sublicensees for sales
of the Product 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
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allowances actually granted upon claims, rejections or returns of such sales of
the Product, 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.
1.6 "PRODUCT" means an estropipate product currently labeled and packaged under
the name ORTHO EST(R) in one of the dosage forms listed in Exhibit B hereto.
1.7 "SPECIFICATIONS" means the product Specifications for ORTHO-EST(R) attached
hereto as Exhibit A.
1.8 "TERRITORY" means the United States of America and Puerto Rico.
1.9 "TRADEMARK" means ORTHO-EST(R).
ARTICLE II.
ORTHO-EST(R) TRANSFER OF OWNERSHIP
AND TRADEMARK LICENSE
2.1 OWNERSHIP TRANSFER. As of January 1, 2001, ORTHO agrees to sell, assign,
transfer and deliver to WFHC the Product in the Territory, in accordance with
the following provisions. The transfer of the Product shall consist of a
transfer of all of ORTHO's right, title and interest in and to the new drug
applications, product registrations, government permits and licenses and similar
items, all as is, to the extent used exclusively for the Product in the
Territory. ORTHO agrees to sell, assign, transfer and deliver to WFHC all
necessary documentation and other materials and property in ORTHO's possession
needed by WFHC to assume regulatory and eventually manufacturing control of the
Product in the Territory. The Distribution Agreement and the First Amendment
shall remain in effect until December 31, 2000 at which time each shall
terminate;
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except that the following shall apply to the calculation of payments for the
fourth calendar quarter of 2000. The Net Trade Sales basis is hereby reduced
from $6,009,000 to $5,261,000 and the Income Before Tax or IBT is reduced from
$5,424,000 to $4,749,000. The reconciliation process shall be performed as
follows. The September ▇▇▇▇ ▇▇▇ reconciliation will be completed using 9 months
of the annual amounts specified in the Distribution Agreement. The next
reconciliation will occur following December 31, 2000 utilizing the amended
amounts specified above. All calculations shall be adjusted to reflect amounts
previously paid.
2.2 EXCLUDED ASSETS. Anything to the contrary notwithstanding, the following
assets are specifically excluded from being transferred as an asset to WFHC
hereunder:
(a) the Trademark;
(b) the Manufacturing Know-How, other than as recited in Section
3.3;
(c) All cash, cash equivalents, securities and bank accounts;
(d) Any regulatory filings or approvals outside the Territory; and
(e) All of ORTHO's receivables relating to the Product arising on or
before the Effective Date.
2.3 TAX LIABILITIES. Any tax liabilities accruing to WFHC that arise out of the
transfer of the Product to WFHC and the resulting ownership of the Product by
WFHC shall be the sole responsibility of WFHC, and ORTHO shall have no liability
therefor.
2.4 TRADEMARK LICENSE. ORTHO hereby grants to WFHC for the term set forth in
Section 2.9 an exclusive license (subject to ORTHO retaining certain rights as
recited hereinafter) (the "License") in the Territory to use the Trademark in
connection with the advertisement, manufacture, use, distribution, marketing and
sale of the Product. ORTHO agrees that so long as this Agreement shall remain in
effect, it shall not grant or license any other person or entity any
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right in the Territory to use the Trademark and that it shall not itself use the
Trademark in the Territory, upon or in connection with any Products, provided,
however, that should an Event of Default described in Section 6.2(c) occur with
respect to WFHC or if WFHC shall be delinquent for two or more consecutive
calendar quarters in paying ORTHO undisputed amounts under Section 3.5, ORTHO
shall have the right to use the Trademark in connection with its own products.
Should ORTHO gain the right to use the Trademark as a result of the foregoing
sentence, ORTHO's right shall not terminate if WFHC cures such defaults. The
License is not transferable even in the event of a change of control and
revocable in the event of a change of control of WFHC. Notwithstanding the
foregoing, in the case of a change of control, WFHC has the right to request
ORTHO to permit WFHC or the new entity to retain the License granted hereunder.
In such event, ORTHO shall consider such request and either approve or
disapprove such request.
2.5 USE OF TRADEMARKS. WFHC's use of the Trademark hereunder shall be in
accordance with the Guidelines For the Use of the Trademark ORTHO-EST(R), as set
forth in Exhibit C, attached hereto.
2.6 VALIDITY & OWNERSHIP OF TRADEMARK. ORTHO represents and warrants to WFHC
that (i) it owns all right, title and interest in and to the Trademark and all
registrations therefor in the Territory; and (ii) there is no existing claim,
actual or threatened, of any person or entity which would affect the validity of
the Trademark or derogate from or impede WFHC's ability to use it. Based solely
upon the foregoing representations and warranties of ORTHO, WFHC acknowledges
the validity of the Trademark, and that ORTHO is the sole and exclusive owner
thereof. WFHC agrees that it shall not contest the validity or ownership of the
Trademark or any registrations relating thereto. WFHC acknowledges that this
Agreement does not constitute any form of assignment or transfer of ownership in
the Trademark. WFHC agrees that nothing in this
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Agreement shall give WFHC any proprietary or other interest or right in the
Trademark, or the right to register it or trademarks similar to the Trademark in
the Territory, other than pursuant to the License. WFHC agrees that all use of
the Trademark shall inure to the benefit of ORTHO. WFHC agrees at the reasonable
request of ORTHO to execute any and all documents necessary or appropriate to
assist ORTHO in maintaining ORTHO's rights in and to the Trademark, all at
ORTHO's sole cost and expense.
2.7 QUALITY CONTROL. In the event that ORTHO is neither manufacturing nor
supplying the Products for or to WFHC, WFHC shall comply with all good
manufacturing practices, and in any event shall comply with good storage
practices applicable to the Product and all laws and regulations having
application to the advertisement, production, manufacture, distribution or sale
of them and, upon thirty days prior written request by ORTHO, shall provide
ORTHO with a written certificate from an officer of WFHC that to such officer's
knowledge, the Products bearing the Trademark sold within the Territory meet all
applicable specifications required by law, industry standards, and applicable
federal, state and local regulatory authorities. WFHC shall permit ORTHO
reasonable access to WFHC's facilities during regular business hours and upon
thirty days prior written notice for the purpose of ascertaining WFHC's
compliance with the aforesaid quality assurance requirements.
2.8 TRADEMARK REVIEW. Advertising and other promotional materials created by
WFHC to promote sales of the Products, and any use of the Trademark, will be
submitted to ORTHO for its prior written approval which approval shall not be
unreasonably withheld; provided that if no response is sent by ORTHO within
thirty (30) days after receipt of such request , approval shall be deemed to
have been given. All promotional costs and expenses and all selling costs and
expenses shall be borne by WFHC from and after the January 1, 2001.
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2.9 TERM OF TRADEMARK LICENSE. The License shall expire on June 1, 2008, unless
earlier terminated pursuant to Sections 6.1 and 6.2. Notwithstanding the
foregoing, WFHC shall use reasonable efforts to establish its own trademark for
the Product and discontinue use of the Trademark prior to June 1, 2008.
2.10 ADVERSE REACTION REPORTING. Until December 31, 2000, 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 the
Product, including the filing with the FDA of any such reports that it receives
directly from third parties or WFHC. Such adverse reporting during this period
shall be as recited in the Distribution Agreement. As of January 1, 2001, WFHC
shall assume exclusive authority and responsibility for handling any serious
adverse drug experience reported to WFHC and all other safety related
information regarding the drug that needs to be reported to the FDA and ORTHO
agrees to notify WFHC within seven (7) calendar days of receipt of notice from
any source of any and all serious adverse experiences reported to ORTHO alleged
to have been caused by any Product. As used herein, serious adverse experience
means an adverse drug experience occurring at any dose which results in death,
is life threatening, requires inpatient hospitalization or prolongation of
existing hospitalization, results in persistent or significant
disability/incapacity, is a congenital anomaly/birth defect, or is medically
significant. WFHC shall establish procedures consistent with and in compliance
with FDA rules and regulations to collect and report serious adverse experiences
and other safety information that is required to be reported to the FDA. ORTHO
has the right to review from time to time the procedure used by WFHC to collect
and report to the FDA serious adverse experiences and other related safety
information that is required to be reported to the FDA to confirm that WFHC is
complying with its obligation hereunder. ORTHO agrees to transfer to WFHC copies
of all information in its possession
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regarding historical serious adverse experience data and other safety data that
has been reported to the FDA at the time of the transfer of the asset in Section
2.1.
ARTICLE III.
SOURCING
3.1 SUPPLY. ORTHO agrees to supply WFHC's requirements of Product and WFHC
agrees to purchase its requirements of the Product from ORTHO until April 1,
2002, unless WFHC obtains an approved Replacement Manufacturer as described in
Sections 3.2 and 3.4. Notwithstanding the foregoing, to prevent stockpiling of
Products, ORTHO shall not be required to supply in any calendar quarter
quantities of Products in excess of 115% of the average quantities supplied by
ORTHO to WFHC in the two consecutive prior calendar quarters.
3.2 REPLACEMENT MANUFACTURER. WFHC shall promptly after the Effective Date seek
to obtain one or more replacement sources of supply for the Product (each a
"Replacement Manufacturer"). WFHC agrees to use efforts that are reasonable and
necessary to obtain a Replacement Manufacturer for the Product no later than
April 1, 2002. If notwithstanding the use of such efforts, WFHC is unable to
obtain a replacement source of supply on or before April 1, 2002, ORTHO agrees
to supply WFHC's requirements beyond that date as described in Section 3.5.
ORTHO agrees to provide WFHC with a list of all suppliers and other sources of
materials relating to the manufacturing and packaging of the Products at WFHC's
request at no cost to WFHC.
3.3 TECHNOLOGY TRANSFER. In order to enable WFHC to transfer the manufacture of
the Product to a Replacement Manufacturer, ORTHO agrees to provide WFHC and the
first Replacement Manufacturer the Manufacturing Know-how and technical
assistance (not to exceed 10 man days in total) needed to commercially
manufacture the Product according to the
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specifications approved and on file with the U.S. Food and Drug Administration.
Such Manufacturing Know-how and technical assistance will be provided without
any cost to WFHC or the Replacement Manufacturer. While WFHC may, at its option
further transfer the Manufacturing Know-How and the manufacture of the Product
to subsequent Replacement Manufacturers, ORTHO shall only be obligated hereunder
to transfer the Manufacturing Know-How and provide technical assistance to the
first Replacement Manufacturer. Thereafter, it shall be WFHC's sole right and
responsibility to effect further transfers of the Manufacturing Know-How. ORTHO
agrees not to transfer or assign the Manufacturing Know-How to any person or
entity which person or entity sells, intends to sells or will sell estropipate
products in the Territory, other than WFHC and one or more Replacement
Manufacturers during the Term of this Agreement.
3.4 REPLACEMENT MANUFACTURING QUALIFICATIONS. ORTHO has the right to approve
each Replacement Manufacturer. ORTHO shall approve a Replacement Manufacturer if
it is in compliance with all laws, ordinances, orders, rules, regulations and
actions of the United States and of any state, county, township or municipal
subdivision or other governmental agency of the United States that may now or
hereafter be applicable to this Agreement, which are incorporated in the
Specifications or relate to the Facility generally, including, but not limited
to, CGMP requirements, employee safety and health, environmental protection and
internal ORTHO safety/industrial hygiene and
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labor standards or equivalent standards as determined by ORTHO. Such labor
standards are as recited in Exhibit D. Such safety/industrial hygiene standards
are as recited in Exhibit E. After the selection of the Replacement Manufacturer
by WFHC, ORTHO shall continue to have the right to inspect and audit the
Replacement Manufacturer's facilities as necessary or reasonable to enable ORTHO
to determine whether or not such manufacturer is manufacturing the Product
pursuant to CGMP and in compliance with internal ORTHO safety/industrial hygiene
and labor standards. In determining whether or not to approve a prospective
Replacement Manufacturer, ORTHO shall be reasonable in determining whether or
not the prospective Replacement Manufacturer is in compliance with all
applicable laws and ORTHO internal standards or equivalents thereto. In the
event that ORTHO rejects or disapproves a proposed Replacement Manufacturer,
ORTHO shall inform WFHC in writing in reasonable detail of the reason(s) for
such rejection or disapproval.
3.5 COST OF SUPPLY. During the period from the Effective Date until April 1,
2002, WFHC agrees to pay ORTHO for Product supplied according to the Fully
Burdened Costs set forth in Exhibit F. Beginning in the 2nd calendar quarter
2002, for product purchases from ORTHO, WFHC agrees to pay the Supply Costs set
forth in Exhibit F plus a premium of 30% of Net Sales, which premium will
increase each calendar quarter thereafter by 10% of Net Sales. Payments to ORTHO
are due on a quarterly basis 30 days after receipt of an invoice for Product
supplied during the past calendar quarter.
3.6 INSPECTION. WFHC shall have 30 days after receipt of any shipment of
Products from ORTHO to examine such Products to determine if they conform to the
Specifications and if they are free from defects in design, material and
workmanship, and, on the basis of such examination, to accept or reject such
shipment. All Products shall have a shelf-life of at least two (2) years prior
to the applicable expiration date at the time such Products are first received
and accepted by WFHC. Any claims shall be made by WFHC in writing to ORTHO,
indicating in detail the nonconforming characteristics of the Products. After
the submission of a claim by WFHC, ORTHO shall, at WFHC's option, provide WFHC
with (i) a refund of the full amount paid by WFHC for such Products, (ii) a
credit against future ▇▇▇▇▇▇▇▇ equal to the full amount paid by WFHC for such
Products, or (iii) replacement for such Products. In no event shall ORTHO be
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required to accept the return of any Products or provide reimbursement or credit
for any Products to WFHC solely because the expiration date for such Products
shall have passed, provided that such Products have been received and accepted
by WFHC at least two (2) years prior to the applicable expiration date. ORTHO
shall pay for all shipping costs of returning the Products that are the subject
of claims. ORTHO shall bear the risk of loss for such Products, beginning at
such time as they are taken at WFHC's premises for return delivery.
3.7 RELEASE. Any shipment of the Products to WFHC for which WFHC shall not
submit a claim within 30 days after delivery shall be deemed accepted. Upon
acceptance, WFHC shall release ORTHO from all claims for non-conformity or
defects except claims for latent defects which are not reasonably detectable at
the time of acceptance.
3.8 CONTINUING ASSISTANCE. ORTHO shall, at WFHC's request, provide reasonable
assistance and information to WFHC relating to WFHC's regulatory, reporting and
compliance requirements relating to the Products during the period from January
1, 2001 through the expiry of the last Product manufactured or supplied by
ORTHO.
3.9 PRODUCT RESPONSIBILITY. ORTHO shall be responsible for any and all rebates,
chargebacks, discounts, returned goods and the like for all Products sold by
ORTHO and its Affiliates prior to the date of this Agreement. In the event that
WFHC issues any rebates, refunds or customer credits in respect of any such
Products, WFHC shall be entitled to offset any amounts owed to ORTHO under this
Agreement by the full amount of any such rebates, refunds or customer credits.
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ARTICLE IV.
INDEMNIFICATION
4.1 ORTHO WARRANTY FOR PRODUCT SUPPLIED BY ORTHO. ORTHO warrants that any
Products to be supplied to WFHC by ORTHO hereunder will, upon shipment, comply
in all respects with the Specifications and the specifications referred to in
the Federal Food Drug and Cosmetic Act, and regulations issued pursuant to that
Act, including but not limited to, regulations concerning current good
manufacturing practices and the Quality System Regulations (as defined by the
FDA)(the "QSR's"). The foregoing warranty shall not apply to any Products that
after delivery to WFHC (i) has been tampered with or otherwise altered; (ii) has
been subjected to misuse, negligence or accident; or (iii) has been stored,
handled or used in a manner contrary to FDA or other governmental requirements
or ORTHO's written instructions or applicable industry practices or standards.
Subject to the first sentence of this Section 4.1 and except as otherwise
expressly provided herein. ORTHO MAKES NO REPRESENTATION OR WARRANTY OF ANY
KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTY AS TO
MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR ANY OTHER MATTER WITH
RESPECT TO THE PRODUCT WHETHER USED ALONE OR IN COMBINATION WITH ANY OTHER
MATERIAL. ORTHO agrees to bear the direct, incremental out-of-pocket costs
reasonably incurred by WFHC due to the recall of any Product or seizure of any
Product by appropriate governmental authorities as a result of a wrongful act or
omission by ORTHO, including without limitation negligence in manufacture or
failure to comply with applicable regulations concerning good manufacturing
practices and the QSR's. ORTHO further represents and warrants that to the best
of its knowledge, the Trademark and the Products do not infringe any patent,
trademark, service ▇▇▇▇, trade name, copyright, trade secret or other
proprietary rights (collectively, "Intellectual Property") of third parties in
the
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Territory, and it is the holder of all intellectual Property necessary to
perform its obligations hereunder.
4.2 WFHC WARRANTY. WFHC warrants that it will comply with all laws, regulations
and orders in the United States, respecting sale and, when it or a Replacement
Manufacturer assumes the responsibility for the manufacturing of the Products.
Without limiting the generality of the foregoing, WFHC specifically warrants
that during the term of the this Agreement it will have in place an effective
system for tracking Products in the event a recall is necessary. WFHC further
agrees to use its reasonable best efforts in the event of a recall to notify all
Product purchasers of the recall and to facilitate retrieval of Products
recalled. During the period when ORTHO manufactures the Product, WFHC further
agrees to notify ORTHO within seventy-two hours of receipt of notice from any
source of any and all adverse reactions reported to WFHC alleged to have been
caused by any Product, or any other issues related to the design, materials or
workmanship of the Product reported to WFHC. 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 per occurrence.
4.3 ORTHO INDEMNIFICATION. ORTHO hereby agrees to protect, indemnify, defend and
hold harmless WFHC, its officers, directors, shareholders, Affiliates, agents
and employees form and against any and all claims, demands, actions, causes of
action or judgments of any kind, nature and description for injury to or death
of any person or persons whomsoever, together with cost and expenses thereto,
including reasonable attorneys' fees, arising out of any product liability
claims to the extent that ORTHO has breached its warranties set forth in Section
4.1 hereof.
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4.4 WFHC INDEMNIFICATION. WFHC hereby agrees to protect, indemnify, defend and
hold harmless ORTHO, its Affiliates, officers, agents and employees from and
against any and all claims, demands, actions, causes of action or judgments of
any kind, nature and description as a result of WFHC's breach of any of its
warranties contained herein and for any statement, representation or warranty
made by WFHC or any of its agents with respect to a Product or that is not
consistent with the statements, representations or warranties contained in the
Product labeling or package insert and for any product liability claims for
damages caused by the Products manufactured by a Replacement Manufacturer that
do not meet the Specifications.
4.5 SPECIAL DAMAGES. Except as set forth in Section 4.3 and 4.4 hereof, neither
party shall, in any case, be liable to the other party for special, incidental
or consequential damages arising from breach of warranty, breach of contract,
negligence or any other legal theory. Such damages include, but are not limited
to, loss of profits or revenue, injury to business, cost of capital, cost of any
substitute product, facilities or services, or claims of customers of either
party for such damages.
4.6 PRIOR SALES OF PRODUCTS. The parties agree that WFHC shall have no liability
whatsoever for claims in respect of any Products sold by ORTHO and its
Affiliates prior to the date of this Agreement, including without limitation,
any past or present, pending or threatened personal injury claims relating to
the use of the Products or similar products, and ORTHO agrees to protect,
indemnify, defend and hold harmless WFHC, its officers, directors, shareholders,
Affiliates, agents and employees from and against any and all claims, demands,
actions, causes of action or judgments of any kind, nature and description
arising from or relating to such matters.
4.7 PROCEDURE. The Party seeking indemnification (the "Indemnified Party") shall
inform the other Party promptly of any Indemnifiable Claim which is brought
against it and shall, to the
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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.
4.8 COOPERATION. ORTHO and WFHC agree to promptly notify each other of and
cooperate with and assist each other in investigating and answering any customer
and regulatory complaints
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and inquiries concerning any of the Products without prejudice as to which party
might be ultimately liable or responsible therefor. In connection therewith,
each party will comply with the provisions of the Ortho-▇▇▇▇▇▇ Complaint
Procedures in effect as of the date of this Agreement.
ARTICLE V.
CONFIDENTIALITY
5.1 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 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.
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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.
5.2 RETURN 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.
5.3 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 reasonably possible, only
under conditions of confidentiality.
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ARTICLE VI.
TERM-TERMINATION
6.1 TERMINATION WITH REASON. Notwithstanding any provision herein to the
contrary, ORTHO shall have the right, at its sole option, to terminate this
Agreement only to the extent it relates to ORTHO's obligation to supply the
Products and the License granted hereunder as follows:
(a) upon not less than fifteen (15) 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) acquire 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
(b) only with respect to the License, immediately on June 30, 2003, if
WFHC fails to obtain a replacement source of supply for the Products; or
(c) only with respect to the License, the earlier of June 1, 2008 or
when WFHC establishes its own trademark for the Product, in accordance with
Section 2.9 of this Agreement.
6.2 TERMINATION FOR EVENT OF DEFAULT. 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 6.2(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
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for sixty (60) days following written notice of such failure (if such default is
cured within the cure period, such written notice shall be null and void),
provided that, if the default cannot be reasonably cured within sixty (60) days,
and 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.
(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 ninety (90) 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 ninety (90) days of the date filed, or (v) is dissolved or
liquidated.
6.3 EFFECT OF TERMINATION.
(a) Upon termination or expiration of this Agreement, neither WFHC nor
its Affiliates shall thereafter have any further rights to (i) purchase Products
from ORTHO; or (ii) use the Trademark.
(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
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unpaid by one Party to the other, or from any obligations provided for in this
Agreement which survive termination of this Agreement.
ARTICLE VII.
MISCELLANEOUS
7.1 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.
7.2 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:
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If to WFHC: Women First HealthCare, Inc.
▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇ ▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇. ▇▇▇▇▇
Attn: President
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Phone No.: (▇▇▇) ▇▇▇-▇▇▇▇
If to ORTHO: Ortho-▇▇▇▇▇▇ Pharmaceutical, Inc.
▇.▇. ▇▇▇▇▇ #▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attn: President
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy: ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: Office of General Counsel
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
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.
7.3 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,
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the Parties shall meet promptly to determine an equitable solution to the
effects of any such event. The term of this Agreement shall not be extended by
any force majeure event.
7.4 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 6.
7.5 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.
7.6 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.
7.7 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. The parties hereto agree to litigate all disputes
arising under this Agreement in Federal Courts as the State of New York, U.S.A.
For that purpose, the parties submit to the jurisdiction of the Federal Courts
of the State of New York for the purposes relating to this Agreement and agree
to service of process by registered mail to the addresses listed in Section 7.2.
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7.8 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 reasonably 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 G .
7.9 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.
7.10 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
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covenants, promises, agreements, warranties, representations, conditions or
understandings, either oral or written, between the Parties other than as set
forth herein. The Distribution Agreement and the First Amendment are hereby
terminated effective as of December 31, 2000.
7.11 LIMITATION OF LIABILITY. Except with respect to the Parties' respective
indemnification obligations for third party claims pursuant to Article IV, 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.
7.12 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.
7.13 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 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.
7.14 CAPTIONS. All captions herein are for convenience only and shall not be
interpreted as having any substantive meaning.
7.15 SURVIVAL. The provisions of Articles IV and V 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
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(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.
7.16 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.
7.17 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.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be
executed by their respective duly authorized officers or representatives as of
the day and year first above written.
ORTHO-▇▇▇▇▇▇
PHARMACEUTICAL, INC. WOMEN FIRST HEALTHCARE, INC.
By: By:
--------------------------------- ----------------------------------
President President
Date Date
--------------------------------- ----------------------------------
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EXHIBIT B
PRODUCTS-ORTHO-EST (ESTROPIPATE)
DOSAGE
Trade Product:
.625 mg Bottles of 100 tablets
1.250 mg Bottles of 100 tablets
Sample Product:
.625 mg Bottles of 30 tablets
1.250 mg Bottles of 30 tablets
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EXHIBIT C
All advertising copy, promotional materials, press releases, labels, packaging
and other materials relating to the Products and displaying the Trademark shall
comply with the following guidelines:
A. The Trademark shall be used only in a manner reasonably intended to (i)
promote the general goodwill and public acceptance of the products, and
(ii) maintain enforceability of the Trademark against misuse or
infringement by others.
B. The Trademark is to appear prominently, in a distinctive type size
and/or style, on all packaging and labels. The proper trademark symbol
(i.e., (R)) should follow the Trademark in its most prominent location
on all packaging and labels. The Trademark symbol should follow the ▇▇▇▇
once in each piece of printed matter and preferably where the Trademark
appears most prominently on the first page of the piece.
C. The Trademark shall always be used in a manner that will distinguish it
from the surrounding text. The Trademark may be distinguished in the
following ways: In all capital letters: ORTHO-EST; in italic print with
an initial capital letter: Ortho-Est Tablets; and in print that is
larger and/or bolder than text: ORTHO-EST.
D. The Trademark shall always be used as a proper adjective. The Trademark
should, whenever possible, be followed by the word(s) comprising the
remainder of the Official Product Name, e.g., Tablets. This shall be
done at least where the Trademark appears most prominently and on the
first and last pages of a printed piece.
1. The official product names to be used with the Trademark
shall have initial capital letters, e.g., ORTHO-EST Tablets.
2. If a promotional piece discusses more than one presentation
of a product, the Trademark should be followed by the words
comprising the remainder of the official product names, e.g.,
ORTHO-EST Tablets and Caplets.
3. The Trademark shall not be used in conjunction with a
non-descriptive noun, e.g., "ORTHO-EST studies" is an incorrect
usage.
4. The word "brand" may also be used to reduce the possibility
that the Trademark will be thought of as the generic name for
the product. When used, it should always appear in small print,
e.g., ORTHO-EST brand tablets.
E. The Trademark Shall Not Be Used In The Possessive Form
Correct: ___mg size ORTHO-EST Tablets
Wrong: ORTHO-EST's 400 mg size
31
F. The Trademark Shall Not Be Used In The Plural Form
Correct: The doctor recommended ORTHO-EST Tablets
Wrong: The doctor recommended ORTHO-ESTS
G. The Trademark Shall Not Be Hyphenated Or Divided To Create A New Word
From The Trademark
Correct: Patients Treated With ORTHO-EST Tablets
Wrong: ORTHO-EST-treated patients
H. The Trademark Shall Not Be Used As A Verb
I. The Trademark Shall Not Be Equated With The Active Ingredient.
Correct: ORTHO-EST Tablets (estropipate)
Wrong: ORTHO-EST (estropipate)
J. The Trademark, wherever it is used with respect to ORTHO-EST Rx
products, shall utilize the same type style as currently used by ORTHO
for Ortho-Est products.
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EXHIBIT F
ORTHO-▇▇▇▇▇▇ PHARMACEUTICAL
ORTHO EST AGREEMENT
MANUFACTURING AND SUPPLY COSTS
PRODUCT CODE PRODUCT 2001 2002 2003
------------ ------- ---- ---- ----
FULLY BURDENED COST: 110101 EST .625MG 100'S $ 2.71 $ 2.80 $ 2.90
110127 EST .625MG 30'S $ 1.27 $ 1.31 $ 1.36
110201 EST 1.25MG 100'S $ 3.43 $ 3.55 $ 3.67
110227 EST 1.25MG 30'S $ 1.50 $ 1.55 $ 1.61
SUPPLY COST: 110101 EST .625MG 100'S $ 3.25 $ 3.36 $ 3.48
110127 EST .625MG 30'S $ 1.52 $ 1.57 $ 1.63
110201 EST 1.25MG 100'S $ 4.12 $ 4.26 $ 4.40
110227 EST 1.25MG 30'S $ 1.80 $ 1.86 $ 1.93
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EXHIBIT G
PRESS RELEASE
CONTACT: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Vice President/CFO
Women First HealthCare, Inc.
▇▇▇-▇▇▇-▇▇▇▇
▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇.▇▇▇
FOR IMMEDIATE RELEASE
WOMEN FIRST HEALTHCARE, INC. REVISES ITS AGREEMENTS WITH
ORTHO-▇▇▇▇▇▇ PHARMACEUTICAL, INC.
SAN DIEGO, OCTOBER XX, 2000 - Women First HealthCare, Inc. (NASDAQ:WFHC)
announced that effective September 30, 2000 it has revised its contractual
agreements with Ortho-▇▇▇▇▇▇ Pharmaceutical, Inc. Women First expects the
revised agreement to result in increased liquidity, short-term revenue gain and
expense reduction during 2000. In addition, Women First expects the revised
agreement to provide significant long-term margin improvement beginning in 2001.
Under the terms of the revised agreement, Women First will permanently acquire
all rights to the ANDA for ORTHO-EST(R) and is no longer obligated to make
required aggregate payments of $28 million to Ortho-▇▇▇▇▇▇ over the next seven
years. In addition, Women First will license the trademark for ORTHO-EST(R)
through June 2008, during which time it will seek to register a new ▇▇▇▇ for the
product.
As part of the revised agreement, the three-year ORTHO-PREFEST(R) contract has
been shortened and will expire on December 31, 2000. Women First will continue
to generate revenue from the ORTHO-PREFEST(R) contract through year-end 2000.
In addition, the revised agreement provides for a three-month contract for the
new Trialogue(TM) division of Women First. Under the terms of the agreement,
Trialogue will fund a medical education program, Lifetime Hormonal
Management-Patient Acceptance of HRT, and will contract with an outside vendor
for program management and development.
"These changes represent short-term and long-term advantages to the Company,"
said ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, Vice President and Chief Financial Officer of Women
First. "The cash elements of the revised agreement provide substantial
improvement in our liquidity and will positively impact our 3rd quarter results.
Our ownership of ORTHO-EST(R) will bring profit margin improvements beginning in
2001. Importantly, our sales force now has two effective estrogen options for
midlife women - an oral form with ORTHO-EST(R) and a patch with esclim(R)."
-more-
Women First HealthCare Revises Its Agreements With Ortho-▇▇▇▇▇▇ Pharmaceutical,
Inc.
34
2-2-2
ABOUT WOMEN FIRST HEALTHCARE, INC.
Founded in 1996, Women First HealthCare, Inc. is a San Diego-based company
dedicated to improving the health and well being of women transitioning from
perimenopause through postmenopause and to supporting the OB/GYNs, Nurse
Practitioners, and other health professionals who manage their care. The
Company, which has established solutions for midlife women and their clinicians,
is structured into three operating divisions. Pharmaceutical is responsible for
the marketing of prescription products, which currently include hormone
replenishment--both oral and patch--and cholesterol-lowering prescription
products, and Daily Difference(TM) dietary supplements developed in consultation
with Tufts University School of Nutrition Science and Policy. Consumer is
responsible for the Company's self-care line of products available through its
▇▇▇.▇▇▇▇▇▇▇▇▇▇.▇▇▇ Marketplace, As We Change(R) national mail order catalog, and
Internet retailer, ▇▇▇.▇▇▇▇▇▇▇▇▇▇.▇▇▇. Trialogue(TM), the Corporate Marketing
Division, is responsible for providing access to Women First's network of
opinion leaders and clinicians through strategic marketing programs for sale to
major pharmaceutical companies. Integrated access includes the Company's
comprehensive online health portal, ▇▇▇.▇▇▇▇▇▇▇▇▇▇.▇▇▇/▇▇▇▇▇▇▇ (Professional
Gateway for Health Professionals); database communications; and continuing
medical education programs.
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
intent or obligation to update these forward-looking statements. Actual results
could differ materially due to a number of factors, including (i) changes in our
contractual relationships with Ortho-▇▇▇▇▇▇ Pharmaceutical and ▇▇▇▇▇▇▇-▇▇▇▇▇
Squibb, (ii) our ability to obtain additional financing for our future capital
needs, and (iii) 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, 1999 and its Quarterly Report on Form 10-Q for the
six-month period ended ▇▇▇▇ ▇▇, ▇▇▇▇
# # #
▇▇
