EX-10.26
EXECUTION COPY
LICENSE AND SUPPLY AGREEMENT
dated as of January 6, 2004
between
WYETH
acting through its Wyeth Consumer Healthcare Division
and
ACCESS PHARMACEUTICALS, INC.
THIS LICENSE AND SUPPLY AGREEMENT (this "Agreement") is made
and entered into as of this 6th day of January, 2004 (the
"Effective Date"), between WYETH, a corporation organized and
existing under the laws of Delaware, acting through its Wyeth
Consumer Healthcare Division, and having an address at Five
▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ("WYETH") and Access
Pharmaceuticals, Inc., a corporation organized and existing
under the laws of Delaware and having an address at ▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
("ACCESS").
RECITALS
WHEREAS, ACCESS is developing a proprietary oral mucoadhesive,
erodible form of drug that contains * as more fully described
in Exhibit A attached hereto (the "Product"), * ;
WHEREAS, WYETH possesses substantial resources and expertise in
the commercialization and marketing of over-the-counter
pharmaceutical products; and
WHEREAS, ACCESS desires to grant to WYETH, and WYETH desires to
obtain from ACCESS, an exclusive license to market the Product
and an exclusive right to purchase from ACCESS and distribute
the Product, all under the terms and subject to the conditions
set forth herein.
NOW, THEREFORE, in consideration of the mutual covenants and
agreements set forth herein, and for good and valuable
consideration the receipt and sufficiency of which are hereby
acknowledged, the parties hereto hereby agree as follows:
1. DEFINITIONS
1.1 Definitions.
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As used in this Agreement, the following capitalized terms have
the meanings indicated below:
1.1.1 "ACCESS" has the meaning set forth in the Preamble.
1.1.2 "ACCESS Confidential Information" means all information,
specifications (including, without limitation, the
Specifications), know-how and data pertaining to the Product
and ACCESS's business or its Manufacturing operations disclosed
to WYETH or its Affiliates, Third Party manufacturers or
distributors hereunder, including, without limitation, all
information, Specifications, know-how and data related to the
design, implementation, performance and manufacture of the
Product, and any correspondence with the FDA or any other
Regulatory Authority, clinical study data, analytical data, or
operating procedures.
* - Confidential portions have been omitted and are on file
separately with the Commission.
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1.1.3 "ACCESS Trademark" means any trademark, trade name, trade
dress, slogan, logo, or similar item used by ACCESS prior to or
as of the Effective Date, or subsequent to the Effective Date
in connection with any ACCESS product other than the Product.
1.1.4 "Affiliate" means, in the case of either Party, any
corporation, joint venture, or other business entity which
directly or indirectly controls, is controlled by, or is under
common control with that Party. The term "control," as used in
this definition, means having the power to direct, or cause the
direction of, the management and policies of an entity, whether
through ownership of voting securities, by contract or
otherwise. Notwithstanding the foregoing, for purposes of this
Agreement, the term "Affiliate" does not include entities in
which a Party or its Affiliates owns a majority of the ordinary
voting power to elect a majority of the board of directors but
is restricted from electing such majority by contract or
otherwise, until such time as such restrictions are no longer
in effect.
1.1.5 "Batch" means the volume of finished, packaged Product
obtained from a validated Manufacturing run.
1.1.6 "Certificate of Analysis" means the document identifying
the results of the Methods of Analysis for a specific Batch of
Product in a form agreed to by the Parties in writing but which
shall include, without limitation, the applicable Product
Batch's manufacturing date, expiration date, lot number and
testing results and data.
1.1.7 "Confidential Information" means either WYETH
Confidential Information, ACCESS Confidential Information, or
both, as the context requires.
1.1.8 "Contract Year" means each consecutive twelve (12) month
period during the Term, the first of which shall commence on
the first day of the calendar month following the date of
Launch and end on the first anniversary thereof.
1.1.9 "Control" means, with respect to any item of information
or intellectual property right, the possession, whether by
ownership or exclusive license, of the right to grant a license
or other right with respect thereto.
1.1.10 "Effective Date" has the meaning set forth in the
Preamble.
1.1.11 "Extraordinary Event Increase" has the meaning set
forth in Section 5.5.2.
1.1.12 "Facility" means ACCESS's initial Third Party
Manufacturing facility, and any subsequent or replacement Third
Party Manufacturing facility identified to and approved by
WYETH in accordance with Section 2.9.
1.1.13 "FDA" means (a) the United States Food and Drug
Administration, or (b) with respect to countries in the
Territory other than the United States, any foreign regulatory
agency or governmental entity which fulfills a role similar to
the United States Food and Drug Administration, or any
successor entities thereto.
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1.1.14 "FD&C Act" means (a) the Federal Food, Drug and
Cosmetic Act, and all regulations promulgated thereunder, or
(b) with respect to countries in the Territory other than the
United States, any foreign laws, statutes, rules or regulations
fulfilling a role similar to the Federal Food, Drug and
Cosmetic Act (and all regulations promulgated thereunder), as
the same may be amended or supplemented from time to time.
1.1.15 "Field" means the treatment of oral pain utilizing
anesthetics (excluding the treatment of sore throat and
excluding any product containing amlexanox as an active
ingredient).
1.1.16 "Force Majeure Event" has the meaning set forth in
Article 10.
1.1.17 "Good Manufacturing Practice" or "GMP" means (a) the
then current standards for the manufacture of pharmaceuticals,
as set forth in the FD&C Act, (b) such standards of good
manufacturing practice as are required by the applicable laws
and regulations of countries in which the Product is intended
to be sold, to the extent such standards are not inconsistent
with the then current standards for the manufacture of
pharmaceuticals as set forth in the FD&C Act, and (c) any
quality requirements set forth in this Agreement or the Quality
Agreement attached hereto as Exhibit C.
1.1.18 "Indemnified Party" has the meaning set forth in
Section 7.1.3.
1.1.19 "Indemnifying Party" has the meaning set forth in
Section 7.1.3.
1.1.20 "Intellectual Property Rights" means Patents, designs,
formulae, trade secrets, know-how, industrial models, and
technical information Controlled by ACCESS and whether now
existing or coming into existence during the Term and which are
necessary for and/or related to the use or distribution of the
Product.
1.1.21 "Invention" means any new or useful method, process,
manufacture, compound or composition of matter, whether or not
patentable or copyrightable, or any improvement thereof arising
during the Term with respect to the Product, its Manufacture
and/or use.
1.1.22 "Launch" means the date on which the Product is sold by
WYETH for the first time to a Third Party for commercial
distribution in the Territory.
1.1.23 "Manufacture," "Manufactured" or "Manufacturing" means
all activities involved in the production of the Product,
including, without limitation, the preparation, formulation,
finishing, testing, packaging, storage and labeling of the
Product and the handling, storage and disposal of any residues
or wastes generated thereby.
1.1.24 "▇▇▇▇" has the meaning set forth in Section 2.1.4.
1.1.25 "Materials" means all materials, including, without
limitation, all raw
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materials, ingredients, packaging supplies and labels, required for
the Manufacture of Product.
1.1.26 "Methods of Analysis" means the methods of analysis for
the Product which are mutually agreed upon in writing between
the Parties and, on a date to be mutually agreed upon by the
Parties, attached as an exhibit to the development plan (which
development plan shall be agreed upon in accordance with
Section 2.10).
1.1.27 "Net Sales" means, with respect to the Product, the
gross invoiced sales amount of the Product sold by WYETH or its
Affiliates to non-affiliate Third Parties, after deduction of
the following items, to the extent that such deductions are
reasonable and actually allowed, taken or incurred, and
(provided that such items do not exceed reasonable and
customary amounts in the country in which the sale occurred):
(a) trade and quantity discounts, net of any give-backs
received by WYETH in return; (b) refunds, rebates, retroactive
price adjustments, service allowances and broker's or agent's
commissions; (c) credits or allowances given for rejection or
return of previously sold Product or for wastage replacement
actually taken or allowed; and (d) any tax, duties or
government charge levied on the sale of Product and borne by
WYETH and/or its Affiliates (excluding national, state or local
taxes based on income). Such amounts shall be determined from
the books and records of WYETH and its Affiliates maintained in
accordance with generally accepted accounting principles,
consistently applied. Sales of the Product by and between a
Party and its Affiliates for further distribution to a Third
Party are not sales to Third Parties and shall be excluded from
Net Sales calculations for all purposes.
1.1.28 "Party" or "Parties" means either WYETH, ACCESS or
both, as the context requires.
1.1.29 "Patents" shall mean (a) * , and (b) any and all
patents, patent applications, patent disclosures awaiting
filing determination, patent divisionals, continuations,
continuations-in-part, reissues, re-examinations, renewals and
extensions thereof Controlled by ACCESS during the Term, within
the Territory, which are necessary for the Manufacture, use or
distribution of the Product.
1.1.30 "Person" means any natural person, corporation, general
partnership, limited partnership, limited liability company,
limited liability partnership proprietorship, other business
organization, trust, union, association or governmental
authority.
1.1.31 "PPI Adjustment" has the meaning set forth in Section
5.2.
1.1.32 "Product" has the meaning set forth in the first
recital above.
* - Confidential portions have been omitted and are on file
separately with the Commission.
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1.1.33 "Recall" means any action by any Party to recover title
to or possession of any Product sold or shipped to Third
Parties or any action to prevent or interrupt the sale or
shipment by a Party of the Product to Third Parties that would
have been subject to recall if it had been sold or shipped.
1.1.34 "Regulatory Approval" means all consents, permits,
approvals, licenses, authorizations, qualifications, notices or
orders that are issued or granted by Regulatory Authorities
which are required for the manufacture, marketing, promotion,
pricing and sale of the Product in a country within the
Territory.
1.1.35 "Regulatory Authority" means any domestic or foreign,
federal, national, regional, state, county, city, municipal,
local or other administrative, legislative regulatory or other
governmental authority, agency, department, bureau, commission,
or council involved in the granting of Regulatory Approval for
the Product in the Territory.
1.1.36 "Rolling Forecast" has the meaning set forth in Section
2.2.
1.1.37 "Seizure" means any action by the FDA or any other
Regulatory Authority to detain or destroy the Product or
prevent the release of the Product.
1.1.38 "Shortfall" has the meaning set forth in Section 2.6.
1.1.39 "Specifications" means the specifications for the
Product which are mutually agreed upon in writing between the
Parties and, on a date to be mutually agreed upon by the
Parties, attached as an exhibit to the development plan (which
development plan shall be agreed upon in accordance with
Section 2.10).
1.1.40 "Term" means, with respect to each country in the
Territory, the period commencing on the Effective Date and
ending upon the expiration of the last-to-expire patent within
the Patents in such country, except as and if sooner terminated
in accordance with Section 8.
1.1.41 "Territory" means, initially, the United States,
Canada, Mexico and their respective territories and
possessions, including, without limitation, Puerto Rico.
Countries may be added to the Territory from time to time in
accordance with the terms of Section 2.7.
1.1.42 "Third Party" means any Person other than WYETH, ACCESS
and their respective Affiliates.
1.1.43 "Trademark" means any trademark, trade name, trade
dress, slogan, logo, or similar item selected by WYETH for use
in connection with the Product.
1.1.44 "WYETH" has the meaning set forth in the Preamble.
1.1.45 "WYETH Confidential Information" means all information,
specifications, know-how and data pertaining to WYETH's
business disclosed to ACCESS, its Affiliates or its
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Third Party manufacturer hereunder, including, without limitation,
marketing and sales plans, artwork, formats, equipment, logos,
drawings, customer lists, regulatory filings, correspondence
with the FDA or any other Regulatory Authority, clinical study
data, analytical data, operating procedures and all ordering
and sales information.
1.2 Construction of Certain Terms and Phrases.
Unless the context of this Agreement otherwise requires, (i)
words of any gender include each other gender; (ii) words using
the singular or plural number also include the plural or
singular number, respectively; (iii) the terms "hereof,"
"herein," "hereby" and derivative or similar words refer to
this entire Agreement; (iv) the terms "Article" or "Section"
refer to the specified Article or Section of this Agreement;
and (v) Article and Section headings shall not affect the
meaning or construction of any provision of this Agreement.
2. SUPPLY
2.1 Grant of License.
2.1.1 Subject to the terms and conditions of this Agreement,
ACCESS hereby grants to WYETH (a) the exclusive right and
license in the Field under ACCESS's Intellectual Property
Rights to market, offer for sale, sell and import products,
including the Product, in the Territory, (b) the exclusive
right and license in the Field under ACCESS's Intellectual
Property Rights to use the Product in the Territory, provided
that such right and license is limited to such use as is
necessary for WYETH to market, offer for sale, sell, import
and, subject to the terms and conditions set forth in Section
2.6, Manufacture the Product in the Territory, and (c) a non-
exclusive right and license to use the Product and all
information and Intellectual Property Rights with respect
thereto (including, without limitation, data, studies and
clinical trials) solely for the purpose of obtaining Regulatory
Approvals for the Product. Except as expressly granted herein,
ACCESS retains all rights in the Intellectual Property Rights
and the Product.
2.1.2 Except as specifically provided to the contrary in
Section 2.1.1, the license granted in Section 2.1.1 shall not
be construed (a) to effect any sale of ACCESS's Intellectual
Property Rights or any other proprietary ACCESS technology; (b)
subject to the terms and conditions set forth in Section 2.6,
to grant any license relating to ACCESS's methods of
formulating, fabricating and Manufacturing the Product; (c) to
▇▇▇▇▇ ▇▇▇▇▇ any rights in or to the use of the Intellectual
Property Rights by implication or otherwise. WYETH shall ▇▇▇▇
or have marked all containers or packages of the Product in
accordance with the patent marking laws of the jurisdiction in
which such units of Product are to be used or distributed.
2.1.3 Upon expiration of the Term in any country due solely to
the expiration of the last-to-expire patent within the Patents
in such country, WYETH shall have a non-exclusive, fully paid
up license to those licenses set forth in Section 2.1.1.
2.1.4 Subject to the terms and conditions of this Agreement,
ACCESS hereby grants to WYETH an exclusive, non-transferable
(except in accordance with a permitted
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assignment of this Agreement under Section 13.3) license in the Field
to use ACCESS's "ORADISC" trademark (the "▇▇▇▇") solely in connection
with the production, marketing and sale of the Product under
this Agreement, within the Territory. Based on the information
provided by ACCESS, WYETH acknowledges that ACCESS is the
exclusive owner of the ▇▇▇▇ and all associated goodwill and
registrations. WYETH agrees that it has no rights to use the
▇▇▇▇ except for the right to use the ▇▇▇▇ as provided for in
this Agreement and all uses of the ▇▇▇▇ by WYETH, and the
associated goodwill, shall inure solely to the benefit of
ACCESS. WYETH further agrees that upon the termination or
expiration of this Agreement, all right to use the ▇▇▇▇
provided to WYETH hereby shall revert fully to ACCESS. WYETH
shall faithfully reproduce the Mark's design and appearance, as
such design and/or appearance may be modified from time to time
by ACCESS. WYETH shall not modify the design or appearance of
the ▇▇▇▇ unless requested to do so in writing by ACCESS. All
uses of the ▇▇▇▇ shall be subject to ACCESS's prior written
approval on the basis of samples submitted by WYETH and shall
be made in strict conformance with such specifications as
ACCESS shall establish, as such specifications may be modified
by ACCESS from time to time. All displays of the ▇▇▇▇ shall
bear such trademark notices as ACCESS shall require. Except as
consistently with this Agreement with respect to the Product,
WYETH shall not (a) use the ▇▇▇▇ as part of, or in conjunction
with, any other names or marks without ACCESS's prior written
approval; (b) use the ▇▇▇▇ or any confusingly similar marks,
terms or designs, except as expressly authorized in this
Section 2.1.4; (c) attempt to register any such marks, terms or
designs; (d) take any actions inconsistent with ACCESS's
ownership of the ▇▇▇▇ and any associated registrations, or
attack the validity of the ▇▇▇▇, ACCESS's ownership thereof, or
any of the terms of this Section 2.1.4; (e) use the ▇▇▇▇ in any
manner that would indicate WYETH is using such ▇▇▇▇ other than
as a licensee of ACCESS; nor (f) assist any Affiliate or Third
Party to do any of the same. ACCESS, and/or its authorized
agents or representatives, shall have the right from time to
time, upon reasonable notice to WYETH, to inspect WYETH's (or
its contractors') facilities and operations during regular
business hours, that are involved in the Manufacture of the
Product pursuant to Section 2.6; provided that such inspections
shall be subject to, and ACCESS shall require its authorized
agents and representatives to agree in writing to, the
confidentiality provisions set forth in Section 9 of this
Agreement. Upon ACCESS's request, WYETH shall provide ACCESS
with examples of all uses of the ▇▇▇▇ as actually used by
WYETH, and a reasonable number of actual samples of the goods
produced, marketed and sold by WYETH under the ▇▇▇▇. WYETH
agrees to cooperate with and offer reasonable assistance to
ACCESS in facilitating ACCESS's control of the quality of the
Product (and associated labels and marketing materials and
other documentation) branded with the ▇▇▇▇ hereunder.
2.2 Manufacture; Marketing.
Subject to Section 2.3, ACCESS shall Manufacture and deliver
the Product to WYETH in such quantities and at such times as
ordered by WYETH in accordance with this Agreement. During the
Term, ACCESS shall maintain the resources necessary to
Manufacture the Product and shall provide, at its own expense,
all Materials and labor necessary to do so. WYETH shall market
and sell the Product in each country in the Territory; provided
that, nothing shall require WYETH to continue to market or sell
the Product in any country within the Territory during a period
of time that WYETH determines, in its sole judgment, that such
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Product is reasonably likely to be subject to adverse
regulatory or legal action, or infringe any intellectual
property right of any Third Party in such country; and provided
further that, in the event that, commencing as of the third
Contract Year, the royalties paid by WYETH to ACCESS under
Section 5.5 do not, in the aggregate, equal or exceed *
Dollars (US$ * ) for any Contract Year, then ACCESS shall
have, as its sole and exclusive remedy, the right to convert
the rights and licenses granted to WYETH under this Agreement
to non-exclusive rights and licenses by delivery of written
notice to such effect. WYETH shall have the right to purchase
the Product in the final packaged form described in Section
5.1; provided that in the event of a Shortfall (as hereinafter
defined) WYETH shall have the right to purchase the Product in
bulk and package the Product itself or arrange for a Third
Party to package the Product.
2.3 Forecasts.
At least four (4) months prior to Launch, WYETH shall submit to
ACCESS a forecast of the quantity of the Product that WYETH
anticipates ordering from ACCESS prior to WYETH's anticipated
Launch of Product. WYETH shall submit to ACCESS a forecast of
the quantity of the Product that WYETH anticipates ordering
from ACCESS during the twelve (12) month period (broken down by
month) following Launch and WYETH shall update such forecast on
a rolling twelve (12) months basis every month thereafter
(each, a "Rolling Forecast"). WYETH shall place purchase
orders for at least the quantity of the Product specified in
the first three (3) months of each such Rolling Forecast and
the remaining nine (9) months shall be a non-binding good faith
estimate. Except as set forth in this Section 2.3 or in
Section 8.8, WYETH shall not be required to order any fixed
minimum quantity of the Product or any quantity of the Product,
notwithstanding any forecast or prior course of dealing.
2.4 Orders and Delivery.
WYETH shall place its firm orders for the Product with ACCESS
by submitting a purchase order, at least ninety (90) days prior
to the delivery date requested therein, which sets forth (a)
the quantity of the Product ordered for delivery; and (b) the
delivery date for that order. Any such purchase order which is
in accordance with the terms and conditions of this Agreement
shall be deemed to be accepted by ACCESS. For all other
purchase orders placed by WYETH, unless ACCESS notifies WYETH
in writing within fifteen (15) days of receipt of a purchase
order that it is unable to deliver the Product in accordance
with such purchase order, ACCESS shall be deemed to have
accepted such purchase order as a binding order. If ACCESS
notifies WYETH that it is unable to fill a purchase order that
is not in accordance with the terms and conditions of this
Agreement, it shall indicate the portion of such purchase order
ACCESS cannot supply by the requested delivery date and specify
alternate delivery dates; provided that in the event that WYETH
delivers a purchase order less than ninety (90) days prior to
the requested delivery date, ACCESS shall use commercially
reasonable efforts to meet such requested delivery date despite
the shortened lead time, and ACCESS will not be in breach of
its obligations hereunder if, despite such commercially
reasonable efforts, ACCESS is not able to meet such requested
delivery date with respect to such order.
* - Confidential portions have been omitted and are on file
separately with the Commission.
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WYETH may cancel or modify any firm purchase order (in whole or
in part) at any time prior to the delivery for any quantity of
Product for which Manufacturing has not been completed pursuant
to such purchase order at the time that notice of cancellation
or modification is received by ACCESS; provided that if
Manufacturing has commenced but not completed pursuant to such
firm purchase order, WYETH shall reimburse ACCESS for Material
and labor costs in respect of any works-in-progress pursuant to
such cancelled or modified purchase order (or part thereof) at
the time notice of cancellation or modification is received by
ACCESS; and provided, further, that WYETH shall reimburse
ACCESS for the actual, reasonable out-of-pocket cost of any
other Material purchased by ACCESS to fill a cancelled purchase
order (or part thereof) that are unique to the Product and
cannot within a reasonable period of time otherwise be used in
ACCESS's operations. All Product shall be delivered F.O.B. the
Facility and in accordance with WYETH's instructions. Title,
possession and risk of loss shall pass to WYETH upon delivery
of Product to WYETH's designated carrier at the Facility's
loading dock. The provisions of this Agreement shall prevail
over any inconsistent statement or provisions contained in any
document related to this Agreement passing between the parties
hereto including, but not limited to, any purchase order,
acknowledgment, confirmation or notice.
2.5 Shelf Life.
ACCESS shall schedule Manufacturing operations so that all of
the Product delivered has the latest expiry date possible, and
in no event shall any Product be delivered to WYETH with an
expiry date less than the maximum established expiry date (as
set forth in the Specifications) less three (3) months. If
Product is delivered to WYETH whose expiry date does not
conform with the requirements set forth in this Section 2.4,
ACCESS shall promptly, at its sole expense, replace the non-
conforming Product.
2.6 Alternative Supply.
Notwithstanding any provision herein to the contrary, in the
event that (1) ACCESS is in default of its supply obligations
under this Agreement with respect to three (3) accepted WYETH
purchase orders within any twelve month period (a "Shortfall"),
or (2) if during Manufacture or supply of the Product to WYETH
there is a material violation of the requirements set forth in
Sections 2.9, 3.1, 3.2, 3.4, 3.6. 3.8 or the representations
set forth in Sections 6.2.1, 6.2.4 or 6.2.5 (a "Regulatory
Shortfall") that is not cured within forty-five (45) days of
the later to occur of the (i) date of the violation or (ii)
notice to ACCESS of such violation, then WYETH, in addition to
any other rights and remedies it may have, shall have the right
to Manufacture the Product itself and/or qualify an alternative
supplier of Product. ACCESS shall, at its cost, (a) cooperate
with WYETH in the transfer of copies of the Confidential
Information, technology and know-how necessary to Manufacture
the Product to WYETH and/or its designated alternative
supplier, (b) deliver to WYETH copies of such drawings,
specifications, and other information in ACCESS's possession as
may be necessary to Manufacture the Product or cause the
Product to be Manufactured and (c) grant to WYETH a limited
license in the Field under ACCESS's Intellectual Property
Rights during the Term of this Agreement to Manufacture, make,
or have made for WYETH's distribution of the Product in the
Territory, the Product; provided that to the extent that such
technology and know-how constitutes ACCESS Confidential
Information (or any information constitutes Confidential
Information of
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ACCESS's Third Party manufacturer) it shall be subject to the
provisions of Article 9 and WYETH's designated
alternative supplier shall be required to enter into a
confidentiality agreement with ACCESS containing substantially
the same terms as Article 9; and further provided that all
items provided under clauses (a) and (b) above will be subject
to the license granted pursuant to clause (c). In addition to
WYETH's aforementioned right to Manufacture the Product itself
and/or qualify an alternative supplier of the Product by reason
of a Shortfall, WYETH shall be relieved of its obligation to
order its purchase requirements of the Product from ACCESS if
ACCESS, for any reason, is unable, anticipates that it will be
unable or is unwilling to supply Product meeting WYETH's
forecasted requirements for a period of time of three (3)
months until such ability or willingness to supply resumes;
provided that WYETH shall continue to be relieved of its
obligation to order its purchase requirements of Product from
ACCESS to the extent necessary to fulfill any reasonable
contractual commitment entered into during such period and to
the extent that it has accumulated an inventory of Product
during such period. In the case of a Regulatory Shortfall,
WYETH shall immediately be relieved of any obligation to order
its purchase requirements of the Product from ACCESS and shall
not be required to purchase or accept any Product from ACCESS
until and unless the Regulatory Shortfall has been remedied.
In the event that WYETH elects to manufacture the Product
itself and/or qualify an alternative supplier of the Product in
accordance with this Section 2.6, then ACCESS shall reimburse
WYETH for WYETH's reasonable additional cost in obtaining and
establishing an alternative supplier.
2.7 Expansion of the Territory.
At any time during the initial twelve (12) months of the Term
of this Agreement, WYETH shall have the right and option to
negotiate for the addition of countries or geographic areas to
the Territory. Such right is exercisable by delivery of
written notice to ACCESS, specifying the countries or
geographic areas with respect to which WYETH would like to add
to the Territory, and is subject to mutual agreement of the
Parties. Upon receipt of such notice, the Parties shall
negotiate in good faith the terms of the exclusive or non-
exclusive (as the parties may mutually agree) arrangement with
respect to the additional countries or geographic areas. In
the event that the Parties are unable to reach agreement on
such terms on or prior to the 60th day following commencement
of such negotiations, ACCESS shall bear no further obligation
to WYETH under this Section 2.7 with respect to the applicable
countries or geographic area; provided that ACCESS shall not
thereafter enter into or be a party to any arrangement,
agreement, license or distribution relationship with a Third
Party with respect to the Product in all or any portion of the
applicable countries or geographic areas on terms and
conditions in the aggregate more favorable to such Third Party
than the aggregate terms and conditions offered to WYETH
without first offering such aggregate terms and conditions to
WYETH.
2.8 Non-Compete.
During the Term, neither WYETH nor any Affiliate of WYETH may
directly or indirectly market, offer for sale, sell, import or
distribute in the Territory any human, over-the-counter,
mucoadhesive, erodible product in the Field and in the form of
the Product other than the Product. For the avoidance of
doubt, this Agreement shall not preclude WYETH from
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continued manufacture and sale of any product which was marketed, offered
for sale, sold, imported or distributed by WYETH as of the
Effective Date.
2.9 Third-Party Manufacturer.
ACCESS shall, in accordance with the terms of this Section 2.9,
establish a Manufacturing Facility (operated by a Third Party
manufacturer) in compliance with the FDA's requirements,
including, without limitation, compliance with the written
requirements of WYETH as provided as of the Effective Date. As
of the Effective Date, ACCESS has identified to WYETH the Third
Party manufacturer it intends to use to Manufacture and supply
to WYETH the Product and the location of the Facility. ACCESS
shall promptly provide WYETH with access to the Facility for
inspection by WYETH. In addition, ACCESS shall promptly
provide WYETH with information requested by WYETH regarding the
Third Party manufacturer (including, without limitation, any
information requested by WYETH in accordance with WYETH's due
diligence, its GMP audit procedures and its "Level One
Compliance Assessment"). During the Term and upon reasonable
prior notice to ACCESS, WYETH shall have the right, from time
to time, to audit the Facility and the performance of the Third
Party manufacturer to ensure that the Facility and the Third
Party manufacturer are in compliance with GMP and WYETH's other
manufacturing standards. Any such audits or inspections shall
be undertaken by WYETH in accordance with the provisions of
Section 3.5.
2.10 Development Plan.
ACCESS and WYETH acknowledge and agree that, as of the
Effective Date, the Product has not been fully developed and is
still in the "prototype" stage of product development. The
Parties, on or prior to March 31, 2004, shall mutually agree
upon a development plan, which development plan shall include,
without limitation, (a) the stages of development set forth in
Exhibit B hereto (and shall be based upon the development
program model set forth therein). The final development plan
shall also include, at times mutually agreed upon by the
Parties the (a) the mutually agreed upon Methods of Analysis,
and (b) the mutually agreed upon Specifications. Once the
Parties have mutually agreed upon a final development plan,
ACCESS shall, at its own cost and expense (unless and to the
extent otherwise indicated in the final development plan), use
commercially reasonable efforts to implement each of the stages
of such development plan in accordance with such development
plan. Each of such stages must be completed in accordance with
the applicable specifications or criteria before Launch will
occur.
2.11 Additional Responsibilities.
2.11.1 ACCESS shall be responsible for (a) at WYETH's cost
and expense, supplying to WYETH, prior to the commencement of
Manufacturing of the Product, a full scale validation Batch and
the data reasonably requested by WYETH (including, without
limitation, the final Product formulation, the processing
requirements from start to finish for all production, the
validated analytical methods, the Specifications and test
method (both chemical and physical) for all elements of the
disc component and the Product through the finished production
of the Product and the validation protocols and schedules for
processes, equipment, cleaning and
12
packaging) and WYETH shall reimburse ACCESS for ACCESS's actual,
reasonable, out-of-pocket costs for the supply of such Batch and data,
(b) at WYETH's cost and expense, scale-up, validation and stability of the
Product for commercial production of the Product, including,
without limitation, bulk production of the * ,
production of the * and development and
validation of a mutually acceptable package configuration, (c)
cooperating with WYETH with respect to the obtaining by WYETH
of any Regulatory Approvals required to be obtained by WYETH
with respect to the marketing, sale, offering to sell,
importing and/or distribution of the Product, and (d) providing
to WYETH complete Batch records for all validation Batches and,
on an annual basis, providing one representative full Batch
record.
2.11.2 WYETH shall be responsible, at WYETH's cost and
expense, for any clinical trials, consumer product testing and
commercialization of the Product, including, without
limitation, all sales and marketing activities related to the
Product and the design of all Product packaging and related
artwork, and the design of all labeling.
2.11.3 WYETH shall retain, at its own expense a selling and
service organization with adequate experience, ability and
training for purposes of marketing and selling the Product in
the Territory.
2.12 ACCESS Manufacturing and Supply Obligations.
It is understood and agreed by the Parties that ACCESS will be
entering into an agreement with a Third Party manufacturer to
perform the Manufacturing and supply obligations that ACCESS
has under this Agreement. In accordance with such
understanding, ACCESS acknowledges and agrees that with respect
to ACCESS's obligations to WYETH under this Agreement (a)
despite the performance by the Third Party manufacturer of
ACCESS's Manufacturing and supply obligations hereunder, ACCESS
shall be fully responsible for the performance of such as
though it were performing such Manufacturing and supply
obligations itself, (b) all of the provisions of this Agreement
(including, without limitation, indemnification) shall be
interpreted in such a way as to impute any actions or omissions
by the Third Party manufacturer to ACCESS, and (c) except with
respect to any matters falling within the scope of Section 10,
ACCESS shall not be relieved or excused of any of its
obligations hereunder due to any action or failure to act by
the Third Party manufacturer. For avoidance of doubt, with
respect to the obligations of ACCESS regarding Manufacture and
supply to WYETH of the Product, reference to ACCESS in this
Agreement shall also mean ACCESS's contractors, Third Party
manufacturer and Affiliates.
3 COMPLIANCE, QUALITY AND ENVIRONMENTAL
3.1 Compliance with Law.
ACCESS shall conduct all Manufacturing hereunder in a safe and
prudent manner, in compliance with all applicable laws and
regulations (including, without limitation, those dealing with
occupational safety and health, those dealing with public
safety and health, those dealing with protecting the
environment, and those dealing with disposal of wastes), and in
* - Confidential portions have been omitted and are on file separetly
with the Commission,
13
compliance with all applicable provisions of this Agreement.
ACCESS shall obtain and maintain all necessary Regulatory
Approvals with respect to the Manufacture and supply to WYETH
of the Product. To the extent necessary for the Regulatory
Approval of the Product, ACCESS, shall permit the inspection of
its premises and the Facility by Regulatory Authorities and
shall supply all documentation and information requested by
WYETH or such Regulatory Authority to obtain or maintain
Regulatory Approval of the Product.
3.2 Manufacturing Quality; Storage.
All Product shall be Manufactured by ACCESS at the Facility
using Materials and processing aids free of animal derived
materials. ACCESS shall sample and analyze all Materials upon
receipt to ensure that such Materials are unadulterated, free
of defects and meet the applicable Specifications therefor.
ACCESS shall take all necessary steps to prevent contamination
and cross contamination of Product. The Product shall be
unadulterated and free from contamination, dilutents and
foreign matter in any amount in accordance with the Product
specifications and generally accepted pharmaceutical standards.
ACCESS shall perform the quality control tests (both when the
Product is in-process and when it is finished) with respect to
the Product in accordance with the Methods of Analysis, the
cost of such to be included in the price hereinafter specified.
ACCESS shall promptly, upon completion of such tests, deliver
to WYETH a copy of the record of such tests performed on, and
a Certificate of Analysis for, each Batch of Product. ACCESS
shall deliver a representative sample from each Batch of
Product to WYETH's designated representative by the date
reasonably specified by such representative. Within thirty
(30) days of the Effective Date, each of the Parties shall
execute and deliver the Quality Agreement substantially in the
form of Exhibit C and as mutually agreed to by the parties. Each Party
agrees to perform its respective obligations under the Quality Agreement in
accordance with such agreement. Prior to shipment, the Product shall be
stored at all times in conditions at least as favorable as those set forth on
the Product's label, or in accordance with conditions reasonably specified
by WYETH.
3.3 Testing by WYETH.
WYETH may test the Product samples in accordance with the applicable
Methods of Analysis. If the analysis of any Product performed by or for
WYETH differs from ACCESS's analysis of the same Batch, WYETH shall
advise ACCESS and ACCESS and WYETH agree to consult with each
other in order to explain and resolve the discrepancy between each other's
determination. If, after good faith attempt by the Parties to do so, such
consultation does not resolve the discrepancy, an independent, reputable
laboratory as mutually agreed by the Parties shall repeat the applicable
Methods of Analysis on representative samples from such Batch provided
by both ACCESS and WYETH. The costs of the independent laboratory
referred to above shall be borne by (a) WYETH if such laboratory
determines that the Product conforms to the Specifications or (b) ACCESS
if such laboratory determines that the Product does not conform to the
Specifications. If so requested by WYETH in writing, ACCESS shall
promptly send a new Batch of the Product (of similar quantity as to the
amount of such Product being analyzed as set forth above) to WYETH.
WYETH shall not be obligated to pay for any of the Product (and if
WYETH has paid for such Product ACCESS shall promptly reimburse WYETH
14
for the cost of replacing such Product, including, without
limitation, related costs such as testing and transportation costs) that such
laboratory determines does not conform to the Specifications, but shall be
obligated to pay for any new Batch of Product that is sent as specified
above; provided that WYETH must destroy (and certify destruction of) such
non-conforming Product.
3.4 Samples and Record Retention.
ACCESS shall retain records and retention samples of each Batch of the
Product for at least thirty-eight (38) months after the expiration date of that
Batch and shall make the same available to WYETH upon request.
Retention samples shall only be destroyed after the required holding period;
provided that in the event that WYETH provides written notice to ACCESS
during such thirty-eight (38) month period that it desires ACCESS to retain
such retention samples for a longer period of time, then ACCESS shall
comply with such request until notified by WYETH that the sample need
no longer be retained. During and after the Term of this Agreement
ACCESS shall reasonably assist WYETH with respect to any complaint,
issue or investigation relating to the Product.
3.5 Inspection.
ACCESS shall give access to representatives of WYETH, at all reasonable
times during regular business hours, to the Facility and any other facility
in which Product is Manufactured, tested, packaged and/or stored, and to
all Manufacturing records with respect to the Product, for the purpose of
inspection. WYETH shall have the right while at any such Facility to
inspect and copy (provided that to the extent that such copies constitute
ACCESS Confidential Information (or Confidential Information of
ACCESS's Third Party Manufacturer) they shall be subject to the
provisions of Article 9) records and Regulatory Approvals solely to evaluate
work practices and compliance with all applicable FDA and other
Regulatory Authority laws and regulations, occupational health and safety,
and environmental laws and regulations, GMP and warehousing practices
and procedures. The conduct of (or right to conduct) any inspection under
this Section 3.5 does not impose upon WYETH responsibility or liability
for the operation of the Facility. Such inspection shall be conducted after
prior written notice to ACCESS, will be conducted consistently with the
WYETH policies and procedures provide to ACCESS as of the Effective
Date (and as such policies and procedures are modified and provided in
writing to ACCESS from time to time, which modified policies and
procedures shall not conflict with any of the provisions of this Agreement)
and in a manner that is not disruptive to ACCESS's operations, and shall
not be more frequent than is reasonable.
3.6 Adverse Drug Experience Reporting.
Each Party shall fully, accurately and promptly provide the other Party with
all data known to it at any time during the Term of this Agreement or
thereafter, which data indicate that any Product is or may be unsafe, lacks
utility, or otherwise does not meet the Specifications in accordance with the
Adverse Event Reporting Procedures set forth in Exhibit D attached hereto
(as the same may be amended from time to time by notice in writing from
WYETH to ACCESS; provided that such amendment shall not conflict with
any of the provisions of this
15
Agreement). WYETH shall determine whether such information is required to
be reported to the FDA and any other Regulatory Authority.
3.7 Recalls and Seizure.
3.7.1 Each Party shall keep the other Party promptly and fully informed
of any notification or other information whether received directly or
indirectly which might result in the Recall or Seizure of the Product. If
either Party determines that it is necessary to Recall any Product, it shall
immediately notify the other Party and, prior to commencing any Recall,
the Parties shall consult with one another to determine whether or not a
Recall is necessary. If it is mutually agreed that a Recall is necessary (or
if WYETH determines, in its sole discretion, that a Recall is necessary),
then the parties shall meet and determine the manner in which the Recall
is to be carried out and review any instructions or suggestions of the
applicable Regulatory Authorities. ACCESS and WYETH shall effect the
Recall in the manner agreed upon between the Parties in as expeditious a
manner as possible and in such a way as to cause the least disruption to the
sales of any Product and to preserve the goodwill and reputation associated
with the Product. In any such situation, WYETH shall have the right to
make all final decisions regarding such Recall.
3.7.2 In the event that a Recall results from any cause or event arising
from ACCESS's breach of Sections 2.9, 3.1, 3.2, 3.4, 3.6. 3.8 or the
representations set forth in Sections 6.2.1, 6.2.4 or 6.2.5 and/or the
defective Manufacture, storage or handling of the Product by ACCESS
(excluding defects relating to packaging or labeling supplied by or prepared
at and in accordance with the direction of WYETH), ACCESS shall be
responsible for all expenses of the Recall incurred by WYETH and
ACCESS shall promptly replace such Product at no additional cost to
WYETH consistent with directions received from the appropriate
Regulatory Authority. In the event that a Recall results from any cause or
event arising from defective Manufacture, storage, handling, or distribution
of the Product by WYETH or its Affiliates, distributors or contractors
(including but not limited to defective Manufacture, storage, handling or
distribution undertaken at the direction of WYETH and consistently with
WYETH's instructions), WYETH shall be responsible for the expenses of
the Recall, including the cost of replacement Product. For the purposes of
this Agreement, the expenses of a Recall shall include, without limitation,
the expenses of notification and destruction or return of the recalled Product
and all other costs incurred in connection with such Recall, including
reasonable costs and attorneys' fees, but shall not include lost profits of
either party.
3.8 Environmental, Occupational Health and Safety.
3.8.1 ACCESS shall promptly report to WYETH after any of the following
incidents related to the Manufacturing operations hereunder occurs: (a)
fatalities and/or significant injuries or occupational illness; (b) property
damage in excess of $50,000; (c) inspections by any environmental
protection agency or occupational health and safety agency; or (d) requests
for information, notices of violations or other significant governmental and
safety agency communications relating to environmental, occupational
health and safety compliance.
16
3.8.2 ACCESS shall only use waste haulers, brokers and disposal sites
which WYETH has approved in writing for hazardous waste generated by
the Manufacturing operations. As between ACCESS and WYETH,
ACCESS shall have title to and be responsible for disposing in an
environmentally safe manner all residue and waste resulting from the
Manufacturing operations performed hereunder. ACCESS shall not use
WYETH trademarks or trade dress to identify any waste materials or
residues.
4. MANUFACTURING CHANGES
4.1 Voluntary Changes.
ACCESS shall not make, nor shall any other Person make, any changes to
the Manufacturing process, the Manufacturing equipment, the
Specifications, the Materials, the sources of Materials or the Methods of
Analysis without the prior written consent of WYETH. If either Party
requests in writing a change in the Manufacturing process, the
Manufacturing equipment, the Specifications, the Materials, the source of
Materials or Methods of Analysis with respect to the Product that is not the
result of a requirement of the FDA or any other Regulatory Authority, the
other Party shall use commercially reasonable efforts to make or accept
such change, as the case may be. The requesting Party shall provide the
other Party with a detailed written report of all proposed changes to the
Manufacturing process, the Manufacturing equipment, the Specifications,
the Materials, the sources of Materials or the Methods of Analysis.
4.2 Required Changes.
If the FDA or any other Regulatory Authority requests or requires, or takes
any action that requires, any change in the Manufacturing process, the
Manufacturing equipment, the Specifications, the Materials, the source of
Materials or Methods of Analysis with respect to the Product, the Parties
shall meet and discuss an implementation plan for such change and use
commercially reasonable efforts to accommodate as soon as practicable such
change to meet the FDA's or such other Regulatory Authority's
requirements. Each Party will bear its respective costs associated with, or
incurred as a result of, such change. Each Party agrees to promptly
forward to the other copies of any written communication received by such
Party from the FDA or any other Regulatory Authority that may affect the
Manufacture, supply, or distribution of the Product as contemplated herein.
5. PRICE AND PAYMENT
5.1 Price.
ACCESS shall invoice WYETH for the Product supplied to WYETH
hereunder at the applicable price per Product set forth on Exhibit E. The
cost of the Product shall be comprised of four components: Materials,
labor, fixed overhead and variable overhead. The cost of each such
component will be set forth in Exhibit E within sixty (60) days after the
Effective Date, and shall remain in effect unless and until the price of the
Product is adjusted pursuant to this Article 5.
17
5.2 Price Adjustment.
5.2.1 Commencing on any date in the second Contract Year, ACCESS
may adjust the then-current price to reflect documented increases or
decreases in labor costs, variable overhead costs or the acquisition cost of
Materials per unit of Product at the beginning of the Contract Year in
question as compared to the acquisition cost of such labor, variable
overhead or Materials per unit of Product at the beginning of the
immediately preceding Contract Year; provided that ACCESS gives
WYETH not less than ninety (90) days' prior written notice of any price
increase or decrease and that ACCESS may not increase the price more
than once during any Contract Year; and provided, further, that except as
provided in Section 5.2.2, any price increase per unit of Product shall not
exceed the PPI Adjustment for the Contract Year in question. Until the
effective date of such price increase, ACCESS shall supply WYETH such
Product at the prices then in effect without such price increase. "PPI
Adjustment" means for the Contract Year in question, the amount calculated
in accordance with the following formula:
MC x PPI - BPPI
BPPI
Where,
MC = the documented labor costs, variable overhead costs and the
acquisition cost of all Materials per unit of Product at the beginning of the
Contract Year immediately preceding the Contract Year in question;
BPPI = the Bureau of Labor Statistics Producer's Price Index for
Pharmaceutical Preparations (Code 2834) for the first month of the Contract
Year immediately preceding the Contract Year in question; and
PPI = the Bureau of Labor Statistics Producer's Price Index for
Pharmaceutical Preparations (Code 2834) for the first month of the Contract
Year in question.
Notwithstanding anything to the contrary contained in this Section 5.2.1,
there shall be no price increases made due to any increases with respect to
the fixed overhead component of the cost of the Product.
5.2.2 Notwithstanding anything to the contrary in Section 5.2.1, in the
event of an extraordinary event that results in a documented material
increase (with "material increase" meaning, for purposes of this Section
5.2.2, an increase of at least fifteen (15%) percent in the aggregate) in the
collective cost of a major component of Manufacturing for the Product (as
such components are set forth in Exhibit E) during any annual period after
the end of the first Contract Year (an "Extraordinary Event Increase"),
ACCESS need not wait until the next annual period to adjust the pricing for
the Product. Upon ACCESS's determination that an Extraordinary Event
Increase has occurred, ACCESS shall notify WYETH in writing of the
applicable price adjustment, together with supporting documentation
evidencing such change including without
18
limitation, evidence that ACCESS shall have used its commercially reasonable
efforts to secure alternative sources of supply for any components or
consumables, at lesser costs without detracting from the quality or efficacy
of the Product. Any such pricing adjustment will become effective thirty (30)
days following the date of ACCESS's written notice thereof.
5.3 Continuous Improvement Price Adjustment.
Continuous improvement initiatives, mutually agreeable to the Parties shall
be established annually to provide for attempting to achieve continuous cost
reductions during the Term hereof. Continuous improvement teams
consisting of equal representation from each Party shall use reasonable
efforts to work to identify and implement cost savings at a targeted rate of
five percent (5%) of WYETH's purchase price per Contract Year. Any
documented savings shall be allocated to the Parties in proportion to the
level of contribution by each party to realize the savings. Any cost savings
allocated to WYETH shall be in the form of reduced purchase price,
effective (with respect to any subsequent WYETH purchase orders)
immediately upon documentation and allocation of the savings.
5.4 License Payments.
During the Term, the license payments set forth in Exhibit F shall be due
and payable from WYETH to ACCESS within ten (10) days of the
occurrence of the applicable milestone set forth in Exhibit F.
5.5 Royalty Payments.
In addition to the payments set forth above, WYETH shall pay to ACCESS
a royalty (the "Royalty"), on a country-by-country basis in the Territory,
equal to * percent ( * %) of Net Sales of the Product in such country
during each calendar quarter (or portion thereof) during the Term (each
such period, a "Royalty Period"), commencing as of the date on which the
Product is sold by WYETH for the first time to a Third Party for
commercial distribution in such country. If, during the Term, in any
country in the Territory, (a) another * (other than those
containing amlexanox as an active ingredient)
for oral pain (excluding sore throat pain) becomes commercially available,
which has the same labeling and indications on the Product and which
adversely impacts either the sales price or the unit volume by greater than
* percent ( * %), or (b) ACCESS exercises its rights under Section 2.2
to convert the exclusive license with respect to a country to a non-exclusive
license, then the Royalty with respect to such country shall be immediately
reduced to * percent ( * %). Each Royalty will be payable not later
than forty-five (45) days following the expiration of each applicable Royalty
Period. WYETH shall pay the Royalty with respect to a country that
accrues during the Term of this Agreement for so long as the license
granted by ACCESS under Section 2.1.1 remains in effect in such country.
WYETH will include with each such payment a written report detailing (i)
the number of Product units, per country, and the sales price of such
Product units by WYETH and its Affiliates; and (ii) Net Sales of the
Product during the applicable Royalty Period, all in a manner consistent
with WYETH's internal sales reporting.
* - Confidential portions have been omitted and are on file separately
with the Commission.
19
5.6 Payment.
WYETH shall pay invoices for Product delivered hereunder not later than
thirty (30) days after the later of receipt of Product covered by such invoice
and receipt of such invoice.
5.7 Taxes and Other Charges.
All Product prices are exclusive of taxes, shipping costs to the point of
delivery, customs duties and other charges, and WYETH agrees to bear and
be responsible for the payment of all such charges imposed, excluding taxes
based upon ACCESS's net income.
5.8 Audit Rights.
5.8.1 WYETH shall have the right, at its own expense, to access the books
and records of ACCESS and its Affiliates as may be reasonably necessary
to verify the accuracy of the labor costs and Material costs referred to in
Section 5.2. Such access shall be conducted after thirty (30) days' prior
written notice to ACCESS and during ordinary business hours, will be
conducted in a manner that is not disruptive to ACCESS's operations, and
shall not be more frequent than once per Contract Year or in respect of any
Contract Year ending not more than twenty-four (24) months prior to the
date of such notice. Subject to Section 5.8.3, if such independent certified
public accountant's report shows any overpayment by WYETH, ACCESS
shall remit to WYETH within thirty (30) days after ACCESS's receipt of
such report, (a) the amount of such overpayment, and (b) if such
overpayment exceeds five percent (5%) of the total amount owed for the
period then being audited, the reasonable fees and expenses of any
independent accountant performing the audit on behalf of WYETH. Subject
to Section 5.8.3, if such independent certified public accountant's report
shows any underpayment by WYETH, WYETH shall pay to ACCESS
within thirty (30) days after WYETH's receipt of such report, the amount
of such underpayment. Any audit or inspection conducted under this
Agreement by WYETH or its agents or contractors will be subject to the
confidentiality provisions of this Agreement, and WYETH will be
responsible for compliance with such confidentiality provisions by such
agents or contractors.
5.8.2 WYETH shall maintain books of account with respect to its sales of
the Product in each country in the Territory. ACCESS shall have the right,
not more than once during each calendar year, to have an independent
accountant selected and retained by ACCESS to inspect and examine such
books of WYETH during regular business hours for the purpose of
verifying the statements of the aggregate Net Sales resulting from sales of
Product and determining the correctness of the Royalties paid. Subject to
Section 5.8.3, if such independent certified public accountant's report shows
any underpayment by WYETH, WYETH shall pay to ACCESS within
thirty (30) days after WYETH's receipt of such report, (a) the amount of
such underpayment, and (b) if such underpayment exceeds five percent
(5%) of the total amount owed for the period then being audited, the
reasonable fees and expenses of any independent accountant performing the
audit on behalf of ACCESS. Subject to Section 5.8.3, if such independent
certified public accountant's report shows any overpayment by WYETH,
ACCESS shall remit to WYETH within thirty (30) days after ACCESS's
receipt of such report, the amount
20
of such overpayment. Any audit or
inspection conducted under this Agreement by ACCESS or its agents or
contractors will be subject to the confidentiality provisions of this
Agreement, and ACCESS will be responsible for compliance with such
confidentiality provisions by such agents or contractors.
5.8.3 If any dispute arises under this Section 5.8 between the Parties
relating to overpayments or underpayments, and the Parties cannot resolve
such dispute within thirty (30) days of a written request by either Party to
the other Party, the Parties shall hold a meeting, attended by the Chief
Executive Officer or President of each party (or their respective designees),
to attempt in good faith to negotiate a resolution of the dispute. If, within
sixty (60) days after such meeting request, the Parties have not succeeded
in negotiating a resolution of the dispute, either Party may pursue any other
available remedy, including, upon prior written notice to the other Party,
instituting legal action.
5.9 Late Payments.
If any payment due to ACCESS under this Agreement is not received by
ACCESS within ten (10) days of the due date, then, commencing from the
date on which such payment was due the amount of such payment shall
accrue interest calculated at an annual rate equal to the prime rate plus two
percent (2%) until such time as payment of the overdue amount is made in
full; provided that no interest shall accrue on any amounts being disputed
in good faith by WYETH with respect to which WYETH is making diligent
and good faith efforts to resolve.
5.10 Currency Exchange.
All payments to be made pursuant to this Agreement shall be made in
United States dollars. Amounts based on Net Sales in currencies other than
United States dollars shall be converted on the last business day of each
calendar month to United States dollars at the WYETH financial statement
exchange rate applied by WYETH on a consistent basis in WYETH's own
financial accounting.
6. REPRESENTATIONS AND WARRANTIES
6.1 Representation and Warranties of Each Party.
Each of WYETH and ACCESS hereby represents, warrants and covenants
to the other Party hereto as follows:
6.1.1 it is a corporation or entity duly organized and validly existing under
the laws of the state or other jurisdiction of incorporation or formation;
6.1.2 the execution, delivery and performance of this Agreement by such
Party has been duly authorized by all requisite corporate action and do not
require any shareholder action or approval;
21
6.1.3 it has the power and authority to execute and deliver this Agreement
and to perform its obligations hereunder;
6.1.4 the execution, delivery and performance by such Party of this
Agreement and its compliance with the terms and provisions hereof does
not and will not conflict with or result in a breach of any of the terms and
provisions of or constitute a default under (a) a loan agreement, guaranty,
financing agreement, agreement affecting a product or other agreement or
instrument binding or affecting it or its property; (b) the provisions of its
charter or operative documents or by laws; or (c) any order, writ,
injunction or decree of any court or governmental authority entered against
it or by which any of its property is bound; and
6.1.5 it shall comply with all applicable laws and regulations relating to its
activities under this Agreement.
6.2 Representations and Warranties of ACCESS.
ACCESS hereby further represents and warrants to WYETH that:
6.2.1 as of the date of each delivery of the Product by ACCESS to a
carrier, the Product (a) has been Manufactured, stored and shipped in strict
accordance with GMPs, all applicable laws, rules, regulations or
requirements and all applicable Regulatory Approvals in effect at the time
of Manufacture; (b) conforms to the Specifications and the Quality
Agreement, and is free from defects and are merchantable; (c) is not
adulterated or misbranded; and (d) has been shipped and stored in
accordance with procedures requested by WYETH;
6.2.2 as of the date of each delivery of the Product by ACCESS to a
carrier, ACCESS has good and marketable title to the Product and the
Product is free from all liens, charges, encumbrances and security interests;
6.2.3 to ACCESS's actual knowledge as of the Effective Date, the
Manufacture, use, importation, offer for sale and sale of the Product does
not infringe any intellectual property rights of any Third Party within the
Territory;
6.2.4 as of the date of each delivery of the Product by ACCESS to a
carrier, neither ACCESS not any Affiliate, contractor or Third Party
manufacturer of ACCESS, used or uses in any capacity the services of any
person debarred under the U.S. Generic Drug Enforcement Act, 21 USA
%335a(k)(l) and further it did not use any person who has been convicted
of a crime as defined under the Generic Drug Enforcement Act in
connection with the Manufacture of Product;
6.2.5 as of the date of each delivery of the Product by ACCESS to a
carrier, ACCESS possesses all necessary Regulatory Approvals relating to
ACCESS's Manufacture and supply to WYETH of the Product;
6.2.6 as of the Effective Date, U.S. Patent No. * is existing and has not
* - Confidential portions have been omitted and are on file separately
with the Commission.
22
been held to be invalid or unenforceable, in whole or in part;
6.2.7 as of the Effective Date, ACCESS is the sole and exclusive owner
of the Intellectual Property Rights existing as of the Effective Date, all of
which are free and clear of any liens, charges and encumbrances (other than
any licenses granted by ACCESS to Third Parties, which grants do not
conflict with the license grants to WYETH hereunder);
6.2.8 as of the Effective Date, and, except as disclosed to WYETH in
writing, as of the date of each delivery of the Product by ACCESS to a
carrier, ACCESS has received no notice that the practice of the Intellectual
Property Rights or the ▇▇▇▇ are subject to an infringement claim of any
issued patent or ▇▇▇▇ owned or possessed by any Third Party within the
Territory;
6.2.9 as of the Effective Date, the Intellectual Property Rights are not the
subject to any funding agreement with any government or governmental
agency; and
6.2.10 as of the Effective Date, or within ten (10) days thereof, ACCESS
has provided WYETH with any and all information relating to the Product,
its Manufacture and formulation necessary for WYETH to conduct a
freedom to operate opinion relating to the Territory, and all information has
been provided so that WYETH may complete its due diligence.
6.3 No Presumption.
Each Party hereto represents that it has been represented by legal counsel
in connection with this Agreement and acknowledges that it has participated
in the drafting hereof. In interpreting and applying the terms and
provisions of this Agreement, the Parties agree that no presumption shall
exist or be implied against the Party which drafted such terms and
provisions.
6.4 Remedy.
As WYETH's sole and exclusive remedy for any breach of Section 6.2.1
discovered prior to the distribution by WYETH or its Affiliates of the
applicable Product, ACCESS shall promptly replace, at its sole cost and
expense, any Product which fails to comply with the representations set
forth in Section 6.2.1; provided that such non-conforming Product shall be
returned to ACCESS in accordance with ACCESS's return procedures, and
only if after ACCESS's inspection, such Product is determined to have been
non-conforming pursuant to the procedures set forth in Section 3.3. Except
as otherwise provided expressly in this Agreement, each Party is free to
seek legal and equitable recourse against the other in the event of any
breach of this Agreement (including, without limitation, any breach of such
other Party's obligations, representations, or warranties under this
Agreement), subject to the limitations of liability set forth in Section 6.7
and, in such case, the breaching party shall be liable for all damages,
losses, liabilities, expenses or penalties (excluding attorneys' fees and
expenses) incurred, assessed or sustained by or against the non-breaching
party, its Affiliates, directors, officers, employees or agents arising out of
such breach.
23
6.5 WYETH Responsibility.
WYETH shall not be responsible for any loss or cost incurred by ACCESS
during Manufacture of the Product in compliance with the requirements of
Section 6.2.1.
6.6 Disclaimer.
6.6.1 THE FOREGOING WARRANTIES ARE THE SOLE AND
EXCLUSIVE WARRANTIES GIVEN BY ACCESS WITH RESPECT TO
THE PRODUCTS AND SERVICES PROVIDED HEREUNDER, AND
ACCESS GIVES AND MAKES NO REPRESENTATIONS OR
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, OTHER
THAN THE FOREGOING. WITHOUT LIMITING THE GENERALITY
OF THE FOREGOING, EXCEPT FOR THE WARRANTIES
EXPRESSLY PROVIDED IN SECTION 6, NO IMPLIED WARRANTY
OF MERCHANTABILITY, VALIDITY, NON-INFRINGEMENT, TITLE,
FITNESS FOR ANY PARTICULAR PURPOSE, AND NO IMPLIED
WARRANTY ARISING BY USAGE OF TRADE, COURSE OF
DEALING OR COURSE OF PERFORMANCE IS GIVEN OR MADE BY
ACCESS OR SHALL ARISE BY OR IN CONNECTION WITH ANY
SALE OR PROVISION OF PRODUCTS OR SERVICES BY ACCESS,
OR WYETH'S USE OR SALE OF THE PRODUCT, OR ACCESS'S
AND/OR WYETH'S CONDUCT IN RELATION THERETO OR TO
EACH OTHER. NO REPRESENTATIVE OF ACCESS IS
AUTHORIZED TO GIVE OR MAKE ANY OTHER REPRESENTATION
OR WARRANTY OR TO MODIFY THE FOREGOING WARRANTY IN
ANY WAY.
6.6.2 EXCEPT FOR THE WARRANTIES GIVEN BY WYETH AS
EXPRESSLY PROVIDED IN SECTION 6, WYETH GIVES AND
MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND
OR NATURE, EXPRESS OR IMPLIED, WITH RESPECT TO THE
MATTERS ADDRESSED IN THIS AGREEMENT.
6.6.3 The warranties set forth in this Section 6 do not apply to any non-
conformity of the Product resulting from (a) repair, alteration, misuse,
negligence, abuse, accident, mishandling or storage in an improper
environment by any party other than ACCESS (or its contract
manufacturer), or (b) use, handling, storage or maintenance other than in
accordance with Product Specifications or Product label.
6.7 Limitation of Liability.
ACCESS'S LIABILITY, AND THE EXCLUSIVE REMEDY, IN
CONNECTION WITH THE SALE OR USE OF THE PRODUCT
(WHETHER BASED ON CONTRACT, NEGLIGENCE, BREACH OF
WARRANTY, STRICT LIABILITY OR ANY OTHER LEGAL
THEORY), SHALL BE STRICTLY LIMITED TO ACCESS'S
OBLIGATIONS AND WYETH'S RIGHTS AS SPECIFICALLY AND
EXPRESSLY PROVIDED IN THIS AGREEMENT.
24
IN NO EVENT WHATSOEVER SHALL EITHER PARTY HAVE ANY
LIABILITY, OBLIGATION OR RESPONSIBILITY TO THE OTHER
PARTY OR SUCH OTHER PARTY'S AFFILIATES FOR ANY
INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE
OR EXEMPLARY DAMAGES ARISING IN ANY WAY IN
CONNECTION WITH PRODUCT OR ITS PURCHASE, SALE, USE OR
INABILITY TO USE.
7. INDEMNIFICATION AND INSURANCE
7.1 Indemnification.
7.1.1 ACCESS shall defend, indemnify and hold harmless WYETH, its
Affiliates, directors, officers, employees and agents from and against all
damages, losses, liabilities, expenses, claims, demands, suits, penalties or
judgments or administrative or judicial orders (including, without limitation,
reasonable attorneys' fees and expenses) incurred, assessed or sustained by
or against WYETH, its Affiliates, directors, officers, employees or agents
with respect to a claim by a Third Party arising out of (a) the negligent acts
or omissions of ACCESS; (b) any breach by ACCESS of this Agreement
or its representations, warranties or covenants hereunder; (c) any Recall or
Seizure attributable to ACCESS's performance (including, without
limitation, amounts WYETH pays or credits to its customers for Product
so Recalled or Seized); (d) product liability, tort, nuisance or other claim
arising out of the defective manufacture, storage or supply of the Product
by ACCESS; (e) any allegation that the manufacture, importation, sale,
offer for sale or use of the Product infringes any patent or other intellectual
property, proprietary or protected right within the Territory; provided that
ACCESS will not be obligated to indemnify WYETH if and to the extent
that the alleged infringement is caused by: (i) WYETH's (including, without
limitation, its Affiliates, agents, contractors, and sub-distributors) or its
customers misuse or modification of the Product; or (ii) WYETH's
(including, without limitation, its Affiliates, agents, contractors, and sub-
distributors) or its customers use of the Product in combination with any
products or materials not provided by ACCESS; and further provided that
if the Product is held to constitute an infringement or misappropriation of
any Third Party's intellectual property rights or if in ACCESS's opinion,
the Product is, or is likely to be held to constitute, an infringement or
misappropriation, ACCESS may at its expense and option: (x) procure the
right for WYETH to continue distributing the Product; (y) upon prior
approval by WYETH, which approval will not be unreasonably withheld or
delayed, promptly replace the Product with a non-infringing and non-
misappropriating equivalent product conforming to the applicable Product
Specifications and Regulatory Approvals; provided that there shall not be
any material delay in any such replacement; or (z) upon prior approval by
WYETH, which approval will not be unreasonably withheld or delayed,
modify the Product to make it non-infringing and non-misappropriating
while conforming to the applicable Product Specifications and Regulatory
Approvals; provided that there shall not be any material delay in any such
modification; (f) any enforcement or other action by any Regulatory
Authority relating to the Manufacture, the pricing of the Product by
ACCESS to WYETH or sale of the Product by ACCESS to WYETH; or
(f) ACCESS's failure to comply with any applicable law, regulation or
order (including, without limitation, environmental laws, regulations and
orders). The foregoing indemnification obligation shall not apply in the
event and to the extent that such claim arose as a
25
result of any indemnitee's negligence, intentional misconduct or breach of
this Agreement. The provisions of this Section shall survive the termination
or expiration of this Agreement.
7.1.2 WYETH shall defend, indemnify and hold harmless ACCESS, its
directors, officers, employees and agents from and against all damages,
losses, liabilities, expenses, claims, demands, suits, penalties or judgments
or administrative or judicial orders (including, without limitation,
reasonable attorneys' fees and expenses) incurred, assessed or sustained by
or against ACCESS, its directors, officers, employees or agents with
respect to a claim by a Third Party arising out of (a) the negligent acts or
omissions of WYETH; (b) any breach by WYETH of this Agreement or of
its representations, warranties or covenants hereunder; (c) any allegation
that the Trademarks or WYETH's packaging or WYETH's (or any Affiliate
of WYETH's) marketing materials infringes any patent or other proprietary
or protected right of any Third Party; (d) any Recall or Seizure attributable
to WYETH's performance; (e) any enforcement or other action by any
Regulatory Authority relating to the distribution, the pricing of the Product
by WYETH or sale of the Product by WYETH to Third Parties; (f)
WYETH's failure to comply with any applicable law, regulation or order
(including, without limitation, environmental laws, regulations and orders),
or (g) the marketing and distributing of the Product by WYETH, its
Affiliates or sub-distributors. The foregoing indemnification obligation shall
not apply in the event and to the extent that such claim arose as a result of
any indemnitee's negligence, intentional misconduct or breach of this
Agreement. The provisions of this Section shall survive the termination or
expiration of this Agreement.
7.1.3 To receive the benefit of indemnification under this Section 7.1, the
Party and its Affiliates, directors, officers, employees or agents seeking
indemnification (an "Indemnified Party") shall promptly notify the other
Party (the "Indemnifying Party"), in writing, of any claim asserted or
threatened against such Indemnified Party for which such Indemnified Party
is entitled to indemnification hereunder from the Indemnifying Party. With
respect to any such claim the Indemnified Party shall, at no out-of-pocket
expense to it, reasonably cooperate with and provide such reasonable
assistance to such Indemnifying Party as such Indemnifying Party may
reasonably request. Such reasonable assistance may include, without
limitation, providing copies of all relevant correspondence and other
materials that the Indemnifying Party may reasonably request. The
obligations of an Indemnifying Party under Sections 7.1.1 and 7.1.2 are
conditioned upon the delivery of written notice to the Indemnifying Party
of any asserted or threatened claim promptly after the Indemnified Party
becomes aware of such claim; provided that the failure of the Indemnified
Party to give such notice or any delay thereof shall not affect the
Indemnified Party's right to indemnification hereunder, except to the extent
that such failure or delay impairs the Indemnifying Party's ability to defend
or contest any such claim. The Indemnifying Party shall have the right to
assume the defense of any suit or claim for which indemnification is sought
with counsel reasonably acceptable to the Indemnified Party. If the
Indemnifying Party defends the suit or claim, the Indemnified Party may
participate in the defense thereof at its sole cost and expense. An
Indemnifying Party may not settle a suit or claim without the consent of the
Indemnified Party if (a) such settlement would impose any monetary
obligation on the Indemnified Party for which indemnification is not
provided hereunder, (b) or require the Indemnified Party to submit to an
injunction or otherwise limit the Indemnified Party's rights under this
Agreement, or (c) does not include a release of the Indemnified Party
26
from all liability arising out of such suit or claim. Any payment made by an
Indemnifying Party to settle any such suit or claim shall be at its own cost
and expense.
7.1.4 The indemnification provided by this Section 7 shall be the Parties'
sole and exclusive remedy in connection with any third party claim.
7.2 Insurance.
At the time of Launch and continuing through the Term of this Agreement,
ACCESS shall maintain the following kinds of insurance with the minimum
limits set forth below.
Kind of Insurance Minimum Limits
Commercial General Liability, including
Contractual, Completed Operations and
Product Liability $2,000,000 Per Occurrence
$5,000,000 Aggregate
Workers Compensation Statutory with Employer's Liability
of not less than $1,000,000
Per Accident/Disease
Automobile Bodily Injury Liability
(including hired automobile and non-
ownership Liability) $1,000,000 Each Accident
Combined Single Limit
Upon request, ACCESS shall furnish insurance certificates as
directed by WYETH, satisfactory in form and substance to WYETH,
showing the above coverages, and providing for at least thirty (30) days'
prior written notice to WYETH by the insurance company of cancellation
or modification. WYETH shall be named as an additional insured on the
ACCESS's policies. Coverage shall be procured with carriers having an
A.M. Best rating of A-VII or better.
8. TERM AND TERMINATION
8.1 Term.
This Agreement shall commence on the Effective Date and
continue, unless sooner terminated as set forth below in this Article 8 or
as otherwise specifically stated in this Agreement, for the duration of the
Term.
8.2 Termination Without Cause.
WYETH may terminate this Agreement at any time (a)
after Launch by giving twelve (12) months prior written notice to
ACCESS if WYETH, in its sole discretion, determines to cease
marketing the Product, or (b) prior to Launch by giving thirty (30) days
prior written notice to ACCESS if WYETH, in its sole discretion,
determines not to Launch the Product. If
27
WYETH terminates this
Agreement pursuant to subsection (a) above, WYETH is not obligated to
transfer to ACCESS any data relating to the Product (including, without
limitation, marketing studies or otherwise) that WYETH generated prior
to such termination. If WYETH terminates this Agreement pursuant to
subsection (b) above, then, subject to the exceptions set forth in Section
8.3, WYETH shall transfer to ACCESS any data relating solely to the
Product that WYETH generated, excluding any NDAs.
8.3 Pre-Launch Termination.
In the event that, prior to Launch, WYETH terminates this
Agreement in accordance with Section 8.2(b) above, and such
termination is for any of the following reasons, then WYETH shall have
no obligation to provide to ACCESS any data relating to the Product
(including, without limitation, marketing studies or otherwise) that
WYETH generated prior to such termination: (a) ACCESS fails to
provide an approvable Third Party manufacturer of the Product in
accordance with Section 2.9, (b) WYETH and ACCESS are unable to
mutually agree upon a final development plan (including, without
limitation, exhibits setting forth the Methods of Analysis and
Specifications), as described in Section 2.10, in a timely manner, (c)
WYETH and ACCESS are unable to mutually agree upon a final Exhibit
E (Prices) in a timely manner, (d) consumer use testing of the Product
generates negative reactions from consumers, (e) the cost of purchasing
and marketing the Product relative to the effective retail price of the
Product makes the sale of the Product, in WYETH's sole determination,
not viable, (f) the stages of a mutually agreed upon development plan are
not completed in accordance with Section 2.10 (through no fault of
WYETH), (g) breach of the Agreement, or (h) ACCESS fails to
complete and validate Manufacturing process, scale up and all other
obligations set forth in Section 2.11.
8.4 Termination for Regulatory Action or Claim of Infringement.
WYETH may terminate this Agreement in its entirety
immediately if the FDA or any other Regulatory Authority takes any
action, the result of which is to prohibit or permanently or otherwise
restrict the Manufacture, storage, importation, sale, offer for sale or use
of the Product in any way that will have a material, adverse effect on the
sale price or sales volumes of the Product, or if any claim is made that
the Manufacture, storage, importation, sale, offer for sale or use of the
Product infringes any patent or other proprietary or protected right of
any Third Party.
8.5 Termination for Breach.
If either Party shall at any time fail to discharge any of its
obligations hereunder and shall fail to correct such default within thirty
(30) days after the other Party shall have given written notice to it
thereof, the aggrieved Party shall be entitled to notify the other Party
that it intends to terminate this Agreement unless such default is
corrected and may so terminate ten (10) days after the end of such thirty
(30) day period if such default is continuing; provided that if such default
by the other Party shall be a recurring default and the other Party does
not reasonably satisfy the aggrieved party that such defaults shall cease
to occur, the aggrieved Party shall be entitled to terminate this
Agreement upon the occurrence of such default and the other
28
Party shall not be entitled to correct such default.
8.6 Termination for Bankruptcy.
If either Party by voluntary or involuntary action goes into
liquidation, dissolves or files a petition for bankruptcy or suspension of
payments, is adjudicated bankrupt, has a receiver or trustee appointed for
its property or estate, becomes insolvent or makes an assignment for the
benefit of creditors, the other Party shall be entitled by notice in writing
to such Party to terminate this Agreement forthwith.
8.7 Effect of Termination.
Termination or expiration of this Agreement, in whole or
in part, shall be without prejudice to the right of either Party to receive
all payments accrued and unpaid at the effective date of such termination
or expiration, without prejudice to the remedy of either Party in respect
to any previous breach of any of the representations, warranties or
covenants herein contained and without prejudice to any other provisions
hereof which expressly or necessarily call for performance after such
termination or expiration.
8.8 WYETH's Rights on Termination.
Upon termination or expiration of this Agreement for any
reason, then (a) at WYETH's request, ACCESS shall supply WYETH
with its inventory of Materials, Product and/or works-in-progress for the
Manufacture, packaging and labeling of Product and WYETH shall pay
ACCESS the manufacturing fee for the Product, a prorated portion
thereof for work-in-progress commenced against firm orders by WYETH
and the cost of Materials; and (b) at WYETH's request, ACCESS shall
return to WYETH all retention samples of the Product.
8.9 Survival.
The following provisions shall survive the expiration or
termination of this Agreement: Sections 3.4, 3.6, 3.7, 5.5, 5.6, 5.7, 5.8,
5.9, 5.10, 7.1, 8.7, 8.8, 8.9, and 8.10 and Articles 6, 9, 11, 12 and 13.
9. CONFIDENTIALITY
9.1 Nondisclosure Obligation.
Each of ACCESS and WYETH shall use only in
accordance with this Agreement and shall not disclose to any Third Party
the Confidential Information received by it from the other Party pursuant
to this Agreement, without the prior written consent of the other Party.
The foregoing obligations shall survive for a period of five (5) years
after the termination or expiration of this Agreement. These obligations
shall not apply to Confidential Information that: (a) is known by the
receiving Party at the time of its receipt, and not through a prior
disclosure by the disclosing Party, as documented by business records;
(b) is at the time of disclosure or
29
thereafter becomes published or
otherwise part of the public domain without breach of this Agreement by
the receiving Party; (c) is subsequently disclosed to the receiving Party
by a Third Party who has the right to make such disclosure; (d) is
developed by the receiving Party independently of the Confidential
Information received from the disclosing Party and such independent
development can be documented by the receiving Party; or (e) is
required by law, regulation, rule, act or order of any governmental
authority or agency to be disclosed by a Party, provided that notice is
promptly delivered to the other Party in order to provide an opportunity
to seek a protective order or other similar order with respect to such
Confidential Information and thereafter the disclosing Party discloses to
the requesting entity only the minimum Confidential Information required
to be disclosed in order to comply with the request, whether or not a
protective order or other similar order is obtained by the other Party.
9.2 Permitted Disclosures.
Each Party may disclose the other Party's Confidential
Information to its employees and Affiliates on a need-to-know basis and
to its agents or consultants to the extent required to accomplish the
purposes of this Agreement; provided that the recipient Party obtains
prior agreement from such agents and consultants to whom disclosure is
to be made to hold in confidence and not make use of such Confidential
Information for any purpose other than those permitted by this
Agreement. Each Party will use at least the same standard of care as it
uses to protect proprietary or confidential information of its own to
ensure that such employees, agents, consultants, and Affiliates do not
disclose or make any unauthorized use of the other Party's Confidential
Information.
9.3 Disclosure of Agreement.
Neither ACCESS nor WYETH shall release to any Third
Party or publish in any way any non-public information with respect to
the terms of this Agreement without the prior written consent of the
other Party, which consent shall not be unreasonably withheld or
delayed, provided that either Party may disclose the terms of this
Agreement (a) to the extent required to comply with applicable laws,
including, without limitation, the rules and regulations promulgated by
the United States Securities and Exchange Commission; provided,
further, that prior to making any such disclosure, the Party intending to
so disclose the terms of this Agreement shall (i) provide the
nondisclosing Party with written notice of the proposed disclosure and an
opportunity to review and comment on the intended disclosure which is
reasonable under the circumstances and (ii) shall seek confidential
treatment for as much of the disclosure as is reasonable under the
circumstances, including, without limitation, seeking confidential
treatment of any information as may be requested by the other Party; or
(b) to one or more Third Parties and/or their advisors in connection with
a proposed spin-off, joint venture, divestiture, merger or other similar
transaction involving all, or substantially all, of the Product, assets or
business of the disclosing Party to which this Agreement relates or to
lenders, investment bankers and other financial institutions of its choice
solely for purposes of financing the business operations of such Party;
provided, further, that either (i) the other Party has consented to such
disclosure or (ii) such Third Parties have signed confidentiality
agreements with respect to such information on terms no less restrictive
than those contained in this Article 9; or (c) to its legal counsel.
30
9.4 Publicity.
All publicity, press releases and other announcements
relating to this Agreement or the transactions contemplated hereby shall
be reviewed in advance by, and shall be subject to the approval of, both
Parties.
10. FORCE MAJEURE
If the Manufacture, production, delivery, acceptance or
use of Product specified for delivery under this Agreement or if the
performance of any other obligation hereunder is prevented, restricted or
interfered with by reason of fires, accidents, explosions, earthquakes,
floods, breakdown of plant, embargoes, government ordinances or
requirements, civil or military authorities, acts of God or of the public
enemy, or other similar causes beyond the reasonable control of the
Party whose performance is affected (any of the foregoing a "Force
Majeure Event"), then the Party affected, upon giving prompt written
notice to the other Party, shall be excused from such performance on a
day-for-day basis to the extent of such prevention, restriction, or
interference (and the other Party shall likewise be excused from
performance of its obligations on a day-for-day basis to the extent such
Party's obligations relate to the performance so prevented, restricted or
interfered with); provided that the Party so affected shall use
commercially reasonable efforts to avoid or remove such causes of non-
performance and both Parties shall proceed to perform their obligations
with dispatch whenever such causes are removed or cease. If such Force
Majeure Event continues for a period of ninety (90) consecutive days or
more and as a result either party has been unable to perform its
obligations under this Agreement for such ninety (90) day period, the
other Party may terminate this Agreement effective immediately, upon
delivery of a notice of termination in writing, provided that such event of
Force Majeure Event is continuing. If as a result of any Force Majeure
Event above, ACCESS is unable to fully supply WYETH's orders
hereunder, ACCESS shall allocate all available quantities of Materials
and Product to WYETH in the ratio that the quantities ordered by
WYETH in the twelve (12) month period immediately preceding such
force majeure event bears to ACCESS's requirements for its own use
and for supply to Third Parties for that same period; provided that if this
Agreement has not been in effect for a full twelve (12) month period,
then such shorter period shall be used in lieu of a twelve (12) month
period.
11. INTELLECTUAL PROPERTY
11.1 Trademarks; WYETH Intellectual Property.
11.1.1 WYETH may advertise, promote, market
and sell the Product either separately or as part of other products under
any of its Trademarks and/or trade dress, whether registered or
unregistered, in its sole discretion; provided that except as otherwise
expressly permitted under Section 2.1.4 with respect to the ▇▇▇▇,
WYETH may not use or adopt any ACCESS Trademark or trade dress,
or any such item confusingly similar thereto used or intended to be used
prior to the first use of such Trademark. ACCESS shall have no right,
title or interest in or to any such Trademark or trade dress, and WYETH
shall have no right, title or interest in or
31
to any such ACCESS Trademark (except for the license to the ▇▇▇▇ granted
under Section 2.1.4). So long as WYETH or any Affiliate of WYETH shall have
any interest in any such Trademark or trade dress, whether registered or
unregistered, whether as proprietor, owner, or licensee in any country of
the world, ACCESS shall not adopt, use, apply for registration, register
or own such Trademark or trade dress, or any such item confusingly
similar thereto in any country of the world, or take any action which
weakens or undermines WYETH's proprietary rights therein. So long as
ACCESS or any Affiliate of ACCESS shall have any interest in any such
ACCESS Trademark or trade dress, whether registered or unregistered,
whether as proprietor, owner, or licensee in any country of the world,
except as otherwise expressly permitted under Section 2.1.4 with respect
to the ▇▇▇▇, WYETH shall not adopt, use, apply for registration,
register or own such ACCESS Trademark or trade dress, or any such
item confusingly similar thereto in any country of the world, or take any
action which weakens or undermines ACCESS's proprietary rights
therein.
11.1.2 For the avoidance of doubt, WYETH shall
at all times retain sole and exclusive ownership of its intellectual
property, including, without limitation, all marketing and sales plans,
artwork, formats, equipment, logos, drawings, customer lists, regulatory
filings, correspondence with the FDA or any other Regulatory Authority,
clinical study data, analytical data, operating procedures and all ordering
and sales information.
11.2 Inventions.
11.2.1 Except as otherwise provided for in this
Section 11.2, each Party shall own all Inventions made solely by
employees of such Party (or Third Parties acting on behalf of such Party)
and shall jointly own with the other Party any Invention made jointly by
employees of both Parties (or Third Parties on behalf of one or both
Parties); provided that such Inventions were made without violation of
any term or condition of this Agreement. All determinations of
inventorship under this Agreement shall be made in accordance with
United States law.
11.2.2 If and to the extent applicable, Inventions
Controlled by ACCESS and know-how arising during the Term which
relates to the Product and is Controlled by ACCESS shall be
automatically included in the Intellectual Property Rights under which
WYETH is licensed pursuant to Section 2.1.1 hereof. With respect to
any Inventions or know-how Controlled by WYETH specifically relating
to the Product, WYETH hereby grants to ACCESS an exclusive (subject
to retained rights in WYETH), royalty-free license to use such Invention
for the Manufacture of the Product for WYETH in the Territory during
the Term.
11.2.3 During the Term of this Agreement both
Parties shall require their employees and personnel involved in the
performance of its duties under this Agreement to deliver such
assignments, confirmations of assignments or other written instruments
as are necessary to vest in the respective Party clear and marketable title
to the Inventions.
11.2.4 All rights, title and interest in and to the
ACCESS Intellectual Property Rights shall remain exclusively owned by
ACCESS. The Inventions owned by ACCESS under this Section shall
be referred to herein as "ACCESS Inventions".
32
11.2.5 All rights, title, and interest in and to know-
how, which is developed jointly by the Parties during the Term of this
Agreement and related to the Product, its Manufacture and/or use shall
be owned jointly by the Parties. All rights, title, and interest in and to
any Regulatory Approval the primary responsibility for which is
allocated to a particular Party hereunder that is developed or collected
solely or jointly by the Parties in the Territory during the Term of this
Agreement shall be owned exclusively by such Party.
11.3 Confidentiality of Information related to Intellectual Property.
Any and all information and material, including, without
limitation, any and all intellectual property rights therein and thereto,
assigned to a Party pursuant to the terms of this Agreement shall
constitute Confidential Information of such Party which shall be deemed
the Disclosing Party with respect to such Confidential Information.
11.4 Patent Rights to New Inventions.
11.4.1 ACCESS, at its own expense, shall use
commercially reasonable efforts to prepare, file, prosecute and maintain
its Intellectual Property Rights in the countries of the Territory.
11.4.2 With respect to any filings after the
Effective Date, ACCESS shall give WYETH a reasonable opportunity to
review and comment upon the text of such applications in the Territory
before filing, shall consult in good faith with WYETH with respect to
such applications in the Territory, and shall supply WYETH with a copy
of such applications in the Territory as filed, together with notice of its
filing date and serial number. ACCESS shall inform WYETH about the
status of the prosecution of all patent applications included within the
ACCESS Intellectual Property Rights and its Intellectual Property Rights
to Inventions and the maintenance of any patents included within the
ACCESS Intellectual Property Rights and its Intellectual Property Rights
to Inventions in a country in the Territory.
11.4.3 ACCESS shall consult with WYETH and
provide WYETH with reasonable opportunity to comment on all
correspondence received from and all submissions to be made to any
Regulatory Authority in the Territory with respect to any such patent
application or patent. ACCESS shall consider in good faith, but will not
be bound by, WYETH's suggestions with respect to all submissions in
the Territory made to any Regulatory Authority in the Territory with
respect to any such patent application or patent.
11.4.4 If ACCESS elects not to file a patent
application with respect to its new Inventions or to cease the prosecution
and/or maintenance of any Patent under the ACCESS Intellectual
Property Rights in a country in the Territory, ACCESS shall provide
WYETH with written notice promptly after the decision to not file or
continue the prosecution of such patent application or maintenance of
such patent.
11.4.5 In such event, ACCESS shall permit WYETH, in WYETH's sole
33
discretion, to file a patent application with
respect to such Invention or continue prosecution or maintenance of any
such Patent under the ACCESS Intellectual Property Right in such
country at WYETH's own expense. If WYETH elects to continue such
prosecution or maintenance, ACCESS shall execute such documents and
perform such acts, at WYETH's expense, as may be reasonably
necessary to permit WYETH to file, prosecute or maintain such
application or Patent in such country. In such event, WYETH shall own
such patent application or Patent filed by WYETH hereunder.
11.4.6 In the event that WYETH continues the
prosecution or maintenance of such patent application or Patent pursuant
to this Section, WYETH's Royalty obligations hereunder, and this
Agreement, shall expire if, and at such time, that such patent application
or Patent becomes the only non-expired Patent rights within the
Intellectual Property Rights.
11.4.7 (a) The Parties shall mutually agree in
good faith on a case-by-case-basis on which of the Parties shall have the
first right to prepare, file, prosecute and maintain any jointly owned
Invention and patent rights thereon ("Joint Patent Rights") throughout the
world as well as on the split of the applicable expenses and costs.
(b) The acting Party shall keep the other Party
completely informed during the whole application procedure as well as
during the whole patent duration. The acting Party shall provide the
other Party advance copies of any official correspondence related to the
filing, prosecution and maintenance of such patent filings, and shall
provide the other Party a reasonable opportunity to comment on all
correspondence received from and all submission to be made to any
government patent office or authority with respect to any such patent
application or patent, and shall consider in good faith the other Party's
suggestions with respect to all submission made to any government office
or authority.
(c) If either Party (the "Declining Party") at
any time declines to share in the costs of filing, prosecuting and
maintaining any such Joint Patent Right, on a country by country basis,
the Declining Party shall provide the other Party (the "Continuing
Party") with thirty (30) days prior written notice to such effect, in which
event, the Declining Party shall (i) have no responsibility for any
expenses incurred in connection with such Joint Patent Right and (ii) if
the Continuing Party elects to continue prosecution or maintenance, the
Declining Party, upon the Continuing Party's request, shall execute such
documents and perform such acts, at the Continuing Party's expense, as
may be reasonably necessary (x) to assign to the Continuing Party all of
the Declining Party's right, title and interest in and to such Joint Patent
Rights and (y) to permit the Continuing Party to file, prosecute and/or
maintain such Joint Patent Right.
(d) If WYETH is (i) the sole owner of a Joint
Patent Right or (ii) the Continuing Party, such Joint Patent Right shall no
longer be considered to be part of the ACCESS Intellectual Property
Rights for purposes of this Agreement and thereafter shall be part of
WYETH's intellectual property.
(e) If ACCESS is (i) the sole owner of a Joint
Patent Right or (ii) is the Continuing Party, such Joint Patent Rights
shall no longer be considered to be part of WYETH's
34
intellectual property for purposes of this Agreement and thereafter shall
be part of the ACCESS Intellectual Property Rights.
11.4.8 Each Party shall, and shall cause its
Affiliates, employees, attorneys and agents to, cooperate fully with the
other Party and provide all information and data and execute any
documents reasonably required or requested in order to allow the other
Party to prosecute, file, and maintain patents and patent applications
pursuant to this Section 11.4. Neither Party shall require the other Party
to make any payment or reimburse for any expenses in connection with
such cooperation, provision of information and data and execution of
documents.
11.5 Enforcement of Intellectual Property Rights.
11.5.1 If either Party becomes aware of any
infringement of any of the Intellectual Property Rights or the ▇▇▇▇, or
the validity of any of the Intellectual Property Rights or the ▇▇▇▇ is
challenged by a Third Party in the Territory, such Party will notify the
other Party in writing to that effect. Any such notice shall include, as
applicable, evidence to support an allegation of infringement by such
Third Party.
11.5.2 ACCESS shall have the first right, but not
the obligation, to take action to obtain a discontinuance of infringement
or bring suit against a Third Party infringer of Intellectual Property
Rights and/or the ▇▇▇▇ in the Territory. Such right shall remain in
effect until ninety (90) days after the date of notice given under Section
11.5.1. In the event that ACCESS exercises such right, then: (a)
ACCESS shall not consent to the entry of any judgment or enter into any
settlement with respect to such an action or suit without the prior written
consent of WYETH (not to be unreasonably withheld), and (b) ACCESS
shall bear all the expenses of any such suit brought by ACCESS claiming
infringement of any Intellectual Property Rights and/or the ▇▇▇▇. If,
after the expiration of the ninety (90) day period, ACCESS has not
obtained, or is not diligently pursuing, a discontinuance of infringement
of the Intellectual Property Rights and/or the ▇▇▇▇, filed suit against any
such Third Party infringer of the Intellectual Property Rights and/or the
▇▇▇▇, or provided WYETH with information and arguments
demonstrating to WYETH's reasonable satisfaction that there is
insufficient basis for the allegation of such infringement of the
Intellectual Property Rights and/or the ▇▇▇▇, then WYETH shall have
the right, but not the obligation, to bring suit against such Third Party
infringer of the Intellectual Property Rights and/or the ▇▇▇▇ and to join
ACCESS as a party plaintiff, provided that WYETH shall bear all the
expenses of such suit. In such event, WYETH shall not consent to the
entry of any judgment or enter into any settlement with respect to such
an action or suit without the prior written consent of ACCESS (which
consent shall not unreasonably be withheld) if such judgment or
settlement includes a finding or agreement that such Intellectual Property
Right and/or the ▇▇▇▇ is invalid or would enjoin or grant other equitable
relief against ACCESS.
11.5.3 Each Party shall cooperate (including,
without limitation, by executing any documents reasonably required to
enable the other Party to initiate such litigation, testifying when
requested or providing relevant documents) with the other Party in any
suit for infringement of Intellectual Property Rights and/or the ▇▇▇▇
brought by the other Party against a
35
Third Party in accordance with this
Section and shall have the right to consult with the other Party and to
participate in and be represented by independent counsel in such
litigation at its own expense.
11.5.4 Neither Party shall be required pursuant to
this Section 11.5 to undertake any activities, including, without
limitation, legal discovery at the request of a Third Party except as may
be required by lawful process of a court of competent jurisdiction.
11.5.5 Neither Party shall incur any liability to the
other Party as a consequence of any such litigation or any unfavorable
decision resulting therefrom, including, without limitation, any decision
holding any of the patents within the Intellectual Property Rights invalid
or unenforceable.
11.5.6 Any recovery obtained by either Party as a
result of any such proceeding against a Third Party infringer shall be
allocated as follows: (a) such recovery shall first be used to reimburse
each Party for all litigation costs in connection with such litigation paid
by that Party; and (b) the Party bringing the action shall receive the
remaining portion of such recovery after payment of the amounts
specified in clause (a).
11.6 Trademarks.
Subject to the restrictions in Sections 2.1.4 and 11.1,
WYETH shall select and own all Trademarks in connection with the
marketing, promotion and sale of the Product in the Territory. WYETH
hereby grants to ACCESS a limited, non-exclusive, non-transferable,
fully paid, royalty free, sublicensable license in and to all WYETH
Trademarks and copyrights to be contained in any such labeling for the
sole purpose of manufacturing and applying such labels to the Product in
the conduct of ACCESS's obligations hereunder; provided, however, that
ACCESS agrees to cooperate with and offer reasonable assistance to
WYETH in facilitating WYETH's control of the quality of the Product
branded with WYETH's trademarks hereunder; but further provided that
in no event is ACCESS obligated to provide such cooperation or
assistance in any way that will (i) lower the quality of the Product below
that which ACCESS deems acceptable for general commercial
distribution, (ii) be contrary to or in violation of any regulatory or
statutory obligations, or (iii) increase the cost of manufacturing and
delivering the Product hereunder beyond that contemplated by the parties
as of the Effective Date.
11.7 Publications.
11.7.1 The Parties recognize that limited rights of
review and/or comment exist for certain Third Party publications, such
as medical, academic and scientific publications. Each Party agrees to
provide the other Party with any such proposed publication or
presentation promptly upon its receipt. Each Party may advise the other
of any comments that it may have relating to such proposed publication
or presentation and do so within the applicable time frame.
11.7.2 During the Term of this Agreement, unless
otherwise prohibited by law, each Party shall submit to the other Party
for review and approval any proposed publication or
36
public presentation, especially including, without limitation, academic,
scientific and medical information, which contains the non-disclosing
Party's Confidential Information or which disclose any non-public
information contained within the Intellectual Property Rights or which
makes any reference to the subject matter of this Agreement or the Product.
11.7.3 Written copies of each such proposed
publication or presentation required to be submitted hereunder shall be
submitted to the non-disclosing Party no later than fifteen (15) days
before its intended submission for publication or presentation. The non-
disclosing Party shall provide its comments with respect to such
publications and presentations within ten (10) business days of its receipt
of such written copy. The review period may be extended for an
additional thirty (30) days in the event the non-disclosing Party can
demonstrate reasonable need for such extension. By mutual agreement
of the Parties in writing, this period may be further extended.
11.7.4 The Parties acknowledge that as publicly
held corporations, the Parties may not lawfully disclose in advance
certain information to any party, including, without limitation, the other
Party. This may affect the Parties' ability to submit for review certain
proposed publications and public presentations.
11.7.5 Regarding their publications under this
Section 11.7, ACCESS and WYETH will each comply with standard
academic practice regarding authorship of scientific publications and
recognition of contribution of other parties in any publication.
12. NOTICES
12.1 Ordinary Notices.
Correspondence, reports, documentation, and any other
communication in writing between the Parties in the course of ordinary
implementation of this Agreement shall be delivered by hand, sent by
facsimile or by overnight courier to the employee or representative of the
other Party who is designated by such other Party to receive such written
communication at the address or facsimile numbers specified by such
employee or representative.
12.2 Extraordinary Notices.
Extraordinary notices and communications (including,
without limitation, notices of termination, Force Majeure Event, material
breach, change of address, requests for disclosure of Confidential
Information, claims or indemnification) shall be in writing and shall be
delivered by hand, sent by facsimile or by overnight courier (and shall
be deemed to have been properly served to the addressee upon receipt of
such written communication) to the address set forth in Section 12.3 or
such other address as notified in writing by such Party to the other Party.
12.3 Addresses.
If to WYETH:
37
Wyeth Consumer Healthcare, a division of Wyeth
Five Giralda Farms
Madison, New Jersey 07940
Attention: Associate Director of Contract Manufacturing
Facsimile No.: ▇▇▇-▇▇▇-▇▇▇▇
With a copy to:
Wyeth
Five Giralda Farms
Madison, New Jersey 07940
Attention: General Counsel
Facsimile No.: ▇▇▇-▇▇▇-▇▇▇▇
If to ACCESS:
Access Pharmaceuticals, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Attention: President
Facsimile No.: ▇▇▇-▇▇▇-▇▇▇▇
With a copy to:
▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, Esq.
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ LLP
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile No.: ▇▇▇-▇▇▇-▇▇▇▇
13. GENERAL
13.1 Governing Law.
This Agreement shall be construed in accordance with and
governed by the law of the State of New York, without giving effect to
its conflict of laws provisions, and to the exclusion of the provisions of
the United Nations Convention on Contracts for the International Sale of
Goods.
13.2 Equal Opportunity Clause.
The Equal Opportunity Clause required by Executive
Orders 11246, as amended (41-CFR 60-1.4) and 11375, the Employment
Assistance to Veterans Clause required by
38
Executive Order 11701 (41CFR 60-250.4), the Vietnam Era Veteran
Readjustment Act of 1972, the Employment of the Handicapped Clause required
by the Rehabilitation Act of 1973 (41 CFR 60-741.4) and the Americans
with Disabilities Act of 1991 are part of this Agreement and binding
upon ACCESS unless exempted by rules, regulations or orders of the
Secretary of Labor. ACCESS agrees that the applicable clause with
regard to the utilization of minority contractors set forth at
41 CFR 1-1.303 and the applicable
clause with regard to the Utilization of Small Business Concerns and
Small Business Concerns Owned and Controlled by Socially and
Economically Disadvantaged Individuals set forth at 41 CFR 1-1.13 are
incorporated herein by reference, as applicable. ACCESS agrees to
provide information and documentation with respect to the foregoing to
WYETH upon request.
13.3 Assignment.
This Agreement shall not be assignable or transferable by
either Party without the prior written consent of the other Party(which
consent shall not be unreasonably withheld); provided that either Party
may assign this Agreement and its rights and obligations hereunder
without the other Party's consent in connection with the transfer or sale
of all or substantially all of the business of such party to which this
Agreement relates (or, if applicable, the business unit or division of such
Party primarily responsible for performance under this Agreement) to
another party, whether by merger, sale of stock, sale of assets or
otherwise; and provided further that in the event any NDA has been filed
with respect to the Product, WYETH shall have the right to assign or
sublicense this Agreement and its rights and obligations hereunder
without ACCESS's consent. In the event that WYETH sublicenses the
Agreement or any rights or obligations hereunder in accordance with the
previous sentence, then WYETH shall guaranty the performance of the
sublicensee. In the event that either WYETH or ACCESS assigns this
Agreement in accordance with this Section 13.3, then the assigning Party
shall be released from its obligations hereunder and shall have no further
obligations to the other Party pursuant to this Agreement. The rights
and obligations of the parties under this Agreement shall be binding upon
and inure to the benefit of the successors and permitted assigns of the
parties. Any attempted assignment in violation of this Section 13.3 shall
be null and void, without any force or effect.
13.4 Entire Agreement.
This Agreement and all Exhibits attached hereto (as the
same may be amended from time to time by the written agreement of the
Parties) constitute the entire agreement between the Parties with respect
to the subject matter hereof and supersedes all other documents,
agreements, verbal consents, arrangements and understandings between
the Parties with respect to the subject matter hereof. This Agreement
shall not be amended orally, but only by an agreement in writing, signed
by both Parties that states that it is an amendment to this Agreement.
13.5 Severability.
If any term of this Agreement shall be found to be invalid,
illegal or unenforceable, it is the intention of the parties that the
remainder of this Agreement shall not be
39
affected thereby; provided that
neither Party's rights under this Agreement are materially adversely
affected. It is further the intention of the parties that in lieu of each such
provision which is invalid, illegal or unenforceable, there be substituted
or added as part of this Agreement a provision which shall be as similar
as possible in the economic and business objectives intended by the
Parties to such invalid, illegal or unenforceable provision, but which
shall be valid, legal and enforceable. In the event that either Party's
rights are materially adversely affected as a result of a change in this
Agreement as contemplated by this Section, such Party may terminate
this Agreement by notice in writing to the other Party given no later than
sixty (60) days after such change.
13.6 Independent Contractor.
Each Party shall act as an independent contractor and
neither Party shall have any authority to represent or bind the other Party
in any way.
13.7 No Waiver.
Any waiver by one Party of any right of such Party or
obligation of the other Party must be in writing and shall not operate as a
waiver of any subsequent right or obligation.
13.8 Counterparts.
This Agreement may be executed in two or more
counterparts (including, without limitation, by facsimile transmission),
each of which when so executed and delivered shall be an original, but
all of which together shall constitute one and the same instrument.
13.9 HSR Compliance.
Within 15 business days after signing, WYETH will value
ACCESS's grant of the exclusive license contemplated by this License
and Supply Agreement in compliance with Title II of the ▇▇▇▇-▇▇▇▇▇-
▇▇▇▇▇▇ Antitrust Improvements Act of 1976, 15 U.S.C % 18a, and the
regulations promulgated thereunder, 16 C.F.R %% 801.1 et seq. ("the
Act") and will notify ACCESS whether a Notification and Report
Form is required under the Act based upon such valuation. If an HSR
filing is required, the parties will, at their own expense, prepare and
make appropriate filings under the Act as soon as reasonably practicable
after WYETH's notice. The parties agree to cooperate in the antirust
clearance process and agree to furnish promptly to the Federal Trade
Commission and/or the Antitrust Division of the Department of Justice
any additional information reasonably requested by them in connection
with such filings. In the event that the waiting period provided under the
Act does not occur within three (3) months after the date of signature of
the this Agreement by both parties, the parties shall revert to their status
prior to signing the Agreement.
40
IN WITNESS WHEREOF, the Parties have executed this
Agreement as of the Effective Date.
WYETH, acting through its
Wyeth Consumer Healthcare
Division
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Name: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Title: Sr. Vice President
ACCESS PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇
Name: ▇▇▇▇▇ ▇. ▇▇▇▇
Title: President & CEO