EXHIBIT 10.2
LICENSE AGREEMENT (FOREIGN)
THIS Agreement is made this 6th day of October, 1997 by and between
PharmaPrint Inc., a corporation organized and existing under the laws of the
State of Delaware having its principal place of business at 0 Xxxx Xxxxx,
Xxxxx 0000, Xxxxxx, Xxxxxxxxxx 00000 and its subsidiaries, including
PharmaPrint B.V. ("PharmaPrint"), and American Home Products Corporation,
acting through its Whitehall-Robins Healthcare division, a corporation
organized and existing under the laws of the State of Delaware, having its
principal place of business at 0 Xxxxxxx Xxxxx, Xxxxxxx, Xxx Xxxxxx 00000
("AHP").
A. PharmaPrint has developed a method for the identification,
characterization of and regulation of the amounts of bioactive
components in herbal products and is seeking to commercialize
certain of the herbal products identified, characterized and
regulated thereby.
B. PharmaPrint has developed technological know-how, obtained
patents and filed patent applications relating to and/or covering
the subjects of Paragraph A above.
C. AHP desires to obtain an exclusive license and right under the
above technology, patent and patent applications to market and
sell such herbal products.
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D. AHP desires to obtain the aforementioned rights so that it can
purchase, pursuant to a separate, contemporaneous agreement, its
supply of licensed herbal products from PharmaPrint so that AHP
can market, distribute and sell same (as hereinafter provided)
throughout the Territory free of charges of or suits for
infringement of PharmaPrint's present or future Patent Rights and
Technology.
ARTICLE I
DEFINITIONS
Terms defined in this Article I shall for all purposes of this
Agreement, as the same may be amended or supplemented from time to time, have
the meaning herein specified.
1.1 The term "Act" shall mean the Federal Food, Drug and Cosmetic
Act, as amended from time to time.
1.2 (a) The term "AHP Affiliate" shall mean any company which
directly or indirectly through stock ownership or through other contractual
arrangement either controls, or is controlled by, or is under common control
with AHP.
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(b) The term "PharmaPrint Affiliate" shall mean any company which
directly or indirectly through stock ownership or through other contractual
arrangement either controls, or is controlled by, or is under common control
with PharmaPrint.
1.3 The term "Branded Product(s)" shall mean a product manufactured,
marketed or sold under a regional or national brand label, whether or not a
registered trademark.
1.4 The term "Combination Product(s)" shall mean a composition
containing at least one (1) Herbal Product in admixture with at least one (1)
mineral, vitamin and/or other nutrient other than an Herbal Product. For the
avoidance of doubt, Combination Products do not include Dual Products.
1.5 The term "Commercially Reasonable Efforts" shall mean efforts and
resources normally used by a party for a non-prescription pharmaceutical product
of its own discovery of similar market potential at a similar stage in its
product life, taking into account the competitiveness of the marketplace, the
proprietary position of the product and its dosage form, the regulatory
structure involved, the profitability of the product, and other relevant
factors. It is anticipated by the parties that the level of effort will change
over time reflecting changes in the status of the relevant product and the
marketplace.
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1.6 The term "Dual Product(s)" shall mean a composition wherein its
components (excluding inactive ingredients, excipients and coating compositions)
consist solely of Licensed Products.
1.7 The term "Effective Date" shall mean the date first written
hereinabove.
1.8 The term "FDA" shall mean the national agency in a country of the
Territory from which approval is necessary to market pharmaceutical products
within such jurisdiction for administration to humans.
1.9 The term "U.S. Agreement" means the counterpart of this Agreement
granting certain rights to AHP in the United States of America, as executed by
the parties concurrently with this Agreement.
1.10 The term "Government Approvals" shall mean any approvals,
licenses, registrations or authorizations, howsoever called, of any national,
state or local regulatory agency, department, bureau or other government entity,
including the FDA, necessary for the manufacture, use, storage, transport or
sale in the Territory of Product. The term "'Government Approvals" further
means compliance with the requirements of any legislation directed to the same
or similar subject matter contained in the United States Dietary Supplement
Health and Education Act of 1994.
1.11 The term "Improvements" shall mean any and all new and useful
processes, manufactures, devices, compositions of matter (except as limited
below) or methods of use first conceived, reduced to practice or developed
after the Effective Date and during the term of this Agreement
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by PharmaPrint, or a Pharmaprint Affiliate or any employees, consultants or
other persons under their direction or control which increase the
performance, efficacy or safety of a Licensed Product, reduce the cost of
manufacture, harmful side-effects or adverse reactions to Licensed Product,
or otherwise relate to the manufacture or use of Licensed Product or the
practice of the method claimed in any of the patents and/or patent
applications within the Patent Rights. For the avoidance of doubt, the
defined term "Improvement" does not include Licensed Products per se.
1.12 The term "National Launch Date" as applied to a Licensed Product
shall mean the date when commercial quantities of such Licensed Product are
first shipped to the trade by AHP for sale in the OTC Market.
1.13 The term "NDA" shall mean New Drug Application as defined in
regulations promulgated by the FDA under the Act filed with or intended to be
filed with the FDA for approval for marketing the Licensed Product in the
Territory.
1.14 The term "NDA Product" shall mean a herbal Licensed Product which
(i) it or its method of manufacture or use is claimed in one or more claims of a
patent or patent application within the Patent Rights in the country of its
manufacture, use or sale, (ii) is the subject of an NDA program proposed by
PharmaPrint or an approved NDA based on an application filed by PharmaPrint in
the Territory.
1.15 The term "Net Sales" as applied to a Licensed Product shall
mean gross sales of such Licensed Product as packaged for sale to
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an end-user, less transportation charges, returns and allowances (actually
paid or allowed by AHP), customary discounts (actually paid or allowed,
whether in cash or trade), and sales and other taxes based on sales when
included in gross sales, but not including taxes assessed on income derived
from such sales. Net Sales shall not include Free Goods as defined in the
Supply Agreement.
1.16 The term "OTC Market" shall mean sales to the general public
other than those requiring a physician's prescription.
1.17 The term "Patent Rights" shall mean any and all issued patents in
the Territory and any and all patent applications for letters patent pending in
the Territory (until such time as such applications or any of them are denied,
abandoned, or issued into patents) listed in Schedule B of the U.S. Agreement
and any patents issuing from such applications, all divisions, continuations,
continuations-in-part and all patents granted thereon, as well as all other
patents in the Territory, including any re-issues, renewals, or extensions
thereof, which are owned by PharmaPrint, a PharmaPrint Affiliate or under which
PharmaPrint or a PharmaPrint Affiliate shall have the right to grant rights, and
which claim a Product or Improvement, or the manufacture or use of a Product or
Improvement, which claim, has not lapsed, become abandoned or been declared
invalid or unenforceable by a final non-appealed or unappealable decision or
judgment of a court or tribunal of competent jurisdiction.
1.18 The term "Patent (s)" shall mean any and all issued patents
within the Patent Rights, including the Process Patent.
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1.19 The term "Process Patent" shall mean the foreign counterparts
within the Territory to U.S. Patent Application No. 08/838,199, filed April
15, 1997, a continuation-in-part application of U.S. Patent Application No.
08/632,273, filed April 15, 1996 or a patent issued on a divisional,
continuation or continuation-in-part application on one or more of the patent
applications for the Process Patent.
1.20 The term "Licensed Product(s)" shall have a meaning identical
to that of the definition of Licensed Products contained within the U.S.
Agreement at any given time, unless otherwise agreed to by the parties.
1.21 The term "Supply Agreement" means the agreement for the sale
and supply of Licensed Products by PharmaPrint to AHP, as executed by the
parties concurrently with this Agreement.
1.22 The term "Territory" shall mean Canada and Mexico.
1.23 The term "Trademark" shall mean the trademark "PHARMAPRINT",
which is applied for, owned by and/or registered in the name of PharmaPrint .
1.24 The term "Herbal Product" shall mean a dietary supplement
derived from botanical herbal extracts.
ARTICLE II
GRANT OF LICENSE
2.1 (a) PharmaPrint hereby grants to AHP, and AHP accepts, the sole
and exclusive right, without the right to grant sublicenses
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except to AHP Affiliate(s), under the Patent Rights to market and sell Herbal
Products, including Licensed Products, in the OTC Market in the Territory.
(b) PharmaPrint hereby grants to AHP, and AHP accepts, a
non-exclusive right, without the right to grant sublicenses except to AHP
Affiliate(s), under the Patent Rights to use Herbal Products, including the
Licensed Products, in the OTC Market in the Territory.
2.2 During the term of this Agreement, PharmaPrint further grants to
AHP a royalty-free non-exclusive license, without the right to grant
sublicenses except to AHP Affiliate(s), under the Trademark for use in
conjunction with the marketing and/or sale of the Licensed Products in the
OTC Market in the Territory, provided any such use of the Trademark shall be
consistent with and recognize PharmaPrint's ownership thereof and reasonably
comply with the standards of quality used and/or established by PharmaPrint.
ARTICLE III
CLINICAL DEVELOPMENT
AND REGULATORY REGISTRATION
3.1 PharmaPrint shall expend Commercially Reasonable Efforts to conduct
all research and development necessary to produce the Licensed Product and
fulfill its obligations hereunder. PharmaPrint shall further conduct all
stability testing and clinical trials necessary for the marketing of Licensed
Product in the OTC Market in the Territory.
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3.2 (a) All regulatory filings to obtain Government Approvals and all
Government Approvals in the Territory shall be filed in the name of and owned
by PharmaPrint. PharmaPrint agrees, to the extent practical, to provide AHP
with a sufficient opportunity to review and comment on all regulatory filings
and material correspondence to regulatory agencies prior to submission, and
with material correspondence from regulatory agencies prior to submission of
a response.
(b) PharmaPrint agrees to expend Commercially Reasonable Efforts in
the filing, securing and maintenance of all Government Approvals, including
those necessary due to changes in the applicable statutes, rules and related
regulations. All such costs shall be borne by PharmaPrint.
(c) In the event of the requirement for financial commitments
related to the obtaining or maintenance of such Government Approva1s are
significantly greater than those for such Product in the United States, the
parties shall discuss the apportionment of expenses related thereto. In the
event that an agreement cannot be reached at AHP's sole discretion, AHP may
terminate its rights to the affected Licensed Product in accordance with the
provisions of Paragraph 12.3 or 12.4.
ARTICLE IV
ROYALTY PAYMENTS
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4.1 During the term of this Agreement, as royalty for the licenses
granted under Paragraph 2.1, AHP shall pay to PharmaPrint a running royalty
as set forth below on the total Net Sales of Licensed Products sold by AHP
and AHP Affiliates in the Territory ("Earned Royalties").
Royalty Year Cumulative Net Sales
of Product under this Agreement
ROYALTY RATE
I. For the period commencing on the National
Launch Date and ending one year thereafter.
a. For Licensed Products covered by a 4%
Patent which contains a process or product claim at
least as broad as that recited in Schedule B.
II. Subsequent to one year after the National
Launch Date through expiration or termination
of this Agreement.
a. For Licensed Products covered by a 6%
Patent which contains a process or product claim at
least as broad as that recited in Schedule D.
For the avoidance of doubt, no running royalty shall be due PharmaPrint
from AHP for Licensed Products not meeting the patent coverage requirements
set forth in this Paragraph 4.1.
4.2 Earned Royalties as provided in Paragraph 4. 1 accrued shall be
paid by AHP to PharmaPrint within thirty (30) days after the end of each
quarter of each Royalty Year. Each payment shall be accompanied by a report
in writing showing the period for which such payment is made, the Net Sales
of Licensed Product during such period, and the amount of Earned Royalty
thereon and any credit pursuant to Paragraph 4.7. The
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first Royalty Year shall consist of the period commencing on the day of the
first National Launch Date within the Territory, and ending on the last day
of the fourth calendar quarter thereafter. Each subsequent Royalty Year shall
consist of the twelve (12) month period commencing the first day after the
'Last day of the previous Royalty Year.
4.3 In the event that the parties disagree whether Earned Royalties
should accrue wi th respect to patent issues on a specific product are unable
to successfully resolve the issue after good faith negotiation, the matter
shall be referred to an independent patent attorney agreed to by both
parties. The ultimate determination of such independent patent attorney
shall be final and binding upon the parties. All fees incurred in connection
with resolution of this dispute shall be borne by the party which determined
incorrectly that Earned Royalties were or were not due.
4.4 In the event that AHP fails to meet the requirements of Paragraph
4.7 of the U.S. Agreement, then PharmaPrint shall have the right to convert
AHP's rights under Paragraphs 2.1 and 2.2 of this Agreement from exclusive to
semi-exclusive such that PharmaPrint may offer such rights to one third party
other than AHP for the sale of Branded Products only. PharmaPrint's right to
convert AHP's rights from exclusive to semi-exclusive shall be the sole
remedy of PharmaPrint for failure of AHP to meet the requirements of such
Paragraph 4.7 of the U.S. Agreement.
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4.5 During the term of this Agreement, AHP shall expend
Commercially Reasonable Efforts in the marketing of the Licensed Products.
4.6 No royalties as set forth in this Article IV shall be
payable on intercompany sales transactions as between or among AHP and AHP
Affiliates, the final sale by AHP or AHP Affiliate to a third party, alone,
being used for the purposes of determining the royalty payments due
hereunder. A Licensed Product subject to royalty payment shall be deemed
sold when invoiced or, if not invoiced, when the same shall be delivered to
the third party.
4.7 Whenever, because of price adjustment, including allowances
or returned goods sold during any period, or for any other reason, AHP shall
have overpaid or underpaid the royalty amount due for such period, AHP shall,
upon determining the amount of overpayment or underpayment, deduct or add the
same from or to the payment payable for the period during which the amount of
the overpayment or the underpayment is determined; and if after such
deduction and addition there remains an overpayment, such overpayment shall
be deducted from the payment payable for the immediately following period or,
if there is no following payment period, such overpayment shall be refunded
to AHP.
4.8 AHP shall keep, and shall cause its AHP Affiliates to keep,
complete and accurate records of all sales of Licensed Product for a minimum
of three (3) years after the sales period to which they pertain. Said
records shall be open during reasonable business hours to
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a certified public accountant selected by PharmaPrint and acceptable to AHP,
who shall, at PharmaPrint's expense, have access to all records deemed by
such accountant as reasonably necessary in verifying for PharmaPrint, not
more often than once each calendar year, the royalties accrued, payments made
or to be made, and the accuracy of the reports to be made, as herein
provided. However, said accountant shall agree in writing to treat as
confidential and not to disclose to PharmaPrint any information other than
information relating solely to the royalties accrued and the accuracy of the
reports and payments required to be made under this Agreement, and that in no
event will the quantities or prices to individual customers be disclosed to
PharmaPrint by said accountant.
ARTICLE V
EXPANSION OF THE TERRITORY
5.1 PharmaPrint hereby grants AHP, and AHP accepts, an option to
expand the Territory to further include any countries other than the United
States of America.
5.2 Such option may be exercised by AHP in its sole discretion
at any time during a period of three (3) years commencing upon the initial
National Launch Date within the Territory ("Option Period") through the
provision by AHP to PharmaPrint of notice of such exercise in conformance
with the notice provisions of this Agreement.
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5.3 AHP's rights to expand the Territory pursuant to Paragraph
5.1 shall irrevocably expire upon the expiration of the Option Period.
ARTICLE VI
PATENTS AND TRADEMARKS
6.1 PharmaPrint sha1l be responsible, at its cost and expense,
for prosecuting to issuance all patent applications, for filing and
prosecuting all patent reissues and re-examinations, for applying for and
obtaining any patent term extensions, and for paying all maintenance fees, on
a large-entity basis (if applicable), on all patents, as PharmaPrint
determines to be commercially reasonable, which applications and patents
constitute the Patent Rights under this Agreement.
6.2 (a) AHP shall have the right to use and market the
Licensed Products under any AHP-owned trademarks, tradenames and/or
tradedress it may choose. Except as provided in subparagraph (b), AHP agrees
to promote the Licensed Products in association with AHP's CENTRUM-Registered
Trademark-trademark. AHP further agrees that the packaging of the License
Products shall bear a reference to PharmaPrint's ownership of the Trademark.
(b) AHP is not obligated to promote any Herbal Products under
the Centrum-Registered Trademark- trademark is such Herbal Products are
covered under Paragraph 13.1(c).
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6.3 Other than the Trademark, PharmaPrint shall have no right,
title or interest in or to any trademarks, tradenames or tradedress which AHP
may use on or in connection with Product, or the packaging, advertising,
promotion, labeling, marketing or selling thereof. So long as AHP or any AHP
Affiliate shall have any interest in or to any such trademarks, tradenames or
tradedress, whether as proprietor, owner, licensee or licensor, in any state
or country of the world, PharmaPrint shall not adopt, use, apply for
registration, register, own or acquire such trademarks, tradenames or
tradedress, or any xxxx, name or tradedress confusingly similar thereto, in
any state or country of the world.
6.4 Except as provided herein, AHP shall have no right, title or
interest in or to the Trademark so long as PharmaPrint shall have any
interest in or to the Trademark, whether as proprietor, owner, licensee or
licensor, in any state or country of the world, AHP shall not adopt, use,
apply for registration, register, own or acquire such Trademark, or any xxxx
confusingly similar thereto, in any state or country of the world.
ARTICLE VII
IMPROVEMENTS
7.1 PharmaPrint hereby agrees to disclose to AHP any
improvement, whether believed to be patentable or unpatentable, made or
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discovered during the term of this Agreement within sixty (60) days after the
Improvement is first reduced in writing.
7.2 PharmaPrint shall have sole right, title and interest in and
to any patentable Improvement invented solely by its employees or consultants
or those of a PharmaPrint Affiliate, and shall be solely responsible, at its
cost and expense, for obtaining and maintaining patent protection therefor.
Both parties shall have joint rights, title and interests in and to any
patentable Improvement invented jointly by employees or consultants of each
party, and both parties shall share equally in the costs and expenses of
obtaining and maintaining patent protection therefor, with independent patent
counsel, acceptable to both parties, being appointed to obtain such patent
protection. In the event that either party should elect not to share in such
costs and expenses, the other party may elect to pay all such costs and
expenses and shall be the sole owner of all right, title and interest in all
patent applications and patents obtained.
7.3 (a) PharmaPrint hereby grants to AHP, and AHP accepts, sole
and exclusive right, without the right to grant sublicensees except to AHP
Affiliates, in and to the Improvements which relate to the sale and
distribution of the Licensed Products for the life of this Agreement.
(b) PharmaPrint further grants to AHP, and AHP accepts, a
non-exclusive right, without the right to sublicenses except to AHP
Affiliates, under the Improvements to use the Licensed Products in the OTC
Market in the Territory.
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(c) PharmaPrint hereby agrees that such Improvements shall be
added to the escrowed Manufacturing Know-how as defined in Paragraph 3.2 of
the Supply Agreement.
ARTICLE VIII
INFRINGEMENTS
8.1 If during the term of this Agreement, any third party should
sell, or make known its intent to sell, in the Territory a herbal product and
PharmaPrint should have a patent within the Patent Rights to lawfully
preclude such third-party sales, then PharmaPrint shall, take action
expeditiously and effectively to preclude the third-party sales, at its own
cost and expense. AHP shall have the right, at its sole option, to appear as
a party in the action and participate, at its cost and expense, in the
prosecution of any suit. Any amount of damages or settlement received shall
be apportioned between the parties equitably to compensate the parties for
their direct costs and expenses (including reasonable attorneys' fees) and
thereafter to compensate AHP for lost sales and profits and PharmaPrint for
lost royalties and profits.
8.2 In the event PharmaPrint does not act as provided hereabove
in Paragraph 8.1 within ninety (90) days of its first having knowledge of
third-party sales, or intent to sell, to preclude such sales, AHP shall have
the right, but not the obligation, to act to preclude the third-party sales,
including the right to file a patent
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infringement claim or counterclaim in any court of competent jurisdiction
naming PharmaPrint as party plaintiff if necessary or desirable.
If AHP shall initiate such an action, all costs and expenses
(including reasonable attorneys' fees) incurred by AHP in attempting to
eliminate such unlicensed competition shall be deducted in full from the
Earned Royalties and Marketing Support owed to PharmaPrint. Any amount of
damages or settlement received shall belong to AHP. PharmaPrint shall
cooperate fully with AHP regarding any action undertaken by AHP based upon
the infringement by a third party of a PharmaPrint patent.
Should AHP elect not to initiate such an action as set forth above,
the Earned Royalties due PharmaPrint and the Marketing Support from AHP shall
be halved.
ARTICLE IX
MOST FAVORED LICENSEE
In the event that AHP's exclusive rights under this Agreement
become semi-exclusive and should PharmaPrint grant any third party a license
to use or sell a specific Licensed Product on terms more favorable than those
herein, including the royalty rate, PharmaPrint will within thirty (30) days
thereafter provide AHP with a summary of the terms of said third-party
license and offer AHP the benefit of such more favorable terms provided AHP
also accepts the less favorable terms, if any, of such third-party license.
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ARTICLE X
WARRANTIES AND COVENANTS
10.1 PharmaPrint represents and warrants that it has the sole,
exclusive and unencumbered right to grant the licenses and rights herein
granted to AHP and that it has not granted any option, license, right or
interest in or to the Patent Rights, Licensed Product, or any method of
manufacture or use of a Licensed Product to any third party which would
conflict with the rights granted by this Agreement. PharmaPrint agrees to
hold AHP harmless from any and all costs, expenses and damages (including
reasonable attorneys' fees) incurred or sustained by AHP as the result of any
third party's challenge to PharmaPrint's right to grant the rights and
licenses herein granted to AHP.
10.2 (a) PharmaPrint represents and warrants that to the best
of its present knowledge, all, and only, the true inventors of the subject
matter claimed are named in the Patents Rights and all such inventors have
irrevocably assigned all their rights and interests therein (i) to
PharmaPrint and/or (ii) to the University of Southern California and
PharmaPrint has acquired an exclusive license thereto, with rights to
sublicense AHP thereunder
(b) PharmaPrint covenants that subsequent to the
Effective Date all, and only, the true inventors of the subject matter
claimed shall be named in the Patents Rights and all such inventors shall
have irrevocably assigned all their rights and interests therein to (i)
PharmaPrint and/or (ii) to the University of Southern California and
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PharmaPrint has an exclusive license thereto, with rights to sublicense AHP
thereunder.
10.3 PharmaPrint represents and warrants that as of the Effective
Date it is not aware of any information material to the examination of the
Patent Rights listed in Schedule B, within the meaning of 37 C.F.R. 1.56,
that was not disclosed in writing to the United States Patent Office.
10.4 PharmaPrint represents and warrants that it is not presently
aware of any asserted or unasserted claim or demand of any right in or to any
of the Patent Rights, including but not limited to claim or demand of a
shopright, joint ownership, inventorship, or misappropriation, or which would
or could in any way impede or interfere with the licenses and rights herein
granted to AHP.
10.5 PharmaPrint represents and warrants that the execution of
this Agreement and the full performance and enjoyment of the rights of
PharmaPrint and AHP under this Agreement will not breach or in any way be
inconsistent with the terms and conditions of any license, contract,
understanding or agreement, whether express, implied, written or oral between
PharmaPrint and any third party.
10.6 PharmaPrint represents and warrants that to the best of its
knowledge no patents or patent applications if issued would be infringed by
the manufacture, use or sale of a Licensed Product.
10.7 (a) PharmaPrint represents and warrants that with respect to
all regulatory filings to obtain Government Approvals, the data and
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information in PharmaPrint's submissions to date have been free from fraud or
material falsity, that the Government Approvals have not been obtained either
through bribery or the payment of illegal gratuities, that the data and
information in PharmaPrint's submissions are accurate and reliable for
purposes of supporting approval of the submissions, and that the Government
Approvals were obtained without illegal or unethical behavior of any kind.
(b) PharmaPrint covenants that with respect to all regulatory
filings to obtain Government Approvals, the data and information in
PharmaPrint's submissions shall be free from fraud or material falsity, that
the Government Approvals shall not be obtained either through bribery or the
payment of illegal gratuities, that the data and information in PharmaPrint's
submissions shall be accurate and reliable for purposes of supporting
approval of the submissions, and that the Government Approvals shall be
obtained without illegal or unethical behavior of any kind.
10.8 PharmaPrint shall indemnify, defend and hold harmless AHP
from all actions, losses, claims, demands, damages, costs and liabilities
(including reasonable attorneys' fees) except as arise solely from events
listed herebelow in paragraph 10.9, to which AHP is or may become subject
insofar as they arise out of or are alleged or claimed to arise out of (i)
any breach by PharmaPrint of any of the warranties of PharmaPrint, or (ii)
any grossly negligent or willful act or omission by PharmaPrint or its
employees.
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10.9 AHP shall indemnify, defend and hold harmless PharmaPrint
from all actions, losses, claims, demands, costs and liabilities (including
reasonable attorneys' fees) to which PharmaPrint is or may become subject to
insofar as they arise out of or are alleged or claimed to arise out of (i)
any breach by AHP of any of its warranties under this Agreement, or (ii) any
grossly negligent or willful act or omission by AHP or its Affiliates, or
their employees.
10.10 A party entitled to indemnification hereunder agrees to give
prompt written notice (in no event later than five (5) business days) to the
indemnifying Party after the receipt by such party of any written notice of
the commencement of any action, suit, proceeding or investigation or threat
thereof made in writing for which such party will claim indemnification
pursuant to this Agreement. Unless, in the reasonable judgment of the
indemnified party, a conflict of interest may exist between the indemnified
party and the indemnifying party with respect to a claim, the indemnifying
party may assume the defense of such claim with counsel reasonably
satisfactory to the indemnified party. If the indemnifying party is not
entitled to, or elects not to, assume the defense of a claim, it will not be
obligated to pay the fees and expenses of more than one counsel with respect
to such claim. The indemnifying party will not be subject to any liability
for any settlement made without its consent, which shall not be unreasonably
withheld.
10.11 The provisions and obligations of this Article X shall
survive any termination of this Agreement.
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ARTICLE XI
THIRD-PARTY LICENSES
11.1 In the event AHP reasonably concludes, at any time prior to the
first commercial sale of a Licensed Product, that a license(s) under any third-
party patent is necessary in order to make, use or sell Licensed Product in the
Territory, and neither PharmaPrint nor AHP are able to obtain such license (s)
on terms reasonably acceptable to both, then PharmaPrint and AHP shall negotiate
in good faith to reach an agreement on the return to AHP of all or a portion of
the payments made pursuant to Article IV, in the case where AHP reasonably
concludes after good faith discussions and negotiations between the parties that
AHP is precluded from selling Licensed Products in the Territory.
11.2 In the event AHP and PharmaPrint agree, at any time during the
term of this Agreement, that a license(s) under any third-party patent is
necessary or advisable in order to make, use or sell Licensed Product sold by
PharmaPrint as of the Effective Date in the Territory, any and all payments and
royalties paid by AHP for such License(s) shall be deducted in full from
payments and royalties (including Minimum Royalty payments) due to PharmaPrint
under this Agreement.
11.3 In the event that PharmaPrint and AHP cannot agree on any
matters requiring agreement under Paragraph 11.2 above, and a license(s) under
the third-party patent is otherwise available to AHP, PharmaPrint shall
indemnify, defend and hold harmless AHP from all actions, losses,
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claims, demands, damages, costs and liability (including reasonable
attorney's fees) to which AHP is or may become insofar as they arise out of
or are alleged or claimed to arise out of any infringement of the third-party
patent.
ARTICLE XII
DURATION AND TERMINATION
12.1 This Agreement shall continue in full force and effect, unless
earlier terminated by either party pursuant to the provisions set forth in this
Article XII, or until expiration of the last to expire patent within the Patent
Rights in the Territory. Following expiration of the Agreement, the licenses
granted hereunder to AHP with respect to the Patent Rights shall be fully paid-
up and irrevocable.
12.2 Prior to the initial National Launch Date within the Territory,
AHP may terminate this Agreement in its sole discretion, at any time upon thirty
(30) days written notice to PharmaPrint.
12.3 After the initial National Launch Date within the Territory,
AHP may terminate this Agreement on a per Licensed Product basis in its sole
discretion, upon ninety (90) days written notice to PharmaPrint.
12.4 After the initial National Launch Date in the Territory, AHP
may terminate this Agreement in its entirety in its sole discretion, upon one
(1) year's written notice to PharmaPrint.
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12.5 Either party hereto shall be entitled to terminate this
Agreement upon thirty (30) days written notice to the other party (i) if the
other party shall commit a breach of any material provision hereof and shall not
within sixty (60) days from receipt of notice of such breach by the complaining
party remedy the same (if capable of remedy), or offer full compensation
therefor, or (ii) upon termination of the Supply Agreement.
12.6 Insofar as is lawful and legally permissible, this Agreement
may be terminated with immediate effect by a party upon giving written notice to
the other if the other is insolvent or has committed any act of bankruptcy or an
order is made or resolution passed for the winding up of the other party.
12.7 Failure on the part of either party to exercise or enforce any
right conferred upon it hereunder shall neither be deemed to be a waiver of any
such right nor operate to bar the exercise or enforcement thereof at any time
thereafter.
12.8 Upon termination of this Agreement for any reason, other than
under the provisions of Paragraph 12.1 of Article XII, (a) AHP and AHP
Affiliates shall have the right to advertise, promote, market and sell all
Licensed Product then in inventory, provided AHP makes the appropriate royalty
payments to PharmaPrint upon the sale of such Licensed Product.
12.9 This Agreement shall immediately terminate upon termination of
the U. S. Agreement.
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ARTICLE XIII
NON-COMPETITION
13.1 During the term of this Agreement, neither AHP nor an AHP
Affiliate shall market or sell any Herbal Product in the Territory in
association with the Centrum-Registered Trademark- trademark within the
Territory except as permitted by this Agreement; provided, however, nothing in
this provision shall prevent AHP or an AHP Affiliate from (a) performing its
obligations under this Agreement, the Foreign Agreement or the Supply Agreement,
(b) developing manufacturing, promoting and/or selling Combination Products, (c)
developing, manufacturing, promoting and/or selling any branded Herbal Product
acquired after the Effective Date provided that AHP continues to promote and
sell such product under the acquired brand name or store/private label brand, or
(e) PharmaPrint cannot or fails to deliver any Licensed Product (s) within nine
(9) months.
13.2 Except as provided immediately below, in the event of an
acquisition or merger pursuant to Paragraphs 13.1(c) or failure to deliver
Licensed Product pursuant to Paragraph 13.1(d), AHP agrees not to utilize the
Trademark in association with any herbal products acquired thereby. However,
AHP may utilize the Trademark in any association with an Herbal product acquired
pursuant to Paragraph 13.1(c) so long as it contains Licensed Product. Should
AHP utilize the Trademark in association with a product acquired under Paragraph
13.1(c), the Trademark shall be conspicuously displayed and clearly refer to
PharmaPrint's ownership of the Trademark.
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ARTICLE XIV
MISCELLANEOUS
14.1 Any notice required or permitted under this Agreement shall be
in writing and deemed to have been sufficiently provided and effectively made as
of the delivery date if hand-delivered with written acknowledgment, or as of the
date received if mailed by registered or certified mail, postage-prepaid, and
addressed to the receiving party at its respective address as follows:
AMERICAN HOME PRODUCTS CORPORATION
Five Giraida Farms
Madison, New Jersey 07940
Attn: Senior Vice President and General Counsel
PHARMAPRINT INCORPORATED
0 Xxxx Xxxxx
Xxxxx 0000
Xxxxxx, Xxxxxxxxxx 00000
Attn: President
or such other address which the receiving party has given notice pursuant to the
provisions of this Paragraph 14.1.
14.2 The relationship of the parties under this Agreement is that of
independent contractors and not as agents of each other or partners or joint
venturers, and neither party shall have the power to bind the other in any way
with respect to any obligation to any third party unless a specific power of
attorney is provided for such purpose. Each party shall be solely and
exclusively responsible for its own employees and operations.
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14.3 In the event that the performance of this Agreement or of any
obligation hereunder, other than payment of money as herein provided by either
party hereto is prevented, restricted or interfered with by reason of any cause
not within the control of the respective party, and, which could not by
reasonable diligence have been avoided by such party, the party so affected,
upon giving prompt notice to the other party, as to the nature and probable
duration of such event shall be excused from such performance to the extent and
for the duration of such prevention, restriction or interference, provided that
the party so affected shall use its reasonable efforts to avoid or remove such
cause of non-performance and shall fulfill and continue performance hereunder
with the utmost dispatch whenever and to the extent such cause or causes are
removed.
For the purpose of the preceding paragraph but without limiting the
generality thereof, the following shall be considered as not within the control
of the respective party: acts of God, acts or omissions of a governmental
agency, compliance with requests, recommendations, rules, regulations or orders
of any governmental authority or any officer, department, agency or instrument
thereof, flood, storm, earthquake, fire, war, riots, insurrection, accidents,
acts of the public enemy, invasion, Quarantine restrictions, strike, lockout,
differences with workmen, embargoes, delays or failure in transportation and
acts of a similar nature.
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14.4 Should one of the provisions of this Agreement become or prove
to be null and void, such will be without effect on the validity of this
Agreement as a whole. Both parties will, however, endeavor to replace the void
provision by a valid one which in its economic effect is most consistent with
the void provision.
14.5 This Agreement shall be governed by and construed in accordance
with the laws of the State of New York without regard to principles of conflicts
of laws.
14.6 This Agreement and the rights and obligations hereunder shall
not be assignable by either of the parties without the previous written consent
of the other party, such consent not to be unreasonably withheld, except that
AHP may assign this Agreement (i) in connection with the transfer of all or
substantially all of the business to which it relates without any such consent,
and (ii) in whole or in part to an AHP Affiliate without any such consent.
14.7 This Agreement, the U.S. Agreement and the Supply Agreement
constitute the entire understanding between the parties regarding the subject
matter hereof in the Territory and no party has relied on any representation not
expressly set forth or referred to in this Agreement. No amendment, variation,
waiver or modification of any of the terms or provisions of this Agreement shall
be effected unless set forth in writing, specifically referencing this
Agreement, and duly signed on behalf of the parties hereto.
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14.8 No press release or other public announcement concerning this
Agreement shall be made by either party without the prior written approval of
the other party hereto, such approval not to be unreasonably withheld, except as
otherwise required by law. Press releases or other public announcements
reasonably required by law shall be reviewed with the other party and their
comments given due consideration. Approval will be deemed granted if no
response is received by the proposing party within fifteen (15) days of its
written request for approval to the other party.
IN WITNESS WHEREOF, the duly authorized representatives of the parties
hereto have caused this Agreement to be executed.
AMERICAN HOME PRODUCTS CORPORATION PHARMAPRINT INC.
By: By:
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Title: Title:
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Date: Date:
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PHARMAPRINT B.V.
By:
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Title:
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Date:
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