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EXHIBIT 10.1
LICENSE AGREEMENT
THIS LICENSE AGREEMENT ("Agreement") is entered into as of June 30,
1997 ("Effective Date"), between XXXXX PHARMACEUTICAL PRODUCTS INC., a Delaware
corporation with its principal office at 0000 Xxxxxxx Xxxx, Xxxxx 000,
Xxxxxxxxxx, Xxxxxxxx 00000 ("RPPI") and XXXXXX LABORATORIES, INC., a Nevada
corporation with its principal office at 000 Xxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxx
00000 ("Xxxxxx").
R E C I T A L S:
WHEREAS, Xxxxxx and RPPI desire to enter into a transaction pursuant to
which, among other things: (i) RPPI will grant to Xxxxxx an exclusive license of
all of its rights throughout the Territory (as defined below) to market,
advertise, promote, sell and distribute the Royalty-Bearing Products (as defined
below); (ii) RPPI's Affiliate (as defined below) Xxxxx-Xxxxxxx Xxxxx
Pharmaceuticals Inc. ("RPRPI") will sell to Xxxxxx, and Xxxxxx will purchase
from RPPI and RPRPI, certain inventory of and other assets related to the
Product; (iii) RPRPI will manufacture and supply the Product to Xxxxxx; and (iv)
RPPI will grant to Xxxxxx certain option rights with respect to RPPI's right,
title and interest to the Royalty-Bearing Products in the Territory, all on the
terms and conditions contained in this Agreement, the Manufacturing Agreement
(as defined below) and an Inventory Purchase Agreement (as below defined), of
even date herewith, between the parties;
NOW THEREFORE, in consideration of the mutual covenants and
consideration set forth herein, the parties hereto, intending to be legally
bound, hereby agree as follows:
ARTICLE I
1.1 Definitions. As used herein, the following terms shall have the
meanings ascribed to them below:
"Act" shall mean the Federal Food, Drug and Cosmetic Act, as amended,
and the regulations promulgated under such Act.
"Affiliate" shall mean, when used with respect to a Person, any other
Person directly or indirectly controlling, controlled by, or under common
control with the subject Person; provided, however, that with respect to RPPI,
only Xxxxx-Xxxxxxx Xxxxx Inc. ("RPR") and Persons directly or indirectly
controlled by RPR shall be an Affiliate of RPPI for any provision of this
Agreement, or any of the Agreements contemplated hereby. For purposes of this
Agreement, "control" means the direct or indirect ownership of over 50% of the
outstanding voting securities of a Person, or the right to receive over
50% of the profits or earnings of a Person.
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"Bankruptcy Event" shall mean the Person in question becomes insolvent,
or a receiver or custodian is appointed for such Person, or voluntary or
involuntary proceedings by or against such Person are instituted in bankruptcy
or under any insolvency law, or proceedings are instituted by or against such
Person for corporate reorganization or the dissolution of such Person, which
proceedings, if involuntary, shall not have been dismissed within sixty (60)
days after the date of filing, or such Person makes an assignment for the
benefit of its creditors, or substantially all of the assets of such Person are
seized or attached and not released within sixty (60) days thereafter.
"Branded Versions" shall mean any and all versions of the Product and
any and all reformulations and Improvements thereon, and any bioequivalents
thereof, sold or transferred under the Licensed Trademark and/or any other
registered or unregistered trademark and any and all other products sold or
transferred under the License Trademark.
"Change of Control" shall mean (i) the direct or indirect, sale, lease
or other transfer of all or substantially all of the assets of a Person in one
or more transactions to any other Person or group of Persons acting in concert
as a partnership or other group (a "Group of Persons") other than an Affiliate
of such Person, and (ii) a Person or Group of Persons shall, as a result of a
merger or consolidation, tender or exchange offer, open market purchases,
privately negotiated purchases or otherwise, have become the beneficial owner in
one or more transactions, within the meaning of Rule 13d-3 under the Securities
Exchange Act of 1934, of securities of a Person or the entity surviving the
merger or consolidation representing 50% or more of the combined voting power of
the then outstanding securities of the Person in question ordinarily having the
right to vote in the election of directors.
"Consent Agreement" shall mean that certain Consent Agreement, dated as
of even date herewith, between Jago Research AG, Xxxxxx, Circa Pharmaceuticals,
Inc. and RPR.
"FDA" shall mean the Food and Drug Administration of the United States
Department of Health and Human Services, or any successor agency thereto.
"FDA Standards" shall mean the Act, the establishment license
requirements and the Current Good Manufacturing Practice regulations of the FDA
applicable to the Royalty-Bearing Products in question or, with respect to the
Royalty-Bearing Products, any manufacturing facility at which such
Royalty-Bearing Products are manufactured by or for RPPI, and all relevant
guidelines of the FDA.
"Generic Versions" shall mean any and all versions of the Product and
any and all reformulations and Improvements thereon, and any bioequivalents
thereof, sold or transferred without a trademark.
"Improvement" to a Royalty-Bearing Product shall mean any and all
inventions, discoveries, developments, modifications and improvements, whether
or not patented or patentable, relating to such Royalty-Bearing Product;
provided, however, that such
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Improvements must relate to any pharmaceutical preparation or formulation
consisting of diltiazem formulated for extended release using the delivery
technology licensed under the Jago License Agreement.
"Jago License Agreement" shall mean that certain Diltiazem SR
Development and License Agreement, dated August 10, 1988, between RPR (formerly
known as Xxxxx Group Inc.) and Jago Research AG, as amended.
"Licensed Trademark" means RPPI's Dilacor XR(R) trademark, including
all goodwill associated therewith; provided, however, in no event shall the term
"Licensed Trademark" be deemed to include the trade dress used by RPRPI or any
of its Affiliates with respect to the Product.
"Manufacturing Agreement" means that certain Manufacturing and Supply
Agreement, dated as of even date herewith, between Xxxxxx and RPRPI.
"Net Sales" shall mean, with respect to the Royalty-Bearing Products,
the gross amount invoiced on or in connection with the sale or other transfer of
Royalty-Bearing Products by Xxxxxx or its Affiliates or sublicensees appointed
by Xxxxxx to an un-Affiliated third party (other than a sale or transfer by
Xxxxxx or its Affiliates to a Xxxxxx sublicensee), (A) after subtracting all
applicable, bona fide trade and cash discounts, volume discounts and rebates, to
the extent actually paid, allowed or incurred on such sales or transfers, and
(B) taking into account all bona fide refunds and returns of such
Royalty-Bearing Product in the ordinary course of business.
"Person" shall mean any corporation, partnership, joint venture, other
entity or natural person.
"Product" shall mean the pharmaceutical preparation consisting of
diltiazem formulated for extended release using the delivery technology licensed
under the Jago License Agreement and currently marketed by RPRPI in the United
States of America under the Licensed Trademark.
"Regulatory Approval" shall mean, with respect to any country in the
Territory, filing for and receipt of all governmental and regulatory
registrations and approvals (including, but not limited to, approvals of all
final Royalty-Bearing Product labeling and all other data and documents of any
nature contained therein) required for the marketing and sale of any
Royalty-Bearing Product for the indication for which it is being marketed in
such country.
"Reserved Countries" shall mean New Zealand, the Republic of Korea and
North Korea.
"Royalty-Bearing Products" shall mean any and all Branded Versions and
Generic Versions.
"Territory" shall mean the entire world, excluding the Reserved
Countries.
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ARTICLE II
Marketing and Distribution Rights
2.1 Right to Market, Distribute and Sell the Royalty-Bearing Products.
(a) Subject to the terms and conditions of this Agreement, RPPI hereby
grants to Xxxxxx, during the term of this Agreement, the exclusive license to
all of RPPI's and its Affiliates' rights to market, advertise, promote,
distribute and sell the Royalty-Bearing Products throughout the Territory.
Xxxxxx accepts such license and agrees to use commercially reasonable efforts to
market, advertise, promote, distribute and sell the Royalty-Bearing Products in
the United States of America, and such other countries in the Territory as
Xxxxxx determines from time to time, all in accordance with the terms of this
Agreement.
(b) Subject to the terms and conditions of this Agreement, RPPI hereby
grants to Xxxxxx, and Xxxxxx hereby accepts, an exclusive right and license,
with the right to grant sublicenses on terms subject to and consistent with this
Agreement, all of RPPI's and its Affiliates' rights to use the Licensed
Trademark during the term of this Agreement in connection with the marketing,
advertising, promotion, distribution and sale of the Royalty-Bearing Products
throughout the Territory. During the term of this Agreement, except to the
extent necessary to perform its obligations under this Agreement and the
Manufacturing Agreement or in connection with the exercise of its rights with
respect to the Royalty-Bearing Products and/or the Licensed Trademark outside
the Territory, RPPI shall not use the Licensed Trademark or grant to any other
Person any rights to use the Licensed Trademark in the Territory. During the
term of this Agreement, Xxxxxx shall not use the Licensed Trademark or authorize
any of its sublicensees to use the Licensed Trademark for any purpose other than
in connection with the marketing, advertising, promotion, distribution and sale
of the Royalty-Bearing Products throughout the Territory and in making reports
to its shareholders, the Securities & Exchange Commission or any other
government entities.
(c) Nothing in this Agreement shall impair or limit the right and ability
of RPPI or any Affiliate of RPPI to make or have made Branded Versions and/or
Generic Versions within the Territory and to sell or transfer such products to
Affiliate(s) and/or un-Affiliated third parties for marketing, distribution,
sale or use in the Reserved Countries. Notwithstanding anything contained herein
to the contrary, RPRPI shall have the right, but not the obligation, during the
third calendar quarter of 1997 to continue to detail and promote the Product to
cardiologists in the United States through the distribution of Product samples
and promotional and other materials retained by Seller pursuant to Sections
2.2(a) and 2.2(d) respectively of the Inventory Purchase Agreement, dated of
even date herewith, between RPRPI and Xxxxxx.
(d) Subject to compliance with the terms of this Agreement and the Jago
License Agreement, Xxxxxx shall have the right to grant one or more Persons
exclusive or non-exclusive marketing, sales, sales agency and/or distribution
rights, with respect to any rights conferred upon Xxxxxx under this Agreement,
for one or more countries within the Territory, without the necessity of
obtaining the prior written consent of RPPI.
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(e) Xxxxxx shall not use the Licensed Trademark outside the Territory, nor
shall it sell the Royalty-Bearing Products to any Person (other than RPPI or its
Affiliates) that Xxxxxx knows or has reason to know, or believes, will sell such
Royalty-Bearing Product outside the Territory, either during the term of this
Agreement or after the expiration or termination hereof, notwithstanding
Xxxxxx'x exercise of the Purchase Option, as hereinafter defined.
(f) The granting of the licenses set forth by this Section 2.1 is
conditioned upon Xxxxxx'x timely payment of the amounts set forth in Sections
2.2(a)(i) and 2.5(a).
2.2 Annual Licensing Fees
(a) In consideration of the rights granted Xxxxxx under this Agreement,
Xxxxxx shall pay to RPPI, as specified below and by wire transfer to an account
specified in writing by RPPI, a licensing fee with respect to each calendar year
or portion thereof during the term of this Agreement in the amount and on the
date indicated below:
(i) With respect to the second half of calendar year 1997, the sum of
Forty Million Dollars ($40,000,000), due July 1, 1997;
(ii) With respect to calendar year 1998, the sum of Forty-Five Million
Dollars ($45,000,000), due within ten (10) business days after January 1, 1998;
(iii) With respect to calendar year 1999, the sum of Thirty Million
Dollars ($30,000,000), due within ten (10) business days after January 1, 1999;
(iv) With respect to calendar year 2000, the sum of Fifteen Million
Dollars ($15,000,000), due within ten (10) business days after January 1, 2000;
and
(v) With respect to calendar year 2001, the sum of Five Million Dollars
($5,000,000), due within ten (10) business days after January 1, 2001.
2.3 Royalties
(a) In further consideration of the rights granted to Xxxxxx under this
Agreement, Xxxxxx shall pay to RPPI the following royalties on Net Sales of
Royalty-Bearing Products in the Territory ("Royalties"):
(i) in respect of Net Sales resulting from sales or transfers of a
Branded Version, a Royalty of five percent (5.0%) of Net Sales attributable to
such Royalty-Bearing Product shall be paid by Xxxxxx to RPPI; provided, however,
such Royalty shall be two percent (2.0%) of the Net Sales attributable to any
specific Branded Version sold or transferred in a specific country (other than
the United States of America) if (A) at least one extended release, once-a-day
diltiazem product labeled for cardiovascular indications is being sold by a
third party competitor in that country at the time such
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Branded Version is initially launched for sale in that country, and (B) such
Branded Version is launched with a published list price or governmentally
regulated price (or the closest analogous price if both such prices are
inapplicable in that country) that is 75.0% or less of the comparable price
charged for the substantially equivalent product that is the Market Leader (as
defined below) in that country. "Market Leader" means an extended release,
once-a-day diltiazem product labeled for cardiovascular indications with the
largest annual sales volume in that country, measured in the applicable local
currency.
(ii) in respect of Net Sales resulting from sales or transfers of a
Generic Version, a Royalty of two percent (2.0%) of Net Sales attributable to
such Royalty-Bearing Product shall be paid by Xxxxxx to RPPI .
(b) Royalties payable in respect of sales outside the United States of
America will be payable by Xxxxxx to RPPI at its offices in Greenville, Delaware
in United States Dollars calculated in accordance with the following exchange
rate policies and procedures: Each calendar quarter Xxxxxx shall translate Net
Sales made in each country outside the United States of America into United
States Dollars at the average rate of exchange for the applicable currency for
such quarter, based upon daily exchange rate information reported in the Wall
Street Journal, New York edition.
(c) With respect to Royalties owed with respect to sales or transfers in
the United States of America, Xxxxxx shall deliver to RPPI at its offices in
Greenville, Delaware, within forty-five (45) days after the close of each
calendar quarter, a written report of Xxxxxx'x best good faith estimates of Net
Sales during such calendar quarter and corresponding estimated Royalties owed,
which report shall be accompanied by the estimated Royalties due for such
calendar quarter as shown on the report. With respect to Royalties owed with
respect to sales or transfers outside of the United States of America, Xxxxxx
shall deliver to RPPI at its offices in Greenville, Delaware, within sixty (60)
days after the close of each calendar quarter a written report of Xxxxxx'x best
good faith estimates of Net Sales during such calendar quarter, the applicable
currency conversion rates and corresponding estimated Royalties owed, separately
with respect to each country in the Territory, which report shall be accompanied
by the estimated Royalties due for such calendar quarter as shown on the report.
Each report with respect to a particular calendar quarter shall also contain a
reconciliation of the report for the preceding calendar quarter with the final
figures for Net Sales as reported on the formal books of Xxxxxx and its
Affiliates and sublicensees, and any adjustments indicated thereby will be added
or subtracted, as the case may be, to or from the current calendar quarter's
payment.
(d) With respect to Royalties payable on sales or transfers outside the
United States of America, Xxxxxx may deduct and withhold from such payments for
or on account of income taxes of RPPI if and as required to comply with
applicable local law. In such event, Xxxxxx shall timely pay or remit all
amounts so withheld to the appropriate taxing authorities on RPPI's behalf and
promptly provide RPPI with a written tax receipt for such amount issued by such
taxing authority. Xxxxxx shall reasonably cooperate with RPPI in lawfully
avoiding or mitigating any such requirement and shall obtain for RPPI, at its
request, any other documentation, receipt or certificate necessary
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or desirable for RPPI to apply for and/or receive any corresponding tax refund
or credit under any applicable tax law or treaty.
2.4 Records and Audit Rights.
(a) Xxxxxx shall maintain, and cause to be maintained by its Affiliates and
other parties to which Xxxxxx or its Affiliates may grant marketing, sales and
distribution rights under this Agreement, complete and accurate books and
records with respect to Net Sales and all related transactions and all Royalties
paid or payable by Xxxxxx under this Agreement, along with such other
reconciliation and other information as may be necessary or desirable to
calculate or verify all Net Sales and the consideration paid or payable by
Xxxxxx under this Agreement.
(b) Xxxxxx and such Affiliates and other parties shall maintain such books
and records in accordance with generally accepted accounting principles
consistently applied and for a period of three (3) years after the submission of
each report required to be submitted by Xxxxxx to RPPI under this Agreement;
provided, however, that if there is a good faith dispute between the parties
continuing at the end of any such three (3) year period with respect to such
books or records, then the time period hereunder to maintain such books and
records under dispute shall be extended until such time as the dispute is
finally resolved.
(c) RPPI shall have the right itself or through an independent accountant
selected by it and acceptable to and approved by Xxxxxx (which approval shall
not be unreasonably withheld or delayed) to have access to the relevant books
and records during reasonable business hours for the purpose of verifying,
inspecting or auditing, at the sole expense of RPPI (except as provided for in
Section 2.4(d) below), the Net Sales by country and the Royalties provided for
in this Agreement for any of the preceding three (3) years, but this right may
not be exercised more than once in any calendar year. RPPI shall solicit or
receive only information relating to or necessary or desirable to verify or
audit the accuracy of the information reported and the payments made or due
under this Agreement. Xxxxxx shall be entitled to withhold approval of an
accountant which RPPI nominates unless the accountant agrees to sign a
confidentiality agreement with Xxxxxx which shall obligate such accountant to
hold the information he receives from Xxxxxx in confidence, except for
disclosure to RPPI of information necessary to establish the accuracy of the
reports and amounts paid or payable to RPPI. Such audit rights shall survive for
three (3) years after the expiration or termination of this Agreement.
(d) Any underpayment determined pursuant to subparagraph (c) above shall be
paid within thirty (30) days of the delivery of a detailed written accountants'
report to the parties hereto. In the event of any such underpayment of ten
percent (10%) or more, Xxxxxx shall also at the same time reimburse RPPI for the
out-of-pocket costs of the verification, inspection or audit conducted. Any
overpayment shall be credited to the next payment due from Xxxxxx. If no further
payments from Xxxxxx will be due then a refund of any such overpayment will be
made within sixty (60) days of the audit.
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(e) The provisions of this Section 2.4 shall survive the expiration or
sooner termination of the term of this Agreement.
2.5 Purchase Option.
(a) Xxxxxx shall have the exclusive right and option described in this
Section 2.5 (the "Purchase Option") to acquire from RPPI, upon the scheduled
termination of this Agreement as set forth in Section 5.1 hereof, (i) all of
RPPI's rights to market, sell and distribute the Royalty-Bearing Products in the
Territory (including the assignment of rights under the Jago License Agreement
set forth in the Consent Agreement) and (ii) an exclusive, perpetual license to
use the Licensed Trademark in the Territory (collectively, the "Royalty-Bearing
Product Rights").
(b) The purchase price for the Royalty-Bearing Product Rights shall be
Fifteen Million Dollars ($15,000,000.00) (the "Rights Purchase Price"). The
Rights Purchase Price shall be paid in advance by Xxxxxx to RPPI on July 1,
1997, by wire transfer to an account specified in writing by RPPI.
(c) The Purchase Option shall be conclusively deemed to have been exercised
by Xxxxxx as of February 1, 2001, unless Xxxxxx delivers to RPPI a written
notice specifically stating its election not to exercise the Purchase Option;
provided, however, that such notice shall be effective solely if it is given
between December 1, 2000 and January 31, 2001; and provided further that time is
expressly made of the essence for purposes of this Section 2.5(c). After
delivery of such a notice timely electing not to exercise the Purchase Option,
RPPI shall within thirty (30) days after the scheduled expiration of this
Agreement in accordance with Section 5.1 hereof return the Rights Purchase Price
to Xxxxxx, together with interest accrued thereon at 6.0% per annum.
(d) In the event Xxxxxx exercises or is deemed to have exercised the
Purchase Option during the time period set forth in Section 2.5(c) or as
provided in Section 2.5(e), then the purchase hereunder of the Royalty-Bearing
Product Rights shall be effective as of, and shall occur at 11:59 p.m. on, the
scheduled expiration of this Agreement in accordance with Section 5.1 hereof and
the parties shall promptly execute such assignments and other documents of
conveyance and transfer as may be necessary or appropriate in order to transfer
the Royalty-Bearing Product Rights to Xxxxxx on and as of that date and time.
(e) Notwithstanding anything herein to the contrary, in the event of a
Change of Control of Xxxxxx, RPPI shall have the right within 60 days of such
Change of Control of Xxxxxx to accelerate the Purchase Option and deem it duly
exercised, such right to be exercised by delivery to Xxxxxx of a written notice
declaring the Purchase Option so accelerated and exercised. In such event any
rights hereunder of Xxxxxx to elect not to exercise the Purchase Option and
receive a refund of the Rights Purchase Price shall terminate.
(f) Xxxxxx shall have the unconditional right during the term of this
Agreement to make Improvements to the formulation of any Royalty-Bearing
Product.
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All such Improvements created or developed pursuant to the terms hereof, by or
on behalf of Xxxxxx, during the term of this Agreement shall, as between RPPI
and Xxxxxx, be the property of Xxxxxx, provided, however, that Xxxxxx'x rights
in such Improvements do not include any rights to own or use the underlying
formulation separate from the rights granted hereunder. In the event that Xxxxxx
does not exercise the Purchase Option, Xxxxxx shall, upon termination of this
Agreement, grant RPPI a nonexclusive, worldwide, perpetual, royalty-free
license, with the right to sublicense and assign such rights, in form and
substance satisfactory to each of the parties hereto, to use the Improvements
and the Research (as hereinafter defined).
(g) Xxxxxx hereby grants to RPPI, for the term of this Agreement, a
non-exclusive, royalty-free license, (with the right to sublicense and assign
such rights) to use any and all Improvements and Research in connection with the
development, manufacture, distribution, marketing, promotion, advertising and
sale of Royalty-Bearing Products outside the Territory.
(h) All marketing, clinical research and similar information and/or data
developed by Xxxxxx and its Affiliates relating to the Royalty-Bearing Products
(the "Research") shall remain the property of Xxxxxx or its Affiliates.
ARTICLE III
General Terms and Conditions
3.1 Confidentiality; Press Releases.
(a) Pursuant to the terms hereof, from time to time during the term of this
Agreement, each of Xxxxxx and RPPI and/or its respective Affiliates (in such
capacity, the "Disclosing Party") have disclosed and will be disclosing to the
other party and/or its Affiliates (in such capacity, the "Receiving Party")
certain proprietary information, technical data, trade secrets and know-how of
the Disclosing Party including, without limitation, know-how, plans, designs,
methods, formulations, ingredients, samples, processes, machines, processing and
control information, Royalty-Bearing Product performance data, manuals, INDs,
NDAs, Regulatory Approvals, the content of any unpublished patent applications,
drawings, formulae, devices, structures, models, prototypes, data, test results,
photographs, film, techniques, apparatus, tapes, disks, unpublished trademarks,
trade names and copyrights, customer lists, supplier lists, operating methods
and procedures, marketing, distribution and sales methods and systems, sales
figures, projections, finances and other business information. The Receiving
Party shall, during the term of this Agreement, and for seven (7) years after
the expiration or sooner termination of the term of this Agreement, make no use
of such confidential information except to advance the purposes of this
Agreement and of the agreements contemplated herein or therein or executed
concurrently herewith in accordance with their provisions, and shall use the
same efforts to keep secret and prevent the disclosure of such confidential
information to third parties as it would use with respect to its own
confidential information. Information disclosed by the Disclosing Party shall
remain the sole and absolute property of the Disclosing Party, subject to the
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rights granted in this Agreement and the transactions contemplated herein. The
above restrictions on the use and disclosure of information shall not apply to
any information which: (i) is already known to the Receiving Party at the time
of disclosure, as demonstrated by competent proof; (ii) is or becomes generally
available to the public other than through any act or omission of the Receiving
Party in breach of this Agreement; (iii) is acquired by the Receiving Party from
a third party who is not, directly or indirectly, under an obligation of
confidentiality to the Disclosing Party with respect to same; (iv) is required
to be disclosed pursuant to applicable law, rule or regulation; (v) is required
to be disclosed to government regulatory authorities to obtain Regulatory
Approval for the Royalty-Bearing Products or to respond to a regulatory or
governmental inquiry concerning the Royalty-Bearing Products; or (vi) is
developed independently by the Receiving Party without use, direct or indirect,
of information that is required to be held confidential hereunder.
(b) Notwithstanding this Section 3.1, but still subject to compliance with
the terms of the Jago License Agreement, Xxxxxx shall be permitted to disclose
to its distributors, wholesalers and other direct customers such confidential
information relating to the Royalty-Bearing Products as Xxxxxx shall reasonably
determine to be necessary in order to effectively market and distribute the
Royalty-Bearing Products, provided that such entities undertake the
substantially same confidentiality obligation as Xxxxxx has with respect to
RPPI's confidential information.
(c) Except as may be required by applicable laws, rules or regulations,
neither party will originate any publicity, press or news release, or other
public announcement, written or oral, whether to the public press or otherwise,
relating to this Agreement and the other agreements contemplated hereby or
thereby or executed concurrently therewith, the transactions contemplated hereby
or thereby, or to the existence of an arrangement between the parties, without
the prior written approval of the other party. In the event disclosure of this
Agreement, any of the agreements referred to herein or therein, any of the terms
and conditions of this Agreement or such agreements, or any of the transactions
contemplated by this Agreement or such agreements, is required by applicable
law, rules or regulations, then the party required to so disclose such
information shall, to the extent possible, provide to the other party for its
prior approval (such approval not to be unreasonably withheld or delayed) a
written copy of such public announcement. When practicable, the disclosing party
will provide such copy to the other party at least three (3) business days prior
to disclosure.
(d) Except as otherwise provided herein, neither party shall use the name
of the other for marketing, advertising or promotional claims without the prior
written consent of the other party.
(e) The provisions of this Section 3.1 shall survive the expiration or
sooner termination of this Agreement.
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3.2 Noncompetition.
(a) RPPI acknowledges and agrees that Xxxxxx'x business will be conducted
throughout the Territory and that Xxxxxx would be irreparably damaged if RPPI
were to provide Royalty-Bearing Products, rights or services to any person or
entity in violation of the restrictions contained in this Agreement.
Accordingly, as an inducement to Xxxxxx to enter into this Agreement, RPPI
agrees, subject to Section 2.1(c), that during the term of this Agreement and,
assuming the Purchase Option set forth in Section 2.5 is exercised or deemed
exercised by Xxxxxx, for two (2) years thereafter, RPPI shall not, and will
cause each of its Affiliates not to, directly or indirectly, without the prior
written consent of Xxxxxx and except as necessary to perform its obligations
under this Agreement and the Manufacturing Agreement: (i) in the U.S.A. produce,
supply, market, distribute or sell any pharmaceutical product containing
diltiazem that competes with the Product, or acquire, own or maintain an
interest in any Person that in the U.S.A., directly or indirectly, produces,
supplies, markets, distributes or sells any such pharmaceutical product, as a
direct or indirect proprietor, partner, stockholder, officer, director,
principal, agent or trustee; or (ii) outside the U.S.A. but in the Territory,
produce, supply, market, distribute or sell the Product or any bioequivalent
pharmaceutical product, or acquire, own or maintain an interest in any Person
that outside the U.S.A. but in the Territory, directly or indirectly, produces,
supplies, markets, distributes or sells the Product or any bioequivalent
pharmaceutical product, as a direct or indirect proprietor, partner,
stockholder, officer, director, principal, agent or trustee; provided, however,
that nothing herein shall in any way limit or restrict RPPI's and its
Affiliates' rights to engage in any of such activities, or to acquire any such
interest, solely in connection with its exercise of its rights with respect to
the Royalty-Bearing Products, or any other product that is covered by this
non-competition provision, outside the Territory.
(b) Xxxxxx acknowledges and agrees that RPPI's business will be conducted
throughout the Territory in the event that this Agreement terminates without
exercise of the Purchase Option and that RPPI would be irreparably damaged if
Xxxxxx were to provide Royalty-Bearing Products, rights or services to any
person or entity in violation of the restrictions contained in this Agreement.
Accordingly, as an inducement to RPPI to enter into this Agreement, upon the
termination or expiration of this Agreement at a time when Xxxxxx shall not
theretofore have exercised the Purchase Option, and for five (5) years
thereafter, Xxxxxx shall not, and will cause each of its Affiliates not to,
directly or indirectly, produce, supply, market, distribute or sell the Product
or any bioequivalent pharmaceutical product anywhere in the world or acquire,
own or maintain any interest in any Person that anywhere in the world, directly
or indirectly, produces, supplies, markets, distributes or sells the Product or
any bioequivalent pharmaceutical product, as a direct or indirect proprietor,
partner, stockholder, officer, director, principal, agent or trustee.
(c) RPPI or Xxxxxx (as the case may be) will not be considered in breach of
Section 3.2(a) or 3.2(b), as applicable, by reason of an acquisition of a Person
if (i) the activity of such Person which would cause such breach in the absence
of this provision is not the primary business of such Person; (ii) prior to the
closing of such acquisition said party commits in writing to the other party, on
terms acceptable to such other party (not to be unreasonably withheld or
delayed), to promptly divest itself of the offending assets
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and/or activity and (iii) such party diligently and reasonably pursues such
divestiture and, in the event such divestiture is not completed within twelve
(12) months after the date of such acquisition, such Person thereupon ceases all
such activity.
(d) Each party and its Affiliates recognize that the territorial, time and
scope limitations set forth in this Section 3.2 are reasonable and are required
for the protection of the other party and in the event that any such
territorial, time or scope limitation is deemed to be unreasonable by a court of
competent jurisdiction, RPPI and Xxxxxx agree to the reduction of either or any
of said territorial, time or scope limitations to such an area, period or scope
as said court shall deem reasonable under the circumstances. In the event of any
breach of Section 3.2(a) or 3.2(b), the time period of the breached covenant
shall be extended for the period of such breach.
(e) Each party specifically recognizes that any breach by it of this
Section 3.2 will cause irreparable injury to the other party and that actual
damages may be difficult to ascertain, and in any event, may be inadequate.
Accordingly (and without limiting the availability of legal or equitable,
including injunctive, remedies under any other provisions of this Agreement),
such party agrees that in the event of any such breach, such other party shall
be entitled to injunctive relief in addition to such other legal and equitable
remedies that may be available.
(f) The provisions of this Section 3.2 shall survive the expiration or
sooner termination of this Agreement.
3.3 Trademark Rights
(a) Maintenance
(i) Xxxxxx shall undertake and shall bear all costs of the maintenance
of the Licensed Trademark in the Territory; provided, however, that Xxxxxx shall
not abandon, let lapse or otherwise fail to maintain such Licensed Trademark in
any jurisdiction in which it is registered on the Effective Date without the
consent of RPPI. In connection with Xxxxxx'x maintenance of the Licensed
Trademark, RPPI shall cooperate with Xxxxxx, at Xxxxxx'x expense, by executing
any necessary documents, supplying Xxxxxx with specimens and performing other
reasonable acts, as requested by Xxxxxx in writing from time-to-time.
(ii) Xxxxxx shall not use any variation of the Licensed Trademark, or
any new trademark in connection with the Branded Versions in the Territory,
without the prior written consent of RPPI, which consent shall not be
unreasonably withheld or delayed. In the event RPPI gives its prior written
approval for the use of such a variation or new trademark, Xxxxxx may apply for
a registration of that variation or trademark in the United States Patent and
Trademark Office or the trademark office or other appropriate similar office in
any foreign jurisdiction in the Territory ("PTO") in the name of RPPI or its
designee. If such an application is filed by Xxxxxx, upon the receipt by Xxxxxx
of a serial number for an application from the PTO, the trademark shall become a
Licensed Trademark hereunder and be subject to the terms of this Agreement. All
costs of filing
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and prosecuting any such application and maintaining any registration resulting
therefrom shall be paid by Xxxxxx. No additional licensing fees shall be owed
Xxxxxx for the use by Xxxxxx of such variations or new trademarks referred to
herein.
(iii) In foreign jurisdictions in the Territory where registered user
agreements apply, the parties will promptly execute and file with the
appropriate authority all required instruments or agreements relating to this
Agreement and the Licensed Trademark.
(b) Infringement or Other Actions.
(i) If either party shall become aware of any infringement or
threatened infringement of the Licensed Trademark in the Territory or any unfair
competition, disparagement or other tortious act by any third party in relation
to the Licensed Trademark or Royalty-Bearing Products in the Territory, then the
party having such knowledge shall give notice to the other within ten (10) days
of becoming aware of such infringement, unfair competition, disparagement or
threatened infringement, unfair competition, disparagement or other tortious
act.
(ii) Xxxxxx shall have the right to take such action as it deems
appropriate to protect and enforce the Licensed Trademark in the Territory,
including but not limited to bringing an action, suit or other appropriate
proceeding to prevent or eliminate the infringement of such Licensed Trademark,
or the unfair competition, disparagement or other tortious act by any third
party in relation to the Licensed Trademark or Royalty-Bearing Products in the
Territory. RPPI agrees to cooperate with Xxxxxx in any reasonable manner in any
such action, suit or proceeding, at Xxxxxx'x expense, including joining as a
party to such action, suit or proceeding, if necessary to maintain standing.
(iii) Xxxxxx shall consult with RPPI with respect to its decision
whether to take any action of the nature specified in Section 3.3(b)(ii), giving
due consideration to RPPI's views with respect to the necessity or desirability
of taking such action. Xxxxxx further agrees that it will take action of the
nature specified in Section 3.3(b)(ii) if, in Xxxxxx'x reasonable business
judgment, after considering the value of the Licensed Trademark and the
Royalty-Bearing Products and the cost of such action and giving due
consideration to RPPI's right of reversion under Section 5.2 hereof, such action
is commercially reasonable; provided, however, that nothing in this Section
3.3(b)(iii) shall in any way diminish or reduce Xxxxxx'x obligations under
Section 3.5(a) hereof.
(c) Xxxxxx acknowledges that as between Xxxxxx and RPPI the Licensed
Trademark belongs to RPPI.
(d) During the term of this Agreement and thereafter Xxxxxx shall not
challenge RPPI's ownership in or right to use the Licensed Trademark or attempt
to register the Licensed Trademark in its own name.
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3.4 Third Party Claims
(a) If either party shall become aware of any action, suit or proceeding or
threat of action, suit or proceeding, by a third party alleging that the use of
the Licensed Trademark, or manufacture, use or sale of Royalty-Bearing Products
in the Territory infringes a trademark or violates any other proprietary right
of any third party, the party so aware shall promptly notify the other party of
the same and fully disclose the basis therefor.
(b) Xxxxxx shall use commercially reasonable efforts to defend such action,
suit or proceeding within the Territory if in Xxxxxx'x reasonable business
judgment, after considering the value of the Licensed Trademark and
Royalty-Bearing Products and the cost of each such action, suit or proceeding,
and giving due consideration to RPPI's right of reversion under Section 5.2
hereof, such action, suit or proceeding is commercially reasonable; provided,
however, that nothing in this Section 3.4(b) shall diminish or reduce Xxxxxx'x
obligations under Section 3.5(a) hereof. Xxxxxx will keep RPPI fully informed
with respect to all significant aspects of such action, suit or proceeding. RPPI
shall assist Xxxxxx, at Xxxxxx'x expense, by providing information in the
possession and control of RPPI and otherwise cooperating with Xxxxxx as may be
reasonably necessary to such defense. RPPI shall have the right at any time, and
at its expense, to consult with Xxxxxx with respect to any such action, suit or
proceeding or to take control of such action, suit or proceeding should Xxxxxx
elect not to defend or settle it. Xxxxxx shall not enter into any agreement or
settle any action, suit or proceeding specified in this Section 3.4 without the
express written consent of RPPI, which consent shall not be unreasonably
withheld or delayed, if such agreement would in any way limit or reduce the
nature or scope of Xxxxxx'x or any other Person's rights with respect to the
Licensed Trademark or the Royalty-Bearing Products at the time such agreement is
executed or at a future date. All amounts awarded as damages, profits or
otherwise in connection with any such litigation shall be paid to and become the
sole property of Xxxxxx.
3.5 Quality Control
(a) Xxxxxx will use commercially reasonable efforts to advertise and
promote the Royalty-Bearing Products, and to use the Licensed Trademark in
connection with the distribution, advertising, marketing and sale of the Branded
Versions, in the U.S.A., and such other countries in the Territory as Xxxxxx
determines from time to time, all in accordance with the terms of this
Agreement.
(b) Xxxxxx and its Affiliates shall not use the Licensed Trademark in any
manner which will tarnish or disparage the Licensed Trademark or otherwise have
a material adverse effect upon the Licensed Trademark or the goodwill associated
therewith.
(c) The Licensed Trademark shall be used in substantially the same form as
it was heretofore used by RPPI or its Affiliates in connection with the Product.
In the event Xxxxxx or any of its Affiliates wishes to use the Licensed
Trademark in a substantially different form, Xxxxxx shall submit such different
form to RPPI for approval, which shall not be unreasonably withheld or delayed.
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(d) Xxxxxx agrees that the nature and quality of all Royalty-Bearing
Products, and the advertising, packaging and other materials associated
therewith, sold by Xxxxxx or any of its distributors bearing the Licensed
Trademark shall be of a quality at least as high as the Product heretofore sold
under the Licensed Trademark and the advertising, packaging and other materials
heretofore associated therewith, as the case may be. Xxxxxx shall, and shall
cause its Affiliates to, comply with applicable foreign, federal, state and
local laws, rules and regulations in distributing, marketing, promoting,
advertising, selling, storing and packaging the Royalty-Bearing Products,
including without limitation all FDA Standards and all applicable portions of
the Regulatory Approvals for the Royalty-Bearing Products.
(e) RPPI shall have the following rights to exercise quality control over
Xxxxxx'x use of the License Trademark to assure itself of Xxxxxx'x adherence to
the standards set forth in Sections 3.5(b), (c) and (d):
(i) Xxxxxx shall upon request by RPPI, from time to time, submit to
RPPI a reasonable number of samples of any Royalty-Bearing Product and any
packaging, advertising and other materials which bear or are used with the
Licensed Trademark, provided however, that nothing in this Section 3.5 shall be
deemed to give RPPI the right to preapprove, prior to the initial dissemination
thereof, the advertising, packaging, and other materials used by Xxxxxx in
connection with the Royalty-Bearing Products; and
(ii) With respect to any Royalty-Bearing Product that RPPI does not
manufacture or have manufactured for Xxxxxx, RPPI shall have the right, during
regular business hours, after reasonable advance written notice to Xxxxxx, to
undertake up to two (2) inspections per annum of any facilities used to
manufacture or store such Royalty-Bearing Product.
(f) In the event of a material breach of any of the quality control
provisions set forth in this Section 3.5 by Xxxxxx or any of its Affiliates,
RPPI shall provide Xxxxxx with written notice specifying in detail the nature of
the alleged breach. Xxxxxx shall then have 60 business days, from its receipt of
such notice, to cure the breach. If Xxxxxx fails to do so by the end of such
60-business day period, RPPI shall provide Xxxxxx with additional written notice
of such failure and the parties shall then endeavor to cooperate and negotiate
in good faith, for a period of 20 business days, their dispute concerning such
alleged breach of the Agreement. If the parties do not resolve their dispute at
the expiration of the foregoing negotiation period, RPPI shall be entitled to
bring suit against Xxxxxx hereof seeking a declaratory judgment that Xxxxxx has
materially breached this Agreement and injunctive relief as appropriate to
prevent Xxxxxx'x further breaches of the quality control provisions. Xxxxxx
agrees that a material breach of the quality control provisions set forth in
this Section 3.5 would constitute irreparable harm to RPPI, entitling RPPI to
such injunctive relief appropriate under the circumstances
3.6 Adverse Event Reports.
Each of RPPI and Xxxxxx shall report to the other potentially serious
alleged adverse drug experiences with respect to the Royalty-Bearing Products of
which it becomes aware
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promptly and in no event later than five (5) days after initial receipt of the
information by such party. Each such report shall identify lot numbers and
customers affected, if known. Each of RPPI and Xxxxxx will report to the other
party summaries of other adverse drug experiences with respect to the
Royalty-Bearing Products of which it becomes aware every twelve (12) months. The
terms of this Section 3.6 will survive the expiration or sooner termination of
this Agreement.
ARTICLE IV
Indemnification
4.1 In order to distribute among themselves the responsibility for claims
arising out of this Agreement, and except as otherwise specifically provided for
herein, the parties agree as follows:
(a) Xxxxxx shall defend, indemnify and hold RPPI its Affiliates, and
their respective officers, directors, agents, employees and shareholders
(collectively, "RPPI Indemnitees") harmless, from and against, any and all
losses, obligations, liabilities, penalties, and damages (including but not
limited to compensatory and punitive damages), costs and expenses (including
reasonable attorneys' fees), which the RPPI Indemnities may incur or suffer, and
all deficiencies, actions (including without limitation, any proceedings to
establish insurance coverage), claims, suits, legal, administrative,
arbitration, governmental or other proceedings or investigations, and judgments,
with which any of them may be faced arising out of (1) the manufacture (with
respect to Royalty-Bearing Products not supplied by RPPI or any of its
Affiliates, directly or indirectly), storage, handling or use of the
Royalty-Bearing Products or the marketing, advertising, promotion, distribution
or sale of the Royalty-Bearing Products by Xxxxxx and its Affiliates and other
parties to which Xxxxxx or its Affiliates may grant marketing, sales and
distribution rights under this Agreement; and (2) the enforcement by the RPPI
Indemnitees of their rights under this Section 4.1(a).
(b) If any action, claim, suit, proceeding or investigation arises as
to which a right of indemnification provided in this Article IV applies, the
RPPI Indemnitee in question (the "indemnified party"), shall promptly notify the
party obligated under this Article IV to indemnify the indemnified party (the
"indemnifying party") thereof in writing, and allow the indemnifying party and
its insurers the opportunity to assume direction and control of the defense
against such action, claim, suit, proceeding or investigation, at its sole
expense, including without limitation, the settlement thereof at the sole option
of the indemnifying party or its insurers to the extent that the indemnified
party's liability is not thereby invoked. The indemnified party shall fully
cooperate with the indemnifying party and its insurer in the disposition of any
such matter and the indemnified party will have the right and option to
participate in (but not control) the defense of any action, claim, suit,
proceeding or investigation as to which this Article IV applies, with separate
counsel at its election and cost. If the indemnifying party fails or declines to
assume the defense of any such action, claim, suit, proceeding or investigation
within thirty (30) days after notice thereof, the indemnified party may assume
the defense thereof for the account and at the risk of the indemnifying party.
The indemnifying party
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shall pay promptly to the indemnified party any losses, obligations,
liabilities, penalties, damages, judgments, reasonable costs and expenses
(including reasonable legal fees) to which the indemnity under this Article IV
applies, as incurred.
4.2 The provisions of this Article IV shall survive the expiration or
sooner termination of the term of this Agreement.
ARTICLE V
Term and Rights on Expiration or Termination
5.1 The term of this Agreement shall commence on the Effective Date and
shall continue until December 31, 2001.
5.2 Upon the termination or expiration of this Agreement at a time when
Xxxxxx shall not have theretofore exercised the Purchase Option: (i) all rights
granted hereunder to Xxxxxx with respect to the Royalty-Bearing Products, and
the Licensed Trademark shall revert to RPPI; (ii) Xxxxxx shall cease marketing,
advertising, promoting, distributing and selling the Royalty-Bearing Products
and using the Licensed Trademark; and (iii) Xxxxxx shall return to RPPI all
written or other materials, including all preclinical and clinical research and
development data, if any, relating to the Royalty-Bearing Products that is in
the possession or control of Xxxxxx or its Affiliates; provided, however, that,
unless RPPI or one of its Affiliates shall have elected to acquire all of the
stock of Royalty-Bearing Products that Xxxxxx and its Affiliates possess or
control or have bona fide commitments to purchase from third parties at a price
equal to the amount Xxxxxx or such Affiliate paid or is committed to pay for the
same, Xxxxxx and its Affiliates shall have one hundred eighty (180) days in
which to sell out its stock of any Royalty-Bearing Products it possesses or has
committed to purchase under this Agreement (it being understood that Xxxxxx'x
payment obligations to RPPI under this Agreement shall continue to apply to any
such sales).
ARTICLE VI
Default
6.1 The occurrence of any one or more of the following acts, events or
occurrences shall constitute an "Event of Default" under this Agreement:
(a) Xxxxxx shall fail to pay to RPPI when due any licensing fee under
Section 2.2 above or any Royalty under Section 2.3 above, and such failure shall
continue for more than sixty (60) days after notice thereof from RPPI; or
(b) either party commits a material breach of this Agreement or the
Manufacturing Agreement, or materially defaults in the performance or observance
of any provision of this Agreement or the Manufacturing Agreement, and fails to
remedy such breach or default within one hundred eighty (180) days after receipt
of notice thereof.
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Article VII
Remedies
7.1 Immediately upon the occurrence of any Event of Default by RPPI
pursuant to Section 6.1 hereof, then Xxxxxx shall have the right to terminate
this Agreement, exercisable by delivering written notice thereof to RPPI, and/or
to pursue any and all remedies available to it at law or in equity including,
without limitation, the right to seek to recover from RPPI any and all damages
and losses of any nature whatsoever (including, without limitation,
consequential damages, lost profits, and direct damages); provided, however,
that, without in any way limiting Xxxxxx'x right to recover damages, RPPI shall
not be obliged under any such circumstance to refund all or any portion of any
licensing fee paid by Xxxxxx under Section 2.2 above.
7.2 Immediately upon the occurrence of any Event of Default by Xxxxxx
pursuant to Section 6.1 hereof, RPPI shall have the right to terminate this
Agreement, exercisable by delivering written notice thereof to Xxxxxx, and/or to
pursue any and all remedies available to it at law or in equity including,
without limitation, the right to seek to recover from Xxxxxx any and all damages
and losses of any nature whatsoever (including, without limitation,
consequential damages, lost profits, and direct damage).
7.3 The parties expressly acknowledge that the remedy provisions contained
in this Article are reasonable, considering the intended nature and scope of
this Agreement.
7.4 Without limiting the indemnification rights set forth in Article IV
hereof, if either party terminates this Agreement in accordance with the terms
herein, the terminating party shall owe no statutory termination penalty or
indemnity or other similar payment that might otherwise be due under local law
to the terminated party on account of such termination.
7.5 The obligations of RPPI and Xxxxxx under this Agreement shall be
subject to any delays or non-performance caused by: acts of God, earthquakes,
fires, floods, explosion, sabotage, riot, accidents; regulatory, governmental,
or military action or inaction; strikes, lockouts or labor trouble; perils of
the sea; or failure or delay in performance by third parties, including
suppliers and service providers; or any other cause beyond the reasonable
control of either party. The party which is not performing its obligations under
this Agreement as a result of any such event of force majeure shall use
commercially reasonable efforts to resume compliance with this Agreement as soon
as possible.
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ARTICLE VIII
Certain Additional Covenants
8.1 During the term of this Agreement, each of RPPI and its Affiliates
shall:
(a) Comply with, perform, observe and enforce in all material respects
its obligations, if any, under the provisions of the Jago License Agreement to
the extent such obligations survive as its respective responsibility after the
Effective Date;
(b) Provide Xxxxxx in a timely manner, but in no event less than thirty
(30) days following the request therefor, all information in RPPI's possession
or control which Xxxxxx reasonably requests regarding the Royalty-Bearing
Products in order to comply with applicable foreign, federal and state laws.
8.2 During the term of this Agreement, each of Xxxxxx and its Affiliates
shall:
(a) Comply with, perform, observe and enforce in all material respects
its obligations under the provisions of the Jago License Agreement to the extent
such obligations are its respective responsibility after the Effective Date.
(b) Provide RPPI in a timely manner, but in no event less than thirty
(30) days following the request therefor, all information in Xxxxxx'x possession
or control which RPPI reasonably requests regarding the Royalty-Bearing Product
in order to comply with applicable foreign, federal and state laws.
ARTICLE IX
Miscellaneous
9.1 In making and performing this Agreement, the parties are acting and
shall act as independent contractors. Nothing in this Agreement shall be deemed
to create an agency, joint venture or partnership relationship between the
parties hereto. Neither party shall have the authority to obligate the other
party in any respect, and neither party shall hold itself out as having any such
authority. All personnel of RPPI shall be solely employees of RPPI and shall not
represent themselves as employees of Xxxxxx. All personnel of Xxxxxx shall be
solely employees of Xxxxxx and shall not represent themselves as employees of
RPPI.
9.2 Neither RPPI nor Xxxxxx may assign or otherwise transfer any of its
rights or obligations hereunder without the prior written consent of the other
party, which shall not be unreasonably withheld or delayed. No such assignment
shall relieve assignor of any of its obligations or liabilities under this
Agreement.
9.3 This Agreement shall inure to the benefit of and be binding upon the
parties hereto and their respective successors and permitted assigns. Nothing
contained herein shall give to any other Person any benefit or any legal or
equitable right, remedy or claim.
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9.4 This Agreement may only be modified, amended or supplemented by an
instrument in writing executed by RPPI and Xxxxxx.
9.5 No term or provision hereof will be considered waived by either party,
and no breach excused by either party, unless such waiver or consent is in
writing signed on behalf of the party against whom the waiver is asserted. No
consent by either party to, or waiver of, a breach by either party, whether
express or implied, will constitute a consent to, waiver of, or excuse of any
other, different, or subsequent breach by either party.
9.6 All notices, claims, certificates, requests, demands and other
communications hereunder shall be in writing and shall be delivered personally
or sent by facsimile transmission, air courier, or registered or certified mail,
return receipt requested, addressed as follows:
If to Xxxxxx: If to RPPI:
Xxxxxx Laboratories, Inc. x/x Xxxxx-Xxxxxxx Xxxxx Pharmaceuticals Inc.
000 Xxxxxx Xxxxxx 000 Xxxxxx Xxxx
Xxxxxx, Xxxxxxxxxx 00000 Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
Fax: (000) 000-0000 Fax: (000) 000-0000
Attn: Xx. Xxxxx Xxxx Attn: Senior Vice President and General
Manager, the Americas
With copies to: With copies to:
X'Xxxxxx & Xxxxxx Xxxxx-Xxxxxxx Xxxxx Pharmaceuticals Inc.
00 Xxxxx XxXxxxx, Xxxxx 0000 000 Xxxxxx Xxxx
Xxxxxxx, Xxxxxxxx 00000 Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
Fax: (000) 000-0000 Attn: General Counsel
Attn: Xxxxxx X. Xxxxxxx Fax: (000) 000-0000
or to such other address as the party to whom notice is to be given may have
furnished to the other parties in writing in accordance herewith. Any such
communication shall be deemed to have been delivered (i) when delivered, if
delivered personally, (ii) when sent (with confirmation received), if sent by
facsimile transmission on a business day, (iii) on the first business day after
dispatch (with confirmation received), if sent by facsimile transmission on a
day other than a business day, (iv) on the second business day after dispatch,
if sent by air courier, and (v) on the fifth business day after mailing, if sent
by mail.
9.7 This Agreement shall become binding when any one or more counterparts
hereof, individually or taken together, shall bear the signatures of each of the
parties hereto. This Agreement may be executed in any number of counterparts,
each of which shall be deemed an original as against the party whose signature
appears thereon, but all of which taken together shall constitute but one and
the same instrument.
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9.8 The article and section headings contained in this Agreement are for
reference purposes only and shall not affect in any way the meaning or
interpretation of this Agreement.
9.9 This Agreement and any claims, disputes or causes of action relating to
or arising out of this Agreement shall be construed in accordance with and
governed by the laws of the State of New York, without giving effect to the
conflict of laws principles thereof.
9.10 Any of the provisions of this Agreement which are determined to be
invalid or unenforceable in any jurisdiction shall be ineffective to the extent
of such invalidity or unenforceability in such jurisdiction, without rendering
invalid or unenforceable the remaining provisions hereof or affecting the
validity or enforceability of any of the provisions of this Agreement in any
other jurisdiction.
9.11 This Agreement and the other agreements contemplated hereby or thereby
or executed concurrently herewith embody the entire agreement and understanding
between the parties hereto with respect to the subject matter hereof and
supersede all prior agreements, commitments, arrangements, negotiations or
understandings, whether oral or written, between the parties hereto and their
respective Affiliates with respect thereto, including, without limitation, that
certain letter of intent, dated May 20, 1997, between RPR and Xxxxxx. There are
no agreements, covenants or undertakings with respect to the subject matter of
this Agreement and the other agreements contemplated hereby or thereby other
than those expressly set forth or referred to herein or therein and no
representations or warranties of any kind or nature whatsoever, express or
implied, are made or shall be deemed to be made herein by the parties hereto
except those expressly made in this Agreement and the other agreements
contemplated hereby or thereby.
9.12 Each party agrees to execute, acknowledge and deliver such further
instruments, and to do all such other acts, as may be reasonably necessary or
appropriate in order to carry out the purposes and intent of this Agreement.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of
date first above written.
XXXXXX LABORATORIES, INC. XXXXX PHARMACEUTICAL
PRODUCTS INC.
By: ______________________ By: _______________________
Its:_______________________ Its:________________________
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