Agreement - ICN Pharmaceuticals Inc., Ribapharm Inc. and F. Hoffman-La Roche Ltd.
EXECUTION COPY
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Agreement
among
ICN Pharmaceuticals, Inc.,
Ribapharm Inc.,
Hoffmann-La Roche Inc.
and
F. Hoffmann-La Roche Ltd
Dated as of January 6, 2003
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TABLE OF CONTENTS
Page
ARTICLE I Definitions and Interpretation..........................................................................1
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1.1 Definitions.................................................................................1
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1.2 Interpretation..............................................................................6
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ARTICLE II Grant of License.......................................................................................6
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2.1 License.....................................................................................6
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2.2 Limit of Grant..............................................................................6
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2.3 Schering Consent............................................................................6
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ARTICLE III Compensation..........................................................................................7
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3.1 Royalties...................................................................................7
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3.2 Most Favored Licensee.......................................................................9
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3.3 Extent of Royalty Obligations..............................................................10
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3.4 Payment Terms..............................................................................11
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3.5 Taxes......................................................................................11
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3.6 Reports and Records........................................................................12
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3.7 Sales in Foreign Currencies................................................................13
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ARTICLE IV Resolution of Contested Proceedings and Release.......................................................13
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4.1 United States Litigations..................................................................13
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4.2 European Litigations.......................................................................13
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4.3 Foreign Oppositions........................................................................14
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4.4 Mutual Releases............................................................................14
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ARTICLE V Representations, Warranties and Limitation of Liability................................................14
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5.1 Representations of Ribapharm and ICN.......................................................14
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5.2 Representations of Roche...................................................................15
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5.3 Mutual Representation and Warranty.........................................................16
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ARTICLE VI Indemnification and Insurance.........................................................................16
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6.1 Indemnification by Roche...................................................................16
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6.2 Indemnification by Ribapharm and ICN.......................................................16
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6.3 Obligations of the Party Seeking to Be Indemnified.........................................17
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6.4 Limits on Indemnification..................................................................17
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ARTICLE VII Publicity and Confidentiality........................................................................17
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7.1 Publicity and Confidentiality..............................................................17
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ARTICLE VIII Term and Termination................................................................................18
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8.1 Term.......................................................................................18
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8.2 Termination................................................................................18
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8.3 Rights and Obligations Upon Termination or Expiration......................................19
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8.4 Surviving Provisions.......................................................................20
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ARTICLE IX Assignment; Successors................................................................................20
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9.1 Assignment.................................................................................20
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9.2 Successors.................................................................................20
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ARTICLE X Dispute Resolution.....................................................................................21
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10.1 Arbitration................................................................................21
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10.2 Pre-Litigation Dispute Resolution..........................................................21
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10.3 Provisional Remedy.........................................................................21
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10.4 Royalty Dispute............................................................................21
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ARTICLE XI General Provisions....................................................................................22
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11.1 Relationship of the Parties................................................................22
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11.2 Excusable Delay............................................................................22
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11.3 Notices....................................................................................22
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11.4 Expenses...................................................................................23
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11.5 Further Assurances.........................................................................23
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11.6 Amendment..................................................................................24
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11.7 Waiver.....................................................................................24
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11.8 No Third Party Beneficiaries...............................................................24
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11.9 Entire Agreement...........................................................................24
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11.10 Construction...............................................................................24
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11.11 Counterparts...............................................................................24
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11.12 Severability...............................................................................24
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11.13 Joint and Several Liability of Roche.......................................................25
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11.14 Bankruptcy.................................................................................25
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11.15 Remedies Cumulative........................................................................25
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11.16 Governing Law..............................................................................25
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Appendices
A. Arbovirus Patent Rights
B. Generic Lawsuits
C. Th1/Th2 Patent Rights
D. Additional Licensed Patents
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AGREEMENT
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This Agreement (Agreement) is made as of January 6, 2003 (the Effective
Date) by and among (i) ICN Pharmaceuticals, Inc. (ICN) and Ribapharm Inc.
(Ribapharm), each a Delaware corporation, and (ii) Hoffmann-La Roche Inc., a New
Jersey corporation, and F. Hoffmann-La Roche Ltd, a Swiss corporation
(individually and together, Roche).
Recitals
A. Ribapharm is the owner of patents in various countries which contain
claims relating to certain pharmaceutical uses of ribavirin, an oral antiviral
product.
B. Roche has developed an antiviral product containing ribavirin.
C. Ribapharm, ICN or both have filed suit and/or counterclaims against
Roche in Europe and the United States contending that Roche's intended
commercialization of its ribavirin product would infringe Ribapharm's patents
relating to ribavirin.
D. Roche has filed suit, opposition proceedings and/or counterclaims
against Ribapharm, ICN or both contending that Ribapharm's ribavirin patents are
neither valid nor infringed by Roche's intended commercialization of ribavirin.
E. The Parties wish to obviate the need for such contested proceedings in
favor of Ribapharm granting a non-exclusive license to Roche under Ribapharm's
ribavirin patents.
Agreement
For consideration, the value, sufficiency, and receipt of which are hereby
acknowledged, the Parties agree as follows.
ARTICLE I
Definitions and Interpretation
1.1 Definitions
In this Agreement, capitalized terms have the meanings set forth below.
Act means the Federal Food, Drug and Cosmetic Act (21 U.S.C.ss.301, et
seq.), including all amendments or supplements.
Accounting Period means [REDACTED].
Adjusted Gross Sales means the amount of gross sales of Products (whether
in active ingredient form, semi-finished form, finished product form, or
otherwise) invoiced by Roche and by its Affiliates to Third Parties less
deductions for returns and reasonably established return reserves (including
allowances actually given for spoiled, damaged, out-dated, rejected, returned
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Products sold, withdrawals, and recalls), rebates [REDACTED], volume (quantity)
discounts, taxes (value added or sales taxes, government mandated exceptional
taxes and other taxes imposed on the gross sales amount), as computed [REDACTED]
in Swiss Francs [REDACTED], whereby the amount of such sales in foreign
currencies is converted into Swiss Francs on the basis of the average monthly
rate of exchange at the time in accordance with Roche's then current standard
practices, which will be in accordance with IAS. Notwithstanding the foregoing,
amounts received by Roche and its Affiliates for the sale of Products among
Roche and its Affiliates for resale will not be included in the computation of
Adjusted Gross Sales. [REDACTED].
Affiliate means any individual or entity directly or indirectly
controlling, controlled by or under common control with, a Party. For the
purposes of this Agreement, the direct or indirect ownership of fifty percent
(50%) or more of the outstanding voting securities of an entity, or the right to
receive fifty percent (50%) or more of the profits or earnings of an entity will
be deemed to constitute control. Such other relationship as in fact results in
actual control over the management, business and affairs of an entity will also
be deemed to constitute control. Anything to the contrary notwithstanding,
Genentech will not be considered an Affiliate of Roche.
Agreement has the meaning set forth in the preamble.
ANDA means an Abbreviated New Drug Application filed with the FDA for
marketing approval for a drug pursuant to the Act and the Regulations.
Approval Authority means a governmental authority whose approval is
required in a country for a Product Registration.
Arbovirus Patents means those patents and patent applications which are
listed in Appendix A.
[REDACTED].
Bankruptcy Code means Title 11, U.S. Code.
Breaching Party has the meaning set forth in Section 8.2(a).
Business Day means a day when banks are open for business in New York City.
Claims has the meaning set forth in Section 6.1.
Combined Product means a pharmaceutical product consisting of or containing
two or more active ingredients, one of which is the Licensed Compound and one or
more of which is not, sold together for a single unit price.
Commercial Sale means, with respect to a Product in any country in the
Territory, all sales by Roche or any of its Affiliates after Product
Registration in such country which transfer to a Third Party purchaser physical
possession and title to commercial quantities of the Product in such country.
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Effective Date has the meaning set forth in the preamble.
Effectively Commercially Available has the meaning set forth in Section
3.1(c).
Effective Royalty Rates has the meaning set forth in Section 3.2.
EPC Countries means the states which at the relevant time are members of
the European Patent Convention.
FDA means the United States Food and Drug Administration, or any successor.
Field means the use of the Licensed Compound in combination therapy with
PEG-IFN-alpha for the treatment of chronic hepatitis C.
Formula means the fraction [REDACTED] described in the definition of Net
Sales.
Genentech means Genentech, Inc., of 1 DNA Way, South San Francisco,
California 94080-4990, U.S.A.
Generic Lawsuits means individually and collectively those (i) certain
federal district court actions filed by ICN and/or Ribapharm which are set forth
in Appendix B, and (ii) any similar court actions in the United States with any
Third Party which may arise in the future related to the Litigation Patents.
IAS has the meaning set forth in Section 3.6(d).
ICN has the meaning set forth in the preamble.
Indemnifying Party has the meaning set forth in Section 6.3.
Licensed Compound means oral ribavirin, having the chemical formula
1-(beta)-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide. For the avoidance of
doubt, oral ribavirin does not include prodrugs of ribavirin such as viramidine.
Licensed Patents means rights under patents and patent applications in the
Field, as well as corresponding certificates of invention or certificates of
protection, substitutes, extensions, provisionals, supplementary protection
certificates, renewals, continuations, continuations-in-part, divisions, patents
of addition (re-examination or re-issue), in any country of the Territory, which
are owned by, or licensed to, Ribapharm and/or its Affiliates as of the
Effective Date or during the term of this Agreement which relate to the use of
the Licensed Compound in the Field. In particular, Licensed Patents shall
include (i) the Arbovirus Patents, (ii) the Th1/Th2 Patents and (iii) those
other patents and patent applications listed in Appendix D.
Litigation Patents means the Arbovirus Patents and the Th1/Th2 Patents,
including any renewals, extensions, re-examinations or re-issues thereof.
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Medical Needs Programs means programs pursuant to which Product is provided
free of charge or at a reduced price to patients who are not adequately covered
by healthcare coverage in their country, [REDACTED].
Net Sales means the amount calculated by subtracting from the amount of
Adjusted Gross Sales a lump sum deduction of [REDACTED] in lieu of those sales
related deductions which are not accounted for on a product by product basis
(e.g., outward freights, postage charges, transportation insurance, packaging
materials for dispatch of goods, custom duties, bad debt, discounts granted
later than at the time of invoicing, cash discounts and other direct sales
expenses). Notwithstanding the foregoing, amounts received by Roche and its
Affiliates for the sale of Products among Roche and its Affiliates for resale
will not be included in the computation of Net Sales. If the Product is sold as
a Combined Product, Net Sales for the Combined Product will be calculated by
multiplying actual Net Sales of such Combined Product by the fraction
[REDACTED], where A is the [REDACTED] of the Product sold separately by Roche or
an Affiliate and containing the Licensed Compound [REDACTED] and B is the
[REDACTED] of any other active component or components in the Combined Product
sold separately by Roche or an Affiliate.
Non-Breaching Party has the meaning set forth in Section 8.2(a).
No-Sales Distributions has the meaning set forth in Section 3.3(c).
Party means each of ICN, Ribapharm and Roche.
PEG-IFN-alpha means any product containing the branched pegylated (40kDa)
interferon alpha 2a that was used, on or before August 10, 2001, as the active
ingredient in Roche's product referred to as PEGASYS. Without limiting the
foregoing, PEG-IFN-alpha includes variations in the composition of the product
due to minor changes in manufacturing that are approved by governmental
regulatory authorities for such product. Examples of such minor changes in
manufacturing are (i) adjustment of excipients, pH, electrolytes, or
preservatives, or use of new raw materials such that the raw materials do not
lead or result in chemical changes to or chemical modifications of the PEG,
linker or interferon alpha portion of the active ingredient, (ii) starting
materials or intermediates that do not chemically change the PEG, linker or
interferon alpha portion of the active ingredient, (iii) other manufacturing
variations that result from the need to accommodate new sources of raw materials
or manufacturing methods, or (iv) changes in the average number of PEG units
and/or their location of attachment on the interferon alpha portion based on
batch to batch variations or manufacturing site to manufacturing site variations
and such that the manufacturing modifications are not chemical changes to or
chemical modifications of the PEG, linker or interferon alpha portion of the
active ingredient. Examples of changes that are not minor manufacturing
modifications are any chemical changes to or chemical modifications of the PEG,
linker or interferon alpha portion of the active ingredient.
Product means any pharmaceutical product consisting of or containing the
Licensed Compound which is promoted and sold for use in combination with
PEG-IFN-alpha, including without limitation a Combined Product.
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Product Registrations means any and all government approvals required by
any government or regulatory authority in the Territory necessary to permit the
development, manufacture, marketing, importing, use, or sale of a pharmaceutical
product in any part of the Territory.
Regulations means the regulations made under the Act, as amended or
supplemented.
Ribapharm has the meaning set forth in the preamble.
Roche has the meaning set forth in the preamble.
ROW Countries has the meaning set forth in Section 3.1(c).
Schering Consent has the meaning set forth in Section 2.3.
Schering License means the Exclusive License and Supply Agreement between
Ribapharm and Schering-Plough Ltd. made as of July 28, 1995, as may be amended.
Successful European Appeal means a decision of the Technical Board of
Appeals of the European Patent Office [REDACTED] holding that at least one Valid
Claim of Ribapharm's patents in the European opposition is valid and otherwise
enforceable.
Successful Japanese Appeal means a decision of a court beyond the right of
further review [REDACTED] holding that at least one claim of Ribapharm's
involved patents is valid and otherwise enforceable.
Successful US Appeal means a decision of a court on appeal [REDACTED]
holding that at least one claim of Ribapharm's patents in suit is valid and
otherwise enforceable (including infringed) against the Third Party's oral
ribavirin product involved in the decision.
Term means the term of this Agreement, as set forth in Section 8.1.
Territory means all countries of the world and their territories and
possessions.
Th1/Th2 Patents means those patents and patent applications which are
listed in Appendix C.
Third Party means any person other than ICN, Ribapharm, Roche, and each of
their respective Affiliates.
United States means the United States of America and its territories and
possessions.
Unlicensed Third Party Sales means the sale of an oral ribavirin product
within the Field by a Third Party without a license from Ribapharm. For the
avoidance of doubt, Unlicensed Third Party Sales do not include sales pursuant
to the Schering License or sales by Genentech and its affiliates.
Valid Claim means a claim of an issued and unexpired patent in a country in
the Territory which is included within the Litigation Patents, and which (i) has
not been finally revoked or
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held unenforceable or invalid by a decision of a court of last resort or other
governmental agency of competent and final jurisdiction, (ii) has not been
abandoned, disclaimed, dedicated to the public or admitted to be invalid or
unenforceable through reissue or disclaimer or otherwise, and (iii) has not been
finally construed or otherwise expressly limited by a court of last resort or
other governmental agency of competent and final jurisdiction so as to not cover
the anti-viral use for which Roche has then received regulatory approval to sell
its oral ribavirin.
1.2 Interpretation
In this Agreement, unless the context requires otherwise
(a) the singular includes the plural and vice versa;
(b) words denoting persons include corporations, partnerships, and
other legal entities;
(c) a reference to a specified section, paragraph, or schedule is a
reference to that specified section, paragraph, or schedule of this Agreement;
(d) the article and section headings and the Table of Contents are for
convenience only, are not part of this Agreement, and do not affect the
interpretation or enforcement of this Agreement;
(e) "including" means including without limitation; and
(f) a reference to a Party includes its successors and permitted
assigns.
ARTICLE II
Grant of License
2.1 License
Ribapharm grants to Roche and its Affiliates, and Roche accepts on behalf
of itself and its Affiliates, a non-exclusive, non-transferable and
non-sublicensable right and license under the Licensed Patents within the Field
throughout the Territory to make, have made, use, sell and distribute Products.
2.2 Limit of Grant
Roche has no right or license with respect to the Licensed Patents except
as expressly granted in this Agreement.
2.3 Schering Consent
Ribapharm represents and warrants to Roche that ICN has previously
exclusively licensed the Licensed Patents for use within the Field throughout
the Territory to Schering Plough Ltd. pursuant to the Schering License and that
the rights and obligations of ICN under the
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Schering License have been assigned to and assumed by Ribapharm with the consent
of Schering-Plough Ltd. pursuant to a letter agreement dated March 8, 2002
between ICN, Schering-Plough Ltd. and Ribapharm. Roche represents and warrants
to Ribapharm and ICN that by a Settlement and License Agreement dated August 10,
2001 by and between Roche and Schering Corporation, an affiliate of Schering
Plough Ltd., Schering Corporation agreed to waive so much of its exclusivity
under the Licensed Patents as to allow ICN and Roche to enter into a license to
commercialize Roche's PEG-IFN-alpha product in combination therapy with the
Licensed Compound, and further agreed that upon written notice to Schering
Corporation, Schering Corporation would consent to and modify Schering-Plough
Ltd.'s exclusive rights under the Schering License to allow for the grant of
such a license to Roche without requiring consideration from ICN to Schering
Plough Ltd. (the Schering Consent). To the best of each Party's information and
belief, the Schering Consent is the only consent that may be required from
Schering Plough Ltd. to enable each of the Parties to enter into and perform
this Agreement. The Parties shall cooperate to promptly obtain the Schering
Consent in writing.
ARTICLE III
Compensation
3.1 Royalties
(a) Roche will pay Ribapharm a royalty, [REDACTED], in the following
amount:
(i) for the United States, [REDACTED] annual Net Sales; and
(ii) for other countries in the Territory, [REDACTED] annual Net
Sales,
on the Net Sales which occur in a country in which a Valid Claim exists.
(b) Subject to Sections 3.1(c) and 3.3, royalties on Net Sales due
under Section 3.1(a) will be calculated [REDACTED] (each being the last day
of an Accounting Period) and will be paid by Roche [REDACTED] within sixty
(60) days after the end of each Accounting Period in which such Net Sales
occur, commencing with the [REDACTED] in which the first Commercial Sale of
any Product is made by Roche or any of its Affiliates; [REDACTED].
(c) If the Licensed Compound from any Third Party becomes Effectively
Commercially Available in a country in the Territory for use in the Field,
Roche will not be obligated to pay the royalty in Section 3.1(a) for that
country from that time. The Licensed Compound shall be considered
"Effectively Commercially Available" in accordance with the following:
(i) In the United States, the Licensed Compound will be
considered Effectively Commercially Available upon the earlier of:
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(A) a decision by a United States District Court in any of the
Generic Lawsuits that all the claims of the Litigation
Patents involved in the US suit are wholly invalid or
otherwise entirely unenforceable against the oral ribavirin
product of the respective ANDA applicant [REDACTED]; or
(B) the issuance of Product Registrations to a Third Party for
an oral ribavirin product and the occurrence of subsequent
Unlicensed Third Party Sales, [REDACTED];
(ii) In EPC Countries, the Licensed Compound will be considered
Effectively Commercially Available:
(A) in any and all EPC Countries in the event that the
Opposition Division or the Technical Board of Appeals of the
European Patent Office rejects all Valid Claims of the
Litigation Patents involved in the opposition, [REDACTED];
or
(B) in a given EPC Country in the event of the issuance of
Product Registrations to a Third Party in such country for
an oral ribavirin product and subsequent Unlicensed Third
Party Sales in such country [REDACTED];
(iii) In Japan, the Licensed Compound will be considered Effectively
Commercially Available upon the earlier of:
(A) a decision by any court in Japan or a decision by the
Japanese Patent Office in an opposition brought by a Third
Party, that all the claims of the Litigation Patents in suit
are wholly invalid or otherwise entirely unenforceable
[REDACTED]; or
(B) the issuance of Product Registrations to a Third Party in
Japan for an oral ribavirin product and the occurrence of
subsequent Unlicensed Third Party Sales in Japan,
[REDACTED]; and
(iv) In countries other than the United States, the EPC Countries and
Japan (ROW Countries), the Licensed Compound will be considered Effectively
Commercially Available:
(A) in all ROW Countries at any time an oral ribavirin product
is Effectively Commercially Available in the United States
and in the EPC Countries; or
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(B) in a given ROW Country in the event of Unlicensed Third
Party Sales in commercial quantities in such country
[REDACTED].
(d) If an Approval Authority imposes a price limitation for specific
indications or patients, [REDACTED], Ribapharm and Roche will discuss [REDACTED]
the applicable royalty [REDACTED].
(e) At its sole discretion, Roche may obtain Product Registrations for a
Combined Product in any country in the Territory. Roche alone will have full
responsibility for obtaining such Product Registrations, and nothing in this
Agreement shall be construed as preventing or limiting Roche from conducting any
Commercial Sales activities with the Combined Product in any manner whatsoever
[REDACTED] or requiring Roche to obtain any approval from Ribapharm or any of
its Affiliates relating to Commercial Sales of the Combined Product. Ribapharm,
however, may notify Roche in writing should Ribapharm reasonably believe a
material purpose for Roche's commercial activities with the Combined Product
[REDACTED] over a specified time period was for reducing the royalties that
otherwise would be due Ribapharm under this Agreement. Such notice shall include
(i) a detailed summary with supportive factual information of Ribapharm's basis
for its belief, and (ii) a specific suggestion of what adjustment should be made
to the Formula used in calculating Net Sales of the Combined Product [REDACTED].
If Roche agrees with Ribapharm that an adjustment to the Formula is appropriate,
the Parties will negotiate in good faith an adjustment. If, [REDACTED] after
Roche receives such notice, (i) Roche does not agree with Ribapharm that an
adjustment to the Formula is appropriate or (ii) the Parties can not agree on an
adjustment, then a Party may submit the matter to arbitration under Section 10.1
[REDACTED].
(f) [REDACTED]
(i) [REDACTED]
(ii) [REDACTED]
3.2 Most Favored Licensee
In the event Ribapharm shall grant a right or license to sell the Licensed
Compound to any Third Party which has Effective Royalty Rates which are lower
than the royalty rates under this Agreement, then Ribapharm shall notify Roche
promptly in writing of the financial terms or any and all other consideration
which directly or indirectly relates to the grant of such right or license and
Roche shall have the right to adopt such Effective Royalty Rates of such Third
Party right or license as the royalty rates for this Agreement as of the
effective date of such Third Party right or license. Effective Royalty Rates as
used herein means [REDACTED]. In the event the Parties are unable to agree on
the computation of the Effective Royalty Rate, it shall be submitted to
arbitration in accordance with Section 10.1. For purposes of this provision, any
lowering of the royalty rates in the Schering License shall effectively
constitute the grant of a new right or license to sell the Licensed Compound.
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3.3 Extent of Royalty Obligations
(a) Subject to Sections 3.3(c) and (e), the obligation of Roche to pay
theroyalty under Section 3.1 with respect to Product will commence on the first
Commercial Sale in a country in the Territory after the Effective Date and will
continue [REDACTED] in the Territory until termination or expiration of this
Agreement [REDACTED] or upon Effective Commercial Availability of the Licensed
Compound in [REDACTED].
(b) Only one royalty payment shall be due on the sale of each unit of
Product under this Agreement.
(c) [REDACTED] no royalties will accrue upon, and Net Sales will not
include, the disposition of Product that Roche or its Affiliates distribute,
free of charge, in good faith to address marketing challenges for the Product.
Such dispositions of Product shall include (i) samples (promotional or
otherwise), (ii) donations (for example, to non-profit institutions or
government agencies for a non-commercial purpose), (iii) use in investigator
initiated clinical studies, or (iv) use in patient assisted programs in the
Field (individually and collectively, No-Sale Distributions). Ribapharm may
notify Roche in writing should Ribapharm reasonably believe a material purpose
for Roche's No-Sale Distributions [REDACTED] over a specified time period was
for reducing the royalties that otherwise would be due Ribapharm under this
Agreement. Such notice shall include (i) a detailed summary with supportive
factual information of Ribapharm's basis for its belief, and (ii) a specific
suggestion of what adjustment should be made to Net Sales [REDACTED]. If Roche
agrees with Ribapharm that an adjustment to Net Sales is appropriate, the
Parties will negotiate in good faith an adjustment. If, within ninety (90) days
after Roche receives such notice, (i) Roche does not agree with Ribapharm that
an adjustment to Net Sales is appropriate or (ii) the Parties can not agree on
an adjustment, then a Party may submit the matter to arbitration under Section
10.1 as further described in Section 3.3(d).
(d) Should an arbitration be commenced in accordance with Section
3.3(c), the arbitrator(s) shall be restricted to deciding only two issues:
(i) Has Ribapharm demonstrated by a preponderance of the evidence
that a material purpose for Roche's No-Sale Distributions of Product [REDACTED]
over a specified time period was for reducing the royalties that otherwise would
be owed to Ribapharm for sales of Product?
(ii) Should the first issue be decided in favor of Ribapharm, what
adjustment should be made to the Net Sales [REDACTED] over the specified time to
compensate Ribapharm in accordance with the intentions of this Agreement, taking
into account the purposes motivating the No-Sales Distributions which are the
subject of the arbitration? In deciding this second issue, each Party will
submit to the arbitrator(s) what the Party believes would be a fair adjustment
to the Net Sales on account of the No-Sale Distributions, and the arbitrators
may only choose between one of these adjustments.
(e) No royalties will accrue upon, and Net Sales will not include, the
disposition of Product by Roche or its Affiliates pursuant to Medical Needs
Programs
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[REDACTED] to the extent that such dispositions if otherwise sold would have
amounted to less than [REDACTED] of the Net Sales for the given [REDACTED]
royalty period under Section 3.1(b). For those dispositions of Product under
Medical Needs Programs that exceed [REDACTED] in the given period, royalties
will accrue to such dispositions of Product as calculated at the [REDACTED] for
such Product.
(f) Roche alone will have full responsibility for distributing the Product
(including the Combination Product or components thereof), such as No-Sale
Distributions under Section 3.3(c) or Medical Needs Programs under Section
3.3(e), and nothing in this Agreement shall be construed as preventing or
limiting Roche from distributing Product in any manner whatsoever or for
requiring Roche to obtain any approval from Ribapharm or any of its Affiliates.
3.4 Payment Terms
Roche will make all payments required under this Agreement in United States
Dollars. Any payments provided for under this Agreement that are not made when
due will bear interest at an annual rate until paid in full, equal to the 60-day
London interbank offered rate (LIBOR) plus [REDACTED], as such rate may from
time to time fluctuate. Roche will make all payments under this Agreement to
Ribapharm by wire transfer of immediately available funds to a bank account of
Ribapharm designated by Ribapharm from time to time in writing in accordance
with this Agreement.
3.5 Taxes
(a) All amounts owed under this Agreement will be paid after deduction
as required by law for all applicable taxes, fees, and other charges except
taxes imposed with respect to or based on a Party's net income. In particular,
any tax required to be withheld by Roche under the laws of any country for the
account of Ribapharm (withholding taxes) will be promptly paid by Roche for and
on behalf of Ribapharm to the appropriate governmental authority, and Roche will
furnish Ribapharm with proof of payment of such tax. All such tax actually paid
on Ribapharm's behalf will be deducted from royalty payments due Ribapharm or
promptly reimbursed to Roche if no further payments are due Ribapharm. Roche
will assist Ribapharm in claiming tax refunds at Ribapharm's request. Each Party
agrees to assist the other Party in minimizing the withholding taxes applicable
to any payment made by Roche, in claiming exemption from such withholding of
taxes of any type under any double taxation or similar agreement or treaty from
time to time in force, and in minimizing the amount required to be so withheld
or deducted.
(b) Notwithstanding the provisions of Section 3.5(a), in the event of a
change in the United States-Switzerland income tax treaty which results in the
imposition by Switzerland or any of its political subdivisions of withholding
taxes on any royalty payment under this Agreement, Roche will pay to Ribapharm
an amount, in addition to all royalties payable under this Agreement, such that
after the deduction of all such taxes (including interest, penalties, or
additions to tax) Ribapharm receives the full amount of the royalty without
diminution for such taxes.
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3.6 Reports and Records
(a) With each royalty payment made in accordance with Section 3.1(b)
Roche will deliver to Ribapharm a royalty report which includes the following
information:
(i) the total Adjusted Gross Sales for each Product subject to
royalty sold by Roche and its Affiliates [REDACTED];
(ii) Net Sales [REDACTED]; and
(iii) total royalties payable to Ribapharm for the relevant period.
(b) [REDACTED].
(c) Roche and its Affiliates will keep, at Roche's principal place of
business, full, true, and accurate books of account containing all particulars
that may be necessary for the purpose of calculating all royalties payable to
Ribapharm with accounting principles consistently applied from period to period
in accordance with IAS.
(d) At the expense of Ribapharm, Ribapharm or its authorized
independent public accountant may engage Roche's officially appointed worldwide
independent public accountant to perform, on behalf of Ribapharm or its
independent public accountant, an audit, conducted in accordance with
international accounting standards (IAS), of such books and records of Roche and
its Affiliates that are deemed necessary by Roche's independent public
accountant to report on Net Sales of Products for the period or periods
requested by Ribapharm and the correctness of any report or payments made under
this Agreement. Upon timely request and at least thirty (30) calendar days'
prior written notice from Ribapharm, such audit will be conducted as an
additional audit work during Roche's annual audit of the countries specifically
requested by Ribapharm, during regular business hours in such a manner as to not
unnecessarily interfere with Roche's normal business activities, and will be
limited to results in the two (2) calendar years prior to audit notification.
Such audit will not be performed more frequently than once per calendar year nor
more frequently than once with respect to records covering any specific period
of time.
(e) All information, data documents, and abstracts herein referred to
will be used only for the purpose of verifying royalty statements or compliance
with this Agreement, will be treated by Ribapharm as confidential information,
and need not be retained beyond the longest of (i) one (1) year after completion
of an audit, if an audit has been requested, (ii) two (2) years from the end of
the calendar year to which such pertains, and (iii) one (1) year after the date
of termination of this Agreement. Audit work papers and results will be shared
by Roche and Ribapharm.
(f) If the audit reveals an overpayment, Ribapharm will promptly
reimburse Roche for the amount of the overpayment. If the audit reveals an
underpayment, Roche will promptly make up such underpayment. If the audit
reveals that the royalties owed by Roche to Ribapharm for the countries
specifically requested and for any calendar year in total have been understated
by more than [REDACTED], Roche will, in addition, pay the reasonable costs of
such additional audit work. The failure of Ribapharm to request verification of
any royalty
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calculation within the period during which corresponding records must be
maintained will be deemed to be conclusive acceptance of the royalty reporting
for the period to which the royalty pertains.
3.7 Sales in Foreign Currencies
Whenever for the purpose of calculating royalties, conversion from any
currency other than United States Dollars is required, such conversion will be
made as follows. When calculating the Adjusted Gross Sales, the amount of such
sales in currencies other than United States Dollars and Swiss Francs will be
converted into Swiss Francs as computed in Roche's central Swiss Francs "sales
statistics" for the countries concerned, using for internal foreign currency
translation Roche's then current standard practices actually used on a
consistent basis in preparing its audited financial statements in accordance
with IAS. When calculating the royalties on Net Sales, the Adjusted Gross Sales
calculated in Swiss Francs will be converted to United States Dollars using the
year to date average exchange rate as retrieved from the Reuters' system for the
applicable Accounting Period.
ARTICLE IV
Resolution of Contested Proceedings and Release
4.1 United States Litigations
The Parties agree to enter into and cause to be filed promptly after the
Effective Date, a stipulated order of dismissal of the suit ICN Pharmaceuticals
et al. v. Hoffmann-La Roche Inc. et al. Case No. 02-6644 MRP filed in the United
States District Court for the Central District of California with each Party
agreeing to assume its own costs and expenses.
4.2 European Litigations
Promptly after the Effective Date, Roche shall withdraw the suit F.
Hoffmann-La Roche AG, CH-Basel/ Roche Pharma Schweiz AG CH-Reinach/ Hoffmann-La
Roche AG D-Grenzach v. ICN Pharmaceuticals Inc. / Ribapharm Inc. filed in the
Handelsgericht Zurich, and Ribapharm or ICN or both, as applicable, shall
withdraw the suits Ribapharm Inc./ICN Pharmaceuticals Inc. v. Roche Nederland
BV, Case No. 2002/1321 and Ribapharm Inc./ICN Pharmaceuticals Inc. v. Roche
Nederland BV, Case No. 2002/1299 filed in the Rechtbank te's Gravenhage,
Ribapharm Inc. v. F. Hoffmann-La Roche AG, Roche Pharma AG, Hoffmann-La Roche
AG, Case No. 21 O 14763/02 filed in the District Court (Landgericht) Munich, and
Ribapharm Inc. v. F. Hoffmann-La Roche AG, Roche Pharma AG, Hoffmann-La Roche
AG, Case No. 21 O 14765/02 filed in the District Court (Landgericht) Munich, by
filing the appropriate applications or letters with the courts in each of these
cases respectively. The respondent Party shall file corresponding letters
agreeing to the withdrawal of the cases as necessary and all Parties shall agree
to assume their own costs and expenses.
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4.3 Foreign Oppositions
Roche agrees promptly after the Effective Date to withdraw its oppositions
to [REDACTED] and to cause all other oppositions to such patents controlled by
Roche as of the Effective Date to be promptly withdrawn.
4.4 Mutual Releases
(a) Each of ICN and Ribapharm hereby releases and discharges Roche and
each of its Affiliates, successors, assigns, directors, officers, employees, and
agents from all causes of action, demands, claims, damages and liabilities of
any nature arising from acts occurring prior to the Effective Date with respect
to commercializing by Roche or its Affiliates of the Product, including, without
limitation, all claims with respect to (and only with respect to) Product that
ICN or Ribapharm has asserted or could have asserted in any of the disputes
identified in this Article IV to which Roche was a party.
(b) Roche hereby releases and discharges ICN and Ribapharm and each of
their Affiliates, successors, assigns, directors, officers, employees, and
agents from all causes of action, demands, claims, damages and liabilities of
any nature arising from acts occurring prior to the Effective Date with respect
to commercializing by Roche or their Affiliates of the Product, including,
without limitation, all claims with respect to (and only with respect to)
Product that Roche has asserted or could have asserted in any of the disputes
identified in this Article IV to which ICN and/or Ribapharm was a party.
ARTICLE V
Representations, Warranties and Limitation of Liability
5.1 Representations of Ribapharm and ICN
Ribapharm and ICN represent and warrant to Roche as follows.
(a) Each of Ribapharm and ICN is a corporation duly organized under the
laws of the State of Delaware, and has all requisite legal and corporate power
and authority to carry on its business and to perform its obligations under this
Agreement. All corporate action on the part of each of Ribapharm and ICN
necessary for the execution and delivery of this Agreement and the performance
of their respective obligations under this Agreement has been taken. The
person(s) executing this Agreement on behalf of Ribapharm and ICN have all
necessary corporate powers and have been duly authorized by Ribapharm and ICN to
execute and deliver this Agreement on its behalf. This Agreement constitutes a
valid and binding obligation of each of Ribapharm and ICN, enforceable against
it in accordance with its terms.
(b) The execution, delivery, and performance of this Agreement by each of
Ribapharm and ICN will not, with or without notice or the passage of time or
both, result in any violation of, be in conflict with or constitute a default
under any material contract, obligation, or commitment to which each is a party
or by which it is bound or, to the best knowledge of Ribapharm or ICN, any
statute, rule, or governmental regulation applicable to each of Ribapharm or
ICN.
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(c) Ribapharm owns or controls under valid licenses with the right of
sublicense all right, title, and interest in and to the Licensed Patents except
to the extent otherwise provided by the exclusivity rights in the Schering
License described in Section 2.3. As of the Effective Date of this Agreement, to
the best knowledge of Ribapharm and ICN, there are no adverse actions, suits, or
claims pending or threatened against Ribapharm or its Affiliates by a Third
Party in any court or by or before any governmental body or agency with respect
to the Licensed Patents except the Generic Lawsuits set forth in Appendix B and,
to the best knowledge of Ribapharm and ICN, there are no Third Party patents
which might give rise to such actions, suits, or claims.
(d) Ribapharm represents, warrants and covenants that on or before the
Effective Date (i) Ribapharm has disclosed to Roche all of its and its
Affiliates' pending patent applications with claims relating to the use of the
Licensed Compound including but not limited to use in combination with
interferon alpha and has disclosed in writing to Roche all of Ribapharm's and
its Affiliates' [REDACTED] patent applications containing such claims, and (ii)
Ribapharm and its Affiliates are not aware of any patent filing, other than the
Licensed Patents, that claim the commercializing of interferon alpha for
therapeutic use in humans as combination therapy with the Licensed Compound.
EXCEPT AS SET FORTH IN SECTIONS 5.1(a) THROUGH (d) AND SUBJECT TO SECTION
5.3, NEITHER RIBAPHARM NOR ICN MAKES ANY WARRANTY CONCERNING THE LICENSED
PATENTS, OR THE PRODUCTS INCLUDING THE FOLLOWING: (I) ANY EXPRESS OR IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH REGARD TO
THE PRODUCTS; [REDACTED]. IN NO EVENT WILL ANY OF RIBAPHARM, ICN OR THEIR
AFFILIATES OR AGENTS BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY
KIND, OR LOST PROFITS, OF ROCHE.
5.2 Representations of Roche
Roche represents and warrants to Ribapharm and ICN as follows.
(a) Hoffmann-La Roche Inc. is a corporation duly organized under the
laws of the State of New Jersey and F. Hoffmann-La Roche Ltd is a corporation
duly organized under the laws of Switzerland. Each of such corporations has all
requisite legal and corporate power and authority to carry on its business and
perform its obligations under this Agreement. All corporate action on the part
of Roche necessary for the execution and delivery of this Agreement and the
performance of Roche's obligations under this Agreement has been taken. The
person(s) executing this Agreement on behalf of Roche have all necessary
corporate powers and have been duly authorized by Roche to execute this
Agreement on its behalf. This Agreement constitutes a valid and binding
obligation of Roche, enforceable against it in accordance with its terms.
(b) The execution, delivery, and performance of this Agreement by Roche
will not, with or without notice or the passage of time or both, result in any
violation of, be in conflict with or constitute a default under any material
contract, obligation or commitment to
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which Roche is a party or by which it is bound or, to the best knowledge of
Roche, any statute, rule, or governmental regulation applicable to Roche.
5.3 Mutual Representation and Warranty
Each Party warrants and represents that it has disclosed all information in
its possession or control (other than information which is subject to
confidentiality or non-disclosure obligations) which is material to the other
Party entering into this Agreement, and such information does not contain any
untrue statement of material fact or omit to state a material fact. Disclosure
to one member of a Party will constitute disclosure to all members of the Party.
ARTICLE VI
Indemnification and Insurance
6.1 Indemnification by Roche
Roche will at all times, during and after the Term, indemnify, defend, and
hold harmless Ribapharm, ICN, their respective Affiliates, and their respective
directors, officers, employees, and agents against all claims, demands, actions,
and liabilities (collectively, Claims), including reasonable attorneys' fees and
costs, arising out of or resulting from
(a) each breach, if any, of any representation, warranty, or covenant
of Roche under this Agreement; or
(b) each Third Party product liability claim or suit, if any, resulting
from the development, manufacture, marketing, import, use, or sale of Products
by Roche or its Affiliates pursuant to this Agreement or from the performance by
Roche of its obligations under this Agreement.
This indemnity obligation will not apply to the extent that Claims result
from any negligent act or willful misconduct of Ribapharm, ICN, their respective
Affiliates, or their respective directors, officers, employees, or agents.
6.2 Indemnification by Ribapharm and ICN
Ribapharm and ICN will at all times, during and after the Term, indemnify,
defend, and hold harmless Roche, its Affiliates, and their respective directors,
officers, employees and agents against all Claims arising out of or resulting
from each breach (respectively), if any, of any representation, warranty, or
covenant of Ribapharm or ICN under this Agreement.
This indemnity obligation will not apply to the extent that the Claims
result from any negligent act or willful misconduct of Roche, its Affiliates, or
their respective directors, officers, employees or agents.
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6.3 Obligations of the Party Seeking to Be Indemnified
If Ribapharm, ICN, Roche, or any Affiliate (in each case, an Indemnified
Party) receives any written Claim which it believes is the subject of indemnity
under this Agreement by Ribapharm, ICN or Roche, as the case may be (in each
case, an Indemnifying Party), the Indemnified Party will, as soon as reasonably
practicable after forming such belief, give notice to the Indemnifying Party,
including full particulars of such claim to the extent known to the Indemnified
Party. Failure to give timely notice to the Indemnifying Party will not release
the Indemnifying Party from any liability to the Indemnified Party except to the
extent that the Indemnifying Party is injured by such delay. The Indemnifying
Party will have the right, by prompt notice to the Indemnified Party, to assume
the defense of the claim at the cost of the Indemnifying Party. If the
Indemnifying Party does not assume the defense of the claim or, having done so,
does not pursue the defense, the Indemnified Party may assume the defense, with
counsel of its choice, but at the cost and for the account of the Indemnifying
Party. If the Indemnifying Party so assumes such defense, the Indemnified Party
may participate through counsel of its choice, but the cost of such counsel will
be for the account of the Indemnified Party. The party not assuming the defense
of the claim will render all reasonable assistance to the party assuming the
defense, and all out-of-pocket costs of such assistance will be for the account
of the Indemnifying Party. No such claim will be settled other than by the party
defending the claim, and then only with the consent of the other party, which
will not be unreasonably withheld or delayed.
6.4 Limits on Indemnification
(a) All Claims for indemnification by an Indemnified Party must be made
(and will otherwise be irrevocably barred) prior to the later of (i) [REDACTED]
after the date the Indemnified Party first has substantial reason to believe a
Claim exists, or (ii) the date when all Claims first equal or exceed [REDACTED].
(b) No Indemnified Party will make any Claims until the aggregate of
all Claims to date of a Party first equals or exceeds [REDACTED], at which time
all Claims to date and all Claims arising thereafter may be asserted.
(c) The limitations in this Section 6.4 do not apply to the provisions
of [REDACTED].
ARTICLE VII
Publicity and Confidentiality
7.1 Publicity and Confidentiality
(a) Except as otherwise provided in this Agreement or required by law
or the rules of any nationally recognized securities exchange on which
securities of a Party or any of its Affiliates are traded, no Party will
originate any publication, news release, or other public announcement, or
otherwise make disclosure to any Third Party, written or oral, whether in the
public press, stockholders' reports, or otherwise, relating to any and all
terms, including the
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financial terms, of this Agreement, without the prior written approval of
the other Parties, which approval will not be unreasonably withheld or delayed.
(b) Notwithstanding the foregoing, within seven (7) days after the
execution and delivery of this Agreement (or such shorter period as may be
required by law or the rules of any nationally recognized relevant securities
exchange), the Parties will issue a press release concerning the general nature
of this Agreement in form and substance agreed between the Parties prior to
publication.
(c) If a Party is required to make disclosure in respect of this
Agreement under applicable laws or the rules of any nationally recognized
securities exchange, the disclosing Party [REDACTED] and consult with the other
Parties, and take into consideration another Party's comments thereon, prior to
such disclosure and, where applicable, will request confidential treatment to
the extent available.
(d) Once information has been released in accordance with this Article,
the information contained in such release may be subsequently released by any
Party without the prior approval or consent of the other Parties.
ARTICLE VIII
Term and Termination
8.1 Term
(a) This Agreement commences as of the Effective Date and, unless
sooner terminated throughout the Territory in accordance with this Agreement,
shall continue [REDACTED] until the expiration of the last to expire Licensed
Patent.
(b) Upon expiration of this Agreement [REDACTED] with respect to any
Product, Roche will have a perpetual, fully paid-up, royalty free, non-exclusive
license within the Field [REDACTED] to make, have made, import, use, offer for
sale, and sell such Product.
8.2 Termination
(a) A Party (as such, the Non-Breaching Party) may terminate this
Agreement if
(i) another Party (other than a Party in the same group to which
the Non-Breaching Party belongs) or its Affiliates (as such, the Breaching
Party) does not comply with any of its material obligations contained in
this Agreement;
(ii) the Non-Breaching Party gives notice to the Breaching Party
specifying the nature of the default, requiring the Breaching Party to cure
the default, and referring to the Non-Breaching Party's right to terminate
this Agreement pursuant to this Section 8.2; and
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(iii) the default is not cured within [REDACTED] after the receipt of
such notice.
(b) Either Party which is in not in default of its obligations hereunder
may terminate this Agreement upon written notice in the event any of the
contested proceedings between the Parties is not terminated in accordance with
the provisions of Article IV [REDACTED] days of the Effective Date, provided,
however, that if notwithstanding the good faith efforts of the other Parties
hereto the termination of such contested proceedings has not been completed by
the end of such [REDACTED] day period, the Parties hereto will agree on a
reasonable extension of such [REDACTED] day period in order to complete the
termination of such proceedings.
(c) A Party may terminate this Agreement if at any time
(i) another Party (other than a Party in the same group to which the
Non-Breaching Party belongs) files in any court or agency pursuant to any
statute or regulation of the United States or of any foreign country, a
petition in bankruptcy or insolvency or for reorganization or for an
arrangement or for the appointment of a receiver or trustee of the other
Party or of its assets;
(ii) another Party (other than a Party in the same group to which the
Non-Breaching Party belongs) proposes a written agreement of composition or
extension of its debts;
(iii) another Party (other than a Party in the same group to which the
Non-Breaching Party belongs) is served with an involuntary petition against
it, filed in any insolvency proceeding, and the petition is not dismissed
within [REDACTED] days after filing; or
(iv) another Party (other than a Party in the same group to which the
Non-Breaching Party belongs) makes an assignment for the benefit of
creditors.
(d) Upon the occurrence of any event under Section 8.2(a)(iii) or Section
8.2(b) that entitles a Party to terminate this Agreement, such Party may deliver
to the other Party written notice of termination of this Agreement, and the
termination will be effective upon delivery of such notice. The right to
terminate will be in addition to and not in substitution of any other available
remedy.
(e) [REDACTED]
(f) Waiver by a Party of any event or succession of events giving rise to
the right of termination will not deprive the waiving Party of the right to
terminate this Agreement under this Section 8.2 on the basis of any subsequent
event giving rise to such right.
8.3 Rights and Obligations Upon Termination or Expiration
Expiration or termination of this Agreement or a license hereunder shall
not relieve the Parties of any obligation accruing prior to such expiration or
termination. Any expiration or
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early termination of this Agreement shall be without prejudice to the rights of
a Party against the other accrued or accruing under this Agreement prior to
termination, including the obligation to pay royalties for Product sold prior to
such termination.
8.4 Surviving Provisions
The Parties' rights and obligations under this Agreement will survive any
termination of this Agreement for the period of the statute of limitations
applicable to such rights or obligations. Termination or expiration of this
Agreement for any reason will be without prejudice to any rights accrued to the
benefit of a Party prior to termination or expiration and will not relieve any
Party from obligations expressly indicated to survive termination or expiration
of this Agreement. Termination or expiration of this Agreement will not
terminate Roche's obligation to pay all royalties accrued. Any other provisions
of this Agreement required to interpret and enforce the Parties' rights and
obligations under this Agreement will also survive to the extent required for
the full observation and performance of this Agreement by the Parties.
ARTICLE IX
Assignment; Successors
9.1 Assignment
(a) Subject to Sections 9.1(c) and (d), neither this Agreement nor any
interest under this Agreement may be assigned by Roche or its Affiliates without
the prior written consent of Ribapharm and ICN. No assignment will release Roche
or its Affiliates from any liability under this Agreement.
(b) Subject to Sections 9.1(c) and (d), neither this Agreement nor any
interest under this Agreement may be assigned by Ribapharm, ICN or their
respective Affiliates without the prior written consent of Roche. No assignment
will release Ribapharm, ICN or their respective Affiliates from any liability
under this Agreement.
(c) Roche, Ribapharm and ICN may assign this Agreement or any rights
under this Agreement to an Affiliate or to any successor by merger,
consolidation, or sale of substantially all of the assets used in the business
which is the subject of this Agreement.
(d) Any assignment not made in accordance with this Section 9.1 will be
void ab initio.
---------
9.2 Successors
Subject to the limitations on assignment under Section 9.1, this Agreement
binds all successors in interest and assigns of Ribapharm, ICN and Roche. Any
successor or assignee of a Party's interest will expressly assume in writing the
performance of all the terms and conditions of this Agreement to be performed by
the Party.
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ARTICLE X
Dispute Resolution
10.1 Arbitration
Subject to compliance with Section 10.2, and other limitations on
arbitration as described elsewhere in this Agreement, any dispute, controversy
or claim arising under, out of, or in connection with this Agreement, including
any subsequent amendments will be referred to and finally be settled under the
Rules of Arbitration of the International Chamber of Commerce, Paris, France, in
force on the date of commencement of the arbitration by three arbitrators
appointed in accordance with those Rules. The place of arbitration will be New
York City, New York, and Delaware law will be applied. The language to be used
in the arbitral proceedings will be English. Notwithstanding the foregoing, the
arbitrators in such proceedings may not make any determination as to the
validity or enforceability of any of the Licensed Patents.
10.2 Pre-Litigation Dispute Resolution
If a Party believes another Party has failed to comply with any of its
respective material obligations contained in this Agreement, the Party that
believes such obligation has not been fulfilled shall provide written notice to
the other Party concerning such possible non-compliance. The Party receiving
such notice shall have [REDACTED] after receipt of such notice to cure such
alleged non-compliance. In the event there is a dispute regarding the matter in
question, during such [REDACTED] period the Parties shall meet to discuss such
dispute. Should such discussion not resolve the dispute, then during such
[REDACTED] period, a Party may request that the unresolved dispute be referred
to the Chief Executive Officer of Ribapharm, or the President of ICN (if
appropriate), and the Head of the Pharmaceuticals Division of Roche to resolve
the dispute. In any event, if the matter in question is not resolved within
[REDACTED] after receipt of such notice, then either Party may proceed to
arbitration pursuant to Section 10.1. Nothing stated or left unstated in this
Article shall be deemed, directly, indirectly, expressly, or by implication, to
constitute a waiver of any rights that a Party may possess under this Agreement
or by law.
10.3 Provisional Remedy
Nothing in this Agreement limits the right of a Party to seek to obtain in
any court of competent jurisdiction any interim relief or provisional remedy,
including injunctive relief. Seeking or obtaining any interim relief or
provisional remedy in a court will not be deemed a breach or waiver of the
agreement in this Agreement to arbitrate.
10.4 Royalty Dispute
If a dispute between the Parties relates to the amount of royalties payable
under this Agreement, Roche will continue to pay Ribapharm not less than
[REDACTED] of the amount alleged by Roche in good faith to be payable, until the
dispute is resolved.
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ARTICLE XI
General Provisions
11.1 Relationship of the Parties
For purposes of this Agreement, the relationship of Ribapharm and ICN to
Roche is that of an independent contractor. Ribapharm, ICN and Roche are not
joint venturers, partners, principal and agent, master and servant, or employer
and employee. With respect to the subject matter of this Agreement, Ribapharm,
ICN and Roche have no power to bind or obligate each other in any manner, other
than as expressly set forth in this Agreement. A change of this relationship is
not precluded by this Agreement.
11.2 Excusable Delay
The failure or omission by a Party in the performance of any obligation
under this Agreement will not be deemed a breach of this Agreement or create any
liability if it arises from cause beyond the control of the Party, such as
strikes, riots, war, acts of God, invasion, fire, explosion, floods, delay of
carrier, shortage or failure in the supply of materials, energy shortage, and
acts of government or governmental agencies or instrumentalities. If due to such
an event either Party is delayed or hindered in or prevented from the
performance of its duties or doing acts required under the terms of this
Agreement, the performance of such act will be excused for the period of the
delay not to exceed ninety (90) days. A Party subject to such an excusable delay
will take all reasonable steps to resolve any condition forming the basis of the
delay.
11.3 Notices
All notices, consents, requests, waivers, and other communications in
connection with this Agreement
(a) must be in writing, signed by an authorized officer of the sender
(in the case of Roche, an authorized officer of either of Hoffmann-La Roche Inc.
or F. Hoffmann-La Roche Ltd will be sufficient), and sent by personal delivery,
fax (with confirmation copy), internationally recognized courier, or certified
or registered mail, postage prepaid (airmail where applicable);
(b) will be deemed to be given when actually received; and
(c) must be sent to the receiving Party at the address or fax number,
as applicable, set forth below, or any replacement address or fax number
notified to the sender by notice actually received by the sender:
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if to Ribapharm or ICN, to
Ribapharm Inc.
3300 Hyland Avenue
Costa Mesa, California 92626
United States of America
Attention: General Counsel
Fax: 1 (714) 668-3108
with a copy to
ICN Pharmaceuticals, Inc.
3300 Hyland Avenue
Costa Mesa, California 92626
United States of America
Attention: General Counsel
Fax: 1 (714) 641-7206
if to Roche, to
Hoffmann-La Roche Inc.
340 Kingsland Street
Nutley, New Jersey 07110
United States of America
Attention: Corporate Secretary
Fax: 1 (973) 235-3500
and to
F. Hoffmann-La Roche Ltd
Grenzacherstrasse 124
4070 Basel, Switzerland
Attention: Corporate Law Department
Fax: 41-62-688-1396
11.4 Expenses
Except as expressly provided otherwise in this Agreement, all legal and
other costs and expenses incurred in connection with the negotiation, execution,
and delivery of this Agreement and the transactions contemplated by this
Agreement will be paid by the Party incurring such costs or expenses.
11.5 Further Assurances
Except as expressly provided elsewhere in this Agreement, each Party will
at its expense promptly execute and deliver any further instruments and
documents and take any further action as another Party may reasonably request in
order to further evidence and confirm the transactions contemplated by this
Agreement.
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11.6 Amendment
This Agreement may not be altered or otherwise amended except by an
instrument in writing executed and delivered by each of the Parties.
11.7 Waiver
A Party may extend the time for the performance of any obligations of
another Party, waive any inaccuracies and representations by another Party in
this Agreement or in any document delivered pursuant to this Agreement, or waive
compliance by another Party with any of the covenants, conditions or performance
of any of its obligations under this Agreement. Any such waiver must be in a
writing executed and delivered by the Party sought to be charged. Any such
waiver or failure to insist upon strict compliance with such covenant, condition
or obligation will not operate as a waiver of, or estoppel with respect to, any
subsequent or other failure.
11.8 No Third Party Beneficiaries
This Agreement does not confer any rights, remedies, agreements,
undertakings, obligations, or liabilities on any person other than the Parties,
their Affiliates, and their respective successors-in-interest and permitted
assigns.
11.9 Entire Agreement
This Agreement constitutes the entire agreement between the Parties with
respect to its subject matter and supersedes all prior discussions,
negotiations, correspondence, agreements, and understandings, both oral and
written, between the Parties with respect thereto. There are no covenants,
promises, agreements, warranties, representations, conditions or understandings,
either oral or written, among the Parties that are material to the subject
matter of this Agreement other than as are set forth in this Agreement.
11.10 Construction
The Parties have participated jointly in the negotiation and drafting of
this Agreement. If a question of intent or interpretation arises, this Agreement
will be construed as if drafted jointly by the Parties, and no presumption or
burden of proof will arise favoring or disfavoring a party because of the
authorship of any provision of this Agreement.
11.11 Counterparts
This Agreement may be executed in any number of counterparts and by
facsimile, each of which will be deemed to be an original and all of which
together will constitute one and the same agreement.
11.12 Severability
If any provision of this Agreement is finally determined to be invalid,
unlawful, or unenforceable in a jurisdiction, (a) (i) it will be deemed to be
severed from this Agreement in
24
<PAGE>
such jurisdiction, (ii) every other provision of this Agreement will remain in
full force and effect in such jurisdiction, and (iii) the Parties will negotiate
in good faith to modify this Agreement so as to achieve the original intent of
the Parties as closely as possible in an acceptable manner with respect to such
jurisdiction, and (b) such invalidity, unlawfulness, or unenforceability will
not affect the interpretation or enforcement of this Agreement in any other
jurisdiction.
11.13 Joint and Several Liability of Roche
The representations, warranties, covenants, and liabilities of Roche under
this Agreement are joint and several except as otherwise expressly provided in
this Agreement.
11.14 Bankruptcy
All rights and licenses granted under or pursuant to this Agreement by
Ribapharm to Roche are, and will otherwise be deemed to be, for purposes of
Section 365(n) of the Bankruptcy Code, licenses of rights to "intellectual
property" as defined under Section 101(35A) of the Bankruptcy Code. Roche, as a
licensee of such rights under this Agreement, will retain and may fully exercise
all of its rights and elections under the Bankruptcy Code.
11.15 Remedies Cumulative
The rights and remedies of the Parties under this Agreement are in addition
to any other rights available to them at law or in equity. The use of any right
or remedy by a Party does not preclude or waive the right to use any other
rights or remedies. This Section 11.15 does not relieve the Parties of their
obligations under Section 9.1 (Assignment) and Section 9.2 (Successors).
11.16 Governing Law
This Agreement will be governed by and construed in accordance with the
laws of the State of Delaware without regard to its principles governing
conflict of laws.
25
<PAGE>
IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly
authorized representatives as of the date set forth above.
ICN PHARMACEUTICALS, INC.
By: ______________________________
Name:
Title:
RIBAPHARM INC.
By: ______________________________
Name:
Title:
HOFFMANN-LA ROCHE INC.
By: ______________________________
Name:
Title:
F. HOFFMANN-LA ROCHE LTD
By: ______________________________
Name:
Title:
By: ______________________________
Name:
Title:
26
<PAGE>
Appendix A
----------
Arbovirus Patents
-----------------
Docket No. Country Title Status Filing Date Application No. Patent No.
100848.169097AT Austria (EP) Ribavirin Human Use Issued 16-Apr-85 EP 94118300 EP0643970 B1
100848.169097CH Switzerland (EP) Ribavirin Human Use Issued 16-Apr-85 EP 94118300 EP0643970 B1
100848.169097DE German Democratic Ribavirin Human Use Issued 09-Oct-85 DD 261094 261 094
Republic
100848.169097DE2 Germany Ribavirin Human Use Pending 05-Nov-01 EP 94118300 261 094
100330.169097EP Germany (EP) Ribavirin Human Use Issued 16-Apr-85 EP 94118300 EP0643970 B1
100848.169097EP2 European Ribavirin Human Use Issued 16-Apr-85 EP 94118300 EP0643970 B1
Patent(EP)
100848.169097FR France (EP) Ribavirin Human Use Issued 16-Apr-85 EP 94118300 EP0643970 B1
100848.169097HK Hong Kong(EP) Ribavirin Human Use Issued 13-Nov-01 EP 94118300 HK 1010985
100848.169097IT Italy (EP) Ribavirin Human Use Issued 16-Apr-85 EP 94118300 EP0643970 B1
100848.169097JP Japan Ribavirin Human Use Issued 05-Jun-85 JP 122351/85 2005448
100848.169097NL Netherlands (EP) Ribavirin Human Use Issued 16-Apr-85 EP 94118300 EP0643970 B1
100848.169097SE Sweden (EP) Ribavirin Human Use Issued 16-Apr-85 EP 94118300 EP0643970 B1
100848.169097UK Great Britain (EP) Ribavirin Human Use Issued 16-Apr-85 EP 94118300 EP0643970 B1
27
<PAGE>
Appendix B
----------
Generic Lawsuits
----------------
1. ICN Pharmaceuticals, Inc v. Geneva Pharmaceuticals Technology Corporation,
filed on September 21, 2001 in the United States District Court for the
Central District of California, related to Geneva Pharmaceuticals
Technology Corporation submission of ANDA No. 76-192 to the FDA on June 22,
2001; and ICN v. Geneva Pharmaceuticals, Inc., filed on September 24, 2001
in the United States District Court for the Central District of California,
both of which have been consolidated into case No. CV 02-3543 MRP (FMOx) in
the United States District Court for the Central District of California.
2. ICN v. Three Rivers Pharmaceuticals, LLC, filed on May 24, 2002 in the
United States District Court for the Eastern District of Pennsylvania, No.
2:02 CV 3231, related to Three Rivers Pharmaceuticals, LLC submission of
ANDA No. 76-203 to the FDA on July 13, 2001 (this case has been transferred
to the United States District Court for the Central District of
California).
3. ICN v. Teva Pharmaceuticals USA, Inc., filed on February 5, 2002 in the
United States District Court for the Eastern District of Pennsylvania, No.
2:02 CV 600, related to Teva Pharmaceuticals USA, Inc., submission of ANDA
No. 76-277 to the FDA on November 19, 2001 (this case has been transferred
to the United States District Court for the Central District of
California).
28
<PAGE>
Appendix C
----------
Th1/Th2 Patents
---------------
Docket No. Country Title Status Filing Date Application No. Patent No.
100848.213102AT Austria (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102AU Australia Specific Modulation of Issued 21-Jan-97 17478/97 700642
(ex WO 97/26883) TH1/TH2 Cytokine
Expression
100848.213102BA Bosnia/Herzegovina Specific Modulation of Pending 21-Jan-97 Up-4270/98
(ex WO 97/26883) TH1/TH2 Cytokine
Expression
100848.213102BE Belgium (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102BR Brazil (ex WO Specific Modulation of Pending 21-Jan-97 PI 9707154-4
97/26883) TH1/TH2 Cytokine
Expression
100848.213102CA Canada (ex WO Specific Modulation of Issued 21-Jan-97 2246162 2246162
97/26883) TH1/TH2 Cytokine
Expression
100848.213102CH Switzerland (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102CN China (exWO Specific Modulation of Pending 21-Jan-97 97191776.0
97/26883) TH1/TH2 Cytokine
Expression
100848.213102CZ Czech Republic Specific Modulation of Pending 21-Jan-97 PV 2329-98
(exWO 97/26883) TH1/TH2 Cytokine
Expression
100848.213102DE Germany (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 69712316
TH1/TH2 Cytokine
Expression
100848.213102DK Denmark (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102EP EPO Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102EP2 EPO Specific Modulation of Pending 21-Jan-97 EP 01112901.2
TH1/TH2 Cytokine
Expression
100848.213102EP3 EPO Specific Modulation of Pending 21-Jan-97 EP 02009781.2
TH1/TH2 Cytokine
Expression
100848.213102ES Spain (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102FI Finland (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102FR France (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102GB Great Britain Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
(EP) TH1/TH2 Cytokine
Expression
100848.213102GR Greece (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102HK Hong Kong (EP) Specific Modulation of Pending 21-Jan-97 99100284.7
TH1/TH2 Cytokine
Expression
100848.213102HU Hungary (exWO Specific Modulation of Issued 21-Jan-97 P9900681 220 105
97/26883) TH1/TH2 Cytokine
Expression
100848.213102IE Ireland (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
29
<PAGE>
Docket No. Country Title Status Filing Date Application No. Patent No.
TH1/TH2 Cytokine
Expression
100848.213102IL Israel (exWO Specific Modulation of Issued 21-Jan-97
97/26883) TH1/TH2 Cytokine
Expression
100848.213102IT Italy (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102JP Japan (exWO Specific Modulation of Pending 21-Jan-97 526907/97
97/26883) TH1/TH2 Cytokine
Expression
100848.213102KR South Korea Specific Modulation of Issued 21-Jan-97 98/705645 298158
(exWO 97/26883) TH1/TH2 Cytokine
Expression
100848.213102LU Luxembourg (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102MC Monaco (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102MK Macedonia (exWO Specific Modulation of Allowed 21-Jan-97 P-067/98 900534
97/26883)? TH1/TH2 Cytokine
Expression
100848.213102MX Mexico (exWO Specific Modulation of Issued 21-Jan-97 985963 204061
97/26883) TH1/TH2 Cytokine
Expression
100848.213102NL Netherlands (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102NO Norway (exWO Specific Modulation of Pending 21-Jan-97 98.3372
97/26883) TH1/TH2 Cytokine
Expression
100848.213102NZ New Zealand Specific Modulation of Issued 21-Jan-97 330784 330784
(exWO 97/26883) TH1/TH2 Cytokine
Expression
100848.213102PL Poland (exWO Specific Modulation of Pending 21-Jan-97 P.328 003
97/26883) TH1/TH2 Cytokine
Expression
100848.213102PT Portugal (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102RU Russia (exWO Specific Modulation of Pending 21-Jan-97 2186569
97/26883) TH1/TH2 Cytokine
Expression
100848.213102SE Sweden (EP) Specific Modulation of Issued 21-Jan-97 EP 97904765 EP0879056 B1
TH1/TH2 Cytokine
Expression
100848.213102SK Slovakia (exWO Specific Modulation of Pending 21-Jan-97 PV 1004-98
97/26883) TH1/TH2 Cytokine
Expression
100848.213102UA Ukraine (exWO Specific Modulation of Issued 21-Jan-97 98073815/M 46815
97/26883) TH1/TH2 Cytokine
Expression
100848.213102US1 USA Specific Modulation of Issued 23-Jan-96 590449 5767097
TH1/TH2 Cytokine
Expression
100848.213102US2 USA Specific Modulation of Issued 23-Jan-96 09/097450 6063772
TH1/TH2 Cytokine
Expression
100848.213102US3 USA Specific Modulation of Issued 23-Jan-96 09/156646 6150337
TH1/TH2 Cytokine
Expression
100848.213102US4 USA Specific Modulation of Pending 23-Jan-96 09/624855
TH1/TH2 Cytokine
Expression
100848.213102US5 USA Specific Modulation of Pending 08-Mar-02 10/094032
TH1/TH2 Cytokine
Expression
30
<PAGE>
Docket No. Country Title Status Filing Date Application No. Patent No.
100848.213102YU Yugoslavia (exWO Specific Modulation of Issued 21-Jan-97 P-9720013 9720013
97/26883)? TH1/TH2 Cytokine
Expression
31
<PAGE>
Appendix D
----------
Additional Licensed Patents
---------------------------
Docket No. Country Title Status Filing Date Application No. Patent No.
100848.0002AR Argentina Cytokine Related Pending 17-Jul-98 P98 01 03953
Treatments of Disease
100848.0002AU Australia (ex Cytokine Related Issued 13-Jan-1998 60238/98 736075
WO 98/30223) Treatments of Disease
100848.0002BA Bosnia-Herzegowina Cytokine Related Pending 13-Jan-1998 BAP 99398A
(ex WO Treatments of Disease
98/30223)
100848.0002BR Brazil(ex WO Cytokine Related Pending 13-Jan-1998 P19807473-3
98/30223) Treatments of Disease
100848.0002CA Canada (ex WO Cytokine Related Pending 13-Jan-1998 2278158
98/30223) Treatments of Disease
100848.0002CN3 China (ex WO Cytokine Related Pending 13-Jan-1998 00126807.4
98/30223, Treatments of Disease
divisional)
100848.0002CZ3 Chech Republic Cytokine Related Pending 13-Jan-1998 PV 2000-3805
(ex WO Treatments of Disease
98/30223
divisional)
100848.0002EPO European Cytokine Related Pending 13-Jan-1998 EP-A 0 998 293
Patent (ex WO Treatments of Disease
98/30223)
100848.0002HK Hong Kong (EP) Cytokine Related Pending 13-May-00 00102855.0
Treatments of Disease
100848.0002HR2 Croatia (ex WO Cytokine Related Issued 23-Jun-00 P20000421A PK20000421
98/30223 Treatments of Disease
divisional)
100848.0002HU Hungary (ex WO Cytokine Related Pending 13-Jan-1998 P0001526
98/30223) Treatments of Disease
100848.0002IL3 Israel (ex WO Cytokine Related Pending 19-Jul-00 137392
98/30223 Treatments of Disease
divisional)
100848.0002IN India Cytokine Related Pending 13-Jan-1998 1614/Ca/98
Treatments of Disease
100848.0002KR South Korea Cytokine Related Pending 13-Jan-1998 1999-7006393
(ex WO Treatments of Disease
98/30223)
100848.0002MK Macedonia (ex Cytokine Related Issued 13-Jan-1998 P-01/99 900705
WO 98/30223) Treatments of Disease
100848.0002MX Mexico (ex WO Cytokine Related Pending 13-Jan-1998 9906418
98/30223) Treatments of Disease
100848.0002NO3 Norway (ex WO Cytokine Related Pending 31-Aug-00 2000 4329
98/30223 Treatments of Disease
divisional)
100848.0002NZ3 New Zealand Cytokine Related Pending 13-Jan-1998 505530
(ex WO Treatments of Disease
98/30223
divisional)
100848.0002PL Poland (ex WO Cytokine Related Pending 13-Jan-1998 P.336 579
98/30223) Treatments of Disease
100848.0002RU3 Russia (ex WO Cytokine Related Pending 23-Aug-00 RU 2000122127
98/30223 Treatments of Disease
divisional)
100848.0002SB Serbia (ex WO Cytokine Related Pending 13-Jan-1998 P-615/98
98/30223) Treatments of Disease
100848.0002SI Slovenia (ex Cytokine Related Issued 13-Jan-1998 P-9820003 980003
WO 98/30223) Treatments of Disease
100848.0002SK Slovakia (ex Cytokine Related Pending 13-Jan-1998 PV 940-99
WO 98/30223) Treatments of Disease
100848.0002UA3 Ukraine (ex WO Cytokine Related Pending 05-Jul-00?? 2000073980/I
98/30223 Treatments of Disease
divisional)
100848.0002US10 USA (Divisonal Cytokine Related Pending 29-Apr-02 10/136745
of US6) Treatments of Disease
100848.0002US6 USA Cytokine Related Issued 09-Jul-99 09/467443 6423695
Treatments of Disease
100848.0002US8 USA (ex WO Cytokine Related Pending 15-Jun-00 09/594372
98/30223 Treatments of Disease
divisional of
US1)
32
<PAGE>
Docket No. Country Title Status Filing Date Application No. Patent No.
100848.0002US9 USA (ex WO Cytokine Related Pending 16-Jun-00 09/595448
98/30223 Treatments of Disease
divisional of
US1)
100848.0002ZA South Africa Cytokine Related Issued 24-Jul-98 98/6641 98/6641
(ex WO Treatments of Disease
98/30223)
100848.0012AR Argentina Modulation of Immune Pending 03-Aug-01 P01 01 03731
Response by Ribavirin
100848.0012AU Australia (ex Modulation of Immune Pending 20-Dec-1999 24833/00
WO 2000/24833) Response by Ribavirin
100848.0012BA Bosnia-Herzegowin Modulation of Immune Pending 20-Dec-1999 BAP01842A
(ex WO Response by Ribavirin
2000/24833
100848.0012BR Brazil (ex WO Modulation of Immune Pending 20-Dec-1999 P19917090-6
2000/24833) Response by Ribavirin
100848.0012CA Canada (ex WO Modulation of Immune Pending 20-Dec-1999 2357735
2000/24833) Response by Ribavirin
100848.0012CN China (ex WO Modulation of Immune Pending 20-Dec-1999 99815897.6
2000/24833) Response by Ribavirin
100848.0012CZ Czech Republic Modulation of Immune Pending 20-Dec-1999 PV 2001-2519
(ex WO Response by Ribavirin
2000/24833
100848.0012DE Germany (EP Modulation of Immune Issued 05-Feb-02 DE 29924200 ????
-Utility Response by Ribavirin
Patent)
100848.0012EPO European Modulation of Immune Pending 20-Dec-1999 99968155.6
Patent (ex WO Response by Ribavirin
2000/24833)
100848.0012HK Hong Kong (EP) Modulation of Immune Allowed 18-Apr-02 02102923.6
Response by Ribavirin
100848.0012HR Croatia (ex WO Modulation of Immune Pending 20-Dec-1999 P20010496A
2000/24833) Response by Ribavirin
100848.0012HU Hungary (ex WO Modulation of Immune Pending 20-Dec-1999 P0200027
2000/24833) Response by Ribavirin
100848.0012IL Israel (ex WO Modulation of Immune Pending 20-Dec-1999 144130
2000/24833) Response by Ribavirin
100848.0012IN India (ex WO Modulation of Immune Pending 20-Dec-1999
2000/24833) Response by Ribavirin
100848.0012JP Japan (ex WO Modulation of Immune Pending 20-Dec-1999 2000-595690
2000/24833) Response by Ribavirin
100848.0012KR South Korea Modulation of Immune Pending 20-Dec-1999 (PCT)
(ex WO Response by Ribavirin 2001-7009609
2000/24833)
100848.0012MK Macedonia (ex Modulation of Immune Pending 20-Dec-1999 P/PCT20010/060
WO 2000/24833) Response by Ribavirin
100848.0012MX Mexico (ex WO Modulation of Immune Pending 20-Dec-1999 PA/a/2001/007211
2000/24833) Response by Ribavirin
100848.0012NO Norway (ex WO Modulation of Immune Pending 20-Dec-1999 2001 3529
2000/24833) Response by Ribavirin
100848.0012NZ New Zealand Modulation of Immune Pending 20-Dec-1999 512879
(ex WO Response by Ribavirin
2000/24833)
100848.0012PL Poland (ex WO Modulation of Immune Pending 20-Dec-1999
2000/24833) Response by Ribavirin
100848.0012RU Russia (ex WO Modulation of Immune Pending 20-Dec-1999 RU 2001119056
2000/24833) Response by Ribavirin
100848.0012SB Serbia (ex WO Modulation of Immune Pending 20-Dec-1999 P-524/01
2000/24833) Response by Ribavirin
100848.0012SI Slovenia (ex Modulation of Immune Pending 20-Dec-1999 P-9920099
WO 2000/24833) Response by Ribavirin
100848.0012SK Slovakia (ex Modulation of Immune Pending 20-Dec-1999 PV-2001-1009
WO 2000/24833) Response by Ribavirin
100848.0012UA Ukraine (ex WO Modulation of Immune Pending 20-Dec-1999 2001074909/M
2000/24833) Response by Ribavirin
100848.0012US3 USA Ukraine Modulation of Immune Pending 20-May-02 10/154189
(ex WO Response by Ribavirin
2000/24833-Divisional
of US2/US3)
33
<PAGE>
Docket No. Country Title Status Filing Date Application No. Patent No.
100848.0012ZA South Africa Modulation of Immune Pending 20-Dec-1999 20015595
(ex WO Response by Ribavirin
2000/24833)
100848.0034US1 USA Multiple Agent Modulation Pending 27-Apr-2000 09/561402
of Chemokines
100848.0102PCT PCT Appl. Nucleoside Vaccine Pending 14-Jun-00 PCT/US02/18724
Adjuvants
100848.0229PCT (100848.0131, Antiviral Combination Pending 31-Oct-02
0132, 0133, Therapy and Compositions
0134 PRO Apps)
34