EXHIBIT 10.21
*** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT (INDICATED BY ASTERISKS) HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER 17
C.F.R. SECTIONS 200.80(B)(4), 200.83 AND 230.406.
AGREEMENT
This Agreement is made effective December 20, 2002 (the "Effective
Date"), by and among ICN Pharmaceuticals, Inc., a Delaware corporation, with
offices at 0000 Xxxxxx Xxxxxx, Xxxxx Xxxx, Xxxxxxxxxx 00000 ("ICN"), Ribapharm
Inc., a Delaware corporation with offices at 0000 Xxxxxx Xxxxxx, Xxxxx Xxxx,
Xxxxxxxxxx 00000 ("Ribapharm"), Xxxxxx Xxxxxxx, an individual residing at
[...***...] ("Xxxxxxx"), and Anadys Pharmaceuticals, Inc., a Delaware
corporation, with offices at 0000 Xxxxxx Xxxxx Xx, Xxx Xxxxx, Xxxxxxxxxx 00000
("Anadys"), with ICN and Ribapharm being collectively referred to herein from
time to time as "Licensors", and ICN, Ribapharm, Xxxxxxx and Anadys being
collectively referred to herein from time to time as the "Parties".
WITNESSETH
WHEREAS ICN and Xxxxxxx entered into a letter agreement effective
January 22, 1999 (the "1999 Letter Agreement"), wherein ICN licensed various
intellectual property rights to Xxxxxxx, a true and correct copy of which is
attached hereto as Exhibit A;
WHEREAS ICN and Xxxxxxx entered into a license agreement effective
October 11, 1999 (the "1999 License Agreement"), wherein ICN licensed various
intellectual property and compound rights to Xxxxxxx, a true and correct copy of
which is attached hereto as Exhibit B;
WHEREAS in March 2000, Xxxxxxx (i) sublicensed to Anadys, formerly
known as Scriptgen Pharmaceuticals, Inc., all of his rights arising from the
1999 Letter Agreement and 1999 License Agreement and (ii) granted to Anadys a
power of attorney; a true and correct copy of such sublicense agreement is
attached hereto as Exhibit C.
WHEREAS ICN has transferred certain of the relevant intellectual
property rights to Ribapharm in 2002; and
WHEREAS a dispute exists among the Parties as to whether the "1999
License Agreement" supercedes the "1999 Letter Agreement", and additional
disputes have arisen among the Parties with respect to their various rights and
obligations under the 1999 Letter and 1999 License Agreements (the "Dispute").
NOW THEREFORE the Parties have agreed to a full and final settlement of
the Dispute under the terms and conditions set forth below.
AGREEMENT
In consideration of the above, and the mutual covenants set forth in
this Agreement, and other good and valuable consideration received by the
Parties, the Parties agree as follows.
***CONFIDENTIAL TREATMENT REQUESTED
1. Definitions and Interpretation
1.1. "Active Metabolite" means any chemical entity, whose detection
and structure are demonstrable to the satisfaction of
reviewers at either the US FDA or the Journal of Medicinal
Chemistry, that is derived from a Compound after
administration of a Compound to humans, provided that such
derived chemical entity both retains specific biological
activity in an assay in which the compound is active and is
produced in sufficient quantity in humans after administration
of a Compound to humans such that the arithmetic result of the
biological activity of the active metabolite multiplied by the
levels achieved in human plasma is at least [...***...]
percent ([...***...]%) of the result of a similar arithmetic
operation applied to a Compound or Prodrug. Furthermore, a
derived chemical entity is an Active Metabolite only if it
retains [...***...] of the structural integrity (atoms and
their covalent bonds) of the Compound.
1.2. "Compounds" means the following:
[...***...] (ICN Registry Number [...***...]);
[...***...]
[...***...] (ICN Registry Number [...***...]);
[...***...]
[...***...] (ICN Registry Number [...***... ]);
[...***...]
[...***...] (ICN Registry Number [...***...]);
[...***...]
[...***...] (ICN Registry Number [...***...])
[...***...]
***CONFIDENTIAL TREATMENT REQUESTED
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and/or
[...***...] (ICN Registry Number [...***...]
[...***...].
While not explicitly shown, the Compounds include their naturally occurring
[...***...].
(In the event of a discrepancy between the name listed and the chemical
structure, the structure controls.)
1.3 "Inactive Metabolite" means any chemical entity, whose
detection and structure are demonstrable to the satisfaction
of reviewers at either the US FDA or the Journal of Medicinal
Chemistry, that is derived from a Compound after
administration of a Compound to humans, provided that such
derived chemical entity is neither an Active Metabolite nor a
Prodrug.
1.4 "Anadys Prosecuted Applications" means those patent
applications that are to be prosecuted by or at the direction
of Anadys to secure formal patent protection with respect to
any of the Intellectual Property Rights, including reissues,
extensions, divisionals, continuations, continuations-in-part,
and/or any other applications claiming priority to the same.
Among other things, Exhibit D-1, which is incorporated herein,
identifies currently existing applications deemed to be Anadys
Prosecuted Applications, which applications are identified in
Exhibit D-1 as being prosecuted by Anadys. For ease of
reference, Exhibit D-1 also identifies additional applications
and patents which Anadys has only a license to under the terms
of this Agreement, which applications and patents are
identified in Exhibit D-1 as being prosecuted by Licensors. In
addition, Anadys shall be able to prosecute additional claims
within the Anadys Prosecuted Applications to both (i)
intellectual property created or owned solely by Anadys and
(ii) intellectual property deriving from the subject matter
disclosed in PCT applications US [...***...] and US
[...***...], and corresponding and subsequent US and foreign
applications and patents, including reissues, extensions,
divisionals, continuations, continuations-in-part, and/or any
other applications claiming priority to the same. Subject to
the provisions of this Agreement, Licensors own all rights in
all Anadys Prosecuted Applications and applications claiming
priority to the Anadys Prosecuted Applications.
1.5 "Licensor Prosecuted Applications" means those patent
applications that are to be prosecuted by or at the direction
of ICN or Ribapharm to secure formal patent protection with
respect to subject matter disclosed in PCT
***CONFIDENTIAL TREATMENT REQUESTED
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applications US [...***...] and US [...***...], and
corresponding and subsequent US and foreign applications and
patents, including reissues, extensions, divisionals,
continuations, continuations-in-part, and/or any other
applications claiming priority to the same. Exhibit D-2, which
is incorporated herein, identifies applications deemed to be
Licensor Prosecuted Applications. Licensor owns all rights in
all Licensor Prosecuted Applications subject to the provisions
of this Agreement.
1.6 "Intellectual Property Rights" means the rights ICN or
Ribapharm owns now, and/or during the term of this Agreement
that were disclosed in any of US Patents [...***...] and
[...***...], PCT applications [...***...] and [...***...], and
corresponding, priority and subsequent US and foreign
applications and patents, with respect to a) any of the
Compounds, b) all Prodrugs and Metabolites of such Compounds,
and c) all methods of using the Compounds, Prodrugs and/or
Metabolites.
1.7 "Metabolite" means a chemical entity that is an Active
Metabolite and/or a Phosphorylated Metabolite, but expressly
excludes the following compounds:[...***...], [...***...],
[...***...], [...***...], and [...***...] and any other
compounds that Licensors have commercialized or are actively
pursuing in human clinical trials pursuant to an
Investigational New Drug Application that has been filed with
the United States Food and Drug Administration or equivalent
filing with an equivalent foreign body at the time a
Metabolite is identified pursuant to Section 2.3.
1.8 "Net Sales" means, in relation to a Product, the gross amount
received by Anadys, and its respective sublicensees from third
parties that are not affiliates or sublicensees of the selling
party (unless such affiliate or sublicensees is the end user
of such Product, in which case the amount billed therefor
shall be deemed to be the amount that would have been billed
to a third party in an arm's-length transaction) for sales of
Products to third parties, less the following items, as
allocable to such Product (if not previously deducted from the
amount invoiced): (a) trade discounts, credits or allowances;
(b) credits or allowances additionally granted upon returns,
rejections or recalls (except where any such recall arises out
of Anadys' or its sublicensee's gross negligence, willful
misconduct or fraud); (c) freight, shipping and insurance
charges; (d) taxes, duties or other governmental tariffs
(other than income taxes); and (e) government mandated
rebates. With regard to a Product that is comprised as part of
one or more Products and in part of one or more other active
ingredients that are not Products (a "Combination Product"),
Net Sales shall be determined by multiplying Net Sales of such
Combination Product (calculated in accordance with the
preceding sentence) by the fraction A/A+B, in which A is the
fair market value of the Product included in the Combination
Product, and B is the fair market value of the other active
ingredient(s) included in the Combination Product.
***CONFIDENTIAL TREATMENT REQUESTED
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1.9 "[...***...]" means a chemical entity related to a Compound by
incorporation into a Compound of a [...***...] at the
[...***...]- or [...***...] - position, or a
[...***...],[...***...] or [...***...] at the [...***...] -
position.
1.10 "Prodrug" means any chemical entity that upon or after
administration to a human is transformed into a Compound,
wherein said Compound and/or its metabolites are substantially
the only pharmaceutically active metabolic products.
1.11 "Product" means any human or animal pharmaceutical product
containing, in whole or as a component, one or more of the
Compounds, a Prodrug, or a Metabolite.
1.12 In this Agreement, unless the context requires otherwise: the
singular includes the plural and vice versa; words denoting
persons include corporations, partnerships and other legal
persons; a reference to a specified section, paragraph or
schedule is a reference to that specified section, paragraph
or schedule of this Agreement; the article and section
headings are for convenience only and do not affect the
interpretation of this Agreement; "including" means including
without limitation; and a reference to a Party includes its
successors and permitted assigns.
2. Grant
2.1 Licensors hereby grant to Anadys an exclusive (even as to
Licensors), worldwide license to Intellectual Property Rights,
with the right to sublicense, to develop, make, have made,
market, import, export, distribute, use, offer for sale, sell,
or have sold any of the Compounds, Prodrugs, and/or
Metabolites. For clarity, the license grant in this Section
2.1 includes, without limitation, rights to the Intellectual
Property Rights disclosed in any of the patents or
applications listed in Exhibits D-1 or D-2. Simultaneously
with the execution of this Agreement, Licensors shall execute
an assignment to Anadys of all US and foreign patents
corresponding to US Patent [...***...], US Patent [...***...],
US Patent [...***...] and US Patent Application No.
[...***...], which assignment is attached as Exhibit E to this
Agreement. Licensors also grant Anadys a paid-up, irrevocable,
non-exclusive, worldwide license to Licensor technical
information related to the Compounds, but only for technical
information in existence as of the Execution Date of this
Agreement.
2.2 During the term of this Agreement, Licensors agree not to xxx,
threaten to xxx, or otherwise object to, Anadys, its
sublicensees, assigns or others receiving any of Anadys'
rights herein, under any existing or future Licensor patents
with respect to developing, making, having made, marketing,
importing, exporting, distributing, using, offering for sale,
selling or having sold any of the Compounds, Prodrugs, and/or
***CONFIDENTIAL TREATMENT REQUESTED
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Metabolites, unless Anadys, its sublicensees, assigns or
others receiving rights herein, sell a Combination Product (as
defined in Section 1.8) which includes as a component of such
Combination Product a proprietary compound owned or acquired
by Licensors and not licensed herein.
2.3 During the term of this Agreement, Licensors agree not to xxx,
threaten to xxx, or otherwise object to, Anadys, its
sublicenses, assigns or others receiving any of Anadys' rights
herein, under any existing or future Licensor patents with
respect to the formation, presence or activity of an Inactive
Metabolite resulting from the administration of a Compound,
Prodrug and/or Metabolite to a human. Prior to the
determination of whether a metabolite is an Active Metabolite
or an Inactive Metabolite, Anadys shall be free to synthesize
and characterize all metabolites for the purpose of full
structural characterization and determination of activity. If,
after completion of the studies permitted pursuant to the
immediately preceding sentence, it is determined that a
metabolite is an Inactive Metabolite, then Anadys' rights with
respect to such Inactive Metabolite shall be limited to those
contained in this Section 2.3. If at any time a metabolite is
determined to meet the criteria for an Active Metabolite as
set forth in Section 1.1, Anadys will promptly notify
Licensors of such determination and such metabolite will be
deemed a Metabolite for the duration of this Agreement and all
the rights to Metabolites as set forth in this Agreement will
apply; provided, however, that if, within thirty (30) days of
receiving such notification from Anadys, Licensors can show
that as of the date of receiving the notification from Anadys,
the identified metabolite has been commercialized by Licensors
or is being actively pursued in human clinical trials by
Licensors pursuant to an Investigational New Drug Application
that has been filed with the United States Food and Drug
Administration or equivalent filing with an equivalent foreign
body, then such metabolite will be treated as an Inactive
Metabolite with Anadys' rights restricted to the freedom to
operate considerations in this Section 2.3. Once a
determination is made that a metabolite is an Inactive
Metabolite, Anadys' rights with respect to Inactive
Metabolites are limited to the context of administration of
the Compound to a human and the freedom to operate
considerations in this Section 2.3.
3. Royalty
3.1 Anadys will pay a royalty to Licensors based on Net Sales of
all Products, computed on a country by country basis, as
follows. The royalty shall be [...***...] percent
([...***...]%) of the Net Sales for those Products containing
a Compound, and shall be [...***...] percent ([...***...]%) of
the Net Sales for those Products containing a Prodrug or
Metabolite. Only a single royalty shall be paid on sales of
Product no matter how many patents licensed under the
Intellectual Property Rights contain claims encompassing
Product. In any event, the royalty payments due for each
***CONFIDENTIAL TREATMENT REQUESTED
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Product in each country shall terminate upon the expiration of
the last patent within the Intellectual Property Rights in
that country having a claim reading on the Product.
3.2 Royalties shall be remitted to Ribapharm quarterly, no later
than sixty (60) days following the end of each calendar
quarter, and shall be calculated according to then-applicable
United States Generally Accepted Accounting Standards
("GAAP").
3.3 Anadys shall pay a minimum annual royalty (a "Minimum Annual
Royalty") of [...***...] United States Dollars (US
$[...***...]) for calendar year [...***...], [...***...]
United States Dollars (US $[...***...]) for calendar year
2007, and [...***...] United States Dollars (US $[...***...])
for each calendar year thereafter through [...***...].
3.3.1 The Minimum Annual Royalty shall be due and payable
in advance, on or before the first day of December of
the preceding year, (the "Due Date"), and will be
credited as an advance payment of royalties which may
accrue during the applicable calendar year.
3.3.2 In no event shall a Minimum Annual Royalty payment be
carried over as a pre-payment of royalties for any
subsequent year, nor shall any minimum royalty
payment be refunded in whole or in part.
3.3.3 In the event that Anadys fail to make any minimum
annual royalty within ninety (90) days following any
Due Date, all of the Granted Rights shall
automatically revert back to Licensors. Any such
result is subject to the cure provision of subsection
6.3.
3.4 All applicable taxes relating to the sale of Products are the
responsibility of Anadys, its sublicensee, and assignees, and
shall not be charged to or against Licensors.
4. Special Duties and Responsibilities of Licensors
4.1 At their own expense, Licensors will execute the documents
which constitute Powers of Attorney attached to this Agreement
as Exhibits F and letters to foreign associates, and will
comply with and honor the terms of such documents.
4.2 To assist Anadys in prosecuting the Anadys Prosecuted
Applications, Licensors will offset the actual out-of-pocket
costs of Anadys' expenses in prosecuting the Anadys Prosecuted
Applications up to a maximum of [...***...] United States
Dollars (US $[...***...]). Licensors agree to pay such
expenses within thirty (30) days of receiving written invoices
from Anadys indicating such costs.
***CONFIDENTIAL TREATMENT REQUESTED
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4.3 At all times during the Term of this Agreement, Licensors will
fully cooperate with Anadys in the prosecution of all the
Anadys Prosecuted Applications, including, but not limited to,
promptly signing all declarations, powers of attorney, and
other papers needed to be executed to further the prosecution
of such applications.
4.4 Within sixty (60) days, after receiving written notice from
Anadys that an Anadys Prosecuted Application has been issued
as a patent in a country, and after establishing in good faith
that (a) the claims of such patent do not extend beyond the
Intellectual Property Rights, and that (b) an assignment to
Anadys will not adversely affect the prosecution of any of
Licensor Prosecuted Applications, Licensors will execute an
assignment assigning such patent to Anadys. Such an assignment
is voided ab initio if the assigned patent subjects any of
Licensor or Anadys Prosecuted Applications to any rejections
that may be overcome by showing the co-ownership of the
assigned patent and the rejected application, provided, in no
event shall an assignment be voided more than four (4) years
after its execution. Licensors or Anadys shall notify the
other in writing if the assignment is voided, and will provide
written documentation establishing that the co-ownership is
necessary. If an assignment is voided pursuant to this
subsection 4.4, Anadys shall retain an exclusive worldwide
license to the affected Anadys or Licensor Prosecuted
Application as set forth in subsection 2.1. In the event of
any dispute between the Parties under this subsection 4.4, the
Parties agree to submit such a dispute to an independent
patent attorney mutually selected by the Parties, and the
decision of the patent attorney shall be binding.
4.5 For the first Product proposed to be commercialized for each
of the Compounds (or its Prodrugs or Metabolites), Licensors
shall make milestone payments to Anadys as follows:
4.5.1 [...***...] United States Dollars (US $[...***...])
upon filing of an Investigational New Drug
Application with the United States Food and Drug
Administration (the "FDA") for the proposed Product;
4.5.2 [...***...] United States Dollars (US $[...***...])
upon regulatory approval to initiate Phase 2 studies
of the proposed Product;
4.5.3 [...***...] United States Dollars (US $[...***...])
upon regulatory approval to initiate Phase 3 studies
of the proposed Product; and
4.5.4 [...***...] United States Dollars (US $[...***...])
each for the first two proposed Products and
[...***...] United States Dollars (US $[...***...])
for each proposed Product thereafter, upon regulatory
approval by the FDA for commercial sale of the
proposed Product.
***CONFIDENTIAL TREATMENT REQUESTED
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4.5.5 Such payments shall be due and payable upon written
notification to Licensors by Anadys or their duly
authorized agents, of the occurrence of the
triggering event.
4.6 Failure by Licensors to make any milestone payment within
ninety (90) days of such written notification shall
automatically result in a fully paid-up, worldwide,
irrevocable, exclusive license to Anadys and their
sublicensees for the corresponding Product. Any such result is
subject to the cure provision of subsection 6.3.
4.7 Licensors shall be jointly and severally liable for all
Licensor obligations under this Agreement.
5. Special Duties and Responsibilities of Anadys and Xxxxxxx
5.1 At all times during the Term of this Agreement, Anadys and
Xxxxxxx will fully cooperate with Licensors in the prosecution
of all the Licensor Prosecuted Applications, including, but
not limited to, promptly signing all declarations, powers of
attorney, and other papers needed to be executed to further
the prosecution of such applications.
5.2 Anadys shall use commercially reasonable efforts to
commercialize the Compounds, Prodrugs, and/or Metabolites.
5.3 Anadys shall ensure that no Products will be marketed using
the names ICN(R) or Ribapharm(TM) without written permission
of the respective owner.
6. Term and Termination
6.1 The Term of this Agreement shall be effective on a country by
country basis from the Effective Date set forth above until
the last patent within the Intellectual Property Rights
claiming any of the Compounds, Prodrugs, or Metabolites shall
expire in that country, and shall continue in full force and
effect, unless terminated earlier according to the provisions
hereof.
6.2 Anadys may terminate this Agreement upon sixty (60) days
written notice to Licensors, with or without cause, as to any
of the Compounds, their Prodrugs or Metabolites of such
Compounds, without further obligation on their part with
respect to same except as to accrued hold harmless rights and
accrued but unpaid royalties, by assigning back to Licensors
all right, title, and interest that Anadys, its sublicensees,
and assigns had previously obtained herein with respect to
such Compounds, Prodrugs and Metabolites, and in such instance
Anadys, its sublicensees, and assigns would thereupon also be
relieved of their royalty obligations with respect to such
Compounds, Prodrugs and Metabolites.
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6.3 If any Party fails to perform any of its material obligations
under this Agreement, the non-defaulting Parties may give
written notice of the default to the defaulting Party. Unless
such default is cured within sixty (60) days after such
notice, the non-defaulting Party may give a final written
notice of the default to the defaulting Party. If the default
is not cured within thirty (30) days after such final notice,
the Agreement may be terminated. Notwithstanding the
foregoing, to the extent a material breach of this Agreement
relates to one or more Compounds, Metabolites, Prodrugs, or
Products, but not all Compounds, Metabolites, Prodrugs or
Products, then any termination of this Agreement in accordance
with this Section 6.3 shall apply solely to the affected
Compound(s), Metabolite(s), Prodrug(s) or Product(s) only, and
in such case this Agreement will remain in full force and
effect with respect to the Compounds, Metabolites, Prodrugs or
Products that are not terminated. If this Agreement is
terminated by Anadys under this Section 6.3 for the willful
breach by Licensors of Section 4.1, 4.2, 4.3 or 4.4, then the
financial obligations of Anadys and its sublicensees under
this Agreement with respect to the Compound, Metabolite,
Prodrug affected by such breach shall be extinguished and
Anadys shall have a fully paid-up, worldwide, irrevocable,
exclusive license to (a) such Compound, Prodrug, and/or
Metabolite, and (b) to the Intellectual Property Rights
associated therewith.
6.4 In the event that this Agreement is terminated or rejected by
a Party or its receiver or trustee under applicable bankruptcy
laws due to such Party's bankruptcy, then all rights and
licenses granted under or pursuant to this Agreement by such
Party are, and shall otherwise be deemed, for purposes of
Section 365(n) of the Bankruptcy Code and any similar law or
regulation in any other country, licenses or rights to
"intellectual property" as defined under Section 101(52) of
the Bankruptcy Code. The Parties agree that all Intellectual
Property Rights licensed hereunder, including without
limitation, any patents or patent applications in any country
of a Party covered by the license grants under this Agreement
are part of the definition of "intellectual property" under
the Bankruptcy Code or any similar law or regulation in any
other country.
6.5 All provisions of this Agreement required to interpret and
enforce the Parties' rights and obligations under this
Agreement also will survive to the extent required for the
full observation and performance of this Agreement by the
Parties. The termination or expiration of this Agreement for
any reason shall be without prejudice to any rights that shall
have accrued to the benefit of any other Party under this
Agreement prior to such termination or expiration, including,
but not limited to, injunctive relief, and any damages arising
from any breach hereunder.
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7. Records and Record Keeping
7.1 Beginning the calendar quarter following execution of this
Agreement, Anadys shall submit written quarterly reports to
Ribapharm notifying Licensors of (i) any Prodrugs or
Metabolites that have been identified in the preceding quarter
and (ii) summarizing what trials and non-clinical work is
being conducted in an effort to bring Products to market. Upon
receipt of the first regulatory approval for any of the
Products, Anadys shall submit royalty reports with each
quarterly payment, setting forth the quantity and net selling
price of each Product sold in that quarter and the date of
such sale, and the total amount of royalties being paid for
that quarter.
7.2 Anadys will keep and shall require its sublicensees and
assignees to keep, full, accurate and complete books and
records (together with supporting documentation) as are
necessary to establish compliance with the terms and
conditions of this Agreement. Such records shall be maintained
for a period of at least five (5) years from the end of the
reporting period to which they relate.
7.3 During the term of this Agreement with at least thirty (30)
days' prior written notice to Anadys, Licensors have the right
to have a duly authorized independent agent or representative
of its selection audit, inspect, and verify all books,
records, and supporting documentation relating to the
royalties contemplated herein, whether kept by Anadys, its
sublicensees, assignees or others receiving any of Anadys'
rights herein, at a place mutually agreed upon by the Parties
involved during regular business hours. Such audit shall be
for the purpose of verifying compliance with the terms and
conditions of this Agreement, including verification of
reports and payments made hereunder. Other information
disclosed during such audit shall be considered confidential
to the audited Party and shall not be revealed to Licensors by
their agent or representative other than as required under the
audit provisions of this subsection 7.3.
7.4 Should Licensors or their representatives determine that a
royalty deficiency exists, such deficiency shall become
immediately due and owing, and shall be subject to interest at
a rate equal to the lesser of: [...***...] of the sum of the
then current US annual prime rate and [...***...] percent
([...***...]%) per month, or the maximum interest rate allowed
by law. Said interest shall accrue and be calculated from the
date the corresponding royalty was originally due. In the
event an audit shall disclose a royalty deficiency of greater
than [...***...] percent ([...***...]%), the costs of such
audit shall be borne by Anadys.
***CONFIDENTIAL TREATMENT REQUESTED
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8. Licensing, Sublicensing and Assigning
8.1 Anadys shall ensure that all of their sublicensees, assignees,
and others receiving any of Anadys' rights herein ("Other
Parties") are subject to the same royalties, duties and
responsibilities, and other obligations required of Anadys
herein, as though each such entity had been a party to this
Agreement. This Agreement binds all such Other Parties.
8.2 This Agreement shall be attached as an Exhibit to any such
agreement ("Other Party Agreement") under which all Other
Parties receive any of any of Anadys' rights herein. Anadys
shall have the right to redact the financial terms from this
Agreement prior to attaching it as an Exhibit.
8.3 Within 30 days of the execution or modification of any Other
Party Agreement, Anadys shall furnish Licensors with a true
and complete copy of same.
8.4 Any Party may assign any of its rights or obligations under
this Agreement, provided, however, that such assignment shall
not relieve the assigning party or its assigns of the
responsibilities for performance under this Agreement. Each
assigning party shall provide written notice to the other
Parties of any assignment within thirty (30) days.
8.5 For purposes of this Agreement, the Parties are not joint
venturers, partners, principal and agent, master and servant
or employer and employee. With respect to the subject matter
of this Agreement, the Parties 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,
however, is not precluded by this Agreement.
9. Patent Application and Maintenance
9.1 Licensors are responsible for prosecution fees and costs with
respect to all Licensor Prosecuted Applications.
9.2 Licensors covenant and agree that they will not, prior to
[...***...], intentionally abandon any Licensor Prosecuted
Application (including by virtue of issuance of any patents)
for which a continuation or divisional application has not
been filed unless they give Anadys at least one hundred twenty
(120) days prior written notice (unless such period of advance
notice is not possible due to no fault of Licensors' or their
counsel, in which case the maximum possible notice under such
shorter period shall be provided) of such intended abandonment
or issuance; provided, however, that the unavoidable
abandonment of a Licensor Prosecuted Application will not be
deemed a breach of this Section 9.2 so long as Licensors
actively pursue any revival possibilities; and provided
further, that if Anadys at its sole discretion no longer needs
access to a particular Licensor Prosecuted Application, Anadys
shall give notice of
***CONFIDENTIAL TREATMENT REQUESTED
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such fact to Licensors and as of the date of Licensors'
receipt of such notice, such Licensor Prosecuted Application
shall no longer remain subject to this Section 9.2. For
purposes of this Section 9.2, "intentionally abandon" shall
include, without limitation, Licensors' or Licensors'
counsel's failure to respond to a notification of an upcoming
abandonment or the failure to take action which leads to an
abandonment.
9.3 Subject to subsection 4.2, Anadys is responsible for
prosecution fees and costs with respect to all Anadys
Prosecuted Applications.
9.4 Anadys has no obligation to pursue or maintain any of the
Anadys Prosecuted Applications.
9.5 Both Licensors and Anadys shall promptly notify the other, in
writing, upon the issuance of any patent issued from the
Anadys Prosecuted Applications or Licensor Prosecuted
Applications claiming Intellectual Property Rights or claiming
priority to PCT applications US[...***...], or US [...***...]
or US provisional applications [...***...], [...***...],
[...***...] or [...***...] and promptly upon receiving any
notice of allowance related to the foregoing.
10. Infringement
10.1 None of the Parties has any obligation to enforce any patents
issuing under the Intellectual Property Rights. However, if
called upon by another Party to assist in a legal action
against an alleged infringer, each of the Parties will assist
to the best of its abilities, provided that it is compensated
for reasonable out-of-pocket expenses on an ongoing basis for
such assistance.
10.2 In the event that a Party does take legal action against an
alleged infringer of any of the Intellectual Property Rights
at its own expense, then such acting Party is under no
obligation to distribute any awards that may arise from such
legal action to the other Parties.
11. Validity and Enforceability
11.1 Anadys and Xxxxxxx agree that they will not challenge directly
or indirectly the validity or enforceability of any patents
issued from Licensor Prosecuted Applications of which patents
Xxxxxxx is an assignor.
11.2 Licensors agree that they will not challenge directly or
indirectly the validity or enforceability of any patents
issued from Anadys Prosecuted Applications of which patents
Licensor is an assignor.
***CONFIDENTIAL TREATMENT REQUESTED
13 of 23
11.3 The parties agree that the failure of either party to satisfy
its obligations set forth in any of Sections 4.1, 4.3, 4.4,
5.1, 5.3 and 14.13, will subject the non-breaching party to
immediate and irreparable harm that will leave the
non-breaching party without an adequate remedy at law, and
entitle the non-breaching party to immediate injunctive relief
in a court of law to compel the breaching party to comply with
its obligations under paragraphs 4.1, 4.3, 4.4, 5.1, 5.3 and
14.13, as well as such further relief as may be granted by a
court of competent jurisdiction.
12. Representations And Warranties
12.1 Licensors (as well as their employees and agents) make no
representation or warranty as to the patentability of the
Intellectual Property Rights.
12.2 Licensors and Anadys (as well as their employees and agents)
make no representation or warranty with respect to any aspect
of the drafting, prosecution, or content of the Licensor
Prosecuted Applications, the Anadys Prosecuted Applications,
or any patents maturing from any such applications, except
that Licensors represent and warrant that to their best
knowledge they have fully disclosed all existing issued
patents related to Intellectual Property Rights, all existing
Anadys Prosecuted Applications and all existing Licensor
Prosecuted Applications to Anadys. Should Licensors become
aware of any other existing patents and applications related
to Intellectual Property Rights, Licensors will promptly
disclose them to the Anadys and provide to Anadys copies of
such patents and applications.
12.3 Licensors represent and warrant that they own the Intellectual
Property Rights and that they have full right and power to
grant the licenses and assignments contained herein. Licensors
represent and warrant that to their best knowledge their
rights to the listed patent applications and patents set forth
in Exhibits X-0, X-0 and E are unencumbered by any liens,
security interests, or other rights or claims of any third
party, and that no other person or entity has or shall have
any claim of ownership, except as defined by this Agreement.
Licensors also represent and warrant that to their best
knowledge they have not assigned or transferred Intellectual
Property Rights to any third party, except as provided for
under this Agreement, and they know of no fact that does or
could materially adversely affect the rights granted to Anadys
under this Agreement.
12.4 LICENSORS AND ANADYS (AS WELL AS THEIR EMPLOYEES AND AGENTS)
MAKE NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER HEREIN
OR DEFINED BY THE CLAIMS OF ANY OF THE LICENSOR PROSECUTED
14 of 23
APPLICATIONS, THE ANADYS PROSECUTED APPLICATIONS, OR ANY
PATENTS MATURING FROM ANY SUCH APPLICATIONS.
12.5 Anadys shall not indemnify, but will hold harmless Licensors,
their employees, agents, consultants and representatives, from
and against all liability, demands, damages, expenses, and
losses, including, but not limited to, death, personal injury,
illness, or property damage in connection with or arising out
of the design, manufacture, distribution, or use by Anadys,
its sublicensees, assignees, or others receiving any of
Anadys' rights herein, of any Product or materials or other
products of processes developed in connection with or arising
out of any of Anadys' rights herein.
12.6 Each of the Parties warrants that it has all requisite legal
and (where appropriate) corporate power and authority to carry
on its business and to perform its obligations under this
Agreement. Each Party warrants that it has taken all action
necessary for the execution and delivery of this Agreement and
the performance of its obligations under this Agreement. Each
of the corporate entities warrants that the person(s)
executing this Agreement on its behalf has all necessary
corporate powers and have been duly authorized to execute and
deliver this Agreement on its behalf.
13. Release
13.1 Except for the liabilities and obligations arising out of this
Agreement, the Licensors, for themselves and to the full
extent that execution of this Agreement renders it legally
possible, for each of their predecessors, successors,
partners, assigns, parents, subsidiaries, divisions, officers,
employees, directors, shareholders, and agents, release and
forever discharge Anadys and Xxxxxxx, and each of their
respective predecessors, successors, assigns, agents,
affiliates, representatives, heirs, parents, subsidiaries,
divisions, officers, employees, directors, shareholders, and
attorneys from any and all claims, demands, debts,
liabilities, obligations, damages, accounts, actions, and
causes of action of every kind in law, equity, or otherwise,
and every other thing whatsoever, whether known or unknown,
suspected or unsuspected, certain or speculative, which each
Licensor ever had, or now has, against Anadys or Xxxxxxx,
existing as of the Effective Date of this Agreement or which
may have at any time prior to the Effective Date hereof come
into existence or which may in the future arise out of any
acts or omissions of Anadys or Xxxxxxx taken at any time prior
to Effective Date hereof, including, without limitation, any
and all claims, demands, debts, liabilities, obligations,
damages, accounts, actions, and causes of action known or
suspected that relate in any manner to the Dispute.
13.2 Except for the liabilities and obligations arising out of this
Agreement, Anadys, for itself and to the full extent that
execution of this Agreement
15 of 23
renders it legally possible, for its predecessors, successors,
partners, assigns, parents, subsidiaries, divisions, officers,
employees, directors, shareholders, and agents, release and
forever discharge Licensors herein, and each of their
respective predecessors, successors, assigns, agents,
affiliates, representatives, heirs, parents, subsidiaries,
divisions, officers, employees, directors, shareholders, and
attorneys from any and all claims, demands, debts,
liabilities, obligations, damages, accounts, actions, and
causes of action of every kind in law, equity, or otherwise,
and every other thing whatsoever, whether known or unknown,
suspected or unsuspected, certain or speculative, which Anadys
ever had, or now has, against Licensors, existing as of the
Effective Date of this Agreement or which may have at any time
prior to the Effective Date hereof come into existence or
which may in the future arise out of any actions or omissions
of Licensors taken at any time prior to the Effective Date
hereof, including, without limitation, any and all claims,
demands, debts, liabilities, obligations, damages, accounts,
actions, and causes of action know or suspected that relate in
any manner to the Dispute.
13.3 Except for the liabilities and obligations arising out of this
Agreement, Xxxxxxx, for himself and to the full extent that
execution of this Agreement renders it legally possible, for
each of his predecessors, successors, partners, assigns,
parents, subsidiaries, divisions, officers, employees,
directors, shareholders, and agents, releases and forever
discharges Licensors herein, and each of their respective
predecessors, successors, assigns, agents, affiliates,
representatives, heirs, parents, subsidiaries, divisions,
officers, employees, directors, shareholders, and attorneys
from any and all claims, demands, debts, liabilities,
obligations, damages, accounts, actions, and causes of action
of every kind in law, equity, or otherwise, and every other
thing whatsoever, whether known or unknown, suspected or
unsuspected, certain or speculative, which Xxxxxxx ever had,
or now has, against Licensors, existing as of the Effective
Date of this Agreement or which may have at any time prior to
the Effective Date hereof come into existence or which may in
the future arise out of any actions or omissions of Licensors
taken at any time prior to the Effective Date hereof,
including, without limitation, any and all claims, demands,
debts, liabilities, obligations, damages, accounts, actions,
and causes of action know or suspected that relate in any
manner to the Dispute.
13.4 Each of the Parties hereto acknowledges that it is aware of,
has read, has had explained to it by its attorneys,
understands and expressly waives any and all rights it has or
may have under California Civil Code Section 1542 and every
like provision in any foreign jurisdiction. Section 1542
provides as follows:
"A general release does not extend to
claims which the creditor does not know or
suspect to exist in his favor at the time
of executing the release, which if
16 of 23
known by him must have materially affected
his settlement with the debtor."
13.5 Each of the Parties hereto acknowledges that it may later
discover facts different from or in addition to those which it
knows or believes to be true with respect to these released
claims, and it agrees that, in such event, this Agreement
shall nevertheless remain effective in all respects,
notwithstanding such different or additional facts or the
discovery of those facts, except as to facts represented,
warranted, and/or covenanted under this Agreement.
14. General
14.1 This Agreement may not be altered or otherwise amended except
by an instrument in writing signed by each of the Parties;
provided, however, that an alteration or amendment to this
Agreement shall not require Xxxxxxx'x signature unless
Xxxxxxx'x rights hereunder are prejudiced by such amendment.
14.2 None of the Parties herein may waive or release any of its
rights under this Agreement except if the same be in writing.
The failure of any Party to assert a right hereunder or to
insist upon compliance with any term or condition of this
Agreement shall not constitute a waiver of that right or
excuse a similar subsequent failure to perform any such term
by any of the other Parties.
14.3 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 any
cause or causes 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 a 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.
14.4 All notices, consents, requests, waivers and other
communications in connection with this Agreement: must be in
writing, signed by an authorized officer of the sender, and
sent by personal delivery, fax (with confirmation copy),
internationally recognized courier, or certified or registered
mail, postage prepaid (airmail where applicable); will be
deemed to be given when actually received; and must be sent to
the receiving Party at the address or fax number, as
applicable, set forth
17 of 23
below, or any replacement address or fax number notified to
the sender by notice actually received by the sender.
above, or any replacement address or fax number notified to
the sender by notice actually received by the sender.
If to Xxxxxx Xxxxxxx:
Xxxxxx Xxxxxxx, Ph.D.
[...***...]
If to Anadys:
Anadys Pharmaceuticals, Inc.
0000 Xxxxxx Xxxxx Xx
Xxx Xxxxx, XX 00000
Attn: Xxxxxxx Xxxxxx, Vice President, Corporate Development
With copy to:
Xxxxxxxxx X. Xxxx,
Senior Director, Legal Affairs
If to ICN Pharmaceuticals:
0000 Xxxxxx Xxxxxx
Xxxxx Xxxx, XX 00000
Attn: Xxxxx Xxxxxx, VP Legal
If to Ribapharm, Inc:
0000 Xxxxxx Xxxxxx
Xxxxx Xxxx, XX 00000,
Attn: Xxxxx Xxxxxx, General Counsel
14.5 Except as expressly provided otherwise in this Agreement, all
legal and other costs and expenses incurred in connection with
the negotiation and entering into of this Agreement and the
transactions contemplated by this Agreement will be paid by
the Party incurring such costs or expenses. Notwithstanding
the foregoing, a Party prevailing in a litigation shall be
entitled to recover attorney's fees and costs as a result of
the successful enforcement of the terms of this Agreement.
14.6 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 the other Party may reasonably request in order to give
effect to the transactions contemplated by this Agreement.
14.7 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
***CONFIDENTIAL TREATMENT REQUESTED
18 of 23
burden of proof will arise favoring or disfavoring a party
because of the authorship of any provision of this Agreement.
14.8 The Exhibits identified in this Agreement are incorporated by
reference and made a part of this Agreement.
14.9 The provisions of this Agreement are severable, and in the
event that any provision of this Agreement is determined to be
invalid or unenforceable under any controlling body of law,
such determination shall not in any way affect the validity or
enforceability of the remaining portions of this Agreement.
14.10 This Agreement and the exhibits hereto contains the entire
agreement between the Parties related to the subject matter
herein, and all prior negotiations, representations,
agreements, and understandings are merged into, extinguished
by, and completely expressed by this Agreement and the
exhibits hereto. This Agreement supercedes the 1999 License
Agreement and the 1999 Letter Agreement.
14.11 This Agreement will be governed by and construed in accordance
with the laws of the State of California.
14.12 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.
14.13 The Parties agree that the material terms of this Agreement
will be considered confidential information of the Parties.
Notwithstanding the foregoing, each Party shall have the right
to disclose the material terms of this Agreement (a) in
confidence to any bona fide potential investor, investment
banker, acquirer, merger partner or other potential financial
partner, and where reasonably practicable, shall obtain an
adequate agreement of confidentiality consistent with the
terms of this Agreement; (b) to exercise its rights under this
Agreement and in connection with regulatory filings or to
comply with applicable laws or regulations or valid court
orders; and/or (c) to record assignment documents.
Notwithstanding the foregoing, in the event a Party is
required to make a disclosure of the material terms of this
Agreement pursuant to (b) above, it will give reasonable
advance written notice to the other Party of such disclosure
and endeavor in good faith to secure confidential treatment of
such information or a protective order related to such
information. In any event, the Parties agree to take all
reasonable action to avoid disclosure of the material terms of
this Agreement. The parties also agree that the reports and
disclosures made under Section 2.3 and Section 7.1 shall be
deemed "Confidential Information" and shall be subject to the
terms of the Confidentiality and Non-Disclosure Agreement
dated as of the date hereof by and between the Parties and
attached hereto as Exhibit G.
19 of 23
14.14 The obligations of the parties under Sections 5.3, 11.1, 11.2,
12.5, 13 and 14.13 shall survive the termination of this
Agreement.
In Witness whereof, the Parties have caused this Agreement to be
signed, effective as of the Effective Date set forth above.
ICN PHARMACEUTICALS, INC.
By: /s/ Xxxxx Xxxxxx
------------------
Xxxxx Xxxxxx
V.P. Legal
RIBAPHARM INC.
By: /s/ Xxxxxxx Xxx
---------------------------
Xxxxxxx Xxx, MD, Ph.D.
Chief Executive Officer
XXXXXX XXXXXXX
/s/ Xxxxxx Xxxxxxx
-------------------
ANADYS PHARMACEUTICALS, INC.
By: /s/ Xxxxxxxxx X. Xxxxxxxxxxxx
------------------------------------
Xxxxxxxxx X. Xxxxxxxxxxxx, Ph.D.
President and CEO
[SIGNATURE PAGE TO THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
20 of 23
EXHIBIT A
ICN Pharmaceuticals, Inc. [LOGO]
January 22, 1999
BY HAND
Xx. Xxxxxx X. Xxxxxxx
[...***...]
[...***...], [...***...]
Dear Xxxxxx:
As we have discussed, [...***...]. After due review and consideration, and
[...***...], it is the intent of the Company to license these compounds to you
on a contract basis, by compound.
Subject to the negotiation of a definitive License Agreement, the Company
and yourself ("Xxxxxxx") hereby agree as follows:
1. The compounds subject to this Agreement ("Compound(s)") are listed in
Exhibit 1, appended to this Agreement.
2. Nothing in this Agreement is to be construed as limiting [...***...].
On a compound by compound basis, the Company will [...***...] and [...***...] as
to [...***...]. This [...***...] shall be [...***...].
3. Should the Company [...***...], or [...***...], Xxxxxxx shall
[...***...].
4. Xxxxxxx and the Company shall have 120 days in which to decide to
license said compound(s) and negotiate a definitive license agreement. Should
the parties be unable to negotiate terms satisfactory to both parties, the
Company shall have the right to seek other licensees. However, the Company will
not enter into a license agreement with a third party with respect to such
compound on terms and conditions which, in the aggregate, are more favorable
than those offered to Xxxxxxx unless Xxxxxxx has i) declined in writing to
accept such terms or ii) has not responded after a period of sixty (60) days
from the date of such offer.
5. However, should the [...***...], the Company shall [...***...].
6. With respect to those compounds that the Company [...***...], the
Company's continuing [...***...]. Thus, the Company agrees [...***...]. Xxxxxxx
shall have the right to a semi-annual executive summary of the progress of said
Compound(s) in development [...***...]. Xxxxxxx agrees to hold information
received in such executive summary confidential upon terms customarily
associated with confidential disclosures.
7. Should any dispute arise between the parties regarding any terms of
this agreement, said dispute shall be submitted for arbitration through an
agreed arbitrator with expertise in the field.
Page 1 of 3
***CONFIDENTIAL TREATMENT REQUESTED
Should these terms meet with your approval, please execute in the
designated space and return to me.
ICN Pharmaceuticals, Inc.
/s/ Xxxxx X. Xxxx
----------------------------------------
Xxxxx X. Xxxx
Executive Vice President, General
Counsel and Corporate Secretary
Agreed and Accepted this 22nd day of January, 1999.
Signature: /s/ Xxxxxx X. Xxxxxxx
--------------------------
Xx. Xxxxxx X. Xxxxxxx
Page 2 of 3
EXHIBIT 1: Compounds per the ICN/Xxxxxxx License Agreement
ICN Registry Number Compound name, as in ICN Registry
------------------- ---------------------------------
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
Page 3 of 3
***CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT B
LICENSE AGREEMENT
This Agreement is made effective this 11th day of October, 1999 by and
between ICN Pharmaceuticals, Inc., a Delaware corporation with offices at 0000
Xxxxxx Xxxxxx, Xxxxx Xxxx, Xxxxxxxxxx 00000, (hereinafter referred to as "ICN"),
and Xxxxxx X. Xxxxxxx, an individual with an address of [...***...],
[...***...], [...***...], [...***...], (hereinafter referred to as "Xxxxxxx").
WITNESSETH:
WHEREAS, ICN has a substantial library of proprietary compounds which may
be suitable for use as human pharmaceutical products; and
WHEREAS, Xxxxxxx acquired knowledge relating to ICN's proprietary
compounds during the course of his employment as Senior Vice President for
Research and Development at ICN, and wishes to further develop ICN's proprietary
compounds on his own behalf; and
WHEREAS, Xxxxxxx wishes to obtain a license to use the know how and data
developed by ICN concerning ICN's proprietary compounds.
NOW THEREFORE, in consideration of the above and foregoing, and the mutual
covenants, promises and undertakings contained herein, the parties intending to
be legally bound hereby agree as follows:
1. x. XXXXX OF LICENSE. Subject to the terms and conditions contained
herein, during the term of this Agreement as set forth below, ICN hereby grants
to Xxxxxxx an exclusive right and license to further develop or have developed,
produce or have produced, make or have made, use or have used, sell or have
sold, and promote or have promoted the compounds described as [...***...] (ICN
Registry Number [...***...]); [...***...] (ICN Registry Number [...***...]);
[...***...] (ICN Registry Number [...***...]); [...***...] (ICN Registry Number
[...***...]); [...***...] (ICN Registry Number [...***...]); [...***...] (ICN
Registry Number [...***...]); (collectively the "ICN Compounds") for use as
human pharmaceutical products, (the "Products") on a worldwide basis.
b. SCOPE. Without limiting in any way the rights described above, the
grant of right and license to the listed compounds shall also include copies of
all intellectual property, assignment documentation, patent applications,
synthetic routes, primary data, results of tests, data sheets, data summaries,
correspondence, publications, and disclosures related to said compounds
(collectively, the information), and all existing physical samples of said
compounds, except that ICN may retain copies of the information and a 10 mg (ten
milligram) sample of each compound for archival purposes. ICN agrees to not
submit such archival samples to any other entity for any purpose unless
compelled by legitimate court order. In addition, this grant of right and
license includes any and all metabolites of such compounds as may be
subsequently identified, and shall not limit Xxxxxxx'x rights in any way to
improve upon said compounds by the identification of prodrugs or other modified
forms as may be identified in the course of development. Also, this agreement
does not provide to ICN any rights to any inventions by Xxxxxxx in the ordinary
course of his activities.
2. ROYALTY. In Consideration of the grant of the exclusive license set
forth above, Xxxxxxx shall pay to ICN a royalty of [...***...] percent
([...***...]%) of the Net Sales of the Products. In
Page 1 of 5
***CONFIDENTIAL TREATMENT REQUESTED
the event that the commercialized form of the Product is a chemically distinct
form of a compound described in Section 1a, which upon administration gives rise
to a compound described in Section 1a, Xxxxxxx shall pay to ICN a royalty of
[...***...] percent ([...***...]%) of the Net Sales of the Products. For
purposes of this Agreement, "Net Sales" shall mean the total revenues generated
by Xxxxxxx from the sale, supply, or sublicense of a Product, less returns and
refunds. Said royalty shall be remitted to ICN quarterly, no later than sixty
(60) days following the end of each calendar quarter, and shall be calculated
according to United States Generally Accepted Accounting Standards ("GAAP").
Xxxxxxx shall pay a minimum annual royalty of fifty thousand dollars ($
50,000.00) for calendar year 2004, seventy five thousand dollars ($ 75,000.00)
for calendar year 2005, and one hundred thousand dollars ($ 100,000.00) for each
calendar year thereafter for a period equivalent to the currently existing
patent term for any marketed compound listed in Section One (a) of this
agreement. The minimum annual royalty set forth above shall be due and payable
in advance, on or before the first day of December of the preceding year, (the
"Due Date") and will be credited as an advance payment of royalties which may
accrue during the applicable calendar year. In no event shall a minimum annual
royalty payment be carried over as pre payment of royalties for any subsequent
year, nor shall any minimum annual royalty payment be refunded in whole or in
part. In the event that Xxxxxxx fails to make any minimum annual royalty within
ninety (90) days following any Due Date, the license granted in Section One
hereof, shall automatically terminate.
3. XXXXXXX'X PERFORMANCE; MILESTONES. During the continuance of this
Agreement, Xxxxxxx shall use commercially reasonable efforts to commercialize
the ICN Compounds and bring products stemming therefrom to market. For each
compound listed in Section One (a) ICN shall pay Xxxxxxx milestone payments as
follows: fifty thousand dollars ($ 50,000.00) upon filing of an IND with the
U.S. FDA, seventy five thousand dollars ($ 75,000.00) upon regulatory approval
to initiate Phase 2 studies, one hundred thousand dollars ($ 100,000.00) upon
regulatory approval to initiate Phase 3 studies, and two hundred thousand
dollars ($ 200,000.00) upon approval for commercial sale by the FDA. Such
payment shall be due and payable upon written notification to ICN by Xxxxxxx or
his duly authorized agent. Failure to make any milestone payment within 90 days
following said notification shall result in forfeiture by ICN to any rights
described under this agreement, and result in a fully paid-up exclusive license
(exclusive even with respect to ICN) to the compounds described in this
agreement.
4. TERM AND TERMINATION. This Agreement shall be effective from the date
of its execution, which is set forth above, and shall continue in full force and
effect in perpetuity unless terminated earlier according to the provisions
hereof. Notwithstanding anything to the contrary contained herein, in the event
that Xxxxxxx is in default in the performance of any obligation under this
Agreement, and the default has not been cured within ninety (90) days following
written notice of such default, ICN may terminate this Agreement by written
notice. Xxxxxxx shall have the right to terminate this agreement by giving ICN
ninety (90) days written notice thereof. In the event that ICN is in default in
the performance of any obligation under this agreement, and the default has not
been cured within ninety (90) days following written notice of such default,
[...***...].
In the event Xxxxxxx becomes insolvent, files a petition in bankruptcy,
has such a petition filed against him, determines to file a petition in
bankruptcy, or receives notice of a third party's intention to file an
involuntary petition in bankruptcy, Xxxxxxx shall immediately notify ICN in
writing.
Page 2 of 5
***CONFIDENTIAL TREATMENT REQUESTED
Upon termination of this Agreement, Xxxxxxx shall cease development,
production, making, selling, and promoting the ICN Compounds and the Products,
and all right, title, and interest therein shall revert to ICN automatically.
Within ninety (90) days after termination hereunder, a final royalty report
shall be submitted by Xxxxxxx. Any royalty payments, or patent expense if
applicable, shall become immediately due and payable upon termination.
5. REPORTING AND RECORD KEEPING. Beginning the calendar quarter following
execution of this Agreement, Xxxxxxx shall submit quarterly reports to ICN
detailing his efforts to bring the ICN Compounds to market. Upon receipt of the
first regulatory approval for any ICN Product, royalty reports shall be included
with each quarterly payment, setting forth the quantity and net selling price of
each Product sold in that quarter and the date of such sale, and the total
amount of royalties being paid for that quarter.
Xxxxxxx agrees to keep and shall require his sublicensees to keep, full,
accurate and complete books and records (together with supporting documentation)
as are necessary to establish compliance with the terms and conditions of this
Agreement. Such records shall be maintained for a period of five (5) years from
the end of the reporting period to which they relate.
6. AUDIT. During the continuance of this Agreement, ICN shall have the
right to have a duly authorized agent, employee, or representative audit,
inspect, and verify all books, records, and supporting documentation relating to
the ICN Compounds or the Products, kept by Xxxxxxx or his sublicensees, at
Xxxxxxx'x or his sublicensees premises, or at a place mutually agreed upon by
the parties involved. Such audit shall be for the purpose of verifying
compliance with the terms and conditions of this Agreement, including
verification of reports and payments hereunder. Should ICN or its representative
determine that a royalty deficiency exists, such deficiency shall become
immediately due and owing, and shall be subject to interest at a rate equal to
the lesser of: one twelfth of the then current U.S. prime rate plus 0.5% per
month, or the maximum interest rate allowed by law. Said interest shall accrue
and be calculated from the date the corresponding royalty was originally due. In
the event an audit shall disclose a royalty deficiency of greater than five
percent (5%), the costs of such audit shall be born by Xxxxxxx.
7. SUBLICENSING. Xxxxxxx may enter into sublicensing agreement(s) under
his rights granted herein. Xxxxxxx agrees that any sublicenses shall provide
that the obligations to ICN shall be binding on the sublicensee as if it were a
party to this Agreement. This Agreement shall be attached as an Exhibit to any
sublicense granted by Xxxxxxx.
Any sublicenses granted by Xxxxxxx shall provide for termination of the
sublicense, or the conversion of the sublicense to a license between the
sublicensees and ICN for the portion of the rights reverting to ICN, contingent
upon acceptance by the sublicensee of the provisions of this Agreement, at the
option of the sublicensee, upon termination of this Agreement.
Within thirty (30) days after the issuance or modification of any sublicense
hereunder, Xxxxxxx shall furnish ICN with a true and complete copy of the
sublicense or any modification thereof. ICN shall be entitled to [...***...]
percent ([...***...]%) of any sublicensing fee, lump sum, or milestone payment
due under any sublicense granted by Xxxxxxx in excess of any recoupment or
reimbursement of Xxxxxxx'x development expenses, which shall be paid to ICN
within forty five (45) days following the effective date of any sublicense
agreement granted hereunder or the date of payment, if later.
Page 3 of 5
8. PATENT APPLICATION AND MAINTENANCE. Except as otherwise provided
herein, Xxxxxxx agrees to take responsibility for, but to consult with ICN in
the preparation, filing, prosecution, and maintenance of any and all patent
applications or patents included in the licensed rights, and shall furnish
copies of all relevant patent related documents to ICN. [...***...]. Xxxxxxx
shall select registered patent attorneys or patent agents to provide services on
behalf of Xxxxxxx and ICN. ICN shall provide appropriate powers of attorney and
other documents necessary to undertake such actions to the patent attorneys or
patent agents providing such services. Xxxxxxx shall provide ICN sufficient
opportunity to comment on any document that Xxxxxxx intends to file or to cause
to be filed with the relevant intellectual property or patent office.
In the event Xxxxxxx fails to fully comply with his obligation to prepare,
file, prosecute and maintain any and all patent applications or patents
hereunder, ICN may by written notice to Xxxxxxx, assume control thereof. If ICN
so elects, Xxxxxxx shall cooperate fully with ICN, its attorneys and agents, and
provide ICN with complete copies of all documents or other materials that ICN
deems necessary to undertake such responsibilities. Notwithstanding the above
and foregoing, Xxxxxxx shall be responsible for all costs associated with
transferring patent responsibilities to ICN's agents or attorneys, and for all
costs associated with said responsibilities during the continuance of this
Agreement.
9. REPRESENTATIONS AND WARRANTIES. ICN makes no representation or warranty
as to the validity of any patents covering the ICN Compounds or of the scope of
any of the claims contained therein or that the exercise of this license will
not result in the infringement of other patents. Neither ICN nor its employees
assume any liability whatsoever resulting from the exercise of this license. ICN
MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OF ANY SUBJECT MATTER HEREIN OR DEFINED BY THE CLAIMS OF ANY
LICENSED PATENT RIGHTS.
ICN does not represent that it will commence legal actions against third
parties infringing the rights granted hereunder. Xxxxxxx will have the right to
prosecute such legal actions, and ICN will cooperate fully in any such legal
actions initiated by Xxxxxxx.
Xxxxxxx shall not indemnify but will hold harmless ICN, its employees,
agents, consultants and representatives from and against all liability, demands,
damages, expenses, and losses, including but not limited to death, personal
injury, illness, or property damage in connection with or rising out of the use
by or on behalf of Xxxxxxx, his sublicensees, employees, or third parties of any
licensed rights, or the design, manufacture, distribution, or use of any Product
or materials by Xxxxxxx, or other products or processes developed in connection
with or arising out of the licensed rights.
10. GENERAL. Neither party may waive or release any of its rights under
this Agreement except if the same be in writing. The failure of either ICN or
Xxxxxxx to assert a right hereunder or to insist upon compliance with any term
or condition of this Agreement shall not constitute a waiver of that right or
excuse a similar subsequent failure to perform any such term by the other party.
This Agreement contains the entire agreement between the parties relating to the
subject matter herein, and all prior negotiations, representations, agreements
and understandings are merged into, extinguished by, and completely expressed by
this Agreement. The provisions of this Agreement are severable, and in the event
that any provision of this Agreement is determined invalid or unenforceable
under any controlling body of law, such determination shall not in any way
affect the validity or enforceability of the remaining portions of this
Agreement. This Agreement shall not be assigned by Xxxxxxx without the
Page 4 of 5
***CONFIDENTIAL TREATMENT REQUESTED
prior written agreement of ICN, except that Xxxxxxx may and without such consent
assign this agreement to a corporation ("Newco") in exchange for stock in Newco
and any subsequent merger of Newco with or other acquisition of Newco by another
corporation shall not be considered an assignment of this Agreement.
IN WITNESS WHEREOF, the parties have caused this Agreement to be signed,
effective as of the date set forth above.
XXXXXX X. XXXXXXX ICN PHARMACEUTICALS, INC.
/s/ Xxxxxx X. Xxxxxxx By: /s/ Xxxxx X. Xxxx
--------------------- --------------------------------
Xxxxx X. Xxxx
Executive Vice President,
General Counsel and Corporate Secretary
Page 5 of 5
EXHIBIT C
SUBLICENSE AGREEMENT
SUBLICENSE AGREEMENT made as of the first day of March 2000, between
Scriptgen Pharmaceuticals, Inc. ("Scriptgen") and Xxxxxx X. Xxxxxxx ("Xxxxxxx").
WHEREAS, Xxxxxxx desires to grant to Scriptgen an exclusive sublicense of
compounds under that certain License Agreement dated October 11, 1999 (the
"License Agreement") by and between Xxxxxxx and ICN Pharmaceuticals, Inc.
("ICN") attached hereto as Exhibit A;
WHEREAS , Scriptgen desires to obtain a license to use the compounds that
are a subject of the License Agreement.
NOW, THEREFORE, in consideration of the mutual covenants herein set forth
and for other good and valuable consideration, the receipt of which is hereby
acknowledged, it is agreed as follows:
1. License. Xxxxxxx hereby grants to Scriptgen an exclusive right and
license to further develop or have developed, produce or have produced, make or
have made, use or have used, sell or have sold, and promote or have promoted the
compounds set forth in Section 1.a. of the License Agreement with the same scope
as provided to Xxxxxxx under Section 1.b. of the License Agreement. Scriptgen
agrees that the obligations to ICN as set forth in the License Agreement shall
be binding on Scriptgen as if it were a party to the License Agreement. Xxxxxxx
agrees that Scriptgen will be entitled to all of the rights and benefits of
Xxxxxxx under the License Agreement as if Scriptgen were a party to the License
Agreement.
2. Sublicense Fee. Scriptgen shall pay to Xxxxxxx a sublicense fee of
$[...***...] in connection with his grant of the license hereunder.
3. Representations and Warranties. Xxxxxxx represents and warrants that
(i) the License Agreement is in full force and effect and is the legal, valid
and binding agreement of the parties thereto, (ii) there are no defaults
currently existing or threatened under the License Agreement, (iii) Xxxxxxx is
not a party to or bound by any agreement, instrument, arrangement, contract,
obligation, commitment or understanding of any character, whether written or
oral, express or implied, other than this Agreement and the License Agreement
relating to the compounds set forth in Section 1.a. of the License Agreement and
(iv) Xxxxxxx has full power and authority to enter into this Agreement and to
grant the sublicense pursuant hereto.
4. Covenants. Xxxxxxx hereby covenants and agrees that he will (i) use his
best efforts to perform his obligations under the License Agreement and to take
all actions reasonably necessary to ensure that such License Agreement remains
in full force and effect, (ii) notify Scriptgen immediately of any
correspondence or notice given by ICN under either the License Agreement or the
Letter Agreement, (iii) give Scriptgen notice of any default or likely default
on the part of the Xxxxxxx under the License Agreement or the Letter Agreement,
and (iv) give Scriptgen a reasonable opportunity to cure on his behalf any
default by the Xxxxxxx under the License Agreement or the Letter Agreement.
Page 1 of 4
***CONFIDENTIAL TREATMENT REQUESTED
5. Right of First Refusal, Power of Attorney. Xxxxxxx agrees that if he
enters into a further license agreement with ICN pursuant to the terms of the
Letter Agreement dated January 22, 1999 (the "Letter Agreement") between ICN and
Xxxxxxx for any of the compounds set forth on Exhibit 1 of the Letter Agreement,
Xxxxxxx will grant to Scriptgen a license with respect to such compounds on
substantially the same terms and conditions set forth herein, with the exception
that no additional sublicense fee shall be payable. In connection therewith,
Xxxxxxx hereby irrevocably constitutes and appoints Scriptgen his true and
lawful attorney-in-fact and agent, with full power of substitution and
resubstitution, for him and in his name, place and xxxxx, in any and all
capacities to exercise his rights under the Letter Agreement and any and all
agreements, contracts, certificates or regulatory filings necessary to be
executed by Xxxxxxx in order to effect the license of such compounds, granting
unto said attorney-in-fact and agent full power and authority to do and perform
each and every act and thing requisite and necessary fully to all intents and
purposes as it might or could do in person, hereby ratifying and confirming all
that said attorney-in-fact and agent or his substitute or substitutes, may
lawfully do or cause to be done by virtue hereof.
5. Miscellaneous.
a. Term and Termination. This Agreement shall be effective from the
date of its execution, which is set forth above, and shall continue in full
force and effect in perpetuity unless terminated earlier in accordance with the
provisions hereof. Scriptgen will have the right to terminate this Agreement by
giving Xxxxxxx ninety (90) days written notice thereof. If, pursuant to the last
sentence of the first paragraph of Section 4 of the License Agreement, the
termination of the License Agreement results in Xxxxxxx receiving a fully
paid-up exclusive license (exclusive even with respect to ICN) in perpetuity to
the compounds described in the License Agreement, then Scriptgen will be
entitled to an identical fully paid-up exclusive, perpetual license with respect
to the same compounds. At Scriptgen's option, upon termination of the License
Agreement, the sublicense granted hereunder will either terminate or will
convert to a direct license between Scriptgen and ICN for the portion of any
rights reverting to ICN pursuant to the same terms and conditions set forth in
the License Agreement.
b. Further Assurances. Each party shall, upon request of another
party, from time to time, execute and deliver, and use its reasonable best
efforts to cause other persons to execute and deliver all such further documents
and instruments, and will do or use its reasonable best efforts of cause to be
done such other acts, as such other party may reasonably request more completely
to consummate and make effective the transactions contemplated by this
Agreement.
c. Notices. Notices and other communications provided for herein
shall be in writing (including wire, telecopy or similar writing) and shall be
sent, delivered, or telecopied to the addresses designated by each party in
writing.
d. Section Headings. The section headings in this Agreement are
included for convenience only, are not a part of this Agreement, and shall not
be used in construing it.
e. Severability. In the event that any provision or any part of any
provision of this Agreement is held to be illegal, invalid or unenforceable,
such illegality, invalidity or
Page 2 of 4
unenforceability shall not affect the validity or enforceability of any other
provision or part hereof.
f. Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
g. Governing Law. The validity, interpretation, enforceability, and
performance of this Agreement shall be governed by and construed in accordance
with the laws of the Commonwealth of Massachusetts, without regard to conflicts
of law principles.
h. Jurisdiction; Consent to Service of Process. Each party hereby
irrevocably and unconditionally submits, for itself and its property, to the
jurisdiction of any state court or Federal court of the United States of America
sitting in the District of Massachusetts in the Commonwealth of Massachusetts,
and any appellate court from any thereof, in any action or proceeding arising
out of or relating to this Agreement, and each of the parties hereto hereby
irrevocably and unconditionally agrees that all claims in respect of any such
action or proceeding may be heard and determined in such Massachusetts state or
federal court. Each of the parties hereto agrees that a final judgment in any
such action or proceeding shall be conclusive and may be enforced in other
jurisdictions by suit on the judgment or in any other manner provided by law.
i. Amendment and Modifications. This Agreement may be amended,
modified and supplemented only by written agreement of the parties.
j. Waiver of Compliance. No failure or delay by either party to
exercise any right under this Agreement, and no partial or single exercise of
that right, shall constitute a waiver of that or any other right, unless
otherwise expressly provided herein.
k. Binding Effect. This Assignment shall be binding upon and inure
to the benefit of the heirs, successors and assigns of each of the parties.
Page 3 of 4
IN WITNESS WHEREOF, this Agreement is executed under seal as of the day
and year first above written.
XXXXXXX:
/s/ Xxxxxx X. Xxxxxxx
-------------------------------------------------
Xxxxxx X. Xxxxxxx
SCRIPTGEN:
SCRIPTGEN PHARMACEUTICALS, INC.
By: /s/ Xxxx X. Xxxxxx
----------------------------------------------
Name: Xxxx X. Xxxxxx
Title: President and Chief Executive Officer
Page 4 of 4
EXHIBIT D-1
ANADYS PROSECUTED AND OTHER LICENSED APPLICATIONS
COUNTRY
XXXXX & XXXXXX PROSECUTED
DOCKET NO. APPL. NO. TITLE INVENTOR STATUS BY
-------------- --------- ----- -------- ------ -----------
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Allowed Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
***CONFIDENTIAL TREATMENT REQUESTED
[EXHIBIT D-1 TO THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 1 of 5
COUNTRY
XXXXX & XXXXXX PROSECUTED
DOCKET NO. APPL. NO. TITLE INVENTOR STATUS BY
-------------- --------- ----- -------- ------ -----------
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
***CONFIDENTIAL TREATMENT REQUESTED
[EXHIBIT D-1 TO THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 2 of 5
COUNTRY
XXXXX & XXXXXX PROSECUTED
DOCKET NO. APPL. NO. TITLE INVENTOR STATUS BY
-------------- --------- ----- -------- ------ -----------
[...***...] [...***...] [...***...] [...***...] Abandoned Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
***CONFIDENTIAL TREATMENT REQUESTED
[EXHIBIT D-1 TO THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 3 of 5
COUNTRY
XXXXX & XXXXXX PROSECUTED
DOCKET NO. APPL. NO. TITLE INVENTOR STATUS BY
-------------- --------- ----- -------- ------ -----------
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Pending Anadys
[...***...] [...***...] [...***...] [...***...] Issued/6,479,463 Licensors
***CONFIDENTIAL TREATMENT REQUESTED
[EXHIBIT D-1 TO THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 4 of 5
COUNTRY
XXXXX & XXXXXX PROSECUTED
DOCKET NO. APPL. NO. TITLE INVENTOR STATUS BY
-------------- --------- ----- -------- ------ -----------
[...***...] [...***...] [...***...] [...***...] Pending Licensors
[...***...] [...***...] [...***...] [...***...] Pending Licensors
[...***...] [...***...] [...***...] [...***...] Issued[...***...] Licensors
[...***...] [...***...] [...***...] [...***...] Pending Licensors
[...***...] [...***...] [...***...] [...***...] Issued[...***...] Licensors
[...***...] [...***...] [...***...] [...***...] Issued[...***...] Licensors
***CONFIDENTIAL TREATMENT REQUESTED
[EXHIBIT D-1 TO THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 5 of 5
EXHIBIT D-2
LICENSOR PATENTS AND
PATENT APPLICATIONS
COUNTRY
XXXXX & XXXXXX DOCKET
NO. APPL. NO. TITLE INVENTOR STATUS
[...***...] [...***...] [...***...] [...***...] Issued/[...***...]
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Issued/[...***...]
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Issued/[...***...]
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
***CONFIDENTIAL TREATMENT REQUESTED
[EXHIBIT D-2 TO THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 1 of 3
[...***...] [...***...] [...***...] [...***...] Allowed
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Issued/[...***...]
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Issued/[...***...]
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Issued/[...***...]
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Issued/[...***...]
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Issued/[...***...]
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
***CONFIDENTIAL TREATMENT REQUESTED
[EXHIBIT D-2 TO THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 2 of 3
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Issued/[...***...]
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Issued/[...***...]
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Superceded
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Issued/[...***...]
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Pending
[...***...] [...***...] [...***...] [...***...] Issued/[...***...]
***CONFIDENTIAL TREATMENT REQUESTED
[EXHIBIT D-2 TO THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 3 of 3
ASSIGNMENT
WHEREAS, ICN Pharmaceuticals, Inc., a Delaware corporation, with
offices at 0000 Xxxxxx Xxxxxx, Xxxxx Xxxx, Xxxxxxxxxx 00000 ("ICN"), and
Ribapharm Inc., a Delaware corporation with offices at 0000 Xxxxxx Xxxxxx, Xxxxx
Xxxx, Xxxxxxxxxx 00000 ("Ribapharm"), with ICN and Ribapharm being collectively
referred to herein from time to time as "Assignors," own the rights to the
patents and patent applications listed in Schedule A;
AND WHEREAS, Anadys Pharmaceuticals, Inc., a Delaware corporation, with
offices at 0000 Xxxxxx Xxxxx Xx, Xxx Xxxxx, Xxxxxxxxxx 00000 ("Anadys"), Anadys
being referred to herein from time to time as "Assignee," is desirous of
acquiring the entire right, title and interest in and to said patents and patent
applications listed in Schedule A;
NOW THEREFORE, to all whom it may concern, be it known that pursuant to
the Agreement dated December 20, 2002, Assignors have sold, assigned, and
transferred, and by these presents do sell, assign and transfer unto said
Assignee, its successors or assigns, the entire right, title and interest in and
to all inventions and improvements claimed in all patents listed in Schedule A,
and in and to all renewals thereof, which may be granted therefrom, and all
extensions of such patents, which assignment is subject to Section 4.4 of the
Agreement; and Assignors do hereby authorize and request the Commissioner of
Patents and Trademarks to issue any and all United States Letters Patent for the
aforesaid inventions and improvements to the Assignee as the assignee of the
entire right, title and interest in and to the same, for the use of the
Assignee, its successors and assigns;
AND, in accordance with the Agreement signed on December 20,
2002, Assignors do hereby agree that we and our executors and legal
representatives will make, execute and deliver any and all other instruments in
writing including any and all further application papers, affidavits,
assignments and other documents, and will testify in all legal proceedings and
generally do all things which may be necessary or desirable more effectually to
secure to and vest in said Assignee, its successors or assigns the entire
right, title and interest in and to the patents, rights, titles, benefits,
privileges and advantages hereby sold, assigned and conveyed, or intended so to
be;
AND, furthermore Assignor covenants and agrees with said
Assignee, its successors and assigns, that no assignment, grant, mortgage,
license or other agreement affecting the rights and property herein conveyed has
been made to others by Assignors and that full right to convey the same as
herein expressed is legally possessed.
IN TESTIMONY WHEREOF, I have hereunto set my hand this 20th
day of December, 2002.
ICN PHARMACEUTICALS, INC.
By: /s/ Xxxxx Xxxxxx
---------------------------
Xxxxx Xxxxxx
V.P. Legal
RIBAPHARM INC.
By: /s/ Xxxxxxx Xxx
---------------------------
Xxxxxxx Xxx, MD, Ph.D.
Chief Executive Officer
SCHEDULE A TO ASSIGNMENT
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COUNTRY APPL. NO. TITLE INVENTOR PATENT NO.
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
----------------------------------------------------------------------------------------------------------
[...***...] [...***...] [...***...] [...***...] [...***...]
----------------------------------------------------------------------------------------------------------
[...***...] [...***...] [...***...] [...***...] [...***...]
----------------------------------------------------------------------------------------------------------
***CONFIDENTIAL TREATMENT REQUESTED
[SCHEDULE A TO EXHIBIT E OF THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 1 of 4
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COUNTRY APPL. NO. TITLE INVENTOR PATENT NO.
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[...***...] [...***...] [...***...] [...***...] [...***...]
----------------------------------------------------------------------------------------------------------
[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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[...***...] [...***...] [...***...] [...***...] [...***...]
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***CONFIDENTIAL TREATMENT REQUESTED
[SCHEDULE A TO EXHIBIT E OF THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
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***CONFIDENTIAL TREATMENT REQUESTED
[SCHEDULE A TO EXHIBIT E OF THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 3 of 4
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COUNTRY APPL. NO. TITLE INVENTOR PATENT NO.
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***CONFIDENTIAL TREATMENT REQUESTED
[SCHEDULE A TO EXHIBIT E OF THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 4 of 0
XXXXXXX X
XXXXXX XXXXXX PATENT AND TRADEMARK OFFICE
Applicant: [...***...] Examiner: [...***...]
Serial No.: [...***...] Group Art Unit: 1623
Filed: [...***...] Docket No.: [...***...]
Title: [...***...]
REVOCATION AND NEW POWER OF ATTORNEY
Commissioner for Patents
Xxxxxxxxxx, X.X. 00000
Dear Sir:
The undersigned assignee of record hereby revokes any existing Powers
of Attorney and appoints Merchant & Xxxxx, P.C. as attorneys and/or patent
agents with the full power to represent the applicant in connection with the
above-identified application.
Please direct all correspondence to [...***...], MERCHANT & XXXXX P.C.,
X.X. Xxx 0000, Xxxxxxxxxxx, XX 00000-0000, telephone [...***...] and list This
application to the Merchant & Xxxxx Customer No. 23552.
ICN PHARMACEUTICALS, INC.
Date:______________________ By: ___________________________
Xxxxx Xxxxxx
V.P. Legal
RIBAPHARM INC.
Date:______________________ By: ___________________________
Xxxxxxx Xxx, MD, Ph.D.
Chief Executive Officer
***CONFIDENTIAL TREATMENT REQUESTED
[EXHIBIT F TO THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 1 of 2
UNITED STATES PATENT AND TRADEMARK OFFICE
Applicant: [...***...] Examiner: [...***...]
Serial No.: [...***...] Group Art Unit: 1623
Filed: [...***...] Docket No.: [...***...]
Title: [...***...]
REVOCATION AND NEW POWER OF ATTORNEY
Commissioner for Patents
Xxxxxxxxxx, X.X. 00000
Dear Sir:
The undersigned assignee of record hereby revokes any existing Powers
of Attorney and appoints Merchant & Xxxxx, P.C. as attorneys and/or patent
agents with the full power to represent the applicant in connection with the
above-identified application.
Please direct all correspondence to [...***...], MERCHANT & XXXXX P.C.,
X.X. Xxx 0000, Xxxxxxxxxxx, XX 00000-0000, telephone [...***...] and list This
application to the Merchant & Xxxxx Customer No. 23552.
ICN PHARMACEUTICALS, INC.
Date:______________________ By: _____________________________
Xxxxx Xxxxxx
V.P. Legal
RIBAPHARM INC.
Date:______________________ By: _____________________________
Xxxxxxx Xxx, MD, Ph.D.
Chief Executive Officer
***CONFIDENTIAL TREATMENT REQUESTED
[EXHIBIT F TO THE AGREEMENT DATED DECEMBER 20, 2002
BY AND BETWEEN ICN, RIBAPHARM, ANADYS AND XXXXXXX]
Page 2 of 2