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EXHIBIT 10.58
COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
BETWEEN
COMBICHEM, INC.
AND
ICOS CORPORATION
MARCH 30, 1998
***Certain confidential portions of this Exhibit were omitted by means of
blackout of the text (the "Xxxx"). This Exhibit has been filed separately with
the Secretary of the Commission without the Xxxx pursuant to the Company's
Application Requesting Confidential Treatment under Rule 406 of Regulation C of
the Securities Act of 1933.
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COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
THIS COLLABORATIVE RESEARCH AND LICENSE AGREEMENT (the "Agreement") is
entered into and made effective as of March 30, 1998 (the "Effective Date"), by
and between COMBICHEM, INC., a Delaware corporation having its principal offices
at 0000 Xxxxxx Xxxxx Xx, Xxx Xxxxx, Xxxxxxxxxx 00000 ("CombiChem") and ICOS
CORPORATION, a Delaware corporation having its principal offices located at
00000 00xx Xxxxxx X.X., Xxxxxxx, Xxxxxxxxxx 00000 ("ICOS").
WHEREAS, CombiChem has developed, licensed and/or owns certain drug
discovery technology and intellectual property rights, including chemical
library design software, multi-parallel synthesis and purification methods,
chemical libraries suitable for high throughput biological screening assays and
medicinal chemistry (collectively, "CombiChem Technology");
WHEREAS, as of the Effective Date, ICOS and its Affiliates have
developed and own certain drug discovery and intellectual property rights,
including certain assays, methods and know how regarding the Initial Target and
any Alternative Target(s), among other things (collectively "ICOS Technology");
WHEREAS, ICOS desires to utilize CombiChem Technology for its drug
discovery activities under ICOS know-how concerning the identification and
characterization of novel small molecule inhibitors for development as
therapeutics for treatment of *** and other diseases in humans;
WHEREAS, the parties wish to collaborate in a chemical lead and drug
discovery program, commencing on the Effective Date against a Collaboration
Target ("Collaboration");
WHEREAS, during the Collaboration, the Parties intend to initially focus
on one (1) Initial Target, and thereafter on any Alternative Target(s) as
determined by ICOS;
NOW, THEREFORE, the Parties agree as follows:
1. DEFINITIONS
1.1 "Active Compound(s)" means a compound (or compounds) or
its Derivatives which
(a) (i) is selected by the RMC under the
Research Program from Collaboration
Compounds under Section 4.2, or
(ii) is a Derivative of a Collaboration
Compound which has been so selected by
the RMC to be an Active Compound; and
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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(b) shows In Vitro Activity satisfactory to the
requirements of the Research Plan.
1.2 "Affiliate" of a Party means any corporation or other
business entity controlled by, controlling or under common control with, such
Party. For this purpose "control" shall mean direct or indirect beneficial
ownership of more than fifty percent (50%) of the voting securities or income
interest in such corporation or other business, or if not meeting the preceding
requirements, any company owned or controlled by or owning or controlling such
Party at the maximum control or ownership right permitted in the country where
such company exists.
1.3 "Alternative Target" shall have the meaning set forth in
Section 3.2 hereof.
1.4 "Collaboration" has the meaning set forth in the
preamble.
1.5 "Collaboration Compound(s)" means a compound (or
compounds) which (a) is synthesized following the Effective Date for screening
against a Collaboration Target under the Research Program, (b) is a pre-existing
or hereafter acquired CombiChem compound which CombiChem desires to designate as
a Collaboration Compound, or (iii) is a pre-existing or hereafter acquired ICOS
compound which ICOS desires to designate as a Collaboration Compound.
1.6 "Collaboration Patent" means a Patent to which CombiChem
has made an inventive contribution arising out of the Collaboration, as
determined under U.S. Patent law.
1.7 "Collaboration Target" means (a) the Initial Target
beginning on the Effective Date or (b) an Alternative Target substituted for the
Initial Target under Section 3.2(b) or (c) any other target by mutual agreement
of the Parties.
1.8 "CombiChem Compound" means a chemical compound that is
proprietary to CombiChem, or whose use or manufacture is proprietary to
CombiChem.
1.9 "CombiChem Technology" has the meaning set forth in the
preamble.
1.10 "Confidential Information" includes, but is not limited
to,
(a) all information and materials received by either
Party from the other Party pursuant to this
Agreement which is confidential under Article 11
hereof;
(b) all information and materials by either Party
arising out of the Collaboration during the
Research Period including, without limitation,
information directly and specifically deduced
from Confidential Information such as
information regarding compounds that were not
active against the Targets in the screening or
secondary selective assays; and
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(c) the terms and conditions of this Agreement.
1.11 "CPI" means the Consumer Price Index, All Urban
Consumers, as published by the U.S. Bureau of Labor Statistics.
1.12 "Daughter Libraries" shall mean the compound libraries
which are designed and synthesized as a part of the Collaboration either by
CombiChem or under the direction of the RMC.
1.13 "Derivative" shall mean a compound (or compounds) which
has resulted
(a) (i) from chemical synthesis, during the
Exclusivity Period, to generate an Active
Compound or Development Compound in support of
the Research Program or (ii) from chemical
synthesis on an Active Compound or Development
Compound in support of the Research Program; and
(b) is covered under claims of any Collaboration
Patent.
1.14 "Development Compound(s)" means a Collaboration Compound
(or compounds) which
(a) (i) is an Active Compound or (ii) is a
Derivative of an Active Compound; and
(b) is determined by ICOS to be appropriate for the
purpose of IND filing by ICOS either before
preclinical studies or from the results of
preclinical studies to determine without
limitation, data on efficacy, potency, toxicity,
bioavailability and other pharmacokinetics
related parameters.
1.15 "Due Diligence" means the use of by a Party of its
resources in the Collaboration in a manner which is consistent with the exercise
of reasonable and prudent scientific and business judgment as applied to other
programs of ICOS or CombiChem, as the case may be, targeting products aimed at
markets or patient groups of similar sizes and of similar scientific and
commercial potential. With respect to any Development Compound, "Due Diligence"
shall also require ICOS or its Affiliates, partners or licensees to use
commercially reasonable efforts to conduct all necessary preclinical studies and
to file an IND for such Development Compound within a commercially reasonable
period from the date upon which ICOS has designated such Development Compound
from any Active Compound or its Derivatives. For purposes of this Agreement,
failure to exercise Due Diligence by any Party may be alleged by written notice
to such Party describing such failure with specificity and describing the
actions necessary to cure such failure with specificity (the "Due Diligence
Notice"). Sixty (60) days after delivery of a Due Diligence Notice, if the Party
receiving such Due Diligence Notice has not completed the actions necessary to
cure such failure as specified in such Due
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Diligence Notice to the reasonable satisfaction of the other Party, the Parties
shall immediately be subject to the dispute resolution provisions set forth in
Article 15 hereof starting at the discussions between the Parties' Chief
Executive Officers described in Section 15.1 hereof.
1.16 "Exclusivity Period" means the Research Period plus ***
as may be extended or reduced pursuant to Article 4 hereof.
1.17 "Field" means all therapeutic indications in humans for
any Target against which a Collaboration Compound, Active Compound, Development
Compound or Products may be directed.
1.18 "First Commercial Sale" of a Product shall mean the
first sale for use or consumption of such Product in a country after required
marketing and pricing approval has been granted by the governing health
regulatory authority of such country. Sale to an Affiliate shall not constitute
a First Commercial Sale unless the Affiliate is the end user of the Product.
1.19 "FTE" shall mean a full-time equivalent employee of
CombiChem having the requisite skills to fulfill CombiChem's obligations under
this Agreement. For purposes of this Agreement, the FTEs shall include synthetic
and analytical chemists, compound control scientists and computational
scientists.
1.20 "Inactive Compound(s)" means a Collaboration Compound(s)
which is not an Active Compound or an Active Compound that is reclassified as
described in Section 4.2 hereof.
1.21 "ICOS Compound" means a chemical compound that is
proprietary to ICOS or whose use or manufacture is proprietary to ICOS or its
Affiliates.
1.22 "ICOS Technology" shall have the meaning set forth in
the preamble of this Agreement.
1.23 "In Vitro Activity" shall mean during the Research Term,
the observation of *** in assays as described by ICOS in the Research Plan for
each Collaboration Target.
1.24 "Initial Target" shall have the meaning set forth in
Section 3.1 hereof.
1.25 "Net Sales" means the gross sales invoiced by ICOS, its
Affiliates or its sublicensees for Products to non-Affiliated Third Parties (and
to Affiliates who are the end users of such Products) less actual deductions or
returns (including withdrawals and recalls), rebates (price reductions,
including formulary or Medicaid and similar types of rebates, e.g. chargebacks),
cash, trade or volume (quantity) discounts, discounts granted at the time of
invoicing, the cost of transport, insurance, delivery, sales taxes and use,
tariff, excise or other taxes (other than income taxes) directly linked to and
included in the gross sales amount as computed on a product-by-product basis
for the countries concerned, whereby the amount of such sales in foreign
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currencies is converted into United States dollars at the exchange rate of the
last business day for each calendar month as reported in The Wall Street
Journal.
1.26 "Patent" means (a) valid and enforceable U.S. or non
U.S. Patent, and any non-U.S. equivalent, including any extension (including
Supplemental Protection Certificates), registration, confirmation, reissue,
continuation, divisionals, continuation-in-part, reexamination or renewal
thereof, or (b) pending applications for any of the foregoing, whether filed or
issued before or after the Effective Date.
1.27 "Party" means CombiChem or ICOS, as the case may be,
including their respective Affiliates, permitted successors and assigns.
1.28 "Product(s)" means any product containing an Active
Compound or Development Compound with such compound as the active ingredient or
one of the active ingredients, which is the subject of one or more claims under
a Collaboration Patent and which is granted regulatory approval by the governing
health regulatory authority of the applicable country for marketing in the
Field.
1.29 "Project Team" shall have the meaning set forth in
Section 2.1(c).
1.30 "Research Management Committee" or "RMC" has the meaning
set forth in Article 6 below.
1.31 "Research Period" means that part of the Collaboration
commencing *** or sooner by mutual agreement *** unless earlier terminated, and
which can be extended in accordance with Section 7.1 below for the Initial
Target or an Alternative Target substituted therefore under Section 3.2(b)
herein.
1.32 "Research Plan" means the research plan to be agreed in
writing between the Parties, which describes in mutually agreed upon detail the
research activities to be performed for each Collaboration Target.
1.33 "Research Program" means the research and activities to
be conducted for the Collaboration during the Research Period including, without
limitation, the activities described in the Research Plan and set forth in
Sections 2.1 and 2.2 of this Agreement.
1.34 "Returned Compound" shall have the meaning set forth in
Section 9.2.
1.35 "Royalty Term" means, in the case of any Product, in any
country, the period of time commencing on the First Commercial Sale and ending
upon the later of (a) *** or (b) the expiration of the last-to-expire Patent
resulting from the Research Program filed in the Field during the Exclusivity
Period with claims covering that Product in the relevant country. In the event
such *** period shall extend beyond the end of the term or terms of the last to
expire Patents resulting from the Research Program containing a valid claim in
such country, the earned royalties
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hereunder in such country shall be *** for the remainder of such *** period so
long as *** as the Product exists and is sold in competition with the Product.
1.36 "Target" means a biomolecular entity that a
Collaboration Compound is synthesized against wherein the small molecule
demonstrates relevant activity and unless otherwise specified may include both
Initial and Alternative Targets.
1.37 "Target Exclusivity Obligations" shall have that meaning
set forth in subsection 4.1(a) hereof.
1.38 "Territory" means the entire world.
1.39 "Third Party" means an entity other than CombiChem or
ICOS or their respective Affiliates or assigns.
1.40 "UIL" means CombiChem's proprietary Universal Informer
Library(TM).
2. RESEARCH COLLABORATION
2.1 CombiChem Responsibilities. CombiChem shall with Due
Diligence provide the following resources to ICOS and conduct the following
activities under the Research Program and as more fully described in the
Research Plan:
(a) Within thirty (30) days of the Effective Date,
CombiChem will deliver to ICOS its UIL
sufficient in quantity for ICOS to screen
against the Initial Target and any Target
contained in Appendix B at the time of such
shipment.
(b) At any time following the Effective Date,
CombiChem shall provide to ICOS data analysis
and evaluations for results from the screening
of the UIL against the Initial Target and any
substituted Alternative Target under Section
3.2(b) herein within *** of CombiChem's receipt
of the relevant screening data from ICOS.
(c) During the Research Period, CombiChem shall (i)
review data and information regarding the
Collaboration Target provided by ICOS and
derived from the UIL by CombiChem; (ii) based on
such data and information and using the
CombiChem Technology, design Daughter Libraries;
and (iii) supply all lead chemistries and
synthesize compounds as provided in Section 5.4
hereof.
(d) During the Research Period, CombiChem shall keep
ICOS informed of its activities performed in
connection with the Collaboration,
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including, without limitation, providing ICOS
with data and information (and, upon ICOS's
request, reasonable quantities of samples
pursuant to Section 5.4) regarding the status of
all Collaboration Compounds prior to the
meetings of the Research Management Committee.
(e) Subject to Section 2.3, Article 3 and Section
8.3 hereof, and at all times during the Research
Period, CombiChem shall dedicate, in separate
laboratory facilities as to its chemistry
efforts *** to conduct all of CombiChem's
activities in connection with the Collaboration
at a per annum rate of U.S. *** per FTE to be
paid by ICOS. The *** unless the RMC recommends
otherwise and ICOS and CombiChem agree in
writing to alter the size of *** .
2.2 ICOS Responsibilities. ICOS shall with Due Diligence
provide the following resources to CombiChem and conduct the following
activities under the Research Program as more fully described in the Research
Plan:
(a) ICOS shall make payment to CombiChem for the
Collaboration as set forth in Article 8 hereof,
provide screening, biological and structural
data and information (including leads and/or
screening hits and any assay methods relating to
Collaboration Compounds) to CombiChem necessary
for CombiChem to perform its duties under this
Agreement, and will assume scientific, financial
and administrative responsibility for screening
and biological support activities, drug
development and regulatory filings during and
after the term of the Collaboration on the terms
set forth below.
(b) During the Research Period, ICOS shall provide
CombiChem with data and information regarding
Collaboration Compounds and the Collaboration
Target assays developed by ICOS under the
Research Program prior to the meetings of the
Research Management Committee.
(c) During the Exclusivity Period, ICOS shall screen
Collaboration Compounds for *** and, where ICOS
reasonably deems it to be appropriate, ***
against the Collaboration Target.
(d) During the Exclusivity Period, with respect to
any Collaboration Target against which an Active
Compound has been designated by the RMC, ICOS
shall (i) screen Active Compounds, (ii)
determine Development Compounds, and (iii)
endeavor to develop Products.
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At any time during the Collaboration, ICOS may
apply chemistry effort, including synthesis, to
any Collaboration Compound as agreed and
directed by the RMC.
(e) Following the first IND filing through First
Commercial Sale, ICOS shall provide CombiChem
with an annual report similar to that which
would be provided in the usage of the trade or
business, by a licensee to a licensor
summarizing ICOS's activities in developing
Development Compounds that shall include,
without limitation, all material information
with respect to the following: (i) status of
both regulatory filings and communications with
the United States Food and Drug Administration
or any foreign equivalent ("FDA"); (ii) status
of Patents within and outside of the United
States; (iii) status of current and planned
clinical trials; (iv) occurrence of any
milestone events; and (v) any permitted
sublicensing under this Agreement.
(f) During the Research Period and in connection
with CombiChem providing the services in Section
2.1(c) hereof, ICOS shall, at its option, send
*** to conduct ICOS' activities at CombiChem's
facilities under the Research Program. ICOS
shall have sole responsibility for the expenses
associated with its visiting chemists,
including, without limitation, salary, travel,
living and other associated expenses of such
chemists.
2.3 Conduct of Research Program. The Parties hereby agree
that the Research Programs shall be carried out in accordance with the Research
Plan and this Agreement, as each may be amended from time to time. The Research
Management Committee shall review the Research Plan on a regular and ongoing
basis and may make written changes to the Research Plan so long as such changes
are mutually agreed to in writing by CombiChem and ICOS.
2.4 Third Party Licenses. Each Party shall be solely
responsible for any Third Party license fees required to perform its obligations
under this Agreement.
3. TARGETS
3.1 Initial Target. ***.
3.2 Alternative Target.
(a) An Alternative Target is any of those
alternative targets selected from Appendix B attached hereto, as amended in
writing by mutual agreement of the Parties hereto from time to time, and for
which ICOS has identified such selection in a written notice to CombiChem.
Unless otherwise agreed by the Parties in writing or as set forth in this
Section 3.2, ICOS shall have the right to screen the UIL against any target
contained in Appendix B, as
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amended, but shall *** in accordance with Section 8.1(b) hereof.
(b) At any time prior to *** , ICOS may decide, or
may accept a recommendation by the RMC, to pursue any Alternative Target in
substitution for the Initial Target and thereafter the Alternative Target shall
be deemed to be a Collaboration Target for all purposes under this Agreement.
Such substitution by ICOS shall be effective upon the date of a written notice
provided to CombiChem by ICOS expressly stating that such substitution shall be
made and identifying the Alternative Target from Appendix B to be substituted.
3.3 Substitute Target. After the commencement of a Research
Program with respect to the Collaboration Target, the Parties, by mutual
agreement, may substitute another target for such Collaboration Target.
4. EXCLUSIVITY
4.1 Collaboration Target Exclusivity.
(a) Following the Effective Date, so long as ICOS or
its Affiliates are proceeding with Due Diligence
for that Collaboration Target, CombiChem shall
not work on, or provide services, or advise,
either independently, or with any Third Parties
(except where CombiChem is providing its UIL to
Third Parties without knowledge of such Third
Parties' target) (the "Target Exclusivity
Obligations"), except (a) as provided for in
Section 12.2 hereof with regard to any Public
Statements, (b) with respect to any Third
Parties who are collaborators or proposed
collaborators of CombiChem, CombiChem shall have
the right, consistent with its corporate policy
(but without identifying any Collaboration
Target), to notify any such Third Party of its
decision and/or inability to work on such
Collaboration Target with that Third Party or
(c) if CombiChem's Target Exclusivity
Obligations have terminated pursuant to
subsection 4.1 (b) below.
(b) Upon the commencement of the Research Period and
following synthesis of a Daughter Library by
CombiChem for the Collaboration Target, the
Target Exclusivity Obligations with respect to
such Collaboration Target shall continue until
(1) ICOS has provided CombiChem with a notice
and release of Target Exclusivity Obligations,
effective in sixty (60) days, that, because of
business and scientific reasons, ICOS has
decided to cease research and/or development
activities for the Initial Target, or (2) ICOS
has provided CombiChem with a notice and release
of Target Exclusivity Obligations, effective ***
from the date of such notice and release, that
ICOS has decided to cease research
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and/or development activities for a specific
Collaboration Target except the Initial Target,
or (3) *** after the date of the written notice
provided by ICOS under Section 3.2(b) herein, or
(4) (A) ICOS has failed to exercise Due
Diligence with respect to that Collaboration
Target and (B) has not transferred or assigned
its control of the development of its program
for that Collaboration Target to a Third Party
with due diligence requirements no less
stringent than those set forth in this
Agreement. In the event of such transfer or
assignment to a Third Party, the Target
Exclusivity Obligations with respect to such
Collaboration Target shall continue until the
earlier of (a) receipt by CombiChem of a written
release from such Third Party, or (b) the
failure of such Third Party to exercise Due
Diligence with respect to that Target. Any
notice under this subsection 4.1(b) shall be
provided by ICOS to CombiChem promptly following
the relevant decision under subsections (1), (2)
or (3) above or failure under subsection (4)
above.
4.2 Alternative Target Exclusivity. From the Effective Date
through *** CombiChem shall not work on, or provide services or advise, either
independently, or with any Third Parties (except where CombiChem is providing
its UIL to Third Parties without knowledge of such Third Parties' target),
except as provided for in Section 12.2 hereof with regard to any Public
Statements or (b) with respect to any Third Parties who are collaborators or
proposed collaborators of CombiChem, CombiChem shall have the right, consistent
with its corporate policy (but without identifying any Alternative Target), to
notify any such Third Party of its decision and/or inability to work on such
Alternative Target with that Third Party.
4.3 Active Compound Exclusivity. Any Active Compound shall
be exclusively available to ICOS for research or application within or outside
the Collaboration, during the Research Period, and CombiChem shall not work on
or provide information regarding such Active Compound to any Third Party, except
to take any steps necessary to protect ICOS's exclusivity hereunder. Following
the expiration of the Research Period, Active Compounds for which a Patent has
not been filed within ninety (90) days following the Research Period shall be
deemed to be Inactive Compounds for all purposes hereunder; provided, that any
Active Compound which is the subject of claim(s) under a pending Collaboration
Patent shall continue to be treated as Active Compounds until a Collaboration
Patent is issued with respect to one or more of such claims; or until all of
such Patent claims have been denied and all appeals and refiling procedures have
been exhausted, at which time the compounds which are the subject of those
claims shall be Inactive Compounds hereunder.
4.4 Inactive and Returned Compounds. Any Inactive Compounds
and Returned Compounds (subject to Section 9.2 hereof) shall be available to
CombiChem (except for any pre-existing ICOS Compound) and ICOS for any purpose.
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4.5 Survival. This Article 4 shall survive termination or
expiration of this Agreement.
5. COLLABORATION COMPOUNDS
5.1 Pre-Existing Compounds or Other Pre-Existing Rights.
Neither Party shall have any rights then existing in the other Party to any
pre-existing compound of the other Party unless and until such compound is
designated as a Collaboration Compound by such Party. Additionally, CombiChem
may decline (after informing ICOS) to synthesize a particular compound or
library of compounds by written notice to ICOS of existing Patents, Patent
Applications and/or contractual obligations with Third Parties restricting
CombiChem's performance of such activities and such notice shall contain a
statement of warranty that such Patents, Patent Applications and/or contractual
obligations exist and that their existence and the obligations of CombiChem
predate an ICOS request of CombiChem to synthesize such compound or library of
compounds.
5.2 Intellectual Property Rights; License to ICOS. Subject
to Section 9.2 hereof, and except as set forth in this Section 5.2, ICOS shall
have *** relating to Active Compounds, Development Compounds and Products and
the subject matter contained therein and resulting from the Research Program ***
. ICOS shall be responsible for filing, maintaining and prosecuting all
Collaboration Patents at its sole expense and CombiChem shall use commercially
reasonable efforts to assist ICOS in filing such Collaboration Patent
applications. Prior to the filing of any such Collaboration Patent applications,
CombiChem shall assign to ICOS or its designee all intellectual property rights
it may have in *** and the subject matter claimed therein which are necessary
for the development and commercialization by ICOS or its designee; provided
under no circumstances does *** in any Active Compound, Development Compound or
Products are *** to the extent such Active Compound, Development Compound or
Products may be *** . If ICOS fails to so file, maintain or prosecute such
Collaboration Patent, CombiChem shall have the right to request ICOS to do so.
If ICOS elects not to file, maintain or prosecute such Collaboration Patent, on
a country-by-country basis, ICOS shall provide CombiChem with a fully-paid up
license so that CombiChem can take over such filing, maintenance or prosecution
of such Collaboration Patent, at its sole expense.
5.3 Structural Information. Neither Party shall disclose the
structure of the other Party's compound, any Active Compound, Development
Compound or Product to any Third Party without the other Party's written
permission, unless required to do so by law, in which case such Party shall
promptly notify the other Party of such required disclosure. If a subpoena or
other legal process concerning the same is served upon either Party, the other
Party shall
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cooperate with the Party served in any effort to contest the validity of such
subpoena or other legal process.
5.4 Supply of Collaboration Compounds. Aliquots of *** of
any Collaboration Compound that has been synthesized will be prepared and given
to ICOS. CombiChem shall replenish that amount upon ICOS's reasonable request.
CombiChem shall maintain aliquots of any Collaboration Compound that has been
synthesized by CombiChem. CombiChem shall also provide ICOS with additional
requirements of samples at CombiChem's cost. To the extent that Collaboration
Compounds are not available in a timely and sufficient quantity to allow the
earliest start of necessary large scale preclinical or other studies such
unavailability of Collaboration Compounds shall not be cited as a lack of Due
Diligence provided that the Parties have made commercially reasonable attempts,
and continue such attempts, to provide such unavailable Collaboration Compounds
in required quantities in the most expedient manner.
6. RESEARCH MANAGEMENT COMMITTEE
The design, review and conduct of the Research Program will be
coordinated by the Research Management Committee, which will meet regularly on a
mutually-agreeable schedule. Each Party shall bear its own expenses related to
such meetings. The Research Management Committee may establish and amend or
revise the Research Plan as reasonable and necessary to reflect the scientific
progress and work performed under the Research Program, such amendments to be
mutually agreed to in writing by ICOS and CombiChem. The Research Management
Committee will consist of an equal number of members from ICOS and CombiChem and
will include appropriate representatives from ICOS and CombiChem as mutually
agreed. The co-chairs of the Research Management Committee will initially be ***
and subsequently may change as each Party determines for its co-chair. Decisions
of the Research Management Committee shall be by consensus. If a decision is not
reached by the RMC with respect to management of the Research Program, the
dispute will be referred to the co-chairs of the RMC. If the co-chairs of the
RMC are unable to resolve the dispute, the dispute will be referred to the Chief
Executive Officer of CombiChem and the Chief Executive Officer of ICOS for
resolution. If those officers are unable to resolve the dispute, after good
faith discussions, the dispute shall be resolved first by a process of mediation
and then in the case of a failure to resolve the dispute, as determined per
Section 15.2 hereof. Any decisions, recommendations, amendments or performance
criteria agreed by consensus of the RMC which could, or may, materially affect
any obligations concerning consideration or ownership of intellectual property
shall be consistent with the terms of this Agreement and shall be ratified in
writing by both CombiChem and ICOS prior to it being binding on either party and
any performance or partial performance of an unratified agreement shall not be
construed as a waiver or acquiescence of the right of ratification.
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7. RESEARCH PERIOD; TERMINATION OF RESEARCH PROGRAM
7.1 Research Period: Option to Extend the Research Period.
The initial term of the Collaboration shall commence on the Effective Date and
conclude at the end of the Research Period, subject to extension upon mutual
agreement. To extend the Research Period, ICOS must notify CombiChem no later
than ninety (90) days prior to the then-current expiration date and the Parties
shall negotiate in good faith the terms and conditions of any such extension.
7.2 Termination of Research Program Upon Breach. The
Research Program and/or this Agreement may be terminated by a Party for the
material breach by the other Party as provided by Section 10.2 hereof.
8. CONSIDERATION
8.1 Fees.
(a) As of the Effective Date, ICOS shall be
obligated to pay CombiChem a non-refundable, noncontingent project initiation
fee of U.S. *** in cash, by registered check or wire transfer, to initiate the
Research Program for the Initial Target within fifteen (15) days of the
Effective Date. Such initiation fee shall include payment for the *** made for
the Initial Target. Should ICOS request in writing a *** for any *** ICOS shall
pay CombiChem an additional U.S. *** for the *** and *** for *** for a total of
up to *** such *** . If any such request occurs after *** such *** shall only be
upon the mutual agreement of the Parties. The action of replacing an *** for an
*** pursuant to Section *** hereof shall not obligate ICOS to an additional ***
for such *** .
8.2 Research Program Funding.
(a) Research Support for Project Team. Beginning ***
,or earlier if mutually agreed by the Parties, and continuing throughout the
Research Period, ICOS shall make payments to CombiChem for direct research
support for its Project Team, which shall initially consist of *** full time
employees ("FTEs") of CombiChem, as modified by the RMC pursuant to Section
8.2(b) below. The total amount per FTE payable shall be U.S. *** per FTE per
annum, which amount shall be upwardly adjusted annually based on cumulative
changes in the CPI, using 1998 as the base year. All payments for direct
research support shall be paid by ICOS to CombiChem, quarterly in advance, and
adjusted as necessary in subsequent quarters, of such amounts as are equal to
the product of (i) the number of CombiChem FTEs allocated to the Research
Program by the RMC for the calendar quarter to which each such payment applies,
multiplied by (ii) U.S. *** (i.e., the quarterly amount per CombiChem FTE on the
basis of U.S. *** per annum).
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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15
(b) Expansion or Contraction of Project Team.
Notwithstanding Section 2.1(e) herein, either Party may request that CombiChem
expand or contract its Project Team during the Research Period in order to
properly regulate the work-flow on a Collaboration Target. In such event, the
RMC shall promptly confer as to the appropriate number of FTEs to be added to
the Project Team, at a cost to ICOS of U.S. *** per FTE as upwardly adjusted
annually based upon cumulative changes in the CPI, using 1998 as the base year,
to be paid as specified in Section 8.2(a) hereof and make a recommendation to
such expansion or contraction of the Project Team which recommendation may be
adopted by mutual written agreement of ICOS and CombiChem.
8.3 Milestone Payments. Within thirty (30) days of the
occurrence of a development milestone triggered by the activities of ICOS or its
Affiliates as shown on Appendix A attached hereto, ICOS shall pay CombiChem the
related milestone payment in U.S. dollars as set forth on Appendix A attached
hereto. Such payments shall apply to any milestone reached by an Active
Compound, Development Compound or Product, for a Target within the
Collaboration.
8.4 Royalties. During the Royalty Term, ICOS will pay
CombiChem an earned royalty of (i) *** of Net Sales of Products sold by ICOS,
its Affiliates or its sublicensees on the first *** of Net Sales made per
calendar year in *** and (ii) *** on any Net Sales of Products sold by ICOS, its
Affiliates or its sublicensees over *** made per calendar year in *** (iii) ***
of Net Sales of Products sold by ICOS, its Affiliates or its sublicensees on the
first *** of Net Sales made per calendar year *** and (iv) *** on any Net Sales
of Products sold by ICOS, its Affiliates or its sublicensees over *** made per
calendar year *** . Each payment of royalties shall be accompanied by a report
of Net Sales of Products in sufficient detail to permit confirmation of the
accuracy of the royalty payment made.
(a) ICOS may reduce the percentage amount of earned
royalties payable for a Product under this Agreement by *** the amount in excess
of *** that ICOS decides, in its reasonable business judgment, to pay to third
parties who are not Affiliates or sublicensees of ICOS (not including any
royalties payable to CombiChem hereunder) in order to sell the Product to avoid
or settle a patent infringement action relating to *** under a Collaboration
Patent; provided however, that the royalties payable by ICOS to CombiChem for
the sale of Product shall not be reduced to less than *** the amount that ICOS
would otherwise be obligated to pay to CombiChem.
(b) For any Product which is sold in combination
with any other active ingredient which other ingredient is not royalty bearing
hereunder (a "Combination Product"), Net Sales, for purposes of calculating
royalties, as defined in this Section 8.4, on a Combination Product, shall be
calculated by multiplying the net sales with respect to the Combination Product
determined in the same manner as Net Sales for a Product by the fraction A/B
where A is the gross selling price of the Product sold separately (i.e., without
the other active ingredients) and B is the gross selling price of the
Combination Product. In the event that no such separate sales
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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16
are made, net sales value shall be calculated by multiplying net sales of the
Combination Product by the fraction C/(C + D), where C and D shall be negotiated
by the Parties in good faith prior to such sales.
(c) Earned royalty shall be paid in the manner
provided herein on a country-by-country basis.
8.5 Manner and Place of Payment. Royalty payments and
reports for Net Sales of Products shall be calculated in local currencies and
reported for each calendar quarter. All royalty payments owed under this
Agreement shall be made by wire transfer to the bank account to be designated by
CombiChem within sixty (60) days following the end of each such calendar
quarter.
8.6 Records and Audit. During the term of this Agreement and
for a period of three (3) years thereafter, ICOS shall keep complete and
accurate records pertaining to the sale or other disposition of Products in
sufficient detail to permit CombiChem to confirm the accuracy of all payments
due hereunder. CombiChem shall have the right to cause an independent certified
public accounting firm reasonably acceptable to ICOS to audit such records to
confirm ICOS's Net Sales for the preceding year. Any information obtained during
such audit shall be treated as Confidential Information. Such audits may be
exercised after reasonable notice during normal business hours of ICOS no more
than once each year. CombiChem shall bear the full cost of such audit unless
such audit discloses a deficiency of the greater of U.S. $100,000 or more than
five percent (5%) from the amount of the Net Sales reported by ICOS for such
audited period. In such case, ICOS shall bear the reasonable cost of such audit.
8.7 Taxes. All income and other taxes levied on account of
the royalties and other payments accruing to CombiChem under this Agreement
shall be paid by CombiChem, including taxes levied thereon as income to
CombiChem. If provision is made in law or regulation for withholding, such tax
shall be deducted from the royalty or other payment made by ICOS to the proper
taxing authority and a receipt of payment of the tax secured and promptly
delivered to CombiChem. Each Party agrees to assist the other Party reasonably
in claiming exemption from such deductions or withholdings under any double
taxation or similar agreement or treaty from time to time in force.
9. LICENSE GRANTS; SUBLICENSE
9.1 CombiChem License Grant to ICOS. In addition to ICOS's
non-exclusive right to use CombiChem Technology as necessary to conduct
activities under the Research Program as described in Section 2.2 hereof,
subject to the terms and conditions of this Agreement, CombiChem hereby grants
to ICOS an exclusive, royalty-free, worldwide license, with the right to
sublicense to use such CombiChem Technology as is necessary to make, have made,
use, have used, sell, have sold, import and export Active Compounds, Development
Compounds and/or Products in the Territory. Such license shall remain exclusive
(including as to CombiChem) in relation to an Active Compound, Development
Compound and/or Product so
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17
long as ICOS or its licensee continues to develop and commercialize such Active
Compound, Development Compound and/or Product against a Collaboration Target
with Due Diligence.
9.2 ICOS License Grant to CombiChem. Subject to Article 4
hereof and following the decision of ICOS or its licensee to not develop and
commercialize with Due Diligence an Active Compound, a Development Compound or
Product, as the case may be (collectively, "Returned Compounds"), ICOS shall
grant to CombiChem a royalty-bearing license, with the right to sublicense,
under those Collaboration Patents and know-how which are resulting from the
Research Program and related exclusively to the Returned Compound, to make, have
made, use, have used, sell, have sold, import and export such Returned Compound
in the Territory. The royalty payments payable to ICOS for the license granted
to CombiChem pursuant to this Section 9.2 shall be identical to the royalty
payments provided for in Section 8.4 hereof (including the Royalty Term in
Section 1.35 hereof) substituting CombiChem for ICOS and ICOS for CombiChem. No
additional payments shall be due ICOS in consideration of the license grant
under this Section 9.2.
9.3 ICOS Sublicense. ICOS shall have the right to transfer,
assign or sublicense to a Third Party the Products or Collaboration Patents
covering the Products, subject to CombiChem's right to receive all royalties and
milestone payments as provided in Sections 8.4 and 8.5 hereof. All payments
payable hereunder shall be made to CombiChem by wire transfer to such bank
account designated by CombiChem within five (5) business days after receipt by
ICOS or its Affiliates of such payments from a Third Party. As an express
condition of any such sublicense, any such licensee shall be required to agree
in writing (a) to be bound by due diligence, royalty reporting and recordkeeping
and inspection provisions no less stringent than those contained in this
Agreement and (b) to allow CombiChem to institute or join legal actions against
any ICOS sublicensee who fails to satisfy any obligations provided pursuant to
this Section 9.3. ICOS shall remain responsible to CombiChem for all milestone
and royalty payments actually received by ICOS from its sublicensees. In
addition, CombiChem shall have the right to receive all audit reports relating
to sales of Products of ICOS's sublicensees, and to cause ICOS or its Affiliates
or assigns to have an independent certified public accounting firm (reasonably
acceptable to ICOS) audit such sublicensee's records on the same terms as those
specified in Section 8.6 hereof.
9.4 Rights to Inactive Compounds. Each Party shall be free
to screen Inactive Compounds against any target other than a Collaboration
Target. In the event that either ICOS or CombiChem shall develop, market and/or
sell, or enter into a binding agreement with a Third Party to develop, market
and/or sell, any product containing the Inactive Compound as an active
ingredient, then except to the extent that such Inactive Compound is subject of
a valid claim in a Patent or Collaboration Patent giving rights to the Party,
the other Party hereto shall not be entitled to any payments, milestones,
royalties, fees or compensation of any kind.
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18
10. TERM AND TERMINATION OF THE AGREEMENT
10.1 Term. The term of this Agreement shall commence upon the
Effective Date and unless earlier terminated as provided in this Agreement,
shall expire at the end of the Research Period.
10.2 Termination by ICOS or CombiChem. If either Party
materially breaches this Agreement and fails to remedy that breach within ninety
(90) days of receiving written notice thereof from the other Party, or enters
into any arrangement of compromise with its creditors or goes into liquidation,
insolvency, bankruptcy, receivership or reorganization proceedings, whether
voluntarily or compulsorily which is not dismissed by a court of competent
jurisdiction within ninety (90) days, then the other Party may at any time, by
notice in writing or by facsimile transmission, terminate this Agreement. Within
ninety (90) days following termination for any Research Program and/or research
related to any Target under this Agreement, the RMC shall prepare a detailed,
final written report to each Party, and provide any remaining supply of
compounds in synthesis to date, for each Target or Research Program being
terminated.
10.3 Termination by ICOS. ICOS may terminate this Agreement
effective at any time after *** from the Effective Date, in its sole discretion,
upon ninety (90) days' prior written notice.
10.4 Termination by CombiChem. CombiChem may terminate this
Agreement effective at any time after *** from the Effective Date, in its sole
discretion, upon ninety (90) days' prior written notice. In the event that
CombiChem elects to terminate under this Section 10.4, CombiChem shall not work
on or provide services, or advice, either independently or with any Third Party
on any Collaboration Target for a period of *** from the date that the
termination is effective. No termination of this Agreement pursuant to this
Section 10.4 shall extend the Target Exclusivity Obligations set forth in
Section 4.1 hereof.
10.5 After Termination. Any termination of this Agreement or
the Research Program shall be without prejudice to the accrued rights of either
Party prior to the termination. In case of termination of this Agreement or the
Research Program pursuant to Sections 10.2, 10.3 or 10.4 above, all royalty,
milestone, payment and confidentiality obligations set forth in Sections 8.1,
8.4, 8.5, 9.3, 9.4 hereof and Articles 11 and 12 hereof shall survive any such
termination. Moreover, ICOS shall not be entitled to any refund of any payments
made to CombiChem hereunder upon the expiration of the term of this Agreement or
earlier termination pursuant to this Article 10.
10.6 Effect of Termination on Licensees. In the event of any
termination of this Agreement pursuant to this Article 10 where such termination
shall not have been caused by the action or inaction on the part of any
respective licensee of ICOS or CombiChem, or by any breach by such licensee of
its obligations under its license from ICOS or CombiChem, as appropriate, such
termination of this Agreement shall be without prejudice to the rights of each
non-breaching licensee and such licensee shall be deemed to be a direct licensee
hereunder.
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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19
11. CONFIDENTIAL INFORMATION
11.1 Nondisclosure. During the term of this Agreement and for
a period of *** years after termination or expiration thereof, each Party will
maintain all Confidential Information in trust and confidence and will not
disclose any Confidential Information to any third party or use any Confidential
Information for any purpose except (i) as expressly authorized by this
Agreement, (ii) as required by law or court order, after as much advance notice
as is practical to the other Party, (iii) to its consultants, subcontractors or
agents who need to know to accomplish the purposes of this Agreement and who are
bound by equivalent written confidentiality obligations. Each Party may use the
other Party's Confidential Information only to the extent required to accomplish
the purposes of this Agreement. Each Party will use at least the same standard
of care as it uses to protect proprietary or confidential information of its own
to ensure that its Affiliates, employees, agents, consultants and other
representatives do not disclose or make any unauthorized use of the Confidential
Information. Each Party will promptly notify the other upon discovery of any
unauthorized use or disclosure of the Confidential Information.
11.2 Exceptions. Confidential Information shall not include
any information which the receiving Party can prove by competent evidence: (a)
is now, or hereafter becomes, through no act or failure to act on the part of
the receiving Party, generally known or available; (b) is known by the receiving
Party at the time of receiving such information, as evidenced by its written
records; (c) is hereafter disclosed to the receiving Party by a Third Party, as
a matter of right and without restriction on disclosure; (d) is independently
developed by the receiving Party without the aid, application or use of
Confidential Information; or (e) is the subject of a written permission to
disclose provided by the disclosing Party.
12. PUBLICATIONS AND PUBLIC STATEMENTS
12.1 Publications. Without affecting obligations under
Article 11 above, neither Party shall publish any information with respect to
Collaboration Compounds or Development Compound during the Exclusivity Period
without the prior written permission of the other Party. Such permission shall
be approved or disapproved within thirty (30) days of written request for
permission unless the other Party requests additional time (not to exceed ninety
(90) days) for the purpose of protecting its intellectual property position.
Such permission shall not be unreasonably withheld. The Party proposing to
publish such information shall give the other Party ninety (90) days prior
written notice and an opportunity to review such manuscript in order to
determine the patentability of the information contained therein.
12.2 Public Statements. Neither Party shall use the name of
the other Party in any public statement, prospectus, annual report or press
release or other public communication (collectively "Public Statements") (except
to the extent that use of the name is required for disclosure by the Securities
and Exchange Commission or other governmental rules or regulations) without the
prior written approval of the other Party, which may not be unreasonably
withheld or delayed; provided, however, that both Parties shall endeavor in good
faith to give the other Party a minimum of two (2) business days to review such
Public Statements; provided,
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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20
further, that, upon approval of any such Public Statement, both Parties may
disclose to Third Parties the information contained in such Public Statement
without the further approval of the other; and provided, further, that if a
Party does not approve such Public Statement, either Party may still use the
name of the other Party in any Public Statement without the prior written
approval of the other Party, if such Party is advised by counsel that such
disclosure is required to comply with applicable law.
13. INDEMNIFICATION
13.1 EACH PARTY HEREBY AGREES TO SAVE, DEFEND AND HOLD THE
OTHER PARTY AND ITS OFFICERS, DIRECTORS, EMPLOYEES, CONSULTANTS AND AGENTS
HARMLESS FROM AND AGAINST ANY AND ALL SUITS, CLAIMS, ACTIONS, DEMANDS,
LIABILITIES, EXPENSES AND LOSSES, INCLUDING REASONABLE LEGAL EXPENSES AND
ATTORNEYS' FEES ("LOSSES") RESULTING DIRECTLY OR INDIRECTLY FROM THE
INDEMNIFYING PARTY'S ACTS OR OMISSIONS IN CONNECTION WITH THE MANUFACTURE,
DEVELOPMENT, USE, HANDLING, STORAGE, SALE OR OTHER DISPOSITION OF CHEMICAL
AGENTS, COLLABORATION COMPOUNDS, ACTIVE COMPOUNDS, DEVELOPMENT COMPOUNDS OR
PRODUCTS BY SUCH PARTY, ITS AFFILIATES OR LICENSEES except to the extent such
Losses result from the negligence (whether active, passive or imputed), breach
of this Agreement or willful misconduct of the Party claiming a right of
indemnification under this Article 13.
13.2 Infringement
(a) Subject to Section 13.2(c) below, ICOS shall
hold CombiChem and its officers, directors, employees, consultants, and agents
harmless from and against any and all losses resulting from the infringement of
any Third Party's Patent issued as of the Effective Date due to the performance
by ICOS or its Affiliates of any activity contemplated hereunder, including, but
not necessarily limited to, ICOS's responsibilities under Section 2.2 above,
developing Products, and selling Products.
(b) Subject to Section 13.2(c) below, CombiChem
shall hold ICOS and its officers, directors, employees, consultants, and agents
harmless from and against any and all losses resulting from the infringement of
any Third Party's Patent issued as of the Effective Date due to the performance
by CombiChem of any activity contemplated hereunder, including, but not
necessarily limited to, CombiChem's responsibilities under Section 2.1 above.
(c) The indemnity provided in Sections 13.2(a) and
13.2(b) above shall not apply where the loss is due to the breach by the
indemnified Party of a warranty made in Article 19.
13.3 Procedures. If either Party (the "Indemnified Party")
seeks indemnification under this Article 13, it shall inform the other Party
(the "Indemnifying Party") of a claim as soon as reasonably practicable after it
receives notice of the claim, shall permit the Indemnifying Party to assume
direction and control of the defense of the claim (including the right to settle
any claim
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21
brought against the Indemnified Party upon prior written consent, which shall
not be unreasonably withheld), and shall give reasonable cooperation (at the
expense of the Indemnifying Party) in the defense of such claim.
14. ASSIGNABILITY
This Agreement may not be assigned by either Party without the prior
written consent of the other Party, not to be unreasonably withheld; provided,
however, that either Party may assign this Agreement, in whole or in part, to an
Affiliate or to a successor of a Party in connection with the merger,
consolidation or sale of all or substantially all of such Party's assets or that
portion of its business pertaining to the subject matter of this Agreement (and
upon doing so will promptly notify the other Party in writing); provided that
the assigning Party remains fully liable as obligated hereunder.
15. DISPUTE RESOLUTION PROCEDURES
15.1 Senior Executives Discussions. If a decision on a matter
regarding the management of the Research Program as provided herein is not
reached by the RMC, the dispute will be resolved as set forth in Article 6
above. If a dispute arises between CombiChem and ICOS with respect to matters
other than the management of the Research Program, either during or after the
Research Period, such dispute will be referred to the appropriate senior
management in the area of the dispute. If such senior management are unable to
resolve such dispute, such dispute will be referred to the Chief Executive
Officer of ICOS and the Chief Executive Officer of CombiChem. If such officers
are unable to reach an agreement within thirty (30) days following the
initiation of discussions between them, such dispute shall be submitted to
mediation and if there is no settlement of the dispute within sixty (60) days
following the commencement of such mediation process, such dispute may, at the
Party's mutual written agreement, be settled by arbitration as described in
Section 15.2 below.
15.2 Binding Arbitration. If the Parties have not been able
to resolve the dispute as provided in Section 15.1 above and the Parties
mutually agree in writing, the dispute shall be finally settled by binding
arbitration. Any arbitration hereunder shall be conducted under rules of the
American Arbitration Association. The arbitration shall be conducted before
three arbitrators chosen according to the following procedure: each of the
parties shall appoint one arbitrator and the two so nominated shall choose the
third. If the arbitrators chosen by the parties cannot agree on the choice of
the third arbitrator within a period of thirty (30) days after their
appointment, then the third arbitrator shall be appointed by the Court of
Arbitration of the American Arbitration Association. If CombiChem brings an
arbitration action, such arbitration shall occur in Seattle, Washington. If ICOS
brings an arbitration action, such arbitration shall occur in San Diego,
California. The arbitrators shall have the authority to grant specific
performance, and to allocate between the parties the costs of arbitration in
such equitable manner as they determine. The arbitral award (i) shall be final
and binding upon the parties; and (ii) may be entered in any court of competent
jurisdiction.
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15.3 Injunctive and Other Relief. Nothing contained in this
Article 15 or any other provisions of this Agreement shall be construed to limit
or preclude a Party from bringing any action in any court of competent
jurisdiction for injunctive or other provisional relief to compel the other
Party to comply with its obligations hereunder before or during the pendency of
arbitration proceedings. In the event that the Parties do not mutually agree to
enter binding arbitration as provided in Section 15.2 hereof, the Parties may
pursue all available legal remedies.
16. NOTICES
Any notice required or permitted to be given hereunder shall be deemed
sufficient if sent by facsimile letter or overnight courier, or delivered by
hand to ICOS or CombiChem at the respective addresses and facsimile numbers as
set forth below or at such other address and facsimile number as either Party
hereto may designate. If sent by facsimile letter, notice shall be deemed given
when the transmission is completed if the sender has a confirmed transmission
report. If a confirmed transmission report does not exist, then the notice will
be deemed given when the notice is actually received by the person to whom it is
sent. If delivered by overnight courier, notice shall be deemed given when it
has been signed for. If delivered by hand, notice shall be deemed given when
received.
if to CombiChem, to:
CombiChem, Inc.
0000 Xxxxxx Xxxxx Xx
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: President
Fax number: (000) 000-0000
with a copy to:
Xxxxxxx, Xxxxxxx & Xxxxxxxx LLP
000 Xxxx X Xxxxxx, Xxxxx 0000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: Xxxx X. Xxxxxxx, Esq.
Fax number: (000) 000-0000
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23
if to ICOS to:
ICOS Corporation
00000 00xx Xxxxxx, X.X.
Xxxxxxx, Xxxxxxxxxx 00000
Attention: Legal Department
Fax number: (000) 000-0000
17. SURVIVAL
The provisions of Sections 2.4, 5.1, 5.2, 5.3, 10.5, 10.6 and Articles
4, 8, 9, 11, 12, 13, 15, and this Article 17 shall survive termination of this
Agreement in addition to those provisions which by their terms survive.
18. ADDITIONAL TERMS
18.1 Entire Agreement. This Agreement constitutes the entire
understanding between the Parties with respect to the subject matter hereto and
supersedes and replaces all previous negotiations, understandings,
representations, writings and contract provisions and rights relating hereof.
18.2 Amendment; No Waiver. No provision of this Agreement may
be amended, revoked or waived except by a writing signed and delivered by an
authorized officer of each Party. Any waiver on the part of either Party of any
breach or any fight or interest hereunder shall not imply the waiver of any
subsequent breach or waiver of any other right or interest.
18.3 Validity. The invalidity or unenforceability of any
provision of this Agreement shall not affect the validity or enforceability of
any other provision of this Agreement, each of which shall remain in full force
and effect.
18.4 Headings. The descriptive headings are inserted for
convenience of reference only and are not intended to be part of or to affect
the meaning of or interpretation of this Agreement.
18.5 Counterparts. This Agreement may be executed in one or
more counterparts, each of which shall be deemed an original, and all of which
together shall be deemed to be one and the same instrument.
18.6 Further Assurances. At any time and from time to time
after the Effective Date, the Parties shall each do, execute, acknowledge and
deliver, and cause to be done, executed, acknowledged or delivered, all such
further acts, transfers, conveyances, or assignments as may be reasonably
required to carry out the transactions contemplated by this Agreement.
19. REPRESENTATIONS AND WARRANTIES
19.1 Authorization. All action on the part of each of
CombiChem, ICOS and their respective officers, and directors necessary for the
authorization, execution and delivery of this
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24
Agreement and the performance of all obligations of CombiChem, ICOS and ICOS,
respectively, hereunder has been taken.
19.2 Rights to Intellectual Property. Each Party warrants
that it has the power to grant all of the rights granted and make such required
assignments, and to assume all of the obligations required, under this
Agreement. Under no circumstances does CombiChem warrant to ICOS that its rights
in any Active Compound, Development Compound or Products are exclusive to the
extent such Active Compound, Development Compound or Products may be covered
under the patent claims of Third Parties wherein such claims are not the direct
result of a collaboration between the Third Party and CombiChem.
[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]
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IN WITNESS WHEREOF, the parties have executed this Agreement to be
effective as of the Effective Date.
COMBICHEM, INC. ICOS CORPORATION
By: /s/ Illegible By: /s/ Illegible
---------------------------- --------------------------------
Its: Illegible Its: Illegible
--------------------------- -------------------------------
[SIGNATURE PAGE TO COLLABORATIVE
RESEARCH AND LICENSE AGREEMENT]
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26
Appendix A
Milestones and Payments(1)
(in U.S. Dollars)
Milestone Milestone Payment(2)
--------- --------------------
*** ***
Total ***
(1) Paid in U.S. Dollars
***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
Appendix A-1
27
Appendix B
Targets
-------
Initial Target: ***
Alternative Targets: ***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
Appendix B-1
