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EXHIBIT 10.22
COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
BETWEEN
COMBICHEM, INC.
AND
IMCLONE SYSTEMS INCORPORATED
OCTOBER 10, 1997
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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 October 10, 1997 (the
"Effective Date"), by and between COMBICHEM, INC., a Delaware corporation having
its principal offices at 0000 Xxxxxx Xxxxx Xx, Xxx Xxxxx, Xxxxxxxxxx
("CombiChem"), and IMCLONE SYSTEMS INCORPORATED, a Delaware corporation having
its principal offices located at 000 Xxxxxx Xxxxxx, 0xx Xxxxx, Xxx Xxxx, Xxx
Xxxx ("ImClone").
WHEREAS, CombiChem has developed and owns certain drug discovery
technology and intellectual property rights, including but not necessarily
limited to chemical library design software, multi-parallel synthesis and
purification methods, chemical libraries suitable for biological screening
assays and medicinal chemistry (collectively, "CombiChem Technology");
WHEREAS, ImClone desires to utilize CombiChem Technology for its
drug discovery activities under ImClone know-how concerning the identification
and characterization of novel small molecule inhibitors for development as
therapeutics for treatment of human disease in the area of oncology;
WHEREAS, the parties wish to collaborate in a Research Program
against Collaboration Target(s) ("Collaboration");
WHEREAS, for purposes of the Collaboration, the Parties intend to
focus on up to *** related to ImClone's Areas of Interest;
NOW, THEREFORE, the Parties agree as follows:
1. DEFINITIONS
1.1 "Abandoned Compound" shall have the meaning set forth in Section
3.1.
1.2 "Abandoned Target" shall have the meaning set forth in Section
3.1.
1.3 "Active Compound(s)" means a compound (or compounds) which
(a) (i) is selected by *** under the Research
Program from Collaboration Compounds, or
(ii) is derived from a Collaboration Compound; and
(b) shows In Vitro Activity.
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1.4 "Additional Target(s)" means a Target that is added to the
Collaboration in accordance with Section 4.2.
1.5 "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.
1.6 "Areas of Interest" shall include ***
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1.7 "Collaboration" has the meaning set forth in the preamble.
1.8 "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 CombiChem
Compound which CombiChem desires to designate as a Collaboration Compound, or
(iii) is a pre-existing ImClone Compound which ImClone desires to designate as a
Collaboration Compound.
1.9 "Collaboration Target(s)" means either an Initial Target or an
Additional Target.
1.10 "CombiChem Compound" means a chemical compound that is
proprietary to CombiChem, or whose use or manufacture is proprietary to
CombiChem.
1.11 "CombiChem Technology" has the meaning set forth in the
preamble.
1.12 "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;
(b) all information and materials developed in the course of
the Collaboration; and
(c) the material financial terms of this Agreement.
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1.13 "Development Compound(s)" means a compound ( or compounds)
which
(a) (i) is a Lead Compound or (ii) is derived from a Lead
Compound; and
(b) are determined by *** to be appropriate for preclinical
studies for the purpose of IND filing by ImClone.
1.14 "Due Diligence" means the use of the resources of ImClone or
its licensees or CombiChem in a manner which is consistent with the exercise of
prudent scientific and business judgment as applied to other programs of ImClone
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 ImClone
or its licensees to conduct all necessary preclinical studies and to file an IND
for such Development Compound within *** from the date upon which ImClone has
designated such Development Compound from any Lead Compound or its derivatives.
1.15 "Exclusivity Period" means the Research Period plus ***.
1.16 "Field" means all therapeutic indications of human disease for
the Collaboration Target.
1.17 "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 or licensee shall not constitute a First
Commercial Sale unless the Affiliate or licensee is the end user of the Product.
1.18 "FTE" means full time equivalent with respect to employees of
CombiChem.
1.19 "ImClone Compound" means a chemical compound that is
proprietary to ImClone, or whose use or manufacture is proprietary to ImClone.
1.20 "Inactive Compound(s)" means a Collaboration Compound(s) which
does not have the In Vitro Activity required for an Active Compound.
1.21 "In Vitro Activity" shall mean the observation of ***
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1.22 "Initial Target" shall have the meaning set forth in Section
4.1 hereof.
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1.23 "Lead Compound(s)" means a compound (or compounds) which
(a) is selected from an Active Compound(s) by *** under
the Research Program, or
(b) is derived from Active Compound(s) and is selected by
***
1.24 "Net Sales" means the gross sales invoiced by ImClone or its
Affiliates or licensees for Products to non-Affiliated Third Parties less actual
deductions of returns (including withdrawals and recalls), rebates (price
reductions, including Medicaid and similar types of rebates e.g. chargebacks),
volume (quantity) discounts, discounts granted at the time of invoicing, the
cost of transport, insurance, delivery, sales taxes and 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 currencies is converted into United States
dollars at the exchange rate of the last business day for each calendar month as
reported by Citibank, N.A. (New York).
1.25 "Patent" means, (a) valid and enforceable Letters Patent,
including any extension (including Supplemental Protection Certificate),
registration, confirmation, reissue, continuation, divisionals,
continuation-in-part, reexamination or renewal thereof, or (b) pending
applications for any of the foregoing.
1.26 "Payments" shall have the meaning set forth in Section 9.3
1.27 "Party" means CombiChem or ImClone, as the case may be,
including their respective Affiliates, permitted successors and assigns.
1.28 "Product(s)" means any product containing a Development
Compound with such compound as the active ingredient 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 the initial twenty-four (24) month term
of the Collaboration, which can be extended in accordance with Section 7.1
below.
1.32 "Research Plan" means the mutually-agreed research plan for the
Collaboration attached hereto as Appendix A.
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1.33 "Research Program" means the research to be conducted as part
of the Collaboration under the Research Plan, and shall include, without
limitation, the activities and items 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) ***
*** from the date of First Commercial Sale in such country; or (b) the
expiration of the last-to-expire Patent resulting from the Research Program
filed in the Field with claims covering that Product in the relevant country.
1.36 "Target" means a biomolecular entity that a small molecule is
screened against in order to determine whether the small molecule demonstrates
relevant activity.
1.37 "Territory" means the entire world.
1.38 "Third Party" means an entity other than CombiChem or ImClone
or their respective Affiliates.
1.39 "Universal Informer Library" shall mean CombiChem's proprietary
Universal Informer Library of compounds.
2. RESEARCH COLLABORATION
2.1 CombiChem Responsibilities. CombiChem shall with Due Diligence
conduct the following activities under the Research Program in accordance with
the terms of this Agreement and as more fully described in the Research Plan:
(a) During the Research Period, CombiChem shall (i) review
data and information regarding the Collaboration Targets
provided by ImClone; (ii) based on such data and
information and using the CombiChem Technology, design
informative compound libraries; and (iii) supply all
lead chemistries and synthesize compounds as provided in
Section 5.3 below.
(b) During the Research Period, CombiChem shall keep ImClone
informed of its activities performed in connection with
the Collaboration, including, without limitation,
providing ImClone with
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data and information regarding Collaboration Compounds
prior to the meetings of the Research Management
Committee.
(c) Subject to Article 4 and at all times during the
Research Period, CombiChem shall dedicate a project team
of *** comprised of synthetic and analytical chemists,
compound control scientists, and a computational
scientist (the "Project Team") to conduct all of its
activities in connection with the Collaboration;
provided, however, that the RMC may at any time during
the Research Period substitute employees for the FTEs
described above; provided, further, that ImClone may
request that CombiChem expand its Project Team by adding
additional FTEs to work on the Collaboration at the rate
and in the manner specified in Section 8.2(b).
2.2 ImClone Responsibilities. ImClone shall with Due Diligence
provide CombiChem with the following resources under the Research Program as
more fully described in the Research Plan:
(a) ImClone shall provide CombiChem with support and
assistance useful or necessary for the conduct of the
Research Program, including providing data and
information (including leads and/or screening hits to
the extent available) relating to Collaboration Targets,
certain chemistries useful in compound synthesis,
information concerning assay methods and screening data.
(b) During the Research Period, ImClone shall provide
CombiChem with data and information regarding
Collaboration Compounds and the Collaboration Target
assays developed by ImClone under the Research Program
prior to the meetings of the Research Management
Committee.
(c) During the Exclusivity Period and with Due Diligence,
ImClone shall screen Collaboration Compounds for In
Vitro and, where appropriate, in vivo activity against
the Collaboration Target.
(d) During the Exclusivity Period and with Due Diligence,
ImClone shall (i) screen Lead Compounds, (ii) endeavor
to determine Development Compounds, and (iii) develop
Products.
2.3 Research Plan. The Parties hereby agree that the Research
Program shall be carried out in accordance with the Research Plan which is
attached hereto as Appendix A.
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At the direction of the RMC, the Research Program shall involve the use of
CombiChem's Universal Informer Library in order to initiate CombiChem's
discovery process with the objective of identifying Lead Compounds with respect
to a specific Collaboration Target. The Research Management Committee shall
review the Research Plan on an ongoing basis and may make changes to the
Research Plan so long as such changes are mutually agreed to by CombiChem and
ImClone.
2.4 Annual Reports. Following the first IND filing through First
Commercial Sale, ImClone shall provide CombiChem with an annual report
summarizing ImClone's activities in developing Development Compounds.
2.5 Third Party Licenses. Each Party shall be solely responsible
for any Third Party license fees required to perform its obligations under this
Agreement subject to Section 8.4. Any agreements between a Party and a Third
Party shall in all material respects permit performance under this Agreement.
3. EXCLUSIVITY
3.1 Collaboration Target Exclusivity. So long as ImClone or its
licensee is proceeding with Due Diligence, CombiChem shall not work on a
Collaboration Target with any Third Parties. In the event that ImClone or its
licensee fails to exercise Due Diligence with respect to, or notifies CombiChem
that it has abandoned work on, any Collaboration Target (an "Abandoned Target")
and any Collaboration Compound, other than an ImClone Compound which
*** associated with such Collaboration Target (together with
all derivatives of such Collaboration Compound, an "Abandoned Compound"), then,
(a) such Abandoned Target shall not be subject to any provision hereunder, and
(b) such Abandoned Compound shall be available to CombiChem for any purpose
thereafter.
3.2 Active Compounds.
(a) Following the designation of any Collaboration Compound as
an Active Compound, such Active Compound shall be exclusively available to
ImClone during the Research Period. Following the expiration of the Research
Period, Active Compounds with respect to which ImClone fails to proceed with Due
Diligence 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 Patent shall continue to be treated as an Active Compound during the
Exclusivity Period so long as ImClone exercises Due Diligence with respect to
any Collaboration Compound.
(b) Prior to the existence of Patent(s) in accordance with
Section 5.2, ImClone shall have exclusive rights in all intellectual property
relating to Active Compounds, their use, and method of manufacture so long as
ImClone continues to show Due Diligence under this Agreement; provided, however,
that ImClone acknowledges and agrees that CombiChem
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reserves the right to assign or grant exclusive rights, including rights to
Active Compounds, to a third party collaborator who first identifies a novel
compound, a novel use of a compound, or a novel method of manufacturing a
compound, to the extent CombiChem is obligated to do so under its existing
contractual obligations. Upon notice by ImClone that it intends to file a Patent
application with respect to any Active Compound, Lead Compound, Development
Compound or Product, CombiChem shall promptly inform ImClone whether CombiChem
has the power to grant the exclusive rights in accordance with this Section 3.2
and the assignments in accordance with Section 5.2; provided, however, that
under no circumstances CombiChem will grant assurances to ImClone to the effect
that any Active Compound, Lead Compound, Development Compound or Product is not
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.
3.3 Inactive Compounds/Returned Compounds. Subject to Section 9.4,
Inactive Compounds and Returned Compounds shall be available to both Parties for
any purpose.
4. TARGETS
4.1 Initial Targets. During the Research Period, ImClone may
designate ***
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In addition, ImClone's right to designate or substitute a Target (including
those Additional Targets set forth in Section 4.2) relating to ImClone's Areas
of Interest shall be subject to the written notice and approval requirements
specified in Section 4.2(b).
4.2 Additional Targets.
(a) Within ninety (90) days prior to the commencement of the
second 12-month period of the Research Program, ImClone may add up to ***
relating to ImClone's Areas of Interest to the Collaboration by notifying
CombiChem in writing that it wishes to designate such Target(s) as Additional
Target(s); it being understood that the Project Team shall be obligated to
simultaneously work on no more than *** Collaboration Targets as directed by the
RMC.
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(b) ***
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*** Otherwise, the RMC shall establish the specific scientific achievements
(to be mutually agreed between CombiChem and ImClone) for such Target and the
same shall be designated as an Additional Target for the Collaboration and
subject to the terms (including the commercial terms) of this Agreement.
4.3 Expansion of Project Team. Notwithstanding the provisions of
Sections 4.1 and 4.2, ImClone may request that CombiChem expand its Project Team
during the Research Period in order to accelerate work on Collaboration Targets
and/or to add additional Target(s). In such event, the RMC shall promptly confer
as to the appropriate number of FTEs to be added to Project Team to work on the
Collaboration at a cost to ImClone as specified in Section 2.1(c).
5. COLLABORATION COMPOUNDS
5.1 Pre-Existing Compounds. ImClone shall have no rights to any
pre-existing CombiChem Compound unless and until such compound is designated as
a Collaboration Compound by CombiChem. Additionally, CombiChem may decline to
synthesize a particular compound or library of compounds by reason of existing
Patents or contractual obligations. CombiChem shall have no rights to any
pre-existing ImClone Compound which is not utilized in the Research Program.
5.2 Intellectual Property Rights; Assignment to ImClone. Subject to
Section 3.2(b) above, ImClone shall have the right and responsibility at
ImClone's expense to file, maintain and prosecute Patents relating to Active
Compounds, Lead Compounds, Development Compounds and Products, their use, and
their methods of manufacture. At ImClone's request, CombiChem shall assign all
its right, title and interest in such Patents to ImClone. If ImClone fails to so
file, maintain or prosecute such Patent, CombiChem shall have the right to
request ImClone to do so. If ImClone elects not to file, maintain or prosecute
such Patent, CombiChem shall have the right to take over such filing,
maintenance or prosecution of such Patent, at its sole expense, and ImClone
shall assign all intellectual property rights it may have in the Active
Compound, Lead Compound, Development Compound or Product to CombiChem.
5.3 Supply of Collaboration Compounds. Aliquots of *** of any
Collaboration Compound that has been synthesized will be prepared and given to
ImClone. CombiChem shall replenish that amount upon ImClone's reasonable
request. CombiChem shall maintain aliquots of any Collaboration Compound that
has been synthesized by CombiChem. CombiChem shall also provide ImClone with
additional requirements of samples at CombiChem's cost.
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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. The Research Management Committee may establish and
amend or revise the Research Plan as necessary to reflect the scientific
progress and work performed under the Research Program, such amendments to be
mutually agreed to by ImClone and CombiChem. The Research Management Committee
will consist of an equal number of members from ImClone and CombiChem and will
include appropriate representatives from ImClone and CombiChem as mutually
agreed. The co-chairs of the Research Management Committee will initially be the
Vice President, Chemistry of CombiChem and the Vice President for Research of
ImClone and subsequently may change as mutually-agreed upon by the Parties.
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 respective Chief Executive Officers of CombiChem and ImClone.
7. RESEARCH PERIOD; TERMINATION OF RESEARCH PROGRAM
7.1 Research Period: Option to Extend the Research Period. The
initial term of the Collaboration shall be the Research Period, subject to
extension upon mutual agreement. To extend the Research Period, ImClone 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.
(a) The Research Program may be terminated by a Party for the
material breach by the other Party of obligations under the Research Program by
giving the breaching party notice of the breach and of the intent of the
non-breaching Party to terminate the Research Program unless the breach is cured
within *** . The non-breaching Party may terminate the Research Program
following *** by providing the breaching party with *** prior written notice
that the Research Program is terminated, and the Research Program shall be
terminated on the *** following such date.
(b) Within thirty (30) days prior to the one (1) year
anniversary of this Agreement, ImClone and CombiChem senior and scientific
management personnel shall meet to review the status of the Collaboration. ***
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(c) CombiChem shall, within thirty (30) days following the
effective date of termination under Section 7.2(a) or 7.2(b), ***
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8. CONSIDERATION
8.1 Equity Purchase. Upon execution of this Agreement, ImClone shall
purchase 1,000,000 shares (on a pre-split basis and subject to adjustment) of
Common Stock of CombiChem at a per share purchase price equal to $2.00 per share
for an aggregate purchase price of U.S. $2 million, pursuant to the terms of
that certain Common Stock Purchase Agreement, dated as of the Effective Date, by
and between CombiChem and ImClone (together with all ancillary agreements
thereto, the "Stock Purchase Agreement"). ***
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8.2 Program Funding.
(a) ImClone shall support CombiChem's efforts in conducting
the Research Program by making a payment upon the execution of this Agreement in
the sum of U.S.
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(b) In the event that the Project Team is expanded in
accordance with Section 4.3, ImClone shall make payments, in cash, to CombiChem,
at a per annum rate of U.S.
*** payable quarterly in advance of the work to be
performed by such FTE(s).
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8.3 Milestone Payments. Within thirty (30) days of the occurrence of
a development milestone triggered by the activities of ImClone as shown on
Appendix B, ImClone shall pay CombiChem the related milestone payment in U.S.
dollars as set forth on Appendix B. Alternatively, in the event that ImClone
shall outlicense the Patents covering any Product, CombiChem shall be entitled
to the payments set forth in Section 9.3 in lieu of any payments pursuant to
this Section 8.3.
8.4 Royalties.
(a) Direct Sales by ImClone
(i) Subject to Section 8.4(c), during the Royalty
Term, ImClone will pay CombiChem a running royalty of *** sold by ImClone or its
Affiliates in all countries in the Territory. 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.
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(b) Sales by ImClone's Licensees
In the event that ImClone outlicenses Active Compounds,
Lead Compounds, Development Compounds and resulting Products are sold by
ImClone's licensees in any country in the Territory, ImClone's royalty payable
to CombiChem shall be as follows:
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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
thirty (30) 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 five (5) years thereafter, ImClone 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 ImClone to audit such records to
confirm ImClone's Net Sales for the preceding year. Any information obtained
during such audit shall be treated as Confidential Information. Such audits may
be exercised during normal business hours of ImClone no more than once each
year. CombiChem shall bear the full cost of such audit unless such audit
discloses a variance of more than five percent (5%) in ImClone's favor from the
amount of the Net Sales reported by ImClone for such audited period.
In such case, ImClone shall bear the fill 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 ImClone 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 in claiming exemption
from such deductions or withholdings under any double taxation or similar
agreement or treaty from time to tune in force.
9. LICENSE GRANTS; OUTLICENSE
9.1 CombiChem License Grant to ImClone. Subject to the terms and
conditions of this Agreement, CombiChem hereby grants to ImClone an exclusive
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
and import Collaboration Compounds or Products in the Territory. Such license
shall remain exclusive in relation to each Collaboration Compound and/or Product
so long as ImClone or its licensee continues to develop and commercialize such
Collaboration Compound and/or Product containing such Collaboration Compound
against a Collaboration Target with Due Diligence.
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9.2 ImClone License Grant to CombiChem. Subject to the terms and
conditions of this Agreement and following the failure of ImClone or its
licensee to develop and commercialize with Due Diligence a Lead Compound, a
Development Compound or Product, as the case may be, (collectively, and together
with all Abandoned Compounds, "Returned Compound"), ImClone shall grant to
CombiChem an exclusive license (exclusive even as to ImClone and its
Affiliates), with the right to sublicense, under those ImClone 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 and import such
Returned Compound in the Territory.
9.3 ImClone Outlicense. ImClone shall have a right to outlicense the
Patents covering the Product to a Third Party subject to CombiChem's right to
receive ***
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In addition, CombiChem shall have the right to receive all audit reports
relating to sales of Products of ImClone's licensees, and to cause ImClone or
its successor to have an independent certified public accounting firm audit such
licensees records on the same terms as those specified in Section 8.6. All
payments shall be made by wire transfer to such bank account designated by
CombiChem. Failure of such licensee to make any milestone or royalty payment in
respect of such Product shall not relieve ImClone of its obligations to make
royalty and milestone payments to CombiChem hereunder.
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9.4 Rights to Inactive Compounds/Returned Compounds. No provision of
this Agreement shall prevent either Party from making, having made, using,
having used, selling, having sold, or importing Inactive Compounds, products
containing Inactive Compounds, Returned Compounds or products containing
Returned Compounds or screening Inactive Compounds and Returned Compounds
against any target other than the Collaboration Targets.
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9.5 Miscellaneous License. In addition to any other rights granted
by either Party in accordance with this Article 9, each Party grants to the
other party a non-exclusive license without the right to grant sublicenses,
under any intellectual property rights the granting Party has the power to grant
in order for the other Party to carry out its rights and obligations under this
Agreement including, but not necessarily limited to, conducting the Research
Program and manufacturing, developing, selling and importing Products.
10. TERM AND TERMINATION
10.1 Term. The term of this Agreement shall commence upon the
Effective Date of this Agreement, and shall expire on the expiration of the last
royalty obligation under this Agreement, except as provided hereunder.
10.2 Termination by ImClone or CombiChem. Subject to Section 7.2, if
either Party materially breaches this Agreement and fails to remedy that breach
within *** of receiving written notice thereof from the other Party, or enters
into any arrangement of composition with its creditors or goes into liquidation,
insolvency, bankruptcy, receivership or reorganization proceedings, whether
voluntarily or compulsorily which is not dismissed within
*** then the other Party may at any time, by notice in writing or
by telefax, terminate this Agreement.
10.3 After Termination.
(a) Upon any termination of the Research Program under Section
7.2(a) due to a material breach of this Agreement by ImClone, ImClone's rights
pursuant to Sections 3.1, 3.2, 5.3, 9.1, 9.3 and 9.5 shall immediately cease,
and all rights granted hereunder with respect to Targets and Collaboration
Compounds, Active Compounds, Lead Compounds, Development Compounds, or Products
shall immediately revert to CombiChem without further obligation to ImClone.
ImClone's rights pursuant to Section 5.2 and 9.3 above that accrue prior
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to such termination shall be retained by ImClone. ImClone may make, use, sell
and import Active Compounds, Lead Compounds, Development Compounds or Products
under rights retained by ImClone pursuant to this Section 10.3(a) so long as
ImClone continues to satisfy all of its royalty, milestone, and Payment
obligations in accordance with Sections 8.3, 8.4, 9.3 and 9.4.
(b) Upon any termination of the Research Program under Section
7.2(a) due to a material breach of this Agreement by CombiChem with respect to a
Collaboration Compound, Active Compound, Lead Compound, Development Compound or
Product, all of ImClone's rights pursuant to Sections 3.1, 3.2, 5.2, 5.3, 9.1,
9.3 and 9.5 shall be retained by ImClone. ImClone may make, use, sell or import
Active Compounds, Lead Compounds, Development Compounds and Products with
respect to which ImClone is not in material breach under rights retained by
ImClone pursuant to this Section 10.3(b) so long as ImClone continues to satisfy
all of its royalty, milestone, and Payment obligations in accordance with
Sections 8.3, 8.4, 9.3 and 9.4, except that ImClone shall not be required to
satisfy such obligations with respect to any Collaboration Compound, Active
Compound, Lead Compound, Development Compound or Product with respect to which
CombiChem is in material breach.
(c) If ImClone materially breaches this Agreement following
the Research Period with respect to an Active Compound, Lead Compound,
Development Compound or Product for any reason including, but not limited to,
failing to satisfy its royalty, milestone and Payment obligations pursuant to
Sections 8.3, 8.4, 9.3 and 9.4, ImClone shall not make, use, sell or import
Active Compounds, Lead Compounds, Development Compounds or Products with respect
to which ImClone is in material breach. ImClone shall retain the right to make,
use, sell and import Active Compounds, Lead Compounds, Development Compounds or
Products with respect to which ImClone is not in material breach so long as
ImClone continues to satisfy all of its royalty, milestone, and Payment
obligations in accordance with Sections 8.3, 8.4, 9.3 and 9.4.
(d) If CombiChem materially breaches this Agreement following
the Research Period for any reason including, but not limited to, failing to
satisfy its confidentiality and warranty obligations under Articles 11 and 19,
ImClone shall have the right to make, use, sell or import Active Compounds, Lead
Compounds, Development Compounds and Products with respect to which ImClone is
not in material breach so long as ImClone continues to satisfy all of its
royalty, milestone, and Payment obligations in accordance with Sections 8.3,
8.4, 9.3 and 9.4.
(e) Upon any expiration or earlier termination of this
Agreement for any reason, ImClone shall not be entitled to any refund of any
payments made to CombiChem hereunder except as provided in Section 7.2(c).
10.4 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 ImClone or CombiChem, or by any breach by such licensee
of its obligations under its licensee from ImClone 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.
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11. CONFIDENTIAL INFORMATION
11.1 Nondisclosure. During the term of the Collaboration and for a
period of five (5) years after termination thereof, each Party will maintain all
Confidential Information in trust and confidence and will not disclose any
Confidential Information to any third party for any purpose except (i) as
expressly authorized by this Agreement, or (ii) as required by law or court
order, or (iii) to its consultants, subcontractors or agents who need to know to
accomplish the purposes of this Agreement. Each Party may use such 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. Confidential Information is
understood to include, but not necessarily to be limited to, the structures of
chemical compounds and the identification of chemical compounds as Collaboration
Compounds, Active Compounds, Inactive Compounds, Lead Compounds, Development
Compounds, or Products.
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 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; (e) is the subject of a written permission to disclose provided by
the disclosing Party; or (f) is necessary to obtain regulatory approval for a
Product, or patent protection with respect to Active Compounds, Lead Compounds,
Development Compounds, or Products, and the uses and methods of manufacturing
thereof.
12. PUBLICATIONS AND PUBLIC STATEMENTS
12.1 Publications. Each Party shall be permitted to publish any
information, except Confidential Information, relating to the Research Program
as long as the Party has the prior written permission of the other Party. Such
permission shall be approved or disapproved within twenty-one (21) days of
written request for permission. Such permission shall not be unreasonably
withheld.
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") 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, 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
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disclosure is required to comply with applicable law.
13. ***
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14. ASSIGNABILITY
This Agreement may not be assigned by either Party without the prior
written consent of the other Party; 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.
15. DISPUTE RESOLUTION PROCEDURES
15.1 Senior Executives Discussions. If a decision 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 ImClone 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 Officers of
CombiChem and ImClone. If such officers are unable to reach an agreement within
thirty (30) days following the initiation of discussions between them, such
dispute shall 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, 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 ***
If the Parties cannot agree on the choice of the arbitrator within a period of
thirty (30) days after submission, then the arbitrator shall be appointed by the
Court of Arbitration of the American Arbitration Association. Any such
arbitration shall be held in a mutually agreeable location; provided, however
that if the parties cannot so agree, the location(s) for such arbitration(s)
shall alternate between San Diego, California and New York, New York, with the
first such arbitration to be located 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 he or she may
determine. The arbitral award (i) shall be final and binding upon the parties;
and (ii) may be entered in any court of competent jurisdiction.
15.3 Injunctive 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.
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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 ImClone 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 Xxxxx Xxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxxxxx, Xxxxxxxxxx 00000
Attention: Xxxxxx X. Xxxxx, Esq.
Fax number: (000) 000-0000
if to ImClone, to: ImClone Systems Incorporated
000 Xxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attn: Vice President, Business Development
Fax number: (000) 000-0000
with a copy to: Xxxxxxxx and Xxxxx
000 Xxxxxxx Xxxxxxxx
Xxxxxxx, Xxx Xxxx 00000
Attn: Xxxxxx X. Xxxx, Esq.
Fax number: (000) 000-0000
17. SURVIVAL
The provisions of Sections 2.5, 5.1, 5.2, 7.2(c),10.3, 10.4, and
Articles 1, 3, 8, 9, 11, 12, 13, 14, 15, 16, 18 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 and the Common Stock Purchase
Agreement constitute 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. The Parties agree that
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all services provided hereunder shall be subject to and governed by the terms
and provisions set forth herein, and none of the terms and conditions contained
on any proposal, purchase order, invoice or other writing shall have any effect
or change the provisions of this Agreement.
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, 9each of which shall remain in full force and
effect. In addition, should the invalidity or unenforceability of any provision
of this Agreement cause an unintended result or result in any unfairness to
either Party, then ImClone and CombiChem shall promptly meet and negotiate in
good faith to modify or amend this Agreement to change such result or to
eliminate such unfairness.
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 Governing Law. This Agreement shall be governed by and
construed and enforced in accordance with the laws of the State of California,
without regard to conflicts of laws principles.
19. WARRANTY
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. If, at the time a Patent application is to be
filed by ImClone with respect to any Active Compound, Lead Compound, Development
Compound or Products, CombiChem informs ImClone that CombiChem has the power to
grant the exclusive rights to such Active Compound, Lead Compound, Development
Compound or Products, and to assign such Patents related thereto, to ImClone in
accordance with Sections 3.2 and 5.2 above, CombiChem further warrants that, in
fact, as of such date, it has such power subject to the proviso that under no
circumstances does CombiChem warrant to ImClone that its rights in any Active
Compound, Lead Compound, Development Compound or Products are exclusive to the
extent such Active Compound, Lead 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.
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IN WITNESS WHEREOF, the parties have executed this Agreement to be
effective as of the Effective Date.
COMBICHEM, INC. IMCLONE SYSTEMS INCORPORATED
By: /s/ Xxxxxxx Xxxxx By:/s/ illegible
-------------------------------- -------------------------------------
Its: President and CEO Its:CFO
------------------------------- ------------------------------------
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Appendix A
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