Exhibit 10.38
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[ * ] =
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Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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COLLABORATION
AGREEMENT
T HIS C OLLABORATION A GREEMENT (the “ Agreement ”) is made
and entered into as of December 15, 2006 (the “
Execution Date ”) by and between E
XELIXIS , I NC ., a
Delaware corporation having its principal place of business at 170
Harbor Way, P.O. Box 511, South San Francisco, California
94083-0511 (“ Exelixis ”), and B
RISTOL -M YERS S QUIBB C OMPANY , a
Delaware corporation headquartered at 345 Park Avenue, New York,
New York, 10154 (“ BMS ”). Exelixis and BMS are
sometimes referred to herein individually as a “ Party
” and collectively as the “ Parties
”.
R ECITALS
A. BMS is a multinational health care company that
has expertise and capability in researching, developing and
marketing human pharmaceuticals.
B. Exelixis is a drug discovery company that has
expertise and proprietary technology relating to therapeutics that
modulate signal transduction pathways involved in oncology and
other disease areas.
C. BMS and Exelixis desire to establish a
collaboration to apply such Exelixis technology and expertise to
the discovery, lead optimization and characterization of small
molecule compounds that directly bind and modulate certain targets,
with a goal of filing an Investigational New Drug applications for
small molecule compounds in [ * ] , and to provide for the
development and commercialization of novel therapeutic and
prophylactic products based on such compounds.
N OW ,
T HEREFORE
, the Parties agree as follows:
Capitalized terms used in this
Agreement (other than the headings of the Sections or Articles)
have the following meanings set forth in this Article 1 ,
or, if not listed in this Article 1 , the meanings as
designated in the text of this Agreement.
1.1
“Affiliate” means, with respect to a particular Party, a
person, corporation, partnership, or other entity that controls, is
controlled by or is under common control with such Party. For the
purposes of the definition in this Section 1.1 , the
word “ control ” (including, with correlative
meaning, the terms “ controlled by ” or “
under the common control with ”) means the actual
power, either directly or indirectly through one (1) or more
intermediaries, to direct or cause the direction of the management
and policies of such entity, whether by the ownership of at least
fifty percent (50%) of the voting stock of such entity, or by
contract or otherwise.
1.2 “Allowable
Expenses” means
those expenses that are specifically attributable to a Co-Promotion
Product in the U.S. and that consist of: [ * ] .
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confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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1.3 “ANDA”
means an Abbreviated New Drug
Application submitted to the FDA in conformance with applicable
laws and regulations, or the foreign equivalent of any such
application in any other country.
1.4 “Appealable
Matter” means any
dispute between the Parties (or their respective designees or
Committees) concerning: (a) whether the [ * ] have or
may [ * ] have [ * ] the [ * ] of any [ *
] ; (b) [ * ] have or may [ * ] have a [
* ] the [ * ] of any [ * ] . For clarity, any
dispute regarding whether [ * ] shall be an Appealable
Matter.
1.5 “Approved
Plan” means, with
respect to a Product, any one or more of the Global Development
Plans, each Annual Development Plan, the Global Commercialization
Strategy, and the U.S. Commercialization Plan, in each case as
adopted or approved under the terms of this Agreement.
1.6 “BMS [ * ]” or
“[ * ]” means
[ * ] which the [ * ] (or a successor thereto) (
“[ * ]” ) [ * ] , including [ * ]
(typically, [ * ] ) and [ * ] to that effort. At [
* ] , the following have been established: (a) one or more
[ * ] (through BMS [ * ] ); (b) [ * ] to
BMS; (c) [ * ] at [ * ] ; (d) [ *
] ; (e) assay [ * ] for the [ * ] assays;
(f) assays for [ * ] ; and (g) [ * ]
assays.
1.7 “BMS [ * ]” or
“[ * ]” means
[ * ] which [ * ] for a compound that has [ *
] and a [ * ] made to [ * ] . For clarity, [ *
] .
1.8 “BMS [ * ]” or
“[ * ]” means
[ * ] which [ * ] one or more compounds [ * ]
to [ * ] . [ * ] , the [ * ] for [ * ]
information needed [ * ] . [ * ] is [ * ] .
This [ * ] is typically made about [ * ] prior to
[ * ] . At [ * ] there will be evidence of [ *
] , [ * ] , which will include [ * ] . There will
be [ * ] , and [ * ] . Not all [ * ] testing (
[ * ] ) will be [ * ] at [ * ] , but [ *
] be [ * ] reached. The [ * ] will be [ *
] .
1.9 “BMS [ * ]” or
“[ * ]” means
[ * ] which the BMS [ * ] based [ * ] . An
[ * ] follows [ * ] . BMS [ * ] once it
contains [ * ] .
1.10 “BMS Licensed
Know-How” means all
Information (other than Patents) Controlled by BMS and its
Affiliates, including Information Controlled jointly with Exelixis,
as of the Effective Date and during the term of the Agreement that:
(a) covers a Collaboration Compound, a composition containing
a Collaboration Compound (e.g., a formulation containing a
Collaboration Compound), or the manufacture or use of a
Collaboration Compound; and (b) is [ * ] for Exelixis
to exercise the rights licensed to it under the Agreement or to
perform its obligations to the Collaboration under the
Agreement.
1.11 “BMS Licensed
Patents” means all
Patents Controlled by BMS and its Affiliates, including Patents
Controlled jointly with Exelixis, as of the Effective Date and
during the term of this Agreement that: (a) cover a
Collaboration Compound, a composition containing a Collaboration
Compound (e.g., a formulation containing a Collaboration Compound),
or the manufacture or use of a Collaboration Compound; and
(b) are [ * ] for Exelixis to exercise the rights
licensed to it under the Agreement or to perform its obligations to
the Collaboration under the Agreement.
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brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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1.12 “Change of
Control” means any
transaction in which a Party: (a) sells, conveys or otherwise
disposes of all or substantially all of its property or business;
or (b)(i) merges, consolidates with, or is acquired by any other
Person (other than a wholly-owned subsidiary of such Party); or
(ii) effects any other transaction or series of transactions;
in each case of clause (i) or (ii), such that the stockholders
of such Party immediately prior thereto, in the aggregate, no
longer own, directly or indirectly, beneficially or legally, at
least fifty percent (50%) of the outstanding voting securities
or capital stock of the surviving Person following the closing of
such merger, consolidation, other transaction or series of
transactions. As used in this Section 1.12 , “
Person ” means any corporation, firm, partnership or
other legal entity.
1.13 “Clinical
Costs” means the
costs incurred by a Party or for its account, during the term and
pursuant to this Agreement, in connection with clinical studies of
a Co-Developed Product in the Co-Development Territory, including
the following: (a) the preparation for and conduct of clinical
trials (except for related Manufacturing Costs otherwise included
in Development Costs); (b) data collection and analysis, and
report writing; and (c) clinical laboratory work. The Clinical
Costs shall exclude costs incurred in connection with [ * ]
.
1.14 “Co-Developed
Product” shall mean
a Product for which: (a) Exelixis has exercised an Exelixis
Co-Development Option; and (b) Exelixis has not opted-out
pursuant to Section 4.7(a) .
1.15 “Co-Development
Territory” shall
mean [ * ] .
1.16
“Collaboration” means the collaborative research, development,
and commercialization program between the Parties that is
contemplated by this Agreement.
1.17 “Collaboration
Compounds” means
the Lead Compound and Program Backups in each Lead Op Program,
Provisional Collaboration Program or Collaboration
Program.
1.18
“Commercialize” means to promote, market, distribute, sell (and
offer for sale or contract to sell) or provide product support for
a Product, including by way of example: (a) detailing and
other promotional activities in support of a Product;
(b) advertising and public relations in support of a Product,
including market research, development and distribution of selling,
advertising and promotional materials, field literature,
direct-to-consumer advertising campaigns, media/journal
advertising, and exhibiting at seminars and conventions;
(c) developing reimbursement programs and information and data
specifically intended for national accounts, managed care
organizations, governmental agencies (e.g., federal, state and
local), and other group purchasing organizations, including
pull-through activities; (d) co-promotion activities not
included in the above; (e) conducting medical education
activities and journal advertising; and (f) [ * ] .
For clarity, “Commercializing” and
“Commercialization” have a correlative
meaning.
1.19
“Committee” means the JEC, JRC, JDC, JCC, or JFC, as the
case may be.
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brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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1.20 “Committee-Governed
Product” means:
(a) any Co-Promotion Product; (b) any Co-Developed
Product; and (c) any Product with respect to which Exelixis
exercised its Product-Opt-Out option pursuant to
Section 4.7(a) [ * ] .
1.21 “ Completed Screening Program
” means a Screening Program for which there exists a lead
molecule that has completed the following activities (as applicable
to such lead molecule): (a) [ * ] ; (b) [ *
] ; (c) [ * ] ; (d) completion of [ *
] ; (e) completion of [ * ] ; (f) [ *
] .
1.22
“Controlled” means, with respect to any compound, material,
Information or intellectual property right, that the Party owns or
has a license to such compound, material, Information or
intellectual property right and has the ability to grant to the
other Party access, a license or a sublicense (as applicable) to
such compound, material, Information or intellectual property right
as provided for herein without violating the terms of any agreement
or other arrangements with any Third Party existing at the time
such Party would be first required hereunder to grant the other
Party such access, license or sublicense.
1.23 “Co-Promotion
Product” means a
Product for which Exelixis has exercised its option to Co-Promote
in the U.S. as set forth in Section 6.4 .
1.24 “Core
Program” shall
mean, with respect to a Product, [ * ] for which any [ *
] or any [ * ] first [ * ] with respect to such
Product.
1.25
“Development” means, with respect to a Product, those
activities, including research, pre-clinical development
activities, clinical trials, supporting manufacturing activities
and related regulatory activities, that are [ * ] to:
(a) obtain the approval by the applicable Regulatory
Authorities of the Drug Approval Application with respect to such
Product in the applicable regulatory jurisdiction, whether alone or
for use together, or in combination, with another active agent or
pharmaceutical product; (b) maintain such approvals; or
(c) obtain or maintain compendia listings with respect to such
Product. For clarity, “ Co-Develop ”,
“Develop” and “Developing”
have a correlative meaning.
1.26 “Development
Candidate” means a
[ * ] that has met Exelixis’ internal developability
criteria, which criteria are consistent with Exelixis’
internal developability criteria for all Exelixis programs
(including programs outside of the Collaboration), and that has
been approved by Exelixis to transition from [ * ] to [ *
] .
1.27 “Development
Costs” means the
costs incurred by a Party or for its account, during the term and
pursuant to this Agreement, that are specifically identifiable (or
reasonably allocable) to the Development of a Co-Developed Product
in the Co-Development Territory and that are directed to achieving
or maintaining Regulatory Approval of such Co-Developed Product in
the Co-Development Territory. The Development Costs shall include
amounts that a Party pays to Third Parties involved in the
Development of a Co-Developed Product ( [ * ] ), and all
internal costs incurred by a Party in connection with the
Development of such Co-Developed Product. Development Costs include
the following: (a) preclinical costs such as toxicology and
formulation development, test method development, delivery system
development, stability testing and statistical analysis;
(b) Clinical Costs; (c) expenses related to adverse event
reporting;
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and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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(d) Manufacturing Costs for a Co-Developed
Product for use in preclinical and clinical activities including
the manufacture, purchase or packaging of comparators or placebo
for use in Clinical Trials (with the manufacturing costs for
comparators or placebo to be determined in the same manner as
Manufacturing Costs are determined for any Product), as well as the
direct costs and expenses of disposal of drugs and other supplies
used in such Clinical Trials and any associated release testing and
QA/QC development costs; (e) [ * ] incurred in
connection with [ * ] , to the extent provided therein; and
(f) development of the Manufacturing process for a
Co-Developed Product (including with respect to any excipients or
any active pharmaceutical ingredient included in such Co-Developed
Products) and related scale-up, manufacturing process validation,
manufacturing process improvements, and qualification and
validation of Third Party contract manufacturers;
(g) regulatory expenses relating to Development activities for
the purpose of obtaining Regulatory Approval for an indication for
a Co-Developed Product; (h) costs of real property rented
specifically for Development activities (to the extent actually
used); and (i) other out-of pocket development expenses
including, without limitation institutional and advisory review
boards, investigator meetings, quality of life studies,
epidemiology and outcomes research.
1.28 “Diligent
Efforts” means the
carrying out of obligations or tasks in a sustained manner
consistent with the efforts a Party devotes to a product or a
research, development or marketing project of similar market
potential, profit potential or strategic value resulting from its
own research efforts, based on conditions then prevailing. Diligent
Efforts requires that the Party: (a) [ * ] , (b)
[ * ] , and (c) [ * ] with respect to such [
* ] .
1.29 “Distribution
Costs” means the
costs, [ * ] , incurred by a Party or for its account,
during the term and pursuant to the Agreement that are reasonably
allocable (as determined by the JFC) to the distribution of a
Co-Promotion Product in the U.S., including: (a) handling and
transportation to fulfill orders (excluding such costs to the
extent they are treated as a deduction in the definition of Net
Sales); (b) customer services, including order entry, billing
and adjustments, inquiry and credit and collection; and
(c) direct costs of storage and distribution of Co-Promotion
Products.
1.30
“Dollars” or
“$” means the legal tender of the United
States.
1.31 “Drug Approval
Application” or
“ DAA ” means: (a) in the United States, an
NDA (or a supplemental NDA for following indications), and
(b) in any other country or regulatory jurisdiction, an
equivalent application for regulatory approval required before
commercial sale or use of a Product (or with respect to a
subsequent indication) in such country or regulatory
jurisdiction.
1.32 “ECN”
or “Early Candidate
Nomination” means a compound or other substance that has
been approved [ * ] to transition from [ * ] in a
[ * ] to [ * ] .
1.33
“EMEA” means
[ * ] commercial territory, consisting of the following
countries and regions: [ * ] . The EMEA also includes:
(a) [ * ] ; and (b) exports from [ * ] not
separately identified in the list. For clarity, the specific list
of countries and regions may change to align with any corresponding
[ * ] .
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brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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1.34 “EU”
means the European Union, as its
membership may be altered from time to time, and any successor
thereto. The member countries of the European Union as of the
Execution Date are Belgium, Denmark, Germany, Greece, Spain,
France, Ireland, Italy, Luxembourg, The Netherlands, Austria,
Portugal, Finland, Sweden, the United Kingdom, Estonia, Latvia,
Lithuania, Poland, Czech Republic, Slovakia, Hungary, Slovenia,
Malta, and Cyprus.
1.35 “Executive
Officers” means:
(a) in the case of Exelixis, the President and Chief Executive
Officer of Exelixis; and (b) in the case of BMS, either
(i) a direct report of the BMS CSO (for disputes involving
development matters) or (ii) the Head of U.S. Operations (for
disputes involving commercial matters).
1.36 “Exelixis Licensed
Know-How ” means all Information (other than Patents)
Controlled by Exelixis and its Affiliates, including Information
Controlled jointly with BMS, as of the Effective Date and during
the term of this Agreement that: (a) covers a Collaboration
Compound, a composition containing a Collaboration Compound (e.g.,
a formulation containing a Collaboration Compound), or the
manufacture or use of a Collaboration Compound; and (b) is
[ * ] for BMS to exercise the rights licensed to it under
the Agreement or to perform its obligations to the Collaboration
under the Agreement.
1.37 “Exelixis Licensed
Patents” means all
Patents controlled by Exelixis and its Affiliates, including
patents controlled jointly with BMS, as of the Effective Date and
during the term of this Agreement that: (a) cover a
Collaboration Compound, a composition containing a Collaboration
Compound (e.g., a formulation containing a Collaboration Compound),
or the manufacture or use of a Collaboration Compound; and
(b) are [ * ] for BMS to exercise the rights licensed
to it under the Agreement or to perform its obligations to the
Collaboration under the Agreement.
1.38 “FDA”
means the U.S. Food and Drug
Administration, and any successor thereto.
1.39 “FTE”
means the equivalent of the work of
one (1) employee full time for one (1) year consisting of
a total of [ * ] hours per year (or such other number as may
be agreed to by the JFC) directly related to the Development or
Commercialization of any Co-Developed Product or Co-Promotion
Product, as the case may be, or any other activities contemplated
under this Agreement. Any individual who devotes less than
[ * ] hours per year (or such other number as may be agreed
by the JFC) shall be treated as an FTE on a pro-rata basis upon the
actual number of hours worked divided by [ * ] (or such
other number as may be agreed by the JFC). Unless modified by
the JFC, the [ * ] figure shall be used without regard to
the Parties’ own internal definition of the number of hours
that comprises an FTE.
1.40
“GAAP” means
U.S. generally accepted accounting principles, consistently
applied.
1.41 “[ *
]” means, with
respect to a particular Product in a country, [ * ] such
Product ( [ * ] ); and (b) is [ * ] or
otherwise), whether [ * ] or [ * ] .
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brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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1.42 “HSR
Act” means the U.S.
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended
from time to time, and the rules, regulations, guidance and
requirements promulgated thereunder as may be in effect from time
to time.
1.43 “Identified
Target(s)” means
the set of one or more Lead Op Targets or Collaboration Targets (as
applicable) that the JRC, the JDC or the Parties (as the case may
be) reasonably believes [ * ] in such Lead Op Program,
Provisional Collaboration Program or Collaboration
Program.
1.44 “IND”
means an Investigational New Drug
Application submitted to the FDA in conformance with applicable
laws and regulations, or the foreign equivalent of any such
application in any other country.
1.45
“Information” means information, results and data of any type
whatsoever, in any tangible or intangible form whatsoever,
including, databases, practices, methods, techniques,
specifications, formulations, formulae, knowledge, know-how, skill,
experience, test data including pharmacological, biological,
chemical, biochemical, toxicological and clinical test data,
analytical and quality control data, stability data, studies and
procedures. For clarity, Information does not include any
Patents.
1.46 “Initial Lead Op
Programs” means the
[ * ] programs conducted by Exelixis on the initial Lead Op
Targets selected by the Parties pursuant to
Section 3.3(a) .
1.47
“Invention” means any and all inventions and improvements
thereto, invented or discovered by or on behalf of a Party (and/or
its Affiliates) in the performance of its obligations under this
Agreement.
1.48 “Joint
Invention” means
any Invention invented or discovered jointly by or on behalf of the
employee(s), contractor(s) or agent(s) of both Parties (and/or
their Affiliates).
1.49 “Joint
Commercialization Committee” or “JCC” means the committee
described in Section 2.4 .
1.50 “Joint Development and
Regulatory Committee” or “JDC” means the committee
described in Section 2.3 .
1.51 “Joint Executive
Committee” or
“JEC” means the committee described in
Section 2.2 .
1.52 “Joint Finance
Committee” or
“JFC” means the committee described in
Section 2.6 .
1.53 “Joint Research
Committee” or
“JRC” means the committee described in
Section 2.5 .
1.54
“Knowledge” means, with respect of a Party, the good faith
[ * ] facts and information in the possession of an [ *
] of such Party, or any [ * ] of, or [ * ] , such
Party or its Affiliates, [ * ] execution of this Agreement.
For purposes of this definition, an “[ * ]”
means any person in the [ * ] of a Party.
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brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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1.55
“Launch” means, for each Product in each country, the
first arm’s-length sale to a Third Party for use or
consumption by the public of such Product in such country after
Regulatory Approval of such Product in such country. A Launch shall
not include any Product sold for use in clinical trials, for
research or for other non-commercial uses, or that is supplied as
part of a compassionate use or similar program .
1.56 “Lead
Compound” means,
with respect to a Provisional Collaboration Program or
Collaboration Program: (a) the Program Lead for such
Provisional Collaboration Program or Collaboration Program; and
(b) any [ * ] compound described in subsection
(a).
1.57 “Lead Op
Program” has the
meaning described in Section 3.3 . The Lead Op Programs
include: (a) Initial Lead Op Programs; and (b) any [ *
] programs that were [ * ] and that were [ * ]
programs pursuant to Section 3.3(c) .
1.58 “Lead Op
Target(s)” means:
(a) the initial list of targets identified by the Parties
pursuant to Section 3.3(a) ; and (b) any
additional target(s) identified by the Parties pursuant to
Sections 3.2(b) or 3.3(a) . The Lead Op Targets shall
be listed in Exhibit 3.3 , which shall be updated
periodically by the Parties.
1.59 “Major European
Countries” means
France, Germany, Spain, Italy, and the United Kingdom.
1.60 “Major
Territory” means
each of the following territories: (a) [ * ]
.
1.61
“Manufacturing” means all activities related to the production,
manufacture, processing, filling, finishing, packaging, labeling,
inspection, receiving, holding and shipping of Lead Compounds,
Program Backups, Collaboration Compounds, Products, or any raw
materials or packaging materials with respect thereto, or any
intermediate of any of the foregoing, including process and cost
optimization, process qualification and validation, commercial
manufacture, stability and release testing, quality assurance and
quality control. For clarity, “Manufacture” has a
correlative meaning.
1.62 “Manufacturing
Costs” means costs
that relate to a Co-Developed Product or a Co-Promotion Product
which is: (a) supplied by a Third Party; or
(b) manufactured directly by a Party or its Affiliate, in each
case to the extent such costs relate to the development of a
Co-Developed Product or the Commercialization of a Co-Promotion
Product in the U.S., as further described below and as allocated in
accordance with GAAP.
For costs in subsection (a) ,
Manufacturing Costs means: (i) the amount paid to such a Third
Party [ * ] ; plus (ii) the relevant manufacturing
Party’s reasonable direct and identifiable internal costs and
out-of-pocket costs, incurred or accrued (including any
prepayments) by the manufacturing Party in connection with
manufacturing process improvements, storage, manufacturing
scale-up, manufacturing site qualification, quality assurance and
quality control (including testing), supply chain management,
capital equipment, similar activities comprising the manufacturing
Party’s oversight of the manufacturing process of the
non-Affiliate Third Party, and any value-added tax or similar tax
due for amounts paid to such Third Party.
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and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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For costs in subsection (b) ,
Manufacturing Costs means the “standard cost” per unit,
including variances to standard costs and inventory write-offs.
This standard cost shall include the cost of raw materials, labor,
and other direct and identifiable variable costs incurred or
accrued by the manufacturing Party in connection with the
manufacture of a Co-Promotion Product, manufacturing process
improvements, storage, manufacturing scale-up, manufacturing site
qualification, quality assurance and quality control (including
testing), supply chain management, and costs of equipment, plant
operations and plant support services necessary to produce a
Co-Promotion Product. These costs of plant operations and support
services shall include [ * ] and other similar activities,
including [ * ] charges. Costs that cannot be identified to
a specific activity supporting manufacturing of a Co-Promotion
Product, such as charges for corporate overhead that are not
controllable by the manufacturing plant, shall be [ * ] from
the determination of Manufacturing Cost.
Subject to the preceding paragraph,
“standard cost” per unit for purposes of ongoing cost
accounting purposes shall be calculated in accordance with [ *
] . The Parties shall reconcile the standard cost charges and
appropriate credit or payment shall be made to effect such
reconciliation as directed by the JFC not less than annually
against the above Manufacturing Cost definition.
Manufacturing Costs shall include
costs of such activities that are undertaken at any time during the
term of this Agreement (including [ * ] ).
1.63 “Medical Education
Activities” means
activities designed to ensure or improve appropriate medical use
of, conduct medical education of, or further research regarding, a
Co-Promotion Product sold in the U.S., including by way of
example: (a) activities of medical sales liaisons;
(b) grants to support continuing medical education, symposia,
or research related to a Co-Promotion Product in the U.S.
(excluding Phase IV Clinical Trials and Development activities
conducted for purposes of obtaining an initial Regulatory Approval
for an indication for a Co-Promotion Product in the U.S.);
(c) development, publication and dissemination of publications
relating to Co-Promotion Product in the U.S., as well as medical
information services provided in response to inquiries communicated
via sales representatives or received by letter, phone call or
email; and (d) conducting advisory board meetings or other
consultant programs, the purpose of which is to obtain advice and
feedback related to the Development or Commercialization of a
Co-Promotion Product in the U.S.
1.64 “NDA”
means a New Drug Application
submitted to the FDA in conformance with applicable laws and
regulations.
1.65 “Net
Sales” means the
amount invoiced or otherwise billed by BMS or its Affiliate or
sublicensee for sales or other commercial disposition of a Product
to a Third Party purchaser, less the following to the extent
included in such billing or otherwise actually allowed or incurred
with respect to such sales: (a) discounts, including cash,
trade and quantity discounts, price reduction programs, retroactive
price adjustments with respect to sales of a product, charge-back
payments and rebates granted to managed health care organizations
or to federal,
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Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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9
state and local governments (or their respective
agencies, purchasers and reimbursers) or to trade customers,
including but not limited to, wholesalers and chain and pharmacy
buying groups; (b) credits or allowances actually granted upon
rejections or returns of Products, including for recalls or damaged
goods; (c) freight, postage, shipping and insurance charges
actually allowed or paid for delivery of Products, to the extent
billed; (d) customs duties, surcharges and other governmental
charges incurred in connection with the exportation or importation
of a Product; (e) bad debts relating to sales of Products that
are actually written off by BMS in accordance with GAAP during the
applicable calculation period; (f) costs due to the factoring
of receivables; and (g) taxes, duties or other governmental
charges levied on, absorbed or otherwise imposed on sale of
Products, including value-added taxes, or other governmental
charges otherwise measured by the billing amount, when included in
billing, as adjusted for rebates and refunds, but specifically
excluding taxes based on net income of the seller; provided that
all of the foregoing deductions are calculated in accordance with
generally accepted accounting principles consistently applied
throughout the Party’s organization.
Notwithstanding the foregoing, if
any Product is sold under a bundled or capitated arrangement with
other BMS products, then, solely for the purpose of calculating Net
Sales under this Agreement, any discount on such Products sold
under such an arrangement shall be [ * ] for the applicable
accounting period. In case of any dispute as to the applicable [
* ] under the preceding sentence, the determination of same
shall be calculated and certified by [ * ] , whose decision
shall be binding.
A sale of a Product is deemed to
occur upon invoicing. [ * ] .
For sake of clarity and avoidance of
doubt, sales by BMS, its Affiliates or sublicensees of a Product to
[ * ] . Any Products [ * ] considered in determining
Net Sales hereunder.
In the event a Product is sold as an
end-user product consisting of a combination of active functional
elements or as a combined product and/or service, Net Sales, for
purposes of determining royalty payments on such Product, shall be
calculated by multiplying the Net Sales of the end-user product
and/or service by the fraction A over A+B, in which A is the gross
selling price of the Product portion of the end-user product and/or
service when such Product is sold separately during the applicable
accounting period in which the sales of the end-user product were
made, and B is the gross selling price of the other active elements
and/or service, as the case may be, of the end-user product and/or
service sold separately during the accounting period in question.
All gross selling prices of the elements of such end-user product
and/or service shall be calculated as the average gross selling
price of the said elements during the applicable accounting period
for which the Net Sales are being calculated. In the event that, in
any country or countries, no separate sale of either such
above-designated Product or such above designated elements of the
end-user product and/or service are made during the accounting
period in which the sale was made or if gross retail selling price
for an active functional element, component or service, as the case
may be, cannot be determined for an accounting period, Net Sales
allocable to the Product in each such country shall be determined
by mutual agreement reached in good faith by the Parties prior to
the end of the accounting period in question based on an equitable
method of determining same that takes into account, on a
country-by-country basis, variations in potency, the relative
contribution of each active agent, component or service, as
the
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Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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10
case may be, in the combination, and relative
value to the end user of each active agent, component or service,
as the case may be. Notwithstanding the foregoing, the Parties
agree that, for purposes of this paragraph, drug delivery vehicles,
adjuvants, and excipients shall not be deemed to be “
active ingredients ” or “ active functional
elements ”.
1.66 “Operating Profit (or
Loss)” means Net
Sales of Co-Promotion Products in the U.S. less Allowable Expenses
in the U.S. For sake of clarity, Operating Profit (or Loss) shall
be determined [ * ] , and if such terms are used
individually, “ Operating Profit ” shall mean a
positive Operating Profit (or Loss), and “ Operating
Loss ” shall mean a negative Operating Profit (or
Loss).
1.67
“Patent” means all: (a) unexpired letters patent
(including inventor’s certificates and utility models) which
have not been held invalid or unenforceable by a court of competent
jurisdiction from which no appeal can be taken or has been taken
within the required time period (and which have not been admitted
to be invalid or unenforceable through reissue, disclaimer or
otherwise, or been abandoned in accordance with or as permitted by
the terms of this Agreement or by mutual written agreement),
including any substitution, extension, registration, confirmation,
reissue, re-examination, supplementary protection certificates,
confirmation patents, patent of additions, renewal or any like
filing thereof; (b) pending applications for letters patent
which have not been canceled, withdrawn from consideration, finally
determined to be unallowable by the applicable governmental
authority or court for whatever reason (and from which no appeal is
or can be taken), and/or abandoned in accordance with or as
permitted by the terms of this Agreement or by mutual written
consent, including any continuation, division or
continuation-in-part thereof and any provisional or other priority
applications; and (c) any international counterparts, and
counterparts in any country, to clauses (a) and
(b) above.
1.68 “Phase I Clinical
Trial” means a
clinical trial of a Product on sufficient numbers of normal
volunteers and/or patients that is designed to establish that such
Product is safe for its intended use, can be delivered in a dose(s)
that is therapeutically useful, and to support its continued
testing in Phase II Clinical Trials.
1.69 “Phase II Clinical
Trial” means a
Phase IIa Clinical Trial or a Phase IIb Clinical Trial.
1.70 “Phase IIa Clinical
Trial” means a
controlled clinical trial of a Product that utilizes the
pharmacokinetic and pharmacodynamic information obtained from one
(1) or more previously conducted Phase I Clinical Trial(s)
and/or other Phase IIa Clinical Trial(s) in order to confirm the
optimal manner of use of such Product (dose and dose regimens) and
to better determine safety and efficacy.
1.71 “Phase IIb Clinical
Trial” means a
clinical trial of a Product on sufficient numbers of patients that
is designed to provide a preliminary determination of safety and
efficacy of such Product in the target patient population over a
range of doses and dose regimens.
1.72 “Phase III Clinical
Trial” means a
clinical trial of a Product on sufficient numbers of patients that
is designed to establish that such Product is safe and efficacious
for its
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confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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11
intended use, and to define warnings,
precautions and adverse reactions that are associated with such
Product in the dosage range to be prescribed, and to support
Regulatory Approval of such Product or label expansion of such
Product.
1.73 “Phase IIIb Clinical
Trial” means a
clinical trial of a Product, initiated before regulatory approval
and is not required for same, but which may provide data that
further defines how and where the drug should be used. A Phase IIIb
Clinical Trial may include epidemiological studies, modeling and
pharmacoeconomic studies, and investigator-sponsored clinical
trials that are approved by the JDC and that otherwise fit the
foregoing definition.
1.74 “Phase IV Clinical
Trial” means a
product support clinical trial of a Product commenced after receipt
of Regulatory Approval in the country where such trial is
conducted. A Phase IV Clinical Trial may include epidemiological
studies, modeling and pharmacoeconomic studies, and
investigator-sponsored clinical trials studying Product that are
approved by the JDC and that otherwise fit the foregoing
definition.
1.75
“Product” means any therapeutic or prophylactic product
(for use in animals or humans) that contains or comprises a
Collaboration Compound for which BMS has exercised its
Co-Development Option in accordance with the terms of this
Agreement.
1.76 “Program
Backups” means,
with respect to a Lead Op Program, Provisional Collaboration
Program or Collaboration Program any compounds, other than the
Program Lead, that: (a) were created by BMS or Exelixis as
part of such Lead Op Program, Provisional Collaboration Program or
Collaboration Program (or Backup Program pursuant to
Section 3.5 ); (b) [ * ] the applicable
Lead Op Target(s) or Collaboration Target(s) [ * ] ; and
(c) [ * ] Lead Op Target(s) or Collaboration
Target(s), based on the [ * ] , and any [ * ] of any
such compounds described in ((a), (b) and (c))
above.
1.77 “Program
Lead” means, for
any Lead Op Program, Provisional Collaboration Program or
Collaboration Program, a small molecule compound that: (a) was
created by Exelixis as part of the relevant Lead Op Program,
Provisional Collaboration or Collaboration Program; (b) [
* ] the applicable Lead Op Target(s) or Collaboration Target(s)
[ * ] ; (c) [ * ] Lead Op Target(s) or
Collaboration Target(s), based on the [ * ] ; (d) meets
Exelixis’ internal standards applicable to a Development
Candidate; and (e) is [ * ] that would otherwise result
in [ * ] .
1.78 “Registrational
Trial” means, with
respect to a given Product, either (i) a Phase III Clinical
Trial with such Product or (ii) a Phase IIb Clinical Trial
that, at the time of commencement, is expected to be the basis for
initial Regulatory Approval of such Product.
1.79 “Regulatory
Approval” means any
and all approvals (including Drug Approval Applications,
supplements, amendments, pre- and post-approvals, pricing and
reimbursement approvals), licenses, registrations or authorizations
of any Regulatory Authority, national, supra-national (e.g., the
European Commission or the Council of the EU), regional, state or
local regulatory agency, department, bureau, commission, council or
other governmental entity, that are necessary for the manufacture,
distribution, use or sale of a Product in a regulatory
jurisdiction.
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Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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12
1.80 “Regulatory
Authority” means
the applicable national (e.g., the FDA), supra-national (e.g., the
European Commission or the Council of the EU), regional, state or
local regulatory agency, department, bureau, commission, council or
other governmental entity that, in each case, governs the approval
of a Product in such applicable regulatory jurisdiction.
1.81 “Regulatory
Expenses” means
costs incurred to prepare product regulatory submissions and to
obtain and maintain Regulatory Approval in the U.S. and to comply
with Regulatory Approvals and requirements of Regulatory
Authorities, including FDA user and other fees, reporting and
regulatory affairs activities, and recalls and withdrawals for
Co-Promotion Product (other than costs for Co-Promotion Product
that are deductible from Net Sales or that are included as
Development Costs).
1.82 “Reporting-Only
Product” means any
Product with respect to which Exelixis exercised a Product Opt-Out
pursuant to Section 4.7(a) prior to [ * ] such
Product.
1.83 “Royalty-Bearing
Product” means a
Product: (a) with respect to which Exelixis failed to make the
co-development election contemplated by Section 3.7(c)
; or (b) with respect to which: (i) Exelixis has notified
BMS of a Product Opt-Out; or (ii) with respect to which
Exelixis elected not to exercise its Co-Promotion Option or where
such Co-Promotion Option expired unexercised.
1.84 “Royalty
Territory” means
the world, excluding the U.S.
1.85 “Sales and Marketing
Costs” means the
[ * ] costs that are [ * ] the sales and marketing of
a Co-Promotion Product in the U.S., including: (a) activities
directed to the advertising and marketing of a Co-Promotion
Product; (b) professional education (to the extent not
performed by sales representatives), including launch meetings;
(c) costs of advertising, public relations and medical
education agencies; (d) peer-to-peer activities, such as
continuing medical education, grand rounds, and lunch and dinner
meetings; (e) speaker programs, including the training of such
speakers; (f) grants to support continuing medical education
or research (excluding Clinical Costs); (g) development,
publication and dissemination of publications relating to a
Co-Promotion Product; (h) developing, obtaining and providing
training packages of a Co-Promotion Product, promotional
literature, promotional materials and other selling materials;
(i) developing and performing market research;
(j) conducting symposia and opinion leader development
activities; (k) development reimbursement programs;
(l) developing information and data specifically intended for
national accounts, managed care organizations and group purchasing
organizations; (m) [ * ] incurred in connection with
[ * ] , to the extent provided therein; (n) direct
expenses relating to selling by non-Affiliate Third Parties;
(o) costs of transporting, housing and maintaining sales
representatives for training; (p) conducting Phase IIIb
Clinical Trials and Phase IV Clinical Trials, and clinical trials
performed for marketing purposes and post-marketing surveillance
activities; (q) administration, operation and maintenance of
the sales force that promotes a Co-Promotion Product in the U.S.,
sales bulletins and other communications, sales meetings, specialty
sales forces, consultants, call reporting and other
monitoring/tracking costs, district and regional sales management,
home office personnel who support the sales force; and
(r) costs associated with Medical Education Activities, and
other ancillary services to the foregoing (to the extent not
otherwise falling within
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confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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13
subsections (a) through (r)
. Sales and Marketing Costs shall
include costs of such activities that are undertaken at any time
during the term of this Agreement (including prior to the initial
Regulatory Approval of a Co-Promotion Product in the
U.S.).
1.86 “Screening
Target(s)” means
any one or more targets that: (a) the Parties mutually agree
becomes part of the Collaboration pursuant to
Section 3.2(a) ; and (b) are not the subject of:
(i) a collaboration between Exelixis and a Third Party; or
(ii) discussions between Exelixis and a Third Party concerning
a bona fide collaboration. The Screening Targets shall be
listed in Exhibit 3.2 , which shall be updated periodically
by the Parties.
1.87 “Sole
Invention” means
any Invention invented or discovered solely by or on behalf of a
Party (or its Affiliate) and its employees, contractors and/or
agents.
1.88 “Specificity
Criteria” means,
for each Collaboration Compound, that such Collaboration Compound:
(a) demonstrates [ * ] as determined [ * ]; and (b) has a
[ * ] in such [ * ].
1.89 “Target Potency
Threshold” means,
for each Collaboration Compound, that such Collaboration Compound [
* ].
1.90
“Territory” means the world.
1.91 “Third
Party” means any
entity other than: (a) Exelixis; (b) BMS; or (c) an
Affiliate of either Party.
1.92 “Third Party
Royalties” means
royalties and other payments payable to a Third Party in
consideration for rights [ * ] for the [ * ] of
Co-Promotion Product.
1.93 “Trademark
Costs” mean the
fees and expenses paid to outside counsel and other Third Parties,
direct costs of in-house counsel and filing and maintenance
expenses, incurred in connection with the establishment and
maintenance of rights under trademarks applicable to Co-Promotion
Product in the U.S., including costs of filing and registration
fees, actions to enforce or maintain a trademark and other
proceedings.
1.94 “United
States” or
“U.S.” means the United States of America, and
its territories, districts and possessions.
1.95 “Unrelated
Compound” means,
with respect to a Lead Op Program, Provisional Collaboration
Program or Collaboration Program, any Program Backups that:
(a) were created by BMS or Exelixis as part of such Lead Op
Program, Provisional Collaboration Program or Collaboration Program
(or Backup Program pursuant to Section 3.5 ); and
(b) either: (i) [ * ] applicable Lead Op
Target(s) or Collaboration Target(s) [ * ] ; or
(ii) are [ * ] Lead Op Target(s) or Collaboration
Target(s), based on the [ * ] .
1.96 “Valid
Claim” means
(a) a claim in an issued Patent that has not: (i) expired
or been canceled; (ii) been declared invalid by an unreversed
and unappealable or unappealed decision of a court or other
appropriate body of competent jurisdiction; (iii) been
admitted to be
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Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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14
invalid or unenforceable through reissue,
disclaimer or otherwise; or (iv) been abandoned in accordance
with or as permitted by the terms of this Agreement or by mutual
written agreement of the Parties; or (b) a claim under an
application for a Patent that has been pending for [ * ] for [ * ],
and, in any case, which has not been canceled, withdrawn from
consideration, finally determined to be unallowable by the
applicable governmental authority or court for whatever reason (and
from which no appeal is or can be taken), or abandoned.
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Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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Additional Definitions
The following table identifies the
location of definitions set forth in various Sections of the
Agreement.
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Alliance Manager
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2.8(a)
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Annual Development
Plan
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4.2(a)
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Backup Program
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3.5(b)(i)
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[ * ]
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[ * ]
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BMS Rejected Lead Op
Target
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3.3(d)
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Co-Development
Option
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3.1(b)
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Collaboration
Program
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3.4(b)(i)
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Collaboration
Target
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3.3(b)
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[ * ]
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[ * ]
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[ * ]
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[ * ]
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Co-Promotion
Agreement
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6.4(a)
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Co-Promotion
Notice
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6.4(b)
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Co-Promotion
Option
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6.4(a)
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DCP
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3.3(b)
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[ * ]
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[ * ]
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Effective Date
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13.6
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Exelixis Co-Development
Option
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3.7(c)
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[ * ]
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[ * ]
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Global Commercialization
Strategy
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6.2(a)
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Global Development
Plan
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4.1(a)
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Indication Opt-Out
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4.7(b)
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JAMS
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3.6(b)(iii)
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Lead Op Candidate
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3.2(b)
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[ * ]
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[ * ]
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Party Implementation
Matter
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2.7(c)(ii)
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Party Vote
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2.7(c)(i)
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Pharmacovigilance
Agreement
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5.7
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Product Opt-Out
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4.7(a)
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Provisional Collaboration
Program
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3.4(a)
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Rejected Lead Op
Target
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3.3(c)
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[ * ]
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[ * ]
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Rejected Screening
Target
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3.2(b)
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Research Term
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3.10
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ROC
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1.6
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Royalty Term
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9.11
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Screening Program
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3.2
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[ * ]
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[ * ]
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[ * ]
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[ * ]
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Term
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12.1
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U.S. Commercialization
Plan
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6.2(a)
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Working Group
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2.7(f)
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confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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16
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2.
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MANAGEMENT
OF COLLABORATION
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2.1 General.
(a) Role of
Committees. Subject to
Section 2.1(b) and the other terms and conditions of
this Agreement, the Parties shall establish: (i) a joint
executive committee (the “ Joint Executive Committee
” or “ JEC ”) that will oversee the
Collaboration and facilitate communications between the Parties
with respect to the Development, Regulatory Approval, and
Commercialization of Committee-Governed Products hereunder; and
(ii) four (4) specialized joint committees consisting of
one to focus on each of the following areas arising out of the
Collaboration: (A) discovery efforts in connection with
Screening Programs, Lead Op Programs, Provisional Collaboration
Programs and Collaboration Programs, as described in Article
3 (such committee, the “Joint Research
Committee” or “JRC” );
(B) Development and Regulatory Approval and other regulatory
matters (such committee, the “ Joint Development and
Regulatory Committee ” or “ JDC ”);
(C) Commercialization (such committee, the “ Joint
Commercialization Committee ” or “ JCC
”); and (D) financial issues (such committee, the
“ Joint Finance Committee ” or “
JFC ”). Each Committee shall have the
responsibilities and authority allocated to it in this Article
2 and elsewhere in this Agreement. It is contemplated
that: (X) all significant matters (other than Party
Implementation Matters, as defined in
Section 2.7(c)(ii) ) relating to: (I) the
discovery and pre-clinical Development of Collaboration Compounds;
and (II) the clinical Development of Committee-Governed Products
and the Commercialization of Co-Promotion Products, in each case
under this Agreement will be addressed by the applicable first-tier
Committees ( i.e ., the JRC, the JDC, the JCC, or the JFC)
and, if appropriate, by the JEC, as contemplated by
Section 2.7(c) ; and (Y) the Parties’
respective activities under this Agreement (including Party
Implementation Matters) will be reported to the relevant Committees
in a reasonable and appropriate level of detail. Each of the JRC
(to the extent applicable), JDC, JCC, and the JFC shall provide, on
a [ * ] basis (unless otherwise requested by the JEC),
updates on its activities and achievements to the JEC for review
and comment. The Parties intend that their respective organizations
will work together to assure the success of the
Collaboration.
(b) Limitations on the Authority
of Committees. Notwithstanding the Committee structure
established pursuant to Section 2.1(a) to oversee the
Collaboration, each Party shall retain the rights, powers and
discretion granted to it under this Agreement, and no such rights,
powers, or discretion shall be delegated to or vested in a
Committee unless such delegation or vesting of rights is expressly
provided for in this Agreement or the Parties expressly so agree in
writing. Without limiting the generality of the foregoing, no
Committee shall have any authority or jurisdiction
to: (i) amend, modify, or waive compliance with this
Agreement, any of which shall require mutual written agreement of
the Parties; (ii) interpret this Agreement, or determine
whether or not a Party has met its diligence or other obligations
under the Agreement or whether or not a breach of this Agreement
has occurred; (iii) require Exelixis to [ * ] (other
than [ * ] , [ * ] that are carried out in accordance
with the [ * ] , and any [ * ] obligations with
respect to [ * ] that are set forth in the applicable [ *
] ) without Exelixis’ express written consent ( [ *
] ); (iv) require Exelixis to [ * ] (other than
[ * ] , [ * ] that are carried out in accordance with
[ * ] , and any [ * ] with respect to [ * ]
that are set forth in the applicable [ * ] )
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Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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17
without Exelixis’ express written consent
(which [ * ] ); (v) require BMS to [ * ] (other
than [ * ] ) without BMS’ express written consent
(which [ * ] ); (vi) make any decision on any matter
that this Agreement expressly states is an option or election to be
made by a Party; (vii) make any retroactive updates,
amendments and modifications to, or waivers of provisions of, an
Approved Plan, any which shall require the mutual agreement of the
Parties; and (viii) such other matters as are reserved to the
consent, approval, agreement or other decision-making authority of
one or both Parties in this Agreement and that are not required by
this Agreement to be considered by one or more Committees prior to
the exercise of such consent, approval or other decision-making
authority. For clarity, a Party’s right to cast a deciding
vote on a matter in a Committee pursuant to Article 2 shall
not, in and of itself, subject such matter to the preceding
sentence. Notwithstanding the foregoing, neither Party shall be
restricted from bringing before any appropriate Committee for
discussion any matter relating to the Collaboration that it
believes warrants discussion between the Parties through the
Committees, provided that the consideration of any such
matter by any Committee shall not infringe or limit the exercise of
a Party’s right of consent or approval or other
decision-making authority granted to it by this Agreement nor shall
any such consideration, as contemplated by this sentence, subject
any such right of consent or approval or other decision-making
authority to any dispute resolution mechanism provided for in
Section 2.7(c) or Article 15 or elsewhere in
this Agreement.
2.2 Joint Executive
Committee.
(a) Formation and
Purpose. Exelixis
and BMS shall establish the JEC within [ * ] after the first
exercise by BMS of its Co-Development Option pursuant to
Section 3.4(b) . Subject to Sections 2.1(b)
and 2.7(c) , the JEC shall have overall responsibility for
the success of the Collaboration, and its general areas of
responsibility shall be: (a) to determine the global
Development, regulatory, Commercialization, and manufacturing
strategy for the Collaboration; (b) to coordinate the
Parties’ activities hereunder; and (c) as applicable, to
review, comment on, approve, and resolve disputes with respect to,
plans and budgets for, and the implementation of, the
Collaboration, including the specific responsibilities of the JEC
outlined below, in each case (clauses (a), (b) and
(c) above) solely with respect to Committee-Governed
Products. The JEC shall have the membership and shall operate
by the procedures set forth in Section 2.7 .
(b) Specific Responsibilities of
the JEC. In
addition to its overall responsibility for the Collaboration, but
subject to Sections 2.1(b) and 2.7(c) , the JEC
shall, in particular, have the following specific responsibilities
with respect to Committee-Governed Products:
(i) approve the global development, regulatory and
commercialization strategies for the Collaboration;
(ii) coordinate the Parties’ activities
hereunder;
(iii) approve plans and budgets for the Collaboration
proposed by the JDC or JCC;
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[ * ] =
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Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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(iv) review all significant and strategic issues
within the purview of the various Committees;
(v) manage and oversee the development and
commercialization of each Product pursuant to the terms of the
Agreement;
(vi) review and approve any material amendments to
the Approved Plans and any other items submitted to the JEC by the
JDC or JCC;
(vii) oversee life cycle management of, and
intellectual property protection for, a Product;
(viii) provide a forum for dispute resolution;
and
(ix) such other responsibilities as may be assigned
to the JEC pursuant to the Agreement or as may be agreed between
the Parties from time to time.
2.3 Joint Development and
Regulatory Committee.
(a) Formation and
Purpose. Exelixis and BMS
shall establish the JDC within [ * ] after the earlier of:
(i) [ * ] ; or (ii) [ * ] . Subject
to Sections 2.1(b) and 2.7(c) , the JDC shall oversee,
coordinate and expedite the Development of, and the making of
regulatory filings for, each Committee-Governed Product worldwide
in order to obtain Regulatory Approvals (or compendia listings, as
applicable). The JDC will also facilitate the flow of
information with respect to Development activities being conducted
for each Product and oversee Development activities required to
support Regulatory Approvals (or compendia listings, as
applicable). The JDC shall have the membership and shall
operate by the procedures set forth in Section 2.7
.
(b) Specific Responsibilities of
the JDC. In
support of its responsibility for overseeing, coordinating and
expediting the Development of, and regulatory filings for, each
Committee-Governed Product, but subject to Sections 2.1(b) and
2.7(c) , the JDC shall, in particular, and solely with respect
to Committee Governed Products:
(i) monitor Development activities;
(ii) prepare the Global Development Plan and each
Annual Development Plan;
(iii) review all material information generated in the
course of implementing the Global Development Plan and the Annual
Development Plans;
(iv) assist in coordinating scientific interactions
and division of responsibilities with respect to Development
Activities, and resolving disagreements during the course of
implementing the Global Development Plan and the Annual Development
Plans;
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(v) design, in collaboration with the JCC,
pharmacoeconomic studies or Phase IV Clinical Trials;
(vi) monitor and coordinate all regulatory actions,
communications and submissions for Products, including establishing
the schedule and implementation strategy for all regulatory filings
for Products;
(vii) provide on a quarterly basis updates on its
activities and achievements to the JEC for review and
comment;
(viii) pursuant to Section 3.6(b) , review
and determine whether the definition of Identified Target(s) for
each applicable Lead Op Program, Provisional Collaboration Program
and Collaboration Program need to be modified; and
(ix) such other responsibilities as may be assigned
to the JDC pursuant to the Agreement or as may be agreed between
the Parties from time to time.
2.4 Joint Commercialization
Committee.
(a) Formation and
Purpose. Exelixis
and BMS shall establish the JCC within [ * ] after [ *
] , which Committee shall, subject to Sections 2.1(b) and
2.7(c) , oversee: (i) the Commercialization strategy of
each Co-Promotion Product in the Co-Development Territory; and
(ii) the Commercialization of Co-Promotion Products in the
U.S. including the marketing, sales and distribution of each
Co-Promotion Product in the U.S. The JCC shall have the membership
and shall operate by the procedures set forth in
Section 2.7 .
(b) Specific Responsibilities of
the JCC. In
support of its responsibilities as described in clause
(a) above, the JCC shall, subject to Sections 2.1(b) and
2.7(c) , perform the following activities solely with respect
to Co-Promotion Products:
(i) prepare the Global Commercialization Strategy
and the U.S. Commercialization Plan, and any updates
thereto;
(ii) review the allocation of Commercialization
responsibilities between the Parties to ensure consistency with the
terms of this Agreement, the Global Commercialization Strategy, and
the U.S. Commercialization Plan;
(iii) coordinate and oversee the Parties’ plans
for labeling, branding and selecting trademarks for each
Product;
(iv) review life cycle management
opportunities;
(v) review pricing and reimbursement strategies with
respect to Products in the Royalty Territory and
(vi) With respect to Co-Promotion Products in the
U.S. only:
(1) review and approve advertising materials and
strategies and promotional materials developed by a Party for the
Parties’ Sales Representatives;
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(2) approve the selection of major or key marketing
vendors (e.g., public relations and advertising agencies and
medical education agencies) ;
(3) approve pricing and reimbursement, patient
assistance, vendor return and co-pay strategies;
(4) design, in collaboration with the JDC,
pharmacoeconomic studies or Phase IV Clinical Trials;
(5) approve market research plans;
(6) approve and coordinate all sales force
activities, including training, number, proportion of time to be
devoted to promotion, and territory alignment;
(7) approve packaging designs, and oversee
educational and professional symposia, and speaker and peer-to-peer
activity programs;
(8) discuss a range of suggested prices at which a
Co-Promotion Product will be sold to unaffiliated Third Parties and
any discount strategies for such Co-Promotion Product (it being
understood that BMS will determine all pricing and reimbursement
terms for Co-Promotion Products sold to customers);
(9) review of each Party’s reports pertaining
to its Sales and Marketing Costs; and
(10) review early access and compassionate use
programs.
(c) Available
Resources. Except as
otherwise provided in Article 6 or any applicable
Co-Promotion Agreement, the JCC shall, in allocating
responsibilities between the Parties with respect to
Commercialization activities for Co-Promotion Products under this
Agreement in the United States: (i) endeavor to take advantage
of the respective resources, capabilities and expertise of Exelixis
and BMS; and (ii) endeavor to: (A) maintain, to the
extent reasonably practical and commercially appropriate,
continuity in functions and commitments of personnel and physical
resources of the Parties; (B) avoid duplication of efforts by
the Parties; and (C) foster efficient use by the Parties of
resources and personnel, consistent with this Agreement and the
applicable Global Commercialization Strategy and the applicable
U.S. Commercialization Plan. For clarity, BMS shall be solely
responsible for the Commercialization of each Product in the
Royalty Territory and for each Royalty-Bearing Product in the
United States.
2.5 Joint Research
Committee. Exelixis and
BMS shall establish the JRC within [ * ] after the Effective
Date, which Committee shall, subject to Sections 2.1(b) and
2.7(c) , oversee the discovery efforts with respect to
Screening Programs, Lead Op Programs, Provisional Collaboration
Programs and Collaboration Programs, as described in Article
3 , including work
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performed by BMS on Provisional Collaboration
Programs in accordance with Section 3.4(a) . The JRC
shall have the membership and shall operate by the procedures set
forth in Section 2.7 , and shall disband subsequent to
the Research Term or otherwise at the direction of the JEC. Without
limiting the generality of the foregoing, the JRC shall have the
specific responsibilities set forth below:
(a) provide a forum to allow BMS to review and
comment with respect to discovery and pre-clinical Development
activities and for Exelixis to report progress with respect to
discovery and pre-clinical Development activities;
(b) make decisions with respect to: (i) which
targets will become Screening Targets, Lead Op Candidates and
Lead-Op Programs; (ii) which Screening Targets, Lead Op
Candidates, Lead-Op Targets and Collaboration Candidates will be
terminated; and (iii) which compounds will become Program
Leads;
(c) review [ * ] proposed by BMS, and discuss
the progress of Lead-Op Candidates, Development Candidates and
Collaboration Candidates in relation to those [ * ] ;
and
(d) pursuant to Section 3.6(b) , review
and determine whether the definition of Identified Target(s) for
each applicable Lead Op Program, Provisional Collaboration Program
and Collaboration Program need to be modified.
2.6 Joint Finance
Committee. Exelixis and
BMS shall establish a JFC within forty-[ * ] subsequent to the [ *
]. The JFC shall provide support to all other Committees with
respect to accounting and financial matters relating to
Committee-Governed Products. The JFC shall have the membership and
shall operate by the procedures set forth in Section
2.7.
2.7 General Committee Membership
and Procedures.
(a) Membership.
Each Committee shall be composed of
such number of representatives as may be agreed by the Parties.
Each of BMS and Exelixis shall designate representatives with
appropriate expertise to serve as members of each Committee, and
each representative may serve on more than one Committee as
appropriate in view of the individual’s expertise. Each
Party may replace its Committee representatives at any time upon
written notice to the other Party. Each Committee shall have
co-chairpersons. BMS and Exelixis shall each select from their
representatives a co-chairperson for each of the Committees, and
each Party may change its designated co-chairpersons from time to
time upon written notice to the other Party. The Alliance
Managers shall be responsible for calling meetings, preparing and
circulating an agenda in advance of each meeting of such Committee,
and preparing and issuing minutes of each meeting within [ *
] thereafter; provided that a Committee co-chairperson shall
call a meeting of the applicable Committee promptly upon the
written request of the other co-chairperson to convene such a
meeting. The minutes of each meeting shall, among other
things, record all matters acted upon and approved or disapproved
by the Committee, actions to be taken, and any matters the
Committee failed to resolve. Such minutes will not be
finalized until both Alliance Managers review and confirm in
writing the accuracy of such minutes.
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(b) Meetings.
Each Committee shall hold meetings
at such times as it elects to do so, but in no event shall such
meetings be held less frequently than once every [ * ] for
the JRC and once every [ * ] for the JDC, the JCC, and the
JFC, and once every [ * ] for the JEC. Each Committee shall
meet alternately at Exelixis’ facilities in South San
Francisco, California, and BMS’ facilities in Princeton, New
Jersey, or at such other locations as the Parties may agree. The
Alliance Managers shall, and other employees of each Party involved
in the Development, Manufacture or Commercialization of any Product
may as needed, attend meetings of each Committee (as nonvoting
participants unless they are members of such Committee), and
consultants, representatives or advisors involved in the
Development, Manufacture or Commercialization of any Product may
attend meetings of each Committee as nonvoting observers;
provided that such Third Party representatives are under
obligations of confidentiality and non-use applicable to the
Confidential Information of each Party that are at least as
stringent as those set forth in Article 11 , and in the case
of non-employees of a Party, subject to the consent of the other
Party, which shall not be unreasonably withheld or delayed. Each
Party shall be responsible for all of its own expenses of
participating in any Committee (including in any Working Group).
Meetings of any Committee may be held by audio or video
teleconference with the consent of each Party, which shall not be
unreasonably withheld or delayed; provided that at least
[ * ] per year of such Committee shall be held in person. No
action taken at any meeting of a Committee shall be effective
unless a representative of each Party is participating.
(c) Decision-Making
.
(i) Voting on Committee
Decisions. Subject
to Section 2.1(b) , each Party’s designees on a
Committee shall, collectively, have one (1) vote (the “
Party Vote ”) on all matters brought before the
Committee, which Party Vote shall be determined by [ * ] of
such Party’s designees present (in person or otherwise) at
the meeting. Except as expressly provided in this
Section 2.7(c) and subject to
Section 2.1(b) , each Committee shall operate as to
matters within its jurisdiction by unanimous Party Vote. All
decisions of a Committee shall be documented in writing in the
minutes of the applicable Committee meeting by the Alliance
Managers, and, to the extent applicable, included on the target
status list described in Section 3.9 .
(ii) Operational
Decisions. Before
selection by BMS of a Collaboration Program pursuant to exercise of
BMS’ Co-Development Option, day-to-day operational level
decisions concerning the identification, optimization, non-clinical
development and clinical development (up through IND submission) of
Collaboration Compound shall be made by Exelixis, except as
expressly stated in this Agreement. Following selection by BMS of a
Collaboration Program pursuant to exercise of BMS’
Co-Development Option, day-to-day operational level decisions
concerning the Development and Commercialization of Products in
such Collaboration Program shall be made by the Party to which
responsibility for such decisions has been allocated under the
Agreement (each such decision, a “ Party Implementation
Matter ”). Unless otherwise directed by the appropriate
Committee(s), [ * ] shall be the lead Party, and shall be
primarily responsible for, all Development, regulatory activities
and Manufacturing and, subject to [ * ] , Commercialization
activities with respect to a Product. Any disputes with respect to
a Party Implementation Matter shall first be referred to the
Alliance Managers, and, if the dispute is not resolved within [
* ] after such referral to the Alliance
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Managers, then it shall, upon written notice by
a Party to the other, be referred for resolution as follows:
(A) disputes between designees of BMS and Exelixis with
respect to Development and Regulatory Approval matters shall be
referred to the JDC for resolution; and (B) disputes between
designees of BMS and Exelixis with respect to Commercialization
shall be referred to the JCC for resolution. In each case, except
for Appealable Matters, the Committee to which such matter is
referred shall have final decision-making authority with respect to
such matter, and [ * ] shall [ * ] with respect to
such matter, [ * ] .
(iii) Disagreements on
Committees. Except
for: (A) matters outside the jurisdiction and authority of the
Committees as provided in Section 2.1(b); and
(B) any Party Implementation Matter (other than Appealable
Matters), and in any event without limiting the other rights and
obligations of the Parties under this Agreement, any disagreement
between the designees of BMS and Exelixis on the JDC, JCC, JRC or
JFC as to matters within such Committee’s jurisdiction shall,
at the election of either Party, be addressed, first, with the
Alliance Managers, and, if the dispute is not resolved within [
* ] after such referral to the Alliance Managers, then it
shall, upon written notice by a Party to the other, be submitted to
the JEC for resolution (except that (1) any disputes arising
from the JFC shall be submitted to the Committee to which such
dispute relates (i.e., the JRC, JDC, or the JCC), and
(2) prior to the creation of the JEC, disputes at the JRC
shall be referred to management of the Parties as set forth in the
following sentence). If the JEC (or JRC, prior to the creation of
the JEC) does not resolve any such matter submitted to it for
resolution within [ * ] after such submission, or in the
event of any disagreement between the designees of BMS and Exelixis
on the JEC (or JRC, prior to the creation of the JEC) with respect
to any other matter within its jurisdiction, then, subject to
Section 2.1(b) , the JEC (or JRC, prior to the creation
of the JEC) shall submit the respective positions of the Parties
with respect to such matter for discussion in good faith by the
Chief Executive Officer of Exelixis and either the Head of R&D
or Head of U.S. Operations of BMS (depending on the nature of the
dispute). If such individuals are not able to mutually agree upon
the resolution to such matter within [ * ] after submission
of the matter to them, then: (X) [ * ] , the [ *
] , subject to Section [ * ] ; [ * ] (Y)
[ * ] , the [ * ] , subject to Section [ * ]
.
(iv) [ * ] Decisions.
[ * ] right to [ * ]
pursuant to Section [ * ] ( “[ * ]
Decisions” ) shall be subject to the following
limitations:
(1) All [ * ] Decisions shall be made in good
faith, with due regard for the impact of such decisions on
Collaboration Compounds. No such decision by [ * ] shall
violate or breach any term or condition of this Agreement. [ *
] shall make all [ * ] Decisions only after [ * ]
(through its JEC or JRC members, as applicable) on such matters and
the proposed [ * ] Decision.
(2) [ * ] shall [ * ] : (A) on matters that
would [ * ] ; (B) on any decision that would [ *
] ; (C) any decision that would [ * ] ; (D) on
[ * ] ; (E) on which [ * ] (F) on [ *
] ; (G) on [ * ] for Collaboration Compounds within
the associated [ * ] ; (H) on [ * ] ;
(I) to [ * ] ; (J) on [ * ] in [ * ]
; (K) whether to [ * ] ; or (J) decisions
described in Section [ * ] . Resolution of disputes relating
to the foregoing matters shall [ * ] (except as otherwise
expressly set forth in this Agreement).
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(v) [ * ] Decisions.
[ * ] right to [ * ]
( “[ * ] Decisions” ) shall be subject to the
following limitations:
(1) All [ * ] Decisions shall be made in good
faith, with due regard for the impact of such decisions on Products
[ * ] , and, consistent in all material respects with the
applicable Approved Plan and the terms of this Agreement. No such
decision [ * ] shall violate or breach any term or condition
of this Agreement. [ * ] shall make all [ * ]
Decisions only after [ * ] (through its JEC or JRC members,
as applicable) on such matters and [ * ] , and in the case
of [ * ] Decision made pursuant to Section [ * ],
only after [ * ] and the [ * ] on such
matters.
(2) [ * ] shall [ * ] : (A) on any decision
that would [ * ] ; (B) any decision that would amend,
violate or breach any provision of this Agreement; (C) on
which [ * ] within the associated [ * ] ; (D) on
the decision to [ * ] (except to the extent provided for in
Section [ * ] ); (E) to adjust the [ * ] ;
(F) on the [ * ] ; (G) on matters related to the
determination of [ * ] ; or (H) whether [ * ] .
Resolution of disputes relating to the foregoing matters shall [
* ] (except as otherwise expressly set forth in this
Agreement).
(d) Meeting Agendas and
Minutes. Each Party shall
disclose to the other proposed agenda items along with appropriate
information at least [ * ] in advance of each meeting of the
applicable Committee; provided that under exigent
circumstances requiring Committee input, a Party may provide its
agenda items to the other Party within a shorter period of time in
advance of the meeting, or may propose that there not be a specific
agenda for a particular meeting, so long as such other Party
consents to such later addition of such agenda items or the absence
of a specific agenda for such Committee meeting.
(e) Multiple JDCs and JCCs at the
Discretion of the JEC .
The JEC may determine that a separate JDC and/or JCC be formed for
each Provisional Collaboration Program or Collaboration Program. In
such event, the Parties will appoint representatives to such
additional committees and such committees will be subject to the
all of the applicable terms and conditions of this Agreement with
respect to the JDC and the JCC, in each case, solely with respect
to the Provisional Collaboration Program or Collaboration Program
to which such Committees relate.
(f) Working Groups.
From time to time, the JEC,
JDC, JCC, JRC or JFC may establish and delegate duties to other
committees, sub-committees or directed teams (each, a “
Working Group ”) on an “as-needed” basis
to oversee particular projects or activities, which delegation
shall be reflected in the minutes of the meetings of the applicable
Committee. Each such Working Group shall be constituted and shall
operate as the JEC, JDC, JCC, JRC or JFC, as the case may be,
determines. The Working Groups may be established on an ad hoc
basis for purposes of a specific project, for the life of a
Product, or on such other basis as the applicable Committee may
determine. Each Working Group and its activities shall be subject
to the oversight, review and approval of, and shall report to, the
Committee that established such Working Group. In no event shall
the authority of the Working Group exceed that specified for the
relevant Committee in this Article 2 . Any disagreement
between the designees of BMS and Exelixis on a Working Group shall
be referred to the applicable Committee for resolution.
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(g) Interactions Between
Committees and Internal Teams. The Parties recognize that each Party possesses
an internal structure (including various committees, teams and
review boards) that will be involved in administering such
Party’s activities under this Agreement. Each Committee shall
establish procedures to facilitate communications between such
Committee or Working Group and the relevant internal committee,
team or board of each of the Parties in order to maximize the
efficiency of the Collaboration, including by requiring appropriate
members of such Committee to be available at reasonable times and
places and upon reasonable prior notice for making appropriate oral
reports to, and responding to reasonable inquiries from, the
relevant internal committee, team or board.
2.8 Alliance
Managers.
(a) Appointment.
Each of the Parties shall appoint a
single individual to act as a single point of contact between the
Parties to assure a successful Collaboration (each, an “
Alliance Manager ”). Each Party may change its
designated Alliance Manager from time to time upon written notice
to the other Party. Any Alliance Manager may designate a substitute
to temporarily perform the functions of that Alliance Manager by
written notice to the other Party.
(b) Responsibilities.
The Alliance Managers shall use good
faith efforts to attend all Committee meetings and support the
co-chairpersons of each Committee in the discharge of their
responsibilities. Alliance Managers shall be nonvoting participants
in such Committee meetings, unless they are also appointed members
of such Committee pursuant to Section 2.7(a) . An
Alliance Manager may bring any matter to the attention of any
Committee if such Alliance Manager reasonably believes that such
matter warrants such attention. Each Alliance Manager shall be
charged with creating and maintaining a collaborative work
environment within and among the Committees. In addition, each
Alliance Manager: (i) will be the point of first referral in
all matters of conflict resolution; (ii) will coordinate the
relevant functional representatives of the Parties in developing
and executing strategies and plans for the Products in an effort to
ensure consistency and efficiency throughout the world;
(iii) will provide a single point of communication for seeking
consensus both internally within the respective Parties’
organizations and between the Parties regarding key strategy and
plan issues; (iv) will identify and bring disputes to the
attention of the appropriate Committee in a timely manner;
(v) will plan and coordinate cooperative efforts and internal
and external communications (including the preparation of the
target status list described in Section 3.9 ); and
(vi) will take responsibility for ensuring that governance
activities, such as the conduct of required Committee meetings and
production of meeting minutes, occur as set forth in this
Agreement, and that relevant action items resulting from such
meetings are appropriately carried out or otherwise
addressed.
2.9 Collaboration
Guidelines.
(a) General.
Each Party, in working with the
other to Develop and Commercialize each Product and otherwise as
set forth herein, shall assign responsibilities for the various
operational aspects of the Collaboration to those portions of its
organization that have the appropriate resources, expertise and
responsibility for such functions and, consistent with this
Agreement, treat each Product as if it were a proprietary product
solely of its own organization. In all matters related to the
Collaboration, the Parties shall strive to balance as best they can
the legitimate interests and concerns of the Parties and to realize
the full economic potential of each Product (taking into account
the risks and costs of further Development and
Commercialization).
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(b) Independence.
Subject to the terms of this
Agreement, the activities and resources of each Party shall be
managed by such Party, acting independently and in its individual
capacity. The relationship between Exelixis and BMS is that of
independent contractors and neither Party shall have the power to
bind or obligate the other Party in any manner.
2.10 Reports Relating to
Reporting-Only Products. Beginning [ * ] after the first
existence of a Reporting-Only Product or a Royalty-Bearing Product,
and every [ * ] thereafter during the term of the Agreement,
BMS shall submit to Exelixis a written progress report [ * ]
the research and development performed by BMS on Reporting-Only
Products. If reasonably [ * ] for Exelixis to exercise its
rights under this Agreement, Exelixis may request that BMS provide
more detailed information and data regarding such reports by BMS,
and BMS shall promptly provide Exelixis with information and data
as is reasonably related to such request, at Exelixis’
expense. All such reports shall be considered Confidential
Information of BMS.
2.11 Overview of
Accounting.
(a) Development Costs and
Allowable Expenses. For
purposes of determining Development Costs and Allowable Expenses,
any expense allocated by either Party to a particular category
under Development Costs or Allowable Expenses for a particular
Co-Promotion Product shall not be allocated to another category
under Development Costs or Allowable Expenses for such Co-Promotion
Product. Each Party agrees to determine Development Costs and
Allowable Expenses for Co-Promotion Products using its standard
accounting procedures, consistently applied, to the maximum extent
practical as if such Co-Promotion Product were a solely owned
Product of such Party, except as specifically provided in this
Agreement. The Parties also recognize that such procedures may
change from time to time and that any such changes may affect the
definition of Development Costs or Allowable Expenses. The Parties
agree that, where such changes are economically material to either
Party, and consistent with GAAP, adjustments shall be made to
compensate the affected Party to preserve the same economics as
reflected under this Agreement under such Party’s accounting
procedures in effect as of the date on which the activity in
question (e.g., Development, Commercialization or Manufacturing)
first commences under this Agreement. Where the change is or would
be material to the other Party, the Party proposing to make the
change shall provide the other Party with an explanation for the
proposed change and an accounting of the effect of the change on
the relevant expense category. Should the Parties disagree on the
adjustment, the matter shall be placed before the JFC to resolve.
Transfers between a Party and its Affiliates (or between its
Affiliates) shall not have effect for purposes of calculating
revenues, costs, profits, royalties or other payments or expenses
under this Agreement.
(b) Affiliates.
If either Party enters into any
agreement with any of its Affiliates for the provision of materials
or services pursuant to this Agreement, all costs incurred for the
provision of such materials or services that are shared by the
Parties under this Agreement shall be accounted for on the basis of
the cost thereof to such Affiliate and not on the basis of any
higher transfer price in effect between such Party and such
Affiliate.
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2.12 Compliance with
Law. Each Party hereby
covenants and agrees to comply with applicable law in performing
its activities connected with the Development, manufacture and
Commercialization (as applicable) of each Product.
2.13 Records.
Each Party shall maintain complete
and accurate records of all work conducted under the Collaboration
and all results, data and developments made pursuant to its efforts
under the Collaboration. Such records shall be complete and
accurate and shall fully and properly reflect all work done and
results achieved in the performance of the Collaboration in
sufficient detail and in good scientific manner appropriate for
patent and regulatory purposes. Each Party shall maintain such
records for a period of [ * ] after such records are
created; provided that the following records may be maintained for
a longer period, in accordance with each Party’s internal
policies on record retention, provided that in no case shall such
period be shorter than [ * ] from the date of creation of
such records: (a) scientific notebooks; and (b) any other
records that the other Party reasonably requests be retained in
order to ensure the preservation, prosecution, maintenance or
enforcement of intellectual property rights. Either Party shall
have the right to review and copy such records of the other Party
at reasonable times to the extent [ * ] for it to conduct
its obligations or enforce its rights under this
Agreement
3.1 Overview.
(a) Programs.
During the Research Term, Exelixis
shall be responsible for conducting the [ * ] . Exelixis
will devote to each program similar resources (including comparably
qualified and experienced personnel) and funding as it does to
internal programs at a similar stage of discovery or pre-clinical
development, with the goal of delivering not less than six
(6) Provisional Collaboration Programs for possible exercise
by BMS of up to three (3) of its Co-Development
Options.
(b) BMS Co-Development
Option . BMS shall have
the [ * ] option to select each Provisional Collaboration
Program as a Collaboration Program for collaborative Development
and Commercialization under this Agreement (the
“Co-Development Option” ); provided,
however , that in no event would BMS be permitted to select
more than three (3) Collaboration Programs pursuant to this
Co-Development Option. The Co-Development Option shall be
exercisable solely in accordance with the remainder of this
Article 3 .
3.2 Screening
Programs.
(a) In General.
During each year of the Research
Term, as described in more detail below, Exelixis shall conduct
programs as part of the Collaboration (“ Screening
Programs ”) in which Exelixis will [ * ] . As of
the Execution Date, the Parties shall mutually agree to the initial
prioritized list of up to [ * ] Screening Targets for the
[ * ] Research Term, which shall be listed in Exhibit
3.2 . No later than at the last JRC meeting prior to the [ *
] ,
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Exelixis will share its list of planned
screening targets for the [ * ] Research Term and, within
[ * ] subsequent to the date upon which such planned
screening targets are shared, BMS shall select up to [ * ]
such prioritized targets as Screening Targets for the [ * ]
Research Term, which shall be added to the table described in
Section 3.9 ; provided that BMS may [ * ]
Screening Targets and up to [ * ] such targets [ * ]
Screening Targets by mutual agreement of the Parties. If at the
start of the [ * ] Research Term, or during any quarter
thereafter, and subject to Section 3.2(c) , the number
of Lead Op Candidates has dropped below [ * ] , then
Exelixis shall conduct at least [ * ] Screening Programs in
each subsequent calendar quarter, with the Screening Targets for
such new Screening Programs [ * ] or, [ * ] added to
the table described in Section 3.9 . Such [ * ]
shall continue until such time as either: (A) [ * ] ;
or (B) there [ * ] . Each quarter during the [ *
] Research Term, the JRC (by mutual agreement) may [ * ]
, in which case the Alliance Managers shall reflect such [ *
] pursuant to Section 3.9 .
(b) Completion of Screening; Lead
Op Candidates. After a
given Screening Program has become a Completed Screening Program,
[ * ] (such Completed Screening Program, if [ * ] ,
becomes a “ Lead Op Candidate ”). If the [ *
] , then the target(s) associated with such Lead Op Program
shall become a “ Lead Op Target(s) .” If the
[ * ] , not to maintain such Lead Op Candidate(s) within the
Collaboration, then the Screening Target(s) associated with such
advanced Screening Program shall no longer be Screening Target(s)
but shall instead be “ Rejected Screening Target(s)
”, subject to Section 8.6(b) . Otherwise, such
Lead Op Candidate(s) shall remain Lead Op Candidate(s) (pending a
future decision by: (i) [ * ] . For clarity, Exelixis
may, [ * ] , [ * ] (s) into a [ * ] , provided
that: (I) Exelixis will maintain an [ * ] (by mutual
agreement) [ * ] ; and (II) [ * ] will remain subject
to the terms and conditions of this Agreement, including without
limitation Section [ * ] ; provided that BMS may [ *
] at any time prior to the [ * ] , and (for clarity)
[ * ] be deemed to be either (1) [ * ] a Lead
Op Program pursuant to Section [ * ] , or (2) [ *
] with respect to such Lead Op Program for purposes of
Section [ * ] and or Section [ * ] .
(c) Removal of Lead Op
Candidates. Notwithstanding the Parties designation of a
Screening Program as a Lead Op Candidate, [ * ] may, at any
time after the number of Lead Op Candidates becomes greater than
[ * ] , designate a Lead Op Candidate as Rejected Screening
Target, except if such designation would reduce the number of Lead
Op Candidates below [ * ] .
3.3 Lead Op
Programs.
(a) In General.
During each [ * ] Research
Term, as described in more detail below, Exelixis shall conduct
programs as part of the Collaboration (“ Lead Op
Programs ”) in which Exelixis will optimize lead
compounds that were identified in Screening Programs for the
purpose of advancing a lead compound to Development Candidate
status. As of the Execution Date, the initial list of the [ *
] Lead Op Targets for the first year of the Research Term is
set forth in Exhibit 3.3 . These initial Lead Op Targets
shall serve as the targets for the Initial Lead Op Programs.
Additional Lead Op Targets shall be added to the table described in
Section 3.9 , which shall be updated by the Alliance
Managers pursuant to Section 3.9 . Exelixis shall use
Diligent Efforts to maintain and advance, [ * ] Lead Op
Programs on behalf of the Collaboration during the Research Term
[ * ] Lead Op Programs [ * ] Exelixis shall use
Diligent Efforts to
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maintain and advance [ * ] during the
[ * ] Research Term (such minimum Lead Op Programs,
“[ * ]” ). For clarity, Exelixis may, [ *
] , advance [ * ] Lead Op Candidate(s) into lead
optimization programs other than [ * ] , provided that such
lead optimization programs will remain subject to the terms and
conditions of this Agreement (as described in the last sentence of
Section 3.2(b) ).
(b) Completion of Lead Op
Programs. Once Exelixis
determines that a compound in any Lead Op Program has completed
lead optimization and has met the criteria of a Program Lead,
Exelixis will so notify BMS in writing and provide BMS with the
Development Candidate proposal including such information as
included in [ * ] and documenting the properties of such
Program Lead as per [ * ] (the “ DCP ”).
Within [ * ] of receiving the DCP, BMS shall notify Exelixis
in writing if BMS will [ * ] with respect to the Lead Op
Program that generated such Program Lead. If Exelixis receives
BMS’ notice stating that [ * ] , then the provisions
of Section [ * ] shall apply. Otherwise, Exelixis will
advance such Lead Op Program into preclinical development as a
Provisional Collaboration Program, and [ * ] on [ * ]
. The target(s) associated with each such Provisional Collaboration
Program shall no longer be Lead Op Target(s) but shall instead
automatically be a “ Collaboration Target(s)
.”
(c) Termination of Lead Op
Programs. If the JRC (by
mutual agreement) elects to terminate a Lead Op Program before the
lead compound in such Lead Op Program has completed lead
optimization, then, [ * ] . If no such [ * ] , or if
[ * ] , then Exelixis will [ * ] (subject to
Exelixis’ obligations to a Third Party that would [ *
] ), which program shall be [ * ] ; or (ii) in the
event that [ * ] . In any case, any such Lead Op Target(s)
associated with such a terminated Lead Op Program shall no longer
be Lead Op Target(s) but shall instead automatically be a “
Rejected Lead Op Target(s) ”, subject to
Section 8.6(e) .
(d) Limited Replacement of Lead
Op Programs. At any time
prior to the date which is [ * ] subsequent to the delivery
by Exelixis of the DCP with respect to a given Lead Op Program in
accordance with Section 3.3(b) , [ * ] replace
such Lead Op Program, [ * ] , with any of the following:
(i) [ * ] for which Exelixis [ * ] ; (ii)
[ * ] ; or (iii) a [ * ] . [ * ] shall
cease after [ * ] . The target(s) associated with each such
former Lead Op Program shall no longer be Lead Op Target(s) but
shall instead automatically be “ Rejected Lead Op
Target(s) ”, subject to Section 8.6(e)
.
3.4 Provisional Collaboration
Programs; Exercise of BMS’ Co-Development
Option.
(a) In General.
Exelixis shall conduct programs as
part of the Collaboration in which Exelixis pre-clinically develops
compounds (that were identified as Program Leads in Lead Op
Programs) with the goal of submitting an IND on such compound where
such IND meets the criteria for clinical development that is
consistent with Exelixis’ internal criteria for all Exelixis
programs (including programs outside of the Collaboration) and,
where reasonably possible, takes into account the [ * ]
(such programs, “Provisional Collaboration Programs
”). BMS [ * ] activities (for purposes of [ * ]
) that were [ * ] , including one or more of the following:
[ * ] as needed to help [ * ] for Provisional
Collaboration Programs [ * ] . [ * ] solely for use
[ * ] described in this Section 3.4(a)
.
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(b) Exercise of BMS’
Co-Development Option .
Once Exelixis determines that [ * ] , Exelixis will provide
to BMS written notice and a data package (containing data not
already in BMS’ possession) with sufficient detail regarding
such Collaboration Compound (and any Program Backups) as per
Exelixis’ internal standards and incorporating data
applicable to the [ * ] . Upon receipt of each such data
package, BMS will have [ * ] to notify Exelixis in writing
whether BMS exercised its Co-Development Option with respect to the
Provisional Collaboration Program to which such Collaboration
Compound relates; provided that such [ * ] . For clarity,
BMS may exercise its Co-Development Option at any time prior to
such date, including [ * ] .
(i) Acceptance.
If Exelixis receives BMS’
notice (within the applicable [ * ] period) stating that BMS
exercised its Co-Development Option for a given Provisional
Collaboration Program, then such Provisional Collaboration Program
shall become a “Collaboration Program” , and the
provisions of Section 3.7 shall apply, and BMS shall be
responsible for submitting the IND for such Collaboration
Program’s Lead Compound (and other applicable regulatory and
clinical documents).
(ii) Rejection.
If Exelixis receives BMS’
notice (within the applicable [ * ] period) stating that BMS
did not exercise its Co-Development Option for a given Provisional
Collaboration Program, or if Exelixis did not receive BMS’
notice within the applicable [ * ] period, then in either
case, the provisions of Section 3.8 shall apply, and
BMS shall not be responsible for submitting the IND for such
Provisional Collaboration Program’s Lead Compound (and other
applicable regulatory and clinical documents).
(iii) [ * ].
If Exelixis receives BMS’
notice (within the applicable [ * ] period) stating that
[ * ] its Co-Development Option for a given Provisional
Collaboration Program, [ * ] set forth in such notice, then
Exelixis may [ * ] . Alternatively, Exelixis may [ *
] . If the [ * ] for such Lead Compound, then Exelixis
may elect to either (i) [ * ] or (ii) [ *
] . If the [ * ] for such Provisional Collaboration
Program’s Lead Compound, then Exelixis will so notify BMS in
writing. BMS will [ * ] . Upon receipt of such notice from
BMS, the provisions of Section [ * ] shall apply if Exelixis
received BMS’ notice (within the applicable [ * ]
period) stating that [ * ] , or Section [ * ] shall
apply if either (A) [ * ] , or (B) [ * ]
.
3.5 Backup
Compounds.
(a) Provisions Relating to
BMS’ Exercise of its Co-Development Option.
If BMS does not exercise its
Co-Development Option with respect to a Provisional Collaboration
Program by the applicable deadline, then Exelixis shall retain all
right, title and interest in all compounds generated for such
Provisional Collaboration Program, subject to [ * ] . If BMS
does exercise its Co-Development Option with respect to a
Provisional Collaboration Program, then any compounds generated for
such Provisional Collaboration Program (or Lead Op Program that
became such Provisional Collaboration Program) that satisfy the
definition of a Program Backup shall become part of the
Collaboration Program, and, subject to Section 8.1(d) ,
neither Party shall use any such compounds for any purpose outside
of the Collaboration without the prior written consent of the other
Party. The compounds generated for such Provisional Collaboration
Program (or Lead Op Program that became such Provisional
Collaboration Program) that do not
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satisfy the definition of Program Backups shall
become Unrelated Compounds, and Exelixis shall be free to use such
Unrelated Compounds outside of the Collaboration, subject to
Section 8.6. For clarity, BMS shall pay Exelixis the
milestone payments described in Section 9.5 for Program
Backups that are Royalty-Bearing Products and that meet the
applicable milestone events.
(b) Provisions Relating to
Exercise of the Exelixis Co-Development Option.
In the event that Exelixis has
exercised the Exelixis Co-Development Option with respect to a
Collaboration Program, then the following terms shall apply with
respect to Backup Programs:
(i) Commencement of a Backup
Program. The Parties
shall determine, via the JDC, whether or not to commence a backup
program (a “Backup Program” ) with respect to
some or all of the Collaboration Programs, as well as the
appropriate timing for such Backup Program(s). The Backup
Program(s) shall be subject JDC oversight and decision making and
to a Backup Research Plan to be established by the JDC prior to the
start of backup work.
(ii) Exelixis Conduct of Backup
Programs. Exelixis shall
have the first right to conduct such backup work up until
designation of a backup compound as a Development Candidate and
shall promptly notify the JDC in writing whether Exelixis will
conduct such Backup Program. Upon designation of a backup compound
as a Development Candidate, the JDC shall determine [ * ]
(with [ * ] , in any case, having the right to perform [
* ] . In the event that [ * ] work on Backup Programs
for Collaboration Programs shall be [ * ] , to the extent
such work is incurred and with reimbursement on a quarterly basis,
up to [ * ] Dollars ($ [ * ] ) per Backup Program
(such amount, the “ [ * ] Backup Funding ”);
provided, however , that: (A) such [ * ] Backup
Funding shall not be deemed to be [ * ] (except as set forth
below); and (B) any costs associated with such Backup Program
that are in excess of [ * ] shall be [ * ] .
Notwithstanding clause (A) above, [ * ] , then the [
* ] Backup Funding [ * ] .
(iii) BMS Conduct of Backup
Programs. If Exelixis
notifies BMS that Exelixis will not conduct such Backup Program, or
in the event that Exelixis opts-out of co-Development with respect
to such Collaboration Program, then BMS may conduct such Backup
Program and such any costs associated with such Backup Program
shall be [ * ] and shall be [ * ] . Exelixis will
transition to BMS any necessary [ * ] and other know-how
necessary or reasonably useful for BMS to conduct such Backup
Program.
(iv) Reporting and
Accounting. Except as set
forth in paragraph (ii) above, reporting and accounting of
shared costs for the Backup Programs shall be as set forth in
Section 4.6 for Development Costs.
3.6 Information Exchange; [ * ];
and Identified Targets.
(a) Information Exchange and [ *
]. BMS, through the JRC,
shall be allowed to review data from Screening Programs, Lead Op
Programs and Provisional Collaboration Programs on a [ * ]
basis, excluding any [ * ] relating to any compounds in
any
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such Screening Programs, Lead Op Programs or
Provisional Collaboration Programs (unless the Parties expressly
agree in writing to disclosure of such [ * ] ; [ * ]
). Once a Lead Op Program or Provisional Collaboration Program
contains a Program Lead, BMS shall be notified and may at any time
(or from time to time) thereafter (with reasonable prior written
notice) request that Exelixis provide [ * ] with the
following information solely for the purpose of [ * ] :
(i) a summary describing the [ * ] such Program Lead;
(ii) the [ * ] ; (iii) a list of [ * ] ;
and (iv) any other information reasonably requested by BMS and
in the possession of Exelixis. In the event that BMS has not
provided written request for disclosure, or has only made written
request for disclosure [ * ] , then Exelixis shall at all
times [ * ] . BMS may make suggestions with respect to the
direction or conduct of a Screening Program, Lead Op Program or
Provisional Collaboration Program, but Exelixis shall retain all
authority over the conduct of such program (subject to Sections
3.2(b), 3.3(c), 3.3(d), 3.4(a) and 3.5 ). To maximize the
probability that a Provisional Collaboration Program will be
ultimately accepted by BMS, Exelixis shall give good faith
consideration to the [ * ] (the “[ * ]” )
and shall endeavor through the JRC to work with BMS to [ * ]
; provided, however, that Exelixis shall not be required to [ *
] . It is expected that both Parties will work closely together
through the JRC to discuss and to endeavor to jointly establish the
[ * ] .
(b) Identified Targets, Potency
Threshold and Specificity Criteria.
(i) Determination.
For each Lead Op Program,
Provisional Collaboration Program and Collaboration Program (as
applicable), the JRC or the JDC (or the Parties in the case of a
Collaboration Program with respect to which Exelixis has exercised
a Product Opt-Out) shall determine: (A) whether the definition
of Identified Target(s) for each applicable Lead Op Program,
Provisional Collaboration Program and Collaboration Program need to
be [ * ] ; and/or (B) whether the definition of the
Target Potency Threshold and/or Specificity Criteria need to be
[ * ] . If so, the Parties shall do so by mutual agreement
and in writing through a separate side letter. The JRC, JDC or the
Parties (as the case may be) shall also specify [ * ] If the
Parties mutually agree that the definitions of Identified
Target(s), Target Potency Threshold or Specificity Criteria (as
applicable) [ * ] . If the Parties mutually agree that the
definitions of Identified Target(s), Target Potency Threshold or
Specificity Criteria (as applicable) [ * ] , then Exelixis
may [ * ] the Collaboration as [ * ] to the extent
such [ * ] (as applicable), and subject to [ * ]
.
(ii) Party Resolution of
Disputes. If the JRC or
JDC (or the Parties, as the case may be) is unable to agree on the
definition of Identified Target(s), Target Potency Threshold or
Specificity Criteria (as applicable) at the applicable JRC or JDC
meeting (or other meetings and correspondence between the Parties),
including as to whether such definition(s) need revision, then the
Parties shall try to settle their differences amicably between
themselves first, by referring the disputed matter to the
Party’s respective Executive Officers. Either Party may
initiate such informal dispute resolution by sending written notice
of the dispute to the other Party, and, within [ * ] after such
notice, such Executive Officers shall meet for attempted resolution
by good faith negotiations. If such Executive Officers are unable
to resolve such dispute within [ * ] of their first meeting for
such negotiations, then the Parties shall proceed to dispute
resolution pursuant to Section 3.6(c)(iii).
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(iii) Arbitration of
Disputes. Any dispute not
resolved internally by the Parties pursuant to
Section 3.6(b)(ii) must be finally resolved through binding
arbitration by JAMS (formerly, the Judicial Arbitration and
Mediation Service) (“JAMS”) in accordance with its
Streamlined Arbitration Rules and Procedures in effect at the time
the dispute arises, except as modified in this Agreement and
applying the substantive law specified in Section 15.2. Either
Party may initiate arbitration under this Section 3.6(b)(iii)
by written notice to the other Party of its intention to arbitrate,
and such notice shall specify in reasonable detail the nature of
the dispute. For each arbitration: (A) each Party shall submit
to the arbitrator its proposal for resolving such dispute, such
proposal based on the applicable scientific factors, and shall
provide a copy of such proposal to the other Party; (B) each
Party may, within [ * ] of receipt of the other Party’s
proposal, provide a rebuttal to such other Party’s proposal
to the arbitrator (which rebuttal shall be limited to responding to
arguments or scientific evidence presented in such other
Party’s proposal), and shall provide a copy of such rebuttal
to the other Party; (C) the arbitrator shall select the
proposal that is the most scientifically reasonable; and
(D) such proposal shall become the new definition of
Identified Target(s), Target Potency Threshold or Specificity
Criteria (as applicable). Notwithstanding anything to the contrary,
the arbitrators will not have the ability to change the terms of
either Party’s proposal. The determination of the arbitrator
shall be final. The arbitration proceedings shall be conducted in
such location as determined by the arbitrator. The Parties agree
that they shall share equally the cost of the arbitration filing
and hearing fees, and the cost of the arbitrator. Each Party shall
bear its own attorneys’ fees and associated costs and
expenses.
3.7 Acceptance of Collaboration
Programs . In the event
that BMS timely exercises its Co-Development Option with respect to
a Provisional Collaboration Program, then such Provisional
Collaboration Program shall become a Collaboration Program, and
each of the following shall apply:
(a) Payment.
BMS shall pay the fee set forth in
Section 9.2 .
(b) [ * ] CMC
Responsibilities . If not
already completed (i.e., [ * ] ), [ * ] shall:
(i) complete the Chemistry, Manufacturing and Control (“
CMC ”) portion of an IND submission package for each
Collaboration Compound approved for IND submission (as well as such
other sections of the IND submission package as may be reasonably
required of it); and (ii) complete any pre-IND toxicity
testing and other testing reasonably required to file an IND for
the applicable Collaboration Compound.
(c) Exelixis Co-Development
Option. Exelixis shall
provide written notice to BMS, within [ * ] after the
acceptance of such Collaboration Program by BMS, as to whether or
not Exelixis will exercise its option to Co-Develop with BMS the
Lead Compound arising from such Collaboration Program (the “
Exelixis Co-Development Option ”). In the event
Exelixis declines to exercise its right to Co-Develop such Lead
Compound, Exelixis shall lose any right to Co-Develop and
Co-Promote any Product containing such Lead Compound and any
subsequent Products or Related Products generated from such
Collaboration Program.
(d) Transfer.
Exelixis shall use Diligent Efforts
to transfer to BMS within [ * ] of BMS’ exercise of
its Co-Development Option: (i) reasonable quantities of the
relevant Lead
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Compound; (ii) all Information reasonably
necessary for the further development and commercialization of such
Collaboration Program’s Lead Compound; (iii) all
regulatory filings (including any INDs, drug dossiers, and drug
master files) in Exelixis’ name for such Lead Compound;
(iv) any agreements with Third Parties necessary for the
further development and commercialization of such Collaboration
Program’s Lead Compound (including any agreements relating to
the conduct of the Phase I Clinical Studies of such Lead Compound);
and (v) any trademark rights Controlled by Exelixis covering
such Collaboration Program’s Lead Compound, that in each case
((i) through (v)) are existing, in Exelixis’ Control, and
specifically relate to such Lead Compound. The costs and expenses
incurred by Exelixis in carrying out such transfer shall be either:
(A) treated as Development Expenses in the event that such
expenses relate to a Co-Developed Product, or (B) reimbursed
one hundred percent (100%) by BMS in the in the event that
such expenses relate to a Royalty-Bearing Product. For clarity,
Exelixis’ transfer of Manufacturing-related rights and
materials shall be governed by Section 7.3 .
3.8 Rejection of Provisional
Collaboration Programs .
In the event that BMS declines to exercise its Co-Development
Option with respect to a Provisional Collaboration Program, or if
Exelixis does not receive BMS’ notice of exercising its
Co-Development Option with respect to a Provisional Collaboration
Program, then each of the following shall apply:
(a) Reversion of
Rights. All rights with
respect to such Provisional Collaboration Program shall
automatically revert to Exelixis, and BMS shall have no further
rights with respect to the Development or Commercialization of any
compounds (including Program Backups) by Exelixis under such
Provisional Collaboration Program ( [ * ] .
(b) Expiration of
Rights . Without limiting
the generality of Section 3.8(a) , Exelixis’
obligations, and BMS rights, under Sections 3.1, 3.4(a) (to
the extent applicable), and 3.6 shall expire with respect to
such Provisional Collaboration Program.
(c) Phase I Clinical Trial
Requirement. [ * ]
shall be required to use Diligent Efforts to commence a Phase I
Clinical Trial with respect to such Provisional Collaboration
Program within [ * ] subsequent to acceptance of an IND with
respect to such Provisional Collaboration Program. For purposes of
this Section 3.8(c) , “ commence a Phase I
Clinical Trial ” means that the first site at which such
clinical trial will be conducted has received approval from the
appropriate investigational review board (“ IRB
”) and is ready to enroll patients.
(d) Transfer &
Transition. If BMS
conducted any work on such Provisional Collaboration Program
pursuant to Section 3.4(a) , then BMS shall:
(i) provide to Exelixis all data generated by BMS with respect
to the studies undertaken by it; (ii) grant to Exelixis the
license set forth in Section 8.2(c) ; and
(iii) transition over to Exelixis any ongoing studies then
being conducted by BMS (with Exelixis to assume the cost therefore
from and after the date that BMS transfers such studies). With the
prior written agreement of the Parties, BMS may complete any of the
ongoing studies described in the foregoing clause (iii) at
Exelixis’ expense.
(e) [ * ].
For any compound arising out of a
Provisional Collaboration Program that [ * ] (a “ [
* ] ”), if Exelixis decides to [ * ] prior to [
* ] (whichever occurs first) for such [ * ] , then [
* ] . During the [ * ] , [ * ] . If [ * ]
at or before the end of such [ * ] (or at such earlier time
that [ * ] ), then [ * ] .
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Nothing herein shall preclude [ * ] ,
including with the goal of [ * ] , and any such work shall
not [ * ] , unless otherwise agreed by the Parties in
writing. Additionally, if BMS declines to exercise its
Co-Development Option with respect to a Provisional Collaboration
Program, then any [ * ] as the Provisional Collaboration
Program [ * ] shall not [ * ] .
3.9 Target Status List
. Based on the applicable minutes
from each JRC and JDC meeting, the respective Alliance Managers
shall prepare a list that is substantially in the form of
Exhibit 3.9 and that shall reflect the status of each target
that is active (or was at one time) within the Collaboration. Each
target shall be labeled with one of the following: Screening Target
(chosen-awaiting-screening); Screening Target (screen-in-progress);
Rejected Screening Target; Lead Op Candidate; Lead Op Target;
Rejected Lead Op Target; or Collaboration Target. The updated
target list shall be attached to all JRC and JDC minutes with
written confirmation provided in a timely manner by the Alliance
Managers.
3.10 Research Term.
The “ Research Term
” shall commence on the Effective Date and continue until the
earliest to occur of the following: (a) [ * ] ; or
(b) delivery to BMS of the [ * ] for possible exercise
of its Co-Development Option. The Parties may extend the Research
Term upon their mutual written agreement. Following the end of the
Research Term, Exelixis shall have no obligation to conduct any
work under any Screening Programs, Lead Op Programs, Provisional
Collaboration Programs and Collaboration Programs (other than
Exelixis’ responsibilities, as set forth in the remainder of
this Agreement, with respect to Co-Developed Products and Backup
Programs for Collaboration Targets), and all rights with respect to
Lead Op Candidates, Lead Op Targets and Collaboration Compounds,
other than Collaboration Compounds included in a Collaboration
Program for which BMS has exercised its Co-Development Option under
Section 3.4 , and in any case subject to
Section 3.8(e) , shall revert to Exelixis.
3.11 Record of Discovery Efforts;
Inspection. Exelixis
shall keep complete, true and accurate books of accounts and
records for the purpose of determining the resources and funding
that Exelixis provides pursuant to Section 3.1 . All
such books, records and accounts shall be retained by Exelixis for
a period of [ * ] after the end of the period to which such
books, records and accounts pertain or such longer period as may be
required by applicable law. BMS shall have the right to have an
independent certified public accountant, reasonably acceptable to
Exelixis, have access during normal business hours, and upon
reasonable prior written notice, to examine only those records of
Exelixis as may be reasonably necessary to determine, with respect
to any calendar year ending not more than [ * ] prior to
such Party’s request, Exelixis’ compliance with the
requirements of Section 3.1 . The foregoing right of
review may be exercised only once per year and only once with
respect to any given period. Results of any such examination shall
be: (i) limited to information relating to the applicable
Screening Program, Lead Op Program, Provisional Collaboration
Program or Collaboration Program; (ii) made available to both
Parties; and (iii) subject to Article 11 . In general,
BMS shall bear the full cost of the performance of any such audit.
However, if such audit discloses a [ * ] to the applicable
Screening Program, Lead Op Program, Provisional Collaboration
Program or Collaboration Program, [ * ] (as determined by
the auditor(s)), then Exelixis shall bear the full cost of the
performance of such audit. The results of such audit shall be
final, absent manifest error.
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[ * ] =
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Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24B-2 of the Securities
Exchange Act of 1934, as amended.
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36
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4.
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DEVELOPMENT
OF PRODUCTS
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4.1 Global Development
Plans.
(a) Scope.
The Development of each Co-Developed
Product shall be governed by a comprehensive, multi-year, worldwide
plan (each, a “Global Development Plan” )
covering the Development of such Product for use in the U.S.,
Canada, each of the Major European Countries and Europe as a whole,
and, broken out on a region-by-region or country-by-country basis
only to the extent BMS does so for its own internal oncology
products, the remaining countries in the Co-Development Territory.
Each Global Development Plan shall: (i) provide a planned
Development p