EXHIBIT 10.35
[ * ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
COLLABORATION
AGREEMENT
T HIS C OLLABORATION A GREEMENT (the “ Agreement ”) is made
and entered into as of December 5, 2005 (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 developing and marketing human
pharmaceuticals and has research and development programs,
including expertise and proprietary technology relating to
compounds that modulate the Liver X Receptor.
B. Exelixis is a drug discovery company that has
expertise and proprietary technology relating to compounds that
modulate the Liver X Receptor.
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, 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:
1. DEFINITIONS
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.
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1.2 “Alliance
Manager” has the
meaning set forth in Section 2.4(a).
1.3 “ANDA”
means an Abbreviated New Drug
Application filed with the FDA in conformance with applicable laws
and regulations, or the foreign equivalent of any such application
in any other country.
1.4 “BMS
Compound” means:
(a) those LXR Modulators or Dual LXR/FXR Modulators that are
set forth in the Disclosure Letter and that are being contributed
to the Collaboration by BMS as of [ * ] ; (b) any LXR
Modulators or Dual LXR/FXR Modulators that are contributed to the
Collaboration by BMS [ * ] at [ * ] and subject to
[ * ] ; and (c) [ * ] .
1.5 “BMS Decision Point
4.5” or
“BMS DP 4.5” means the point at which BMS
determines that [ * ] .
1.6 “BMS Independent
Activity Period” means the period, if any, commencing on the date
[ * ] and ending on the first to occur of: (a) the date
that [ * ] ; or (b) [ * ] .
1.7 “BMS
Know-How” means all
Information Controlled by BMS (other than BMS Patents) and its
Affiliates [ * ] that is: (a) [ * ] for
Exelixis to exercise the rights licensed or granted to it under
Sections 10.4(d)(i) and 10.4(d)(ii); and/or (b) [ * ]
: (i) to perform its obligations to the Collaboration under
this Agreement; and (ii) for Exelixis to exercise the rights
licensed or granted to it under Sections 5.3, 10.4(d)(iii) and
10.4(d)(iv).
1.8 “BMS
Patents” means all
Patents Controlled by BMS and its Affiliates, including Patents
Controlled jointly with Exelixis, [ * ] that are: (a)
[ * ] for Exelixis to exercise the rights licensed or
granted to it under Sections 10.4(d)(i) and 10.4(d)(ii); and/or
(b) [ * ] : (i) to perform its obligations to the
Collaboration under this Agreement; and (ii) for Exelixis to
exercise the rights licensed or granted to it under Sections 5.3,
10.4(d)(iii) and 10.4(d)(iv).
1.9
“Collaboration” means all the activities performed by or on
behalf of either Exelixis or BMS in the course of performing work
contemplated in Article 2.
1.10 “Collaboration
Compound” means
any: (a) Exelixis Compound; (b) BMS Compound;
(c) Derivative that is identified or created by [ * ] ;
(d) Derivative that is identified or developed by [ * ]
; or (e) Derivative that is identified or developed by [ *
] . For clarity, Collaboration Compounds exclude [ * ]
.
1.11 “Collaborative
Research Period” has the meaning set forth in
Section 2.5.
1.12
“Committee” means either of the Joint Research Committee or
the Discovery Working Group, as the case may be.
1.13 “Competitive
Compound” means any
Small Molecule Compound, [ * ] that directly binds and
modulates LXR [ * ] based on displaying [ * ]
.
1.14
“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
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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.
1.15
“Derivatives” means all: (a) LXR Modulators or Dual
LXR/FXR Modulators that are made [ * ] ; and (b) [
* ] .
1.16 “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) promptly assign
responsibility for such obligations to specific employee(s) who are
held accountable for progress and monitor such progress on an
on-going basis, (b) set and consistently seek to achieve
specific and meaningful objectives for carrying out such
obligations, and (c) consistently make and implement decisions
and allocate resources designed to advance progress with respect to
such objectives.
1.17 “Disclosure
Letter” means one
or more mutually agreed written letters or memoranda that are
delivered by each of Exelixis and BMS to the other
contemporaneously with the execution of this Agreement and are
identified therein as a Disclosure Letter contemplated by this
Agreement and any amendments or replacement thereof approved in
writing by both Parties.
1.18 “Discovery Working
Group” or
“DWG” means the committee described in
Section 2.2(d).
1.19
“Dollars” or
“$” means the legal tender of the United States
of America.
1.20 “Dual LXR/FXR
Modulator” means
any Small Molecule Compound that: (a) directly binds and
modulates LXR and FXR [ * ]; and (b) [ * ] based on displaying
[ * ].
1.21 “ECN”
or “Early Candidate
Nomination” means a compound or other substance that has
been approved by BMS [ * ] . This decision point is known
within BMS as “ Decision Point 3.0 ” or “
DP3.0 ”. This decision point is typically made [ *
] prior to [ * ] . For such a transition to be
considered, the relevant scientific submissions for such compound
shall generally need to include: [ * ] . For clarity, not
all [ * ] shall be necessarily completed at DP3.0; however,
all such [ * ] must be completed before a decision to [ *
] can be reached. Typically, the [ * ] shall also be
[ * ] .
1.22 “Effective
Date” has the
meaning set forth in Section 11.6.
1.23 “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
Effective Date are Belgium, Denmark, Germany, Greece, Spain,
France, Ireland, Italy, Luxembourg, Netherlands, Austria, Portugal,
Finland, Sweden, the United Kingdom, Estonia, Latvia, Lithuania,
Poland, the Czech Republic, Slovakia, Hungary, Slovenia, Malta, and
Cyprus.
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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1.24 “Exelixis
Compounds” mean:
(a) those LXR Modulators or Dual LXR/FXR Modulators that are
set forth in the Disclosure Letter and that are being contributed
to the Collaboration by Exelixis as of [ * ] ; (b) any
LXR Modulators or Dual LXR/FXR Modulators that are contributed to
the Collaboration by Exelixis [ * ] at [ * ] and
subject to [ * ] ; and (c) [ * ] .
1.25 “Exelixis
Know-How” means all
Information Controlled by Exelixis (other than Exelixis Patents)
and its Affiliates [ * ] that is [ * ] for BMS to
exercise the rights licensed or granted to it under Sections 5.1
and 10.4 hereof and/or to perform its obligations to the
Collaboration under this Agreement.
1.26 “Exelixis
Patents” means all
Patents Controlled by Exelixis and its Affiliates, including
Patents Controlled jointly with BMS, as of [ * ] that are
[ * ] for BMS to exercise the rights licensed or granted to
it under Sections 5.1 and 10.4 hereof and/or to perform its
obligations to the Collaboration under this Agreement. It is
understood and agreed that “Exelixis Patents” include,
without limitation, those issued and published Patents listed on
Schedule 1.26 .
1.27 “Exelixis Prosecuted
Patents” has the
meaning set forth in Section 8.3(a)(i).
1.28 “FDA”
means the United States Food and
Drug Administration, and any successor thereto.
1.29 “FTE”
means the equivalent of a full-time
scientist’s work time over a twelve (12) month period
(including normal vacations, sick days and holidays). The portion
of an FTE year devoted by a scientist to a particular activity or
program shall be determined by dividing the number of full working
days during any twelve (12) month period devoted by such
scientist to such activity or program by the total number of
working days during such twelve (12) month period.
1.30 “FXR”
means: (a) the gene for the
Farnesoid X Receptor (for any species); (b) the protein
encoded by such gene; and (c) all subtypes, mutants, variants
and fragments thereof.
1.31 “Generic
Product” means,
with respect to a particular Product in a country, a pharmaceutical
product that: (a) contains the same Collaboration Compound(s)
as such Product (or equivalent as determined by the relevant
regulatory authority); and (b) is approved for use in such
country (pursuant to 21 U.S.C. 355(b)(2), an ANDA, a separate NDA,
compendia listing, other drug approval application or otherwise),
whether for use as monotherapy or for use in combination with any
other vaccine, biologic or compound.
1.32 “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.
1.33 “IND”
means an Investigational New Drug
Application filed with the FDA in conformance with applicable laws
and regulations, or the foreign equivalent of any such application
in any other country.
1.34
“Information” means information, results and data of any type
whatsoever, in any tangible or intangible form whatsoever,
including, databases, practices, methods, techniques,
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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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.
1.35
“Invention” means any and all inventions and improvements
thereto, invented or discovered by a Party in the performance of
its obligations under this Agreement.
1.36 “Joint
Invention” means
any Invention invented or discovered jointly by employee(s) or
agent(s) of both Parties.
1.37 “Joint Research
Committee” or
“JRC” means the committee described in
Section 2.2(a).
1.38
“Knowledge” means, with respect of a Party, the good faith
understanding of the facts and information in the possession of an
officer of such Party, or any in-house legal counsel of, or
in-house Patent agents employed by, such Party or its Affiliates,
without any duty to conduct any additional investigation with
respect to such facts and information by reason of the execution of
this Agreement. For purposes of this definition, an
“officer” means any person in the position of
vice president, senior vice president, president or chief executive
officer of a Party.
1.39
“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
1.40 “Lead
Compound” means the
Exelixis Compound set forth in the Disclosure Letter.
1.41 “Listed
NHR” means:
(a) the genes (for any species) for any nuclear hormone
receptors listed in Schedule 1.41 as of the Effective Date;
(b) the genes (for any species) for any nuclear hormone
receptors added to Schedule 1.41 after the Effective Date
pursuant to Section 2.6(c); (c) the proteins encoded by
such genes described in subsections (a) and (b); and
(d) all subtypes, mutants, variants and fragments thereof.
Notwithstanding anything to the contrary, Listed NHRs do not
include FXR in conjunction with LXR as contemplated by this
Agreement.
1.42 “LXR”
means: (a) the gene for the
Liver X Receptor (for any species); (b) the protein encoded by
such gene; and (c) all subtypes (including the alpha and beta
subtypes), mutants, variants and fragments thereof.
1.43 “LXR
Modulator” means
any Small Molecule Compound that: (a) directly binds and
modulates LXR [ * ] but not FXR; and (b) [ * ]
based on displaying [ * ] .
1.44 “Major Market
Countries” means [
* ].
1.45 “Major
Territory” means
each of the following territories: [ * ] .
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1.46 “NDA”
means a New Drug Application filed
with the FDA in conformance with applicable laws and regulations,
or the foreign equivalent of any such application in any other
country.
1.47 “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, 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 U.S. generally
accepted accounting principles, consistently applied, during the
applicable royalty calculation period; and (f) 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 for royalty purposes hereunder, any discount on such Products
sold under such an arrangement shall be no greater, on a percentage
basis based on the gross selling price prior to discount, than the
largest percentage discount applied on any other ethical
pharmaceutical product sold within such bundled arrangement for the
applicable accounting period. In case of any dispute as to the
applicable discount numbers under the preceding sentence, the
determination of same shall be calculated and certified by
BMS’ independent public accountants, whose decision shall be
binding.
A sale of a Product is deemed to
occur upon invoicing In the event that BMS, after reasonable
efforts, cannot calculate accurately the Net Sales of a sublicensee
in a particular country, the Parties shall meet and negotiate in
good faith an appropriate means for calculating Net Sales in such a
situation.
For sake of clarity and avoidance of
doubt, sales by BMS, its Affiliates or sublicensees of a Product to
a Third Party distributor of such Product in a given country shall
be considered a sale to a Third Party customer. Any Products used
(but not sold for consideration) for promotional or advertising
purposes or used for clinical or other research purposes shall not
be considered in determining Net Sales hereunder.
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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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
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 ”.
1.48 “Non-LXR
Modulator” means
any: (a) Small Molecule Compound that is identified or created
by [ * ] by [ * ] and that is not an LXR Modulator or
a Dual LXR/FXR Modulator; (b) Small Molecule Compound that:
(i) is identified or developed by [ * ] , through [
* ] ; and (ii) is not an LXR Modulator or a Dual LXR/FXR
Modulator; and [ * ] .
1.49
“Patent” means all: (a) unexpired letters patent
(including inventor’s certificates) 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 applications; and (c) any international
counterparts to (a) and (b) above.
1.50 “Phase I Clinical
Trial” means a
trial on sufficient numbers of normal volunteers and patients that
is designed to establish that a pharmaceutical product is safe for
its intended use, and to support its continued testing in Phase IIa
Clinical Trials.
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1.51 “Phase IIa Clinical
Trial” means a
trial on sufficient numbers of patients that is designed to provide
a preliminary determination of safety and efficacy in the target
patient population over a range of doses. For sake of clarity, [
* ] .
1.52 “Phase IIb Clinical
Trial” means a
controlled clinical trial which utilizes the pharmacokinetic and
pharmacodynamic information obtained from one (1) or more
previously conducted Phase I Clinical Trial(s) and/or Phase IIa
Clinical Trial(s) in order to confirm the optimal manner of use of
a pharmaceutical product (dose and dose regimen) prior to
initiation of the pivotal Phase III Clinical Trials of such
pharmaceutical product. [ * ] .
1.53 “Phase III Clinical
Trial” means a
trial on sufficient numbers of patients that is designed to
establish that a pharmaceutical product is safe and efficacious for
its intended use, and to define warnings, precautions and adverse
reactions that are associated with the pharmaceutical product in
the dosage range to be prescribed, and to support Regulatory
Approval of such pharmaceutical product or label expansion of such
pharmaceutical product.
1.54 “Post-Termination
Compound” means:
(a) any Competitive Compound for which BMS, its Affiliate or
sublicensee [ * ] subsequent to expiration of the
Collaborative Research Period; or (b) any LXR Modulator or a
Dual LXR/FXR Modulator for which BMS [ * ] . For clarity,
Post-Termination Compounds shall not include: [ * ] ; and
[ * ] .
1.55
“Product” means any therapeutic or prophylactic product
(for use in animals or humans) that comprises or incorporates any:
(a) Collaboration Compound; or (b) Post-Termination
Compound.
1.56 “Regulatory
Approval” means any
and all approvals (including supplements, amendments, pre- and
post-approvals, pricing and reimbursement approvals), licenses,
registrations or authorizations of any 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.
1.57 “Research
Plan” has the
meaning set forth in Section 2.6(a).
1.58 “Reverted
Compounds” means
any Collaboration Compounds licensed to Exelixis under Sections
10.4(d)(i) and (ii).
1.59 “Reverted Compounds
License Agreement” has the meaning set forth in
Section 10.4(d)(v).
1.60 “Royalty
Term” has the
meaning set forth in Section 7.7.
1.61 “Safety
Reasons” has the
meaning set forth in Section 10.5.
1.62
“Scaffold” means any: (a) scaffold of [ * ] ;
(b) new scaffold added in accordance with Section 2.13;
and (c) [ * ] . For clarity, a scaffold is [ *
] to another scaffold described in the foregoing subsections
(a) and (b) only if [ * ] .
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1.63 “Small Molecule
Compound” means a
molecule with a molecular weight less than or equal to [ * ]
.
1.64 “Sole
Invention” means
any Invention invented or discovered solely by a Party and its
employees or agents.
1.65 “Success
Criteria” has the
meaning set forth in Section 2.6(b).
1.66 “Third
Party” means any
entity other than: (a) Exelixis; (b) BMS; or (c) an
Affiliate of either Party.
1.67 “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 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 [ * ] from its date of
filing, and 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.
2. COLLABORATION
2.1 Overview.
The general goals and intent of the
Collaboration are to apply each Party’s technology to
discover, optimize and characterize Collaboration Compounds that
are LXR Modulators or Dual LXR/FXR Modulators that may be developed
into Products by BMS. Each Party shall have responsibilities under
the Collaboration in accordance with the allocation of duties set
forth in the Research Plan, including responsibilities for
discovery, lead optimization and in vitro and in vivo
characterization of Collaboration Compounds up to receipt of
approval as an ECN for such Collaboration Compounds.
2.2 Joint Research Committee and
Discovery Working Group.
(a) Membership of JRC
. The JRC shall be composed of [
* ] members. Within [ * ] after the Effective Date, each
Party shall appoint [ * ] representatives to the JRC. Each
Party may replace its appointed JRC representatives at any time
upon written notice to the other Party. Each Party shall designate
one (1) of its representatives as co-chairperson of the JRC.
Each of the co-chairpersons shall be responsible, on an alternating
basis with the BMS co-chairperson having responsibility with
respect to the initial meeting, for working with the Alliance
Managers to schedule meetings, prepare and circulate an agenda in
advance of each meeting, and to prepare and issue minutes of each
meeting within [ * ] days thereafter. Any JRC member may add
topics to the draft agenda. Each Party may invite, with the
approval of the other Party (which shall not be unreasonably
withheld, delayed or conditioned), additional employees or
consultants (provided such employees and consultants: (i) have
contractual confidentiality obligations to such Party that are at
least as stringent as those set forth in this Agreement; and
(ii) are under intellectual property assignment obligations to
such party in accordance with Section 8.1(c)) to attend one
(1) or more meetings of the JRC as ad hoc, non-voting
guests.
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(b) Decision-making
. The [ * ] JRC
representatives of each Party shall collectively have one
(1) vote, and the JRC shall operate by unanimous consent of
all JRC members present and in accordance with the principles set
forth in this Article 2. In the event of a dispute between the
Parties with regard to the performance of the Collaboration, the
matter shall be first referred to the [ * ] for resolution.
If these two (2) individuals are unable to resolve the
dispute, then the matter shall be elevated to [ * ] . If
these two (2) individuals are unable to resolve the dispute,
then the matter shall be elevated to [ * ] . If these two
(2) individuals are unable to resolve the dispute, then,
subject to the last sentence of this Section 2.2(b) and to
Section 2.2(c), [ * ] shall have the final decision so
long as such decision does not conflict with the terms of the
Agreement. Notwithstanding anything to the contrary, no decision by
a Party shall require the other Party to: (i) breach any
obligation or agreement that such other Party may have with or to a
Third Party; (ii) perform any activities that are materially
different or greater in scope than those provided for in the
then-current Research Plan; or (iii) incur any material
financial costs in addition to those expressly described in Article
7 of this Agreement.
(c) Exceptions to
Decision-making. Notwithstanding anything to the contrary, [ *
] shall not have the final decision with respect to any dispute
involving any of the following: (i) moving the performance of
the Collaboration away from the identification, development and
commercialization of LXR Modulators and Dual LXR/FXR Modulators to
the identification, development and commercialization of other
compounds; (ii) reducing the number of [ * ] required
by the Research Plan below [ * ] FTEs during each of the
first [ * ] years of the Research Term;
(iii) unilaterally changing the [ * ] in a manner that
produces [ * ] that are not reasonably consistent with [
* ] ; (iv) unilaterally changing the [ * ] of an
LXR Modulator or Dual LXR/FXR Modulator; (v) unilaterally
changing the [ * ] for a Competitive Compound;
(vi) requiring [ * ] ; (vii) changing the
performance of the Research Plan to include new technology (e.g.,
assays, targets, or animal models) for which [ * ] would
bear the sole cost pursuant to [ * ] ;
(viii) unilaterally adding new receptors to the list of Listed
NHRs under Section 2.6(c); or (ix) unilaterally
contributing new compounds or scaffolds (as applicable) to the
Agreement in contravention of the process described in
Section 2.13.
(d) Responsibilities of the JRC
and DWG . The JRC shall
be responsible for the overall planning and execution of the
Collaboration and the approval and oversight of the Research Plan.
The DWG shall report to the JRC and shall manage the day-to-day
activities and decisions required under the Collaboration.
Membership of the DWG shall be determined by the JRC and shall not
be limited with respect to number of appointees (in total or from
either Party). Each Party shall designate one (1) of its
representatives as co-chairperson of the DWG. At its meetings, the
DWG shall evaluate the data generated by the Parties in the course
of carrying out the Research Plan, shall recommend project
prioritization within the Research Plan (subject to approval by the
JRC), shall perform those activities specifically described in this
Agreement, and may recommend revisions to the Research Plan to the
JRC. At each DWG meeting, the DWG shall summarize the progress in
carrying out the Research Plan since the last DWG meeting, bring to
attention of the JRC any overarching issues or significant changes
in the Research Plan, and address any issues raised at its previous
meeting. To the extent necessary to carry out its responsibilities,
a Party’s DWG and/or JRC members shall be granted access to
the other Party’s Confidential Information relevant to any
decision required to be made by the DWG or the JRC.
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2.3 Meetings of JRC and
DWG. During the
Collaborative Research Period: (a) the JRC shall meet
quarterly by audio or video teleconference and, at a minimum, once
each [ * ] in person (which in-person meeting shall be held
on an alternating basis in New Jersey and in San Francisco); and
(b) the DWG shall meet [ * ] by audio or video
teleconference and, at a minimum, [ * ] in person (which
in-person meeting shall be held on an alternating basis in New
Jersey and in San Francisco). With the consent of the
representatives of each Party serving on a particular Committee,
other representatives of each Party may attend meetings of that
Committee as nonvoting observers (provided such representatives:
(i) have contractual confidentiality obligations to such Party
that are at least as stringent as those set forth in this
Agreement; and (ii) are under intellectual property assignment
obligations to such party in accordance with Section 8.1(c)).
Meetings of a Committee shall be effective only if at least one
(1) representative of each Party is present or participating.
Each Party shall be responsible for all of its own expenses of
participating in the Committee meetings. The Parties shall endeavor
to schedule meetings of the JRC and the DWG at least [ * ]
in advance.
2.4 Alliance
Managers.
(a) Appointment.
Each of the Parties shall appoint an
individual (each, an “ Alliance Manager ”) who
possesses a general understanding of the scientific and business
issues relevant to this Agreement. Each Party may change its
designated Alliance Manager from time to time upon prior written
notice to the other Party. Any Alliance Manager may designate a
substitute to temporarily perform the functions of that Alliance
Manager by prior 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. 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: (a) shall be the point of
first referral in all matters of [ * ] ; (b) shall
identify and bring [ * ] to the attention of the appropriate
Committee in a timely manner; (c) shall plan and coordinate
cooperative efforts and internal and external communications; and
(d) shall 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.
2.5 Collaborative Research
Period. Subject to
Section 10.2, the Collaborative Research Period shall begin on
the Effective Date and continue for two (2) years thereafter.
BMS shall have the option to extend the Collaborative Research
Period for an additional one (1)-year term by providing written
notice to Exelixis no later than [ * ] before the end of the
initial two (2)-year Collaborative Research Period. The
Collaborative Research Period may be further extended (i.e., beyond
such three (3)-year period) upon mutual agreement of the Parties,
and the Parties may choose to agree to an alternate level of
research funding with respect to such extension.
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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2.6 Research Plan; Success
Criteria; Additional Listed NHRs.
(a) The Parties have agreed in writing upon a
detailed plan for the research to be carried out by the Parties
during the Collaborative Research Period, which is set forth in the
Disclosure Letter and incorporated herein by reference (the “
Research Plan ”). The Research Plan includes each
Party’s respective obligations in furtherance of the
Collaboration and timelines for completion of key stages, and the
Research Plan shall provide guidance as to whether the work
performed by each Party meets the standards of Diligent Efforts.
The ultimate goal of the Research Plan shall be to identify LXR
Modulators and Dual LXR/FXR Modulators. The DWG shall review the
Research Plan at least [ * ] and may propose to the JRC
revised versions of the Research Plan that are consistent with the
terms of this Agreement. The revised Research Plan may only be
approved by the JRC, subject to Sections 2.2(b) and 2.2(c). Once
approved by the JRC, such revised Research Plan shall replace the
prior Research Plan. During the Collaborative Research Period, each
Party shall use Diligent Efforts to perform the tasks assigned to
it in the Research Plan then in effect.
(b) The Research Plan shall also contain success
criteria for the submission of a compound for approval as an ECN
(the “ Success Criteria ”), which are
incorporated by reference herein. The Success Criteria are as set
forth in the Disclosure Letter. Any Success Criteria that are not
reasonably ascertainable or completely known as of the Effective
Date, or requiring adjustment based on results obtained during the
conduct of the Collaboration, shall be supplemented and/or modified
as recommended by the DWG and reviewed and approved by the JRC from
time to time as appropriate.
(c) From [ * ] during the term of the [ *
] , [ * ] may decide to add additional targets to the
list of Listed NHRs. The Parties shall discuss in good faith
whether to add any such additional targets, and such targets shall
only be added with the prior written agreement of [ * ]
.
2.7 Obligations of
Parties. Exelixis and BMS
shall provide the DWG and the JRC and their respective authorized
representatives with reasonable access during regular business
hours to all records, documents, and Information relating to the
performance of its obligations under the Collaboration which such
Committee may reasonably require in order to perform its
obligations hereunder, provided that if such documents are under a
bona fide obligation of confidentiality to a Third Party, then
Exelixis or BMS, as the case may be, may withhold access thereto to
the extent necessary to satisfy such obligation.
2.8 Collaboration
Guidelines. 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 shall not constitute a
partnership, joint venture or agency, and neither Party shall have
the power to bind or obligate the other Party in any manner, other
than as is expressly set forth in this Agreement.
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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2.9 Conduct of
Research. The Parties
shall use Diligent Efforts to conduct their respective tasks
throughout the Collaboration and shall conduct the Collaboration in
good scientific manner, and in compliance in all material respects
with the requirements of applicable laws, rules and regulations and
all applicable good laboratory practices to attempt to achieve
their objectives as efficiently and expeditiously as reasonably
practicable.
2.10 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) [ * ] ; and (b) [ * ]
records that the other Party reasonably requests be retained in
order to ensure the preservation, prosecution, maintenance or
enforcement of [ * ] . Either Party shall have the right to
review and copy such records of the other Party at reasonable times
to the extent necessary or useful for it to conduct its obligations
or enforce its rights under this Agreement.
2.11 Reports.
During the Collaborative Research
Period, each Party shall report to the JRC no less than [ *
] and shall submit to the other Party and the JRC a [ *
] written progress report summarizing the work performed under
the Collaboration, including, with respect to Exelixis, the [ *
] with respect to the activities set forth in the Research
Plan, and, with respect to BMS, the status of each Collaboration
Compound that reaches [ * ] (as defined in the Research
Plan) and each Collaboration Compound that reaches [ * ] .
If reasonably necessary for a Party to perform its work under the
Collaboration or to exercise its rights under the Agreement, such
Party may request that the other Party provide more detailed
information and data regarding such results reported by such other
Party, and such other Party shall promptly provide the requesting
Party with information and data as is reasonably related to such
request, including any records created by a Party pursuant to
Section 2.10. All such reports shall be considered
Confidential Information of the Party providing same.
2.12 Database.
The Parties shall work together to
evaluate the possibility and practicality of setting up an
electronic data-sharing arrangement to allow each Party to access
Confidential Information of the other Party consisting of [ *
] , including all [ * ] . In the event that such a
data-sharing arrangement is possible and practical: (a) each
Party shall restrict access to such data only to its employees,
consultants and independent contractors who, in each case, need
such access to perform activities, or exercise its rights, under
this Agreement, and who, prior to such access, have executed
appropriate confidentiality and invention assignment agreements
with such Party; and (b) [ * ] shall be responsible
for any costs related to the implementation, use and maintenance of
such data-sharing arrangement by [ * ] ; provided,
however , that if [ * ] does not deem the costs of using
a particular data-sharing system to be reasonable, the Parties
shall not be obligated to implement such system, and the Parties
shall discuss alternative systems with more reasonable costs of
implementation, use and maintenance. In any event, access to any
such data shall in all cases be password-protected or otherwise
similarly restricted.
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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2.13 Contribution of New
Compounds and New Scaffolds. If either Party desires to contribute additional
LXR Modulators, Dual LXR/FXR Modulators or scaffolds to the
Collaboration, then such Party (the “Contributing
Party” ) shall provide the other Party with a written
description of such additional compounds or scaffolds, and the
Parties shall meet to discuss such contribution. If such other
Party determines in good faith that the contribution of any such
compounds or scaffolds by the Contributing Party would not result
in the breach of any obligation or agreement that such other Party
may have with or to a Third Party, and would not result in the
potential infringement of Third Party Patents (it being understood
that any such determination [ * ] , then: (a) such
additional compounds shall be included in the scope of the
Agreement as BMS Compounds (in the case of compounds contributed by
BMS); (b) such additional compounds shall be included in the
scope of the Agreement as Exelixis Compounds (in the case of
compounds contributed by Exelixis); or (c) such additional
scaffolds shall be included in the scope of the Agreement as
Scaffolds. Notwithstanding anything to the contrary, if such other
Party determines in good faith that the contribution of any such
compounds or scaffolds by the Contributing Party would result in
the breach of any obligation or agreement that such other Party may
have with or to a Third Party, or would result in the potential
infringement of Third Party Patents, then such additional compounds
or scaffolds shall not be included within the scope of this
Agreement; [ * ] .
2.14 Review of Collaboration
Compounds. As part of the
criteria for the submission of a compound [ * ], Exelixis shall
review the results of all [ * ] conducted by either Party in the
normal course of performing research under the Research Plan or by
BMS in the normal course of performing research during the BMS
Independent Activity Period. In the event review by Exelixis is
during the BMS Independent Activity Period, BMS shall provide
Exelixis with the results of all [ * ] for such [ * ] Collaboration
Compound, and sufficient samples of any [ * ] Collaboration
Compound that has completed [ * ] (as such term is described in the
Research Plan), or its equivalent stage of research, to have such
assays conducted. Exelixis may use such results and samples for the
sole purpose of performing assays to verify that such [ * ]
Collaboration Compound does not display [ * ] ( “ [ *
] Activity” ). [ * ] shall be responsible for having
such assays conducted as well as any costs associated with such
assays. If Exelixis notifies BMS in writing within [ * ] days of
receiving a sample of a submitted [ * ] Collaboration Compound that
such Collaboration Compound displays [ * ] Activity, then BMS shall
not [ * ] such Collaboration Compound, and BMS’ licenses [ *
] such Collaboration Compound shall terminate (solely with respect
to such Collaboration Compound); provided, however , that
BMS may perform research on such Collaboration Compound using its
applicable licenses in Section 5.1 to derivatize away the [ *
] Activity of such Collaboration Compound. For clarity,
(i) nothing in this Section 2.14 shall be deemed to
preclude BMS from conducting screening activities, at any time,
with respect to Collaboration Compounds in order to determine
whether Collaboration Compounds display [ * ] Activity, and
(ii) BMS may continue its research and development activities
with respect to any such submitted [ * ] Collaboration Compound
during such review period prior to receiving any such written
notice from Exelixis. In the event that Exelixis does not provide
written notice to BMS with respect to the [ * ] Activity of a
submitted [ * ] Collaboration Compound within such [ * ] day
period, then BMS shall be free to develop and commercialize such
Collaboration Compound on the terms and conditions set forth in
this Agreement. Notwithstanding the foregoing, Exelixis shall use
commercially reasonable efforts to notify BMS as soon as
practicable [ * ] in the event that Exelixis becomes aware in the
course of performing its obligations under the Research Plan during
the Collaborative Research Period that a Collaboration Compound
displays [ * ] Activity.
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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3. BMS INDEPENDENT RESEARCH, DEVELOPMENT,
MANUFACTURE AND COMMERCIALIZATION OF PRODUCTS
3.1 BMS Research, Development and
Commercialization. As
between the Parties, BMS (or its Affiliates or sublicensees) has
sole authority to conduct: (a) all preclinical development
(including any discovery activities) with respect to Collaboration
Compounds from and after the expiration of the Collaborative
Research Period and during the BMS Independent Activity Period; and
(b) clinical development, pre clinical, clinical and
commercial manufacturing and commercialization activities,
including all regulatory activities, with respect to any
Collaboration Compounds and/or Products during the BMS Independent
Activity Period. All regulatory applications with respect to the
Products shall be owned by BMS and/or its Affiliates or
sublicensee(s), as applicable. Upon [ * ] (and at [ *
] ), (i) Exelixis shall [ * ] provide BMS with any
Exelixis Know-How that is [ * ] for BMS to conduct the
activities set forth in clauses (a) and (b) above, and
(ii) Exelixis shall cooperate with BMS in connection with
regulatory submissions related to any Product. BMS shall have sole
control and responsibility for, and shall bear all of its costs and
expenses associated with, the development, manufacture (including
formulation) and commercialization of all Products, as
applicable.
3.2 Diligence.
BMS shall use Diligent Efforts to
[ * ] during the term of this Agreement; provided that BMS
may satisfy such obligation by [ * ] pursuant to the terms
of this Agreement. Exelixis may notify BMS in writing if Exelixis
in good faith believes that BMS is not meeting its diligence
obligations set forth in this Section 3.2, and the Parties
shall meet and discuss the matter in good faith. Exelixis may
further request review of BMS’ records generated and
maintained as required under Section 3.3 below, to the extent
those records relate to development and commercialization of a
Product.
3.3 Records.
BMS shall maintain complete and
accurate records of all research, development, manufacturing and
commercialization conducted by it or on its behalf related to each
Product, and all Information generated by it or on its behalf in
connection with development under this Agreement with respect to
each such Product. BMS shall maintain such records at least until
the later of: (a) [ * ] after such records are
created, or (b) [ * ] after the Launch of the Product
to which such records pertain; provided that the following records
may be maintained for a longer period, in accordance with each
Party’s internal policies on record retention: (i) [
* ] and (ii) [ * ] records that Exelixis
reasonably requests be retained in order to ensure the
preservation, prosecution, maintenance or enforcement of [ *
] . Such records shall be at a level of detail appropriate for
[ * ] purposes. Exelixis shall have the right to review and
copy such records of BMS at reasonable times to the extent
necessary or useful for Exelixis to conduct its obligations or
enforce its rights under this Agreement.
3.4 Reports.
Beginning [ * ] after the end
of the Collaborative Research Period, and [ * ] thereafter
during the [ * ] , BMS shall submit to Exelixis a written
progress report summarizing the research, development and
commercialization performed by BMS on Products, including [ *
] since the last report, the [ * ] that reaches [ *
] (as defined in the Research Plan) and each Collaboration
Compound that reaches [ * ] . If reasonably necessary or
useful for
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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Exelixis to exercise its rights under this
Agreement, Exelixis may request that BMS provide more detailed
information and data regarding such results reported 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.
3.5 Technology
Transfer. Subject to any
applicable agreement with a Third Party and the terms of this
Agreement, Exelixis shall transfer technology to BMS as described
in this Section 3.5.
(a) BMS Transition of an ECN to
Development Activities. Subject to Section 3.5(c) and within [ *
] of receiving a written request from BMS to transfer one or
more particular items of Information relating to the manufacture of
a Collaboration Compound that has received ECN approval, Exelixis
shall use commercially reasonable efforts to transfer to BMS such
items that are in Exelixis’ possession, including any [ *
] generated by Exelixis under the Research Plan. Further, upon
written request from BMS and to the extent that [ * ] ,
Exelixis shall provide reasonable assistance to BMS with respect to
the transfer and implementation of technology required for BMS to
manufacture or have manufactured such Collaboration Compound. If
BMS requests that Exelixis provide on-site advice or support in
connection with the foregoing, BMS shall reimburse Exelixis for
reasonable travel costs incurred.
(b) BMS Independent Activity
Period. Subject to
Section 3.5(c), BMS may request in writing that Exelixis
transfer one or more particular items of Information that are in
Exelixis’ possession and that were used by Exelixis in the
performance of its responsibilities under the Research Plan. After
receiving such request, Exelixis shall use commercially reasonable
efforts to transfer to BMS such items, including any [ * ]
generated by Exelixis under the Research Plan. If BMS requests that
Exelixis provide on-site advice or support in connection with the
foregoing, BMS shall reimburse Exelixis for reasonable travel costs
incurred. For a period of [ * ] after the end of the
Collaborative Research Period, Exelixis shall not [ * ] that
may be transferred to BMS pursuant to this Section 3.5(b).
After such [ * ] period, Exelixis shall not have any
obligation to [ * ] , provided that Exelixis shall notify
BMS of the [ * ] in order to allow BMS the opportunity to
[ * ] , subject to [ * ] .
(c) Restrictions on
Transfer. Transfer of
items as described in Sections 3.5(a) and 3.5(b) shall be subject
to the following conditions: (i) Exelixis shall transfer such
items to BMS to the extent that items requested by BMS are [ *
] and Exelixis’ ability to grant BMS a sublicense to the
intellectual property rights covering such items is not [ *
] ; (ii) Exelixis shall not be obligated to transfer such
items to BMS to the extent that Exelixis’ ability to grant
BMS a sublicense to the intellectual property rights covering such
items is [ * ] ; and (iii) in the event that Exelixis
may sublicense to BMS the intellectual property rights covering
such requested items, BMS must [ * ] ; provided that
Exelixis [ * ] , and BMS [ * ] that BMS desired to
[ * ] . If BMS does not take such sublicense subject to all
such [ * ] , then such sublicense of intellectual property
rights shall automatically be null and void, and Exelixis shall not
be obligated to transfer the items covered by such
sublicense.
(d) Discussion Regarding Further
Collaboration. With
respect to items that cannot be transferred due to
Section 3.5(c)(ii), the Parties shall meet and discuss in good
faith opportunities for collaboration that the Parties could
undertake to achieve similar outcomes
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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as if such items were transferred. For example,
the Parties could [ * ] with respect to such items that
cannot be transferred. Any such [ * ] must be consistent
with [ * ] . Notwithstanding anything to the contrary,
nothing in this Section 3.5(d) shall obligate either Party to
[ * ] .
4. MANUFACTURING BY
EXELIXIS
4.1 Pre-ECN Collaboration
Compounds During the Collaborative Research Period.
During the Collaborative Research
Period and prior to approval of a Collaboration Compound as an ECN,
the JRC shall determine responsibility(ies) among the Parties with
respect to the manufacture of such Collaboration Compound in
sufficient quantities for the Parties to conduct the Research
Plan.
4.2 Post-ECN Collaboration
Compounds and Collaboration Compounds During the BMS Independent
Activity Period. Notwithstanding BMS’ authority to
manufacture Collaboration Compounds as set forth in
Section 3.1 above, BMS may request in writing that BMS’
requirements for: (a) any Collaboration Compounds that receive
approval as an ECN; or (b) any Collaboration Compounds being
researched or developed by BMS during the BMS Independent Activity
Period, be manufactured by Exelixis, or on behalf of Exelixis by a
mutually agreed subcontractor, and BMS shall provide Exelixis with
the relevant information for Exelixis to make a reasonable
determination of manufacturing costs for each such Collaboration
Compound. Within [ * ] of receiving BMS’ request,
Exelixis shall notify BMS in writing of whether Exelixis desires to
manufacture such Collaboration Compound, and, with respect to any
approved subcontractor, shall provide BMS with information relating
to such subcontractor’s operations, including information on
any regulatory inspections, quality related observations,
reliability, security of supply and other relevant commercial
considerations. If Exelixis does not desire to manufacture (or
subcontract the manufacture of) such Collaboration Compound, then
Exelixis shall have no obligation to manufacture (or subcontract
the manufacture) of such Collaboration Compound. If Exelixis
desires to manufacture (or subcontract the manufacture of) such
Collaboration Compound, then: (i) BMS and Exelixis shall
promptly meet, over a [ * ] period, to negotiate in good
faith the commercially reasonable terms of a manufacturing
agreement and a quality agreement for such Collaboration Compound;
and (ii) in the event that manufacturing of such Collaboration
Compound had been undertaken by BMS prior to ECN approval, then BMS
shall provide reasonable assistance to Exelixis with respect to the
transfer and implementation of technology required for Exelixis to
manufacture or have manufactured such Collaboration Compound.
BMS’ right to request the manufacture of Collaboration
Compounds that receive approval as an ECN shall expire at the
earlier of: (1) the [ * ] of the end of the
Collaborative Research Period; or (2) the [ * ]
.
5. LICENSES AND RELATED
RIGHTS
5.1 Licenses to BMS.
Subject to the terms of this
Agreement:
(a) Collaboration
Research . Exelixis
hereby grants BMS a co-exclusive, worldwide, royalty-free license
(with the right to sublicense to its Affiliates, but without the
right to sublicense to Third Parties except with prior written
consent of Exelixis), under any Exelixis Know-How and Exelixis
Patents solely to perform the research tasks assigned to BMS
pursuant to the Research Plan.
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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(b) BMS Independent
Research . During the BMS
Independent Activity Period, Exelixis hereby grants BMS an
exclusive, worldwide, royalty-free license (without the right to
sublicense except to third party contract research providers and
manufacturers) to research, identify, derivatize, pre-clinically
develop, make, have made and use: (i) Collaboration Compounds
solely for research purposes; and (ii) Non-LXR Modulators
solely for the purposes of identifying, developing, making, having
made and using Collaboration Compounds, under: (A) any
Exelixis Know-How and Exelixis Patents covering one (1) or
more Collaboration Compounds or Non-LXR Modulators, and/or any
composition containing any of the foregoing, or the manufacture or
use thereof; and (B) subject to Section 3.5, any other
Exelixis Know-How and/or Exelixis Patents, which is useful or
reasonably necessary for the research, identification,
derivatization, pre-clinical development, making, having made and
use of Collaboration Compounds. Notwithstanding anything to the
contrary in this Agreement, the licenses granted in this
Section 5.1(b) shall not create (by any means, whether
expressly, impliedly or by estoppel) any right or license under any
other Patents, Information or other intellectual property right
that is Controlled by Exelixis.
(c) Development and
Commercialization .
Exelixis hereby grants BMS an exclusive, worldwide, royalty-bearing
(solely to the extent provided in Section 7.4) license (with
the right to sublicense) to clinically develop, make, have made,
use, import, sell, offer to sell and have sold Products
incorporating any Collaboration Compound, under: (i) any
Exelixis Know-How and Exelixis Patents covering one (1) or
more Collaboration Compounds, and/or any composition containing any
of the foregoing, or the manufacture or use thereof; and
(ii) subject to Section 3.5, any other Exelixis Know-How
and/or Exelixis Patent, which is useful or reasonably necessary to
clinically develop, make, have made, use, import, sell, offer to
sell and have sold Products incorporating any Collaboration
Compound.
5.2 BMS License Limitations,
Covenants and Retained Rights.
(a) BMS hereby covenants that:
(i) BMS shall not (and shall ensure that any of its
permitted sublicensees shall not) use any Exelixis Know-How or
Exelixis Patents for a purpose other than that expressly permitted
in Section 5.1 and 10.4(e).
(ii) During the [ * ] , BMS shall not (and
shall ensure that any of its permitted sublicensees shall not) [
* ] .
(iii) During the [ * ] , BMS shall not [ *
] . For clarity, BMS retains the right to use BMS Compounds for
any and all research purposes.
(b) Each sublicense granted by BMS, pursuant to
Section 5.1, to a party who is an Affiliate at the time such
license is granted shall terminate immediately upon such party
ceasing to be an Affiliate.
(c) BMS retains all rights to use all BMS Know-How
and BMS Patents except those expressly granted to Exelixis on an
exclusive basis under the terms of this Agreement.
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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(d) BMS acknowledges and agrees that, the licenses
granted in Section 5.1(c) shall not create (by any means,
whether expressly, impliedly or by estoppel) any right or license
under any other Patents, Information or other intellectual property
right that is Controlled by Exelixis and that covers any compounds
(other than Collaboration Compounds), and/or any composition
containing any of the foregoing, or the manufacture or use
thereof.
5.3 License to Exelixis for
Collaboration Research. Subject to the terms of this Agreement, BMS
hereby grants Exelixis a co-exclusive, worldwide, royalty-free
license (with the right to sublicense to Affiliates, but without
the right to sublicense to Third Parties except with prior written
consent of BMS) under the BMS Know-How and BMS Patents, solely to
perform the research tasks assigned to Exelixis pursuant to the
Research Plan.
5.4 Exelixis License Limitations,
Covenants and Retained Rights.
(a) Exelixis hereby covenants that:
(i) Exelixis shall not (and shall ensure that any of
its permitted sublicensees shall not) use any BMS Know-How or BMS
Patents for a purpose other than that expressly permitted in
Sections 5.3 and 10.4(d).
(ii) During the [ * ] , Exelixis shall not
(and shall ensure that any of its permitted sublicensees shall not)
[ * ] ; provided, however , that the foregoing
restriction shall not apply to [ * ] .
(iii) During the [ * ] , Exelixis shall not
[ * ] . For clarity, Exelixis retains the right to use
Exelixis Compounds for any and all research purposes; provided,
however , that in the event that an Exelixis Compound reaches
[ * ] , then Exelixis shall not [ * ] . Furthermore,
if BMS notifies Exelixis pursuant to BMS’ reporting
obligations described in Sections 2.11 and 3.4 (as applicable) that
an Exelixis Compound has reached [ * ] , then Exelixis shall
not [ * ] .
(b) Each sublicense granted by Exelixis, pursuant to
Section 5.3, to a party who is an Affiliate at the time such
license is granted shall terminate immediately upon such party
ceasing to be an Affiliate.
(c) Exelixis retains all rights to use all Exelixis
Know-How and Exelixis Patents except those expressly granted to BMS
on an exclusive basis under the terms of this Agreement.
5.5 No Additional
Licenses. Except as
expressly provided in Sections 5.1, 5.3, and 10.4, nothing shall
grant either Party any right, title or interest in and to the
intellectual property rights of the other Party (either expressly
or by implication or estoppel).
5.6 Sublicensing.
Each Party shall provide the other
Party with the name of each permitted sublicensee of its rights
under this Article 5 and a copy of the applicable sublicense
agreement; provided that each Party may redact confidential or
proprietary terms from such copy, including financial terms. The
sublicensing Party shall remain responsible for each permitted
sublicensee’s compliance with the applicable terms and
conditions of this Agreement.
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , IS FILED WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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6. EXCLUSIVITY
6.1 Collaborative Research
Period. During the
Collaborative Research Period, neither Party shall do any of the
following with respect to a Competitive Compound: [ * ] .
Notwithstanding anything to the contrary: (i) [ * ] ;
and (ii) [ * ] .
6.2 BMS Independent Activity
Period. During the BMS
Independent Activity Period, Exelixis shall not do any of the
following with respect to a Competitive Compound: [
*