[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
E XHIBIT 10.1
COLLABORATION
AGREEMENT
T HIS C OLLABORATION A GREEMENT (the “ Agreement ”) is made
and entered into as of March 20 th , 2006 (the “ Effective
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 S ANKYO C OMPANY , L IMITED , a Japanese corporation having its
principal place of business at 3-5-1 Nihonbashi-honcho, Chuo-ku,
Tokyo 103-8426 Japan (“ Sankyo ”). Exelixis and
Sankyo are sometimes referred to herein individually as a “
Party ” and collectively as the “ Parties
”.
R ECITALS
A. Sankyo is a multinational health care company
that has expertise and capability in researching, developing and
commercializing human pharmaceuticals.
B. Exelixis is a drug discovery company that has
expertise and proprietary technology relating to compounds that
modulate the Mineralocorticoid Receptor.
C. Sankyo and Exelixis desire to establish a
collaboration to apply such Exelixis technology and such expertise
of Exelixis and Sankyo to the lead optimization and
characterization of small molecule compounds that modulate the
Mineralocorticoid Receptor, and to the development and
commercialization of novel therapeutic and prophylactic products
based on such compounds.
N OW T HEREFORE , Exelixis and Sankyo agree as
follows:
Capitalized terms used in this
Agreement (other than the headings of the Sections or Articles)
shall have the following meaning set forth in this
Article 1 , or, if not listed in this
Article 1 , the meaning 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 any
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 “Annual FTE Rate” means the
amount to be paid by Sankyo to support one (1) FTE for one
(1) year. The Annual FTE Rate during the Initial Research Term
is [ * ] per year.
The Annual FTE Rate for the Research Term
Extension, if any, shall be as agreed upon by the Parties pursuant
to Section 2.5 .
1.3 “Back-up
Compounds” means:
(a) the following Small Molecule Compounds: [ * ] ; and
(b) [ * ] .
1.4 “Back-up Compound Know-How”
means all Information that is Controlled by Exelixis and its
Affiliates [ * ] that comprises Inventions [ * ] .
Back-up Compound Know-How does not include any Back-up Compound
Patent or any information licensed to Exelixis or its Affiliate
[ * ] .
1.5 “Back-up Compound Patents”
means all Patents that are Controlled by Exelixis and its
Affiliates [ * ] and that claim Inventions [ * ] .
Back-up Compound Patents do not include any Joint Patents or any
Patents licensed to Exelixis or its Affiliate [ * ]
.
1.6 “Collaboration” means all the
activities performed by or on behalf of Exelixis or Sankyo in the
course of performing work contemplated in Article 2
.
1.7
“Commercialize” or “Commercialization” means
all activities that are undertaken after Regulatory Approval for a
particular Product and that relate to the commercial marketing and
sale of such Product including advertising, marketing, promotion,
distribution, and post-approval clinical studies.
1.8
“Control” or
“Controlled” means, with respect to any Small
Molecule Compound, material, Information or intellectual property
right, that the Party owns or has a license to such Small Molecule
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 Small Molecule 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.
1.9
“Derivatives” means all: (a) Small Molecule Compounds
that [ * ] ; and (b) [ * ] .
1.10 “Develop” or
“Development” means, with respect to the
Product, the performance of all research, pre-clinical, clinical
and regulatory activities required to obtain Regulatory Approval of
a Product.
1.11 “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;
-2-
[ * ] = C
ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
and (c) consistently make and implement
decisions and allocate resources designed to advance progress with
respect to such objectives.
1.12 “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, Luxemburg, Netherlands, Austria, Portugal,
Finland, Sweden, the United Kingdom, Estonia, Latvia, Lithuania,
Poland, the Czech Republic, Slovakia, Hungary, Slovenia, Malta, and
Cyprus.
1.13 “Exelixis Know-How” means the
Existing Compound Know-How and the Back-up Compound
Know-How.
1.14 “Exelixis Net Sales” means
net sales of any Product by Exelixis or its sublicensees pursuant
to the license granted by Sankyo in Section 10.3(b) and
Section 10.4(c) and as determined on the same basis as
Net Sales, substituting Exelixis for Sankyo.
1.15 “Exelixis Patents” means the
Existing Compound Patents and the Back-up Compound
Patents.
1.16 “Existing
Compounds” mean
all: (a) the following Small Molecule Compounds: [ * ]
; and (b) [ * ] .
1.17 “Existing Compound Know-How”
means all Information that is Controlled by Exelixis and its
Affiliates [ * ] Existing Compounds. Existing Compound
Know-How does not include any Existing Compound Patent or any
information licensed to Exelixis or its Affiliate [ * ]
.
1.18 “Existing Compound Patents”
means all Patents: (a) that are Controlled by Exelixis and its
Affiliates [ * ] in Exhibit 1.18; or (b) issuing from
or claiming priority to any of the foregoing. Existing Compound
Patents do not include any Back-up Compound Patents, Joint Patents
or any Patents licensed to Exelixis or its Affiliate [ * ]
.
1.19 “FTE” means the equivalent of
a single person working full time for Exelixis over a twelve
(12) month period (including normal vacations, sick days and
holidays).
1.20 “IND”
means: (a) an Investigational
New Drug Application filed with the U.S. Food and Drug
Administration (the “ FDA ”) or its equivalent
in any country outside the United States where a regulatory filing
is required or obtained to conduct a clinical trial; or
(b) with respect to any country where a regulatory filing is
not required or obtained to conduct a clinical trial, the first
enrollment of a human subject in the first trial involving the
first use of a Product in humans.
1.21
“Information” means information, material, results and data of
any type whatsoever, in any tangible or intangible form whatsoever,
including databases, inventions, practices, methods, techniques,
specifications, formulations, formulae, cell lines, cell media,
knowledge, know-how, skill, experience, manufacturing materials,
financial data, test data
-3-
[ * ] = C
ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
including pharmacological, biological, chemical,
biochemical, toxicological and clinical test data, analytical and
quality control data, quality assurance data, stability data,
studies and procedures, and patent and other legal information or
descriptions.
1.22 “Initial Research Term” means
the period commencing on the Effective Date and ending fifteen
(15) months later.
1.23 “Initiation” means, with
respect to a Phase II Trial or Phase III Trial, the first
enrollment of a patient in such trial.
1.24 “Invention” means any
invention or improvement that in each case is made, conceived or
reduced to practice by or on behalf of a Party or both Parties in
the course of performing under this Agreement.
1.25 “Joint
Patents” has the
meaning set forth in Section 7.1 .
1.26 “Joint Research
Committee” or
“JRC” means the committee described in
Section 2.2 .
1.27
“Launch” means, for each Product in each country, the
first arm’s-length sale to a Third Party (or an Affiliate of
a Party if such Affiliate is the end user 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.
1.28 “Lead
Compound” means the
Existing Compound, [ * ] .
1.29 “Licensed
Compound” means any
Existing Compound, Back-up Compound or Derivative.
1.30 “Major Country” means any of
the following countries, and their respective territories and
possessions: [ * ] .
1.31 “MR” means: (a) the gene
for the Mineralocorticoid Receptor (for any species); (b) the
protein encoded by such gene; and (c) all subtypes, mutants,
variants and fragments thereof.
1.32 “NDA”
means: (a) a New Drug
Application (as more fully defined in 21 C.F.R. 314.5 et
seq. ) and all amendments and supplements thereto filed with
the FDA in order to obtain Regulatory Approval in the United
States; or (b) an application for Regulatory Approval required
before commercial sale or use of a Product as a drug in a
regulatory jurisdiction other than the United States.
1.33 “NDA
Acceptance” means
the submission to the FDA in the United States or the corresponding
authorities in a country other than the United States of an NDA for
the Product and filing of such NDA in such country.
-4-
[ * ] = C
ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
1.34 “Net Sales” means, for any
period, the gross amount invoiced or otherwise charged by Sankyo or
its Affiliates or Sublicensees for the sale of any Product to any
Third Party, less the following deductions to the extent actually
incurred or allowed in connection with the sale of such Product
(and in accordance with the integrated system of International
Accounting Standards and International Financial Reporting
Standards, consistently applied): (a) trade, quantity and cash
discounts allowed; (b) commissions, discounts, refunds,
rebates, charge-backs, retroactive price adjustments, and any other
allowances which effectively reduce the net selling price;
(c) actual Product returns and allowances; (d) delayed
ship order credits and discounts pursuant to indigent patient
programs and patient discount programs, including, but not limited
to, “Together Rx” and coupon discounts; and
(e) any tax imposed on the production, sale, delivery or use
of the Product, including, without limitation, sales, use, excise
or value added taxes.
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” .
1.35 “Non-Disclosure
Agreements” means:
(a) the Confidential Disclosure Agreement among Sankyo,
Exelixis and Exelixis’ Affiliate X-Ceptor Therapeutics, Inc.,
effective as of July 27, 2005, and all amendments thereto; and
(b) the Consultant’s Confidential Disclosure Agreement
among Exelixis, Sankyo, and Sankyo’s consultant Jim Zeller
Consulting LLC, effective as of October 18, 2005.
1.36
“Patents” means all: (a) United States patents,
re-examinations, reissues, renewals, extensions and term
restorations, inventors’ certificates and non-U.S.
counterparts
-5-
[ * ] = C
ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
thereof; (b) pending applications for
United States patents, including provisional applications,
continuations, continuations-in-part, continued prosecution,
divisional and substitute applications; and (c) non-U.S.
counterparts of the foregoing.
1.37 “Phase II
Trial” means a
human clinical trial of the Product, the principal purpose of which
is to make a preliminary determination that such Product is safe
for its intended use and to obtain sufficient information about
such Product’s efficacy to permit the design of further
clinical trials, and generally consistent with 21 C.F.R. §
312.21(b), as amended (or its successor regulation).
1.38 “Phase III
Trial” means a
pivotal human clinical trial of a Product, which trial is designed
to: (a) establish that the Product is safe and efficacious for
its intended use; (b) define warnings, precautions and adverse
reactions that are associated with the Product in the dosage range
to be prescribed; (c) support Regulatory Approval of such
Product; and (d) be generally consistent with 21 C.F.R. §
312.21(c), as amended (or its successor regulation).
1.39
“Product” means any human therapeutic or prophylactic
product that contains or comprises any Licensed Compounds as a main
ingredient.
1.40 “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 European
Union), 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.
1.41 “Research Plan” shall have
the meaning set forth in Section 2.3 .
1.42 “Research Term” means the
period of the Initial Research Term plus any extension agreed upon
by the Parties pursuant to Section 2.5 .
1.43 “Sankyo
Know-How” means all
Information that is Controlled by Sankyo or its Affiliates [ *
] , excluding any Information jointly owned by the Parties.
Sankyo Know-How does not include any Sankyo Patents.
1.44 “Sankyo
Patents” means all
Patents Controlled by Sankyo or its Affiliates [ * ] , but
excluding any Joint Patents.
1.45 “Small Molecule Compound”
means a molecule with a molecular weight less than or equal to [
* ] .
1.46
“Sublicensee” means a person, corporation, partnership or
other entity, other than an Affiliate, that is granted a sublicense
by Sankyo under the grant in Section 4.1 or that is
granted a license to develop and/or commercialize
Products.
1.47
“Term” means
the period beginning on the Effective Date and ending on the
expiration or earlier termination of this Agreement.
-6-
[ * ] = C
ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
1.48 “Third
Party ” means any
person or entity other than Exelixis, Sankyo or an Affiliate of
Exelixis or Sankyo.
1.49 “Valid
Claim” means:
(a) any claim of an issued Patent in the Exelixis Patents,
Joint Patents or the Sankyo Patents that has not (i) expired
or been abandoned, (ii) 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 or
(iii) been admitted to be invalid or unenforceable through
reissue, disclaimer or otherwise; or, [ * ] , (b) any
claim under a application for a Patent in the Exelixis Patents,
Joint Patents or the Sankyo Patents that has not been abandoned,
canceled, withdrawn from consideration, or finally determined to be
unallowable in a decision from which no appeal can be
taken.
2.1 Overview. The general goals and intent of
the Collaboration are to apply each Party’s technology and
expertise to optimize and characterize Licensed Compounds that may
be developed into Products. During the Initial Research Term of the
Collaboration: (a) Sankyo will focus on the completing the
characterization of the Lead Compound for the filing of an IND and
on the optimization of Licensed Compounds (other than the Lead
Compound) through the creation and testing of Derivatives; and
(b) Exelixis will focus on the optimization of Licensed
Compounds (other than the Lead Compound) through the creation and
testing of Derivatives. The details of the work to be conducted
under the Collaboration will be set forth in the Research Plan, as
described in Section 2.3 .
2.2 Joint Research
Committee.
(a) Membership . The Joint Research Committee
(the “ JRC ”) shall be composed of [ * ]
members. Within [ * ] days after the Effective Date, each
Party shall appoint [ * ] to the JRC, with one (1) of
those representatives being the individual at the Party with
primary responsibility for the day-to-day management and execution
of the Research Plan. Each Party may replace its appointed JRC
representatives at any time upon written notice to the other Party.
[ * ] shall designate one (1) of its representatives as
Chairperson of the JRC. The Chairperson shall be responsible for
scheduling meetings, preparing and circulating an agenda in advance
of each meeting, and preparing and issuing minutes of each meeting
within [ * ] days thereafter. Any JRC member may add topics
to the draft agenda.
(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 elevated to the [ * ] . If these two
(2) individuals are unable to agree, then the matter shall be
elevated to the [ * ] . 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
-7-
[ * ] = C
ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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 5 of this Agreement.
(c) Responsibilities . The JRC shall be
responsible for the planning and execution of the Collaboration,
and it may appoint various scientific working groups that will
report to the JRC and that will manage the day-to-day activities
and decisions required under the Collaboration. At its meetings,
the JRC shall evaluate the data generated by the Parties in the
course of carrying out the Research Plan, shall prioritize projects
within the Research Plan, shall perform those activities
specifically described in this Agreement, and may propose revisions
to the Research Plan in accordance with Section 2.3 .
To the extent necessary to carry out its responsibilities, a
Party’s JRC members shall be granted access to the other
Party’s Confidential Information relevant to any decision
required to be made by the JRC.
(d) Meetings. During the Research Term, the
JRC shall meet quarterly by audio or video teleconference and, at a
minimum, once each [ * ] in person. Such quarterly meetings
of the JRC shall be held on an alternating basis at Sankyo’s
facilities in Shinagawa, Tokyo and at Exelixis’ facilities in
South San Francisco or San Diego (as applicable). 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. Meetings of the JRC 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 at least [ * ] in advance.
2.3 Research Plan. The Parties have agreed in
writing upon a detailed plan for the research to be carried out by
the Parties during the Research Term, which is incorporated herein
by reference to the Disclosure Letter (the “ Disclosure
Letter ”) between the Parties of even date herewith (the
“ Research Plan ”). The Research Plan includes
each Party’s respective obligations in furtherance of the
Collaboration and timelines for performance of such obligations.
The Research Plan shall call for at least [ * ] FTEs
throughout the Initial Research Term. Sankyo shall compensate
Exelixis, in accordance with Section 5.2 , for all FTEs
called for in the Research Plan, and Exelixis shall not have any
obligation to devote more than such number of FTEs in the
performance of its obligations under the Research Plan. The JRC
shall review the Research Plan at least [ * ] and may
propose revisions to the Research Plan that are consistent with the
terms of this Agreement. The revised Research Plan may only be
approved with the mutual written agreement of the Parties. Once so
approved, such revised Research Plan shall replace the prior
Research Plan.
2.4 Compound Transfer. Within [ * ] of
the Effective Date, Exelixis shall use commercially reasonable
efforts to transfer to Sankyo the items listed on Exhibit
2.4 . Upon Sankyo’s reasonable request, Exelixis shall
facilitate the transfer of technology relating to the manufacturing
process, if any, for the Existing Compounds to Sankyo, at any time
during the period of [ * ] following the Effective Date.
During the Research Term, within [ * ] of receiving
Sankyo’s reasonable request for one or more particular items
of Information that is in Exelixis’ possession, including any
[ * ] , and that is generated by Exelixis under the Research
Plan,
-8-
[ * ] = C
ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Exelixis shall use commercially reasonable
efforts to transfer such items to Sankyo. Sankyo shall reimburse
Exelixis for any out-of-pocket costs incurred by Exelixis in
connection with this Section 2.4 and for reasonable
travel expenses incurred by Exelixis to attend, at Sankyo’s
request, any meetings not held at an Exelixis facility.
2.5 Extension of Research Term. The Parties
may mutually agree to extend the Research Term beyond the end of
the Initial Research Term for an additional two (2) year
period, during which time Sankyo shall fund at least [ * ]
FTEs per year at the Annual FTE Rate(s) to be agreed upon by the
Parties and such FTEs shall either: (a) [ * ] ; or
(b) develop [ * ] . If the Parties intend to so extend
the Research Term, then at least [ * ] prior to the end of
the Initial Research Period, the Parties shall agree upon a written
Research Plan that covers such extension period and specifies the
applicable Annual FTE Rate(s) and shall amend this Agreement as
necessary including, if applicable, to clarify each Parties’
rights and obligations with respect to the [ * ] and [ *
] .
2.6 Obligations of Parties. Exelixis and
Sankyo shall provide the JRC and its authorized representatives
with reasonable access during regular business hours to all
records, documents, and Information relating to 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 Sankyo, as the case may be, may withhold access thereto
to the extent necessary to satisfy such obligation.
2.7 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 Sankyo
is that of independent contractors, 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.
2.8 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. Except as set forth in Section 5.2 , each
Party shall bear its own costs in performing its obligations under
the Collaboration.
2.9 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.
2.10 Reports. During the Research Term, each
Party shall report to the JRC no less than [ * ] and will
submit to the other Party and the JRC a [ * ] written
progress report summarizing the work performed under the
Collaboration. If reasonably necessary for a Party to perform its
work under the Collaboration or to exercise its rights under the
Agreement, such
-9-
[ * ] = C
ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
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. All such reports shall be considered
Confidential Information of the Party providing same.
2.11 Review of Licensed
Compounds. As part of the
criteria for the submission of a Licensed Compound for [ * ]
(a “ Development Candidate ”), Exelixis shall
review the results of all [ * ] conducted by either Party in
the normal course of performing research under the Research Plan or
by Sankyo in the normal course of performing research after the
expiration of the Research Term. In the event review by Exelixis is
after the expiration of the Research Term, Sankyo shall provide
Exelixis with the results of all [ * ] for such Development
Candidate, and sufficient samples of any such Development Candidate
to have such assays conducted. Exelixis may use such results and
samples for the sole purpose of performing assays to verify that
such Development Candidate does not display [ * ] (“
[ * ] Activity ”). [ * ] shall be responsible
for having such assays conducted as well as any costs associated
with such assays. If Exelixis notifies Sankyo in writing within
[ * ] of receiving a sample of a submitted Development
Candidate that such Development Candidate displays [ * ]
Activity, then Sankyo shall not [ * ] such Development
Candidate, and Sankyo’s licenses [ * ] such
Development Candidate shall terminate (solely with respect to such
Development Candidate). In the event that Exelixis does not provide
written notice to Sankyo with respect to the [ * ] Activity
of a submitted Development Candidate within such [ * ]
period, then Sankyo shall be free to develop and commercialize such
Development Candidate on the terms and conditions set forth in this
Agreement.
If Sankyo is required to [ *
] of a Development Candidate under this
Section 2.11 due to a [ * ] , Sankyo may choose
from the following options:
(a) Sankyo may [ * ] or derivatize away the
[ * ] Activity; or
(b) Sankyo may select a different Licensed Compound
for [ * ] . Furthermore, any substitution of a Licensed
Compound under this Section 2.11 [ * ] .
|
3.
|
D
EVELOPMENT
AND C OMMERCIALIZATION OF P RODUCTS
|
3.1 Sankyo Development and Commercialization.
As between the Parties, Sankyo (or its Affiliates or sublicensees)
have sole authority to conduct, at its own expense, all clinical
development, manufacturing and commercialization activities,
including all regulatory activities, with respect to any Products.
All regulatory applications with respect to the Products will be
owned by Sankyo and/or its Affiliates or sublicensee(s), as
applicable. Upon [ * ] , Exelixis shall cooperate with
Sankyo in connection with regulatory submissions related to any
Product, including, but not limited to [ * ] . Sankyo 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. Sankyo shall use Diligent
Efforts to [ * ] and shall be deemed to have fully
discharged its diligence obligation upon [ * ] . Exelixis
may notify Sankyo in writing if
-10-
[ * ] = C
ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
Exelixis in good faith believes that Sankyo is
not meeting its diligence obligations set forth in this
Section 3.2 , and may further request review of
Sankyo’s records generated and maintained as required under
Section 3.5 , to the extent those records relate to
[ * ] . Promptly after receiving such notice, Sankyo shall
meet with Exelixis and discuss the matter in good faith. Exelixis
may terminate this Agreement pursuant to Section 10.4
if Sankyo fails to meet such diligence obligations.
3.3 Progress Reporting. Sankyo will keep
Exelixis appropriately informed about Sankyo’s Development
and Commercialization efforts with respect to Products. Without
limiting the generality of the foregoing, Sankyo shall provide
Exelixis with written notice within [ * ] of the occurrence
of any of the milestone events listed in Section 5.3 .
Sankyo shall also provide Exelixis with [ * ] written
reports on the general progress of Sankyo’s efforts to
Develop and Commercialize Products, including a [ * ] .
Additionally, Sankyo shall provide Exelixis with a [ * ]
written report describing Sankyo’s progress at Developing and
Commercializing Products. If reasonably necessary or useful for
Exelixis to exercise its rights under this Agreement, Exelixis may
request that Sankyo provide more detailed information and data
regarding the work reported by Sankyo, and Sankyo will, without
delay, provide Exelixis with information and data as is reasonably
related to such request. All such reports shall be considered
Confidential Information of Sankyo.
3.4 Compliance with Laws. Sankyo shall
perform, and shall ensure that its Affiliates, Sublicensees and
Third Party contractors perform, all Development and
Commercialization activities for which it is responsible under this
Agreement in good scientific and medical manner and in compliance
with all applicable laws, rules and regulations.
3.5 Records. Sankyo shall maintain complete
and accurate records of all 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. Sankyo shall maintain such records until the
later of: (a) [ * ] after such records are created, or
(b) [ * ] after the Launch of the Product to which
such records pertain. Such records shall be at a level of detail
appropriate for [ * ] purposes. Exelixis shall have the
right to review and copy such records of Sankyo at reasonable times
to the extent necessary or useful for Exelixis to conduct its
obligations or enforce its rights under this Agreement.
|
4.
|
L
ICENSES A ND O THER R IGHTS
|
4.1 Exclusive
Licenses.
(a) Subject to the terms and conditions of this
Agreement, Exelixis hereby grants to Sankyo a worldwide, exclusive,
royalty-bearing license (with the right to sublicense), under the
Existing Compound Patents, the Existing Compound Know-How and
Exelixis’ interest in the Joint Patents, to make, have made,
use, develop, sell, offer for sale and import Products containing
or comprising Existing Compounds or Derivatives thereof (but not
Back-up Compounds or Derivatives thereof).
-11-
[ * ] = C
ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .
(b) Subject to the terms and conditions of this
Agreement, Exelixis hereby grants to Sankyo a worldwide, exclusive,
royalty-bearing