Exhibit 10.83
COLLABORATION AGREEMENT
BY AND BETWEEN
PHARMACYCLICS, INC.,
AND
LES LABORATOIRES SERVIER
AND
INSTITUT
DE RECHERCHES INTERNATIONALES SERVIER
April 16, 2009
*** Certain information in this
document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
SUMMARY
RECITALS
Article 1 -
DEFINITIONS
Article 2 - MANAGEMENT OF THE
COLLABORATION
Article 3- RESEARCH
PROGRAM
Article 4- DEVELOPMENT,
REGISTRATION AND COMMERCIALIZATION
Article 5 - FINANCIAL
TERMS
Article 6 - LICENSES
Article 7 - INTELLECTUAL
PROPERTY
Article 8 -
CONFIDENTIALITY
Article 9 - REPRESENTATIONS,
WARRANTIES AND COVENANTS
Article 10 - INDEMNIFICATION,
INSURANCE, LIMITATION OF LIABILITY
Article 11 - TERM AND
TERMINATION
Article 12 - GOVERNING LAW AND
DISPUTE RESOLUTION
Article 13 - GENERAL
PROVISIONS
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
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COLLABORATION AGREEMENT
THIS COLLABORATION
AGREEMENT (the "
Agreement ") is made effective as of April 16, 2009 (the
"Effective Date") by and between Pharmacyclics, Inc., a corporation
organized under the laws of the State of Delaware, having offices
at 995 East Arques Avenue, Sunnyvale, California 94085, United
States of America, (" Pharmacyclics "),and Les
Laboratoires Servier , a company organized under the laws of
France, having offices at 22 rue Garnier, 92200 Neuilly sur Seine
Cedex, France (" Servier ") and Institut de Recherches
Internationales Servier, a company organized under the laws of
France, having offices at 6, Place des Pléiades, 92415
Courbevoie. Pharmacyclics and Servier are sometimes referred to
herein individually as a " Party " and collectively as the "
Parties ."
RECITALS
WHEREAS, Pharmacyclics is
developing novel small molecule Pan-HDAC Inhibitors (as defined
below), including without limitation intravenous and oral
formulations of a certain clinical lead compound and a certain
backup compound;
WHEREAS, Servier is a global
company devoted to discovering, developing, manufacturing and
marketing human pharmaceutical products;
WHEREAS, Pharmacyclics owns or
has rights under certain patents, patent applications, other
valuable technology and pre- clinical know-how relating to small
molecule Pan-HDAC Inhibitors, and may develop or acquire additional
related rights;
WHEREAS, Pharmacyclics and
Servier share a mutual interest in a collaboration aimed at further
research and development of Pan-HDAC Inhibitors back-up
compounds;
*** Certain information in this
document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
WHEREAS, Servier desires to
further , develop, register and commercialize the Pan-HDAC
Inhibitors in the Territory (as defined below), and Pharmacyclics
desires to have the Pan-HDAC Inhibitors , developed, registered and
commercialized in the Territory, in accordance with this
Agreement;
WHEREAS, Servier desires to
obtain from Pharmacyclics certain exclusive rights and licences for
the Pan-HDAC Inhibitors, and Pharmacyclics is willing to grant to
Servier such rights and licences on the terms and conditions set
forth below;
WHEREAS, Pharmacyclics is willing
to grant to Servier an exclusive option to obtain the right to
develop, register and commercialize the Option Compounds (as
defined below) in the Territory.
In consideration of the premises
and of the mutual covenants and obligations set forth herein, the
Parties hereby agree as set out below.
ARTICLE 1
DEFINITIONS
The following capitalized terms
shall have the following meanings:
1.1
"Active Component " means any product other than a Licensed
Product that performs an identifiable prophylaxis, treatment,
amelioration or maintenance function when combined with a Licensed
Product.
1.2
"Agreement "
shall have the meaning set forth in the first paragraph of this
Agreement.
1.3
"Affiliate "
means a Person that, directly or indirectly, through one or more
intermediaries, controls, is controlled by or is under common
control with Servier or Pharmacyclics. For purposes of this
definition, "control" means the possession, direct or indirect, of
the power to
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
cause
the direction of the management and policies of a Person, whether
through ownership of fifty percent (50%) or more of the voting
securities of such Person, by contract or otherwise
1.4
"Applicable Laws " means all laws, statutes, ordinances, codes,
rules and regulations that have been enacted by a Government
Authority and are in force as of the Effective Date or come into
force during the Term, in each case to the extent that the same are
applicable to the performance by the Parties of their respective
obligations under this Agreement.
1.5
"Approval Application " means any application necessary and
appropriate to obtain a Regulatory Approval, together with all
required documents, data and information concerning any Licensed
Product that is the subject of such application.
1.6
"Back-Up Compound(s)" means any Pan-HDAC Inhibitor, other than the
Initial Compound and the Initial Back- Up Compound, selected by the
JRDC or Servier to replace the Initial Compound or the Initial
Back-up Compound as a Collaboration Compound or a Licensed Product.
The Back-up Compounds may be identified within the frame of the
Research Program.
1.7
"Biomarker "
means a biochemical feature, such as a change in a signaling
pathway or the expression level of a protein that can be used to
measure the progress of disease or the effects of a treatment. For
purposes of illustration, but not limitation, a Biomarker may be
one or more proteins or mRNA or DNA that (a) reflect drug exposure
(for example, a pharmacodynamic biomarker), (b) are a surrogate of
an effective outcome (for example, a pharmacoefficacy biomarker)
and/or (c) are a predictor as to whether an individual patient will
respond to treatment (for example, a predictive
biomarker).
1.8
"Bulk Form "
means (a) bulk active pharmaceutical ingredient or (b) any
pharmaceutical ingredient that as sold cannot be used or
distributed without further processing, combination with other
Active Components or inactive components or packaging into Dosage
Form.
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
1.9
"Business Day " means any day (other than Saturday, Sunday or
federal or state legal holiday) on which banking institutions are
open for business in New York, New York, USA, and Paris,
France.
1.10
"Calendar Quarter " means for each Calendar Year, each of the
three month periods ending March 31, June 30, September 30 and
December 31; provided, however, that (a) the first Calendar Quarter
of any particular period shall extend from the commencement of such
period to the end of the first complete Calendar Quarter
thereafter; and (b) the last Calendar Quarter shall end upon the
expiration or termination of this Agreement.
1.11
"Calendar Year " means, for the first Calendar Year, the period
beginning on the Effective Date and ending December 31, 2009, and
for each Calendar Year thereafter, each successive period beginning
on January 1 and ending twelve (12) consecutive calendar months
later on December 31; provided, however, that the last Calendar
Year of the Term will be the period beginning on January 1 and
ending on the effective date of expiration or termination of the
Agreement Term.
1.12
"Collaboration " means all activities by and obligations of the
Parties under this Agreement.
1.13
"Collaboration Compound(s) " means the Initial Compound, the Initial
Back-Up Compound and any and all Back-Up Compounds.
1.14
"Combination Product " means a product that contains a Licensed
Product and one (1) or more Active Components.
1.15
"Competitive Compound " shall have the meaning set forth in Section
6.3.1
1.16
"Confidential Information " shall have the meaning set forth in Section
8.1.
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
1.17
"Contract Year " means each one (1) year period beginning on
the Effective Date or each anniversary thereof.
1.18
"Control "
means, with respect to item, intellectual property, or other
information, that the Party named as having Control (or an
Affiliate controlled by such Party) owns such item, intellectual
property, or other information, or otherwise possesses the ability
to grant a license or sublicense under such intellectual property
without violating the terms of any agreement or other arrangement
with a Third Party.
1.19
"Data "
means all preclinical data, clinical data, CMC data, clinical
pharmacology data, research data, Manufacturing data and all
regulatory documentation and filings and Regulatory Approvals
submitted or obtained in or outside the Territory together with its
supporting data and regulatory correspondence and rights to
reference the same, in each case pertaining to any Collaboration
Compound or Licensed Product, which are Controlled by each Party at
any time during the Term of this Agreement.
1.20
"Development Plan " shall have the meaning set forth in Section
4.1.2.
1.21
"Disclosing Party " shall have the meaning set forth in Section
8.1.
1.22
"DMF " shall
have the meaning set forth in Section 4.2
1.23
"Dollars "
or " $ " means the lawful currency of the United States of
America.
1.24
"Dosage Form " means a pharmaceutical product that as sold is
in individual dosage amounts and in the form approved for clinical
supply or for sale to end users.
1.25
"Effective Date " shall have the meaning set forth in the first
paragraph of this Agreement.
1.26
"EMEA "
means the European Medicines Agency, and any successor
thereto.
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
1.27
"FDA " means
the United States Food and Drug Administration, and any successor
thereto.
1.28
"Field "
means the prophylaxis, treatment, amelioration, and maintenance of
human diseases.
1.29
"First Commercial Sale " means the first sale of a Licensed Product by
Servier, its Affiliates or its Sublicensees (including without
limitation any of its co-marketing partners) for use or consumption
of such Licensed Product in a country where Regulatory Approval of
such Licensed Product has been obtained, or otherwise permitted for
sale by the Governmental Authority of such country. Sale of a
Licensed Product by Servier to an Affiliate of Servier or a
Sublicensee of Servier shall not constitute a First Commercial Sale
unless such Affiliate or such Sublicensee is the end user of the
Licensed Product; provided, however, that in no event shall any
sales for premarketing, testing or sampling be deemed a First
Commercial Sale.
1.30
"Fully Burdened Cost of Goods of
Manufacturing " means, as
applicable:
1.30.1 "Fully Burdened Cost of
Goods of Manufacturing Bulk Form" as such term is defined in Exhibit 1.32(a);
and
1.30.2 "Fully Burdened Cost of
Goods of Manufacturing Dosage Form" as such term is defined in 1.32(b).
1.31
"GAAP "
means U.S. Generally Accepted Accounting Principles, consistently
applied.
1.32
"GLP " means
the regulations set forth in 21 C.F.R. Part 58 and the requirements
expressed or implied thereunder imposed by the FDA and (as
applicable) any equivalent or similar standards in jurisdictions
outside the United States.
1.33
"Government Authority " means any supranational, national, regional,
state or local government, court, governmental agency, authority,
board, bureau, instrumentality or regulatory
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
body,
including without limitation any national (e.g., the FDA or the
MHLW), supranational (e.g., the EMEA), regional, state or local
regulatory agency, department bureau, commission, council or other
government entity in any jurisdiction of the world that has
responsibility for granting any licenses or approvals or granting
pricing and/or reimbursement approvals necessary for the marketing
and sale of a pharmaceutical product in any country.
1.34
[***]
1.35
"Improvement(s) " means any future new or useful discovery,
invention, contribution, finding, or improvement that is generally
applicable to the Collaboration Compounds and / or Licensed
Products, the Manufacture, design, testing use or formulation
thereof, whether or not patentable, and all related Know-How, that
is conceived and reduced to practice by Pharmacyclics and/or
Servier (or their Affiliates exercising rights under this
Agreement) under this Agreement, either solely or
jointly.
1.36
"IND " shall
mean an Investigational New Drug application filed with FDA or a
similar application filed with an applicable Governmental Authority
outside of the United States such as a clinical trial application
(CTA).
1.37
"Infringement " shall have the meaning set forth in Section
7.4.1.
1.38
"Initial Back-Up Compound " means [***].
1.39
"Initial Compound " means the Pan-HDAC Inhibitor known as
PCI-24781, having the structure shown in Exhibit 1.7.
1.40
"Inspected Party " shall have the meaning set forth in Section
4.7.
1.41
"Joint Invention " means any invention, development, or
discovery, whether or not patentable, pertaining to a Collaboration
Compound or a Licensed Product, conceived and reduced to practice
during the course of performance under this Agreement jointly by
(a) employees or
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
agents
of Pharmacyclics or any of its Affiliates and (b) employees or
agents of Servier or any of its Affiliates.
1.42
"Joint Patents " means (a) all patent applications that claim
Joint Inventions and that are filed by or for the behalf of
Pharmacyclics and Servier or an Affiliate of either pursuant to
Section 7.3; (b) all patent applications that claim Improvements
with respect to Joint Inventions; (c) all divisional, continuation,
continuation-in-part or substitute applications which claim
priority from any of the patent applications within (a) or (b)
above; and (d) all patents which may issue on any of the patent
applications within (a), (b) or (c) above, and all extensions,
reexaminations or re-issues of any of such patents.
1.43
"JNDA "
means a marketing authorization application filed with the
MHLW
1.44
"Know-How "
means information, data (including Data) and proprietary rights of
any type whatsoever (other than Patent Rights and trademarks) in
any tangible or intangible form whatsoever, including, without
limitation, inventions, practices, methods, techniques,
specifications, formulations, formulae, knowledge, know-how, skill,
experience, test data and other similar information.
1.45
"Licensed Product(s) " means any pharmaceutical preparation in final
form (or, where the context so indicates, the form under
development) containing a Collaboration Compound as a primary
active therapeutic ingredient for use in the Territory.
1.46
"Losses "
shall have the meaning set forth in Section 10.1.
1.47
"MAA " shall
mean a marketing authorization application filed with the EMEA
pursuant to the centralized approval procedure in Europe or to
national approval procedure with the applicable Governmental
Authority of a country of the Territory outside Europe.
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
1.48
"Manufacturing " or " Manufacture " shall mean
activities directed to producing, manufacturing, processing,
filling, finishing, packaging, labeling, quality assurance testing
and release, shipping and storage of a product.
1.49
"MHLW "
means the Ministry of Health, Labor and Welfare, otherwise referred
to as "Koseisho," or any successor thereto, which governs the
review of human pharmaceutical products in Japan.
1.50
"NDA " shall
mean a New Drug Application pursuant to Section 505 of the United
States Federal Food, Drug and Cosmetic Act (21 U.S.C. Section 355)
and the regulations promulgated thereunder related to a Product
submitted to the FDA or any successor application.
1.51
"Negotiation Period " shall have the meaning set forth in Section
3.2.2.
1.52
"Net Sales "
means: [***]
1.53
"Option "
shall have the meaning set forth in Section 3.2.1.
1.54
"Option Compound(s) " means any compound developed by Pharmacyclics
prior or during the Research Term:
1.54.1 that comprises
a.
an [***] Inhibitor or
b.
an active ingredient of which is a
small molecule and the mechanism of action of which is solely as an
inhibitor of [***];
1.54.2 that is not the Initial Compound, the Initial
Back-Up Compound or any Back-Up Compound(s).
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
1.55
"Option Compound License Agreement
" shall have the meaning set forth
in Section 3.2.2
1.56
"Pan-HDAC Inhibitor " means a small molecule that inhibits the
enzymatic activity of all active isoforms of histone deacetylase
with similar potency, but not including any [***]-[***], including,
for example, [***] [***].
1.57
"Party " or
" Parties " shall have the meaning set forth in the first
paragraph of this Agreement.
1.58
"Patents" means all patents and patent applications, and
all continuing and divisional patent applications,
continuations-in-part and reissue applications claiming priority,
indirectly and directly, to such applications, and all patents
issuing therefrom in the relevant Territory as well as any patent
term extensions.
1.59
"Patent Costs " means all reasonable out of pocket fees and
expenses, actually incurred in connection with the establishment
and maintenance of rights under the Patent Rights, including
without limitation, the official fees and reasonable patent
attorneys' fees associated with the preparing, filing, prosecuting
(including translation fees) and maintenance of such patent
applications and patents, the costs of conducting re-examinations,
reissues, requests for patent term extensions and the like with
respect to such patents, and the costs associated with the conduct
of interferences, the defense of oppositions and other similar
proceedings in the Territory with respect to any such patent
applications and/or patents.
1.60
"Patent Rights " means (a) patent applications and patents
Controlled by a Party or the Parties at any time during the Term
relating to the subject matter of this Agreement, including without
limitation patent applications and patents with respect to
Improvements; (b) all divisional, continuation,
continuation-in-part or substitute applications which claim
priority from any of the
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
patent
applications within (a) above; (c) all patents that may issue on
any of the patent applications within (a) or (b) above; (d) all
extensions, re-examinations, or reissues of patents within (a) or
(c) above.
1.61
"Person "
means any person or legal entity.
1.62
"Pharmacyclics " shall have the meaning set forth in the first
paragraph of this Agreement.
1.63
"Pharmacyclics Biomarker " means a Biomarker Controlled by Pharmacyclics
which is necessary or useful for clinical development and/or
commercialization (e.g., [***] Biomarker) of a Pan-HDAC
Inhibitor.
1.64
"Pharmacyclics Know-How " means Know-How Controlled by Pharmacyclics
that is necessary or useful to Manufacture, have Manufactured, use,
sell, have sold, import and export Licensed Products.
1.65
"Pharmacyclics IP " shall have the meaning set forth in Section
7.1.1.
1.66
"Pharmacyclics Patent Rights " means any Patent Right controlled by
Pharmacyclics before or during the Term (including Pharmacyclics
interests in Joint Patents) and necessary or useful to Manufacture,
have Manufactured, use, have used, sell, have sold, import and
export Licensed Product and Combination Product including but not
limited to the Patent Rights listed in Exhibit 1.66.
1.67
"Phase II Clinical Trial " means a human clinical trial of a Licensed
Product conducted for purposes of preliminary determination of
efficacy and/or preliminary establishment of appropriate dosage
ranges for efficacy and safety in patients as described under 21
C.F.R. 312.21(b) with respect to the United States, or, with
respect to a jurisdiction other than the United States, a similar
clinical study.
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
1.68
"Phase III Clinical Trial " means any clinical study intended as a pivotal
study for purposes of seeking Regulatory Approval that is conducted
on sufficient numbers of human subjects to establish that the
Licensed Product is safe and efficacious for its intended use, to
define warnings, precautions, and adverse reactions that are
associated with the Licensed Product in the dosage range to be
prescribed, and to support Regulatory Approval of the Licensed
Product or label expansion of such pharmaceutical product, or a
similar clinical study prescribed by the Governmental Authorities
in a foreign country. The term "Phase III Clinical Trial" shall
include without limitation any clinical trial that would satisfy
requirements of 21 C.F.R. 312.21(c), whether or not it is
designated a Phase III Clinical Trial.
1.69
"Product Materials " shall have the meaning set forth in Section
11.6.2.
1.70
"Reasonable Efforts " means the level of efforts and resources
required to actively develop, register and commercialize a Licensed
Product in a sustained manner consistent with the efforts a
similarly situated company would typically devote to a product
directed to a market of similar size.
1.71
"Receiving Party " shall have the meaning set forth in Section
8.1.
1.72
"Regulatory Approval " means, with respect to a nation or, where
applicable, a multinational jurisdiction, any approvals, licenses,
registrations or authorizations necessary for the manufacture,
marketing and sale of a Licensed Product or Combination Product in
such nation or such jurisdiction.
1.73
"Research Plan " shall have the meaning set forth in Section
3.1.
1.74
"Research Program " shall have the meaning set forth in Section
3.1.
1.75
"Research Term " means the period commencing on the Effective
Date and expiring on the [***] anniversary thereof, unless extended
by the Parties in accordance with Section 3.4.
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
1.76
"Research Work " means the research work to be conducted by the
Pharmacyclics under the Research Program during the Research
Term
1.77
"Responsible Executive " means the President of Pharmacyclics or a duly
authorized officer of Servier, or an executive officer of a Party
designated by such Party with authority to bind such
Party.
1.78
"Servier "
shall have the meaning set forth in the first paragraph of this
Agreement.
1.79
"Servier IP " shall have the meaning set forth in Section
7.1.2.
1.80
"Servier Know-How " means Know-How Controlled by Servier that is
necessary or useful to Manufacture, have Manufactured, use, sell,
have sold, import and export Licensed Products.
1.81
"Servier Patent Rights " means any Patent Right Controlled by Servier
before or during the Term and necessary or useful to Manufacture,
have Manufactured, use, sell, have sold, import and export Licensed
Products, including Servier's interest in Joint Patents.
1.82
"Sublicensee " means with respect to a particular Licensed
Product or Combination Product, a Third Party to whom Servier has
granted directly or indirectly (i) a license to make and sell
such Licensed Product or Combination Product, or (ii) a right
or license to market, promote or distribute such Licensed Product,
provided that such Third Party is responsible for some or all of
the marketing or promotion of such Licensed Product or Combination
Product within such Third Party's portion of the
Territory.
1.83
"Term "
shall have the meaning set forth in Section 11.1.1.
1.84
"Territory "
means all territories and countries throughout the world, except
the United States and its territories and possessions.
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
1.85
"Territory-specific Patents " shall have the meaning set forth in Section
7.3.1.
1.86
"Third Party " means any Person other than Pharmacyclics or
Servier or their respective Affiliates.
1.87
""Third Party Technology " shall have the meaning set forth in Section
6.1.4.
1.88
"Valid Claim " means with respect to Pharmacyclics Patent
Rights (a) any claim of an issued, unexpired patent that has not
been held unenforceable, unpatentable or invalid by a decision of a
court or other governmental agency of competent jurisdiction
following exhaustion (or expiration) of all possible appeal
processes, and that has not been admitted to be invalid or
unenforceable through reissue, reexamination or disclaimer or has
not been made unenforceable due to a failure to pay maintenance
fees, or (b) any composition of matter, article of manufacture or
method of use claim contained in an application for a patent that
has been pending for less than [***] years.
ARTICLE 2
MANAGEMENT OF THE
COLLABORATION
2.1
Joint Research and Development Committee
("JRDC")
2.1.1 Formation and
Purpose . Within fifteen
(15) Business Days after the Effective Date, Servier and
Pharmacyclics shall establish the JRDC, which shall facilitate
communication between the Parties by providing a forum for review
and discussion of each Party's activities under this Agreement and
by coordinating the exchange of Data and other information
contemplated in this Agreement. Each party shall designate four (4)
representatives to serve as members of the JRDC. Each Party may
replace any or all of its JRDC representatives at any time upon
written notice to the other Party.
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and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
2.1.2 Meetings
. The JDRC shall meet at least twice
a year during the Term, unless otherwise agreed by the Parties.
Such meetings may be in person or via telephone or video conference
or other mutually agreeable means. With the consent of the JDRC
members, other representatives of Servier or Pharmacyclics may
attend JDRC meetings as ad hoc members. Each Party shall bear its
own personnel and travel costs and expenses relating to JDRC
meetings.
2.1.3 Specific Responsibilities of
the JDRC . In support of
its function of facilitating communication between the Parties, the
JRDC shall, in particular:
a.
review and discuss the Research
program, and the Research Plan and the Development Plan , the
pivotal clinical protocols, the regulatory strategies, as well as
modifications and updates of the Plans ;
b.
provide a forum for the review of
progress and exchange of ideas and suggestions regarding the
development, the registration and commercialization of Licensed
Products both inside and outside the Territory ;
c.
coordinate the exchange of Data
between the Parties;
d.
review and discuss the data and
results generated under the Research Program;
e.
maintain a list of all Option
Compounds identified by Pharmacyclics ; and perform such other
functions as appropriate to further the purposes of this Agreement
as determined by the Parties.
ARTICLE 3
RESEARCH PROGRAM
3.1
Scope of
Research
During
the Research Term, Pharmacyclics shall engage in the research
activities indicated in the Research Program listed in Exhibit 3.1
(the " Research
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and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
Program "). Pharmacyclics will set forth the activities
to be conducted under the Research Program in a research plan,
which may be amended from time to time by the Parties (the "
Research Plan "). Pharmacyclics will provide results of the
Research Program as soon as practicable to benefit ongoing research
and/or clinical development on the Initial Compound, the Initial
Back-Up Compound and/or the Back-up Compounds, or facilitate
selection of an Option Compound and will present a report on its
research results on a [***] basis to the JRDC.
3.2
Evaluation of Option
Compounds ; Option Exercise
3.2.1 Option Exercise
. Pharmacyclics will notify Servier
when it identifies an Option Compound under or outside the Research
Program during the Term, and provide a written description of such
Option Compound. Such notice will include, but not be limited to
the chemical structure of any new chemical entity; synthesis and
characterization, in vitro panel, and preliminary safety and
efficacy data sufficient to support initiation of IND enabling
studies. Servier shall have an option with respect to each such
Option Compound to obtain a royalty-bearing, exclusive,
sublicensable right and license under the Pharmacyclics IP to
develop, register and commercialize such Option Compound in the
Territory in the Field (each such option, an " Option ").
Each such Option shall be exercisable for [***] after delivery of
such notice upon written notice to Pharmacyclics.
3.2.2 License
Negotiation . Promptly
following Pharmacyclics' receipt of Servier's notice that it is
exercising its Option with respect to a particular Option Compound,
Pharmacyclics and Servier shall commence good faith negotiations
regarding the terms under which Pharmacyclics would grant to
Servier a royalty-bearing, exclusive, sublicensable right and
license under the Pharmacyclics IP to (a) use the Option Compound
supplied by Pharmacyclicsfor pre-clinical and/or clinical
development activities, and (b) develop, have developed,
Manufacture, have Manufactured, use, have used, offer for sale,
lease, market, sell, have sold, import and export finished products
containing such Option Compound in the Field in the Territory (each
such license, an " Option Compound License Agreement "). The
Parties shall use good faith efforts to successfully
conclude
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
such
negotiations as soon as reasonably practicable and in any event on
or before the end of the period which is [***] after the date of
Servier's exercise of the Option (" Negotiation Period
").
3.2.3 Option Compound
Return .
If
Servier does not give notice with respect to an Option Compound in
accordance with Section 3.2.1, or, having exercised its Option in
accordance with Section 3.2.1, fails to execute an Option Compound
License Agreement prior to the expiration of the Negotiation
Period, then any and all rights with respect to such Option
Compound shall revert to Pharmacyclics and, thereafter, Servier
shall have no right to or interest in such Option
Compound.
3.3
Personnel and Resources
.
Pharmacyclics agrees to commit the personnel,
facilities, expertise, and other resources needed to perform the
Research Plan; provided, however, that Pharmacyclics does not
warrant that the Research Program shall achieve any of the research
objectives contemplated by them.
3.4
Term of the Research
Program
Pharmacyclics shall conduct the Research Work
under the Research Program during the Research Term. At the end of
the Research Term, Pharmacyclics' obligation to conduct the
Research Work, will cease unless the Parties mutually agree to
extend the Research Term prior to the [***] anniversary of the
Effective Date, subject to additional payments, to be agreed upon
by the Parties, for research activities conducted by Pharmacyclics
during any such extended period. An inventory of all Option
Compounds then existing shall be prepared by the
Pharmacyclics.
3.5
Expenses
Except
as otherwise set forth elsewhere in this Agreement, Pharmacyclics
shall bear the costs and expenses of Research Work done pursuant to
the Research Program at its laboratories and its affiliated
laboratories. For clarity, the cost of synthesis of Option
Compound(s) for which Servier has obtained a license pursuant to
Section 3.2, and related costs of scale-up and
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document has been omitted and filed separately with the Securities
and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
process
development for such Option Compound(s) shall be allocated between
the Parties as set forth in the Option Compound License
Agreement.
3.6
Exclusivity
Nothing
in this Agreement shall restrict Pharmacyclics from researching,
developing, registering and/or commercializing any [***] Inhibitor
for any indication(s) in any country or countries in the world, or
prevent Pharmacyclics from licensing a Third Party to do the same,
however Pharmacyclics agrees that during the Term it will not (a)
research, develop, register or commercialize any [***] Inhibitor
for use in the Field in the Territory except in connection with its
performance of the Re