[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
COLLABORATIVE RESEARCH,
DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
This COLLABORATIVE
RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the “
Agreement ”), effective as of January 30, 2006
(the “ Effective Date ”) is made by and between
Pharmion Corporation, a corporation organized under the laws of the
State of Delaware, USA, with a place of business at 2525-28
th Street, Suite 200, Boulder, Colorado,
803301, USA (“ Pharmion Corporation ”) and
Pharmion GmbH, a wholly-owned subsidiary of Pharmion Corporation
registered in Switzerland having its principle place of business at
Aeschenvorstadt 71, 4051 Basel, Switzerland (“ Pharmion
GmbH ” and, collectively with Pharmion Corporation,
“ Pharmion ”) on the one hand and MethylGene
Inc., a corporation organized under the laws of Quebec, Canada,
with its principal place of business at 7220 Frederick-Banting,
Suite 200, Montreal, Québec H4S 2A1, Canada (“
MG ”). Each of Pharmion and MG shall be referred to as
a “ Party ” and, together, as the “
Parties .”
A. MG has
developed certain proprietary technology related to small molecule
HDAC Inhibitors (as defined below), which may be useful for
developing pharmaceutical products for the treatment and
prophylaxis of cancer in humans.
B. Pharmion
possesses pharmaceutical development and commercialization
capabilities.
C. MG has
identified certain novel, proprietary HDAC Inhibitors, including
the Compound designated as MGCD0103, which MG is pursuing as
potential development candidates for cancer.
D. MG and
Pharmion desire to collaborate to pursue potential commercial
development in the cancer field of one or more HDAC Inhibitors,
discovered by MG prior to the Effective Date, and discover and
potentially commercialize additional HDAC Inhibitors as potential
development compounds for cancer, all on the terms and conditions
set forth herein.
E. In
addition, MG desires to grant to Pharmion, and Pharmion desires to
obtain, a license from MG of HDAC Inhibitors for use in the
Territory (as defined below) in the Field (as defined below), on
the terms and conditions set forth herein.
NOW THEREFORE, for
and in consideration of the covenants, conditions, and undertakings
hereinafter set forth, it is agreed by and between the Parties as
follows:
1.1 “
Actions ” shall have the meaning set forth in
Section 17.5.
- 1 -
1.2 “
Additional Clinical Candidate(s) ” shall mean a
Selected Compound with respect to which IND enabling studies have
been completed pursuant to the Collaboration, other than the
Initial Clinical Candidate.
1.3 “
Additional Partner ” shall mean each Third Party who
is granted by MG, directly or indirectly, a right to market or
commercialize Compounds and/or Products outside the Territory,
other than a Non-Cancer Partner or an Opt-out Non-Cancer Partner.
It is understood that, for purposes of this definition, “a
right to market or commercialize” shall include an option to
acquire such rights. As of the Effective Date, the sole Additional
Partner is Taiho.
1.4 “
Affiliate ” shall mean, in the case of a subject
entity, another entity which controls, is controlled by or is under
common control with the subject entity. For purposes of this
definition only, “control” shall mean beneficial
ownership (direct or indirect) of at least fifty percent (50%) of
the shares of the subject entity entitled to vote in the election
of directors (or, in the case of an entity that is not a
corporation, in the election of the corresponding managing
authority).
1.5 “
Agreement ” shall have the meaning set forth in the
Preamble.
1.6 “
Audited Party ” and “ Auditing Party
” shall have the meanings set forth in
Section 12.5.1.
1.7 “
Cancer Compound ” shall have the meaning set forth in
Section 11.7.1.
1.8 “
Cancer HDAC Research ” shall mean Research conducted
by or under authority of MG that is not conducted as part of
Non-Cancer HDAC Research.
1.9 “
Cancer Royalty ” shall have the meaning set forth in
Section 11.7.1.
1.10 “
Change of Control ” shall mean with respect to a
Party, (a) a merger, consolidation, share exchange or other
similar transaction involving such Party and any Third Party which
results in the holders of the outstanding voting securities of such
Party immediately prior to such merger, consolidation, share
exchange or other similar transaction ceasing to hold more than
fifty percent (50%) of the combined voting power of the surviving,
purchasing or continuing entity immediately after such merger,
consolidation, share exchange or other similar transaction,
(b) any transaction or series of related transactions in which
any “person”, as such term is used in Sections 13(d)
and 14(d) of the Securities Exchange Act of 1934, as amended (the
“ Exchange Act ”), together with any of such
person’s “affiliates” or
“associates”, as such terms are used in the Exchange
Act, becomes the beneficial owner of fifty percent (50%) or more of
the combined voting power of the outstanding securities of a Party,
or (c) the sale or other transfer to a Third Party of all or
substantially all of a Party’s assets.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 2 -
1.11 “
Clinical Studies ” shall mean the Preclinical Studies,
as well as those certain clinical trials of a Compound and/or
Product in the Territory in the Field, as set forth in the
Development Plans established in accordance with Article 4
below.
1.12 “
Collaboration ” shall mean the Research, the
Development and the Commercialization conducted pursuant to this
Agreement.
1.13 “
Collaboration Term ” shall have the meaning set forth
in Section 20.1.
1.14 “
Commercialization Costs ” shall mean, with respect to
a Product Co-Promoted in North America, the variable costs and
fixed costs properly incurred by each Party with respect to work
performed by the Parties and their subcontractors in connection
with the conduct of the applicable Commercialization Plan for such
Product, and in accordance with the budget contained therein,
including (a) the Fully Absorbed Cost of Goods for batches of
such Product sold, (b) marketing, distribution and sales expenses
attributable to a Product, including costs incurred in connection
with commercial launch, market research, post-approval marketing
studies, advertising, producing Product Promotional Materials,
sponsoring seminars and symposia (including continuing medical
education sponsored by the Marketing Party), sales training
meetings and seminars specific to the Product, reimbursement and
other patient support services, distribution costs, product
liability insurance, transportation expenses including insurance
(but only to the extent not charged to customers), inventory losses
(except to the extent caused by the gross negligence or willful
misconduct of a Party), allocated based upon the proportion of such
expenses directly attributable to such Product or the activities of
the Parties in connection with the conduct of the Commercialization
Plan, (c) to the extent not included in the Fully Absorbed
Cost of Goods of a Product, license fees, milestone payments and
other amounts required to be paid to Third Parties in consideration
for rights required to conduct activities under the applicable
Commercialization Plan as agreed to pursuant to this Agreement,
allocated based on the proportion of such costs directly
attributable to such Product, (d) costs associated with
Prosecution and enforcement of Licensed Patents in North America
pursuant to Sections 17.4 and 17.6 covering any Co-Promoted
Products and defense of Third Party intellectual property claims in
North America pursuant to Section 17.5 incurred after the
Marketing Approval of such Product, and (e) post-Marketing
Approval regulatory expenses directly related to the Product,
including costs to maintain such Marketing Approval (including user
fees paid after Marketing Approval), medical and safety activities,
adverse event reporting, market withdrawals, field adjustments or
recalls. For purposes of this paragraph and to the extent agreed
upon by the JSC and included in the applicable Commercialization
Plan, “ variable costs ” shall be deemed to be
the cost of labor (calculated on a full-time equivalent basis) and
other material resources directly consumed in the execution of the
applicable Commercialization Plan and “ fixed costs
” shall be deemed to be the fixed costs directly related to
the execution of the applicable Commercialization Plan, allocated
based upon the proportion of such costs directly attributable to
support of the applicable Commercialization Plan or by such other
method of cost allocation as may be approved by the JSC. A
Party’s internal costs associated with efforts of sales
representatives shall be allocated to Commercialization Costs based
on reasonable metrics established by the JSC prior to obtaining
Marketing Approval of a Product. Except as otherwise provided in
this Agreement, all cost determinations made hereunder shall be
made in accordance with GAAP.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 3 -
1.15 “
Commercialization Plan ” shall mean, with respect to a
Product, the comprehensive plan and budget for such Product, as
more fully described in Section 5.4 and approved by the JSC in
accordance Sections 3.1 and 5.4.2.
1.16 “
Commercialization Program ” shall mean, with respect
to a Product, the program for the Commercialization of such
Product, as more fully described in Section 5.4 and the
applicable Commercialization Plan.
1.17 “
Commercialization ” shall mean any and all activities
directed to marketing, promoting, distributing, offering for sale
and selling a Product, importing a Product for sale and
manufacturing a Product for sale.
1.18 “
Commercially Reasonable and Diligent Efforts ” shall
mean the carrying out of obligations in a diligent and sustained
manner using efforts reasonably necessary or appropriate to
actively develop a product in an expeditious manner, taking into
consideration the countries in question and the market potential
for such product. “Market potential” for a product
shall be fairly determined in good faith and without limitation may
be based upon the market size, labeled indication, price,
competition, patent rights, product liability issues and general
marketing parameters. Without limiting the foregoing, Commercially
Reasonable and Diligent Efforts requires that the applicable 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 meaningful objectives for
carrying out such obligations, and (c) consistently make and
implement decisions and allocate the full complement of resources
necessary or appropriate to advance progress with respect to such
objectives in accordance with the foregoing, in each case in a
manner similar to other high priority drug development
programs.
1.19 “
Complaint ” shall mean any oral or written
communication of dissatisfaction regarding the identity, quality,
durability, reliability or performance of a Product. Examples
include, but are not limited to appearance, low fills, foreign
materials, foreign product, defective packaging or defective
labeling.
1.20 “
Compounds ” shall mean all HDAC Inhibitors identified,
synthesized, discovered or acquired (collectively, “
Discovered ”) by or under authority of MG or its
Affiliates: (a) prior to the Effective Date, or (b) during the
Research Term, or (c) any time during the term of this
Agreement after the Research Term, if Discovered in connection with
Cancer HDAC Research, or (d) any time during the term of this
Agreement prior to [***] after completion of the last Cancer
HDAC Research, if Discovered pursuant to Non-Cancer HDAC Research;
provided that in each case such HDAC Inhibitors are used or useful
in the Field. With respect to each Compound, such Compound shall
include all salts, esters, hydrates, solvates, polymorphs, free
base, isomers, prodrugs, metabolites, conjugated forms and/or
liposomal or other formulations thereof, and other compositions
consisting of such Compound non-covalently bounded with other
moieties. In the event that MG or its Affiliate has entered or
enters into an agreement with a Third Party (including an
Additional Partner or Non-Cancer Partner) in connection with
Research or prior to the end of the time periods, each as described
in clauses (a) through (d) above, Compounds
shall
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 4 -
include HDAC
Inhibitors Discovered by or under authority of such Third Party
during the term of its right to conduct Research granted by MG, but
shall exclude those compounds that were identified or being
developed by such Third Party, as an inhibitor that directly
inhibits the activity of HDAC enzymes or that has therapeutic
effect through the inhibition of HDAC enzymes, prior to the time an
agreement was first entered into with MG or its Affiliate. For
clarity, it is understood that as used herein, the term
“Discovered” shall be deemed to include HDAC Inhibitors
covered by a patent application filed during the particular period,
it being understood that the set of HDAC Inhibitors covered by a
patent or patent application shall not be deemed a single Compound
for purposes of defining Selected Compounds and Non-Cancer Selected
Compounds below, solely because they are covered by such patent
application.
1.21 “
Compound Disclosure Date ” shall mean ninety
(90) days after the Compound Registration Date with respect to
any Compound.
1.22 “
Compound Registration Date ” shall mean, with respect
to all Compounds, the date such Compound is Registered in the MG
Compound Registry, which shall be no later than thirty (30) days
after the date such Compound is first synthesized or acquired by or
on behalf of MG or its Affiliates, a Non-Cancer Partner or its
Affiliates, any Additional Partner or its Affiliates or Pharmion or
its Affiliates, as the case may be.
1.23 “
Confidential Information ” shall have the meaning set
forth in Section 16.1.
1.24 “
Contracted Research Work ” shall mean the research
work conducted by or under authority of MG which is funded, in
whole or in part, by Pharmion under this Agreement, including
without limitation all Research conducted under the Research
Plan.
1.25 “
Controlling Party ” shall have the meaning set forth
in Section 17.5.
1.26 “
Co-Promote ” or “ Co-Promoted ” or
“ Co-Promoting ” or “ Co-Promotion
” shall mean to promote jointly a Product in North America
through Pharmion and MG and their respective sales forces under
both Parties’ trade names (in accordance with
Section 5.5.2), unless otherwise agreed.
1.27 “
Cost of Goods ” shall mean, with respect to units of a
Compound or Product to be supplied to a Party hereunder:
(a) those costs of the supplying party associated with the
manufacture of such units that would normally be included as
inventoriable costs of such units in accordance with GAAP, and
would include raw materials (including normal scrap) and actual
direct labor costs and a proper allocation of overhead, subject to
Section 11.3 below ( i.e. , with respect to Third Party
royalties), and would exclude excess capacity, unusable raw
materials, cost of capital and other costs not normally included as
inventoriable costs as set forth above; or (b) if the units
are purchased from a Third Party that is not an Affiliate, the
purchase price thereof. Notwithstanding the foregoing, royalties
paid by the manufacturing party with respect to patent rights for
generic manufacturing processes used in such manufacture, but that
are not primarily used for nor primarily related to Compounds,
Products and/or HDAC, shall not be treated as a Third Party
royalties subject to Section 11.3 below, for purposes of
Section 1.27(a).
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 5 -
1.28 “
Data ” shall mean, collectively, Research Data,
Preclinical and Clinical Data and Manufacturing Data.
1.29 “
Detail ” shall mean an interactive face-to-face
contact of a sales representative, who is fully equipped with, and
knowledgeable of, applicable Product Promotional Materials and
Product labeling, with a physician or other medical professional
licensed to prescribe drugs or other healthcare professional that
has a significant impact or influence on prescribing decisions, in
which relevant characteristics of the Product are described by the
sales representative in a fair and balanced manner consistent with
the requirements of this Agreement and applicable laws and
regulations, and in a manner that is customary in the industry for
the purpose of promoting a prescription pharmaceutical product.
Details shall be accounted for in accordance with the Marketing
Party’s internal methodology for recording such activity as
approved by the JSC.
1.30 “
Development ” shall mean the Preclinical Development
and the clinical development of each Compound selected by the JSC
for Clinical Studies; such activities shall include, among others,
test method development and stability testing, toxicology,
formulation, process development, including process automation,
manufacturing scale-up, development-stage manufacturing and
QC/QA.
1.31 “
Development Costs ” with respect to a Product shall
mean the variable costs and fixed costs incurred after the
Effective Date by a Party pursuant to the conduct of activities
covered by this Agreement and in accordance with the relevant
approved Development Plan (including the budget contained therein),
for the development of such Product, including (a) direct,
out-of-pocket external costs, including clinical grants, clinical
laboratory fees, formulation costs and the cost of studies
conducted and services provided by contract research organizations
for clinical development and IND enabling studies and individuals,
consultants, toxicology contractors, and manufacturers necessary or
useful for the purpose of obtaining Marketing Approvals for such
Product, (b) costs incurred in connection with process
development and pre-clinical and clinical Product supply as set
forth in the relevant approved Development Plan for such Product,
including the efforts of Pharmion and MG to develop and document
process methods and procedures for the manufacture of such Product,
manufacturing process improvements, scale-up, manufacturing site
qualification, supply chain management and storage and the Fully
Absorbed Cost of Goods for batches of such Product manufactured and
supplied for use in Clinical Studies, (c) costs for preparing,
submitting, reviewing or developing data or information for the
purpose of submissions to any Regulatory Authority, including
submission of applications to obtain Marketing Approvals for such
Product (including user fees paid prior to Marketing Approval),
(d) to the extent not otherwise included in Fully Absorbed
Cost of Goods of a Product, license fees and other amounts paid to
a Third Party pursuant to a Third Party agreement in consideration
for rights necessary to conduct activities under the Development
Plans as approved by the JSC and (e) costs associated with
Prosecution and enforcement of Licensed Patents in North America
pursuant to Sections 17.4 and 17.6 and defense of Third Party
intellectual property claims in North America pursuant to
Sections 17.5 to the extent not included in Commercialization
Costs. For purposes of this definition and to the extent agreed
upon by the JSC and included in the applicable Development Plan,
“ variable costs ” means the cost of labor
(calculated on a full-time equivalent basis) and other material
resources directly
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 6 -
consumed in the
conduct of and in accordance with the Development Plans; and
“ fixed costs ” means the fixed costs directly
related to the conduct of activities under the Development Plans,
allocated based upon the proportion of such costs directly
attributable to the support or performance of activities under the
Development Plans or by such other method of cost allocation as may
be approved by the JSC. Except as otherwise provided in this
Agreement, all cost determinations made hereunder shall be made in
accordance with GAAP.
1.32 “
Development Plans ” shall mean the plans and budgets
for Development, as described in Article 4.
1.33 “
Distributor ” shall mean a Third Party in one or more
countries in the Territory that (a) purchases a Product in
finished form or in bulk form (to be packaged or labeled by such
Third Party in accordance with applicable law) from Pharmion, its
Sublicensees or their Affiliates for such country(ies) for a price
which in no event is less than seventy-five percent (75%) of the
average selling price of such Product in countries that are member
states of the European Union within the Territory, (b) assumes
responsibility from Pharmion for all or a portion of the
Commercialization of such Product in such country(ies) and
(c) sells such Product in such country(ies). The countries in
which Pharmion has engaged a Distributor as of the Effective Date
are identified in Exhibit 1.33.
1.34 “
DMF ” shall mean the Drug Master File filed with the
FDA or such corresponding files in other countries or regulatory
jurisdictions of the Territory, in each case, with respect to a
Product for use within the Field.
1.35 “
Effective Date ” shall have the meaning set forth in
the Preamble.
1.36 “
EMEA ” shall mean the European Medicines Agency and
any successor agency thereto.
1.37 “
Enforcement Action ” shall have the meaning set forth
in Section 17.6.
1.38 “
Exempt Patent Licensees ” shall have the meaning set
forth in Section 8.3.3(a).
1.39 “
FDA ” shall mean the U.S. Food and Drug
Administration, or any successor agency.
1.40 “
Field ” shall mean the therapeutic or prophylactic
treatment of cancer in humans (including neoplasia and other
pre-cancerous conditions, including myelodysplasia syndrome) using
a Compound or Product.
1.41 “
Full Time Equivalent ” or “ FTE ”
shall mean one (1) full-time research scientist, or in the
case of less than a full-time dedicated research scientist, a
full-time, equivalent person year of activities under the Research
Plan. The term “research scientists” means personnel of
MG assigned to conduct research, scientific and/or technical
activities under the Research Plan and having qualifications
reasonably approved by the JSC.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 7 -
1.42
“Fully Absorbed Cost of Goods ” with respect to
units of a Product shall mean (a) the variable costs and fixed
costs incurred by a Party associated with the manufacture
(inclusive of finishing processes including filling, packaging,
labeling and/or other preparation) quality assurance, quality
control and other testing, storage and shipping of batches of such
units of such Product or (b) if such units or components of a
Product are not manufactured by the Parties, the amounts paid to
the vendor plus costs associated with acquisition from such vendor
plus the other variable costs and fixed costs incurred by a Party
associated with any finishing processes conducted by such Party,
including filling, packaging, labeling and QA/QC testing. For
purposes of this definition, “ variable costs ”
means the cost of labor (calculated on a full-time equivalent
basis), raw materials, scrap, obsolescence, supplies and other
resources directly consumed in the manufacture, quality assurance,
quality control and other testing, storage and shipping of batches
of such Product, and “ fixed costs ” means the
cost of facilities, utilities, insurance (including any product
liability insurance or accrual for self-insurance), facility and
equipment depreciation and other fixed costs directly related to
the manufacture, quality assurance, quality control and other
testing, storage and shipping of batches of such Product, as well
as amounts paid to Third Parties under a Third Party agreement
(subject to Section 11.3 below), as a result of the manufacture,
use or sale of such units of Products. Fixed costs shall be
allocated to such units of Product based upon the proportion of
such costs directly attributable to support of the manufacturing,
quality assurance, quality control and other testing, storage and
shipping processes for such Product. If a facility is used to
manufacture Products and has the capacity to manufacture products
for other programs of either Pharmion or MG, fixed costs shall be
allocated in proportion to the actual use of such facility for the
manufacture of Products and the capacity to manufacture products
for such other programs. For the avoidance of doubt, no idle
capacity of a manufacturing facility, or a proportionate use
thereof, shall be included in Fully Absorbed Cost of Goods except,
in the case of a facility dedicated solely to the manufacture of
Products, it shall be included to the extent the JSC determines in
good faith that such facility is appropriately sized. Fully
Absorbed Cost of Goods shall exclude all costs otherwise reimbursed
pursuant to this Agreement. All cost determinations made hereunder
shall be made in accordance with GAAP. Notwithstanding the
foregoing, royalties paid by the manufacturing party with respect
to patent rights for generic manufacturing processes used in such
manufacture, but that are not primarily used for nor primarily
related to Compounds, Products and/or HDAC, shall not be treated as
a Third Party royalties subject to Section 11.3 below, for
purposes of Section 1.42(a).
1.43 The “
FTE Rate ” for Research conducted by MG hereunder
shall be Two Hundred and Fifty Thousand Dollars (US $250,000) per
FTE (consisting of at least a total of eighteen hundred (1,800)
hours per calendar year, or such other number as may be agreed by
the JSC) for work directly related to the Research or any other
activities contemplated under the Research Plan. No additional
payment shall be made with respect to any person who works more
than eighteen hundred (1,800) hours per calendar year and any
person who devotes less than eighteen hundred (1,800) hours per
calendar year shall be treated as an FTE on a pro-rata basis based
upon the actual number of hours worked divided by eighteen hundred
(1,800). Each Party acknowledges that the foregoing FTE rate has
been set to include all salary, employee benefits, materials and
other expenses, including support staff and overhead for or
associated with an FTE.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 8 -
1.44 “
GAAP ” shall mean United States generally accepted
accounting principles, consistently applied.
1.45 “
Generic Competition ” shall have the meaning set forth
in Section 11.5.1.
1.46 “
Global Development Committee ” shall have the meaning
set forth in Section 3.2.
1.47 “
HDAC ” shall mean histone deacetylase and shall
include without limitation any one of a family of enzymes that
remove acetyl groups from amino groups of lysine residues at the
N-terminus of a histone, including but not limited to HDAC1, HDAC2,
HDAC3, HDAC4, HDAC5, HDAC6, HDAC7, HDAC8, HDAC9, HDAC10, HDAC11,
SIRT1, SIRT2, SIRT3, SIRT4, SIRT5, SIRT6, SIRT7, and any histone
deacetylase as described or referenced in MG’s patent
application WO2003024448A2, or the articles Nature Reviews, Drug
Discovery, 1, 287-299 (2002) or J. Biol. Chem., 277, 25748-55
(2002).
1.48 “
HDAC Assay ” shall mean the evaluation in vitro of a
compound’s dose dependent inhibition of at least one
(1) isolated, partially purified, recombinant human HDAC
enzyme from any HDAC Class I or HDAC Class II enzyme
families.
1.49 “
HDAC Inhibitors ” means Small Molecules that directly
inhibit HDAC enzymatic activity or which have therapeutic effect
through the inhibition of HDAC enzymes. The Parties hereby agree
that such inhibition must be with an IC50 value less than or equal
to [***] towards at least one of the tested HDAC isotypes
using the HDAC Assay.
1.50 “
Indemnitor ” or “ Indemnitee ”
shall have the meaning set forth in Section 19.5.
1.51 “
Initial Clinical Candidate ” shall mean the Compound
designated internally at MG as MGCD0103 (as further identified in a
side letter between the Parties exchanged on the Effective Date),
or any other Compound as selected by the JSC to replace MGCD0103 as
a clinical candidate.
1.52 “
Initial Clinical Candidate Milestone Events ” shall
have the meaning set forth in Section 10.1.1.
1.53 “
Insolvency Event ” shall have the meaning set forth in
Section 20.2.2.
1.54 “
IND ” shall mean an Investigational New Drug
application, as defined in the U.S. Federal Food, Drug and Cosmetic
Act and the regulations promulgated thereunder, or comparable
filing in a foreign jurisdiction, in each case, with respect to a
Product for use within the Field.
1.55 “
JAMS ” shall have the meaning set forth in
Section 21.1.
1.56 “
Joint Intellectual Property ” shall have the meaning
set forth in Section 17.2.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 9 -
1.57 “
Joint Steering Committee ” or “ JSC
” shall have the meaning set forth in
Section 3.1.
1.58 “
Licensed Technology ” shall mean the Licensed Patents
and Licensed Technical Information.
1.59 “
Licensed Patents ” shall mean all patents and all
reissues, renewals, re-examinations, and extensions thereof, and
patent applications therefor, and any divisions, continuations, in
whole or in part, thereof, which claim or otherwise cover the
composition, manufacture, sale or use of a Compound(s) or a
Product(s), that are owned or acquired by MG or its Affiliates, or
that cover inventions made by or under authority of MG or its
Affiliates, prior to or during the term of this Agreement,
including those patents and applications listed on Exhibit 1.59. It
is understood and agreed that for purposes of this Agreement,
“acquired” when applied to patents, information, data,
materials or other intellectual property shall include such items
that are in-licensed, of or within the scope of the relevant
licenses, rights or obligations herein, including, without
limitation, the Taiho Blocking Patents (as that term is defined in
the Taiho Agreement), Non-Cancer Partner Blocking Patents and any
similar blocking patents licensed to MG pursuant to an agreement
with an Additional Partner.
1.60 “
Licensed Technical Information ” shall mean all
material confidential information and tangible materials related to
the development, manufacture, sale or use of a Compound or a
Product, including, but not limited to: pharmaceutical, chemical,
biological and biochemical compositions; and technical data and
information; available descriptions, if any, of assays, methods and
processes; the results of tests, including without limitation
screening results, SAR data, optimization data, in vitro and in
vivo data; preclinical, clinical and research, manufacturing
processes and procedures; analytical and quality control data; and
plans, specifications and/or other documents containing said
information and data; in each case which are owned or acquired by
MG prior to the Effective Date or discovered, developed or acquired
by or under authority of MG or its Affiliates during the term of
this Agreement. Notwithstanding the foregoing, Licensed Technical
Information shall not include confidential information or tangible
materials generated by a Non-Cancer Partner or MG in collaboration
with a Non-Cancer Partner (in each case, other than those items set
forth in part 1.121B of Exhibit 1.121), unless such
confidential information or tangible materials is permitted by the
Non-Cancer Partner to be provided to an Additional Partner and is
not specific to indications outside the Field. As used in this
Section 1.60 and in Sections 1.64, 1.108 and 1.121 below,
information, data or materials shall be deemed generated by MG
“in collaboration” with a Non-Cancer Partner only if
such information, data or materials is generated in the course of
Research directly solely to indications outside the Field that:
(a) is conducted pursuant to an agreement with such Non-Cancer
Partner in compliance with this Agreement; (b) is funded
initially at least [***] percent ( [***] %) by such
Non-Cancer Partner and continues to be funded in whole or in part
by such Non-Cancer Partner over the entire course of such Research;
and (c) is not conducted by MG personnel who are involved in
Research that is not directed solely to indications outside the
Field.
1.61 “
Litigation Agreement ” shall have the meaning set
forth in Section 17.6.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 10 -
1.62 “
MAA ” shall mean a marketing authorization application
filed with the EMEA pursuant to the centralized approval procedure
or with the applicable Regulatory Authority of a country of the
Territory in Europe with respect to the mutual recognition or any
other national approval procedure.
1.63 “
Major Country ” shall mean the United States of
America, Canada, Australia, France, Germany, Italy, Spain and the
United Kingdom.
1.64 “
Manufacturing Data ” shall mean all material
information and data relating to or used in connection with the
manufacturing of Compounds and/or Products by MG, Pharmion,
Additional Partners, their Affiliates, or others working under
authority of such entities, including without limitation, such
information and data as generated or used during process
development, stability studies, formulation development, scale-up
of manufacturing, production of preclinical and clinical product
batches, validation studies, development of quality
assurance/quality control testing, and related regulatory affairs;
and all information and data contained in the DMF or in the CMC
section of an IND or NDA (or their counterparts in other countries)
with respect to Compounds and/or Products. Without limiting the
foregoing, Manufacturing Data shall include information and data
described in Exhibit 1.64. Notwithstanding the foregoing, to
the extent MG, Pharmion, Additional Partners or their Affiliates do
not have rights to such know-how, the term “ Manufacturing
Data ” shall exclude any proprietary manufacturing
know-how described in a DMF that was disclosed by a contract
manufacturer of MG, Pharmion, Additional Partners or their
Affiliates directly to the Regulatory Authority (and not to MG,
Pharmion, Additional Partners or their Affiliates), which know-how
had been independently developed by such contract manufacturer
outside of its relationship with MG, Pharmion, Additional Partners
or their Affiliates; provided that in the case of a contract
manufacturer of MG, MG ensures that, upon the request of Pharmion,
such contract manufacturer shall file with Regulatory Authorities
in the Territory a similar DMF containing such know-how in support
of Pharmion’s regulatory filings. In addition,
notwithstanding the foregoing, Manufacturing Data shall not include
information or data generated by a Non-Cancer Partner or MG in
collaboration with a Non-Cancer Partner, unless the same is
provided to an Additional Partner and is not specific to
indications outside the Field.
1.65 “
Marketing Approval ” shall mean all approvals,
registrations or authorizations of any governmental entity that are
necessary for the manufacturing, use, storage, import, transport
and sale of a Compound or Product in a regulatory jurisdiction. For
countries where governmental approval is required for pricing or
reimbursement for the Product to be reimbursed by national health
insurance, Marketing Approval shall not be deemed to occur until
such pricing or reimbursement approval is obtained; provided, that
Marketing Approval shall be deemed to have occurred in such country
where government approval of pricing has not been obtained if, at
any time, the party undertakes a full commercial launch of such
Product in the country without obtaining pricing
approval.
1.66 “
Marketing Party ” shall mean the Party designated
under this Agreement as having specific responsibilities for
marketing, sales and distribution of a Product within a particular
country, as set forth in Section 5.4.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 11 -
1.67
“Material Non-Performance” shall have the meaning set
forth in Section 20.2.2.
1.68
“MG” shall have the meaning set forth in the
Preamble.
1.69 “MG
Blocking Patents” shall have the meaning set forth in
Section 5.3.7(a).
1.70 “ MG
Compound Registry ” shall mean the comprehensive registry
of Compounds maintained by or on behalf of MG, which comprehensive
registry includes (i) all Compounds, (ii) the chemical
structure of each Compound, (iii) a unique identifying number
for each Compound, (iv) the Compound Registration Date for
such Compound, (v) the potency of each Compound, as determined
by MG, and (vi) such other information and Data as MG may
determine to include in the MG Compound Registry from time to time,
in each case in a format suitable to reasonably enable Pharmion to
access and use Compounds as contemplated by this
Agreement.
1.71 “ MG
Indemnitees ” shall have the meaning set forth in
Section 19.2.
1.72 “ [
***] Programs ” shall mean an [***]
research and development program directed solely to the discovery
and/or characterization of HDAC Inhibitors having therapeutic
utility in particular disease areas outside the Field and with
respect to which [***] is devoting [***] resources or
causing resources to be devoted but excluding Non-Cancer
Partners.
1.73 “ MG
Opt-out Right ” shall have the meaning set forth in
Section 8.6.
1.74 “ [
***] Reserve Compounds ” shall mean a list
of up to [***] individual Compounds designated by
[***] as potential development candidates which [***]
desires to reserve in the Territory in the fields of [***]
Programs in accordance with Section 5.3.3(b) below. The
[***] Reserve Compounds as of the Effective Date are
identified on Exhibit 18.2.4.
1.75 “ [
***] Selected Compounds ” shall mean
(i) those individual Compounds selected by [***] under
Section 5.3.3(d), (ii) those Compounds that are
[***] Selected Compounds in accordance with
Section 5.3.3(c) below, and (iii) [***] Reserve
Compounds selected in accordance with Section 5.3.3(b) below, in
each case subject to Section 5.3.4. With respect to each such
Compound, the [***] Selected Compound shall also include the
prodrugs, metabolites, salts, esters, hydrates, solvates, free
base, polymorphs, isomers thereof, conjugated forms and/or
liposomal or other formulations thereof and other compositions
consisting of such Compound non-covalently bonded with other
moieties, which together shall be deemed a single [***]
Selected Compound (and a single [***] Reserve Compound) for
purposes of Sections 5.3.3(b)(iii), 5.3.3(c) and 5.3.3(d)
below.
1.76 “
Milestone Events ” shall have the meaning set forth in
Section 10.1.2.
1.77 “
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
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 12 -
or procedure or
any foreign counterpart of a U.S. New Drug Application for approval
to market (such as a MAA for EMEA), including, where applicable,
applications for pricing and reimbursement approval, and all
supplements and amendments thereto.
1.78 “
Net Profits and Losses ” shall mean, as to any period
for which there is a determination thereof, Net Revenues less
Commercialization Costs; provided that in no event shall any
amounts deducted from gross sales for the purpose of calculating
the Net Sales component of Net Revenues also be counted toward the
amount of Commercialization Costs. To the extent Net Revenues
exceeds Commercialization Costs for the relevant period, such
amount of difference shall be deemed “ Net Profits
,” and to the extent Commercialization Costs exceeds Net
Revenues for the relevant period, such amount of difference shall
be deemed “ Net Losses .”
1.79 “
Net Revenues ” shall mean the sum of (a) Net
Sales received with respect to a Product sold in North America
plus, if any, (b) the fair market value of any consideration
other than the proceeds of Net Sales (whether in cash, payment in
kind, exchange or other form) actually received by a Party or its
Affiliates from Third Parties with respect to transactions
involving the research, development or commercialization of a
Product or exploitation of Licensed Technology in North America, to
the extent such consideration is fairly and reasonably attributable
to such Product, or Licensed Technology.
1.80 “
Net Sales ” shall mean the gross invoice price for
Product sold by either of the Parties, or both, their Sublicensees
or their Affiliates to a Distributor or a non-Affiliate Third Party
customer less the reasonable and customary accrual-basis
deductions from such gross amounts for: (i) normal and
customary trade, cash and other discounts, allowances and credits
actually allowed and taken directly with respect to sales of
Product; (ii) credits or allowances actually granted for
damaged goods, returns or rejections of Product; (iii) sales
taxes or similar taxes (including duties or other governmental
charges levied on, absorbed or otherwise imposed directly on the
sales of Product, including, without limitation, value added taxes
or other governmental charges otherwise measured by the billing
amount) which are included in billing amount, and excluding any
taxes imposed on or measured by the net income or profits of the
selling party; (iv) charge back payments and rebates granted
to trade customers, including, but not limited to, wholesalers and
government or private insurers; (v) packaging, handling fees,
freight, insurance and the like, and (vi) actual uncollectible
accounts. For purposes of determined Net Sales in order to
calculate the Non-Cancer Royalties owed to Non-Cancer Partners
pursuant to Section 11.7.2, amounts deducted under subsection
(v) shall not exceed [***] % of Net Sales and amounts
deducted under subsection (vi) shall not exceed [***] %
of Net Sales. Such amounts shall be determined from the books and
records of a Party, its Affiliates and their Sublicensees
maintained in accordance with GAAP consistently applied, and such
amounts shall be calculated using the same accounting principles
used for other products of the Party. Sales between or among a
Party, its Affiliates and Sublicensees shall be excluded from the
computation of Net Sales if such Affiliates or Sublicensees are not
end-users, but Net Sales shall include the subsequent final sales
to non-Affiliate Third Parties by any such Affiliates or
Sublicensees. Where (a) Product is sold by a Party, its
Affiliates or Sublicensees other than in an arms-length sale or as
one of a number of items without a separate invoiced price; or (b)
consideration for Product shall include any non-cash element, the
Net Sales applicable to any such transaction
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 13 -
shall be deemed
to be the Party’s average Net Sales for the applicable
quantity of the Product at that time; provided, however, Net Sales
shall not include Product sold or used for development of the
Product hereunder (including for clinical trials) or as samples
(provided the cost of such samples does not exceed [***] %
of Net Sales). For purposes of determined Net Sales in order to
calculate the Non-Cancer Royalties owed to Non-Cancer Partners
pursuant to Section 11.7.2, amounts deducted in respect of the
preceding sentence shall not exceed [***] % of Net
Sales.
1.81 “
Non-Cancer Compound ” shall have the meaning set forth
in Section 11.7.2.
1.82 “
Non-Cancer HDAC Research ” shall mean Research
conducted by or under authority of MG that is directed only to
applications outside the Field and for which MG shall not grant a
Third Party rights to commercialize resulting compounds for
applications in the Field.
1.83 “
Non-Cancer Partner ” shall mean a non-Affiliate Third
Party who (i) is or will be granted by MG, directly or
indirectly, a right to develop, market and/or commercialize
Compounds and/or Products outside the Field, (ii) is not and
will not be granted by MG, directly or indirectly, any rights with
respect to Compounds or Products in the Field anywhere in the
world, and (iii) who is not an Opt-out Non-Cancer Partner. A
Non-Cancer Partner and all of its Affiliates shall be deemed a
single Non-Cancer Partner.
1.84 “
Non-Cancer Partner Agreement ” shall mean any written
agreement or arrangement between MG or its Affiliates and a
Non-Cancer Partner that governs a Non-Cancer Research Program or
the manufacture or commercialization of HDAC Inhibitors and
resulting products for the treatment or prevention of diseases
outside of the Field.
1.85 “
Non-Cancer Partner Blocking Patents ” shall mean all
patents owned and controlled by a Non-Cancer Partner which are
necessarily infringed by the composition, manufacture, sale, use or
importation of Compounds.
1.86 “
Non-Cancer Research Program ” shall mean activities
directed to the research, discovery, characterization,
optimization, in vitro testing, in vivo evaluation,
preclinical and/or clinical development of HDAC Inhibitors other
than for the treatment or prevention of diseases within the Field,
which activities are conducted by or on behalf of a Non-Cancer
Partner or its Affiliates pursuant to any written agreement or
arrangement with MG or its Affiliates.
1.87 “
Non-Cancer Reserve Compounds ” shall mean a list of up
to ten (10) individual Compounds designated by a Non-Cancer
Partner as potential development candidates which such Non-Cancer
Partner desires to reserve in the Territory outside the Field in
accordance with Section 5.3.2(b) below. The Non-Cancer Reserve
Compounds as of the Effective Date are identified on Exhibit
18.2.4.
1.88 “
Non-Cancer Royalty ” shall have the meaning set forth
in Section 11.7.2.
1.89 “
Non-Cancer Selected Compounds ” shall mean
(i) those individual Compounds selected by Non-Cancer Partners
under Section 5.3.2(d), (ii) those Compounds that are
Non-Cancer Selected Compound in accordance with
Section 5.3.2(c) below, and (iii) Non-Cancer
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 14 -
Reserve
Compounds selected in accordance with Section 5.3.2(b) below,
in each case subject to Section 5.3.4 and provided that MG has
obtained all rights and covenants as set forth in
Section 8.3.1(b) from the respective Non-Cancer Partner. With
respect to each such Compound, the Non-Cancer Selected Compound
shall also include the prodrugs, metabolites, salts, esters,
hydrates, solvates, free base, polymorphs, isomers thereof,
conjugated forms and/or liposomal or other formulations thereof and
other compositions consisting of such Compound non-covalently
bonded with other moieties, which together shall be deemed a single
Non-Cancer Selected Compound (and a single Non-Cancer Reserve
Compound) for purposes of Sections 5.3.2(b)(iii), 5.3.2(c) and
5.3.2(d) below.
1.90 “
North America ” shall mean the United States of
America and Canada.
1.91 “
North American Development Costs ” shall mean the
Development Costs incurred in connection with development
activities designed to support or obtain Marketing Approval for a
Product and/or Compound anywhere in North America. For clarity,
“North American Development Costs” shall not include
Development Costs incurred in connection with development
activities designed solely to support or obtain Marketing Approval
for a Product and/or Compound outside North America.
1.92 “
Opt-out Non-Cancer Partner ” shall have the meaning
set forth in Section 8.3.4(a).
1.93 “
Opt-out Non-Cancer Partner Blocking Patents ” shall
have the meaning set forth in Section 8.3.4(d)(ii).
1.94 “
Opt-out Non-Cancer Reserve HDAC Inhibitor ” shall mean
a list of up to [ *** ] individual compounds
designated by a Opt-out Non-Cancer Partner as potential development
candidates which such Opt-out Non-Cancer Partner desires to reserve
in the Territory outside the Field in accordance with
Section 5.3.7(b) below. It is understood that an Opt-out
Non-Cancer Partner and all of its Affiliates shall be deemed a
single Opt-out Non-Cancer Partner (for example, for purposes of
Section 5.3.7(b)(iii)). The Opt-out Non-Cancer Reserved HDAC
Inhibitors as of the Effective Date are identified on
Exhibit 18.2.4.
1.95 “
Opt-out Non-Cancer Selected HDAC Inhibitor ” shall
mean (i) those compounds that are Opt-out Non-Cancer Selected
HDAC Inhibitors in accordance with Section 5.3.7(c) below, and
(ii) Opt-out Non-Cancer Reserve HDAC Inhibitors selected in
accordance with Section 5.3.7(b) below, in each case subject
to Section 5.3.4 and provided that MG has obtained all rights
and covenants as set forth in Section 8.3.4 from the
respective Opt-out Non-Cancer Partner. With respect to each such
compound, the Opt-out Non-Cancer Selected HDAC Inhibitor shall also
include the prodrugs, metabolites, salts, esters, hydrates,
solvates, free base, polymorphs, isomers thereof, conjugated forms
and/or liposomal or other formulations thereof and other
compositions consisting of such compound non-covalently bonded with
other moieties, which together shall be deemed a single Opt-out
Non-Cancer Selected HDAC Inhibitor (and a single Opt-out Non-Cancer
Reserve HDAC Inhibitor) for purposes of Sections 5.3.7(b)(iii)
and 5.3.7(c) below.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 15 -
1.96 “
Patent Counsel ” shall mean a Third Party patent
attorney retained by MG and reasonably acceptable to
Pharmion.
1.97 “
Party ” or “ Parties ” shall have
the meaning set forth in the Preamble.
1.98 “
Pharmion ” shall have the meaning set forth in the
Preamble.
1.99 “
Pharmion Blocking Patents ” shall have the meaning set
forth in Section 8.5.
1.100 “
Pharmion Indemnitees ” shall have the meaning set
forth in Section 19.3.
1.101 “
Pharmion Patent Rights ” shall have the meaning set
forth in Section 17.1.
1.102 “
Pharmion Research Funds ” shall have the meaning set
forth in Section 9.1.
1.103 “
Pharmion Reserve Compounds ” shall mean a list of up
to [ *** ] individual Compounds designated by
Pharmion as potential development candidates which Pharmion desires
to reserve in the Territory for the Field in accordance with
Section 5.3.1(a).
1.104 “
Phase I ” shall mean human clinical trials, the
principal purpose of which is preliminary determination of safety
in healthy individuals or patients (for example, as described in 21
C.F.R. §312.21(a), or similar clinical study in a country
other than the United States).
1.105 “
Phase II ” shall mean a study of a Product in human
patients designed to determine initial efficacy and dose range
finding that satisfies the requirements of 21 C.F.R. §
312.21(b), or similar clinical study in a country other than the
United States.
1.106 “
Phase III ” shall mean a study of a Product in human
patients designed to determine efficacy and safety of a Product for
the purpose of preparing and submitting applications for Marketing
Approval to the competent Regulatory Authority in a country of the
world, and that satisfies the requirements of 21 C.F.R. §
312.21(c), or similar clinical study in a country other than the
United States.
1.107 “
Phase IV ” shall mean a study of a Product in human
patients conducted in a particular jurisdiction after the Product
has received Marketing Approval and has been Commercialized in that
jurisdiction, the principal purpose of which is to continue testing
the Product to collect information about its safety or efficacy in
broader or various populations, long-term safety and side effects
associated with long-term use, and its use in additional
indications other than for which Marketing Approval was previously
granted.
1.108 “
Preclinical and Clinical Data ” shall mean all filings
and supporting documents submitted or to be submitted to a
Regulatory Authority in a Major Country, relating to the
Compound(s) or Product(s), and all data contained therein,
including, without limitation, any INDs, NDAs and their
counterparts in other countries, investigator’s brochures,
correspondence to and from such Regulatory Authorities, minutes
from teleconferences with Regulatory Authorities, registrations and
licenses, regulatory drug lists, advertising and
promotion
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 16 -
documents
shared with Regulatory Authorities, adverse event files and
complaint files. In addition, Preclinical and Clinical Data shall
include all investigator reports (both preliminary and final),
statistical analysis, expert opinions and reports, safety and other
electronic databases and all other material documentation and
information related to Preclinical Development or clinical
development of a Compound or a Product. Without limiting the
foregoing, Preclinical and Clinical Data shall include all items
described in Exhibit 1.108 that are generated from the
Contracted Research Work. Notwithstanding the foregoing,
Preclinical and Clinical Data shall not include filings, supporting
documents, data, reports, analysis, databases or other
documentation or information generated by a Non-Cancer Partner or
MG in collaboration with a Non-Cancer Partner, unless the same is
permitted by the Non-Cancer Partner to be provided to an Additional
Partner and is not specific to indications outside the
Field.
1.109 “
Preclinical Development ” shall mean those preclinical
studies with respect to the Compounds and/or Products that are
specifically required for an IND, including without limitation ADME
and GLP toxicology studies, pharmacology or studies required for
the CMC section of an IND or an NDA. It is understood that
“preclinical” testing will continue after the filing of
an IND in support of the clinical development of a Compound or
Product, including ongoing toxicology, metabolic, PK and other
non-clinical testing of such Compound or Product, and that
“Preclinical Development” as used herein shall include
such ongoing non-clinical testing.
1.110 “
Preclinical Studies ” shall mean those certain
Preclinical Development studies in the Field, set forth in the
Development Plans established in accordance with Article 4
below.
1.111 “
Product(s) ” shall mean product(s), in any
formulation, containing a Compound(s) as an active
ingredient(s).
1.112 “
Product Promotional Materials ” shall mean all sales
representative training materials and all written, printed,
graphic, electronic, audio or video matter related to the marketing
or promotion of a Product, including, but not limited to, journal
advertisements, sales visual aids, direct mail, direct-to-consumer
advertising, Internet postings, broadcast advertisements, and sales
reminder aids ( e.g. , scratch pads, pens and other such
items) intended for use or used by or for a Party in connection
with such marketing or promotion.
1.113 “
Programs ” shall mean, collectively, Research
conducted pursuant to the Research Plan and Development conducted
pursuant to the Development Plan.
1.114 “
Prosecution ” shall mean the preparing, filing,
prosecuting and maintenance of patent applications and patents and
re-examinations, reissues and requests for patent term extensions
therefor, together with the conduct of any interference, opposition
or other similar proceeding pertaining to patent applications or
patents.
1.115 “
Register ” or “Registration ” shall
mean entering a compound into the MG Compound Registry together
with (i) a unique identifying number for such compound,
(ii) the chemical structure of such compound, and
(iii) the Compound Registration Date for such compound, in
each case in a format suitable to reasonably enable Pharmion to
access and use
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 17 -
Compounds,
their chemical structures and any related Data included in the MG
Compound Registry, as contemplated by this Agreement.
1.116 “
Registrational Trial ” shall mean one or more
controlled, multi-center clinical trials in human patients, whether
a Phase II trial or a Phase III trial, that is designed in
consultation with the JSC to obtain sufficient efficacy and safety
data to support Marketing Approval and labeling of the Product by
the competent Regulatory Authority in any country of the
Territory.
1.117 “
Regulatory Authority ” shall mean any national (
e.g. , the FDA), supra-national ( e.g. , the European
Commission, the Council of the European Union, or the EMEA), or
other governmental entity in any jurisdiction of the world involved
in the granting of Marketing Approval for pharmaceutical
products.
1.118 “
Rejection ” or “ Rejected ” shall
have the meaning set forth in Section 5.3.4(c).
1.119 “
Reporting Period ” shall have the meaning set forth in
Section 9.6(a).
1.120 “
Research ” shall mean activities directed to the
research, discovery, characterization, optimization, in
vitro testing and/or in vivo evaluation of HDAC
Inhibitors, conducted by or under authority of MG.
1.121 “
Research Data ” shall mean all material screening
results, SAR data, optimization information, in vitro and
in vivo data, compositions, samples and other information
generated in the course of research conducted by or under authority
of MG or Pharmion with respect to Compounds and/or Products,
including without limitation all information and data described in
part 1.121A of Exhibit 1.121. In case of data that is
generated by an entity with rights with respect to Compounds and/or
Products both in and outside of the Field, Research Data shall mean
the foregoing, but only to the extent it is not specific to
non-cancer indications. With respect to such data generated by
Non-Cancer Partners or MG in collaboration with a Non-Cancer
Partner, Research Data shall mean only the items set forth in part
1.121B of Exhibit 1.121, unless such data is provided to an
Additional Partner and is not specific to indications outside
Field.
1.122 “
Research Plan ” shall mean the plan and budget for
Research, as described in Article 4 below.
1.123 “
Research Term ” shall mean the period beginning forty
five (45) days following the Effective Date and, unless
earlier terminated in accordance with Article 20, terminating
one (1) year thereafter, unless extended by the Parties in
writing upon mutual agreement.
1.124 “
Resolution ” shall have the meaning set forth in
Section 20.2.2(a).
1.125 “
Royalty Term ” shall mean, with respect to a
particular Product in a country (on a Product-by-Product and
country-by-country basis), the period commencing on the Effective
Date and continuing until the later of (a) expiration or
abandonment of the last Valid Claim within the
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 18 -
Licensed
Patents covering such Product in the particular country, or (b)
[ *** ] years after the first commercial sale in
such country of the first Product.
1.126 “
Selected Compounds ” shall mean the Initial Clinical
Candidate and (i) those other individual Compounds selected as
a Selected Compound by the JSC under Section 5.2,
(ii) those Compounds that are Selected Compounds under
Section 5.3.1(b), (iii) Compounds for which an Additional
Partner or Third Party has rights to develop, market or
commercialize as described in Section 5.3.5, and (iv) all
Pharmion Reserve Compounds in compliance with Section 5.3.1(a)
below. With respect to each such Compound, the Selected Compound
shall include prodrugs, metabolites, salts, esters, hydrates,
solvates, free base, polymorphs, isomers thereof, conjugated forms
and/or liposomal or other formulations thereof and other
compositions consisting of such Compound non-covalently bonded with
other moieties, which together shall be deemed a single Selected
Compound (and a single Pharmion Reserve Compound) for purposes of
Sections 5.2, 5.3.1(a)(ii) and 5.3.1(b) below.
1.127 “
Senior Representatives ” shall have the meaning set
forth in Section 20.2.2(a).
1.128 “
Share of Net Profits and Losses ” shall have the
meaning set forth in Section 9.7.1.
1.129 “
Small Molecule ” shall mean a compound with a
molecular weight no greater than 1,500 daltons.
1.130 “
Subject Infringements ” shall have the meaning set
forth in Section 17.6.
1.131 “
Sublicensee ” shall mean, when permitted under this
Agreement, a non-Affiliate Third Party other than a Distributor to
whom Pharmion has granted (i) a sublicense to sell and offer
for sale a Product made in accordance with this Agreement, provided
that such Third Party has primary responsibility for the marketing
and promotion of such Product in its distribution territory and has
the right to record sales of such Product for its account or
(ii) the right to make and sell a Product, with respect to
Products made and sold by such Third Party, within the scope of the
license hereunder. In addition, for purposes of this Agreement,
Pharmion and MG shall not be deemed Sublicensees of the other, nor
shall either Party be deemed to be acting “under
authority” of the other Party.
1.132 “
Taiho ” shall mean Taiho Pharmaceutical Co., Ltd. and
its successors and permitted assigns.
1.133 “
Taiho Agreement ” shall mean the Collaboration and
License Agreement dated as of October 16, 2003 between MG and
Taiho, as amended on December 15, 2004.
1.134 “
Taiho Initiated Studies ” shall mean those clinical
studies initiated under the Taiho Agreement prior to the Effective
Date, as identified in Exhibit 1.134.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 19 -
1.135 “
Taiho Territory ” shall mean the territory set forth
in the Taiho Agreement (i.e. Japan, South Korea (or both South
Korea and North Korea if united), Taiwan and the People’s
Republic of China).
1.136 “
Target Claims ” shall have the meaning set forth in
Section 8.3.3(b).
1.137 “
Territory ” shall mean the United States of America,
Canada, member states of the European Union as of the Effective
Date (i.e. Austria, Belgium, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Poland, Portugal, Slovakia, Slovenia,
Spain, Sweden, the Netherlands, the United Kingdom), Norway,
Switzerland, Bulgaria, Romania, Singapore, Malaysia, Philippines,
Indonesia, South Africa, countries of the Middle East (i.e.
Bahrain, Cyprus, Dubai, Egypt, Turkey, Iran (Persia), Iraq, Israel,
Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Syria, the
United Arab Emirates, Yemen, the West Bank and the Gaza Strip),
Australia, New Zealand and Thailand and specifically excludes the
Taiho Territory.
1.138 “
Third Party ” shall mean any individual, limited
liability company, corporation, partnership, trust, unincorporated
organization, association or other entity, but excluding MG or
Pharmion and their respective Affiliates.
1.139 “
Third Party IP ” shall have the meaning set forth in
Section 11.3.1.
1.140 “
Valid Claim ” shall mean (a) a claim of an issued
and unexpired patent, which has not been held unenforceable,
unpatentable or invalid by an unappealed or unappealable decision
of a court or other governmental agency of competent jurisdiction,
and which has not been admitted to be invalid or unenforceable
through reissue, disclaimer or otherwise, or (b) a claim in a
pending patent application being prosecuted in good faith that has
not been abandoned or finally rejected and which has been pending
for less than seven (7) years after the earliest priority date
to which it is entitled. In the event subsequent to such seven
(7) year period, such pending claim is issued as a claim of an
issued and un-expired patent included within (a) above, such
claim shall be reinstated thereafter as a “Valid Claim”
in accordance with clause (a) above.
1.141 “
Vidaza ” shall mean Pharmion’s proprietary
pharmaceutical product known generically as azacitidine, and
commercialized by Pharmion in the United States under the trademark
“VIDAZA ® ” as of the Effective Date.
1.142 “
Withholding Party ” shall have the meaning set forth
in Section 9.7.2(d).
1.143 “
$ ” or “ US$ ” shall mean U.S.
Dollars.
2.1 Scope of
Collaboration . Subject to the terms and conditions of this
Agreement, the Parties shall collaborate: (a) to develop and
commercialize the Initial Clinical Candidate in the Field in the
Territory, (b) to conduct Research to identify, characterize
and discover other
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 20 -
Compounds
useful in the Field, and (c) to develop and commercialize
Compounds in the Field in the Territory.
2.2 Conduct of
the Collaboration . Subject to the terms and conditions of this
Agreement, each Party shall use Commercially Reasonable and
Diligent Efforts to conduct Research in accordance with the
Research Plan, the Clinical Studies in accordance with the
Development Plans and the Commercialization under the
Commercialization Plans, in each case under the supervision of the
JSC.
2.3 MG
Co-Promotion Right . Provided that MG has not exercised its MG
Opt-out Right in respect of the Development of a Compound and/or
Product, MG shall have the right (but not the obligation) to elect
to Co-Promote such Compound and/or Product in North America with
Pharmion under the terms of this Collaboration in lieu of receiving
royalties from Pharmion in respect of North America under
Section 11.2. Within thirty (30) days of the approval of
the Commercialization Plan specified in Section 5.4.2, MG
shall notify Pharmion in writing (i) of its decision, in its
sole discretion, to elect to Co-Promote in North America in
accordance with the terms of Section 5.5, and (ii) of its
Co-Promotion Level as per Section 5.5.1. In the event MG fails
to elect, or elects not, to Co-Promote a Compound and/or Product in
accordance with the foregoing, the license set forth in
Section 8.1.1 shall be, in respect of such Compound and/or
Product, an exclusive right and license (even as to MG) under the
Licensed Technology in favour of Pharmion in North America in the
Field, with the right to grant and authorize sublicenses. In the
event MG elects to Co-Promote in accordance with the foregoing,
MG’s Co-Promotion shall nevertheless remain subject to
MG’s Op-out Right as per the terms of
Section 8.6.
2.4
Participation . Subject to the MG Opt-out Right set forth in
Section 8.6 below and notwithstanding anything herein to the
contrary, the Parties shall jointly conduct and each play a
significant role in the conduct of the Development of each Product
in the Field in the Territory as described in the Development
Plans. Provided that MG has elected to exercise its right to
Co-Promote under Section 2.3, Pharmion shall conduct the
Commercialization of each Product in the Field in the Territory
other than North America, and the Parties shall jointly conduct and
each play a significant role in the Commercialization of each
Product in the Field in North America as described in the
Commercialization Plans.
2.5 Restrictive
Covenants .
2.5.1
Exclusive Relationship in the Territory . During the term of
the Collaboration, neither Pharmion or its Affiliates nor MG or its
Affiliates, shall, directly or indirectly, on its own or in
collaboration with a Third Party, conduct research or development
regarding, or engage in the manufacture, marketing, sale or
distribution of, or otherwise exploit, any compound that directly
inhibits the activity of HDAC enzymes or has therapeutic effect
through the inhibition of HDAC enzymes (or a product containing the
same) for use within the Field in the Territory, or grant any Third
Parties the rights to do any of the foregoing, other than as part
of the Collaboration or to an Additional Partner.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 21 -
2.5.2
Additional Undertakings . Neither Pharmion nor any of its
Affiliates shall: (1) research, develop or commercialize, or
authorize any Third Party to research, develop or commercialize, a
Compound or any other HDAC Inhibitor (or a product containing the
same) outside of the Field in the Territory; (2) develop or
commercialize, or authorize any Third Party to develop or
commercialize, a Compound or any other HDAC Inhibitor (or a product
containing the same) in the Field outside the Territory or
(3) research, develop or commercialize any Non-Cancer Selected
Compounds, [***] Selected Compounds and Opt-out Non-Cancer
Selected HDAC Inhibitor in the Territory for any purpose, either
inside or outside the Field (other than internal research in the
Field). The covenant in clause (1) of the preceding sentence
shall expire [***] following the earlier to occur of
(i) the expiration or other termination of the last
Development Plan or (ii) earlier termination of this Agreement, or,
as to a field of use governed by a Non-Cancer Partner Agreement,
(a) such time as may be specifically provided for thereunder
or (b) such time as the applicable Non-Cancer Partner is no
longer required to, or fails to, comply with a similar covenant or
covenants. The covenant in clause (2) of the preceding
sentence shall terminate in respect of the Taiho Territory upon the
termination of the Taiho Agreement.
2.5.3
Research Activities Conducted by Pharmion . During the
period from the Effective Date until the earlier of (i)
[***] thereafter, (ii) the termination of this
Agreement as a result of a Material Non-Performance by MG under
Section 20.2.2 and (iii) the termination of this
Agreement by MG under Section 20.2.1 or as a result of a
Material Non-Performance by Pharmion under Section 20.2.2,
neither Pharmion nor any of its Affiliates shall conduct any
research in the Field specifically directed to compounds that
directly inhibit the activity of HDAC enzymes or have therapeutic
effect through the inhibition of HDAC enzymes, either within or
outside the Territory, other than those to be conducted in
connection with or in the exercise of rights granted under this
Agreement, unless Pharmion agrees to treat compounds first
identified as HDAC Inhibitors in the course of such research as
Compounds under this Agreement.
2.5.4 Change of
Control . If [***] undergoes a Change of Control during
the term of this Agreement, and [***] controls [***]
or has an active research program specifically directed to
[***] , [***] shall, upon written notice to
[***] within thirty (30) days of such Change of
Control, either: (a) [***] , [***] , other than as
provided in subsection 0 and in Section Error! Reference source
not found. ; or (b) [***], [***], [***] within
[***] after the effective date of such Change of Control or
(c) [***] . If [***] undergoes a Change of Control
after termination of this Agreement, [***] , [***] ,
[***] other than as provided in subsection 0 and in Section
Error! Reference source not found.
2.5.5
Survival . In the event [***] elects to [***]
upon a Change of Control as set forth in subsection Error!
Reference source not found. above, (i) [***] and its
Affiliates shall continue to be subject to [***] above until
the termination of [***] , and (ii) all of [***]
obligations to pay its pro rata share of [***] under
this Agreement that are incurred in connection with the budget set
forth in the [***] in existence prior to the effective date
of termination (and subject to all other applicable provisions of
this Agreement) shall continue notwithstanding such termination
throughout the period ending [***] following the Effective
Date, to the extent [***] and such [***] in the Field
that covers any portion of the Territory under which such
[***] assumes an obligation to [***] that would be
considered [***] hereunder; provided, however , that
[***] obligations under this clause (ii) shall
terminate at such time that [***][***] .
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 22 -
2.5.6
Independent Combination Studies . Nothing in this
Section 2.5 shall prevent Pharmion from: (a) entering
into a standard investigator initiated studies agreement with
independent investigators requesting to conduct investigations
studying the combination of Vidaza with any compound that directly
inhibits the activity of HDAC enzymes or have therapeutic effect
through the inhibition of HDAC enzymes pursuant to which Pharmion
provides quantities of Vidaza with or without charge (the “
Investigator Studies ”); provided that Pharmion
is not contributing either personnel or financial support for the
conduct of such studies and that such studies are conducted outside
the Taiho Territory and in the Territory; (b) modifying the
approved label for Vidaza to satisfy the requirements of any
Regulatory Authority or to include data generated in any such
Investigator Studies; or (c) continuing to satisfy its
obligations under existing agreements as of the Effective Date with
independent investigators who are conducting in the Territory
investigations studying the combination of Vidaza with any compound
that directly inhibits the activity of HDAC enzymes or have
therapeutic effect through the inhibition of HDAC enzymes. Pharmion
shall in each case use its best efforts to ensure that the name of
Pharmion or its Affiliates is not mentioned or referred to in any
publication by such independent investigators other than to
acknowledge that Vidaza was supplied by Pharmion for such
studies.
2.6
Subcontracting . Neither MG nor Pharmion shall delegate or
subcontract its performance of the Programs, except as approved by
the JSC or as provided in the Research Plan or Development Plans.
In addition, any financial commitments included in any agreements
to be entered into by either Party with a Third Party to perform
any portion of the Programs shall be approved by the JSC. Such
agreements shall contain provisions as materially protective of
each Party’s rights, including without limitation with
respect to access to Data, ownership and licenses of intellectual
property rights and protection of confidential information, as set
forth in this Agreement.
3.1 Joint
Steering Committee . Within thirty (30) days after the
Effective Date, MG and Pharmion shall establish a “ Joint
Steering Committee ” or “ JSC ” in
accordance with this Section 3.1 to provide oversight and
management of the Collaboration, as further described in this
Section 3.1.
3.1.1
Membership . The JSC shall be comprised of an equal number
of representatives from each of MG and Pharmion, selected by such
Party. The minimum number of such representatives on the JSC shall
be two (2) for each of MG and Pharmion, which may
be
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 23 -
increase to
such other number as the Parties may agree. Each of Pharmion and MG
may replace its respective JSC representatives at any time, with
prior written notice to the other Party. In addition, each Party
may, at its discretion, invite employees, and, with the consent of
the other Party, consultants or scientific advisors, to attend
meetings of the JSC, or any committee thereof, as non-voting
observers.
3.1.2
Meetings . The JSC shall meet no less frequently than once
each calendar quarter, or as otherwise agreed by the Parties, at
mutually agreed locations alternating between Boulder, Colorado and
Montreal, Québec, or if agreed, by phone, video conference,
web-cast, or at such other locations as the Parties agree, and
thereafter as the Parties agree. Each Party shall bear its own
personnel, travel and lodging expenses relating to JSC
meetings.
3.1.3
Responsibilities . At its meetings, the JSC shall,
consistent with the terms and conditions of this Agreement,
(i) formulate and review the objectives of the Parties’
collaboration hereunder, (ii) monitor the progress of the
Parties toward those objectives, (iii) review and approve the
Programs pursuant to Article 4 of this Agreement, as well as
all budgets relating thereto, (iv) undertake and/or approve
such other matters as are specifically provided for the JSC under
this Agreement, (v) amending the Programs or the
Commercialization Plan, (vi) determining whether to continue
Development with respect to any Product or Compound, and
(vii) serve as a forum for communication between the Parties
and to resolve issues as mutually agreed. Each Party agrees to keep
the JSC informed as to the progress of its activities under the
Programs. The JSC shall create, when advisable, subcommittees such
as, for example, a joint research committee, a joint development
committee, a joint commercialization committee and/or a joint
manufacturing committee, comprised of representatives of each Party
having qualifications and experience relevant to the subject matter
to be overseen by each subcommittee. All such subcommittees shall
report to the JSC and, in the event that such subcommittee is
unable to reach a decision by consensus as to any matter
considered, such matter shall be referred to the JSC for
resolution.
3.1.4
Decisions of the JSC . Decisions of the JSC shall be made by
unanimous agreement of the members (with each Party’s JSC
members collectively having one vote) present in person or by other
means ( e.g. , teleconference) at any meeting; provided that
at least one (1) representative of each Party is present at
such meeting. It is understood that the decisions of the JSC,
whether under this Section 3.1.4 or under any other section of
this Agreement, shall not vary the terms of this Agreement. In the
event that the JSC is unable to reach unanimous agreement on an
issue as set forth in this Section 3.1.4, then such issue
shall be referred to the Senior Representatives of MG and Pharmion
who shall use good faith efforts to attempt to reach unanimous
agreement on such issue within thirty (30) days of such
referral. These individuals may obtain the advice of other
employees or consultants as they deem necessary or advisable in
order to make the decision. If the Senior Representatives are
unable to reach agreement on any matter within such thirty
(30) days, the Senior Representative of Pharmion shall have
the final decision making authority on such matter, except with
respect to any decision that would result in: (i) where MG has
not then exercised its MG Opt-out Rights, approval of a budget in a
Development Plan or a Commercialization Plan to be approved by the
JSC that results in North American Development Costs exceeding the
limits specified in Section 9.4.2, a material
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 24 -
modification of
a budget in a Development Plan or a Commercialization Plan
previously agreed upon by the Parties that results in Development
Costs exceeding the limits specified in Section 9.4.2 unless
, in each case, with respect to any activities that result in North
American Development Costs incurred above those specified in the
applicable budget, Pharmion agrees to bear all resulting
Development Costs attributable to such activities; (ii) a
breach or violation by MG of its obligations under the Taiho
Agreement; (iii) a breach, violation or modification of the
terms of this Agreement, including an alteration of any
participation rights granted to MG under the terms of this
Agreement, or (iv) a material modification to, or the
interruption or the discontinuance of, the Taiho Initiated
Studies.
3.1.5
Effect of Opt-Out on JSC . In the event MG exercises the MG
Opt-out Right set forth in Section 8.6 below, Pharmion shall
review and determine, at its sole discretion, whether any or all
subcommittees of the JSC should be disbanded (whether temporarily
or permanently) or its or their responsibilities limited pursuant
hereto, and the final decision making of the JSC shall henceforth
rest with the Senior Representative of Pharmion. The foregoing
shall not apply to the Global Development Committee.
3.2 Global
Development Committee . At such time as any Preclinical
Development and clinical development is undertaken by or under
authority of Pharmion or MG (including by an Additional Partner)
anywhere in the world within the Field with respect to a Compound
and/or Product, the Parties shall establish a joint committee among
MG, Pharmion and any Additional Partner(s) to discuss and
coordinate such development of such Compound and/or Product (the
“ Global Development Committee ”). To the extent
there are not Additional Partners, the function of the Global
Development Committee set forth in this Section 3.2 shall be
handled by the JSC. The primary role of such Global Development
Committee shall be to provide a forum for communication between MG,
Pharmion and any Additional Partner(s) with respect to activities
related to the ongoing Preclinical Development and clinical
development of Compounds and/or Products in the Field. Pharmion, MG
and each Additional Partner having rights to such Compounds or
Products shall each have at least two (2) representatives on
such Global Development Committee. Each member of the Global
Development Committee shall keep the other members fully informed
in English (subject to Section 6.6) as to the ongoing
Preclinical Development and clinical development of, and regulatory
activities with respect to, such Compounds or Products in the
Field. It is understood and agreed, however, that formal approval
of such Global Development Committee shall not be required for any
such activities. The Global Development Committee shall meet no
less frequently than twice each calendar year, or as otherwise
agreed by the Parties, until the termination or expiration of this
Agreement and each of Pharmion, MG and any Additional Party shall
give a full report in English (subject to Section 6.6) at each
such meeting of activities relating to the particular Compounds and
Products such Party or Additional Partner has rights to that is
undergoing Preclinical Development or clinical development in the
Field. Additional Partners will participate in such meeting only
with respect to Compounds and/or Products for which they have
rights. It is further understood that MG shall not be deemed in
breach of this Section 3.2 in the event an Additional Partner
fails to comply with this Section 3.2, provided that MG has
obtained in its agreement with such Additional Partner the
obligation to comply with this Section 3.2, and has used
reasonable efforts to cause such Additional Partner to comply with
such agreement.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 25 -
4.1 Contents of
the Plans . The Research Plan and the Development Plans shall
specify the objectives and work plan activities of (i) the
Research to be conducted during the Research Term or of
(ii) the Development, respectively. The Parties will use good
faith efforts to determine and agree upon the Research Plan within
forty five (45) days after the Effective Date. In addition,
the Parties agree to use all good faith and commercially reasonable
efforts to create a definitive Development Plan for the Initial
Clinical Candidate not later than sixty (60) days after the
Effective Date that shall be based upon the outline of Development
projects specified in a letter from MG to Pharmion on the Effective
Date.
4.1.1
Periodic Review . JSC shall review the Programs on a
semi-annual basis, including the content of the Research Plan and
the Development Plans, and may make any changes thereto as it deems
necessary or appropriate, in accordance with Section 4.2
below.
4.1.2
Participation . The Programs shall provide such reasonable
detail as either Party may request. Without limiting the foregoing,
with respect to clinical trials, the Development Plans shall
include detailed budgets of Development Costs, CROs, schedules,
trial sites, investigators, protocols, quality controls,
manufacturing procedures and the like, as requested by either
Party. It is understood and agreed that the JSC shall have the
right to review, request changes to, participate in revisions of
and finally approve the Research Plan and all Development Plans,
subject to all applicable provisions of this Agreement.
4.2 Approval of
Plans by the JSC . The Research Plan and each Development Plan,
including any changes thereto, must be reviewed and approved by the
JSC before it becomes effective. Each such approval by the JSC
shall render such plan effective for a period of twelve
(12) months after such date of approval. The JSC may forecast
plans for longer periods, but such approvals shall not render a
plan effective for a period of more than twelve (12) months
after the date of such approval, and the portions of each plan
setting forth activities after its expiration shall be non-binding
for either Party. Upon request by either Pharmion or MG, or both,
the Development Plans shall include separate plans for each
Compound or Product and each Clinical Study.
ARTICLE 5
STRUCTURE OF COLLABORATION
5.1
Registration and Disclosure of Compounds.
5.1.1
Compounds First Synthesized or Acquired Prior to the Effective
Date . On or before the Effective Date, all Compounds first
identified, synthesized, discovered, designed or acquired by or on
behalf of (i) MG or its Affiliates, (ii) a Non-Cancer
Partner or its Affiliates after it has entered into a Non-Cancer
Partner Agreement with MG, or (iii) an Additional Partner or
its Affiliates after it has entered into an agreement with MG,
shall be Registered if so identified, synthesized, discovered,
designed or acquired at least thirty (30) days prior to
the
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 26 -
Effective Date
in the MG Compound Registry together with their corresponding
Compound Registration Dates. From and after the Effective Date, all
Compounds first identified, synthesized, discovered, designed or
acquired by or on behalf of (a) MG or its Affiliates,
(b) a Non-Cancer Partner or its Affiliates after it has
entered into a Non-Cancer Partner Agreement with MG, or (c) an
Additional Partner or its Affiliates after it has entered into an
agreement with MG, shall be Registered if so identified,
synthesized, discovered, designed or acquired less than thirty
(30) days prior to the Effective Date in the MG Compound
Registry, together with their corresponding Compound Registration
Date, within thirty (30) days of the date each such Compound
was first identified, synthesized, discovered, designed or acquired
(as the case may be).
5.1.2
Compounds First Synthesized or Acquired After the Effective
Date . With respect to any compound first identified,
synthesized, discovered, designed or acquired after the Effective
Date by or on behalf of (A) MG or its Affiliates pursuant to
an MG Internal Program, (B) Pharmion or its Affiliates
hereunder (including by MG or its Affiliates hereunder), as
described in Section 2.5.3, (C) a Non-Cancer Partner or its
Affiliates pursuant to a Non-Cancer Research Program (including by
MG thereunder), or (D) an Additional Partner or its Affiliates
pursuant to MG’s agreement with such Additional Partner
(including by MG thereunder), such compound shall be Registered in
the MG Compound Registry within thirty (30) days of the date
such compound is first identified, synthesized, discovered,
designed or acquired (as the case may be). Within thirty (30) days
of the Compound Registration Date, such compound shall be screened
by MG using the HDAC Assay to determine if such compound is an HDAC
Inhibitor. Upon determination that any such compound is an HDAC
Inhibitor, such compound shall be deemed a Compound hereunder, and
shall be subject to the terms and conditions of this
Agreement.
5.1.3
Disclosure of Compounds; Limited Access Prior to the Compound
Disclosure Date . Within ten (10) Business Days after the
Effective Date, MG shall disclose to Pharmion the chemical
structures and isoforms (to the extent that such isoforms are
available as of the Effective Date and thereafter promptly after
such isoforms become available) of all Compounds having a Compound
Registration Date on or prior to the Effective Date. From and after
the Effective Date, MG shall provide Pharmion with regular reports,
disclosing to Pharmion the chemical structures and isoforms (to the
extent such isoforms are available) for all Compounds having a
Compound Disclosure Date on or prior to the date of the applicable
report. Such reports shall be provided by MG at least once every
thirty (30) days, or more often as reasonably requested by
Pharmion. For clarity, neither MG for purposes of an MG Internal
Program pursuant to Section 5.3.3, nor a Non-Cancer Partner
for purposes of a Non-Cancer Research Program, shall have access to
any Compounds of Pharmion or MG developed pursuant to this
Agreement until the Compound Disclosure Date for such Compound.
Similarly, Pharmion shall not have access under any Development
Program to any Compounds of MG developed outside the scope of this
Agreement (other than Compounds that are selected or reserved by
any Additional Partners to which Pharmion shall have access
pursuant to Section 5.3.5) or any Non-Cancer Partner until the
corresponding Compound Disclosure Date for such
Compound.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 27 -
5.2 Selection
by the JSC . From time to time, either Party may suggest that
the JSC consider a particular Compound to be further advanced into
Clinical Studies. Upon approval of the JSC of such Compound for
such Clinical Studies and the designation of such Compound as such
by the JSC under the terms of Section 5.3.1, the Parties shall
proceed to establish the appropriate Development Plan for such
Compound.
5.3 Selection
of Compounds
5.3.1
Designation by Pharmion.
(a)
Pharmion’s Designation of Reserve Compounds . Pharmion
may designate a Compound as a Pharmion Reserve Compound at any time
upon notice to MG, provided at the time of such notice: (i) as to
any Compound that is identified, synthesized, discovered, designed
or acquired after the Effective Date other than under this
Collaboration, one (1) year has elapsed since its Compound
Registration Date; (ii) such Compound is not then a Non-Cancer
Selected Compound, an Opt-out Non-Cancer Selected HDAC Inhibitor or
an MG Selected Compound; and (iii) there are not then more
than [***] Pharmion Reserve Compounds. In the event there
are then-currently [***] Pharmion Reserve Compounds, then
Pharmion shall not have the right to include any additional
Compound(s) as Pharmion Reserve Compounds, until Pharmion has
removed an equal number of Compounds from the list of Pharmion
Reserve Compounds, chosen at Pharmion’s sole discretion. For
the foregoing purpose, it is understood and agreed that Pharmion
shall have the right to remove any Compound from the list of
Pharmion Reserve Compounds at any time upon written notice to MG.
In the event a Compound is so removed from the list of Pharmion
Reserve Compounds, then such Compound shall thereafter cease to be
a Selected Compound, unless re-designated in accordance with this
Section 5.3.1(a), or such Compound becomes a Selected Compound
in accordance with Section 5.3.1(c) or 5.3.5 below.
(b)
Elevation of Pharmion Reserve Compounds . Upon commencement
of (i) Phase I clinical studies by or under authority of
Pharmion with respect to a Compound(s) in the Field, and provided
that (ii) such Compound(s) are Pharmion Reserve Compound(s) at
the time of Pharmion’s notice to MG of such commencement
under this Section 5.3.1(b), such Compound shall cease to be a
Pharmion Reserve Compound but shall remain a Selected Compound
hereunder ( i.e ., such Compound will no longer count
against the maximum number of [***] Pharmion Reserve
Compounds). Pharmion shall promptly notify MG of any Compounds for
which Phase I clinical studies have been commenced by or under its
authority.
(c)
Development Candidate Selection by the JSC . The JSC may
designate a particular Compound at any time after the Effective
Date to be a Selected Compound, provided that (i) as to any
Compound that is identified, synthesized, discovered, designed or
acquired after the Effective Date other than under this
Collaboration, one year has elapsed since its Compound Registration
Date; and (ii) such Compound is not then-currently a
Non-Cancer Selected Compound, an Opt-out Non-Cancer Selected HDAC
Inhibitor or an MG Selected Compound. In the event the JSC has not
begun Preclinical Development or Clinical Studies of such Compound
in the Field within [***] after such selection, such
Compound
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 28 -
shall
thereafter cease to be Selected Compound (and cannot be reselected
as Selected Compound under this Section 5.3.1(c) for at least
a period of [***] thereafter) but such Compound may be
immediately re-selected as or may remain a Selected Compound
pursuant to Section 5.3.1(a) above.
(d)
Selected Compounds . For the sake of clarity, MG agrees that
MG shall not grant any Non-Cancer Partner, Opt-out Non-Cancer
Partner or MG itself, with respect to an MG Internal Program, any
rights to select or reserve any Compound that is identified,
synthesized, discovered, designed or acquired after the Effective
Date pursuant to the activities conducted under this Agreement
until one (1) year has elapsed since the Compound Registration
Date of each such Compound.
5.3.2
Rights of Non-Cancer Partners; Designation by Non-Cancer
Partners .
(a)
Rights granted to Non-Cancer Partners . MG may grant each
Non-Cancer Partner rights to develop, market and/or commercialize
in the Territory outside the Field only a limited number of
individual Compounds (and Products containing the same) which have
been selected as Non-Cancer Selected Compounds in accordance with
this Section 5.3.2.
(b) Non-Cancer Partner’s Designation of
Reserve Compounds . A Non-Cancer Partner may designate a
Compound as a Non-Cancer Reserve Compound at any time upon notice
to MG, provided at the time of such notice (i) as to any
Compound that is identified, synthesized, discovered, designed or
acquired after the Effective Date other than under the
collaboration with such Non-Cancer Partners, one (1) year has
elapsed since its Compound Registration Date; (ii) such
Compound is not then a Selected Compound, an Opt-out Non-Cancer
Selected HDAC Inhibitor or an MG Selected Compound and
(iii) there are not then more than [***] Non-Cancer
Reserve Compounds for such Non-Cancer Partner. In the event the
Non-Cancer Partner then-currently has [***] Non-Cancer
Reserve Compounds, then such Non-Cancer Partner shall not have the
right to include any additional Compound(s) as Non-Cancer Reserve
Compounds, until such Non-Cancer Partner has removed an equal
number of Compounds from its list of Non-Cancer Reserve Compounds,
chosen at such Non-Cancer Partner’s sole discretion. For the
foregoing purpose, it is understood and agreed that a Non-Cancer
Partner shall have the right to remove any Compound from its list
of Non-Cancer Reserve Compounds at any time upon written notice to
MG. In the event a Compound is so removed from the list of
Non-Cancer Reserve Compounds, then such Compound shall thereafter
cease to be a Non-Cancer Selected Compound (unless re-designated in
accordance with this Section 5.3.2(b)), and the Non-Cancer
Partner shall have no further rights to develop, market and/or
commercialize such Compounds in the Territory outside the
Field.
(c)
Elevation of Non-Cancer Reserve Compounds . Upon
commencement of (i) Phase I clinical studies by or under
authority of a Non-Cancer Partner with respect to a Compound(s)
outside the Field, and provided that (ii) such Compound(s) are
Non-Cancer Reserve Compound(s) at the time of the Non-Cancer
Partner’s notice to MG of such commencement under this
Section 5.3.2(c) such Compound shall cease to be a Non-Cancer
Reserve Compound but shall remain a Non-Cancer Selected Compound
hereunder ( i.e. , such
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 29 -
Compound will
no longer count against the maximum number of [ ( )] Non-Cancer
Reserve Compounds for such Non-Cancer Partner).
(d)
Development Candidate Selection by a Non-Cancer Partner .
With respect to each Non-Cancer Partner, such Non-Cancer Partner
may designate one (1) Compound at any time after the Effective
Date (that is its development candidate outside the Field) to be a
Non-Cancer Selected Compound, provided that (i) as to any
Compound that is identified, synthesized, discovered, designed or
acquired after the Effective Date other than under the
collaboration with such Non-Cancer Partners, one year has elapsed
since its Compound Registration Date; and (ii) such Compound
is not then-currently a Selected Compound, an Opt-out Non-Cancer
Selected HDAC Inhibitor or an MG Selected Compound. In the event MG
and such Non-Cancer Partner have not begun Preclinical Development
or clinical trials of such Compound outside the Field within six
(6) months after such selection, such Compound shall
thereafter cease to be Non-Cancer Selected Compound (and cannot be
reselected as Non-Cancer Selected Compound under this
Section 5.3.2(d) for at least a period of six (6) months
thereafter) but such Compound may be immediately re-selected as or
may remain a Selected Compound pursuant to Section 5.3.2(b)
above.
5.3.3
Rights of [***] ; Designation by [***]
.
(a) Rights of [***] . [***]
shall continue to have rights to develop, market and/or
commercialize in the Territory outside the Field only a limited
number of individual Compounds (and Products containing the same)
which have been selected as [***] Selected Compounds in
accordance with this Section 5.3.3 for [***]
Programs.
(b) [***] ’s Designation
of Reserve Compounds . [***] may designate a Compound as
an [***] Reserve Compound at any time upon notice to Patent
Counsel, provided at the time of such notice (i) as to any
Compound that is identified, synthesized, discovered, designed or
acquired after the Effective Date other than pursuant to an
[***] Program, one year has elapsed since its Compound
Registration Date; (ii) such Compound is not then a Selected
Compound, a Non-Cancer Selected Compound or an Opt-out Non-Cancer
Selected HDAC Inhibitor, and (iii) there are not then more
than [***] [***] Reserve Compounds for [***] .
In the event [***] then-currently has [***]
[***] Reserve Compounds, then [***] shall not have
the right to include any additional Compound(s) as [***]
Reserve Compounds, until [***] has removed an equal number
of Compounds from its list of [***] Reserve Compounds,
chosen at [***] ’s sole discretion. For the foregoing
purpose, it is understood and agreed that [***] shall have
the right to remove any Compound from its list of [***]
Reserve Compounds at any time upon written notice to Patent
Counsel. In the event a Compound is so removed from the list of
[***] Reserve Compounds, then such Compound shall thereafter
cease to be an [***] Selected Compound (unless re-designated
in accordance with this Section 5.3.3(b)), and [***]
shall have no further rights to develop, market and/or
commercialize such Compounds in the Territory as part of
[***] Program outside the Field.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 30 -
(c)
Elevation of [***] Reserve Compounds . Upon
commencement of (i) Phase I clinical studies by or under
authority of [***] with respect to a Compound(s) outside the
Field, and provided that (ii) such Compound(s) are
[***] Reserve Compound(s) at the time of the [***]
’s notice to Patent Counsel of such commencement under this
Section 5.3.3(c) such Compound shall cease to be an
[***] Reserve Compound but shall remain an [***]
Selected Compound hereunder ( i.e. , such Compound will no
longer count against the maximum number of [***]
[***] Reserve Compounds for [***] ).
(d) Development Candidate Selection by
[***] . [***] may designate one (1) Compound
at any time (that is its development candidate outside the Field)
to be an [***] Selected Compound, provided that (i) as
to any Compound that is identified, synthesized, discovered,
designed or acquired after the Effective Date other than pursuant
to an [***] Program, one year has elapsed since its Compound
Registration Date; and (ii) such Compound is not
then-currently a Selected Compound, a Non-Cancer Selected Compound
or an Opt-out Non-Cancer Selected HDAC Inhibitor. In the event
[***] has not begun Preclinical Development or clinical
trials of such Compound outside the Field within six
(6) months after such selection, such Compound shall
thereafter cease to be an [***] Selected Compound (and
cannot be reselected as an [***] Selected Compound under
this Section 5.3.3(d) for at least a period of six
(6) months thereafter) but such Compound may be immediately
re-selected as or may remain a Selected Compound pursuant to
Section 5.3.3(b) above.
(a)
Designation by Non-Cancer Partner . A Non-Cancer
Partner’s designation, or removal, of a Compound as a
Non-Cancer Selected Compound or Non-Cancer Reserve Compound shall
be effective only upon notice to [***] of such designation
or removal.
(b)
Designation by [***] . [***] ’s
designation, or removal, of a Compound as an [***] Selected
Compound or [***] Reserve Compound shall be effective only
upon notice to the Patent Counsel of such designation or removal.
[***] agrees that the Patent Counsel shall promptly provide
Pharmion upon written request details of any determinations made by
such Patent Counsel as authorized under the terms of this Agreement
in respect of [***] Selected Compound or [***]
Reserve Compound.
(c)
Designation by Pharmion . [***] shall have a period
of ten (10) business days, after Pharmion’s written
notice of designation of Pharmion Reserve Compound(s) under Section
5.3.1(a) above, to inform Pharmion of any reasons under this
Agreement why such Compound cannot be a Pharmion Reserve Compound,
including without limitation if such Compound is already a
Non-Cancer Selected Compound, an Opt-out Non-Cancer Selected HDAC
Inhibitor or an [***] Selected Compound prior to such notice
(a “ Rejection ”). In the event [***]
does not notify Pharmion in writing of a Rejection within such ten
business (10) day period, or notifies Pharmion during such ten
(10) business day period that such Compound has been accepted
as a Pharmion Reserve Compound, then Pharmion’s designation
of such Compound as a Pharmion Reserve Compound shall conclusively
be deemed effective under Section 5.3.1(a) above. In the event
a Compound is Rejected as a Pharmion Reserve Compound, then
[***] agrees
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 31 -
to promptly
notify Pharmion if such Compound is thereafter removed from any
list of Non-Cancer Selected Compounds, Opt-out Non-Cancer Selected
HDAC Inhibitor or an [***] Selected Compound no later than
[***] notifies any other third party of such
removal.
(d)
Disclosure . [***] shall promptly disclose to
Pharmion the structures of all [***] Selected Compounds and
of all Non-Cancer Selected Compounds to the extent [***] has
the right to do so under its agreement with the Non-Cancer Partner
that designated such Non-Cancer Selected Compound. To the extent
that [***] has the right to disclose structures of such
Non-Cancer Selected Compounds to Pharmion, [***] may
reciprocally disclose to such Non-Cancer Partner the structures of
the Selected Compounds hereunder; but [***] shall not
disclose the structures of Selected Compounds to a Non-Cancer
Partner who does not permit [***] to disclose its Non-Cancer
Selected Compounds to Pharmion.
(e)
After Commencement of Clinical Trials . Any provisions of
this Agreement to the contrary notwithstanding, Pharmion, a
Non-Cancer Partner or [***] shall have the right, upon
written request to [***] , or to Patent Counsel in the case
of [***] , to remove the chemical structure of any Selected
Compound, Non-Cancer Selected Compound or [***] Selected
Compound, respectively, from the [***] Compound Registry
from and after the date of elevation of such Compound pursuant to
Section 5.3.1(b) in the case of a Pharmion Reserve Compound,
pursuant to Section 5.3.2(c) in the case of a Non-Cancer
Reserve Compound and pursuant to Section 5.3.3(c) in the case
of a [***] Reserve Compound; provided , that, if such
Compound is no longer being pursued in any clinical study
thereafter, the chemical structure of such Compound shall be
promptly added to the [***] Compound Registry.
(f)
Designation by an Opt-out Non-Cancer Partner; Disclosure .
An Opt-out Non-Cancer Partner’s designation, or removal, of a
compound as an Opt-out Non-Cancer Partner Selected HDAC Inhibitor
or Opt-out Non-Cancer Partner Reserve HDAC Inhibitor shall be
effective only upon notice to [***] of such designation or
removal. Except to the extent necessary to prevent a prohibited
selection pursuant to the selection procedures set forth in
Section 5.3.4(c) hereof, [***] shall not
(i) disclose the identities of any Opt-out Non-Cancer Selected
HDAC Inhibitor to Pharmion, Additional Partners or Non-Cancer
Partners, or (ii) disclose the identities of any Selected
Compounds, Non-Cancer Selected Compounds or [***] Selected
Compounds to Opt-out Non-Cancer Partners.
5.3.5
Selection by Additional Partners . At such time as
[***] grants an Additional Partner rights to develop, market
and/or commercialize any Compounds in the Field, such Compounds
that are selected or reserved for development by such Additional
Partner (including, without limitation, all Taiho Reserve
Compounds, as such term is defined in the Taiho Agreement) shall
thereafter be deemed Selected Compounds under this Agreement.
[***] shall promptly notify Pharmion of any such Compounds.
Compounds that are “selected or reserved for
development” shall include any Compounds that are selected or
reserved for development by the Additional Partner in a manner
similar to this Section 5.3 ( i.e. , Compounds that
cannot become Non-Cancer Selected Compounds, [***] Selected
Compounds or Opt-out Non-Cancer Selected HDAC Inhibitors without
such Additional Partner consent) and all Compounds for which
the
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 32 -
Additional
Partner has actually commenced Preclinical Development or Clinical
Studies in the Field. [***] shall notify Pharmion of all
Selected Compounds under this Section 5.3.5.
5.3.6
No Obligation to Develop Reserve Compounds . It is
understood that each of Pharmion, the Additional Partners, MG and
the Non-Cancer Partners shall have no obligation to advance any
Reserve Compounds into Preclinical Development or clinical
development, but each may do so in its discretion in accordance
with its respective licenses and rights.
5.3.7
Rights of Opt-out Non-Cancer Partners; Designation by Opt-out
Non-Cancer Partners .
(a)
Rights granted to Opt-out Non-Cancer Partners . It is
understood that the designation mechanism described in this
Section 5.3.7 is contemplated by the Parties only for the
specific situation in which an Opt-out Non-Cancer Partner
independently discovers a Small Molecule compound, which directly
inhibits the activity of HDAC enzymes or has therapeutic effect
through the inhibition of HDAC enzymes, that falls with in the
definition of “Compound” hereunder. In such case,
neither the Opt-out Non-Cancer Partners, nor Pharmion, Additional
Partners and Non-Cancer Partners, desire to block the others via
Opt-out Non-Cancer Patents Blocking Patents, Pharmion Blocking
Patents or MG Blocking Patents, as the case may be, in the
other’s development and/or commercialization of such
Compounds in their respective fields consistent with this
Agreement. For the avoidance of doubt, this Section 5.3.7, and
the designation of Opt-out Non-Cancer Selected HDAC Inhibitors by
the Opt-out Non-Cancer Partners, is not intended to limit the
effect of Section 8.3.4(a)(iii), nor to grant or permit MG to grant
Opt-out Non-Cancer Partners rights or licenses with respect to
Compounds beyond those described below.
MG may grant each
Opt-out Non-Cancer Partner, rights with respect to Compounds
limited to: a non-exclusive license under MG Blocking Patents to
develop, market and/or commercialize in the Territory outside the
Field the Opt-out Non-Cancer Selected HDAC Inhibitors that are
Compounds. MG shall otherwise not grant any rights, nor provide any
Data or Licensed Technical Information, to such Opt-out Non-Cancer
Partners to develop, market and/or commercialize in the Territory
outside the Field any Compounds. As used herein, “ MG
Blocking Patents ” shall mean all patents owned and
controlled by MG which are necessarily infringed by the
composition, manufacture, sale or use of the Opt-out Non-Cancer
Selected HDAC Inhibitors that are Compounds.
(b)
Opt-out Non-Cancer Partner’s Designation of Reserved HDAC
Inhibitor . An Opt-out Non-Cancer Partner may designate a Small
Molecule compound, which directly inhibits the activity of HDAC
enzymes or has therapeutic effect through the inhibition of HDAC
enzymes, as an Opt-out Non-Cancer Reserve HDAC Inhibitor at any
time after the Effective Date upon notice to MG, provided at the
time of such notice (i) as to any Compound that is identified,
synthesized, discovered, designed or acquired after the Effective
Date other than by Opt-out Non-Cancer Partner, one year has elapsed
since its Compound Registration Date, (ii) such compound is
not then a Selected Compound, an [***] Selected Compound or
a Non-Cancer Selected Compound, and (iii) there are not then
more than [***] Opt-out Non-Cancer
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 33 -
Reserve HDAC
Inhibitor for such Opt-out Non-Cancer Partner. In the event the
Opt-out Non-Cancer Partner then-currently has [***] Opt-out
Non-Cancer Reserve HDAC Inhibitors, then such Opt-out Non-Cancer
Partner shall not have the right to include any additional
compound(s) as Opt-out Non-Cancer Reserve HDAC Inhibitors, until
such Opt-out Non-Cancer Partner has removed an equal number of
compounds from its list of Opt-out Non-Cancer Reserve HDAC
Inhibitors, chosen at such Opt-out Non-Cancer Partner’s sole
discretion. For the foregoing purpose, it is understood and agreed
that a Opt-out Non-Cancer Partner shall have the right to remove
any compound from its list of Opt-out Non-Cancer Reserve HDAC
Inhibitors at any time upon written notice to MG. In the event a
compound is so removed from the list of Opt-out Non-Cancer Reserve
HDAC Inhibitors, then such compound shall thereafter cease to be a
Opt-out Non-Cancer Selected HDAC Inhibitor (unless re-designated in
accordance with this Section 5.3.7(b)), and if such compound
is a “Compound” hereunder, the Opt-out Non-Cancer
Partner shall have no further rights to develop, market and/or
commercialize such Compound in the Territory outside the
Field.
(c)
Elevation of Opt-out Non-Cancer Reserve HDAC Inhibitors .
Upon commencement of (i) Phase I clinical studies outside the Field
by or under authority of a Opt-out Non-Cancer Partner with respect
to a Small Molecule compound(s) that directly inhibits the activity
of HDAC enzymes or has therapeutic effect through the inhibition of
HDAC enzymes, and provided that (ii) such compound(s) are
Opt-out Non-Cancer Reserve HDAC Inhibitor(s) at the time of the
Non-Cancer Partner’s notice to MG of such commencement under
this Section 5.3.7(c), such compound(s) shall cease to be a
Opt-out Non-Cancer Reserved HDAC Inhibitor(s) but shall remain a
Opt-out Non-Cancer Selected HDAC Inhibitor(s) hereunder (
i.e. , such compound will no longer count against the
maximum number of [***] Opt-out Non-Cancer Reserve HDAC
Inhibitors for such Opt-out Non-Cancer Partner).
5.4.1
Plans . The commercialization of each Product shall be
governed by a Commercialization Plan which shall describe the
overall plan for commercializing such Product, including (a) a
comprehensive marketing, sales, pricing, manufacturing,
distribution and licensing strategy for such Product in all
applicable countries, including the identification of any Third
Parties engaged or to be engaged in connection with such activities
and the arrangements with them that have been or are proposed to be
agreed upon (including policies and procedures for adjustments,
rebates, bundling and the like), (b) estimated launch date,
market and sales forecasts, in numbers of patients and local
currency, and competitive analysis for such Product for the overall
Territory and for each country within the Territory, (c) a
detailed budget for the Commercialization Costs to be incurred in
connection with performing such Commercialization Plan, (d) an
allocation of specific responsibilities of each of the Parties with
respect to Commercialization objectives, including a specification
of target market segments and Detailing requirements and strategy
to be achieved during the calendar year to which the
Commercialization Plan relates, (e) product positioning and
promotional plans (including examples of planned Product
Promotional Materials), (f) Phase IV clinical trial support,
if applicable, (g) managed care contracting strategy,
(h) conduct of Product-specific training programs for sales
representatives, and (i) a detailed manufacturing
plan.
[***] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
- 34 -
5.4.2
Commercialization Plans . No later than [***]
following the earlier of (i) commencement of the first Phase III
clinical trial and (ii) commencement of the first
Registrational Trial, in each case, for a Product in any given
country within the Territory, the Marketing Party shall develop and
submit for approval an initial Commercialization Plan for such a
Product in accordance with customary standards for a product of
comparable market potential, taking into consideration factors such
as market conditions, regulatory f
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