Exhibit 10.27


 


EXECUTION COPY


 


COLLABORATION AND LICENSE AGREEMENT


 


This COLLABORATION AND LICENSE
AGREEMENT (this “Agreement”), dated as of December 23, 2008 (the “Execution
Date”), is entered into by and between SYNTA PHARMACEUTICALS CORP., a
Delaware corporation having a principal office at 45 Hartwell Avenue,
Lexington, MA 02421, U.S.A. (“SYNTA”), and F. HOFFMANN-LA ROCHE LTD, a
Swiss corporation having a principal office located at Grenzacherstrasse 124, CH-4070 Basel,
Switzerland (“ROCHE BASEL”) and HOFFMANN-LA
ROCHE INC., a New Jersey corporation
having a principal office at 340 Kingsland Street, Nutley, New Jersey
07110, U.S.A.  (“ROCHE NUTLEY”; ROCHE BASEL and
ROCHE NUTLEY together referred to as “ROCHE”).


 


INTRODUCTION


 


WHEREAS, ROCHE has expertise
and capability in the research, development, manufacture and commercialization
of pharmaceutical products;


 


WHEREAS, SYNTA is a
biopharmaceutical company focused on discovering, developing and
commercializing products for extending and enhancing the lives of patients with
severe medical conditions, including inflammatory and immune-mediated diseases
and disorders; and


 


WHEREAS, SYNTA and ROCHE desire
to collaborate on the discovery, research, development and commercialization of
certain potential products containing small-molecule compounds that may be
contributed to the collaboration by either party and directed to the inhibition
of calcium release-activated calcium channels.


 


NOW, THEREFORE, in
consideration of the mutual covenants contained herein and other good and
valuable consideration the receipt of which is hereby acknowledged, SYNTA and
ROCHE agree as follows:


 


ARTICLE I
-DEFINITIONS


 


General.  When used in this Agreement, each of the
following terms shall have the meanings set forth in this Article I:


 


1.1.          “Affiliate” means any Person
directly or indirectly controlled by, controlling, or under common control
with, a Party, but only for so long as such control shall continue.  For purposes of this definition, “control”
(including, with correlative meanings, “controlled by”, “controlling” and “under
common control with”) means, with respect to a Person, possession, direct or
indirect, of (a) the power to direct or cause direction of the management
and policies of such Person (whether through ownership of securities or
partnership or other ownership interests, by contract or otherwise), or (b) at
least fifty percent (50%) of the voting securities (whether directly or
pursuant to any option, warrant, or other similar arrangement) or other
comparable equity interests.  Anything to
the contrary in this paragraph notwithstanding, Genentech, Inc., a
Delaware corporation (“Genentech”) and its subsidiaries, and Chugai
Pharmaceutical Co., Ltd, a 


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Securities Exchange Act of 1934, as amended.


 


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Japanese corporation (“Chugai”)
and its subsidiaries (each, Genentech, Chugai and their subsidiaries a “ROCHE
Entity”), shall not be deemed an Affiliate of ROCHE unless ROCHE provides
written notice to SYNTA of its desire to include a particular ROCHE Entity as
an Affiliate of ROCHE.  ROCHE shall have
the right to include such ROCHE Entity in whole or in part, i.e. on a legal
entity-by-legal entity basis. 
Notwithstanding such written notice, if any ROCHE Entity does not agree
to be bound by the terms and conditions of this Agreement, then such ROCHE
Entity shall have none of the rights and obligations of an Affiliate of ROCHE
under this Agreement.  Notwithstanding
the preceding provisions, once an entity ceases to be an Affiliate, then such
entity shall, without any further action, cease to have any rights, including
license and sublicense rights, under this Agreement that it has by reason of
being an Affiliate but shall remain bound by the provisions of Article IX
in accordance with its terms.


 


1.2.          “Business Day” means a day that
is not a Saturday, Sunday or a day on which banking institutions in Boston,
Massachusetts, U.S., or in Basel, Switzerland are authorized by Law to remain
closed.


 


1.3.          “Calendar Quarter” means each
of the three (3) month periods ending on March 31, June 30, September 30,
and December 31 of any year.


 


1.4.          “Change of Control” means, with
respect to a Party:  (a) the
acquisition by any Third Party of beneficial ownership of fifty percent (50%)
or more of the then-outstanding common shares or voting power of such Party,
other than acquisitions by employee benefit plans sponsored or maintained by
such Party; or (b) the consummation of a business combination involving
such Party, unless, following such business combination, the stockholders of
such Party immediately prior to such business combination beneficially own
directly or indirectly more than fifty percent (50%) of the then-outstanding
common shares or voting power of the entity resulting from such business
combination.


 


1.5.          “Clinical Trial” means a Phase
1 Clinical Trial, a Phase 2 Clinical Trial, a Phase 2a Clinical Trial, a Phase
2b Clinical Trial or a Phase 3 Clinical Trial.


 


1.6.          “Collaboration Compound” means
any small-molecule compounds Controlled by a Party which such Party knows or
believes is a CRAC Channel Inhibitor. 
Any Collaboration Compound shall also include all pro-drugs,
metabolites, constitutional and geometric isomers, regioisomers, stereoisomers
including enantiomers and diastereoisomers, salt forms, hydrates, solvates and
polymorphs of such Collaboration Compound, all of which shall constitute a
single Collaboration Compound.


 


1.7.          “Commercialization” and “Commercialize”
means all activities undertaken relating to the marketing, promotion (including
advertising, detailing and Phase 4 studies), any other offering for sale,
distribution and sale of a product.


 


1.8.          “Commercially Reasonable Efforts”
means such level of efforts required to carry out an obligation in a sustained
manner consistent, as to ROCHE, with the efforts normally used by major global
pharmaceutical companies or, as to SYNTA, with the efforts normally used by 


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Securities Exchange Act of 1934, as amended.


 


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biopharmaceutical companies of
comparable size and resources and at the same stage of development as SYNTA,
for a product or compound which is of similar market potential and at a similar
stage of development or commercialization, as applicable, taking into account
the existence of other competitive products in the market place or under
development, the proprietary position of the product, the regulatory structure
involved, the anticipated profitability of the product (without regard to any
amounts paid or payable with respect to Licensed Products under this Agreement)
and other relevant factors.  It is also
to be appreciated that a major global pharmaceutical company does not always
seek to market products in every country or seek regulatory approval for every
potential Indication, but that ROCHE shall undertake to commercialize Licensed
Products in the Major Markets absent a compelling reason not to do so.  It is understood that such products’
potential may change from time to time based upon changing scientific, business
and marketing and return on investment considerations.  As a result, the exercise of diligence by
ROCHE is to be determined by judging ROCHE’s commercially reasonable efforts
taken as a whole.


 


1.9.          “Confidential Information”
means all proprietary Know-how of a Party which are disclosed (whether in
written, graphic, oral, electronic or other form) by or on behalf of such Party
to another Party pursuant to this Agreement, including: information regarding a
Party’s or its licensor’s technology, products, business or financial status,
and biological or chemical substances, formulations, techniques, methodology,
equipment, sources of supply, patent positioning, and business plans.  The status, prospects or objectives regarding
the Research Program, Collaboration Compounds or Licensed Products shall be
deemed “Confidential Information” of both Parties.  All information disclosed prior to the
Effective Date by or on behalf of either Party under, and subject to, any of
the confidentiality agreements between SYNTA and ROCHE NUTLEY dated [***], and
[***] or the confidentiality agreement between SYNTA and Roche Palo Alto LLC,
an Affiliate of ROCHE, dated [***] (together, the “Confidentiality
Agreements”) shall be deemed “Confidential Information” of the disclosing
Party hereunder.


 


1.10.        “Contract Year” means each
successive twelve (12) month period commencing on January 1, 2009 and on
each anniversary thereof.


 


1.11.        “Control” or “Controlled”
means, with respect to any Patent Rights or Know-how and with respect to any
Person, possession (whether by ownership or license, other than a license
granted pursuant to this Agreement) by such Person of the ability to grant the
licenses or sublicenses as provided for herein without violating the terms of
any agreement or other arrangement with any Third Party.


 


1.12.        “Co-promoted Product” means a
Licensed Product with respect to which SYNTA has exercised its Co-promotion
Option pursuant to Section 5.3.


 


1.13.        “Co-promotion” means the joint
marketing and promotion (including detailing) of Licensed Products in the
United States as further described in Article V.


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Securities Exchange Act of 1934, as amended.


 


3

















 


1.14.        “Cover”, “Covering” or “Covered”
means, with respect to a product, composition, technology, process or method
that, in the absence of ownership of or a license granted under a Valid Claim,
the manufacture, use, offer for sale, sale or importation of such product or
the practice of such technology, process or method would infringe such Valid
Claim (or, in the case of a Valid Claim that has not yet issued, would infringe
such Valid Claim if it were to issue).


 


1.15.        “CRAC Channel” means the genes
for the calcium release-activated calcium channel (also known by names [***].


 


1.16.        “CRAC Channel Inhibitor” means
[***].


 


1.17.        “Development” and “Develop”
means, with respect to a Licensed Compound, non-clinical (including
preclinical) and clinical drug development activities, pre-marketing activities
and related research, including: 
conducting toxicology studies, DMPK studies, process and drug product
(dosage form) development, statistical analysis and report writing, clinical
trials for the purpose of obtaining or maintaining Regulatory Approval
(including post-marketing studies intended to support Regulatory Approval but
excluding Phase 4 studies) and regulatory affairs related to all of the
foregoing.  Development shall not include
Research.


 


1.18.        “Development Cost” means the
costs incurred by SYNTA for its account after the Effective Date which are
consistent with a Development Plan and are specifically attributable to the
Development of Licensed Compounds or Licensed Products.  Such costs shall mean the direct cost and
indirect costs of all SYNTA Development personnel and Third Party costs, all of
them incurred to further the Development of Licensed Compounds or Licensed
Products.  SYNTA shall calculate the
direct and indirect costs of SYNTA Development personnel based on the FTE Rate.


 


1.19.        “Effective Date” means the
Execution Date.


 


1.20.        “EMEA” means the European
Medicines Agency and any successor agency thereto.


 


1.21.        “EU” means the European Union, as
it may be redefined from time to time.


 


1.22.        “Executive Officer(s)” means,
with respect to SYNTA, the Chief Executive Officer of SYNTA, and with respect
to ROCHE, Head of Pharma Partnering.


 


1.23.        “FBMC” means, for a Licensed
Product, the standard manufacturing cost, as defined by the manufacturing Party’s
standard cost accounting practices and policies and consistently applied by
such Party.  FBMC shall include direct
labor, materials, product testing costs, including quality control and quality
assurance bulk testing and in-process testing (e.g.,
adventitious virus and mycoplasma testing), and allocable overhead for
manufacturing or contracting for each stage of the manufacturing process of the
Licensed Product shipped.  In addition,
FBMC includes failures that are considered normal yield losses that could be
reasonably expected or justified in this area of technology, excess capacity
and idle plant cost to 


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Securities Exchange Act of 1934, as amended.


 


4

















 


the extent associated with the
Licensed Product, and write off and disposal costs of expired goods (raw
materials, intermediates and products).


 


1.24.        “FDA” or “Food and Drug
Administration” means the United States Food and Drug Administration and
any successor agency thereto.


 


1.25.        “Field” means all human
pharmaceutical and diagnostic uses, excluding medical device uses.


 


1.26.        “First Commercial Sale” means,
with respect to a Licensed Product in a country in the Territory, the first bona fide arms-length sale of such Licensed Product sold to
a Third Party in such country by or on behalf of ROCHE, its Affiliates or
Sublicensees after Regulatory Approval has been obtained for such Licensed
Product in such country.


 


1.27.        “First Licensed Compound” means,
with respect to each stage of Development (the early stages of which are
described in Section 2.4.1), the first Licensed Compound to enter such
stage of Development during the Term.


 


1.28.        “FTE” means a full-time
equivalent person-year (consisting of a total of [***] hours per year) of scientific, technical, or managerial work on
or directly related to activities performed under the Research Plan or
Development Plan.


 


1.29.        “FTE Rate” means $[***] per FTE,
increased annually by the percentage increase in the Consumer Price Index (“CPI”)
as of the then-most-recent December 31 over the CPI as of December 31,
[***].  [***] $[***].  As used in this Section 1.29, Consumer
Price Index or CPI means the Consumer Price Index — Urban Wage Earners and
Clerical Workers, US City Average, All Items, 1982-84 = 100, published by the
United States Department of Labor, Bureau of Labor Statistics (or its successor
equivalent index).


 


1.30.        “Generic Competition” means, with
respect to a Licensed Product in any country in the Territory in a given
Calendar Quarter, if, during such Calendar Quarter, one or more Generic
Products shall be commercially available in such country and such Generic
Products shall have a market share of [***] percent ([***]%) or more of the
aggregate market in such country of such Licensed Product and Generic Products
(based on sales of units of such Licensed Product and such Generic Products, as
reported by IMS International, or if such data are not available, such other
reliable data source as reasonably determined by ROCHE and agreed by SYNTA).


 


1.31.        “Generic Product” means, with
respect to a Licensed Product in a country, any pharmaceutical product sold by
a Third Party not authorized by or on behalf of ROCHE or its Affiliates, that (a) contains
as an active pharmaceutical ingredient the same CRAC Channel Inhibitor (or its
pro-drug, metabolite, constitutional or geometric isomer, regioisomer,
stereoisomer including enantiomer or diastereoisomer, salt form, hydrate,
solvate or polymorph of such CRAC Channel Inhibitor), as the one contained in
such Licensed Product, (b) is “a therapeutic equivalent” to such Licensed
Product as such term is used in the Approved Drug Products with Therapeutic
Equivalence Evaluations published by the FDA Center for Drug Evaluation and
Research or any successor publication, and (c) is approved in reliance on
the 


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Securities Exchange Act of 1934, as amended.


 


5

















 


prior approval of such Licensed
Product as determined by the applicable Regulatory Authority in such country.


 


1.32.        “GLP Toxicology Study” means an in vivo toxicology study designed to be no less than [***]
([***]) days in duration, that is conducted in compliance with GLP and is
required to meet the requirements for filing an IND.


 


1.33.        “GLP” or “Good Laboratory
Practice” means current good laboratory practice standards promulgated or
endorsed by the FDA as defined in 21 C.F.R. Part 58, or any comparable
regulatory standards in any country other than the United States.


 


1.34.        “IND” or “Investigational New
Drug Application” means an Investigational New Drug Application filed with
the FDA in the United States or any equivalent counterpart in any country other
than the United States, including all supplements and amendments thereto.


 


1.35.        “Indication” means any human
disease or condition, or sign or symptom of a human disease or condition.


 


1.36.        “Initiation” means, with respect
to a Clinical Trial, the first dosing of the first patient enrolled in such
Clinical Trial with a Licensed Product; and with respect to a GLP Toxicology
Study, the first dosing of the first mammal in such study.


 


1.37.        “Joint Intellectual Property”
means the Joint Know-how and Joint Patent Rights.


 


1.38.        “Joint Know-how” means Know-how
that is developed by one or more employees, agents or consultants of SYNTA or
any of its Affiliates, on the one hand, and one or more employees, agents or consultants
of ROCHE or any one of its Affiliates, on the other hand, in the conduct of
Research, Development, Manufacturing or Commercialization of Collaboration
Compounds, Licensed Compounds or Licensed Products, including Joint Inventions.


 


1.39.        “Joint Patent Rights” means all
Patent Rights that claim or disclose Joint Know-how.


 


1.40.        “Know-how” means any information
and materials, whether patentable or not, including (a) ideas,
discoveries, inventions, improvements or trade secrets, (b) pharmaceutical,
chemical and biological materials, products and compositions, (c) tests,
assays, techniques, data, methods, procedures, formulas, or processes, (d) technical,
medical, clinical, toxicological, and other scientific data and other
information relating to any of the foregoing, and (e) drawings, plans,
designs, diagrams, sketches, specifications, or other documents containing or
relating to such information or materials.


 


1.41.        “Law” or “Laws” means all
laws, statutes, rules, regulations, orders, judgments, or ordinances having the
effect of law of any federal, national, multinational, state, provincial,
county, city or other political subdivision.


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Securities Exchange Act of 1934, as amended.


 


6

















 


1.42.        “Licensed Compound” means
[***].  For further clarity, if ROCHE terminates
a Licensed Compound in one or more regions pursuant to Section 12.3, such
Licensed Compound shall continue to be deemed a Licensed Compound except as
provided in Article XII unless and until ROCHE terminates such Licensed
Compound in all Regions pursuant to Section 12.3 (whether ROCHE so
terminates such Licensed Compound in all Regions simultaneously or terminates
such Licensed Compound in all Regions over time).  For the sake of clarity, any Licensed
Compound shall also include all pro-drugs, metabolites, constitutional and
geometric isomers, regioisomers, stereoisomers including enantiomers and
diastereoisomers, salt forms, hydrates, solvates and polymorphs of such
Licensed Compound, all of which shall constitute a single Licensed Compound.  [***].


 


1.43.        “Licensed Product” means any
pharmaceutical product containing as an active pharmaceutical ingredient a
Licensed Compound; provided, however, that such product may not
contain an active pharmaceutical ingredient having a composition of matter that
is Covered by SYNTA Patent Rights unless such active pharmaceutical ingredient
is a Licensed Compound.


 


1.44.        “Major EU Country” means France,
Germany, Italy, Spain or the United Kingdom.


 


1.45.        “Major Market” means any Major EU
Country, Japan, or the United States.


 


1.46.        “Manufacture” means all
activities related to the manufacturing of a compound or product, including
test method development and stability testing, formulation, process
development, manufacturing scale-up, manufacturing for use in non-clinical and
clinical studies, manufacturing for commercial sale, packaging, release of
product, quality assurance/quality control development, quality control testing
(including in-process, in-process release and stability testing) and release of
product or any component or ingredient thereof, and regulatory activities
related to all of the foregoing.


 


1.47.        “Marketing Exclusivity” means,
with respect to a pharmaceutical product in a country: (a) the exclusivity
afforded to the pharmaceutical product for being the first drug product
containing the active ingredient to receive regulatory approval in that
country, (b) pediatric exclusivity, or (c) orphan drug exclusivity,
but only when the pharmaceutical product does not also have a non-orphan drug
indication that is not protected by an unexpired exclusivity.


 


1.48.        “MHLW” means the Japanese
Ministry of Health, Labor and Welfare and any successor agency thereto.


 


1.49.        “NDA” means a New Drug
Application or a supplemental New Drug Application, as defined in 21 C.F.R.
§§314.50 and 314.70, respectively, filed with the FDA with respect to a
Licensed Product, or an equivalent application filed with the Regulatory
Authority of a country in the Territory other than the United States, including
any Marketing Authorization Application filed with the EMEA.


 


1.50.        “Net Sales” means the amount
calculated by subtracting from the amount of Adjusted Gross Sales (as defined
below) a lump sum deduction of (1) [***] percent ([***]%) of 


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Securities Exchange Act of 1934, as amended.


 


7

















 


Adjusted Gross Sales, with
respect to Net Sales in the United States, (2) [***] percent ([***]%) of
Adjusted Gross Sales, with respect to Net Sales in the Major Markets (other
than the U.S.) and Canada, and (3) [***] percent ([***]%) of Adjusted
Gross Sales, with respect to Net Sales in all territories other than those set
forth in clause (1) and (2) above, in lieu of all deductions
corresponding to charges allocable to the sale of Licensed Product and paid by
ROCHE but which are not accounted for by ROCHE, its Affiliates, ROCHE Entities
and Sublicensees on a product-by-product basis in the calculation of Adjusted
Gross Sales (e.g., outward freights, postage charges, transportation insurance,
packaging materials for dispatch of goods, custom duties, bad debt expense).


 


For purposes
of this definition of “Net Sales”, “Adjusted Gross Sales” shall mean the
amount of gross sales of Licensed Product invoiced by ROCHE, its Affiliates,
ROCHE Entities and its Sublicensees to Third Parties less deductions (which
deductions shall in all cases be as consistently applied by ROCHE to its
products) for:


 


(a)        Governmental
price reductions and changes to reserves for governmental price reductions,
such as rebates to managed care organizations or social and welfare systems,
charge backs or reserves for chargebacks, cash sales incentives (but only to
the extent it is a sales related deduction which is accounted for within ROCHE
on a product-by-product basis), government mandated rebates and similar types
of rebates (e.g., Pharmaceutical Price Regulation Scheme, Medicaid, clawback
schemes and any other similar such scheme);


 


(b)        Contract
pricing chargebacks and changes to reserves of contract pricing chargebacks,
such as periodic charges of wholesalers and chargebacks for price capping
programs;


 


(c)        Customer
rebates and changes to reserves of customer rebates, such as volume (quantity)
discounts or price discounts;


 


(d)        Returns
and return reserves, including allowances actually given for spoiled, damaged,
out-dated, rejected, returned Licensed Product sold, withdrawals and recalls;


 


(e)        Cash
discounts; and


 


(f)         Taxes,
such as value added or sales taxes, government mandated exceptional taxes and
other taxes directly linked to the gross sales amount (but excluding income or
capital gains taxes).


 


For the avoidance of doubt, the
“Adjusted Gross Sales” shall be determined on a Licensed Product-by-Licensed
Product basis using the same methodology as ROCHE consistently uses to
recognize sales in its financial reporting, which is in accordance with the
then-used International Financial Reporting Standards (IFRS), and is reviewed
and approved by ROCHE’s external auditors, it being understood that if the
amount of any of the reserves accounted for as a deduction in the definition of
“Adjusted Gross Sales” above exceeds the actual amount for which the reserve
was established, the amount of such excess shall be treated as Net Sales.


 


Portions of
this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended.


 


8

















 


Notwithstanding the foregoing,
amounts received by ROCHE, its Affiliates, ROCHE Entities and Sublicensees for
the sale of Licensed Product among ROCHE, its Affiliates, ROCHE Entities or
Sublicensees for resale shall not be included in the computation of Adjusted
Gross Sales or Net Sales.


 


If a Licensed Product is sold
as part of a Combination Product (as defined below), the Net Sales of the
Licensed Product, for the purposes of determining royalties based on Net Sales,
shall be determined country-by-country by multiplying the Net Sales of the
Combination Product (as determined using the standard Net Sales definition),
during the applicable reporting period, by the fraction, A/(A+B), where A is
the average sale price of the Licensed Product when sold separately in similar
quantities in finished form and B is the average sales price of the other
compounds having independent therapeutic activity included in the Combination
Product when sold separately in similar quantities in finished form, in each
case in the same country as the Combination Product during the applicable
reporting period or, if sales of both the Licensed Product and the other
compounds having independent therapeutic activity did not occur in such period,
then in the most recent reporting period in which sales of both occurred in the
same country as the Combination Product. 
If such average sale price cannot be determined for both the Licensed
Product and all other compounds having independent therapeutic activity
included in the Combination Product, Net Sales of the Licensed Product for the
purposes of determining royalty payments shall be calculated by multiplying the
Net Sales of the Combination Product by the fraction of C/(C+D) where C is the
fair market value of the Licensed Product and D is the fair market value of all
other compounds having independent therapeutic activity included in the
Combination Product.  In such event,
ROCHE shall in good faith make a determination of the respective fair market
values of the Licensed Product and all other compounds having independent
therapeutic activity included in the Combination Product, and shall notify
SYNTA of such determination and provide SYNTA with data to support such
determination.  SYNTA shall have the
right to review such determination and supporting data, and to notify ROCHE if
it disagrees with such determination.  If
SYNTA does not agree with such determination and if the Parties are unable to
agree in good faith as to such respective fair market values, then such matter
shall be resolved in accordance with Section 13.2.


 


As used in this Agreement, “Combination
Product” means any Licensed Product containing one or more additional
active pharmaceutical compounds having independent therapeutic activity other
than a Licensed Compound.


 


1.51.     “Party” or “Parties” means SYNTA
or ROCHE, as the context requires.


 


1.52.     “Patent Rights” means all rights
under any patent or patent application, in any country or jurisdiction in the
Territory, including any patents issuing on such patent application and any
substitution, extension or supplementary protection, certificate, reissue,
reexamination, renewal, division, continuation or continuation-in-part of any
of the foregoing.


 


1.53.     “Person” means any natural person,
corporation, general partnership, limited partnership, joint venture,
proprietorship or other business organization or a governmental agency or a
political subdivision thereto.


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Securities Exchange Act of 1934, as amended.


 


9

















 


1.54.     “Phase
1 Clinical Trial” means a human clinical trial in any country, the
principal purpose of which is a preliminary determination of safety in
individuals or patients, that would satisfy the requirements of 21 C.F.R.
§312.21(a), or an equivalent clinical study required by a Regulatory Authority
outside of the United States.


 


1.55.     “Phase
2 Clinical Trial” means a human clinical trial conducted in any
country, intended to explore multiple doses, dose response, and duration of
effect to generate initial evidence of safety and activity in a target patient
population, that would satisfy the requirements of 21 C.F.R. §312.21(b), or an
equivalent clinical study required by a Regulatory Authority outside of the
United States.


 


1.56.     “Phase
2a Clinical Trial” means, as to a particular Licensed Compound for
an Indication, a Phase 2 Clinical Trial, or the relevant portion thereof,
conducted in a sufficient number of patients to generate sufficient data, if
successful, to commence a Phase 2b Clinical Trial or a Phase 3 Clinical Trial
of such Licensed Compound for such Indication.


 


1.57.     “Phase
2b Clinical Trial” means, as to a particular Licensed Product for an
Indication, a Phase 2 Clinical Trial, or the relevant portion thereof,
conducted in a sufficient number of patients to generate sufficient data, if
successful, to either commence a Phase 3 Clinical Trial of such Licensed
Compound for such Indication or file an NDA for such Licensed Product for such
Indication.


 


1.58.     “Phase
3 Clinical Trial” means a human clinical trial in any country that
would satisfy the requirements of 21 C.F.R. §312.21(c), or an equivalent
clinical study required by a Regulatory Authority outside of the United States.


 


1.59.     “Region” means each of the
following:  (a) United States and
Canada, collectively, (b) the EU, Iceland, Liechtenstein, Norway and
Switzerland, collectively, (c) Japan, and (d) all countries in the
rest of the world, collectively.


 


1.60.     “Regulatory Approval” means any
approval (including, if applicable, pricing and reimbursement approvals),
licenses, registrations or authorizations by a Regulatory Authority that are
necessary for the marketing and sale of product in a country or group of
countries.


 


1.61.     “Regulatory Authority” means any
federal, national, multinational, state, provincial or local regulatory agency,
department, bureau or other governmental entity with authority over the
marketing, pricing or sale of a product in a country, including the FDA.


 


1.62.    “Research” means
all activities relating to the discovery, evaluation and early preclinical
testing of a compound or product, including identification of potential
candidates, synthesis and testing by in
vitro or in vivo
assays, leading up to (with respect to Collaboration Compounds) the nomination
and approval for advancement into Development of a Licensed Compound(s).  Research shall exclude Development; provided however
that Research and Development activities with respect to any compound or
product may proceed in parallel.


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under Rule 24b-2
of the Securities Exchange Act of 1934, as amended.


 


10














 


1.63.     “Research Program” means the conduct
of the Research activities described in the Research Plan.


 


1.64.     “Right of Reference or Use” means a “right
of reference or use” as that term is defined in 21 C.F.R. §314.3(b), or an
equivalent in a country in the Territory other than the United States.


 


1.65.     “ROCHE Intellectual Property” means
the ROCHE Know-how, the ROCHE Patent Rights, and ROCHE’s interest in the Joint
Know-how and Joint Patent Rights.


 


1.66.     “ROCHE Know-how” means, as of the
relevant time during the Term, any Know-how that (a) is Controlled by
ROCHE or its Affiliates, and (b) is, at that time, necessary or useful for
the Research, Development, Manufacture or Commercialization of any
Collaboration Compound, Licensed Compound or Licensed Product; provided,
however, that ROCHE Know-how excludes Joint Know-how.


 


1.67.     “ROCHE Patent Rights” means as of
the relevant time during the Term, all Patent Rights that are Controlled by
ROCHE or any of its Affiliates that, at such time, claim or disclose ROCHE
Know-how.  ROCHE Patent Rights exclude
Joint Patent Rights.


 


1.68.     “SYNTA Intellectual Property” means
the SYNTA Know-how, the SYNTA Patent Rights and SYNTA’s interest in Joint
Know-how and the Joint Patent Rights.


 


1.69.     “SYNTA Know-how” means as of the
relevant time during the Term, any Know-how that (a) is Controlled by
SYNTA, and (b) is, at that time, necessary or useful for the Research,
Development, Manufacture or Commercialization of any Collaboration Compound,
Licensed Compound or Licensed Product; provided, however, that
SYNTA Know-how excludes Joint Know-how.


 


1.70.     “SYNTA Patent Rights” means, as of
the relevant time during the Term, all Patent Rights Controlled by SYNTA that,
at such time, claim or disclose SYNTA Know-how. 
Certain SYNTA Patent Rights existing as of the Execution Date are set forth on Exhibit A; provided,
however, that SYNTA Patent Rights exclude Joint Patent Rights.


 


1.71.     “[***]” means [***].


 


1.72.     “[***]” means [***].


 


1.73.     “[***]” means [***].


 


1.74.      “Sublicensee” means a Third Party
to whom such Party has granted a sublicense pursuant to Sections 6.4, 12.6.6 or
12.10.7.


 


1.75.     “Territory” means all countries of
the world, but excluding, with respect to any Licensed Compound (and any
products containing such Licensed Compound as an active ingredient), each
Terminated Region.


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


11

















 


1.76.     “Third Party” means any Person other
than SYNTA or ROCHE or any of their respective Affiliates.


 


1.77.     “United States” or “US” means
the United States of America, its territories and possessions.


 


1.78.     “Valid Claim” means any claim in any
(a) unexpired and issued patent that has not been disclaimed, revoked or
held invalid by a final nonappealable decision of a court or other governmental
agency of competent jurisdiction, or (b) patent application that has not
lapsed, in the case of a provisional patent application, or been cancelled,
withdrawn or abandoned without the possibility of revival, nor has been pending
for more than [***] ([***]) years from the earliest priority date claimed for
such application.


 


1.79.     Additional Definitions.  Each of the following definition is set forth
in the section of this Agreement indicated below:


 


	
  Definition:

  	
   

  	
  Section:

  	
   

  
	
  AAA

  	
   

  	
  13.2.1

  	
   

  
	
  Accounting Period

  	
   

  	
  7.7.1

  	
   

  
	
  Actual Costs

  	
   

  	
  2.5.4

  	
   

  
	
  Adjusted Gross Sales

  	
   

  	
  1.51

  	
   

  
	
  Agent

  	
   

  	
  9.1

  	
   

  
	
  Agreement

  	
   

  	
  Preamble

  	
   

  
	
  Alliance Manager

  	
   

  	
  3.1.3

  	
   

  
	
  Bankruptcy Code

  	
   

  	
  6.7

  	
   

  
	
  Budget

  	
   

  	
  2.4.3

  	
   

  
	
  Chugai

  	
   

  	
  1.1

  	
   

  
	
  Combination Product

  	
   

  	
  1.50

  	
   

  
	
  Commercialization Decision

  	
   

  	
  5.3

  	
   

  
	
  Confidentiality Agreements

  	
   

  	
  1.9

  	
   

  
	
  Co-promotion Option

  	
   

  	
  5.3

  	
   

  
	
  Covered Excess Amount

  	
   

  	
  2.5.4

  	
   

  
	
  CPI

  	
   

  	
  1.29

  	
   

  
	
  Development Plan

  	
   

  	
  2.4.3

  	
   

  
	
  Execution Date

  	
   

  	
  Preamble

  	
   

  
	
  Genentech

  	
   

  	
  1.1

  	
   

  
	
  Indemnified Party

  	
   

  	
  11.3

  	
   

  
	
  Indemnifying Party

  	
   

  	
  11.3

  	
   

  
	
  Infringement Claim

  	
   

  	
  8.3.1

  	
   

  
	
  Joint Inventions

  	
   

  	
  8.1.1

  	
   

  
	
  JRDC

  	
   

  	
  3.1.1

  	
   

  
	
  JSC

  	
   

  	
  3.2.1

  	
   

  
	
  Notice

  	
   

  	
  9.3.2

  	
   

  
	
  Paragraph IV Certification

  	
   

  	
  8.6

  	
   

  
	
  Patent Challenge

  	
   

  	
  12.5

  	
   

  



 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


12

















 


	
  Definition:

  	
   

  	
  Section:

  	
   

  
	
  Publishing Party

  	
   

  	
  9.3.2

  	
   

  
	
  Research Plan

  	
   

  	
  2.3.3

  	
   

  
	
  Research Term

  	
   

  	
  2.3.1

  	
   

  
	
  Royalty Term

  	
   

  	
  7.6.3(a)

  	
   

  
	
  ROCHE

  	
   

  	
  Preamble

  	
   

  
	
  ROCHE BASEL

  	
   

  	
  Preamble

  	
   

  
	
  ROCHE Entity

  	
   

  	
  1.1

  	
   

  
	
  ROCHE NUTLEY

  	
   

  	
  Preamble

  	
   

  
	
  SYNTA

  	
   

  	
  Preamble

  	
   

  
	
  Term

  	
   

  	
  12.1

  	
   

  
	
  Terminated Commercial Product

  	
   

  	
  12.10.6

  	
   

  
	
  Terminated Region

  	
   

  	
  12.3

  	
   

  
	
  Uncovered Excess Amount

  	
   

  	
  2.5.4

  	
   

  



 


ARTICLE II
-COLLABORATION


 


2.1.                              Overview.  The primary objective of the collaboration
between the Parties will be to identify and select Collaboration Compounds
under the Research Program that are suitable for further Research and, subject
to Section 2.4, to advance the Development of such Collaboration Compounds
as Licensed Compounds and the Commercialization of related Licensed Products in
the Field, as further described below.


 


2.2.                              Commercially
Reasonable Efforts.  Each Party shall
use Commercially Reasonable Efforts to conduct the activities which are
assigned to such Party under the Research Plan or any Development Plan; provided,
however, that neither Party guarantees the success of the Research
Program or any individual Research, Development or Manufacturing activity
undertaken under the Research Plan or Development Plan.  Without limiting ROCHE’s obligations pursuant
to this Section 2.2, ROCHE shall use Commercially Reasonable Efforts to (a) Develop,
at any given time, at least one Licensed Compound, and (b) seek Regulatory
Approval for at least one Licensed Compound and then Commercialize each such
approved Licensed Product for each approved Indication in the Field in the
Territory.


 


2.3.                              Research
Program.


 


2.3.1.       Research Term. 
The initial term of the Research Program shall commence on January 1,
2009 and end on the second (2nd) anniversary thereof, unless (a) earlier
terminated hereunder, or (b) extended by mutual agreement of the Parties
for additional one (1) year term(s), in which case the Parties shall agree
upon appropriate FTE commitment levels, budget adjustments and other necessary
amendments to the Research Plan (such initial two (2) year term, together
with any extension, the “Research Term”).  The SYNTA FTE Rate for any such extension
shall be determined as set forth in Section 1.29.


 


2.3.2.       Collaboration Compounds.  The Research Program shall be conducted on
Collaboration Compounds; provided, however, that if, in the
course of the Research Program, it 


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


13

















 


is determined that any such
compound is not a CRAC Channel Inhibitor, such compound shall no longer be
considered a Collaboration Compound, and provided, further, that
any Collaboration Compound that is not a Licensed Compound as of the end of the
Research Term shall revert to the Controlling Party (including all rights
thereto and to any Confidential Information with respect to such Collaboration
Compound which had been disclosed by such Controlling Party) and shall no
longer be deemed a Collaboration Compound for purposes of this Agreement.  It is the intent of the Parties that the
initial Collaboration Compounds with respect to which Research will be
conducted under the Research Program will be the Collaboration Compounds
Controlled and identified by SYNTA hereunder. 
Compounds Controlled by ROCHE will be included as a Collaboration
Compound with respect to which Research will be conducted under the Research
Program and for other purposes of this Agreement only if mutually agreed by the
Parties.  The goal of the Research
Program is for one or more Licensed Compounds to be approved for advancement
into Development under Section 2.3.4.


 


2.3.3.       Research Plan.  The initial plan for the first two (2) Contract
Years of the Research Program is attached hereto as Exhibit B (as
may be amended from time to time upon mutual agreement of the Parties, the “Research
Plan”).  The Parties agree and
acknowledge that this Research Plan reflects, as of the Execution Date, SYNTA’s
good faith estimates of Research activities and the timing, internal costs, and
external costs associated with such activities, all of which could be subject
to change.  During the Research Term,
SYNTA and ROCHE shall prepare an updated Research Plan for the third and each
subsequent Contract Year, if applicable, at least [***] ([***]) days prior to
the start of each such Contract Year. 
The Research Plan shall be consistent with the terms and conditions of
this Agreement and shall be subject to review and approval by the JRDC and the JSC.  The Research Plan shall specify, among other
things, (a) key objectives, (b) Research and related Manufacturing
activities to be performed up to nomination of a Licensed Compound for
Development, (c) the number and types of FTEs to be assigned to specific
activities and the Party supplying such FTEs, (d) costs and expenses for
services to be provided by Third Parties, (e) to the extent known in
advance, the academic collaborations and subcontractor arrangements anticipated
for the applicable Contract Year, and (f) the budget for the applicable
Contract Year.  With respect to the first
(2) Contract Years, all FTEs specified in the Research Plan shall be
supplied by SYNTA.  For the sake of
clarity, neither the initial Research Plan attached hereto, nor any subsequent
Research Plan once agreed by the Parties, may be amended except by mutual
agreement of the Parties.


 


2.3.4.       Licensed Compound
Nomination.


 


(a)                   Either
Party may nominate to the JDRC, for approval by the JSC, a Licensed Compound
for advancement into Development leading up to a GLP Toxicology Study.  Upon request by a Party, the other Party
shall provide relevant available information and study results to support such
nomination.  If no Licensed Compound is
approved for advancement into Development during the Research Term or within
[***] ([***])[***] after expiration of the Research Term, SYNTA shall have the
option, not the obligation, to perform the Development activities described in Section 2.4.1.


 


Portions
of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended.


 


14

















 


(b)                   ROCHE
shall have no right to Develop or Commercialize any Licensed Compound (other
than any activities that may be assigned to ROCHE under the Research Plan)
unless and until such Licensed Compound has been nominated by the JRDC, and
approved by the JSC, for advancement into Development hereunder.


 


2.4.                              Development.  The Parties shall pursue the Development of
at least one Licensed Compound in accordance with a Development Plan and the
remainder of this Article II, including seeking to pursue the Initiation
of a GLP Toxicology Study.  For clarity,
for each Licensed Compound approved by the JSC for advancement into Development
under Section 2.3.4(a), a set of Development activities will be conducted
prior to the Initiation of a GLP Toxicology Study, as exemplified in Exhibit C.  As of the Execution Date, the Parties agree
that [***] is anticipated to be the First Licensed Compound.


 


2.4.1.       First Licensed Compound.  For the relevant First Licensed Compound,
SYNTA (itself or through an Affiliate or a Third Party) shall, in accordance
with the Development Plans: conduct pre-IND Development, Phase 1 Clinical
Trials, and other nonclinical Development activities that are typically
performed during each of the foregoing Development stages, and shall have the
right, at SYNTA’s option, to conduct a Phase 2a Clinical Trial for an
Indication other than rheumatoid arthritis, provided, that such
Indication is part of the Development Plan.


 


2.4.2.       Other Licensed Compounds.  Except as mutually agreed by the Parties or
as set forth in Section 2.4.1, and subject to oversight by the JRDC and
the JSC, ROCHE shall be solely responsible for the Development of Licensed
Compounds and Licensed Products in the Field and in the Territory in accordance
with the Development Plan and the terms and conditions of this Agreement; provided,
however, that for Licensed Compounds other than the First Licensed
Compound, the JRDC shall decide which Party shall conduct Development for such
Licensed Compound; provided, further, that the JRDC and JSC
cannot require SYNTA to undertake such responsibility unless SYNTA agrees to do
so.  Prior to the initiation of each
stage of activity to be so conducted by SYNTA with respect to any Licensed
Compound, the Parties shall discuss and undertake to finalize the anticipated
scope, design, content, criteria, protocols, budget and other terms associated
with the conduct of Development for such Licensed Compound and shall update the
Development Plan to reflect such agreement.


 


2.4.3.       Development Plans. 
For the First Licensed Compound, the initial Development Plans through
and including one Phase 2a Clinical Trial with respect thereto are attached
hereto as Exhibit C and Exhibit D (as may be amended
from time to time upon mutual agreement of the Parties, the “Development
Plans,” including the “Development Plan — Pre-IND” and “Development
Plan — Phase 1 and Phase 2a,” respectively).  The Parties agree and acknowledge that these
initial Development Plans reflect, as of the Execution Date, SYNTA’s good faith
estimates of Development activities and the timing, internal costs, and
external costs associated with such activities, all of which may be subject to
change.  With respect to the further
Development of the relevant First Licensed Compound or following the approval for
advancement into Development of any subsequent Licensed Compound, SYNTA and
ROCHE, under the guidance of the JRDC, shall prepare initial or updated
Development Plans directed to 


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


15

















 


Development activities in the Territory for
such Licensed Compound for the next twelve (12) month period.  An updated Development Plan for each
subsequent twelve (12) month period will be prepared by SYNTA and ROCHE at
least [***] ([***]) days prior to the beginning of each such subsequent twelve
(12) month period.  The Development Plan
shall be consistent with the terms and conditions of this Agreement, and shall
be subject to review and approval by the JRDC and the JSC.  The Development Plan shall specify, among
other things, (a) key objectives, (b) Development and related
Manufacturing activities to be performed with respect to a Licensed Compound,
including Initiation of Clinical Trials, (c) the Party responsible for
performance of an activity, (d) the number and types of FTEs to be
assigned to specific activities by SYNTA, (e) anticipated costs to be
incurred under the Development Plans (the “Budget”) for the applicable
twelve (12) month period, and (f) Development timelines.  For the sake of clarity, neither the initial
Development Plans attached hereto, nor any subsequent Development Plan once
agreed by the Parties, may be amended except by mutual agreement of the
Parties.


 


2.5.                              Development
Costs.


 


2.5.1.       General.  ROCHE shall pay its own Development expenses
in carrying out each Development Plan, and shall pay SYNTA for all Development
Costs incurred pursuant to each Development Plan and the applicable Budget as
set forth below.


 


2.5.2.       Audit Rights.  ROCHE shall have the right to audit SYNTA to
verify all of SYNTA’s Development Costs incurred pursuant to a Development Plan
and the Budget.


 


(a)                   SYNTA
shall keep, and shall require its Affiliates to keep, for [***] ([***]) years,
full, true and accurate books of account containing all particulars that may be
necessary for the purpose of calculating all Development Costs under this
Agreement. Such books of accounts shall be kept at SYNTA’s or the relevant
Affiliate’s principal place of business. At the expense of ROCHE, ROCHE has the
right to engage an independent, certified public accountant mutually acceptable
to both Parties to perform, on behalf of ROCHE, an audit of such books and
records of SYNTA and its Affiliates, that are deemed necessary by such
accountant to report on Development Costs for the period or periods requested
by ROCHE and the correctness of any report or payments made under this
Agreement.  Such accountant shall not
have the authority to interpret this Agreement.


 


(b)                   Upon
timely request and at least [***] ([***]) days prior written notice from ROCHE,
such audit shall be conducted, during regular business hours in such a manner
as to not unnecessarily interfere with SYNTA’s or its Affiliates’ normal
business activities, and shall be limited to results in the [***] ([***])
calendar years prior to audit notification.


 


(c)                   Such
audit shall not be performed more frequently than once per calendar year nor
more frequently than once with respect to records covering any specific period
of time.


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


16

















 


(d)                   All
information, data and documents herein referred to shall be used only for the
purpose of verifying Development Costs, shall be treated as SYNTA Confidential
Information subject to the obligations of this Agreement and need neither be
retained more than the longer of one (1) year after completion of an audit
hereof, if an audit has been requested; nor more than [***] ([***]) years from
the end of the calendar year to which each shall pertain; nor more than [***]
([***]) [***] after the date of termination of this Agreement.


 


(e)                   The
final audit report shall be shared by ROCHE and SYNTA.


 


(f)                    If
the audit reveals an underpayment, ROCHE shall reimburse SYNTA for the amount
of the underpayment within [***] ([***]) days with interest as set forth in Section 7.7.2.  If the audit reveals an overpayment, ROCHE
shall have the right to credit the amount of such overpayment against the next
payment payable to SYNTA hereunder. 
SYNTA shall pay for the audit costs if the audit reveals that an
overpayment of ROCHE exceeds [***] percent ([***]%).


 


(g)                   The
failure of ROCHE to request verification of any Actual Costs within the period
during which the corresponding records must be maintained under Section 2.5.2(d) will
be deemed acceptance of the Actual Cost payments and reports with respect
thereto.


 


2.5.3.       Budget.  It is agreed between the Parties that for the
calendar year 2009, the Budget for payment to SYNTA of its Development Costs
under the Development Plan as of the Execution Date is [***] dollars ($[***]).  On or before October 1, 2009 and not later
than October 1 of each subsequent calendar year during the Term, the JSC
shall approve annual Budgets for Development Costs scheduled for the following
year; such annual Budgets to be consistent with the Development Plan(s).  Upon approval, the annual Budget shall be the
Budget then in effect.


 


2.5.4.       Payments to SYNTA; Reconciliation.  ROCHE shall pay to SYNTA the amount set forth
as SYNTA’s Development Costs under the Budget for each Calendar Quarter on or
before the later of (a) the first day of such Calendar Quarter or (b) [***]
([***]) days after receipt of an invoice from SYNTA with respect to such
Development Costs.  Within [***] ([***])
days following the end of each such Calendar Quarter, SYNTA shall provide an
accounting to ROCHE of the actually incurred Development Costs during such
Calendar Quarter (the “Actual Costs”). 
Following the reporting by SYNTA of Actual Costs for each Calendar
Quarter, the Parties shall reconcile any difference between the amounts paid by
ROCHE to SYNTA for Development Costs and SYNTA’s Actual Costs for such Calendar
Quarter.  If the amounts paid by ROCHE to
SYNTA for Development Costs exceed SYNTA’s Actual Costs during such Calendar
Quarter, then the amount of such excess shall be credited to ROCHE against the
next payment payable to SYNTA hereunder. 
If SYNTA’s Actual Costs during the Calendar Quarter exceeds by less than
[***] percent ([***]%) the amount paid by ROCHE for Development Costs during
such Calendar Quarter (the amount of such excess, the “Covered Excess Amount”),
then ROCHE shall pay the Covered Excess Amount to SYNTA as a supplemental
payment.  If SYNTA’s Actual Costs during
the Calendar Quarter exceeds by [***] 


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


17

















 


percent ([***]%) or more the
amount paid by ROCHE for Development Costs during such Calendar Quarter, then (y) ROCHE
shall pay the Covered Excess Amount to SYNTA as a supplemental payment and (z) with
respect to the amount of such excess over and above the Covered Excess Amount
(the “Uncovered Excess Amount”), ROCHE shall pay the Uncovered Excess
Amount but only if the JSC approves such Uncovered Excess Amount.  ROCHE shall pay SYNTA any Covered Excess
Amount and, to the extent payable by ROCHE hereunder, any Uncovered Excess
Amount within [***] ([***]) days after receipt of an invoice from SYNTA
therefor, subject to the cap of $[***] for calendar year 2009.  For purposes of clarity, ROCHE’s obligation
under this Section 2.5.4 to pay SYNTA for Development Costs shall be
separate from, and in addition to, ROCHE’s obligation under Section 7.2 to
pay SYNTA for internal and external Research costs incurred by SYNTA under the
Research Plan.


 


2.6.                              Manufacturing.  Each Party shall be responsible for the
Manufacture and supply of all preclinical and clinical quantities of
Collaboration Compounds Controlled by such Party in accordance with the
Research Plan and Development Plan until such time as the Parties decide to
transfer Manufacturing responsibility to ROCHE pursuant to Section 2.7.


 


2.7.                              Transfer
of Responsibility to ROCHE.


 


2.7.1.       Development; Regulatory.  Subject to Section 2.4,  SYNTA shall transfer to ROCHE all Development
responsibility with respect to a Licensed Compound, on a Licensed
Compound-by-Licensed Compound basis, once the relevant Collaboration Compound
is designated a Licensed Compound or, if SYNTA is undertaking any Development
activities with respect to such Licensed Compound in accordance with Section 2.4,
once SYNTA’s activities with respect to a GLP Toxicology Study or Phase 1
Clinical Trials for such Licensed Compound are complete, in accordance with a
transition plan to be established by the Parties, including the transfer to
ROCHE of any IND or other regulatory filings with respect to such Licensed
Compound that are held by SYNTA in SYNTA’s name.  Notwithstanding the foregoing, for the First
Licensed Compound, such transition shall occur promptly following completion of
the first Phase 2a Clinical Trial, if such Clinical Trial is conducted by
SYNTA, or promptly following completion of Phase 1 Clinical Trials, if SYNTA
does not conduct the first Phase 2a Clinical Trial.  Each Party shall continue to use Commercially
Reasonable Efforts to perform critical Development activities which may be
assigned to such Party under the relevant Development Plan, in a manner
consistent with the transition plan, until the completion of such transfer of
Development responsibility to ROCHE.


 


2.7.2.       Manufacturing.  Unless otherwise agreed by the Parties,
concurrently with the transfer of all Development responsibility to ROCHE with
respect to a Licensed Compound pursuant to Section 2.7.1 above, (a) SYNTA
shall transfer to ROCHE, and ROCHE shall assume sole responsibility for, the
Manufacture of non-clinical, clinical and commercial quantities of such
Licensed Compound necessary for the Development and Commercialization of
Licensed Products in the Field in the Territory, at ROCHE’s sole cost and
expense, and (b) SYNTA shall provide to ROCHE reasonable technical
assistance, manufacturing and analytical Know-how, and material specifications
Controlled by SYNTA that are necessary for ROCHE, its Affiliate or a Third
Party manufacturer identified by ROCHE to Manufacture such Licensed Compound.


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


18

















 


2.7.3.       Technology Transfer.  If ROCHE requests that SYNTA provide ROCHE
with technical assistance in transferring technology required for the
manufacture of a Licensed Compound at a manufacturing facility, then SYNTA
shall provide for each such Licensed Compound one (1) visit of up to [***]
([***]) [***] in duration of one full time SYNTA employee’s time to provide such
services.  If ROCHE desires additional
technical assistance, then SYNTA, at its option, shall provide such assistance
and ROCHE shall compensate SYNTA on a time and materials basis at the FTE Rate
per eight (8) hour day.  Subject to
the foregoing, SYNTA shall assist
ROCHE, as
reasonably requested by ROCHE, in (a) causing the assignment to ROCHE of
any and all applicable Third Party manufacturing and supply agreements for such
Licensed Product, to the extent assignable and related to such Licensed Products,
or (b) transferring the manufacturing process for such Licensed Product to
ROCHE or to a Third Party contract manufacturer engaged by ROCHE.  Such assistance shall include assisting ROCHE
by providing reasonable technical and regulatory assistance and documentation
relating to the manufacture, testing and supply of such Licensed Product as
necessary for ROCHE to be qualified or to qualify a Third Party for the
manufacturing of such Licensed Product.  Promptly
after the transfer of all Development responsibility to
ROCHE with respect to a Licensed Compound pursuant to Section 2.7.1 above, SYNTA shall
deliver to ROCHE:  (i) [***]
([***]) [***] of all intermediates pure enough to calibrate analytical instruments, (ii) analytical
methods, (iii) batch records of the whole chemical synthesis, to the
extent they exist, (iv) safety investigation (RC1, DSC, ARC) reports (if
any) for relevant chemical steps, and (v) a list of key suppliers
including agreements (if any) and all respective lead times.


 


2.8.                              Exchange
of Information.  For so long as a
Party is conducting Research activities with respect to any Collaboration
Compound or Development activities with respect to any Licensed Compound
hereunder, each Party shall regularly provide the other Party, through the JRDC
(if the JRDC remains in place), with all material information, data and results
relating to such Research and Development activities.


 


2.9.                              Recordkeeping.  All Research and Development work conducted
by either Party under the Research Plan or Development Plan shall be completely
and accurately recorded in separate laboratory notebooks, in sufficient detail
and in good scientific manner appropriate for patent and regulatory
purposes.  Upon reasonable advance
notice, and at reasonable intervals, each Party shall have the right to inspect
and copy such records of the other Party reflecting on work done under the
Research Plan or Development Plan, to the extent reasonably required to carry
out its respective obligations and to exercise its respective rights hereunder.


 


2.10.                        Academic
Collaborations; Subcontractors. 
Subject to the oversight of the JRDC and, with respect to clause (a) below,
the approval of the JSC, either Party may enter into one or more agreements,
solely in furtherance of conducting activities assigned to such Party under the
Research Plan or Development Plan, with (a) academic, research or other
non-commercial institutions; or (b) subcontractors (e.g., a Third Party
providing pharmacology or other services); in each case under clause (a) or
(b), provided that (i) such Party shall use
Commercially Reasonable Efforts to obtain ownership of any inventions relevant
to the Research and Development activities contemplated under the Research Plan
or Development Plan, or an exclusive license, or option to secure an exclusive
license, with the right to grant sublicenses to 


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


19

















 


the other Party, (ii) none
of the rights of the other Party hereunder are diminished or otherwise
adversely affected as a result of such subcontracting, and (iii) such
Third Party shall be bound to protect both Parties’ Confidential Information at
least as stringently as the confidentiality provisions set forth in Article IX
(subject to reasonable variations to Section 9.3.2 as may be required by
academic, research or other non-commercial institutions).


 


2.11.                        Biological
Samples.  Subject to applicable Law
and any restrictions or conditions imposed by informed consents, institutional
review boards, ethical committees or other obligations to Third Parties, (a) as
between the Parties, all biological samples (i.e., blood and tissue samples)
generated in connection with the clinical Development activities set forth in
this Agreement shall be owned by ROCHE, and (b) if the Parties reasonably
agree that such samples will no longer be used, either at such time or in the
foreseeable future thereafter, for the Development of Licensed Compounds
hereunder, ROCHE shall have the right to use such samples for any purpose
whatsoever and shall indemnify SYNTA and all its related Indemnified Parties
with respect to any Third Party claims arising out of such use.


 


ARTICLE III
-GOVERNANCE; DECISION-MAKING


 


3.1.                              Joint
Research and Development Committee.


 


3.1.1.       Formation and Membership.  Within twenty (20) Business Days after the
Effective Date, ROCHE and SYNTA shall establish a joint research and
development committee (the “JRDC”) comprised of an approximately equal
number of representatives of ROCHE and SYNTA, which number is recommended to be
between three (3) and five (5) representatives of each Party, and
each of whom shall have experience and seniority sufficient to enable him or
her to make day-to-day operational decisions on behalf of the Party he
represents.  Each Party may change any
one or more of its representatives to the JRDC at any time upon written notice
to the other Party.  SYNTA’s
participation on the JRDC after the expiration of the Research Term shall be at
SYNTA’s election.  From time to time, the
JRDC may, in its discretion, establish one or more project teams, or identify
project leaders from each Party, to, upon mutual agreement of the Parties,
implement and coordinate various aspects of the Research Plan and the
Development Plans or other elements of the collaboration hereunder, such as
Manufacturing technology transfer or coordination of patent prosecution matters
as set forth in Section 8.2.


 


3.1.2.       Administrative Matters.  The JRDC shall appoint a chairperson from
among its members, who shall rotate annually during the Research Term between
the representatives from SYNTA and the representatives from ROCHE, with the
first chairperson to be a representative of SYNTA.  After the Research Term, the chairperson of
the JRDC shall be from ROCHE.  The
chairperson shall be responsible for calling meetings of the JRDC and for
leading the meetings.  A JRDC member of
the chairing Party shall serve as secretary of such meetings.  The secretary shall promptly prepare and distribute
to all members of the JRDC draft minutes of the meeting for review and comment,
including a list of any actions or decisions approved by the JRDC, with the
goal of distributing final approved minutes of each JRDC meeting within thirty
(30) days after the meeting.


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


20














 


3.1.3.                     Alliance
Managers.  Each Party shall appoint
one of its designees to serve as an alliance manager (“Alliance Manager”)
with responsibility for overseeing that the Parties’ activities are conducted
in accordance with this Agreement and the Research Plan and any Development
Plan, and for being the primary point of contact between the Parties with
respect to such activities.  The Alliance
Manager is responsible to drive the alliance progress and issue resolution between
the Parties.  The Alliance Managers will
also be members of the JSC, attend JSC meetings and be responsible for
communicating with and reporting to the JSC on all relevant matters.


 


3.1.4.                     Decision
Making.  Each Party shall have one (1) vote
on the JRDC.  Both Parties must vote in
the affirmative to allow the JRDC to take any action that requires the vote of
the JRDC.  Action on any matter may be
taken at a meeting, by teleconference or videoconference or by written
agreement.  If the JRDC is unable to
reach unanimous agreement on any matter within its jurisdiction, then the
matter shall be referred to the JSC for resolution under Section 3.2.4.


 


3.1.5.                     Meetings.


 


(a)                                                          The
JRDC shall meet at least once during each Calendar Quarter during the Research
Term and thereafter at least once per calendar half year for so long as the
JRDC is in force.  The location of JRDC
meetings shall be as agreed by the Parties, and may be held in person,
alternating locations between the Parties, or by telephone conference call or
by videoconference.


 


(b)                                                         Each
Party shall use reasonable efforts to cause its representatives to attend the
meetings of the JRDC.  If a Party’s
representative is unable to attend a meeting, such Party may designate an
alternate representative to attend such meeting in place of the absent
representative.  In addition, each Party
may, at its discretion, invite a reasonable number of additional employees,
and, with the consent of the other Party, consultants or scientific advisors,
to attend the meetings of the JRDC or the relevant portion thereof, provided that
any such consultants or scientific advisors are bound by written obligations of
confidentiality that are at least as stringent as those set forth in this
Agreement.


 


(c)                                                          Either
Party may also request that a special meeting of the JRDC be convened for the
purpose of resolving disputes in connection with, or for the purpose of
reviewing or making a decision pertaining to, the implementation of the
Research Plan or Development Plan by providing written notice to the other
Party.  Such meeting shall be convened at
such time as may be mutually agreed upon by the Parties, but in any event shall
be held within fifteen (15) days after the date of such notice.


 


3.1.6.                     Responsibilities.  Without limiting any of the foregoing, the
JRDC shall be responsible for:


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


21

















 


(a)                                                          managing
the development and execution of the Research Plan and any Development Plans,
including developing, and recommending to the JSC for JSC approval, any
associated Research Plan budgets and Budgets of Development Costs;


 


(b)                                                         developing,
and recommending to the JSC for JSC approval, amendments to the Research Plan
and any Development Plan, including amendments to any associated Research Plan
budgets and Budgets of Development Costs;


 


(c)                                                          actively
participating in the initial assessment of all Collaboration Compound(s) and
providing strategic direction with respect to non-clinical and clinical
activities for Licensed Compounds;


 


(d)                                                         overseeing
the Research and Development of all Collaboration Compounds, including the
preparation of Collaboration Compounds for advancement into Development;


 


(e)                                                          overseeing
and advising on the technical development and clinical Manufacture of
Collaboration Compounds;


 


(f)                                                            overseeing
the preclinical and clinical Manufacture of Collaboration Compounds;


 


(g)                                                         overseeing
the progress of the Research Program and monitoring the Parties’ compliance
with their respective obligations under the Research Plan or any Development
Plan, including the accomplishment of key objectives;


 


(h)                                                         determining
whether a Licensed Compound nominated pursuant to Section 2.3.4(a) is
appropriate to be so nominated for advancement into Development leading up to a
GLP Toxicology Study and, if so, recommending such nomination to the JSC for JSC
approval;


 


(i)                                                             monitoring
any reports submitted by the Parties pursuant to the Research Plan or any
Development Plan;


 


(j)                                                             overseeing
the transfer of Development and Manufacturing responsibility from SYNTA to
ROCHE under Section 2.7; and


 


(k)                                                          performing
such other tasks and undertaking such other responsibilities as may be set
forth in this Agreement.


 


3.2.                              Joint
Steering Committee.


 


3.2.1.                     Formation
and Membership.  Within twenty (20)
Business Days after the Effective Date, ROCHE and SYNTA shall establish a joint
steering committee (the “JSC”) to review, coordinate and provide overall
strategic direction to their activities pursuant to the Research Plan and any
Development Plan and, if SYNTA exercises the Co-promotion Option, 


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


22





















 


the promotion of the
Co-promoted Product(s).  The JSC shall be
comprised of approximately three (3) senior executives of ROCHE and three (3) senior
executives of SYNTA with appropriate levels of decision making authority.  In addition, the Alliance Manager will be a
member of the JSC.  Each Party may change
any one or more of its representatives to the JSC at any time upon written
notice to the other Party.  SYNTA’s
participation on the JSC after the end of the Research Term shall be at SYNTA’s
election.  From time to time, the JSC
may, in its discretion, establish one or more subcommittees or project teams to
oversee particular projects or activities, as the JSC deems necessary or
advisable.  No Executive Officer shall
serve on the JSC.


 


3.2.2.                     Responsibilities.  The JSC shall be responsible for:


 


(a)                                                          reviewing
the initial Research Plan and the initial Development Plan, including any
associated budgets for the Research Plan and Budgets for the Development Plan;


 


(b)                                                         periodically
reviewing the Research Plan and any Development Plan and suggesting or
approving such amendments to the Research Plan or Development Plan as the JSC
deems appropriate, including budget amendments;


 


(c)                                                          approving
the criteria for advancement of Licensed Compounds into each stage of
Development;


 


(d)                                                         providing
overall strategic direction with respect to Research or Development activities
conducted under the Research Plan or Development Plan;


 


(e)                                                          overseeing
the JRDC and the Parties’ progress in the conduct of the Research Program and
in Research and Development activities hereunder;


 


(f)                                                            approving
the nomination of Licensed Compounds which have been recommended by the JRDC
for advancement into Development;


 


(g)                                                         receiving
updates (in accordance with Section 5.2) on ROCHE’s progress in the
Commercialization of Licensed Products;


 


(h)                                                         reviewing
and approving the initial Detailing plan (which shall be in accordance with Schedule
5.3), if SYNTA exercises the Co-promotion Option;


 


(i)                                                             periodically
reviewing the Detailing plans and approving such amendments to the Detailing
plans (which shall be in accordance with Schedule 5.3) as the JSC deems
appropriate, if SYNTA exercises the Co-promotion Option;


 


(j)                                                             serving
as a forum for communication between the Parties regarding other aspects of
Development or Commercialization matters relating to the Co-promoted
Product(s);


 


(k)                                                          attempting
to resolve disputes arising under this Agreement that are referred to the JSC
by the JRDC or either of the Parties;


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


23

















 


(l)                                                             reviewing
Uncovered Excess Amounts and determining whether such Uncovered Excess Amounts
will be approved; and


 


(m)                                                       performing
such other tasks and undertaking such other responsibilities as may be set
forth in this Agreement.


 


3.2.3.                     Administrative
Matters.  The JSC shall appoint a
chairperson from among its members, who shall be from ROCHE.  The Alliance Manager from ROCHE will work
with the Chair, and may act as the Chair, and work together with SYNTA’s
Alliance Manager to develop JSC meeting agendas.  The chairperson shall be responsible for
calling meetings of the JSC and for leading the meetings.  A JSC member of the chairing Party shall
serve as secretary of such meetings.  The
secretary shall promptly prepare and distribute to all members of the JSC draft
minutes of the meeting for review and comment, including a list of any actions
or decisions approved by the JSC, with the goal of distributing final approved
minutes of each JSC meeting within thirty (30) days after the meeting.


 


3.2.4.                     Decision Making.  Each Party shall have one (1) vote on
the JSC.  Both Parties must vote in the
affirmative to allow the JSC to take any action that requires the vote of the
JSC.  Action on any matter may be taken
at a meeting, by teleconference, videoconference or by written agreement.  Either Party may convene a special meeting of
the JSC in accordance with Section 3.2.5(c) for the purpose of
resolving any disagreement at the JRDC level or other disputes within its
jurisdiction.  If the JSC is unable to
resolve any dispute, or unanimously agree on any other matter before it, such
dispute or other matter shall be referred to the Executive Officers pursuant to
Section 13.1.  If the Executive
Officers are unable to resolve the matter under Section 13.1, then [***], provided that
such activities are conducted in compliance with the terms and conditions of
this Agreement and with the Research Plan and Development Plans, as applicable;
provided,  further, that [***]; and provided, further,
that, certain decisions must be decided unanimously (or, if not able to
be decided unanimously, pursuant to Section 13.2 (Alternative Dispute
Resolution)), in that [***]:


 


(a)                                                          Increase
[***] obligations or reduce [***] rights under this Agreement, including any
obligation to devote additional personnel or financial resources to a specific
activity or project,


 


(b)                                                         make
any amendments to any Research Plan or Development Plan which includes
activities by [***],


 


(c)                                                          determine
that the events required for the payment of development event payments have not
occurred,


 


(d)                                                         determine
that it has fulfilled any obligations under this Agreement or that [***] has
breached any obligation under this Agreement,


 


(e)                                                          unilaterally
make a decision that is expressly stated to require the mutual agreement of the
Parties, or


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


24

















 


(f)                                                            otherwise
expand [***] rights or reduce [***] obligations under this Agreement.


 


3.2.5.                     Meetings.


 


(a)                                                          The
JSC shall meet at least twice annually. 
The location of JSC meetings shall be as agreed by the Parties, and may
be held in person, alternating locations between the Parties, or by telephone
conference call or by videoconference.


 


(b)                                                         Each
Party shall use reasonable efforts to cause its representatives to attend the
meetings of the JSC.  In addition, each
Party may, at its discretion, invite a reasonable number of non-voting
employees, and, with the consent of the other Party, consultants or scientific
advisors, to attend meetings of the JSC or the relevant portion thereof; provided that
any such consultants or scientific advisors are bound by written obligations of
confidentiality that are at least as stringent as those set forth in this
Agreement.


 


(c)                                                          Either
Party may also request that a special meeting of the JSC be convened for the
purpose of resolving disputes in connection with, or for the purpose of
reviewing or making a decision pertaining to, any matter within the purview of
the JSC by providing written notice to the other Party.  Such meeting shall be convened at such time
as may be mutually agreed upon by the Parties, but in any event shall be held
within fifteen (15) days after the date of such notice.


 


(d)                                                         At
its initial meeting, the JSC shall, among other things, (i) review the
initial Research Plan and the initial Development Plan, including any
associated budgets for the Research Plan and Budgets for the Development Plan,
and (ii) discuss the criteria for advancement of Licensed Compounds into
the GLP Toxicology Study stage of Development.


 


ARTICLE IV
-REGULATORY MATTERS


 


4.1.                              Regulatory
Filings.


 


4.1.1.                     For any given
Licensed Compound, subject to Section 2.4.3, until such time as
Development responsibility is transferred to ROCHE pursuant to Section 2.7.1,
(i) SYNTA shall be responsible for preparing, filing and maintaining (a) the
IND in its own name with respect to such Licensed Compound and (b) any
other regulatory filings in its own name that are required in connection with
the clinical Development of such Licensed Compound; (ii) ROCHE shall
provide SYNTA with all reasonable assistance with respect to such filings and
the conduct of preclinical or clinical Development activities leading up to
such filings in accordance with the relevant Development Plan; (iii) SYNTA
shall own and maintain all such regulatory filings for such Licensed Compounds;
and (iv) ROCHE shall have a Right of Reference or Use to such regulatory
filings to the extent necessary for the conduct of ROCHE’s Development
activities under this Agreement.


 


4.1.2.                     Except as
provided in Section 4.1.1, ROCHE shall own, and be responsible for
preparing, filing, obtaining or maintaining, all regulatory filings and
Regulatory 


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


25





















 


Approvals relating to Licensed
Compounds and Licensed Products in the Field in the Territory.  SYNTA shall have a Right of Reference or Use
to such regulatory filings to the extent necessary for the conduct of SYNTA’s
Development activities under this Agreement.


 


4.2.                              Communications with Regulatory Authorities.


 


4.2.1.                     ROCHE shall
keep SYNTA  informed on an ongoing basis
through the JRDC or JSC regarding its (or its Affiliate’s or Sublicensee’s)
regulatory strategy, planned regulatory submissions and material communications
with Regulatory Authorities in Major Markets with respect to all Licensed
Compounds and Licensed Products.  If, and
to the extent SYNTA is responsible for the filing of the IND and other
regulatory filings with respect to a Licensed Compound pursuant to Section 4.1.1,
then the obligations of ROCHE set forth in Sections 4.2.1 above shall apply to
SYNTA, mutatis mutandis until such time as Development
responsibility is transferred to ROCHE pursuant to Section 2.7.1, except
that such obligations shall apply with regard to all countries of the Territory
as opposed to just the Major Markets.


 


4.2.2.                     In addition,
ROCHE shall provide SYNTA with reasonable advance notice of any material
meeting or substantive telephone conference with the FDA, MHLW or EMEA relating
to any Licensed Compound or Licensed Product. 
SYNTA shall have the right to attend and observe (but not participate
actively in) any such material meeting or material conference call with the FDA
regarding any Licensed Compound or Licensed Product under Development by ROCHE
(or by its Affiliates or Sublicensees). 
In addition, ROCHE shall promptly provide SYNTA with a copy of all
material correspondence that ROCHE (or its Affiliate or Sublicensee) receives
from, or submits to, any Regulatory Authority in the Major Markets (including
contact reports concerning conversations or substantive meetings, contact
reports of all Regulatory Authority interactions concerning conversations or
substantive meetings, all IND annual reports (including any equivalent filings
outside the US), and cover letters of all agency submissions, it being
understood that SYNTA may request, and shall then receive, copies of all
attachments to any such cover letters) relating to any Licensed Compound or
Licensed Product.  ROCHE shall also
provide SYNTA with any meeting minutes that reflect material communications
with any Regulatory Authority in the Major Markets regarding a Licensed
Compound or Licensed Product.


 


4.2.3.                     Notwithstanding
the foregoing, if, and to the extent SYNTA is responsible for the filing of the
IND and other regulatory filings with respect to a Licensed Compound pursuant
to Section 4.1.1, the rights and obligations of ROCHE set forth in
Sections 4.2.2 above shall apply to SYNTA, mutatis
mutandis until such time as
Development responsibility is transferred to ROCHE pursuant to Section 2.7.1.


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


26

















 


4.3.                              Pharmacovigilance.  The Parties agree that they will execute a
separate pharmacovigilance agreement, if legally required, specifying the
procedures and timeframes for compliance with the applicable Laws pertaining to
safety reporting of any Licensed Compound or Licensed Product and its related
activities.  Should the Parties determine
that it is appropriate to execute such a pharmacovigilance agreement, they
shall do so within a reasonable period of time following the Effective Date,
but no later than initiation of clinical activities by ROCHE.


 


ARTICLE V -
COMMERCIALIZATION; CO-PROMOTION


 


5.1.                              General.  Subject to SYNTA’s Co-promotion Option and
the other terms and conditions of this Agreement, ROCHE will have sole
responsibility for the Commercialization of Licensed Products in the Field in
the Territory, including all costs and expenses relating thereto.


 


5.2.                              Commercialization
Summary.  With respect to each
Licensed Product Developed pursuant to this Agreement, commencing with the
calendar year in which an application for Regulatory Approval is first filed
with respect to each such Licensed Product, and for each subsequent calendar
year during next [***] ([***]) years, ROCHE shall provide SYNTA, through the
JSC (if the JSC remains in place), for its review and comment, a written
summary of the Commercialization activities conducted in the Major Markets
other than Japan during the prior year and planned to be conducted in such
upcoming year by or on behalf of ROCHE and its Affiliates and Sublicensees with
respect to such Licensed Product in such countries.  ROCHE shall consider in good faith the
reasonable suggestions and comments of SYNTA with respect to such summary.


 


5.3.                              Co-promotion.  Upon ROCHE’s decision to file an application
for Regulatory Approval in the United States of a Licensed Product for any
Indication other than rheumatoid arthritis (which decision is expected to occur
at least [***] ([***]) [***] prior to filing any such application) (such
decision, the “Commercialization Decision”), ROCHE shall notify SYNTA in
writing within twenty (20) Business Days thereof.  For clarity, such obligation of ROCHE to
notify SYNTA of any Commercialization Decision shall apply to all Licensed
Products with respect to which the Commercialization Decision is made.  On a Licensed Product-by-Licensed Product
basis, SYNTA shall have the right to participate in the Co-promotion of any
Licensed Product in the United States for the applicable Indication (the “Co-promotion
Option”).  SYNTA may exercise its
Co-promotion Option by providing written notice to ROCHE within [***] ([***])
[***] after receipt of ROCHE’s Commercialization Decision notice, in which
event the minimum terms set forth on Schedule 5.3 shall apply.  If SYNTA does not exercise its Co-promotion
Option within such [***] ([***]) [***] period, then SYNTA shall have no further
right to elect to participate in the Co-promotion of such Licensed Product in
the United States for the applicable Indication; provided, however,
that the Co-promotion Option shall continue to apply to any and all subsequent
Licensed Products, and the failure of SYNTA to exercise its Co-promotion Option
with respect to any Licensed Product for any Indication shall not prevent or
waive SYNTA’s right to exercise its Co-promotion Option with respect to such
Licensed Product for any other Indication or with respect to any other Licensed
Product.


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


27





















 


5.4.                              Labeling.  In the event of SYNTA’s Co-promotion of any
Licensed Product in accordance with Section 5.3, ROCHE shall include on
all secondary packaging, literature, labels and other printed matter for
Licensed Products used in clinical Development or in Commercialization, to the
extent permitted by applicable Law, the SYNTA name and logo so as to
acknowledge that the Licensed Products were developed under license from and
together with SYNTA.


 


ARTICLE VI —
LICENSE GRANTS; EXCLUSIVITY


 


6.1.                              Research
Licenses.


 


6.1.1.                     SYNTA hereby
grants to ROCHE a co-exclusive (with SYNTA to enable SYNTA to perform its
obligations under the Research Program during the Research Term), worldwide,
paid-up right and license, without the right to grant sublicenses (except in
accordance with Section 6.4), under the SYNTA Intellectual Property solely
to enable ROCHE to perform ROCHE’s obligations under the Research Program
during the Research Term.


 


6.1.2.                     ROCHE hereby
grants to SYNTA a co-exclusive (with ROCHE to enable ROCHE to perform its
obligations under the Research Program during the Research Term), worldwide,
paid-up right and license, without the right to grant sublicenses, other than
to its Affiliates (except in accordance with Section 6.4), under the ROCHE
Intellectual Property solely to enable SYNTA to perform its obligations under
the Research Program during the Research Term.


 


6.2.                              Development
and Commercialization License to ROCHE. 
SYNTA hereby grants to ROCHE an exclusive (even as to SYNTA), worldwide,
royalty-bearing right and license, with the right to grant sublicenses (solely
in accordance with Section 6.4), under the SYNTA Intellectual Property  to Develop, Manufacture, have Manufactured, use,
Commercialize and import Licensed Compounds and Licensed Products in the Field
in the Territory, provided that SYNTA shall retain rights
sufficient to enable SYNTA to perform its Development and Manufacturing
obligations with respect to Licensed Compounds and Licensed Products hereunder,
and to participate in the Co-promotion of Co-promoted Products pursuant to Section 5.3.


 


6.3.                              Development
and Commercialization License to SYNTA. 
ROCHE hereby grants to SYNTA a co-exclusive (with ROCHE), worldwide,
royalty-free right and license, without the right to grant sublicenses (except
in accordance with Section 6.4), under the ROCHE Intellectual Property  to Develop, Manufacture, have Manufactured, use,
Commercialize and import Licensed Compounds and Licensed Products in the Field
in the Territory, solely to the extent necessary to enable SYNTA to perform its
Development and Manufacturing obligations with respect to Licensed Compounds
and Licensed Products hereunder, and to participate in the Co-promotion of
Co-promoted Products pursuant to Section 5.3.


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


28

















 


6.4.                              Sublicensing Rights.


 


6.4.1.                     ROCHE shall have the right to grant sublicenses under the rights granted
to it under Section 6.2 to its Affiliates (with the right to sublicense)
and to Third Parties (with no further right to sublicense); provided,
that in the Major Markets ROCHE shall have the right to grant sublicenses under
the rights granted to it under Section 6.2 to Third Parties only upon
prior written consent of SYNTA, such consent not the unreasonably
withheld.  ROCHE shall provide to SYNTA a
fully-executed copy of any agreement (redacted as necessary to protect
confidential or commercially sensitive information) reflecting such sublicense (a) promptly
after the execution thereof if such sublicense impacts upon one or more of the
Major Markets, and (b) upon request by SYNTA if such sublicense impacts
upon any country other than a Major Market. 
If ROCHE grants a sublicense, all of the terms and conditions of this
Agreement shall apply to the sublicensee to the same extent as they apply to
ROCHE for all purposes of this Agreement. 
ROCHE assumes full responsibility for the performance of all obligations
so imposed on such sublicensee and will itself pay and account to SYNTA for all
payments due under this Agreement by reason of operation of any such
sublicense.


 


6.4.2.                     SYNTA may not grant sublicenses under the rights granted to it in Section 6.3
without the prior written consent of ROCHE, except (a) to SYNTA’s
Affiliates, and (b) to Third Parties solely to the extent necessary to
carry out SYNTA’s Research, Development or Manufacturing obligations.  SYNTA shall guarantee the performance of its
Affiliates and Sublicensees with respect to any sublicense granted pursuant to
this Section 6.4.2.


 


6.5.                              Rights
Retained by the Parties.  Any rights
of SYNTA or ROCHE, as the case may be, not expressly granted to the other Party
pursuant to this Agreement shall be retained by such Party.  Without limiting the generality of the
foregoing, no right or license is granted to ROCHE under the SYNTA Intellectual
Property to Develop or Commercialize any composition that is not a Licensed
Compound or Licensed Product.


 


6.6.                              Exclusivity.  Each Party agrees that, during the Research
Term this Agreement shall serve as the exclusive means through which such Party
and its Affiliates may, (i) either alone or in collaboration with a Third
Party, engage in the Research, Development, Manufacture, or Commercialization
of any compound which such Party or its Affiliates knows or believes to be a
CRAC Channel Inhibitor, or any product containing such a compound in the Field in
the Territory, or (ii) grant a license to, or otherwise assist or contract
with, any Third Party, to Research, Develop, Manufacture, or Commercialize any
compound which such Party or its Affiliates knows or believes to be a CRAC
Channel Inhibitor, or any product containing such a compound in the Field in
the Territory.


 


6.7.                              Section 365(n) of
the Bankruptcy Code.  All rights and
licenses granted pursuant to any section of this Agreement, including pursuant
to Sections 6.1, 6.2 and 6.3, are rights and licenses to “intellectual property”
(as defined in Section 101(35A) of title 11 of the United States  Code (the “Bankruptcy Code”)).  Each Party shall retain and may fully
exercise all of its rights and elections under the Bankruptcy Code.


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


29

















 


ARTICLE VII
-FINANCIAL PROVISION; AUDIT RIGHTS


 


7.1.                              Initial
License Payment.  ROCHE will make a
non-refundable, non-creditable payment to SYNTA of sixteen million dollars
($16,000,000) within ten (10) Business Days after the Effective Date and
receipt of invoice from SYNTA.


 


7.2.                              Research
Funding.


 


7.2.1.                     FTE
Funding.  In order to fund SYNTA’s
Research activities hereunder performed by SYNTA FTEs, ROCHE shall pay to SYNTA
a total of nine million dollars ($9,000,000), to be paid in eight (8) payments,
each in the amount of one million one hundred twenty-five thousand dollars
($1,125,000), each such payment due and payable [***] ([***]) days after the
later of (a) the first day of each Calendar Quarter, starting January 1,
2009, and (b) receipt by ROCHE of an invoice for such sum.


 


7.2.2.                     Third
Party Costs.  For the calendar year
2009, ROCHE will reimburse SYNTA for the Third Party costs incurred by SYNTA
under the Research Plan, for which the budget is [***] dollars ($[***]).  For the calendar year 2010, ROCHE will
reimburse SYNTA for SYNTA’s Third Party costs incurred under the Research Plan,
for which the budget is [***] dollars ($[***]). 
Within thirty (30) days following the end of each Calendar Quarter
during the Research Term, SYNTA shall provide an accounting to ROCHE of the
Third Party costs SYNTA actually incurred under the Research Plan during such
Calendar Quarter.  Roche shall reimburse
SYNTA such amount up to the limits set forth in this paragraph 7.2.2, within
[***] ([***]) days after receipt of such accounting and an invoice for such
amount.  Any amounts in excess of the
limits in a given year shall be the responsibility of SYNTA.


 


7.3.                              Co-promotion
Activities.  If SYNTA exercises its
right to participate in the Co-promotion of one or more Licensed Products in
the United States pursuant to Section 5.3, then ROCHE shall reimburse
SYNTA for costs of such Co-promotion, as set forth on Schedule 5.3.


 


7.4.                              Development
Event Payments.  ROCHE shall make the
following non-refundable, non-creditable payments to SYNTA upon achievement of
any of the events set forth below with respect to any Licensed Product:


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


30














 




	
   

  	
   

  	
  Payment

  (US$ millions)

  	
   

  
	
  Development Event

  	
   

  	
  First Indication

  to Achieve the

  Relevant

  Development

  Event

  	
   

  	
  Second

  Indication to

  Achieve the

  Relevant

  Development

  Event

  	
   

  	
  Third Indication

  to Achieve the

  Relevant

  Development

  Event

  	
   

  
	
  (a)

  	
  Initiation
  of GLP Toxicology Study

  	
   

  	
  $

  	
  [***]

  	
   

  	
  n/a

  	
   

  	
  n/a

  	
   

  
	
  (b)

  	
  Filing of an
  IND anywhere in the world

  	
   

  	
  $

  	
  [***]

  	
   

  	
  n/a

  	
   

  	
  n/a

  	
   

  
	
  (c)

  	
  Initiation
  of a Phase 2a Clinical Trial

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  (d)

  	
  Initiation
  of a Phase 2b Clinical Trial

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  (e)

  	
  Initiation
  of a Phase 3 Clinical Trial

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  (f)

  	
  Filing of an
  NDA in the United States

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  (g)

  	
  Filing of an
  NDA in any Major EU Country (or with the EMEA)

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  (h)

  	
  Filing of an
  NDA in Japan

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  (i)

  	
  Regulatory
  Approval in the United States

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  (j)

  	
  Regulatory
  Approval in a Major EU Country (or by the EMEA)

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  (k)

  	
  Regulatory
  Approval in Japan

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  






 


Each of the event payment
amounts set forth in the table above shall be paid (i) as set forth above
upon the first occurrence of such event, and (ii) at fifty percent (50%)
of the amount 


 


Portions of
this Exhibit were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


31

















 


set forth
above with respect to each of the second and third occurrences of such event by
another Licensed Product.


 


For the sake of clarity (A) the
same Indication need not achieve each development event in a column (Example 1
below); (B) the same Licensed Product need not achieve each development
event in a row (Example 2 below); and (C) no payment shall be made with
respect to the occurrence of an event for which a payment had been made with
respect to the prior occurrence of the same event with the same Licensed Product
for the same Indication (Example 3 below). 
By way of example,


 


·                  Example 1:  If the first Initiation of a Phase 2a
Clinical Trial is for Licensed Product A in Indication rheumatoid arthritis,
$[***] will be due (row (c), first column times 100%).  If the second Initiation of a Phase 2a
Clinical Trial is for Licensed Product A in Indication asthma, $[***] will be
due (row (c), second column times 100%). 
If the third Initiation of a Phase 2a Clinical Trial is for Licensed
Product B in Indication asthma, $[***] will be due (row (c), first column times
50%).


 


·                  Example 2:  If the first Initiation of a Phase 2a
Clinical Trial is for Licensed Product A in Indication rheumatoid arthritis,
$[***] will be due (row (c), first column times 100%).  If the second Initiation of a Phase 2a Clinical
Trial is for Licensed Product B in Indication rheumatoid arthritis, $[***] will
be due (row (c), first column times 50%). 
If the third Initiation of a Phase 2a Clinical Trial is for Licensed
Product B in Indication asthma, $[***] will be due (row (c), second column
times 100%).


 


·                  Example 3:  If the first Initiation of a Phase 2a
Clinical Trial is for Licensed Product A in Indication rheumatoid arthritis,
$[***] will be due (row (c), first column times 100%).  If the second (or subsequent) Initiation of a
Phase 2a Clinical Trial is for Licensed Product A in Indication rheumatoid
arthritis, no milestone payment shall be due with respect to such Initiation.


 


On a Licensed
Product-by-Licensed Product basis, the achievement of a development event in
any of rows (f) through (k) shall result in a simultaneous obligation
to pay all payments in rows (a) through (e) that had not been
previously paid and which are in the same column as the payment then to be
made.  On a Licensed Product-by-Licensed
Product basis, and a country-by-country or regional basis, the achievement of a
development event in any of rows (i) through (k) shall result in a
simultaneous obligation to pay the relevant earlier milestone in rows (f) through
(h), as applicable, that had not previously been paid and which are in the same
column as the payment then to be made.


 


Upon achievement by or on
behalf of ROCHE, its Affiliates or Sublicensees of any of the foregoing
development events, ROCHE shall promptly (but in no event more than ten (10) Business
Days following achievement thereof) notify SYNTA and shall pay to SYNTA all 


 


Portions of
this Exhibit were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


32

















 


corresponding
development event payments within [***] ([***]) days after occurrence of the
applicable event and receipt of an invoice from SYNTA.


 


If SYNTA is the Party that
achieves any of the development events set forth above, SYNTA shall provide
notice to ROCHE promptly upon achievement of each such development event and
shall deliver to ROCHE an invoice for such event.  ROCHE shall pay the applicable development
event payment within [***] ([***]) days of receipt of invoice therefor.


 


7.5.                              Sales
Event Payments.  In addition to all
other amounts payable under this Agreement, ROCHE shall make the following
non-refundable, non-creditable payments to SYNTA based on aggregate worldwide
annual (on a calendar year basis) Net Sales, on a Licensed Product-by-Licensed
Product basis for up to three (3) Licensed Products, upon the first
achievement of the events set forth below by each of such Licensed Products:


 


	
  Sales Event

  	
   

  	
  Payments

  (in US$ millions)

  	
   

  
	
  (a)

  	
  Aggregate
  worldwide annual Net Sales of such Licensed Product reaches or exceeds $[***]
  (> $[***])

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  (b)

  	
  Aggregate
  worldwide annual Net Sales of such Licensed Product reaches or exceeds $[***]
  (> $[***])

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  (c)

  	
  Aggregate
  worldwide annual Net Sales of such Licensed Product reaches or exceeds $[***]
  (> $[***])

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  (d)

  	
  Aggregate
  worldwide annual Net Sales of such Licensed Product reaches or exceeds $[***]
  (> $[***])

  	
   

  	
  $

  	
  [***]

  	
   

  



 


For purposes of clarity, the
sales event payments set forth in this Section 7.5 shall be paid only once
for each Licensed Product, upon the first achievement of the applicable sales
event.


 


Upon achievement by ROCHE, its
Affiliates, Sublicensees or ROCHE Entities of any of the foregoing sales
events, ROCHE shall promptly (but in no event more than thirty (30) days
following achievement thereof) notify SYNTA and shall pay to SYNTA the
corresponding sales event payment within [***] ([***]) days after
occurrence of the applicable event and receipt of an invoice from SYNTA.


 


7.6.                              Licensed
Product Royalties.


 


7.6.1.                     ROCHE shall
pay to SYNTA royalties on the aggregate worldwide annual (on a calendar year
basis) Net Sales of each Licensed Product in the Territory, on a Licensed Product-by-Licensed
Product basis, as follows:


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


33

















 


	
  Aggregate Worldwide Annual Net Sales of Licensed Product

  	
   

  	
  Royalty Rate

  	
   

  
	
  (i)

  	
  First $[***]

  	
   

  	
  [***]

  	
  %

  
	
  (ii)

  	
  Portion above $[***] and up to and
  including $[***]

  	
   

  	
  [***]

  	
  %

  
	
  (iii)

  	
  Portion above $[***] and up to and
  including $[***]

  	
   

  	
  [***]

  	
  %

  
	
  (iv)

  	
  Portion above $[***]

  	
   

  	
  [***]

  	
  %

  



 


7.6.2.                     Applicability
of Royalty Rates to Net Sales in the Territory.  Royalties payable pursuant to this Section 7.6
shall be paid at the rate applicable to the portion of Net Sales within each of
the Net Sales levels during the applicable calendar year for such Licensed
Product.  For example, if, during a
calendar year, aggregate worldwide annual Net Sales of a particular Licensed
Product were equal to $[***], then the royalties payable by ROCHE would be
calculated by adding (i) the royalties with respect to the first $[***] at
the first-level percentage of [***] percent ([***]%) ($[***]), and (ii) the
royalties with respect to the next $[***] at the second-level percentage of
[***] percent ([***]%) ($[***]), for a total royalty of $[***].


 


7.6.3.                     Royalty
Term and Adjustments.


 


(a)                                                          ROCHE’s
royalty obligations to SYNTA pursuant to this Section 7.6 shall commence
on a country-by-country and Licensed Product-by-Licensed Product basis on the
First Commercial Sale in such country of such Licensed Product and shall expire
on a country-by-country basis and Licensed Product-by-Licensed Product basis on
the later of: (A) the expiration of the last Valid Claim of the SYNTA
Patent Rights, ROCHE Patent Rights and Joint Patent Rights Covering such
Licensed Product in such country, or (B) the [***] ([***]) anniversary of
the date of the First Commercial Sale of such Licensed Product in such country
by or on behalf of ROCHE or any of its Affiliates or Sublicensees to a Third
Party who is not a Sublicensee (the “Royalty Term”).  Thereafter, the licenses granted to ROCHE
shall be fully paid-up, royalty-free and non-exclusive with respect to such
Licensed Product in such country, on a Licensed Product-by-Licensed Product and
country-by-country basis.


 


(b)                                                         Notwithstanding
the foregoing, the royalty rate applicable to such Licensed Product sold in any
country in the Territory shall be reduced to [***] percent ([***]%) of the rate
otherwise payable pursuant to Section 7.6.1 above during any portion of
the Royalty Term when there is no Valid Claim of the SYNTA Patent Rights, ROCHE
Patent Rights or Joint Patent Rights Covering such Licensed Product in such
country; provided that such reduction shall not apply if the
Licensed Product is entitled to Marketing Exclusivity  in such country and there is no Generic
Product on the market in such country.


 


7.6.4.                     Royalty
Adjustment in Case of Generic Competition. 
If, during a given Calendar Quarter there is Generic Competition with
respect to a particular Licensed Product in a country of the Territory, then
the royalties on Net Sales of the affected Licensed Product payable 


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


34

















 


pursuant to this Section 7.6
in such country for such Calendar Quarter shall be reduced by [***] percent
([***]%) of the amounts otherwise payable pursuant to Section 7.6.1.  For clarity, the determination of whether
there is Generic Competition with respect to a particular Licensed Product in a
country and, if so, the market share of such Generic Product(s) in such
country, shall be made on a Calendar Quarter-by-Calendar Quarter basis.  For example, if with respect to a particular
Licensed Product in a country there is Generic Competition with respect to such
Licensed Product in a Calendar Quarter then the applicable royalty reductions
set forth in this Section 7.6.4 shall apply for such Calendar Quarter, and
if, with respect to the same Licensed Product in the same country there is no
Generic Competition during any subsequent Calendar Quarter, then the royalty
reductions set forth in this Section 7.6.4 shall not be applicable in any
such subsequent Calendar Quarter. 
Notwithstanding any of the foregoing, if both deductions under Section 7.6.3
and this Section 7.6.4 apply for a Licensed Product in a given country,
then ROCHE may apply only one of the two deductions for such Licensed Product
in such country.


 


7.6.5.                     Third
Party Payments.  ROCHE shall be
responsible for obtaining, and paying or having paid any consideration owed to
any Third Party to license or otherwise secure and maintain, Third Party Patent
Rights necessary to manufacture or sell Licensed Products in the Field in the
Territory.  ROCHE shall have the right to
deduct a maximum of [***] percent ([***]%) of such royalties actually paid to
such Third Party with respect to such license to permit the manufacture or sale
of Licensed Product(s) in the Field in a country(ies), from royalty
payments otherwise due and payable by ROCHE to SYNTA under this Agreement with
respect to such Licensed Product(s) in such country(ies), on a Licensed
Product-by-Licensed Product and country-by-country basis; provided, however,
that (i) in no event shall the deduction permitted by this Section 7.6.5
reduce the royalties payable to SYNTA with respect to any such Licensed Product(s) in
such country(ies) to less than [***] percent ([***]%) of the royalties
otherwise due after any deduction pursuant to Section 7.6.3 or 7.6.4.


 


7.6.6.                     Limitation
on Aggregate Deduction.  In no event
shall the deductions permitted by Sections 7.6.3, 7.6.4 and this 7.6.5, in the
aggregate, reduce the royalties payable to SYNTA with respect to any such
Licensed Product(s) in such country(ies) to less than [***] percent ([***]%)
of the royalties otherwise due for such Licensed Product(s) in such
country(ies) pursuant to Section 7.6.1, on a Licensed Product-by-Licensed
Product and country-by-country basis.


 


7.7.                              Accounting
and Reporting.


 


7.7.1.                     Timing of
Payments.  ROCHE shall calculate
royalties on Net Sales quarterly as of March 31, June 30, September 30
and December 31 (each being the last day of an “Accounting Period”)
and shall pay royalties on Net Sales within [***] ([***]) days after the end of
each Accounting Period in which such Net Sales occur.


 


7.7.2.                     Late
Payment.  Any payment under this
Agreement that is not paid on or before the date such payment is due shall bear
interest, to the extent permitted by applicable Law, at [***] above the average
one-month London Interbank Offered Rate (LIBOR), as reported by Reuters for
time to time, calculated on the number of days such payment is overdue.  In addition, 


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential treatment under Rule 24b-2
of the Securities Exchange Act of 1934, as amended.


 


35

















 


ROCHE shall reimburse SYNTA for
all costs and expenses, including attorneys’ fees and legal expenses, incurred
in the collection of late payments, provided that the
foregoing shall not apply with respect to payments disputed in good faith by
ROCHE unless SYNTA is successful in such dispute or ROCHE ceases to dispute such
payments.


 


7.7.3.                     Method of
Payment.  Royalties on Net Sales and
all other amounts payable by ROCHE hereunder shall be paid by or on behalf of
ROCHE in U.S. Dollars.  All payments due
to SYNTA hereunder shall be made directly from an account located in either (at
ROCHE’s option) the United States or Switzerland to account(s) designated
by SYNTA.


 


7.7.4.                     Currency
Conversion.  Whenever calculating
royalties requires conversion from any currency, ROCHE shall make such
conversion as follows:


 


(a)                                                          When
calculating the Net Sales for countries other than the United States, ROCHE
shall convert the amount of such sales in currencies other than Swiss Francs
into Swiss Francs using ROCHE’s then current standard practices actually used
on a consistent basis in preparing its audited financial statements.


 


(b)                                                         Upon
converting the amount of Adjusted Gross Sales into Swiss Francs, ROCHE shall
convert into US Dollars (or other currency), using the quarterly average rate (currently Reuters) at the
last working day for the applicable period.


 


7.7.5.                     Reporting.  With each payment ROCHE shall provide SYNTA
in writing for the relevant Calendar Quarter on a Licensed Product-by-Licensed
Product basis the following information with respect to each of the following
territories:  (1) the United States,
(2) the Major Markets (other than the United States) and Canada, and (3) all
territories other than those set forth in the foregoing clause (1) and
(2):


 


(a)                                                          Net
Sales and Adjusted Gross Sales;


 


(b)                                                         Adjustments
made pursuant to Section 7.6; and


 


(c)                                                          Total
royalty payable to SYNTA.


 


The report for the fourth Calendar Quarter
shall include a list of all countries in which a Licensed Product is sold in
the Territory for the applicable calendar year.


 


7.7.6.                     United
States Dollars.  All dollar ($)
amounts specified in this Agreement are United States dollar amounts.


 


7.7.7.                     Nonrefundable.  All payments made by ROCHE to SYNTA under
this Agreement shall be non-refundable and non-creditable, except as expressly
set forth in Sections 2.5.2(f), 2.5.4 and 7.9.2.


 


7.8.                              Taxes.  Any tax required to be withheld by ROCHE
under the Laws of any country for the account of SYNTA shall be promptly paid
by ROCHE for and on behalf of 


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


36

















 


SYNTA to the appropriate
government authority, and ROCHE shall furnish SYNTA with proof of payment of
such tax.  Any such tax actually paid on
SYNTA’s behalf shall be deducted from royalty payments due to SYNTA
hereunder.  ROCHE shall assist SYNTA in
minimizing the withholding taxes applicable to any payment made by ROCHE and in
claiming tax refunds at SYNTA’s request.


 


7.9.                              Auditing.


 


7.9.1.                     Audit
Rights.


 


(a)                                                          ROCHE
shall keep, and shall require its Affiliates and Sublicensees to keep, for
[***] ([***]) years, full, true and accurate books of account containing all
particulars that may be necessary for the purpose of calculating all royalties
and all other amounts payable under this Agreement.  Such books of accounts shall be kept at ROCHE’s
or the relevant Affiliate’s or Sublicensee’s principal place of business. At
the expense of SYNTA, SYNTA has the right to engage an independent, certified
public accountant reasonably acceptable to both Parties to perform, on behalf
of SYNTA, an audit of such books and records of ROCHE and its Affiliates and
Sublicensees, that are deemed necessary by such accountant to report on Net
Sales of Licensed Products for the period or periods requested by SYNTA and the
correctness of any report or payments made under this Agreement.  Such accountant shall not have the authority
to interpret this Agreement.


 


(b)                                                         Upon
timely request and at least [***] ([***]) days prior written notice from SYNTA,
such audit shall be conducted in the countries specifically requested by SYNTA,
during regular business hours in such a manner as to not unnecessarily
interfere with ROCHE’s normal business activities, and shall be limited to
results in the [***] ([***]) calendar years prior to audit notification.


 


(c)                                                          Such
audit shall not be performed more frequently than once per calendar year nor
more frequently than once with respect to records covering any specific period
of time.


 


(d)                                                         All
information, data and documents herein referred to shall be used only for the
purpose of verifying royalty statements, shall be treated as ROCHE Confidential
Information subject to the obligations of this Agreement and need neither be
retained more than the longer of one (1) year after completion of an audit
hereof, if an audit has been requested; nor more than [***] ([***]) years from
the end of the calendar year to which each shall pertain; nor more than [***]
([***])[***] after the date of termination of this Agreement.


 


(e)                                                          The
final audit report shall be shared by ROCHE and SYNTA.


 


7.9.2.                     Over- or
Underpayment.  If the audit reveals
an underpayment, ROCHE shall reimburse SYNTA for the amount of the underpayment
within [***] ([***]) days with interest as set forth in Section 7.7.2.  If the audit reveals an overpayment, ROCHE
shall have the right to credit the amount of such overpayment against the next
royalty payment payable to 


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


37





















 


SYNTA hereunder.  ROCHE shall pay for the audit costs if the
audit reveals that an underpayment of ROCHE exceeds [***] percent ([***]%).


 


7.9.3.                     Duration
of Audit Rights.  The failure of
SYNTA to request verification of any royalty calculation within the period
during which the corresponding records must be maintained under Section 7.9.1
will be deemed acceptance of the royalty payments and reports.


 


ARTICLE VIII
-INTELLECTUAL PROPERTY MATTERS


 


8.1.                              Know-How.


 


8.1.1.                  Ownership.  Each Party shall exclusively own all
inventions conceived or reduced to practice solely by employees, agents and
consultants of such Party or its Affiliates. 
The Parties shall jointly own all Joint Know-how, including all
inventions conceived or reduced to practice by one or more employees, agents or
consultants of SYNTA or any of its Affiliates, on the one hand, and one or more
employees, agents or consultants of ROCHE or any of its Affiliates, on the
other hand (“Joint Inventions”). 
Only following the end of the Research Term, each Party shall have the
right to use and license Joint Know-how and Joint Patent Rights to its
Affiliates or any Third Party, without the consent of or accounting to the
other Party, so long as such use or license is subject to the licenses granted
pursuant to this Agreement and is otherwise consistent with this Agreement.


 


8.1.2.                     Inventorship.  The determination of inventorship shall be
made in accordance with United States patent laws.


 


8.2.                              Prosecution
and Maintenance of Patent Rights.


 


8.2.1.                     Prosecution
of SYNTA Patent Rights.  SYNTA shall
have the first right to prepare, file, prosecute and maintain SYNTA Patent
Rights, [***].  ROCHE shall be given
access to all documentation, filings and communications to or from the
respective patent offices in connection with the prosecution and maintenance of
the SYNTA Patent Rights, at reasonable times and upon reasonable written
notice, which access shall only include review of said documents but not
receipt of copies thereof.  SYNTA shall
keep ROCHE informed of the status of all pending patent applications included
in the SYNTA Patent Rights, and ROCHE shall have the right to comment on the
prosecution of such pending patent applications and SYNTA, its agents and
attorneys will consider in good faith timely suggestions and comments of ROCHE
regarding any such activities.  SYNTA
shall not discontinue prosecution or maintenance of any SYNTA Patent Rights (including
selection of countries for foreign filing or entry into the PCT National Stage)
without at least [***] ([***]) [***] prior written notice to ROCHE.  If SYNTA decides to discontinue prosecution
or maintenance of any SYNTA Patent Rights, ROCHE shall have the option to
assume responsibility for prosecuting and maintaining such SYNTA Patent Rights,
at ROCHE’s sole expense, and in such case, except for a change in
responsibility for prosecuting and maintaining SYNTA Patent Rights under this Section 8.2.1,
no changes in ownership or licensing terms pertaining to any SYNTA Patent
Rights shall occur.


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


38

















 


8.2.2.                     Prosecution
of ROCHE Patent Rights.  ROCHE shall
have the first right to prepare, file, prosecute and maintain ROCHE Patent
Rights, [***].  SYNTA shall have access
to all documentation, filings and communications to or from the respective
patent offices in connection with the prosecution and maintenance of the ROCHE
Patent Rights, at reasonable times and upon reasonable written notice, which
access shall only include review of said documents but not receipt of copies
thereof.  ROCHE shall keep SYNTA informed
of the status of all pending patent applications included in the ROCHE Patent
Rights that pertain to any Collaboration Compound or Licensed Product, and
SYNTA shall have the right to comment on the prosecution of such pending patent
applications and ROCHE, its agents, and attorneys will consider in good faith
timely suggestions and comments of SYNTA regarding any such activities.  ROCHE shall not discontinue prosecution or
maintenance of any ROCHE Patent Rights (including selection of countries for
foreign filing or entry into the PCT National Stage) without at least [***]
([***]) prior written notice to SYNTA. 
If ROCHE decides to discontinue prosecution or maintenance of any ROCHE
Patent Rights that pertain to any Collaboration Compound, Licensed Compound or
Licensed Product, SYNTA shall have the option to continue to prosecute and
maintain such ROCHE Patent Rights, at SYNTA’s sole expense, and in such case,
except for a change in responsibility for prosecuting and maintaining the ROCHE
Patent Rights under this Section 8.2.2, no changes in ownership or
licensing terms pertaining to any ROCHE Patent Rights shall occur.


 


8.2.3.                     Prosecution
of Joint Patent Rights.  SYNTA shall
be responsible for preparing, filing, prosecuting, or maintaining Joint Patent
Rights in appropriate countries in the Territory.  The out-of-pocket costs and expenses incurred
to obtain, prosecute and maintain Joint Patent Rights shall be [***]; provided that
[***] may elect, at its sole discretion, on a country-by-country basis, to
discontinue paying such out-of-pocket expenses with respect to any Joint Patent
Right and in such case all licenses granted hereunder to [***] under any such
Joint Patent Right shall immediately terminate. 
SYNTA shall keep ROCHE informed of the status of all pending
applications disclosing Joint Inventions, and shall consider in good faith all
of ROCHE’s comments regarding any aspect of such patent prosecution.  SYNTA shall not discontinue prosecution or
maintenance of any Joint Patent Right without at least [***] ([***]) prior
written notice to ROCHE.  If SYNTA
decides to discontinue prosecution or maintenance of any Joint Patent Rights,
ROCHE shall have the option to continue to prosecute and maintain such Joint
Patent Rights, at ROCHE’s sole expense, and in such case, except for the change
in responsibility for prosecuting and maintaining Joint Patent Rights under
this Section 8.2.3, no changes in ownership or licensing terms pertaining
to any such Joint Patent Rights shall occur.


 


8.2.4.                     Procedures.  If the Parties deem it appropriate, the
Parties may form a patent committee or elect to have the JRDC serve as a forum
for the communication between the Parties regarding the handling of such patent
prosecution matters as set forth in this Section 8.2.


 


8.2.5.                     Payments.  Following the end of each Calendar Quarter,
the Party entitled to reimbursement pursuant to this Section 8.2 shall
provide to the other Party a reasonable accounting of the reimburseable
expenses incurred during such Calendar Quarter. 
Within sixty (60) days after receipt of an invoice therefor, the other
Party shall pay such reimburseable 


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


39

















 


expenses.  The provisions of Section 2.5.2 shall
apply mutatis mutandis to each Party and such reimburseable
expenses.


 


8.2.6.                     Patent
Term Extensions.


 


(a)                                                          SYNTA
and ROCHE shall determine together whether to seek patent term extensions or
supplemental patent protection, including supplementary protection
certificates, in any country in the Territory in relation to the Licensed
Products Covered by SYNTA Patent Rights and Joint Patent Rights.  SYNTA and ROCHE shall cooperate in connection
with all such activities.


 


(b)                                                         Subject
to Section 8.2.6(a), ROCHE shall have the exclusive right to seek patent
term extensions or supplemental patent protection, including supplementary
protection certificates, in any country in the Territory in relation to the
Licensed Products Covered by ROCHE Patent Rights.  SYNTA and ROCHE shall cooperate in connection
with all such activities, and ROCHE, its agents and attorneys will consider in
good faith timely suggestions and comments of SYNTA regarding any such
activities, provided that all final decisions under this Section 8.2.6(b) shall
be made by ROCHE.


 


8.3.                              Third
Party Infringement.


 


8.3.1.                     Notice.  Each Party shall promptly report in writing
to the other Party during the Term any known or suspected (a) infringement
of any of the SYNTA Patent Rights, ROCHE Patent Rights or Joint Patent Rights,
or (b) unauthorized use or misappropriation of any of the SYNTA Know-how,
ROCHE Know-how, or Joint Know-how (each of (a) and (b), an “Infringement
Claim”) of which such Party becomes aware, and shall provide the other
Party with all available evidence supporting such known or suspected
infringement or unauthorized use or misappropriation.


 


8.3.2.                     Right
to Enforce the SYNTA Intellectual Property.


 


(a)                                                          SYNTA
shall have the first right, but not the obligation, to initiate a suit or take
other appropriate action that it believes is reasonably required to protect
(i.e., prevent or abate actual or threatened infringement or misappropriation
of) or otherwise enforce the SYNTA Intellectual Property (other than Joint
Intellectual Property).  Any suit by
SYNTA shall be either in the name of SYNTA or its Affiliate, the name of ROCHE
or its Affiliate, or jointly by ROCHE, SYNTA and their respective Affiliates,
as may be required by applicable Law if the relevant court would otherwise lack
jurisdiction if such Party or its Affiliate were absent from such suit.  For this purpose, ROCHE agrees to be joined
as a party to the suit if so required and shall execute such legal papers and
cooperate in the prosecution of such suit as may be reasonably requested by SYNTA,
provided that SYNTA shall promptly reimburse all
out-of-pocket expenses (including reasonable attorneys’ fees and expenses)
actually incurred by ROCHE in connection with such cooperation.


 


(b)                                                         If
SYNTA does not initiate a suit or take other appropriate action that it has the
initial right to initiate or take pursuant to Section 8.3.2(a), then ROCHE
may, in its


 


Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


40














 


discretion, provide SYNTA with
notice of ROCHE’s intent to initiate a suit or take other appropriate
action.  If ROCHE provides such notice
and SYNTA does not initiate a suit or take such other appropriate action within
[***] ([***]) [***] ([***] ([***]) [***] in the case of a Paragraph IV
Certification) after receipt of such notice from ROCHE, then ROCHE shall have
the right to initiate a suit or take other appropriate action that it believes
is reasonably required to protect the SYNTA Intellectual Property solely owned
by SYNTA; provided, however, that ROCHE shall not initiate
a lawsuit or take other enforcement action without first consulting with
SYNTA.  Any suit by ROCHE shall be either
in the name of ROCHE or its Affiliate, the name of SYNTA or its Affiliate, or
jointly by ROCHE, SYNTA and their respective Affiliates, as may be required by
applicable Law if the relevant court would otherwise lack jurisdiction if such
Party or its Affiliate were absent from such suit.  For this purpose, SYNTA agrees to be joined
as a party to the suit if so required and shall execute such legal papers and
cooperate in the prosecution of such suit as may be reasonably requested by
ROCHE, provided that ROCHE shall promptly reimburse all
out-of-pocket expenses (including reasonable attorneys’ fees and expenses)
actually incurred by SYNTA in connection with such cooperation.


 


8.3.3.                     Right
to Enforce the ROCHE Intellectual Property.


 


(a)                                                                  ROCHE
shall have the first right, but not the obligation, to initiate a suit or take
other appropriate action that it believes is reasonably required to protect
(i.e., prevent or abate actual or threatened infringement or misappropriation
of) or otherwise enforce the ROCHE Intellectual Property (other than Joint
Intellectual Property).  Any suit by
ROCHE shall be either in the name of ROCHE or its Affiliate, the name of SYNTA
or its Affiliate, or jointly by ROCHE, SYNTA and their respective Affiliates,
as may be required by applicable Law if the relevant court would otherwise lack
jurisdiction if such Party or its Affiliate were absent from such suit.  For this purpose, SYNTA agrees to be joined
as a party to the suit if so required and shall execute such legal papers and
cooperate in the prosecution of such suit as may be reasonably requested by
ROCHE, provided that ROCHE shall promptly reimburse all
out-of-pocket expenses (including reasonable attorneys’ fees and expenses)
actually incurred by SYNTA in connection with such cooperation.


 


(b)                                                                 If
ROCHE does not initiate a suit or take other appropriate action that it has the
initial right to initiate or take pursuant to Section 8.3.3(a), then SYNTA
may, in its discretion, provide ROCHE with notice of SYNTA’s intent to initiate
a suit or take other appropriate action. 
If SYNTA provides such notice and ROCHE does not initiate a suit or take
such other appropriate action within [***] ([***]) [***] ([***] ([***]) [***]
in the case of a Paragraph IV Certification) after receipt of such notice from
SYNTA, then SYNTA shall have the right to initiate a suit or take other
appropriate action that it believes is reasonably required to protect the ROCHE
Intellectual Property solely owned by ROCHE; provided, however, that
SYNTA shall not initiate a lawsuit or take other enforcement action without
first consulting with ROCHE.  Any suit by
SYNTA shall be either in the name of SYNTA or its Affiliate, the name of ROCHE
or its Affiliate, or jointly by ROCHE, SYNTA and their respective Affiliates,
as may be required by applicable Law if the relevant court would otherwise lack
jurisdiction if such Party or its Affiliate were absent from such suit.  For this purpose, ROCHE agrees to be joined
as a party to the suit and shall execute such legal papers and cooperate in the
prosecution 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


41

















 


of such suit as may be
reasonably requested by SYNTA, provided that SYNTA shall
promptly reimburse all out-of-pocket expenses (including reasonable attorneys’
fees and expenses) actually incurred by ROCHE in connection with such
cooperation.


 


8.3.4.                     Right to
Enforce the Joint Patent Rights and Joint Know-how.  Responsibility for protecting (i.e.,
preventing or abating actual or threatened infringement or misappropriation of)
or otherwise enforcing the Joint Patent Rights and the Joint Know-how shall be
determined in the same manner as the SYNTA Patent Rights.  The enforcing Party shall keep the other
Party informed of the status of all enforcement activities, and shall consider
in good faith all comments of the other Party regarding any aspect of such
enforcement.  The enforcing Party shall
not discontinue enforcement of Joint Patent Right or Joint Know-how without
providing prior written notice to, and consultation with, the non-enforcing
Party.


 


8.3.5.                     Conduct of
Certain Actions; Costs.  The Party
initiating suit shall have the sole and exclusive right to select counsel for
any suit initiated by it pursuant to Section 8.3.2, 8.3.3 or 8.3.4.  The initiating Party shall assume and pay all
of its own out-of-pocket costs incurred in connection with any litigation or
proceedings initiated by it pursuant to Section 8.3.2, 8.3.3 or 8.3.4,
including the fees and expenses of the legal counsel selected by it.  The other Party shall have the right to
participate and be represented in any such suit by the initiating Party’s
counsel, or by its own legal counsel at its own expense.


 


8.3.6.                     Recoveries.  If ROCHE assumes control over any suit in
response to any Infringement Claim, SYNTA shall be entitled, at its option, to (a) treat
as Net Sales or (b) receive  [***] percent
([***]%) of, any damages, settlements, accounts of profits, or other financial
compensation recovered by ROCHE from a Third Party based upon any suit
initiated by ROCHE in response to such Infringement Claim after deducting ROCHE’s
actual out-of-pocket expenses (including reasonable attorneys’ fees and
expenses) incurred in pursuing such Infringement Claim, and ROCHE may retain
the balance.  If SYNTA assumes control
over any suit in response to any Infringement Claim, ROCHE shall be entitled to
receive [***] percent ([***]%) of any damages, settlements, accounts of
profits, or other financial compensation recovered from a Third Party based
upon such suit in response to any such Infringement Claim after deducting SYNTA’s
actual out-of-pocket expenses (including reasonable attorneys’ fees and
expenses) incurred in pursuing such suit in response to such Infringement
Claim, and SYNTA may retain the balance.


 


8.4.                              Patent
Invalidity Claim.  Each of the
Parties shall promptly notify the other in the event of any legal or
administrative action by any Third Party against a ROCHE Patent Right, SYNTA
Patent Right or Joint Patent Right, of which it becomes aware, including any
nullity, revocation, reexamination or compulsory license proceeding or, in
accordance with Section 8.6, any Paragraph IV Certification.  ROCHE shall have the first right, but not the
obligation, to defend against any such action or Paragraph IV Certification
involving a ROCHE Patent Right, in its own name, and the costs of any such
defense shall be at ROCHE’s expense. 
SYNTA shall have the first right, but not the obligation, to defend
against any such action or Paragraph IV Certification involving a SYNTA Patent
Right or Joint Patent Right, in its own name, and the costs of any such defense
shall be at SYNTA’s expense.  The
non-initiating Party, upon request 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


42

















 


of the initiating Party, agrees
to join in any such action and to cooperate reasonably with the initiating
Party, provided that the initiating Party shall promptly
reimburse all out-of-pocket expenses (including reasonable counsel fees and
expenses) actually incurred by the non-initiating Party in connection with such
cooperation.  If the initiating Party
does not defend against any such action, then the non-initiating Party shall
have the right, but not the obligation, to defend such action and any such
defense shall be at the non-initiating Party’s expense.


 


8.5.                              Patent
Marking.  ROCHE shall comply with the
patent marking statutes in each country in which the Licensed Product is sold
by ROCHE, its Affiliates, or its Sublicensees.


 


8.6.                              Certification
Under Drug Price Competition and Patent Restoration Act.  If a Party becomes aware of any certification
filed pursuant to 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV), or
any notice under any future analogous provisions of United States Law relating
to regulation or approval of pharmaceutical products (or any amendment or
successor statute thereto), or any comparable Law under any other jurisdiction,
claiming that any SYNTA Patent Right, ROCHE Patent Right or Joint Patent Right,
in each case Covering a Licensed Product in the Field, is invalid or otherwise
unenforceable, or that infringement will not arise from the manufacture, use,
import or sale or offer of sale of a product by a Third Party (a “Paragraph
IV Certification”), such Party shall promptly notify the other Party in
writing within three (3) Business Days after its receipt thereof.


 


8.7.                              Cooperation.  SYNTA and ROCHE shall reasonably cooperate in
the prosecution, procurement, maintenance and enforcement of all SYNTA Patent
Rights, ROCHE Patent Rights and Joint Patent Rights.  Such cooperation may include assistance by
either Party and its respective Affiliates, employees, agents, consultants and
designees in formulating responses to official actions received from the United
States Patent and Trademark Office and foreign patent offices, signing
documents in connection with the prosecution, maintenance and enforcement of
such Patent Rights and taking steps to perfect title in such Patent
Rights.  No Party may, without obtaining
the prior written consent of such other Party, settle or compromise any claim
or proceeding relating to the Joint Know-how, Joint Patent Rights or the other
Party’s solely-owned Patent Rights or Know-how.


 


ARTICLE IX
-CONFIDENTIAL INFORMATION


 


9.1.                              Treatment
of Confidential Information.  During
the Term and for [***] ([***]) [***] thereafter, each Party shall maintain
Confidential Information of the other Party in confidence, and shall not
disclose, divulge, or otherwise communicate such Confidential Information to
others or use it for any purpose other than in performance of its obligations
or exercise of its rights pursuant to this Agreement, except that each Party
may disclose such Confidential Information to its agents, directors, officers,
employees, consultants, subcontractors, Affiliates and advisors (collectively, “Agents”)
under written obligations of confidentiality at least as stringent as the
confidentiality provisions set forth in this Article IX and with a need to
know such information to perform such obligations or exercise such rights on
behalf of the disclosing Party.  Each
Party shall exercise efforts that are at least as diligent as those generally used
by such Party in protecting its own confidential and proprietary information
(but no less 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


43

















 


than reasonable efforts), to
prevent and restrain the unauthorized disclosure or use of such Confidential
Information by any of its Agents.  Each
Party will be responsible for a breach of this Article IX by its
Agents.  For clarity, either Party may
disclose Confidential Information of the other Party (a) to Regulatory
Authorities, to the extent necessary to obtain or maintain INDs or Regulatory
Approvals for any Licensed Product as permitted under this Agreement; (b) to
outside consultants, scientific advisory boards, managed care organizations,
and non-clinical and clinical investigators (in each case, other than ROCHE
Entities which are not then Affiliates hereunder) to the extent necessary to
Research, Develop or Commercialize any Collaboration Compound or Licensed
Product, provided that such Party shall obtain
confidentiality obligations from such Third Parties at least as stringent as
the confidentiality provisions set forth in this ARTICLE IX; and (c) to
the extent necessary to prosecute and enforce ROCHE Patent Rights, SYNTA Patent
Rights or Joint Patent Rights; in each of the foregoing cases, solely to the
extent applicable to such Party’s activities under this Agreement.  For clarity, ROCHE may disclose Confidential
Information of SYNTA to Chugai, solely to the extent necessary for Chugai to be
able to determine whether to Develop or Commercialize any Licensed Compound or
Licensed Product on ROCHE’s behalf hereunder, provided that ROCHE shall
obtain confidentiality obligations from Chugai at least as stringent as the
confidentiality provisions set forth in this ARTICLE IX.


 


9.2.                              Exceptions.  Notwithstanding the foregoing, the receiving
Party’s obligations under Section 9.1 shall not apply to any Confidential
Information that, as shown by competent evidence:


 


9.2.1.                     either before
or after the date of the disclosure to the receiving Party is lawfully
disclosed to the receiving Party by Third Parties without any violation of any
obligation to the other Party; or


 


9.2.2.                     either before
or after the date of the disclosure to the receiving Party, becomes published
or generally known to the public through no fault or omission on the part of
the receiving Party or its Agents; or


 


9.2.3.                     is
independently developed by or for the receiving Party without reference to or
reliance upon the other Party’s Confidential Information as demonstrated by
contemporaneous written records of the receiving Party; or


 


9.2.4.                     is required
to be disclosed by the receiving Party to comply with applicable Laws or legal
process, including the rules or regulations of the U.S. Securities and
Exchange Commission, or similar regulatory agency in any country other than the
United States, or of any stock exchange, including Nasdaq, or to defend or
prosecute litigation, provided that the receiving Party
promptly provides prior notice to the extent practicable of such disclosure to
the other Party and uses reasonable efforts to avoid or minimize the degree of
such disclosure.


 


9.3.                              Publication
Rights. 
During the Term of this Agreement, the following restrictions
shall apply with respect to disclosure by any Party of the other Party’s
Confidential Information 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


44

















 


relating to Collaboration
Compounds, Licensed Compounds or the Licensed Product in any publication or
presentation:


 


9.3.1.                     Clinical
Trial Registries.  Both Parties
acknowledge that it is their policy for the Clinical Trials with respect to the
Licensed Products and results thereof to be registered and published in
accordance with their internal guidelines. 
ROCHE, in accordance with its internal policies and procedures, shall
have the right to publish all Clinical Trials with respect to the Licensed
Products and results thereof on the clinical trial registries which are
maintained by or on behalf of ROCHE. 
SYNTA shall not publish any Clinical Trials with respect to the Licensed
Products or results thereof on its clinical trial registry; provided, however,
that ROCHE’s clinical trial registry can be accessed via a link from SYNTA’s
clinical trial registry; and provided, further, that SYNTA shall
be permitted, in accordance with applicable Law, to post Clinical Trial
information with respect to the Licensed Products on clinicaltrials.gov or any
other mandated registry.


 


9.3.2.                     Publication.  A Party (the “Publishing Party”) shall
provide the other Party with a copy of any proposed publication or presentation
at least [***] ([***]) [***] (or at least [***] ([***]) [***] in the case of
abstracts or oral presentations) prior to submission for publication by the
Publishing Party or its Affiliates so as to provide such other Party with an
opportunity to recommend any changes it reasonably believes are necessary to
continue to maintain the Confidential Information disclosed by the other Party
to the Publishing Party in accordance with the requirements of this
Agreement.  The incorporation of such
recommended changes shall not be unreasonably refused; and if such other Party
notifies (“Notice”) the Publishing Party in writing, within [***]
([***]) [***] after receipt of the copy of the proposed publication or
presentation (or at least [***] ([***]) [***] in the case of oral presentations),
that such publication or presentation in its reasonable judgment (a) contains
an invention, solely or jointly conceived or reduced to practice by the other
Party, for which the other Party reasonably desires to obtain patent protection
or (b) could be expected to have a material adverse effect on the
commercial value of any Confidential Information disclosed by the other Party
to the Publishing Party, the Publishing Party shall prevent such publication or
delay such publication for a mutually agreeable period of time.  In the case of inventions, a delay shall be
for a period reasonably sufficient to permit the timely preparation and filing
of a patent application(s) on such invention, and in no event less than
[***] ([***]) [***] from the date of the Notice.  In the case of Confidential Information, any
of the non-publishing Party’s Confidential Information shall be deleted as
requested.


 


9.3.3.                     Confidential
Information in Patents.  Nothing in
this Agreement shall prevent either Party from filing or prosecuting a patent
application or its resulting patents related to a Licensed Product; provided,
that such Party is in compliance with Sections 8.2 and 9.1(c).


 


9.3.4.                     Return of
Confidential Information.  Upon the
expiration or termination of this Agreement, the receiving Party shall return
to the disclosing Party or, at the disclosing Party’s request, destroy all
Confidential Information received from the disclosing Party and all copies and
reproductions thereof.  Notwithstanding
the foregoing, (a) the receiving Party’s legal counsel may retain one copy
of the disclosing Party’s Confidential Information for archival 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.


 


45

















 


purposes, and (b) the
receiving Party may retain one copy of the disclosing Party’s Confidential
Information solely to the extent necessary to exercise the rights and licenses
of the receiving Party expressly surviving expiration or termination of this
Agreement. Notwithstanding the return or destruction of the disclosing Party’s
Confidential Information, the receiving Party shall continue to be bound by its
obligations of confidentiality and other obligations under this Article IX.


 


ARTICLE X
-REPRESENTATIONS, WARRANTIES AND COVENANTS


 


10.1.                        Mutual
Representations.  Each Party hereby
represents and warrants to the other Party as of the Execution Date as follows:


 


10.1.1.               It is duly
organized and validly existing under the Laws of its jurisdiction of
incorporation and has the corporate power and authority to execute and deliver
this Agreement and to perform its obligations hereunder.


 


10.1.2.               The execution,
delivery and performance of this Agreement by such Party has been duly and
validly authorized and approved by proper corporate action on the part of such
Party.  It has taken all other action required
by applicable Law, its certificate of incorporation or by-laws or any agreement
to which it is a party or by which it or its assets are bound, to authorize
such execution, delivery and performance. 
Assuming due authorization, execution and delivery on the part of the
other Party, this Agreement constitutes a legal, valid and binding obligation
of such Party.


 


10.1.3.               The execution and
delivery of this Agreement, and the performance of this as contemplated
hereunder, by such Party will not violate any applicable Law.


 


10.1.4.               Neither the
execution and delivery of this Agreement nor the performance hereof by such
Party requires such Party to obtain any permit, authorization or consent from
any governmental authority or from any other Person, and such execution,
delivery and performance by such Party will not result in the breach of or give
rise to any conflict, termination of, rescission, renegotiation or acceleration
under or trigger any other rights under any agreement or contract to which such
Party may be a party existing as of the Execution Date, except any that would
not, individually or in the aggregate, reasonably be expected to adversely
affect the other Party’s rights under this Agreement or the ability of such
Party to perform its obligations under this Agreement.


 


10.2.                        SYNTA’s
Representations.  SYNTA hereby
represents and warrants to ROCHE as of the Execution Date as follows:


 


10.2.1.               To SYNTA’s
knowledge, SYNTA has not, up through and including the Execution Date,
intentionally withheld any material information requested by ROCHE in
connection with ROCHE’s due diligence relating to the subject matter of this
Agreement and the underlying transaction, and, when provided, the information
related to Collaboration Compounds that SYNTA provided to ROCHE prior to the
Execution Date was up-to-date, timely and accurate in all material respects.


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


46

















 


10.2.2.               SYNTA has the right
to grant to ROCHE the rights and licenses described hereunder.


 


10.2.3.               To SYNTA’s knowledge,
Exhibit A is a complete and correct list of all SYNTA Patent Rights
in the Territory that Cover the Collaboration Compounds Controlled by SYNTA as
of the Execution Date.


 


10.2.4.               To SYNTA’s
knowledge, no Third Party is infringing any of the SYNTA Patent Rights
identified on Exhibit A.


 


10.2.5.               To SYNTA’s
knowledge, the making, using or selling of [***] as contemplated under this
Agreement will not infringe any Third Party patent rights that exist as of the
Execution Date.


 


10.3.                        ROCHE’s
Representations.  ROCHE hereby
represents and warrants to SYNTA as of the Execution Date as follows:


 


10.3.1.               ROCHE has the right
to grant to SYNTA the rights and licenses described hereunder.


 


10.3.2.               To ROCHE’s
knowledge, there are no ROCHE Patent Rights in the Territory that Cover the
Collaboration Compounds Controlled by ROCHE as of the Execution Date.


 


10.4.                        Covenants
of the Parties.


 


10.4.1.               Each of ROCHE and
SYNTA shall require by written agreement that all of its personnel, employees,
and agents involved in the Research, Development, Manufacture or
Commercialization of Collaboration Compounds or Licensed Products have entered
into confidentiality and invention assignment agreements that are consistent
with the terms of this Agreement and shall be obligated to assign any rights
they may have in any inventions made during such work to ROCHE or SYNTA,
respectively.


 


10.4.2.               Each Party and its
Affiliates shall conduct, and shall use Commercially Reasonable Efforts to
cause its Sublicensees, contractors, and consultants to conduct, all of its
activities contemplated under this Agreement in accordance with all applicable
Laws of the country in which such activities are conducted.


 


10.5.                        No
Warranty.  EXCEPT AS OTHERWISE
EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY HERETO MAKES ANY
REPRESENTATION AND EXTENDS NO WARRANTY OF ANY KIND, EITHER EXPRESS, IMPLIED,
STATUTORY OR OTHERWISE, WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT
(INCLUDING ANY COLLABORATION COMPOUND OR LICENSED PRODUCT), INCLUDING ANY
WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, OR FITNESS FOR A PARTICULAR
PURPOSE.


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


47

















 


ARTICLE XI
-INDEMNIFICATION


 


11.1.                        Indemnification
by ROCHE.  ROCHE shall indemnify,
hold harmless and defend SYNTA, its Affiliates and their respective directors,
officers, employees and agents from and against any and all losses, expenses,
cost of defense (including reasonable attorneys’ fees, witness fees, damages,
judgments, fines and amounts paid in settlement) and any amounts SYNTA becomes
legally obligated to pay because of any claim or claims against it, to the
extent that such claim or claims arise out of (a) the Research,
Development, Manufacture, Commercialization, use or importation of Licensed
Compounds or Licensed Products by or on behalf of ROCHE, its Affiliates or
Sublicensees (including product liability claims), (b) the breach of any
of ROCHE’s representations or warranties hereunder, or (c) any
infringement of any Third Party Patent Rights or misappropriation of any Third
Party Know-How in connection with the Development, Manufacture,
Commercialization, use or import of any Licensed Compounds or Licensed
Products, in all cases except to the extent such losses, expenses, costs and
amounts are due to the gross negligence or willful misconduct of SYNTA or
breach of any of SYNTA’s representations and warranties hereunder.


 


11.2.                        Indemnification
by SYNTA.  SYNTA shall indemnify,
hold harmless and defend ROCHE, its Affiliates and their respective directors,
officers, employees and agents from and against any and all losses, expenses,
cost of defense (including reasonable attorneys’ fees, witness fees, damages,
judgments, fines and amounts paid in settlement) and any amounts ROCHE becomes
legally obligated to pay because of any claim or claims against it, to the
extent that such claim or claims arise out of the breach of any of SYNTA’s
representations or warranties hereunder, in all cases except to the extent such
losses, expenses, costs and amounts are due to the gross negligence or willful
misconduct of ROCHE or breach of any of ROCHE’s representations and warranties
hereunder.


 


11.3.                        Procedure.  In the event of a claim by a Third Party
against any Person entitled to indemnification under this Agreement (in such
capacity, the “Indemnified Party”), the Indemnified Party shall promptly
notify the other Party (in such capacity, the “Indemnifying Party”) in
writing of the claim (it being understood that the failure by the Indemnified
Party to give prompt notice of a Third Party claim as provided in this Section 11.3
shall not relieve the Indemnifying Party of its indemnification obligation
under this Agreement except and only to the extent that such Indemnifying Party
is actually prejudiced as a result of such failure to give prompt notice).
Within [***] ([***]) days after delivery of such notification, the Indemnifying
Party may, upon written notice thereof to the Indemnified Party, undertake and
solely manage and control, at its sole expense and with counsel reasonably
satisfactory to the Indemnified Party, the defense of the claim. If the
Indemnifying Party does not undertake such defense, the Indemnified Party shall
control such defense.  The Party not
controlling such defense shall cooperate with the other Party and may, at its
option and expense, participate in such defense, provided that
if the Indemnifying Party assumes control of such defense and the Indemnified
Party in good faith concludes, based on advice from counsel, that the
Indemnifying Party and the Indemnified Party have conflicting interests with
respect to such action, suit, proceeding or claim, the Indemnifying Party shall
be responsible for the reasonable fees and expenses of counsel to the
Indemnified Party solely in connection therewith.  The Party controlling such defense shall 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


48

















 


keep the other Party advised of
the status of such action, suit, proceeding or claim and the defense thereof
and shall consider recommendations made by the other Party with respect
thereto.  The Indemnifying Party shall
not be liable for any litigation costs or expenses incurred by the Indemnified
Party without the Indemnifying Party’s written consent. The Indemnified Party
shall not settle any such action, suit, proceeding or claim without the prior written
consent of the Indemnifying Party, which shall not be unreasonably withheld,
delayed or conditioned.  Without the
prior written consent of the Indemnified Party, the Indemnifying Party shall
not settle any such action, suit, proceeding or claim, or consent to any
judgment in respect thereof, that does not include a complete and unconditional
release of the Indemnified Party from all liability with respect thereto, that
imposes any liability or obligation on the Indemnified Party or that
acknowledges fault by the Indemnified Party.


 


11.4.                     Insurance.  Each Party shall maintain appropriate product
liability insurance (or self-insurance) with respect to its Research,
Development, Manufacture and Commercialization activities hereunder in such
amount as such Party customarily maintains with respect to its other products
for similar patient populations and commercial markets.  Each Party shall maintain such insurance for
so long as it continues to conduct such activities hereunder, and for so long
as such Party customarily maintains insurance with respect to sales of its
other products for similar patient populations and commercial markets.


 


11.5.                        No
Consequential Damages.  IN NO EVENT
SHALL EITHER SYNTA OR ROCHE BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY,
MULTIPLE OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT BASED ON
CONTRACT, TORT OR ANY OTHER LEGAL THEORY. 
NOTHING IN THIS SECTION 11.5 IS INTENDED TO LIMIT OR RESTRICT (A) THE
INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER THIS ARTICLE XI, (B) REMEDIES
AVAILABLE TO EITHER PARTY WITH RESPECT TO A BREACH OF ARTICLE IX OR (C) REMEDIES
AVAILABLE TO EITHER PARTY WITH RESPECT TO A BREACH OF SECTION 6.6.


 


ARTICLE XII
-TERM AND TERMINATION


 


12.1.                        Term.  The term of this Agreement shall commence on
the Effective Date and, unless earlier terminated as provided in this Article XII,
shall continue in full force and effect until the expiration of the Royalty
Term for all Licensed Products (the “Term”).


 


12.2.                        Termination
for No Activity.  SYNTA may terminate
this Agreement in its entirety, effective immediately upon giving of written
notice thereof to ROCHE, in the event that, during any [***] ([***]) [***]
period after the Research Term and prior to First Commercial Sale of any
Licensed Product anywhere in the Territory, no Development has been conducted
by or on behalf of ROCHE with respect to any Licensed Compound, unless such
absence of Development occurs as a result of an action by a Regulatory
Authority prohibiting clinical development of all Licensed Products, in which
case the [***] ([***]) [***] time period will be reset to begin as of the date
of such action.


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


49

















 


12.3.                        Termination for Convenience.  At any time after [***] during the Term, ROCHE
shall have the right to terminate this Agreement in its entirety for any reason
upon [***] ([***]) [***] prior written notice to SYNTA, such notice to be
provided no earlier than [***].  At any
time during the Term, ROCHE shall have the right to terminate this Agreement on
a Licensed Compound-by-Licensed Compound basis in one or more Regions (each, a “Terminated
Region”), for any reason upon [***] ([***]) [***] prior written notice to
SYNTA; provided, that ROCHE cannot terminate this Agreement with respect
to all Licensed Compounds except as provided in the first sentence of this Section 12.3.


 


12.4.                        Termination for Cause.  In the event of a material breach of this
Agreement by a Party, the other Party may give the Party in default notice of
such material breach.  If such material
breach is not cured within [***] ([***]) [***] after receipt of such notice (or
within [***] ([***]) [***] in the case of a payment breach), the notifying
Party shall be entitled (without prejudice to any of its other rights conferred
on it by this Agreement or under applicable Law) to terminate this Agreement by
giving written notice to the defaulting Party, with such termination to take
effect immediately.


 


12.5.                        Termination
if ROCHE Challenges SYNTA Patent Rights. 
If ROCHE or any of ROCHE’s Affiliates or Sublicensees challenges the
validity, enforceability, patentability or scope of an claim included in any
SYNTA Patent Rights or supports, directly or indirectly, any such challenge
(any of the foregoing, a “Patent Challenge”), SYNTA shall have the right
to terminate this Agreement upon [***] ([***]) days’ written notice to ROCHE
with respect to the SYNTA Patent Right so challenged by ROCHE or any of its
Affiliates or Sublicensees; provided, however, that if such
Patent Challenge is terminated during such [***] ([***]) day period, then SYNTA
shall not have the right to terminate this Agreement in respect of such Patent
Challenge; provided, however, that (a) at SYNTA’s request,
ROCHE shall issue a joint press release with SYNTA promptly after the
termination of such Patent Challenge, which press release shall publicize that
the relationship between ROCHE and SYNTA with respect to this Agreement is
strong, and (b) if ROCHE or any of its Affiliates or Sublicensees was the
first Person to initiate any such Patent Challenge, then ROCHE shall reimburse
SYNTA for all costs and expenses, including attorneys’ fees, incurred by SYNTA
in defending such Patent Challenge and any similar Patent Challenge made by any
Third Party within [***] ([***]) [***] after the initial Patent Challenge, and
shall pay all such reimbursement amounts within [***] ([***]) days after
receipt of an invoice from SYNTA therefor.


 


12.6.                        Consequences
of Termination by ROCHE for Convenience in its Entirety; Termination by SYNTA
for ROCHE Breach or Patent Challenge. 
If this Agreement is terminated by SYNTA in its entirety pursuant to Section 12.2
(Termination for No Activity), by ROCHE in its entirety pursuant to Section 12.3
(Termination for Convenience), or by SYNTA pursuant to Section 12.4
(Termination for Cause) or 12.5 (Termination if ROCHE Challenges SYNTA Patent
Rights), then:


 


12.6.1.               Termination of
Licenses.  The licenses granted by
SYNTA to ROCHE pursuant to Sections 6.1 (Research Licenses) and 6.2
(Development and Commercialization License to ROCHE) shall terminate;


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


50














 


12.6.2.               Regulatory
Matters.  ROCHE shall transfer to
SYNTA ownership of all regulatory filings and Regulatory Approvals in ROCHE’s
or its Affiliates’ possession or control relating to all Collaboration
Compounds that are not Licensed Compounds  (other than
ROCHE solely Controlled Collaboration Compounds), Licensed Compounds and
Licensed Products;


 


12.6.3.               Preclinical and
Clinical Matters.  ROCHE shall assign
to SYNTA its entire right, title, and interest in and to all preclinical and
clinical data, including pharmacology and biology data, in ROCHE’s or its
Affiliates’ possession or control relating to and to the extent necessary for
SYNTA to continue the Research, Development or Commercialization of
Collaboration Compounds that are not Licensed Compounds (other than ROCHE
solely Controlled Collaboration Compounds), Licensed Compounds and Licensed
Products;


 


12.6.4.               Manufacturing
Matters.  At SYNTA’s option, ROCHE
shall:


 


(a)                                                                  To
the extent assignable and related to Licensed Compounds or Licensed Products,
assign to SYNTA each manufacturing agreement then in effect with respect to the
Manufacture of such Licensed Compounds and Licensed Products;


 


(b)                                                                 transfer
Manufacturing documents and materials which are used (at the time of the
termination) by or on behalf of ROCHE, its Affiliates or Sublicensees in the
Manufacture of such Licensed Compounds and Licensed Products; and


 


(c)                                                                  upon
SYNTA’s request, sell to SYNTA (or its designee) ROCHE’s then-existing
inventory of such Licensed Compounds and Licensed Products, at ROCHE’s FBMC;


 


12.6.5.               Manufacturing Obligations after Termination.  To the extent ROCHE (or an Affiliate of
ROCHE) is Manufacturing (on its own or through any Third Party contract
manufacturer) any Licensed Product, ROCHE (or its Affiliate) shall, at SYNTA’s
request, continue, for a period up to [***] ([***]) [***], to Manufacture (or
have Manufactured) such Licensed Product and supply such Licensed Product to
SYNTA.  ROCHE shall be obligated to
supply quantities of such Licensed Product sufficient to satisfy SYNTA’s
requirements under a manufacturing transfer and transition plan to be
negotiated by the Parties in good faith so that SYNTA can assume all
Development and Commercialization activities with regard to such Licensed
Product.  ROCHE will supply such
quantities of Licensed Product at ROCHE’s FBMC (as such term is consistently
applied by ROCHE at the time of supply) plus [***] percent ([***]%).  In addition, for a period of time to be
agreed upon in good faith by the Parties up to [***] ([***]) [***], ROCHE shall
assist SYNTA as reasonably requested in (a) causing the assignment to
SYNTA of any and all applicable Third Party Manufacturing and supply agreements
for such Licensed Product, to the extent possible, or (b) transferring the
Manufacturing process for such Licensed Product to SYNTA or a Third Party
contract manufacturer engaged by SYNTA. 
Such assistance shall include assisting SYNTA in developing and
executing a reasonable transfer and providing reasonable technical and
regulatory assistance and documentation relating to the manufacture, testing
and supply of such Licensed Product as necessary for SYNTA to be qualified or
to qualify a Third Party for the 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


51

















 


Manufacturing of such Licensed
Product.  Notwithstanding the above, if
at the time of termination of this Agreement, the transfer of Development
responsibility per Section 2.7.1 for such Licensed Product has not yet
occurred, then the transfer activities regarding Manufacture and testing of
such Licensed Product shall be limited to the transfer of documents and
shipment of such Licensed Product, including reference materials and stability
samples, at no cost to SYNTA.


 


12.6.6.               License Grants
to SYNTA.  ROCHE hereby grants to
SYNTA an exclusive, royalty-bearing (as set forth in Section 12.6.8
below), irrevocable, perpetual license, with the right to grant sublicenses,
under the ROCHE Patent Rights, ROCHE Know-how, and ROCHE’s interest in any
Joint Patent Rights or Joint Know-how, in each case Covering Collaboration
Compounds, Licensed Compounds or Licensed Products, to Research, Develop,
Manufacture, have Manufactured, use, Commercialize and import such
Collaboration Compounds and Licensed Compounds (or products containing any such
Collaboration Compound or Licensed Compound as an active ingredient) or
Licensed Products; provided, that SYNTA shall not exercise such license
unless and until this Agreement is terminated by ROCHE pursuant to Section 12.3
(Termination for Convenience), or by SYNTA pursuant to Section 12.2
(Termination for No Activity), 12.4 (Termination for Cause) or 12.5
(Termination if ROCHE Challenges SYNTA Patent Rights);


 


12.6.7.               Prosecution and
Enforcement.  The provisions of
Sections 8.2 (Prosecution and Maintenance of Patent Rights), 8.3 (Third Party
Infringement), 8.4 (Patent Invalidity Claim), 8.6 (Certification Under Drug
Price Competition and Patent Restoration Act) and 8.7 (Cooperation) shall
remain in effect with respect to the ROCHE Patent Rights, ROCHE Know-how, Joint
Patent Rights and Joint Know-how licensed to SYNTA under Section 12.6.6
above, provided, that SYNTA shall have the first right, at its
expense, to prosecute, maintain, enforce or defend, or initiate litigation with
respect to, the ROCHE Patent Rights or ROCHE Know-how under such provisions,
with ROCHE having the step-in rights of the non-initiating Party as set forth
therein;


 


12.6.8.               Royalties
Payable to ROCHE.  In the event that
this Agreement is terminated after the expiration of the Research Term, SYNTA
shall pay ROCHE, on a country-by-country and Licensed Product-by-Licensed
Product basis, royalties on the net sales (with the definition of Net Sales set
forth in Section 1.51 applied to such Licensed Product) by SYNTA, its
Affiliates and Sublicensees of Licensed Products, at the rate of [***] percent
([***]%) with respect to Licensed Products containing a Licensed Compound that
is Covered by SYNTA Patent Rights or Joint Patent Rights; provided, however,
that if such Licensed Product is instead or also Covered by ROCHE Patent
Rights, then such royalty rate shall be [***] percent ([***]%).  Any royalties payable by SYNTA pursuant to
this Section 12.6.8 shall be payable commencing on the first commercial
sale (with the definition of First Commercial Sale set forth in Section 1.26
applied to such Licensed Product) of such Licensed Product by SYNTA, its
Affiliates or Sublicensees, and shall expire on a country-by-country basis and
Licensed Product-by-Licensed Product basis on the expiration of the last Valid
Claim of the ROCHE Patent Rights, SYNTA Patent Rights or Joint Patent Rights,
as applicable, Covering the Licensed Compound contained 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


52

















 


in such Licensed Product in
such country, and subject to royalty deductions and adjustments corresponding
to those set forth under Section 7.6; and


 


12.6.9.               Assignment of
Trademark.  ROCHE shall assign to
SYNTA ROCHE’s and its Affiliates’ entire right, title and interest in, to and
under any trademark used by ROCHE, its Affiliates or Sublicensees exclusively
in connection with the Commercialization of a Licensed Product, it being
understood that such assignment shall not include the ROCHE name or trademark
for the ROCHE company itself.


 


12.7.                        Consequences
of Termination by ROCHE for SYNTA Breach. 
If ROCHE terminates this Agreement pursuant to Section 12.4
(Termination for Cause), then, at ROCHE’s election, (a) the Research
licenses granted to ROCHE pursuant to Section 6.1 (Research Licenses)
shall continue solely if the termination occurs during the Research Term and
solely to enable ROCHE to perform the Research activities with respect to any
Collaboration Compound which were not completed by SYNTA under the Research
Plan, and (b) the Development and Commercialization licenses granted to
ROCHE pursuant to Section 6.2 (Development and Commercialization License
to ROCHE) shall continue solely with respect to Licensed Compounds and Licensed
Products; in each case subject to ROCHE’s continued compliance with ROCHE’s
payment and other obligations under Article VII with respect to such
Collaboration Compounds, Licensed Compounds or Licensed Products.


 


12.8.                        Effect
of Termination and Expiration; Accrued Rights and Obligations.  Upon termination or expiration of this
Agreement for any reason, all rights and obligations of the Parties, including
the licenses granted hereunder, shall end, unless otherwise set forth in this Article XII.  Termination of this Agreement for any reason
shall not release either Party from any liability that, at the time of such
termination, has already accrued or that is attributable to a period prior to
such termination (including payments for Research and Development work
performed, and other payment obligations under Article VII accrued, prior
to the effective date of termination) nor preclude either Party from pursuing
any right or remedy it may have hereunder or at Law or in equity with respect
to any breach of this Agreement. 
Notwithstanding the preceding sentence, (a) if this Agreement is
terminated by ROCHE pursuant to Section 12.4 (Termination for Cause), then
ROCHE need not make any payments pursuant to Section 7.4 (Development
Event Payments) that first accrue during the applicable cure period set forth
in Section 12.4 with respect to the breach for which ROCHE so terminated
this Agreement, and (b) if this Agreement is terminated in its entirety by
ROCHE pursuant to Section 12.3 (Termination for Convenience), then ROCHE
need not make any payments pursuant to rows (a) through (d) in the
table in Section 7.4 (Development Event Payments) that first accrue during
the three (3) month notice period set forth in Section 12.3 with
respect to such termination.  In
addition, if this Agreement is terminated, by ROCHE pursuant to Section 12.3
(Termination for Convenience), or by SYNTA pursuant to Section 12.2
(Termination for No Activity), 12.4 (Termination for Cause) or 12.5
(Termination if ROCHE Challenges SYNTA Patent Rights), then ROCHE shall
continue to be responsible for all non-cancellable costs committed to by SYNTA
which would otherwise have been reimbursed by ROCHE hereunder and all costs
committed to by SYNTA for Development activities which cannot be cancelled for
ethical reasons; provided, that SYNTA shall use Commercially Reasonable
Efforts to mitigate such costs.  It is
understood and agreed 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


53

















 


that monetary damages may not
be a sufficient remedy for any breach of this Agreement and that the
non-breaching Party may be entitled to seek injunctive relief as a remedy for
any such breach.


 


12.9.                        Survival.  The rights and obligations set forth in this
Agreement shall extend beyond the termination or expiration of this Agreement
only to the extent expressly provided for in this Agreement or to the extent
required to give effect to a termination of this Agreement or the consequences
of a termination of this Agreement as expressly provided for in this
Agreement.  Without limiting the
generality of the foregoing, it is agreed that the provisions of Sections
2.5.2, 6.5, 6.7, 7.7.2, 7.7.6, 7.7.7, 7.9, 8.1, 9.1, 9.2, 9.3.4, 10.5, 11,
12.6, 12.7, 12.8, 12.9, 12.10, 13 and 14, except for Section 14.3, and,
solely with respect to Joint Intellectual Property, Sections 8.2.3, 8.2.5,
8.2.6, 8.3.1, 8.3.4, 8.3.5, 8.3.6, 8.4, 8.6 and 8.7 shall survive expiration or
termination of this Agreement for any reason.


 


12.10.                  Consequences
Regarding Termination of Licensed Compounds in One or More Regions for
Convenience.  If ROCHE terminates
this Agreement pursuant to Section 12.3 (Termination for Convenience) with
respect to a Licensed Compound in one or more Regions, then:


 


12.10.1.         Termination of
Licenses.  The licenses granted by
SYNTA to ROCHE pursuant to Section 6.2 (Development and Commercialization
License to ROCHE) shall automatically terminate, in all Terminated Regions,
with respect to such Licensed Compound and all Licensed Products containing
such Licensed Compound;


 


12.10.2.         Regulatory Matters.  ROCHE shall (a) transfer to SYNTA
ownership of all regulatory filings filed in, and Regulatory Approvals received
with respect to, any Terminated Region (or any country therein), which filings
or Regulatory Approvals are in ROCHE’s or its Affiliates’ possession or control
and relate to such Licensed Compound and Licensed Products containing such
Licensed Compound; and (b) grant SYNTA or its designees a Right of
Reference or Use to any and all regulatory filings filed in, and Regulatory
Approvals received with respect to, any Region (or country) other than a
Terminated Region (or any country therein), which filings or Regulatory
Approvals are in ROCHE’s or its Affiliates’ possession or control and relate to
such Licensed Compound and Licensed Products containing such Licensed Compound,
and ROCHE shall sign, and cause its Affiliates to sign, any instruments reasonably
requested by SYNTA in order to effect such grant.  For the sake of clarity, SYNTA may publish on
its clinical trial registry any Clinical Trials with respect to Licensed
Products containing such Licensed Compound or results thereof;


 


12.10.3.         Preclinical and
Clinical Matters.  (a) Once such
Licensed Compound is terminated in all Regions, ROCHE shall assign to SYNTA its
entire right, title, and interest in and to all preclinical and clinical data,
including pharmacology and biology data, in ROCHE’s or its Affiliates’
possession or control, relating to, and to the extent necessary for SYNTA to
continue, the Development or Commercialization of such Licensed Compound and
Licensed Products containing such Licensed Compound; (b) If such Licensed
Compound is terminated in some, but not all, Regions, then ROCHE shall provide
to SYNTA a copy of all preclinical and clinical data, including pharmacology
and biology data, in ROCHE’s or its 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


54

















 


Affiliates’ possession or control,
relating to, and to the extent necessary for SYNTA to continue, the Development
or Commercialization of such Licensed Compound and Licensed Products containing
such Licensed Compound;


 


12.10.4.         Worldwide
Manufacturing Matters.  Once such
Licensed Compound is terminated in all Regions, then, at SYNTA’s option, ROCHE
shall (a) to the extent assignable at no cost to ROCHE, assign to SYNTA
each manufacturing agreement then in effect with respect to the Manufacture of
such Licensed Compound and Licensed Products containing such Licensed Compound;
(b) transfer to SYNTA Manufacturing documents and materials which are used
(at the time of the termination) by or on behalf of ROCHE, its Affiliates or
Sublicensees in the Manufacture of such Licensed Compound and Licensed Products
containing such Licensed Compound; and (c) upon SYNTA’s request, sell to
SYNTA (or its designee) ROCHE’s then-existing inventory of such Licensed
Compound and Licensed Products containing such Licensed Compound, at FBMC;


 


12.10.5.         Regional Manufacturing
Matters.  If such Licensed Compound
is terminated in some, but not all, Regions, then, at SYNTA’s option, ROCHE
shall sell to SYNTA (or its designee) a proportionate amount of ROCHE’s
then-existing inventory of such Licensed Compound and Licensed Products
containing such Licensed Compound, at FBMC, which proportion reflects (a) if
such Licensed Products had been Commercialized in each Region prior to such
termination, the proportion of units of such Licensed Products sold in the
Terminated Regions during the [***] ([***]) [***] period prior to such
termination, compared to the number of units of such Licensed Products sold
worldwide during such [***] ([***]) [***] period, or (b) if such Licensed
Products had not been Commercialized in each Region prior to such termination,
an estimate, as mutually agreed by the Parties in good faith, of the number of
units of such Licensed Products anticipated to be sold in the Terminated
Regions during the [***] ([***]) [***] period immediately following such
termination, compared to the number of units of such Licensed Products
anticipated to be sold worldwide during such [***] ([***]) [***] period; provided,
however, that, if the then-existing inventory is not sufficient to
provide both SYNTA with such amounts and ROCHE with the amounts of such
Licensed Compound and Licensed Products containing such Licensed Compound it
reasonably requires to Commercialize such Licensed Products in the next [***]
([***]) [***] period, then ROCHE may retain as much of such then-existing
inventory as it reasonably requires to Commercialize such Licensed Products in
the next [***] ([***]) [***] period;


 


12.10.6.         ROCHE Manufacturing.  To the extent ROCHE (or an Affiliate of
ROCHE) is Manufacturing (on its own or through any Third Party contract
manufacturer) any such Licensed Product that has achieved First Commercial Sale
in any country (a “Terminated Commercial Product”), ROCHE (or its
Affiliate) shall, at SYNTA’s request, continue, for a period up to [***]
([***]) [***], to Manufacture (or have Manufactured) such Terminated Commercial
Product and supply such Terminated Commercial Product to SYNTA, for SYNTA to
Develop such Terminated Commercial Product for, and Commercialize such
Terminated Commercial Product in, the Terminated Regions.  ROCHE shall be obligated to supply, with the
proviso that ROCHE need not increase its manufacturing capacity, quantities of
such Terminated Commercial Product sufficient to satisfy SYNTA’s requirements
under a manufacturing transfer 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


55

















 


and transition plan to be negotiated by the
Parties in good faith so that SYNTA can assume, with regard to such Terminated
Commercial Product, all Development activities for, and Commercialization
activities in, the Terminated Regions. 
ROCHE will supply such quantities of Terminated Commercial Product at
ROCHE’s FBMC (as such term is consistently applied by ROCHE at the time of
supply) plus [***] percent ([***]%).  In
addition, for a period of time to be agreed upon in good faith by the Parties
up to [***] ([***]) [***], ROCHE shall assist SYNTA as reasonably requested (a) in
causing the assignment to SYNTA of any and all applicable Third Party
Manufacturing and supply agreements for such Terminated Commercial Product, to
the extent possible without jeopardizing ROCHE’s manufacturing needs, and (b) in
transferring the Manufacturing process for such Terminated Commercial Product to
SYNTA or a Third Party contract manufacturer engaged by SYNTA.  Such assistance shall include assisting SYNTA
in developing and executing a reasonable transfer and providing reasonable
technical and regulatory assistance and documentation relating to the
manufacture, testing and supply of such Licensed Product as necessary for SYNTA
to be qualified or to qualify a Third Party for the Manufacturing of such
Licensed Product.  Prior to such Licensed
Product achieving First Commercial Sale in any country, the transfer activities
regarding Manufacture and testing of such Licensed Product shall be limited to
the transfer of documents and shipment of such Licensed Product, including
reference materials and stability samples, at no cost to SYNTA;


 


12.10.7.         License Grants to
SYNTA.  ROCHE hereby grants SYNTA (a) an
exclusive, royalty-bearing (as set forth in Section 12.10.9 below),
irrevocable, perpetual license, with the right to grant sublicenses, under the
ROCHE Patent Rights, ROCHE Know-how, and ROCHE’s interest in any Joint Patent
Rights or Joint Know-how, in each case Covering such Licensed Compound, to Develop,
Manufacture, have Manufactured, use, Commercialize and import such Licensed
Compounds or Licensed Products containing such Licensed Compound, in each case
in the Terminated Regions, and (b) to the extent that such Licensed
Compound is not terminated in all Regions, a non-exclusive, royalty-bearing (as
set forth in Section 12.10.9 below), irrevocable, perpetual license, with
the right to grant sublicenses, under the ROCHE Patent Rights, ROCHE Know-how,
and ROCHE’s interest in any Joint Patent Rights or Joint Know-how, in each case
Covering such Licensed Compound, to Develop, Manufacture and have Manufactured,
and to use and import for purposes of Development and Manufacturing, such
Licensed Compounds or Licensed Products containing such Licensed Compound, in
each case in each Region not yet terminated;


 


12.10.8.         Prosecution and
Enforcement.  The provisions of
Sections 8.2 (Prosecution and Maintenance of Patent Rights), 8.3 (Third Party
Infringement), 8.4 (Patent Invalidity Claim), 8.6 (Certification Under Drug
Price Competition and Patent Restoration Act) and 8.7 (Cooperation) shall
remain in effect with respect to the ROCHE Patent Rights, ROCHE Know-how, Joint
Patent Rights and Joint Know-how licensed to SYNTA under Section 12.10.7; provided,
that SYNTA shall have the first right, at its expense, to prosecute,
maintain, enforce or defend, or initiate litigation with respect to, the ROCHE
Patent Rights or ROCHE Know-how under such provisions, with ROCHE having the
step-in rights of the non-initiating Party as set forth therein;


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


56

















 


12.10.9.         Royalties Payable to
ROCHE.  In the event that ROCHE
terminates this Agreement pursuant to Section 12.3 (Termination for
Convenience) with respect to a Licensed Compound after the expiration of the
Research Term, SYNTA shall pay ROCHE, on a country-by-country and Licensed
Product-by-Licensed Product basis, royalties on the net sales (with the
definition of Net Sales set forth in Section 1.50 applied to such Licensed
Product) by SYNTA, its Affiliates and Sublicensees of Licensed Products
containing such Licensed Compound in the Terminated Regions, at the rate of
[***] percent ([***]%) with respect to Licensed Products containing a Licensed
Compound that is Covered by SYNTA Patent Rights or Joint Patent Rights; provided,
however, that if such Licensed Product is instead or also Covered
by ROCHE Patent Rights, then such royalty rate shall be [***] percent
([***]%).  Any royalties payable by SYNTA
pursuant to this Section 12.10.9 shall be payable commencing on the first
commercial sale (with the definition of First Commercial Sale set forth in Section 1.26
applied to such Licensed Product) of such Licensed Product by SYNTA, its
Affiliates or Sublicensees in the relevant country in the Terminated Region,
and shall expire on a country-by-country basis and Licensed Product-by-Licensed
Product basis on the expiration of the last Valid Claim of the ROCHE Patent
Rights, SYNTA Patent Rights or Joint Patent Rights, as applicable, Covering
such Licensed Compound in such country, and subject to royalty deductions and
adjustments corresponding to those set forth under Section 7.6; and


 


12.10.10.   Assignment of Trademark.  ROCHE shall assign to SYNTA ROCHE’s and its
Affiliates’ entire right, title and interest in, to and under any trademark
used by ROCHE, its Affiliates or Sublicensees in connection with the
Commercialization of such Licensed Compound (or Licensed Product containing
such Licensed Compound) in the Terminated Regions, it being understood that
such assignment shall not include the ROCHE name or trademark for the ROCHE
company itself.


 


ARTICLE XIII
-DISPUTE RESOLUTION


 


13.1.                        Referral
of Unresolved Matters to Executive Officers.  Subject to Section 3.2.4, and except for
matters that are subject to a Party’s final decision making authority pursuant
to Section 8.2.6(b) (Patent Term Extensions) or Section 2 of Schedule
5.3 (Co-Promotion Terms), if the JSC is unable to resolve any matter
considered by it, including matters referred to it by the JRDC, within [***]
([***]) [***] after the matter is first considered by it, the matter shall be
referred to the Executive Officers to be resolved by negotiation in good faith
as soon as is practicable but in no event later than [***] ([***]) [***] after
referral.  Such resolution, if any, of a
referred issue by the Executive Officers shall be final and binding on the
Parties.


 


13.2.                        Alternative
Dispute Resolution.  Subject to
Sections 3.2.4 (Decision-Making) and 13.1, if a dispute referred to the
Executive Officers has not been resolved by the Executive Officers within [***]
([***]) days after referral, or if the Executive Officers fail to meet within
such [***] ([***]) days, a Party may seek resolution of the dispute by
initiating arbitration in accordance with the following provisions.


 


13.2.1.               Location.  All disputes arising out of this Agreement
and referred to arbitration pursuant to this Section 13.2 shall be finally
resolved by arbitration conducted by a 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


57

















 


single arbitrator (unless the
Parties mutually agree to three (3) arbitrators) in New York, New York in
the English language in accordance with the Commercial Arbitration Rules of
the American Arbitration Association (“AAA”).  Such arbitrator shall be appointed by the AAA
pursuant to its procedures.  The AAA
shall be the administrator of the arbitration proceedings.


 


13.2.2.               Ruling.  The arbitrator(s) may proceed to an
award notwithstanding the failure of the other Party to participate in the
proceedings.  The Parties shall use good
faith efforts to complete arbitration under this Section 13.2 within
ninety (90) days following the initiation of such arbitration.  The arbitrator(s) shall establish
reasonable additional procedures to facilitate and complete such arbitration
within such ninety (90) day period.  The
arbitrator(s) shall be authorized to grant interim relief, including to
prevent the destruction of goods or documents involved in the dispute, protect
trade secrets and provide for security for a prospective monetary award.  The arbitrator(s) shall issue a written
decision in order to explain the basis of the ruling, unless otherwise agreed
by the Parties.  The arbitrator(s) shall
not have the authority to award special, incidental, consequential, exemplary,
punitive, multiple or other indirect damages or loss of profits, loss of data
or loss of use damages, except as permitted under Section 11.5.


 


13.2.3.               Fees.  The arbitrator(s) shall be paid
reasonable fees plus expenses.  These
fees and expenses, along with the reasonable legal fees and expenses of the
prevailing Party (including all expert witness fees and expenses), the fees and
expenses of a court reporter, and any expenses for a hearing room, shall be
paid as follows:


 


(a)                                                                  If
the arbitrator(s) rule in favor of one Party on all disputed issues
in the arbitration, the losing Party shall pay all such fees and expenses.


 


(b)                                                                 If
the arbitrator(s) rule in favor of one Party on some issues and the
other Party on other issues, the arbitrator(s) shall issue with the ruling
a written determination as to how such fees and expenses shall be allocated
between the Parties.  The arbitrator(s) shall
allocate fees and expenses in a way that bears a reasonable relationship to the
outcome of the arbitration, with the Party prevailing on more issues, or on
issues of greater value or gravity, recovering a relatively larger share of its
legal fees and expenses.


 


13.2.4.               Decision.  Any decision or award of the arbitrator(s) shall
be final, conclusive, and binding on the Parties, and judgment may be entered
on any award in any court of competent jurisdiction, subject only to revocation
on grounds of fraud or clear bias on the part of the arbitrators.  To the extent lawful, the Parties otherwise
exclude any right of application or appeal to the courts in connection with any
matter arising in the arbitration or in connection with any award or decision
made by the arbitrators.


 


13.2.5.               No Limitation.  Notwithstanding the foregoing, (a) nothing
in this Article XIII shall be construed as limiting in any way the right
of a Party to seek injunctive or other equitable relief from a court of
competent jurisdiction with respect to any actual or threatened breach of this
Agreement, and (b) each Party shall have the right to institute judicial
proceedings against the other Party (or anyone acting by or through such other
Party), in order to 


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


58

















 


enforce such Party’s rights
under this Agreement or under any decision or award of the arbitrator(s),
through reformation of contract, specific performance, injunction or similar
equitable relief.


 


13.2.6.               No Arbitration
of Patent Matters.  Unless otherwise
agreed by the Parties, a dispute between the Parties relating to the validity,
infringement or enforceability of patents shall not be subject to arbitration
and shall by submitted to a court of competent jurisdiction.


 


ARTICLE XIV
-MISCELLANEOUS


 


14.1.                        Governing
Law.  This Agreement and any dispute
arising from the performance or breach of this Agreement shall be governed by,
construed and enforced in accordance with the laws of the State of Delaware,
other than any principle of conflict or choice of laws that would cause the
application of the laws of any other jurisdiction; provided that
with respect to matters involving enforcement of intellectual property rights,
the Laws of the applicable country shall apply. 
The provisions of the United Nations Convention on Contracts for the
International Sale of Goods shall not apply to this Agreement or any subject
matter hereof.


 


14.2.                        Waiver.  Waiver by a Party of a breach hereunder by
the other Party shall not be construed as a waiver of any succeeding breach of
the same or any other provision.  No
delay or omission by a Party to exercise or avail itself of any right, power or
privilege that it has or may have hereunder shall operate as a waiver of any
right, power or privilege by such Party. 
No waiver shall be effective unless made in writing with specific
reference to the relevant provision(s) of this Agreement and signed by a
duly authorized representative of the Party granting the waiver.


 


14.3.                        Change
of Control.  If SYNTA undergoes a
Change of Control to or with a Third Party, then, at ROCHE’s election, ROCHE
may terminate either:  (i) the
rights of such Third Party, as assignee of SYNTA’s rights under this Agreement,
to participate on the JRDC or JSC, or (ii) the rights of such Third Party,
as assignee of SYNTA’s rights under this Agreement, to Co-promote Licensed
Products under this Agreement, or both (i) and (ii).


 


14.4.                        Notices.  All notices, instructions and other
communications hereunder or in connection herewith shall be in writing, shall
be sent to the address specified in this Section 14.4 and shall be:  (a) delivered personally; (b) sent
by registered or certified mail, return receipt requested, postage prepaid; (c) sent
via a reputable nationwide overnight courier service; or (d) sent by
facsimile transmission.  Any such notice,
instruction or communication shall be deemed to have been delivered upon receipt
if delivered by hand, three (3) Business Days after it is sent by
registered or certified mail, return receipt requested, postage prepaid, one (1) Business
Day after it is sent via a reputable nationwide overnight courier service, or
when transmitted with electronic confirmation of receipt, if transmitted by
facsimile (if such transmission is on a Business Day; otherwise, on the next
Business Day following such transmission).


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


59

















 


Notices to
ROCHE shall be addressed to:


 


F. Hoffmann-La
Roche Ltd


Grenzacherstrasse
124


4070 Basel


Switzerland


Attention: 
Legal Department


Facsimile:  41 61 688 1396


 


And:


 


Hoffmann-La Roche Inc.


340 Kingsland Street


Nutley, New Jersey 07110


USA


Attention: 
Corporate Secretary


Facsimile:  1-(973) 235-3500


 


With a copy to:


 


F. Hoffmann-La Roche Ltd


Grenzacherstrasse
124


4070 Basel


Switzerland


Attention:  Pharma Partnering


Facsimile:  41 61 688 7990


 


Notices to
SYNTA shall be addressed to:


 


Synta Pharmaceuticals Corp.


45 Hartwell Avenue


Lexington, MA 02421


USA


Attention: 
Business Development


Facsimile:
1-(781) 274-8228


 


With copies to:


 


Synta Pharmaceuticals Corp.


45 Hartwell Avenue


Lexington, MA 02421


USA


Attention: 
General Counsel


Facsimile:
1-(781) 274-8228


 


Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.


 


60














 


And:


 


WilmerHale

60 State Street

Boston, MA USA 02109


Attention:  
Belinda M. Juran, Esq.

Facsimile:   1-(617) 526-5000


 


Either Party may change its address by giving
notice to the other Party in the manner provided above.


 


14.5.   Entire
Agreement.  This Agreement (including
all attachments hereto) contains the complete understanding of the Parties with
respect to the subject matter hereof, sets forth all the covenants, promises,
agreements, warranties, representations, conditions and understandings between
the Parties and supersedes all prior understandings and writings relating to
such subject matter.  In particular, and
without limitation, it supersedes and replaces the Confidentiality Agreements
and any and all term sheets relating to the transactions contemplated by this
Agreement and exchanged between the Parties prior to the Effective Date.  For the sake of clarity, nothing herein shall
terminate or supersede the Confidential Disclosure Agreement between SYNTA and
ROCHE NUTLEY dated as of August 5, 2005. 
No amendment, change or addition to this Agreement will be effective or
binding on either Party unless reduced to writing and duly executed on behalf
of both Parties.


 


14.6.   Headings.  Headings in this Agreement are for
convenience of reference only and shall not be considered in construing this
Agreement.


 


14.7.   Severability.  If any provision of this Agreement is held
unenforceable by a court or tribunal of competent jurisdiction because it is
invalid or conflicts with any Law of any relevant jurisdiction, the validity of
the remaining provisions shall not be affected. 
In such event, the Parties shall negotiate a substitute provision that,
to the extent possible, accomplishes the original business purpose.


 


14.8.   Assignment.  Neither this Agreement nor any right or
obligation hereunder may be assigned or otherwise transferred by any Party
without the written consent of the other Party; provided, however
that any Party may, without such consent, assign this Agreement, in whole or in
part:  (a) to any of its respective
Affiliates, provided that such Party shall remain jointly
and severally liable with such Affiliate in respect of all obligations so
assigned and such Affiliate has acknowledged and confirmed in writing that,
effective as of such assignment or other transfer, such Affiliate shall be
bound by this Agreement as if it were a party to it as and to the identical
extent applicable to the transferor; or (b) to any successor in interest
by way of merger or acquisition or by sale of all or substantially all of its
assets to which this Agreement pertains (whether by merger, reorganization,
acquisition, sale or otherwise), provided, that such successor
agrees in writing to be bound by the terms of this Agreement as if it were the
assigning party.  Any purported
assignment in violation of this Section 14.8 shall be void.  The terms of this 


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


61

















 


Agreement shall be binding on
and inure to the benefit of the permitted successors and assigns of the
Parties.


 


14.9.   Counterparts.  This Agreement may be executed in any number
of counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument


 


14.10.  Force Majeure. 
No Party shall be liable for failure of or delay in performing
obligations set forth in this Agreement, and no Party shall be deemed in breach
of its obligations, if such failure or delay is due to a natural disaster,
explosion, fire, flood, tornadoes, thunderstorms, earthquake, war, terrorism, riots,
embargo, losses or shortages of power, labor stoppage, substance or material
shortages, damage to or loss of product in transit, events caused by reason of
Laws of any Regulatory Authority, events caused by acts or omissions of a Third
Party, or any other cause reasonably beyond the control of such Party.  The Party affected by such force majeure will
provide the other Party with full particulars thereof as soon as it becomes
aware of the same (including its good faith estimate of the likely extent and
duration of the interference with its activities), and will use Commercially
Reasonable Efforts to overcome the difficulties created thereby and to resume
performance of its obligations as soon as practicable.  If the performance of any such obligation under
this Agreement is delayed owing to such a force majeure for any continuous
period of more than one hundred eighty (180) days, the Parties will consult
with respect to an equitable solution, including the possibility of the mutual
termination of this Agreement.


 


14.11.  Press
Releases and Other Disclosures.  The
Parties will cooperate in the release of a joint press release, substantially
in the form set forth in Schedule 14.11, as soon as practicable after
the Execution Date of this Agreement. 
The Parties also recognize that each Party may from time to time desire
to issue additional press releases and make other public statements or
disclosures regarding the subject matter of this Agreement.  In such event, the Party desiring to issue an
additional press release or make a public statement or disclosure shall provide
the other Party with a copy of the proposed press release, statement or
disclosure for review, comment and approval at least [***] ([***]) Business
Days in advance (or such shorter period as would permit the publicizing Party
to comply with applicable Law), which advance approval shall not be
unreasonably withheld, conditioned or delayed (except that neither Party shall
have any obligation to disclose Confidential Information except to the extent
required or permitted pursuant to Article IX).  The reviewing Party shall notify the
publicizing Party within such [***] ([***]) Business Days period (or such
shorter period) of its comments and whether it approves such disclosure.  It is agreed that each such disclosure shall
only be done with such approval of the other Party and no other public
statement or disclosure concerning the existence or terms of this Agreement
shall be made, either directly or indirectly, by either Party, without first
obtaining the written approval of the other Party.  Notwithstanding the foregoing provisions of
this Section 14.11 or of Article IX, (a) a Party may make any
disclosure or public announcement if the contents of such disclosure or public
announcement have previously been made public other than through a breach of
this Agreement by the issuing Party; (b) if a Party reasonably determines
that a public disclosure shall be required by Law, including in a public filing
with the U.S. Securities and Exchange Commission, such Party may disclose the
existence and terms of this Agreement 


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under Rule 24b-2
of the Securities Exchange Act of 1934, as amended.


 


62

















 


and any material developments
that occur under this Agreement where so required, provided that
such Party shall, to the extent practicable and permitted by applicable Law,
notify the other Party and allow the other Party to comment on the proposed
disclosure, which comments shall be considered by the disclosing Party in good
faith; (c) a Party may disclose the existence and terms of this Agreement
under obligations of confidentiality to bona fide potential or actual advisors,
consultants, investors, lenders, investment bankers or other potential
financial partners in connection with such Party’s proposed financing or
business combination activities; and (d) a Party may disclose the terms
and existence of this Agreement to bona fide potential or actual Sublicensees,
as reasonably necessary in connection with a permitted sublicense under the
licenses granted in this Agreement.


 


14.12.  Third
Party Beneficiaries.  None of the
provisions of this Agreement shall be for the benefit of or enforceable by any
Third Party other than an indemnitee under Article XI.  No such Third Party shall obtain any right
under any provision of this Agreement or shall by reason of any such provision
make any claim in respect of any debt, liability or obligation (or otherwise)
against either Party.


 


14.13.  Relationship of the Parties.  Each Party shall bear its own costs incurred
in the performance of its obligations hereunder without charge or expense to
the other, except as expressly provided in this Agreement.  Neither Party shall have any responsibility
for the hiring, termination or compensation of the other Party’s employees or
for any employee compensation or benefits of the other Party’s employees.  No employee or representative of a Party
shall have any authority to bind or obligate the other Party for any sum or in
any manner whatsoever, or to create or impose any contractual or other
liability on the other Party without such other Party’s approval.  For all purposes, and notwithstanding any
other provision of this Agreement to the contrary, the legal relationship under
this Agreement of each Party to the other Party shall be that of independent
contractor.  Nothing in this Agreement
shall be construed to establish a relationship of partners or joint venturers
between the Parties.


 


14.14.  Performance by Affiliates.  Either Party may use one or more of its
Affiliates to perform its obligations and duties hereunder and Affiliates of a
Party are expressly granted certain rights herein; provided, that each
such Affiliate shall be bound by the corresponding obligations of such Party
and the relevant Party shall remain liable hereunder for the prompt payment and
performance of all their respective obligations hereunder.  ROCHE BASEL and ROCHE NUTLEY shall be jointly
and severally liable to SYNTA for any obligations owed hereunder by ROCHE
BASEL, ROCHE NUTLEY or ROCHE.  ROCHE
BASEL and ROCHE NUTLEY shall coordinate their exercise of ROCHE’s rights and
performance of ROCHE’s obligations to ensure that SYNTA does not receive
inconsistent notices or instruction with respect thereto.


 


14.15.  Construction.  Each Party acknowledges that it has been
advised by counsel during the course of negotiation of this Agreement, and,
therefore, that this Agreement shall be interpreted without regard to any
presumption or rule requiring construction against the Party causing this
Agreement to be drafted.  Any reference
in this Agreement to an Article, Section, subsection, paragraph, clause,
Schedule, or Exhibit shall be deemed to be a reference to any 


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


63

















 


Article, Section, subsection,
paragraph, clause, Schedule, or Exhibit, of or to, as the case may be, this
Agreement.  Except where the context
otherwise requires, (a) wherever used, the use of any gender will be
applicable to all genders, (b) the word “or” is used in the inclusive
sense (and/or), (c) any definition of or reference to any agreement,
instrument or other document refers to such agreement, instrument other
document as from time to time amended, supplemented or otherwise modified
(subject to any restrictions on such amendments, supplements or modifications
set forth herein or therein), (d) any reference to any Laws refers to such
Laws as from time to time enacted, repealed or amended, (e) the words “herein”,
“hereof” and hereunder”, and words of similar import, refer to this Agreement
in its entirety and not to any particular provision hereof, and (f) the
words “include”, “includes” and “including” shall be deemed to be followed by
the phrase “but not limited to”, “without limitation” or words of similar
import.


 


[Remainder of page intentionally left blank.]


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


64

















 


IN WITNESS WHEREOF, the Parties
have entered into this Collaboration and License Agreement as of the Execution
Date.


 


SYNTA
PHARMACEUTICALS CORP.


 


	
  By:

  	
  /s/ Safi R. Bahcall

  	
   

  	
   

  
	
   

  	
  Name: 

  	
  Safi R. Bahcall

  	
   

  
	
   

  	
  Title: 

  	
  President & CEO

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  F.
  HOFFMANN-LA ROCHE LTD

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Jorg Kazenwadel

  	
   

  	
  By:

  	
  /s/ Stefan Arnold

  
	
   

  	
  Name: 

  	
  Jorg Kazenwadel

  	
   

  	
  Name: 

  	
  Stefan Arnold

  
	
   

  	
  Title: 

  	
  GAO

  	
   

  	
  Title: 

  	
  Legal Counsel

  
	
   

  	
   

  
	
   

  	
   

  
	
  HOFFMANN-LA
  ROCHE INC.

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ George W. Johnston

  	
   

  	
   

  
	
   

  	
  Name: 

  	
  George W. Johnston

  	
   

  
	
   

  	
  Title: 

  	
  Vice President

  	
   

  
							



 


[Execution Page]


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

















 


EXHIBIT A


 


SYNTA PATENT RIGHTS


 


	
  Country

  	
   

  	
  Patent Application # or Patent No.

  	
   

  	
  Filing Date

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


A-1

















 


	
  Country

  	
   

  	
  Patent Application # or Patent No.

  	
   

  	
  Filing Date

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


A-2

















 


	
  Country

  	
   

  	
  Patent Application # or Patent No.

  	
   

  	
  Filing Date

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


A-3

















 


	
  Country

  	
   

  	
  Patent Application # or Patent No.

  	
   

  	
  Filing Date

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


A-4

















 


EXHIBIT B


 


RESEARCH PLAN


 


[***]


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


B-1














 


EXHIBIT C


 


DEVELOPMENT PLAN — PRE-IND


 


[***]


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


C-1

















 


[***]


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


C-2

















 


EXHIBIT D


 


DEVELOPMENT PLAN — PHASE 1 AND PHASE 2A


 


[***]


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


D-1

















 


SCHEDULE 5.3


 


Co-Promotion Terms


 


1.                                       Certain
Definitions:


 


(a)           “Detail”
means that part of an in-person, face-to-face sales call during which a Sales
Representative makes a presentation, including core selling message and
features and benefits, of a Licensed Product to one or more member of the
Target Audience.  E-details and
presentations made at conventions and exhibit booths shall not constitute one
or more Details.


 


(b)           “Detail
Percentage” means (i) with respect to asthma, up to [***] percent
([***]%), as determined by SYNTA, and (ii) with respect to any other
Indication other than asthma, up to [***] percent ([***]%), as determined by
SYNTA.


 


(c)           “Sales
Representative” means a professional pharmaceutical sales representative
engaged or employed by either Party to conduct, among other sales
responsibilities, Detailing and other promotional efforts with respect to a
Co-promoted Product and who has been trained by either Party in accordance with
Paragraph 4 below.  In the case of SYNTA,
a Sales Representatives shall be an employee of SYNTA.


 


(d)           “Sales
Representative FTE Rate” means the lower of (a) ROCHE’s fully
burdened, average annual cost for its Sales Representatives that are ROCHE
employees or (b) SYNTA’s fully burdened average annual cost for its Sales Representatives
that are SYNTA employees; in each case with respect to Sales Representatives
promoting the same Co-promoted Product. 
For purposes of this subsection (d), such costs shall be determined in a
manner reasonably consistent between the Parties.


 


(e)           “Target
Audience” means the physicians who meet the relevant criteria for promoting
and Detailing a Licensed Product for a particular Indication.


 


2.                                       Co-promotion
Guidelines.  With respect to each
Co-promoted Product, SYNTA shall have the right to assume responsibility for
the applicable Detail Percentage of the annual budgeted Detailing effort for
such Co-promoted Product in the United States for the applicable
Indication.  If SYNTA elects to
participate in the Co-promotion of a Licensed Product as set forth above, then
the Parties shall work in good faith to most effectively assign sales
territories and assign target physicians between their respective sales
forces.  Notwithstanding the foregoing,
SYNTA shall have final decision-making authority as to whether it will accept
the geographic location and size of its sales territories within the U.S.  If SYNTA does not accept a particular
geographic location or size of its sales territories within the U.S., then ROCHE
shall in good faith discuss with SYNTA a reasonably acceptable alternative such
that SYNTA has the ability to provide the Detail Percentage of the annual
budgeted Detailing effort for such Co-promoted Product in the United States for
the applicable Indication.  Promptly
following exercise by SYNTA of its right to participate in the Co-promotion of
a Product in the United States, ROCHE shall modify its relevant
Commercialization plans to provide for the Co-promotion of the Co-promoted
Product in the United States for the applicable Indication (the “Co-promotion



 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


1

















 


Guidelines”), which
shall consider in good faith the reasonable suggestions and comments of
SYNTA.  Notwithstanding the previous
sentence, ROCHE shall have final decision making authority with regard to (i) generating
the Co-promotion Guidelines (provided, that, such Co-Promotion
Guidelines shall (A) comply with applicable Law, (B) be generated in
good faith and (C) not contain provisions that disfavor SYNTA and its
Sales Representatives or that cause an undue burden on SYNTA or its Sales
Representatives) and (ii) all promotional materials and strategies.  The Co-promotion Guidelines shall address the
following matters:


 


(1)           the
annual budgeted total Detailing effort for the United States;


 


(2)           the
allocation of the total Detailing effort between the Parties, it being
understood that, SYNTA may elect to be responsible for the applicable Detailing
Percentage of the annual budgeted Detailing effort;


 


(3)           the
number and position of Details and categories of professionals or institutions
to be targeted, and the allocation of such professionals or institutions
between the Parties in accordance with the Detail Percentage elected by SYNTA;
and


 


(4)           policies
and procedures relating to Co-promoted Product sampling.


 


3.                                       Co-promotion
Detail Records and Metrics.  Each
Party shall manage in good faith its annual Detailing on a basis consistent
with the Co-promotion Guidelines.  Each
Party shall keep track of the number and position of Details performed by its
Sales Representatives in accordance with its normal internal reporting
procedures.  Within [***] ([***]) days
after the last day of each Calendar Quarter, each Party shall submit to the
other Party a report with respect to the number of Details performed by its
Sales Representatives during such Calendar Quarter.


 


4.                                       Co-promotion
Training and Materials.


 


(a)           Except
as set forth below, each Party shall be responsible for staffing, training,
supervising and compensating (including incentives) its own sales personnel.  ROCHE shall be responsible for the
development of Co-promoted Product-specific training materials, and shall
provide such materials to SYNTA’s sales force, at ROCHE’s expense.  Each
Party shall use the same training materials for its respective sales
personnel.  ROCHE shall conduct
Co-promoted Product-specific training of SYNTA’s sales management, sales
training personnel, and sales representatives, at ROCHE’s expense.  Following such initial training, any
subsequent training of SYNTA’s training personnel shall be made available by
ROCHE at ROCHE’s expense only when ROCHE trains its own Sales Representatives
on the Co-promoted Product. All Co-promoted Product-specific training materials
prepared and supplied by ROCHE for use in the United States will comply with
all applicable Laws and the Co-promotion Guidelines.


 


(b)           SYNTA’s
Sales Representatives will utilize only the promotional materials provided to
them by ROCHE, and will not utilize any other promotional, advertising,
communications or other materials, relating to or referring to the Co-promoted
Product.  SYNTA’s Sales Representatives
will conduct only those promotional activities relating to the Co-promoted
Product that have been approved in advance in accordance with the Co-promotion 


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


2

















 


Guidelines. 
SYNTA’s Sales Representatives shall not modify, change or alter the
promotional materials in any way whatsoever without the express prior written
consent of ROCHE.  SYNTA’s Sales
Representatives shall use the promotional materials solely for the purpose of
performing their obligations under this Agreement.  SYNTA shall require that its Sales
Representatives perform Co-promotion activities in compliance with all applicable
Laws and the Co-promotion Guidelines.


 


5.                                       Co-promotion
Costs.  If SYNTA exercises its right
to participate in the Co-promotion of one or more Licensed Products in the
United States pursuant to Section 5.3 of this Agreement, then ROCHE shall
reimburse SYNTA for all Sales Representative costs incurred by or on behalf of
SYNTA or its Affiliates in connection with the Co-promotion of the Co-promoted
Product in the United States for the applicable Indication.  Costs of SYNTA’s Sales Representatives shall
be determined on a full-time equivalent cost basis using the Sales
Representative FTE Rate.  SYNTA shall
invoice, on a quarterly basis, ROCHE for the costs of its Sales Representatives
to be paid by ROCHE and such invoice shall be paid by ROCHE within [***] ([***])
days after receipt thereof.


 


Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 


3