Exhibit 10.40

EXECUTION COPY

CONFIDENTIAL

 

 

Amended and Restated

License and Collaboration Agreement

by and between

Cytokinetics, Inc.

and

Astellas Pharma Inc.

 

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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AMENDED AND RESTATED LICENSE AND COLLABORATION AGREEMENT

This AMENDED AND RESTATED LICENSE AND COLLABORATION AGREEMENT (this “Agreement”)
is made as of December 22, 2014 (the “Amendment Effective Date”), by and between
Cytokinetics, Inc., a corporation organized and existing under the laws of
Delaware, having its principal place of business at 280 East Grand Avenue, South
San Francisco, CA 94080, USA (“Cytokinetics”), and Astellas Pharma Inc., a
corporation organized and existing under the laws of Japan, having its
registered office at 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo 103-8411, Japan
(“Astellas”). Astellas and Cytokinetics are referred to in this Agreement
individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, Cytokinetics is a biopharmaceutical company directed to the research
and development of small molecule compounds that modulate muscle function, and
owns certain patents and know-how relating to skeletal sarcomere activators;

WHEREAS, Astellas is a pharmaceutical company working to create and develop
novel therapies;

WHEREAS, Cytokinetics has conducted and continues to conduct research activities
(including biochemistry, cellular characterization, chemistry and pharmacology)
directed to the discovery of small molecules that activate the skeletal muscle
sarcomere and early stage development relating thereto;

WHEREAS, Astellas has conducted [*]

WHEREAS, Cytokinetics and Astellas are parties to a License and Collaboration
Agreement, dated June 21, 2013 (the “Effective Date”), as previously amended
(the “Existing Agreement”), pursuant to which they established a collaboration
for the research and development and, if successful, commercialization of
pharmaceutical products that contain certain fast skeletal [*] activators
(except for Cytokinetics’ clinical development candidate tirasemtiv and related
molecules) and certain other skeletal sarcomere activators, all under the terms
and conditions set forth therein;

WHEREAS, Cytokinetics has [*];

WHEREAS, the Existing Agreement provides for the collaborative research,
development and commercialization of [*] Activators in the Licensed Indications,
and the Parties now desire to expand the scope of collaboration for [*]
Activators to include certain neuromuscular indications and to amend and restate
the Existing Agreement;

WHEREAS, Cytokinetics will retain the right to products that contain tirasemtiv
and related molecules, and will develop and, if successful, commercialize such
products outside the scope of this Agreement.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants contained herein, the receipt and sufficiency of which are hereby
acknowledged, Astellas and Cytokinetics hereby agree as follows:

ARTICLE 1

DEFINITIONS

The terms in this Agreement with initial letters capitalized shall have the
meanings set forth below, or the meaning as designated in the indicated places
throughout this Agreement.

1.1 “Active Ingredient” means the clinically active material(s) that provide
pharmacological activity in a pharmaceutical product (excluding formulation
components such as coatings, stabilizers, excipients or solvents, adjuvants or
controlled release technologies).

1.2 “[*] Indications” means, for [*] Activators, (a) [*] pursuant to Section
[*], and (b) any [*] Indication(s) [*] pursuant to Section [*].

1.3 “[*] Indication” means: (a) as of the Amendment Effective Date, any of the
Indications set forth on Exhibit L; and (b) any other [*] Indication that may be
added to Exhibit L as [*] Indication during the Term by written agreement of the
Parties.

1.4 “Affiliate” means, with respect to a Party, any Person that controls, is
controlled by, or is under common control with that Party. For the purpose of
this definition only, “control” (including, with correlative meaning, the terms
“controlled by” and “under the common control”) means the actual power, either
directly or indirectly through one or more intermediaries, to direct or cause
the direction of the management and policies of such Person, whether by the
ownership of more than fifty percent (50%) of the voting stocking of such
Person, by contract or otherwise.

1.5 “[*]” means [*].

1.6 “Astellas Know-How” means all Know-How that is (a) Controlled by Astellas or
its Affiliates during the Term and (b) reasonably necessary or useful for the
Research, Development, Manufacture, Commercialization or Medical Affairs
Activities of any Compound and/or Collaboration Product, provided, however, that
Astellas Know-How specifically excludes Collaboration Know-How.

1.7 “Astellas Patents” means any Patent Right that is (a) Controlled by Astellas
or its Affiliates during the Term and (b) reasonably necessary or useful for the
Research, Development, Manufacture, Commercialization or Medical Affairs
Activities of any Compound and/or Collaboration Product, provided, however, that
Astellas Patents specifically exclude Collaboration Patents. The Astellas
Patents existing as of the Effective Date are listed in Exhibit A.

1.8 “Astellas Technology” means Astellas Know-How and Astellas Patents.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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1.9 “Astellas Territory” means worldwide other than the Shared Territory.

1.10 “Business Day” means a day other than a Saturday, Sunday or a day that is a
statutory holiday in Japan or a bank holiday in New York, USA.

1.11 “Claims” means all Third Party demands, claims, actions, proceedings and
liability (whether criminal or civil, in contract, tort or otherwise) for
losses, damages, reasonable legal costs and other reasonable expenses of any
nature.

1.12 “CMC Activities” means the chemistry, manufacturing, control and other
activities necessary or useful for generating the CMC Information required for
Marketing Approval of the Collaboration Products, including Manufacture of
validation and/or clinical trial materials, which are necessary or useful to
obtain Marketing Approval of the Collaboration Products.

1.13 “CMC Information” means information related to the chemistry, manufacturing
and controls of a Compound or a Collaboration Product, as specified by FDA, EMA
or other applicable Regulatory Authority.

1.14 “Collaboration” means the collaboration of the Parties with respect to the
Research, Development, Manufacture, Commercialization and Medical Affairs
Activities of the Compounds and Collaboration Products in the Collaboration
Indications (for [*] Activators) or the Field (for [*] Activators), as and to
the extent set forth in this Agreement.

1.15 “Collaboration Intellectual Property” means any information and materials,
including discoveries, improvements, modifications, processes, methods, assay,
designs, protocols, formulas, data, inventions, algorithms, forecasts, profiles,
strategies, plans, results, coordinates for compound/apo protein structures,
expression constructs, know-how and trade secrets, patentable or otherwise, that
is discovered, generated, conceived and/or reduced to practice by or on behalf
either Party (including its Affiliates, employees, agents and contractors),
whether solely or jointly, as a result of: (a) the performance of its activities
under the Research Plan and/or (b) the performance of its activities under the
Development Plan [*], in each case including all rights, title and interest in
and to the intellectual property rights therein and thereto.

1.16 “Collaboration Indications” means (a) Licensed Indications [*]); (b) [*]
Indications; and (c) any [*] Indications.

1.17 “Collaboration Know-How” means Know-How that is within the Collaboration
Intellectual Property.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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1.18 “Collaboration Patents” means Patent Rights that claim any Collaboration
Intellectual Property, provided that any Patent Rights [*] Collaboration
Patents.

1.19 “Collaboration Product” means any pharmaceutical product containing a
Compound, alone or in combination with other Active Ingredients, in any
formulation or dosage form and for any mode of administration.

1.20 “Commercialize” or “Commercialization” means all activities directed to
marketing, promoting, advertising, exhibiting, distributing (including
management of wholesalers), detailing or selling a Collaboration Product in the
Field (including importing and exporting activities in connection therewith).
For the avoidance of doubt, Commercialization does not include Medical Affairs
Activities.

1.21 “Committee” means the JSC, JRC, JDC, JMC, JCC, JMAC, [*] or JPC, as
applicable.

1.22 “Compound” means any [*] Activator or [*] Activator.

1.23 “Compound Criteria” means the criteria listed in Exhibit B for each of [*]
Activators, [*] Activators and [*] Activators.

1.24 “Confidential Information” of a Party means all Know-How, unpublished
patent applications and other non-public information and data of a financial,
commercial, business, operational or technical nature of such Party that is
disclosed by or on behalf of such Party or any of its Affiliates or otherwise
made available to the other Party or any of its Affiliates, in each case in
connection with this Agreement, whether made available orally, visually, in
writing or in electronic form. To the extent that Cytokinetics discloses to
Astellas and/or its Affiliates any information relating to any [*] (such
disclosure to be made at Cytokinetics’ sole discretion), such information shall
also be deemed Confidential Information. Collaboration Intellectual Property
shall be deemed Confidential Information of both Parties.

1.25 “Control” or “Controlled” means, with respect to any Know-How, Patent
Rights or other intellectual property rights, that a Party has the legal
authority or right (whether by ownership, license or otherwise) to grant a
license, sublicense, access or right to use (as applicable) under such Know-How,
Patent Rights, or other intellectual property rights to the other Party on the
terms and conditions set forth herein, in each case without breaching the terms
of any agreement with a Third Party.

1.26 “Co-Promote” and “Co-Promotion” means the promotional activities relating
to the Collaboration Products directed to healthcare professionals or otherwise
in furtherance of the Commercialization of the Collaboration Products to be
conducted by Cytokinetics (whether alone

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

4

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or together with Astellas with respect to a particular Collaboration Product in
a particular Indication) in the Co-Promotion Territory or Shared Territory in
the event Cytokinetics exercises its rights under Section 9.6. For clarity, if
[*] with respect to a particular [*] in accordance with Section [*] shall also
be referred to as Co-Promote or Co-Promotion for the purpose of this Agreement.

1.27 “Co-Promotion Territory” means: (a) the U.S.; and (b) Canada.

1.28 “Cytokinetics Commercialization Period” means, on a [*], in the event [*]
for a Collaboration Product with respect to [*] for which such Collaboration
Product [*], and at the time of such [*] such Collaboration Product has [*] for
any [*] Indication, [*] Indication or [*] Indication for which [*] such
Collaboration Product is [*] if and when such Collaboration Product is [*] for
any [*] Indication, [*] Indication or [*] Indication for which [*].

1.29 “Cytokinetics Know-How” means all Know-How that is (a) Controlled by
Cytokinetics or its Affiliates during the Term and (b) reasonably necessary or
useful for the Research, Development, Manufacture, Commercialization or Medical
Affairs Activities of any Compound and/or Collaboration Product, provided,
however, that Cytokinetics Know-How specifically excludes Collaboration
Know-How.

1.30 “Cytokinetics Patents” means any Patent Right that is (a) Controlled by
Cytokinetics or its Affiliates during the Term and (b) reasonably necessary or
useful for the Research, Development, Manufacture, Commercialization or Medical
Affairs Activities of any Compound and/or Collaboration Product, provided,
however, that Cytokinetics Patents specifically exclude Collaboration Patents.
The Cytokinetics Patents existing as of the Effective Date are listed in Exhibit
C. For clarity, Cytokinetics Patents shall include any Patent Rights arising
after the Effective Date that [*]

1.31 “Cytokinetics Technology” means Cytokinetics Patents and Cytokinetics
Know-How.

1.32 “Develop” or “Development” means all development activities for any
Compound or Collaboration Product that are directed to obtaining Marketing
Approval(s) of the Collaboration Products, including: all non-clinical,
preclinical and clinical activities, testing and studies of such Compound or
Collaboration Product (including IND-Enabling Studies and translational
research); manufacturing development, process and formulation development;
toxicology, pharmacokinetic, pharmacodynamic, drug-drug interaction, safety,
tolerability and pharmacological studies;

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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distribution of such Compound or Collaboration Product for use in clinical
trials (including placebos and comparators); statistical analyses; assay
development; instrument design and development; protocol design and development;
quality assurance and control; report writing; and the preparation, filing and
prosecution of any MAA for such Collaboration Product; development activities
directed to label expansion (including prescribing information) and/or obtaining
Marketing Approval for one or more additional Indications or patient populations
following initial Marketing Approval; development activities conducted after
receipt of Marketing Approval which were a condition for the receipt of such
Marketing Approval; and all regulatory activities related to any of the
foregoing.

1.33 “Development Costs” means the [*] costs incurred by or on account of a
Party in performing Development in accordance with the Development Plan.

1.34 “Diligent Efforts” means: (a) where applied to carrying out specific tasks
and obligations of a Party under this Agreement, expending [*] to accomplish
such task or obligation as such Party (on its own and/or acting through any of
its Affiliates, sublicensees or subcontractors) would [*]; and (b) where applied
to the Research, Development, Manufacture, and/or Commercialization of, or
Medical Affairs Activities for, a Compound or Collaboration Product, the use of
[*], in an [*], as [*], taking into account relevant factors including, without
limitation, [*] and other relevant factors, including [*]. “Diligent Efforts”
shall require that such Party (on its own and/or acting through any of its
Affiliates, sublicensees or subcontractors), at a minimum: (i) promptly assign
responsibility for such obligations to qualified personnel, set annual goals and
objectives for carrying out such obligations, and monitor and hold personnel
accountable for progress with respect to such goals and objectives; (ii) set and
seek to achieve specific and meaningful objectives for carrying out such
obligations, with timelines consistent with a comparable [*] program; and
(iii) make and implement decisions and [*] designed to [*] with respect to such
objectives.

1.35 “Dollars” means the U.S. dollar, and “$” shall be interpreted accordingly.

1.36 “EMA” means the European Medicines Agency or any successor entity thereto.

1.37 “EU” or the “European Union” means the European Union and its member states
as of the Amendment Effective Date, which are: Austria, Belgium, Bulgaria,
Croatia, Cyprus,

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

6

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Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom, as
well as Norway and Iceland, and each of their successors to the extent such
successors occupy the same territory.

1.38 “[*] Indication” means, for [*] Activators: (a) SMA; and (b) any additional
[*] Indication [*] pursuant to Section [*].

1.39 “[*] Activator” means (a) any small molecule compound that (i) is [*],
(ii) has a specified level of stimulatory activity against any [*], as set forth
in the applicable Compound Criteria, and (iii) the [*]; and (b) any [*] in
subclause (a) above.

1.40 “[*] Activator” means, subject to the final sentence of this paragraph,
(a) any small molecule compound that (i) is [*], (ii) has a specified level of
stimulatory activity against any [*], as set forth in the applicable Compound
Criteria, and (iii) the [*]; and (b) any [*] in subclause (a) above. [*]
Activators include [*], but exclude all [*].

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

1.42 “Field” means the treatment, prevention and/or amelioration of any diseases
and medical conditions in humans.

1.43 “Filing” of an MAA means the acceptance by a Regulatory Authority of an MAA
for filing and review, if applicable, or otherwise the submission of such MAA.

1.44 “First Commercial Sale” means, with respect to any Collaboration Product in
any country or jurisdiction, the first sale of such Collaboration Product to a
Third Party for distribution, use or consumption in such country or jurisdiction
after the Marketing Approvals have been obtained for such Collaboration Product
in such country or jurisdiction.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

7

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1.45 “FTE” means the equivalent of a full-time individual’s work for a twelve
(12) month period (consisting of a total of [*] hours per year of dedicated
effort). Any person who devotes more or less than [*] hours per year on the
applicable activities shall be treated as an FTE on a pro-rata basis, based upon
the actual number of hours worked by such person on such activities, divided by
[*]. For avoidance of doubt, the hours allocated to the work of general
corporate or administrative personnel shall not be incorporated into FTE.

1.46 “FTE Rate” means an initial rate of [*] Dollars [*] per FTE per year for
each Astellas and Cytokinetics, which shall apply through [*]. Thereafter, the
FTE Rate shall be changed annually on a calendar year basis to reflect any
year-to-year percentage increase or decrease (as the case may be) in the
Consumer Price Index for All Urban Consumers for the U.S., as published by the
U.S. Department of Labor, Bureau of Labor Statistics (“CPI”) (based on the
change in the CPI from the most recent index available as of the Effective Date
to the most recent index available as of the date of the calculation of such
revised FTE Rate). The FTE Rate applicable to [*] shall be subject to the
adjustment set forth in Section [*].

1.47 “GAAP” means the U.S. generally accepted accounting principles.

1.48 “Generic Product” means, with respect to a Collaboration Product in a
particular country, any pharmaceutical product that (a) contains the same Active
Ingredients and formulation as such Collaboration Product; (b) [*] in such
country and [*] in such country; and (c) is sold in such country by a Third
Party that is not a sublicensee of Astellas or its Affiliates and did not
purchase such product in a chain of distribution that included any of Astellas
or its Affiliates or sublicensees.

1.49 “Governmental Authority” means any federal, state, national, state,
provincial or local government, or political subdivision thereof, or any
multinational organization or any authority, agency or commission entitled to
exercise any administrative, executive, judicial, legislative, police,
regulatory or taxing authority or power, any court or tribunal (or any
department, bureau or division thereof, or any governmental arbitrator or
arbitral body).

1.50 “IFRS” means International Financial Reporting Standards.

1.51 “IND” means any investigational new drug application, clinical trial
application, clinical trial exemption or similar or equivalent application or
submission for approval to conduct human clinical investigations filed with or
submitted to a Regulatory Authority in conformance with the requirements of such
Regulatory Authority.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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1.52 “IND-Enabling Studies” means studies that are specifically required for an
IND, including ADME (absorption, distribution, metabolism, and excretion), GLP
toxicology studies, or studies required for the preparation of the CMC section
of an IND, including studies related to analytical methods and purity analysis,
and formulation and manufacturing development studies, all as necessary to
obtain the permission of Regulatory Authorities to begin human clinical
investigations.

1.53 “Indication” means any human diseases, syndromes and medical conditions
that can be diagnosed, treated, prevented or ameliorated.

1.54 “Initiate” or “Initiation” means, with respect to a clinical trial of a
Collaboration Product, the first dosing of the first human subject for such
clinical trial.

1.55 “Know-How” means any information and materials, including discoveries,
improvements, modifications, processes, methods, assays, designs, protocols,
formulas, data, inventions, algorithms, forecasts, profiles, strategies, plans,
results, coordinates for compound/apo protein structures, expression constructs,
know-how and trade secrets (in each case, patentable, copyrightable or
otherwise), but excluding any Patent Rights.

1.56 “Law” means any federal, state, local, foreign or multinational law,
statute, standard, ordinance, code, rule, regulation, resolution or
promulgation, or any order by any Governmental Authority, or any license,
franchise, permit or similar right granted under any of the foregoing, or any
similar provision having the force or effect of law.

1.57 “Lead Compound” means (a) Cytokinetics’ proprietary compound known as
CK-2127107, which is the subject of the Lead Compound IND, and (b) any [*] in
subclause (a) above.

1.58 “Lead Compound IND” means U.S. IND No. [*].

1.59 “Lead Product” means a Collaboration Product that contains the Lead
Compound.

1.60 “Licensed Indications” means the following Indications: (a) [*]
non-neuromuscular diseases and conditions (e.g., [*]; and (b) [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

9

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1.61 “MAA” or “Marketing Authorization Application” means an application to the
appropriate Regulatory Authority for approval to commercially sell a
Collaboration Product (but excluding pricing approval) in the Field in a
particular jurisdiction (including, without limitation, a New Drug Application
in the U.S.) and all amendments and supplements thereto.

1.62 “Major EU Market Countries” means [*].

1.63 “Major Market Countries” means the [*].

1.64 “Manufacture” and “Manufacturing” mean activities directed to
manufacturing, processing, filling, finishing, packaging, labeling, quality
control, quality assurance testing and release, post-marketing validation
testing, inventory control and management, storing and transporting any Compound
and/or Collaboration Product.

1.65 “Manufacturing Costs” means, with respect to a particular Compound or
Collaboration Product Manufactured and supplied by a Party pursuant to the
Development Plan:

(a) if such Compound or Collaboration Product is Manufactured by such Party’s
Third Party manufacturer, [*] costs incurred by such Party in association
therewith, including for [*] with respect thereto;

(b) if such Compound or Collaboration Product is Manufactured by such Party
itself, [*] including without limitation [*] manufacturing costs. Such [*] of
Compound or Collaboration Product [*] and (ii) in accordance with IFRS (in the
case of Astellas) or GAAP (in the case of Cytokinetics) consistently applied.

1.66 “Marketing Approval” means all approvals necessary for the commercial sale
of a Collaboration Product in the Field in a given country or regulatory
jurisdiction.

1.67 “Medical Affairs Activities” means activities, in compliance with all the
applicable Law, designed to ensure or improve appropriate medical use of,
conduct medical education regarding, or further research regarding, the
Compounds and the Collaboration Products or to increase disease state awareness,
including by way of example: (a) activities of medical scientific liaisons,
which shall mean the following functions: (x) conduct of service based medical
activities including providing input and assistance with consultancy meetings,
recommending

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

10

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investigators for clinical trials and providing input in the design of such
trials and other research related activities, and (y) delivery of
non-promotional communications and conduct of non-promotional activities
including presenting new clinical trial data and other scientific or disease
state awareness information; (b) grants to support continuing medical education,
symposia, or Third Party research related to Collaboration Products;
(c) development, publication and dissemination of publications relating to the
Compounds and the Collaboration Products and relevant disease states;
(d) medical information services provided in response to inquiries communicated
via sales representatives or received by letter, phone call or email;
(e) conducting advisory board meetings or other consultant programs; (f) support
of investigator-initiated trials; (g) managing relationships with cooperative
groups, physician/hospital networks and disease state or patient and caregiver
advocacy groups; (h) establishing and implementing risk, evaluation and
mitigation strategies, (i) voluntary phase 4 trials or post-approval patient
registries, (j) health economic and outcomes research (HEOR) activities,
(k) independent medical education activities, and (l) non-promotional exhibiting
at medical and scientific fora. For the purposes of clarity, post-approval
clinical studies within the approved Indications, which were a condition for the
receipt of Marketing Approval, shall be included within Development and shall
not be included within Medical Affairs Activities.

1.68 “Net Sales” means the gross amount billed or invoiced by or for the benefit
of Astellas, its Affiliates, and its sublicensees to independent, unrelated
persons in bona fide arm’s length transactions with respect to a Collaboration
Product, less the following deductions, as allocable to such Collaboration
Product (if not previously deducted from the amount invoiced):

 

  (a) [*]

 

  (b) [*]

 

  (c) [*]

 

  (d) [*] and

 

  (e) [*]

If a single item falls into more than one of the categories set forth in clauses
(a)-(e) above, such item may not be deducted more than once.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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Sales between Astellas and its Affiliates and sublicensees shall be disregarded
for purposes of calculating Net Sales except if such purchaser is a distributor,
pharmacy or end user.

If a Collaboration Product either (i) is sold in the form of a combination
product containing both a Compound and one or more Active Ingredient(s) as
separate molecular entity(ies) that are not Compounds; or (ii) is sold in a form
that contains (or is sold bundled with) a delivery device therefor (in either
case ((i) or (ii)), a “Combination Product”), the Net Sales of such
Collaboration Product for the purpose of calculating royalties and sales-based
milestones owed under this Agreement for sales of such Collaboration Product,
shall be determined as follows: first, Astellas shall determine the actual Net
Sales of such Combination Product (using the above provisions) and then such
amount shall be multiplied by the fraction A/(A+B), where A is the invoice price
of such Collaboration Product, if sold separately, and B is the total invoice
price of other Active Ingredient or delivery device in such Combination Product
if sold separately. If any other Active Ingredient or delivery device in such
Combination Product is not sold separately, Net Sales shall be calculated by
multiplying actual Net Sales of such Combination Product by a fraction A/C where
A is the invoice price of such Collaboration Product if sold separately, and C
is the invoice price of such Combination Product. If neither such Collaboration
Product nor any other Active Ingredient (or delivery device) in such Combination
Product is sold separately, the adjustment to Net Sales shall be determined by
the Parties in good faith to reasonably reflect the fair market value of the
contribution of such Collaboration Product in such Combination Product to the
total fair market value of such Combination Product.

With respect to any sale of any Collaboration Product in a given country for any
substantive consideration other than monetary consideration on arm’s length
terms (which has the effect of reducing the invoiced amount below what it would
have been in the absence of such non-monetary consideration), for purposes of
calculating the Net Sales, such Collaboration Product shall be deemed to be sold
exclusively for cash at the average Net Sales price charged to Third Parties for
cash sales of such Collaboration Product in such country during the applicable
reporting period (or if there were only de minimis cash sales in such country,
at the fair market value as determined in good faith based on pricing in
comparable markets). Notwithstanding the foregoing, Net Sales shall not include
amounts (whether actually existing or deemed to exist for purposes of
calculation) for Collaboration Products distributed for use in clinical trials.

Net Sales shall be calculated on an accrual basis, in a manner consistent with
Astellas’ accounting policies for external reporting purposes, as consistently
applied, in accordance with IFRS. To the extent any accrued amounts used in the
calculation of Net Sales are estimates, such estimates shall be trued-up in
accordance with Astellas’ accounting policies for external reporting purposes,
as consistently applied, and Net Sales and related payments under this Agreement
shall be reconciled as appropriate.

1.69 [*] Indication” means (a) [*], and (b) any other Indication [*] that is
designated by the JDC as a [*] Indication pursuant to Section [*].

1.70 [*] Activators” means [*] Activators and [*] Activators, and specifically
excludes (a) [*] Activators, (b) [*], and (c) any compound targeting any [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

12

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1.71 “Patent Rights” means all patents and patent applications (which shall be
deemed to include certificates of invention and applications for certificates of
invention), including all divisionals, continuations, substitutions,
continuations-in-part, re-examinations, reissues, additions, renewals,
revalidations, extensions, registrations, pediatric exclusivity periods and
supplemental protection certificates and the like of any such patents and patent
applications, and any and all foreign equivalents of the foregoing.

1.72 “Person” means any individual, partnership, limited liability company,
firm, corporation, association, trust, unincorporated organization or other
entity.

1.73 “Phase 1 Clinical Trial” means a controlled human clinical trial of a
Collaboration Product that would satisfy the requirements of 21 CFR 312.21(a) or
corresponding foreign regulations, regardless of whether such trial is referred
to as a “phase 1 clinical trial” in the Development Plan.

1.74 “Phase 2 Clinical Trial” means a controlled human clinical trial of a
Collaboration Product that would satisfy the requirements of 21 CFR 312.21(b) or
corresponding foreign regulations, regardless of whether such trial is referred
to as a “phase 2 clinical trial” in the Development Plan.

1.75 “Phase 3 Clinical Trial” means a controlled or uncontrolled human clinical
trial of a Collaboration Product that would satisfy the requirements of 21 CFR
312.21(c) or corresponding foreign regulations, regardless of whether such trial
is referred to as a “phase 3 clinical trial” in the Development Plan.

1.76 [*] means any [*] that is intended [*] may be necessary to [*] in the
Development Plan.

1.77 “Regulatory Authority” means any applicable Governmental Authority
responsible for granting Marketing Approvals or pricing approvals for
Collaboration Products, including the FDA, the EMA and any corresponding
national or regional regulatory authorities.

1.78 “Regulatory Exclusivity” means any exclusive marketing rights or data
exclusivity rights conferred by any Regulatory Authority with respect to a
pharmaceutical product other than patents, including, without limitation, orphan
drug exclusivity, new chemical entity exclusivity, data exclusivity, pediatric
exclusivity, rights conferred in the United States under the Hatch-Waxman Act or
the FDA Modernization Act of 1997, or rights similar thereto outside the United
States.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

13

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1.79 “Regulatory Materials” means any regulatory application, submission,
notification, communication, correspondence, registration and other filings made
to, received from or otherwise conducted with a Regulatory Authority in order to
Research a Compound and/or Develop, Manufacture, or Commercialize a Compound or
Collaboration Product in the Field in a particular country or jurisdiction.
“Regulatory Materials” includes any IND, MAA and Marketing Approval.

1.80 “Registration Dossier” means the registration dossier designed to support
Marketing Approval by the FDA and Marketing Approval in the EU (excluding any
country-specific approvals for pricing or reimbursement).

1.81 “Research” means all research activities conducted by or on behalf of
either Party or the Parties jointly pursuant [*].

1.82 “Retained Indications” means Indications that are not Licensed Indications.
Retained Indications include the Indications listed in Exhibit D.

1.83 [*] Compounds” means (a) Tirasemtiv, (b) any compositions of matter
(i) falling within the scope of any of the generic formulas disclosed in the
Patent Rights listed in Exhibit E (the “[*] Patent Rights”) and/or
(ii) specifically disclosed in the [*] Patent Rights; and (c) any [*] in
subclause (a) or (b) above.

1.84 “Shared Territory” means (a) the Co-Promotion Territory and (b) the
European Union and Switzerland.

1.85 [*] Activator” means (a) any small molecule compound that (i) is [*],
(ii) has a specified level of stimulatory activity against any [*], as set forth
in the applicable Compound Criteria, and (iii) the [*] and (b) any [*] in
subclause (a) above.

1.86 “SMA” means spinal muscular atrophy.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

14

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1.87 “Third Party” means any Person other than a Party or an Affiliate of a
Party.

1.88 “Tirasemtiv” means Cytokinetics’ proprietary compound formerly known as
CK-2017357.

1.89 “United States” or “U.S.” means the United States of America, including its
fifty (50) states and the District of Columbia.

1.90 “Valid Claim” means a claim of an issued and unexpired patent (as may be
extended through supplementary protection certificate or patent term extension)
or a pending patent application included within [*], which claim has not been
revoked, held invalid or unenforceable by a patent office, court or other
governmental agency of competent jurisdiction in a final and non-appealable
judgment (or judgment from which no appeal was taken within the allowable time
period) and has not been disclaimed, denied or admitted to be invalid or
unenforceable through reissue, re-examination or disclaimer or otherwise.

1.91 Additional Definitions. The following table identifies the location of
definitions set forth in various Sections of the Agreement:

 

Definition

  

Section

Alliance Manager

   2.1

[*] Indication

   [*]

[*] Advance Invoice

   11.3(c)(i)

[*]

   [*]

[*]

   [*]

[*] True-Up Report

   11.3(c)(ii)

[*] Development Work

   [*]

[*] Date

   [*]

[*] Products

   14.3(a)

Astellas [*]

   [*]

Astellas Co-Promotion Notice

   9.6(b)(i)

Astellas Indemnitee

   [*]

Astellas [*]

   [*]

Astellas [*]

   [*]

Astellas [*]

   [*]

Bankruptcy Code

   3.8

Combination Product

   1.68

Commercial Operating Team

   9.7

Commercialization Plan

   9.3(a)

[*]

   [*]

Confidentiality Agreement

   17.8

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

15

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Co-Promotion Agreement

9.6(g)

[*]

[*]

Co-Promotion Matters

9.6(b)(i)

CY 5012

11.5(c)(i)

Cytokinetics Co-Funding Option

4.1(b)

Cytokinetics Co-Promotion Effort

9.6(c)

Cytokinetics Co-Promotion Recommendation

9.6(b)(ii)

Cytokinetics [*]

[*]

Cytokinetics Indemnitee

16.2

Cytokinetics [*]

[*]

Cytokinetics [*]

[*]

Cytokinetics Product Marks

12.5(b)

Cytokinetics Research FTEs

5.3

Cytokinetics [*]

[*]

Cytokinetics [*]

[*]

Development Advance Invoice

11.3(a)(i)

Development Plan

6.2(a)

Development Program

6.2(a)

Development Project Team

6.10

Development True-Up Report

11.3(a)(ii)

Disclosing Party

13.1(a)

[*]

[*]

Earlier Milestone Event

11.5(b)(i)

Early Stage Work

6.3(b)(ii)

Established Commercial Infrastructure

9.9

[*]

[*]

[*] Indication

[*]

[*]

[*]

FCPA

17.7(a)

FCPA Covered Person

17.7(a)

Federal Arbitration Act

17.6(a)

[*]

[*]

Indemnified Party

16.3

Indemnifying Party

16.3

[*] Rules

17.6(a)

JCC Determination

9.6(b)(ii)

Joint Commercialization Committee or JCC

2.6

Joint Development Committee or JDC

2.4

Joint Manufacturing Committee or JMC

2.5

Joint Medical Affairs Committee or JMAC

2.7

Joint Patent Committee or JPC

2.8

Joint Research Committee or JRC

2.3

Joint Steering Committee or JSC

2.2

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

16

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[*] Regulatory Materials 7.2(a) Later Milestone Event 11.5(b)(i) Lead Compound
[*] [*] Lead Compound [*] [*] [*] Products [*] Medical Affairs Plan 10.3 MSL
10.1 [*] [*] Neuromuscular Indications 9.6(a) [*] [*] [*] [*] Pharmacovigilance
Agreement 7.5 Phase 1 Work 6.3(b)(i) [*] [*] [*] [*] Product Infringement
12.4(a) Product Marks 12.5(a) Receiving Party 13.1(a) Remainder 12.4(f) Remedial
Action 7.7 Research Advance Invoice 11.2(a) Research Budget 5.3 Research Plan
5.3 Research Plan Costs 5.6 Research Program 5.1 Research Project Team 5.9
Research Term 5.2 Research True-Up Report 11.2(b) Responsible Committee 13.4 [*]
Product [*] [*] [*] Royalty Term 11.7(b) [*] [*] SEC 13.5(b) Term 14.1

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

17

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1.92 Interpretation. In this Agreement, unless otherwise expressly specified:

(a) The words “include”, “includes” and “including” shall be deemed to be
followed by the phrase “without limitation”.

(b) words denoting the singular shall include the plural and vice versa and
words denoting any gender shall include all genders;

(c) words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as
a whole and not merely to the particular provision in which such words appear;

(d) “days” means calendar days; and

(e) the Exhibits and other attachments form part of the operative provision of
this Agreement and references to “this Agreement” shall include references to
the Exhibits and attachments.

ARTICLE 2

GOVERNANCE

2.1 Alliance Managers. Each Party hereby appoints the person listed on Exhibit F
to act as its alliance manager under this Agreement as of the Amendment
Effective Date (the “Alliance Manager”). The Alliance Managers shall: (a) serve
as the primary contact points between the Parties for the purpose of providing
the other Party with information on the progress of such Party’s activities
under this Agreement; (b) be primarily responsible for facilitating the flow of
information and otherwise promoting communication, coordination and
collaboration between the Parties; (c) act as advocates for the Collaboration as
a whole; (d) have regular telephone calls; (e) use Diligent Efforts to
facilitate the prompt resolution of any disputes; (f) attend as appropriate JRC,
JDC, JMC, JCC and JMAC meetings; and (g) have the right to attend all other
Committee and subcommittee meetings, all as non-voting members. An Alliance
Manager may also bring any matter to the attention of any Committee if such
Alliance Manager reasonably believes that such matter warrants such attention.
Each Party may replace its Alliance Manager at any time upon written notice to
the other Party.

2.2 Joint Steering Committee. The Parties shall establish a joint steering
committee (the “Joint Steering Committee” or the “JSC”), composed of [*] of each
Party, including the [*] under this Agreement and [*] under this Agreement. All
JSC representatives will have sufficient authority within the applicable Party
to make decisions [*] arising within the scope of the JSC’s responsibilities.
Either Party may request that its own or the other Party’s personnel with
expertise on a particular matter attend a JSC meeting where such matter will be
discussed. The JSC shall in particular:

(a) oversee and provide strategic direction to the Collaboration;

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

18

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(b) oversee the integration and coordination of the Research, Development,
Manufacture (as applicable), Commercialization and Medical Affairs Activities of
the Compounds and Collaboration Products within the JSC member’s company;

(c) provide a forum for discussion of the Research, Development, Manufacture,
Commercialization and Medical Affairs Activities of the Compounds and
Collaboration Products;

(d) review the Parties’ progress against the Research Plan, Development Plan,
Commercialization Plan and Medical Affairs Plan;

(e) oversee the operation of the JRC, JDC, JMC, JCC, JMAC and JPC, including
resolving any disputed matter of the JRC, JDC, JMC, JCC, JMAC and JPC; and

(f) perform such other duties as are expressly assigned to the JSC in this
Agreement, and such other functions as appropriate to further the purposes of
this Agreement as may be allocated to it by the Parties’ written agreement.

2.3 Joint Research Committee. The Parties shall establish a joint research
committee (the “Joint Research Committee” or the “JRC”), composed of [*] of each
Party that have [*] in the research of compounds similar to the Compounds, to
monitor and coordinate the Research of Compounds under the Collaboration. The
JRC shall exist during the Research Term. All JRC representatives will have
sufficient authority within the applicable Party to make decisions [*] arising
within the scope of the JRC’s responsibilities. The JRC shall in particular:

(a) coordinate the activities of the Parties under the Research Plan and oversee
the implementation of the Research Plan;

(b) prepare and approve annual or interim amendments to the Research Plan
(including the Research Budget);

(c) provide a forum for and facilitate communications between the Parties with
respect to the Research of Compounds;

(d) establish joint subcommittees, as appropriate, to carry out its functions;
and

(e) perform such other functions as may be appropriate to further the purposes
of this Agreement with respect to the Research of Compounds.

2.4 Joint Development Committee. The Parties shall establish a joint development
committee (the “Joint Development Committee” or the “JDC”), composed of [*] of
each Party that have [*] in the development of products similar to the Compounds
and Collaboration Products, to monitor and coordinate the Development of the
Compounds and Collaboration Products under the Collaboration. All JDC
representatives will have sufficient authority within the applicable Party to
make decisions [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

19

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[*] arising with the scope of the JDC’s responsibilities. The JDC shall in
particular:

(a) coordinate the activities of the Parties under the Development Plan and
oversee the implementation of the Development Plan;

(b) establish the protocol and statistical analysis plan for each human clinical
trial conducted under the Development Plan;

(c) prepare and approve annual or interim amendments to the Development Plan
(including the Cytokinetics Development Budget);

(d) provide a forum for and facilitate communications between the Parties with
respect to the Development of the Compounds and Collaboration Products;

(e) review the data and results of [*] a Collaboration Product [*] such
Collaboration Product [*] in which case [*];

(f) monitor and coordinate all regulatory actions, communications and
submissions for the Compounds and Collaboration Products under the Development
Plan, including allocating related medical affairs responsibilities between the
Parties;

(g) until formation of the JMAC, oversee medical education activities and
establish a joint review process for medical affairs materials, including
disease state awareness, medical education and other non-promotional materials;

(h) establish joint subcommittees, as appropriate, to carry out its functions;
and

(i) perform such other functions as may be appropriate to further the purposes
of this Agreement with respect to the Development of the Compounds and
Collaboration Products.

2.5 Joint Manufacturing Committee. The Parties shall establish a joint
manufacturing committee (the “Joint Manufacturing Committee” or “JMC”), composed
of up to [*] of each Party that have [*] in the manufacture of compounds and
products similar to the Compounds and Collaboration Products, to monitor and
oversee the CMC Activities and other activities related to the Manufacture of
the Compounds and Collaboration Products for use under the Collaboration. All
JMC representatives will have sufficient authority within the applicable Party
to make decisions [*] arising within the scope of the JMC’s responsibilities.
The JMC shall in particular:

(a) discuss, approve and oversee implementation of and progress against the
Development Plan and Commercialization Plan as they relate to CMC Activities;

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

20

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(b) coordinate and facilitate cooperation and flow of information between the
Parties with respect to the Manufacture and supply of the Compounds and
Collaboration Products for Development and Commercialization use in accordance
with Article 8;

(c) coordinate and facilitate the transfer of Manufacturing Know-How as and to
the extent provided in Article 8;

(d) establish joint subcommittees, as appropriate, to carry out its functions;
and

(e) perform such other functions as may be appropriate to further the purposes
of this Agreement with respect to the Manufacture of Compounds and Collaboration
Products, as directed by the JDC or JCC (as applicable).

2.6 Joint Commercialization Committee. Unless otherwise agreed upon between the
Parties, within [*], the Parties shall form and establish a joint
commercialization committee (the “Joint Commercialization Committee” or “JCC”),
composed of [*] of each Party that have [*] in the commercialization of products
similar to the Collaboration Products, to monitor and oversee the
Commercialization activities of the Collaboration Products under the
Collaboration. All JCC representatives will have sufficient authority within the
applicable Party to make decisions [*] arising within the scope of the JCC’s
responsibilities. The JCC shall in particular:

(a) coordinate the activities of the Parties under the Commercialization Plan
and oversee the implementation of the Commercialization Plan;

(b) prepare and approve annual or interim amendments to the Commercialization
Plan;

(c) provide a forum for and facilitate communications between the Parties with
respect to the Commercialization of the Collaboration Products;

(d) establish joint subcommittees, as appropriate, to carry out its functions;
and

(e) perform such other functions as may be appropriate to further the purposes
of this Agreement with respect to the Commercialization of the Collaboration
Products.

2.7 Joint Medical Affairs Committee. Unless otherwise agreed upon between the
Parties, [*] the Parties may agree upon, the Parties shall form and establish a
joint medical affairs committee (the “Joint Medical Affairs

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

21

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Committee” or “JMAC”), composed of [*] of each Party that have [*] in Medical
Affairs Activities of products similar to the Collaboration Products, to monitor
and oversee the Medical Affairs Activities for the Compounds and Collaboration
Products under the Collaboration. All JMAC representatives will have sufficient
authority within the applicable Party to make decisions [*] arising within the
scope of the JMAC’s responsibilities. The JMAC shall in particular:

(a) coordinate the activities of the Parties under the Medical Affairs Plan and
oversee the implementation of the Medical Affairs Plan;

(b) prepare and approve annual or interim amendments to the Medical Affairs
Plan;

(c) prepare and approve the protocol and statistical analysis plan for each
human clinical trial to be conducted under the Medical Affairs Plan;

(d) provide a forum for and facilitate communications between the Parties with
respect to the Medical Affairs Activities for the Compounds and Collaboration
Products;

(e) establish a joint review process for medical affairs materials, including
disease state awareness, medical education and other non-promotional materials;

(f) establish joint subcommittees, as appropriate, to carry out its functions;
and

(g) perform such other functions as may be appropriate to further the purposes
of this Agreement with respect to the Medical Affairs Activities for the
Compounds and Collaboration Products.

2.8 Joint Patent Committee. The Parties shall establish a joint patent committee
(the “Joint Patent Committee” or “JPC”), composed of [*] representing each
Party, to coordinate the prosecution and enforcement of Collaboration Patents
under Article 12. Such patent counsel shall have sufficient authority within or
on behalf of the applicable Party to make decisions [*] arising within the scope
of the JPC’s responsibilities. The JPC shall in particular:

(a) coordinate and facilitate the prosecution and enforcement of the
Collaboration Patents, and make periodic reports of the same to the JSC and
other Committees upon request;

(b) discuss and develop patent strategy for Collaboration Patents, including
making key decisions on drafting, filing, prosecution, maintenance, enforcement
and defense of Collaboration Patents, as well as providing a forum for the
Parties to discuss material issues and provide input to each other regarding
Collaboration Patents;

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

22

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(c) determine which Patents are to be considered Collaboration Patents, and
oversee the determination of inventorship of Collaboration Intellectual
Property;

(d) confer regarding patent term extensions and listings in the FDA’s Approved
Drug Products with Therapeutic Equivalence Evaluations (known as the “Orange
Book”) and its foreign counterparts; and

(e) perform such other functions as may be appropriate to further the purposes
of this Agreement with respect to the patent prosecution and enforcement
activities under this Agreement.

2.9 [*] In the event that [*] a Compound and corresponding Collaboration Product
[*] under Section [*] such Compound and Collaboration Product [*], the Parties
shall [*] and discuss and decide [*] such Compound and Collaboration Product
[*]; provided that, with respect to [*] contemporaneously with or following the
[*] as agreed by the Parties. [*] such Compound and Collaboration Products [*]
taking into consideration [*] as well as the [*] the roles and responsibilities
of each Party [*] such Compound and Collaboration Product. For clarity, [*]
pursuant to Section [*]

2.10 Limitation of Committee Authority. Each Committee shall only have the
powers expressly assigned to it in this Article 2 and elsewhere in this
Agreement and shall not have the authority to: (a) modify or amend the terms and
conditions of this Agreement; (b) waive either Party’s compliance with the terms
and conditions of under this Agreement; or (c) determine any such issue in a
manner that would conflict with the express terms and conditions of this
Agreement.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

23

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2.11 Committee Membership and Meetings.

(a) Committee Members. The members of each Party on the JSC, JRC, JDC and JPC as
of the Amendment Effective Date are set forth in Exhibit F. Each Party may
replace its representatives on any Committee by written notice to the other
Party. Each Party shall appoint one (1) of its representatives on each Committee
to act as a co-chairperson of such Committee. The co-chairpersons shall jointly
prepare and circulate agendas and reasonably detailed minutes for each Committee
meeting within thirty (30) days of such meeting.

(b) Meetings. Unless the Parties otherwise agree, each Committee shall hold
meetings at such times as it elects to do so, but no less frequently than once
every [*] for (i) the JRC; (ii) the JDC; (iii) the JMC; and (iv) the JCC. In all
other circumstances, each Committee shall hold regular meetings no less
frequently than once every [*] and more frequently as needed upon written
request of either Party and consent of the other Party, which consent shall not
be unreasonably withheld or delayed. Meetings of each Committee shall be held
via teleconference, via videoconference or in person, provided that at least [*]
per year for the [*] and [*] per year for the [*] shall be held in person
(unless the Parties otherwise agree) at locations to be alternately selected by
each Party. Each Party shall be responsible for all of its own expenses of
participating in any Committee. No action taken at any meeting of a Committee
shall be effective unless a representative of each Party is participating.

(c) Non-Member Attendance. Each Party may from time to time invite a reasonable
number of participants, in addition to its representatives, to attend the
Committee meetings in a non-voting capacity; provided that if either Party
intends to have any Third Party (including any consultant) attend such a
meeting, such Party shall provide prior written notice to the other Party and
shall ensure that such Third Party is bound by confidentiality and non-use
obligations consistent with the terms of this Agreement.

2.12 Continuity of Representation. Notwithstanding the Parties’ respective right
to replace its Alliance Manager and members of Committees by written
notification to the other Party, each Party shall strive to maintain continuity
in the representation of such Alliance Manager and Committee members. If a
particular Committee ceases to exist but certain activities that have been
overseen by such Committee are still ongoing, then the Parties shall by mutual
written agreement allocate the responsibility for overseeing such activities to
another then-operating Committee that is competent and suitable in authority and
expertise.

2.13 Decision-Making. All decisions of each Committee shall be made by [*]. If
after reasonable discussion and good faith consideration of each Party’s view on
a particular matter before a Committee, the representatives of the Parties
cannot reach an agreement as to such matter within [*] after such matter was
brought to such Committee for resolution or after such matter has been referred
to such Committee, such disagreement shall be referred to the JSC (in the case
of disagreement of the JRC, JDC, JMC, JCC, JMAC, JPC or other joint
subcommittees)

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

24

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for resolution. If the JSC cannot resolve such matter within [*] after such
matter has been referred to them, then:

 

  (a) [*] [*] for those set forth in Section [*]

 

  (b) [*] [*]:

 

  (i) pertaining to [*] as to whether to [*]; and/or

 

  (ii) pertaining to the following aspects of activities relating to [*]:

(1) the [*] Activators in any such Indication (including the related [*]) to
generate the [*] as part of the Collaboration and the related [*] for so long as
[*] such Development, including the generation of the [*] as set forth in
Section [*] for which [*] is responsible under Section 6.3[*] related matters,
but [*], as well as the [*]. For clarity, after [*] without the [*];

(2) the [*] Activators in any such [*], as set forth in more detail in Section
[*]. For clarity, [*] shall not cover the [*], which shall be [*] subject to the
[*] if the matter is [*] during the [*];

(3) the [*] Activators in any such [*] during the [*];

(4) if [*] for such [*] for such [*]; and

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

25

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(5) if [*] for such [*] for such [*] consistent with Article [*] set forth in
this Section 2.13(b).

(c) [*] The following issues in Sections 2.13(c)(i) through (v) below (the [*])
shall be subject to [*]

(i) the [*] Indication ([*] Indication) as [*] Indication and the related [*]
the Development Plan pertaining to the Development of one or more [*]
Activator(s) in such Indication as set forth in Section [*]. For clarity, if the
Parties [*] Indication ([*] Indication [*]) as [*] Indication, or on the [*]
Development Plan pertaining to such Indication, then such [*] Indication shall
[*] Indication;

(ii) the [*] Activator in any [*] Indications, including [*] to support (A) [*]
such Compound and corresponding Collaboration Product [*]; and (B) [*] such
Compound and corresponding Collaboration Product [*] with respect to such [*]
Activator and [*] with respect thereto;

(iii) the [*] (but the related [*] subject to the [*] (as applicable) subject to
the [*] if the matter is [*]) described in Sections [*] as subject to [*];

(iv) the [*] set forth in the Development Plan [*], except for any [*]); and

(v) any other decision [*] under this Agreement.

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

26

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(d) [*]

(i) With respect to [*] the Development activities (which include [*] in
connection with such Development activities to the extent provided in Article
[*]) pursuant to Section [*] with respect to [*] as well as the related [*]
(which shall be subject to [*]), unless such activities [*] under the
Collaboration, in which case the status quo will remain in effect until the
issue is resolved. For clarity, [*], such matters shall be [*].

(ii) [*] with respect to [*] Indications [*] as set forth in Section [*].

(iii) [*] Indication, the Party [*] shall have the [*] with respect to [*] as
set forth in Section [*].

(iv) The Party [*] Collaboration Product [*] will have the [*] with respect to
[*].

2.14 Discontinuation of Participation on a Committee. The activities to be
performed by each Committee shall solely relate to governance under this
Agreement, and are not intended to be or involve the delivery of services. Each
Committee shall continue to exist until the first to occur of: (a) the Parties
mutually agreeing to disband the Committee; or (b) Cytokinetics providing
written notice to Astellas of its intention to disband and no longer participate
in such Committee. Once the Parties mutually agree or Cytokinetics has provided
written notice to disband such Committee, such Committee shall have no further
obligations under this Agreement and, thereafter, the Alliance Managers shall be
the contact persons for the exchange of information under this Agreement and
decisions of such Committee shall be decisions as between the Parties, subject
to the other terms and conditions of this Agreement.

2.15 Budgets and Fiscal Years. The Parties acknowledge that Astellas’ fiscal
year runs from April 1 through March 31, while Cytokinetics’ fiscal year runs
from January 1 through December 31. Accordingly, [*] relating to the Research,
Development, Medical Affairs and Commercialization of the Compounds and
Collaboration Products [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

27

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ARTICLE 3

LICENSES

3.1 License to Astellas. Subject to the terms and conditions of this Agreement,
Cytokinetics hereby grants to Astellas the following royalty-bearing worldwide
licenses [*] under the Cytokinetics Technology and Cytokinetics’ interest in the
Collaboration Intellectual Property:

(a) to Research (i) [*] Activators in the Collaboration Indications and (ii) [*]
Activators in the Field, in each case pursuant to the Research Plan during the
Research Term, which license shall be [*] as set forth in Section [*];

(b) to Develop (i) [*] Activators in the Collaboration Indications and (ii) [*]
Activators in the Field, in each case pursuant to the Development Plan, which
license shall be [*] as set forth in Section [*];

(c) to use [*] Activators and Collaboration Products containing [*] Activators
in the Collaboration Indications and to make, have made, offer for sale, sell
and otherwise Commercialize [*] Activators and Collaboration Products containing
[*] Activators for use in the Collaboration Indications, [*] except as provided
in Sections [*] below;

(d) to use [*] Activators and Collaboration Products containing [*] Activators
in the Field and to make, have made, offer for sale, sell and otherwise
Commercialize [*] Activators and Collaboration Products containing [*]
Activators for use in the Field, [*], except as provided in Sections [*] below;
and

(e) to perform Medical Affairs Activities for the Compounds and Collaboration
Products pursuant to the Medical Affairs Plan, [*], except as provided in
Sections [*] below.

Subject to Section [*] the licenses granted by Cytokinetics to Astellas under
this Agreement [*] to develop, make, have made, use, sell, offer for sale or
otherwise commercialize [*] that is [*] with a Compound.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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3.2 Sublicense Rights. Subject to the terms and conditions of this Agreement:

(a) Further subject to Section [*] below, each Party may exercise its rights and
perform its obligations under this Agreement by itself or through the engagement
of any of its Affiliates [*] in the performance of this Agreement.

(b) Each Party may sublicense the rights granted to it under Section [*] (as
applicable) to one (1) or more Third Parties, provided, however, that such Party
shall: (i) [*], and (ii) [*] the other Party [*].

(c) Notwithstanding the foregoing, [*] with respect to Collaboration Products
[*] but in any event [*].

(d) Each Party shall remain directly responsible for all of its obligations
under this Agreement that have been delegated, subcontracted or sublicensed to
any of its Affiliates, sublicensees or subcontractors and shall ensure that such
Affiliates, sublicensees and subcontractors comply with the terms and conditions
of this Agreement.

3.3 Cytokinetics’ Retained Rights. Cytokinetics and its Affiliates hereby
retain:

(a) the rights to practice the Cytokinetics Technology and Cytokinetics’
interest in the Collaboration Intellectual Property to exercise its and their
rights and perform its and their obligations under this Agreement, whether
directly or through one or more licensees; and

(b) subject to Section [*] the exclusive rights to otherwise practice and
license the Cytokinetics Technology and Cytokinetics’ interest in the
Collaboration Intellectual Property outside the scope of the licenses granted to
Astellas under Section 3.1, including researching, developing, manufacturing,
having manufactured and commercializing [*] in the Retained Indications.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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3.4 License to Cytokinetics. Subject to the terms and conditions of this
Agreement, Astellas hereby grants to Cytokinetics the following fully paid-up
licenses [*]:

(a) under the Astellas Technology and Astellas’ interest in the Collaboration
Intellectual Property to Research (i) [*] Activators in the Collaboration
Indications and (ii) [*] Activators in the Field, in each case pursuant to the
Research Plan during the Research Term, [*];

(b) under the Astellas Technology and Astellas’ interest in the Collaboration
Intellectual Property to Develop the Compounds and Collaboration Products
pursuant to the Development Plan, [*];

(c) under the Astellas Technology and Astellas’ interest in the Collaboration
Intellectual Property to manufacture and have manufactured the Compounds and
Collaboration Products pursuant to the Development Plan or Commercialization
Plan as appropriate, [*];

(d) under the Astellas Technology and Astellas’ interest in the Collaboration
Intellectual Property to Co-Promote the Collaboration Products in the
Co-Promotion Territory (or Shared Territory, as applicable and as set forth in
Section 9.6) pursuant to the Commercialization Plan upon Cytokinetics’ exercise
of the Co-Promotion option under Section 9.6, [*];

(e) under the Astellas Technology and Astellas’ interest in the Collaboration
Intellectual Property to Commercialize in the Shared Territory the Collaboration
Products in any [*] Indication(s) [*];

(f) further subject to Section [*] under Astellas’ interest in the Collaboration
Intellectual Property to research, develop, manufacture, have manufactured and
commercialize [*] for uses in the Retained Indications worldwide, [*]; and

(g) under the Astellas Technology and Astellas’ interest in the Collaboration
Intellectual Property to perform Medical Affairs Activities for the Compounds
and Collaboration Products in the Co-Promotion Territory (or Shared Territory,
as applicable and as set forth in Article 10) pursuant to the Medical Affairs
Plan, [*].

3.5 No Implied Licenses; Negative Covenant. Except as set forth herein, neither
Party shall acquire any license or other intellectual property interest, by
implication or otherwise,

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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under or to any trademarks, Patent Rights, Know-How, or other intellectual
properties owned or Controlled by the other Party. For clarity, the license
granted to each Party under any particular Patent Rights or Know-How Controlled
by the other Party shall confer exclusivity to the Party obtaining such license
only to the extent the Party granting such license Controls the exclusive rights
to such Patent Rights or Know-How. Neither Party shall, nor shall permit any of
its Affiliates or sublicensees to, practice any Patent Rights or Know-How
licensed to it by the other Party outside the scope of the license granted to it
under this Agreement.

3.6 [*]

(a) Except as set forth in Section [*] and subject to Sections [*] below, [*]:

(i) [*], other than [*] Activators for use in the [*] pursuant to this
Agreement;

(ii) [*] Activators for use in the [*] (A) pursuant to this Agreement [*];
(B) pursuant to Section [*] or (C) as otherwise agreed by the Parties; or

(iii) [*] for use in the [*] pursuant to this Agreement or the Collaboration.

(b) Notwithstanding the foregoing, [*] will not be deemed to be conducted under
or pursuant to this Agreement or the Collaboration. [*] shall mean any [*] for
which the [*], but excluding any [*] means: (i) [*] unless and until the [*];
and (ii) any other [*] but only if the [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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[*]

(c) [*] shall use Diligent Efforts to [*] Activator that is [*] the
Collaboration Indications, including by [*] any Collaboration Product containing
a [*] the Collaboration Indications, or [*] any Collaboration Product containing
a [*]. So long as [*] set forth in this subsection (c), the [*] Collaboration
Products [*] shall not, by itself, be deemed [*] under Section [*] of its
obligations under this Section 3.6.

(d) [*] shall use Diligent Efforts to [*] the Licensed Indications [*],
including by [*] the Licensed Indications [*] the Licensed Indications [*]. So
long as [*] set forth in this subsection (d), the [*] shall not, by itself, be
deemed [*] under Section [*] of its obligations under this Section 3.6.

(e) If either Party [*] and if such [*], as of the [*] such Party would [*] set
forth in Section [*], then such Party shall [*] either (i) [*] of this
Agreement, in which event [*] a Compound and/or Collaboration Product under this
Agreement and subject to the terms and conditions hereunder and any [*] the
Research, Development, Manufacture or Commercialization of [*], or (ii) [*].
Such Party’s [*] shall not be deemed [*] set forth in this Section 3.6; provided
that such Party [*] under this Agreement and [*] the other Party [*] [*] as used
in this Section 3.6(e), means [*] by such Party [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(f) If [*] with respect only to any of the [*] pursuant to Section [*] apply
with respect to [*].

3.7 Subcontractors. Each Party shall have the right to engage subcontractors for
purposes of conducting activities assigned to it under this Agreement and grant
a limited sublicense to such Third Parties solely for the purpose of performing
such activities, provided that any such subcontractor is bound by written
obligations of confidentiality and non-use consistent with this Agreement [*]
and has agreed to [*] that relate to any Compounds or Collaboration Products or
their use, manufacture or sale, which [*] as appropriate. Each Party shall
remain directly responsible for any obligations under this Agreement that have
been delegated or subcontracted to any subcontractor, and shall be directly
responsible for the performance of its subcontractors.

3.8 365(n) Rights. All rights and licenses granted under or pursuant to any
section of this Agreement, including the licenses granted under this Article 3
and Section 14.3, are and will otherwise be deemed to be for purposes of
Section 365(n) of the United States Bankruptcy Code (Title 11, U.S. Code), as
amended (the “Bankruptcy Code”), licenses of rights to “intellectual property”
as defined in Section 101(35A) of the Bankruptcy Code. Each Party will retain
and may fully exercise all of its respective rights and elections under the
Bankruptcy Code. Each Party agrees that the other Party, as licensee of such
rights under this Agreement, will retain and may fully exercise all of its
rights and elections under the Bankruptcy Code or any other provisions of
applicable Law outside the United States that provide similar protection for
“intellectual property.” Each Party further agrees that, in the event of the
commencement of a bankruptcy proceeding by or against such Party under the
Bankruptcy Code or analogous provisions of applicable Law outside the United
States, to the extent permitted by Law, [*] the Research and/or Development of
the Compounds and/or Collaboration Products under this Agreement pursuant to the
Research Plan and/or Development Plan, as appropriate, which, [*]. Additionally,
upon request by the other Party, the bankruptcy Party shall [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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ARTICLE 4

EXPANSION OF COLLABORATION

4.1 [*] Indications.

(a) Addition of [*] Indications. In addition to SMA, the Parties may add one or
more Retained Indication(s) [*] as [*] Indication(s) by mutual agreement. If a
Party is interested in adding any such Indication as [*] Indication, such Party
shall notify the other Party and provide the other Party with [*] for such
Indication, and the Parties shall confer and discuss such proposed addition.
Such Indication shall be added as [*] Indication [*] the Development Plan
pertaining to the Development of [*] Activators in such Indication. If such
Indication is added to the [*] Indications, the Parties shall [*] agreed by the
Parties).

(b) Cytokinetics Co-Funding Option. On a [*] Activator-by-[*] Activator basis,
Cytokinetics shall have [*] option to co-fund [*] (the “Cytokinetics Co-Funding
Option”). Cytokinetics may exercise the Cytokinetics Co-Funding Option for a
particular [*] Activator by providing a written notice of option exercise to
Astellas at any time [*] Indication for such [*] Activator. Astellas shall
provide Cytokinetics with [*].

(c) [*]. If: (i) [*] for a particular [*] Activator, or (ii) [*] for such [*]
Activator [*] with written notification [*] then in each case [*].

(d) [*] means, with respect to a particular [*] Activator, the [*], including,
but not limited to, [*] regardless of the [*] pursuant to Section [*] in
accordance with the Development Plan and [*] Indication(s) (including any [*],

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

34

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but excluding any [*]) to generate the [*] for a particular [*] Activator in [*]
Indications. For clarity, [*] shall include the [*] for such [*] Activator with
the [*], regardless of [*], but shall exclude the [*] in the Shared Territory,
or [*] for such [*] Activator in a [*] in the Astellas Territory. [*] shall
include the [*] of the Compound and Collaboration Product [*] but shall exclude
the [*] necessary for the [*].

4.2 [*] Indications.

(a) [*] Indications. [*] one or more [*] a [*] Indication upon written notice to
[*] Development activities for such Collaboration Product for such Indication.
In connection with [*] shall provide [*] the Development Plan (including the
[*]) pertaining to the Development of [*] Activators in such Indication(s) and
[*] the JDC. If the JDC [*] and if the [*] will have the [*].

(b) [*] [*] shall have the right to [*] the [*] Indication [*] for such
Indication [*]. If [*] shall also be [*] Development activities for such
Indication pursuant to Section [*] shall continue to [*] ([*], to the extent
practicable [*] Development program, and [*] under the Development Plan) [*]
Development work [*] including, but not limited to, the [*] pertaining to such
Indication subject to [*] set forth in Article [*]. [*] with respect to any [*]
Indication [*] at any of the [*]: (i) [*] (for any [*] Indication) [*] such
Indication to the Collaboration under Section [*]; (ii) if applicable, [*] with
respect to the [*] the Development of the [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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[*] Activator in such Indication under Section [*] Development activities with
respect to such Compound in such Indication; and/or (iii) if applicable, [*]
with respect to the [*] Indication [*] the Development of a [*] in such
Indication under Section [*] for such Indication. [*] related Development work
[*] the Development Plan [*].

(c) [*] means with respect to a particular [*] Activator in [*] Indication, the
[*], as well as any [*], but excluding any [*]). [*] Indication [*] shall
include the [*] for [*] Activator with the [*], regardless of [*] but shall
exclude the [*] in the Shared Territory, or [*] for [*] Activator in a [*] in
the Astellas Territory, which [*] shall be [*] Indication [*] shall include the
[*] but shall exclude the [*].

ARTICLE 5

RESEARCH

5.1 General. The Parties will conduct a research collaboration to discover,
identify, characterize and optimize [*] Activators for further Development in
the Licensed Indications and/or [*] Indications and [*] Activators in the Field
pursuant to the Research Plan (the “Research Program”).

5.2 Research Term. The term of such Research Program (the “Research Term”) shall
commence on the Effective Date and end on December 31, 2016. The Research Term
may be extended by the Parties’ mutual written agreement.

5.3 Research Plan. All Research activities under this Agreement shall be
conducted pursuant to a comprehensive written Research plan for Astellas’ fiscal
year during the Research Term (the “Research Plan”). The Research Plan shall
allocate Research responsibilities between the Parties and shall set forth the
objectives, activities and criteria for evaluation for such Research, as well as
the timeline related thereto. The Research Plan shall also set forth the
detailed budget

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

36

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for such Research activities, including a minimum of [*] Cytokinetics FTEs that
Astellas shall support annually [*] (the “Cytokinetics Research FTEs”), the
number of Astellas FTEs committed by Astellas during the Research Term and
outsourced costs (the “Research Budget”). From time to time during the Research
Term, the JRC shall prepare updates and amendments, as appropriate, to the
then-current Research Plan (including the Research Budget). In any event, the
Research Plan for the forthcoming Astellas’ fiscal year shall be approved by [*]
of the preceding year, provided that by [*] of each calendar year, the JRC shall
agree upon a proposed budget for the following Astellas fiscal year with respect
to costs other than for the Cytokinetics Research FTEs, and Astellas shall use
good faith efforts to obtain internal approval for such proposed budget to
become effective by [*]. The JRC shall have the right to approve updates and
amendments to the Research Plan (including the Research Budget), provided that
no amendment to the Research Plan (including the Research Budget) shall decrease
the number of Cytokinetics Research FTEs supported by Astellas without
Cytokinetics’ consent. Once approved by the JRC, such revised Research Plan
shall replace the prior Research Plan. If the terms of the Research Plan
contradict, or create inconsistencies or ambiguities with, the terms of this
Agreement, then the terms of this Agreement shall govern.

5.4 Conduct of Research. Each Party shall use Diligent Efforts to carry out the
Research activities assigned to it in the Research Plan and shall conduct such
activities in good scientific manner, and in compliance with all applicable
Laws. Each Party shall keep the other Party reasonably informed as to its
progress in the conduct of the Research Plan through meetings of the JRC. At
least [*] Business Days before each JRC meeting, each Party shall submit to the
JRC a written summary of its Research activities since its prior report. All [*]
under the Research Plan will be [*], provided that neither Party will be
required to [*] where it reasonably believes that [*].

5.5 Research Records. Each Party shall maintain complete, current and accurate
records of all Research activities conducted by it hereunder, and all data and
other information resulting from such activities. Such records shall fully and
properly reflect all work done and results achieved in the performance of the
Research activities in good scientific manner [*] to the extent [*]. After the
Effective Date, upon reasonable request of [*] to be mutually agreed by the
Parties, [*] that pertain to the Compounds and/or Collaboration Products or
otherwise relate to the Research performed pursuant to the Research Plan [*] as
described in the [*] shall be deemed Confidential Information [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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5.6 Research Plan Costs. Subject to this Section 5.6, Astellas shall be
responsible for all the costs and expenses incurred by both Parties in
performing the Research in accordance with the Research Plan (the “Research Plan
Costs”) and shall reimburse Cytokinetics for the Research Plan Costs incurred by
or on account of Cytokinetics in accordance with the Research Budget pursuant to
Section 11.2. Research Plan Costs that are incurred by Cytokinetics and subject
to reimbursement by Astellas shall include the costs of [*] set forth in the
Research Plan, and [*]. During any given Astellas fiscal year, Astellas shall
not be responsible for reimbursement of (i) any [*]; or (ii) any [*] the
applicable Research Budget.

5.7 Research in [*] Indications. Notwithstanding anything to the contrary in
this Agreement, the Parties may conduct Research of [*] Activators in one or
more [*] Indications to [*], but only to the extent agreed and set forth in the
Research Plan as part of the Research Program governed by this Article 5.
Neither Party shall be obligated to agree to the conduct of any such Research.
For clarity, the Parties may [*] the Collaboration in accordance with Article
[*].

5.8 Other [*]. Each Party shall have the right to [*] the Research Plan solely
for the purpose of [*], provided that such activities shall [*] and neither
Party shall have the right to [*] the other Party or [*] the other Party in
connection therewith.

5.9 Research Project Team. The Parties will establish a research project team
(the “Research Project Team”) that will be responsible for managing, reviewing
and implementing the performance of the day to day activities of both Parties
for all stages of the Research Program, including review and decision making
regarding lead optimization, safety evaluation, structural biology,
computational chemistry and pharmacology. Each Party will have representation on
the Research Project Team throughout the Research Program. The Research Project
Team shall be subordinate to and governed by the JRC.

ARTICLE 6

DEVELOPMENT

6.1 General. Subject to the terms and conditions of this Agreement, the Parties
will collaborate with respect to the Development of the Compounds and
Collaboration Products in the Collaboration Indications (for [*] Activators) or
the Field (for [*] Activators) for Regulatory Approval under the direction of
the JDC and

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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pursuant to the Development Plan, as set forth in more details below. The
Parties intend to pursue Development of the Lead Compound and other Compounds
and Collaboration Products broadly across an array of Indications.

6.2 Development Plan.

(a) The Development of the Compounds and Collaboration Products under this
Agreement (the “Development Program”) shall be conducted pursuant to a
comprehensive written Development plan (the “Development Plan”). The Development
Plan for each Compound and corresponding Collaboration Products shall set forth
the timeline and details of: (i) all preclinical and clinical Development
activities to be conducted by the Parties as necessary to generate data
sufficient to meet the requirements for Marketing Approval of such Compound and
corresponding Collaboration Products for each of the Indications as agreed by
the Parties and set forth in the Development Plan; (ii) the protocol synopsis
for each clinical trial included in such Development Plan; (iii) a Manufacturing
plan; and (iv) any other Development activities that the Parties agree to pursue
in collaboration for such Compound and corresponding Collaboration Products. The
Parties agree that: (A) the Development Plan will contain detailed plans for at
least [*] covered by the Development Plan, and summary plans for periods
thereafter, and (B) the budget associated with such Development Plan shall be
subject to the approval process set forth in Section 6.2(d). The Development
Plan shall include a coordinated development and regulatory strategy, including
the Parties’ respective roles in the development of each Collaboration Product
and the countries in which Development of Collaboration Product will occur. The
Development Plan shall also set forth: (1) a detailed budget of the Development
activities to be [*]; (2) if Cytokinetics has exercised the Cytokinetics
Co-Funding Option for a Collaboration Product and [*] for such Collaboration
Product, a detailed budget for [*] of such Collaboration Product in the [*]
Indications (the [*]); and (3) if [*] Indication [*] the Collaboration and [*]
for such [*] Indication, a detailed budget for such [*] Indication Development
Work (the “[*] Indication Development Budget”). Upon the other Party’s
reasonable request, each Party shall [*] Development activities under the
Development Plan. The [*] shall be included in the Development Plan and [*]
shall be subject to JDC approval. For reference, the Development Plan in effect
as of the Amendment Effective Date is [*] which was approved by the JDC and
signed by the JDC co-chairs in [*].

(b) The initial focus of the Development Program was the conduct of Phase 1
Clinical Trials and Phase 2 readiness activities for the Lead Compound in 2013,
with the [*] for the Lead Compound [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(c) The Development Program in 2015 shall include the initial Phase 2 Clinical
Trial of the Lead Compound in SMA. As of the Amendment Effective Date, the
Parties have agreed on a [*] for such initial Phase 2 Clinical Trial within the
document attached hereto as Exhibit M. Promptly after the Amendment Effective
Date, the JDC shall update the Development Plan to include the conduct of such
initial Phase 2 Clinical Trial in 2015, consistent with [*] set forth in such
exhibit.

(d) The JDC shall update the Development Plan (including [*] as applicable) at
least annually, with such annual update to be finally approved no later than [*]
of the preceding Astellas’ fiscal year, provided that [*] Indication [*] subject
to the [*] the JDC (and [*] Indication [*]) after [*] for such Indication. By
[*] of each calendar year starting on [*] Development activities are [*] the
updated Development Plan, the JDC shall agree upon a proposed [*] for the
following Astellas fiscal year beyond [*]. Astellas shall use good faith efforts
to [*]. From time to time during the Term, the JDC shall prepare amendments, as
appropriate, to the then-current Development Plan (including [*] as applicable),
including adding additional Compounds and Collaboration Products as well as
additional Indications [*] the Collaboration pursuant to Article [*] The JDC
shall have the right to approve updates and amendments to the Development Plan
(including [*] as applicable), provided that [*] subject to the [*] the JDC (and
[* ]) after [*] for such Indication. Once approved by the JDC, such revised
Development Plan shall replace the prior Development Plan.

(e) If the terms of the Development Plan contradict, or create inconsistencies
or ambiguities with, the terms of this Agreement, then the terms of this
Agreement shall govern.

6.3 Allocation of Development Responsibilities. The Development Plan shall
allocate Development responsibilities of the Compounds and Collaboration
Products between the Parties as follows:

(a) Astellas Responsibilities. Subject to Sections 6.3(b), 6.3(c) and 6.3(d)
below, Astellas shall be primarily responsible for the Development of (i) [*]
Activators and corresponding Collaboration Products: (A) in the Licensed
Indications and [*] Indications throughout the world; (B) in [*] Indications for
[*] in the Shared Territory and [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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Development activities in Astellas Territory; and (C) and [*] Indications unless
Astellas [*] the conduct of such [*] or as otherwise set forth in Article [*]
and (ii) [*] Activators and corresponding Collaboration Products in the Field
throughout the world, in each case pursuant to the Development Plan. While it is
contemplated that Cytokinetics shall be responsible for the Phase 1 Work and
Early Stage Work as described in subsection (b) below, the JDC may allocate to
Astellas specific clinical and non-clinical activities to be conducted in
parallel with the Phase 1 Work and/or Early Stage Work [*].

(b) Cytokinetics Responsibilities. Notwithstanding Section 6.3(a), Cytokinetics
shall be responsible for the conduct of:

(i) the Phase 1 Clinical Trials of the Lead Compound (but excluding [*]
Development activities in the Astellas Territory) and Phase 2 readiness
activities in Licensed Indications (including [*] but excluding any activities
allocated to Astellas pursuant to subsection (a) above) pursuant to the
Development Plan through the initiation of the first Phase 2 Clinical Trial for
the Lead Compound in Licensed Indications (the “Phase 1 Work”);

(ii) the Development activities for the Lead Compound in [*] Indications prior
to [*] (but excluding any [*] Development activities in the Astellas Territory )
(the “Early Stage Work”), including the [*] and the initiation of the initial
Phase 2 Clinical Trial in SMA in 2015, and, subject to the Parties’ mutual
agreement, in Licensed Indications;

(iii) other Development activities for the Lead Compound and other [*]
Activators in [*] Indications allocated to Cytokinetics by the JDC, taking into
consideration [*] of the Collaboration;

(iv) all Development activities for [*] Activators in [*] Indications to
generate [*] for such Compounds in such Indications (the “[*] Indication
Development Work”), including [*] (to the extent provided in Article [*]) in
connection with such Development activities but excluding [*] for such [*]
Indication and [*]; and

(v) other Development activities under the Development Plan [*] [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

41

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(c) Development in [*] Indications.

(i) Notwithstanding Section [*] shall have the right, but not the obligation, to
conduct Development activities for Compounds and Collaboration Products in [*]
Indication(s) [*] as set forth in this Section 6.3(c) (“[*] Indication
Development”).

(ii) [*] and shall not be subject to the [*] set forth in Section [*]. [*] shall
have the right, but not the obligation, to [*] Compounds and Collaboration
Products [*] Indication pursuant to subsections (iv) through (vi) below.

(iii) In addition to [*] as set forth in subsection (ii) above, [*] Development
Plan [*] Development activities for one or more Collaboration Products for [*]
Indication, [*] Development activities for such Indication [*] the Development
Plan [*] Development in such Indication in accordance with the Development Plan,
[*] such Indication as a [*] Indication. Upon [*] such Indication [*]
Indication, provided that, in [*] Development in such Indication under the
Development Plan will [*] the Development and/or Commercialization of Compound
and Collaboration Product in Indications [*] Developed and/or Commercialized [*]
pursuant to the Development Plan and/or Commercialization Plan.

(iv) [*] Indication Development, [*] a reasonably [*] by the JDC, such [*] the
Development Plan and such [*] Indication Development shall be conducted pursuant
to such plan.

(v) [*] Indication Development as part of the regular JDC reporting cycle.
Following the [*] Indication Development for a Compound and corresponding
Collaboration Product in a [*] Indication Development as well as the [*]
Indication Development for such Collaboration Product [*] as well as the [*] the
Development of such Compound or Collaboration Product in such Indication [*]
[*]); provided that if such [*] Indication is [*] as set forth in Section [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(vi) [*] such Development work, then (A) [*] Indication Development [*] as set
forth in Section [*] (B) [*] such Compound and Collaboration Product in such
Indication as set forth in Section [*]; and (C) all [*] Development in such [*]
Indication shall be subject to the [*] under this Agreement applicable to the
Development for [*] Indications other than [*] Indication, and the [*] the
Development Plan and Cytokinetics Development Budget to include such continued
Development work in such [*] Indication, including allocation of the Parties’
respective responsibilities for [*] Development work (i.e., the Parties’
respective activities in [*]).

(vii) [*] such Development work, then such Compound and Collaboration Product
will [*] Indication; provided that if the Development of such Compound or
Collaboration Product in such [*] Indication [*] or otherwise by the Parties,
then Section [*] shall apply.

(d) Development in [*] Indications; Lead Party Responsibilities. Subject to [*]
the Development of [*] Activators in [*] Indications, for as long as [*] such
Development, the Parties [*] with respect to Development activities for [*]
Indications, except that:

(i) Cytokinetics shall lead all [*] Indication Development Work, including [*]
(to the extent provided in Article [*]) in connection with such Development
activities, to generate [*] in the Shared Territory. Subject to
Section 6.3(d)(iii), Astellas shall lead all [*] Indication Development Work,
including all [*] (to the extent provided in Article [*]) in connection with
such Development activities, pertaining to [*] in the Shared Territory and [*]
in the Astellas Territory. For clarity, [*] for such Indication [*] such
Indication and [*].

(ii) Notwithstanding anything to the contrary, including Section [*] the Party
designated to lead certain [*] Indication Development Work (which includes [*]
and, to the extent provided in

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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Article [*] in connection with such Development activities) shall have the right
to make decisions concerning the operation of such activities without the
approval of the JDC as far as such activities are being conducted under the
Development Plan (but shall keep the JDC reasonably informed on its conduct of
such activities, at a level of detail reasonably requested by the other Party,
as part of the regular JDC reporting cycle); and

(iii) In the event that [*] further right to [*] Indication Development Work for
such Indication [*] shall have the [*] Indication [*], provided, however, that
[*] shall consider in good faith [*] with respect to the [*] shall keep the JDC
reasonably informed on its conduct of such Development activities at a level of
detail [*] as part of the regular JDC reporting cycle.

6.4 Development Costs.

(a) General. Except as set forth in Sections 6.4(b), (c) and (d) below, Astellas
shall be solely responsible for all Development Costs incurred by or on behalf
of either Party in performing Development activities under the Development Plan,
and shall reimburse Cytokinetics for Development Costs incurred by Cytokinetics
as set forth in Section 11.3(a), to the extent [*].

(b) Development Costs for [*] Indication Development. [*] the Development Costs
incurred by or on behalf of [*] Indication Development (the “[*] Indication
Development Costs”); provided that if [*] the Development of any Compound or
Collaboration Product in any [*] Indication that were the [*] Indication
Development after [*] as set forth in Section [*]. The Development Costs
incurred by either Party in the continued Development in such Indication [*]
Indication Development shall be [*] as set forth in Section [*] above.

(c) Development Costs in [*] Indications. If [*] with respect to a [*] Activator
and subject to the [*] set forth in Section [*] for such [*], to the extent [*]
Budget as approved by the JDC [*]. [*] pursuant to Section [*]. [*] Development
Costs for the [*] Indications.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(d) Development Costs in [*] Indications. For all [*] Indications, subject to
the [*] set forth in Section [*] Development Costs, provided that [*]
Development Budget as approved by the JDC [*] pursuant to Section [*]
Development Costs for [*] Indications, including the [*] Development activities
[*] in the Shared Territory and [*] in Astellas Territory for [*] Activators in
[*] Indications.

6.5 Diligence.

(a) Each Party shall use Diligent Efforts to conduct the Development activities
assigned to it under the Development Plan. Without limiting the foregoing, [*]

(i) [*] set forth in the Development Plan; and

(ii) [*] (i.e., a [*] Activator or [*] Activator) and [*]). If [*] for a
particular [*] at any time after the [*] immediately following the [*] will be
deemed to [*] pursuant to Section [*] with respect to Compounds and
Collaboration Products [*] provided that [*]. In such event, Section [*] shall
apply with respect to [*] shall no longer apply with respect to [*].

(b) [*] Compound or Collaboration Product if: (i) [*] such Compound or
Collaboration Product are [*] Development Plan in a [*] such Compound or
Collaboration Product, and [*] in accordance with the Development Plan; or
(ii) [*] such Collaboration Product.

(c) In the event of [*] Compound or Collaboration Product [*], the Parties shall
[*]. In the event the [*] [*] shall be subject to [*] in accordance with [*] set
forth in Section [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(d) Without limiting [*] set forth herein, [*] the Development of the Lead
Compound and [*] the Lead Compound. [*] the Lead Compound [*] Indication [*]
shall have the right (but not the obligation) to [*] [*] Indication [*]
Indication and [*] the Lead Compound [*] Indication in accordance with Section
[*]. [*] such Development [*] Indication shall [*] under Section [*]

(e) Without limiting [*] set forth herein, [*] Activators for Development [*]
Indications, and [*] Activators for Development [*] Indication(s). [*]
pertaining to the [*] Activators, [*] Development activities [*] Activator [*]
Indication, then:

(i) [*] Activators with respect to [*] Indications [*] Indications [*]
Indications;

(ii) [*] Activators [*] Indications [*] notwithstanding Section [*] Indications
[*] provided that [*] Development activities for a [*] Activator [*] Indication
[*] Development under the Development Plan [*] Activator in any [*] Indication
or any [*] Indication under this Agreement; and

(iii) [*] the Collaboration relating to [*] Activators [*] with respect to [*]
Indications. [*] [*] Activators in the [*] Indications in accordance with this
Section 6.5(e).

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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6.6 Lead Compound Development; Advancement to Phase 2.

(a) Cytokinetics will be the Party responsible for continuing to conduct the
Phase 1 Work as described in Section 6.3(b)(i). In connection therewith,
Cytokinetics will continue to: (i) hold the Lead Compound IND; (ii) be the lead
Party interacting with the Regulatory Authorities on matters pertaining to the
Development of the Lead Compound and the Lead Product; and (iii) Manufacture and
supply the Lead Compound and the Lead Product for use in such Development
activities. Cytokinetics shall provide the JDC with the data and results from
the Phase 1 Work on an ongoing basis.

(b) Concurrently with Cytokinetics’ conduct of the Phase 1 Work, the Parties,
through the JDC, shall jointly plan for the initiation of the first Phase 2
Clinical Trial for the Lead Compound by agreeing on the initial Indication to be
pursued, drafting the study protocol and related documents and planning for the
conduct of such Clinical Trial.

(c) Promptly following completion of the Phase 1 Work (including any additional
Phase 1 Clinical Trials, PK studies, formulation work or meetings with
Regulatory Authorities that may be added through amendments to the Development
Plan) by Cytokinetics, and other Phase 2a enabling studies conducted by Astellas
in parallel with Phase 1 Work (including any additional studies or meetings with
Regulatory Authorities that may be added through amendments to the Development
Plan) and in any event, [*] the JDC will determine whether or not to advance the
Lead Compound into a Phase 2 Clinical Trial (currently anticipated to be a Phase
2a study). Astellas may conduct Phase 2a enabling studies for the Lead Compound
in accordance with the Development Plan prior to and following the Lead Compound
[*] in accordance with the Development Plan [*] as determined by the JDC (e.g.,
[*]). “Lead Compound [*]” means the [*] from the applicable [*] if the JDC
determines that such [*] the Lead Compound into the first Phase 2 Clinical
Trial, provided that [*] described in the initial Development Plan.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(d) As of the Amendment Effective Date, the JDC has decided to advance the Lead
Compound into a Phase 2 Clinical Trial, and as the result of such decision,
Astellas shall pay to Cytokinetics the fifteen million Dollars ($15,000,000)
milestone payment set forth in Section 11.5(b)(i) for the achievement of such
milestone within thirty (30) days after the Amendment Effective Date.

6.7 Development Records. Each Party shall maintain complete, current and
accurate records of all Development activities conducted by it hereunder, and
all data and other information resulting from such activities. Such records
shall fully and properly reflect all work done and results achieved in the
performance of the Development activities in good scientific manner [*]. Each
Party shall document all non-clinical studies and clinical trials in formal
written study reports according to applicable Laws and national and
international guidelines (e.g., ICH, GCP, GLP, and GMP). Each Party shall have
the right to review and copy such records maintained by the other Party at
reasonable times and to obtain access to the original [*].

6.8 Data Exchange and Development Reports. In addition to adverse event and
safety data reporting obligations pursuant to Section 7.5, each Party shall
promptly provide the other Party with copies of all data and results generated
by or on behalf of such Party in the course of performing the Development
hereunder (including final reports), and including, in each case of data arising
from clinical trials, [*] as the JDC may agree from time to time. The Party
receiving such data shall have the right to use and reference such data to
perform its obligations or to exercise its rights under this Agreement,
including as set forth in Section 7.1(f). Each Party shall provide the JDC with
regular reports detailing its Development for the Collaboration Products, and
the results of such Development at each regularly scheduled JDC meeting. The
Parties shall discuss the status, progress and results of each Party’s
Development at such JDC meetings.

6.9 Advisory Panels; Medical Education Activities. The Development Plan may also
provide for advisory panels with key opinion leaders with respect to the
Development of Collaboration Products to be held by one or both Parties. The
Party organizing the advisory panel shall give the other Party written notice at
least [*] in advance of any such advisory panel meetings, and the other Party
shall have the right to attend such meetings. If the Parties agree to conduct
non-promotional medical education activities and the JMAC has not been
established at that time, the Parties shall conduct non-promotional medical
education activities as part of the Development Activities under the Development
Plan and under the oversight of the JDC, and [*] in connection therewith shall
[*] provided that, if for any Collaboration Product, [*] such medical education
activities [*] medical education activities for such Collaboration Product, then
[*] shall have the right to conduct such medical education activities for such
Collaboration Product under the JDC’s oversight, and, [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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[*] such medical education activities shall be: (a) [*] medical education
activities for such Collaboration Product under the Development Plan and (b) [*]
such activities. If the non-promotional medical education activities [*]
Compounds, the Parties shall discuss in good faith an appropriate [*] each
Party. Nothing in this Section 6.9 will [*] scientific and/or medical
conferences, or [*] continuing medical education activities [*] in connection
with [*] Compounds.

6.10 Development Project Team. The Parties will establish a project team for
each Compound (the “Development Project Team”) that will be responsible for
managing, reviewing and implementing the performance of the day to day
activities of both Parties for all stages of the Development Program for such
Compound, including review and decision making regarding CMC, toxicology,
clinical trial designs and regulatory filings and strategy. Each Party will have
representation on the Development Project Team throughout the Development
Program. The Development Project Team shall be subordinate to and governed by
the JDC (except with respect to CMC issues, with respect to which the
Development Project Team will be subordinate to and governed by the JMC).

ARTICLE 7

REGULATORY

7.1 Regulatory Responsibilities.

(a) The Development Plan shall set forth the regulatory strategy for seeking
Marketing Approval for the Compounds and Collaboration Products by the FDA, EMA
and other Regulatory Authorities in [*] as agreed upon by the Parties. [*]
Development under the Development Plan (including the [*] Development), [*]
necessary to obtain and maintain Regulatory Approval of the Compounds and
Collaboration Products in the Collaboration Indications (for [*] Activators) or
the Field (for [*] Activators) throughout the world, which activities shall be
conducted using Diligent Efforts and in accordance with the regulatory strategy
set forth in the Development Plan. For the Development Plan, the regulatory
strategy will be set by Astellas except where [*]; in such case [*]. For the
Development Plan, Cytokinetics will set the regulatory strategy for [*] and
other activities [*] except when [*] in the Shared Territory [*] [*]) for [*]
Indications [*] in the Shared Territory, and Astellas will set the regulatory
strategy for [*] Indications for the Astellas Territory. Except where [*]
regulatory activities related to [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(b) Cytokinetics shall hold the Lead Compound IND during the conduct of the
Early Stage Work. Prior to the [*], Cytokinetics shall transfer the Lead
Compound IND [*] to Astellas, unless the JDC [*] as set forth in
Section 6.3(b)(iii), in which case Cytokinetics shall continue to hold the Lead
Compound IND and Regulatory Materials related to such Development work.

(c) [*] Regulatory Materials for [*] Activators for [*] Indication to support
the Development of such Compound in such Indications in the Shared Territory. If
[*] Activator for [*] Indication or [*] Indication [*] Indication. [*]
regulatory strategy in the Development Plan for [*] (but excluding [*] in the
Shared Territory [*]) for such [*] Indications [*] in the Shared Territory. If
[*] Indication, [*] regulatory activities related to [*] Activators for such
Indication. If [*] the right to [*] a Collaboration Product in the Shared
Territory [*] as set forth in Section [*] shall have the right to [*] pertaining
to such Collaboration Product in the Shared Territory [*].

(d) In addition, [*] shall be responsible for [*] regulatory activities related
to [*] Development (including [*] applicable Regulatory Authorities) until the
JDC [*] the Development of [*] Indication under Section [*].

(e) [*] in connection with [*] under Sections 7.1(b), (c), and (d) will be [*]
Indication [*] Indication [*], as applicable.

(f) Astellas hereby grants Cytokinetics and its Affiliates and (sub)licensees
the right to reference any IND and other Regulatory Materials Controlled by or
on behalf of Astellas

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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or its Affiliates for use in the Development by Cytokinetics in accordance with
this Agreement, and Cytokinetics hereby grants Astellas, its Affiliates and
sublicensees the right to reference any IND for Compounds and/or Collaboration
Products and other Regulatory Materials Controlled by or on behalf of
Cytokinetics or its Affiliates for use in the Development by Astellas, its
Affiliates and sublicensees in accordance with this Agreement. Each Party hereby
grants the other Party the right to use any data resulting from such Party’s
activities under this Agreement to perform its obligations or to exercise its
rights under this Agreement. Each Party may file its own IND(s) and other
Regulatory Materials for each [*] Activator to support its Development work
under this Agreement, which may cross reference the other Party’s IND(s) and
other Regulatory Materials for such [*] Activator.

(g) Except as set forth in Sections 7.1(b), (c) and (d) above and otherwise
agreed in writing by the Parties, [*] shall be responsible, [*] for the
Collaboration Products [*]. Without limiting the foregoing:

(i) Astellas shall file its own IND for the Development of the Lead Compound for
the activities allocated to it under the Development Plan and Astellas shall
have the right to cross reference the Lead Compound IND if necessary.

(ii) Astellas shall hold IND(s) and other Regulatory Materials for [*]
Activators for each [*] Indication to support the Development of such Compound
in such Indication in the Astellas Territory, and Astellas shall [*] for such
Indication in the Astellas Territory.

(iii) [*] shall be responsible for regulatory activities related to [*]
Activators for each [*] Indication, unless [*] for such Indication.

7.2 Cooperation. Each Party shall cooperate reasonably with the other Party with
respect to key regulatory activities relating to the Compounds and Collaboration
Products, shall provide such other Party with all reasonable assistance in the
preparation and filing of Regulatory Materials relating to the Compounds and
Collaboration Products, and shall keep such other Party reasonably and timely
informed of its preparation and submission of all Regulatory Materials relating
to the Compounds and Collaboration Products and the Regulatory Authorities’
review of such Regulatory Materials. Without limiting the foregoing, each Party:

(a) shall consult with the other Party through the JDC or JCC, as applicable,
regarding regulatory matters pertaining to [*] Regulatory Materials [*] relating
to the Compounds and Collaboration Products, including plans, strategies,
filings, reports, updates and supplements in connection therewith. As used
herein, “[*] Regulatory Materials” means IND and MAA filings, [*] or materials

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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that: (i) are [*] a Regulatory Authority; (ii) contain [*] such Regulatory
Authority; (iii) contain [*] to such Regulatory Authority; or (iv) [*] the
relevant Compound or Collaboration Product or its Development or
Commercialization;

(b) shall provide the other Party with drafts of any [*] Regulatory Materials
for the Compounds and Collaboration Products to be submitted by such Party to
the Regulatory Authority in [*] days prior to submission for review and comment
(or if [*] such as in the event of [*] by Regulatory Authority that [*] but in
no event in a manner that would [*] such reporting or response), and shall
consider in good faith any comments received from the other Party;

(c) shall provide the other Party with copies of [*] Regulatory Materials ([*]
(as defined below)) submitted to the Regulatory Authority [*] for each calendar
month as well as copies of [*] correspondence [*] received from the Regulatory
Authority [*] pertaining to the Compounds and Collaboration Products for [*]
Business Days [*] to a Regulatory Authority that: (i) is [*] from a Regulatory
Authority or is in response to an administrative request or inquiry from a
Regulatory Authority; (ii) contains [*] provided to such Regulatory Authority;
(iii) contains [*] to such Regulatory Authority; (iv) [*] the receiving
Regulatory Authority [*] to the relevant Compound or Collaboration Product or
its Development or Commercialization; and (v) is required by Laws to be
periodically filed to an existing IND or MAA. [*] includes correspondence such
as [*], notifications and non-substantive amendments, but excludes all [*]; and

(d) shall provide the other Party written minutes or other records of any oral
key discussions (such as Type A, Type B and Type C meetings in the U.S. and
foreign similar or equivalent meetings) with the Regulatory Authority [*]
pertaining to the Compounds and Collaboration Products promptly after any such
discussion.

For purpose of Section 7.2, the Parties shall establish a direct line of contact
between the persons responsible for the overall regulatory strategies and
activities for the Collaboration Products within each Party.

If any [*] to be provided under Section [*] was originally [*] the providing
Party shall provide [*] [*] to the receiving Party at the [*] except the case
where such Party reasonably believes such [*] such as in the event of [*] by
Regulatory Authority that [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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7.3 Meetings with Regulatory Authorities. Each Party shall provide the other
Party with at least [*] days advance notification of key in-person meeting or
teleconference (such as [*] in the U.S. and foreign similar or equivalent
meetings) with the Regulatory Authorities [*] that relates to the Development of
the Compounds and Collaboration Products under the Development Plan. Such other
Party shall have the right, but not the obligation, to have its representatives
attend (but, unless otherwise requested by the Party responsible for such
meeting, not participate in) such meetings.

7.4 Product Complaints. Each Party shall be responsible for handling product
complaints (except for those covered by Section 7.5 below) arising pursuant to
its Development of the Compounds and Collaboration Products in compliance with
all applicable Laws. Each Party shall promptly provide the other Party with
written notice of any such product complaint received by such Party and arising
pursuant to its Development. Upon request of either Party, the Parties shall
convene a meeting to discuss such product complaint and collaborate to resolve
any such product complaint. Astellas shall be responsible for handling product
complaints (except for those covered by Section 7.5 below) relating to marketed
Collaboration Products in compliance with all applicable Laws.

7.5 Adverse Events Reporting. At least [*] prior to the [*] Development [*]
Development or as otherwise may be required to satisfy regulatory requirements,
the Parties shall enter into a pharmacovigilance and adverse event reporting
agreement setting forth the worldwide pharmacovigilance procedures for the
Parties with respect to the Collaboration Products, such as safety data sharing,
adverse events reporting and prescription events monitoring (the
“Pharmacovigilance Agreement”). Such procedures shall be in accordance with, and
enable the Parties to fulfill, local and national regulatory reporting
obligations under applicable Laws. A Party responsible for the first Pivotal
Registration Study for a Collaboration Product in any Collaboration Indication
shall establish, prior to the Initiation of the first Pivotal Registration Study
for the applicable Collaboration Product, the global safety database for the
Collaboration Products, and shall maintain such global safety database for so
long as such Collaboration Product is under Development and/or Commercialization
hereunder. The [*] to the extent [*] such Collaboration Product for use in a
Collaboration Indication. Until the First Commercial Sale of a Collaboration
Product, such responsible Party shall hold the primary responsibility for
reporting quality complaints, adverse events and safety data related to the
Collaboration Products to such database and to the applicable Regulatory
Authorities, as well as responding to safety issues and to all requests of
Regulatory Authorities related to the Collaboration Products, in each case [*]
and to the extent required by the applicable

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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Law. If each of the Parties is separately conducting Pivotal Registration
Studies for the same Collaboration Product for the same Collaboration
Indication, then Astellas shall hold the primary responsibility for establishing
and maintaining the global safety database for such Collaboration Product and
reporting quality complaints, adverse events and safety data; provided however,
that the [*]. After the First Commercial Sale of a Collaboration Product,
Astellas shall hold primary responsibility for reporting quality complaints,
adverse events and safety data, except during the Cytokinetics Commercialization
Period, in which case Cytokinetics shall hold primary responsibility for such
activities [*], unless the Parties agree otherwise in writing. After the
Cytokinetics Commercialization Period, Cytokinetics will transfer the global
safety data in such global safety database for such Collaboration Product to
Astellas. Each Party agrees to comply with its respective obligations under the
Pharmacovigilance Agreement and to cause its Affiliates, licensees and
sublicensees to comply with such obligations.

7.6 Notification of Threatened Action. Each Party shall immediately notify the
other Party of any information it receives regarding any threatened or pending
action, inspection or communication by any Regulatory Authority, which may
affect the safety or efficacy claims of any Collaboration Product or the
continued marketing of any Collaboration Product. Upon receipt of such
information, the Parties shall promptly consult with each other in an effort to
arrive at a mutually acceptable procedure for taking appropriate action.

7.7 Remedial Actions. Each Party shall notify the other immediately, and
promptly confirm such notice in writing, if it obtains information indicating
that any Collaboration Product may be subject to any recall, corrective action
or other regulatory action with respect to the Collaboration Product taken by
virtue of applicable Law (a “Remedial Action”). The Parties shall fully assist
each other in gathering and evaluating such information as is necessary to
determine the necessity of conducting a Remedial Action. Each Party shall (and,
in case of Astellas, shall ensure that its Affiliates and sublicensees shall)
maintain adequate records to permit the Parties to trace the Manufacture,
distribution and use of the Collaboration Products. Astellas shall have sole
discretion with respect to any matters relating to any Remedial Action,
including the decision to commence such Remedial Action and the control over
such Remedial Action, at its cost and expense.

7.8 Collaboration Products [*]. Notwithstanding anything to the contrary in this
Article 7, in the event that [*] Collaboration Product in the Shared Territory
[*] pursuant to Section [*], then Sections [*] (with the Parties’ [*]) to such
Collaboration Product in the Shared Territory [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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ARTICLE 8

MANUFACTURING AND SUPPLY

8.1 General. The Manufacture of the Compounds and Collaboration Products,
including all process and formulation development in connection therewith,
including CMC Activities, shall be overseen and coordinated by the JMC and
conducted pursuant to the Manufacturing plan included in the Development Plan
and the Commercialization Plan. At each regularly scheduled JMC meeting, each
Party shall provide the JMC with reports summarizing its Manufacturing
activities and the results of such activities and [*] Compound and Collaboration
Product [*] such Party under this Agreement [*]. The Parties acknowledge that it
is in the Collaboration’s interest that, for each Collaboration Product under
Development, the clinical trial materials for Development be made with the same
process under the JMC’s oversight.

8.2 Transfer of Manufacturing Know-How to Astellas.

(a) Technology Transfer. The Parties intend that [*] the Manufacture of the
Compounds and Collaboration Products (including the [*]). To this end, promptly
following the [*] or at the timing agreed by the JMC but in any event [*] the
Compounds and Collaboration Products for the [*] and provided that the [*]
Development of such [*] the JMC shall establish the procedures for Cytokinetics
to effect the transfer to Astellas of the Cytokinetics Know-How that is then
being used by Cytokinetics or its Third Party manufacturer in the Manufacture of
the Lead Compound and Lead Products, to the extent such Cytokinetics Know-How is
not already in Astellas’ possession. Cytokinetics shall conduct such technology
transfer as soon as practicable in accordance with such procedures, [*].

(b) Assistance. In connection with the transfer of Know-How under this
Section 8.2, Cytokinetics shall provide reasonable technical assistance at
Astellas’ request [*]. Such technical assistance shall be included as an element
of the Development Plan [*].

8.3 [*] Supply. Subject to Sections [*] shall be responsible, itself and/or
through Affiliates or Third Party contract manufacturers, for the Manufacture
and supply of [*] Compounds and Collaboration Products for use [*] in the
Development and Commercialization under this Agreement, [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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8.4 [*] Supply.

(a) Notwithstanding Section [*] (i) [*] shall Manufacture and supply the [*] as
agreed by the JMC, under the Development Plan and the [*] associated therewith
will be [*], (ii) [*] shall have the right, but not the obligation, to
Manufacture and supply the Compounds and Collaboration Products to conduct [*]
Development as set forth in [*], and (iii) if [*] Activator in [*] Indication,
[*] have the obligation, and [*] shall have the right, to Manufacture and supply
such Compound and related Collaboration Product for use in the Development and
Commercialization of such Compound and Collaboration Product in such Indication.

(b) With respect to [*] Development, [*] shall have the right to elect to either
(i) [*] the applicable Compounds and Collaboration Products [*] Development if
[*] Manufacturing such Compounds and Collaboration Products for [*] under the
Development Plan, to be provided [*]; or (ii) [*] such Compound and/or
Collaboration Products [*] in which event, [*] then being used by [*] the
Manufacture of the Compounds and Collaboration Products to the extent necessary
or useful for [*] Manufacture such Compounds and Collaboration Products.
Promptly following [*] Development and provided that (x) the JDC [*] has
determined to [*] in accordance with Section [*] and (y) [*] Manufactures or has
Manufactured such Compound and/or Collaboration Products [*] for such
Development work, the JMC shall [*] that is then being used [*] such Compound
and such Collaboration Product, to the extent [*] is not already [*] as soon as
practicable in accordance with [*]. In connection with the [*] under this
Section 8.4, [*]. [*] shall be included [*] the Development Plan and [*].

(c) With respect to a [*] Activator in [*] Indication, where [*] such
Indication:

(i) if [*] Manufacture and supply such Compound and related Collaboration
Product for use in the Development and Commercialization of such Compound and
Collaboration Product in such Indication, or if [*] Manufacture and supply [*]
such Compound and Collaboration Product for such use, then such Party shall
promptly notify the other Party, and [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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[*] then being used [*] Manufacture of such Compound and Collaboration Product
to the extent [*] Manufacture such Compound and Collaboration Product. [*]
Manufacture and supply such Compound and Collaboration Product [*] and for any
[*] to the extent [*] to the extent that it [*] Development [*] Indication(s)
and/or [*] Indication(s).

(ii) If the Parties agree, [*] Manufacture and supply, and [*], such
Collaboration Product for use in the Development and Commercialization of such
Collaboration Product in such Indication. In such event, [*] such Collaboration
Product to the extent [*] Manufacture and supply under this Agreement (e.g., if
Astellas is compensated for such Manufacture and supply [*]), and shall have [*]
as set forth in Section [*]

(d) If [*] (e.g., to [*] a Compound or Collaboration Product or the Manufacture
of a Compound or Collaboration Product) and [*] under Section [*] shall have the
right to [*] and under the Development Plan. If [*] and the Parties [*] such
Compound or Collaboration Product for a [*] Indication [*] by the Parties or [*]
(i.e., [*] Indication or [*] Indication, as applicable) of the Development [*]
in connection with [*].

8.5 Manufacturing Records. Each Party shall promptly provide the other Party,
upon its reasonable request for the purpose of this Agreement, copies of the
Manufacturing records (including specifications, protocols, batch records,
master batch records and other CMC Information) maintained by the first Party,
its Affiliates or Third Party contractors pertaining to Compounds and
Collaboration Products for such other Party’s use in connection with the
Manufacture of the Compounds and/or Collaboration Products under this Agreement
(and in the case of [*]). Each Party hereby grants the other Party the right to
reference (and have referenced by its contract manufacturer) the Drug Master
Files, if any, maintained by the first Party, its Affiliates or Third Party
contractors pertaining to Compounds and Collaboration Products for such other
Party’s use in connection with the Manufacture of the Compounds and/or
Collaboration Products under this Agreement (and in the case of [*]). For as
long as [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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[*] Manufacture any Collaboration Product pursuant to Section [*] shall have the
right to [*] such Collaboration Product [*] (it being understood such [*] the
Collaboration Product so long as [*]), upon reasonable request by [*] mutually
agreed upon by Astellas and Cytokinetics, provided that [*] have the right to
[*]. As between the Parties, all [*] shall be deemed [*].

8.6 Manufactured Products. Each Party represents and warrants that all Compounds
and Collaboration Products Manufactured and supplied by such Party for clinical
trial and/or commercial use under this Agreement shall: (a) meet the applicable
specifications; (b) be Manufactured in accordance with current Good
Manufacturing Practices; and (c) be Manufactured in accordance with all
applicable Laws, including any Governmental Authority requirements then in
effect.

ARTICLE 9

COMMERCIALIZATION

9.1 General. Astellas shall have the primary responsibility, at its own expense,
for all aspects of (including the conduct of) the Commercialization of the
Collaboration Products in the Collaboration Indications (for [*] Activators) or
the Field (for [*]) throughout the world, subject to: (a) Cytokinetics’ right to
Co-Promote one or more Collaboration Product(s) in the Co-Promotion Territory or
Shared Territory, as applicable and as set forth below, (b) Cytokinetics’ right
to establish certain Commercialization strategy in [*] Indications as set forth
below, (c) Cytokinetics’ right to Commercialize the Collaboration Product(s) in
[*] Indications in the Shared Territory during the Cytokinetics
Commercialization Period, and (d) other terms and conditions of this Article 9.

9.2 Commercial Diligence.

(a) Astellas shall use Diligent Efforts to Commercialize each Collaboration
Product [*]. Without limiting the foregoing, and subject to subsection
(b) below, Astellas shall [*] Collaboration Product [*] such Collaboration
Product [*] in order to [*] such Collaboration Product, solely to the extent [*]
such Collaboration Product [*] and provided that [*] to do so (the [*]).

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(b) [*] a Collaboration Product [*] it shall give written notice to [*] together
with [*] with respect to the Commercialization of such Collaboration Product
[*]. The Parties shall meet and confer in good faith [*] and seek to agree on
(i) [*] such Collaboration Product [*], or (ii) whether [*] such Collaboration
Product [*] in accordance with Section [*]. If the Parties [*] under Section [*]
such Collaboration Product [*] such Collaboration Product [*] such Collaboration
Product [*] within the applicable time period. If [*] will be deemed [*]
pursuant to Section [*] with respect to such Collaboration Product [*] provided
that [*] within the applicable time period. If [*] will continue to [*] such
Collaboration Product [*].

9.3 Commercialization Plan.

(a) No later than [*], subject to Sections 9.3(d) and 9.3(e), Astellas shall
prepare and provide to the JCC for review and discussion a written plan for the
Commercialization of such Collaboration Product in an Astellas’ fiscal year (the
“Commercialization Plan”). The Commercialization Plan shall include a reasonably
detailed description of and anticipated timeline for the Parties’, their
respective Affiliates’ and sublicensees’ Commercialization activities with
respect to such Collaboration Product, including pre-launch plans, launch plans,
market analytics, product forecasts, pricing assumptions and competitive
intelligence. It is the Parties’ understanding that, [*] Astellas will be the
Party primarily responsible for the conduct of the Commercialization activities
under the Commercialization Plan. Each Party shall use Diligent Efforts to [*]
of the collaboration under the Commercialization Plan (including [*]). The
Parties agree that the Commercialization Plan and the applicable
Commercialization strategy shall be consistent.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(b) If Cytokinetics exercises its Co-Promotion option for a Collaboration
Product, the Commercialization Plan shall also include a reasonably detailed
description of and anticipated timeline for Cytokinetics’ Co-Promotion
activities as well as a budget therefor, which shall be consistent with
Section 9.6 below.

(c) Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall periodically (at
least on an annual basis) prepare updates and amendments to its
Commercialization Plan to reflect changes in its plans, including in response to
changes in the marketplaces and related product forecasts, relative success of
the Collaboration Products and other relevant factors influencing such plans and
activities. Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall submit all
updates and amendments to its Commercialization Plan to the JCC for review and
discussion. For clarity, the Commercialization budget is subject to the final
determination by the JCC, subject to [*], subject to Section 9.8. Cytokinetics
may perform [*] activities within the scope of its responsibilities under the
Commercialization Plan, [*].

(d) The Commercialization Plan (and any amendment thereto) for any Collaboration
Product (i) for a [*] Indication, (ii) for [*] Indication for which Cytokinetics
exercises the Cytokinetics Co-Funding Option [*], and (iii) subject to
Section 9.3(e) and Section 9.8, for [*] Indication, must be agreed by the JCC by
[*]. Neither Party shall conduct any Commercialization activities that are
inconsistent with such agreed-upon Commercialization Plan and any Co-Promotion
Agreement.

(e) With respect to the Commercialization of a Collaboration Product in [*]
Indication, subject to Section 9.8, then:

(i) If Cytokinetics has an Established Commercial Infrastructure, Cytokinetics
shall have [*] for the Commercialization strategy for such Collaboration Product
for such Indication in the Shared Territory (but not for the Commercialization
strategies with respect to such Collaboration Product as a whole), provided
however, such Commercialization strategy and the overall Commercialization Plan
shall be consistent.

(ii) Regardless of [*] as relates to the portions of the Commercialization Plan
for such Collaboration Product that are specific to such Indication for the
Shared Territory, as well as any update and/or amendment thereof. The
Commercialization strategy with respect to [*] Indications includes the
following [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(iii) [*] the Shared Territory and the [*] Astellas and Cytokinetics as well as
the [*] such Collaboration Product for such Indication, subject to the
discussion and final determination by the JCC, taking into account [*].

(iv) Notwithstanding anything to the contrary, the [*] for such Collaboration
Product in such Indication in a particular country will have the decision making
authority with respect [*] and other terms of sale for such Collaboration
Product in such Indication for such country, provided that the other Party may
conduct, [*].

(v) If [*] the Collaboration Product(s) in such [*] Indication, but the Parties
have not determined which Party will [*] for the Collaboration Product(s) in
such [*] Indication under Section 9.8(b), then [*] shall be responsible for the
pre-commercialization activities for the Collaboration Product in such [*]
Indication.

(f) Subject to Section 9.3(c), Astellas shall be solely responsible for all
costs incurred by or on behalf of either Party in performing their respective
obligations under the Commercialization Plan except [*] (or [*] determined by
the JCC), which shall be agreed between the Parties acting reasonably and in
good faith and [*], for its Co-Promotion activities as set forth in the
Co-Promotion Agreement.

9.4 Patent Marking. Astellas (and Cytokinetics, if it Commercializes any
Collaboration Product in the Shared Territory in [*] Indication, where [*] for
such Indication) shall mark all Collaboration Products with patent information
in each country in accordance with the applicable Law and to the extent
customary in such country, and shall require all of its Affiliates and
sublicensees to do the same. To the extent permitted by applicable Law and
customary, Astellas shall indicate on Collaboration Product packaging,
advertisement and promotional materials that such Collaboration Product is
licensed from Cytokinetics.

9.5 Reports. Astellas (and Cytokinetics, if (a) it exercises its Co-Promotion
option or (b) it Commercializes any Collaboration Product in the Shared
Territory in [*] Indication, where [*] for such Indication) shall update the JCC
at each regularly scheduled JCC meeting regarding its Commercialization of the
Collaboration Products. Each such update shall be in a form to be agreed by the
JCC and shall

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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summarize its, its Affiliates’ and its sublicensees’ significant
Commercialization activities with respect to the Collaboration Products
throughout the world. The update by Astellas will be at a level of detail
reasonably requested by Cytokinetics and sufficient to enable Cytokinetics to
determine Astellas’ compliance with its diligence obligations pursuant to
Section 9.2.

9.6 Co-Promotion Option.

(a) On a Collaboration Product-by-Collaboration Product,
Indication-by-Indication, [*] basis, Cytokinetics shall have the right to elect
to (i) co-promote each Collaboration Product in the Co-Promotion Territory, and
(ii) co-promote or promote each Collaboration Product that contains a [*]
Activator for [*] Indications, and, if Astellas is the Party Commercializing
such Collaboration Product, for [*] Indications, (collectively “Neuromuscular
Indications”) in the Shared Territory, all as set forth in this Section 9.6.

(b) Unless otherwise agreed upon between the Parties, on a Collaboration
Product-by-Collaboration Product, Indication-by-Indication, [*] basis, at least
[*] prior to the [*] such Collaboration Product in such Indication [*] in the
Co-Promotion Territory (or Shared Territory, for any Collaboration Product
containing a [*] Activator in Neuromuscular Indications) as set forth in the
then-current Development Plan (the “[*]), Astellas shall provide Cytokinetics
with a written confirmation that [*]. Then:

(i) If the [*] Indication or [*] Indication, then, concurrent with [*] Astellas
shall provide the JCC with a [*] on: (A) the [*] such Indication [*]; and
(B) the [*] Astellas and Cytokinetics, for such Collaboration Product for such
Indication [*]; and (C) [*] (such matters described in (A) and (B) collectively,
the “Co-Promotion Matters”, and such notice, the “Astellas Co-Promotion
Notice”).

(ii) If such [*] Indication, then, within [*] pursuant to Section 9.3(e)(iii),
Cytokinetics shall provide the JCC with [*] the Co-Promotion Matters for such
Collaboration Product for such Indication [*], as well as a [*] (the
“Cytokinetics Co-Promotion Recommendation”).

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(iii) The JCC shall discuss [*] on the Co-Promotion Matters (which Co-Promotion
Matters shall be subject to [*] if the matter [*]), in each case within [*]
after its receipt of such Astellas Co-Promotion Notice or Cytokinetics
Co-Promotion Recommendation, as applicable, taking into account [*] of the
Collaboration (the “JCC Determination”). Notwithstanding the foregoing, the JCC
Determination will [*] which will be agreed by the Parties in the applicable
Co-Promotion Agreement.

(iv) Within [*] after receiving the JCC Determination, Cytokinetics shall have
the right to exercise its option to Co-Promote such Collaboration Product for
such Indication [*] in the Co-Promotion Territory (or to Co-Promote such
Collaboration Product for such Neuromuscular Indication [*] in the Shared
Territory) pursuant to such JCC Determination by written notice to Astellas. If
Cytokinetics fails to provide such written notice within such [*] period, then
Cytokinetics shall be deemed to have elected not to exercise its Co-Promotion
option for such Collaboration Product for such Indication [*].

(v) In the event [*] determines that there is a reasonable likelihood that [*]
such Collaboration Product for such Indication [*] shall promptly notify [*] in
writing after such determination together with [*] therefor, and the [*]
obligation to [*] obligation to [*] (and the period during which [*]) shall be
extended accordingly based on such [*].

(c) If Cytokinetics exercises its Co-Promotion option to co-promote a
Collaboration Product for a particular Indication [*] the Co-Promotion Territory
(or Shared Territory, for any Collaboration Product containing a [*] Activator
in Neuromuscular Indications), unless Cytokinetics terminates the Co-Promotion
in accordance with Section 9.6(e) below, its Co-Promotion efforts for such
Collaboration Product in such Indication (the “Cytokinetics Co-Promotion
Effort”) shall be determined by the JCC on a Collaboration
Product-by-Collaboration Product, Indication-by-Indication [*] basis, but in any
event shall be no less than [*] particular Collaboration Products for a
particular Indication [*] the Co-Promotion Territory (or Shared Territory, for
any Collaboration Product containing a [*] Activator in Neuromuscular
Indications), unless otherwise agreed in writing by the Parties. It is the
Parties’ understanding that Cytokinetics Co-Promotion Effort for the first
Indication approved for any Collaboration Product in the Co-Promotion Territory
[*] shall not be required to exceed [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(d) If Cytokinetics exercises its Co-Promotion option [*] a Collaboration
Product that contains a [*] Activator for a particular Neuromuscular Indication
[*] of the Shared Territory, unless Cytokinetics terminates the Co-Promotion in
accordance with Section 9.6(e) below, Cytokinetics shall be responsible for [*]
for such Collaboration Product for such Neuromuscular Indication and [*] of the
Shared Territory (in which case, the Cytokinetics Co-Promotion Effort shall be
[*] of the promotional efforts), unless otherwise agreed in writing by the
Parties. For the avoidance of doubt, the Parties acknowledge that Cytokinetics’
exercise of its Co-Promotion option to [*] for the case where [*] are expected
to be [*] of the Shared Territory for an Indication pursuant to the JCC
Determination.

(e) If Cytokinetics exercises its Co-Promotion option for a Collaboration
Product for a particular Indication [*] of the Co-Promotion Territory (or Shared
Territory, for any Collaboration Product containing a [*] Activator in
Neuromuscular Indications), it shall have the right to continue to Co-Promote
such Collaboration Product for as long as such Collaboration Product is being
sold for such Indication [*]. Cytokinetics shall have the right to relinquish
its Co-Promotion rights for such Collaboration Product for such Indication [*]
written notification to Astellas, in which case the Parties shall reasonably
cooperate to transition to Astellas all of Cytokinetics’ Co-Promotion activities
with respect to such Collaboration Product for such Indication [*], so as to
minimize disruption to sales activity and the Parties shall [*] for such
transition. In such event, Cytokinetics shall withdraw its sales representatives
from such Co-Promotion activities in a professional manner. If Cytokinetics [*]
a Collaboration Product for the [*] such Collaboration Product is [*], then
Cytokinetics shall have the right to [*] such Collaboration Product.

(f) If Cytokinetics exercises its Co-Promotion option for a Collaboration
Product, Astellas shall [*] in the Co-Promotion Territory (or Shared Territory
as applicable) based on the Cytokinetics Co-Promotion Efforts. However, if [*]
for a particular Indication [*] shall so notify [*] in the applicable [*], and
the Parties will discuss in good faith through the JCC [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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[*] Cytokinetics’ exercise of its Co-Promotion option applicable to such
Collaboration Product for such Indication [*]. In addition, the JCC shall take
into account [*] sales force, such as [*] in each case [*].

(g) Promptly after Cytokinetics exercises its Co-Promotion option for a
Collaboration Product in the Co-Promotion Territory (or Shared Territory, for
any Collaboration Product containing a [*] Activator in Neuromuscular
Indications), the Parties, in case of Astellas, Astellas and/or its Affiliate,
as applicable, shall commence negotiations in good faith and enter into one or
more co-promotion or promotion agreement(s) (the “Co-Promotion Agreement”) in
accordance with the terms and conditions set forth in Exhibit I attached hereto
for such Collaboration Product, allowing for any future exercise by Cytokinetics
of its Co-Promotion option for the same Collaboration Product in other
Indications subject to different allocation of Cytokinetics Co-Promotion efforts
as applicable. The Parties shall use Diligent Efforts to enter into and execute
the applicable Co-Promotion Agreement within [*] following Cytokinetics’
exercise of its Co-Promotion option.

9.7 Commercial Operating Team. The JCC will establish an operating team for each
Collaboration Product (the “Commercial Operating Team”) [*] in which
Cytokinetics exercises its Co-Promotion option, which will be responsible for
managing, reviewing, and implementing the performance of the day-to-day
responsibilities of both Parties for all stages of the commercialization program
for such Collaboration Product [*] in accordance with the Commercialization
Plan, including review and decision making regarding plans for manufacture,
promotion, marketing, sale, and distribution. Each Party will have
representation on the Commercial Operating Team for such Collaboration Product
[*] throughout the commercialization of such Collaboration Product [*] under
this Agreement. The Commercial Operating Team shall be subordinate to and
governed by the JCC.

9.8 Cytokinetics Commercialization Period. Notwithstanding anything to the
contrary, during the Cytokinetics Commercialization Period, Cytokinetics shall
be responsible (subject to subsection (b) below) for the Commercialization of
Collaboration Products in the Shared Territory for each [*] Indication for which
[*]:

(a) During the Cytokinetics Commercialization Period, if any, Cytokinetics shall
have the sole right to Commercialize the Collaboration Product(s) in the Shared
Territory, and Astellas shall have the sole right to Commercialize the
Collaboration Product(s) in the Astellas Territory, in each case in accordance
with the Commercialization Plan.

(b) Specifically and without limiting the foregoing, during the Cytokinetics
Commercialization Period, Cytokinetics [*] sales of such Collaboration
Product(s) in the

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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Shared Territory if at such time: (i) Cytokinetics has an Established Commercial
Infrastructure and (ii) there is [*] Collaboration Product [*] Indication, and
subject to the [*] set forth in Section [*]. If the foregoing conditions are not
met, then (A) Astellas will [*] of such Collaboration Product(s) in the Shared
Territory, and (B) the Parties shall discuss in good faith and agree on the [*]
in connection with [*] subject to the payment obligations set forth in Section
[*].

(c) At the end of the Cytokinetics Commercialization Period, Astellas shall [*]
of such Collaboration Product(s) for all Collaboration Indications worldwide. If
Cytokinetics [*] of such Collaboration Product(s) in the Shared Territory during
the Cytokinetics Commercialization Period, the Parties shall collaborate to
transition the [*] such Collaboration Product(s) in the Shared Territory from
Cytokinetics to Astellas pursuant to a process to be agreed to by the JCC by
consensus. The Parties will endeavor to [*] Cytokinetics and to [*] of the
Collaboration.

9.9 Established Commercial Infrastructure. For the purpose of this Agreement,
“Established Commercial Infrastructure” means, with respect to Cytokinetics, it
has plans to launch within [*] or has launched one or more product(s), either
under this Agreement or otherwise, that address a comparable market opportunity
in the applicable therapeutic area. For clarity, Cytokinetics shall be deemed to
have an Established Commercial Infrastructure in a country if Cytokinetics has
received Marketing Approval for Tirasemtiv in such country, is readying for the
launch of or launched Tirasemtiv, or is promoting one (1) or more other
product(s), either under this Agreement or otherwise, or has in place the
requisite capabilities to market, sell, and distribute Tirasemtiv in any
Retained Indication or a Collaboration Product for [*] Indication. In the event
that [*] in accordance with [*] set forth in Section [*].

ARTICLE 10

MEDICAL AFFAIRS ACTIVITIES

10.1 General. Subject to Cytokinetics’ right to field medical science liaisons
(“MSLs”) for one or more Collaboration Product(s) in the Co-Promotion Territory
or Shared Territory, as applicable, and other terms and conditions of this
Article 10, Astellas shall have the primary responsibility, at its own expense,
for all aspects of the Medical Affairs Activities of the Collaboration Products
in the Collaboration Indications (for [*] Activators) or the Field (for [*]
Activators) throughout the world, and the Parties shall have the rights and
obligations for Medical Affairs Activities for the Collaboration Products in [*]
Indications, all subject to Section 10.5(b), provided, however, that if any Law
is to the contrary to a Medical Affairs Activities, the Parties will discuss in
good faith to reasonably fit such Medical Affairs Activities to such Law.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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10.2 Diligence. During [*] and thereafter, Astellas shall use Diligent Efforts
to perform Medical Affairs Activities for each Collaboration Product [*] and to
the extent appropriate [*].

10.3 Medical Affairs Plan. The Parties shall coordinate with respect to the
strategy and implementation of the Medical Affairs Activities with respect to
each Collaboration Product in each Indication [*] for such Indication, and such
coordination will be set forth in the Medical Affairs Plan. No later than [*]
Collaboration Product, Astellas shall prepare and provide to the JMAC for review
and discussion a written plan for the Medical Affairs Activities for such
Collaboration Product (the “Medical Affairs Plan”), subject to Section 10.5
below. The Medical Affairs Plan shall include a reasonably detailed description
of and anticipated timeline for the Parties’, their respective Affiliates’ and
sublicensees’ Medical Affairs Activities with respect to such Collaboration
Product. The Medical Affairs Plan shall also include a reasonably detailed
description of and anticipated timeline for Cytokinetics’ MSLs’ activities
during [*] such Collaboration Product (and thereafter if Cytokinetics exercises
its Co-Promotion option for such Collaboration Product or if such Collaboration
Product is Developed in [*] Indication), as well as a budget therefor, which
shall be consistent with Section 10.5 below. Astellas shall periodically (at
least on an annual basis) prepare updates and amendments to the Medical Affairs
Plan to reflect changes in its plans, subject to Section 10.5. Astellas shall
submit all updates and amendments to the Medical Affairs Plan to the JMAC for
review and discussion. Astellas shall be solely responsible for all costs
incurred by or on behalf of either Party in performing their respective
obligations under the Medical Affairs Plan and shall pay [*] as set forth in the
Medical Affairs Plan, except as set forth in Section 10.5(b)(ii)(1). For
clarity, [*] Medical Affairs Activities [*] each Indication will be determined
by the JMAC, subject to [*]. If and when [*] MSL support for the [*] Indications
[*] for the [*] Indications and/or [*] Indications. Cytokinetics may perform
additional activities within the scope of its responsibilities under the Medical
Affairs Plan, in addition to those funded in the JMAC-approved budget, [*] for
the [*] Indication and/or [*] Indications in the Shared Territory.

10.4 Reports. Astellas (and Cytokinetics, if it exercises the right to field its
own MSLs in the Co-Promotion Territory or Shared Territory pursuant to
Section 10.5) shall update the JMAC at each regularly scheduled JMAC meeting
regarding its Medical Affairs Activities of the

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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Collaboration Products. Each such update shall be in a form to be agreed by the
JMAC and shall summarize its, its Affiliates’ and its sublicensees’ significant
Medical Affairs Activities with respect to the Collaboration Products throughout
the world. The update by a Party will be at a level of detail reasonably
requested by the other Party and sufficient to enable such Party to determine
the other Party’s compliance with its diligence obligations pursuant to
Section 10.2.

10.5 Medical Scientific Liaisons.

(a) Licensed Indications and [*] Indications for Collaboration Products
Containing [*] Activators; Field for all other Collaboration Products. At
(i) any time after [*] Indication or [*] Indication, or (ii) any time in
connection with [*] Indication or any [*] Indication, Cytokinetics shall have
the right to field its own MSLs in the Co-Promotion Territory (for [*]
Activators in Licensed Indications and for Collaboration Products in the Field)
or Shared Territory (for [*] Activators for [*] Indications and [*]
Indications), in connection with such Pivotal Registration Study. The percentage
of total MSL deployment by Cytokinetics shall be agreed upon by the Parties, but
in any event shall be no less than [*] and no more than [*]. If Cytokinetics
exercises the Cytokinetics Co-Funding Option, the portion of the Medical Affairs
Plan specific to such Collaboration Product for the [*] Indication(s) and any
amendment thereto [*], and Cytokinetics may prepare [*]. If Cytokinetics
exercises the option to Co-Promote pursuant to Section 9.6 in any geographic
region (i.e., Canada, the US, and EU plus Switzerland), Cytokinetics shall have
the right to field MSLs [*] unless the Parties otherwise agree. Such MSLs of
Cytokinetics shall perform certain Medical Affairs Activities allocated to them
under the Medical Affairs Plan. Astellas shall reimburse the costs and expenses
incurred by Cytokinetics in fielding the MSLs, which shall be calculated at a
rate equal to [*].

(b) [*] Indications. For all [*] Indications:

(i) [*] a Collaboration Product in such Indication:

(1) The terms of Section 10.5(a) shall also apply to such Indication in the
Shared Territory.

(2) The portion of the Medical Affairs Plan specific to such Collaboration
Product for such Indication and any amendment thereto [*], and Cytokinetics may
[*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(3) Astellas will lead the conduct of and be responsible for the strategy for
all Medical Affairs Activities with respect to such Collaboration Product in
such Indication, except Cytokinetics will [*] for all Medical Affairs Activities
which are specific to such Indication in the Shared Territory [*] Medical
Affairs Activities with respect to such Collaboration Product [*].

(ii) [*] a Collaboration Product in any [*] Indication, thereafter:

(1) [*] the conduct of, and shall [*] Medical Affairs Activities for
Collaboration Product in such Indication [*]; and

(2) [*] shall have the right, but not the obligation, to [*], and shall have [*]
Medical Affairs Activities for Collaboration Product in such Indication [*].

ARTICLE 11

FINANCIAL PROVISIONS

11.1 Upfront Payment; Equity Purchase.

(a) Astellas shall pay to Cytokinetics a one-time, non-refundable,
non-creditable upfront payment of sixteen million Dollars ($16,000,000) within
thirty (30) days after the Effective Date.

(b) Astellas shall pay to Cytokinetics a one-time, non-refundable,
non-creditable upfront payment of thirty million Dollars ($30,000,000) within
thirty (30) days after the Amendment Effective Date.

(c) Concurrent with the execution of this Amended and Restated Agreement,
Astellas and Cytokinetics have entered into a Common Stock Purchase Agreement,
pursuant to which Astellas will purchase from Cytokinetics ten million Dollars
($10,000,000) of Cytokinetics’ common stock.

11.2 Reimbursement of Research Plan Costs. Astellas shall reimburse
Cytokinetics’ Research Plan Costs as follows:

(a) Advance Payment. Within [*] days of the Effective Date, Astellas shall pay
to Cytokinetics an amount equal to Cytokinetics’ estimated Research Plan Costs

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(as set forth in the initial Research Budget) for the then-current calendar
quarter. Thereafter, during the Research Term, Cytokinetics shall submit to
Astellas an invoice setting forth Cytokinetics’ estimated Research Plan Costs
based on the then-current Research Budget for the current calendar quarter, no
later than [*] Business Days following the first day of such calendar quarter
(the “Research Advance Invoice”).

(b) True-Up. Within [*] days after the end of each calendar quarter during the
Research Term, Cytokinetics shall submit to Astellas a reasonably detailed
reconciliation report setting forth the actual Research Plan Costs incurred by
or on account of Cytokinetics in such prior calendar quarter and any credits or
deficits from the corresponding Research Advance Invoice previously provided for
such quarter (the “Research True-Up Report”). If the estimated Research Plan
Costs paid by Astellas pursuant to Section 11.2(a) above for such prior calendar
quarter is less than Cytokinetics’ actual Research Plan Costs for such quarter,
subject to Section 5.6, Astellas shall pay the deficit to Cytokinetics as
described in this Section 11.2(b). If the estimated Research Plan Costs paid by
Astellas pursuant to Section 11.2(a) above for such prior calendar quarter is
more than Cytokinetics’ actual Research Plan Costs for such quarter, the excess
shall be credited towards the Research Advance Invoice for the current calendar
quarter (except where such invoice is the final such invoice to be provided by
Cytokinetics, in which case the excess shall be refunded by Cytokinetics to
Astellas within [*] days after the delivery of such invoice).

(c) Timing of Payment. For ease of administration, Astellas shall pay
Cytokinetics a single payment reflecting the amount due under the Research
Advance Invoice for the current calendar quarter plus any deficits (or less any
credits) reflected in the Research True-Up Report for the prior calendar quarter
within the later of (i) [*] days of Astellas’ receipt of such Research Advance
Invoice, or (ii) [*] days of Astellas’ receipt of such Research True-Up Report.

11.3 Reimbursements and Sharing of Development Costs.

(a) Reimbursement. Astellas shall reimburse Cytokinetics’ Development Costs as
follows:

(i) Advance Payment. Within [*] days of the Effective Date, Astellas shall pay
to Cytokinetics an amount equal to Cytokinetics’ estimated Development Costs (as
set forth in the initial Cytokinetics Development Budget) for the then-current
calendar quarter. Thereafter, for each calendar quarter in which Cytokinetics is
anticipated to conduct Development activities under the Development Plan (other
than [*] Development), Cytokinetics shall submit to Astellas an invoice setting
forth Cytokinetics’ estimated Development Costs based on the then-current
Cytokinetics Development Budget for the current calendar quarter, no later than
[*] Business Days following the first day of such calendar quarter (the
“Development Advance Invoice”).

(ii) True-Up. Within [*] days after the end of each calendar quarter in which
Cytokinetics has conducted Development activities under the Development Plan
(other than

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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[*] Development), Cytokinetics shall submit to Astellas a reasonably detailed
reconciliation report setting forth the actual Development Costs incurred by or
on account of Cytokinetics in such prior calendar quarter and any credits or
deficits from the corresponding Development Advance Invoice previously provided
for such quarter (the “Development True-Up Report”). If the estimated
Development Costs paid by Astellas pursuant to Section 11.3(a)(i) above for such
prior calendar quarter is less than Cytokinetics’ actual Development Costs for
such quarter, then Astellas shall pay the deficit to Cytokinetics as described
in this Section 11.3(a)(ii) to the extent such amounts do not exceed the
applicable then-current [*] Budget as approved by the JDC by more than [*]. If
the estimated Development Costs paid by Astellas pursuant to Section 11.3(a)(i)
above for such prior calendar quarter is more than Cytokinetics’ actual
Development Costs for such quarter, the excess shall be credited toward the
Development Advance Invoice for the current calendar quarter (except where such
invoice is the final such invoice to be provided by Cytokinetics, in which case
the excess shall be refunded by Cytokinetics to Astellas within [*] days after
the delivery of such invoice).

(iii) Timing of Payment. For ease of administration, Astellas shall pay
Cytokinetics a single payment reflecting the amount due under the Development
Advance Invoice for the current calendar quarter plus any deficits (or less any
credits) reflected in the Development True-Up Report for the prior calendar
quarter within the later of (1) [*] days of Astellas’ receipt of such
Development Advance Invoice, or (2) [*] of Astellas’ receipt of such Development
True-Up Report.

(b) Sharing of [*] Costs.

(i) If Cytokinetics has exercised the Cytokinetics Co-Funding Option, [*] for a
[*] Activator in [*] Indications, then within [*] days after the end of each
calendar quarter during which Astellas has incurred any [*] Costs for such [*]
Activators in [*] Indications (including such costs incurred by Cytokinetics and
reimbursed by Astellas under Section 11.3(a)), Astellas shall submit to
Cytokinetics a reasonably detailed accounting for, and an invoice for [*] Costs
incurred during such calendar quarter. Subject to subsection (ii) below,
Cytokinetics shall pay to Astellas the amount invoiced within [*] days after the
receipt of the invoice, to the extent such amounts do not exceed the applicable
then-current [*] Budget as approved by the JDC by more than [*].

(ii) [*] subject to the following [*]: (1) [*] for its share of [*];
(2) Cytokinetics [*] at any given time; and (3) Cytokinetics [*] by more than
[*] [*] is not intended to be [*] to continue to fulfill its obligations [*]
(e.g., due to any modifications and/or additions to [*]. If Cytokinetics [*] any
of the [*] shall be deemed [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(c) Sharing of [*] Development Costs. For all [*] Indications for which [*]
Activator in such Indication, then [*] Costs for such Indication as follows:

(i) Advance Payment. For each calendar quarter in which [*] Development Work for
such [*] Activator in such Indication under the Development Plan, [*] shall
submit to [*] an invoice setting forth [*] Costs for such [*] Activator in such
Indication based on the then-current [*] Budget for the current calendar
quarter, no later than [*] Business Days following the first day of such
calendar quarter (the “[*] Advance Invoice”).

(ii) True-Up. Within [*] days after the end of each calendar quarter in which
[*] Development Work for such [*] Activator in such Indication under the
Development Plan, [*] shall submit to [*] a reasonably detailed reconciliation
report setting forth the accounting for, and an invoice for [*] Development
Costs for such [*] Activator in such Indication incurred by or on account of [*]
in such prior calendar quarter and any credits or deficits from the
corresponding [*] Advance Invoice previously provided for such quarter (the “[*]
True-Up Report”). If the estimated [*] Development Costs paid by [*] pursuant to
Section 11.3(c)(i) above for such prior calendar quarter is less than [*]
Development Costs for such quarter, then [*] shall pay the deficit to [*] as
described in this Section 11.3(c)(ii) to the extent such amounts do not exceed
the applicable then-current [*] Development Budget as approved by the JDC by
more than [*]. If the estimated [*] Development Costs paid by [*] pursuant to
Section 11.3(c)(i) above for such prior calendar quarter is more than [*]
Development Costs for such quarter, the excess shall be credited toward the [*]
Advance Invoice for the current calendar quarter (except where such invoice is
the final such invoice to be provided by [*] in which case the excess shall be
refunded by [*] days after the delivery of such invoice).

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(iii) Timing of Payment. For ease of administration, [*] shall pay [*] a single
payment reflecting the amount due under the [*] Advance Invoice for the current
calendar quarter plus any deficits (or less any credits) reflected in the [*]
True-Up Report for the prior calendar quarter within the later of (1) [*] days
of [*] receipt of such [*] Advance Invoice, or (2) [*] days of [*’] receipt of
such [*] True-Up Report.

11.4 Reimbursement of [*] Development Costs. Astellas shall, within [*] days
after the receipt of [*] Indication pursuant to Section [*)], pay to
Cytokinetics an amount equal to [*] Development Costs, which shall be reported
to the JDC pursuant to Section [*].

11.5 Research and Development Milestone Payments.

(a) Research Milestones. Astellas shall pay to Cytokinetics the non-refundable,
non-creditable payment set forth in the table below upon [*] achievement of each
milestone event for each Compound in accordance with Section 11.5(d):

 

Milestone Event

  

Milestone Payment

 

[*]

     [*]   

[*]

     [*]   

(b) Development Milestones.

(i) Existing Milestones. Subject to Section 11.5(c), Astellas shall pay to
Cytokinetics the non-refundable, non-creditable payment set forth in the table
below upon [*] achievement of each milestone event (whether by or on behalf of

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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Astellas or its Affiliates or sublicensees, or by or on behalf of Cytokinetics
or its Affiliates) in accordance with Section 11.5(d):

 

Milestone Event

   Milestone Payment      [*] Activator      [*] Activator      Lead
Compound/
Lead Product      Collaboration
Product
containing a
[*] Activator
(other than the
Lead
Compound)      Collaboration
Product
containing a
[*] Activator      Collaboration
Product
containing a
[*] Activator   [*]      [*].         [*]         [*]         [*]    Initiation
of CY 5012*1    $ 2,000,000         n.a.         n.a.         n.a.    JDC’s
decision to enter into a Phase 2 Clinical Trial pursuant to Section 6.6(d)*1   
$ 15,000,000         n.a.         n.a.         n.a.    [*]      [*]         [*]
        [*]         [*]    [*]      [*]         [*]         [*]         [*]   
[*]      [*]         [*]         [*]         [*]    [*]      [*]         [*]   
     [*]         [*]    [*]      [*]         [*]         [*]         [*]    [*]
     [*]         [*]         [*]         [*]    [*]      [*]         [*]        
[*]         [*]    [*]      [*]         [*]         [*]         [*]      

 

 

    

 

 

    

 

 

    

 

 

  Total   [*]      [*]      [*]      [*]      

 

 

    

 

 

    

 

 

    

 

 

 

Milestone events marked as *1 shall be referred to as “Earlier Milestone Events”
and milestone events marked as *2 shall be referred to as “Later Milestone
Events”.

(ii) Additional Development Milestone for [*] Indications. Subject to
Section 11.5(c), Astellas shall pay to Cytokinetics non-refundable,
non-creditable payment set forth in the table below, on a Compound-by-Compound
and Indication-by-Indication

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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basis, upon [*] achievement of each milestone event in [*] Indication(s)
(whether by or on behalf of Astellas or its Affiliates or sublicensees, or by or
on behalf of Cytokinetics or its Affiliates) in accordance with Section 11.5(d):

 

Milestone Event

  

Milestone Payment

  

For Lead Compound/
Lead Product

  

For each [*] Activator
other than the Lead
Compound

[*]

   [*]    [*]

[*]

   [*]    [*]

Whether Cytokinetics exercises Cytokinetics Co-Funding Option [*]

   If yes:    If no:    If yes:    If no:

[*]

   [*]    [*]    [*]    [*]

[*]

   [*]    [*]    [*]    [*]

[*]

   [*]    [*]    [*]    [*]

[*]

   [*]    [*]    [*]    [*]

[*]

   [*]    [*]    [*]    [*]

[*]

   [*]    [*]    [*]    [*]

[*]

   [*]    [*]    [*]    [*]

[*]

   [*]    [*]    [*]    [*]   

 

  

 

  

 

  

 

Total

[*] [*] [*] [*]   

 

  

 

  

 

  

 

(iii) Additional Development Milestone for [*] Indications. Subject to
Section 11.5(c), with respect to each [*] Indication, then for so long as [*]
such Indication, Astellas shall pay to Cytokinetics non-refundable,
non-creditable payment set forth in the table below, on a Compound-by-Compound
and Indication-by-Indication basis, upon [*] achievement of each milestone event
in such Indication(s) (whether by or on behalf of Astellas or its Affiliates or

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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sublicensees, or by or on behalf of Cytokinetics or its Affiliates) in
accordance with Section 11.5(d):

 

Milestone Event

   Milestone Payment      For Lead Compound/Lead
Product      For each [*] Activator other
than the Lead Compound  

[*]

     [*]         [*]   

[*]

     [*]         [*]   

[*]

     [*]         [*]   

[*]

     [*]         [*]   

[*]

     [*]         [*]   

[*]

     [*]         [*]   

[*]

     [*]         [*]   

[*]

     [*]         [*]   

[*]

     [*]         [*]   

[*]

     [*]         [*]      

 

 

    

 

 

 

Total

  [*]      [*]      

 

 

    

 

 

 

(c) Interpretations of Section 11.5(b):

(i) “CY 5012” means the multiple ascending dose Phase 1 Clinical Trial for the
Lead Compound as set forth in the Development Plan. For clarity, the first
multiple ascending dose Phase 1 Clinical Trial for the Lead Compound conducted
under the Development Plan will be deemed to be CY 5012 even if not specifically
designated as CY 5012 in the Development Plan.

(ii) In the event the Parties disagree as to whether [*] the Parties shall meet
and discuss in good faith. In the event the Parties cannot agree on the matter
[*] in accordance with [*] set forth in Section [*].

(iii) For determination of Astellas’ payment obligations set forth in
Section 11.5(b), it is confirmed that, if a particular milestone for the [*] for
a particular Collaboration Product, then [*] such Collaboration Product [*] such
milestone. For clarity, [*] refers to the [*] the table above, e.g., [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(iv) Notwithstanding the foregoing, the [*] Collaboration Products, regardless
of [*] subject to Section [*]. For clarity, the [*] Sections [*].

(v) The milestone payment obligation set forth in Section 11.5(b)(i) shall be
[*]. Accordingly, and subject to Section [*] described in Section [*]
Collaboration Product [*] Collaboration Products [*]

(vi) The milestones in Section 11.5(b)(i) for [*] Activators shall be payable if
such milestone event is achieved in [*] and the third milestone (i.e., JDC’s
decision to enter into Phase 2 Clinical Trial), which may be achieved in either
Licensed Indications or [*] Indications. Astellas acknowledges that such third
milestone has been achieved as of the Amendment Effective Date and the
corresponding milestone payment (fifteen million Dollars ($15,000,000)) shall be
paid by Astellas within thirty (30) days after the Amendment Effective Date.

(vii) The milestone payment in in Section 11.5(b)(ii) marked by the asterisk [*]
Indication.

(viii) If Cytokinetics exercises the Cytokinetics Co-Funding Option [*] then
each subsequent milestone payment in Section 11.5(b)(ii) will be payable upon
the occurrence of the corresponding milestone event for [*] triggering such
milestone payment, it being understood that the [*] triggering milestone
payments [*].

(ix) If Cytokinetics does not exercise the Cytokinetics Co-Funding Option [*],
then each subsequent milestone payment in Section 11.5(b)(ii) will be payable
[*].

(x) The milestone payment in in Section 11.5(b)(iii) marked by the asterisk
(i.e., for the [*]) will be payable [*]. [*] milestone payments in
Section 11.5(b)(iii) shall be payable for [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

77

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(d) Notice and Payment. Each Party shall notify the other Party in writing
within [*] days after the achievement of any milestone set forth in this
Section 11.5 by such Party, its Affiliates or its sublicensees. Astellas shall
pay to Cytokinetics the applicable milestone payments within [*] days after the
receipt of such notice from Cytokinetics (for milestones achieved by
Cytokinetics, its Affiliates or (sub)licensees) or achievement of such milestone
by Astellas or its Affiliates or sublicensees.

(e) [*] Indications. If the JDC [*] a Collaboration Product in a [*] Indication
after [*] then Astellas shall pay to Cytokinetics:

(i) [*] set forth in the table in Section [*] upon the achievement of [*] for
such Collaboration Product [*] such achievement is [*] achievement of such [*]
the Collaboration Product, as well as [*] achievement of the same [*]
Collaboration Product in [*] Indication; or

(ii) [*] set forth in the table in Section [*)] upon the achievement of [*] for
such Collaboration Product [*] achieved in [*] Indication for the Collaboration
Product.

(iii) It is confirmed that:

 

  (A) Astellas’ milestone payment under Section [*] Indication shall [*] in
Section [*] and Astellas’ milestone payment for [*] Indication under Section [*]
in Section [*]. Astellas’ milestone payment under Section [*] in Section [*];

 

  (B) the achievement of [*] the Collaboration Products in a [*] Indication
shall not trigger Astellas’ payment obligations for the [*] set forth in Section
[*];

 

  (C)

upon [*] achievement of [*] the Collaboration Products in [*] Indication
(irrespective of

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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  whether such achievement takes place before the achievement of [*]
Collaboration Product in a [*] Indication), Astellas shall make to Cytokinetics
the milestone payment for [*] achievement of [*] such Collaboration Product in
[*] Indication; and

 

  (D) achievement of [*] a Collaboration Product in a [*] Indication shall not
be deemed to have achieved [*] and shall not trigger Astellas’ payment
obligations for [*].

11.6 Commercial Milestones.

(a) Commercial Milestones. Astellas shall, in accordance with Section 11.6(b),
pay to Cytokinetics the one-time, non-refundable, non-creditable payments set
forth in the table below when the aggregated annual (based on Astellas’ fiscal
year) worldwide Net Sales of all Collaboration Products first reach the values
indicated below. For clarity, the milestone payments in this Section 11.6 shall
[*] specified below is [*].

 

Annual worldwide Net Sales of all Collaboration Products

   Milestone Payments  

[*]

     [*]   

[*]

     [*]   

[*]

     [*]   

[*]

     [*]   

(b) Notice and Payment. Astellas shall notify Cytokinetics in writing within [*]
days after the end of the calendar quarter during which the aggregated annual
worldwide Net Sales of all Collaboration Products first reach the values set
forth in Section 11.6(a) above, and shall pay to Cytokinetics the applicable
milestone payments concurrent with such notice.

11.7 Royalty Payments for Products.

(a) Royalty Rates. Subject to the other terms of this Section 11.7, during the
Royalty Term, Astellas shall make quarterly non-refundable, non-creditable
royalty payments to Cytokinetics on the Net Sales of each Collaboration Product
at the applicable royalty rate set forth below. Net Sales shall be aggregated on
a Compound-by-Compound basis across all Indications.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(i) [*] Activators. The royalty rates set forth in the table below shall apply
to Collaboration Product containing [*] Activator.

 

Worldwide Net Sales of each Collaboration

Product in an Astellas’ fiscal year

 

Royalty Rate for Net Sales of Collaboration

Product containing [*] Activator in such

Astellas’ fiscal year

[*]

  [*]

[*]

  [*]

[*]

  [*]

[*]

  [*]

(ii) [*] Activator Approved for [*] Indication(s) and/or [*]. The royalty rates
set forth in the table below shall apply to each Collaboration Product
containing a [*] Activator, unless and until any of the royalty rates set forth
in Sections 11.7(a)(iii), (iv) and (v) below become applicable to such
Collaboration Product. Once any of the royalty rates set forth in Sections
11.7(a)(iii), (iv) and (v) below become applicable to such Collaboration
Product, the royalty rates set forth in this Section 11.7(a)(ii) shall no longer
apply.

 

Worldwide Net Sales of each

Collaboration Product in an

Astellas’ fiscal year

 

Royalty Rate for Net Sales in such Astellas’ fiscal year

 

Lead Product

 

Collaboration Product

containing [*] Activator

(other than the Lead

Compound)

[*]

  [*]   [*]

[*]

  [*]   [*]

[*]

  [*]   [*]

[*]

  [*]   [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(iii) [*] Activator Approved for [*] Indication(s) ([*] Indications). The
royalty rates set forth in the table below shall apply to Collaboration Product
containing a [*] Activator after the first Marketing Approval of such
Collaboration Product in [*] Indication for which Cytokinetics exercises the
Cytokinetics Co-Funding Option [*] for such Collaboration Product and [*] such
Collaboration Product for [*] Indication.

 

Worldwide Net Sales of each

Collaboration Product in an

Astellas’ fiscal year

 

Royalty Rate for Net Sales in such Astellas’ fiscal year

 

Lead Product

 

Collaboration Product

containing [*] Activator

(other than the Lead

Compound)

[*]   [*]   [*] [*]   [*]   [*] [*]   [*]   [*] [*]   [*]   [*]

(iv) [*] Activator Approved for [*] Indication(s) and [*] Indication(s)/[*]
Indication(s). The royalty rates set forth in the table below shall apply to
Collaboration Product containing a [*] Activator after the first Marketing
Approval of such Collaboration Product for [*] Indication (except during the
Cytokinetics Commercialization Period) and provided that such Collaboration
Product has obtained Marketing Approval for a [*] Indication or [*] Indication,
provided that: (A) where such Collaboration Product is approved for [*]
Indication, if Cytokinetics either did not exercise the Cytokinetics Co-Funding
Option or [*] for such Collaboration Product, then Astellas shall have the right
to [*] as set forth in Section [*]; (B) if [*] for such Collaboration Product
for such approved [*] Indication(s), then Cytokinetics shall have the right to
[*] as set forth in Section [*]; and (C) if both the [*] apply, then Section [*]
shall apply.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

81

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Worldwide Net Sales of each

Collaboration Product in an

Astellas’ fiscal year

   Royalty Rate for Net Sales in such Astellas’ fiscal year      Lead Product  
   Collaboration Product
containing [*] Activator
(other than the Lead
Compound)  

[*]

     [*]         [*]   

[*]

     [*]         [*]   

[*]

     [*]         [*]   

[*]

     [*]         [*]   

(v) [*] Activator Approved for [*]. The royalty rates set forth in the table
below shall apply to Collaboration Product containing a [*] Activator after the
first Marketing Approval of such Collaboration Product for one or more [*]
Indication(s) [*] such Collaboration Product obtains Marketing Approval in any
[*] Indication or [*] Indication (except during the Cytokinetics
Commercialization Period), provided that [*] for such Collaboration Product for
any of [*] Indication(s), then [*] shall have the right to [*] as set forth in
Section [*].

 

Worldwide Net Sales of each

Collaboration Product in an

Astellas’ fiscal year

   Royalty Rate for Net Sales in such Astellas’ fiscal year      Lead Product  
   Collaboration Product
containing [*] Activator
(other than the Lead
Compound)  

[*]

     [*]         [*]   

[*]

     [*]         [*]   

[*]

     [*]         [*]   

[*]

     [*]         [*]   

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(vi) [*].

 

(1) [*] Under circumstances where [*] has the right to [*] as set forth in this
Section 11.7, and subject to Section 11.7(a)(vi)(3) below, the [*] set forth in
this Section 11.7 or Section 11.8(b) shall [*] shall no longer apply.

 

(2) [*] Under circumstances where [*] has the right to [*] as set forth in this
Section 11.7 or Section 11.8(b), and subject to Section 11.7(a)(vi)(3) below,
the [*] shall be [*] shall no longer apply.

 

(3) If, for a particular Collaboration Product, [*] under Section 11.7(a)(iv),
then each Party shall [*] of the applicable [*] shall have the right to [*]
under Section 11.7(a)(iv) but only [*] shall have the right to [*] but only [*].

 

(4) [*] means, with respect to a Collaboration Product [*] Indication(s) for
which [*] for such [*] Indication. If [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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  [*] such Collaboration Product and [*] such Collaboration Product, then the
[*] such Collaboration Product [*] was deemed to have [*] such Collaboration
Product pursuant to Section [*] such Collaboration Product and [*] will be
included in the [*].

 

(5) [*] means, with respect to a Collaboration Product which [*] one or more [*]
Indication(s), the [*] Indication(s). If [*] Indication [*] Indication(s) and
[*] Indication [*] such Collaboration Product [*]

(b) Royalty Term. Astellas’ royalty payment obligations under this Agreement
shall commence upon the First Commercial Sale of the first Collaboration Product
anywhere in the world by Astellas, its Affiliates or its sublicensees, and shall
continue, on a Collaboration Product-by-Collaboration Product and
country-by-country basis, until the latest of (i) the expiration of the last to
expire Valid Claim [*] such Collaboration Product in such country; (ii) the
expiration of the last to expire Valid Claim [*] Collaboration Product, provided
that [*] with respect to such Collaboration Product [*]; (iii) [the expiration
of any Regulatory Exclusivity granted] with respect to such Collaboration
Product in such country; and (iv) [*] years after the First Commercial Sale of
such Collaboration Product in such country (the “Royalty Term”).

(c) [*]

(i) If a Collaboration Product is [*] in a country during the applicable Royalty
Term [*] with respect to such Collaboration Product [*], and (i) such [*] in
such country [*] or (ii) such [*] for such Collaboration Product in such country
[*] in such country, then the [*] of such Collaboration Product in such country
[*] so long as the [*] with respect to such Collaboration Product [*] in such
country [*].

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(ii) If, for a particular Collaboration Product in a particular country, [*] the
First Commercial Sale of such Collaboration Product in such country: (A) there
is [*] such Collaboration Product [*]; and (B) the Royalty Term set forth in
Section 11.7(b) [*] such Collaboration Product [*] such Collaboration Product
[*] then the applicable [*] such Collaboration Product [*] so long as the [*] in
this Section 11.7(c)(ii) [*]. This Section 11.7(c)(ii) shall not operate to [*]
in Section [*].

(d) Basis for Royalty. This Section 11.7 is intended to provide for payments to
Cytokinetics equal to the percentages of Net Sales set forth in this
Section 11.7 for the duration of the Royalty Term. In establishing this payment
structure, the Parties recognize, and Astellas acknowledges, the substantial
value of the various actions and investments undertaken by Cytokinetics prior to
the Effective Date and that Cytokinetics will undertake under this Agreement,
and that the value of the Cytokinetics Technology licensed to Astellas hereunder
resides substantially in Cytokinetics Know-How. As a result, the Parties
attribute such value to Cytokinetics’ leading proprietary knowledge in the
subject matter, including trade secrets, preclinical and clinical data
pertaining to the Compounds and Collaboration Products, and regulatory filings
made by Cytokinetics prior to the Effective Date, in each case created or
generated by Cytokinetics through the expenditure of significant resources and
as a result of Cytokinetics’ unique innovative capabilities. The Parties agree
that because Cytokinetics is not separately compensated under this Agreement for
such additional benefits, the royalties set forth above are appropriate for the
duration of the Royalty Term. The Parties have agreed to the payment structure
set forth herein as a convenient and fair mechanism for both Parties in order to
compensate Cytokinetics for these additional benefits as part of the overall
consideration for Cytokinetics to enter into this Agreement.

(e) Royalty Reports and Payment. Within [*] days after each calendar quarter,
commencing with the calendar quarter during which the First Commercial Sale of
the first Collaboration Product is made anywhere in the world, Astellas shall
provide Cytokinetics with a report that contains the following information for
the applicable calendar quarter, on a Collaboration Product-by-Collaboration
Product and country-by-country basis: (i) the amount of gross sales of the
Collaboration Products, (ii) an itemized calculation of Net Sales showing
deductions provided for in the definition of “Net Sales”, (iii) a calculation of
the royalty payment due on such sales, including [*] in accordance with Section
[*] and (iv) the exchange rate for such country. Within [*] days after each
calendar quarter, Astellas shall pay in Dollars all royalties due to
Cytokinetics with respect to Net Sales by Astellas, its Affiliates and their
respective sublicensees for such calendar quarter.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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11.8 Payments during Cytokinetics Commercialization Period. If a Collaboration
Product [*] Indication(s) and [*] for a Collaboration Product in such
Indication(s), then, during the Cytokinetics Commercialization Period:

(a) Shared Territory.

(i) If Cytokinetics is [*] such Collaboration Product in the Shared Territory,
then [*] such Collaboration Product in the Shared Territory. Subject to
agreement by the Parties regarding the [*] with respect to such Collaboration
Product and [*], on a quarterly basis within [*] days after the end of each
calendar quarter, [*] shall provide [*] with an itemized invoice for the [*]
during such calendar quarter. [*] shall pay the amount of each such invoice
within [*] days after its receipt.

(ii) If Astellas [*] of such Collaboration Product in the Shared Territory, then
Astellas shall pay to Cytokinetics [*] for such Collaboration Product in the
Shared Territory, which payment shall be made within [*] days after each
calendar quarter and accompanied with a reasonably detailed report. Subject to
agreement by the Parties regarding the [*], Astellas shall have the right to [*]
during such calendar quarter. Concurrent with such payment, Astellas shall
provide Cytokinetics with a report equivalent to the royalty report set forth in
Section 11.7(e) and an itemized accounting for the [*].

(iii) “[*]” means, to the extent applicable and [*] in accordance with the scope
of [*] agreed by the Parties: (A) [*]); (B) any related [*]; and (C) [*] to be
agreed by the Parties (which will not [*]) to cover related costs incurred by
Astellas. For the convenience of the Parties, the Parties may agree on [*]
Cytokinetics under Section [*] with respect to [*] Collaboration Product,
Cytokinetics will [*] such Collaboration Product pursuant to Section [*]

(iv) [*]” means the [*] (A) [*] the Collaboration Product; (B) [*]; (C) [*]; and
(D) a reasonable [*] Collaboration Product [*]; in each case, only to the extent
[*] mutually agreed [*] shall exclude any [*] Cytokinetics.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(v) If the Parties cannot reach agreement [*] each Party with [*] will meet in
person and seek to resolve the matter prior to escalation to the JSC. If the
matter is unresolved after escalation to the JSC[*] in accordance with [*] set
forth in Section [*].

(b) Astellas Territory. If Astellas Commercializes such Collaboration Product in
such Indication in the Astellas Territory, then Astellas shall make payments to
Cytokinetics as follows:

(i) During the Cytokinetics Commercialization Period. During the Cytokinetics
Commercialization Period, Astellas shall make quarterly non-refundable,
non-creditable royalty payments to Cytokinetics on the Net Sales of each
Collaboration Product at the applicable royalty rate set forth below. Net Sales
shall be aggregated on a Compound-by-Compound basis across all Indications.

 

Net Sales in Astellas

Territory of each

Collaboration Product in an

Astellas’ fiscal year

   Royalty Rate for Net Sales in such Astellas’ fiscal year      Lead Product  
   Collaboration Product
containing [*] Activator
(other than the Lead
Compound)   [*]      [*]         [*]    [*]      [*]         [*]    [*]      [*]
        [*]    [*]      [*]         [*]   

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(ii) After the Cytokinetics Commercialization Period. After the Cytokinetics
Commercialization Period, Astellas shall make quarterly non-refundable,
non-creditable royalty payments to Cytokinetics on the Net Sales of each
Collaboration Product at the royalty rates set forth in Section 11.7 (a)(iv) (if
Astellas has [*] Indication or [*] Indication for such Collaboration Product in
the applicable country) or Section 11.7(a)(v) (if Astellas has [*] Indication or
[*] Indication for such Collaboration Product in the applicable country [*]
Indication in such country for which [*]), but in each case [*] shall have the
right to [*] as set forth in Section [*] provided that the [*].

11.9 Currency; Exchange Rate. All payments to be made by a Party to the other
Party under this Agreement shall be made in Dollars by bank wire transfer in
immediately available funds to a bank account designated by written notice from
the Party that receives the payment. The rate of exchange to be used in
computing the amount of currency equivalent in Dollars for calculating Net Sales
shall be made at the average quarterly rate as published by Bloomberg (based on
20:00 Tokyo time) for the applicable quarterly reporting period for which the
payment is due, or such other source as the Parties may agree in writing.
Astellas shall provide Cytokinetics with written documentation of the applicable
average quarterly rate, in English, along with the applicable royalty report
under Section 11.7(e).

11.10 Late Payments. If a Party does not receive payment from the other Party of
any sum due to it on or before the due date therefor, simple interest shall
thereafter accrue on the sum due to such receiving Party from the due date until
the date of payment at a [*] or the [*].

11.11 Taxes.

(a) Taxes on Income. Each Party shall be solely responsible for the payment of
all taxes imposed on its share of income arising directly or indirectly from the
activities of the Parties under this Agreement.

(b) Tax Cooperation. The Parties agree to cooperate with one another and use
reasonable efforts to avoid or reduce tax withholding or similar obligations in
respect of royalties, milestone payments, and other payments made by a Party to
the other Party under this Agreement. To the extent such paying Party is
required to deduct and withhold taxes on any payment to the other Party, such
paying Party shall pay the amounts of such taxes to the proper Governmental
Authority in a timely manner, and the sum payable to such other Party shall be
increased to the extent necessary to ensure that such other Party receives a sum
equal to the sum which it would have received had there been no such withholding
tax. Notwithstanding the foregoing, if the paying Party is obliged to pay
withholding taxes and the other Party reasonably foresees that it will

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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be able to utilize as a tax credit any amounts withheld or deducted by such
paying Party, such other Party shall immediately so notify and, upon such
notice, with respect to the amount in question, such paying Party will be
released from the obligation to increase the amount pursuant to this
Section 11.11. Such other Party shall provide such paying Party any tax forms
that may be reasonably necessary in order for such paying Party to not withhold
tax or to withhold tax at a reduced rate under an applicable bilateral income
tax treaty, to the extent legally able to do so. Such other Party shall use
reasonable efforts to provide any such tax forms to such paying Party in advance
of the due date. Each Party shall provide the other with reasonable assistance
(i) to enable the recovery, as permitted by Law, of withholding taxes or similar
obligations resulting from payments made under this Agreement and (ii) in
connection with any audit by any tax authority relating to this Agreement. In
the event the paying Party increased the amount of its payment to the other
Party to account for any withholding tax, and such other Party later utilizes
any such amount withheld by such paying Party to achieve any tax saving for the
benefit of such other Party in the form of a tax deduction, such other Party
shall notify such paying Party in writing of the amount of such tax saving and
such paying Party shall have the right to credit such amount of tax saving
against its future payment obligations to such other Party.

11.12 Records and Audit Rights. Each Party shall maintain complete and accurate
records in sufficient detail to permit the other Party to confirm the accuracy
of the amount of Research Plan Costs, Development Costs, [*] to be reimbursed,
achievement of sales milestones, royalty payments and other amounts payable
under this Agreement. Upon reasonable prior notice, such records shall be open
during regular business hours for a period of [*] years from the creation of
individual records for examination by an independent certified public accountant
selected by the auditing Party and reasonably acceptable to the audited Party
for the sole purpose of verifying for the auditing Party the accuracy of the
financial reports furnished by the audited Party pursuant to this Agreement or
of any payments made, or required to be made, by or to the audited Party
pursuant to this Agreement. Such audits not occur more often than once each
calendar year. Such auditor shall not disclose the audited Party’s Confidential
Information to the auditing Party, except to the extent such disclosure is
necessary to verify the accuracy of the financial reports furnished by the
audited Party or the amount of payments to or by the audited Party under this
Agreement. Any amounts shown to be owed but unpaid shall be paid within [*] days
after the accountant’s report, plus interest (as set forth in Section 11.10)
from the original due date. The auditing Party shall bear the full costs of such
audit unless such audit reveals an overpayment to, or an underpayment by, the
audited Party that resulted from a discrepancy in the financial report provided
by the audited Party for the audited period, which underpayment or overpayment
was more than [*] of the amount set forth in such report, in which case the
audited Party shall reimburse the auditing Party for the costs for such audit.
If any such overpayment exceeds such [*] amount, then the auditing Party will
refund such amount to the audited Party within [*] days after the accountant’s
report. On the other hand, if any such overpayment does not exceed such [*]
amount, the auditing Party shall have the right to credit the amount of such
overpayment against its future payment obligations to the audited Party,
provided that such future payments are expected.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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ARTICLE 12

INTELLECTUAL PROPERTY RIGHTS

12.1 Ownership of Collaboration Intellectual Property.

(a) All Collaboration Intellectual Property shall be [*]. Each Party shall [*]
in any Collaboration Intellectual Property [*] the other Party, subject to [*.]
To the extent any Collaboration Intellectual Property is [*] a Party, such Party
shall, [*] such Collaboration Intellectual Property to the extent [*] the other
Party [*]. To the extent any Patent Right [*] any Collaboration Intellectual
Property [*] such Patent Right to [*].

(b) The Parties shall cooperate with respect to the filing, prosecution,
maintenance and enforcement of Collaboration Patents through the JPC. This
Agreement shall be deemed a joint research agreement under 35 U.S.C. §102(c) or
§103(c), as applicable, and any foreign counterparts entered into for the
purpose of researching, identifying and developing Compounds and Collaboration
Products under the terms set forth herein.

12.2 Disclosure of Collaboration Intellectual Property. Each Party shall
promptly disclose to the other Party all Collaboration Intellectual Property,
including all invention disclosures or other similar documents submitted to such
Party by its, or its Affiliates’, directors, officers, employees, agents or
independent contractors relating to such Collaboration Intellectual Property,
and shall also respond promptly to reasonable requests from the other Party for
additional information relating to such Collaboration Intellectual Property.
Notwithstanding the foregoing, the Parties may [*] in connection with the
Research Plan.

12.3 Patent Prosecution.

(a) Cytokinetics Sole Patents.

(i) Cytokinetics shall be responsible for filing, prosecuting and maintaining
the Cytokinetics Patents[*]. Cytokinetics shall consult with Astellas and keep
Astellas reasonably informed of the status of the Cytokinetics Patents and shall
promptly provide Astellas with copies of material correspondence received from
any patent

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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authorities in connection therewith. In addition, Cytokinetics shall promptly
provide Astellas with drafts of all proposed material filings and
correspondences to any patent authorities with respect to the Cytokinetics
Patents for Astellas’ review and comment prior to the submission of such
proposed filings and correspondences. Cytokinetics shall confer with Astellas
and reasonably consider Astellas’ comments prior to submitting such filings and
correspondences, provided that Astellas shall provide such comments within [*]
days of receiving the draft filings and correspondences from Cytokinetics. If
Astellas does not provide comments within such period of time, then Astellas
shall be deemed to have no comment to such proposed filings or correspondences.
In case of disagreement between the Parties with respect to the filing,
prosecution and maintenance of such Cytokinetics Patents, the final decision
shall be made by Cytokinetics, subject to subsection (ii) below. For the purpose
of this Article 12, “prosecution” shall include any post-grant proceeding
including supplemental examination, post-grant review proceeding, inter parties
review proceeding, patent interference proceeding, opposition proceeding,
reexamination, patent term restoration (under but not limited to the U.S. Drug
Price Competition and Patent Term Restoration Act), supplemental protection
certificates or their equivalents, and patent term extensions.

(ii) Cytokinetics shall notify Astellas in writing of any decision to cease
prosecution and/or maintenance of, any Cytokinetics Patents in any country.
Cytokinetics shall provide such notice at least [*] days prior to any filing or
payment due date, or any other due date that requires action in order to avoid
loss of rights, in connection with such Cytokinetics Patent. Upon request by
Astellas, Cytokinetics shall permit Astellas, at Astellas’ discretion and
expense, to continue prosecution or maintenance of such Cytokinetics Patent in
such country, and for as long as Astellas assumes such prosecution and
maintenance at its own costs, such Cytokinetics Patent shall be [*].

(b) Collaboration Patents.

(i) Astellas shall be responsible for filing, prosecuting and maintaining any
Collaboration Patents, [*]. Astellas shall consult with Cytokinetics and keep
Cytokinetics reasonably informed of the status of the Collaboration Patents and
shall promptly provide Cytokinetics with copies of material correspondence
received from any patent authorities in connection therewith. In addition,
Astellas shall promptly provide Cytokinetics with drafts of all proposed
material filings and correspondences to any patent authorities with respect to
the Collaboration Patents for Cytokinetics’ review and comment prior to the
submission of such proposed filings and correspondences. Astellas shall confer
with Cytokinetics and reasonably consider Cytokinetics’ comments prior to
submitting such filings and correspondences, provided that Cytokinetics shall
provide such comments within [*] days of receiving the draft filings and
correspondences from Astellas. If Cytokinetics does not provide comments within
such period of time, then Cytokinetics shall be deemed to have no comment to
such proposed filings or correspondences. In case of disagreement between the
Parties with respect to the filing, prosecution and maintenance of such
Collaboration Patents, the final decision shall be made by Astellas, subject to
subsection (ii) below.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(ii) Astellas shall notify Cytokinetics in writing of any decision to cease
prosecution and/or maintenance of, any Collaboration Patents in any country.
Astellas shall provide such notice at least [*] days prior to any filing or
payment due date, or any other due date that requires action in order to avoid
loss of rights, in connection with such Collaboration Patent. In such event,
Astellas shall permit Cytokinetics, at its discretion and expense, to continue
prosecution or maintenance of such Collaboration Patent in such country, and for
as long as Cytokinetics assumes such prosecution and maintenance at its own
costs, such Collaboration Patent shall be [*].

(c) Astellas Patents.

(i) Astellas shall be responsible for filing, prosecuting and maintaining the
Astellas Patents, [*]. Astellas shall keep Cytokinetics reasonably informed of
the status of the Astellas Patents.

(ii) Astellas shall notify Cytokinetics in writing of any decision to cease
prosecution and/or maintenance of, any Astellas Patents in any country. Astellas
shall provide such notice at least [*] days prior to any filing or payment due
date, or any other due date that requires action in order to avoid loss of
rights, in connection with such Astellas Patent. In such event, Astellas shall
permit Cytokinetics, at its discretion and expense, to continue prosecution or
maintenance of such Astellas Patent in such country and, after such notice by
Astellas, such Astellas Patent shall be [*].

(d) Collaboration. When a Party assumes the responsibilities for the prosecution
and maintenance of a Patent under Section 12.3(a)(ii), 12.3(b)(ii), 12.3(c)(ii)
or 14.3(c), the other Party shall promptly transfer to such Party the patent
prosecution files for such Patent and provide reasonable assistance in the
transfer of the prosecution responsibilities. The Party assuming such
prosecution and maintenance responsibilities shall have the right to engage its
own counsel to do so.

12.4 Patent Enforcement.

(a) Each Party shall notify the other within [*] Business Days of becoming aware
of any alleged or threatened infringement by a Third Party of any of the
Cytokinetics Patents, Astellas Patents or Collaboration Patents, which
infringement adversely affects or is expected to adversely affect the
Development or Commercialization of any Collaboration Product, including any
“patent certification” filed in the United States under 21 U.S.C. §355(b)(2) or
21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions and of any
declaratory judgment, opposition, or similar action alleging the invalidity,
unenforceability or non-infringement of any of the Cytokinetics Patents,
Astellas Patents or Collaboration Patents (collectively “Product Infringement”).

(b) Astellas shall have the first right to bring and control any legal action in
connection with any Product Infringement at its own expense as it reasonably
determines appropriate, and Cytokinetics shall have the right to be represented
in any such action by counsel of its choice. Astellas shall provide Cytokinetics
and its counsel with copies all court filings and

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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material supporting documentation, and, at the request of Cytokinetics,
reasonable access to Astellas’ counsel for consultation, provided that, unless
Cytokinetics is joined as a party to such action, any counsel retained by
Cytokinetics shall not act as attorney of record for any such action, or conduct
any legal proceedings as part of such action, unless specifically requested by
Astellas and at Astellas’ expense. If Astellas decides not to bring such legal
action, it shall so notify Cytokinetics promptly in writing and Cytokinetics
shall have the right to bring and control any legal action in connection with
such Product Infringement at its own expense as it reasonably determines
appropriate after consultation with Astellas.

(c) Cytokinetics shall have the exclusive right to enforce the Cytokinetics
Patents for any infringement that is not a Product Infringement at its own
expense as it reasonably determines appropriate. Astellas shall have the
exclusive right to enforce the Astellas Patents for any infringement that is not
a Product Infringement at its own expense as it reasonably determines
appropriate. Each Party shall have the right to enforce the Collaboration
Patents for any infringement that is not a Product Infringement at its own
expense as it reasonably determines appropriate.

(d) At the request of the Party bringing the action, the other Party shall
provide reasonable assistance in connection therewith, including by executing
reasonably appropriate documents, cooperating in discovery and joining as a
party to the action if required.

(e) In connection with any such proceeding, the Party bringing the action shall
not enter into any settlement admitting the invalidity of, or otherwise
impairing the other Party’s rights in, the Cytokinetics Patents, Astellas
Patents or Collaboration Patents without the prior written consent of the other
Party.

(f) Any recoveries resulting from enforcement action relating to a claim of
Product Infringement shall be first applied against payment of each Party’s
costs and expenses in connection therewith. Any such recoveries in excess of
such costs and expenses (the “Remainder”) shall be [*] provided that if the
Product Infringement involves a Collaboration Product in [*] Indication [*] in
the Shared Territory, and [*] for such Indication, the Remainder shall be paid
to [*]. Any Remainder [*] in accordance with Section [*].

12.5 Trademarks.

(a) Except as set forth in Section 12.5(b) below, Astellas shall have the right
to brand the Collaboration Products using any trademarks and trade names it
determines appropriate for the Collaboration Products, which may vary by country
or within a country (“Product Marks”). Astellas shall own all rights in the
Product Marks and shall register and maintain the

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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Product Marks in the countries and regions that it determines reasonably
necessary, at Astellas’ cost and expense. If Cytokinetics exercises its
Co-Promotion option for a Collaboration Product, Astellas shall mark such
Collaboration Product in the Co-Promotion Territory (or Shared Territory, as
applicable) with logos of both Astellas and Cytokinetics in equal prominence.

(b) If Cytokinetics is Commercializing a Collaboration Product in an [*]
Indication during the Cytokinetics Commercialization Period, Cytokinetics shall
have the right to brand such Collaboration Product in the Shared Territory using
any trademarks and trade names it determines appropriate for the Collaboration
Products, which may vary by country or within a country (the “Cytokinetics
Product Marks”). Cytokinetics shall own all rights in the Cytokinetics Product
Marks and shall register and maintain the Cytokinetics Product Marks in the
countries and regions in the Shared Territory that it determines reasonably
necessary, at Cytokinetics’ cost and expense. After the Cytokinetics
Commercialization Period, Astellas has the right to take over the Cytokinetics
Product Marks (but not Cytokinetics’ name or its corporate marks) from
Cytokinetics in the countries and regions in the Shared Territory without any
additional compensation to Cytokinetics, provided that Astellas shall bear any
costs and expenses incurred in connection with such transfer.

ARTICLE 13

CONFIDENTIALITY; PUBLICATION

13.1 Duty of Confidence. Subject to the other provisions of this Article 13:

(a) all Confidential Information of a Party (the “Disclosing Party”) shall be
maintained in confidence and otherwise safeguarded by the other Party (the
“Receiving Party”) and its Affiliates, using Diligent Efforts, but in any event
no less than in the same manner and with the same protections as the Receiving
Party maintains its own confidential information;

(b) the Receiving Party may only use any such Confidential Information for the
purposes of performing its obligations or exercising its rights under this
Agreement; and

(c) the Receiving Party may disclose Confidential Information of the other Party
to: (i) its Affiliates and sublicensees; and (ii) officers, employees,
directors, agents, contractors, consultants and advisers of the Receiving Party
and its Affiliates and sublicensees, in each case to the extent reasonably
necessary for the purposes of, and for those matters undertaken pursuant to,
this Agreement; provided that such Persons are bound by legally enforceable
obligations to maintain the confidentiality of the Confidential Information in a
manner consistent with the confidentiality provisions of this Agreement.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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13.2 Exceptions. The foregoing obligations as to particular Confidential
Information of a Disclosing Party shall not apply to the extent that the
Receiving Party can demonstrate through competent evidence that such
Confidential Information:

(a) is known by the Receiving Party at the time of its receipt without an
obligation of confidentiality, and not through a prior disclosure by the
Disclosing Party, as documented by the Receiving Party’s business records;

(b) is in the public domain before its receipt from the Disclosing Party, or
thereafter enters the public domain through no fault of the Receiving Party;

(c) is subsequently disclosed to the Receiving Party by a Third Party who may
lawfully do so and is not under an obligation of confidentiality to the
Disclosing Party; or

(d) is developed by the Receiving Party independently and without use of or
reference to any Confidential Information received from the Disclosing Party, as
documented by the Receiving Party’s business records.

No combination of features or disclosures shall be deemed to fall within the
foregoing exclusions merely because individual features are published or
available to the general public or in the rightful possession of the Receiving
Party, unless the combination itself and principle of operation are published or
available to the general public or in the rightful possession of the Receiving
Party.

13.3 Authorized Disclosures. Notwithstanding the obligations set forth in
Sections 13.1 and 13.5, a Party may disclose the other Party’s Confidential
Information (including this Agreement and the terms herein) to the extent:

(a) such disclosure: (i) is reasonably necessary for the filing or prosecuting
Patent Rights as contemplated by this Agreement; (ii) is reasonably necessary in
connection with regulatory filings for Collaboration Products; (iii) is
reasonably necessary for the prosecuting or defending litigation as contemplated
by this Agreement; or (iv) is made to any Third Party bound by written
obligation of confidentiality and non-use substantially consistent with to those
set forth under this Article 13 (subject to subsection (b) below with respect to
[*]), to the extent otherwise necessary or appropriate in connection with the
exercise of its rights or the performance of its obligations hereunder;

(b) such disclosure is to [*], does not include the disclosure of Confidential
Information relating to [*], and otherwise meets the requirements of subsection
(a) above, in which case the Party [*] may agree with [*] of no less than [*]
and in any event no less than [*]. Notwithstanding the foregoing, the
subcontracting Party may request that the other Party grant a waiver to such
requirement, which waiver shall not be unreasonably withheld or delayed and may
be provided by e-mail. Each Party agrees to use Diligent Efforts to respond to a
request for such a waiver within [*] Business Days.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(c) such disclosure is reasonably necessary: (i) to such Party’s directors,
attorneys, independent accountants or financial advisors for the sole purpose of
enabling such directors, attorneys, independent accountants or financial
advisors to provide advice to such Party, provided that in each such case on the
condition that such directors, attorneys, independent accountants and financial
advisors are bound by confidentiality and non-use obligations substantially
consistent with those contained in this Agreement; or (ii) to actual or
potential investors, acquirors, (sub)licensees and other financial or commercial
partners solely for the purpose of evaluating or carrying out an actual or
potential investment, acquisition or collaboration; provided that in each such
case on the condition that such Persons are bound by confidentiality and non-use
obligations substantially consistent with those contained in the Agreement; or

(d) such disclosure is required by judicial or administrative process, provided
that in such event such Party shall promptly notify the other Party in writing
of such required disclosure and provide the other Party an opportunity to
challenge or limit the disclosure obligations. Confidential Information that is
disclosed by judicial or administrative process shall remain otherwise subject
to the confidentiality and non-use provisions of this Article 13, and the Party
disclosing Confidential Information pursuant to law or court order shall take
all steps reasonably necessary, including seeking of confidential treatment or a
protective order, to ensure the continued confidential treatment of such
Confidential Information.

13.4 Publications. The JMAC (and prior to the establishment of the JMAC, the JRC
(for Research-related publications) or the JDC (for Development-related
publications)) (each of the JRC, JDC and the JMAC, the “Responsible Committee”)
shall establish publication review and approval procedures for this
Collaboration consistent with the publication policies of both Parties. The
Parties shall review and approve any publication by either Party or its
Affiliates or (sub)licensees relating to the Compounds or Collaboration
Products, including scientific, health economic or pharmacoeconomic
publications, in accordance with such procedures, considering Astellas’ and
Cytokinetics’ interest in publishing the results of the work in the Research,
Development, and Medical Affairs Activities in order to obtain recognition
within the scientific or other applicable community and to advance the state of
knowledge in the field, the need to protect Confidential Information and the
Parties’ mutual interest in obtaining valid patent protection, protecting
reasonable business interests and trade secret information, and having an
integrated approach to developing one or more Collaboration Products for one or
more Indications. Consequently, except for disclosures permitted pursuant to
Sections 13.3 and 13.5, each Party and their Affiliates, employee(s) and
consultant(s) shall deliver to the Responsible Committee for review and comment
a copy of any proposed publication or presentation that pertains to any Compound
or Collaboration Product, pursuant to a procedure to be established by the
Responsible Committee (but excluding general corporate publications and
presentations), any such comments to be provided within [*] days of receipt. The
Responsible Committee shall have the right to require modifications of the
publication or presentation: (a) to protect each Parties’ respective
Confidential Information; (b) for trade secret reasons or business reasons;
and/or (c) to delay such submission for an additional [*] days as may be
reasonably necessary to seek patent protection for the information disclosed in
such proposed submission.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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13.5 Publicity; Use of Names.

(a) The Parties have agreed on language of a joint press release announcing the
restatement of the Agreement, which is attached hereto as Exhibit J, to be
issued by the Parties promptly after the Amendment Effective Date. No other
disclosure of the existence or the terms of this Agreement may be made by either
Party or its Affiliates except as provided in Section 13.3 and this
Section 13.5. No Party shall use the name, trademark, trade name or logo of the
other Party, its Affiliates or their respective employees in any publicity,
promotion, news release or disclosure relating to this Agreement or its subject
matter, except as provided in this Section 13.5 or with the prior express
written permission of the other Party, except as may be required by applicable
Law.

(b) A Party may disclose this Agreement in securities filings with the
Securities Exchange Commission (the “SEC”) or equivalent foreign agency to the
extent required by applicable Law. In such event, the Party seeking such
disclosure shall prepare a proposed redacted version of this Agreement to
request confidential treatment for this Agreement, and the other Party agrees to
promptly (and in any event, no less than [*] Business Days after receipt of such
proposed redactions) give its input in a reasonable manner in order to allow the
Party seeking disclosure to file its request within the time lines prescribed by
applicable Law. The Party seeking such disclosure shall reasonably consider any
comments thereto provided by the other Party within such [*] Business Day
period.

(c) Each Party acknowledges that the other Party may be legally required to make
public disclosures (including in filings with the Governmental Authorities or by
issuing a press release) of certain terms of or material developments or
material information generated under this Agreement and agrees that each Party
may make such disclosures as required by Law, provided that the Party seeking
such disclosure first provides the other Party a copy of the proposed
disclosure, and shall reasonably consider any comments thereto provided by the
other Party within [*] days after the receipt of such proposed disclosure,
provided that in no event shall the Party having such disclosure obligation be
required to delay its disclosure in a manner that may cause such Party to
violate any Law or incur any legal liability.

(d) Other than the press release set forth in Exhibit J and any press release
issued pursuant to Section 13.5(c), the Parties agree that the portions of any
other news release or other public announcement relating to this Agreement or
the performance hereunder that would disclose information other than that
already in the public domain, shall first be reviewed and approved by both
Parties (with such approval not to be unreasonably withheld or delayed);
provided, however, that notwithstanding the foregoing, Cytokinetics shall have
the right to disclose publicly (including on its website): (i) the fact that it
has entered into this Agreement; (ii) the commencement, progress, status,
completion and key results of each clinical trials conducted by the Parties
under this Agreement; (iii) the receipt of any milestone payments under this
Agreement; (iv) Marketing Approval of any Collaboration Product; (v) the First
Commercial Sale of any Collaboration Product; and (vi) royalties received from
Astellas. For each such disclosure, unless Cytokinetics otherwise has the right
to make such disclosure under this Article 13, Cytokinetics shall provide
Astellas with a draft of such disclosure at least [*] Business Days prior

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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to its intended release for Astellas’ review and comment, and shall consider
Astellas’ comments in good faith. If Cytokinetics does not receive comments from
Astellas within [*] Business Days, Cytokinetics shall have the right to make
such disclosure without further delay. The Parties shall use reasonable efforts
to coordinate the timing of such disclosures to be outside the trading hours of
the NASDAQ and Tokyo stock markets, provided that neither Party shall be
required to so delay such a disclosure where such delay would reasonably be
expected to give rise to liability for or sanctions upon such Party in such
Party’s sole judgment.

(e) The Parties agree that after a disclosure pursuant to Section 13.5(b), a
press release (including the initial press release) or other public announcement
pursuant to Section 13.5(c) has been reviewed and approved by the other Party,
either Party may make subsequent public disclosures reiterating such information
without having to obtain the other Party’s prior consent or approval.

(f) Each Party agrees that the other Party shall have the right to use such
first Party’s name and logo in presentations, the company’s website, collateral
materials and corporate overviews to describe the collaboration relationship, as
well as in taglines of press releases issued pursuant to this Section 13.5.

13.6 Attorney-Client Privilege. Neither Party is waiving, nor shall be deemed to
have waived or diminished, any of its attorney work product protections,
attorney-client privileges or similar protections and privileges or the like as
a result of disclosing information pursuant to this Agreement, or any of its
Confidential Information (including Confidential Information related to pending
or threatened litigation) to the Receiving Party, regardless of whether the
Disclosing Party has asserted, or is or may be entitled to assert, such
privileges and protections. The Parties: (a) share a common legal and commercial
interest in such disclosure that is subject to such privileges and protections;
(b) are or may become joint defendants in proceedings to which the information
covered by such protections and privileges relates; (c) intend that such
privileges and protections remain intact should either Party become subject to
any actual or threatened proceeding to which the Disclosing Party’s Confidential
Information covered by such protections and privileges relates; and (d) intend
that after the Effective Date both the Receiving Party and the Disclosing Party
shall have the right to assert such protections and privileges.

ARTICLE 14

TERM AND TERMINATION

14.1 Term. The term of this Agreement shall commence upon the Effective Date and
continue in full force and effect, on a Collaboration Product-by-Collaboration
Product basis, until the expiration of the Royalty Term with respect to the
applicable Collaboration Product, unless earlier terminated as set forth in
Section 14.2 below (the “Term”). Upon expiration of the Royalty Term with
respect to such Collaboration Product in such country, the license granted to
Astellas under this Agreement with respect to such Collaboration Product in such
country shall remain in effect on a perpetual, fully paid-up and royalty-free
basis.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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14.2 Termination.

(a) Termination by Astellas for Convenience. At any time after the expiration of
the Research Term, Astellas may terminate this Agreement for convenience in its
entirety or on a [*] basis by providing written notice of termination to
Cytokinetics, which notice includes an effective date of termination at least
one hundred eighty (180) days after the date of the notice. [*].

(b) Termination for Material Breach. If either Party believes that the other is
in material breach of its obligations hereunder or material breach of any
representation or warranty set forth in this Agreement, then the non-breaching
Party may deliver notice of such breach to the other Party. For all breaches
other than a failure to make a payment as set forth in this Agreement, the
allegedly breaching Party shall have [*] days from such notice to dispute or
cure such breach. For any breach arising from a failure to make a payment set
forth in this Agreement, the allegedly breaching Party shall have [*] days from
the receipt of the notice to dispute or cure such breach. If the Party receiving
notice of breach fails to cure, or fails to dispute, that breach within the
applicable period set forth above, then the Party originally delivering the
notice of breach may terminate this Agreement effective on written notice of
termination to the other Party. If the allegedly breaching Party in good faith
disputes such material breach or disputes the failure to cure or remedy such
material breach and provides written notice of that dispute to the other Party
within the applicable period set forth above, the matter shall be addressed
under the dispute resolution provisions in Section 17.6(a), and the termination
shall not become effective unless and until it has been determined under
Section 17.6(a) that the allegedly breaching Party is in material breach of this
Agreement. Notwithstanding the foregoing, if the material breach [*] and
provided that such material breach [*] under this Section 14.2(b) shall be [*]
set forth in Section [*] with respect to such [*] except as provided in Section
[*].

(c) Termination for Patent Challenge. Except to the extent the following is
unenforceable under the laws of a particular jurisdiction, Cytokinetics may
terminate this Agreement if Astellas or its Affiliates or sublicensees,
individually or in association with any other person or entity, commences a
legal action challenging the validity, enforceability or scope of any
Cytokinetics Patents.

(d) Termination for Bankruptcy. Either Party may terminate this Agreement, if,
at any time, the other Party files in any court or agency pursuant to any
statute or regulation of any state, country or jurisdiction, a petition in
bankruptcy or insolvency or for reorganization or for an arrangement or for the
appointment of a receiver or trustee of such other Party or of its assets, or

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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if the other Party proposes a written agreement of composition or extension of
its debts, or if the other Party is served with an involuntary petition against
it, filed in any insolvency proceeding, and such petition shall not be dismissed
within [*] days after the filing thereof, or if the other Party proposes or is a
party to any dissolution or liquidation, or if the other Party makes an
assignment for the benefit of its creditors.

14.3 Effect of Termination. Upon the termination (but not expiration) of this
Agreement for any reason, all licenses and other rights granted to Astellas
under the Cytokinetics Technology and Collaboration Intellectual Property shall
terminate. In the case of a partial termination under Section 14.2(a) or
14.2(b), such licenses and rights will terminate solely with respect to [*]. In
addition, the following consequences shall apply in the event of termination by
Astellas pursuant to Section 14.2(a) or by Cytokinetics pursuant to
Section 14.2(b), 14.2(c) or 14.2(d):

(a) [*] Products. Within [*] days after the effective date of termination, [*]
Collaboration Products containing a [*] (the “[*] Products”). In addition,
Astellas [*] Products. [*].

(b) [*] Products. [*] (i) in the event this Agreement is terminated with respect
to [*] (other than [*] Product), such [*] Product; and/or (ii) in the event this
Agreement is terminated with respect to [*] Products containing such [*] (other
than [*] Product(s)), in each case in the Field [*] (such [*] Products, the “[*]
Products”, and collectively with [*] Products, the “[*] Products”). [*] Products
(other than any [*] Product) as follows:

(i) if on the effective date of such termination, the Parties have [*] for such
[*] Product [*];

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(ii) if on the effective date of such termination, the Parties have [*] for such
[*] Product but have [*] for such [*] Product [*];

(iii) if on the effective date of such termination, the Parties have [*] for
such [*] Product but have [*] for such [*] Product [*];

(iv) if on the effective date of such termination, the Parties have [*] for such
[*] Product but have [*] for such [*] Product [*]; and

(v) if on the effective date of such termination, the Parties have [*] for such
[*] Product and [*] for such [*] Product [*].

In such event, Sections [*] shall apply to [*] (adjusted for [*]), and Section
[*] shall no longer apply to the [*] Products. Cytokinetics may [*] by written
notice to Astellas.

(c) Patent Prosecution and Enforcement. After the effective date of termination,
Astellas shall promptly transfer to Cytokinetics, and Cytokinetics shall
thereafter be solely responsible for, the prosecution and maintenance of
Collaboration Patents that are [*] under Section [*] under Section [*].
Cytokinetics shall have the first right to enforce at Cytokinetics’ sole cost
the Collaboration Patents that are [*] under Section [*] and the Collaboration
Patents that are [*] under Section [*], in each case against any infringement
that adversely affects or is expected to adversely affect any [*] Product.

(d) Regulatory Materials; Data. Within thirty (30) days of the effective date of
such termination, Astellas shall transfer and assign to Cytokinetics, at no cost
to Cytokinetics, all Regulatory Materials relating to any [*] Products, data
from preclinical, non-clinical and clinical studies conducted by or on behalf of
Astellas, its Affiliates or sublicensees relating to any [*] Products and all
pharmacovigilance data (including all adverse event databases) relating to any
[*] Products. At Cytokinetics’ request, Astellas shall provide Cytokinetics with
assistance with any inquiries and correspondence with Regulatory Authorities
relating to any [*] Product for a period of [*] months after such termination.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(e) Trademarks. Astellas shall transfer and assign, and shall ensure that its
Affiliates transfer and assign, to Cytokinetics, at no cost to Cytokinetics, all
Product Marks relating to any [*] Product and any applications therefor
(excluding any such marks that include, in whole or part, any corporate name or
logos of Astellas or its Affiliates or sublicensees). Cytokinetics and its
Affiliates and licensees shall have the right to use other identifiers specific
to such [*] Product (e.g., Astellas compound identifiers). Astellas shall also
transfer to Cytokinetics any in-process applications for generic names for any
[*] Product.

(f) Transition Assistance. Astellas shall provide the following transitional
assistance, at its own cost unless specifically set forth below.

(i) If this Agreement is terminated in its entirety, Astellas shall promptly
return to Cytokinetics all Know-How, data, materials and other Confidential
Information made available to Astellas by Cytokinetics under this Agreement.

(ii) Upon request by Cytokinetics after termination of this Agreement, Astellas
shall promptly provide Cytokinetics with a copy of each license agreement,
collaboration agreement and/or vendor agreement then effective between Astellas
(or its Affiliates) and a Third Party with respect to any [*] Product, or the
Development, Manufacture and Commercialization thereof. Upon Cytokinetics’
request, Astellas shall use its Diligent Efforts to assign or sublicense, and
shall ensure that its Affiliates assign or sublicense, to Cytokinetics any such
agreement(s) and shall permit Cytokinetics access through any communication
portal so established with such Third Party under any agreement so assigned to
Cytokinetics.

(iii) Astellas shall, at Cytokinetics’ request after termination of this
Agreement, transfer (including when available, in electronic format) all
Astellas Know-How and Collaboration Know-How relating to any [*] Products to
Cytokinetics or its designee, including without limitation: study protocols,
study results, analytical methodologies, CMC Information (including bulk and
final product manufacturing processes, batch records, vendor information and
validation documentation), expert opinions, analyses, in each case to the extent
such materials pertain to any [*] Products, and shall provide Cytokinetics
reasonable technical assistance in connection therewith. From and after such
time, all such Know-How shall be deemed Confidential Information of
Cytokinetics.

(iv) Astellas shall transfer to Cytokinetics or its designee any and all
inventory of [*] Products (including all research materials, final product, bulk
drug substance, intermediates, work-in-process, formulation materials, reference
standards, drug product clinical reserve samples, packaged retention samples,
and the like) then in the possession of Astellas, its Affiliates or sublicensees
at Astellas’ Manufacturing Costs. Astellas shall continue or have continued any
ongoing stability studies pertaining to any materials so transferred if such
studies will take less than [*] to complete. The Parties will agree on the
procedures by which to transfer any longer stability studies to Cytokinetics or
its designee in a manner that minimizes the disruption of such studies.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(v) If at the time of such termination, Cytokinetics or its Affiliates are not
Manufacturing a particular [*] Product, then, at Cytokinetics’ request, Astellas
shall: (A) continue to Manufacture and supply Cytokinetics with such [*] Product
at [*] for a period of [*] year after such termination; (B) assign or transfer
to Cytokinetics any Manufacturing agreement between Astellas and a Third Party
contract manufacturer with respect to such [*] Product; and/or (C) transfer to
Cytokinetics (or its designee) all Know-How and materials to enable Cytokinetics
or such designee to assume the Manufacture and supply of such [*] Product and
shall provide reasonable technical assistance in connection therewith;

(vi) If at the time of such termination, Astellas or its Affiliates are
conducting any clinical trials for a [*] Product, then, at Cytokinetics’
election on a trial-by-trial basis: (A) Astellas shall fully cooperate, and
shall ensure that its Affiliates fully cooperate, with Cytokinetics to transfer
the conduct of all such clinical trials to Cytokinetics. [*] the conduct of such
clinical trials after the effective date of such termination (except to the
extent [*]); or (B) Astellas shall, [*], orderly wind-down the conduct of any
such clinical trial which is not assumed by Cytokinetics under clause (A). In
each case [*] in connection with the conduct or wind-down of all such clinical
trials as of the effective date of such termination.

(vii) In addition to the foregoing, Astellas shall use its Diligent Efforts with
respect to those activities for which it is responsible to ensure orderly
transition and uninterrupted Development, Manufacturing, Commercialization and
Medical Affairs Activities of [*] Products by Cytokinetics and to enable
Cytokinetics to enter into an agreement with a Third Party to continue these
activities with minimal disruption and delay.

(viii) Astellas shall transfer to Cytokinetics all rights to publications
relating to any [*] Products (including data to be published, manuscript in
preparation and pending publications).

(g) Termination Press Releases. In the event of termination of this Agreement
for any reason and subject to the provisions of Section 13.5, the Parties shall
cooperate in good faith to coordinate public disclosure of such termination and
the reasons therefor, and shall not, except to the extent required by applicable
Law, disclose such information without the prior approval of the other Party.
The principles to be observed in such disclosures shall be accuracy, compliance
with applicable Law and regulatory guidance documents, and reasonable
sensitivity to potential negative investor reaction to such news.

14.4 Survival. Expiration or termination of this Agreement shall not relieve the
Parties of any obligation accruing prior to such expiration or termination.
Without limiting the foregoing, the provisions of Articles 1, 11 (solely with
respect to payments accrued before the date of

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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expiration or termination or [*]), 16 (solely with respect to Claims arising
from actions and/or omissions during the Term) and 17, and Sections 3.4(f),
3.6(f), 3.8, 5.8, 8.6, 12.1(a), 12.1(b) (the second sentence only), 12.3(c),
12.3(d), 13.1, 13.2, 13.3, 13.5, 13.6, 14.3, 14.4, 14.5 and 15.5 shall survive
the expiration or termination of this Agreement.

14.5 Termination Not Sole Remedy. Termination is not the sole remedy under this
Agreement and, whether or not termination is effected and notwithstanding
anything contained in this Agreement to the contrary, all other remedies shall
remain available except as agreed to otherwise herein.

ARTICLE 15

REPRESENTATIONS AND WARRANTIES

15.1 Representations and Warranties of Each Party. Each Party represents and
warrants to the other Party as of the Effective Date that:

(a) it is duly organized and validly existing under the laws of its jurisdiction
of incorporation or formation, and has full corporate or other power and
authority to enter into this Agreement and to carry out the provisions hereof;

(b) it has the full right, power and authority to enter into this Agreement, to
perform its obligations hereunder; and

(c) this Agreement has been duly executed by it and is legally binding upon it,
enforceable in accordance with its terms, and does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any material law or regulation of any
court, governmental body or administrative or other agency having jurisdiction
over it.

15.2 Representations and Warranties by Cytokinetics. Cytokinetics represents and
warrants to Astellas as of the Effective Date that:

(a) it has not previously assigned, transferred, conveyed or otherwise
encumbered its right, title and interest in Cytokinetics Patents listed in
Exhibit C in a manner that is inconsistent with the license granted to Astellas
under Section 3.1;

(b) to Cytokinetics’ knowledge, all Cytokinetics Patents are listed in Exhibit
C;

(c) it has the right to grant the license and rights herein to Astellas and it
has not granted any license, right or interest in, to or under the Cytokinetics
Patents listed in Exhibit C to any Third Party that is inconsistent with the
license granted to Astellas under Section 3.1;

(d) it has not received any written notice from any Third Party asserting or
alleging that (i) the development of Cytokinetics Patents listed in Exhibit C
prior to the Effective Date or (ii) the practice of any Cytokinetics Know-How
that is contemplated to be utilized in the Research Plan as the Research Plan
exists as of the Effective Date, infringed or misappropriated the intellectual
property rights of such Third Party;

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(e) to Cytokinetics’ knowledge, (i) the practice of Cytokinetics Patents listed
in Exhibit C prior to the Effective Date, and (ii) the practice of any
Cytokinetics Know-How that is contemplated to be utilized in the Research Plan
as the Research Plan exists as of the Effective Date, did not infringe any valid
intellectual property rights owned or possessed by any Third Party and did not
breach any obligation of confidentiality or non-use owed by Cytokinetics to a
Third Party;

(f) there are no judgments or settlements against or owed by Cytokinetics, and
to Cytokinetics’ knowledge, there are no pending or threatened claims or
litigation, in each case relating to Cytokinetics Patents listed in Exhibit C;

(g) up to and including the Effective Date, Cytokinetics has made available to
Astellas the Lead Compound IND and [*]; and

(h) Cytokinetics has sufficient legal and/or beneficial title and ownership in
the Lead Compound IND to perform its rights and obligations under this
Agreement; no Regulatory Authority has, to Cytokinetics’ knowledge, commenced or
threatened to initiate any action or proceeding to refuse to file, reject, not
approve, or withdraw the Lead Compound IND, nor has Cytokinetics received any
notice to such effect; and to Cytokinetics’ knowledge, Cytokinetics is not in
violation of any applicable Laws that could reasonably be expected to form the
basis for such an action.

15.3 Representations and Warranties by Astellas. Astellas represents and
warrants to Cytokinetics as of the Effective Date that:

(a) it has not previously assigned, transferred, conveyed or otherwise
encumbered its right, title and interest in Astellas Patent listed in Exhibit A
in a manner that is inconsistent with the license granted to Cytokinetics under
Section 3.4;

(b) to Astellas’ knowledge, all Astellas Patents are listed in Exhibit A;

(c) it has the right to grant the license and rights herein to Cytokinetics and
it has not granted any license, right or interest in, to or under the Astellas
Patents listed in Exhibit A to any Third Party that is inconsistent with the
license granted to Cytokinetics under Section 3.4;

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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(d) it has not received any written notice from any Third Party asserting or
alleging that: (i) the development of Astellas Patents listed in Exhibit A prior
to the Effective Date, or (ii) the practice of any Astellas Know-How that is
contemplated to be utilized in the Research Plan as the Research Plan exists as
of the Effective Date, infringed or misappropriated the intellectual property
rights of such Third Party;

(e) to Astellas’ knowledge, there are no [*];

(f) to Astellas’ knowledge, (i) the practice of Astellas Patents listed in
Exhibit A prior to the Effective Date, and (ii) the practice of any Astellas
Know-How that is contemplated to be utilized in the Research Plan as the
Research Plan exists as of the Effective Date, did not infringe any valid
intellectual property rights owned or possessed by any Third Party and did not
breach any obligation of confidentiality or non-use owed by Astellas to a Third
Party; and

(g) there are no judgments or settlements against or owed by Astellas, and to
Astellas’ knowledge, there are no pending or threatened claims or litigation, in
each case relating to Astellas Patents listed in Exhibit A.

15.4 Mutual Covenants.

(a) No Debarment. In the course of the Research, Development, Manufacture and
Commercialization of the Compounds and Collaboration Products, neither Party nor
its Affiliates shall use any employee or consultant (including of any
sublicensee), who has been debarred or disqualified by any Regulatory Authority,
or, to such Party’s or its Affiliates’ knowledge, is the subject of debarment or
disqualification proceedings by a Regulatory Authority. Each Party shall notify
the other Party promptly upon becoming aware that any of its or its Affiliates’
employees or consultants has been debarred or is the subject of debarment or
disqualification proceedings by any Regulatory Authority.

(b) Compliance. Each Party and its Affiliates shall comply in all material
respects with all applicable Laws (including all anti-bribery laws) in the
Research, Development, Manufacture, Commercialization and Medical Affairs
Activities of the Compounds and Collaboration Products and performance of its
obligations under this Agreement.

15.5 No Other Warranties. EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 15, (A) NO
REPRESENTATION, CONDITION OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON
BEHALF OF ASTELLAS OR CYTOKINETICS; AND (B) ALL OTHER CONDITIONS AND WARRANTIES
WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE ARE HEREBY EXPRESSLY EXCLUDED,
INCLUDING ANY CONDITIONS AND WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR NON-INFRINGEMENT.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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ARTICLE 16

INDEMNIFICATION; LIABILITY; INSURANCE

16.1 Indemnification by Cytokinetics. Cytokinetics shall indemnify and hold
Astellas, its Affiliates and sublicensees and their respective officers,
directors, agents and employees (“Astellas Indemnitees”) harmless from and
against any Claims against them to the extent arising or resulting from:

(a) the Research, Development, Manufacture, Co-Promotion, or Commercialization
or Medical Affairs Activities of the Compounds and/or Collaboration Products by
Cytokinetics or any of its Affiliates, licensees, sublicensees, distributors or
contractors; or

(b) the negligence, recklessness or willful misconduct of any of the
Cytokinetics Indemnitees; or

(c) the breach of any of the warranties or representations made by Cytokinetics
to Astellas under this Agreement; or

(d) the breach by Cytokinetics of its obligations pursuant to this Agreement;

except in each case, to the extent such Claims result from the breach by any
Astellas Indemnitee of any covenant, representation, warranty or other agreement
made by Astellas in this Agreement or the negligence, recklessness or willful
misconduct of any Astellas Indemnitee.

16.2 Indemnification by Astellas. Astellas shall indemnify and hold
Cytokinetics, its Affiliates, and their respective officers, directors, agents
and employees (“Cytokinetics Indemnitees”) harmless from and against any Claims
arising under or related to this Agreement against them to the extent arising or
resulting from:

(a) the Research, Development, Manufacture, Commercialization or Medical Affairs
Activities of the Compounds and/or Collaboration Products by Astellas or any of
its Affiliates, licensees, sublicensees, distributors or contractors; or

(b) the negligence, recklessness or willful misconduct of any of the Astellas
Indemnitees; or

(c) the breach of any of the warranties or representations made by Astellas to
Cytokinetics under this Agreement; or

(d) any breach by Astellas of its obligations pursuant to this Agreement;

except in each case, to the extent such Claims result from the breach by any
Cytokinetics Indemnitee of any covenant, representation, warranty or other
agreement made by Cytokinetics in this Agreement or the negligence, recklessness
or willful misconduct of any Cytokinetics Indemnitee.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

107

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16.3 Indemnification Procedure. If either Party is seeking indemnification under
Sections 16.1 or 16.2 (the “Indemnified Party”), it shall inform the other Party
(the “Indemnifying Party”) of the Claim giving rise to the obligation to
indemnify pursuant to such Section as soon as reasonably practicable after
receiving notice of the Claim. The Indemnifying Party shall have the right to
assume the defense of any such Claim for which it is obligated to indemnify the
Indemnified Party. The Indemnified Party shall cooperate with the Indemnifying
Party and the Indemnifying Party’s insurer as the Indemnifying Party may
reasonably request, and at the Indemnifying Party’s cost and expense. The
Indemnified Party shall have the right to participate, at its own expense and
with counsel of its choice, in the defense of any Claim that has been assumed by
the Indemnifying Party. Neither Party shall have the obligation to indemnify the
other Party in connection with any settlement made without the Indemnifying
Party’s written consent, which consent shall not be unreasonably withheld or
delayed. If the Parties cannot agree as to the application of Section 16.1 or
16.2 as to any Claim, pending resolution of the dispute pursuant to
Section 17.6(a), the Parties may conduct separate defenses of such Claims, with
each Party retaining the right to claim indemnification from the other Party in
accordance with Section 16.1 or 16.2 upon resolution of the underlying Claim.

16.4 Mitigation of Loss. Each Indemnified Party shall take and shall procure
that its Affiliates take all such reasonable steps and action as are reasonably
necessary or as the Indemnifying Party may reasonably require in order to
mitigate any Claims (or potential losses or damages) under this Article 16.
Nothing in this Agreement shall or shall be deemed to relieve any Party of any
common law or other duty to mitigate any losses incurred by it.

16.5 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY
SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM
OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE
POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS
SECTION 16.5 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION
RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 16.1 OR 16.2, OR DAMAGES
AVAILABLE FOR A PARTY’S BREACH OF ITS OBLIGATIONS RELATING TO CONFIDENTIALITY OR
INTELLECTUAL PROPERTY HEREUNDER.

16.6 Insurance. Each Party shall procure and maintain insurance, including
product liability insurance, with respect to its activities hereunder and which
is consistent with normal business practices of prudent companies similarly
situated at all times during which any Collaboration Product is being clinically
tested in human subjects or commercially distributed or sold. Each Party shall
provide the other Party with evidence of such insurance upon request and shall
provide the other Party with written notice at least [*] days prior to the
cancellation, non-renewal or material changes in such insurance. Such insurance
shall not be construed to create a limit of either Party’s liability with
respect to its indemnification obligations under this Article 16.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

108

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ARTICLE 17

GENERAL PROVISIONS

17.1 Force Majeure. Neither Party shall be held liable to the other Party nor be
deemed to have defaulted under or breached this Agreement for failure or delay
in performing any obligation under this Agreement to the extent such failure or
delay is caused by or results from causes beyond the reasonable control of the
affected Party, potentially including embargoes, war, acts of war (whether war
be declared or not), acts of terrorism, insurrections, riots, civil commotions,
strikes, lockouts or other labor disturbances, fire, floods, earthquakes or
other acts of God, or acts, generally applicable action or inaction by any
governmental authority (but excluding any government action or inaction that is
specific to such Party, its Affiliates or sublicensees, such as revocation or
non-renewal of such Party’s license to conduct business), or omissions or delays
in acting by the other Party, or unavailability of materials related to the
Manufacture of Compounds or Collaboration Products. The affected Party shall
notify the other Party in writing of such force majeure circumstances as soon as
reasonably practical, and shall promptly undertake and continue diligently all
reasonable efforts necessary to cure such force majeure circumstances or to
perform its obligations in spite of the ongoing circumstances.

17.2 Assignment. This Agreement may not be assigned or otherwise transferred,
nor may any right or obligation hereunder be assigned or transferred, by either
Party without the prior written consent of the other Party. Notwithstanding the
foregoing, either Party may, without consent of the other Party, assign this
Agreement and its rights and obligations hereunder in whole or in part to an
Affiliate of such Party, or in whole to its successor-in-interest in connection
with the sale of all or substantially all of its stock or its assets to which
this Agreement relates, or in connection with a merger, acquisition or similar
transaction. Any attempted assignment not in accordance with this Section 17.2
shall be null and void and of no legal effect. Any permitted assignee shall
assume all assigned obligations of its assignor under this Agreement. The terms
and conditions of this Agreement shall be binding upon, and shall inure to the
benefit of, the Parties and their respected successors and permitted assigns.

17.3 Severability. If any one or more of the provisions contained in this
Agreement is held invalid, illegal or unenforceable in any respect, the
validity, legality and enforceability of the remaining provisions contained
herein shall not in any way be affected or impaired thereby, unless the absence
of the invalidated provision(s) adversely affects the substantive rights of the
Parties. The Parties shall in such an instance use their best efforts to replace
the invalid, illegal or unenforceable provision(s) with valid, legal and
enforceable provision(s) which, insofar as practical, implement the purposes of
this Agreement.

17.4 Notices. All notices which are required or permitted hereunder shall be in
writing and sufficient if delivered personally, sent by facsimile (and promptly
confirmed by personal

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

109

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delivery, registered or certified mail or overnight courier), sent by
nationally-recognized overnight courier or sent by registered or certified mail,
postage prepaid, return receipt requested, addressed as follows:

If to Cytokinetics:

Cytokinetics, Inc.

280 East Grand Avenue

South San Francisco, CA 94080

USA

Attn: President

Fax: 650-624-3010

Copy to: General Counsel

with a copy to:

Cooley LLP

3175 Hanover Street

Palo Alto, CA 94304, USA

Attn: Robert L. Jones, Esq.

Fax: (650) 849-7400

If to Astellas:

Astellas Pharma Inc.

2-5-1, Nihonbashi-Honcho

Chuo-ku, Tokyo 103-8411

Japan

Attn: Vice President, Legal & Compliance

Fax: [*]

or to such other address(es) as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith. Any such notice
shall be deemed to have been given: (a) when delivered if personally delivered
or sent by facsimile on a Business Day (or if delivered or sent on a
non-Business Day, then on the next Business Day); (b) on the fifth
(5th) Business Day after dispatch if sent by nationally-recognized overnight
courier; or (c) on the tenth (10th) Business Day following the date of mailing,
if sent by mail.

17.5 Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of [*] and the patent laws of the United
States without reference to any rules of conflict of laws.

17.6 Dispute Resolution.

(a) The Parties shall negotiate in good faith and use reasonable efforts to
settle any dispute, controversy or claim arising from or related to this
Agreement or the breach thereof. If the Parties do not fully settle, and a Party
wishes to pursue the matter, each such dispute, controversy or claim that is not
a matter addressed in Section [*] shall be finally shall be

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

110

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settled by binding arbitration administered by [*] pursuant to its [*] then in
effect (the “[*] Rules”), except as otherwise provided herein. The arbitration
shall be governed by the United States Federal Arbitration Act, 9 U.S.C. §§ 1-16
(the “Federal Arbitration Act”), to the exclusion of any inconsistent state
laws. The U.S. Federal Rules of Civil Procedure shall govern discovery and the
U.S. Federal Rules of Evidence shall govern evidence for the arbitration. The
arbitration will be conducted in San Francisco, California and the Parties
consent to the personal jurisdiction of the United States federal courts, for
any case arising out of or otherwise related to this arbitration, its conduct
and its enforcement. Any situation not expressly covered by this Agreement shall
be decided in accordance with the [*] Rules. The arbitrator shall be one
(1) neutral, independent and impartial arbitrator selected from a pool of
retired federal judges to be presented to the Parties by [*]. Failing the
agreement of the Parties as to the selection of the arbitrator within [*] days,
the arbitrator shall be appointed by [*] in accordance with the [*] Rules.
Notwithstanding any other provision of this Section 17.6(a), either Party shall
have the right to seek and be granted exigent, injunctive or temporary relief in
any court of competent jurisdiction.

(b) Any unresolved dispute between the Parties under Section [*] as follows. The
Parties shall agree on [*] both Parties and all of [*] relating to [*], each
Party shall [*] and the other Party [*] with any relevant [*], each Party may
[*] the other Party’s [*] may also [*]. The Parties [*] days after the Parties
have [*], at which time each Party shall [*] to the Parties [*], provided that
the [*]. Neither Party shall have any [*] without the participation of the other
Party. Within [*] days after [*] on such [*] the Parties. The [*] by the Party
[*].

17.7 Foreign Corrupt Practices Act Compliance.

(a) Compliance with FCPA. The U.S. government imposes and enforces prohibitions
on the payment or transfer of anything of value to governments, government
officials, political parties or political party officials (or relatives or
associates of such officials) (“FCPA Covered Person”) for the purpose of
illegally influencing them, whether directly or indirectly, to obtain or retain
business. This U.S. law is referred to as the Foreign Corrupt Practices Act
(“FCPA”), and it can have application to conduct of a U.S. corporation’s foreign
subsidiaries, employees, agents and distributors. A summary of the law and
related information can be found at http://www.justice.gov/criminal/fraud/fcpa.
By signing this Agreement, each Party warrants that:

(i) It is familiar with the provisions and restrictions contained in the OECD
Convention and FCPA.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

111

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(ii) It shall comply with the FCPA in marketing, selling and/or servicing the
Collaboration Products under this Agreement.

(iii) It shall not, in the course of its duties under the Agreement, offer,
promise, give, demand, seek or accept, directly or indirectly, any gift or
payment, consideration or benefit in kind to any FCPA Covered Person that would
or could be construed as an illegal or corrupt practice.

(iv) It is not an FCPA Covered Person or affiliated with any FCPA Covered
Person.

(v) It shall immediately notify the other Party of any attempt by any FCPA
Covered Person to directly or indirectly solicit, ask for, or attempt to extort
anything of value from the first Party, and shall refuse any such solicitation,
request or extortionate demand except a facilitating payment as expressly
permitted under the FCPA.

(b) Compliance Certificate. From time to time upon request from one Party, the
other Party shall submit a compliance certificate in the form set forth in
Exhibit K stating that (i) it fully understands its obligations under this
Section 17.7 and any other applicable laws and regulations mentioned herein or
as may come into existence from time to time after the Effective Date; (ii) it
has been complying with this Section 17.7 and any other applicable laws and
regulations mentioned herein or as may come into existence from time to time
after the Effective Date; and (iii) it will continue to comply with this
Section 17.7 and any other applicable laws and regulations mentioned herein or
as may come into existence from time to time after the Effective Date.

(c) No Action. In no event shall one Party be obligated under the Agreement to
take any action or omit to take any action that such Party believes, in good
faith, would cause it to be in violation of any applicable laws and regulations,
including the anti-bribery laws referenced in this Section 17.7.

(d) Due Diligence. Each Party shall have the right to visit the offices of the
other Party from time to time during the term of the Agreement on an “as needed”
basis and conduct due diligence in relation to the other Party’s business
related to performance of its obligations under this Section 17.7 and may do so
in the way it deems necessary, appropriate or desirable so as to ensure that the
other Party complies with this Section 17.7 and any other applicable laws and
regulations in its business operations. Each Party shall make every effort to
cooperate fully with the other Party in any such due diligence.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

112

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(e) Audit. In the event that one Party has reason to believe that a breach of
any obligation of the other Party under this Section 17.7 has occurred or may
occur, the first Party shall have the right to select an independent third party
to conduct an audit of the other Party and review relevant books and records of
the other Party, to satisfy itself that no breach has occurred. Unless otherwise
required under applicable laws and regulations or by order of a competent court
or regulatory authority, the first Party shall ensure that the selected
independent third party will keep confidential all audited matters and the
results of the audit. The first Party does reserve the right to disclose to the
U.S. or foreign government, its agencies and/or any other government or
non-government party, information relating to a possible violation by the other
Party of any applicable law, including a violation of the FCPA or any other
applicable anti-bribery law.

17.8 Entire Agreement; Amendments. This Agreement, together with the Exhibits
hereto, contains the entire understanding of the Parties with respect to the
collaboration and the licenses granted hereunder. Any other express or implied
agreements and understandings, negotiations, writings and commitments, either
oral or written, in respect to the collaboration and the licenses granted
hereunder are superseded by the terms of this Agreement. The Exhibits to this
Agreement are incorporated herein by reference and shall be deemed a part of
this Agreement. This Agreement may be amended, or any term hereof modified, only
by a written instrument duly executed by authorized representative(s) of both
Parties hereto. The Parties agree that, effective as of the Effective Date, that
certain Non-Disclosure Agreement between the Parties dated as of September 4,
2012, as amended (“Confidentiality Agreement”) shall be superseded by this
Agreement, and that disclosures made prior to the Effective Date pursuant to the
Confidentiality Agreement shall be subject to the confidentiality and non-use
provisions of this Agreement.

17.9 Headings. The captions to the several Articles, Sections and subsections
hereof are not a part of this Agreement, but are merely for convenience to
assist in locating and reading the several Articles and Sections hereof.

17.10 Independent Contractors. Cytokinetics and Astellas are independent
contractors and that the relationship between the two Parties shall not
constitute a partnership, joint venture or agency. Neither Cytokinetics nor
Astellas shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding on the
other Party, without the prior written consent of the other Party.

17.11 Waiver. The waiver by either Party hereto of any right hereunder, or of
any failure of the other Party to perform, or of any breach by the other Party,
shall not be deemed a waiver of any other right hereunder or of any other breach
by or failure of such other Party whether of a similar nature or otherwise.

17.12 Cumulative Remedies. No remedy referred to in this Agreement is intended
to be exclusive, but each shall be cumulative and in addition to any other
remedy referred to in this Agreement or otherwise available under law.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

113

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17.13 Waiver of Rule of Construction. Each Party has had the opportunity to
consult with counsel in connection with the review, drafting and negotiation of
this Agreement. Accordingly, no ambiguity in this Agreement shall be strictly
construed against either Party.

17.14 Business Day Requirements. In the event that any notice or other action or
omission is required to be taken by a Party under this Agreement on a day that
is not a Business Day then such notice or other action or omission shall be
deemed to be required to be taken on the next occurring Business Day.

17.15 Translations. This Agreement is in the English language only, which
language shall be controlling in all respects, and all versions hereof in any
other language shall be for accommodation only and shall not be binding upon the
Parties. All communications and notices to be made or given pursuant to this
Agreement, and any dispute proceeding related to or arising hereunder, shall be
in the English language. If there is a discrepancy between any translation of
this Agreement and this Agreement, this Agreement shall prevail.

17.16 Further Actions. Each Party agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as necessary or
appropriate in order to carry out the purposes and intent of this Agreement.

17.17 Counterparts. This Agreement may be executed in two or more counterparts
by original signature, facsimile or PDF files, each of which shall be deemed an
original, but all of which together shall constitute one and the same
instrument.

<REMAINDER OF PAGE INTENTIONALLY LEFT BLANK>

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

114

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IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement
to be executed by their duly authorized representatives as of the Amendment
Effective Date.

 

Cytokinetics, Inc. Astellas Pharma Inc. By:

/s/ Robert I. Blum

By:

/s/ Yoshihiko Hatanaka

Name: Robert I. Blum Name: Yoshihiko Hatanaka Title: President and CEO Title:
President and CEO

<SIGNATURE PAGE OF THE AMENDED  AND RESTATED LICENSE AND COLLABORATION AGREEMENT

BY AND BETWEEN

CYTOKINETICS, INC. AND ASTELLAS PHARMA INC.>

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

--------------------------------------------------------------------------------

LIST OF EXHIBITS

Exhibit A:

Existing Astellas Patents

Exhibit B:

Compound Criteria

Exhibit C:

Existing Cytokinetics Patents

Exhibit D:

Retained Indications

Exhibit E:

[*] Patent Rights

Exhibit F:

Alliance Managers and Committee Members

Exhibit G:

[Omitted]

Exhibit H:

[Omitted]

Exhibit I:

Term sheet for Co-Promotion Agreement

Exhibit J:

Press Release for the Amended and Restated Agreement

Exhibit K:

Form of Certificate of Compliance

Exhibit L:

[*] Indications

Exhibit M:

Certain Development Activities for SMA

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

--------------------------------------------------------------------------------

Exhibit A

Existing Astellas Patents

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

A-i

--------------------------------------------------------------------------------

Exhibit B

Compound Criteria 1

[*]

 

1  [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

B-i

--------------------------------------------------------------------------------

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

B-ii

--------------------------------------------------------------------------------

Exhibit C

Existing Cytokinetics Patents

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

C-i

--------------------------------------------------------------------------------

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

C-ii

--------------------------------------------------------------------------------

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

C-iii

--------------------------------------------------------------------------------

Exhibit D

Retained Indications

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

D-i

--------------------------------------------------------------------------------

Exhibit E

[*] Patent Rights

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

E-i

--------------------------------------------------------------------------------

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

E-ii

--------------------------------------------------------------------------------

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

E-iii

--------------------------------------------------------------------------------

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

E-iv

--------------------------------------------------------------------------------

Exhibit F

Alliance Managers and Committee Members

 

     Astellas   Cytokinetics Joint Steering Committee    [*]   [*] Joint
Research Committee    [*]   [*] Joint Development Committee    [*]   [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

F-i

--------------------------------------------------------------------------------

    

[*]

  

[*]

Joint Manufacturing Committee    [*]    [*] Joint Patent Committee    [*]    [*]
Alliance Managers    [*]    [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

F-ii

--------------------------------------------------------------------------------

Exhibit I

Term sheet for Co-Promotion Agreement for Collaboration Products

This Exhibit I sets forth material terms and conditions that, together with the
terms of Section 9.6 of the Agreement, shall be incorporated into a Co-Promotion
Agreement to be negotiated and entered into by the Parties for the Collaboration
Product for which Cytokinetics exercises its option to Co-Promote in accordance
with Section 9.6 of the Agreement (such Collaboration Product, the “Co-Promotion
Product”).

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

I-i

--------------------------------------------------------------------------------

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

I-ii

--------------------------------------------------------------------------------

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

I-iii

--------------------------------------------------------------------------------

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

I-iv

--------------------------------------------------------------------------------

Exhibit J

Press Release

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

J-i

--------------------------------------------------------------------------------

LOGO [g828167ex10_40pg136.jpg]

CYTOKINETICS AND ASTELLAS ANNOUNCE EXPANSION OF COLLABORATION

FOR DEVELOPMENT OF CK-2127107 IN SPINAL MUSCULAR ATROPHY

AND OTHER NEUROMUSCULAR INDICATIONS

Cytokinetics Expects to Receive Over $75 Million in Committed Capital and
Reimbursements For Planned Activities

Companies Plan to Initiate Phase II Clinical Trial in 2015

South San Francisco, CA, and Tokyo, December 23, 2014 – Cytokinetics,
Incorporated (NASDAQ:CYTK) and Astellas Pharma Inc. (Tokyo Stock Exchange: 4503,
“Astellas”) announced today an amendment to their collaboration agreement
focused on the research, development and commercialization of skeletal muscle
activators. The companies have been jointly conducting research and development
activities with the objective to advance novel skeletal sarcomere targeted
therapies for diseases and medical conditions associated with muscle weakness in
non-neuromuscular indications. The collaboration has been expanded to enable
development of CK-2127107, a fast skeletal troponin activator, in Spinal
Muscular Atrophy (SMA) and potentially other neuromuscular indications. As the
companies have agreed, Cytokinetics will conduct a Phase II clinical trial of
CK-2127107 in patients with SMA, which is planned to begin in 2015. Cytokinetics
and Astellas will jointly develop and may jointly commercialize CK-2127107 and
other fast skeletal troponin activators in neuromuscular indications. The
companies have extended their joint research program focused on the discovery of
additional skeletal sarcomere activators through 2016.

Upon execution of the amended agreement, Cytokinetics will receive $55 million
from Astellas comprising $30 million as an upfront license fee, $10 million paid
for Astellas’ purchase of Cytokinetics’ common stock and $15 million in a
milestone payment in connection with the decision made by Astellas to advance
CK-2127107 into Phase II clinical development. In addition, Cytokinetics expects
to receive potentially over $20 million payable by Astellas to reimburse
Cytokinetics for planned research and development expenses over the next 2
years. Under the amended agreement, Cytokinetics is eligible to receive over
$600 million in pre-commercialization and commercialization milestone payments,
of which over $100 million is payable for CK-2127107 in each of SMA and other
neuromuscular indications. The agreed terms also provide for escalating
royalties to Cytokinetics with increased sales. Cytokinetics retains the option
to co-fund the development of CK-2127107 in SMA and other neuromuscular
indications in exchange for increased milestone payments and royalties and, if
Cytokinetics exercises its co-promotion option, Astellas will reimburse
Cytokinetics for certain expenses associated with its promotion activities.

“We are pleased to expand our collaboration with Astellas to enable the joint
pursuit of CK-2127107 in SMA and other potential neuromuscular indications as
well as the indications which were the initial focus of our collaboration,”
stated Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We
are impressed with Astellas’ strategic vision for skeletal muscle activators and
look forward to increasing the scope of our activities to prioritize the
treatment of neuromuscular diseases that may benefit from our novel mechanism
approach to increased muscle function and time to muscle fatigue.”

“We are excited to expand our collaboration with Cytokinetics and to advance
this drug candidate into Phase II,” stated Yoshihiko Hatanaka, Astellas’
President and Chief Executive Officer. “We are encouraged by the result of the
completed Phase I studies for CK-2127107 and are hopeful for the future of this
new frontier of muscle biology. The expansion of our alliance is a testament to
our productive collaboration together and illustrates the broad potential that
we envision for this program.”

Expanded Scope of Collaboration

Cytokinetics and Astellas entered into collaboration in 2013. Cytokinetics
exclusively licensed to Astellas the rights to co-develop and commercialize
CK-2127107, a fast skeletal troponin activator drug candidate, for potential
application in non-neuromuscular indications under the collaboration agreement.
In accordance with the initial scope of the collaboration, Cytokinetics
completed Phase I clinical development activities and other Phase II readiness
activities. In connection with the

--------------------------------------------------------------------------------

Cytokinetics’ and Astellas’ Announcement Regarding Expansion of Skeletal Muscle
Activator Collaboration

Page 2

 

expanded collaboration, the companies have agreed to advance CK-2127107 into
Phase II clinical development initially in SMA. The development program may
include other neuromuscular indications as the companies may agree in the
future. In connection with the expanded collaboration, Cytokinetics and Astellas
have also agreed to extend their joint research program through 2016. Under the
amended collaboration, Astellas has exclusive rights to co-develop and
commercialize CK-2127107 and other fast skeletal troponin activators in
non-neuromuscular indications and certain neuromuscular indications (including
SMA) and other novel mechanism skeletal muscle activators in all indications,
subject to certain Cytokinetics’ development and commercialization rights;
Cytokinetics may co-promote and conduct certain commercial activities in North
America and Europe under agreed scenarios. Outside the collaboration,
Cytokinetics may continue to independently develop tirasemtiv, a fast skeletal
troponin activator that recently completed a Phase II clinical trials program
for the potential treatment of amyotrophic lateral sclerosis (ALS), in ALS and
other neuromuscular indications subject to certain agreed limitations.

Cytokinetics Conference Call / Webcast

Cytokinetics will host a conference call on January 5, 2015 at 8:30 a.m. Eastern
Time. The conference call will be simultaneously webcast and will be accessible
in the Investor Relations section of Cytokinetics’ Web site; for further
information please go to www.cytokinetics.com. The live audio of the conference
call is also accessible via telephone to investors, members of the news media
and the general public by dialing either (866) 999-2985 (CYTK) (United States
and Canada) or (706) 679-3078 (International) and typing in the passcode
52398702. An archived replay of the webcast will be available via Cytokinetics’
website until February 5, 2015. The replay will also be available via telephone
from January 5, 2015 at 11:30 a.m. Eastern Time until February 5, 2015 by
dialing (855) 859-2056 (United States and Canada) or (404) 537-3406
(International) and typing in the passcode 52398702.

About CK-2127107

Skeletal muscle contractility is driven by the sarcomere, the fundamental unit
of skeletal muscle contraction. It is a highly ordered cytoskeletal structure
composed of several key proteins. Skeletal muscle myosin is the cytoskeletal
motor protein that converts chemical energy into mechanical force through its
interaction with actin. A set of regulatory proteins, which includes tropomyosin
and several types of troponin, make the actin-myosin interaction dependent on
changes in intracellular calcium levels. CK-2127107, a novel skeletal muscle
activator arising from Cytokinetics’ skeletal muscle contractility program,
slows the rate of calcium release from the regulatory troponin complex of fast
skeletal muscle fibers, which sensitizes the sarcomere to calcium, leading to an
increase in skeletal muscle contractility. CK-2127107 has demonstrated
pharmacological activity that may lead to new therapeutic options for diseases
associated with muscle weakness and fatigue. In non-clinical models of Spinal
Muscular Atrophy, a skeletal muscle activator has demonstrated increases in
skeletal submaximal muscle force in response to neuronal input and delays in the
onset and reductions in the degree of muscle fatigue. CK-2127107 has been the
subject of five completed Phase I clinical trials in healthy volunteers, which
evaluated safety, tolerability, bioavailability, pharmacokinetics and
pharmacodynamics.

About Spinal Muscular Atrophy

Spinal Muscular Atrophy (SMA) is a severe neuromuscular disease that occurs in 1
in every 6,000 to 10,000 live births each year and is one of the most common
fatal genetic disorders. Spinal muscular atrophy manifests in various degrees of
severity as progressive muscle weakness resulting in respiratory and mobility
impairment. There are four types of SMA, named for time of the initial onset of
muscle weakness and related symptoms: Type I (Infantile), Type II
(Intermediate), Type III (Juvenile) and Type IV (Adult onset). Life expectancy
and disease severity varies by type of SMA from Type I, who have the worst
prognosis and a life expectancy of no more than 2 years from birth, to the Type
IV, who have a normal life span but with gradual weakness in the proximal
muscles of the extremities resulting in mobility issues. Few treatment options
exist for these patients, resulting in a high unmet need for new therapeutic
options to address symptoms and modify disease progression.

About Cytokinetics

Cytokinetics is a clinical-stage biopharmaceutical company focused on the
discovery and development of novel small molecule therapeutics that modulate
muscle function for the potential treatment of serious diseases and other
medical conditions. Cytokinetics currently has three compounds in clinical
development: omecamtiv mecarbil in Phase II for acute and chronic heart failure,
tirasemtiv in Phase II for ALS and CK-2127107 progressing to Phase II in SMA.
All of the company’s drug candidates have arisen from Cytokinetics’ muscle
biology focused research activities and are directed towards the cytoskeleton.
The cytoskeleton is a complex biological infrastructure that plays a fundamental
role within every human cell. Additional information about Cytokinetics can be
obtained at http://www.cytokinetics.com.

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Cytokinetics’ and Astellas’ Announcement Regarding Expansion of Skeletal Muscle
Activator Collaboration

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About Astellas

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceuticals. Astellas has approximately
18,000 employees worldwide. The organization is committed to becoming a global
category leader in Urology, Immunology (including Transplantation) and
Infectious diseases, Oncology, Neuroscience and DM Complications and Kidney
diseases. For more information on Astellas Pharma Inc., please visit the company
website at www.astellas.com/en.

Forward-Looking Statements: Cytokinetics

This press release contains forward-looking statements for purposes of the
Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics
disclaims any intent or obligation to update these forward-looking statements,
and claims the protection of the Act’s Safe Harbor for forward-looking
statements. Examples of such statements include, but are not limited to,
statements relating to Cytokinetics’ and Astellas’ planned research and
development activities, including the expected timing, scope and conduct of a
Phase II clinical trial of CK-2127107 in SMA; the significance and utility of
preclinical and non-clinical study and clinical trial results; potential
milestone payments, royalties and other payments; the expected roles of
Cytokinetics and Astellas under the collaboration and in developing or
commercializing drug candidates or products subject to the collaboration; the
indications to be pursued under the collaboration; the potential size of markets
for CK-2127107; Cytokinetics’ continued development of tirasemtiv; and the
properties and potential benefits of Cytokinetics’ skeletal muscle activators,
including CK-2127107. Such statements are based on management’s current
expectations, but actual results may differ materially due to various risks and
uncertainties, including, but not limited to, further clinical development of
tirasemtiv in ALS patients will require significant additional funding, and
Cytokinetics may be unable to obtain such additional funding on acceptable
terms, if at all; potential difficulties or delays in the development, testing,
regulatory approvals for trial commencement, progression or product sale or
manufacturing, or production of Cytokinetics’ drug candidates that could slow or
prevent clinical development or product approval, including risks that current
and past results of clinical trials or preclinical studies may not be indicative
of future clinical trials results, patient enrollment for or conduct of clinical
trials may be difficult or delayed, Cytokinetics’ drug candidates may have
adverse side effects or inadequate therapeutic efficacy, the U.S. Food and Drug
Administration or foreign regulatory agencies may delay or limit Cytokinetics’
or its partners’ ability to conduct clinical trials, and Cytokinetics may be
unable to obtain or maintain patent or trade secret protection for its
intellectual property; Amgen’s and Astellas’ decisions with respect to the
design, initiation, conduct, timing and continuation of development activities
for omecamtiv mecarbil and CK-2127107, respectively; Cytokinetics may incur
unanticipated research and development and other costs or be unable to obtain
additional financing necessary to conduct development of its products;
Cytokinetics may be unable to enter into future collaboration agreements for its
drug candidates and programs on acceptable terms, if at all; standards of care
may change, rendering Cytokinetics’ drug candidates obsolete; competitive
products or alternative therapies may be developed by others for the treatment
of indications Cytokinetics’ drug candidates and potential drug candidates may
target; and risks and uncertainties relating to the timing and receipt of
payments from its partners, including milestones and royalties on future
potential product sales under Cytokinetics’ collaboration agreements with such
partners. For further information regarding these and other risks related to
Cytokinetics’ business, investors should consult Cytokinetics’ filings with the
Securities and Exchange Commission.

Forward-Looking Statements: Astellas

This press release includes forward-looking statements based on assumptions and
beliefs in light of the information currently available to management and
subject to significant risks and uncertainties. Forward-looking statements
include all statements other than statements of historical fact, including
plans, strategies and expectations for the future, statements regarding the
expected timing of filings and approvals relating to the transaction, the
expected timing of the completion of the transaction, the ability to complete
the transaction or to satisfy the various closing conditions, future revenues
and profitability from or growth or any assumptions underlying any of the
foregoing. Statements made in the future tense, and words such as “anticipate,”
“expect,” “project,” “continue,” “believe,” “plan,” “estimate,” “pro forma,”
“intend,” “potential,” “target,” “forecast,” “guidance,” “outlook,” “seek,”
“assume,” “will,” “may,” “should,” and similar expressions are intended to
qualify as forward-looking statements. Forward-looking statements are based on
estimates and assumptions made by management that are believed to be reasonable,
though they are inherently uncertain and difficult to predict. Investors and
security holders are cautioned not to place undue reliance on these
forward-looking statements.

Actual financial results may differ materially depending on a number of factors
including adverse economic conditions, currency exchange rate fluctuations,
adverse legislative and regulatory developments, delays in new product launch,
pricing and product initiatives of competitors, the inability of the company to
market existing and new products effectively,

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Cytokinetics’ and Astellas’ Announcement Regarding Expansion of Skeletal Muscle
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interruptions in production, infringements of the company’s intellectual
property rights and the adverse outcome of material litigation. This press
release contains information on pharmaceuticals (including compounds under
development), but this information is not intended to make any representations
or advertisements regarding the efficacy or effectiveness of these
pharmaceuticals nor provide medical advice of any kind.

Contact:

Cytokinetics, Inc.

Joanna L. Goldstein

Investors & Media

Tel: (650) 624-3000

Fax: (650) 624-3010

Astellas Pharma Inc.

Corporate Communications

Tel: +81-3-3244-3201

Fax: +81-3-5201-7473

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Exhibit K

Form of Certificate of Compliance

I, [                                ] of Astellas Pharma Inc., which is
conducting business with Cytokinetics, Inc. per our License and Collaboration
Agreement dated [                    ].

I hereby acknowledge and certify that I am familiar and knowledgeable about the
requirements of the FCPA and other applicable Anti-Corruption Laws and their
requirements.

I certify that Astellas has not, and will not, take any action in furtherance of
an unlawful offer, promise, or payment to a foreign official that would cause
Cytokinetics, Inc. to be in violation of the FCPA, any other applicable
Anti-Corruption Law. I further certify that Astellas has made no agreement or
commitment, directly or indirectly, which, if carried out in the future, would
cause Cytokinetics, Inc. to be in violation of the FCPA or any other applicable
Anti-Corruption Law.

“FCPA” shall mean the U.S. Foreign Corrupt Practices Act (15 U.S.C.
Section 78dd-1, et seq.) as amended.

“Anti-Corruption Laws” shall mean all applicable laws, regulations, orders,
judicial decisions, conventions and international financial institution rules
regarding corruption, bribery, ethical business conduct, money laundering,
political contributions, gifts and gratuities, or lawful expenses to public
officials and private persons, agency relationships, commissions, lobbying,
books and records, and financial controls.

 

Signature:

 

Printed Name:

 

Title:

 

Company:

Astellas Pharma Inc.

Dated:

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

K-i

--------------------------------------------------------------------------------

Form of Certificate of Compliance

I, [                                ] of Cytokinetics, Inc., which is conducting
business with Astellas Pharma Inc. per our License and Collaboration Agreement
dated [                    ].

I hereby acknowledge and certify that I am familiar and knowledgeable about the
requirements of the FCPA and other applicable Anti-Corruption Laws and their
requirements.

I certify that Cytokinetics has not, and will not, take any action in
furtherance of an unlawful offer, promise, or payment to a foreign official that
would cause Astellas Pharma Inc. to be in violation of the FCPA, any other
applicable Anti-Corruption Law. I further certify that Cytokinetics has made no
agreement or commitment, directly or indirectly, which, if carried out in the
future, would cause Astellas Pharma Inc. to be in violation of the FCPA or any
other applicable Anti-Corruption Law.

“FCPA” shall mean the U.S. Foreign Corrupt Practices Act (15 U.S.C.
Section 78dd-1, et seq.) as amended.

“Anti-Corruption Laws” shall mean all applicable laws, regulations, orders,
judicial decisions, conventions and international financial institution rules
regarding corruption, bribery, ethical business conduct, money laundering,
political contributions, gifts and gratuities, or lawful expenses to public
officials and private persons, agency relationships, commissions, lobbying,
books and records, and financial controls.

 

Signature:

 

Printed Name:

 

Title:

 

Company: Cytokinetics, Inc. Dated:

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

K-ii

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Exhibit L

[*] Indications

1. [*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

L-i

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Exhibit M

Certain Development Activities for SMA

[*]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

M-i