|
Exhibit 10.63
Collaboration and Option Agreement
between
Amgen Inc.
and
Cytokinetics, Incorporated
dated
December 29, 2006
Collaboration and Option Agreement
This Collaboration and Option
Agreement (this "Agreement" ) is entered into as of the 29th
day of December, 2006 (the "Effective Date" ) by and between
Cytokinetics, Incorporated, a Delaware corporation ( "CK" )
and Amgen Inc., a Delaware corporation ( "Amgen" ). CK and
Amgen are sometimes referred to herein, individually, as a "Party"
or, collectively, as "Parties."
WHEREAS, CK is a leading
biopharmaceutical company focused on the discovery, development and
commercialization of novel small molecule drugs that specifically
target the cytoskeleton;
WHEREAS, Amgen is a global
biotechnology company that conducts pharmaceutical research,
development, manufacturing and commercialization;
WHEREAS, CK has developed
proprietary technologies and intellectual property relating to the
Collaboration (as defined below);
WHEREAS, CK has conducted
research into, and has developed expertise in, the cell biology
related to cardiac muscle contractility;
WHEREAS, CK is developing
CK-452 (as defined below) for the potential treatment of heart
failure;
WHEREAS, CK intends to
conduct the Research Program (as defined below) to develop back-up
and follow-on molecules to CK-452, and to better characterize the
actin-myosin interaction in cardiac muscle;
WHEREAS, Amgen may wish to
perform similar research in coordination with CK and the Research
Plan;
WHEREAS, Amgen desires to
obtain a non-exclusive license in the Field in the Territory to
certain of CK’s intellectual property and proprietary rights
related to cardiac muscle contractility;
WHEREAS, Amgen desires to
obtain an exclusive right to obtain an exclusive license in the
Field in the Territory (as defined below) to research, develop,
manufacture and commercialize CK-452 and other Compounds (as
defined below); and
WHEREAS, contemporaneous
with the execution of this Agreement, the Parties are entering into
a stock purchase agreement whereby CK shall sell to Amgen equity
securities of CK.
-1-
NOW, THEREFORE, in
consideration of the mutual promises and covenants set forth
herein, and for other good and valuable consideration, the receipt
and sufficiency of which is hereby acknowledged, the Parties,
intending to be legally bound, agree as follows:
1. Definitions
|
1.1.
|
|
"Affiliate" shall mean any corporation
or other entity which directly or indirectly controls, is
controlled by or is under common control with a Party, for so long
as such control exists. For the purposes of this Section 1.1,
"control" shall mean: (i) in the case of any corporate entity,
direct or indirect ownership of fifty percent (50%) or more (or, if
less than fifty percent (50%), the maximum ownership interest
permitted by applicable Law) of the stock having the right to vote
for the election of directors thereof; or (ii) in the case of
any non-corporate entity, direct or indirect ownership of fifty
percent (50%) or more (or, if less than fifty percent (50%), the
maximum ownership interest permitted by applicable Law) of the
equity or income interest therein.
|
|
1.2.
|
|
"Amgen Joint Patent Rights" shall mean
Amgen’s (or its Affiliates’) interest in any and all
Patent Rights jointly owned by Amgen or its Affiliate, on the one
hand, and CK or its Affiliate, on the other, to the extent they
claim: (i) the composition, formulation, manufacture or use of
Research Eligible Compounds; or (ii) any method of treatment
involving modulation of the contractile elements of cardiac muscle
tissue to activate cardiac contractility; in each case, that arise
out of the performance of the Collaboration.
|
|
|
|
|
|
1.3.
|
|
"Alliance Manager" shall have the
meaning set forth in Section 2.1.
|
|
1.4.
|
|
"Amgen Patent Rights" shall mean any
and all Patent Rights Controlled by Amgen or its Affiliates on or
after the Effective Date to the extent they claim: (i) the
composition, formulation, manufacture or use of Research Eligible
Compounds; or (ii) any method of treatment involving
modulation of the contractile elements of cardiac muscle tissue to
activate cardiac contractility; in each case, that arise out of the
performance of the Collaboration.
|
|
1.5.
|
|
"Amgen Option" shall mean Amgen’s
exclusive option to obtain the license set forth in Section 9.1.2
on the terms and conditions set forth herein, as more fully
described in Article 10 below, and other rights as expressly
set forth herein.
|
|
1.6.
|
|
"Change of Control" shall mean, with
respect to a Party, the occurrence of any of the following events:
(i) any corporation or other person or entity is or becomes
the "beneficial owner" (as such term is used in sections 12(d) and
13(d) of the Securities Exchange Act of 1934, as amended, except
that a corporation or other entity shall be deemed to have
"beneficial ownership" of all shares that any such corporation or
other entity has the right to acquire, whether such right may be
exercised immediately or only after the passage of time), of a
majority of the total voting power represented by all classes of
capital stock then outstanding of such Party normally entitled to
vote in elections of directors of the Party; (ii) such Party
consolidates with or merges into another corporation or entity, or
any corporation or
|
-2-
|
|
|
|
|
|
|
entity consolidates with or merges into such
Party, other than: (A) a merger or consolidation which would
result in the voting securities of such Party outstanding
immediately prior to such merger or consolidation continuing to
represent (either by remaining outstanding or by being converted
into voting securities of the surviving entity or any parent
thereof) a majority of the combined voting power of the voting
securities of such Party or such surviving entity or any parent
thereof outstanding immediately after such merger or consolidation;
or (B) a merger or consolidation effected to implement a
recapitalization of such Party (or similar transaction) in which no
corporation or other person or entity becomes the beneficial owner,
directly or indirectly, of voting securities of such Party
representing a majority of the combined voting power of such
Party’s then outstanding securities; and (iii) such
Party conveys, transfers or leases all or substantially all of its
assets to any corporation or other entity other than a wholly-owned
subsidiary of such Party in one or more related
transactions.
|
|
|
|
|
|
1.7.
|
|
" [ *** ] Compound" shall
mean a Compound that is: (i) [ *** ] pursuant to the
[ *** ] , or is [ *** ] , for [
*** ] (e.g., [ *** ] or [ *** ]
) [ *** ] , [ *** ] or [ ***
] ; or (ii) [ *** ] at the relevant time,
subsequent to the Amgen Option Effective Date, [ ***
] Compound.
|
|
|
|
|
|
1.8.
|
|
"CK- [ *** ] "
shall mean the Compound designated by CK as CK- [ ***
] .
|
|
|
|
|
|
1.9.
|
|
"CK-452" shall mean the Compound
designated by CK as CK-1827452, and the subject of clinical
development by CK as of the Effective Date pursuant to IND number
[ *** ] .
|
|
|
|
|
|
1.10.
|
|
"CK Intellectual Property" shall mean
all intellectual property or proprietary rights Controlled by CK or
its Affiliates on or after the Effective Date and necessary or
useful in the conduct of the Collaboration, and CK’s (or its
Affiliates’) interest in any such intellectual property or
proprietary right jointly owned by Amgen or its Affiliate, on the
one hand, and CK or its Affiliate on the other. The CK Intellectual
Property includes the CK Patent Rights.
|
|
|
|
|
|
1.11.
|
|
"CK Joint Patent Rights" shall mean
CK’s (or its Affiliates’) interest in any Patent Rights
jointly owned by Amgen or its Affiliate, on the one hand, and CK or
its Affiliate on the other.
|
|
|
|
|
|
1.12.
|
|
" CK Market Segment " shall mean: (i)
[ *** ] , (ii) [ *** ] and (iii)
[ *** ] .
|
|
|
|
|
|
1.13.
|
|
"CK Patent Rights" shall mean:
(i) any and all Patent Rights Controlled by CK or its
Affiliates on or after the Effective Date in the Territory to the
extent they claim (x) the composition, formulation,
manufacture or use of a Compound; or (y) any method of
treatment involving modulation of the contractile elements of
cardiac muscle tissue to activate cardiac contractility, including,
without limitation, those set forth on Schedule 1.13; and
(ii) the CK Joint Patent Rights.
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-3-
|
1.14.
|
|
"Clinical Trial" shall mean a Phase I
Trial, Phase IIa Trial, Phase IIb Trial or Phase III Trial.
|
|
1.15.
|
|
"Co-Chair" shall mean a co-chairperson
of the applicable Committee appointed by one of the Parties
pursuant to Article 2.
|
|
1.16.
|
|
"Co-Invest Option" shall mean
CK’s option to increase its participation with respect to a
Compound, and to increase its potential royalties for that Compound
and to co-promote that Compound, as detailed more fully in
Article 11.
|
|
1.17.
|
|
"Collaboration" shall mean the
activities undertaken hereunder by the Parties, including the
research, development, manufacture and commercialization of
Compounds.
|
|
1.18.
|
|
"Collaboration Patent Rights" shall
mean the Joint Patent Rights, Amgen Patent Rights and CK Patent
Rights.
|
|
1.19.
|
|
"Commercialization Plan" shall mean the
plan adopted by the JCC in accordance with Section 2.13.3 for
commercialization of Compounds, including a budget for the work to
be provided therein.
|
|
1.20.
|
|
"Committee" shall mean one of the Joint
Steering Committee, Joint Commercialization Committee, Joint
Development Committee and Joint Research Committee.
|
|
1.21.
|
|
"Compound" shall mean any chemical or
molecular entity, however formulated, that [ *** ]
and that, as a [ *** ] of such Compound (as [
*** ] ), [ *** ] and shall include any
[ *** ] . Compound shall include, inter alia, CK-452
and CK- [ *** ] .
|
|
1.22.
|
|
"Compound Criteria" shall mean:
(i) those criteria set forth in Exhibit 1.22, and
(ii) such other or modified criteria as are approved by the
JRC and agreed in writing by the Parties. No criteria shall be
deemed Compound Criteria under (ii) unless such criteria are
formally approved by the JRC and agreed in writing by the Parties,
regardless of whether such criteria are used informally or
discussed by the Parties in the course of the Research
Program.
|
|
1.23.
|
|
"Control" with respect to any
intellectual property or proprietary right shall mean ownership or
the possession of the legal authority or right of a Party hereto
(or any of its Affiliates) to grant a license or sublicense of such
property or right to the other Party, or to otherwise disclose
proprietary or trade secret information to the other Party, without
breaching the terms of any agreement with a Third Party, or
misappropriating the intellectual property or proprietary right or
trade secret information of a Third Party.
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-4-
|
1.24.
|
|
" [ *** ] " shall
mean any of the following [ *** ] : (i) any
[ *** ] with respect to the [ *** ] of
any Compound in [ *** ] including a [ ***
] concerning whether or not to [ *** ] of any
Compound; (ii) the [ *** ] of [ ***
] of a Compound; (iii) [ *** ] for a Compound;
(iv) [ *** ] a Compound; or (v) [ *** ]
(which are expected to [ *** ] ).
|
|
1.25.
|
|
"Development Plan" shall mean the plan
adopted by the JDC in accordance with Section 2.12 for the
conduct of the Development Program, including, from and after the
Amgen Option Effective Date, a budget for the work to be provided
therein. The initial Development Plan (consisting of a detailed
[ *** ] development plan for CK-452 and summary plans
for [ *** ] for CK-452 for the [ *** ]
following the Effective Date is attached hereto as
Schedule 1.25).
|
|
1.26.
|
|
"Development Program" shall mean the
program of pharmaceutical development for the Compounds in the
Field in the Territory to be carried out pursuant to this Agreement
and, in particular, Article 4 hereof. The Development Program
shall, prior to the Amgen Option Effective Date, include the
activities set forth on Schedule 10.2.1 and shall include
activities reasonably intended to provide the data called for in
such schedule.
|
|
1.27.
|
|
"E.U. Marketing Approval" shall mean a
Marketing Approval sufficient for the promotion and sale of a
product in [ *** ] of the following: [ ***
] .
|
|
1.28.
|
|
" Extended Research Term " shall mean the
period commencing on the second anniversary of the Effective Date
until the earlier of (i) the expiration of the Amgen Option;
(ii) termination of this Agreement, or (iii) the Amgen
Option Effective Date.
|
|
1.29.
|
|
"FDA" shall mean the United States Food
and Drug Administration, or any successor entity thereto.
|
|
1.30.
|
|
"Field" shall mean any and all uses for
the treatment, diagnosis, prevention or prophylaxis of any disease
or condition in humans.
|
|
1.31.
|
|
"First Commercial Sale" shall mean the
first sale in the Territory to a Third Party of a Compound by or
under the authority of Amgen or its Affiliate after receipt of the
applicable Marketing Approval.
|
|
1.32.
|
|
"FTE" shall mean the equivalent of the
work of one employee full time for one year (consisting of at least
a total of 45.5 weeks or 1,820 hours per year (excluding
vacations and holidays) of work on or directly related to the
Collaboration). Overtime, weekends, holidays and the like shall not
be counted with any multiplier (e.g. time-and-a-half or double
time) toward the number of hours that are used to calculate the FTE
contribution. No one person shall be permitted to account for more
than one FTE in a given twelve month period.
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-5-
|
1.33.
|
|
" [ *** ]
Co-Invest" shall mean, with respect to a particular Compound,
for CK to exercise its Co-Invest Option [ *** ] for
such Compound.
|
|
1.34.
|
|
"GAAP" shall mean then-current
generally accepted accounting principles in the United States as
established by the Financial Accounting Standards Board or any
successor entity or other entity generally recognized as having the
right to establish such principles, in each case consistently
applied.
|
|
1.35.
|
|
" Global Registration Dossier " shall
mean, with respect to a particular Compound being developed under
the Collaboration, the collective data package from clinical and
other studies specifically applicable to obtaining, maintaining and
expanding regulatory approvals for such Compound throughout the
United States and European Union, excluding country-specific
requirements.
|
|
1.36.
|
|
"GLP Toxicology Studies" shall mean,
with respect to a Compound, the animal toxicology studies conducted
in accordance with cGLP that are a necessary prerequisite for and
intended to support the filing of an IND for such Compound in the
United States.
|
|
1.37.
|
|
"IND" shall mean, with respect to the
United States, an investigational new drug application filed with
the FDA as more fully defined in 21 C.F.R. §312.3 or, with
respect to a jurisdiction other than the United States, an
equivalent filing with the applicable Regulatory Authority for
purposes of obtaining permission to Initiate human clinical testing
in such jurisdiction.
|
|
1.38.
|
|
"Initial Research Plan" shall mean the
plan attached as Exhibit 1.38 hereto.
|
|
1.39.
|
|
"Initial Research Term" shall mean the
period from the Effective Date until the sooner to occur of:
(i) the two (2) year anniversary thereof; and
(ii) the Amgen Option Effective Date.
|
|
1.40.
|
|
"Initiation" of a clinical trial or
to "Initiate" a clinical trial shall mean the first dosing of a
human subject in such trial.
|
|
1.41.
|
|
"Joint Commercialization Committee" or
"JCC" shall mean the committee formed by the Parties
pursuant to Section 2.13 to oversee the commercialization
activities to be conducted with respect to Compounds in the Field
in the Territory hereunder.
|
|
1.42.
|
|
"Joint Development Committee" or "JDC"
shall mean the committee formed by the Parties pursuant to
Section 2.12 to oversee the Development Program in the Field
in the Territory hereunder.
|
|
1.43.
|
|
"Joint Patent Rights" shall mean the
Amgen Joint Patent Rights and the CK Joint Patent Rights.
|
|
1.44.
|
|
"Joint Research Committee" or "JRC"
shall mean the committee formed by the Parties pursuant to
Section 2.11 to oversee the Research Program to be conducted
in the Field in the Territory hereunder.
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-6-
|
1.45.
|
|
"Law" shall mean, individually and
collectively, any and all laws, ordinances, rules, directives and
regulations of any kind whatsoever of any governmental or
Regulatory Authority within the applicable jurisdiction.
|
|
|
|
|
|
1.46.
|
|
[Intentionally omitted.]
|
|
1.47.
|
|
"Marketing Approval" shall mean with
respect to any Compound in any regulatory jurisdiction in the
Territory, approval from the applicable Regulatory Authority
sufficient for the promotion and sale of the Compound in such
jurisdiction in accordance with applicable Laws.
|
|
1.48.
|
|
"Net Sales" shall mean with respect to
a given period, the [ *** ] during such period, less
[ *** ] :
|
|
1.48.1.
|
|
[ *** ] ;
|
|
|
|
|
|
1.48.2.
|
|
[ *** ] ;
|
|
|
|
|
|
1.48.3.
|
|
[ *** ] ;
|
|
|
|
|
|
1.48.4.
|
|
[ *** ] ;
|
|
|
|
|
|
1.48.5.
|
|
[ *** ] ;
|
|
|
|
|
|
1.48.6.
|
|
[ *** ] ; and
|
|
|
|
|
|
1.48.7.
|
|
[ *** ] ;
|
in each case, as applicable to sales of such
Compound: (i) [ *** ] the Territory; or (ii) [
*** ] (a) [ *** ] of this Agreement, or (b)
[ *** ] the Territory.
|
1.49.
|
|
" [ *** ]
Compound" shall mean any Compound that is: (i) [ ***
] pursuant to the [ *** ] , or is [ ***
] , for [ *** ] , [ *** ] or
[ *** ] ; or (ii) [ *** ] at the
relevant time, subsequent to the Amgen Option Effective Date, to be
[ *** ] other than [ *** ] (e.g.,
[ *** ] or [ *** ] ) [ ***
] , [ *** ] or [ *** ] and which
is being so [ *** ]. Every Compound shall be a
[ *** ] Compound [ *** ] .
|
|
1.50.
|
|
"Patent Right" shall mean any of the
following, whether existing now or in the future anywhere in the
Territory: (i) any issued patent, including without limitation
inventor’s certificates, utility model, substitutions,
extensions, confirmations, reissues, re-examination, renewal or any
like governmental grant for protection of inventions; and (ii) any
pending application for any of the foregoing, including
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-7-
without limitation any continuation, divisional, substitution,
additions, continuations-in-part, provisional and converted
provisional applications.
|
1.51.
|
|
"Phase I Trial," "Phase IIa Trial," "Phase IIb
Trial" and "Phase III Trial" shall have the following
meanings:
|
|
|
|
|
|
1.51.1.
|
|
"Phase I Trial" shall mean, with
respect to the United States, any human clinical trial, the
principal purpose of which is preliminary determination of safety
in healthy individuals or patients as described under 21 C.F.R.
§312.21(a), or, with respect to a jurisdiction other than the
United States, a similar clinical study.
|
|
|
|
|
|
1.51.2.
|
|
"Phase IIa Trial" shall mean, with
respect to the United States, any human clinical trial conducted in
patients with the disease or condition of interest for the purpose
of studying the pharmacokinetic or pharmacodynamic properties and
preliminary assessment of safety of the drug being studied over a
measured dose response range as described under 21 C.F.R.
§312.21(b), or, with respect to a jurisdiction other than the
United States, a similar clinical study.
|
|
|
|
|
|
1.51.3.
|
|
"Phase IIb Trial" shall mean, with
respect to the United States, any human clinical trial conducted in
the specific patient population with the disease or condition of
interest intended to be studied in Phase III for the purposes of
preliminary assessment of safety and efficacy, and selection of the
dose regimen(s) to be studied in a Phase III Trial, as described
under 21 C.F.R. §312.21(b), and that if the defined end-points
are met, is sufficient to allow the Initiation of a Phase III
Trial, or, with respect to a jurisdiction other than the United
States, a similar clinical study.
|
|
|
|
|
|
1.51.4.
|
|
"Phase III Trial" shall mean, with
respect to the United States, any human clinical trial, that, if
the defined end-points are met, is intended to be a pivotal trial
for obtaining Marketing Approval or to otherwise establish safety
and efficacy in patients with the indication being studied for
purposes of filing for Marketing Approval with the FDA as described
under 21 C.F.R. §312.21(c), or, with respect to a jurisdiction
other than the United States, a similar clinical study.
|
|
|
|
|
|
1.52.
|
|
"Plan" shall mean the Research Plan,
Development Plan, or Commercialization Plan.
|
|
|
|
|
|
1.53.
|
|
"Program" shall mean the program to
research, develop, manufacture and commercialize Compounds as set
forth herein and in the Plans.
|
|
|
|
|
|
1.54.
|
|
" [ *** ] " shall
mean that certain technology Controlled by CK or its Affiliates and
known internally at CK as " [ *** ] ", consisting of
a [ *** ] of [ *** ] technologies to
interrogate the potential of [ *** ] to yield
[ *** ] that [ *** ] .
|
|
|
|
|
|
1.55.
|
|
" [ *** ] " shall
mean, with respect to a Party, the [ *** ] by or on
behalf of such Party of [ *** ] of [ ***
] , [ *** ] and [ *** ] to
discover, research, develop, manufacture and commercialize (as
applicable) a Compound [ *** ] in pursuing the
discovery, research, development, manufacture and commercialization
of
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-8-
[ *** ] of [ *** ] of [ *** ]
and [ *** ] , but in no event less than [ ***
] and [ *** ] to [ *** ] of
[ *** ] of [*** ] and [ *** ] .
For clarity, it is understood that [ *** ] shall be
evaluated as to the [ *** ] as a [ ***
] based on [ *** ] and may change over time,
but shall not take into account: (i) any [ *** ]
; (ii) the [ *** ] such Party to the other Party
pursuant to this Agreement; or (iii) such Party’s
[ *** ] hereunder in accordance with the [ ***
] .
|
1.56.
|
|
"Regulatory Authority" shall mean any
federal, national, multinational, state, provincial or local
regulatory agency, department, bureau or other governmental entity
with authority over the research, development, manufacture,
commercialization or other use (including the granting of Marketing
Approvals) of any Compound in any jurisdiction, including the FDA
and European Medicines Evaluation Agency.
|
|
1.57.
|
|
"Research Eligible Compounds" shall
mean Compounds: (i) determined by the JRC to [ ***
] ; and (ii) if such Compound is [ *** ]
by [*** ] for [ *** ] in the Collaboration,
that [ *** ] for research hereunder.
|
|
1.58.
|
|
"Research Plan" shall mean the research
plan established in accordance with Section 2.11 for the
conduct of the Research Program, which shall include, from and
after the Amgen Option Effective Date, a budget for the work to be
provided therein. The Initial Research Plan shall consist of the
plan established by [ *** ] (as of the Effective
Date) for [ *** ] to the research of Compounds (and
[ *** ] Third Parties), and is attached as
Exhibit 1.58 hereto.
|
|
1.59.
|
|
"Research Program" shall mean the
program of research to be carried out pursuant to this Agreement
and, in particular, Article 3 hereof.
|
|
1.60.
|
|
"Royalty Term" shall mean, with respect
to a Compound, on a country-by-country basis, that period from the
First Commercial Sale of such Compound following Marketing Approval
in such country until the [ *** ] : (i) the
[ *** ] ; and (ii) such time as the [ ***
] .
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-9-
|
1.61.
|
|
" [ *** ] " shall
mean [ *** ] of the activities and [ ***
] , each as described in [ *** ] .
|
|
1.62.
|
|
"Share Purchase Agreement" shall mean
that certain Common Stock Purchase Agreement entered into by the
Parties of even date herewith, whereby CK shall sell, and Amgen
shall purchase, common stock of CK.
|
|
|
|
|
|
1.63.
|
|
"Territory" shall mean the world, with
the exception of Japan.
|
|
1.64.
|
|
"Third Party" shall mean any person or
entity other than one of the Parties, or an Affiliate of a
Party.
|
|
1.65.
|
|
"United States" or "U.S." shall mean
the United States of America, its possessions, protectorates,
territories and Puerto Rico.
|
|
1.66.
|
|
"Valid Claim" shall mean a claim of an
issued and unexpired patent or patent application included in the
Collaboration Patent Rights, which claim has not been revoked or
held invalid or unenforceable by a court or other government agency
of competent jurisdiction and has not been held or admitted to be
invalid or unenforceable through re-examination or disclaimer,
reissue, opposition procedure, nullity suit or otherwise. [
*** ] if a [***] within the CK Patent Rights, CK Joint
Patent Rights, Amgen Patent Rights or Amgen Joint Patent Rights
[ *** ] from which such [ *** ] of this
Agreement [ *** ] (from and after which [ ***
] subject to the [ *** ] ). With respect to a
[ *** ] , the phrase to "infringe a Valid Claim"
shall mean to engage in activity that would infringe such claim if
it were contained in an issued patent.
|
|
1.67.
|
|
Additional Definitions . Each of the
following capitalized terms shall have the meanings set forth in
the corresponding Sections of this Agreement indicated in the table
below:
|
|
|
|
|
|
Definition
|
|
Section
|
|
" Acquired Party "
|
|
18.7
|
|
" Acquiror "
|
|
18.7
|
|
"Agreement"
|
|
Preamble
|
|
"Alliance Manager"
|
|
2.1
|
|
" Amgen "
|
|
Preamble
|
|
"Amgen Controlled Territories"
|
|
9.4
|
|
" [ *** ]
"
|
|
10.2.1.
|
|
"Amgen Indemnitees"
|
|
17.1
|
|
"Amgen Option Effective Date"
|
|
19.1.1
|
|
" [ *** ]
"
|
|
8.8
|
|
"Breach Notice"
|
|
18.5
|
|
"Bundle"
|
|
13.4.3.2
|
|
"CK Indemnitees"
|
|
17.1
|
|
"CK Option Notice Date"
|
|
11.1
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-10-
|
|
|
|
|
Definition
|
|
Section
|
|
" CK Product Opportunity "
|
|
4.6.1.3
|
|
" CK "
|
|
Preamble
|
|
"Claims"
|
|
17.1
|
|
"Commercial Operating Team"
|
|
5.2
|
|
" [ *** ]
"
|
|
2.9
|
|
"Confidential Information"
|
|
14.1
|
|
" [ *** ]
"
|
|
10.2.1
|
|
"CREATE Act"
|
|
8.7
|
|
"Defending Party"
|
|
8.8
|
|
"Development Plan"
|
|
4.1
|
|
"Development Project Team"
|
|
4.2
|
|
" [ *** ]
"
|
|
2.9
|
|
"DOJ"
|
|
19.1.5.1
|
|
" [ *** ] Milestones
"
|
|
13.3.2
|
|
"Effective Date"
|
|
Preamble
|
|
"Federal Court"
|
|
21.11
|
|
"FTC"
|
|
19.1.5.2
|
|
"Governmental Authority"
|
|
19.1.5.3
|
|
" Guiding Principles "
|
|
2.3
|
|
"HSR Act"
|
|
19.1.5.4
|
|
"HSR Clearance Date"
|
|
19.1.5.5
|
|
"Indemnified Party"
|
|
17.2
|
|
"Indemnifying Party"
|
|
17.2
|
|
" [ *** ]
Compound"
|
|
9.2.3
|
|
" [ *** ]
"
|
|
13.7
|
|
"Joint Steering Committee" or
"JSC"
|
|
2.10.1
|
|
" [ *** ]
"
|
|
8.8
|
|
"Losses"
|
|
17.1
|
|
"Maintenance Period"
|
|
10.5
|
|
"New Affiliates"
|
|
2.9
|
|
"No Adequate Remedies"
|
|
18.5
|
|
"Notifying Party"
|
|
2.9
|
|
"Party" or "Parties"
|
|
Preamble
|
|
"Patent Subcommittee"
|
|
8.2
|
|
" Paying Party "
|
|
13.15.2
|
|
"Prior Agreement"
|
|
14.3
|
|
" Publishing Party "
|
|
14.4
|
|
" [ *** ]
Notice"
|
|
10.2.4
|
|
"Recoveries"
|
|
8.11
|
|
"Research Term"
|
|
3.3
|
|
" Reviewing Party "
|
|
14.4
|
|
" Security Agreement"
|
|
20
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-11-
|
|
|
|
|
Definition
|
|
Section
|
|
"SPCs"
|
|
8.14
|
|
"State Court"
|
|
21.11
|
|
"Subcommittee"
|
|
2.14
|
|
"Subject Transaction"
|
|
2.9
|
|
"Taxes"
|
|
13.15.1
|
|
" Term "
|
|
18.1
|
|
"VAT"
|
|
13.15.1
|
|
"Wind-Down Period"
|
|
18.3.2
|
2. Governance and Oversight
|
2.1.
|
|
Alliance Manager . Each Party will
appoint one senior representative who possesses a general
understanding of clinical, regulatory, manufacturing and marketing
issues to act as its respective alliance manager under the
Collaboration (each, an "Alliance Manager" ). Promptly
following the Effective Date, each Party will notify the other
Party of the name and contact information of its initial Alliance
Manager. Either Party may replace its Alliance Manager at any time
upon written notice to the other Party. Either Alliance Manager may
designate a substitute to temporarily perform the functions of that
Alliance Manager. Each Alliance Manager shall be charged with
creating and maintaining a collaborative work environment within
and among the Committees. Each Alliance Manager will also be
responsible for: (i) coordinating the relevant functional
representatives of the Parties, in developing and executing Plans;
and (ii) providing a single point of communication for seeking
consensus both internally within the respective Party’s
organizations and together regarding key elements of each Plan. The
Alliance Managers shall be entitled to attend meetings of any
Committee, but shall not have, or be deemed to have, any rights or
responsibilities of a member of any Committee. Each Alliance
Manager may bring any matter to the attention of any Committee
where such Alliance Manager reasonably believes that such matter
requires such attention.
|
|
2.2.
|
|
Plans . The timing to establish all
Plans (and associated budgets) shall be consistent with the
internal requirements for each Party’s planning and budgeting
cycles and shall be finalized no later than [ *** ]
of each year (subject to change based on changes to the
Party’s planning periods). Each Plan shall be updated at
least annually and provide for [***] ([***]) [***] of detailed
activities with [***] ([***]) [***] of general guidance; provided
that the existing Plan shall continue to govern until updated by
the applicable Committee.
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-12-
|
2.3.
|
|
Guiding Principles . Each Party shall
make its decisions and conduct its obligations under the
Collaboration in a manner in its good faith determination to be
consistent with and in accordance with the "Guiding Principles" set
forth in Exhibit 2.3 (the " Guiding Principles "),
consistent with its obligations pursuant to
Section 2.4.
|
|
2.4.
|
|
Conduct of the Collaboration . Subject
to the terms and conditions of this Agreement: (i) prior to
the Amgen Option Effective Date, [ *** ] to conduct
the Research Program and the Development Program; and
(ii) subsequent to the Amgen Option Effective Date, [
*** ] to research, develop, manufacture and commercialize
Compounds in the Territory in the Field in accordance with this
Agreement (subject to Section [ *** ] hereof). Amgen
shall have no obligation pursuant to this Section unless and until
the occurrence of the Amgen Option Effective Date.
|
|
2.5.
|
|
Activities in Competition with the
Collaboration . Except as otherwise provided in
Section 2.9, and Section 18.8.4, other than through the
Collaboration in accordance with the Plans, neither Party nor its
Affiliates shall research, develop, manufacture or commercialize
Compounds, itself or through a Third Party, in the Territory during
the term of this Agreement, except as the Parties otherwise
expressly agree in writing.
|
|
2.6.
|
|
[ *** ] Activities .
Notwithstanding Section 2.5, [ *** ] shall have
the right to [ *** ] the Territory and to [
*** ] Compounds (or [ *** ] Compounds), in
each case solely for the purpose of supporting the [ ***
] the Territory, subject to [ *** ] , as to:
(i) the [ *** ] and; (ii) the [ ***
] Compounds ( [ *** ] ).
|
|
2.7.
|
|
Other . There shall be no restriction
under this Agreement on either Party’s research, development
or commercialization activities, except as expressly set forth
herein. Accordingly, subject to the confidentiality obligations set
forth in Article 14, nothing herein shall prevent either Party
from using generally applicable information or technology generated
in the performance of the Collaboration for internal research as
follows: (i) for general technology development purposes,
including the discovery, research and development of assay,
informatics or other technologies, in each case with general
applicability, (ii) to inform structure activity relationships
(SAR) for chemical or molecular entities in other programs,
[ *** ] to limit the possibility of chemistry overlap
with Compounds in the Collaboration or otherwise, or (iii) to
generate specificity data, including negative controls and
information with respect thereto, in each case of (i) –
(iii) outside the Collaboration.
|
|
2.8.
|
|
Acknowledgement . Each of the Parties
acknowledges that the other Party has ongoing research, development
and/or commercialization activities and, except as expressly set
forth herein, such activities are outside the scope of this
Agreement and the Collaboration and such activities are not
prohibited by Section 2.5.
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-13-
| |
|
2.9.
|
|
Post-Effective Date Affiliates . In the
event that either Party enters into any transaction (a "Subject
Transaction" ) after the Effective Date with a Third Party
whereby a Third Party becomes an Affiliate of such Party and such
Third Party is [ *** ] (a " [ ***
] " ), then such Party (the "Notifying Party"
) shall provide notice to the other Party, within [ ***
] ( [ *** ] ) [ *** ] of the
closing of the Subject Transaction, specifying the identity of the
Affiliate and describing in reasonable detail, to the extent
permitted by Law and without disclosing any proprietary
information, [ *** ] and [ *** ] . Any
Third Party that so becomes an Affiliate of the Notifying Party by
reason of the Subject Transaction are referred to below,
collectively, as the "New Affiliates" . Such notice shall
include a notification as to whether the Notifying Party intends
to: (i) [ *** ] , in which case, where CK is the
Notifying Party [ *** ] or, in the case where Amgen
is the Notifying Party, the [ *** ] hereunder, and in
each case any [ *** ] (to the extent [ ***
] hereunder; (ii) [ *** ] , in which case the
Notifying Party shall [ *** ] (including [ ***
] (and vice-versa), and [ *** ] and
vice-versa) and use [ *** ] to [ *** ]
. In the foregoing case, the Notifying Party and its Affiliates
shall [ *** ] to [ *** ] either
Party’s efforts under the Collaboration [ *** ]
; (iii) [ *** ] , in which case the Notifying Party
shall [ *** ] within [ *** ] ( [
*** ] ) [ *** ] of the closing of the Subject
Transaction, during which period the Notifying Party shall [
*** ] (including [ *** ] (and vice-versa), and
[ *** ] and vice-versa); in the foregoing case, the
Notifying Party and its Affiliates shall [ *** ] to
[ *** ] either Party’s efforts under the
Collaboration [ *** ] . Notwithstanding the
foregoing, (x) where such Subject Transaction is undertaken by
Amgen, Amgen may [ *** ] , effective [ ***
] ( [ *** ] ) [ *** ] after
provision of such notice; or (y) where such Subject
Transaction is undertaken by CK, CK may [ *** ] ,
effective [ *** ] ( [ *** ] ) [
*** ] after provision of such notice. In the event such
Party selects option (ii) and, despite the Notifying
Party’s [ *** ] , [ *** ] to
[ *** ] such [ *** ] within [
*** ] of
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-14-
|
|
|
the closing of the Subject Transaction, then such
Party shall be deemed to have [ *** ] , effective as
of such [ *** ] . In the case of [ ***
] , Section [ *** ] shall not apply to the
[ *** ] by the New Affiliate and the [ ***
] , provided, however that the Party that entered into the
Subject Transaction shall not utilize [ *** ] to
benefit the [ *** ] . For purposes of this
Section 2.9, " [ *** ] " shall
mean, with respect to any [ *** ] the [ ***
] ( [ *** ] ) or [ *** ] of
[ *** ] or a [ *** ] (in which case the
above provisions shall apply to the [ *** ] ) of the
[ *** ] , including [ *** ] thereto, to
[ *** ] , without the [ *** ] (other
than [ *** ] ) [ *** ] by the Notifying
Party in such [ *** ] .
|
|
2.10.
|
|
Joint Steering Committee .
|
|
|
|
|
|
2.10.1.
|
|
Membership . The Collaboration shall be
overseen by a joint steering committee (the "Joint Steering
Committee" or "JSC" ) consisting of the [ *** ] or
the [ *** ] of Amgen and the [ *** ] of
Cytokinetics. The initial members are set forth on
Schedule 2.10.1.
|
|
2.10.2.
|
|
Decision Making . The JSC shall decide
issues by [ *** ] , provided, that, after the Amgen
Option Effective Date, in the event [ *** ] .
|
|
2.10.3.
|
|
Responsibilities . The JSC shall be
responsible for: (i) [ *** ] to the Collaboration;
(ii) providing a [ *** ] ; (iii) [ ***
] of the Compounds in accordance with the [ ***
] ; (iv) [ *** ] , and (v) undertaking
and/or approving such other matters as are specifically provided
for the JSC under this Agreement.
|
|
2.10.4.
|
|
Meetings . The JSC shall meet annually,
or more frequently as the members thereof may agree, in person or
via telephone or videoconference, to discuss the progress of the
Collaboration as a whole, and any issue with respect to the
Collaboration as desired by either member thereof. Other than the
members thereof, no personnel of any Party and no Third Party shall
be entitled to attend such meetings without the JSC’s
consent.
|
|
|
|
|
|
2.11.
|
|
Joint Research Committee .
|
|
2.11.1.
|
|
Membership . The JRC shall be
established as soon as practical subsequent to the Effective Date
and shall be comprised of three (3) members appointed by CK
and three (3) members appointed by Amgen, or such other equal
number of members appointed by each of the Parties as the Parties
may agree. All members appointed by each of the Parties shall be
[ *** ] . The initial appointees for the
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-15-
|
|
|
JRC are set forth on Schedule 2.11.1. In
addition, each Party’s Co-Chair shall be a [ ***
] . Each Party shall appoint one of the members appointed by
it as a Co-Chair. At least one member appointed by each Party shall
have the breadth of responsibilities necessary to assert
decision-making authority and oversight such that the JRC may make
the appropriate decisions within the scope of its
responsibility.
|
|
|
|
|
|
2.11.2.
|
|
Decision Making . Decisions of the JRC
shall be made by [ *** ] of the members present in
person or by other means (e.g., teleconference) at any meeting,
with [ *** ] and the Parties shall endeavor in good
faith to [ *** ] with respect to matters
appropriately before the JRC. In order to make any decision the JRC
must have present (in person or telephonically) at least one
representative of each Party.
|
|
|
|
|
|
2.11.3.
|
|
Initial Meeting . Promptly after
January 1, 2007, the JRC shall meet to discuss and review the
Initial Research Plan and determine appropriate modifications
thereto including the [ *** ] hereunder consistent
with the objectives for research hereunder set forth in the Initial
Research Plan. The JRC shall endeavor to [ *** ] and
[ *** ] . For clarity, unless the Parties otherwise
agree, all such activities performed by a Party shall be at such
Party’s expense. As of the Effective Date, the Parties
anticipate that the JRC will [ *** ] . In the event
that the Research Plan [ *** ] , the [ ***
] of the Research Plan may be [ *** ]
.
|
|
|
|
|
|
2.11.4.
|
|
Responsibilities . The JRC shall be
responsible for: (i) deciding and establishing the objectives
and direction for the Research Program; (ii) modifying and
updating the Research Plan, and adopting an annual detailed
Research Plan for the upcoming year, including for the Extended
Research Term and including [ *** ] ;
(iii) reviewing, discussing and updating the [ ***
] ; (iv) reviewing and monitoring the [ ***
] ; (v) communicating with the [ *** ] of
Compounds; (vi) providing such information as requested by
[ *** ] activities with respect thereto; (vii)
[ *** ] ; (viii) undertaking and/or approving
such other matters as are specifically provided for the JRC under
this Agreement; (ix) otherwise providing a forum for the
exchange of scientific information among the scientists
participating in the Research Program; and (x) communicating
to the Parties regarding all of the foregoing.
|
|
|
|
|
|
2.11.5.
|
|
Meetings . The JRC shall meet quarterly
during each year in person or as otherwise agreed by the Parties.
Any in-person meetings shall be held on an alternating basis
between CK’s and Amgen’s facilities, unless otherwise
agreed by the Parties. Each Party shall be responsible for its own
expenses relating to such meetings. As
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-16-
|
|
|
appropriate, other employee representatives of
the Parties may attend JRC meetings as nonvoting observers, but no
Third Party personnel may attend unless otherwise agreed by the
Parties. Each Party may also call for special meetings as
reasonably required to resolve particular matters requested by such
Party by [ *** ] ( [ *** ] ) [
*** ] notice to the Co-Chair appointed by the other Party.
At its meetings, the JRC shall discuss the progress of the Parties
in executing the Research Program and any other matters pertaining
to the Research Program.
|
|
|
|
|
|
2.11.6.
|
|
Reporting . Each Party shall keep the
JRC fully and promptly informed of progress and results of research
activities for which it is responsible or which it is permitted to
conduct under the Collaboration through its members on the JRC and
as otherwise provided herein. Each Party shall fully inform the JRC
of all relevant facts and activities with respect to any research
matter reasonably requested by any member thereof. At least
[ *** ] ( [ *** ] ) [ ***
] prior to each regularly scheduled JRC meeting, each Party
shall deliver to the JRC a written summary of research activities
conducted hereunder by each such Party since the last such
report.
|
|
|
|
|
|
2.12.
|
|
Joint Development Committee .
|
|
|
|
|
|
2.12.1.
|
|
Membership . The JDC shall be
established as soon as practical subsequent to the Effective Date
and shall be comprised of three (3) members appointed by CK
and three (3) members appointed by Amgen, or such other equal
number of members appointed by each of the Parties as the Parties
may agree. All members appointed by each of the Parties shall be
[ *** ] . The initial appointees for the JDC are set
forth on Schedule 2.12.1. In addition, each Party’s
Co-Chair shall be a [ *** ] . Each Party shall
appoint one of the members appointed by it as a Co-Chair. At least
one member appointed by each Party shall have the breadth of
responsibilities necessary to assert decision-making authority and
oversight such that the JDC may make the appropriate decisions
within the scope of its responsibility.
|
|
|
|
|
|
2.12.2.
|
|
Decision Making . Prior to the Amgen
Option Effective Date, the JDC shall constitute a consultative,
information sharing and advisory body and shall not have
decision-making authority. During this time, [ *** ]
with respect to the Development Program and Development Plan.
Subsequent to the Amgen Option Effective Date, the JDC shall be a
decision-making body with respect to the Development Program.
Decisions of the JDC shall be made by [ *** ] of the
members present in person or by other means (e.g., teleconference)
at any meeting, with [ *** ] , and the Parties shall
endeavor in good faith to [ *** ] with respect to
matters appropriately before the JDC. In order to make any decision
the JDC must have present (in person or telephonically) at least
one representative of each Party. [ *** ] .
Notwithstanding anything to the contrary, [ *** ]
shall not have the
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-17-
|
|
|
right to [ *** ] except as
expressly agreed by [ *** ] in writing.
|
|
|
|
|
|
2.12.3.
|
|
Responsibilities .
|
|
|
2.12.3.1.
|
|
Pre-Exercise. Prior to the Amgen Option Effective
Date, the JDC shall be responsible for: (i) providing a
[ *** ] of such development; (ii) ensuring the
[ *** ] relating to the development activities being
conducted hereunder; (iii) reviewing [ *** ] ; and
(iv) providing a [ *** ] relating to development
of Compounds generally.
|
|
|
|
|
|
|
|
2.12.3.2.
|
|
Post-Exercise. Subsequent to the Amgen Option
Effective Date, in addition to the responsibilities set forth in
Section 2.12.3.1, the JDC shall be responsible for:
(i) amending or modifying the Development Plan, and adopting
an annual detailed Development Plan for the upcoming year;
(ii) reviewing and monitoring [ *** ] ;
(iii) communicating with the [ *** ] ;
(iv) establishing the [ *** ] as necessary for
the [ *** ] ; (v) [ *** ] hereunder;
(vi) [***]; (vii), monitoring and reporting [ *** ] ;
(viii) [ *** ] relating to the Development Program;
(ix) undertaking and/or approving such other matters as are
specifically provided for the JDC under this Agreement, including
those set forth in Schedule 2.12.3.2; and
(x) communicating to the Parties regarding all of the
foregoing.
|
|
2.12.4.
|
|
Meetings . The JDC shall meet quarterly
during each year in person or telephonically, or as otherwise
agreed by the Parties. Any in-person meetings shall be held on an
alternating basis between CK’s and Amgen’s facilities,
unless otherwise agreed by the Parties. Each Party shall be
responsible for its own expenses relating to such meetings. As
appropriate, other employee representatives of the Parties may
attend JDC meetings as nonvoting observers, but no Third Party
personnel may attend unless otherwise agreed by the Parties. Each
Party may also call for special meetings as reasonably required to
resolve particular matters requested by such Party by [ ***
] ( [ *** ] ) [ *** ] notice to
the Co-Chair appointed by the other Party. At its meetings, the JDC
shall discuss the
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-18-
|
|
|
progress of the Parties in executing the
Development Program and the status of and potential for Amgen
exercising the Amgen Option.
|
|
|
|
|
|
2.12.5.
|
|
Reporting . Each Party shall keep the
JDC fully and promptly informed of progress and results of
development activities for which it is responsible or permitted to
conduct hereunder through its members on the JDC and as otherwise
provided herein, including by promptly providing copies of all
clinical data and results (in no event later than [ ***
] ( [ *** ] ) [ *** ] after such
information becomes available to the relevant Party). Each Party
shall fully inform the JDC with respect to all relevant facts and
activities with respect to any development matter reasonably
requested by any member thereof. At least [ *** ] (
[ *** ] ) [ *** ] prior to each JDC
meeting, each Party shall deliver to the JDC a written summary of
development activities conducted hereunder by each such Party since
the last such report.
|
|
|
|
|
|
2.13.
|
|
Joint Commercialization Committee
.
|
|
|
|
|
|
2.13.1.
|
|
Membership . The JCC shall be formed
within [ *** ] ( [ *** ] ) [ ***
] after the [ *** ] . The JCC shall be
comprised of three (3) members appointed by CK and three
(3) members appointed by Amgen, or such other equal number of
members appointed by each of the Parties as the Parties may agree.
All members appointed by each of the Parties shall be [ ***
] . In addition, each Party’s Co-Chair shall be a
[ *** ] . Each Party shall appoint one of the members
appointed by it as a Co-Chair. At least one member appointed by
each Party shall have the breadth of responsibilities necessary to
assert decision-making authority and oversight such that the JCC
may make the appropriate decisions within the scope of its
responsibility.
|
|
|
|
|
|
2.13.2.
|
|
Decision Making . Decisions of the JCC
shall be made by [ *** ] of the members present in
person or by other means (e.g., teleconference) at any meeting,
with [ *** ] , and the Parties shall endeavor in good
faith to [ *** ] with respect to matters
appropriately before the JCC. In order to make any decision the JCC
must have present (in person or telephonically) at least one
representative of each Party. [ *** ] . [ ***
] shall not have the right to [ *** ] except
as expressly set forth in Article 5 and as otherwise agreed by
[ *** ] in writing.
|
|
|
|
|
|
2.13.3.
|
|
Responsibilities . The JCC shall be
responsible for: (i) adopting an initial Commercialization
Plan for each Compound at such time as determined by the JCC,
amending or modifying the Commercialization Plan, and adopting an
annual detailed Commercialization Plan for the upcoming year, in
each case consistent with the description set forth on Schedule
2.13.3A; (ii) reviewing, coordinating and ensuring [
*** ] ; (iii) communicating with the [ ***
] ; (iv) [ *** ] (v) reviewing and
monitoring the [ *** ] ; (vi) monitoring and
reporting [ *** ] ;
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-19-
|
|
|
(vii) developing the [ *** ] of
Compounds; (viii) [ *** ] ; (ix) undertaking
and/or approving such other matters as are specifically provided
for the JCC under this Agreement, including those set forth on
Schedule 2.13.3B; and (x) communicating to the Parties
regarding all of the foregoing. When determining the foregoing, the
JCC shall give consideration to [ *** ] performing
commercialization activities. Notwithstanding the foregoing, the
JCC shall have no obligation to [ *** ] except as set
forth in Section [ *** ] .
|
|
|
|
|
|
2.13.4.
|
|
Meetings . The JCC shall meet quarterly
during each year in person or telephonically, or as otherwise
agreed by the Parties. Any in-person meetings shall be held on an
alternating basis between CK’s and Amgen’s facilities,
unless otherwise agreed by the Parties. Each Party shall be
responsible for its own expenses relating to such meetings. As
appropriate, other employee representatives of the Parties may
attend JCC meetings as nonvoting observers, but no Third Party
personnel may attend unless otherwise agreed by the Parties. Each
Party may also call for special meetings as reasonably required to
resolve particular matters requested by such Party by [ ***
] ( [ *** ] ) [ *** ] notice to
the Co-Chair appointed by the other Party. At its meetings, the JCC
shall discuss the progress of the Parties in executing the
Commercialization Plan and any other matters pertaining to
commercialization conducted hereunder.
|
|
|
|
|
|
2.13.5.
|
|
Reporting . Each Party shall keep the
JCC informed of progress and results of commercialization
activities for which it is responsible under the Collaboration
through its members on the JCC and as otherwise provided herein. At
least [ *** ] ( [ *** ] ) [ ***
] prior to each JCC meeting, each Party shall deliver to the
JCC a written summary of commercialization activities conducted
hereunder by each such Party since the last such report.
|
|
|
|
|
|
2.14.
|
|
Subcommittees . From time to time, the
JRC, JDC or JCC may establish subcommittees to oversee particular
projects or activities, and such subcommittees shall be constituted
as such Committee approves (each, a "Subcommittee" ). If any
Subcommittee is unable to reach a decision on any matter after
endeavoring for [ *** ] ( [ *** ] )
[ *** ] to do so, such matter shall be referred to
the applicable Committee that established such Subcommittee for
resolution.
|
|
|
|
|
|
2.15.
|
|
Replacement of Committee Members . Each
Party shall have the right to replace its Committee members or
Co-Chairs by written notice to the other Party. In the event any
Committee member or Co-Chair becomes unwilling or unable to fulfill
his or her duties hereunder, the Party that appointed such member
shall promptly appoint
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-20-
|
|
|
a replacement by written notice to the other
Party. Any replacement member (or Co-Chair) shall be subject to the
requirements for such member as described in this Article 2,
provided, however, that if a Party nominates a replacement member
that does not meet such criteria, the other Party shall consider
the relevant qualifications and experience of such proposed
replacement.
|
|
2.16.
|
|
Input from other Personnel . Any
Committee member shall have the right to solicit input or
assistance from any other personnel of the relevant Party.
|
|
|
|
|
|
2.17.
|
|
No Authority to Amend or Modify .
Notwithstanding anything herein to the contrary, no Committee shall
have any authority to amend, modify or waive compliance with this
Agreement.
|
|
|
|
|
|
2.18.
|
|
Exigent Circumstances . Notwithstanding
anything in this Article 2 to the contrary, each of the
Parties shall have the right to take prompt action within the scope
of their rights hereunder where exigent circumstances so require,
without the necessity for Committee review. In any such case, such
Party shall promptly notify the Committee of such action and the
exigent circumstances.
|
|
|
|
|
|
2.19.
|
|
Japan . Notwithstanding anything to the
contrary, the Committees shall have no authority to govern
activities conducted for purposes outside the Territory and
expressly permitted hereunder.
|
|
|
|
|
|
3.
|
|
Joint Research Program
|
|
|
|
|
|
3.1.
|
|
Research Plan . The JRC shall
establish, update and approve annually an integrated work plan and
budget that defines each Party’s responsibilities and
contribution of resources under the Research Program. The Initial
Research Plan shall be in effect until the JRC agrees to modify
such Initial Research Plan in accordance with
Section 2.11.4.
|
|
|
|
|
|
3.2.
|
|
Conduct of the Research Program Prior to Amgen
Option Exercise . During the Initial Research Term, CK shall
conduct the Research Program in accordance with the Research Plan
at CK’s sole cost and expense except as expressly provided
herein. CK shall use [ *** ] to perform such research
in accordance with the then-current Research Plan. CK’s
intellectual property or proprietary rights developed in the course
of such research shall be included in the definition of CK
Intellectual Property. As currently contemplated by the Parties,
the focus of the Research Program shall be as described in the
Initial Research Plan, and CK shall perform activities thereunder
towards meeting the objectives set forth therein, as such may be
modified based on allocation of responsibilities and activities
between the Parties as established by the JRC. Notwithstanding the
foregoing, the JRC shall have the right to tailor the Research
Program to take into account the best avenue for advancing such
program at a given time taking into account the information
available to it at such time. Amgen shall have the right to request
CK to conduct additional research activities at Amgen’s cost,
and CK shall consider such requests in good-faith and, if CK so
agrees, shall perform such activities. Prior to the Amgen Option
Effective Date, Amgen shall conduct research
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-21-
|
|
|
activities with respect to Compounds, including
with respect to the activities set forth above, solely in
accordance with the Research Plan or as otherwise approved by the
JRC, provided, however that the JRC shall have no right to assign
any research activities to Amgen except as expressly agreed by
Amgen in writing. Amgen and CK shall coordinate through the JRC any
such research activity so conducted by Amgen with the research
conducted by CK. Amgen shall conduct such research at its sole cost
and expense, and any intellectual property or proprietary rights
developed in the course of such research shall be owned by Amgen,
but such rights shall be included in the Collaboration, to the
extent and as provided in Section 9.2. CK shall provide Amgen
with any reasonable assistance and materials requested by Amgen to
enable it to conduct such research, and Amgen shall reimburse CK
any reasonable, out-of-pocket costs incurred by CK in connection
with such cooperation.
|
|
|
|
|
|
3.3.
|
|
Conduct of the Research Program Subsequent to
Amgen Option Exercise . Subsequent to the Amgen
Option Effective Date the Parties shall conduct research in
accordance with the then-current Research Plan for a period of
[ *** ] (such period from the Amgen Option Effective
Date until the conclusion thereof, the "Research Term") .
The JRC shall consult and develop a plan to ensure the continuity
of the research efforts then being undertaken as and to the extent
necessary to maximize continuing progress of the Research Plan. The
JRC shall have the right to tailor the Research Program to take
into account the best avenue for advancing each Program at a given
time taking into account the information available to the JRC at
such time. The JRC shall allocate responsibility for the various
aspects of the Research Plan to the Parties provided, however, that
the JRC shall not allocate more than [ *** ] (
[ *** ] ) FTEs of research responsibility per year to
CK without CK’s prior written consent. Each Party agrees to
allocate those FTEs as reasonably necessary to progress and
complete the tasks assigned to it in the then-current Research Plan
on the timeframes as set forth therein (as currently contemplated,
to potentially include [ *** ] ), but no less than
the number of FTEs set forth for such Party in the then-current
Research Plan on a task-by-task basis (subject to any changes
necessary due to unexpected progress and/or setbacks). From and
after the Amgen Option Effective Date, Amgen shall be responsible
for the direct, reasonable out-of-pocket costs incurred by the
Parties in accordance with the Research Plan, including the Third
Party costs for any activities specified to be outsourced in the
Research Plan. In addition, Amgen shall support [ ***
] CK FTEs [ *** ] and provided in accordance
with the Research Plan by CK at the FTE Rate, payable in accordance
with Section 13.6. With the prior consent of the JRC, CK shall
have the right to provide additional FTEs to the Research Program
[ *** ] .
|
|
|
|
|
|
3.4.
|
|
Provision of [ ***
] . Promptly following the Effective Date, the
Parties shall [ *** ] , for a [ *** ]
of no less than [ *** ] ( [ *** ] )
[ *** ] , for [ *** ] to [ ***
] from [ *** ] for [ *** ] to
discover Compounds for research, development, manufacture and
commercialization in the Territory pursuant to this
Agreement,
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-22-
|
|
|
subject to [ *** ] relating
thereto. It is contemplated that such [ *** ] , and
for [ *** ] to [ *** ] for research,
development, manufacture and commercialization by the Collaboration
[ *** ] . Each [ *** ] for research,
development, manufacture and commercialization to the Collaboration
by [ *** ] shall be a [***] if it [***]. If [
*** ] or if [ *** ] , [ *** ]
shall be [ *** ] , subject to the provisions of
Section [ *** ] .
|
|
|
|
|
|
3.5.
|
|
Extended Research Term . Within
[ *** ] ( [ *** ] ) [ ***
] following the initiation of the Extended Research Term,
the JRC shall meet and establish a Research Plan that sets forth
responsibilities of the Parties for the continuation of the
Research Program during the Extended Research Term. The
responsibilities of the Parties shall be allocated in a manner
consistent with the prior responsibilities of the Parties,
provided, however that the JRC shall have no right to allocate any
activities to a Party except as expressly agreed by such Party in
writing.
|
|
|
|
|
|
4.
|
|
Joint Development Program
|
|
4.1.
|
|
Development Plan . The JDC shall
establish, update and approve annually an integrated work plan and
budget that defines each Party’s responsibilities and
contribution of resources under the Development Program, including
for creating and maintaining the Global Registration Dossier (the
"Development Plan" ). For clarity, the Development Plan
shall encompass and govern the activities of the Parties in the
Field across the Territory.
|
|
|
|
|
|
4.2.
|
|
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, and
the Development Project Team shall be subordinate to and governed
by the JDC.
|
|
|
|
|
|
4.3.
|
|
Manufacturing Subcommittee . Promptly
after the Amgen Option Effective Date, the Parties shall establish
a manufacturing subcommittee to manage, oversee, facilitate and
coordinate the transfer of manufacturing information and protocols
by, and transition manufacturing from, CK to Amgen. Each Party will
have representation on the Manufacturing Subcommittee throughout
the Development Program, and the Manufacturing Subcommittee shall
be subordinate to and governed by the JDC.
|
|
|
|
|
|
4.4.
|
|
Regulatory Subcommittee . The Parties
shall establish a regulatory subcommittee that will be responsible
for coordinating activities regarding regulatory matters as charged
by the JDC. Each Party will have representation on the Regulatory
Sub-
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-23-
|
|
|
committee throughout the Development Program, and
the Regulatory Sub-committee shall be subordinate to and governed
by the JDC.
|
|
4.5.
|
|
Conduct of the Development Program Prior to
Amgen Option Exercise . Prior to the Amgen Option Effective
Date, CK shall conduct a development program designed to pursue the
clinical development of Compounds in accordance with the
Development Plan. CK shall use [ *** ] to perform
such development in accordance with the then-current Development
Plan and to undertake the activities and [ *** ] in a
manner [ *** ] . As currently contemplated by the
Parties, the initial focus of the Development Program with respect
to CK-452 shall be: (i) the [ *** ] , and the
[ *** ] ; and (ii) the conduct of the activities
and [ *** ] . Notwithstanding the foregoing, CK shall
have the right to control and tailor the Development Program to
take into account the best avenue for advancing the Development
Program at a given time taking into account the information
available to it at such time. For clarity, prior to the Amgen
Option Effective Date, Amgen shall not perform any development
activities directed toward CK-452 or any other Compound unless
otherwise expressly agreed by the Parties.
|
|
|
|
|
|
4.6.
|
|
Conduct of the Development Program Subsequent
to Amgen Option Exercise . Subsequent to the Amgen Option
Effective Date, the JDC shall regularly evaluate Compounds that are
the subject of the Research Program to determine which Compounds,
if any, shall be developed by the Parties hereunder.
|
|
|
|
|
|
4.6.1.
|
|
Development Responsibilities .
|
|
|
4.6.1.1.
|
|
[ *** ] Development .
Subsequent to the Amgen Option Effective Date, but prior to the
[ *** ] for a Compound, the JDC shall delegate
operational responsibility for all clinical trials and all other
development activities for such Compound to CK or Amgen, while in
any event [ *** ] in the area. It is the intent of
the Parties that the JDC shall [ *** ] , unless the
JDC determines that [ *** ] (as, for example,
[ *** ] ).
|
|
|
|
|
|
|
|
4.6.1.2.
|
|
[ *** ] Development .
Subsequent to the Amgen Option Effective Date and the [ ***
] for a Compound, the JDC shall [ *** ] .
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-24-
|
|
|
|
The JDC shall [ *** ] related to
such development. The JDC shall assign to CK primary responsibility
for the operational aspects of [ *** ] for such
Compound. If [ *** ] is anticipated to be conducted,
significant [ *** ] shall be assigned by the JDC to
CK.
|
|
|
|
|
|
|
|
4.6.1.3.
|
|
CK Product Opportunities . If CK,
through its participation on the JDC, identifies a development and
commercialization opportunity that arises in consideration of the
Development Program that may fall outside of the then-current
Development Plan and that does not [ *** ] , (each
such development opportunity, a " CK Product Opportunity ") and
[ *** ] and the [ *** ] and [
*** ] hereunder (giving consideration to all relevant
factors), then [ *** ] CK perform such activities
under a mutually agreed modification to the Development Plan,
provided that [ *** ] . If [ *** ] , CK
will have responsibility for the development and commercialization
of the Compound for the CK Product Opportunity, and all costs
associated therewith, and subject to [ *** ] to be
agreed in writing prior to such authorization. CK shall apply
[ *** ] to conduct the development and
commercialization of the Compound for the CK Product Opportunity
and communicate regularly to Amgen through its participation on the
JDC and JCC as to the plans and progress therefor.
|
|
|
|
|
|
|
|
4.6.1.4.
|
|
CK Preference . Amgen shall [
*** ] utilize CK as its [ *** ] services
hereunder, subject to CK [ *** ] for the particular
activities and CK’s agreement to perform such activities
[ *** ] with [ *** ] for [ ***
] from [ *** ] , including by [ ***
] for development activities [ *** ] . In the
event of [ *** ] in good faith.
|
|
|
|
|
|
|
|
4.6.1.5.
|
|
[ *** ] . Subsequent
to the Amgen Option Effective Date, and subject to Section 10.4,
the Parties shall use
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-25-
|
|
|
|
[ *** ] to conduct development as
assigned by the JDC and in accordance with the Development
Plan.
|
|
4.7.
|
|
Development Costs .
|
|
|
4.7.1.1.
|
|
Pre-Exercise . Prior to the Amgen
Option Effective Date, CK shall be responsible for all costs
expended by CK on development.
|
|
|
|
|
|
|
|
4.7.1.2.
|
|
Post-Exercise. Subsequent to the Amgen
Option Effective Date, if CK performs development services pursuant
to Section 4.6.1.4, then Amgen shall reimburse CK for internal
FTEs approved in advance by Amgen at the then agreed FTE rate,
payable in accordance with Section 13.6. In addition, Amgen
shall bear all Third Party costs for any activities specified to be
outsourced pursuant to the Development Plan, provided that such
Third Party costs are approved in advance by Amgen.
|
|
5.
|
|
Joint Commercialization Program
|
|
|
|
|
|
5.1.
|
|
Commercialization Plan . The JCC shall
establish, update and approve annually a plan and budget for
commercialization activities for the Compounds hereunder consistent
with Schedule 2.13.3A. For clarity, the Commercialization Plan
shall encompass and govern the activities of the Parties in the
Field across the Territory.
|
|
|
|
|
|
5.2.
|
|
Commercial Operating Team . From and
after the time [ *** ] , the JCC will establish an
operating team for each Compound ( "Commercial Operating
Team" ) that 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 Compound, including review and decision making regarding plans
for manufacture, promotion, marketing, sale, distribution, and
medical education. [ *** ] the Commercial Operating
Team for such Compound throughout the commercialization of such
Compound hereunder, and the Commercial Operating Team shall be
subordinate to and governed by the JCC.
|
|
|
|
|
|
5.3.
|
|
Pre-Option Exercise Activities . Prior
to the Amgen Option Effective Date, subject to consultation with
Amgen, CK shall have the right to continue its commercialization
activities that it has undertaken prior to the Effective Date
including [ *** ] . Subsequent to the Amgen Option
Effective Date, the Parties shall cooperate through the JCC to
coordinate the transition of such activities.
|
|
|
|
|
|
5.4.
|
|
Amgen Commercialization . Except as set
forth in Section 5.5, subsequent to the Amgen Option Effective
Date, Amgen shall have sole responsibility for commercialization of
Compounds in the Territory, and shall use [ *** ] to
do so in accordance with the Commercialization Plan. Except for
those costs to be borne by CK pursuant to Section 5.5.4, Amgen
shall bear its
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-26-
|
|
|
own internal and out-of-pocket costs incurred
with respect to such commercialization activities. In addition,
Amgen shall bear all Third Party costs for any activities specified
to be outsourced in the Commercialization Plan.
|
|
|
|
|
|
5.5.
|
|
Co-Promotion .
|
|
5.5.1.
|
|
Election and Percentage . For Compounds
in which CK has [ *** ] Co-Invested, CK shall have
the right, but not the obligation, to provide a percentage elected
by CK of up to [ *** ] percent ( [ ***
] %) of the details within the CK Market Segment in the
U.S., Canada and/or Mexico. To exercise its co-promotion rights for
a Compound in which CK has [ *** ] Co-Invested, CK
must notify Amgen in writing, within [ *** ] (
[ *** ] ) [ *** ] of the filing of the
first application for Marketing Approval in U.S., Mexico or Canada
with respect to such Compound and receipt of the Commercialization
Plan therefor, of CK’s election to co-promote such Compound
and the percentage of the details CK elects to provide within the
CK Market Segment (subject to a maximum of [ *** ]
percent ( [ *** ] %)). Specific details in the CK
Market Segment in the U.S., Canada and Mexico shall be allotted by
the JCC, taking into account CK’s interests in developing and
maintaining relationships in the CK Market Segment, and product
strategy for the relevant Compound. In determining CK’s
elected percentage share of the details in the CK Market Segment,
details provided pursuant to Section 5.5.3 shall be taken into
account.
|
|
|
|
|
|
5.5.2.
|
|
Co-Promotion Agreement . At such time
as CK has [ *** ] Co-Invested with respect to a
particular Compound pursuant to Section 11.1 and makes the
election to co-promote such Compound in the U.S., Canada and/or
Mexico pursuant to Section 5.5.1, the Parties shall prepare
and enter into a definitive agreement specifying in more detail the
overall framework for the co-promotion activities of the Parties
for such Compound in the U.S., Canada and Mexico, consistent with
this Section 5.5, and the Parties shall finalize such
agreement as promptly as practical following the filing of an
application for Marketing Approval for such Compound. Such
agreement shall provide for CK’s sales force responsible for
promotion of the Compounds to [ *** ] , and for
CK’s sales force to [ *** ] . In addition, such
co-promotion agreement shall include provisions for [ ***
] .
|
|
|
|
|
|
5.5.3.
|
|
CK Hospitals . For Compounds in which
CK has [ *** ] Co-Invested, the [ *** ]
as set forth in this Section 5.5.3. With respect to [
*** ] specific hospitals in the U.S., Mexico and Canada (
[ *** ] and [ *** ] ), CK shall have
[ *** ] within such hospitals in accordance with the
Commercialization Plan for such Compound (even where those [
*** ] the hospital setting). Amgen and CK shall coordinate
their efforts subject to oversight by the JCC. Such responsibility
shall include [ *** ] to be taken with such [
*** ] , as well as
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-27-
|
|
|
coordinating the details and educational programs
called for in the Commercialization Plan. All promotional
materials, sales aids, monographs, and educational program
materials used by CK shall be approved by the JCC to ensure
compliance with the Commercialization Plan, consistency between the
efforts of the Parties and conformance with compliance standards to
be adopted or approved by the JCC and applicable Law. Amgen shall
have responsibility for [ *** ] the hospital setting,
even where those [ *** ] the hospital setting; for
all such [ *** ] , Amgen and CK shall coordinate
their efforts subject to oversight by the JCC.
|
|
|
|
|
|
5.5.4.
|
|
Payment . Amgen shall pay CK for
details performed pursuant to Section 5.5 in accordance with
the Commercialization Plan [ *** ] , as agreed by the
Parties, provided that the cost to be reimbursed [ ***
] . CK shall bear any other costs associated with its
commercialization activities. In addition, should the JCC request
CK to undertake additional activities and CK agree to do so, then
Amgen shall reimburse CK’s reasonable, out-of-pocket costs
and FTE costs at the FTE Rate, in accordance with a budget to be
established by the JCC.
|
|
|
|
|
|
5.5.5.
|
|
[ *** ] . [
*** ] pursuant to this Article 5 shall be [ ***
] , or [ *** ] necessary to do so in [
*** ] and [ *** ] in such manner.
|
|
6.
|
|
Manufacturing, Sales and
Distribution
|
|
6.1.
|
|
Responsibility . Prior to the Amgen
Option Effective Date, CK shall be solely responsible for the
manufacture of Compounds, provided Amgen shall have the right to
manufacture quantities of Compounds as may be required for its own
research conducted in accordance with the Research Plan. In
addition, CK shall provide to Amgen reasonable quantities of
Compounds as requested by Amgen for its research use, and Amgen
shall reimburse CK therefor [ *** ] (including
[ ***]) as applicable. Subsequent to the Amgen Option
Effective Date, Amgen shall be solely responsible for the
manufacture, distribution and sale of Compounds in the Territory,
provided, however, that CK shall have the right to manufacture
Compounds in accordance with Section 2.6. Amgen shall book all
sales of Compounds in the Territory.
|
|
|
|
|
|
6.2.
|
|
Regulatory Responsibility . Prior to
the Amgen Option Effective Date, CK shall be solely responsible for
securing and maintaining any regulatory approvals needed in
connection with the manufacture of Compounds (except with respect
to Compounds manufactured by Amgen for its research). Subsequent to
the Amgen Option Effective Date, Amgen shall have the sole
responsibility for securing and maintaining any regulatory
approvals needed in connection with the manufacture, distribution
and sale of Compounds in the Territory (except with respect to
Compounds manufactured by or under authority of CK in accordance
with Section
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-28-
|
|
|
2.6). Subsequent to the Amgen Option Effective
Date, all regulatory approvals in the Territory shall be owned by
Amgen, and CK shall promptly transfer to Amgen any such approvals
held in its name [ *** ] and relevant information,
data and protocols to the extent reasonably necessary for Amgen to
manufacture Compounds hereunder and on hand API and formulated
Compounds (other than those reasonably necessary for CK’s
conduct of clinical trials for which it has been assigned
operational responsibility by the JCC, or reasonably necessary for
CK’s use outside the Territory) to Amgen (and Amgen shall
reimburse CK [ *** ] cost with respect to such API
and formulated Compounds), and the Parties shall cooperate to
ensure a smooth transition of regulatory responsibility. Amgen
agrees to reimburse CK’s [ *** ] costs in
connection with such transfer. Subject to [ *** ] ,
CK shall have the right to reference relevant approvals to the
extent reasonably necessary for CK to manufacture and supply
Compounds in support of its activities outside the Territory in
accordance with Section 2.6.
|
|
|
|
|
|
6.3.
|
|
Reasonable Cooperation . After the
Amgen Option Effective Date, CK shall cooperate reasonably with
Amgen in connection with the manufacture, distribution or sale of
Compounds in the Field in the Territory, and the regulatory
approvals therefor, for which Amgen is responsible under this
Agreement, and Amgen shall reimburse CK [ *** ] costs
incurred by CK in connection therewith, as well as for time
incurred by CK at the FTE Rate. Amgen shall cooperate with CK in
connection with the manufacture, distribution or sale of Compounds
for use under the Collaboration and to support activities outside
the Territory and the regulatory approvals therefor, and CK shall
reimburse Amgen [ *** ] costs incurred by Amgen in
connection therewith, as well as for time incurred by Amgen at the
FTE Rate. Without prejudice to any other provision of this
Agreement, the foregoing sentence shall not be deemed to [
*** ] , and [ *** ] . The Parties acknowledge
the possible advantage of collaborative sourcing for Compounds, and
each Party shall consider in good-faith any request by the other
Party to cooperate with respect to such sourcing.
|
|
|
|
|
|
6.4.
|
|
Extent of Cooperation . The
Parties’ cooperation obligations pursuant to this Article 6
shall not impose upon a Party any obligation to create any data,
file any approval or take any action that the Party is not
undertaking for its own accord. By way of example, a Party shall
share, as described herein, information generated by it in the
course of its own activities, but shall have no obligation to
generate additional information that may be useful for the other
Party, except as expressly set forth herein.
|
|
7.
|
|
Regulatory
|
|
|
|
|
|
7.1.
|
|
Regulatory Responsibility .
|
|
|
|
|
|
7.1.1.
|
|
Prior to the Amgen Option Effective
Date. Prior to the Amgen Option Effective Date, CK shall own
and be solely responsible for filing, obtaining and
maintaining
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-29-
|
|
|
all approvals necessary for the research and
development of Compounds; all such approvals shall be held in the
name of CK or its designee. CK shall: (i) promptly provide
Amgen with copies of any written communication from and a summary
of any oral communication with any Regulatory Authority relating to
a Compound; (ii) allow Amgen a reasonable opportunity (but in
no event less than [ *** ] ( [ *** ] )
[ *** ] ) to review and comment on any submission or
correspondence to any Regulatory Authority relating to any
Compound; (iii) consider in good-faith any comments made by
Amgen pursuant to subsection (ii) or otherwise with respect to
interactions with any Regulatory Authority concerning any Compound
or activities conducted pursuant to the Collaboration;
(iv) allow Amgen to attend any in person meetings with any
Regulatory Authority and to listen in on any planned calls with any
Regulatory Authority; and (v) otherwise provide Amgen with any
reasonably requested information or documentation relating to
regulatory submissions or approvals. While CK is responsible for
regulatory activities for a Compound pursuant to this
Section 7.1.1, Amgen shall not independently communicate with
any Regulatory Authority with respect to any such Compounds, except
as may be required by Law.
|
|
|
|
|
|
7.1.2.
|
|
Subsequent to the Amgen Option Effective
Date . Subsequent to the Amgen Option Effective Date, Amgen
shall own and be solely responsible for filing, obtaining and
maintaining approvals necessary for the development and
commercialization of Compounds in the Territory in the Field and
any approval for any product labeling or promotional materials in
the Territory with respect thereto; and unless otherwise agreed or
required by applicable Law, all such approvals shall be held in the
name of Amgen or its designee. Within [ *** ] (
[ *** ] ) [ *** ] of the Amgen Option
Effective Date, CK shall transfer to Amgen, at [ ***
] , all Marketing Approvals in the Territory held in the
name of CK or its designee. CK shall provide Amgen any assistance
reasonably requested in connection with any such approval, and
Amgen shall reimburse CK [ *** ] costs incurred in
connection therewith. Following such transfer, Amgen shall
(i) promptly provide CK with copies of any written
communication from and a summary of any oral communication with any
Regulatory Authority relating to a Compound; (ii) allow CK a
reasonable opportunity (but in no event less than [ ***
] ( [ *** ] ) [ *** ] ) to
review and comment on any submission or correspondence to any
Regulatory Authority relating to any Compound; (iii) consider in
good-faith any comments made by CK pursuant to subsection
(ii) or otherwise with respect to interactions with any
Regulatory Authority concerning any Compound or activities
conducted pursuant to the Collaboration; (iv) allow CK to
attend any in person meetings with any Regulatory Authority and to
listen in on any planned calls with any Regulatory Authority; and
(v) otherwise provide CK with any reasonably requested
information or documentation relating to regulatory submissions or
approvals. While Amgen is responsible for regulatory activities for
a Compound pursuant to this Section 7.1.2, CK shall not
independently communicate with any Regulatory Authority in the
Territory with respect to any such Compounds, except as may be
required by Law.
|
|
|
|
|
|
7.2.
|
|
Clinical Safety Reporting;
Pharmacovigilance . At all times subsequent to the Amgen
Option Effective Date, Amgen shall be solely responsible for
establishing
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-30-
| |
|
|
|
and shall establish operating and other
procedures reasonably sufficient to report to the appropriate
Regulatory Authority(ies) all adverse event reports, safety reports
and similar matters, unless otherwise determined by the JDC in
accordance with the Laws in the Territory (and CK outside the
Territory). Promptly following the Amgen Option Effective Date, the
safety personnel of Amgen and CK will develop and agree upon safety
data exchange procedures governing the coordination of collection,
investigation, reporting, and exchange of information concerning
adverse events with respect to Compounds (including with respect to
pregnancies), product quality and product complaints involving
adverse events with respect to Compounds, sufficient to permit each
Party, its Affiliates and licensees to comply with their legal
obligations, including to the extent applicable, those obligations
contained in FDA regulations. Each Party shall further provide the
other Party any assistance reasonably requested by the other Party
in connection with safety reporting and fulfilling its obligations
to Regulatory Authorities with respect thereto, and the requesting
Party shall reimburse the other Party [ *** ] costs
incurred in connection therewith.
|
|
|
|
|
|
7.3.
|
|
Transfer of Data, Technology and Regulatory
Filings . Promptly following the Amgen Option Effective
Date, such that such transfer is completed within [ ***
] ( [ *** ] ) [ *** ] of the
Amgen Option Effective Date, CK shall deliver to Amgen (or provide
copies where CK is required by Law to maintain original records),
[ *** ] data, [ *** ] data, [
*** ] data, [ *** ] data and [ ***
] data (including [ *** ] (both [ ***
] and [ *** ] ), [ *** ] ,
[ *** ] , [ *** ] ) reasonably
necessary for Amgen to exercise its rights and perform its
obligations under this Agreement with respect to Compounds, and
other information pertaining to the Compounds reasonably requested
by Amgen, in each case Controlled by CK or its Affiliates, and
Amgen shall reimburse CK [ *** ] costs incurred in
connection therewith. Each Party shall provide the other with such
assistance as the other Party reasonably requests from time to
time, to enable such other Party to fully understand and implement
the foregoing and the requesting Party shall reimburse the other
[ *** ] costs incurred in connection therewith.
Without limiting the foregoing, with respect to Confidential
Information of a Party, which Confidential Information the other
Party desires to include in any regulatory filing, the Party whose
Confidential Information it is shall either: (i) make such
information available to the other Party or (ii) make such
information available directly to the applicable Regulatory
Authority (whether by reference or otherwise). In addition, CK
(itself or through a designee) shall have the right to reference
regulatory filings and data [ *** ] with respect to
[ *** ] Compounds for CK’s use [ ***
] for the purposes of development and commercialization of
[ *** ] Compounds [ *** ] , subject to
[ *** ] of Section [ *** ] . The
Parties shall [ *** ] , including [ ***
] and [ *** ] with respect thereto. The
Parties will [ *** ] .
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-31-
|
7.4.
|
|
Use of Contractors . CK ( [ ***
] and [ *** ] ) and Amgen shall each have the
right to use the services of Third Party contractors, including
contract research organizations, contract manufacturing
organizations, contract sales forces and the like, to assist such
Party in fulfilling its obligations and exercising its rights under
this Agreement, [ *** ] , including [ ***
] and [ *** ] . Each Party shall consider in
good faith the possibility of using the other Party’s
resources to perform such activities as an alternative to utilizing
the services of a subcontractor.
|
|
|
|
|
|
7.5.
|
|
Extent of Cooperation . The
Parties’ cooperation obligations pursuant to this Article 7
shall not impose upon a Party any obligation to create any data,
file any approval or take any action that the Party is not
undertaking for its own accord. By way of example, a Party shall
share, as described herein, information generated by it in the
course of its own activities, but shall have no obligation to
generate additional information that may be useful for the other
Party, except as expressly set forth herein.
|
|
8.
|
|
Intellectual Property
|
|
|
|
|
|
8.1.
|
|
Ownership .
|
|
|
|
|
|
8.1.1.
|
|
General. Except to the extent expressly
specified to the contrary in this Agreement, including any
exclusivity in this Agreement, (i) each Party shall retain and
own all right, title, and interest in and to all patent rights,
trade secret, proprietary right and other intellectual property
rights conceived or created solely by such Party, (ii) the
Parties shall jointly own all right, title, and interest in and to
all patent rights, trade secret, proprietary right and other
intellectual property rights conceived or created jointly by the
Parties and, subject to the provisions of this Agreement neither
Party shall have any duty to account or obtain the consent of the
other Party in order to exploit or license such intellectual
property rights, and (iii) inventorship and authorship of any
invention or work of authorship conceived or created by either
Party, or jointly by the Parties, shall follow the rules of the
U.S. Patent and Trademark Office and the Laws of the United States
(without reference to any conflict of law principles). Each Party
shall ensure that all employees and consultants providing services
related to the Compounds executes all documentation necessary to
vest ownership of intellectual property in such Party or its
Affiliate.
|
|
|
|
|
|
8.1.2.
|
|
[ *** ] . All right,
title and interest in and to all technology, patent rights, trade
secrets and other intellectual property and proprietary rights that
are or include a [ *** ] or [ *** ] by
CK, or any portion of any of the foregoing, shall, to the extent
such [ *** ] or [ *** ] , be
exclusively owned by CK. All right, title and interest in and to
all technology, patent rights, trade secrets and other
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-32-
|
|
|
intellectual property and proprietary rights that
are or include a [ *** ] or [ *** ] by
Amgen, or any portion of any of the foregoing, shall, to the extent
such [ *** ] or [ *** ] , be
exclusively owned by Amgen.
|
|
8.2.
|
|
Patent Subcommittee . Promptly
following the Effective Date, the JDC shall establish a
Subcommittee (the "Patent Subcommittee" ) to oversee, review
and coordinate (i) the prosecution, maintenance, defense and
enforcement of Patent Rights within the Collaboration Patent Rights
and (ii) other Patent Rights-related matters as are
specifically provided for the Patent Subcommittee under this
Agreement or assigned to it by the JDC. Such Subcommittee shall
meet, in-person or telephonically, as frequently as agreed to
discuss matters related to such activities. The Patent Subcommittee
shall have equal representation from each Party, with each Party
selecting a co-chair. Each Party’s representatives on the
Patent Subcommittee shall consist essentially of at least one
(1) patent attorney having significant experience relating to
pharmaceutical Patent Rights, and other individuals as agreed to be
appropriate by the Patent Subcommittee. The Patent Subcommittee in
consultation with the JDC shall establish practices and procedures
for the identification and disclosure of patentable subject matter
and the prosecution maintenance of Patent Rights disclosing such
subject matter consistent with the terms and conditions of this
Article 8. In determining which outside counsel to use
pursuant to Sections 8.4 and 8.5, the Patent Subcommittee
shall take into account existing relationships and historical
knowledge of the relevant matters, in addition to other relevant
factors.
|
|
|
|
|
|
8.3.
|
|
Cooperation Generally . Subject to
control by each Party as more particularly set forth below and
decisions of the Patent Subcommittee, the Parties shall cooperate
in order to coordinate reasonably the filing, prosecution,
maintenance, defense and enforcement of the Collaboration Patent
Rights in, and foreign counterparts thereto outside, the Territory,
and each Party shall keep the Patent Subcommittee informed with
respect to activities that it performs pursuant to this
Article 8 or otherwise based upon its activities in connection
with this Agreement. Without limiting the foregoing, in any action
by a Party in the Territory pursuant to this Article 8,
whether or not the non-enforcing Party chooses to participate in
the action, the non-enforcing Party will not oppose being joined,
and the enforcing Party shall have the right to join the
non-enforcing Party, in such enforcement actions as a party
plaintiff, and the non-enforcing Party will take such other actions
as necessary for standing or to satisfy other requirements to file,
pursue or maintain the action, at the enforcing Party’s
request and expense, including reasonably providing testimony,
documents, and the like.
|
|
|
|
|
|
8.4.
|
|
Prosecution and Maintenance – Pre-Option
Exercise .
|
|
|
|
|
|
8.4.1.
|
|
Prior to the Amgen Option Effective Date, subject
to the oversight of the Patent Subcommittee, CK shall control,
through outside counsel mutually acceptable to the Parties and
directed by CK, the filing for, prosecution and maintenance
(including office actions, oppositions and interferences) of CK
Patent Rights and Joint Patent
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-33-
|
|
|
Rights, at [ *** ] , in
consultation with Amgen, as well as filing for any patent term
extensions or similar protections therefor. CK shall provide Amgen
copies of and an opportunity to review and comment upon the text of
the applications relating to CK Patent Rights and Joint Patent
Rights [ *** ] ( [ *** ] ) [ ***
] before filing. CK shall provide Amgen with a copy of each
application for each such CK Patent Right or Joint Patent Right as
filed, together with notice of its filing date and application
number. CK shall keep Amgen advised of the status of all material
communications, actual and prospective filings or submissions
regarding such CK Patent Rights and Joint Patent Rights, and shall
give Amgen copies of and an opportunity to review and comment on
any such communications, filings and submissions proposed to be
sent to any patent office or judicial body. CK shall reasonably
consider in good faith Amgen’s comments on the
communications, filings and submissions for the CK Patent Rights
and Joint Patent Rights. If CK declines to file for, prosecute or
maintain (including defending or prosecuting office actions,
prosecutions or interferences) any CK Patent Right or Joint Patent
Right, it shall give Amgen reasonable notice thereof and
thereafter, Amgen may, upon written notice to CK and at
Amgen’s sole cost, control the filing for, prosecution and
maintenance (including defending or prosecuting office actions,
prosecutions or interferences) of such CK Patent Right or Joint
Patent Right thereafter in accordance with Section 8.4.2
below. Amgen shall provide CK any cooperation or assistance
reasonably requested by CK in connection with the filing,
prosecution and maintenance (including defending or prosecuting
office actions, prosecutions or interferences) of CK Patent Rights
and Joint Patent Rights, and CK shall reimburse Amgen’s
[ *** ] expenses incurred in connection therewith.
From and after such time as Amgen exercises the Amgen Option, CK
Patent Rights and Joint Patent Rights shall be handled as set forth
in Section 8.5 below. With respect to CK Patent Rights and Joint
Patent Rights, CK shall not [ *** ] without
Amgen’s prior written consent, not to be unreasonably
withheld or delayed.
|
|
8.4.2.
|
|
Prior to the Amgen Option Effective Date, subject
to the oversight of the Patent Subcommittee, Amgen shall control,
through outside counsel mutually acceptable to the Parties and
directed by Amgen, the filing for, prosecution and maintenance
(including defending or prosecuting office actions, oppositions and
interferences) of Amgen Patent Rights, at Amgen’s expense, in
consultation with CK, as well as filing for any patent term
extensions or similar protections therefor. Amgen shall provide CK
copies of and an opportunity to review and comment upon the text of
the applications relating to Amgen Patent Rights [ ***
] ( [ *** ] ) [ *** ] before
filing. Amgen shall provide CK with a copy of each application for
such an Amgen Patent Right as filed, together with notice of its
filing date and application number. Amgen shall keep CK advised of
the status of all material communications, actual and prospective
filings or submissions regarding such Amgen Patent Rights, and
shall give CK copies of and an opportunity to review and comment on
any such communications, filings and submissions proposed to be
sent to any patent office or judicial body. Amgen shall reasonably
consider in good faith CK’s comments on the communications,
filings and submissions for the Amgen Patent Rights. If Amgen
declines to file for, prosecute or maintain (including defending
or
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-34-
|
|
|
prosecuting office actions, prosecutions or
interferences) any Amgen Patent Right, it shall give CK reasonable
notice thereof and thereafter, CK may, upon written notice to Amgen
and at CK’s sole cost, control the filing for, prosecution
and maintenance (including defending or prosecuting office actions,
prosecutions or interferences) of such Amgen Patent Right
thereafter in accordance with Section 8.4.1. CK shall provide
Amgen any cooperation or assistance reasonably requested by Amgen
in connection with the filing, prosecution and maintenance
(including defending or prosecuting office actions, prosecutions or
interferences) of Amgen Patent Rights, and Amgen shall reimburse
CK’s [ *** ] incurred in connection therewith.
From and after the Amgen Option Effective Date, Amgen Patent Rights
shall be handled as set forth in Section 8.5 below.
|
|
8.5.
|
|
Prosecution and Maintenance –
Post-Option Exercise . Following the Amgen Option Effective
Date, subject to the oversight of the Patent Subcommittee, Amgen
shall, through outside counsel mutually acceptable to the Parties
and directed by Amgen, control the filing for, prosecution and
maintenance (including defending or prosecuting office actions,
prosecutions or interferences) of Collaboration Patent Rights in
the Territory, at Amgen’s expense, in consultation with CK,
as well as filing for any patent term extensions or similar
protections. Amgen shall provide CK copies of and an opportunity to
review and comment upon the text of the applications relating to
such Collaboration Patent Rights [ *** ] ( [
*** ] ) [ *** ] before filing. Amgen shall
provide CK with a copy of each application for a Collaboration
Patent Right as filed, together with notice of its filing date and
application number. Amgen shall keep CK advised of the status of
all material communications, actual and prospective filings or
submissions regarding Collaboration Patent Rights, and shall give
CK copies of and an opportunity to review and comment on any such
communications, filings and submissions proposed to be sent to any
patent office or judicial body. Amgen shall reasonably consider in
good faith CK’s comments on the communications, filings and
submission for the Collaboration Patent Rights. If Amgen declines
to file for, prosecute or maintain (including defending or
prosecuting office actions, prosecutions or interferences) any
Collaboration Patent Right, it shall give CK reasonable notice
thereof and thereafter, CK may, upon written notice to Amgen and at
CK’s sole cost, control the filing for, prosecution and
maintenance of such Collaboration Patent Right thereafter in
accordance with Section 8.4.1 above. CK shall provide Amgen
any cooperation or assistance reasonably requested by Amgen in
connection with such filing, prosecution and maintenance (including
defending or prosecuting office actions, prosecutions or
interferences), and Amgen shall reimburse CK’s [ ***
] expenses incurred in connection therewith.
|
|
|
|
|
|
8.6.
|
|
Patent Files . Within [ ***
] ( [ *** ] ) [ *** ] after the
Amgen Option Effective Date or [ *** ] , CK shall (to
the extent not previously provided) (i) provide Amgen, at
[ *** ] ( [ *** ] ), with copies of all
documents (including file histories and then current dockets) for
the
|
*** Certain information on this page has been
omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the
omitted portions.
-35-
|
|
|
applicable CK Patent Rights in the Territory that
are in the file maintained by CK’s outside patent counsel for
such CK Patent Rights or otherwise available to CK, including any
communications, filings and drafts as well as written notice of any
pending deadlines or communications for such CK Patent Rights in
the Field in the Territory (provided, however, that CK shall
provide notice of pending deadlines as promptly as possible after
the Amgen Option Effective Date so as to ensure adequate time and
coordination with respect to such deadlines), and (ii) execute
and deliver any legal papers reasonably requested by Amgen to
effectuate transfer of control of the
|
|