AMENDMENT TO THE COLLABORATION
AND LICENSE AGREEMENT
This AMENDMENT
TO THE COLLABORATION AND LICENSE AGREEMENT (this
“Amendment”) is made effective as of September 21,
2005 (the “Amendment Effective Date”) by and between
Cytokinetics, Inc., a Delaware corporation (“CK”) and
Glaxo Group Limited, a GlaxoSmithKline company, a United Kingdom
corporation (“GSK”) (each of CK and GSK a
“Party,” together the
“Parties”).
A.
CK and GSK have entered into that certain Collaboration and License
Agreement by and between the Parties dated June 20, 2001, as
amended (the “ Agreement ”); and
B.
The Parties wish to enter into an amendment to the Agreement in
order to define the rights and obligations of the Parties with
respect to certain development and other activities relating to
that certain Development Compound (as defined in the Agreement)
known as SB-743921 (“SB-921”) and Licensed Products (as
defined in the Agreement) incorporating SB-921 (“SB-921
Products”), all on the terms and conditions set forth herein
below.
NOW, THEREFORE,
for good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the Parties agree as
follows:
All capitalized
terms not defined in this Amendment shall have the meanings given
to them in the Agreement.
1.1
“Additional Indication” shall mean any indication or
dosing schedule for an SB-921 Product determined from the conduct
of the CK Clinical Studies.
1.2
“Additional Indication [***] Notice” shall have the
meaning assigned to it in Section 2.3.1 of this
Amendment.
1.3
“CK Clinical Studies” shall mean clinical studies for
an SB-921 Product conducted by or on behalf of CK for any
indication in the CK Subfield, including such non-clinical studies
as CK determines are [***] to support such clinical
studies.
1.4
“CK Clinical Studies Coordinator” shall mean the
employee designated by CK in accordance with Section 2.4 of
this Amendment.
1.5
“CK Subfield” shall mean non-Hodgkin’s lymphoma,
Hodgkin’s lymphoma and multiple myeloma.
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1.6
“[***]” shall have the meaning assigned to it in
Section 2.6 of this Amendment.
1.7
“GSK [***] Option” shall have the meaning assigned to
it in Section 2.3.1 of this Amendment.
1.8
“GSK [***] Option Period” shall mean the
[***] days after GSK’s receipt of any Additional
Indication [***] Notice; provided that if, as of the date of such
Additional Indication [***] Notice, (a) GSK has not [***] or
[***] for an SB-921 Product for an indication other than the
Additional Indications and (b) GSK has [***] for at least
[***] for an SB-921 Product for any indication other than the
Additional Indications and such [***] then [***] (i.e., [***]),
then GSK shall have the right, upon written notice to CK given
within such [***]-day period, to extend the GSK [***] Option Period
until the earlier to occur of (i) the [***] by GSK of such
[***], and (ii) [***] from the receipt of such Additional
Indication [***] Notice. For purposes of this Section 1.8,
“[***]” of [***] shall be deemed to have occurred upon
the later to occur of (i) [***] days after the [***] to
be [***] in such [***] has been [***], and (ii) receipt by GSK
of the [***] for such [***] in the form and including the
information requested [***] of the Agreement except that the [***]
of such [***] shall be [***] (or [***]) and a [***] appointed by
such [***].
1.9
“SB-921 Co-Funding Option” shall have the meaning
assigned to it in Section 2.4 of this Amendment.
ARTICLE 2
DEVELOPMENT OF SB-921 PRODUCTS
2.1
Acceleration of Joint Development Committee
Establishment.
2.1.1 Notwithstanding anything in
Section 3.5 of the Agreement to the contrary, promptly
following the Amendment Effective Date, the Parties shall establish
the Joint Development Committee as described in Section 3.5 of
the Agreement (“JDC”) with equal representation from
each Party, subject to the following, unless and until otherwise
agreed by the Parties in writing: (i) the JDC shall have
responsibility only over decisions relating to SB-921 Products and
not to any other Licensed Products developed or commercialized
under the Agreement unless CK exercises its Co-Funding Option for
such other Licensed Products in accordance with Section 3.4 of
the Agreement; (ii) in addition to the JDC’s
responsibilities set forth in Section 3.5 of the Agreement,
the JDC shall oversee, review and provide advice with respect to
the clinical studies and other development activities (for clarity,
including non-Later Stage Development) for SB-921 Products by
either GSK or CK, including the CK Clinical Studies and all
clinical studies for SB-921 Products that have been conducted or
are being conducted by GSK as of the Amendment Effective Date,
subject to Section 2.1.2 of this Amendment; and (iii) the JDC
shall assist the Parties in coordinating their efforts with respect
to the clinical and other development of SB-921
Products.
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2.1.2 Notwithstanding the creation
and existence of the JDC or anything in the Agreement to the
contrary (including without limitation, Section 3.5 thereof):
(i) [***] shall have the right to [***] the [***] with respect
to [***] or [***], or the [***] of [***] for the [***] or [***], of
SB-921 Products unless otherwise agreed by [***]; (ii) GSK
shall retain all of its rights to terminate development of any
SB-921 Product or other Licensed Products pursuant to
Section 11.3.2 of the Agreement, subject to other provisions
of the Agreement, including Section 11.7 thereof;
(iii) [***] shall have the right to [***] on issues relating
to the clinical studies for SB-921 Products conducted by [***] that
are [***] or [***] by [***] after the [***] and issues relating to
the development of SB-921 Products other than issues for which
[***] has the right to [***] as provided in clause (iv) of
this Section 2.1.2; (iv) [***] shall have the right to
[***] on issues relating to the [***] or otherwise relating to the
[***]; and (v) the JDC shall seek to resolve all other issues
by mutual agreement in accordance with the Agreement, including
Section 12.2.2 thereof, and if the JDC is unable to do so,
either Party may request that the issue be referred for resolution
through good faith negotiations between the Chief Executive Officer
of CK and the Chairman, Research and Development for GSK, who shall
promptly meet to resolve the issue; provided, however, in the event
they are unable to reach agreement on the matter, [***] shall have
the right to [***] on the matter, except during the period in which
the [***] of SB-921 Products is that being conducted by or on
behalf of [***] for [***] pursuant to Section [***] of this
Amendment, in which case [***] shall have the right to [***] on the
matter.
2.2
CK Clinical Studies. As between the Parties, CK shall take the lead
with respect to, and shall have the exclusive right to conduct, the
development of SB-921 Products for indications in the CK Subfield
up through [***], subject to the GSK [***] Option. Upon the request
of CK from time to time, the Parties shall negotiate in good faith
to expand the CK Subfield to include other indications for SB-921
Products for which GSK is not interested in pursuing clinical
development. Subject to the terms and conditions of the Agreement
as amended hereby, CK shall have the right to (i) conduct
(itself or through Third Party contractors) CK Clinical Studies, in
its sole discretion and at its sole expense, except as otherwise
provided herein, and (ii) make all decisions relating to the
CK Clinical Studies. CK shall keep the JDC apprised of the progress
of the CK Clinical Studies and will provide the JDC with such
information regarding such CK Clinical Studies as the JDC may
reasonably request from time to time.
2.3
GSK [***] Option for SB-921 Product for Additional
Indication.
2.3.1 CK shall notify GSK in writing
of the [***] of each [***] for an SB-921 Product for each
Additional Indication(s) conducted under the CK Clinical Studies
(each, an “Additional Indication [***] Notice”). CK
shall include with the Additional Indication [***] Notice a copy of
the [***] for such [***] in the form and including the information
requested [***] of the Agreement. Upon receipt of the Additional
Indication [***] Notice and the [***] for such [***], GSK shall
have the option to conduct all further development (including
Later
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Stage
Development) and commercialization of such SB-921 Product for the
Additional Indication(s) specified in such Additional Indication
[***] Notice (the “GSK [***] Option”), subject to other
provisions of the Agreement as amended hereby, including CK’s
Co-Promotion Option in Section 7.4 thereof. For purposes of
this Section 2.3.1, “[***]” of a [***] shall be
deemed to have occurred upon the later to occur of (i) thirty
(30) days after the [***] to be [***] in such [***] has been
[***], and (ii) receipt by CK of the [***] for such [***] in
the form and including the information requested [***] of the
Agreement. Following delivery of an Additional Indication [***]
Notice to GSK, CK shall provide such material information and data
regarding the CK Clinical Studies for the Additional Indication(s)
specified in such Additional Indication [***] Notice, to the extent
such information and data has not been previously provided to GSK
or the JDC, as GSK may reasonably request to enable GSK to make an
informed decision whether to exercise such GSK [***] Option under
this Section 2.3.
2.3.2 To exercise the GSK [***]
Option with respect to an SB-921 Product for the Additional
Indication(s) specified in an Additional Indication [***] Notice,
GSK shall provide, prior to the expiration of the GSK [***] Option
Period, written notice to CK referencing this Section 2.3 and
specifying that GSK agrees to conduct all further development
(including Later Stage Development) and commercialization of such
SB-921 Product for such Additional Indication(s) specified in such
Additional Indication [***] Notice in accordance with the Agreement
and Section 2.3.3 of this Amendment; provided, however, that
any development shall be subject to approval by the JDC in
accordance with the terms of this Amendment and the
Agreement.
2.3.3 Upon GSK’s timely
exercise of the GSK [***] Option with respect to an SB-921 Product
for the Additional Indication(s) specified in an Additional
Indication [***] Notice pursuant to this Section 2.3, CK shall
thereafter fund the CK Percentage (as designated by CK pursuant to
Section 2.3 of this Amendment) of the associated Later Stage
Development Costs for such Additional Indication(s), with the
remainder to be funded by GSK. If GSK has extended the GSK [***]
Option Period beyond the initial [***]-day period as provided in
Section 1.8 upon GSK’s exercise of the GSK [***] Option,
GSK shall reimburse CK, within thirty (30) days of receipt of
an invoice, for [***] percent ([***]%) of the costs incurred by CK
in conducting the CK Clinical Studies for such Additional
Indication(s) during the period beginning on the date of the
Additional Indication [***] Notice and ending on the date of such
exercise by GSK of such GSK [***] Option.
2.3.4 In the event GSK elects not to,
or otherwise fails to, exercise the GSK [***] Option with respect
to an SB-921 Product for the Additional Indication(s) specified in
an Additional Indication [***] Notice within the GSK [***] Option
Period, then such GSK [***] Option shall expire, and CK shall have
the right, at its sole discretion and expense, to conduct all
further development and commercialization of the SB-921 Product for
such Additional Indication(s) on terms and conditions to be
negotiated in good faith by the Parties; provided that any
consideration payable to GSK for such rights shall be limited to a
royalty on Net Sales of such SB-921 Product by CK, its Affiliates
and Sublicensees in an amount to be reasonably established by the
Parties in good faith and consistent with Section 4.7.1 of
the
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Agreement;
provided, further, that payments to GSK for the [***] of such
SB-921 Product or [***] to CK or [***] of [***] by GSK on behalf of
CK shall not be considered as “consideration payable to GSK
for such rights” for purposes of this clause or limited by
this section. In the event CK elects to conduct such development
and commercialization for such Additional Indication(s):
(i) GSK shall have no obligation with respect to such
development or commercialization unless otherwise agreed
betwee
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