AMENDMENT TO THE COLLABORATION AND LICENSE AGREEMENT
Exhibit 10.56
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”).
BACKGROUND
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:
ARTICLE 1
DEFINITIONS
DEFINITIONS
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
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 between GSK and CK; (ii) CK shall have the sole right to
make all decisions relating to the development and commercialization of the SB-921 Product for the
Additional Indication(s); (iii) such development or commercialization by or on behalf of CK shall
be subject to the oversight of the JDC or JCC as provided in Section 2.3.5, and (iv) GSK shall have
no obligation to pay the amounts set forth in the column “Additional Indication Amount” in the
table in Section 6.4.1 of the Agreement (as amended hereby) with respect to such development for
such Additional Indication(s). GSK’s decision not to exercise the GSK [***]Option with respect
to one Additional Indication for an SB-921 Product shall not preclude it from exercising the GSK
[***] Option with respect to a different Additional Indication for an SB-921 Product for which
the GSK [***] Option has not expired, subject to the terms and conditions of this Amendment. It
is understood that CK shall have the right to continue to conduct the CK Clinical Studies for the
Additional Indication(s) specified in an Additional Indication [***] Notice, at its sole
discretion and expense, during the GSK [***] Option Period and the time period in which the
Parties are negotiating the terms and conditions for CK’s conduct of all further development and
commercialization of the SB-921 Product for such Additional Indication(s) pursuant to this Section
2.3 of this Amendment.
2.3.5 Notwithstanding Section 2.1.2 of this Amendment, in the event (i) 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; (ii) CK elects to and continues to conduct further development and
commercialization of the SB-921 Product for such Additional Indication(s); and (iii) GSK continues
to develop and commercialize an SB-921 Product for an indication other than an Additional
Indication at the same time that CK is developing or commercializing the same SB-921 Product for an
Additional Indication, then the development and commercialization by CK of the SB-921 Product for
the Additional Indication, in addition to GSK’s development and commercialization of the SB-921
Product, shall be subject to the oversight of the JDC and the JCC. In addition to the
responsibilities of the JDC and JCC set forth in Sections 3.5 and 7.2.1 of the Agreement, the JDC
and the JCC shall provide a forum for the Parties to exchange information and coordinate
development and commercialization of the SB-921 Products by each Party, in accordance with existing
laws. Notwithstanding the foregoing or anything in the Agreement to the contrary (including
without limitation, Section 3.5 or 7.2.2 of the Agreement):
(a) [***] shall have the right
to [***] the [***] with respect to [***] or [***], or the
[***] for the [***] or [***], of SB-921 Products unless otherwise
agreed by [***]; (b) the JDC and JCC shall seek to resolve all other issues by mutual
agreement in accordance with the Agreement, but [***] shall have the right to [***] on issues relating to development and commercialization of SB-921 Products by [***], and [***] shall
have the right to [***] on issues relating to development and commercialization of
SB-921
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Products
by [***]; and (c) any issues that cannot be resolved by mutual agreement of the Parties
[***] under Section [***] or [***] of the Agreement. In
such a situation where GSK and CK are developing or commercializing the same SB-921 Product for
different indications, (1) CK shall keep the JDC and JCC apprised of the development and
commercialization of the SB-921 Product for an Additional Indication and will provide the JDC and
JCC with such information as the JDC and JCC may reasonably request from time to time, including
information as set forth in Section 7.2.1 of the Agreement; and (2) the Parties will work together
in good faith to maximize the commercial potential of and to obtain the optimum commercial return
for each SB-921 Product.
2.3.6 For purposes of Section 2.3.5 and this Amendment, an SB-921 Product being developed or
commercialized by GSK and by CK shall be considered the “same” product, regardless of the dosage
forms or formulations of the SB-921 Product, if both SB-921 Products contain the same active
ingredient or Development Compound. SB-921 Products having a different or additional active
ingredient shall be deemed a separate SB-921 Product if such different or additional active
ingredient is a different or additional Development Compound or another active ingredient in which
CK has proprietary rights (other than the original Development Compound contained in the SB-921
Product).
2.3.7 Nothing in this Amendment or the Agreement shall be construed to require GSK to [***] for SB-921 for an indication other than the Additional Indications, and the
decision whether to [***] for SB-921 for an indication other than the
Additional Indications shall be solely with GSK. GSK shall have the right to the GSK [***]
Option set forth in this Section 2.3 regardless of whether GSK
has [***] for
SB-921 for an indication other than the Additional Indications prior to or after CK’s [***] for SB-921 for an Additional Indication.
2.4 CK Clinical Studies Costs; CK Co-Funding Option for SB-921 Products. Except as
otherwise provided herein, CK shall be responsible for all costs of conducting the CK Clinical
Studies, including with respect to the participation of the CK Clinical Studies Coordinator and its
out-of-pocket costs for work conducted by Third Parties in connection with the CK Clinical Studies.
For clarity, CK shall not be obligated to fund any portion of any [***] or [***] trials
conducted by GSK for SB-921 Products. GSK shall be responsible for its costs in fulfilling its
obligations under this Amendment, including with respect to the participation of the GSK Alliance
Director. Notwithstanding anything in Section 3.4 of the Agreement to the contrary, the Parties
agree that CK’s Co-Funding Option with respect solely to SB-921 Products (“SB-921 Co-Funding
Option”) shall include the following: (i) as of the Amendment Effective Date, CK shall have the
right to exercise its SB-921 Co-Funding Option, and hereby exercises such SB-921 Co-Funding Option;
(ii) if GSK exercises the GSK [***] Option, then, prior to the later of (a) [***] days
after such exercise of the GSK [***] Option by GSK or (b) [***] days prior to the Projected
Start Date of the first [***] for an SB-921 Product, CK shall provide written notice to
GSK specifying whether CK elects to fund either [***] percent
([***]%) or [***] percent ([***]%) of
the Later Stage Development Costs for SB-921 Products pursuant to the SB-921 Co-Funding Option,
provided that GSK provides to CK the [***] Notice for such [***] in accordance with
Section 3.4.1 of the Agreement; and
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(iii) following such election of the CK Percentage for SB-921 Products, CK shall be obligated to
reimburse GSK for the CK Percentage of such Later Stage Development Costs for SB-921 Products,
subject to the other provisions of this Amendment and the Agreement.
2.5 Information and Materials Exchange. GSK shall provide to CK (or CK’s designee)
the information, materials and assistance described in Appendix I hereto (to the extent not
already provided) in accordance with an agreed upon schedule. Promptly after the Amendment
Effective Date, CK shall designate the CK Clinical Studies Coordinator to work with the GSK
Alliance Director to coordinate and facilitate the foregoing, as well as the activities described
under Sections 2.6 and 2.7 of this Amendment. GSK shall also provide CK with such assistance as CK
reasonably requests from time to time to assist CK in [***] and [***] the
information and materials provided by GSK, including the timely provision to CK of copies of
updates and revisions of such information and materials.
2.6
[***] of SB-921. GSK shall provide to CK, at GSK’s expense for CK’s use in the
CK Clinical Studies only, the [***] of SB-921 [***] and [***] in GSK’s [***]
as of the [***] that GSK does not [***] for the [***] of GSK-[***]
SB-921 [***] (the “[***]”). As of [***], the
[***] of [***] is [***] and the [***] of [***] is [***]. GSK and CK shall agree upon a schedule pursuant to which GSK shall [***] and [***] the
[***] to [***] as soon as practicable following the Amendment Effective Date.
CK shall be solely responsible at its cost for [***] and [***] ([***] or through [***]) the requirements for [***] and [***] for the CK
Clinical Studies in [***] of the [***] provided by GSK, and GSK shall have no
obligation to [***] of SB-921 [***] and [***] in [***] of the
[***] for CK for the CK Clinical Studies or to [***] CK with any [***] of SB-921
[***] and [***] in [***] of the [***]. GSK shall provide CK with such
assistance as reasonably requested by CK in [***] the [***] to CK. CK shall be
responsible, at its expense, for the [***] of the [***] and for [***] and
[***] of SB-921 Products for the CK Clinical Studies.
2.7 Regulatory Matters.
2.7.1 CK shall have the right to access, use and reference data and regulatory filings in the
possession or control of GSK for SB-921 Products for use in connection with the CK Clinical
Studies. CK shall file its own IND(s) to support the CK Clinical Studies, which may
cross-reference GSK’s IND for SB-921 Products as appropriate. GSK shall provide such assistance as
reasonably requested by CK with respect to the filing and prosecution of IND(s) to support the CK
Clinical Studies. GSK shall have the [***] to [***] such CK IND(s)
and to [***] to such IND(s) [***]. In addition, GSK shall have the right to access,
use and reference data and regulatory filings in the possession or control of CK for SB-921
Products for use in clinical trials conducted by GSK and in regulatory filings made by GSK for
SB-921 Products, and, as need be, GSK may cross-reference CK’s IND or other regulatory filings for
SB-921 Products as appropriate.
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2.7.2 GSK and CK shall coordinate the submission of serious adverse event (SAE) reports and
routine adverse event (AE) reports to local regulatory authorities as required by applicable law.
To facilitate this reporting requirement, at a minimum, the Parties shall exchange SAE reports and
data-based AE summaries on a quarterly basis starting three (3) months after the Amendment
Effective Date and, promptly after the Amendment Effective Date, shall execute a Pharmacovigilance
Agreement setting forth each Party’s reporting obligations and coordination and exchange of safety
data.
2.7.3 If GSK exercises the GSK [***] Option, the Parties shall reasonably cooperate to
transfer from CK to GSK any regulatory filings made by CK for an SB-921 Product for an Additional
Indication, and CK shall provide such assistance as reasonably requested by GSK with respect to the
prosecution of an MAA for an SB-921 Product for an Additional Indication.
2.8 Additional Indemnification by CK.
2.8.1 General. Section 10.2.2 of the Agreement is hereby amended to add that CK
hereby agrees to indemnify, defend and hold GSK and its agents, directors and employees harmless
from and against any and all Losses resulting directly from (i) the [***] of the [***] or [***] or [***] of SB-921 Products for the CK Clinical Studies, in each case by
CK, its Affiliates, agents or Sublicensees, and (ii) the [***] or [***] of
CK, its Affiliates, agents or Sublicensees in conducting the CK Clinical Studies.
2.8.2 Procedure. In the event GSK is seeking indemnification under Section 2.8.1 of
this Amendment, it shall inform CK of the claim as soon as reasonably practicable after it receives
notice of the claim, shall permit CK to assume direction and control of the defense of the claim
(including the right to settle the claim) and shall cooperate as requested (at the expense of CK)
in the defense of the claim.
ARTICLE 3
ADDITIONAL AMENDMENTS TO THE AGREEMENT
ADDITIONAL AMENDMENTS TO THE AGREEMENT
3.1
Amendment of
Section 4.2.3. In addition to the amendments to the Agreement set
forth in Sections 1 and 2 of this Amendment, Section 4.2.3 of the Agreement is amended in its
entirety to read as follows:
4.2.3. CK Obligations for Extended Targets. Except as set forth herein, for so long
as GSK’s exclusivity with respect to a particular Collaboration Target or Extended Target is
extended under Section 4.2.1 or Section 4.2.2 of the Agreement, CK shall not conduct, participate
in, or fund, directly or indirectly, alone or with a Third Party, any research, development, or
commercialization activities in the Field with respect to such Collaboration Target or Extended
Target, as applicable, except pursuant to this Agreement.
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3.2 Amendment of Section 6.4.1. Section 6.4.1 of the Agreement is amended in its
entirety to read as follows:
6.4.1 [***]. For each Licensed Product that [***]:
Additional | |||||||||||||||||
Indication | |||||||||||||||||
MILESTONE | [***] | [***] | [***] | Amount*** | |||||||||||||
1. [***] |
$ | [***] | [***] | [***] | [***] | ||||||||||||
2. [***] |
$ | [***] | [***] | [***] | [***] | ||||||||||||
3. [***] |
$ | [***] | * | [***] | $ | [***] | $ | [***] | |||||||||
4. [***] |
$ | [***] | * | [***] | $ | [***] | $ | [***] | |||||||||
5. [***] |
$ | [***] | * | [***] | $ | [***] | $ | [***] | |||||||||
6. [***] |
$ | [***] | * | $ | [***] | ** | $ | [***] | $ | [***] | |||||||
7. [***] |
$ | [***] | * | $ | [***] | ** | $ | [***] | $ | [***] |
# For clarity, both “[***]” and “[***]” include any Licensed Product (including an SB-921 Product whether for
[***] or otherwise).
* In the event that an SB-921 Product is [***] for [***] to
achieve any one of Development Milestones 3-7 (each, as described in the table above) and:
(i) if such SB-921 Product is for [***], then, upon the next achievement of
such Development Milestone by an SB-921 Product for [***] other than [***], GSK shall pay to CK the corresponding amount set forth in the column “Additional
Indication Amount” in the table above; and
(ii) if such SB-921 Product is for [***] other than [***], then, upon the next achievement of such Development Milestone by an SB-921 Product for
[***], GSK shall pay to CK the corresponding amount set forth in the column
“Additional Indication Amount” in the table above.
** In
the event that an SB-921 Product achieves any one of Development
Milestones 3-7, but
is not [***] to achieve such Development Milestone (i.e.,
it
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is [***]) and such SB-921 Product is for [***], then GSK shall pay to CK the corresponding amount set forth in the column “Additional
Indication Amount” in the table above. For clarity, in addition to the foregoing milestone
payments, if an SB-921 Product for [***] other than [***] achieves Development Milestone 6 or 7 (whether prior to or after the achievement of the same
Development Milestone by an SB-921 Product for [***]), GSK shall pay to CK the
corresponding amount set forth in the column “[***]” in the table
above.
*** If GSK declines to conduct development of an SB-921 Product for the Additional Indication
specified in an Additional Indication [***] Notice in accordance with Section 2.3.4 of this
Amendment, GSK shall have no obligation to pay the amounts set forth in the column “Additional
Indication Amount” in the above with respect to such development for such Additional Indication.
3.3 Amendment of Section 6.4.3(a). Section 6.4.3(a) of the Agreement is amended in
its entirety to read as follows:
(a) In no event shall multiple Development Milestone payments be made for the same
Licensed Product, except in the event where (i) a Licensed Product for [***] is also the [***] Licensed Product directed against that Mitotic Kinesin Target to be [***]
for a [***], or (ii) an SB-921 Product is also being developed for an
Additional Indication.
3.4 Amendment of Section 6.6.3. Section 6.6.3 of the Agreement is amended to add the
following new Section 6.6.3(d) of the Agreement at the end thereof:
(d) In the event [***] for an SB-921 Product for [***] is [***] for an SB-921 Product for [***]
other than [***], then:
(i) If [***] is [***] for an SB-921 Product for [***] other than [***] after the [***] for [***], the otherwise applicable annual
royalty rate on Net Sales of SB-921 Products as determined according to Section
6.6.1 or 6.6.2 of the Agreement shall be increased by [***]; and
(ii) If [***] is [***] for an SB-921 Product for [***] other than [***] after the
[***] for [***], the otherwise applicable
annual royalty rate on Net Sales of SB-921 Products as determined according to
Section 6.6.1 or 6.6.2 of the Agreement shall be increased by [***] (i.e., [***] above the royalty rate
established under clause (i) of this Section 6.6.3(d) above).
*** 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.
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(iii) For clarity, the adjustments set forth in this Section 6.6.3(d) shall
apply to all Net Sales only after the occurrence of the applicable [***]
from the [***] for [***] regardless of whether
[***] for any SB-921 Product for [***]
other than [***] and provided that in no event shall any such
adjustment apply on a retroactive basis.
ARTICLE 4
MISCELLANEOUS
MISCELLANEOUS
4.1 Confidential Information. The Parties agree that CK’s rights under Sections 9.2
and 9.5 of the Agreement with respect to Confidential Information of GSK and Licensed Technology
shall include the right of CK to use and disclose such Confidential Information and Licensed
Technology in connection with the performance of its obligations or exercise of rights expressly
granted or reserved in this Amendment under appropriate confidentiality provisions equivalent to
those in the Agreement.
4.2 Other. Except as specifically modified or amended hereby, the Agreement shall
remain in full force and effect and, as modified or amended, is hereby ratified, confirmed and
approved. Notwithstanding the foregoing, to the extent any terms of this Amendment conflict with
the terms of the Agreement, the terms of this Amendment shall govern. No provision of this
Amendment may be modified or amended except expressly in a writing signed by both Parties nor shall
any terms be waived except expressly in a writing signed by the Party charged therewith. This
Amendment shall be governed in accordance with the laws of the State of New York, without regard to
principles of conflicts of laws.
[Signatures continue on following page]
***
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.
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IN WITNESS WHEREOF, the Parties have executed this Amendment in duplicate originals by their duly
authorized representatives as of the Amendment Effective Date.
CYTOKINETICS, INC. | GLAXO GROUP LIMITED | |||||||
By:
|
/s/ Xxxxx Xxxxx | By: | /s/ Xxxxxxx Xxxxxxxx | |||||
Name:
|
Xxxxx Xxxxx, M.D., Ph.D. | Name: | Xxxxxxx Xxxxxxxx | |||||
Title:
|
President & CEO | Title: | Assistant Secretary | |||||
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APPENDIX I
INFORMATION, MATERIALS AND ASSISTANCE
• | [***] | |
• | [***] | |
• | [***] | |
• | [***] | |
• | [***] | |
• | [***] | |
• | [***] |
***
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.
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