[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

Exhibit 10.1

Confidential

 

April 11, 2017

 

Masao Kaku

Business Development

Astellas Pharma Inc.

2-5-1, Nihonbashi-Honcho

Chuo-ku, Tokyo 103-8411

Japan

 

 

RE:Amendment to Collaboration Agreement; Payment Mechanism under Section [*]

 

Dear Masao:

 

As you know, Astellas Pharma Inc. (“Astellas”) and Cytokinetics, Inc.
(“Cytokinetics”) are parties to that certain Amended and Restated License and
Collaboration Agreement dated December 22, 2014 (the “Collaboration Agreement”),
as amended, including the amendment dated July 27, 2016 (the “2016
Amendment”).  Capitalized terms used in this letter and not otherwise defined
will have the meaning ascribed in the Collaboration Agreement.  The Parties
hereby agree to amend the Collaboration Agreement as follows, effective as of
April 1, 2017:

 

 

1.

To account for the fact that Astellas will also be incurring a portion of the
Added Indication Development Costs for ALS as an Added Indication, the text in
the attached exhibit shall be added to Section [*] of the Collaboration
Agreement.

If the foregoing is acceptable and agreed to by Astellas, please so indicate by
having an authorized representative of Astellas sign this Amendment in the
appropriate signature line below, and return such signed copy to Elisabeth
Schnieders, Ph.D., Sr. Vice President, Business Development, at your earliest
convenience.  If you have any questions or comments, please do not hesitate to
contact Elisabeth at (650) 624-3083 or by e-mail at
eschnieders@cytokinetics.com.

 

Agreed and accepted:

 

Astellas Pharma Inc.

By:  /s/ Jun Kuno

Name:

Jun Kono

Title:

VP, Global Head of Business Development

Date: April 19, 2017

 

 

 

 

 

 

 

 

 

Sincerely,

 

/s/ Robert I. Blum

 

Robert I. Blum

President & CEO

 

 

 

 

 

 

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

Confidential

Exhibit

(d)Sharing of Development Costs for ALS as an Added Indication.  
Notwithstanding Section [*] above, for ALS as an Added Indication, the
reimbursement of the Development Costs to effect the cost allocation set forth
in this Agreement, as amended by the Amendment shall be as follows:  

(i)Advance Payment.  For each calendar quarter in which Cytokinetics is
anticipated to conduct Added Indication Development Work for ALS under the
Development Plan, Cytokinetics shall submit to Astellas an invoice setting forth
Cytokinetics’ estimated Cytokinetics ALS Development Reimbursement (defined
below) for ALS based on the then-current Added Indication Development Budget for
ALS as an Added Indication for the current calendar quarter, no later than [*]
Business Days following the first day of such calendar quarter (the “ALS
Development Advance Invoice”).    

(ii)True-Up.  Within [*] days after the end of each such calendar quarter,
Cytokinetics shall submit to Astellas a reasonably detailed reconciliation
report setting forth the accounting for the actual Cytokinetics ALS Development
Reimbursement for such prior calendar quarter and any credits or deficits from
the corresponding ALS Development Advance Invoice previously provided for such
quarter (the “ALS Development True-Up Report”).  Then:

 

(1)

If the ALS Development True-Up Report shows that the estimated Cytokinetics ALS
Development Reimbursement shown on the ALS Development Advance Invoice is less
than the actual Cytokinetics ALS Development Reimbursement (the difference
thereof, the “Deficit”), and such Deficit is greater than the Astellas ALS
Development Reimbursement for such prior calendar quarter (as defined below), if
any, then Astellas shall pay the amount that is the difference between such
Deficit and the Astellas ALS Development Reimbursement to Cytokinetics as
described in this Section [*](d)(ii).  

 

(2)

If the ALS Development True-Up Report shows a Deficit and such Deficit is less
than the Astellas ALS Development Reimbursement for such prior calendar quarter,
if any, then the difference between such Deficit and the Astellas ALS
Development Reimbursement shall be credited toward the ALS Development Advance
Invoice for the current calendar quarter (except where such invoice is the final
such invoice to be provided by Cytokinetics, in which case the excess shall be
refunded by Cytokinetics to Astellas within [*] days after the delivery of such
invoice).

 

(3)

If the ALS Development True-Up Report shows that the estimated Cytokinetics ALS
Development Reimbursement shown on the ALS Development Advance Invoice is
greater than the actual Cytokinetics ALS Development Reimbursement (the
difference thereof, the “Credit”), then the sum of such Credit and the Astellas
ALS Development Reimbursement, if any, shall be credited toward the ALS
Development Advance Invoice for the current

 

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

Confidential

 

 

calendar quarter (except where such invoice is the final such invoice to be
provided by Cytokinetics, in which case the excess shall be refunded by
Cytokinetics to Astellas within [*] days after the delivery of such invoice).

 

(4)

“Cytokinetics ALS Development Reimbursement” shall mean, in each case to the
extent permitted by the [*] under Section 6.4(d) of the Agreement: (A) the
Astellas Portion (as defined below) of the Added Indication Development Costs
for ALS incurred by or on account of Cytokinetics; plus (B) 100% of any other
Development Costs for ALS (e.g., country-specific development activities for the
Astellas Territory and [*]) incurred by or on account of Cytokinetics; minus (C)
any portion of the Added Indication Development Costs for ALS incurred by or on
account of Cytokinetics prior to Initiation of the Pivotal Registration Study,
which Astellas is required to solely fund but Cytokinetics elects to co-fund
under Section 1.3(c)(i) of the Amendment; and plus (D) any portion of the Added
Indication Development Costs for ALS incurred by or on account of Cytokinetics
after Initiation of the Pivotal Registration Study, which Cytokinetics is
required to co-fund but makes the deferral election, to the extent permitted by
and in accordance with Section 1.3(c)(iv) of the Amendment.  The “Astellas
Portion” means: (aa) prior to the Initiation of the Pivotal Registration Study
for the Lead Product (or any Other Collaboration Product, if earlier) in ALS,
100%; and (bb) on and after the Initiation of the Pivotal Registration Study for
the Lead Product (or any Other Collaboration Product, if earlier) in ALS, 50%.

 

(5)

“Astellas ALS Development Reimbursement” shall mean, in each case to the extent
permitted by the [*] under Section 6.4(d) of the Agreement: (A) 50% of the Added
Indication Development Costs for ALS incurred by or on account of Astellas after
Initiation of the Pivotal Registration Study; plus (B) any portion of the Added
Indication Development Costs for ALS incurred by or on account of Astellas prior
to Initiation of the Pivotal Registration Study, which Astellas is required to
solely fund but Cytokinetics elects to co-fund under Section 1.3(c)(i) of the
Amendment; and minus (C) any portion of the Added Indication Development Costs
for ALS incurred by or on account of Astellas after Initiation of the Pivotal
Registration Study, which Cytokinetics is required to co-fund but makes the
deferral election, to the extent permitted by and in accordance with Section
1.3(c)(iv) of the Amendment.  

(iii)Timing of Payment.  For ease of administration, Astellas shall pay
Cytokinetics a single payment reflecting the amount due under the ALS
Development Advance Invoice for the current calendar quarter plus any deficits
(or less any credits) reflected in the ALS Development True-Up Report for the
prior calendar quarter, and submit to Cytokinetics a reasonably detailed report
setting forth the accounting for any Astellas Solely Funded Costs as defined in
the Amendment (if any) and Astellas ALS Development Reimbursement, all within
the later of (1) [*] days of Astellas’ receipt of such ALS Development Advance
Invoice, or (2) [*] days of Astellas’ receipt of such ALS Development True-Up
Report.  In addition, for accounting purposes, within [*] days after the end of
each calendar quarter, Astellas shall submit

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

Confidential

 

a reasonable estimate of Astellas Solely Funded Costs as defined in the
Amendment (if any) and Astellas ALS Development Reimbursement for the current
calendar quarter.

(iv)Within [*] days after the end of each calendar quarter in which Cytokinetics
is not anticipated to conduct Added Indication Development Work for ALS under
the Development Plan but in which Astellas conducts Added Indication Development
Work for ALS under the Development Plan, Astellas shall submit to Cytokinetics a
reasonably detailed accounting for the Astellas ALS Development Reimbursement
and the Astellas Solely Funded Costs, as well as an invoice for the Astellas ALS
Development Reimbursement.  Cytokinetics shall either: (aa) pay to Astellas the
amount of Astellas ALS Development Reimbursement invoiced within [*] days after
the receipt of the invoice, to the extent such amounts do not exceed the
applicable then-current Added Indication Development Budget as approved by the
JDC by more than [*]; or (bb) elect to defer such payment obligations to the
extent permitted by and in accordance with Section 1.3(c)(iv) of the Amendment.

 

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.