Exhibit 10.8

 

SECOND AMENDMENT TO DEVELOPMENT AGREEMENT

 

This SECOND AMENDMENT TO DEVELOPMENT AGREEMENT (“Amendment”) is made as of June
27, 2005, by and between BOSTON SCIENTIFIC CORPORATION (“BSC”), a Delaware
corporation, and CORAUTUS GENETICS INC. (the “Company”), a Delaware corporation
(each a “Party,” and collectively, the “Parties”).

 

WHEREAS, pursuant to the Investment Agreement, dated July 30, 2003, between BSC
and Company (the “Investment Agreement”), BSC and Company agreed, subject to the
conditions set forth therein, to enter into a Loan Agreement, an Investor Rights
Agreement, a Development Agreement (as amended, the “Development Agreement”), a
Distribution Agreement and a Patent Sublicense Agreement;

 

WHEREAS, pursuant to such agreements, the Parties agreed to cooperate to develop
products that use VEGF-2 for the treatment of diseases of the heart or
peripheral vascular system;

 

WHEREAS, the Development Agreement requires the Company to use commercially
reasonable efforts to complete Clinical Development of the Final Product in
accordance with an established schedule set forth in Section 2.03 of the
Development Agreement;

 

WHEREAS, the Parties previously have amended the Development Agreement to modify
certain of the dates set forth in Section 2.03 of the Development Agreement in
the form of that certain First Amendment to Development Agreement dated as of
July 22, 2004;

 

WHEREAS, the Parties have agreed to, among other matters, modify further certain
of the dates in the schedule set forth in Section 2.03 of the Development
Agreement; and

 

WHEREAS, capitalized terms that are not defined in this Agreement shall have the
meanings assigned to such terms in the Development Agreement.

 

NOW, THEREFORE, in consideration of the premises and the mutual representations,
agreements and covenants set forth herein, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties desire to amend the Development Agreement as follows:

 

  1. Section 2.02. Section 2.02 of the Development Agreement is hereby deleted
in its entirety and replaced with the following:

 

“Clinical Plan. (a) Attached hereto as Exhibit A is the initial research and
development plan setting forth activities, schedules, milestones,
specifications, pre-clinical and clinical protocols and requirements for
development of the Principal Products (the “Clinical Plan”). The Company may,
from time to time, adopt or institute amendments, supplements and variations
(collectively, “Plan Modifications”) to the Clinical Plan; provided, however,
(i) the Company shall provide the BSC Representative Group with notice of all
such Plan Modifications and (ii) any Plan Modifications that would materially
alter the then current version of the Clinical Plan may only be made in
accordance with paragraphs (b) and (c) below. Notice of Plan Modifications may
be provided by the Company in the form of presentations made to the BSC
Representative Group, which, notwithstanding the provisions of Section 8.01, may
or may not be memorialized in written form.

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(b) With respect to Plan Modifications that would materially alter the then
current version of the Clinical Plan, the BSC Representative Group shall have an
opportunity to review and, except as provided in paragraph (c) below, approve or
reject such Plan Modifications; provided, however, the BSC Representative Group
shall not unreasonably withhold or delay approval of such Plan Modifications,
and if the BSC Representative Group has not rejected such Plan Modifications
within forty five (45) days of receiving notice of such Plan Modifications then
the BSC Representative Group will be deemed to have accepted such Plan
Modifications; provided, further, the Parties acknowledge and agree that it is
not unreasonable for the BSC Representative Group to reject any Plan
Modifications if BSC, in its sole discretion, believes such Plan Modifications
will have a material deleterious effect on BSC’s ability to market or distribute
the Injection Catheter. In the event that the BSC Representative Group rejects
such Plan Modifications, the Representatives shall have thirty (30) days to work
together to revise such Plan Modifications. If the Representatives cannot agree
on such Plan Modifications then, notwithstanding anything herein to the
contrary, the Company may proceed with the Clinical Plan, as modified by the
Company in its sole discretion; but BSC shall have no further obligation to
supply Injection Catheters pursuant to Section 2.10 of this Agreement, and the
Company shall return to BSC any and all Injection Catheters in its possession or
within its control.

 

(c) Notwithstanding paragraph (b) above, in the event any Plan Modifications to
the Clinical Plan are required by the FDA or other relevant Regulatory
Authorities, such Plan Modifications may be made by the Company without the
approval of the BSC Representative Group, and BSC shall continue to have the
obligation to supply Injection Catheters pursuant to Section 2.10 of this
Agreement.”

 

  2. Section 2.03 (b). Section 2.03 (b) of the Development Agreement is hereby
deleted in its entirety and replaced with the following:

 

  “(b) the initiation of a ***; and”

 

  3. Section 2.03 (c). Section 2.03 (c) of the Development Agreement is hereby
deleted in its entirety and replaced with the following:

 

  “(c) the ***.”

 

  4. Section 2.13. Section 2.13 of the Development Agreement is hereby deleted
in its entirety and replaced with the following:

 

“Training Advice and Assistance. BSC shall provide reasonable technical
assistance and training to the Company and its investigators regarding the usage
of Injection Catheter supplied to the Company. BSC shall, at its cost, provide
such assistance and training at a reasonable number of clinical sites, not to
exceed thirty (30) sites; provided, the Company agrees to reimburse BSC if BSC
is required to re-train a physician regarding the Injection Catheter at any such
site as a result of a lapse in such physician’s training.”

 

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“***” indicates redacted confidential information pursuant to a confidential
treatment request filed with the Securities and Exchange Commission.

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  5. All provisions of the Development Agreement, except to the extent
specifically amended as provided above, are hereby in all respects ratified and
confirmed.

 

  6. This Amendment may be signed in one or more counterparts, which when taken
together shall constitute one and the same Amendment.

 

IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed
by their respective officers thereunto duly authorized, as of the date first
above written.

 

CORAUTUS GENETICS INC. By:  

/s/ Richard E. Otto

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Richard E. Otto

President and Chief Executive Officer

BOSTON SCIENTIFIC CORPORATION By:  

/s/ Lawrence C. Best

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Lawrence C. Best

Executive Vice President and

Chief Financial Officer