Exhibit 10.8
AMENDMENT NO. 3 TO DISTRIBUTION AGREEMENT BETWEEN
CARDICA, INC. AND CENTURY MEDICAL, INC. (“DISTRIBUTOR”)
In accordance with Paragraph 14.11 of the Distribution Agreement between Cardica
(“Company”) and Distributor dated June 16, 2003, in consideration of the ongoing
responsibilities of both Company and Distributor under the Distribution
Agreement, Company and Distributor agree as follows:

A.  
Amendment to Section 4.1(ix). Section 4.1(ix) of the Distribution Agreement is
hereby deleted in its entirety and replaced with the following provision:

“4.1 (ix)(a) Distributor shall translate into the local languages of the
Territory, at its own expense, any promotional materials, advertising or
marketing information (“Marketing Materials”) supplied at the discretion of
Company which Distributor determines may be useful in the marketing of Products.
Distributor shall translate the Marketing Materials as is, and shall not make
claims regarding the use of the Products that are not present in the English
language materials. Distributor will forward to Company a copy of all translated
Marketing Materials. Any revision to such translated Marketing Materials must be
sent to Company within 30 days of its release.
4.1(ix)(b) Distributor shall translate labeling, including instructions for use,
for the Products into the official languages of the territory. Distributor will
provide Company such translated labeling within 5 days after such translation is
complete, and before distributing Products bearing such labeling. Distributor
shall not distribute Products bearing translated labeling before receiving
approval from Company, which shall not be unreasonably withheld. Based upon the
fact that Company and Distributor have been necessarily and adequately
communicated regarding translations and amendments of instructions for use for
the Products, both Company and Distributor hereby recognize that current
translation of instructions for use for the Products under use by the
Distributor in Japan is considered approved one by the Company.
4.1(ix)(c) Exemption of the Company approval in 4.1(ix)(b).
With regard to the translation of instructions for use for the Products,
Distributor shall amend the instructions for use as necessary in accordance with
the Japanese Pharmaceutical Affairs Law and its related ordinances or guidance
issued by the MHLW. Distributor shall also amend the translation as necessary
whenever requested by the MHLW or PMDA. In addition, Distributor can amend the
translation as a mean of preventive actions for adverse events or device
malfunctions. In any major amendments (except minor amendments) in the above
cases, Distributor will provide Company such translated instructions for use,
for review by Company.

 

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B. Amendment to Section 5.1(vii). The following provision is added to
Section 5.1(vii):
“(e) Company shall review labeling translated by Distributor under Section
4.1(ix)(b) and (c), including instructions for use, within 10 days of receipt.”

                      Cardica, Inc.:        
 
               
 
  By:   /s/ Chris W. Holscher   Date:   January 24, 2008
 
               

                      Century Medical, Inc.:        
 
               
 
  By:   /s/ Toshio Konishi   Date:   January 25, 2008
 
               

 

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