AMENDMENT NO. 3 TO DISTRIBUTION AGREEMENT BETWEEN CARDICA, INC. AND CENTURY MEDICAL, INC. (“DISTRIBUTOR”)
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.
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/ Xxxxx X. Xxxxxxxx | Date: | January 24, 2008 | |||||
| Century Medical, Inc.: | ||||||||
| By: | /s/ Xxxxxx Xxxxxxx | Date: | January 25, 2008 | |||||
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