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CARDICA INC | Century Medical, Inc.. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here. |
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[*] = CERTAIN INFORMATION IN
THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Exhibit 10.6
Distribution Agreement
by and between
Cardica, Inc.
a Delaware Corporation
and
Century Medical, Inc.
a Japanese Corporation
Dated as of June 16, 2003
Table of Contents
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1. |
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DEFINITION OF TERMS |
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1 |
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1.1 |
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“Competing
Products” |
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1 |
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1.2 |
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“Contract Year” |
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1 |
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1.3 |
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“First Commercial
Sale” |
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1 |
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1.4 |
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“Initial Term” |
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1 |
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1.5 |
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“Party” or
“Parties” |
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1 |
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1.6 |
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“Premarketing
Term” |
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2 |
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1.7 |
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“Products” |
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2 |
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1.8 |
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“Territory” |
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2 |
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2. |
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APPOINTMENT OF DISTRIBUTOR |
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2 |
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2.1 |
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Appointment as DISTRIBUTOR
by COMPANY |
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2 |
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2.2 |
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Subdistributors |
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3 |
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3. |
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TERM OF DISTRIBUTORSHIP |
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3 |
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4. |
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DUTIES OF DISTRIBUTOR |
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3 |
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4.1 |
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Duties of DISTRIBUTOR |
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3 |
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4.2 |
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Product Approvals |
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4 |
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5. |
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DUTIES OF COMPANY |
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5 |
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5.1 |
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Duties of COMPANY |
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5 |
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6. |
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EXPENSES |
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6 |
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6.1 |
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DISTRIBUTOR’s
Expenses |
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6 |
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6.2 |
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COMPANY’s Expenses |
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6 |
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7. |
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RECORDS AND REPORTS |
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6 |
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7.1 |
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Records and Reports |
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6 |
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7.2 |
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Adverse Experience
Reporting |
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7 |
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7.3 |
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Updating/Revising Agreement |
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7 |
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7.4 |
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Recall |
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7 |
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8. |
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SALES OF PRODUCT TO
DISTRIBUTOR |
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7 |
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8.1 |
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Purchase Prices and Terms |
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7 |
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8.2 |
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Risk of Loss, Deliveries |
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8 |
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8.3 |
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Acceptance and Cancellation
of Orders |
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8 |
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-i-
Table of Contents
(continued)
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8.4 |
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Product Specifications |
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8 |
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8.5 |
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Taxes |
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9 |
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8.6 |
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Purchase Levels |
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9 |
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9. |
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PRODUCT LIABILITY |
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11 |
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9.1 |
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Claim, Suit or Action |
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11 |
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9.2 |
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Product Liability Insurance |
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11 |
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10. |
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WARRANTY POLICY |
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12 |
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10.1 |
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Warranties |
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12 |
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10.2 |
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Rejection of Products |
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13 |
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11. |
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PATENTS, TRADEMARKS,
COPYRIGHTS; PROPRIETARY AND CONFIDENTIAL INFORMATION |
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13 |
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11.1 |
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Trademark License |
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13 |
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11.2 |
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Duty to Preserve
Confidentiality |
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14 |
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11.3 |
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Proprietary |
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12. |
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INDEMNITIES |
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14 |
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12.1 |
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Indemnity |
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14 |
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12.2 |
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Infringing Products |
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15 |
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13. |
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TERMINATION |
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15 |
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13.1 |
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Cancellation for Cause |
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15 |
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13.2 |
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Obligations upon
Cancellation or Termination |
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16 |
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14. |
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GENERAL PROVISIONS |
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18 |
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14.1 |
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Force Majeure |
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18 |
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14.2 |
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Relationship Between Parties |
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18 |
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14.3 |
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Successors,
Nonassignability |
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19 |
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14.4 |
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Survival of Obligations |
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19 |
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14.5 |
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Remedies |
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19 |
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14.6 |
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Notices |
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19 |
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14.7 |
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Disputes |
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20 |
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14.8 |
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Unenforceable Terms |
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20 |
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14.9 |
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Waivers |
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20 |
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-ii-
Table of Contents
(continued)
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14.10 |
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Governing Law; Headings |
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20 |
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14.11 |
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Entire Agreement,
Modification |
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21 |
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14.12 |
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Further Assurances |
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21 |
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14.13 |
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Schedules |
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21 |
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14.14 |
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Counterparts |
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21 |
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SCHEDULE 1. |
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Products and Prices |
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22 |
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SCHEDULE 2. |
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Memorandum of Compliance |
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23 |
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SCHEDULE 3. |
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Reporting for Product
Defects, Adverse Events, Overseas Corrective Action Reports and Research
Reports |
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25 |
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-iii-
DISTRIBUTION AGREEMENT
This DISTRIBUTION AGREEMENT
(“Agreement”) is made this 16th day of June, 2003 (“Effective
Date”), by and between Cardica, Inc., a Delaware corporation with its
principal place of business located at 171 Jefferson Drive, Menlo Park, CA
94025, USA (hereinafter referred to as “COMPANY”) and Century
Medical, Inc., a Japanese Corporation with its principal place of business
located at 1-6-4 Ohsaki, Shinagawa-Ku, Tokyo, 141-8588, Japan (hereinafter
referred to as “DISTRIBUTOR”) in consideration of the mutual
covenants and conditions hereinafter stated.
1. DEFINITION OF TERMS
1.1 “Competing
Products”
“Competing
Products” shall mean automated anastomosis products that seal coronary
artery bypass grafts to accomplish surgical anastomosis except for and
excluding hemostasis products that, as of the Effective Date, DISTRIBUTOR
distributes in the Territory that are manufactured by CryoLife, Inc.
(BioGlue™), which shall not be considered Competing Products or other
anastomosis devices that create a surgical anastomosis outside the coronary
area of the body.
1.2 “Contract
Year”
“Contract Year”
shall mean a twelve (12) month period commencing on, and thereafter
beginning on the anniversary of, the first day of the first full month
following the date of First Commercial Sale in the Territory of any Product.
1.3 “First
Commercial Sale”
“First Commercial
Sale” shall mean the first sale of any Product with the intended maximum
shelf life of twelve (12) months or more by DISTRIBUTOR to a third party
in the Territory with all medical device approvals required to market and sell
such Product (“Shonin” or “Lui Betsu Kyoka”) from The
Japanese Ministry of Health, Labour and Welfare (“MHLW”) and all
import permits from the appropriate government authorities (“Hinmoku
Kyoka”). COMPANY hereby represents and warrants that, as of the Effective
Date, COMPANY has obtained conditional CE Mark approval for the “Proximal
Device” Product and the Proximal Device Product is a commercially
available Product to DISTRIBUTOR to begin the device approval process stated
above.
1.4 “Initial
Term”
“Initial Term”
shall mean the five (5) year period beginning on the date of expiration of
the Premarketing Term.
1.5 “Party” or
“Parties”
“Party” or
“Parties” shall mean COMPANY or DISTRIBUTOR, individually and
collectively.
[*] = CERTAIN INFORMATION IN
THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
1.
1.6 “Premarketing
Term”
“Premarketing
Term” shall mean the period beginning on the Effective Date and ending on
the first day of the first full month following the date of First Commercial
Sale of all Products.
1.7 “Products”
“Products” shall
mean those Products specifically listed in Schedule 1, whether
manufactured by or for COMPANY or its affiliates, including any improvements or
modifications thereto, as such schedule may be amended from time to time. As
used herein, “affiliate” means a person or entity that directly, or
indirectly through one or more intermediaries, controls, or is controlled by,
or is under common control with, a specified person or entity, where
“control” means (a) fifty percent (50%) or more common equity
ownership, or (b) the ability to direct the management or policies of a
person or entity, whether by contract or otherwise.
1.8
“Territory”
“Territory” shall
mean Japan.
2. APPOINTMENT OF DISTRIBUTOR






