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Distribution Agreement

Distribution Agreement

Distribution Agreement You are currently viewing:
This Distribution Agreement involves

CARDICA INC | Century Medical, Inc.

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Title: Distribution Agreement
Governing Law: California     Date: 2/2/2006
Industry: HTHEQP     Sector: HEALTH

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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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Page

 

1.

 

DEFINITION OF TERMS

 

 

1

 

 

 

1.1

 

“Competing Products”

 

 

1

 

 

 

1.2

 

“Contract Year”

 

 

1

 

 

 

1.3

 

“First Commercial Sale”

 

 

1

 

 

 

1.4

 

“Initial Term”

 

 

1

 

 

 

1.5

 

“Party” or “Parties”

 

 

1

 

 

 

1.6

 

“Premarketing Term”

 

 

2

 

 

 

1.7

 

“Products”

 

 

2

 

 

 

1.8

 

“Territory”

 

 

2

 

2.

 

APPOINTMENT OF DISTRIBUTOR

 

 

2

 

 

 

2.1

 

Appointment as DISTRIBUTOR by COMPANY

 

 

2

 

 

 

2.2

 

Subdistributors

 

 

3

 

3.

 

TERM OF DISTRIBUTORSHIP

 

 

3

 

4.

 

DUTIES OF DISTRIBUTOR

 

 

3

 

 

 

4.1

 

Duties of DISTRIBUTOR

 

 

3

 

 

 

4.2

 

Product Approvals

 

 

4

 

5.

 

DUTIES OF COMPANY

 

 

5

 

 

 

5.1

 

Duties of COMPANY

 

 

5

 

6.

 

EXPENSES

 

 

6

 

 

 

6.1

 

DISTRIBUTOR’s Expenses

 

 

6

 

 

 

6.2

 

COMPANY’s Expenses

 

 

6

 

7.

 

RECORDS AND REPORTS

 

 

6

 

 

 

7.1

 

Records and Reports

 

 

6

 

 

 

7.2

 

Adverse Experience Reporting

 

 

7

 

 

 

7.3

 

Updating/Revising Agreement

 

 

7

 

 

 

7.4

 

Recall

 

 

7

 

8.

 

SALES OF PRODUCT TO DISTRIBUTOR

 

 

7

 

 

 

8.1

 

Purchase Prices and Terms

 

 

7

 

 

 

8.2

 

Risk of Loss, Deliveries

 

 

8

 

 

 

8.3

 

Acceptance and Cancellation of Orders

 

 

8

 

-i-


 

Table of Contents
(continued)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Page

 

 

 

8.4

 

Product Specifications

 

 

8

 

 

 

8.5

 

Taxes

 

 

9

 

 

 

8.6

 

Purchase Levels

 

 

9

 

9.

 

PRODUCT LIABILITY

 

 

11

 

 

 

9.1

 

Claim, Suit or Action

 

 

11

 

 

 

9.2

 

Product Liability Insurance

 

 

11

 

10.

 

WARRANTY POLICY

 

 

12

 

 

 

10.1

 

Warranties

 

 

12

 

 

 

10.2

 

Rejection of Products

 

 

13

 

11.

 

PATENTS, TRADEMARKS, COPYRIGHTS; PROPRIETARY AND CONFIDENTIAL INFORMATION

 

 

13

 

 

 

11.1

 

Trademark License

 

 

13

 

 

 

11.2

 

Duty to Preserve Confidentiality

 

 

14

 

 

 

11.3

 

Proprietary

 

 

14

 

12.

 

INDEMNITIES

 

 

14

 

 

 

12.1

 

Indemnity

 

 

14

 

 

 

12.2

 

Infringing Products

 

 

15

 

13.

 

TERMINATION

 

 

15

 

 

 

13.1

 

Cancellation for Cause

 

 

15

 

 

 

13.2

 

Obligations upon Cancellation or Termination

 

 

16

 

14.

 

GENERAL PROVISIONS

 

 

18

 

 

 

14.1

 

Force Majeure

 

 

18

 

 

 

14.2

 

Relationship Between Parties

 

 

18

 

 

 

14.3

 

Successors, Nonassignability

 

 

19

 

 

 

14.4

 

Survival of Obligations

 

 

19

 

 

 

14.5

 

Remedies

 

 

19

 

 

 

14.6

 

Notices

 

 

19

 

 

 

14.7

 

Disputes

 

 

20

 

 

 

14.8

 

Unenforceable Terms

 

 

20

 

 

 

14.9

 

Waivers

 

 

20

 

-ii-


 

Table of Contents
(continued)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Page

 

 

 

14.10

 

Governing Law; Headings

 

 

20

 

 

 

14.11

 

Entire Agreement, Modification

 

 

21

 

 

 

14.12

 

Further Assurances

 

 

21

 

 

 

14.13

 

Schedules

 

 

21

 

 

 

14.14

 

Counterparts

 

 

21

 

SCHEDULE 1.

 

Products and Prices

 

 

22

 

SCHEDULE 2.

 

Memorandum of Compliance

 

 

23

 

SCHEDULE 3.

 

Reporting for Product Defects, Adverse Events, Overseas Corrective Action Reports and Research Reports

 

 

25

 

-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