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Exclusive License, Supply and Distribution Agreement

 

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Title:

Exclusive License, Supply and Distribution Agreement

Entities:

Oravax Inc

Date:

2002

Size:

Preview shows 6KB of 78KB total

Price:

$50

ID:

#1408107

 

 

► Licensing ► Distribution ► Supply ► License ► Exclusive License, Supply & Distribution Agreements

 

 

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              EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT

----------------------------------------------------

This Agreement, made as of December 18, 2000 (the "Effective Date"), between
ORGANOGENESIS INC., a company organized under the laws of the State of
Delaware, having a present principal address at 150 Dan Road, Canton,
Massachusetts 02021, USA (hereinafter "Organogenesis"), and Royce Medical
Company, a corporation organized under the laws of the State of California,
having a present principal address at 742 Pancho Road, Camarillo, CA 93012
(hereafter "Royce");

WITNESSETH:
-----------

WHEREAS, Organogenesis has developed a proprietary natural acellular
biomaterial ("ECM(tm)"), defined below, that has applications as a wound
dressing; and

WHEREAS, Royce wishes to purchase products, devices, or processes which
incorporate ECM and are covered by a Valid Patent Claim from Organogenesis
exclusively for resale in the United States as a wound dressing from supplies
purchased by Organogenesis from an entity of Organogenesis' choosing; and

WHEREAS, Royce desires to obtain an exclusive license from Organogenesis in the
United States to distribute ECM, as described herein;

NOW, THEREFORE, the parties agree that:

ARTICLE 1. CERTAIN DEFINITIONS
------------------------------

The following terms shall have the following meanings whenever used in this
Agreement:

1.1 "Affiliate" means any corporation or other entity that controls, is
-----------
controlled by, or is under common control with, a party to this
Agreement. A corporation or other entity shall be regarded as in
control of another corporation or entity if it owns or directly or
indirectly controls more than fifty percent (50%) of the voting
stock or other ownership interest of the other corporation or
entity, or if it possesses, directly or indirectly, the power to
direct or cause the direction of the management and policies of the
corporation or other entity.

1.2 "Alternate Site Market" means general and family practitioners',
-----------------------
orthopedists', dermatologists', Home Healthcare Agencies',
diabeticians', obstetricians', gynecologists', cosmetic surgeons'
and podiatrists' offices or clinics; and nursing homes.

1

<PAGE>


* CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.

1.3 "Collagen Wound Dressing" means any article that is (i) regulated
-------------------------
by FDA as a wound dressing, and (ii) consists primarily of
non-human collagen.

1.4 "Development Plan" shall mean the plan for the development and FDA
------------------
Approval of Products, as hereinafter defined, as set forth in
Schedule A. The parties shall modify and extend Schedule A from
time to time throughout the Term as required to assure successful
commercialization.

1.5 "ECM" means a natural acellular biomaterial derived from porcine
-----
small intestine, which biomaterial is covered by a Valid Patent
Claim, as hereinafter defined.

1.6 "FDA" means the United States Food and Drug Administration.
-----

1.7 "Field" means distribution of ECM to the Alternate Site Market for
-------
use solely as a Collagen Wound Dressing.

1.8 "First Commercial Sale" of any Product means the first bona-fide
-----------------------
commercial sale for use or consumption of that Product in the
Territory after FDA has cleared or approved marketing of that
Product, if required.

1.9 "Marketing Plan" means the financial projections and timelines for
----------------
commercializing any Product as set forth in Schedule B, along with
supporting plans for selling strategies, promotional plans and
other related sales and marketing initiatives. The parties shall
modify and extend Schedule B from time to time throughout the Term
as required to facilitate successful commercialization.

1.10 "Net Sales" means the gross invoice price of any Product sold to
-----------
independent, third-party customers in bona fide, arms-length
transactions, less all credits including (i) quantity and/or cash
discounts actually allowed or taken; (ii) freight, postage and
insurance (allocated in accordance with generally acceptable
accounting principles consistently applied (GAAP)); (iii) amounts
repaid or credited by reasons of rejections or return of goods;

 

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