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Title: |
Product Development and Supply Agreement |
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Entities: |
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Date: |
2002 |
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Size: |
Preview shows 6KB of 87KB total |
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Price: |
$49 |
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ID: |
#1408113 |
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* CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERICKS DENOTE OMISSIONS.
Product Development and Supply Agreement
This Product Development and Supply Agreement, dated as of August 24, 2001
(hereinafter the "Effective Date"), sets forth the agreement between BIOMET,
INC., an Indiana corporation ("Biomet"), having an office and principal place of
business at 56 East Bell Drive, P.O. Box 587, Warsaw, Indiana 46581-0587, and
ORGANOGENESIS INC., a Delaware corporation ("OI") having an office and principal
place of business at 150 Dan Road, Canton, Massachusetts 02021.
BACKGROUND
WHEREAS, OI owns or has licenses for technology and is developing certain
products relating to the use of natural acellular biomaterials for applications
in human musculoskeletal tissues including bone and tissue, and is seeking
funding to further its research and development of products using such
technology through establishment of a sponsored product development program; and
WHEREAS, Biomet is willing to fund such further product development under the
terms and conditions of this Agreement, and
WHEREAS, OI is willing to exclusively sell to Biomet such products for resale by
Biomet for certain applications in human musculoskeletal tissues including bone
and tissue as set forth herein; and
WHEREAS, Biomet is willing to purchase its requirements of such products for
such application exclusively from OI as set forth herein; and
WHEREAS, the Parties acknowledge that as not all proposed products may be
successfully developed or commercialized, the Parties agree that Biomet may,
while retaining the rights for other products, return to OI the rights to
purchase for resale the products which cannot be successfully commercialized in
accordance with the terms and conditions of this Agreement;
NOW, THEREFORE, in consideration of the mutual representations, warranties and
promises contained herein, Biomet and OI agree as follows:
Article 1 - Certain Definitions
When used herein, the following terms shall have the meanings set forth below:
1.1 "Affiliate" shall mean any corporation or other entity that controls,
is controlled by, or is under common control with, a Party.
1.2 "Agreement" shall mean this Product Development and Supply Agreement.
1.3 "Biomet" shall mean Biomet, Inc., an Indiana corporation, and any
Affiliate in which Biomet controls either directly or indirectly at least 50%
dollar value of the stock or voting rights.
Page 1 of 25
<PAGE>
* CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERICKS DENOTE OMISSIONS.
1.4 "Biomet Technology" shall mean technology developed solely by Biomet
after the Effective Date if used in the manufacture of Products, as hereafter
defined, under this Agreement.
1.5 "Clinical Investigation" shall mean each investigation on humans, and
the data derived therefrom, for a proposed or Launched Product, as hereafter
defined.
1.6 "FDA" shall mean the U.S. Food and Drug Administration in the United
States and, for regulatory matters in foreign countries, the competent
regulatory agencies and authorities in such countries.
1.7 "FortaFlex" shall mean a natural acellular collagen derived from
porcine small intestine embodying OI Technology, as hereafter defined. FortaFlex
is a trademark of OI.
1.8 "Field" shall mean each of the following [***] market areas: [***]
(each, separately, referred to as a "Product Application"), but excluding
FortaFlex used as a [***].
1.9 "Improvement(s)" shall mean any enhancement or improvement to any
Product invented or conceived by or on behalf of OI or jointly by both Parties
during the Term, whether or not patentable.
1.10 "Joint Technology" shall mean Proprietary Technology Rights, as
hereafter defined, developed jointly by both Parties during the Term.
1.11 "Launch(ed)" shall mean the first commercial sale of a Product.
1.12 "Management Committee" shall mean the committee described in paragraph
3.1 of this Agreement.
1.13 "Net Sales" shall mean the total of all amounts invoiced by Biomet or
its authorized Affiliates and sublicensees for sales of Products to independent,
unrelated entities, less only the following deductions: (i) trade and/or
quantity discounts actually allowed and taken in such amounts as are customary
in the trade; (ii) sales and other excise taxes and duties paid, absorbed or
allowed; and (iii) amounts repaid or credited by reason of rejection, defects or
returns, or because of retroactive price reductions.
1.14 "OI" shall mean Organogenesis Inc., a Delaware corporation, and any
subsidiary or Affiliate thereof in which OI controls either directly or
indirectly at least 50% of the stock or voting rights.
1.15 "OI Technology" shall mean the Proprietary Technology Rights developed
or owned solely by OI that relate to FortaFlex and/or Products, including but
not limited to Patents.
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