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Exhibit 10.46
LICENSE AGREEMENT
This License Agreement (this "Agreement") is made as of December
9, 1999 by and between Biocoat, Incorporated ("Biocoat"), a
Pennsylvania corporation with its principal place of business at
455 Pennsylvania Ave., Fort Washington, PA 19034 and Micro
Therapeutics, Inc. ("MTI") a California corporation with its
principal place of business at: 2 Goodyear, Irvine,
California 92618.
WHEREAS, Biocoat owns patent rights and is licensed under patent
rights of others with the right to sublicense, and possesses
know-how and technical information relating to lubricious
hydrophilic coatings, for application to medical devices, such as
catheters and guidewires, and
WHEREAS, MTI desires to obtain a license from Biocoat under such
patent rights and to have access to Biocoat know-how and technical
information to enable MTI to apply such coatings, to be furnished
by Biocoat, to certain products and Biocoat is agreeable to
granting such a license pursuant to the terms of this
Agreement,
NOW, THEREFORE, in consideration of the terms, conditions and
covenants set forth below, the parties hereby agree as follows:
1.0
Definitions . For purposes of this
Agreement, the following definitions shall apply:
1.1
"Affiliate " means, with respect to any
party, its direct or indirect parent company, if any, and any
company, firm or other entity more than fifty percent (50%) of
whose issued and
voting capital or share participation is owned or
controlled, directly or indirectly, by such party or by its parent
company, but only for so long as such ownership or control shall
continue.
1.2
" Product " means any of the products
described in Schedule A, which is attached to and made part of this
Agreement. MTI reserves t he right to add and/or modify
Schedule A for newly developed products, subject to approval by
Biocoat, which approval will not be withheld unless the change
conflicts with contractual obligations to a third party.
1.3
" Net Sales " means the net billings of MTI
and its Affiliates from sales of Licensed Products to unaffiliated
(i.e., other than Affiliate) third parties, after deducting normal
and customary cash and trade discounts, returns, allowances and
commissions to agents, and any excise, sales or use or other
similar taxes.
1.4
" Field " means devices used in vascular
access procedures.
1.5
" Medical Device Company " means a company
which manufactures or markets "finished devices" as that term is
defined in the Current Good Manufacturing Practice regulation of
the U.S. Food and Drug Administration.
1.6
" Patents " means the patents and patent
application described in Schedule B, which is attached to and made
a part of this Agreement.
1.7
" Technology " means any process for applying
a coating of hyaluronan to medical devices utilizing any
adhesive
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layer consisting of acrylic
copolymers.
1.8
" Proprietary Information " means all
know-how, trade secrets, inventions, data, technology, and
information, owned, acquired, developed or controlled by, or
licensed to, Biocoat relating to the Patents or the Technology
which is used or useful with respect to Licensed Products,
including the composition and processes for producing the acrylic
copolymers and hyaluronan solutions.
1.9
" Licensed Product " means any Product
indicated for use in the Field which is processed with a coating of
hyaluronan using the Patents or the Proprietary
Information.
1.10
" Territory " means all countries of the
world.
2.1
Subject to the terms of this Agreement, Biocoat
hereby grants to MTI non-exclusive licenses in the Territory under
the Patents and the Proprietary Information, to make, have made,
use and sell Licensed Products with respect to those Products
identified in Schedule A. The foregoing non-exclusive license
does not include the right to grant sublicenses.
2.2
Biocoat hereby retains the right to develop coatings
for, supply coatings to, and enter into coatings license and supply
agreements with third parties so long as such agreements do not
conflict with the rights of MTI pursuant to this
Agreement.
2.3
Biocoat hereby grants to MTI a fully paid,
royalty-free license to use the trademark HYDAK in connection with
the Licensed Products made or sold pursuant to this Agreement.
This
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trademark license shall be in effect only during
the term of this Agreement. MTI agrees that Biocoat shall
have full control over the manner in which MTI uses this licensed
mark, and shall permit representatives of Biocoat to make
inspections of the facilities of MTI during normal business hours
and with reasonable notice, to insure that the requirements of this
license are fulfilled. All use of the licensed mark, by MTI,
shall inure to the benefit of Biocoat and MTI shall not acquire any
ownership rights in the mark by reason of such use.
2.4
MTI agrees to include relevant numbers of the
Patents in the labeling information supplied with Licensed
Products.
2.5
Biocoat agrees to supply the proprietary acrylic
copolymers and hyaluronan solutions needed to produce the Licensed
Products, as set forth in Schedule C, which is attached to and make
a part of this Agreement.
In the event that Biocoat is not able to produce and deliver the
acrylic copolymers or hyaluronan solutions for a period of sixty
(60) days or more, it will promptly advise MTI of such fact and
provide the formulas and process description for producing the
acrylic copolymers to MTI.
In order to ensure that the formulas and process description are
delivered, Biocoat will, within ninety (90) days of the date of
this Agreement, deliver in escrow the formulas and process
description to William H. Eilberg, Esq., 420 Old York Road,
Jenkington, PA 19046, with instructions to deliver such to
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MTI in the event above stated, or in case Biocoat
ceases to exist without there being a rightful Assignee under
Section 12.1 of this Agreement.
2.6
If Biocoat makes any developments or improvements to
the Technology, whether or not such are patented, Biocoat shall
notify MTI of the existence of such development or improvement,
including sufficient technical detail so that MTI can understand
the significance of the development or improvement, and will offer
MTI an opportunity to license such development or improvements on
terms to be negotiated. Notwithstanding the preceding
sentence, Biocoat shall have not obligations to notify MTI of
improvements or developments if such notification would violate an
agreement between Biocoat and a third party. If MTI chooses
not to license such development or improvement, Biocoat shall have
no further obligation to MTI with respect to such development or
improvement.
3.0
Payments . In consideration of the
licenses and other rights granted to MTI herein and the disclosure
to MTI of Proprietary Information, MTI shall make payments to
Biocoat as follows:
3.1
MTI hereby agrees to pay a license fee of
twenty-five thousand U.S. dollars, ($25,000), reduced by previously
paid development costs incurred by MTI of $6,966.76, for a net
payment of $18,033.24 to Biocoat with the signing of this
Agreement.
3.2
Except as modified by Sections 3.3 and 8.2, for each
three (3) months period ending on the last day of March,
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June, September or December after MTI executes
this Agreement, MTI shall pay to Biocoat, in U.S. dollars, a
royalty amount calculated in accordance with the rates set forth in
Schedule D which is attached to and made a part of this
Agreement. Quarterly royalty payments shall be made within
forty five (45) days after the end of such three (3) month
period.
3.3
If, for any Licensed Product, in any calendar year,
the number of units of such Licensed Product sold to any and all
unaffiliated (i.e., other than an Affiliates) Medical Device
Companies ("OEM" sales or units) exceeds 10% of the total units
sold of such Licensed Product, MTI shall adjust the calculation of
Net Sales for such Licensed Product by applying the average per
unit price for non-OEM sales (instead of the average per unit price
for OEM sales) to the OEM units sold.
If it is not possible to determine the average unit price for
non-OEM sales, it shall be assumed that the average unit price for
non-OEM sales is two times the average unit price for OEM
sales.
3.4
Overdue payments to Biocoat shall accrue interest,
which MTI shall pay to Biocoat, at 3% above the prime rate posted
by Chase Manhattan Bank, New York, NY.
3.5
The payment of royalties as set forth in this
Article and in Schedule C is in addition to the purchase price of
the coating solutions as set forth in Schedule C.
4.1
The rate of exchange to be used in computing
the
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amount of the U.S. Dollar equivalent of the
currency in which non-U.S. sales may be expressed shall be the
commercial exchange rate in effect in New York, New York, on the
date on which payment for such Net Sales is due.
4.2
Accompanying each quarterly royalty payment, MTI
will provide Biocoat with a sta
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