JOINT DEVELOPMENT AND
EXCLUSIVE LICENSE AGREEMENT
WHEREAS, Live Tissue Connect (“LTC”)
(“LICENSOR”) owns certain Patents (as hereinafter
defined) and Technical Information (as hereinafter defined)
relating to certain medical devices;
WHEREAS, ConMed Corporation, including its
affiliates, (“LICENSEE”) (collectively
“LICENSEE”), wishes to obtain from LICENSOR and
LICENSOR wishes to grant to LICENSEE certain exclusive rights under
the Patent and Technical Information, all subject to the terms and
conditions set forth herein;
WHEREAS, the parties wish to define research and
development projects to focus on the development of products for
first development of a marketable product for coagulation of tissue
for removal of tissue in duct and vessel sealing and second
reconnection of opposing end or sides of live tissues and organs.
First products for procedures to be developed are listed in
Addendum 1 attached hereto.
NOW, THEREFORE, LICENSEE AND LICENSOR HEREBY
AGREE AS FOLLOWS:
1. Definitions
. As used herein, the following
terms will have the meanings set forth below:
(a) “Boxes” means the power source
which is part of the Product.
(a) “Improvement” or
“Improvements” means any modifications, whether or not
patentable, of the Product (as hereinafter defined), (including any
related patents or unpublished research and development
information, unpatented invention, know-how, trade secrets, and
technical data made by LICENSOR or LICENSEE) provided such
modification, if unlicensed, would infringe one or more claims of
the Patents.
(b) “Licensed Territory” means all
of the world except the former Soviet Union.
(c) “Net Sales” means gross sales of
the Products billed and shipped by LICENSEE or its subsidiaries or
affiliates, less normal and customary allowances and discounts
actually allowed (other than advertising allowances, or fees or
commissions to salesmen or sales representatives), returns,
invoices written off as uncollectible, billed taxes and customs
duties paid by LICENSEE, costs of insurance and transportation
(freight and transit insurance), and shall not include samples or
demonstration materials or any sale to LICENSEE employees for any
reason other than resale. The term “Net Sales” shall
not include sales between the parties, sales by independent
distributors which have purchased Product from LICENSEE, or sales
between LICENSEE and its affiliates or subsidiaries.
(d) “Patents” means all U.S. Patents
listed on Addendum (2) and all divisions, continuation, reissues,
reexaminations, substitutes, extensions, and equivalents, or any
and all patents or applications which derive from, claim priority
from U.S. Patents listed in Addendum 2 attached hereto.
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Exhibit 10.22
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Page 1 of 10 Pages
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(e) “Product” means a power source
and set of hand instruments designed to bond or weld and reconnect
living soft biological tissue without the use of foreign matter or
conventional wound closing devices such as sutures, staples,
sealant, or glues and avoid charring, searing and necrosis using
low heat delivery aimed at restoration of the normal functions of
the live organs and tissue, the manufacture, use or sale of which
would, if unlicensed, infringe a valid claim of the Patents or
utilize the Technical Information. Product expressly includes any
Improvements to such Products. The first Product shall be the duct
and vessel sealing power sources and accompanying hand instruments
and the second Product shall be a reconnection power source and
accompanying hand instruments.
(f) “Technical Information” means
the unpublished research and development information, know-how, and
technical data provided by LICENSOR to LICENSEE or developed by
LICENSOR pursuant to the LICENSEE’S Development Project that
may be necessary or useful to make, use and sell the
Product.
(g) “Third Party” means a person or
entity other than LICENSOR, LICENSEE or their
affiliates.
(h) “Valid Claim” means a claim of
any of the Patents that has not expired or been held invalid by a
court of competent jurisdiction.
2. Exclusive License
.
(a) Grant Of Exclusive License As To Product
Generally . LICENSOR hereby grants to LICENSEE an exclusive
license under the Patents and Technical Information to import,
make, have made, use, sell and/or distribute the Product in the
Licensed Territory. BOXES are to be manufactured by Licensor unless
otherwise agreed by both parties.
(b) Grant of Right to Manufacture .
LICENSOR hereby grants to LICENSEE an exclusive license under the
Patents to manufacture the Products in the Licensed Territory and
to use the Technical Information to manufacture the Products in the
Licensed Territory.
(c) Exclusive License . LICENSOR
represents and warrants that the licenses granted to LICENSEE to
the Patent and the Technical Information pursuant to this Agreement
are, and shall remain, exclusive as to all persons, including
LICENSOR, in the Licensed Territory.
(d) Reservation of Right to Perform
Research . Notwithstanding the above-described grant of
exclusive license, LICENSOR retains a non-exclusive right to use
the Patents and Technical Information in connection with performing
research relating to the development of new Products or to
perfection of prior designs of the Product; provided further that
the retained non-exclusive right to use the Patents and Technical
Information as provided in this subsection shall not be construed
as providing LICENSOR with the right to manufacture or sell any
Product resulting from LICENSOR’S research relating to the
development of new Products, it being understood that any new
Products developed in this manner shall be subject to the terms of
this Agreement to the extent that the manufacture, use or sale of
such newly developed devices infringes a valid claim of a Patent or
utilizes Technical Information.
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Exhibit 10.22
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Page 2 of 10 Pages
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(e) No Express License . Notwithstanding
any other language in this Agreement that may suggest otherwise,
this Agreement shall in no way be construed as providing any
license, express or implied, to any patent or intellectual property
owned by or licensed to LICENSEE.
(f) Improvements to Technology, Equipment and
Instruments by LICENSEE. Product improvements on technology,
equipment and instruments by LICENSEE as provided in this
subsection shall not be construed as providing LICENSEE with the
right to manufacture or sell any Product resulting from
LICENSEE’S research relating to the development of new
Products, without it being understood that any new Products
developed in this manner shall be subject to the terms of this
Agreement to the extent that such newly developed devices infringe
a valid claim of a Patent.
3. Development
Projects.
(a) Licensor’s Development Project.
LICENSOR shall submit the development schedule for the initial
Product, duct and vessel sealing power sources as an addendum to
this Agreement within thirty (30) days of signing this Agreement
which schedule must be acceptable to LICENSEE.
(b) Licensee’s Development Project.
LICENSEE shall submit a development schedule for
the accompanying hand instruments as an addendum to this Agreement
within sixty (60) days of signing of this Agreement.
(c) Cooperation. The parties shall
cooperate in the development projects as defined above such that
each shall have access to the research and development information,
know-how, and technical data that may be necessary or useful to the
other in developing the equipment and handpieces.
4. Regulatory Approvals.
LICENSOR shall be primarily
responsible, including paying any related costs, for obtaining the
appropriate regulatory approvals for the use of the Products. These
approvals will include FDA marketing clearances, CE marking and
applicable safety agency requirements for manufacturing and
distribution of the Products. LICENSOR agrees to submit to LICENSEE
any proposed submissions which relate to the Products prior to
submitting to any governmental agency, for comment and approval,
and agrees not to make any submissions without such
approval. Such approval shall not be unreasonably
withheld.
5. Licensing Fees and Royalty
Payments . In
consideration for the above-described exclusive license of the
Patents, LICENSEE agrees to make royalty payments as
follows:
The total sum
of one million dollars ($1,000,000) to be paid into the account
designated below payable according to Addendum 3:
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Exhibit 10.22
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Page 3 of 10 Pages
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Bank of America
ABA: 111000025
For Further Credit to:
Live Tissue Connect, Inc.
500 No. Shoreline, Suite 701 No.
Corpus Christi, TX 78471
Acct. Number: 005770576306
(a) Ten percent (10%) of the Net Sales sold in
the Licensed Territory by LICENSEE until such time as the
cumulative Net Sales equal Thirty Five Million Dollars
($35,000,000). Royalties shall be paid on a quarterly basis and
shall be paid within 45 days following the end of each
quarter.
(b) Seven percent (7%) of the Net Sales of the
Products sold in the Licensed Territory by LICENSEE after
the cumulative Net Sales reach Thirty Five Million Dollars
($35,000,000) Royalties shall be paid on a quarterly basis and
shall be paid within 45 days following the end of each
quarter.
(c) Nothing in this Agreement shall be construed
as creating any implied royalty obligation, including, but not
limited to, any obligation to pay royalties with respect to the use
of the Technical Information.
(d) Minimums
(1) Conmed agrees to pay a minimum royalty on
handpieces subject to subsection (3) below.
(2) Failure to meet minimum purchases or
royalties set forth below at the earlier of the time when the
Product is officially launched or the commencement of the fourth
year after the execution of the Joint Development and Exclusive
License Agreement between LICENSOR and LICENSEE results in a loss
of exclusivity as the sole remedy. The term “officially
launched” shall mean that the clinical tests of the Product
are complete, key surgeons have used it in their surgeries, have
tested the functional capability of th