Exhibit 10.5
[CONFIDENTIAL TREATMENT REQUESTED]
/*/ INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933,
AS AMENDED.
LICENSE
AGREEMENT
This AGREEMENT (hereinafter
“Agreement”) effective as of February 11, 1992
(“Effective Date”), by and between United States
Surgical Corporation, a corporation organized and existing under
the laws of the State of Delaware, having executive offices at 150
Glover Avenue, Norwalk, Connecticut 06856 (hereinafter
“USSC”) and SPINNAKER R&D ASSOCIATES, a general
partnership organized and existing under the laws of the State of
New Mexico, having offices at 5300 DTC Parkway, Suite 270,
Englewood, Colorado, 80111, on behalf of itself, the University of
New Mexico, and the Inventors, Wolff M. Kirsch, M.D., Yong Hua Zhu,
M.D., and Robert B. Cushman, (hereinafter “INVENTORS”),
together owners of all of the PATENTS RIGHTS and other rights
herein transferred, (altogether hereinafter referred to as
“LICENSOR”).
W I T N E S
S E T H :
WHEREAS, LICENSOR has developed and
is continuing to develop surgical clips for joining vessels and the
like and applicators useful in applying such clips and has filed
U.S. and foreign patent applications and has received certain U.S.
and foreign patents relating to such clips and
applicators;
WHEREAS, LICENSOR is desirous of
continuing the development of such clips and applicators to see
that such products are placed in the marketplace through an
appropriate licensing arrangement;
WHEREAS, USSC develops and markets
surgical products, including wound closure products;
WHEREAS, USSC desires to
manufacture, distribute and sell new surgical products and expand
the availability of such surgical products;
WHEREAS, both parties desire to work
together, calling on their respective areas of expertise, in order
to develop and hopefully market such clips and applicators under
the terms and conditions hereinafter set forth; and
WHEREAS, the parties desire to enter
into a license agreement;
NOW, THEREFORE, in consideration of
the premises and faithful performance of the covenants herein
contained, the parties follows.
ARTICLE I -
DEFINITIONS
For the purposes of this Agreement,
the terms set forth in Article I hereof shall be defined as
follows:
A. “ SURGICAL CLIP
TECHNOLOGY ” means all of the patented or unpatented,
patentable or unpatentable, scientific and technical information
and know-how created and developed by the INVENTORS during or
previous to this Agreement relating to arrangements and techniques
for surgical clips and applicators therefor, and includes, but is
not limited to, the technology shown, described, and claimed in the
patents and patent applications set forth in Exhibit A,
attached hereto and incorporated herein.
B. “ LICENSED PRODUCT
” means any apparatus, product, or device within the SURGICAL
CLIP TECHNOLOGY which includes or encompasses intellectual property
rights which will be or have been transferred from LICENSOR to USSC
under this Agreement.
C. “ LICENSED PROCESS
” means any process, method, or technique within the SURGICAL
CLIP TECHNOLOGY which includes or encompasses intellectual property
rights which will be or have been transferred from LICENSOR to USSC
under this Agreement.
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D. The terms “ MICRO
CLIP ,” “ MEZZO CLIP ,” and “
MACRO CLIP ” and relate only to sizes and dimensions
of surgical clips.
E. “ IMPROVEMENTS
” shall mean any development, refinement or modification of
the SURGICAL CLIP TECHNOLOGY first conceived and reduced to
practice solely by the INVENTORS.
F. “ PATENT ” OR
“ PATENT RIGHTS ” are equivalent terms and shall
mean any patent issuing on a patent application existing as of the
EFFECTIVE DATE drawn to an invention within the SURGICAL CLIP
TECHNOLOGY and covering a LICENSED PRODUCT, a LICENSED PROCESS or
TECHNICAL INFORMATION including, without limitation, the patents
and patent applications set forth on Exhibit A and any
reissue, reexamination, revalidation or registration patents and
patents of addition based thereon and any later filed divisional,
continuation, or reissue applications claiming priority therefrom
and any patents issuing on said applications, and also any patent
issuing on any later filed continuation-in-part application
directed to substantially the same type of invention as that
claimed in any patent or patent application listed on
Exhibit A.
G. “ IMPROVEMENT PATENT
” means any patent issuing on a patent application which
comes into existence on or after the EFFECTIVE DATE drawn to an
invention within the SURGICAL CLIP TECHNOLOGY covering a LICENSED
PRODUCT, a LICENSED PROCESS or TECHNICAL INFORMATION and any
reissue, reexamination, revalidation or registration patents and
patents of addition based thereon and any later filed divisional,
continuation, or reissue applications claiming priority therefrom
and any patents issuing on said applications, and also any patent
issuing on a later filed patent application which is a
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continuation in part of any of the aforesaid
patent applications and directed to substantially the same type of
invention as that claimed in any such patent
application.
H. “ TECHNICAL
INFORMATION ” shall mean all proprietary, trade secret
information and knowledge of a scientific or technical nature,
whether or not patentable, within the SURGICAL CLIP TECHNOLOGY
originated by and in the possession of the LICENSOR previous to or
during the term of this Agreement.
I. “ AFFILIATE ”
shall mean any corporation or organization which directly or
indirectly controls, is or will be controlled by or is or will be
under common control with a party to this Agreement by means of the
ownership, directly or indirectly, of 50% or more of the voting
stock or analogous interest in such corporation or
organization.
J. “ NET SALES ”
shall mean the aggregate of sales of ROYALTY PRODUCTS by USSC and
by any AFFILIATE and/or sublicensee of USSC calculated as the gross
sales invoiced and shipped to customers for sales, leases or uses
of ROYALTY PRODUCTS, less discounts actually allowed, invoices
written off as uncollectible, credits for returns and allowances,
restocking charges, transportation charges, transit insurance,
duties and taxes added to the face of the invoice, sales by
independent distributors, and sales between USSC and its
Affiliates, subsidiaries, sublicensees or permitted assignees. NET
SALES shall be subject to the exclusions set forth in
Article II, Paragraph G. The portion of the gross sales
price of any package, tray or other group of items consisting of
one or more ROYALTY PRODUCTS and non-ROYALTY PRODUCTS
(“Package”) to be included in NET SALES shall be deemed
to be the gross sales price of the Package multiplied by the ratio
of the individual retail list price of the ROYALTY PRODUCTS
contained in the Package to the sum of all individual retail list
prices of every item in the Package (if all of such items were sold
separately). If all such items are not
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sold separately, any item not sold separately
shall have a price attributed to it for purposes of this Paragraph
consistent with pricing of similar products or their functional
equivalents.
K. “ CALENDAR QUARTERS
” shall mean the three month periods during a CALENDAR YEAR
beginning with the first day of January, April, July and
October.
L. “ CALENDAR YEAR
” shall mean a year beginning January 1 and ending the
following December 31.
M. “ TERRITORY ”
shall mean all countries of the world.
N. “ ROYALTY PRODUCTS
” mean products sold by USSC and by any AFFILIATE and/or
sublicensee which are either (a) LICENSED PRODUCTS and/or a
LICENSED PROCESS which are covered by one or more valid,
enforceable patent claims in or which issue on or from the PATENTS
or IMPROVEMENT PATENTS; or (b) LICENSED PRODUCTS and/or a
LICENSED PROCESS which are covered by one or more valid,
enforceable patent claims in or which issue on or from the PATENTS
or IMPROVEMENT PATENTS, in combination with one or more USSC
INVENTIONS.
O. “ USSC INVENTION
” shall have, the meaning set forth in Article III,
Paragraph R hereof.
P. “ CONFIDENTIAL
INFORMATION ” shall have the meaning set forth in
Article III, Paragraph A hereof.
ARTICLE II -
LICENSE
A. Grant of License . On the
Effective Date, LICENSOR agrees to grant and does hereby grant to
USSC an exclusive, worldwide license (with right to sublicense)
upon the terms and conditions hereinafter specified to evaluate,
make, have made, use and sell in the TERRITORY the SURGICAL CLIP
TECHNOLOGY, the LICENSED PRODUCTS, the
5
LICENSED PROCESSES and the TECHNICAL INFORMATION
and including, without limitation, IMPROVEMENTS, PATENTS and
IMPROVEMENT PATENTS. LICENSOR shall retain the right to permit
Wolff M. Kirsch, M.D. and Yong Hua Zhu, M.D. to use any of the
SURGICAL CLIP TECHNOLOGY, the LICENSED PRODUCTS, LICENSED PROCESSES
and TECHNICAL INFORMATION, and including, without limitation,
IMPROVEMENTS, PATENTS and IMPROVEMENT PATENTS for human,
neurosurgical procedures performed only by them in their existing
neurosurgical practice and only until USSC has developed a
potential ROYALTY PRODUCT for clinical field testing. Such usage
shall be without compensation to or liability on the part of USSC;
but all of the same shall be treated by LICENSOR as CONFIDENTIAL
INFORMATION of USSC during the term of this Agreement.
B. Extension of License to
AFFILIATES . USSC may, upon terms and conditions hereinafter
specified, extend the rights and licenses granted under this
Agreement to AFFILIATES of USSC provided USSC agrees in writing to
be responsible for the performance by such AFFILIATES of all USSC
obligations hereunder including payment of royalties by the
AFFILIATES to whom the rights and licenses have been extended. USSC
may on the same conditions also sublicense the rights and licenses
granted hereunder to other third parties.
C. Terms of License . The
term of the rights and licenses granted by this Agreement shall
commence on the Effective Date and terminate upon the expiration of
the last to expire patent issuing on or from the PATENTS and the
IMPROVEMENT PATENTS and which provide claim coverage of a
commercial embodiment of said ROYALTY PRODUCTS, or twenty
(20) years after the commencement of the rights and licenses
granted by this Agreement, whichever is the later, unless earlier
terminated by reason of termination of this Agreement.
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D. USSC’s Initial
Payment . USSC will pay to LICENSOR on the Effective Date the
sum of [CONFIDENTIAL TREATMENT REQUESTED] /*/ Dollars
($[CONFIDENTIAL TREATMENT REQUESTED]/*/). This payment will be made
to Spinnaker R&D Associates.
E. LICENSOR’s Initial
Disclosures . LICENSOR shall furnish to USSC (1) on or
prior to the Effective Date, a copy of its files and its
attorney’s files concerning the PATENTS including all
opinions of counsel; (2) within forty-five (45) days
after the Effective Date, Five Hundred (500) each of the MICRO
CLIPS, MEZZO CLIPS and MACRO CLIPS, plus five (5) applicators
for each size, each suitable for placing the MICRO CLIPS, MEZZO
CLIPS and MACRO CLIPS. USSC shall reimburse LICENSOR for the time
and materials required to supply USSC with said clips and
applicators but the total cost to USSC is not to exceed Fifteen
Thousand Dollars ($15,000); and (3) within forty-five
(45) days after the Effective Date, full and complete
disclosure of all information and knowledge of whatever kind or
description relating to the LICENSED PRODUCTS, the LICENSED
PROCESSES and TECHNICAL INFORMATION which LICENSOR has on the
Effective Date. Such disclosure shall include, without limitation,
a copy of all histological,, biochemical or other written studies,
clinical or other trials, tests, prototypes, models, videos,
photographic film or slides, reports, computerized data, drawings,
patent applications, opinions of patent and FDA (defined below)
counsel, testimonials of surgeons and any other material,
documentary or otherwise, relating to any of the foregoing.
LICENSOR covenants and agrees to promptly furnish to USSC all
IMPROVEMENTS together with the foregoing types of information and
knowledge conceived or developed by the INVENTORS during the term
of this Agreement.
7
F. Earned Royalties . USSC
shall pay royalties to LICENSOR in the manner provided hereunder,
such payments shall be based on NET SALES of ROYALTY PRODUCTS in
accordance with the following schedule:
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CALENDAR YEAR
NET SALES (U.S. DOLLARS)
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Royalty Rate as Percent of
NET SALES
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Up to and including
[CONFIDENTIAL
TREATMENT REQUESTED] /*/
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[CONFIDENTIAL
TREATMENT
REQUESTED] /*/
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Over [CONFIDENTIAL
TREATMENT REQUESTED] /*/
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[CONFIDENTIAL
TREATMENT
REQUESTED] /*/
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G. Exceptions to Royalties .
It is agreed that royalties shall not be due under this Agreement
for any ROYALTY PRODUCTS which are used by USSC solely for the
purpose of clinical testing, market testing, product testing,
promotion or advertising.
H. Single Payment . In no
event shall more than a single royalty payment be due on any
ROYALTY PRODUCT.
I. Minimum Royalties .
Subject to the terms of this Agreement and for so long as this
License is in effect, USSC shall be obligated to pay to LICENSOR
the following minimum royalty according to the following schedule
and subject to the stated conditions:
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1993 CALENDAR YEAR
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$[CONFIDENTIAL
TREATMENT
REQUESTED] /*/
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1994 CALENDAR YEAR
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$[CONFIDENTIAL
TREATMENT
REQUESTED] /*/
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1995 CALENDAR YEAR and
remaining CALENDAR YEARS
until termination of this
Agreement
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$[CONFIDENTIAL
TREATMENT
REQUESTED] /*/
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The payments called for above shall
be prorated on a CALENDAR QUARTERLY basis. A CALENDAR
QUARTER’s minimum royalty payment shall be due and payable
within sixty
8
(60) days after the end of such CALENDAR
QUARTER. USSC shall be deemed to satisfy in full the foregoing
obligation if such amounts are timely paid whether or not there are
any NET SALES.
J. Duration and Timing of
Payments . Royalties on a ROYALTY PRODUCT shall be due and
payable to LICENSOR during the term of the License, as set forth in
this Agreement. At the expiration of the term or upon the earlier
termination of the license granted by this Agreement, no further
royalties will be required to be made by USSC to LICENSOR
hereunder. Royalties which are payable under Article II,
Section F above (“Earned Royalties”) shall be paid
on a quarterly basis within sixty (60) days after the end of
the CALENDAR QUARTER. To the extent Earned Royalties are in excess
of the Article II, Section I minimum royalty in a
CALENDAR QUARTER, such CALENDAR QUARTER’s minimum royalty
obligation shall be deemed to have been satisfied in full and such
excess shall be credited against minimum royalty in other CALENDAR
QUARTERS of that CALENDAR YEAR, but not be carried forward or
credited against minimum royalty in any other CALENDAR YEAR. To the
extent a CALENDAR QUARTER’s minimum royalty exceeds Earned
Royalties for such CALENDAR QUARTER, USSC shall be entitled to
carry forward and credit such excess against Earned Royalties in
subsequent CALENDAR QUARTERS of that CALENDAR YEAR, but no part of
the minimum royalty for a CALENDAR YEAR shall be carried forward or
credited against Earned Royalties in a subsequent CALENDAR
YEAR.
K. Manner of Payments . All
royalty payments under this Agreement will be made to Spinnaker
R&D Associates.
L. Record Keeping . USSC
shall keep complete and accurate records of the sale of ROYALTY
PRODUCTS with respect to which royalty is payable according to this
Agreement
9
and, within sixty (60) days following each
quarterly period of a CALENDAR YEAR during which royalties are due
under this Agreement, USSC shall render to LICENSOR a written
report setting forth the amount of royalty due and payable on such
ROYALTY PRODUCTS during such quarterly period, and USSC shall, upon
rendering such report, remit to LICENSOR the amount of royalty
shown thereby to be due.
M. Inspection . USSC shall
provide to LICENSOR each CALENDAR YEAR and at USSC’s expense
a letter (“Verification Letter”) from an independent
accounting firm verifying the calculation of periodic royalties due
under this Agreement. In lieu of the aforesaid letter, LICENSOR
shall have the right to nominate an independent accounting firm of
nationally recognized standing acceptable to and approved by USSC
(such approval not to be unreasonably withheld), who shall have
access to the records of USSC and those of its AFFILIATES having a
license or separate agreement pursuant to this Agreement. Such
examination shall occur during business hours and not more than
once a year and solely for the purpose of verifying the royalties
payable as provided for in this Agreement. Unless written objection
is made by LICENSOR and delivered to USSC within sixty
(60) days after delivery to LICENSOR of the Verification
Letter or the completion of examination by the accountants selected
by LICENSOR, then calculation of periodic royalties paid by USSC
prior to the date of such Verification Letter or date of such
examination shall be final and binding on the parties, except
insofar as adjusted or corrected as a result of USSC’s
regular annual audit. Any information provided to or inspected by
LICENSOR’s accountants shall be treated as USSC’s
Confidential Information subject to Article IV
Paragraph A. The accountants shall disclose to LICENSOR only
information relating to the accuracy of the royalty report and the
royalty payments made according to this Agreement. The fees and
expenses of such accountants selected by LICENSOR shall be borne
solely by LICENSOR.
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N. Royalties in U.S. Dollars
. Royalties on United States sales and all other payments to be
made to LICENSOR by USSC under this Agreement shall be made in U.S.
Dollars, or in such other currency (“foreign currency”)
as both parties mutually agree upon. Any royalties payable
hereunder on sales outside the United States by USSC will be
payable to LICENSOR in United States Dollars and will be computed
by multiplying the foreign currency sales by the average rate of
exchange for the previous quarter of the currency of the country to
the U.S. Dollar for the quarter in which the sales are made
based on the daily foreign currency exchange rates reported in the
New York Times. Such U.S. Dollar translated sales will then be
included with other sales for computation of the royalties. In the
event that USSC extends its license under this Agreement to any
AFFILIATE of USSC or other party, or LICENSOR enters into a
separate agreement with any AFFILIATE of USSC or other party
pursuant to this Agreement, such AFFILIATE or other party shall pay
the royalty to USSC in accordance with the provisions of this
Agreement (or the separate agreement) in United States Dollars in
the same manner as previously set forth. If the law or regulations
of any country shall at any time operate or prohibit the transfer
of funds therefrom to the United States, LICENSOR shall have the
option to require USSC to make payment hereunder on account of
sales in such country by depositing local currency to the account
of LICENSOR in a bank in said country acceptable to LICENSOR and
notify LICENSOR to such effect and, in such case, USSC shall
thereafter cooperate with LICENSOR by all lawful means to obtain
lawful release of said funds to LICENSOR (provided that LICENSOR
shall reimburse USSC for all out of pocket expenses incurred by it
in providing such assistance) but shall have no further
responsibility therefor.
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O. Taxes . Any sum required
under United States tax laws (or the tax laws of any other
government) to be withheld by USSC from payment for the account of
LICENSOR shall be promptly paid by USSC for and on behalf of
LICENSOR to the appropriate tax authorities, and USSC shall,
furnish LICENSOR with official tax receipts or other appropriate
evidence issued by the appropriate tax authorities sufficient to
enable LICENSOR to support a claim for income tax credit in respect
of any sum so withheld. This same provision shall also apply to any
AFFILIATE of USSC or other party sublicensed pursuant to this
Agreement with relation to the tax laws of the respective country
or countries in which such AFFILIATE is doing business.
P. Direct License to
AFFILIATE . USSC may request at any time to have LICENSOR grant
the applicable rights in any particular country to an AFFILIATE of
USSC, and LICENSOR shall, whenever requested by USSC enter into
direct agreements with such designated AFFILIATES whereby said
AFFILIATE will be obligated to remit its payments due for sales in
such country directly to LICENSOR, and LICENSOR shall execute such
formal direct agreement documents as USSC may request which may be
necessary to effect such purposes, provided that in any such case
USSC shall guarantee the performance of its AFFILIATE under such
direct agreement, and further provided that the formal direct
agreement shall provide for the same terms as this Agreement
insofar as such terms are lawful under the applicable laws and
regulations of the particular country. In the event that laws of a
particular country require any deviation from the terms of this
Agreement, LICENSOR and USSC shall negotiate such appropriate
substitute terms as may be required.
Q. Third Party Patents . If
the manufacture, use or sale of LICENSED PRODUCT, LICENSED PROCESS,
TECHNOLOGICAL INFORMATION, PATENT, and IMPROVEMENTS in connection
with a ROYALTY PRODUCT by USSC, its affiliates,
12
subsidiaries or permitted assigns pursuant to
Article 3, Paragraph G results in a claim, lawsuit or
other legal action by a third party for infringement, the party
receiving such claim, lawsuit or other legal action shall
immediately notify the other party in writing. Subject to
fulfillment by LICENSOR of its notice obligations pursuant to the
immediately preceding sentence, and the correctness of
LICENSOR’s representation and warranty, set forth in
Article III, Paragraph Q(5), USSC shall defend LICENSOR
against such claim, lawsuit or other legal action. USSC shall have
the right to conduct the legal defense, or to enter into any
settlement agreements, as it, in its sole discretion, deems
appropriate. LICENSOR may participate in the lawsuit or other legal
action through its own attorney at LICENSOR’S sole cost and
expense. LICENSOR agrees to cooperate with USSC in its defense of
any such claim. During the pendency of such claim, lawsuit or other
legal action, USSC shall have the right after giving LICENSOR the
above described notice to pay over to an escrow agent [CONFIDENTIAL
TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT
REQUESTED] /*/ %) of the [CONFIDENTIAL TREATMENT REQUESTED] /*/ and
earned royalties on [CONFIDENTIAL TREATMENT REQUESTED] /*/ NET
SALES of the allegedly infringing ROYALTY PRODUCT, and, with
respect to each subsequent year, [CONFIDENTIAL TREATMENT REQUESTED]
/*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/ %) of minimum
royalties and earned royalties on worldwide NET SALES of the
allegedly infringing ROYALTY PRODUCT. The escrow agent shall have
binding instructions to invest such amounts in an interest-bearing
account and to release same as follows: (a) to third party(s),
if, any, for awarded damages, costs and expenses in such lawsuit or
legal action pursuant to such award, (b) to third party(s), if
any, with whom USSC settles any such claim, lawsuit or other legal
action to the extent required by the terms of such settlement, and
(c) to pay fifty percent (50%) of USSC’s legal
costs and expenses as and when billed to USSC in connection with
any such claim, lawsuit or other legal action, with the balance, if
any,
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to be released to LICENSOR afte