Exhibit 10.1
Protected by Fed. R. Evid. 408
SETTLEMENT, LICENSE AND RELEASE AGREEMENT
This Settlement, License and Release
Agreement (the “Agreement”) is made by and between
Sutura, Inc., a corporation organized under the laws of Delaware,
having a principal place of business at 17080 Newhope Street,
Fountain Valley, California 92078 (“Sutura”); Abbott
Laboratories, a corporation organized and existing under the laws
of Illinois, having a principal place of business at 100 Abbott
Park Road, Abbott Park, Illinois 60064-6057 (“Abbott
Laboratories”); and Abbott Vascular Inc., a corporation
organized and existing under the laws of Delaware, and a wholly
owned subsidiary of Abbott Laboratories, having a principal place
of business at 400 Saginaw Drive, Redwood City, California 94063
(“AVI”).
WHEREAS, Sutura is the current
assignee and owner of all right, title and interest in United
States Letters Patent Nos. 5,860,990; 6,117,144; 6,245,079;
6,551,331; 6,562,052; and 7,004,952 (the “Nobles
Patents”).
WHEREAS, Abbott and its subsidiary,
AVI, currently hold an exclusive license in United States Letters
Patent Nos. 5,720,757; 5,810,850; and 6,348,059 (the
“Hathaway Patents”), by virtue of a March 28, 1995
License Agreement between the Indiana University Foundation
(“IUF”) and Perclose, Inc. (the “Hathaway
License”), in which Abbott and AVI now hold all the rights of
Perclose, Inc.
WHEREAS, Sutura has asserted, in a
suit styled Sutura, Inc. v. Abbott Laboratories and Perclose,
Inc. , Civil No. 2:06-CV-536 (TJW) (the “Patent
Litigation”), that Abbott and Perclose, Inc., infringe the
Nobles Patents by making, using, marketing, selling and/or offering
for sale products sold as The Closer, The Closer S, ProGlide and
Perclose A-T.
WHEREAS, Abbott and AVI have asserted
counterclaims in the Patent Litigation alleging that Sutura
infringe the Hathaway Patents by making, using, marketing, selling
and/or offering for sale the SuperStitch.
WHEREAS, Abbott and AVI deny
infringing the Nobles Patents and raise other defenses to
Sutura’s claims including, but not limited to defenses
relating to the alleged invalidity of the Nobles Patents, and
Sutura denies infringing the Hathaway Patents and raises other
defenses to Abbott’s claims including, but not limited to
defenses relating to the alleged invalidity of the Hathaway
Patents.
WHEREAS, the Parties hereto have
mutually agreed to amicably settle their differences and the
dispute between them on the terms and conditions set forth
herein.
NOW, THEREFORE, in consideration of
the promises and covenants set forth herein, the receipt and
sufficiency of which are hereby acknowledged, the Parties do hereby
agree and covenant as follows:
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Protected by Fed. R. Evid. 408
1.0
DEFINITIONS
As used herein, the following terms
shall have the meanings set forth below:
“ Abbott ” means
Abbott Laboratories, together with its parents, subsidiaries,
including without limitation Abbott Vascular Inc. and Perclose
Inc., predecessors, successors, affiliates, divisions, assigns,
present and former directors, officers, shareholders, partners,
principals, agents, employees, representatives, attorneys,
indemnitors, and insurers.
“ Abbott Patents ”
means (a) the Hathaway Patents; (b) all foreign
counterparts, divisions, continuations, continuations-in-part,
patents of addition, substitution, registrations, reissues,
reexaminations or extensions of any kind with respect to any of the
Hathaway Patents, and any other patents that claim priority to or
provide priority for any patent application from which any of the
Hathaway Patents derived. The titles, filing dates, and patent or
serial numbers of the foregoing are set forth on Exhibit A;
provided, however, that the failure to list a patent or counterpart
on Exhibit A shall not exclude the omitted patent or
counterpart from the Abbott Patent Rights. “Abbott
Patents” shall not include any rights in any patents that
Abbott acquires after the Effective Date of this Agreement with a
right to license or sublicense unless they are presently pending
and will automatically fall under the terms of the Hathaway
License.
“ Effective Date ”
means the date of execution by the last Party hereto.
“ Field Of Use ”
means the field of closure of femoral vascular access sites.
“ Hathaway License
” means the certain License Agreement dated March 28,
1995, by and between the Indiana University Foundation on behalf of
Indiana University and Perclose, as amended and as assigned to
ARTI, now known as IURTC. A copy of the Hathaway License is annexed
hereto as “Exhibit C.”
“ IURTC ” means
the Indiana University Research & Technology Corporation,
together with its parents, subsidiaries, predecessors, successors,
affiliates, divisions, assigns, present and former directors,
officers, shareholders, partners, principals, agents, employees,
representatives, attorneys, indemnitors, and insurers.
“ Minor Modification
” means in reference to an existing device a change in the
dimensions, proportions, materials, or the general location of
existing features of the existing device, provided that such
change(s) do not alter the basic configuration or operation of the
device. A change that extends the use of a device outside the Field
of Use is not a Minor Modification.
“ Parties ” means
Sutura, Abbott Laboratories and Abbott Vascular Inc., each
individually referred to as a “Party.”
“ Sutura ” means
Sutura, Inc., together with its parents, subsidiaries,
predecessors, successors, affiliates, divisions, assigns, present
and former directors, officers, shareholders, partners, principals,
agents, employees, representatives, attorneys, indemnitors, and
insurers.
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Protected by Fed. R. Evid. 408
“ Sutura Patents ”
means (a) the Nobles Patents; (b) all foreign
counterparts, divisions, continuations, continuations-in-part,
patents of addition, substitution, registrations, reissues,
reexaminations or extensions of any kind with respect to any of the
Nobles Patents, and any other patents that claim priority to or
provide priority for any patent application from which any of the
Nobles Patents derived. The titles, filing dates, and patent or
serial numbers of the foregoing are set forth on Exhibit B;
provided, however, that the failure to list a patent or counterpart
on Exhibit B shall not exclude the omitted patent or
counterpart from the Sutura Patent Rights. “Sutura
Patents” shall not include any rights in any patents that
Sutura acquires after the Effective Date of this Agreement with a
right to license or sublicense.
“ Net Sales ”
shall have the meaning ascribed to it in the Hathaway license, and
that meaning shall be the gross revenues actually received by
Sutura upon sales of a Licensed Product, which sales would, but for
the license granted hereunder, infringe a Valid Claim in the
country for which the Licensed Product is sold, less
(a) normal and customary rebates, and cash and trade
discounts, (b) sales, use and/or other excise taxes or duties
actually paid, (c) outbound shipping and insurance charges
paid or allowed, (d) import and/or export duties actually
paid, and (e) amounts allowed or credited due to returns or
retroactive price decrease.
2.0
CROSS LICENSES
2.1 License to Abbott . Sutura
hereby grants to Abbott a nonexclusive, paid-up, worldwide license
under the Sutura Patents to make, have made, use, market, offer for
sale, sell and have-sold, devices in the Field Of Use. The rights
granted under this License do not include the right to grant
sublicenses.
2.2 License to Sutura . Abbott
hereby grants to Sutura a nonexclusive, royalty bearing, worldwide
license and sublicense under the Abbott Patents to make, have made,
use, market, offer for sale, sell and have-sold, devices in the
Field Of Use. The rights granted under this License do not include
the right to grant sublicenses.
2.3 No Knock-Offs . The
licenses and sublicense granted under Sections 2.1 and 2.2
above do not extend to any product made by either Party that is a
copy of or is otherwise substantially identical to a product of the
other Party.
2.4 Retained Rights . This
Agreement shall not be construed as granting a license under any
intellectual property rights of Sutura, on the one hand, and
Abbott, on the other hand, other than as expressly set forth
hereunder.
3.0
ROYALTIES
3.1 Royalties Payable by
Sutura . Beginning with the first accrual of Net Sales on which
a royalty is due hereunder, Sutura shall provide to Abbott a
quarterly royalty report as follows: Within fifteen (15) days
after the end of each calendar quarter, Sutura shall deliver to
Abbott a true and accurate report, giving such particulars of the
business conducted by Sutura, if any, during such calendar quarter
as are pertinent to an account for payments hereunder. Such report
shall include at least (a) the total of Net Sales by Sutura;
(b) the calculation of royalties; and (c) the total
royalties so calculated and due Abbott. Simultaneously with the
delivery of each such report, Sutura shall pay to Abbott the total
royalties, if any, due to Abbott for the
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period
of such report. If no royalties are due, Sutura shall so report.
The requirements and obligations of this Section apply only to the
manufacture, use, marketing, offer for sale or sale of products, in
the Field Of Use, following the Effective Date of this Agreement.
If the Hathaway License is amended to provide Abbott with royalty
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