EXCLUSIVE PATENT LICENSE AGREEMENT
Exhibit
10.1
This
agreement (hereinafter referred to as “Agreement”) dated and effective as
of:
17
December 2007 (“Effective Date”) is by and between:
Ethicon
Endo-Surgery, Inc., a corporation organized under the laws of the State of Ohio,
having its principal office at 0000 Xxxxx Xxxx, Xxxxxxxxxx, Xxxx 00000
(hereinafter referred to as “EES”)
AND
Cyberonics,
Inc., having an address at 000 Xxxxxxxxxx Xxxx., Xxxxxxx, XX 00000 (hereinafter
referred to as “Licensor”).
(each a
“Party” and both collectively the “Parties”)
1
TABLE
OF CONTENTS
1.
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BACKGROUND
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3
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2.
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DEFINITIONS
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3
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3.
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LICENSE
GRANT AND SUBLICENSING RIGHTS
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8
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4.
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PAYMENTS
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9
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5.
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ASSIGNMENTS
OF ROSLIN AGREEMENT AND RIGHTS OF FIRST REFUSAL
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13
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6.
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RECORD
KEEPING, REPORTS, CURRENCY & ROYALTY TRANSFER
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15
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7.
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ENFORCEMENT
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18
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8.
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PATENT
PROSECUTION AND MAINTENANCE
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19
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9.
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WARRANTIES
AND RESPRESENTATIONS
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21
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10.
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XXXXXXXXXXXXXXX
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00
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00.
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XXXXXX
LICENSE AGREEMENT
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24
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12.
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TERM
& TERMINATION
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25
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13.
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MISCELLANEOUS
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26
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A.
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ATTACHMENT
A
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34
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B.
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ATTACHMENT
B
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35
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C.
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ATTACHMENT
C
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37
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D.
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ATTACHMENT
D
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38
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E.
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ATTACHMENT
E
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39
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F.
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ATTACHMENT
F
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41
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2
1. BACKGROUND
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a.
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Licensor
has represented to EES that it owns or has obtained exclusive licenses
under the Licensed Patents (defined
below).
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a.
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EES
desires to obtain an exclusive license under the Licensed Patents from
Licensor.
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b.
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Licensor
is willing to grant such a license to EES upon the terms and conditions
set forth below.
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c.
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Therefore,
in consideration of the mutual promises contained in this Agreement, the
Parties agree as follows:
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2.
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DEFINITIONS
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a.
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“Affiliate”
is any entity that directly or indirectly controls, is controlled by, or
is under common control with EES, and for such purpose “control” shall
mean the possession, direct or indirect, of the power to direct or cause
the direction of the management and policies of the entity, whether
through the ownership of voting securities, by contract or
otherwise.
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b.
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“Calendar
Quarter” means the usual and customary EES calendar quarter, used for
internal accounting purposes, of approximately three (3) months, in which
each of the first two months consist of four weeks and the third month
consists of five weeks.
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c.
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“Calendar
Year” shall mean the period of time commencing on January 1 and
terminating on December 31 of each
year.
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d.
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“Clinical(s)”
shall mean any clinical trial or clinical trials on humans or animals of
one or more Products such as those that are required to be performed in
order to obtain approval or clearance from a Regulatory Agency before
commencing commercial marketing and sale of such
Products.
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3
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e.
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“Current
Net Selling Price” shall mean the net selling price of a product at the
time of sale, net of the items referred to in Article 2.t (definition of
“Net Sales”).
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f.
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“Field
of Use” shall mean the treatment (including therapeutic or diagnostic) by
means of a device that applies electrical signals directly or indirectly
to the vagus, trigeminal or glossopharyngeal nerves i) for weight
reduction, or ii) for hypertension or diabetes (including impaired fasting
glycaemia, impaired glucose tolerance or insulin resistance) in patients
having a body mass index of 25 or
more.
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g.
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“First
Commercial Sale” shall mean the first commercial sale of a Licensed
Product by EES, not in connection with a Clinical, in an arms length
transaction to an independent third
party.
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h.
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“First
Competitive Sale” shall mean the first U.S. commercial sale by an
independent third party of any surgically implanted electrical stimulation
device for the Field of Use, not in connection with a Clinical, in an arms
length transaction to an independent
party.
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i.
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“Force
Majeure” shall mean any unforeseen causes beyond a Party’s control
including, but without limitation, acts of God or public enemy, acts or
other order of a government, fire, flood or other natural disasters,
embargoes, accidents, explosions, strikes or other labor disturbances
(regardless of the reasonableness of the demands of labor), shortage of
fuel, power or raw materials, inability to obtain or delays of
transportation facilities, incidents of war, or other unforeseen events
causing the inability of a Party, acting in good faith with due diligence,
to perform its obligations under this
Agreement.
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j.
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“Licensed
Know-How” is all unpatented technology, information, special abilities,
inventions and/or know-how developed particularly for or useful primarily
in the Field of Use owned or controlled by the Licensor as of the
Effective Date of this Agreement, including any and all unpatented data,
processes, techniques, methods,
products,
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4
apparatuses,
materials and compositions developed particularly for or useful primarily in the
Field of Use, including, but not limited to, the Licensed Know-How, if any,
listed in Attachment G.; provided, however, that, Licensed Know-How does not
include any technology, information, special abilities, inventions or know-how
developed particularly for or useful primarily in an indication outside the
Field of Use, including, but not limited to, any invention made the subject of a
patent application pending as of the Effective Date or any technology,
information, special abilities, inventions or know-how relating to the design or
manufacture of surgically implanted electrical stimulation devices and
associated products.
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k.
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“Licensed
Patent(s)” are the Licensed Cyberonics Patent(s) and the Licensed Roslin
Patents.
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l.
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“Licensed
Cyberonics Patent(s)” are the patents and patent applications listed in
Attachment B1. Licensed Cyberonics Patents shall also include
any other counterparts of those listed in Attachment B1 worldwide, as well
as any and all continuations, continuations-in-part, divisions, renewals,
reissues, reexaminations, extensions, and patents of addition and patents
of importation of those listed in Attachment
B1.
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m.
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“Licensed
Roslin Patents” shall mean those Licensed Patents as defined in the Roslin
Agreement, including those patents listed in Attachment
B2.
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n.
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“Licensed
Product” shall mean any Licensed Cyberonics Product or any Licensed Roslin
Product.
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o.
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“Licensed
Method” shall mean any Licensed Cyberonics Method or any Licensed Roslin
Method.
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p.
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“Licensed
Cyberonics Method” is any procedure, the practice of which would, but for
the licenses granted under this Agreement, infringe at least one Valid
Claim of a Licensed Cyberonics
Patent.
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5
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q.
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“Licensed
Cyberonics Product” is any device or component thereof, the manufacture,
use or sale of which would, but for the licenses granted under this
Agreement, infringe (including inducement to infringe) at least one Valid
Claim of a Licensed Cyberonics
Patent.
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r.
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“Licensed
Roslin Method” is any procedure, the practice of which would, but for the
license granted under this Agreement and the Roslin Agreement, infringe at
least one Valid Claim of a Licensed Roslin
Patent.
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s.
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“Licensed
Roslin Product” is any device or component thereof, the manufacture, use
or sale of which would, but for the licenses granted under this Agreement
and the Roslin Agreement, infringe (including inducement to infringe) at
least one Valid Claim of a Licensed Roslin
Patent.
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t.
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“Licensed
Other Product” is any device or component thereof, the manufacture, use or
sale of which would, but for the licenses granted under this Agreement,
infringe (including inducement to infringe) at least one Valid Claim of an
Other Patent, and is not otherwise a Licensed Cyberonics Product or a
Licensed Roslin Product.
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u.
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“Minimum
Royalty Term” shall mean the period of time commencing upon Licensor
giving EES written notice of the First Competitive Sale under Article 4.c
and ending on February 1, 2011. The Minimum Royalty Term shall
be tolled for any period of time during which EES is able to demonstrate
to the reasonable satisfaction of Licensor that no surgically implanted
electrical stimulation device for the Field of Use is actively being
offered for commercial sale by a third
party.
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v.
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“Net
Sales” is the revenue which EES or its Affiliates invoice for the sale of
the Licensed Products to unaffiliated third parties, less the following
amounts to the extent included in invoiced
amounts:
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i.
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discounts,
including cash discounts, or rebates actually allowed or
granted;
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6
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ii.credits
or allowances actually granted upon claims or returns regardless of the
party requesting the return;
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iii.freight
charges paid by EES or its Affiliates for delivery;
and
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iv.taxes
or other governmental charges levied on or measured by the invoiced amount
whether absorbed by the billing or the billed
party.
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w.
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“PMA”
shall mean Pre-market Approval for medical devices as described under the
FDC Act and Title 21 Code of Federal Regulations Part
814.
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x.
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“Product”
is any device, the manufacture, use or sale of which would, but for the
licenses granted under this Agreement, infringe (including inducement to
infringe) at least one Valid Claim of a Licensed
Patent.
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y.
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“Regulatory
Agency” shall mean the U.S. Food and Drug Administration, U.S. Department
of Health and Human Services, or any foreign government
equivalent.
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z.
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“Regulatory
Approval” shall mean approval or clearance from a Regulatory Agency to
sell a Product including that granted by the FDA under a 510(k) or a PMA
application process or a substantially equivalent foreign government
process.
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aa.
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“Roslin
Agreement” shall mean the License Agreement dated as of August 22, 2000 by
and between Xxxxxxxx X. Xxxxxx and Cyberonics, Inc., a copy of which is
attached as Attachment D.
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bb.
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“Term”
shall have the meaning as set forth in Article 12.a of this
Agreement.
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cc.
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“Valid
Claim” is a bona fide, unexpired issued claim in a Licensed Patent that
has not been held invalid or unenforceable by a decision of a court or
other governmental agency of competent jurisdiction, unappealable or not
appealed within the time allowed for appeal, and that has not been
admitted to be invalid by the Licensor or its successors or assigns
through reissue or disclaimer.
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7
dd.
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“Xxxxxx
Agreement” shall mean the License Agreement dated as of March 15, 1998
between Xxxxx Xxxxxx and Cyberonics, Inc., a copy of which is attached as
Attachment 0.
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ee.
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“510(k)”
shall mean pre-market notification for medical devices as described under
the FDC Act and Title 21 of the Code of Federal Regulations part 807,
subpart E.
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3.
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LICENSE
GRANT AND SUBLICENSING RIGHTS
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a.
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Subject
to the terms and conditions of this Agreement, Licensor grants EES an
exclusive worldwide license for the Field of Use under the Licensed
Patents and Licensed Know-How to make, have made for, use, have used for,
sell, have sold for, offer to sell, import and/or otherwise dispose of
Products, to practice, have practiced for, teach and have taught for
Licensed Methods, and to otherwise commercially exploit the Licensed
Know-How and the technology disclosed in the Licensed Patents and Licensed
Know-How.
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b.
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Subject
to the terms and conditions of this Agreement, Licensor grants EES a
non-exclusive worldwide royalty-free license for the Field of Use under
each claim in a patent that issues to Licensor during the Term and that
incorporates express reference to one or more of the following indications
for use of nerve stimulation therapy: weight reduction, hypertension or
diabetes (“Other Patents”).
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c.
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Licensor
shall disclose to EES Licensed Know-How, if any, reasonably required to
enable EES to enjoy the benefit of the licenses granted in this
Agreement. The parties shall agree as to the means by which
such Licensed Know-How shall be communicated by Licensor to EES, such
means to insure reasonably prompt transfer of the information to EES
without imposing an undue burden on
Licensor.
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8
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d.
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EES
shall have the exclusive right to grant sublicenses under the rights
granted EES in this Agreement subject to the terms of this Article
3.c.
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i.
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EES
shall have the right to extend the licenses granted herein to any of its
Affiliates, upon the terms and conditions of this Agreement, and EES
agrees to be responsible for the performance by such Affiliates of all of
EES’s obligations hereunder, including without limitation the payment of
earned royalties set forth in Article 4.b herein on Net Sales of the
Licensed Product by the Affiliates to whom the licenses have been
extended.
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ii.EES
shall have the right to extend sublicenses under the Licensed Patents to
third parties (such licenses shall exclude Licensed Know-How and be
restricted to the Field of Use), upon the terms and conditions of this
Agreement. Any sublicense that EES grants to a third party
shall be nonexclusive. EES shall provide written notice to
Licensor of any sublicense granted to a third party. The notice
shall identify the sublicensee, provided that the agreement between EES
and said sublicensee allows for such identification, but need not disclose
the terms of the sublicense. EES shall require any such
sublicensee to xxxx its Licensed Products in accordance with 35 U.S.C.
§ 287
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iii.EES
shall pay Licensor an amount of revenue from the Licensed Products sold or
royalties advanced by the third-party sublicensee equal to the amount
Licensor would have received from EES if EES had sold such Licensed
Product.
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iv.Subject
to the terms of this Article 3.c, the granting by EES of sublicenses shall
be in the discretion of EES, and EES shall have the sole power to
determine whether or not to grant sublicenses and the royalty rates and
terms and conditions of any such
sublicenses.
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9
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4.
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PAYMENTS
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a.
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In
consideration for the execution of this Agreement, and for the exclusive
license granted to EES under Article 3 herein, EES shall pay Licensor the
non-refundable sum of $9.5 Million within 15 business days after the
Effective Date.
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i.
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Such
payment shall be wired pursuant to instructions from
Licensor.
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b.
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In
further consideration for the license granted to EES under Article 3
herein, EES shall pay Licensor on a quarterly basis during the Term an
earned royalty of:
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1)
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***%
on Net Sales of any Licensed Cyberonics Product that is not a Licensed
Roslin Product;
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2)
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***%
on Net Sales of Licensed Roslin Product; provided that, EES shall pay
Licensor ***% on Net Sales of Licensed Roslin Product as to which Licensor
or EES is entitled to a credit against royalties in accordance with the
Roslin Agreement; or
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3)
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***%
on Net Sales of any Licensed Other
Product.
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i.
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No
earned royalties shall be payable on Net Sales of any Licensed Product in
conjunction with any Clinicals. No earned royalties shall be
payable on Net Sales of any Licensed Product sold in a country before the
date upon which EES obtains Regulatory Approval from such
country. For the avoidance of doubt, EES shall be obligated to
pay royalties on Net Sales of any Licensed Product in countries where EES
is exempt from obtaining Regulatory Approval for Licensed
Products.
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xx.Xx
multiple earned royalties shall be payable because a Licensed Product is
covered by more than one of the Licensed
Patents.
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iii.
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For
the avoidance of doubt, earned royalties payable on the Net Sales of a
Licensed Product covered under a Valid Claim of a Licensed Roslin Patent
shall be calculated solely as set forth in Attachment
B1.
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***
Portions of this page have been omitted pursuant to a Confidential
Treatment request and filed separately with the
Commission.
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10
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iv.EES,
in its sole discretion, may take a license from an unaffiliated third
party under, or assignment of, patents or know-how that arguably cover in
whole or in part any aspect of a Licensed Product or Licensed Method under
terms requiring EES to pay such third party a lump sum and/or an earned
royalty for the sale of such Licensed Product. As to each
country for which EES takes such a third-party license or assignment, the
earned royalty EES pays Licensor on the Net Sales of the Licensed Product
in such country under this Article 4.b shall be reduced by an amount equal
to one-half of the earned royalty EES is required to pay such third party
in such country; provided, however, that the earned royalty payable to
Licensor shall in no case be reduced below a) ***% of Net Sales of a
Licensed Cyberonics Product that is not a Licensed Roslin Product; or b)
***% on Net Sales of Licensed Roslin Product; provided that, EES shall pay
Licensor no less than ***% on Net Sales of Licensed Roslin Product as to
which Licensor or EES is entitled to a credit against royalties in
accordance with the Roslin Agreement. If EES takes such a
third-party license or assignment for one or more lump sum payments only
(no earned royalties), then the earned royalties EES pays Licensor on the
Net Sales of the Licensed Product under this Article 4.b shall be reduced
by 25% (but shall never be reduced below x) ***% of Net Sales of a
Licensed Cyberonics Product that is not a Licensed Roslin Product; or y)
***% on Net Sales of Licensed Roslin Product; provided that, EES shall pay
Licensor no less than ***% on Net Sales of Licensed Roslin Product as to
which Licensor or EES is entitled to a credit against royalties in
accordance with the Roslin Agreement) until the cumulative amount by which
such royalties are reduced equals 25% of such lump sum
payments.
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c.
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Licensor
shall give written notice to EES showing evidence reasonably satisfactory
to EES that the First Competitive Sale has occurred.
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***
Portions of this page have been omitted pursuant to a Confidential
Treatment request and filed separately with the
Commission.
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11
i.
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During
the Minimum Royalty Term, EES shall pay Licensor a one-time payment of
$*** Million within 60 days of EES receiving such written
notice.
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ii.During
the Minimum Royalty Term, and commencing with the first Calendar Year
after the First Competitive Sale, EES shall pay Licensor the minimum
annual royalties as set forth in the following schedule. Such
amounts shall be paid quarterly and become due within 60 days following
the end of the Calendar Quarter. For the avoidance of doubt,
the last such quarterly minimum royalty payment shall be due within 60
days following the end of the Calendar Year 2010, with no further
quarterly minimum royalty payments due for the year 2011 and all
subsequent Calendar Years during the Term. In addition, for the
avoidance of doubt, examples showing the manner in which these payments
are made are set forth in Attachment
C.
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First
Calendar Year after the First Competitive Sale
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$*** Million
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Second
Calendar Year after the First Competitive Sale
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$*** Million
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Third
Calendar Year after the First Competitive Sale
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$***
Million
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d.
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For
any given year during the Minimum Royalty Term, any minimum royalty amount
payable by EES to Licensor for a given Calendar Quarter under Article 4.c shall be reduced by the earned royalty
payable by EES to Licensor under Article 4.b
for such given Calendar Quarter. However, if the earned royalty
payable by EES to Licensor under Article 4.b
exceeds the minimum royalty owed by EES to Licensor under Article 4.c, then EES shall only pay the earned royalty
amount owed to Licensor under Article 4.b. The earned royalty payable on Net
Sales of the Licensed Product for each Calendar Year during the Minimum
Royalty Term shall be credited at the end of each Calendar Year to reflect
any overpayment of such earned royalties with respect to the minimum
royalty payments due during such Calendar Year, and such credit shall
carry forward to subsequent Calendar Quarters as
necessary.
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***
Portions of this page have been omitted pursuant to a Confidential
Treatment request and filed separately with the
Commission.
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12
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e.
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Licensor
shall consider the up-front payment set forth in Article 4.a above as
complete satisfaction of any duty, whether express or implied, that could
be imposed on EES to commercially exploit its rights during the term of
this Agreement, and is accepted by Licensor in lieu of any best efforts or
other obligation on the part of
EES. Furthermore,
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Licensor
acknowledges that EES has assumed sole responsibility for obtaining governmental
approvals, including Regulatory Approvals, and Licensor shall not have any
redress against EES for failure to perform under this Agreement if EES is unable
or unwilling for any reason whatsoever to obtain such governmental
approvals.
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f.
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In
the event that a Licensed Product is sold as part of a surgical kit or
combination product, then for purposes of computing earned royalties, the
following guidelines shall apply to the determination of the selling price
of the Licensed Products:
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i.
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Net
Sales of such Licensed Product shall be based on the Current Net Selling
Price of the Licensed Product sold as a stand-alone product;
or
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ii.If
the computation set forth in Article 4.f.i cannot be made for any reason,
then Net Sales of such Licensed Product shall be based on the product of
(x) a fraction, the numerator of which is the standard material and labor
cost of such Licensed Product and the denominator of which is the standard
material and labor cost of all of the components within the surgical kit,
times (y) the Current Net Selling Price of the surgical
kit.
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g.
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In
the event that EES sells a Licensed Product in a country where such sale
is not covered by a Valid Claim of a Licensed Patent in that country and a
third party is commercially selling a surgically implantable electrical
stimulation device within the Field of Use in that country and such
third-party device is manufactured in a country where such manufacturing
is not covered by a Valid Claim of a Licensed Patent in the country of
manufacture, then the amount of earned royalties EES owes Licensor under
Article 4.b for sales in that country
(including royalties previously reduced in Article 4.b.iv) will be reduced by 50%. In the
event that EES reduces royalties under this Article, EES shall give
written notice to Licensor showing evidence, reasonably satisfactory to
Licensor, that a third party is commercially selling a surgically
implantable electrical stimulation device within the Field of Use in that
country, including the country within which such device was
manufactured.
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13
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5.
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ASSIGNMENT
OF ROSLIN AGREEMENT AND RIGHT OF FIRST
REFUSAL
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a.
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Assignment. Licensor
hereby assigns, sets over and transfers to EES all of Licensor’s right,
title and interest in, to and under the Roslin Agreement. Unless otherwise
agreed to by the Parties herein, EES hereby accepts such assignment and
assumes and agrees to pay, perform and discharge when due all of the
liabilities and obligations of Licensor arising under the Roslin Agreement
on or after the Effective Date.
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i.
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If
EES terminates this Agreement in accordance with Section 12 (Term and
Termination), subsection b or Licensor terminates this Agreement in
accordance with Section 12.c, then EES shall, effective as of the date of
termination, assign, set over and transfer to Licensor all of EES’ right,
title and interest in, to and under the Roslin Agreement; provided that
Licensor shall accept such assignment and assume and agree to pay, perform
and discharge when due all of the liabilities and obligations of EES
arising under the Roslin Agreement on or after the effective date of such
assignment.
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ii.Licensor
and EES each hereby covenants and agrees that it will, at any time and
from time to time if requested by the other Party, or its successors or
assigns, do, execute, deliver and acknowledge, or will cause to be done,
executed, delivered and acknowledged, to such other Party, or its
successors or assigns, as the case may be, such and all further acts,
assignments, assumptions and additional papers and instruments as such
other Party may reasonably request, and do or cause to be done all acts or
things as often as such other Party may reasonably request and which may
be proper or necessary or advisable for better evidencing or effecting the
assignments, assumptions and other agreements made hereby, and effectively
to carry out the intent hereof.
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b.
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Right
of First Refusal. During the Term, if Licensor develops an
invention that is capable for use within the Field of Use (the
“Invention”) and elects, at its sole discretion, to license, sell or
otherwise dispose of such Invention for the Field of Use, Licensor
will
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be
obligated to notify EES in writing of the Invention and provide EES with a copy
of any patent application(s) for such Invention and any prototypes and other
intellectual property developed relating to the Invention (the “Written
Notification”).
14
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i.
|
If
EES is interested in licensing the Invention within the Field of Use, EES
will have 90 days from the Written Notification (the “Option Period”) to
negotiate an agreement to license the Invention (the "Invention
License").
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ii.
|
During
the Option Period, Licensor shall negotiate in good faith in an effort to
consummate the Invention License with EES. If the Parties are
unable to enter into the Invention License or agree in principle to enter
into the Invention License by execution of a term sheet during the Option
Period, then Licensor shall be free, during the twelve-month period
commencing on expiration of the Option Period (the “Out-License Period”),
to negotiate and enter into a license or assignment agreement with a third
party or parties at pricing, terms, conditions and other provisions no
less favorable to Licensor than provisions Licensor offered to
EES. If Licensor fails to conclude a license or
assignment agreement with a third party during the Out-License Period and
Licensor thereafter elects to license, sell or otherwise dispose of the
Invention, then Licensor and EES shall follow the procedures outlined in
this Section 5.b once again, commencing with Licensor’s Written
Notification to EES.
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iii.
|
If
EES is not interested in acquiring the Invention for the Field of Use, EES
shall provide to Licensor written notice to that effect within ninety (90)
days from Written Notification for such Invention, and Licensor shall be
free to negotiate with a third party the sale or license of the
Invention.
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iv.
|
For
the avoidance of doubt, Licensor is obligated to offer EES the Right of
First Refusal as defined in this Section 5.b. for each and every Invention
Licensor develops that is capable for use within the Field of Use if
Licensor elects, at its sole discretion, to license, sell or otherwise
dispose of such Invention for the Field of
Use.
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15
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6.
|
RECORD
KEEPING, REPORTS, CURRENCY & ROYALTY
TRANSFER
|
|
a.
|
EES
shall keep accurate books and records of the Net Sales of Licensed
Products, and of all payments due Licensor
hereunder. Commencing with the First Commercial Sale, EES shall
deliver to Licensor written reports (“Reports”) of Net Sales of the
Licensed Product during the preceding Calendar Quarter, on or before the
sixtieth day following the end of each Calendar Quarter. The
Reports shall include Net Sales (including Net Sales by third-party
sublicensees, if any), a calculation of the earned royalty due Licensor,
and shall be accompanied by the monies due. The earned royalty
payable on Net Sales of the Licensed Product outside the U.S. shall be
estimated for each Calendar Quarter, and adjusted at the end of each
calendar year to reflect actual Net Sales and the earned royalty payable
thereon.
|
|
b.
|
Licensor
shall have the right after 30 days advance written notice to EES, at its
own expense, to nominate an independent accountant acceptable to and
approved by EES (which approval shall not be unreasonably
withheld). Such accountant shall have access to EES’s records
during reasonable business hours for the sole purpose of verifying the
royalties payable for the two preceding Calendar Years. This
right may not be exercised more than once in any Calendar
Year. Licensor shall solicit or receive only information
relating solely to the accuracy of the Report and the royalty payments
made according to Article 4.b, 4.e, and 4.f. EES shall be
entitled to withhold approval of an accountant if the accountant refuses
to agree to the terms of a reasonable confidentiality agreement that
protects EES’s confidential information, except as necessary for
disclosure to Licensor to establish the accuracy of the
Reports.
|
|
c.
|
All
earned royalties and minimum royalties, including those based on sales
outside the U.S., shall be paid in United States Dollars. The
rate of exchange for such payments from sales in a foreign country shall
be the same rate as that used for internal financial accounting purposes,
in accordance with Generally Accepted Accounting Principles, as reported
in EES’s books.
|
|
d.
|
If
a foreign government prohibits the transfer of royalties out of a
particular foreign country, EES has the right to place Licensor’s
royalties in a mutually acceptable independent bank account in the name of
Licensor and under the complete control of Licensor, provided that EES
informs Licensor of the name of the bank, the bank account number and the
amount of money deposited therein. After Licensor has been so
notified, those monies will be considered completely controlled by
Licensor, and EES will not have any further responsibility with respect to
those monies or that bank account. Licensor shall cooperate
with EES to establish such an account if requested by
EES.
|
16
|
e.
|
EES
will make all payments to Licensor under this Agreement without deduction
or withholding for taxes except to the extent that any such deduction or
withholding is required by law in effect at the time of
payment.
|
|
i.
|
Any
tax required to be withheld on amounts payable under this Agreement will
promptly be paid by EES on behalf of Licensor to the appropriate
governmental authority, and EES will furnish Licensor with proof of
payment of such tax. Any such tax required to be withheld will
be an expense of and borne by
Licensor.
|
|
ii.EES
and Licensor will cooperate with respect to all documentation required by
any taxing authority or reasonably requested by EES to secure a reduction
in the rate of applicable withholding
taxes.
|
|
iii.If
EES had a duty to withhold taxes in connection with any payment it made to
Licensor under this Agreement but EES failed to withhold, and such taxes
were
|
assessed
against and paid by EES, then Licensor will indemnify and hold harmless EES from
and against such taxes (excluding any penalty arising as a consequence of EES’s
failure to withhold). If EES makes a claim under this Article
6.e.iii, it will comply with the obligations imposed by Article 6.e.i as if EES
had withheld taxes from a payment to Licensor.
|
f.
|
Unless
prohibited by law or an agreement with a third party, prior to a public
disclosure concerning pre-clinical and clinical data for the Licensed
Products by EES or its clinical investigators, EES agrees to use
commercially reasonable efforts to provide Licensor with an advanced
summary of such pre-clinical and clinical data pertaining to the use of
Products in the Field of Use. (For the avoidance of doubt any breach of
this article 6.f by EES shall not be a
material breach)
|
17
|
7.
|
ENFORCEMENT
|
|
a.
|
In
the event that either Party becomes aware of an infringement in the Field
of Use by a third party of any Licensed Patent hereunder, such Party shall
notify the other of the infringement in writing within 30
days.
|
|
b.
|
EES
shall have the right, but not the obligation, at its sole expense and with
counsel of its own choice, to enforce the Licensed Patents in the Field of
Use against any infringer, including the right to file suit for patent
infringement naming Licensor as a party, and the right to settle such suit
without Licensor’s consent. Notwithstanding the foregoing, in
no event shall EES enter into an agreement with a third party consenting
to the invalidity or unenforceability of any Licensed Patent without the
prior written consent of Licensor. However, nothing herein
shall preclude EES from challenging the validity or enforceability of any
Licensed Patent in a court or patent office proceeding, or in a dispute
resolution proceeding brought under Attachment A. Licensor
shall permit the use of its name in all such suits, sign all necessary
papers, and do all reasonable things necessary, at EES’s expense, to
facilitate the prosecution of such infringement suits. EES
shall incur no liability to Licensor as a consequence of such litigation,
the conduct
|
of such
litigation or any unfavorable decision resulting from it, including any decision
holding any of the Licensed Patents invalid or unenforceable. Nothing
in this Agreement shall prohibit EES from challenging the validity or
enforceability of a Licensed Patent in any venue.
|
c.
|
If
EES prevails in such a suit or settles with such third party infringer,
any and all settlement amounts, damages, and costs recovered in connection
therewith shall first be allocated, pro rata, to Licensor’s and EES’s
reasonable attorney’s fees and expenses, and next towards payment to
Licensor of royalties based upon the sales of the infringing third-party
devices equal to the amount Licensor would have received from EES if EES
had sold such instruments. EES shall keep the balance remaining
from any recoveries, by way of judgment, award, decree or settlement
resulting from such suit.
|
|
d.
|
If
within 180 days following the notice required by Article 7.a EES fails
either to file suit to enforce the Licensed Patents or to give Licensor
written notice of its intent to file suit within a reasonable period of
time, then Licensor shall have the right, but not the obligation, at its
sole expense and with counsel of its own choice, to enforce the Licensed
Patents in the Field of Use against any infringer, and the right to settle
such suit without EES’s consent. Notwithstanding the foregoing,
in no event shall Licensor consent to the invalidity or unenforceability
of any Licensed Patent without the prior written consent of
EES. Licensor shall incur no liability to EES as a consequence
of such litigation, the conduct of such litigation or any unfavorable
decision resulting from it, including any decision holding any of the
Licensed Patents invalid or
unenforceable.
|
|
e.
|
If
Licensor undertakes the enforcement or defense of the Licensed Patents by
litigation, Licensor shall pay EES ***% of the balance remaining from any
cash recoveries by way of judgment, award, decree or settlement resulting
from such suit, after deduction of costs and attorneys fees, if not
included in the recoveries.
|
|
***
Portions of this page have been omitted pursuant to a Confidential
Treatment request and filed separately with the
Commission.
|
18
|
8.
|
PATENT
PROSECUTION AND MAINTENANCE
|
|
a.
|
Licensor
is solely responsible for the continued prosecution of any pending patent
applications included in the Licensed Patents, as well as the prosecution
of patent applications subsequently filed pursuant to Articles 8.a.ii and
8.a.iv below.
|
|
i.
|
Licensor
shall issue as a patent each application included in the Licensed Patents
which receives an allowance from the appropriate patent
office.
|
|
ii.The
parties shall consult with each other concerning the desirability of
filing additional patent applications (continuations and divisionals) to
seek an increase in the amount of protection afforded by the Licensed
Patents. Upon the reasonable request of EES, Licensor shall
prepare and file such applications.
|
|
iii.Licensor
shall pay all government fees in any given country required to maintain
the Licensed Patents.
|
|
xx.Xx
the extent not already barred, Licensor shall file patent applications in
the following countries:
|
|
1)
|
EPO
(All)
|
|
2)
|
Russia
|
|
3)
|
Mexico
|
|
4)
|
Canada
|
|
5)
|
Brazil
|
|
6)
|
Japan
|
|
7)
|
Australia
|
|
8)
|
India
|
|
9)
|
China
|
|
10)
|
Korea
|
|
11)
|
Israel
|
|
12)
|
Singapore
|
|
13)
|
Hong
Kong
|
|
b.
|
Licensor
shall file patent applications in other foreign countries which may be
designated in writing by EES, and EES shall be permitted to consult with
Licensor in the selection of foreign patent counsel and in the preparation
and prosecution of said foreign patent
applications.
|
|
c.
|
Licensor
shall promptly notify EES in the event Licensor decides to abandon or
discontinue prosecution of any one or more patent applications included in
Licensed Patents, or discontinue maintaining an issued patent included in
the Licensed Patents.
|
19
Such
notification will be given as early as possible, which in no event will be less
than 60 days prior to the date on which patent(s)\application(s) will become
abandoned.
|
i.
|
Licensor
may abandon, withdraw or discontinue prosecution of such
patent(s)\application(s) by giving EES written notice at least 60 days
prior to such abandonment.
|
|
ii.Thereafter,
EES shall have the option, exercisable upon written notification to
Licensor, to assume full responsibility for the maintenance and/or
prosecution of such patent(s)\application(s), in which event all right,
title and interest in and to such patent(s)\application(s) shall be
promptly assigned by Licensor to EES. Thereafter, EES shall
have no further royalty obligations to Licensor for any Licensed Product
covered solely by one or more claims of such
patent(s)\application(s).
|
|
d.
|
EES
shall reimburse Licensor for the reasonable attorney fees, maintenance
fees, and other costs related to the filing, prosecution, and maintenance
of the Licensed Patents incurred by Licensor after the Effective Date in
all countries other than the United States. Upon request from
Licensor, EES shall make payment directly to the attorney prosecuting such
applications if such attorney submits an invoice directly to
EES. EES shall not be responsible for and shall not be required
to pay for any such prosecution and filing expenses under this paragraph
unless such expenses are submitted to EES along with an invoice that
provides an itemized accounting for expenses incurred and services
actually rendered. If Licensor grants any third party a license
under a Licensed Patent outside of the Field of Use, all money due by EES
for such Licensed Patent under this article 8.d shall be reduced by
50%.
|
|
e.
|
Within
60 days of the Effective Date, Licensor shall provide EES with copies of
Licensor’s file histories for each patent application included in the
Licensed Patents pending worldwide.
|
20
|
f.
|
Licensor
shall promptly provide EES with all correspondence delivered to or
received from any Patent Office in connection with the Licensed
Patents. EES, upon its own initiative, shall have the right to
consult with Licensor regarding proposed amendments to the claims of
patent applications included in the Licensed Patents during prosecution to
ensure that the scope of patent coverage is
adequate.
|
|
9.
|
WARRANTIES
AND REPRESENTATIONS
|
|
a.
|
Each
party represents and warrants to the other
that:
|
|
i.
|
it
has the power to execute, deliver and perform the terms and conditions of
the Agreement and has taken all necessary action to authorize the
execution, delivery and performance
hereof;
|
|
ii.the
execution, delivery or performance of this Agreement will not constitute a
violation of, be in conflict with, or result in, a breach of any agreement
or contract to which it is a party or under which it is
bound;
|
|
iii.this
Agreement constitutes the legal, valid and binding Agreement of such party
enforceable in accordance with its terms;
and
|
|
xx.xx
complying with the terms and conditions of this Agreement and carrying out
any obligations hereunder, it will comply with all applicable laws,
regulations, ordinances, statutes, decrees or proclamations of all
governmental authorities having jurisdiction over such
party.
|
|
b.
|
Licensor
expressly warrants and represents as of the Effective Date
that:
|
|
i.
|
it
owns all right, title, and interest in and to, or owns an exclusive
license under, the Licensed Patents and Licensed Know-How free and clear
of all encumbrances,
|
21
and no
third party has notified Licensor that it is claiming any ownership of or right
to the Licensed Patents, except as indicated in the Roslin Agreement and the
Xxxxxx Agreement;
|
xx.xx
is presently aware of no patents or patent applications, not already
previously disclosed to EES in writing, owned by a third party which would
present any issue of infringement by reason of the manufacture, use or
sale of any Product;
|
|
xxx.xx
Licensed Patent is involved in any pending or threatened litigation,
arbitration, administrative or other proceedings, or governmental
investigation, other than ordinary patent application prosecution
proceedings;
|
|
xx.xx
has not received any notice of invalidity or infringement of any of the
Licensed Patents or obtained any legal opinions of counsel on
patentability, validity or infringement related
thereto;
|
|
v.
|
it
is empowered to grant the licenses granted
herein;
|
|
xx.xx
has no outstanding encumbrances or agreements, including any agreements
with academic institutions, universities, or third-party employers,
whether written, oral or implied, which would be inconsistent with the
licenses granted herein;
|
|
xxx.xx
has fulfilled all of its obligations under the Roslin and Xxxxxx
Agreements including, but not limited to, its obligations under articles
3.02(a) and (b) of the Roslin Agreement resulting in Roslin receiving at
least $150,000 under such articles;
|
|
viii.
|
it
will not default its obligations under the Xxxxxx Agreement;
and
|
|
ix.
|
it
is not aware of any information, such as prior art, that would raise a
substantial question of the validity or enforceability of any of the
Licensed Patents.
|
22
|
c.
|
EES MAKES NO REPRESENTATION OR
WARRANTY THAT IT WILL MARKET A LICENSED PRODUCT OR, IF EES DOES MARKET A
LICENSED PRODUCT THAT SUCH LICENSED PRODUCT SHALL BE THE EXCLUSIVE MEANS
BY WHICH EES WILL PARTICIPATE IN THIS FIELD. FURTHERMORE, ALL BUSINESS
DECISIONS INCLUDING, WITHOUT LIMITATION, THE DESIGN, MANUFACTURE, SALE,
PRICE AND PROMOTION OF LICENSED PRODUCTS AND THE DECISION WHETHER TO SELL
A LICENSED PRODUCT SHALL BE WITHIN THE SOLE DISCRETION OF
EES.
|
|
d.
|
OTHER
THAN THOSE MENTIONED ABOVE, NEITHER PARTY MAKES ANY OTHER EXPRESS OR
IMPLIED WARRANTIES, AND THERE ARE NO IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR
PURPOSE.
|
10.
|
INDEMNIFICATION
|
|
a.
|
Licensor
shall be liable to EES for and shall defend, indemnify and hold EES (and
its directors, officers, employees and agents) harmless against any
liability, damages or loss, other than loss of potential sales, and from
any claims, suits, proceedings, demands, recoveries or expenses (“Loss”),
in connection with any Products arising out of, based on, or caused
by:
|
|
i.
|
the
gross negligence or intentional wrongdoing of Licensor and its
Affiliates;
|
|
ii.breach
by Licensor of any of its representations, warranties or covenants made
herein.
|
|
b.
|
EES
shall be liable for and shall defend, indemnify and hold Licensor (and it
directors, officers, employees, and agents,) harmless against any Loss, in
connection with any Product arising out of, based on or caused
by:
|
23
|
i.
|
the
gross negligence or intentional wrongdoing of EES, its Affiliates or
sublicensees;
|
|
ii.breach
by EES, its Affiliates or sublicensees of any of its representations,
warranties or covenants made
herein;
|
|
iii.alleged
defects in material, workmanship, design, adequacy of warning, or other
product liability claim with respect to Products manufactured, used or
sold by EES, its Affiliates, or sublicensees;
and
|
|
xx.xxxxxx
of patent infringement made with respect to such
Products.
|
11.
|
XXXXXX
LICENSE AGREEMENT
|
|
a.
|
Licensor
will continue to assume all obligations and liabilities under the Xxxxxx
Agreement.
|
|
b.
|
Licensor
shall provide written notice to EES concurrent with x) delivery of notice
(written or otherwise) of Licensor’s intent to terminate the Xxxxxx
Agreement in accordance with Section 10 of the Xxxxxx Agreement, or y)
receipt of notice (written or otherwise) that the Xxxxxx Agreement may be
terminated in accordance with Section 10 of the Xxxxxx
Agreement.
|
|
i.
|
In
the event the Xxxxxx Agreement is terminated and provided that EES
executes an agreement with Xxxxxx that requires EES to pay a lump sum
and/or an earned royalty under such agreement, then any earned royalty EES
owes Licensor under this Agreement shall be reduced by an amount equal to
the earned royalty EES is required to pay under such agreement. If EES is
required to pay a lump sum(s) under such agreement, then the earned
royalties EES pays Licensor under this Agreement shall be reduced by 50%
until the cumulative amount by which such royalties are reduced equals the
amount of such lump sum(s).
|
24
|
xx.Xx
the event that the Xxxxxx Agreement is terminated, EES shall not be liable
to Licensor for earned royalties based upon post-termination sales of
Products covered only by patents subject to the Xxxxxx
Agreement.
|
|
c.
|
In
the event that the Xxxxxx Agreement is terminated pursuant to Section 10
of the Xxxxxx Agreement and without EES written consent to do so, Licensor
shall pay EES $500,000 within 60 days after such
termination.
|
12.
|
TERM
& TERMINATION
|
|
a.
|
Unless
otherwise terminated in accordance with the provisions below, the term of
this Agreement (“Term”) shall be from the Effective Date until the date
upon which the last of the Licensed Patents or Other Patents
expires.
|
|
b.
|
EES
may terminate this Agreement upon 90 days written notice to Licensor, and
such termination shall become effective at the end of such 90-day notice
period. Provided Licensor has not breached any of its
warranties and representations set forth in Article 9.b above, termination
under this Article 12.b shall not relieve EES of its obligation to pay
earned royalties incurred prior to the effective date of such
termination.
|
|
c.
|
Either
party may terminate this Agreement upon 120 days written notice for any
material breach or default of the other party. Such termination
shall become effective at the end of the 120-day period unless during such
period the party in breach or default cures such breach or default.
Notwithstanding the preceding sentence, from the date either party
notifies the other party that it wishes to commence a proceeding in
accordance with the dispute resolution procedures set forth in Attachment
A until the date such proceeding has been concluded, the running of the
time period referred to in
|
this
paragraph for curing a breach shall be suspended with respect to the subject
matter of the dispute, claim or controversy.
25
|
d.
|
Upon
the termination of this Agreement, all rights and obligations of each
party to this Agreement will terminate, except obligations for breaches of
this Agreement occurring prior thereto. Articles 10 and 13.j
shall expressly survive any
termination.
|
13.
|
MISCELLANEOUS
|
|
a.
|
All
business decisions, including without limitation the design, manufacture,
sale, price and promotion of the Licensed Product shall be within the sole
discretion of EES.
|
|
b.
|
After
the Effective Date, Licensor may issue the press release set forth in
Attachment E. In all other circumstances, no Party to this Agreement shall
originate any publicity, news release or other public announcement,
written or oral, whether relating to this Agreement or any arrangement
between the Parties other than acknowledging the existence of any
arrangement between the Parties, without the prior written consent of the
other Party, except where such publicity, news release or other public
announcement is required by law or regulation (including U.S. securities
laws and regulations); provided that in such event, the Party issuing same
shall still be required to consult with the other Party a reasonable time
prior to its release to allow the other Party to comment on the use of its
name and, after its release, shall provide the named Party with a copy
thereof.
|
|
c.
|
All
notices hereunder shall be in writing and shall be deemed to have been
duly given if delivered personally, one day after delivery to a nationally
recognized overnight delivery service, charges prepaid, three days after
sent by registered or certified mail, postage prepaid, or when receipt is
confirmed if by, facsimile or other telegraphic
means:
|
|
i.
|
In
the case of Licensor:
|
Chief
Executive Officer
Cyberonics,
Inc.
000
Xxxxxxxxxx Xxxx.
Xxxxxxx,
Xxxxx 00000
26
With a
copy to (which will not constitute notice):
Vice
President & General Counsel
Cyberonics,
Inc.
000
Xxxxxxxxxx Xxxx.
Xxxxxxx,
Xxxxx 00000
ii.
|
In
the case of EES:
|
President
Ethicon
Endo-Surgery, Inc.
0000
Xxxxx Xxxx
Xxxxxxxxxx,
Xxxx 00000
With a
copy to (which will not constitute notice):
Chief
Patent Counsel
Xxxxxxx
& Xxxxxxx
Xxx
Xxxxxxx & Xxxxxxx Xxxxx
Xxxxxxxxxx,
Xxxx 00000
|
iii.Such
addresses may be altered by written notice given in accordance with this
Article.
|
|
d.
|
Either
Party may assign this Agreement or any rights and obligations contemplated
herein to an Affiliate or to a company acquiring substantially all of the
Party’s assets to which this Agreement relates without the consent of the
other Party. In all other instances, neither party shall assign
this Agreement, any portion thereof nor any rights granted hereunder
without the prior written consent of the other party. Licensor
shall not assign, sell, convey, dedicate to the public or otherwise
dispose of any intellectual property licensed hereunder, including any
Licensed Patents, without EES’s prior written consent. Licensor
shall indemnify and hold EES harmless from all liabilities, demands,
damages, expenses and losses resulting from any such unauthorized
act. Subject to the foregoing, this Agreement shall bind and
inure to the benefit of the respective parties hereto and their successors
and assigns.
|
27
|
e.
|
Any
delays in or failures of performance by either party under this Agreement
shall not be considered a breach of this Agreement if and to the extent
caused by Force Majeure, in which case any time for performance hereunder
shall be extended by the actual time of delay caused by such Force
Majeure.
|
|
f.
|
The
waiver by either party, whether express or implied, of any provisions of
this Agreement, or of any breach or default of either party, shall not be
construed to be a continuing waiver of such provision, or of any
succeeding breach or default or of a waiver of any other provisions of
this Agreement. Failure to terminate this Agreement following
breach or failure to comply with this Agreement shall not constitute a
waiver of a party's defenses, rights or causes of action arising from such
or any future breach or
noncompliance.
|
|
g.
|
Any
provision hereof which is prohibited or unenforceable in any jurisdiction
shall, as to such jurisdiction, be ineffective only to the extent of such
prohibition or unenforceability without invalidating the remaining
provisions hereof or affecting the validity or enforceability of such
provision in any other
jurisdiction.
|
|
h.
|
All
rights and licenses granted under or pursuant to this Agreement by
Licensor to EES are, for all purposes of Section 365(n) of Title 11, U.S.
Code (the “Bankruptcy Code”), licenses of rights to “intellectual
property” as defined in the Bankruptcy Code. The parties agree
that EES, as a licensee of such rights under this Agreement, shall retain
and may fully exercise all of its rights and elections under the
Bankruptcy Code. Licensor agrees during the term of this
Agreement to create and maintain current copies or, if not amenable to
copying, detailed descriptions or other appropriate embodiments, of all
such licensed intellectual property. If a case is commenced by
or against Licensor under the Bankruptcy Code, then, unless and until this
Agreement is rejected as provided in the Bankruptcy Code, Licensor (in any
capacity, including debtor-in-possession) and its successors and assigns
(including, without limitation, a Bankruptcy Code trustee) shall either
perform all of the obligations provided in this Agreement to be performed
by Licensor or provide to EES all such intellectual property (including
all embodiments
|
28
thereof)
held by Licensor and such successors and assigns, as EES may elect in a written
request, immediately upon such request. If a Bankruptcy Code case is
commenced by or against Licensor, this Agreement is rejected as provided in the
Bankruptcy Code and EES elects to retain its rights hereunder as provided in the
Bankruptcy Code, then Licensor (in any capacity, including debtor-in-possession)
and its successors and assigns (including, without limitation, a Bankruptcy Code
trustee) shall provide to EES all such intellectual property (including all
embodiments thereof) held by Licensor and such successors and assigns
immediately upon EES’s written request therefor. All rights, powers
and remedies of EES provided under this Article are in addition to and not in
substitution for any and all other rights, powers and remedies now or hereafter
existing at law or in equity (including, without limitation, the Bankruptcy
Code) in the event of any such commencement of a bankruptcy proceeding by or
against Licensor. EES, in addition to the rights, powers and remedies
expressly provided herein, shall be entitled to exercise all other such rights
and powers and resort to all other such remedies as may now or hereafter exist
at law or in equity (including the Bankruptcy Code) in such event.
|
i.
|
The
parties hereto are entering into this Agreement as independent
contractors, and nothing herein is intended or shall be construed to
create between the parties a relationship of principal and agent,
partners, joint venturers or employer and employee. Neither
party shall hold itself out to others or seek to bind or commit the other
party in any manner inconsistent with the foregoing provisions of this
Article.
|
|
j.
|
The
parties agree to be bound by the dispute resolution provisions set forth
in Attachment A attached hereto.
|
|
k.
|
It
is the mutual desire and intent of the parties to provide certainty as to
their future rights and remedies against each other by defining the extent
of their mutual undertakings as provided herein. The parties
have in this Agreement incorporated all representations, warranties,
covenants, commitments and understandings on which they have relied in
entering into this Agreement and, except as provided for herein, neither
party has made any covenant or other commitment to the other concerning
its future
|
29
action. Accordingly,
this Agreement constitutes the entire agreement and understanding between the
parties with respect to the matters contained herein, and supersedes all prior
oral or written promises, representations, conditions, provisions or terms
related thereto. The parties may from time to time during the term of
this Agreement modify any of its provisions by mutual agreement in
writing.
|
l.
|
The
inclusion of headings in this Agreement is for convenience only and shall
not affect the construction or interpretation
hereof.
|
m.
|
Except
as otherwise expressly provided in this Agreement or as the context
otherwise requires, the following rules of interpretation apply to this
Agreement:
|
|
i.
|
words
in the singular will be held to include the plural and vice
versa;
|
|
ii.words
of one gender will be held to include the other genders as the context
requires;
|
|
iii.“or”
and “any” are not exclusive and the words “include” and “including,” and
variations thereof, will not be deemed to be terms of limitation, but
rather will be deemed to be followed by the words “without
limitation”;
|
|
iv.a
reference to any agreement or other contract includes amendments
thereto;
|
|
v.
|
a
reference to a law includes any amendment or modification to such law and
any rules or regulations issued
thereunder;
|
|
vi.a
reference to a person includes its permitted successors and assigns;
|
|
vii.a
reference in this Agreement to an Article, Section, Attachment, Annex,
Exhibit or Schedule is to the referenced Article, Section, Annex, Exhibit
or Schedule of this Agreement;
|
30
|
viii.the
terms “hereof,” “herein,” and “herewith” and words of similar import will,
unless otherwise stated, be construed to refer to this Agreement as a
whole (including all of the attachments hereto) and not to any particular
provision of this Agreement;
|
|
ix.all
references to “$” or “dollars” herein mean U.S.
dollars;
|
|
x.
|
each
of the representations, warranties, covenants and conditions contained
herein is separate and not limited or satisfied by the existence, wording
or satisfaction of any other representation, warranty, covenant or
condition contained herein.
|
|
n.
|
The
parties have participated jointly in the negotiation and drafting of this
Agreement. In the event an ambiguity or question of intent
interpretation arises, this Agreement shall be construed as if jointly
drafted by the parties and no presumption or burden of proof shall arise
favoring or disfavoring any Party by virtue of the authorship of any
provision of this Agreement.
|
|
o.
|
The
parties are entering into this Agreement in good faith and after careful
contemplation of terms, with the advice of counsel. The Parties
are not entering into this Agreement because of duress, whether financial
or otherwise, nor has a Party identified any such duress to any other
Party.
|
|
p.
|
This
Agreement will be governed by and construed in accordance with the Laws of
the State of Delaware.
|
|
q.
|
This
Agreement may be executed in any number of counterparts, and each such
counterpart hereof will be deemed to be an original instrument, but all
such counterparts together will constitute but one agreement. Delivery of
an executed counterpart of a signature page of this Agreement by facsimile
will be effective as delivery of a manually executed counterpart of this
Agreement.
|
[SIGNATURE
PAGE TO FOLLOW]
31
This
Agreement is signed on the dates set forth below by duly authorized
representatives of EES and the Licensor, respectively.
Cyberonics,
Inc.
|
Ethicon
Endo-Surgery, Inc.
|
By:
/s/ Xxxxxx X. Xxxxx
|
By:
/s/ Xxxxxxxx
Xxxxxxx
|
Xxxxxx
X. Xxxxx
|
Xxxxxxxx
Xxxxxxx
|
Chief
Executive Officer
|
Worldwide
Vice President
|
Business
Development & Strategy
|
|
Date:
12.17/07
|
Date:
12/17/07
|
[ATTACHMENTS
TO FOLLOW]
32
Attachment
A
Dispute
Resolution Clause
Any
controversy or claim arising out of or relating to this Agreement shall be
resolved by arbitration before a single arbitrator in accordance with the
Commercial Arbitration Rules of the American Arbitration Association (“AAA”)
then pertaining (available at xxx.xxx.xxx), except where those rules conflict
with this provision, in which case this provision controls. Any court with
jurisdiction shall enforce this clause and enter judgment on any award. The
arbitrator shall be selected within twenty business days from commencement of
the arbitration from the AAA’s National Roster of Arbitrators pursuant to
agreement or through selection procedures administered by the AAA. Within 45
days of initiation of arbitration, the parties shall reach agreement upon and
thereafter follow procedures, including limits on discovery, assuring that the
arbitration will be concluded and the award rendered within no more than eight
months from selection of the arbitrator or, failing agreement, procedures
meeting such time limits will be designed by the AAA and adhered to by the
parties. The arbitration shall be held in Wilmington, DE and the arbitrator
shall apply the substantive law of Delaware, except that the interpretation and
enforcement of this arbitration provision shall be governed by the Federal
Arbitration Act. Prior to appointment of the arbitrator or thereafter if he is
unavailable, emergency relief is available from any court to avoid irreparable
harm. THE ARBITRATOR SHALL NOT AWARD EITHER PARTY PUNITIVE, EXEMPLARY,
MULTIPLIED OR CONSEQUENTIAL DAMAGES, OR ATTORNEYS FEES OR COSTS.
Prior to
commencement of arbitration, the parties must attempt to mediate their dispute
using a professional mediator from AAA, the CPR Institute for Dispute
Resolution, or like organization selected by agreement or, absent agreement,
through selection procedures administered by the AAA. Within a period of 45 days
after the request for mediation, the parties agree to convene with the mediator,
with business representatives present, for at least one session to attempt to
resolve the matter. In no event will mediation delay commencement of the
arbitration for more than 45 days absent agreement of the parties or interfere
with the availability of emergency relief.
33
Attachment
B1
Licensed
Cyberonics Patents
Patent
or Application
Publication
Number
|
Title
|
5,188,104
|
Treatment
of Eating Disorders by Nerve Stimulation
|
5,231,988
|
Treatment
of Endocrine Disorders by Nerve Stimulation
|
5,263,480
|
Treatment
of Eating Disorders by Nerve Stimulation
|
5,540,730
|
Treatment
of Motility Disorders by Nerve Stimulation
|
5,540,734
|
Cranial
Nerve Stimulation Treatments Using Neurocybernetic
Prosthesis
|
5,707,400
|
Treating
Refractory Hypertension by Nerve Stimulation
|
20060247719
|
Weight
Loss Method and Device
|
20060247721
|
Identification
of Electrodes for Nerve Stimulation in the Treatment of Eating
Disorders
|
20060247722
|
Noninvasively
Adjustable Gastric Band
|
20070027483
|
Stimulating
Cranial Nerve to Treat Disorders Associated with the Thyroid
Gland
|
20070027484
|
Autonomic
Nerve Stimulation to Treat a Pancreatic Disorder
|
20070027492
|
Autonomic
Nerve Stimulation to Treat a Gastrointestinal Disorder
|
20070027498
|
Selective
Nerve Stimulation for the Treatment of Eating Disorders
|
20070093870
|
Cranial
Nerve Stimulation to Treat Eating
Disorders
|
34
Attachment
B2
Roslin
Patents
Patent
or Application Publication Number
|
Title
|
6,587,719
|
Treatment
of Obesity by Bilateral Vagus Nerve Stimulation
|
6,609,025
|
Treatment
of Obesity by Sub-Diaphragmatic Nerve Stimulation
|
7,299,091
|
Treatment
of Obesity by Bilateral Vagus Nerve Stimulation
|
20040039427
|
Treatment
of Obesity by Sub-Diaphragmatic Nerve
Stimulation
|
35
Attachment
C
Minimum
Royalty Payment Examples
Example
1
|
-
|
The
First Competitive Sale occurs in November of 2007 and the competitive
Product remains on the market
thereafter.
|
Period
|
Minimum
Royalty Payment
|
Upon
notice, 2007
|
$***
|
1Q,
2008
|
$***
|
2Q,
2008
|
$***
|
3Q,
2008
|
$***
|
4Q,
2008
|
$***
|
1Q,
2009
|
$***
|
2Q,
2009
|
$***
|
3Q,
2009
|
$***
|
4Q,
2009
|
$***
|
1Q,
2010
|
$***
|
2Q,
2010
|
$***
|
3Q,
2010
|
$***
|
4Q,
2010
|
$***
|
Example
2
The First
Competitive Sale occurs in January of 2008. In May of 2009, the
competitive Product is pulled from the market. In December of 2009, a
second competitor launches a Product and remains on the market
thereafter.
Period
|
Minimum
Royalty Payment
|
Upon
notice, 2008
|
$***
|
1Q,
2009
|
$***
|
2Q,
2009
|
–
|
3Q,
2009
|
–
|
4Q,
2009
|
–
|
1Q,
2010
|
$***
|
2Q,
2010
|
$***
|
3Q,
2010
|
$***
|
4Q,
2010
|
$***
|
|
***
Portions of this page have been omitted pursuant to a Confidential
Treatment request and filed separately with the
Commission.
|
36
Attachment
D
Roslin
Agreement
37
LICENSE AGREEMENT
THIS AGREEMENT (“Agreement”)
dated as of August 22, 2000 (the “Effective Date”) by and between Xxxxxxxx
X. Xxxxxx, M.D., a citizen of the United States of America residing in New York,
NY (“Licensor”), and Cyberonics, Inc., a Delaware corporation with offices in
Houston, Texas (“Licensee”).
Recitals:
Licensee
is engaged in designing, developing, investigating, testing, and marketing
specialized medical devices primarily used or to be used for treating disorders
by nervous system stimulation, and owns basic patents related to the use of
nerve stimulation for eating, endocrine and other disorders, including patents
on the use of vagus nerve stimulation (VNS) to treat obesity;
Licensor
is medical doctor licensed to practice medicine in the State of New York, and is
a co-inventor with Xxxxx X. Xxxxxxx of Licensee and Xxxxxx Xxxxx, M.D. on a
United States patent application for bi-lateral VNS for the treatment of
obesity, Serial No. 09/346,396, filed on or about July 1, 1999, and/or
continuations or divisions thereof, and a PCT counterpart application thereof
(collectively, “the ‘396 Application”), the original animal studies for which
were initiated by Licensor with participation, assistance, support, advice and
devices of Licensee; and
Licensee
and Licensor desire to enter into an agreement under which Licensee will acquire
from Licensor the exclusive right and license to practice the inventions)
covered by the ‘396 Application to the fullest extent of Licensor’s right, title
and interest in and to the invention(s), and in and to all other inventions
conceived, made, reduced to practice, owned or controlled by Licensor in the
field of nervous system stimulation, on the terms and conditions set forth in
this Agreement.
In
consideration of the foregoing recitals, and the mutual undertakings set forth
herein, Licensee and Licensor (collectively, “the Parties”) do hereby AGREE AS FOLLOWS:
ARTICLE
I
Definitions.
As used
in this Agreement, terms shall have the following meanings:
38
1.02 “FDA” shall mean the
U.S. Food and Drug Administration, which has responsibility under the law for,
among other things, establishing protocol for clinical investigation of medical
devices and granting Investigational Device Exemption (“IDE”), determining from
results of clinical investigation whether a medical device is safe and effective
for treating a disease or disorder, and granting Pre-Market Approval (“PMA”) of
medical devices.
1.03 “Invention” shall mean
an advance, innovation, discovery, or improvement in a product, process, method,
or technique, whether patentable or not, conceived, made, or reduced to practice
by Licensor, alone or with others, or owned or controlled in whole or in part by
Licensor, at any time during the term of this Agreement, in the field of nervous
system stimulation.
1.04 “Licensed Patents”
shall mean United States patent application Serial No. 09/346,396 filed
July 1, 1999 in the names of Xxxxxxxx Xxxxxx and others for “Treatment of
Obesity by Bilateral Vagus Nerve Stimulation”, and all continuations,
continuations in part and divisions thereof, all patents issued, reissued,
reexamined, and renewed (e.g., by payment of maintenance fees or annuities, as
the case may be) thereon, and all counterparts (i.e., corresponding applications
and patents) and equivalents (i.e., statutorily protected or designated by
status of invention, characterized as other than a patent application or patent)
thereof filed or issued in other countries (including but not limited to
nationalizations under the Patent Cooperation Treaty (PCT) in the name
(with or without others), on behalf, or with concurrence of Licensor; and any
and all Inventions, whether or not applications for patent, patents or
equivalents are filed thereon, and, if filed, such patent, patents or
equivalents. The Licensed Patents as of the Effective Date hereof are set forth
in Exhibit A
(attached hereto and integrated herein), subject to modification from time to
time to add newly arising, filed or issued Licensed Patents as provided
herein.
1.05 “Licensed Products”
shall mean any and all products, devices, apparatus, and systems, and “Licensed Methods”
shall mean any and all methods, techniques, and processes, covered by any
claim(s) of the Licensed Patents.
1.06 “Net Sales” shall mean
gross sales of Licensed Products by Licensee or its sublicensee(s), as the case
may be, less taxes and tariffs (by whatever name they may be designated) imposed
by governmental authorities on the manufacture, sale, importation, lease or
storage of Licensed Products and actually paid by Licensee (or its
sublicensee(s)); packing and freight charges (including insurance costs for
transportation) actually included in Licensee’s (or its sublicensee’(s’))
invoices for Licensed Products; and credits for returns, discounts, and
allowances actually granted by Licensee (or it sublicensee(s)) to customers for
Licensed Products. In the event that a Licensed Product is disposed of in a
transaction with a third party other than an arms length sale between unrelated
parties, the transaction shall be treated and accounted for by Licensee and its
sublicensees, as applicable, as a typical sale at the average gross sales price
of the Licensed Product by Licensee or the sublicensee, as the case may be, in
the market in which such transaction occurred.
39
1.07 “License Fee” shall
mean a fee paid to Licensee by a sublicensee for the privilege of receiving a
sublicense, which is neither based on Net Sales by the sublicensee nor
deductible from royalties paid or payable to Licensee by the sublicensee for its
Net Sales.
ARTICLE
II
Grant
of License.
2.01 Exclusive
License. Licensor agrees to grant and hereby does grant to
Licensee the exclusive worldwide right and license to all of Licensor’s rights
in and to the Licensed Patents, including but not limited to the exclusive
worldwide right and license to make, have made, use, sell, import, export and
otherwise dispose of the Licensed Products, and to practice the Licensed
Methods.
2.02 Right to grant
Sublicenses. The license granted to Licensee hereunder shall
include the exclusive right to grant sublicenses to third parties for the
exercise of any or all of the rights granted in the Licensee’s license in any
territory constituting a country, portion of a country, or countries of the
world.
Article III.
Royalties;
Advances; Audit.
3.01 Royalties.
(a) Licensee
shall pay Licensor Royalties at the royalty rate specified in Exhibit B applied to
(i) Net Sales of Licensed Products by Licensee and its sublicensees and
(ii) any License Fees received by Licensee on account of
sublicenses.
(b) Royalties
shall be deemed earned when sales are made, but shall be due and payable
quarterly in United States dollars, within 90 days after the end of the
fiscal quarter of Licensee in which the applicable sales were made. Only one
Royalty shall be due per Licensed Product sold, regardless of the number of
Licensed Patents and/or claims that may apply or the number of times a Licensed
Product may be used to practice Licensed Methods.
(c) With
each quarterly payment of Royalties, Licensee shall furnish a quarterly report
to Licensor setting forth its own and its sublicensees’ cumulative gross sales,
permitted deductions and resulting Net Sales of the Licensed Products, License
Fees and the Royalty payment due thereon for the applicable fiscal quarter. If
no sales of Licensed Products were made in the quarter by Licensee or its
sublicensees, the report shall so state.
3.02 Advances.
(a) Annual. Licensee
shall pay Licensor annual advances (“Annual Advances”) against earned Royalties
in the amount of $25,000.00 each, to be paid on January 1 of each year,
retroactive to January 1, 2000, for a period of five years ending
December 31, 2004 (totaling $125,000.00), or until the first sale of a
Licensed Product, whichever occurs first.
40
Annual
Advances shall be deducted from Royalties earned at any time during the term of
this Agreement (or payable thereafter as provided herein).
(b) Milestone. Licensee
shall also pay Licensor advances for each of the following milestones against
future earned Royalties (“Milestone Advances”), within 30 days after the
respective milestone is first reached during the term of this Agreement, in the
following amounts (up to a maximum cumulative amount of $325,000.00): (1)
$25,000.00 upon the first implant by Licensor of a Licensee VNS device in a
patient in the pilot clinical study of VNS as a treatment for obesity (which
milestone the parties acknowledge has been reached as of the date hereof), (2)
$50,000.00 upon completion of a 30-patient pilot clinical study of VNS as a
treatment for obesity, (3) $100,000.00 upon completion of a pivotal or Phase III
clinical study of VNS as a treatment for obesity that would support a Premarket
Approval (PMA) application to FDA and submission of the
results of that study as part of a PMA application submission to the FDA, and
(d) $150,000.00 upon FDA approval of VNS for the treatment of obesity. A
prerequisite for the payment of each Milestone Advance, in addition to actual
achievement of the respective milestone, is that Licensor shall have performed
the implant for milestone (1), and, except in the event of either his death or a
disability that prevents him from doing so, Licensor shall have been an active
advisor and clinical investigator in the achievement of each of milestones (2),
(3) and (4). Milestone Advances shall be deducted from Royalties earned at
any time during the term of this Agreement (or payable thereafter as provided
herein).
(c) Deductibility. To
the extent that either or both the Annual Advances and Milestone Advances cannot
be deducted from earned Royalties because of an insufficiency of Net Sales of
Licensed Products, the non-deducted amounts of such advance payments shall not
be refundable by Licensor.
3.03 Audit.
(a) Licensee
shall maintain books and records according to generally accepted accounting
principles bearing on its sales of the Licensed Products, and shall, on not less
than 30 days’ advance notice of Licensor’s intent to audit, make same
available for inspection and audit on its own premises during Licensee’s regular
business hours. Any such audit(s) shall be performed by a CPA designated and
paid by Licensor(Licensor’s auditor), not more often than annually during the
term of this Agreement, with respect to applicable sales made in the preceding
calendar year.
(b) Licensee
shall promptly pay any deficiency in Royalties payable to Licensor uncovered by
audit, with interest at an annual rate of 1% over the prime rate, calculated
from the date(s) the underpaid amount(s) should have been paid. If the
deficiency exceeds 10% of the Royalties actually earned for the year under
audit, Licensee shall reimburse Licensor’s cost of the audit. Licensor’s
agreement with its auditor shall require the auditor not to disclose to third
parties Confidential Information of Licensee obtained from the audit, and
Licensee may require Licensor’s auditor to sign a non-disclosure agreement to
that effect prior to allowing the audit.
41
3.04 Change of
Control. In the event that Licensee undergoes a change in
control (measured as a change in legal or beneficial ownership, or a combination
thereof, by a single entity of more than 50% of Licensee’s capital stock
entitled to vote for the election of directors) from that which existed at the
Effective Date, Licensor shall, upon the occurrence of the change of control, be
within 60 days after the change of control is effected, due in cash the
difference between $450,000.00 and the sum of any Annual Advances or Milestone
Advances that have been made as of the occurrence of the change of control (such
difference being the “Accelerated Change of Control Payment”). Upon payment of
the Accelerated Change of Control Payment, Licensor will no longer be entitled
to any additional Annual Advances or Milestone Advances and a total of $450,000
(including any Royalties that have already been deducted as of the occurrence of
the change of control) will be deducted from Royalties earned at any time during
the term of this Agreement (or payable thereafter as provided
herein).
Article IV.
Prosecution
and Maintenance of Licensed Patents.
4.01 Prosecution. Licensee
shall have the right to prosecute or have prosecuted and bear the entire cost of
prosecuting the ‘396 Application, and all other applications among the Licensed
Patents, including any applications for patent or counterpart applications
Licensee may elect to file or have designated and Licensee shall pay all
government fees designated for maintaining the pendency of such applications and
of patents maturing therefrom.
4.02 Notice. Licensor
shall give Licensee notice of each and every Invention within 30 days after
conception thereof; and shall not make an Invention public without first having
given Licensee both notice thereof and a reasonable opportunity to file a patent
application on the Invention.
Article V.
Infringement.
5.01 Of Patents of Third Parties
by Licensee or Its Sublicensees. Licensee and/or its
sublicensees shall defend at their own expense all suits brought against them
for infringement of third party patents by their respective manufacture, use,
sale, or other disposition of Licensed Products. In no event shall Licensee
enter into a settlement containing terms purporting to affect the validity or
scope of a Licensed Patent without obtaining prior written consent of Licensor,
which shall not be withheld unreasonably.
5.02 Of the Licensed Patents by
Third Parties. During the term of this Agreement, Licensee
shall have the option but not the obligation, at its own expense, to investigate
and prosecute infringements of the Licensed Patents. Licensee shall be entitled
to the entirety of any recovery by way of settlement or award of money damages
based on a claim of infringement of a Licensed Patent (collectively, “Claim”),
provided, however, that any such recovery shall be treated as Net Sales and
subject to Licensor Royalties. If Licensee declines to take action against an
alleged infringer, it shall so notify Licensor who shall then have the right to
prosecute the infringer at its own expense, and in that event, Licensor and
Licensee shall share equally the
42
amount of
the recovery, if any, after deduction of Licensor’s costs, including attorney
fees, incurred for such prosecution.
5.03 Joinder and Cooperation of
Licensee. Licensee may join Licensor as a party plaintiff in
any suit or counterclaim instituted by Licensee for infringement or in defense
of validity of a Licensed Patent, provided that Licensee shall indemnify and
hold harmless Licensor from and against any damages, losses, awards, costs, and
expenses (including attorney’s fees) accrued as a result of or arising from or
in connection with such joinder. Whether joined or not, Licensor agrees upon
Licensee’s request to provide reasonable assistance and cooperation to Licensee
in advancing a Claim or in defending the validity of a Licensed Patent, subject
only to Licensee’s reimbursement or direct payment of costs incurred by Licensor
for or in connection with such assistance and cooperation.
5.04 Non-refundable Royalties;
Adjustment. Licensee shall not be entitled to a refund of
Royalties paid to Licensor, but if one or more (but less than all) of the
Licensed Patents is held by final decision of a court of last resort (as the
result of an appeal or a failure to timely prosecute an appeal) to be invalid or
unenforceable, Licensor and Licensee shall promptly negotiate an equitable
downward adjustment of the royalty rate as to the remaining patents which shall
apply to future Net Sales and Exhibit B shall
be modified in writing accordingly.
Article VI.
Representations
and Warranties.
6.01 By
Licensor. Licensor represents and warrants to Licensee that,
as of the Effective Date of this Agreement:
(a) Licensor
owns an undivided interest in the Licensed Patents and has complete power and
authority to enter into this Agreement and to grant the rights and licenses
granted herein to Licensee.
(b) Licensor
is not aware of any information which is material to the patentability or
validity of the ‘396 application that he not already brought to the attention of
Licensee.
(c) Licensor
has not entered into any agreement or understanding with any third party that
conflicts with this Agreement or the rights and licenses granted herein to
Licensee.
6.02 By
Licensee. Licensee represents and warrants to Licensor that,
as of the Effective Date of this Agreement:
(a) Licensee
has complete power and authority to enter into this Agreement, and to accept and
perform all of its other obligations on the terms and conditions set forth
herein.
(b) Licensee
does not require any approval from any third party to enter into this
Agreement.
43
(c) Licensee’s
entry into this Agreement will not conflict with any other agreement or
understanding it has with a third party.
(d) Licensee
will defend, indemnify and hold harmless Licensor from and against any liability
for manufacture, use, sale, or other activity relating to the Licensed Products
or practice of the Licensed Methods, including without limitation all costs,
fees (including attorney’s fees), awards, damages, fines, and penalties finally
awarded against Licensee or Licensor for any Claim of personal injury, death,
emotional distress, property damage, or any other casualty or risk whatsoever.
Licensor shall promptly notify Licensee of any Claim or communication relating
thereto made to Licensor, shall furnish reasonable assistance and information to
Licensee for defense or settlement of such claim, and shall give Licensee
authority to assume control of the defense or settlement of the Claim including
the right to appoint counsel to implement such defense or
settlement.
6.03 Disclaimers.
Nothing contained in this Agreement shall constitute a representation or
warranty by Licensor that:
(a) a
patent will issue from any application encompassed within the Licensed Patents
or Improvement Patents; or
(b) the
Licensed Patents are valid or enforceable; or
(c) the
manufacture, use, sale, or other activity relating to the Licensed Products or
practice of the Licensed Methods will be free from infringement of third party
patent(s).
Article VII.
Term
and Termination.
7.01 Term. This Agreement
shall commence on the Effective Date, and shall remain in force until the last
Licensed Patent expires or is held invalid or unenforceable, unless terminated
earlier as provided herein.
7.02 Termination.
(a) Licensor
or Licensee may terminate this Agreement and the licenses and rights granted to
Licensee herein by notice given to the other at any time after 90 days from
date of notice to the other of a breach which has not been cured prior to the
termination notice; provided, however, if the breach is other than a failure to
pay money and cannot reasonably be cured within 90 days but the party
charged with having committed the breach has taken reasonable steps to effect a
cure within that period and is acting with diligence to complete the cure, then
the notice period for breach shall be extended until the cure is effected, not
to exceed an additional 60 days. The licenses and rights granted herein
shall terminate upon termination of this Agreement.
(b) Upon
termination of this Agreement, Licensee and its sublicensees shall have the
right to sell or otherwise dispose of its and their then remaining inventory of
the
44
Licensed
Products, subject to compliance with all applicable provisions of
Article III above, including the continued payment of
Royalties.
7.03 Surviving
Provisions. The provisions of Articles III, V (to the extent
of any then-remaining obligations of the Parties), VI, section 7.02(b), and
sections 8.01, 8.03, 8.05, and 8.06, shall survive expiration or termination of
this Agreement.
Article VIII.
General.
8.01 Notices. Any
and all notices or other communications required or permitted to be given under
any of the provisions of this Agreement shall be in writing and shall be deemed
to have been duly given when personally delivered or the earlier of (i) 6
business days after the mailing thereof (postage prepaid, first class mail) and
(ii) the actual receipt thereof if delivered by facsimile transmission or
if mailed by first class registered mail, return receipt requested,
addressed:
If
to Licensor:
|
Xxxxxxxx
X. Xxxxxx, M.D.
|
000
Xxxxx 000 Xxxxxx
|
|
Xxx
Xxxxxxxx, XX 00000
|
|
With
copy to:
|
Xxxxxxx
X. Xxxxxx, Esq.
|
Executive
Vice President
|
|
MED3000
Group, Inc.
|
|
Xxxxxx
Plaza 10
|
|
000
Xxxxxxxx Xxxxx
|
|
Xxxxxxxxxx,
XX 00000
|
|
(Facsimile
No: 412-937-9221)
|
|
If
to Licensee:
|
Cyberonics,
Inc.
|
00000
Xxxxx Xxxxxx Xxxxxxxxx, Xxxxx 000
|
|
Xxxxxxx,
XX 00000
Attention:
Xxxxxx X. Xxxxxxx
|
|
(Facsimile
No: 281-218-9332)
|
|
With
copy to:
|
Blank
Rome Xxxxxxx & XxXxxxxx LLP
|
000
00xx Xxxxxx, X.X., Xxxxx 0000
|
|
Xxxxxxxxxx,
X.X. 00000
|
|
Attention:
Xxxxxx X. Xxxxxx, Esq.
|
|
(Facsimile
No: 202-463-6915)
|
or to
such changed address as shall have been designated by notice.
8.02 Assignment. Licensor
shall not assign any rights or delegate any duties under this Agreement. Except
for an assignment to a successor in interest to Licensee’s business to which
this Agreement relates, Licensee shall not assign this Agreement without the
prior written
45
consent
of Licensor, which shall not be unreasonably withheld or delayed. Except as
otherwise provided herein, this Agreement shall be binding on and inure to the
benefit of each Party and their respective heirs, personal representatives,
executors, successors and assigns.
8.03 Confidentiality. Licensor
shall protect and preserve the confidentiality of all Licensee’s Confidential
Information which Licensor may learn in the course of performance under this
Agreement, and Licensor agrees not to disclose any such Confidential Information
to any third party or use it for his own benefit or the benefit of any third
party without the prior written consent of an authorized officer of
Licensee.
8.04 Cooperation. Each
Party shall cooperate, and shall take such further action and shall execute and
deliver such further documents as may be reasonably requested by the other Party
in order to carry out the provisions and purposes of this
Agreement.
8.05 Construction and
Law. This Agreement shall be governed and construed in
accordance with the laws of the State of Texas, U.S.A. applicable to contracts
made and to be performed therein.
Article
and section headings contained in this Agreement are for purposes of convenience
of reference only, and are not intended to define or limit the contents of the
respective Articles or sections or to be otherwise used for construction of the
Agreement.
8.06 Entire
Agreement. This Agreement embodies the entire understanding of
the Parties respecting the subject matter hereof, and supersedes all prior and
contemporaneous agreements between them respecting that subject matter. This
Agreement may not be modified except by a written agreement specifically
referring to this Agreement and signed by both Parties. No waiver of any breach
or default hereunder shall be considered valid unless given in writing and
signed by the Party giving such waiver, and no waiver shall be deemed a waiver
of any other contemporaneous or subsequent breach or default.
IN
WITNESS WHEREOF, the parties have executed this Agreement or caused it to be
executed by their respective duly authorized representatives, in one or more
counterparts, all of which taken together shall be deemed one original, as of
the Effective Date hereof.
LICENSEE
|
|
CYBERONICS,
INC.
|
|
By:
/s/ Xxxxxx X.
Xxxxxxxxx
|
|
Xxxxxx
X. Xxxxxxxxx. Vice President,
Finance
and Administration & CFO
|
|
LICENSOR
|
|
By:
/s/ Xxxxxxxx X.
Xxxxxx
|
|
Xxxxxxxx
X. Xxxxxx, M.D.
|
46
EXHIBIT
A
LICENSED
PATENTS
·
|
U.S.
Patent Application Serial No. 09/346,396, filed July 1, 1999 in
the U.S. Patent and Trademark Office
(PTO).
|
·
|
Patent
Cooperation Treaty (PCT) Application Serial No. US/00/____ ,
filed June 30, 2000 in United States Receiving Office, based on U.S.
Serial No. 09/346,396.
|
47
EXHIBIT
B
ROYALTY
RATE
The
royalty rate payable under Article III of this Agreement shall
be:
1.0 % on
the first US$10 million of Net Sales of the Licensed Products; and 0.5% of
Net Sales of the Licensed Products thereafter.
48
Attachment
E
CYBX
Press Release
CYBERONICS
LICENSES OBESITY-RELATED PATENTS
HOUSTON,
Texas, [December xx], 2007 – Cyberonics, Inc. (NASDAQ:CYBX) announced that
effective [today] the
company has entered into an agreement with Ethicon Endo-Surgery, Inc., a Xxxxxxx
& Xxxxxxx company, granting Ethicon Endo-Surgery exclusive rights to the
company’s patents and patent applications pertaining to vagus nerve stimulation
(“VNS”) for the treatment of obesity and two related co-morbidities, diabetes
and hypertension, in overweight patients.
Ethicon
Endo-Surgery has agreed to pay Cyberonics a signing fee of $9.5 million and
royalties on commercial sales of products covered by the subject
patents.
“This
agreement advances our mission to improve the lives of people affected by
chronic neurological disorders,” commented Xxx Xxxxx, Cyberonics’ President and
Chief Executive Officer. “Out-licensing our obesity-related patents
permits us to obtain value from these assets while we continue to focus on our
other strategic objectives – achieving positive cash flow and profitability,
growing our core epilepsy business, and appropriately developing our
treatment-resistant depression business – and provides an opportunity for a
device leader in the obesity space to utilize Cyberonics’ assets in developing
weight reduction solutions.”
More than
46,000 patients worldwide have benefited from VNS Therapy during the past 10
years.
ABOUT
VNS THERAPY AND CYBERONICS
Information
on Cyberonics, Inc. and VNS Therapy is available at xxx.xxxxxxxxxx.xxx and
xxx.XXXXxxxxxx.xxx.
SAFE
HARBOR STATEMENT
This
press release contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended and Section 21E of the Securities
Exchange Act of 1934, as amended. These statements can be identified
by the use of forward-looking terminology, including "may," "believe," "will,"
"expect," "anticipate," "estimate," "plan," "intend," and "forecast," or other
similar words. Statements contained in this press release are based
upon information presently available to us and assumptions that we believe to be
reasonable. We are not assuming any duty to update this information
should those facts change or should we no longer believe the assumptions to be
reasonable. Investors are cautioned that all such statements involve
risks and uncertainties, including without limitation, statements concerning
achieving positive cash flow and profitability, growing our core epilepsy
business, appropriately developing our TRD business, and developing VNS as a
viable therapy for weight reduction. Our actual results may differ
materially. Important factors that may cause actual results to differ
include, but are not limited to: continued market acceptance of VNS Therapy and
sales of our product; the development and satisfactory completion of clinical
trials and/or market test and/or regulatory approval of VNS Therapy for the
treatment of other indications; satisfactory completion of post-market studies
required by the U.S. Food and Drug Administration as a condition of approval for
the TRD indication; adverse changes in coverage or reimbursement amounts by
third parties; intellectual property protection and potential infringement
claims; maintaining compliance with government regulations and obtaining
necessary government approvals for new indications; product liability claims and
potential litigation; reliance on single suppliers and manufacturers for certain
components; the accuracy of management's estimates of future expenses and sales;
the results of the previously disclosed governmental inquiries; the potential
identification of new material weaknesses in our internal controls over
financial reporting; risks and costs associated with such governmental inquiries
and any litigation relating thereto or to our stock option grants, procedures,
and practices (including the previously disclosed private litigation);
uncertainties associated with stockholder litigation; and other risks detailed
from time to time in our filings with the Securities and Exchange Commission
(SEC). For a detailed discussion of these and other cautionary
statements, please refer to our most recent filings with the SEC, including our
Annual Report on Form 10-K for the fiscal year ended April 27,
2007.
49
Attachment
F
Xxxxxx
Agreement
50
LICENSE AGREEMENT
This
License Agreement (“Agreement”) is entered into as of March 15, 1988 by and
between CYBERONICS, INC., a Delaware corporation, having a principal place of
business at 000 X. Xxxx Xxxxxx, Xxxxxx Xxxx, XX 00000 (“Licensee”), and XX.
XXXXX XXXXXX, an individual residing at 000 Xxxxxx Xxxxxx, #00X, Xxxxxxxxxxxx,
XX 00000 (“Licensor”).
WHEREAS,
Licensor owns a patent relating to Neurocyberenetic Prosthesis Technology (U.S.
Patent No. 4,702,254) and other pending patent applications and know-how,
and technology relating thereto (collectively referred to as the “Technology”);
and,
WHEREAS,
Licensee wishes to obtain all exclusive license under the Licensed Patents as
hereinafter defined and under the Technology generally to further test and
develop the Technology and to manufacture and market products based on such
Technology upon the terms and conditions hereinafter set forth;
NOW,
THEREFORE, in consideration of the promises and of the mutual covenants
hereinafter contained, the parties agree as follows:
|
1.
|
Definitions.
|
(a) The
term “Licensed Patents,” as used in this Agreement, shall mean and include both
individually and collectively the United States and foreign patents and patent
applications listed in Schedule A attached to this Agreement, such
additional United States and foreign patent applications acquired by Licensor on
improvements and variations upon inventions disclosed in said listed
applications or other inventions “in the field of nerve stimulation, and such
additional patent applications as may be filed by Licensor pursuant to
Section 7 of this Agreement, all Letters Patent which shall issue on said
applications and any division thereof, and all reissues, continuations, or
extensions of said Letters Patent.
(b) The
term “Product,” as used in this Agreement, shall mean a product or portion of a
product that (i) embodies a device invention claimed in a Licensed Patent
(or which had been “claimed” in a Licensed Patent which has been declared
invalid), or (ii) which is specifically intended to be used to practice a
method claimed in a Licensed Patent (or which had been “claimed” in a Licensed
Patent which has been declared invalid) and which is manufactured and sold by or
for Licensee (or its sublicensees); provided that at the time and in the
territory of manufacture or sale of such Product a Licensed Patent is pending or
in force claiming such device or method (or such device or method had been
“claimed” in a Licensed Patent previously valid in the territory of manufacture
or sale but which has been declared invalid).
2.Licensor’s Representations
& Warranties. Licensor represents and warrants that:
(a) He
owns the Licensed Patents and has the legal power and authority to extend the
rights granted to Licensee pursuant to this Agreement and he has not assigned,
licensed, pledged or compromised the Licensed Patents or made any commitments or
offers inconsistent with or in derogation of the rights created by this
Agreement.
51
(b) Neither
the Licensed Patents nor any claims contained therein have been declared invalid
or unenforceable and to the best of Licensor’s knowledge there are no patent
infringement suits or asserted patent infringement claims pertaining to the
Licensed Patents and there are no suits or claims attacking the validity of any
Licensed Patent, and Licensor knows of no basis for any such claim.
(c) Licensor
has no knowledge of any information likely to have a material effect on the
validity or enforceability of any Licensed Patent or any claim thereof which was
not disclosed to the Patent Office of the respective countries in which Patent
Applications were filed during the prosecution of the application from which any
Licensed Patent matured or, with respect to pending applications, from which any
Licensed Patent may mature.
|
3.License.
|
(a) Licensor
hereby grants to Licensee, and Licensee hereby accepts from Licensor, upon the
terms and conditions herein after specified, the exclusive, worldwide right and
license under the Licensed Patents and Technology to further test and develop
the Technology, to make, to have made, to use, to sell, to lease, to implant,
and to have implanted and otherwise dispose of Products and to sublicense the
rights created hereby pursuant to the terms of Section 5 hereof. Such
license shall be perpetual unless this Agreement is terminated pursuant to
Section 3.0 hereof.
(b) Any
person, firm, or corporation purchasing Products from Licensee or any
Sublicensee hereunder, and its successors and assigns, shall automatically enjoy
a royalty-free right under the Licensed Patents to implant and/or have implanted
and to use the particular Product, and to manufacture, purchase, implant, and
use any auxiliary products which may be necessary or desirable to provide a
complete implant.
|
4.Royalties, Records and
Reports.
|
(a) Licensee
agrees to pay to Licensor, in consideration for the license granted pursuant to
this Agreement, royalties on the Net Sales Value (as hereinafter defined) of all
Products sold during the term of this Agreement at the rate of six percent
(6.0%) on the first $12,000,000 of Net Sales Value and three percent (3.0%) on
all Net Sales Value after said $12,000,000, cumulative and not annual, for the
life of U.S. Patent No, 4,702,254, including any extensions, renewals,
continuations, divisions, or continuations-in-part thereof. Upon expiration of
the last to expire of U.S. Patent No. 4,702,254 (including any extensions
or renewals thereof) or any continuation, division or continuation-in-part
thereof, the royalty rate payable pursuant to this Section 4(a) shall be reduced
to two percent (2.0%) on the first $12,00.0,000 of Net Sales Value and one
percent (1.0%) on all Net Sales Value after said $12,000,000, cumulative and not
annual. It is understood and agreed that Licensee shall have no obligation to
make any payment to Licensor under this Section 4(a) or Section 4(d) from and
after the date on which all of the Licensed Patents (including any extensions or
renewals thereof) have expired or have been declared invalid by any judicial
decree, order or final judgment beyond right of further appeal, except royalties
at the percentile rate specified in this Section 4(a) or Section 4(b), as
the case may be, on the Net Sales Value of Products sold under the license
created by Section 3 of this
52
Agreement
prior to such date, and upon such date the license granted by Section 3
hereof shall be fully paid.
(b) If
U.S. Patent No. 4,702,254 and all continuations, divisions, and
continuations-in-part thereof are held invalid by any judicial decree, order or
final judgment beyond further right i of appeal, the-percentile rate at which
royalties shall be payable to Licensor pursuant to Section 4(a) shall be
retroactively reduced to two percent (2.0%) on the first $12,000,000 of Net
Sales Value and one percent (1.0%) on all Net Sales Value after said $12,000,000
with respect to Products sold after the filing of a claim in a court of
competent jurisdiction which claim results in the invalidation of U.S. Patent
No. 4,702,254 and all continuations, divisions and continuations-in-part
thereof (the “Claim”).
(c) In
the event of U.S. Patent No. 4,702,254 .and all continuations, divisions
and continuations-in-part thereof being declared invalid, and notwithstanding
anything to the contrary contained herein, no further royalty payments shall be
made to Licensor until such time as the aggregate royalties payable on products
sold after filing of the Claim at the percentile rate specified in Section 4(b)
are equal to the actual aggregate royalties already paid to Licensor on products
sold after filing of the claim, at which time royalty payments as provided in
this Section 4 shall resume. The right created by this Section 4(c) shall be a
right to recover excess royalties paid during the pendency of the claim from
future royalties payable to Licensor hereunder only; Licensee shall have no
right, claim or cause of action against Licensee to recover such excess
royalties from Licensor.
(d) Licensor
agrees to pay Licensee a minimum royalty of $36,000 per year ($12,000 per year
if the events specified in Section 4(b) occur), payable on a monthly basis until
a Product is first sold and on a quarterly basis thereafter. Payments made
pursuant to this Section 4(d) shall be paid at the beginning of the month or
quarter, as the case may be, and shall be deducted from any royalties payable
pursuant to Section 4(a) and shall not constitute an additional royalty
obligation of Licensee.
(e) The
term “Net Sales Value,” as used in this Section 4, shall mean the full
amount actually received by Licensee or its sublicensees (exclusive of sales by
Licensee to its sublicensees) for Products sold by Licensee or its sublicensees
to customers less the sum of the following, where applicable:
(i) Discounts
allowed, commissions paid in lieu of trade discounts, and commissions paid to
independent sales representatives or agents, in the amounts customary in the
trade;
(ii) Sales
and/or use taxes (or other taxes equivalent thereto), duties or any other taxes
or levies directly imposed by any governmental authority upon and with reference
to particular sales;
(iii) Outbound
transportation costs prepaid or allowed by way of freight equalization or
otherwise;
(iv) Cartons,
packing, and crating charged separately ;
53
(v) Amounts
refunded, allowed, or credited in connection with shortages, returns, or
defective, articles;
(f) Where
proceeds from the sale of Products are received in currency other than United
States Dollars, the Net Sales Value of such foreign sales shall be the U.S.
Dollar equivalent of such proceeds determined by multiplying the foreign
currency actually received by the applicable exchange rate in effect on the last
day in the quarter in which such proceeds were received, as published in the
Wall Street Journal for such date.
(g) Only
one royalty shall be payable on a Product at the applicable percentile rate
specified in Section 4(a) or 4(b), as the case may be, regardless of the number
of Licensed Patents or use of Technology under which such Product has been
manufactured, used or sold. In those cases where a Product is sold as a part of
an article which includes additional materials or components, the production of
which does not use the inventions of the Licensed Patents, the Net Sales Value
shall be based on the sales price at which Licensee would sell the Product
independently of such other materials or components in an arm’s length
transaction.
(h) Licensee
agrees to keep full, true, and accurate records and books of account containing
all particulars which may be necessary to show the royalties payable to
Licensor. Such books of account shall be kept at Licensee’s principal place of
business and shall be available, upon thirty (30) days notice, for
inspection during business hours, by independent auditors reasonably acceptable
to Licensee appointed and paid by Licensor provided, however, that if upon audit
it is determined that Licensor is entitled, to., receive an additional royalty
amount in excess of five percent (5%) over the amount previously paid during the
period subject to “audit, then Licensee shall pay the reasonable fees and
expenses of such independent auditors. Such records shall be retained by
Licensee for a period of six (6) years following the end of the calendar
year to which they pertain; provided, however, that Licensor’s right to inspect
such records pursuant to this Section 4(h) shall be limited to the right to
inspect records pertaining to the two-year period ending on the close of the
calendar quarter immediately preceding such inspection. Only one such inspection
shall be made in any calendar year. The auditors shall disclose to Licensor only
the gross sales value of Products sold, the deductions therefrom, the Net Sales
Value thereof, and the amount of royalties due and payable to Licensor thereon,
along with any necessary supporting evidence. Any information obtained by the
auditors from any such inspection shall be kept confidential by Licensor and the
auditors and shall be used only for the purpose of determining the correctness
of the statements of Net Sales value and royalties due and payable to Licensor.
The auditors shall be employed expressly upon such terms and
conditions.
(i) Licensee
agrees that on or before the 60th day after the close of each of its quarterly
accounting periods throughout the term of this Agreement, Licensee shall forward
to Licensor a statement, certified by an Officer of Licensee, of the receipts
for Products sold by Licensee for which payment is received during the
accounting period preceding the period in which each such statement is rendered,
the aggregate in each category of deductions which have been made therefrom
pursuant to the provisions of section 4(e) above, and the royalties payable
thereon. Licensee shall concurrently forward to Licensor a Statement of the
receipts for Products sold by sublicensees for which Licensee received royalty
or other licensing fees from such sublicensees during the accounting period
preceding the period in which each such statement is rendered, the aggregate in
each category of deductions which have been made therefrom
54
pursuant
to Section 4(e) above, and the royalties payable thereon. Licensee shall
simultaneously pay to Licensor the amount of royalties due.
(j) The
parties agree that any subsequent downward adjustments of Licensee’s and its
sublicensees’ receipts from any particular sale of Products upon which royalties
have been paid, due to Product failure or inadequacy, cancellation of purchase
orders or contracts, or any other event causing Licensee to make a financial
refund to its customers, either in whole or in part, will be credited against
any future receipts on which royalties become payable.
|
5.
|
Sublicensing.
|
(a) Licensee
shall have the exclusive right under the Licensed Patents to grant sublicenses
to others provided, however, that with respect to Products sold by any such
sublicensee, Licensee shall pay to Licensor royalties equal to the royalties
that would have been payable with respect to such Product sales had such sales
been made by Licensee. The Net Sales Value of sales made by any sublicensees
shall be aggregated with the Net Sales Value of Sales made by Licensee for
determination of the applicable royalty rate payable pursuant to Section 4(a) or
4(b), as the case may be.
(b) Licensee
shall consult with Licensor regarding any prospective sublicensees.
Notwithstanding the foregoing, the granting by Licensee of sublicenses under the
Licensed Patents shall be in the sole discretion of Licensee, and Licensee shall
have the sole power to determine whether or not to grant sublicenses, to whom
such sublicensees shall be granted and the royalty rates and terms and
conditions of such sublicenses.
|
6.
|
Assignment.
|
(a) This
Agreement and the licenses and rights hereunder are not assignable by either
party without the prior written consent of the other party, which consent will
not be unreasonably withheld; provided, however, that without obtaining
Licensor’s consent, Licensee may assign its rights and obligations hereunder to
a successor in interest who acquires substantially all of the business of
Licensee whether by sale of substantially all of the assets, sale of stock,
merger or other form or corporate reorganization.
(b) This
Agreement shall inure to the benefit of and be binding upon Licensor and
Licensee, and their respective successors and assigns.
|
7.
|
Future Filings; Patent
Expenses.
|
(a) In
the event that Licensee should wish Licensor to file any patent applications
corresponding to any of the Licensed patents in specific countries other than
those enumerated in Schedule A or file any patent applications on
improvements and variations upon inventions disclosed in the Licensed Patents or
other inventions in the field of nerve stimulation, it shall advise Licensor in
writing, naming such countries or improvements, variations or inventions, as the
case may be. Licensor shall thereupon file patent applications as requested. All
such patent applications and patents shall be filed in the name of and, be the
property of Licensor and shall be included in the Licensed Patents. Licensee
shall pay the reasonable expenses,
55
including
reasonable fees for patent counsel, for filing, prosecuting, and paying
annuities or applicable maintenance fees on such requested patent applications,
on any patent applications relating to the Technology pending as of the date
thereof and shall pay the issuance fee of and any applicable maintenance fee on
any patent issued thereon. In the event Licensee elects to discontinue pursuing
any patent application or applications (whether or not such applications have
been prepared or filed) it shall so notify Licensor in writing and Licensor
shall discontinue pursuing such application or applications (or may pursue such
application or applications at its own expense); provided, however, that
Licensee shall pay the reasonable expenses, including reasonable fees for patent
counsel, incurred prior to Licensee notifying Licensor of its election not to
pursue an application or applications. Licensor further agrees that he will not
file any patent applications relating to the Licensed Patents, the Technology or
the field of nerve stimulation without the consent of Licensee; provided,
however, that if such consent is withheld, Licensor may file such application
but shall bear all expenses associated with such filing or any patent issuing
thereon.
(b) In
the event that Licensee notifies Licensor that Licensee would like Licensor to
file any patent applications pursuant to Section 7(a) and Licensor fails to take
reasonable steps within a reasonable amount of time to prepare and file such
application or applications, Licensee reserves the right hereunder to retain its
own patent counsel to prepare and prosecute any such patent applications, and
Licensor hereby agrees to assist and cooperate with Licensee’s patent counsel in
the preparation and prosecution of such patent applications; provided, however,
that notwithstanding Licensee’s retention of patent counsel, Licensee shall pay
the reasonable fees of Licensor’s patent counsel actually incurred in connection
with reviewing any patent applications prepared by Licensee’s patent
counsel.
|
8.Covenants.
|
(a) Licensor
shall promptly furnish Licensee with copies of all applications for Letters
Patent licensed hereunder and shall keep Licensee promptly informed as to their
prosecution, sending Licensee copies of Patent Office actions and amendments to
such applications.
(b) Licensor
covenants that for the term of this Agreement he will use his best efforts to
renew and maintain all Licensed Patents (at Licensee’s expense as provided in
Section 7 hereof).
(c) Licensor
covenants that for the term of this Agreement he will not assign, license,
pledge or compromise the Licensed Patents nor make any commitments or offers
inconsistent with or in derogation of the rights created by this
Agreement.
(d) Licensee
covenants that for the term of this Agreement it will use its best efforts to
develop and market a Product or Products.
9.Term. This Agreement
shall expire at the earlier of (i) the end of the full term of each Letters
Patent included in the Licensed Patents or (ii) at such time as all of the
Licensed Patents shall have been declared invalid by any judicial decree, order
or final judgment beyond
56
further
right of appeal; provided, however, that the license created hereby shall
survive expiration of this Agreement as provided in Section 3(a) hereof.
10.Termination.
(a) This
Agreement may be terminated by Licensee as follows:
(i) For
the first three (3) years of this Agreement, Licensee may terminate this
Agreement without cause on the first, second or third anniversary of execution
hereof by Licensee provided Licensee gives written notice to Licensor of its
intention to terminate no later than sixty (60) days before such
anniversary.
(ii) If
this Agreement is not terminated within the first three years as set forth
above, this Agreement shall run for successive three-year periods starting from
the third anniversary of execution thereof by Licensee and may not be terminated
by Licensee without cause during such three-year periods but may be terminated
without cause by Licensee at the end of each such three-year period provided
Licensee gives notice of its intention to terminate no later than sixty
(60) days before the expiration of such three-year period;
(iii) In
addition to the foregoing, this Agreement may be terminated by Licensee in the
event that Licensor shall have materially breached any provision hereof,
provided that Licensee shall first give written notice of its intention to
terminate which notice shall state the grounds thereof and provided further that
Licensor shall have sixty (60) days to cure any alleged
breach.
(b) This
Agreement may be terminated by Licensor for cause only and provided that
Licensor shall first give written notice of his intention to terminate which
notice shall state the grounds thereof. Licensee shall have sixty (60) days
from receipt of any such notice to cure any alleged breach. Subject to the
provisions of Section 11 hereof, “Cause” for purposes of this Section 10(b)
shall be defined as:
(i) Failure
of Licensee to make royalty payments as provided in Section 4
hereof;
(ii) Failure
to begin feasibility clinical studies of the Technology (such as would be
permitted under the “Custom Devise” exemption of the United States Food and Drug
Administration (“FDA”)) within one (1) year of the date hereof if
stimulators developed and purchased from an independent producer are used or two
(2) years from the date hereof if a stimulator developed by Licensee is
used;
(iii) Failure
to begin formal clinical studies of the Technology (such as would be permitted
under the Investigational Device Exemption of the FDA) within three (3) years
from the date hereof;
(iv) Failure
to file a Pre-Market Approval Application with the FDA within six (6) years
from the date hereof.
57
(c) Upon
termination of this Agreement pursuant to this Section 10, all licenses,
rights, and obligations hereunder shall cease and terminate and Licensee shall
immediately cease manufacturing and selling Products; provided, however, that
the licenses and rights granted under Section 3 hereof shall continue as to
all Products previously manufactured during the term of this Agreement, or
actually in manufacture upon the date of termination, for the full terms of the
Letters Patent under which such Product is manufactured, provided that royalties
are paid with respect to such Products pursuant to Section 4
hereof.
11.Force
Majeure. The time by which, the conditions subsequent
specified in Sections 10(b)(ii) — (iv) must be satisfied shall be extended
for a period of time equal to the period of any delay resulting from delays or
difficulties arising in connection with the clinical studies and/or obtaining
requisite regulatory approval provided such delays or difficulties are due to
events beyond the control of Licensee.
00.Xxxxxxxxx
Requirements. Licensee shall
provide with all Products such notice or notices of the Licensed Patents
reasonably contemplated to comply with the laws of the countries under which
such Letters Patent have issued.
13.Technical
Assistance. Licensor shall
assist, consult, and cooperate with Licensee in the development, design,
engineering, manufacturing/testing and inspection of the Products. Licensor
shall provide such assistance to Licensee at such times and for such duration as
Licensee shall reasonably request, provided such assistance does not interfere
with Licensor’s responsibilities as a faculty member of Temple University. For
two (2) years from the date of this Agreement, such assistance shall be
provided to Licensee without compensation (other than reimbursement of
out-of-pocket expenses reasonably incurred in connection with providing such
assistance). Following such initial two-year period, Licensor shall continue to
provide such assistance as Licensee may reasonably request and shall be
compensated therefor as provided in the separate consulting agreement executed
concurrently herewith.
14.Patent
Enforcement. Licensee may
bring any action for infringement of the Licensed Patents either in Licensor’s
name alone or jointly with Licensor and Licensor agrees to assist Licensee in
any such action upon Licensee’s request. Any such action brought by Licensee
shall be solely at Licensee’s expense, and any amounts recovered thereby shall
be divided between Licensee and Licensor as follows:
(a) Licensee
shall first recoup all expenses and legal fees expended in such
action,
(b) The
amount recovered, net of Licensee’s expenses and fees as provided in
Section 14(a), shall be divided eighty percent (80%) to Licensee and twenty
percent (20%) to Licensor.
15.Public
Statements.
(a) Licensor
agrees not to publish or caused to be published any article, study, analysis, or
other writing concerning the Technology or stimulation of the vagus nerve for
the treatment of epilepsy and not to deliver or permit others to deliver any
oral presentation prepared by Licensor containing information concerning the
Technology or stimulation of the vagus nerve
58
for the
treatment of epilepsy (such writings and presentations being referred to as
“Public Statements”) prior to the earlier of (i) three years from the date
hereof, or (ii) the clinical investigators publishing or presenting the
results of the clinical studies of the Technology conducted on the initial is
patients. After such publication by the clinical investigators or three years,
whichever is earlier, Licensor shall not, for the term of this Agreement, make
any Public Statement without first obtaining the written consent of Licensee,
which consent shall not be unreasonably withheld. The restrictions on Licensor’s
right to make Public statements created by this Section 15(a) shall, terminate
immediately in the event that all of the clinical investigators withdraw from
the clinical study.
(b) Licensee
agrees that Licensor may have access to technical data generated in connection
with scientific studies concerning the Technology conducted by or on behalf of
Licensor and, subject to Section 15(a), may use such data in writings or
oral presentations concerning the Technology. Licensee further agrees that
Licensor will be named as a co-author in any article, study, analysis or other
writing concerning the Technology if Licensor actively participated in the
underlying research. Licensee further agrees that Licensor shall have the right
to review any article, study, analysis or other writing prepared by or on behalf
of Licensee prior to publication; provided, however, that Licensee reserves the
right to publish or present any such article, study, analysis or writing
notwithstanding Licensor’s objections thereto.
16.General.
(a) Modification. This
Agreement may be modified only by a writing signed by each party.
(b) Nonwaiver. The
failure of any party to enforce at any time any of the provisions hereof shall
not be construed to be a waiver of the right of such party thereafter to enforce
any such provision.
(c) Notices. Notices
under this Agreement shall be sufficient only if mailed by certified or
registered United States mail, return receipt requested, or personally delivered
to the parties at their addresses first set forth above or as amended by notice
pursuant to this subsection. Notice by mail shall be deemed received three
(3) days after deposit.
(d) Entire Agreement.
This Agreement terminates the letter of intent between Licensor, Xxxxx Xxxxx,
Cyberonics, Inc., a Texas corporation (“Cyberonics Texas”), as amended and
assigned from Cyberonics Texas to Licensee, and supersedes all proposals, oral
or written, all negotiations, conversations or discussions between or among the
parties relating to this Agreement and all past course of dealing or industry
custom. The terms and conditions of this Agreement shall prevail,
notwithstanding any variance with the written instrument, submitted by any
party.
(e) Counterparts. This
Agreement may be executed in one or more counterparts, each of which shall be an
original and all of which together shall constitute one and the same
instrument.
59
IN
WITNESS WHEREOF, the parties have executed this Agreement as of the date first
set forth above.
LICENSOR:
XX. XXXXX XXXXXX
|
/s/
Xxxxx Xxxxxx
|
|
LICENSEE:
CYBERONICS, INC.
a
Delaware corporation
|
/s/
Xxxxx X. Xxxxx, Xx.
|
|
60
SCHEDULE
A
UPDATED
ATTACHMENT TO
XXXXX XXXXXX LICENSE
AGREEMENT
December 31,
1991
Date
|
||||||
4,702,254
|
US
|
NeuroCybernetic
Prosthesis
|
Oct.
27, 1987
|
|||
4,867,164
|
US
|
NeuroCybernetic
Prosthesis
|
Sept.
19, 1989
|
|||
5,0258,807
|
US
|
NeuroCybernetic
Prosthesis
|
June 25,
1991
|
|||
577,549
|
Australia
|
NeuroCybernetic
Prosthesis
|
March 3,
1989
|
|||
1,259,379
|
Canada
|
NeuroCybernetic
Prosthesis
|
September 12,
1989
|
|||
0,156,854
|
Eurpoean
|
NeuroCybernetic
Prosthesis
|
September 5,
1990
|
|||
Austria,
Belgium, Switzerland, Germany, France, United
|
||||||
Kingdom,
Liechtenstein, Luxembourg, Netherlands, Sweden
|
||||||
503,504/84
|
Japan
|
Application
Number
|
September 11,
1984
|
61
Attachment
G
Licensed
Know-How
None
62