Exhibit 10.1
AMENDED AND
RESTATED
SUPPLY, LICENSE, AND DEVELOPMENT
AGREEMENT
THIS AMENDED AND RESTATED SUPPLY,
LICENSE AND DEVELOPMENT AGREEMENT (this
“Agreement”), is dated as of the 28 th day
of December, 2005 by and between DIGITAL ANGEL CORPORATION ,
a Delaware corporation (“Company”), and VERICHIP
CORPORATION , a Delaware corporation
(“VeriChip”).
RECITALS
WHEREAS, Company and VeriChip
(hereinafter referred to collectively as the “Parties”,
and individually as a “Party”) previously entered into
that certain Supply and License Agreement dated March 4, 2002 (the
“Original Supply and License Agreement”), relating to
the use of the Developed Products (as defined herein) in humans for
security, financial, emergency identification and other
applications;
WHEREAS, the U.S. Food and Drug
Administration (“FDA”) has (i) cleared the Developed
Products for human patient identification and health information
(the “Approved Medical Uses”) and (ii) has provided the
Company with a letter dated October 17, 2002 which states that FDA
approval will not be required for non-healthcare related uses of
the Developed Products in humans, as previously provided to
VeriChip (the “Approved Non-Medical Uses”);
WHEREAS, Company desires to
supply VeriChip with the Developed Products and VeriChip desires to
buy the Developed Products for both the Approved Medical Uses and
the Approved Non-Medical Uses in humans only;
WHEREAS, Company desires to notify
VeriChip of the development of New Products and VeriChip desires to
have the right to buy, market and sell New Products, as more
specifically described herein; and
WHEREAS, the Parties desire to
clarify the circumstances under which VeriChip may have the ability
to manufacture or have manufactured the Developed Products and in
connection therewith have access to certain of the Company’s
Intellectual Property.
NOW THEREFORE, in consideration of
the mutual covenants and obligations hereinafter set forth, and
other consideration, the adequacy and sufficiency of which are
hereby acknowledged, Company and VeriChip agree to be legally bound
as follows:
AGREEMENT
1.
Definitions
. In addition to
the terms defined in the Recitals of this Agreement, the following
terms used in this Agreement shall have the following
meanings:
(a)
The “Act” means the U.S.
Food, Drug and Cosmetic Act as amended from time to time and any
foreign equivalents.
(b)
“Affiliate” of a Party
means a person that directly or indirectly, through one or more
intermediaries, controls or is controlled by or is under common
control with, said Party.
(c)
“Applicable Laws” shall
mean (a) all laws, statutes, constitutions, treaties, rules,
regulations, ordinances, codes, guidance, common law, and (b) all
judicial, executive, legislative, administrative or military
orders, directives, decrees, injunctions, judgments, Permits,
agreements, and other legal requirements of, with, or adopted or
imposed by any Governmental Authority, now or hereafter in effect
and, in each case, as amended from time to time, including, without
limitation, any such legal requirements that relate to or govern
(i) the manufacture or quality of the Developed Products, (ii)
health, safety, industrial hygiene, sanitation, or (iii) conditions
on, under, about, or affecting any real property (including the
environment).
(d)
“Confidential
Information” means any information, not generally known, and
proprietary to either Party or to a third party, including but not
limited to any trade secret information, information relating to
pricing, research, customer lists, diagrams, schematics, product
development, manufacturing, purchasing, accounting, marketing,
merchandising, selling, leasing, finance and business systems and
techniques. The term “Confidential Information” does
not include information: (i) that by reliable documentary evidence
can be shown to have been already lawfully in the possession of the
receiving Party through independent means at the time of disclosure
thereof; (ii) is or later becomes part of the public domain through
no fault of receiving Party; (iii) that by reliable documentary
evidence can be shown to have been lawfully received by the
receiving Party from a third party having no obligations of
confidentiality to the disclosing Party; (iv) is required to be
disclosed by law, by order of a governmental agency, or by a court
of competent jurisdiction provided that the Party required
to disclose such information pursuant to such law or legal process
takes reasonable steps to provide the originally disclosing Party
with the opportunity to contest such law, order or legal process;
or (v) that by reliable documentary evidence can be shown to have
been independently developed by the receiving Party its agents or
employees having no access to the information otherwise
constituting Confidential Information.
(e)
The “Developed Products”
means the radio frequency identification (RFID) transponder
invention, together with related devices, labeling, packaging,
and/or reader equipment described on Schedule 1 , whether or
not such transponder is injected or implanted, and including any
Improvements developed during the Term, but not including any New
Products, unless such New Products are added to this Agreement as
contemplated in Section 3(e) of this Agreement, in which case such
New Products will be deemed to be included in the Developed
Products.
(f)
“Documentation”
means existing and any later-developed technical information,
know-how and documents associated with the Intellectual Property
relating to the Developed Products including, without limitation,
manufacturing instructions, schematic diagrams, printed circuit
board layouts, parts lists, communication protocol specifications,
design specifications (including design logic and flowcharts),
technical data, testing specifications, code, user guides, and the
like.
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(g)
The “Exclusive Market”
means all applications in which the Developed Products are used for
the primary purpose of secure human identification, including, but
not limited to, those used as an implantable device.
(h)
The “Excluded Market”
means applications of Developed Products other than for secure
human identification or for any use in a country not included in
the Territory.
(i)
“Force Majeure Event”
means and includes, with respect to each of the Parties, Acts of
God, acts or omissions of civil or military authority, fires,
strikes, floods, epidemics, riot, war, acts of terrorism,
quarantine restrictions, delays in transportation, inability to
obtain equipment if not due to the acts or failure to act of a
Party or its subcontractors, and prolonged shortage of energy or
other supplies beyond the reasonable control of either Party which
prevents, in whole or in material part, the performance by one of
the Parties of its obligations hereunder or which renders the
performance of such obligations so difficult or costly as to make
such performance commercially unreasonable.
(j)
“Governmental Approvals”
means any and all approvals required from a Governmental Authority
in accordance with any Applicable Law.
(k)
“Governmental Authority”
shall mean any federal, state, commonwealth, provincial, local or
foreign governmental authority, entity, body, branch, agency,
department, bureau, board, commission, officer, official, court,
adjudicator, tribunal or other entity, including any agent thereof,
exercising executive, legislative, judicial, regulatory, or
administrative authority over the manufacture, marketing, pricing,
use, or sale of any Developed Product (including any Improvements
thereto) including, without limitation, any and all state,
commonwealth, provincial, local and foreign equivalents.
(l)
“Improvements” means any
and all upgrades, enhancements or other improvements made by the
Company to the Developed Products during the Term which are
associated with the use of the Developed Products in human tissue
for the purpose of secure identification.
(m)
“Intellectual Property”
means all know-how, ideas, concepts, trade secrets, Confidential
Information, proprietary information, research, developments, mask
works, moral rights, design rights, industrial property rights,
rights in and to inventions, Improvements, and as-yet-undeveloped
ideas, patent rights, patent applications, patents and any other
intellectual property rights in any jurisdiction in the Territory
including modifications and other applications using or based upon
the resulting technology or required for the use of such technology
wherever such concepts, designs, design changes, modifications,
research, and developments might apply and which are created,
developed, conceived, discovered, collected or prepared pursuant or
related to the Developed Products including, but not limited to,
patents set forth on Schedule 4 to this Agreement.
(n)
“New Products” means
microchip products developed by the Company which are primarily
intended for use in applications other than secure identification,
such as
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biometric sensing capabilities, and
for which any identification capabilities are ancillary to the
primary intended use.
(o)
“Term” shall have the
meaning set forth in Section 5 of this Agreement.
(p)
“Territory” shall mean
the World.
2.
Supply and Purchase
Requirements . During the
Term, and with respect to the Exclusive Market, Company shall
manufacture the Developed Products exclusively for, and shall sell
the Developed Products exclusively to, VeriChip and any VeriChip
resellers or other nominees within VeriChip’s control (the
“VeriChip Group”), and the Company shall use its best
efforts to supply, at the time(s) required, all of the requirements
of VeriChip and the VeriChip Group for the Developed Products with
respect to the Exclusive Market. In the event that Company is
unable or unwilling to meet VeriChip’s requirements for
Developed Products, Company shall permit VeriChip to obtain
additional suppliers and shall permit such additional suppliers to
use the Intellectual Property for the sole purpose of meeting
VeriChip’s supply requirements, subject to the provisions of
Section 11(d) of this Agreement.
All reseller agreements shall
contain provisions requiring such resellers to materially comply
with provisions corresponding to those set forth in Sections 4, 7,
9, 10, 12 and 15 of this Agreement. In the event that VeriChip
requests material changes to the foregoing, or desires to enter
into a reseller agreement which does not contain provisions
materially corresponding to those set forth in Sections 4, 7, 9,
10, 12 and 15 of this Agreement, VeriChip shall obtain the prior
written consent of the Company to such changes or such
arrangements, as applicable. During the Term, and with respect to
the Exclusive Market, VeriChip shall purchase from Company and
cause members of the VeriChip Group and any other resellers to
purchase from the Company all of their respective requirements for
the Developed Products with respect to the Exclusive Market. Except
as otherwise provided below, the cost of each unit of the Developed
Products during the Term and the ordering and payment terms shall
be as set forth on Schedule 2 . During the Term,
Company shall not sell any Developed Product, New Product or any
product whose principal use is for secure identification
applications (either individually or otherwise) to any party other
than a member of the VeriChip Group if the Company knows or should
know that such party intends to use, market or otherwise sell or
provide such products in the Exclusive Market. Company agrees that
the covenant contained in the preceding sentence and its exclusive
supply obligations as defined herein are conditions precedent to
VeriChip’s obligations as defined in this paragraph. VeriChip
shall be entitled to seek appropriate injunctive relief (without
the requirement of proving actual damages or irreparable harm) if
Company breaches its exclusivity obligations.
Each Party shall notify the other
Party if such Party learns of (i) any person or entity other than a
member of the VeriChip Group marketing the Developed Products in
the Exclusive Market or (ii) any party who is or may be infringing
upon any of the Intellectual Property. In either such event, the
Company shall have an affirmative duty to prosecute and/or defend
such violation of this Agreement or infringement, and only if
Company refuses to pursue such person or entity, VeriChip shall be
entitled to take any and all actions against such persons or
entities that are marketing, selling or promoting the sale of
Developed Products in violation of this Agreement,
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and Company shall provide VeriChip
such non-financial assistance as may be necessary to pursue such
persons or entities, including the right to bring suit in the name
of Company either directly or as co-plaintiff.
In addition to the obligations set
forth in the preceding paragraph above, if during the Term, to
Verichip’s knowledge and upon providing reasonable notice and
documentation to the Company, a third party (a “VeriChip
Competitor”) makes, uses, sells or offers for sale any
product or service * (a “Competitive Product”), then in
order to permit VeriChip to more effectively compete against such
Competitive Product, the price of the applicable Developed Products
shall be adjusted as follows:
(i) If the parties can determine the wholesale price
paid by the VeriChip Competitor (based on VeriChip’s
knowledge and reasonable documentation thereof) for the Competitive
Product, the Company shall reduce its price for the corresponding
Developed Products.*
(ii) If the parties are unable to determine the
wholesale price paid by the VeriChip Competitor for a Competitive
Product), the Company shall reduce its price for the corresponding
Developed Products.*
(iii) If
the parties cannot agree on the appropriate price reduction
pursuant to clauses (i) and (ii) above, the parties shall submit
the matter to binding arbitration in the manner set forth in
Section 18 below.
(iv) The
price reduction referred to in clauses (i) or (ii) above shall
remain in place so long as *; provided, however, that in the event
that the Company obtains an injunction against the Competing
Product or otherwise prevents the Competing Product from being
offered within such territory, the price of the Developed Product
shall return to the level in effect prior to the introduction of
the Competing Product and, provided that Company (1) engages
in legal action to enjoin or prevent such infringement and (2) uses
all commercially reasonable efforts to recover the aggregate price
reduction granted by the Company pursuant to this paragraph as
damages from the VeriChip Competitor, VeriChip shall reimburse the
Company for * the aggregate price reduction granted by the Company
pursuant to this paragraph which the Company is unable to recover
as damages from such VeriChip Competitor.
(v) In consideration of the price adjustments set
forth in this paragraph, the liability of the Company for breaches
of representations and warranties set forth in Paragraph* shall not
exceed the profits generated by the Company from sales to VeriChip
or the VeriChip Group for the applicable Developed
Products.
3.
Improvements and New
Products .
(a)
The Company shall use commercially
reasonable efforts to make Improvements to the Developed Products.
All such Improvements shall be promptly disclosed to VeriChip. Any
such Improvements shall be deemed to be associated with a Developed
Product for purposes hereof and the provisions of this Agreement
with respect to the Developed Products shall mean the Developed
Products together with any Improvements. The pricing for any
such Improvement shall be negotiated in good faith by the
parties
* Confidential Treatment
requested.
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hereto using the following criteria
only: (i) the increase or decrease in cost of production to
Company, (ii) Company’s direct and demonstrable research and
development costs of developing the Improvements, (iii) a profit
margin consistent with the Developed Products, and (iv)
reimbursement for any payments required to be made by the Company
to third party licensors if the Company is required to license
technology to develop the Improvement.
(b)
In the event Company makes any
Improvements to the Developed Products which are not requested by
VeriChip, Company shall continue to manufacture and supply to
VeriChip the previous (unimproved) iteration of the Developed
Products.
(c)
VeriChip may from time-to-time
request that Company make Improvements to the Developed Products
including, without limitation, changes to packaging, labeling,
transponder color, and the like. The Company shall use commercially
reasonable efforts to incorporate the Improvements requested by
VeriChip into the Developed Products; provided, however, that (a)
VeriChip shall reimburse the Company promptly for all reasonable
out-of-pocket expenses (including FDA costs) incurred by the
Company in making Improvements as requested by VeriChip, and (b)
the Company shall not make any Improvements that are inconsistent
with then applicable FDA authorizations without obtaining any
required FDA approvals. In the event that Company is unable
or unwilling to make an Improvement to meet VeriChip’s
request, Company shall permit VeriChip to obtain additional
suppliers and shall permit such additional suppliers to use the
Intellectual Property for the sole purpose of meeting
VeriChip’s requirement for Improvements, subject to the
provisions of Section 11(d) of this Agreement. In such event,
(i)VeriChip shall have the right to seek any required Governmental
Approvals for such Improvement, and (ii) any Improvement so
developed shall be the property of VeriChip, provided that VeriChip
will make any such Improvement available to Company for license in
non-human applications on reasonable and non-discriminatory
terms.
(d)
If VeriChip desires to use the
Company’s transponder other than for implantation into human
tissue, VeriChip shall provide not less than 120 days written
notice to the Company, and the Company shall have the ability to
make changes to the Developed Products necessary for
VeriChip’s intended use, which changes will not affect the
Developed Products’ functionality.
* Confidential Treatment
requested.
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(e)
If VeriChip desires to use the
Developed Products for applications in humans other than the
Approved Medical Uses or Approved Non-Medical Uses (the “New
Uses”), VeriChip shall so notify the Company, and the Company
shall use all commercially reasonable efforts to obtain any
required Governmental Approvals for such uses, if any. VeriChip
shall not use the Developed Products for New Uses unless all
required Governmental Approvals have been obtained or the Company
has notified VeriChip that no Governmental Approvals are required.
VeriChip shall cooperate with the Company in performing all acts
related to obtaining required Governmental Approvals, including but
not limited to providing marketing and other information related to
the New Uses to the Company and joining the Company in the
development and implementation of any required clinical studies.
VeriChip shall promptly reimburse the Company for all out-of-pocket
expenses incurred by the Company in connection with obtaining any
Governmental Approvals required for VeriChip’s New
Uses. In the event that the Company refuses to seek any
required Governmental Approvals, VeriChip shall notify the Company
in writing of its desire to seek such Governmental Approvals
directly or through its agents, appointees or other third parties,
and unless the Company commences the steps necessary to obtain such
required Governmental Approvals within thirty (30) days from the
date of such notice, VeriChip shall have the right to seek and
obtain such required Governmental Approvals in its own name and
through use of its own resources, including the use of
sub-licensees, OEM manufacturers and other third parties, as may be
applicable, provided that VeriChip also agrees to share with the
Company any information submitted in connection with obtaining such
Governmental Approvals.
(f)
Except as provided herein, the
license granted by this Agreement to VeriChip shall not apply to
New Products. The Company shall promptly disclose any New Products
to VeriChip, and if VeriChip desires to market and sell said New
Products, the Parties shall negotiate in good faith the terms on
which VeriChip shall have the opportunity to market and sell such
New Products. For purposes of such negotiation, the Parties
acknowledge and agree that the pricing applicable to all New
Products should be determined in good faith on the same terms set
forth in Section 3(a) with respect to Improvements. In the
event the Parties are unable to agree on the terms under which
VeriChip shall have the right to market and sell such New Products
within 90 days after the Company first notifies VeriChip of the
existence of any such New Product, the Company shall have the right
to market or sell such New Product, either directly or indirectly,
provided that in the event that Company elects to market such New
Product through any third party, and such third party offers
pricing which is lower than the price last offered by VeriChip,
Company shall again offer VeriChip the exclusive right to market
the New Product on the terms proposed by the third party.
Otherwise, the Company shall have no further obligation to
VeriChip. Notwithstanding the foregoing, for so long as
VeriChip retains its exclusive right to market the Developed
Products in the Exclusive Market, the Company will not authorize
the use of New Products for applications which would violate the
Exclusive Market.
(g)
VeriChip shall have the right to
design and build (or cause to be designed and built) its own
readers which readers may, but shall not be required to, read
Company’s transponders or tags in humans. Company
hereby grants VeriChip a fully-paid, royalty-free,
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perpetual, non-exclusive license to
utilize Company’s U.S. Patent Number 5,952,935 for the
purpose of designing and constructing, using, selling and offering
to sell readers for human applications only.
4.
Market and Other
Restrictions . VeriChip
shall not, either directly or indirectly, promote, rent, lease,
sell or authorize the rental, lease or sale of Developed Products,
Improvements or New Products in the Excluded Market, but shall not
be restricted from licensing its own intellectual property.
VeriChip agrees that it will observe the territorial/market
restrictions and end user limitations set forth herein for all
products covered by this Agreement. VeriChip shall not sell any
Developed Product, Improvements or New Product or other product
covered by this Agreement (either individually or otherwise) to any
party if it knows or should know that such party intends to use,
market or otherwise sell or provide such products in the Excluded
Market. Further, VeriChip shall not sell any Developed Product,
Improvements or New Product to any party if it knows or should know
that such party intends to use, market, or otherwise sell or
provide such Developed Product, Improvements or New Product for
human applications other than for Approved Medical Uses or Approved
Non-Medical Uses. VeriChip shall notify the Company if VeriChip
learns of any person or entity marketing the Developed Products in
the Excluded Market. Company shall be entitled to appropriate
injunctive relief if VeriChip breaches its obligations in this
paragraph with respect to the Excluded Market and such breach
remains uncured following written notice thereof from Company.
Notwithstanding anything to the contrary herein, at any time,
VeriChip and members of the VeriChip Group shall have the right to
purchase, develop, use, have developed, or sell, for themselves and
others, products competitive with the Developed Products, provided
that such products do not infringe upon the Company’s
Intellectual Property.
5.
Term and Termination; Loss of
Exclusivity – Entire Territory .
(a)
The term of this Agreement shall
commence on the date of execution and shall continue until March 4,
2013 (the “Term”). Provided that VeriChip continues to
meet its purchase obligations hereunder, the Term shall thereafter
be automatically renewed on an annual basis until the expiration of
the last patents covering any of the Developed Products.
Notwithstanding the foregoing, either Party hereto may terminate
this Agreement if (i) the other Party shall default in the
performance of any obligations hereunder including the payment of
money and shall not cure such default within 90 days after receipt
of written notice thereof; (ii) a petition of bankruptcy shall be
filed by the other Party; or (iii) a petition of bankruptcy shall
be filed against the other Party and such petition shall not have
been discharged within 30 days after the filing thereof. In the
event of any termination as a result of breach by VeriChip
hereunder, VeriChip shall be required to immediately pay for any
units of the Developed Products that have been ordered, delivered,
and not yet paid for.
(b)
VeriChip shall retain its exclusive
right to distribute the Developed Products for the Term in the
Territory provided that the VeriChip Group takes delivery and pays
for a minimum number of transponders within each year referenced
below (a “Minimum Unit Commitment”) at least equal to
the unit levels set forth in Schedule 5 attached hereto:
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If during any
year VeriChip and the VeriChip Group purchase in excess of the
Minimum Unit Commitment for the applicable year, such excess
purchases shall be credited towards the Minimum Unit Commitment for
the following year or years. Notwithstanding anything contained
herein, if VeriChip fails to purchase and pay for the volumes of
transponders as indicated above, but is otherwise in compliance
with the material terms of this Agreement, Company shall have the
option, upon 60 days written notice, to terminate the exclusivity
of this Agreement unless within 30 days after such written notice,
VeriChip makes sufficient purchases to meet said transponder unit
volumes.
The following shall be credited
against the Minimum Unit Commitment: (a) Developed Products
purchased by the VeriChip Group from the Company, (b) Developed
Products purchased by VeriChip from third parties on which VeriChip
pays the royalty described in Section 11(d) of this Agreement, and
(c) Developed Products purchased by VeriChip from third parties
while the payment of royalties is suspended because of the
Company’s inability to supply VeriChip’s
requirements.
6.
Sales Reports
. VeriChip shall provide the Company
with reports of its sales and marketing activities regarding the
Developed Products in the Territory in such detail and with such
frequency as is reasonably agreed between the Parties. In addition,
VeriChip shall keep and maintain records of its sales of Developed
Products. Such records shall be open to inspection from time to
time, at reasonable times, as requested by the Company, as soon as
practicable after such request and in any event within fifteen (15)
business days after such request, by the Company and its officers,
agents and other representatives. In addition, the Company will
have the right to make or cause to be made an independent
examination and/or audit of the books and records of VeriChip
relating to its sales of Developed Products. Any such inspection
shall be made at the Company’s expense. The records required
by this paragraph shall be maintained and available for inspection
during the Term. All of the foregoing information shall be
deemed to be Confidential Information as described
hereinafter.
7.
Confidentiality
(a)
In furtherance of this Agreement and
performance of the duties and obligations arising under this
Agreement, each party may make Confidential Information available
to the other. During the Term of this Agreement and for a period of
three (3) years thereafter, (i) neither Party will use for its own
benefit or the benefit of any other person or entity any
Confidential Information of the other Party; and (ii) each Party
will use all reasonable care, but in no event less care than it
takes to protect its own Confidential Information of similar
importance, to protect the Confidential Information of the other
Party from unauthorized use, disclosure and publication.
(b)
The Parties acknowledge that each
Party’s Confidential Information is a valuable, special, and
unique asset of the respective Party’s business. Each Party
hereby further acknowledges that such Confidential Information is
the sole and exclusive property of the respective Party, absolutely
and forever, and the other Party agrees not to use, copy, disclose,
make available or divulge such Confidential Information to any
person, firm, corporation, association, or other entity for any
reason or purpose whatsoever.
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(c)
Each of VeriChip and Company
respectively assumes full liability hereunder for the actions,
statements and representations of its employees, officers, agents
and representatives; and agrees to inform each of them of the
provisions of this Section 7 and enforce its provisions against
each of them.
(d)
The Parties mutually agree that the
rights protected by this Section 7 are unique and not adequately
protected or compensated for by liquidated damages. In the event of
a breach, the harmed Party shall be entitled to obtain injunctive
relief against the breaching party and otherwise enjoin the
breaching party from the use or dissemination of such Confidential
Information.
(e)
The provisions of this Section shall
survive the termination or expiration of this Agreement as provided
above.
(f)
The Parties agree that all property
of one Party that is in the possession of the other Parties at the
time of termination of this Agreement, including without
limitation, all designs, schematics, documents, reports, manuals,
memoranda, computer print-outs, customer lists, and Confidential
Information shall be immediately returned to the Parties providing
such information.
8.
Product Warranties, Limitation of
Liability and Indemnification Provisions .
(a)
Company hereby
warrants that (i) the Company is the owner of the patents set forth
on Schedule 4 to this Agreement; (ii) during the term of the
patents set forth on Schedule 4 to