Certain
portions of this Exhibit have been omitted and filed separately
with the Securities and Exchange Commission pursuant to a request
for confidential treatment. Such omitted portions are marked with
brackets [ ] and an asterisk*.
EXCLUSIVE LICENSE
AGREEMENT
This Exclusive
License Agreement (the “Agreement” ) is made and
entered into as of December 1 , 2006 (the “
Effective Date ”) by and between Electro-Optical
Sciences, Inc. , a Delaware corporation, having its principal
place of business at 3 West Main Street, Suite 201, Irvington,
New York (“EOS” ), and KaVo Dental GmbH, a
corporation incorporated under the laws of the Federal Republic of
Germany with its principal place of business at Bismarckring 39,
88400 Biberach an der Riss ( “Licensee” ). EOS
and Licensee are sometimes referred to herein individually as a
“ Party ” and collectively as the “
Parties .”
WHEREAS ,
EOS owns or controls certain intellectual property relating to the
EOS Technology (as defined below) and has obtained 510(k) approval
from the FDA for use of the EOS Technology for the early detection
of coronal tooth decay and fractures, using light rather than
X-ray; and
WHEREAS ,
Licensee has considerable expertise in the development, marketing
and sale of dental diagnostic products, and has in place the large
and experienced development and marketing staff needed to develop
and distribute such products effectively and expeditiously;
and
WHEREAS ,
EOS desires to grant a license to Licensee, and Licensee desires to
obtain a license, to develop and commercialize the EOS Technology
in accordance with the terms and conditions set forth
below;
NOW,
THEREFORE , in consideration of the foregoing premises, the
mutual promises and covenants of the Parties contained therein and
other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties hereto, intending to
be legally bound, do hereby agree as follows:
Unless
otherwise specifically provided herein, the following terms shall
have the following meanings:
1.1 “510(k) Notification” shall mean a 510(k)
Notification within the meaning of FFDCA and the regulations
promulgated thereunder.
1.2 “Additional Patents” shall mean any Patents,
other than the Core Patents, that are Controlled by EOS as of the
Effective Date or at any time during the term of this Agreement
and, in the absence of a license from EOS, would necessarily be
infringed by the practice in the Field of the technology claimed by
the Core Patents.
1.3 “Affiliate” shall mean, with respect to a
Party, any Person that, directly or indirectly, through one or more
intermediaries, controls, is controlled by or is under common
control with such Party. For purposes of this definition,
“control” and, with correlative meanings, the terms
“controlled by” and “under common control
with” shall mean (a) the possession, directly or
indirectly, of the power to direct the management or policies of a
business entity, whether through the ownership of voting
securities, by contract relating to voting rights or corporate
governance, or otherwise, or (b) the ownership, directly or
indirectly, of at least fifty percent (50%) of the voting
securities or other ownership interest of a business entity (or,
with respect to a limited partnership or other similar entity, its
general partner or controlling entity).
1.4 “Agreement” shall have the meaning set forth
in the preamble to this Agreement.
1.5 “Applicable Law” shall mean applicable laws,
rules and regulations, including any rules, regulations, guidelines
or other requirements of the Regulatory Authorities, that may be in
effect from time to time.
1.6 “Arbitration Rules” shall have the meaning
set forth in Section 14.6.3.
1.7 “Audit Referee” shall have the meaning set
forth in Section 6.11.
1.8 “Breaching Party” shall have the meaning set
forth in Section 13.2.
1.9 “Business Day” shall mean a day other than a
Saturday or Sunday on which banking institutions in New York, New
York are open for business.
1.10 “Calendar Quarter” shall mean each
successive period of three (3) calendar months commencing on
January 1, April 1, July 1 and October 1.
1.11 “Calendar Year” shall mean each successive
period of twelve (12) calendar months commencing on January 1
and ending on December 31.
1.12 “ Change of Control ” shall mean,
with respect to a Person, any of the following transactions with a
Third Party (a “ Third Party Acquirer ”),
whether accomplished in one or a series of related transactions:
(a) a merger or consolidation of such Person with the Third
Party Acquirer which results in the holders of the voting
securities of such Person outstanding immediately prior thereto
(other than the Third Party Acquirer, its “affiliates”
and “associates” (as such terms are used in the
Exchange Act)) ceasing to represent at least fifty percent (50%) of
the combined voting power of the surviving entity (or, if
applicable, its parent company) immediately after such merger or
consolidation; (b) the sale to the Third Party Acquirer of all
or substantially all of the business of such Person to which this
Agreement relates (whether by merger, consolidation, sale of stock,
sale of assets or other similar transaction); or (c) the Third
Party Acquirer (which shall not be any trustee or other fiduciary
holding securities under an employee benefit plan of such Person,
or any corporation owned directly or indirectly by the stockholders
of such Person, in substantially the same proportion as their
ownership of stock of such Person), together with any of the Third
Party Acquirer’s “affiliates” or
“associates”, as such terms are used in the Exchange
Act, becoming the beneficial owner of fifty percent (50%) or more
of the combined voting power of the outstanding securities of such
Person or by contract or otherwise having the
- 2 -
right to
control the Board of Directors or equivalent governing body of such
Person or the ability to cause the direction of management of such
Person. Notwithstanding the foregoing, a Change of Control shall
not be deemed to occur on account of the acquisition of securities
of a Party by any institutional investor, or affiliate thereof,
that acquires the Party’s securities in a transaction or
series of related transactions that are primarily a private
financing transaction for the Party.
1.13 “Clinical Data” shall mean all information
with respect to the Licensed Product made, collected or otherwise
generated under or in connection with any Clinical Studies of the
Licensed Product, including any data, reports and results with
respect thereto.
1.14 “Clinical Studies” shall mean, with respect
to a Licensed Product, any clinical trials required by the FDA for
Regulatory Approval of such product in the United States, or
equivalent trials required by Regulatory Authorities for Regulatory
Approval of such product outside the United States.
1.15 “Combination Product” shall mean a product
that contains (a) one or more components that constitute a
Licensed Product and (b) one or more other proprietary
components, whether sold as a single device or as separate devices
in a single package.
1.16 “Commercialization” shall mean any and all
activities (whether conducted before or after Regulatory Approval)
directed to the marketing, detailing and promotion of the Licensed
Product after Regulatory Approval has been obtained, and shall
include post-launch marketing, promoting, detailing, marketing
research, distributing, and commercially selling the Licensed
Product, importing, exporting or transporting the Licensed Product
for commercial sale and regulatory affairs with respect to the
foregoing, but shall not include Manufacturing. When used as a
verb, “Commercializing” means to engage in
Commercialization and “Commercialize” and
“Commercialized” shall have a corresponding
meanings.
1.17 “Commercially Reasonable Efforts” shall
mean, with respect to the Development or Commercialization of the
Licensed Product, that level of efforts and resources commonly
dedicated in the medical device industry to the development or
commercialization, as the case may be, of an internally-developed
device of similar commercial potential at a similar stage in its
lifecycle. Commercially Reasonable Efforts shall be determined on a
market-by-market basis for the Licensed Product without regard to
the particular circumstances of a Party, including any other
product opportunities of such Party and, with respect to Licensee,
without regard to any payments owed to EOS hereunder.
1.18 “Complaining Party” shall have the meaning
set forth in Section 13.2.
1.19 “Confidential Information” shall have the
meaning set forth in Section 10.1.
1.20 “Consumable” shall mean a product, or a
part or component of a product, which product, part or component
thereof (a) is intended to be depleted by consumer use (
e.g. , mouth pieces), (b) requires periodic replacement, or
(c) is a replacement part for any Licensed Product.
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1.21 “Control” shall mean, with respect to any
item of Information, Regulatory Documentation, Patent or
Intellectual Property Right, possession of the right, whether
directly or indirectly, and whether by ownership, license or
otherwise (other than by operation of the licenses and other grants
in Article V and Article XIII of this Agreement), to
assign or grant a license, sublicense or other right to or under,
such Information, Regulatory Documentation, Patent or Intellectual
Property Right as provided for herein without violating the terms
of any written agreement or other formal arrangement with any Third
Party.
1.22 “Core Patents” shall mean (a) the
Patents set forth on Exhibit A, (b) any Patents issuing
from any Patent application claiming priority from any Patent
described in the foregoing clause (a), (c) any foreign
equivalents of any Patents described in the foregoing clauses
(a) and (b), and (d) any Patents Controlled by EOS as of
the Effective Date or at any time during the term of this Agreement
that relate solely to the Existing Products or any Improvements
thereto.
1.23 “Corporate Names” shall mean (a) in
the case of EOS, the EOS corporate logo or such other names and
logos as EOS may designate in writing from time to time and
(b) in the case of Licensee, Licensee’s corporate logo
or such other names and logos of Licensee, in each case ((a) and
(b)) together with any variations and derivatives
thereof.
1.24 “Development” shall mean all activities
related to research, preclinical and other non-clinical testing,
test method development, process development, manufacturing
scale-up, qualification and validation, quality assurance/quality
control and Clinical Studies, including manufacturing in support
thereof, statistical analysis and report writing, the preparation
and submission of any application for Regulatory Approval,
regulatory affairs with respect to the foregoing and all other
activities necessary or reasonably useful or otherwise requested or
required by a Regulatory Authority as a condition or in support of
obtaining or maintaining a Regulatory Approval. When used as a
verb, “Develop” shall mean to engage in
Development.
1.25 “Development Agreement” shall have the
meaning set forth in Section 2.1.3.
1.26 “Dispute” shall have the meaning set forth
in Section 14.6.1.
1.27 “Distributor” shall mean a Person, other
than a Sublicensee or an Affiliate of Licensee, in one or more
countries in the Territory that (a) purchases the Licensed
Product from the Licensee, its Affiliate or Sublicensee for such
country(ies), (b) assumes responsibility from the Licensee for
all or a portion of the Commercialization of the Licensed Product
in such country(ies) and (c) sells the Licensed Product in
such country(ies).
1.28 “Effective Date” shall have the meaning set
forth in the preamble to this Agreement.
1.29 “EOS” shall have the meaning set forth in
the preamble to this Agreement.
1.30 “EOS Know-How” shall mean all Information
that is Controlled by EOS as of the Effective Date or during the
term of this Agreement that (a) is not generally known and
(b) is reasonably necessary or useful for the Exploitation of
the Licensed Product
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in the Field in
the Territory, but excluding any Information to the extent covered
or claimed by EOS Patents.
1.31 “EOS Patents” shall mean the Core Patents
and the Additional Patents, collectively.
1.32 “EOS Technology” shall mean the EOS Patents
and the EOS Know-How, collectively.
1.33 “Exchange Act” shall mean the United States
Securities Exchange Act of 1934, as amended.
1.34 “Existing Products” shall mean the products
listed in Exhibit B.
1.35 “Exploit” shall mean to make, have made,
import, use, sell or offer for sale, including to research,
Develop, Commercialize, register, Manufacture, have Manufactured,
hold or keep (whether for disposal or otherwise), have used,
export, transport, distribute, promote, market or have sold or
otherwise dispose of.
1.36 “Exploitation” shall mean the act of
Exploiting a product or process.
1.37 “Field” shall mean all dental
applications.
1.38 “FDA” shall mean the United States Food and
Drug Administration and any successor agency thereto.
1.39 “FFDCA” shall mean the United States Food,
Drug, and Cosmetic Act, as amended from time to time.
1.40 “First Commercial Sale” shall mean the
first bona fide sale of any Licensed Product by Licensee, its
Affiliates, Sublicensees or Distributors (other than a sale or
other distribution without consideration and, solely for the
purpose of marketing, alpha or beta testing, or product
demonstration) occurring after the grant of the first Regulatory
Approval for such Licensed Product.
1.41 “IDE” shall mean an investigational device
exemption as defined in the regulations promulgated by the FDA for
the authorization to commence human clinical trials, and its
equivalent in other countries or regulatory jurisdictions in the
Territory.
1.42 “Improvement” shall mean any modification,
variation, enhancement or revision to the design, operation or
method of any EOS Technology, the result of which would remain
covered by one or more Valid Claims of any EOS Patent.
1.43 “Incorporating Patents” shall mean any
Patent the Valid Claims of which are primarily related to the
incorporation of the EOS Technology into an Incorporating
Product.
1.44 “Incorporating Product” shall mean any
Combination Product developed by Licensee wherein the EOS
Technology is incorporated into a product (unrelated to the EOS
Technology) currently existing or separately developed by Licensee,
and in which Licensee has in the past or may in the future
Manufacture, Develop or Exploit alternate versions of such product
which do not incorporate the EOS Technology (e.g.
Licensee
- 5 -
manufactures a
camera, the general design of which is Controlled by Licensee, and
as a feature of the camera offers a version which incorporates the
EOS Technology).
1.45 “Indemnification Claim Notice” shall have
the meaning set forth in Section 12.3.
1.46 “Indemnified Party” shall have the meaning
set forth in Section 12.3.
1.47 “Information” shall mean all commercial,
technical, scientific and other know-how and information, trade
secrets, knowledge, technology, means, methods, processes,
practices, formulae, instructions, skills, techniques, procedures,
experiences, ideas, technical assistance, designs, drawings,
assembly procedures, computer programs, apparatuses,
specifications, data, results and other material (whether or not
confidential, proprietary, patented or patentable) in written,
electronic or any other form now known or hereafter developed, but
excluding the Regulatory Documentation.
1.48 “Intellectual Property Rights” shall mean
Trademarks, service marks, trade names, Internet domain names,
registered designs, design rights, copyrights (including rights in
computer software), database rights, trade secrets and any rights
or property similar to any of the foregoing (other than Patents) in
any part of the Territory whether registered or not registered,
together with the right to apply for the registration of any such
rights.
1.49 “Invoiced Sales” shall have the meaning set
forth in Section 1.62.
1.50 “Knowledge” shall mean the collective good
faith understanding of each of the vice presidents, senior vice
presidents, president and chief executive officer of a Party of the
facts and information then in their possession without any duty to
conduct any specific investigation with respect to such facts and
information.
1.51 “Licensed Product” shall mean any product
(a) the Exploitation of which infringes any EOS Patent, or
(b) that incorporates, embodies, comprises, is comprised of,
in whole or in part, or is manufactured using, any EOS Know-How,
including the Existing Products and any Improvements thereto,
including any Incorporating Product, but expressly excluding any
Next Generation Products.
1.52 “Licensed Product System” shall mean any
Licensed Product that is not a Consumable.
1.53 “Licensed Trademarks” shall mean
(a) the Trademarks set forth on Exhibit C, and
(b) any Corporate Name of EOS that Licensee is required to use
hereunder.
1.54 “Licensee” shall have the meaning set forth
in the preamble to this Agreement.
1.55 “Licensee Know-How” shall mean all
Information Controlled (other than pursuant to this Agreement) or
developed by Licensee or any of its Affiliates during the term of
this Agreement that is not generally known and is reasonably
necessary or useful for the Exploitation of the Licensed Product,
but excluding any Information to the extent claimed by Licensee
Patents.
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1.56 “Licensee Patents” shall mean all Patents
Controlled (other than pursuant to this Agreement) by Licensee and
any of its Affiliates developed during the term of this Agreement
that claim any technology that is reasonably necessary or useful
for the Exploitation of the Licensed Product, including any Patents
that claim any Licensed Product or its Exploitation.
1.57 “Licensee Technology” shall mean the
Licensee Patents and the Licensee Know-How,
collectively.
1.58 “Losses” shall have the meaning set forth
in Section 12.1.
1.59 “Manufacture” and
“Manufacturing” shall mean all activities related
to the production, manufacture, packaging, labeling, shipping and
holding of the Licensed Product or any component thereof, including
process development, process qualification and validation,
scale-up, pre-clinical, clinical and commercial manufacture,
quality assurance and quality control.
1.60 “Manufacturing Process” shall mean any
process or step thereof that is necessary or useful for
Manufacturing any Licensed Product or any Improvement
thereto.
1.61 “ Minimum Royalty Payment ” shall
mean the amount set forth in Section 6.2.2.
1.62 “Net Sales” shall mean, for any period, the
gross amount invoiced by Licensee and its Affiliates, or
Sublicensees for the sale, rental, lease, use on a fee-per-patient
basis or other disposal of the Licensed Product (the “
Invoiced Sales ”), less the following, with respect
thereto: (a) sales and use taxes, and tariff duties, invoiced
and actually paid to the applicable governmental entity,
(b) transportation costs, including insurance and shipping,
freight and handling charges, to the extent billed separately to
customers; (c) any trade discounts and allowances actually
granted, including, but not limited to, discounts pursuant to
patient discount programs, rebates and administrative fees paid to
medical health care organizations in line with approved contract
terms, rebates resulting from government-mandated rebate programs
or chargeback programs, and rebates paid to wholesalers for
inventory management programs or distribution management
agreements; (d) sales commissions paid to Distributors or
selling agents (excluding any commissions paid to inside sales
representatives); (e) any credits actually given for returned
or defective Licensed Products, (f) any Third Party Royalty
Payments; and (g) any Recall Expenses incurred by Licensee in
the Calendar Quarter for which the royalties payable are
calculated. Notwithstanding the foregoing, in the case of any sale,
rental, lease, use on a fee-per-patient basis or other disposal of
Licensed Product that occurs other than in an arm’s length
transaction exclusively for money, Net Sales shall mean the fair
market value of such Licensed Product in the relevant country of
disposal. For purposes of determining Net Sales, the Licensed
Product shall be deemed to be sold when invoiced.
Notwithstanding
the foregoing, in the event that the Licensed Product is sold in
conjunction with another proprietary component so as to be a
Combination Product, Net Sales shall be calculated by multiplying
the Net Sales of such Combination Product by a fraction, the
numerator of which shall be the fair market value of the Licensed
Product if sold separately (determined in accordance with the local
generally accepted accounting principles) and the denominator of
which shall be the aggregate fair market value of all the
proprietary components of such Combination Product, including the
Licensed Product, if sold separately.
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In the event
that no such separate sales are made by Licensee or its Affiliates,
Sublicensees or Distributors, Net Sales of the Combination Product
shall be calculated in a manner to be negotiated and agreed upon by
the Parties, reasonably and in good faith, prior to any sale of
such Combination Product, which shall be based upon the relative
estimated commercial values of the proprietary components of such
Combination Product.
Licensee’s or any of its Affiliates’
or Sublicensees’ transfer of Licensed Product to an Affiliate
of Licensee or a Sublicensee shall not result in any Net Sales,
unless such Affiliate or Sublicensee is the end user of such
Licensed Product.
1.63 “Next Generation Patents” shall mean any
Patents Controlled by Licensee which may, directly or indirectly,
relate to the design, operation or method of the EOS Technology,
but are not covered by one or more Valid Claims of the EOS
Patents.
1.64 “Next Generation Products” shall mean any
products the Manufacture, Commercialization or Exploitation of
which infringes any Next Generation Patent, but expressly excluding
any Incorporating Product.
1.65 “Notice Date” shall have the meaning set
forth in Section 13.9.
1.66 “Notice Period” shall have the meaning set
forth in Section 13.2.
1.67 “Party” and “Parties” shall
have the meaning set forth in the preamble to this
Agreement.
1.68 “Patents” shall mean (a) all national,
regional and international patents and patent applications,
including provisional patent applications, (b) all patent
applications filed either from such patents, patent applications or
provisional applications or from an application claiming priority
from either of these, including divisionals, continuations,
continuations-in-part, provisionals, converted provisionals and
continued prosecution applications, (c) any and all patents
that have issued or in the future issue from the foregoing patent
applications ((a) and (b)), (d) any and all extensions or
restorations by existing or future extension or restoration
mechanisms, including revalidations, reissues, re-examinations and
extensions (including any supplementary protection certificates and
the like) of the foregoing patents or patent applications ((a),
(b) and (c)) and (e) any similar rights, including
so-called pipeline protection or any importation, revalidation,
confirmation or introduction patent or registration patent or
patent of additions to any of such foregoing patent applications
and patents.
1.69 “Payments” shall have the meaning set forth
in Section 6.7.
1.70 “Person” shall mean an individual, sole
proprietorship, partnership, limited partnership, limited liability
partnership, corporation, limited liability company, business
trust, joint stock company, trust, unincorporated association,
joint venture or other similar entity or organization, including a
government or political subdivision, department or agency of a
government.
1.71 “PMA Product” shall mean a product, the
sale of which requires the filing with and approval by the FDA of a
PMA.
- 8 -
1.72 “Premarket Approval” or “PMA”
shall mean a premarket approval as defined in the FFDCA and the
regulations promulgated thereunder.
1.73 “Product Labeling” shall mean, with respect
to a country, (a) the full information relating to use of the
Licensed Product approved by the relevant Regulatory Authority for
such country, including any required patient information, and
(b) all labels and other written, printed or graphic matter
utilized with the Licensed Product, including the instructions for
use.
1.74 “Promotional Materials” shall mean all
sales representative training materials with respect to the
Licensed Product and all written, printed, graphic, electronic,
audio or video matter, including journal advertisements, sales
visual aids, direct mail, medical information/education monographs,
direct-to-consumer advertising, Internet postings, broadcast
advertisements and sales reminder aids ( e.g. , scratch
pads, pens and other such items) intended for use or used by
Licensee, or its Affiliates, Sublicensees or Distributors, in
connection with any promotion of the Licensed Product (but
excluding Product Labeling).
1.75 “Recall Expenses” shall have the meaning
set forth in Section 9.2.
1.76 “Regulatory Approval” shall mean, on a
country-by-country basis, the right to commercially distribute,
sell or market the Licensed Product in such country, including in
the case of the United States, a determination by the FDA of
substantial equivalence (within the meaning of 21 C.F.R. §
807.100) following the filing with the FDA of a 510(k)
Notification, or in the event that a PMA is required, the approval
by the FDA of such PMA, and in the case of any other country or
territory, any necessary approvals in such country or
territory.
1.77 “Regulatory Authority” shall mean any
supra-national, federal, national, regional, state, provincial or
local regulatory agencies, departments, bureaus, commissions,
councils or other government entities regulating or otherwise
exercising authority with respect to the Exploitation of the
Licensed Product.
1.78 “Regulatory Documentation” shall mean all
applications, registrations, licenses, authorizations and approvals
(including all Regulatory Approvals), all correspondence submitted
to or received from Regulatory Authorities (including minutes and
official contact reports relating to any communications with any
Regulatory Authority) and all supporting documents and all results
of clinical studies and tests, in each case relating to any
Licensed Product, and all data contained in any of the foregoing,
including all IDEs, 510K Notifications, PMA Notifications,
Regulatory Approvals, advertising and promotion documents, adverse
event files, complaint files and Manufacturing records.
1.79 “Sublicensee” shall mean any Person, other
than an Affiliate of Licensee, that is granted a sublicense by
Licensee as provided in Section 5.2.
1.80 “Territory” shall mean all countries in the
world.
1.81 “Third Party” shall mean any Person other
than EOS, Licensee and their respective Affiliates.
1.82 “Third Party Acquirer” shall have the
meaning set forth in Section 1.12.
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Certain
portions of this Exhibit have been omitted and filed separately
with the Securities and Exchange Commission pursuant to a request
for confidential treatment. Such omitted portions are marked with
brackets [ ] and an asterisk*.
1.83 “Third Party Claims” shall have the meaning
set forth in Section 12.1.
1.84 “Third Party Royalty Payments” shall have
the meaning set forth in Section 7.4.1.
1.85 “Trademark” shall include any word, name,
symbol, color, designation or device or any combination thereof,
including any trademark, trade dress, brand mark, service mark,
trade name, brand name, logo or business symbol, whether or not
registered.
1.86 “Valid Claim” shall mean, with respect to a
particular country, (a) any claim of an issued and unexpired
Patent in such country that (i) has not been held permanently
revoked, unenforceable or invalid by a decision of a court or
governmental agency of competent jurisdiction, which decision is
unappealable or unappealed within the time allowed for appeal and
(ii) has not been abandoned, disclaimed, denied or admitted to
be invalid or unenforceable through reissue or disclaimer or
otherwise in such country; or (b) a claim of a pending Patent
application, which claim has not been abandoned or finally
disallowed without the possibility of appeal or re-filing of the
application.
ARTICLE II
DEVELOPMENT AND REGULATORY MATTERS
2.1 Development of the Licensed Product .
2.1.1 In General. Subject to the terms and conditions of
this Agreement, Licensee shall have the sole right to Develop the
Licensed Product in the Field in the Territory. Any such
Development shall be conducted in good scientific manner and in
compliance with this Agreement and Applicable Law. Except as
otherwise expressly provided herein, Licensee shall be solely
responsible for all costs and expenses in connection with such
Development activities.
2.1.2 Diligence. Licensee agrees to (a) use
Commercially Reasonable Efforts achieve the First Commercial Sale
of the Licensed Product in the Field in the Territory by
July 1, 2008 (provided that failure to meet such deadline
shall not be considered a material breach entitling EOS to
terminate this Agreement under Section 13.2) and
(b) except as expressly limited by Section 13.8.9 shall
incur costs and expenses (including internal costs reasonably
allocable to the Licensed Product program under GAAP) of at least
[*] by July 1, 2009 in support of the Development of, and
market preparation for, the Licensed Product.
2.1.3 EOS Development Activities. The Parties acknowledge
that they may enter into one or more separate agreements (each, a
“ Development Agreement ”) pursuant to which
Licensee would engage EOS to perform certain Development activities
relating to the Licensed Product, at Licensee’s sole cost and
expense, on terms and conditions to be mutually agreed by the
Parties in writing. Except as expressly provided herein or in any
Development Agreement, EOS shall have no obligation to perform any
Development activities with respect to the Licensed Product. Except
to the extent expressly provided otherwise in a Development
Agreement, the respective rights of the Parties with respect to any
intellectual property developed thereunder shall be as set forth in
Section 7.1.2 of this Agreement.
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2.1.4 Know-How Disclosure. EOS shall, and shall cause its
Affiliates to, without additional compensation, disclose and make
available to Licensee all EOS Know-How and any Information claimed
by any unpublished EOS Patent within ten (10) Business Days
after the Effective Date, including, but not limited to, lab work
papers and other research documentation relating to the Existing
Products or any Improvements thereto; any testing and test protocol
documentation relating to the efficacy, validation, or
manufacturing thereof; and research study documentation, incidence
reports and other manufacturing history documentation, parts lists
and supplier information (including any pricing information and
contracts) relating thereto.
2.1.5 Audit. Licensee shall keep complete and accurate books
and financial records (in accordance with generally accepted
accounting principles) pertaining to the costs and expenses it
incurs in connection with the Development of the Licensed Product
in connection with its obligations under Section 2.1.2, which
books and financial records shall be retained by Licensee until
three (3) years after the end of the period to which such
books and records pertain, or such longer period as Applicable Law
may require. EOS shall have the right, at its expense, to have
certified public accountants, who shall be reasonably acceptable to
Licensee, audit the books and financial records of Licensee
relating to such expenses incurred in connection with the
Development of the Licensed Product for the sole purpose of
assessing compliance with Section 2.1.2; provided ,
however , that EOS shall not have the right to audit a
Calendar Quarter more than three (3) years after the end of
such Calendar Quarter, to conduct more than one such audit in any
twelve (12) month period, or to audit any Calendar Quarter more
than once. Any Information obtained by the certified public
accountant from Licensee, other than the aggregate amount of costs
and expenses incurred by Licensee, shall be maintained in strict
confidence by the certified public accountant. The certified public
accountant shall be obligated to execute a written undertaking with
respect to such confidentiality prior to the commencement of the
audit.
2.2.1 Assignment and Transfer of Regulatory Documentation and
Approvals. EOS shall transfer to Licensee all of EOS’ and
its Affiliates’ right, title and interest in and to all
Regulatory Documentation, including, to the extent permitted by
Applicable Law, all IDEs and Regulatory Approvals, Controlled by
EOS or its Affiliates, as of a date to be mutually agreed by the
Parties, which date shall not be later than thirty (30) days
after the Effective Date. In connection with the foregoing, EOS
shall execute and deliver to the FDA (and any other Regulatory
Authority as reasonably requested by Licensee in writing) a letter
in a form approved by Licensee transferring ownership to Licensee
of any and all such Regulatory Approvals filed with the FDA or such
other Regulatory Authority in the Territory by or on behalf of EOS.
The costs and expenses associated with the performance of
EOS’s obligations under this Section 2.2.1 shall be
borne by EOS.
2.2.2 Regulatory Responsibilities. Licensee shall have sole
responsibility for preparing and maintaining all regulatory
submissions and responding to all inquiries from Regulatory
Authorities with respect to (a) Regulatory Approvals for the
Licensed Product in the Field in the Territory and
(b) Development activities for the Licensed Product that are
conducted in support of Regulatory Approvals for the Licensed
Product or Commercialization of the Licensed Product in the Field
in the Territory, and for complying with all requirements of
Applicable Law with respect thereto. Subject to Article XIII,
all Regulatory Approvals with respect to the Licensed Product, and
related submissions by or on
- 11 -
behalf of
License, in the Field in the Territory shall be the property of
Licensee and held in the name of Licensee.
2.2.3 Communications with Regulatory Authorities. Licensee
shall be responsible for all communications with the Regulatory
Authorities relating to the Licensed Product in the Field in the
Territory.
2.2.4 Regulatory Records. Licensee shall maintain, or cause
to be maintained, records of Development activities conducted by or
on behalf of Licensee with respect to the Licensed Product in
sufficient detail and in good scientific manner appropriate for
patent and regulatory purposes, which shall be complete and
accurate and shall fully and properly reflect all work done and
results achieved in the performance of such Development activities,
and which shall be retained for at least three (3) years after
the termination of this Agreement, or for such longer period as may
be required by Applicable Law.
2.3 Reports. Upon the request of EOS, which request may not
be made more than once every calendar quarter, Licensee shall
provide to EOS a brief summary of any material Development
activities with respect to Licensed Products that Licensee has
performed, or has caused to be performed, to date.
ARTICLE III
MANUFACTURING AND SUPPLY
3.1 Manufacturing. Subject to the terms and conditions of
this Agreement, Licensee shall have the sole right, at its expense,
to Manufacture the Licensed Product, including performing
manufacturing process development and scale-up with respect
thereto, for clinical and commercial use in the Field in the
Territory. Licensee may elect to Manufacture supplies of the
Licensed Product itself or through Third Party suppliers. In the
event that Licensee elects to use Third Party suppliers,
(a) all payment obligations to such Third Party suppliers
shall be the sole responsibility of Licensee, and (b) Licensee
shall have sole responsibility for supervising any Manufacturing
activities conducted by such Third Party suppliers.
3.2 Transfer of Manufacturing-Related Materials and
Documentation. Without limitation of Section 2.1.4 or
Section 2.2.1, EOS hereby assigns and transfers to Licensee
all of EOS’s right, title and interest in and to the tooling,
manufacturing drawings and other materials and documentation with
respect to the Licensed Product described in Exhibit D.
Promptly following Licensee’s request, and in no event later
than two (2) weeks thereafter, EOS shall cause such materials
and documentation to be delivered to Licensee at such location
designated by Licensee, at Licensee’s expense. For the
avoidance of doubt, subject to Section 13.6.l and the other
terms of this Agreement, any tooling and manufacturing drawings
developed by or on behalf of Licensee shall be owned by
Licensee.
ARTICLE IV
COMMERCIALIZATION
4.1 Generally; Diligence. Subject to the terms and
conditions of this Agreement, Licensee shall have the sole right,
at its expense, to Commercialize the Licensed Product in the Field
in the Territory. Any such Commercialization shall be in compliance
with this Agreement and Applicable Law.
- 12 -
4.2 Promotional Materials and Activities. Licensee shall be
responsible, at its sole expense, for preparing all Promotional
Materials used to support the Commercialization of the Licensed
Product in the Field in the Territory. All Promotional Materials
shall be consistent with Applicable Law and with the Product
Labeling approved by Licensee for the Licensed Product. Licensee
shall be responsible for obtaining any approvals from the
Regulatory Authorities required for the use of any Promotional
Materials in the Field in the Territory and shall submit all
applicable Promotional Materials to such Regulatory Authorities as
required by Applicable Law.
4.3 Statements and Compliance with Applicable Law
.
4.3.1 Sales Force Compliance. Licensee shall use
Commercially Reasonable Efforts to train and monitor its sales
representatives to (a) use only Promotional Materials (without
any addition, deletion or other modification) approved for use by
Licensee for the promotion of the Licensed Product in the Field in
the Territory, (b) limit claims of efficacy and safety for the
Licensed Product to those that are consistent with Applicable Law
and with approved (by the appropriate Regulatory Authority)
promotional claims in Product Labeling and Promotional Materials
for the Licensed Product, and not add, delete or otherwise modify
claims of efficacy and safety in the promotion of the Licensed
Product in any respect from those claims of efficacy and safety
that are contained in such approved Product Labeling and
Promotional Materials and (c) Commercialize the Licensed
Product in adherence in all material respects with Applicable
Law.
4.3.2 Medical and Other Inquiries. Licensee shall be
responsible for responding to all medical questions or inquiries
relating to the Licensed Product sold in the Field in the
Territory. Licensee shall keep such records and make such reports
as are reasonably necessary to document such communications in
compliance with all Applicable Law.
4.3.3 Compliance with Laws. Licensee shall use Commercially
Reasonable Efforts to, and shall use Commercially Reasonable
Efforts to cause its Affiliates, employees, representatives,
agents, Sublicensees and Distributors to, avoid taking, or failing
to take, any actions that Licensee knows or reasonably should know
would jeopardize the goodwill or reputation of the Licensed Product
or any Trademark associated therewith. Licensee shall in all
material respects conform its practices and procedures relating to
educating the dental community in the Territory with respect to the
Licensed Product to any applicable industry association
regulations, policies and guidelines, as the same may be amended
from time to time, and shall comply with Applicable Law with
respect thereto.
4.4 Sales and Distribution in the Territory. Licensee shall
be solely responsible for invoicing and booking sales of the
Licensed Product in the Territory, establishing all terms of such
sales (including pricing and discounts), and warehousing and
distributing the Licensed Product in the Territory and shall
perform all related activities, in each case in a manner consistent
with the terms and conditions of this Agreement. Licensee shall
also be solely responsible for handling all returns, order
processing, invoicing and collection, distribution and inventory
and receivables with respect to the Licensed Product in the Field
in the Territory. If EOS receives any orders for the Licensed
Product in the Field in the Territory, it shall refer such orders
to Licensee.
4.5 Customer Notification. Promptly after the Effective
Date, the Parties shall mutually agree on the manner, timing and
form of notification to be sent to existing
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customers of
the Licensed Product concerning this Agreement and the related
transfer of customer support functions and regulatory compliance
responsibilities from EOS to Licensee.
ARTICLE V
GRANT OF RIGHTS
5.1 License Grant. Subject to the terms and conditions of
this Agreement, EOS hereby grants to Licensee an exclusive
(including with respect to EOS and its Affiliates), royalty-bearing
license, with the right to grant sublicenses in accordance with
Section 5.2, under the EOS Technology and the Licensed
Trademarks to Exploit the Licensed Product in the Field in the
Territory; provided, however, that such license shall be
non-exclusive with respect to the Additional Patents.
5.2 Sublicenses. The rights and licenses granted to Licensee
under Section 5.1 shall include the right to grant sublicenses
to any Person, subject to the consent of EOS, such consent not to
be unreasonably withheld or delayed. Any such permitted sublicenses
shall be the subject of a written agreement between Licensee and
such Person, which agreement shall be consistent with and subject
to the terms and conditions of this Agreement. Licensee agrees
(a) to use all commercially reasonable efforts to procure the
performance by each Sublicensee, if any, of the terms of each such
sublicense agreement and (b) to cause each Sublicensee, if
any, to comply with the applicable terms and conditions of this
Agreement. The grant of any such sublicense shall not relieve the
Licensee of its obligations under this Agreement, except to the
extent they are satisfactorily performed by such Sublicensee. A
copy of any sublicense agreement executed by Licensee and a
Sublicensee shall be provided to EOS within fourteen (14) days
of its execution.
5.3 Use of Trademarks and Corporate Names.
5.3.1 Subject to this Section 5.3, Licensee shall have
the sole right to determine the Trademarks to be used with respect
to the Commercialization of the Licensed Product in the Field in
the Territory. Licensee shall not, and shall not permit its
Sublicensees, Distributors or Affiliates to use in connection with
the Exploitation of the Licensed Product, any Trademark (other than
the Licensed Trademarks to the extent licensed hereunder) that is
confusingly similar to, misleading or deceptive with respect to or
that dilutes any (or any part) of the Trademarks owned or
Controlled by EOS. Licensee shall execute any documents required,
in the reasonable opinion of EOS, for Licensee to be entered as a
“registered user” or recorded licensee of the Licensed
Trademarks or (in the case of termination of this Agreement) to be
removed as a registered user or licensee thereof.
5.3.2 With respect to any Licensed Trademarks, Licensee
agrees to comply with the customary guidelines of EOS with respect
to manner of use (as provided in writing by EOS from time to time),
and to maintain the quality standards of EOS with respect to the
goods sold and services provided in connection with such
Trademarks.
5.3.3 EOS agrees to transfer to Licensee, promptly after the
Effective Date, all right, title and interest of EOS in and to the
domain name www.difoti.com ; provided ,
however , that Licensee shall transfer to EOS all right,
title and interest of Licensee in and to such domain name promptly
after the effective date of any termination of this Agreement
pursuant to Article XIII.
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Certain
portions of this Exhibit have been omitted and filed separately
with the Securities and Exchange Commission pursuant to a request
for confidential treatment. Such omitted portions are marked with
brackets [ ] and an asterisk*.
5.4 EOS Covenant Not to Compete. From the Effective Date of
this Agreement until the earlier of (a) termination of this
Agreement, or (b) the last to expire of the Core Patents
(whichever occurs first), EOS shall not Develop, Manufacture or
Commercialize, directly or indirectly, in the Field any technology
or product that competes with any Licensed Product or Combination
Product in the Field.
5.5 Retention of Rights; No Implied Rights. Notwithstanding
anything to the contrary in this Agreement and subject to the
limitations in Section 5.4, EOS retains all right, title and
interest in and to the EOS Technology, EOS’s Corporate Name
and any Regulatory Documentation Controlled by EOS to Exploit any
product outside the Field. For the avoidance of doubt, Licensee and
its Affiliates, Sublicensees and Distributors shall have no right,
express or implied, with respect to any EOS Technology, any
Regulatory Documentation Controlled by EOS, or any of EOS’s
Corporate Names or Trademarks, except as expressly provided herein,
and EOS and its Affiliates and sublicensees shall have no right,
express or implied, with respect to any Licensee Patents, Licensee
Know-How, Incorporating Patents, or Next Generation Patents, except
as expressly provided herein.
ARTICLE VI
PAYMENTS AND RELATED MATTERS
6.1 Payments to EOS. In partial consideration of the
licenses and other rights granted herein and subject to the terms
and conditions set forth in this Agreement, Licensee shall make the
following payments to EOS:
6.1.1 Initial Payment. Licensee shall pay to EOS a
non-refundable, non-creditable payment of [*] upon execution of
this Agreement.
6.1.2 Second Payment. Licensee shall pay to EOS a
non-refundable, non-creditable payment of [*] within ten
(10) Business Days following the earlier of (a) the First
Commercial Sale of the Licensed Product, or (b) July 1,
2008. Licensee shall notify EOS promptly of the occurrence of such
First Commercial Sale.
6.2 Royalties. In partial consideration of the licenses and
other rights granted herein, Licensee shall pay to EOS royalties
based on worldwide aggregate Net Sales of Licensed Products at the
rates set forth in Section 6.2.1.
6.2.1 Rate. The royalty rate applicable to Net Sales of any
Licensed Product, whether or not such Licensed Product is a
Licensed Product System, shall be determined based on the aggregate
number of Licensed Product Systems that have been sold throughout
the Territory during such Calendar Year, by or on behalf of
Licensee, and its Affiliates and Sublicensees, on or before the
date on which such Licensed Product is sold, as set forth in the
chart below:
|
|
|
|
|
Royalty
|
|
Aggregate
Units of Licensed Product Systems
|
|
Rate
|
|
Previously
Sold in the Calendar Year
|
|
|
|
Between 0 and
2,500 units
|
|
|
|
Between 2,501
and 3,500 units
|
|
|
|
Between 3,501
and 4,500 units
|
|
|
|
Between 4,501 -
5,500 units
|
|
|
|
Between 5,501 -
6,500 units
|
|
|
|
6,501 units or
greater
|
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Certain
portions of this Exhibit have been omitted and filed separately
with the Securities and Exchange Commission pursuant to a request
for confidential treatment. Such omitted portions are marked with
brackets [ ] and an asterisk*.
6.2.2 Minimum Royalty Payments. Commencing with the Calendar
Year 2008 or, in the event the First Commercial Sale of the
Licensed Product in the Territory occurs prior to July 1,
2008, the Calendar Year in which such First Commercial Sale occurs,
Licensee shall pay to EOS an amount equal to the positive
difference, if any, between the Minimum Royalty Payment for such
Calendar Year and the amounts paid by Licensee pursuant to
Section 6.2.1 for such Calendar Year. Such payment shall be
due as of the date on which the royalty payment for the last
Calendar Quarter of such Calendar Year is due pursuant to
Section 6.5. The Minimum Royalty Payment shall be equal to [*]
per Calendar Year; provided, however, that the Minimum
Royalty Payment shall be pro-rated with respect to the Calendar
Year in which the First Commercial Sale occurs. In the event that
Licensee pays any amount pursuant to this Section 6.2.2 with
respect to a Calendar Year, such amount paid shall be creditable
against royalties due pursuant to Section 6.2.1 with respect
to any of the three (3) Calendar Years immediately following such
Calendar Year.
6.3 Royalty Term; Royalty Reduction. Licensee’s
obligations to pay royalties under this Article VI shall
terminate, on a country-by-country basis, with respect to each
Licensed Product, on the later to occur of (a) the tenth
(10th) anniversary of the First Commercial Sale of such Licensed
Product in such country, and (b) the expiration date in such
country of the last to expire of the EOS Patent(s), if any, that
includes at least one Valid Claim covering the Manufacture, use or
sale of such Licensed Product in such country, whereupon Licensee
shall own a fully paid-up exclusive license to the Licensed Product
in the Field in such country; provided, however, that the
applicable royalty rate shall be reduced to one-third of the rate
set forth in Section 6.2.1, on a country-by-country basis,
upon the expiration in such country of the last to expire of any
EOS Patent that includes at least one Valid Claim covering the
Manufacture, use or sale of the Licensed Product in such country,
which reduced royalty shall be payable through the tenth
anniversary of the First Commercial Sale of such Licensed Product
in such country. For clarity, in the event that there is no such
EOS Patent in a country, then such reduced royalty rate shall apply
in such country from the First Commercial Sale of each Licensed
Product in such country through the tenth anniversary
thereof.
6.4 Royalty Payments. Running royalties based upon the Net
Sales during a Calendar Quarter due pursuant to Section 6.2 or
6.4 shall be payable by Licensee on a Calendar-Quarter basis,
within thirty (30) days after the end of such Calendar
Quarter. Royalties shall be calculated in accordance with United
States generally accepted accounting principles and the terms of
this Article VI. Only one royalty payment shall be due
hereunder on Net Sales, even though the Manufacture, sale or use of
the Licensed Product may be covered by more than one Patent in a
country.
6.5 Royalty Statements. Licensee shall provide to EOS within
fifteen (15) days after the end of each Calendar Quarter, a
statement showing, at a minimum (a) Net Sales during the
relevant Calendar Quarter by country, (b) the currency
exchange rates, if any, used in the calculation of such royalty
payment, (c) the number of units of Licensed Product Systems
sold, and (d) the amount of royalties due on such Net
Sales.
6.6 Mode of Payment. All payments to EOS under this
Agreement shall be made by wire transfer of United States Dollars
to such bank account as EOS may from time to time designate by
notice to Licensee. With respect to sales outside the United
States, payments shall be calculated based on currency exchange
rates for the relevant Calendar
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Quarter, as
follows. For each Calendar Quarter and each currency, such exchange
rate shall equal the arithmetic average of the daily exchange rates
for each Business Day in such Calendar Quarter as set forth in
The Wall Street Journal , Eastern Edition or, if not
available, as otherwise agreed by the Parties.
6.7 Taxes . The royalties and other amounts payable by
Licensee to EOS pursuant to this Article VI (“
Payments ”) shall not be reduced on account of any
taxes unless required by Applicable Law. Licensee shall deduct or
withhold from the Payments any taxes that it is required by
Applicable Law to deduct or withhold. Notwithstanding the
foregoing, if EOS is entitled under any applicable tax treaty to a
reduction of rate of, or the elimination of, applicable withholding
tax, it may deliver to Licensee or the appropriate governmental
authority (with the assistance of Licensee to the extent that this
is reasonably necessary) the prescribed forms necessary to reduce
the applicable rate of withholding or to relieve Licensee of its
obligation to withhold tax, and Licensee shall apply the reduced
rate of withholding, or dispense with withholding, as the case may
be, provided that Licensee has received evidence, in a form
reasonably satisfactory to Licensee, of EOS’s delivery of all
applicable forms (and, if necessary, its receipt of appropriate
governmental authorization) at least fifteen (15) days prior
to the time that the Payments are due. If, in accordance with the
foregoing, Licensee withholds any amount, it shall pay to EOS the
balance when due, make timely payment to the proper taxing
authority of the withheld amount and send to EOS proof of such
payment within sixty (60) days following that
payment.
6.8 Interest on Late Payment. If any payment due to either
Party under this Agreement is overdue then the delinquent Party
shall pay interest thereon (before and after any judgment) at an
annual rate (but with interest accruing on a daily basis) of three
hundred basis points above the prime
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