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Exhibit
10.2
EXCLUSIVE LICENSE
AGREEMENT
This Exclusive License
Agreement (this “Agreement”) is made effective as of
September 11, 2007 (the “Effective Date”) by and
between Alphatec Spine, Inc., a Delaware corporation with a
principal place of business at 2051 Palomar Airport Road, Suite
100, Carlsbad, California 92008 (“Licensee”), and Stout
Medical Group LP, a limited partnership company organized under the
laws of the state of Delaware, and having a place of business at
410 East Walnut Street, Suite #8, Perkasie, Pennsylvania 18944,
(“Licensor”). Licensee and Licensor are each hereafter
referred to individually as a “Party” and together as
the “Parties”.
WHEREAS, Licensor is the
owner of or otherwise controls certain proprietary Licensed Patents
and Licensed Technology (as defined below); and
WHEREAS, Licensee desires to
obtain a license from Licensor under such Licensed Patents and
Licensed Technology to develop and commercialize Licensed Products
(as defined below); and
WHEREAS, Licensor desires to
grant such license to Licensee on the terms and subject to the
conditions of this Agreement.
NOW, THEREFORE, in
consideration of the mutual covenants contained herein, and for
other good and valuable consideration, the receipt and adequacy of
which are hereby acknowledged, the Parties hereby agree as
follows.
1.
DEFINITIONS
Whenever used in the
Agreement with an initial capital letter, the terms defined in this
Article 1 shall have the meanings specified.
1.1 “
Affiliate ” shall mean any company,
corporation, partnership, limited liability company, trust, or
other business entity that directly or indirectly controls, is
controlled by, or is under common control with a designated person
or entity, 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.
1.2 “
Confidential Information ” shall mean with
respect to a Party (the “Receiving Party”), all
information which is disclosed by the other Party (the
“Disclosing Party”) to the Receiving Party hereunder or
to any of its employees, consultants, Affiliates, licensees or
sublicensees, except to the extent that the Receiving Party can
demonstrate by written record or other suitable physical evidence
that such information, (a) as of the date of disclosure is
demonstrably known to the Receiving Party or its Affiliates other
than by virtue of a prior confidential disclosure to such Party or
its Affiliates; (b) as of the date of disclosure is in, or
subsequently enters, the public domain, through no fault or
omission of the Receiving Party; (c) is obtained from a Third
Party having a lawful right to make such disclosure free from any
obligation of confidentiality to the Disclosing Party; or
(d) is independently developed by or for the Receiving Party
without reference to or reliance upon any Confidential Information
of the
Disclosing Party. Any
information in relation to the subject matter of this Agreement
disclosed by a Party under that certain Mutual Confidentiality
Agreement between the parties dated the 2d day of July 2007 shall,
subject to the foregoing exceptions, be considered Confidential
Information for purpose of this Agreement.
1.3 “ First
Commercial Sale ” shall mean the date of the first
transaction, transfer or disposition for value by or on behalf of
Licensee or any Affiliate or Sublicensee of Licensee to a Third
Party of a Licensed Product in the United States following the
applicable regulatory clearance by the FDA (as defined
below).
1.4 “ FDA
” shall mean the United States Food and Drug Administration
and any successor agency or authority thereto.
1.5 “ Joint
Inventions ” shall have the meaning given in
Section 3.3.
1.6 “ Licensor
Indemnitees ” and “ Licensee
Indemnitees ” (each individually an “
Indemnitee ”) shall have the meaning given in
Section 8.1.
1.7 “ Licensed
Field ” shall mean the treatment of spinal vertebral
body compression fractures.
1.8 “ Licensed
Patent Rights ” shall mean any of the patent
applications described in Schedule A attached hereto, and
any divisional, continuation, continuation-in-part (to the extent
that the continuation-in-part is entitled to the priority date of
an initial patent or patent application which is the subject of
this Agreement), reissue, reexamination, registration, renewal, or
extension, or any patent issuing therefrom or any supplementary
protection certificates related thereto, and any foreign
counterparts to any of the foregoing.
1.9 “ Licensed
Product ” shall mean any product sold by Licensee,
its Affiliates or Sublicensees that embodies or uses any aspect of
the Licensed Patent Rights and/or the Licensed
Technology.
1.10 “ Licensed
Technology ” shall mean all Technology
which:
1.10.1 Licensor controls as
of the Effective Date and which (i) is described in or related
to any patent or patent application included in the Licensed Patent
Rights and (ii) is necessary or useful for Licensee to
practice the license granted to it hereunder;
1.10.2 is developed by
Licensor as a part of its efforts contemplated by
Section 3.2;
1.10.3 Licensor controls
after the Effective Date but during the Term and which (i) it
has the right to disclose and license without the payment of
royalties or other consideration to any Third Party and
(ii) constitutes an improvement to the subject matter of the
Licensed Patent Rights or Licensed Technology as it exists on the
date of determination, including Licensor’s interest in any
Joint Inventions; and/or
1.10.4 Licensee controls
after the Effective Date but during the Term and which constitutes
an improvement to the subject matter of the Licensed Patent Rights
or Licensed Technology as it exists on the date of
determination.
1.11 “ Net
Sales ” shall mean the gross amount invoiced or
otherwise payable by Licensee, any of its Affiliates or any
Sublicensee on account of sales or other transfers of a Licensed
Product anywhere in the Territory during a designated period, less
(to the extent otherwise then or previously included in amounts
invoiced for such Licensed Product and in respect of which no
previous deduction was taken):
1.11.1 trade, cash and
quantity discounts or rebates actually allowed or taken on Licensed
Products, including discounts or rebates to governmental or managed
care organizations;
1.11.2 credits or allowances
actually given or made for rejection of, and for uncollectible
amounts (except to the extent later collected) on, or return of
previously sold Licensed Products;
1.11.3 any charges for
insurance, freight, and other transportation costs directly related
to the delivery of Licensed Product to the extent included in the
gross invoiced sales price;
1.11.4 any tax, tariff, duty
or governmental charge levied on the sales, transfer,
transportation or delivery of a Licensed Product (including any tax
such as a value added or similar tax or government charge), other
than franchise or income tax of any kind whatsoever; and
1.11.5 any import or export
duties or their equivalent borne.
In addition, should Licensee be
required, in order to lawfully exercise its rights as to a Licensed
Product, obtain additional rights in a country to patents of any
Third Parties which are not Affiliates of Licensee, which patents
are (i) pending or issued on the Effective Date, and
(ii) required for Licensee to practice the inventions
described in the Licensed Patent Rights or Licensed Technology or
exercise the license granted under this Agreement for reasons not
attributable to a design selection made by Licensee for which
alternative design selections not requiring such additional rights
are available, then Licensee may also deduct from Net Sales with
respect to a designated period the amount of the royalty Licensee
is required to pay to such Third Party or Parties for such
necessary rights to such patents with respect to such Licensed
Product; provided that in no event (i) shall the amount of Net
Sales for any designated period be reduced by more than [***] on
account of royalties paid to Third Parties, and any amount so
disallowed shall be lost and not carried forward and (ii) no
such reduction shall be permitted with respect to additional rights
obtained more than [***] after the First Commercial Sale in such
country.
“Net Sales” shall not
include amounts invoiced to or otherwise payable by Licensee, any
of its Affiliates and/or any Sublicensees for Licensed Products
sold or otherwise transferred to Licensee or any of its Affiliates
and/or its Sublicensees, unless the Licensed Product is consumed by
the invoiced entity.
1.12 “ Product
Trademark ” shall mean the mark
“V-Stent”, U.S. Trademark Application Serial Number
77273484.
1.13 “
Sublicensee ” shall mean any Third Party to
whom Licensee grants a sublicense of some or all of the rights
granted to Licensee under this Agreement.
1.14 “
Technology ” shall mean all of the following
intangible legal rights, whether or not filed, perfected,
registered or recorded, applicable to the Licensed Field:
(i) inventions, patents, patent disclosures, patent rights,
including any and all continuations, continuations-in-part,
divisionals, reissues, reexaminations, utility models, industrial
designs and design patents or any extensions thereof,
(ii) rights associated with works of authorship, including
without limitation, copyrights, copyright applications and
copyright registrations and (iii) any and all proprietary
ideas, inventions, discoveries, Confidential Information, data,
results, formulae, designs, specifications, methods, processes,
techniques, ideas, know-how, technical information (including,
without limitation, structural and functional information), process
information, pre-clinical information, clinical information, and
any and all proprietary control and manufacturing data and
materials, whether or not patentable.
1.15 “
Term ” shall have the meaning given in
Section 9.1.
1.16 “
Territory ” shall mean all countries and
jurisdictions of the world.
1.17 “ Third
Party ” shall mean any person or entity other than
Licensee, Licensor and their respective Affiliates.
2. GRANT OF
RIGHTS
2.1 License to
Licensee .
2.1.1 Grant of License
. Licensor hereby grants to Licensee an exclusive (even as to
Licensor and its Affiliates), royalty-bearing license, including
the right to grant sublicenses in accordance with Subsection 2.1.2,
under the Licensed Patent Rights and Licensed Technology:
(i) to conduct research and development in support of the
licensed uses describe in clause (ii) of this Subsection, and
(ii) to make, have made, import, export, use, offer for sale
or sell Licensed Products in the Licensed Field, subject to the
terms and conditions of this Agreement. In addition, Licensor
hereby grants to Licensee an exclusive license, including the right
to grant sublicenses in accordance with Subsection 2.1.2, to use
and display the Product Trademarks in connection with the exercise
of its rights under the license grant in clause (ii) of this
Subsection, subject to the terms and conditions of this
Agreement.
2.1.2 Right to
Sublicense . Licensee shall have the right to grant
sublicenses, subject to the terms of this Agreement, to all or any
portion of its rights under the license granted pursuant to this
Section.
2.2 Right of First
Discussion in Relation to Sales of Licensed Patent Rights or
Licensed Technology . In the event that Licensor decides to
sell any of the Licensed Patent Rights or Licensed Technology
(subject, of course, to this Agreement), it shall give
prompt notice thereof to the
Licensee. Such notice shall include a description of the Licensed
Patent Rights or Licensed Technology to be sold. Thereafter,
Licensee shall have [***] to notify Licensor whether Licensee is
interested in commencing negotiations to obtain a fully-paid
license to such Licensed Patent Rights or Licensed Technology in
the Licensed Field. If Licensee does not give such notice within
such [***] period, Licensor shall be entitled to sell such Licensed
Patent Rights or Licensed Technology as it sees fit. If Licensee
gives such written notice within such [***], the parties shall for
a further [***] from the giving of such notice, or such longer time
period as upon which the Parties mutually agree in writing,
negotiate in good faith as to the terms of such fully-paid license
in the Licensed Field, and Licensor shall not be entitled to
commence negotiations with any Third Party with respect to the sale
of such Licensed Patent Rights or Licensed Technology, or sell such
Licensed Patent Rights or Licensed Technology, until the end of
such [***] day or longer agreed-upon period, after which it shall
be free to negotiate or sell such intellectual property as it sees
fit.
2.3 Right of First
Discussion as to New In-Field License . If, at any time
during the term of the Agreement, Licensor acquires or develops
intellectual property in respect of uses or applications within
[***] (a “New In-Field Use”) which is not included in
the Licensed Technology and which Licensor has the right to
disclose and license without the payment of royalties or other
consideration to any Third Party, it shall give prompt notice
thereof to the Licensee. Such notice shall include a description of
the intellectual property which Licensor has acquired or developed.
Thereafter, Licensee shall have [***] to notify Licensor whether
Licensee is interested in commencing negotiations to obtain a
license to such rights (the “New In-Field License”). If
Licensee does not give such notice within such [***] period,
Licensor shall be entitled to license such intellectual property as
it sees fit. If Licensee gives such written notice within such
[***], the parties shall for a further sixty (60) days from
the giving of such notice, or such longer time period as upon which
the Parties mutually agree in writing, negotiate in good faith as
to the terms of such New In-Field License, and Licensor shall not
be entitled to commence negotiations with any Third Party in
respect to a license of such intellectual property, or license such
intellectual property, within the Licensed Field until the end of
such [***] or longer agreed-upon period, after which it shall be
free to negotiate or license such intellectual property as it sees
fit. For the sake of clarity, this Section 2.2 does not apply
to any intellectual property that is included in Licensed
Technology and, as such, is subject to the license grant under
Section 2.1.
3. DEVELOPMENT AND
COMMERCIALIZATION OF LICENSED PRODUCTS.
3.1
Commercialization .
3.1.1 Responsibility .
From and after the Effective Date, Licensee shall have full control
and authority over the development and commercialization of
Licensed Products in the Licensed Field in the Territory. Without
prejudice to Section 3.3 hereof, Licensee shall own all
Technology resulting solely from the efforts of its agents,
Affiliates and employees as a part of such development and
commercialization, but for such purposes (or any other purpose of
this Agreement) Licensor shall not be considered an agent of
Licensee. All activities relating to development and
commercialization under this Agreement shall be undertaken at
Licensee’s sole cost and expense.
3.1.2 Diligence .
After the Effective Date, Licensee will exercise commercially
reasonable efforts to develop a Licensed Product, such commercially
reasonable efforts to take into account the competitiveness of the
marketplace, the proprietary position of the Licensed Product, the
relative potential safety and efficacy of the Licensed Product, the
cost of goods and availability of capacity to manufacture and
supply the Licensed Product at commercial scale, the profitability
of the applicable Licensed Product, and other relevant factors
including, without limitation, technical, legal, scientific or
medical factors. Following the First Commercial Sale of a Licensed
Product, the Licensee shall use commercially reasonable efforts to
engage no less than [***] clinicians reasonably acceptable to
Licensor to serve as “product champions” for such
Licensed Product.
3.2 Licensor
Assistance . Prior to the First Commercial Sale of a
Licensed Product, Licensor agrees that it shall provide
commercially reasonable assistance to the Licensee in connection
with the development and commercialization of a Licensed Product as
described in Schedule B hereto in exchange for the
compensation also described in Schedule B . Licensor shall
own all Technology resulting solely from the efforts of the agents,
Affiliates and employees of Licensor as a part of such development
and commercialization, (but for such purposes (or any other purpose
of this Agreement) Licensee shall not be considered an agent of
Licensor), but such Technology shall be deemed included in the
Licensed Technology.
3.3 Joint
Inventions . Technology conceived, developed or reduced to
practice jointly by employees or consultants of Licensor and
Licensee during the term hereof shall be jointly owned by them
(“Joint Inventions”). For purposes of this
Section 3.3 Technology that is the subject of a patent
application shall be deemed to have been developed jointly by
employees or consultants of Licensee and Licensor, and thus be a
Joint Invention, if at least one employee or consultant of each of
Licensee and Licensor is required to be named as an inventor in
such application in order for such patent to be valid, and a
comparable concept shall apply to Technology not the subject of a
patent application. Subject to its right of abandonment or other
forfeiture, Licensee shall be responsible, at its costs, for
preparing, filing and, prosecuting patent applications which are
available with respect to Joint Inventions in the [***] (and
elsewhere as it may elect), using patent counsel reasonably chosen
by Licensee, and for maintaining any patents obtained thereon.
Licensee shall keep Licensor reasonably appraised as to the
prosecution of each such patent application. Licensee agrees to
send Licensor copies of all file histories and prosecution
documents for each of the patent applications of the Licensed
Patent Rights, within thirty (30) days of receipt by Licensor.
Licensee shall have the right in its discretion to abandon or
otherwise cause or allow to be forfeited, any patents or
applications therefore as to Joint Inventions. Licensee shall give
Licensor at least sixty (60) days written notice prior to
abandonment or other forfeiture so as to permit, but not obligate,
Licensor, to file, in the name of Licensor, for protection as to
such patent or application, at its cost and expense, and Licensee
shall have no interest in such patent or applications or underlying
Joint Inventions (which shall thereupon cease to be Joint
Inventions by shall rather be Confidential Information of
Licensor). In any event each Party will, and will cause its
employees and consultants to, provide any assistance and executed
agreements and instruments as are reasonably requested by a Party
which is seeking to obtain in accordance herewith patents or other
protection with respect to any Joint Inventions.
3.4 Licensee License
Grant . Licensee hereby grants to Licensor:
3.4.1 Non-exclusive
License . a non-exclusive, fully-paid and royalty-free,
perpetual license, including the right to grant sublicenses, under
all Technology owned by Licensee as a result of the activities set
forth in Section 3.1: (i) to conduct research and
development in support of the licensed uses describe in clause
(ii) of this Subsection, and (ii) to make, have made,
import, export, use, offer for sale or sell any component or
product for indications outside of the treatment of spinal
disorders, subject to the terms and conditions of this Agreement;
and
3.4.2 Exclusive
License . an exclusive, fully-paid and royalty-free, perpetual
license, including the right to grant sublicenses, under its
interest in all Joint Inventions: (i) to conduct research and
development in support of the licensed uses describe in clause
(ii) of this Subsection, (ii) to make, have made, import,
export, use, offer for sale or sell any component or product for
indications outside of the treatment of spinal disorders, subject
to the terms and conditions of this Agreement, and (iii) to
prosecute at Licensor’s sole cost and for its sole benefit
infringements of Joint Inventions within the scope of the licenses
granted in clauses (i) and (ii) of this Subsection
3.4.2.
4. PAYMENTS AND
ROYALTIES
4.1 Initial Payment;
Milestone Payments, Payment of Royalties; Royalty Rates; Minimum
Royalties; Milestone Payments .
4.1.1 Initial Payment
. Licensee shall pay Licensor a lump-sum, fully-earned and
non-refundable payment of [***] within three (3) business days
of delivery by Licensor to Licensee of a preliminary specification
for an initial Licensed Product as defined in Schedule C ,
which sum shall not be credited against or otherwise reduce any
other amounts payable hereunder. Such delivery shall occur not
later than [***].
4.1.2 Milestone
Payments . Licensee shall pay Licensor milestone payments (each
a “Milestone Payment”) in the amount specified below no
later than thirty (30) days after the occurrence of the
corresponding event designated below, unless this Agreement has
been terminated prior to such due date. No Milestone Payments
described in this Subsection 4.1.2 shall be credited against or
otherwise reduce any other amounts payable hereunder.
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Event
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Milestone Payment
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[***] |
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[***] |
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[***] |
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[***] |
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[***] |
4.1.3 Royalty Payments
. During the Term, Licensee shall pay to Licensor within thirty
(30) days of the end of each calendar quarter earned royalties
of [***] of Net Sales during such calendar quarter. Each royalty
payment shall (i) be accompanied by a report specifying: the
Net Sales (including an accounting of deductions taken in the
calculation of Net Sales) and (ii) state the applicable
exchange rate used in conversion from any foreign country’s
currency to United States Dollars (which conversion shall be
determined in accordance with Subsection 4.2.2). Earned royalties
described in this Subsection 4.1.3 shall only be credited against
minimum royalties which would otherwise be due as contemplated by
Subsection 4.1.4 and shall not be credited against or otherwise
reduce any other amounts payable hereunder.
4.1.4 Minimum
Royalties . Licensee shall pay Licensor the following minimum
annual royalty amounts in each calendar year listed next to such
amount. No minimum annual royalty described in this Subsection
4.1.4 shall be credited against or otherwise reduce any other
amounts payable hereunder. For a particular calendar year, in the
event that the sum of the earned royalties on Net Sales timely paid
in accordance with Subsection 4.1.3 above with respect to the four
calendar quarters of such calendar year are less than the minimum
annual royalty for such year designated below, the obligation to
pay the difference to Licensor shall accrue on the last day of such
calendar year and be payable by Licensee no later than [***]
following the end of such calendar year:
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Calendar Year
Ending
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Minimum Annual Royalty
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4.1.5 One Royalty .
Only one royalty shall be payable to Licensor hereunder for each
sale of a Licensed Product, notwithstanding that more than one
patent or patent claim reads upon such Licensed Product and/or such
Licensed Product embodies or was made using one or more aspects of
Licensed Technology.
4.2 Payment, Conversion
and Withholding .
4.2.1 Payment . All
payments hereunder shall originate in the United States and be made
in United States dollars. Licensor hereby directs that all
payments, save payments for services and expense reimbursement as
contemplated by Section 3.2, be divided as follows and paid by
wire transfer or other means reasonably selected by the payee to
the following persons or as they shall direct from time to
time:
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4.2.2 Conversion .
Conversion of foreign currency to United States dollars shall be
made at the conversion rate existing in the United States (as
reported in The Wall Street Journal ) on the last business
day of the quarter immediately preceding the applicable calendar
quarter. If The Wall Street Journal ceases to be published,
then the rate of exchange to be used shall be that reported in such
other business publication of national circulation in the United
States as the Parties reasonably agree.
4.2.3 Tax Withholding;
Restrictions on Payment . All taxes, assessments and fees of
any nature levied or incurred on account of any payments from
Licensee to Licensor accruing under this Agreement, by national,
state or local governments, will be assumed and paid by Licensee,
except taxes levied thereon as income to Licensor and if such taxes
are required by applicable law to be withheld by Licensee they will
be deducted from payments due to Licensor and will be timely paid
by Licensee to the proper taxing authority for the account of
Licensor, a receipt or other proof of payment therefore secured and
sent to Licensor as soon as practicable. Licensee shall remit all
payments to Licensor hereunder from within the United
States.
4.3 Records Retention;
Review .
4.3.1 Royalties .
Licensee shall keep accurate books and accounts of the computation
of the number of Licensed Products sold and the Net Sales of
Licensee, its Affiliates and Sublicensees of Licensed Products, and
shall cause such Affiliates and Sublicensees to keep such records
of their respective sales of Licensed Products and Net Sales of
Licensed Products, in sufficient detail to permit accurate
determination of all figures ne
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