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Exhibit
10.1
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 an
address of 2051 Palomar Airport Road, Suite 100, Carlsbad,
California 92008 (“Licensee”), and JGMG Bengochea, LLC,
a Florida limited liability company, with an address of 4901
VanDiveer Rd., Jacksonville FL 32210 (“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 “ Change of
Control ” shall mean (a) the sale or disposition
of all or substantially all the assets of the Licensee or its
parent corporation; or (b) the reorganization, merger,
consolidation, or similar transaction involving the Licensee or its
parent corporation which results in the voting securities of such
entity outstanding immediately prior to that transaction ceasing to
represent at least 50% of the combined voting power of the
surviving entity immediately after such transaction.
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.
1.3 “ Design
Freeze ” shall mean, with respect to a particular
Licensed Product, the date on which the Licensee has made a written
decision that the design engineering with respect to such Licensed
Product is complete and such Licensed Product is ready for volume
production.
1.4 “ GLIF
Product ” shall mean the guided lumbar interbody
fusion system and the corresponding implants and
instrumentation.
1.5 “
Improvements ” shall mean any enhancement,
invention or discovery created or identified or controlled by
Licensor during the Royalty Term, which constitutes an improvement
to the subject matter of the Licensed Patent Rights or Licensed
Technology.
1.6 “
Indemnitees ” and “
Indemnifying Party ” shall mean a Party, its
affiliates and their respective directors, officers, employees,
stockholders and agents and their respective successors, heirs and
assigns.
1.7 “ Licensed
Patent Rights ” shall mean (a) 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; or (b) any patent
application arising from the Licensed Technology, 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.
1.8 “ Licensed
Product ” shall mean any product sold by Licensee or
its affiliates or Sublicensees that, absent the license provided in
this Agreement, would infringe a Valid Claim of the Licensed Patent
Rights, including without limitation Valid Claims of the Licensed
Patent Rights covering the GLIF Product.
1.9 “ Licensed
Technology ” shall mean and include all Technology,
whether or not patentable, including but not limited to, techniques
and materials, owned or controlled by Licensor as of the Effective
Date or which becomes owned or controlled by Licensor during the
Royalty Term that (a) (i) is related to any patent or
patent application included in the Licensed Patent Rights,
(ii) is necessary or useful for Licensee to practice the
license granted to it hereunder, and (iii) which is not in the
public domain; or (b) (i) is related to any of the
products listed on Exhibit B attached hereto, (ii) is
necessary or useful for Licensee to practice the license granted to
it hereunder, and (iii) which is not in the public
domain.
1.10 “ Licensee
Inventions ” shall mean any enhancement, invention or
discovery created or identified, owned or controlled by Licensee
that does not fall within the Licensed Technology.
1.11 “ Market
Launch ” shall mean, with respect to a Licensed
Product, the first full-scale national commercial launch of such
Licensed Product following the Licensee's building of an amount of
inventory necessary to conduct such full-scale national commercial
launch.
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1.12 “ Net
Sales ” shall mean the amount received by Licensee
for all Licensed Products sold by Licensee, its affiliates or
Sublicensees to Third Parties throughout the Territory during each
calendar quarter, less the following amounts incurred or paid by
Licensee or its affiliates or Sublicensees during such calendar
quarter with respect to sales of Licensed Products regardless of
the calendar quarter in which such sales were made:
(a) trade, cash and quantity
discounts or rebates actually allowed or taken, including discounts
or rebates to governmental or managed care
organizations;
(b) credits or allowances
actually given or made for rejection of, and for uncollectible
amounts on, or return of previously sold Licensed Products
(including Medicare and similar types of rebates);
(c) 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;
(d) 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) borne by the
seller thereof, other than franchise or income tax of any kind
whatsoever; and
(e) any import or export
duties or their equivalent borne by the seller.
“Net Sales” shall
not include sales or transfers between Licensee and its affiliates
or Sublicensees, unless the Licensed Product is consumed by the
affiliate or Sublicensee.
1.13 “ Royalty
Term ” shall mean, with respect to each Licensed
Product, the period commencing on the Effective Date and continuing
on a country-by-country, and product-by-product basis until the
longer of (a) the last to expire of the Licensed Patent Rights
covering the Licensed Product, or (b) [***] years from the
Effective Date.
1.14 “
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.
1.15 “
Technology ” shall mean and include any and all
unpatented, proprietary ideas, inventions, discoveries,
Confidential Information, data, results, formulae, designs, images,
specifications, instruction manuals, SOPs, methods, processes,
techniques, ideas, know-how, technical information (including,
without limitation, structural and functional information),
notebooks, process information, pre-clinical information, clinical
information, and any and all proprietary control and manufacturing
data and materials.
1.16 “
Term ” shall mean the period commencing on the
Effective Date and continuing until the end of the last Royalty
Term, unless this Agreement is terminated or expires sooner in
accordance with the terms of this Agreement.
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1.17 “
Territory ” shall mean all countries and
jurisdictions of the world.
1.18 “ Third
Party ” shall mean any person or entity other than
Licensee, Licensor and their respective affiliates.
1.19 “ Valid
Claim ” shall mean a claim indicated as allowable in
an issued, unexpired patent or in a pending patent application
within the Licensed Patent Rights that (a) has not been
finally cancelled, withdrawn, abandoned or rejected by any
administrative agency or other body of competent jurisdiction,
(b) has not been revoked, held invalid, or declared
unpatentable or unenforceable in a decision of a court or other
body of competent jurisdiction that is unappealable or unappealed
within the time allowed for appeal, (c) has not been rendered
unenforceable through disclaimer or otherwise, and (d) is not
lost through an interference proceeding.
2. GRANT OF
RIGHTS
2.1 License to
Licensee .
2.1.1 Grant of License
. Licensor hereby grants to Licensee an exclusive, royalty-bearing
license, including the right to grant sublicenses in accordance
with Section 2.1.2, under the Licensed Patent Rights and
Licensed Technology and Licensor’s interest in any
Improvements, to develop, have developed, make, have made, use,
have used, sell, offer for sale, have sold, import, have imported,
export and have exported, Licensed Products and to practice the
Licensed Technology in the Territory, for any and all uses, subject
to the terms and conditions of this Agreement.
2.1.2 Right to
Sublicense . Licensee shall have the right to grant sublicenses
to any Sublicensee to all or any portion of its rights under the
license granted pursuant to this Section.
2.1.3 Retained Rights
. Subject to the other terms of this Agreement, Licensor retains no
right to use the Licensed Technology or practice the Licensed
Patent Rights or to use Licensor’s interest in
Improvements.
3. RESPONSIBILITY FOR
LICENSED PRODUCTS.
3.1 Responsibility and
Assistance .
3.1.1 Responsibility .
From and after the Effective Date, Licensee shall have full control
and authority over the development, commercialization and
regulatory approval of Licensed Products in the Territory. Licensee
shall own all Licensee Inventions and data, results and all other
information arising from any such activities under this Agreement.
All activities relating to development and commercialization under
this Agreement shall be undertaken at Licensee’s sole cost
and expense, except as otherwise expressly provided in this
Agreement.
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3.1.2 Licensor
Assistance . Licensor agrees that it shall provide commercially
reasonable assistance to the Licensee, to the extent that such
assistance does not interfere with [***] practice of medicine, in
connection with the development, commercialization and regulatory
approval of (i) the GLIF Product, and (ii) Licensed
Product's that relate to the Licensed Technology set forth on
Exhibit B attached hereto. The Parties agree that the
Licensor shall not be required to provide more than [***] per
calendar quarter providing such assistance. In addition, the
Parties agree that if the Licensee requests that such assistance be
performed outside of the [***] that the Licensor shall be
compensated at a rate of [***] per hour. Licensor shall promptly
disclose to the Licensee all Licensed Patent Rights and all
Licensed Technology which are created, become owned or controlled
by the Licensor during the [***] following the Effective Date.
Licensee shall reimburse Licensor for any reasonable out-of-pocket
expenses in connection therewith.
4. PAYMENTS AND
ROYALTIES
4.1 Common Stock
Issuance; Milestone Payments and Royalty Payments
.
4.1.1 Common Stock
Issuance . Within thirty (30) days of the Effective Date
Licensee shall issue to Licensor seven hundred fifty thousand
(750,000) shares of Alphatec Holdings, Inc. Common Stock (the
“Common Stock”). [***] shares of the Common Stock shall
be subject to a lockup (the “Lockup”) pursuant to which
the Licensor shall agree to not directly or indirectly, offer,
sell, contract to sell, grant any option to purchase, hypothecate,
pledge, or otherwise dispose of or transfer title to any of the
Common Stock for a period of [***] years after the date that the
stock is granted. Notwithstanding the previous sentence (a) in
the event of a Change of Control, [***], (b) upon the Design
Freeze of the GLIF Product [***], and (c) upon the Market
Launch of the GLIF Product [***].
4.1.2 Milestone
Payments . Licensee shall pay Licensor a milestone payment
(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. All Milestone Payments
described in this Section 4.1.2 shall not be credited against
earned royalties.
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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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[***] |
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[***]
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[***] |
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4.1.3 Market Launch
Milestone. In the event that the Market Launch of the GLIF
Product has not occurred within [***] of the Effective Date (the
“GLIF Projected Market Launch Date”), the Licensor
shall be entitled to terminate the license granted pursuant to this
Agreement with respect to the Licensed Patent Rights and the
Licensed Technology, unless the primary reason that such launch
date has not been met is due to the Licensor's failure to meet the
obligations set forth in Section 3.1.2; provided that the
Licensor shall not be entitled to terminate under this section the
license granted pursuant to this Agreement with respect to the
Licensed Patent Rights and Licensed Technology if the Licensee pays
the Licensor [***] within [***] after the GLIF Projected Market
Launch Date, such payment to be in addition to and not credited
against future royalties due to Licensor.
4.1.4 Royalty Payments for
GLIF Product . During the Royalty Term, Licensee shall pay to
Licensor earned royalties at the rate of [***] of all Net Sales of
the GLIF Product sold by Licensee.
4.1.5 Royalty Payments for
Non-GLIF Licensed Products . During the Royalty Term, Licensee
shall pay to Licensor earned royalties at the rate of [***] of all
Net Sales of Licensed Products (excluding the GLIF Product) sold by
Licensee.
4.1.6 Minimum
Royalties . Licensee shall pay Licensor the following minimum
amounts each calendar year listed next to such amount. No minimum
annual royalty described in this Subsection 4.1.6 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 paid in accordance with Subsections
4.1.4, 4.1.5 and 4.1.7 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 (the “Royalty Shortfall Payment”) shall 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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In the event that the Licensee fails to
pay the Royalty Shortfall Payment within the applicable time
period, the Licensor shall be entitled to terminate this Agreement,
provided that the Licensor gives notice of the requirement to pay
the Royalty Shortfall Amount to the Licensee and gives the Licensee
[***] to pay such amount.
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4.1.7 Payment of
Royalties . For purposes of determining when a sale of any
Licensed Product occurs under this Agreement, the sale shall be
deemed to occur on the date the Licensed Product is invoiced and
paid for in full by the purchaser. Each royalty payment shall be
accompanied by a report specifying: the Net Sales (including an
accounting of deductions taken in the calculation of Net Sales);
the applicable exchange rate to convert from any foreign
country’s currency to United States Dollars (which
calculation shall be determined in accordance with
Section 4.2.1); and the royalties payable in United States
Dollars. Unless otherwise expressly provided, Licensee shall make
any royalty payments owed to Licensor hereunder in arrears, within
thirty (30) days from the end of each quarter in which such
payment accrues.
4.1.8 Third Party Royalty
Offset . In the event that Licensee, in order to exploit the
license granted to it under Section 2.1 of this Agreement,
makes payments to one or more Third Parties (“Third Party
Payments”) as consideration for a license to intellectual
property, in the absence of which the Licensed Product could not
legally be used or sold in such country, then Licensee shall have
the right to reduce the royalties otherwise due to Licensor in
Sections 4.1.3 and 4.1.4 for such Licensed Product by [***] of such
Third Party Payments. Payments to any Third Party by Licensee shall
be cumulative and any excess payments uncredited to a particular
royalty payment period shall be credited to future royalty payments
owed by Licensee or until fully credited. The Parties agree that
the Third Party Payments referred to in this Section 4.1.8
shall not apply to any royalty obligations to which the Licensee is
a party as of the Effective Date.
4.1.9 One Royalty .
Only one royalty, shall be payable to Licensor hereunder for each
sale of a Licensed Product.
4.2 Accounting and
Withholding .
4.2.1 Accounting . All
payments hereunder shall be made in the United States in United
States dollars. 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.
4.2.2 Tax Withholding;
Restrictions on Payment . Licensee shall make, out of amounts
due Licensor, any applicable withholding or other required tax or
duty payments it is required by law to make on behalf of Licensor
and shall provide Licensor upon request with such written
documentation regarding any such payment as available to Licensee
relating to an application by Licensor for a foreign tax credit for
such payment with the United States Internal Revenue
Service.
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4.3 Royalty Payments;
Review .
4.3.1 Royalties .
Commencing as of the date of first commercial sale of the first
Licensed Product hereunder, Licensee and its affiliates and
Sublicensees shall keep for at least two (2) years from the
end of the calendar year to which they pertain, complete and
accurate records of sales by Licensee or its affiliates and
Sublicensees, as the case may be, of each Licensed Product, in
sufficient detail to allow the accuracy of the payments hereunder
to be confirmed.
4.3.2 Review . At the
request of Licensor, which shall not be made more frequently than
once per calendar year during the Term, upon at least thirty
(30) days’ prior written notice from Licensor, and at
the expense of Licensor; Licensee shall permit, u
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