Exhibit 10.54
CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE
BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION.
LICENSE, DEVELOPMENT AND
SUPPLY AGREEMENT
THIS LICENSE, DEVELOPMENT AND
SUPPLY AGREEMENT (the
“Agreement”) , dated as of November 23,
2005, (the “Effective Date”) entered into between SICOR
PHARMACEUTICALS, INC., a Delaware corporation (“Teva /
Sicor”), having a place of business located at
19 Hughes, Irvine, California 92618, and ANTARES PHARMA, INC.,
a Delaware corporation (“Antares”), having a place of
business located at 707 Eagleview Boulevard, Suite 414, Exton,
Pennsylvania 19341,
WITNESSETH
:
WHEREAS, Antares owns or has rights to certain technology
which may be used in the manufacture of **** ;
and
WHEREAS, Antares and Teva / Sicor desire to collaborate
in the development and commercialization of the Device on the terms
and subject to the conditions set forth below; and
NOW, THEREFORE,
in consideration of the foregoing
premises and the mutual covenants herein contained, the parties
hereby agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the
terms defined in this Article 1 have the meanings set forth
below:
1.1 “ Affiliate ”
means, with respect to any Person, any other Person which directly
or indirectly controls, is controlled by, or is under common
control with, such Person. A Person shall be regarded as in control
of another Person if it owns, or directly or indirectly controls,
at least fifty percent (50%) of the voting stock or other
ownership interest of the other Person, provided that such entity
shall be considered an Affiliate only for the time during which
such control exists.
1.2 “ ANDA ”
means an Abbreviated New Drug Application for the Product which has
been or will be submitted to the FDA pursuant to 21 U.S.C. §
355(j) and the regulations promulgated by the FDA thereunder,
including any amendments or supplements thereto.
1.3 “ Antares Patent
Rights ” means all issued patents and patent
applications, divisionals, continuations, continuations-in-part,
reissues, renewals, extensions or additions to any such patent
applications or patents heretofore or hereafter filed in any
country in the
**** — Denotes portions omitted pursuant
to a request for confidentiality under Rule 24b-2 of the Securities
Exchange Act of 1934. A copy of this agreement with the omitted
information intact has been filed separately with the Securities
and Exchange Commission.
Territory owned by or licensed to Antares or to
which Antares otherwise acquires rights, which claim the Device, or
the process of manufacture or use of the Device in the
Territory.
1.4 “ ASP ” means
Teva / Sicor’s average Net Sales price for a single unit of
the Product during a calendar quarter.
1.5 “ cGMP ”
means current Good Manufacturing Practices as promulgated by the
FDA and set forth in 21 CFR Parts 210 and 211.
1.6 “ Change of Control
” shall mean, with respect to the applicable Party, an event
where: (a) any Third Party (alone or together with such Third
Party’s Affiliates) or “group” (as such term is
defined under Section 13(d) of the Securities Exchange Act of
1934, as amended) (i) acquires beneficial ownership of capital
stock of such Party entitling the holder(s) thereof to greater than
fifty percent (50%) of the voting power of the then
outstanding capital stock of such Party with respect to the
election of directors of such Party, or (ii) otherwise
actually controls or is in a controlling position with respect to
the voting power of the then outstanding capital stock of such
Party; or (b) such Party consummates a merger, consolidation,
reorganization or similar transaction or series of related
transactions, whether direct or indirect, with another Third Party,
alone or together with such Third Party’s Affiliates (the
“Acquiring Corporation”), in which: (i) such Party
is not the surviving corporation in such transaction, (ii) the
members of the Board of Directors of such Party prior to such
transaction constitute less than one half of the members of the
Board of Directors of the Acquiring Corporation following such
transaction, (iii) greater than fifty percent (50%) of
the voting power of the outstanding capital stock of the Acquiring
Corporation with respect to the election of directors following
such transaction is held by Third Parties who were shareholders of
the Acquiring Corporation prior to such transaction, or
(iv) such Party is otherwise effectively controlled by the
Acquiring Corporation, or (c) such Party sells to any Third
Party(s) (alone or together with such Third Party’s
Affiliates) in one or more related transactions properties or
assets representing greater than fifty percent (50%) of:
(i) such Party’s consolidated total assets as reflected
on its most recent annual audited financial statements, provided
that all or substantially all of the properties and assets used in
connection with such Party’s pharmaceutical business are
included in such transaction(s), or (ii) such Party’s
pharmaceutical business. Notwithstanding anything to the contrary
in this definition, a Change of Control shall not be deemed to have
occurred with respect to a Party where any acquisition, merger,
consolidation, reorganization, sale or similar transaction occurs
solely between such Party and any one or more of its
Affiliates.
1.7 “ Confidential
Information ” means any invention, discovery, patent
application or claim, trade secret, idea, improvement or other work
of authorship, any process, formula, data, clinical trial data,
program, drawing, information, price, technique, sample, compound,
extract, media, vector or cell line and procedures and formulations
or drawings for producing any such sample, compound, extract,
media, vector or cell line, any process, formula or data relating
to any research project, work in process, future development,
engineering, manufacturing, marketing, servicing, financing or
personnel matter relating to a Party, its present or future
products, sales suppliers, clients, customers, employees,
investors, or business, whether in oral, written, graphic, physical
or electronic form.
1.8 “ Contract Margin
” means **** .
**** — Denotes portions omitted pursuant
to a request for confidentiality under Rule 24b-2 of the Securities
Exchange Act of 1934. A copy of this agreement with the omitted
information intact has been filed separately with the Securities
and Exchange Commission.
1.9 “ Device ”
means ****
1.10 “ Drug ”
means **** .
1.11 “ FDA ”
means the United States Food and Drug Administration.
1.12 “ Field ”
means **** .
1.13 “ Know-How ”
means all information and data, including formulas, procedures,
protocols, techniques and results of experimentation and testing,
which are necessary or useful to make, use, develop, sell or seek
regulatory approval in the Territory to market the Product, which
Antares owns or controls, has the right to license to Teva / Sicor,
and which is in the possession of Antares on the Effective Date of
this Agreement or thereafter during the term of this
Agreement.
1.14 “ Licensed
Technology ” means the Antares Patent Rights together
with all improvements to the Licensed Technology relating to the
Device developed by Antares during the term of this
Agreement.
1.15 ****
1.16 “ Net Sales
” means, with respect to Product sold by Teva / Sicor or its
Affiliates to Third Parties, ****
1.17 “ Paragraph III
Certification ” means a certification pursuant to section
505(j)(2)(A)(vii)(III) of the Food, Drug and Cosmetic Act, 21
U.S.C. § 355(j)(2)(A)(vii)(III).
1.18 “ Party ”
means either Antares or Teva / Sicor respectively.
1.19 “ Person ”
means an individual, corporation, partnership, limited liability
company, trust, business trust, association, joint stock company,
joint venture, pool, syndicate, sole proprietorship, unincorporated
organization, governmental authority or any other form of entity
specifically listed herein.
1.20 “ Product ”
means any product comprising the Device and the Drug.
1.21 “ QSR ”
means the Quality System Regulation as promulgated by the FDA and
set forth in 21 CFR Part 820.
1.22 “ Teva / Sicor Patent
Rights ” means all issued patents and patent
applications, divisionals, continuations, continuations-in-part,
reissues, renewals, extensions or additions to any such patent
applications or patents heretofore or hereafter filed in any
country in the Territory owned by or licensed to Teva / Sicor or
any of its Affiliates or to which Teva / Sicor or any of its
Affiliates otherwise acquires rights, which claim the Drug, or the
process of manufacture or use of the Drug in the
Territory.
1.23 “ Territory
” means the United States of America, including its
territories, possessions and the Commonwealth of Puerto
Rico.
**** — Denotes portions omitted pursuant
to a request for confidentiality under Rule 24b-2 of the Securities
Exchange Act of 1934. A copy of this agreement with the omitted
information intact has been filed separately with the Securities
and Exchange Commission.
1.24 “ Third Party
” means any Person other than Teva / Sicor, Antares and their
respective Affiliates.
1.25 “ Unit Price
” means Teva / Sicor’s purchase price for a single unit
of the Device.
ARTICLE 2
REPRESENTATIONS AND
WARRANTIES
2.1 Representations by Each
Party . Each Party hereby represents and warrants to the other
Party, as of the execution of this Agreement, as
follows:
2.1.1 Corporate Existence and
Power . Such Party (a) is a corporation duly organized,
validly existing and in good standing under the laws of the
jurisdiction in which it is incorporated; (b) has the
corporate power and authority and the legal right to own and
operate its property and assets, to lease the property and assets
it operates under lease, and to carry on its business as it is now
being conducted; and (c) is in compliance with all
requirements of applicable law, except to the extent that any
noncompliance would not have a material adverse effect on the
properties, business, financial or other condition of such Party
and would not materially adversely affect such Party’s
ability to perform its obligations under this Agreement.
2.1.2 Authorization and
Enforcement of Obligations . Such Party (a) has the
corporate power and authority and the legal right to enter into
this Agreement and to perform its obligations hereunder, and
(b) has taken all necessary corporate action on its part to
authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder. The Agreement has been
duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, binding obligation, enforceable against
such Party in accordance with its terms.
2.1.3 Consents . All
necessary consents, approvals and authorizations of all
governmental authorities and other Persons required to be obtained
by such Party in connection with this Agreement have been
obtained.
2.1.4 No Conflicts . The
execution and delivery of this Agreement and the performance of
such Party’s obligations hereunder (a) do not conflict
with or violate any requirement of applicable laws or regulations,
and (b) do not conflict with, or constitute a default under,
any contractual obligation of such Party.
2.2. Representations of
Antares . Antares hereby represents and warrants to Teva /
Sicor that Antares is either in sole possession of or otherwise
possesses all necessary consents, approvals and authorizations to
the Licensed Technology to grant the license set forth in Article 3
hereof to Teva / Sicor.
ARTICLE 3
LICENSE GRANT
3.1 License . Subject to the
terms and conditions of this Agreement, during the term of this
Agreement, Antares hereby grants to Teva / Sicor and its Affiliates
an exclusive license (exclusive even as to Antares), with the right
to sublicense (subject to the provisions of section
**** — Denotes portions omitted pursuant
to a request for confidentiality under Rule 24b-2 of the Securities
Exchange Act of 1934. A copy of this agreement with the omitted
information intact has been filed separately with the Securities
and Exchange Commission.
3.2), under the Antares Patent Rights and Know
How to use the Device in the Product and to sell, offer for sale,
import and distribute the Product in the Field in the
Territory.
3.2 Sublicenses . Teva /
Sicor may grant sublicenses in the Territory, provided that Teva /
Sicor shall ensure all such sublicensees assume and comply with all
terms and conditions under which Teva / Sicor is obligated as a
licensee under this Agreement. Teva / Sicor shall indemnify and
hold Antares harmless from any cost, liability, or damage arising
from any sublicensee’s failure to so comply. Teva / Sicor
shall pay Antares **** .
3.3 Exclusivity . Subject to
the provisions of section 10.2.3 hereof, during the term of this
Agreement, neither Party or any of its Affiliates, either alone or
through any Third Party, will develop, manufacture for use in the
Field and the Territory or commercialize any device or product
comprised of **** which competes with the Product in the Field and
the Territory except pursuant to this Agreement.
3.4 Right of First Refusal .
Antares shall promptly notify Teva / Sicor in writing before
offering a license to the Device for use in the Field to a Third
Party in a country outside the Territory. Teva / Sicor shall have
thirty (30) days from receipt of such notice in which to
negotiate a non-binding term sheet with Antares for an exclusive
license to the Device for use in the Field in such country or
countries. If the parties are unable to reach agreement on such
non-binding terms within such thirty (30) day period, Antares
may negotiate and execute a license with a Third Party, but not on
terms any less favorable to Antares than the terms last offered by
Teva / Sicor. If the Parties agree in writing to such non-binding
terms within such thirty (30) day period, Teva / Sicor shall
have sixty (60) days following immediately from such thirty
(30) day period in which to negotiate and enter into an
exclusive license with Antares for the Device in such country or
countries, as the case may be. All negotiations shall be conducted
in good faith. If the parties do not enter into such a license
within such sixty (60) day period, Antares may negotiate and
execute a license with a Third Party, but not on terms any less
favorable to Antares than the terms last offered by Teva /
Sicor.
3.5 Additional License in the
Event of Failure to Supply . In the event that Antares is
unable to supply conforming Devices to Teva / Sicor in connection
with an accepted purchase order pursuant to Article 5 hereof, with
such failure remaining uncured for thirty (30) days, then
Antares hereby grants to Teva / Sicor a royalty-bearing right and
license in the Territory to (i) make and have made the Device
for use in the Product in the Field in the Territory, and
(ii) use and reference the necessary regulatory documentation,
and any and all data or information included or referenced therein,
to make or have made the Device. For any Device manufactured by
Teva / Sicor pursuant to this Section, Teva / Sicor shall pay
Antares the royalties due under Section 7.1 hereof. If
thereafter Antares notifies Teva/Sicor that Antares is able to
supply conforming Devices again pursuant to Article 5 hereof, then
Antares shall provide notice of the same to Teva / Sicor and
Antares shall resume its supply of Devices as provided in this
Agreement. Upon Antares’ resumption of such supply, the
foregoing license granted to Teva / Sicor in this Section shall
immediately terminate and be of no further force or
effect.
**** — Denotes portions omitted pursuant
to a request for confidentiality under Rule 24b-2 of the Securities
Exchange Act of 1934. A copy of this agreement with the omitted
information intact has been filed separately with the Securities
and Exchange Commission.
ARTICLE 4
DEVELOPMENT PROGRAM AND MILESTONE
PAYMENTS
4.1 Development Program .
Promptly upon execution of this Agreement, the Parties shall
commence a development program (the “Program”), which
shall be designed to complete the Device development and to
scale-up the Device for commercial production for use with the Drug
in the Product. The Program will include finalizing a Product
specification **** Once the Product specifications are finalized by
agreement of the Parties, any additional changes to the Device
requested by Teva / Sicor must be agreed to by Antares. Teva /
Sicor will provide Antares with all change requests in writing.
Antares will provide Teva / Sicor with an estimate of cost and time
required to implement any changes, and Teva / Sicor will be
responsible for all such costs.
4.1.1 Antares’
Responsibilities . Antares will be responsible for ****
Antares will maintain **** any other required regulatory
submissions and approvals, in good standing, and maintain its
facilities in compliance with QSR.
4.1.2 Teva / Sicor’s
Responsibilities . Once the Product specifications are
finalized, Teva / Sicor will be responsible for
****
4.1.3 Additional Costs . Any
costs incurred by Antares to accelerate the Program at the request
of Teva / Sicor will be borne by Teva / Sicor. Any increased costs
directly related to development of the **** Product incurred
by Teva / Sicor as a result of delays in the development or
scale-up of the Device due to Antares’ failure to meet their
obligations in the schedule set forth in the Program will be borne
by Antares.
4.2 Payments By Teva / Sicor
.
4.2.1 Payments Upon Execution of
This Agreement. Upon the execution and delivery of this Agreement,
Teva / Sicor shall pay to Antares the sum of (a) five hundred
thousand dollars ($500,000) in exchange for 400,000 shares of
Antares common stock, subject to the Stock Purchase Agreement
executed by the Parties contemporaneously herewith and attached as
Exhibit “A” hereto ; and **** in exchange for
the exclusive license set forth in Section 3.1
hereof.
4.2.2 Milestone Payment. Upon final
FDA approval of the Product, Teva / Sicor shall pay to Antares the
sum of ****
4.2.3 ****
ARTICLE 5
COMMERCIAL SUPPLY OF
DEVICE
5.1 Device Supply . Upon FDA
approval of the Product, Antares will be the exclusive provider of
the Device to Teva / Sicor in accordance with the terms and
conditions set forth in this Agreement, and such other commercially
reasonable terms and conditions as the Parties shall in good faith
negotiate and agree to in writing including, but not limited to,
specifications for the
**** — Denotes portions omitted pursuant
to a request for confidentiality under Rule 24b-2 of the Securities
Exchange Act of 1934. A copy of this agreement with the omitted
information intact has been filed separately with the Securities
and Exchange Commission.
Device, warranty terms, and other customary
terms and conditions. Teva / Sicor will commercially market the
Product incorporating the Device produced by Antares, and Teva /
Sicor will be responsible for the production of the Drug, **** the
final assembly of the Product, and final packaging and
labeling.
5.2 Forecasts and Delivery .
On or before the 20th day of the third month of each calendar
quarter (i.e.,
March 20, June 20, September 20 and
December 20) Teva / Sicor will provide Antares with a rolling
quarterly forecast for the Device for the next six
(6) calendar quarters. Forecasted unit demand set forth in the
first two (2) quarters of each rolling quarterly forecast will
represent a firm purchase commitment. The last four
(4) quarters will represent a non-binding, good faith estimate
of Teva / Sicor’s expected requirements for the Device. If
any rolling quarterly forecast results in a quarter-to-quarter
increase of **** or more units, or if the forecasted number
of units exceeds **** units in total for any consecutive
four-quarter period, the Parties agree to negotiate in good faith
terms and conditions under which Antares will expand its
manufacturing capacity to achieve the incremental forecasted
volumes.
5.2.1 Purchase Orders . With
each rolling quarterly forecast, Teva / Sicor will submit a firm
purchase order for Devices needed during the second calendar
quarter in the current rolling quarterly forecast. (A purchase
order for Devices to be delivered in the first calendar quarter of
the current rolling quarterly forecast will have been submitted
with the prior forecast.) Each purchase order must specify unit
quantity, delivery dates, delivery instructions, Unit Price and
other applicable invoice information as agreed by the Parties in
writing (“Accepted Purchase Order”). Changes will not
be allowed to any Accepted Purchase Order unless agreed in writing
by the Parties. The terms and conditions of this Agreement shall
govern each purchase order, and in the event of conflict the terms
and conditions of this Agreement shall prevail.
5.2.2 Master Forecast . The
rolling quarterly forecast submitted in September of each calendar
year shall be considered the master forecast for the following
calendar year. Invoice pricing for Devices to be delivered in the
next calendar year shall be determined by matching the units
forecasted in the master forecast to the corresponding Unit Price
contained in the price schedule set forth in section 5.3 herein.
Subject to Section 5.2.2.1 herein, should Teva / Sicor’s
actual Device purchases in a calendar year differ from those set
forth in the master forecast such that a higher or lower price
should have been paid, this difference shall be determined within
60 days after the end of the applicable calendar year and applied
as a credit or debit against royalties payable in subsequent
periods.
5.2.2.1 No price reconciliation will
be made pursuant to Section 5.2.2 as a result of;
(a) increases in actual versus forecasted volumes until after
the first calendar year with at least six (6) consecutive
months of commercial sales of a Product, or (b) increases in
actual versus forecasted volumes due to; (i) changes in any
Accepted Purchase Order, (ii) additional purchase orders
submitted for the current or next quarter after an Accepted
Purchase Order exists for such quarter, or (iii) a change from
Standard Pricing to Reduced Pricing.
5.2.3 Invoices . Teva / Sicor
shall pay each invoice within thirty (30) calendar days from
the date of receipt of the Devices. Antares shall invoice Teva /
Sicor at the time of shipment of the Devices to Teva / Sicor, which
shall be ****
**** — Denotes portions omitted pursuant
to a request for confidentiality under Rule 24b-2 of the Securities
Exchange Act of 1934. A copy of this agreement with the omitted
information intact has been filed separately with the Securities
and Exchange Commission.
5.2.4 Acceptance . Antares
will deliver to Teva / Sicor a certificate of conformance with each
shipment of Devices confirming that all Devices conform to the
specifications. Teva / Sicor shall have forty-five
(45) calendar days after the delivery date to notify Antares
that Devices received were defective or non-conforming. In such
case, the parties shall use good-faith efforts to resolve the
problem.
5.3 Standard Pricing . The
Standard Pricing for the Device supplied by Antares to Teva / Sicor
will be as follows:
****
5.4 ****
5.5 Adjustments to Pricing .
****
5.6 Qualification of Backup
Suppliers . Notwithstanding section 5.1 hereof, Teva / Sicor
shall have the right at any time during the term of this Agreement
to qualify and contract with one or more backup suppliers
(including Antares’ existing supplier) for the Device, in
order to enable Teva / Sicor to timely exercise its rights under
section 3.5 of the Agreement. Antares shall reasonably cooperate
with Teva / Sicor in qualifying such backup suppliers, including,
without limitation, providing appropriate technical information,
subject to the execution of reasonable confidentiality
agreements.
5.7 ****
ARTICLE 6
REGULATORY
SUBMISSIONS
6.1 Teva / Sicor’s
Responsibilities . Teva / Sicor is responsible for preparing,
prosecuting, and maintaining registrations, filings and approvals
relating to the Drug and the Product, and will be responsible for
its own internal and external expenses related to regulatory
submissions and approvals of the Drug and the Product.
6.2 Antares’
Responsibilities . Antares is responsible for preparing,
prosecuting, and maintaining registrations, filings and approvals
relating to the Device and will be r
