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Exhibit 10.39
Pursuant to 17 CFR 240.24b-2, confidential
information has been omitted in places marked "[* * *]" and has
been filed separately with the Securities and Exchange Commission
pursuant to a Confidential Treatment Application filed with the
Commission.
EXECUTION COPY
FIRST AMENDMENT TO THE
DEVELOPMENT AND MARKETING AGREEMENT
This First Amendment ("Amendment") to the Development and
Marketing Agreement ("Agreement") dated February 22, 2006, by
and between Spectrum Pharmaceuticals, Inc. ("Spectrum") and Par
Pharmaceutical, Inc. ("Par") is entered into and is effective as of
November 10, 2006 ("First Amendment Effective Date"),
hereinafter referred to as "Party" and, collectively, as "Parties."
Capitalized terms used but not defined herein shall have the
meanings given them in the Agreement.
WHEREAS , on November 10, 2006, the Parties each
hereby give their consent to Spectrum entering into, and Spectrum
is entering into a Settlement Agreement, dated November 10,
2006 (the "Settlement Agreement"), with Glaxo Group Limited ("GSK")
to settle the Sumatriptan Litigation. Pursuant to the Settlement
Agreement, Spectrum received the right to sell Spectrum Generic
Sumatriptan Products and GSK Supplied Products (both as defined in
the Settlement Agreement and the Supply and Distribution Agreement)
in accordance with the terms of the Settlement Agreement;
WHEREAS , pursuant to the Settlement Agreement, Spectrum
and Par hereby consent to, and GSK and Glaxo Wellcome Manufacturing
PTE Limited and Par are entering into a Supply and Distribution
Agreement, dated November 10, 2006 (the "Supply and
Distribution Agreement")(the Settlement Agreement and the Supply
and Distribution Agreement are collectively referred to herein as
the "GSK Agreements") pursuant to which GSK agrees to supply the
GSK Supplied Products to Par for distribution. Par agrees to
purchase and distribute GSK Supplied Products on behalf of Spectrum
in order to fulfill its obligations under the Agreement;
WHEREAS , the Parties wish the Agreement to apply only to
GSK Supplied Products and the Spectrum Generic Sumatriptan
Products, as defined in the GSK Agreements (collectively, the "GSK
Sumatriptan Products"); and
WHEREAS , the Parties wish to amend certain terms of the
Agreement to reflect the Settlement Agreement and Supply and
Distribution Agreement and the elimination from the Agreement of
all Products except the GSK Sumatriptan Products, among other
changes, as set forth below.
NOW, THEREFORE, in consideration of the mutual covenants,
promises and agreements set forth herein, the Parties hereby agree
as follows:
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1.
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In the event that GSK and Spectrum modify the
terms of the Settlement Agreement or the Supply and Distribution
Agreement in accordance with Sections 4 & 5 of the Settlement
Agreement, then Par and Spectrum shall
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Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
EXECUTION COPY
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consider whether any corresponding modifications
ought to be made to the Agreement, as modified by this First
Amendment, and, if so, they shall negotiate such modifications in
good faith. The Parties acknowledge that, due to reasons stated in
the Settlement Agreement both the Settlement Agreement and the
Supply and Distribution Agreement may be terminated.
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2.
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Spectrum hereby assigns and Par hereby assumes
the commercial and marketing obligations of Spectrum under the
Settlement Agreement. Any material breach of the Supply and
Distribution Agreement or the Settlement Agreement by Par shall be
considered a material breach of the Agreement, subject to cure
under the Agreement. To the extent there is any conflict between
Par’s obligations under the Agreement and the Supply and
Distribution Agreement and the Settlement Agreement solely with
regard to the GSK Sumatriptan Products, the terms of the Supply and
Distribution Agreement and the Settlement Agreement, respectively,
shall apply. Additionally, while Spectrum will remain free to cure
any breach under the Supply and Distribution Agreement pursuant to
Section 7.2(c) thereof, Spectrum agrees that it will not step
in and assume all of Par’s rights and obligations thereunder,
without first giving Par a full and fair opportunity to cure
thereunder.
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3.
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As long as the Settlement Agreement and the
Supply and Distribution Agreement are effective, then Spectrum
shall not be responsible for any development obligations under
Section 2 or any regulatory obligations under Section 3
for any of the GSK Supplied Products. Spectrum’s obligations,
however, with respect to the [* * *] Products set forth
on Schedule 1.33 shall continue. In the event that, the Supply and
Distribution Agreement terminates or expires then
(1) Spectrum’s obligations under the Agreement with
respect to the [* * *] Product set forth on Schedule 1.33
shall promptly resume and (2) with respect to
[* * *] and the [* * *] presentations of
injectable sumatriptan products, the Parties shall discuss in good
faith whether and how best to proceed, if at all.
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4.
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Within thirty (30) days of the First
Amendment Effective Date, Par shall make a non-refundable,
non-creditable payment to Spectrum of five million dollars
($5,000,000) in consideration for Spectrum receiving tentative
approval, amending the Agreement and entering into this Amendment.
Par acknowledges that Spectrum has no future obligations or
performance contingencies associated with this payment.
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5.
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Section 1.10 shall be amended to
read
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Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
EXECUTION COPY
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"Competing Product" means any Drug Product that
is an injectable [* * *] form of sumatriptan, excluding
the Products under this Agreement as made and sold per the terms of
this Agreement and the GSK Supplied Products under the terms of the
GSK Agreements.
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6.
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Section 1.16 shall be deleted in its
entirety.
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7.
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Section 1.18 shall be deleted in its
entirety.
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8.
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Section 1.19 shall be deleted in its
entirety.
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9.
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Section 1.20 shall be deleted in its
entirety.
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10.
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Section 1.22 shall be deleted in its
entirety.
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11.
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Section 1.33 of the Agreement shall be
amended in its entirety to read:
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"‘Products’ means GSK Sumatriptan
Products and the products listed on Schedule 1.33, except for the
injectable [* * *] presentation listed on Schedule 1.33
unless the Settlement Agreement and the Supply and Distribution
Agreement are terminated in which case the injectable
[* * *] presentation will be included.’"
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12.
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In Section 1.36, "and NDAs" shall be added
after "ANDAs".
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13.
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Section 1.37 shall be deleted in its
entirety. Any reference in the Agreement to "Sumatriptan Products"
shall be replaced with "Products."
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14.
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Section 1.38 shall be deleted in its
entirety and replaced by the following:
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15.
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Add a new Section 1.42:
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16.
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Section 2.4 shall be deleted in its
entirety.
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Pursuant to 17 CFR 240.24b-2,
confidential information has been omitted in places marked "[* *
*]" and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed
with the Commission.
EXECUTION COPY
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17.
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Section 4.2.7 shall be deleted in its
entirety.
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18.
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Section 4.2.8 shall be deleted in its
entirety.
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19.
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Section 5.1 shall be deleted in its entirety
and replaced by the following:
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License Grant . Spectrum hereby grants
to Par an exclusive (even as to Spectrum) royalty free (other than
as set forth in Article 7), irrevocable (subject to Article 14)
license to market, promote, distribute, sell and have sold
the
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