Exhibit 10.38

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.

 

AGREEMENT

by and between

GLAXO GROUP LIMITED (d/b/a GLAXOSMITHKLINE) (“GSK”)

and

SPECTRUM PHARMACEUTICALS, INC. (“Spectrum”)

November 10, 2006 (the “Execution Date”)

WHEREAS, Spectrum and GSK are currently parties to certain pending cases in the
United States District Court for the District of Delaware (the “District
Court”), GSK v. Spectrum, Civil Action No. 05-99-GMS and GSK v. Spectrum, Civil
Action No. 06-0558-GMS, (collectively, the “District Court Case”) related to
U.S. Patent No. 5,037,845 (the “‘845 Patent”); and

WHEREAS, GSK and Spectrum wish to stipulate to the dismissal of the District
Court Case with prejudice, and this Agreement (“Agreement”) sets forth terms and
conditions for a stipulated dismissal of the District Court Case with prejudice;
and

WHEREAS, Spectrum and Par Pharmaceutical, Inc. (“Par”) have entered into an
agreement whereby Par is Spectrum’s exclusive marketing partner for Spectrum
Generic Sumatriptan Products in the United States; and

WHEREAS, as a result of this Agreement there will be an opportunity for
pro-competitive generic competition for Spectrum Generic Sumatriptan Products
and GSK Supplied Products for human use for the treatment of migraines, which
competition otherwise may not have existed until the expiration of the ‘845
Patent and its associated pediatric exclusivity; and

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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.

 

WHEREAS, this Agreement, the Supply & Distribution Agreement (as defined below)
and the Stipulation of Dismissal (as defined below) are the only consideration
exchanged by or on behalf of Spectrum and Par on the one side, and GSK on the
other side, in reaching the agreement to dismiss the District Court Case.
Spectrum and Par on one hand and GSK on the other have received no consideration
from the other for their entry into this Agreement other than that which is
described in this Agreement, the Supply & Distribution Agreement and the
Stipulation of Dismissal. This Agreement and the Supply & Distribution
Agreement, therefore, constitute Spectrum’s best independent judgment as to how
most expeditiously enhance competition in the sale of Spectrum Generic
Sumatriptan Products and GSK Supplied Products in the United States in light of
Spectrum’s relative chances of success in the District Court Case.

NOW THEREFORE, in consideration of the promises, representations, warranties,
covenants and agreements contained herein, the receipt and sufficiency of which
are hereby acknowledged, the Parties hereto, intending to be legally bound
hereby, agree as follows:

1. All of the terms and conditions set forth in this Agreement shall be binding
on the Parties. See Appendix A hereto for the definition of certain defined
terms used in this Agreement.

2. The Parties enter into this Agreement, the Supply & Distribution Agreement
and the Stipulation of Dismissal in an effort to avoid the risks of further
litigation and contain associated fees, costs and expenses. The Parties
acknowledge the sufficiency of the consideration recited herein and therein
forming the basis of their agreement stated in this Agreement, the Supply &
Distribution Agreement and the Stipulation of Dismissal.

3. Within one (1) business day after the Execution Date, Spectrum and GSK

 

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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.

 

shall approach the District Court and request that the trial and all associated
deadlines in the District Court Case be stayed pending the Review Period and the
outcome thereof pursuant to the below terms (a “Litigation Stay”). If the
District Court refuses to grant a Litigation Stay in the District Court Case,
for a period of three (3) business days the Parties will use reasonable efforts
to accommodate the requirements of the District Court in order to get the
District Court to grant such a Litigation Stay or reach another mutually
acceptable resolution. [***] .

4. Within three (3) business days after the District Court grants a Litigation
Stay, but in no case later than as required by the MMA (defined below), GSK and
Spectrum shall comply with the provisions of the Title XI of the Medicare
Prescription Drug Improvement and Modernization Act (Subtitle B – Federal Trade
Commission Review) (the “MMA”) signed into law on December 8, 2003, and shall
independently file this Agreement and the Supply & Distribution Agreement with
the U.S. Federal Trade Commission (“FTC”) and U.S. Department of Justice (the
“DOJ”). GSK and Spectrum shall use their Commercially Reasonable Efforts to
coordinate the foregoing filings, and the Parties shall use their Commercially
Reasonable Efforts to respond promptly to any requests for additional
information made by either of such agencies. If, [***] after the [***] or the
[***] or as [***] all or either of which [***]

 

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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.

 

provided that such [***]. If within such [***] the terms of this Agreement [***]
shall within [***] and otherwise [***]. If the Parties agree to certain
modification to the terms of this Agreement or the Supply & Distribution
Agreement, as may be applicable, the Parties shall resubmit the modified
agreement (or the Supply & Distribution Agreement, as may be applicable) (the
“Resubmission”) for an additional Review Period. If a [***] with respect to the
[***] they shall [***] shall within [***]. In the event of [***] shall be deemed
to have [***].

5. Within three (3) business days after the later of: [***]

 

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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.

 

[***], pursuant to Rule 41(a)(1), Fed. R. Civ. P., GSK and Spectrum shall file
the Stipulation of Dismissal in the form attached hereto as Appendix B (the
“Stipulation of Dismissal”) dismissing with prejudice all claims and
counterclaims in the District Court Case. The date upon which the District Court
dismisses the District Court Case against all parties thereto pursuant to the
Stipulation of Dismissal shall be referred to herein as the “Dismissal Effective
Date”. If the District Court does not enter the Stipulation of Dismissal, this
Agreement and the Supply & Distribution Agreement shall automatically become
null and void as of the Execution Date and GSK and Spectrum shall within two
(2) business days thereafter jointly request that the District Court lift its
stay in the District Court Case. In the event [***], the Parties [***] provided
that such [***] by way of example, [***] to contain [***] or to take such [***].
For the avoidance of doubt, [***] due to an issue concerning the [***].

 

5

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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.

 

6. So as to [***] with a [***] against such [***] provided by applicable law.

7. Within [***] after the [***] all appropriate [***] provided, however, [***]
to the extent required by [***].

8. Consistent with the representations, warranties and covenants made in this
Agreement, the Supply & Distribution Agreement and the Stipulation of Dismissal,
as of the Execution Date Spectrum and each of its respective predecessors,
successors, parents, subsidiaries, Affiliates, divisions, general partners,
limited partners, and assigns (collectively, the “Spectrum Releasees”), fully,
finally and forever release, relinquish, acquit, and discharge GSK and each of
its respective predecessors, successors, parents, subsidiaries, Affiliates,
divisions, general partners, limited partners, and assigns, (collectively, the
“GSK Releasees”) of and from, and covenant not to sue, not to assign to any
other entity a right to sue, and not to authorize any other entity to sue, any
GSK Releasee for, any and all claims, counterclaims, defenses, demands, causes
of action, suits, damages, debts, liabilities, obligations, rights, and set-offs
of any and all kind or description whatsoever, including costs, expenses, and
attorneys’ fees (collectively,

 

6

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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.

 

“Losses”), known or unknown, suspected or unsuspected, asserted or unasserted,
in law or equity, on which no judgment has yet been rendered, from the beginning
of the world to the Execution Date that [***] or that arise out of any claim,
counterclaim, affirmative defense, act, transaction, series of transactions,
fact, omission, or matter that [***] (collectively, “Acts”). Consistent with the
representations, warranties and covenants made in this Agreement, the Supply &
Distribution Agreement and the Stipulation of Dismissal, as of the Execution
Date, GSK and each of the other GSK Releasees, fully, finally and forever
release, relinquish, acquit, and discharge the Spectrum Releasees of and from,
and covenant not to sue, not to assign to any other entity a right to sue, and
not to authorize any other entity to sue, any Spectrum Releasee for, any and all
Losses, known or unknown, suspected or unsuspected, asserted or unasserted, in
law or equity, on which no judgment has yet been rendered, from the beginning of
the world to the Execution Date that [***].

9.(a) Subject to the entry by the District Court of the Stipulation of Dismissal
and ruling with respect to the District Court Case and not any other case,
Spectrum and its respective Affiliates each hereby admit that the manufacture,
having manufactured, use, sale, offering for sale, or importing of Products will
infringe the ‘845 Patent and admit that the ‘845 Patent is valid and
enforceable. Spectrum and its respective Affiliates each hereby agree and
covenant that they shall [***].

(b)(i) As of the Dismissal Effective Date, GSK hereby grants to Spectrum an
exclusive (except only as to: (A) GSK (and its Affiliates) for GSK’s

 

7

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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.

 

Imitrex® (or other GSK owned or controlled trademark) branded Sumatriptan
products, and [* * *], waiver of Sumatriptan Pediatric Exclusivity effective as
of the Launch Date with respect to Spectrum Generic Sumatriptan Products in the
United States, so as to allow Spectrum to sell and have sold Spectrum Generic
Sumatriptan Products in the United States as of and after the Launch Date (but
in no event shall Spectrum or its respective Affiliates, directly or indirectly,
sell or have sold Spectrum Generic Sumatriptan Products in the United States
prior to the Launch Date). For the avoidance of doubt, the foregoing waiver
shall only apply to Spectrum Generic Sumatriptan Products in [* * *] forms and
[* * *], nothing herein shall affect or prohibit GSK from granting waivers of
Sumatriptan Pediatric Exclusivity as [* * *] forms of Sumatriptan products (such
as [* * *]). GSK agrees and acknowledges that from the Execution Date until the
Supply Termination Date (as defined in the Supply & Distribution Agreement),
that GSK shall exclusively license to and supply Spectrum with Generic
Equivalent Products for sale in the United States [* * *]. GSK hereby represents
that it [* * *].

(ii) Additionally, [***] of any [* * *] or may later [***]

 

8

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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.

 

[***] as of and after the [***].

(iii) Spectrum may assign the waiver of Sumatriptan Pediatric Exclusivity [***]
that is granted to it above to a Third Party of Spectrum’s choosing (the
“Spectrum Assignee”); provided, (i) such assignment shall be subject to and
contingent upon the Spectrum Assignee agreeing in advance, in a duly authorized
and executed written agreement, to be bound by the terms of this Agreement;
(ii) in such written agreement the Spectrum Assignee shall agree to be fully and
unconditionally liable to GSK for all of GSK’s costs and damages relating to or
arising from any breach of this Agreement by the Spectrum Assignee (and its
Affiliates), and GSK shall be named as a third party beneficiary in such written
agreement; (iii) any such assignment shall not be further assignable,
licensable, or transferable in any manner whatsoever by the Spectrum Assignee
(except in the event of the acquisition of all or substantially all of the
assets of the Spectrum Assignee); and (iv) within five (5) days after the
execution of such written agreement GSK shall be provided with written notice as
to the identity of such Spectrum Assignee. For the avoidance of doubt, in the
event Spectrum were to assign the waiver of Sumatriptan Pediatric Exclusivity
[***] to a Spectrum Assignee, such waiver [***] shall apply to the Spectrum
Assignee and Spectrum would continue to be a beneficiary of such waiver [***]
provided only Spectrum or the Spectrum Assignee (not both) shall market and sell
Products in the United States at any one time. Spectrum hereby represents and
GSK hereby acknowledges that Spectrum has assigned to Par such rights and that
Par is the current Spectrum Assignee.

(c) GSK shall provide Spectrum reasonable cooperation in connection with the
waiver of Sumatriptan Pediatric Exclusivity [***] detailed in Paragraph 9(b),
including providing notices to the U.S. Food and Drug Administration (“FDA”) in
substantially the form attached hereto as Appendix D (or such other form as

 

9

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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.

 

FDA may require) verifying the existence of such waiver [* * *] to support an
approval of the Spectrum ANDAs and not opposing the FDA’s Final Approval of the
Spectrum Generic Sumatriptan Products for sale in the United States as of and
after the Launch Date. [* * *].

(d)(i) As consideration for the foregoing rights granted in Paragraph 9(b),
Spectrum shall remit to GSK (or its Affiliate) [* * *] percent ([* * *]%) of Net
Sales of Spectrum Generic Sumatriptan Products in the United States (the “Net
Sales Split”), and Spectrum’s Net Sales Split obligation to GSK shall
automatically become effective as of the Launch Date. Spectrum’s Net Sales Split
obligation to GSK shall automatically terminate on February 6, 2009; provided,
however, if after February 6, 2009 a Spectrum Generic Sumatriptan Product
continues to fall under a valid claim of a granted and enforceable patent owned
or controlled by GSK (or its Affiliate) Spectrum’s Net Sales Split obligation
with respect to such Spectrum Generic Sumatriptan Product shall continue until
the date that is [* * *] ([* * *]) [* * *] after the Launch Date (or such
earlier date the Spectrum Generic Sumatriptan Product no longer falls under a
valid claim of a granted and enforceable patent owned or controlled by GSK (or
its Affiliate)).

(ii) Within [* * *] ([* * *]) days after the end of each Calendar Quarter in
which a sale of Spectrum Generic Sumatriptan Products has been made in the
United States, Spectrum shall submit to GSK a written report (the “Net Sales
Split Report”) containing the following information regarding such preceding
Calendar Quarter: an itemized accounting and calculation of the total Net Sales
of Spectrum

 

10

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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.

 

Generic Sumatriptan Products sold during such preceding Calendar Quarter in the
United States and the amount of any Net Sales Split due GSK on such Net Sales,
such report to include information in sufficient detail reasonably necessary for
GSK to confirm the accuracy of the amount of the Net Sales Split due GSK, if
any, during such preceding Calendar Quarter. Concurrent with the submission of a
Net Sales Split Report to GSK, Spectrum shall also remit payment to GSK of any
and all Net Sales Splits due GSK for such preceding Calendar Quarter in the
United States. All Net Sales Split Reports shall be considered to be Spectrum
confidential information.

(iii) Any payment due GSK (or its Affiliate) from Spectrum that is past due
under this Agreement shall bear interest at a rate equal to the lesser of
(i) Prime Rate plus [* * *] percent ([* * *]%) per year, or (ii) the maximum
rate permitted by applicable law, calculated based on the number of days that
the payment is delinquent. Spectrum shall make all payments to GSK (or its
Affiliate) in lawful money of the United States by electronic transfer to an
account designated by GSK, or by such other means as may be agreed in advance by
both Parties.

(iv) GSK shall be responsible for and shall pay all taxes payable on any Net
Sales Splits by Spectrum to GSK. Spectrum and GSK shall bear sole responsibility
for payment of compensation to their respective personnel, employees or
subcontractors and for all employment taxes and withholding with respect to such
compensation pursuant to applicable law. Spectrum shall have the right to
withhold taxes in the event that the revenue authorities in any country require
the withholding of taxes on amounts paid hereunder to GSK. Any tax, duty or
other levy paid or required to be withheld by Spectrum on account of Net Sales
Split payments payable to GSK under this Agreement shall be deducted from the
amount of the Net Sales Split due GSK. Spectrum shall secure and promptly send
to GSK proof of such taxes, duties or other levies withheld and paid by Spectrum
or its Affiliates for the benefit of GSK. Each Party agrees to cooperate with
the other Party in claiming exemptions from such deductions or withholdings
under any agreement or treaty from time to time in effect.

 

11

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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.

 

(v) Spectrum shall keep complete and accurate written records of all Net Sales
of Spectrum Generic Sumatriptan Products to the extent commercially reasonably
possible. All such applicable records shall be maintained by Spectrum for the
period required by applicable law or a period of five (5) years from the date of
the record’s creation, whichever is longer.

(vi) Upon the written request of GSK (but not more frequently than once per
calendar year), GSK shall have the right, within sixty (60) days after receipt
of written confirmation that the Auditor (defined below) is reasonably
satisfactory to Spectrum (as set forth below), starting as of the Launch Date
and during the term of this Agreement [***] to have an independent certified
public accountant, satisfactory to Spectrum in Spectrum’s reasonable discretion,
(the “Auditor”) inspect Spectrum’s records with respect to the transactions
contemplated by this Agreement for the preceding [***] during the term (but not
more than one time for any period) for the sole purpose of determining the
accuracy of the Net Sales Split Reports and the associated Net Sales Split
payments made to GSK under this Agreement. Spectrum shall permit the Auditor to
have reasonable confidential access, during normal business hours and upon
having given reasonable prior notice, to such records of Spectrum as may be
necessary to verify Spectrum’s compliance with the Net Sales Split payments due
hereunder for the preceding [***]. The Auditor shall reach its conclusion as
quickly as possible but in no event more than a period of thirty (30) days
following the inspection, and notify the Parties of its conclusion in writing.
Under no circumstances shall the Auditor report to GSK the wholesale prices at
which Spectrum sold the Spectrum Generic Sumatriptan Products. In the event the
Auditor concludes that there was an underpayment of the Net Sales Split to GSK,
the underpayment shall be paid by Spectrum within thirty (30) days after the
date Spectrum receives such Auditor’s

 

12

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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.

 

written report. The Auditor may not be employed on a contingency basis. In the
event the Auditor concludes that there was an overpayment of the Net Sales Split
to GSK, the overpayment shall be credited toward future Net Sales Split payments
to be paid by Spectrum to GSK under this Agreement; provided, however, that in
the event no further Net Sales Split payments shall become due under this
Agreement, said overpayment shall be paid by GSK to Spectrum within thirty
(30) days after the date GSK receives such Auditor’s written report. If the
underpayment of the Net Sales Split is greater than [* * *] percent ([* * *]%)
of the Net Sales Split determined by the Auditor to be payable to GSK, the
reasonable fees and expenses charged by the Auditor shall be paid by Spectrum,
otherwise GSK shall pay the reasonable fees and expenses charged by such
Auditor. The Auditor shall report to GSK only its conclusions as to whether
Spectrum is in compliance with the Net Sales Split obligations and the amount of
any underpayment or overpayment. The Auditor inspecting records of Spectrum
shall execute a written confidentiality agreement reasonably satisfactory to
Spectrum and GSK.

(e) In the event the Launch Date occurs [***], Spectrum and its respective
Affiliates hereby acknowledge and agree that [***]. In the event [***]

 

13

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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.

 

[***], pursuant to the provisions of this Agreement. [***].

10. Nothing in this Agreement shall be deemed or implied to be, and the Parties
disclaim all implied rights to, the grant by any of the Parties to the other
Party of any right, title or interest in any product, intellectual property
rights (including the ‘845 Patent and all ex-U.S. counterparts thereof), any
formulation technology or know-how, manufacturing technology or know-how,
operating procedures, marketing materials or strategies, intangibles, material
or proprietary rights of the other in all countries of the world, except as
expressly set forth in this Agreement.

11. Each Party represents and warrants to the other that (a) it has the
requisite corporate authority to enter into this Agreement and the Stipulation
of Dismissal, (b) this Agreement and the Stipulation of Dismissal do not and
will not conflict with any other agreements to which it or any of its Affiliates
may be a party, (c) except as expressly set forth in Paragraph 4, to the extent
that any approval or authorization is necessary for its valid and lawful
execution, delivery and performance of this Agreement, the Supply & Distribution
Agreement or the Stipulation of Dismissal, such approval or authorization has
been obtained, and (d) this Agreement and the Stipulation of Dismissal are
binding obligations of it and its Affiliates, enforceable in accordance with its
terms, subject, as to enforcement of remedies, to applicable bankruptcy,
insolvency, moratorium,

 

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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.

 

reorganization and similar laws affecting creditors’ rights generally, and to
general equitable principles. This Agreement may be amended or supplemented at
any time by mutual agreement of the Parties, provided that any such amendment or
supplement must be in a writing explicitly referring hereto and approved by all
necessary corporate action.

12. Except as set forth herein, this Agreement and the rights herein shall not
be assigned or otherwise transferred without the written consent of both
Parties, such written consent not to be unreasonably withheld or delayed;
provided, however, that the prior written consent of the other Party shall not
be required for a Party to assign any of its rights, or delegate or subcontract
the performance of any of its obligations hereunder to an Affiliate or pursuant
to a sale of substantially all of the assets of the Party, merger,
consolidation, reorganization or other similar transaction. Each Party
represents and warrants that it has not sold or conveyed or otherwise
transferred any claim, demand or cause of action related to the District Court
Case that it has or had against the other Party.

13. This Agreement, the Supply & Distribution Agreement and the Stipulation of
Dismissal represent the entire understanding and agreement of the Parties and
Par with regard to the matters addressed herein, and there are no other
agreements between the Parties and Par that affect, change, alter, or bear on
that understanding or agreement. This Agreement is the product of negotiation
and preparation by the Parties and their respective attorneys, and the Parties,
therefore, expressly acknowledge and agree that this Agreement shall be deemed
jointly prepared and drafted by all of the Parties and their attorneys, and
shall be construed accordingly. Mistakes of fact or law shall not constitute
grounds for modification, avoidance or rescission of this Agreement.

14. The Parties may state publicly that the District Court Case has been settled
on terms that are confidential, and no public announcement concerning the
existence of, terms, or subject matter of this Agreement shall be made, either
directly or indirectly, by

 

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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.

 

any Party, without first obtaining the approval of the other Party and agreement
upon the nature and text of such public announcement or disclosure which such
agreement and approval shall not be unreasonably withheld, except, in the
opinion of legal counsel for the Party desiring to make such public
announcement, as may be legally required by (i) the applicable law, including
the United States Securities Act of 1933, as amended, the United States
Securities Exchange Act of 1934, as amended, (ii) the listing standards or
agreements of any national or international securities exchange or The NASDAQ
Stock Market or other similar laws of a governmental authority or agency,
(iii) to respond to an inquiry of a governmental authority or agency, or (iv) in
a judicial, administrative or arbitration proceeding, in all instances seeking
appropriate confidential treatment of this Agreement and the subject matter
thereof and the Parties shall agree on any redacted forms of the Agreement that
are filed publicly, such agreement not to be unreasonably withheld or delayed.
The Parties shall keep this Agreement and the Stipulations of Dismissal and
their provisions confidential using at least the level of care they use for
their own proprietary information. Despite the foregoing, the Parties understand
that the Stipulation of Dismissal may become a matter of public record, at least
to some extent, through the District Court, and to the extent, and only the
extent, that the Stipulation of Dismissal becomes a matter of public record,
there shall be no obligation of confidentiality regarding the Stipulation of
Dismissal. If a Party believes that the disclosure of all or portions of this
Agreement, the Supply & Distribution Agreement or the Stipulation of Dismissal
is required by applicable law, then that Party shall inform the other Parties in
sufficient time prior to any such disclosure to allow the other Parties to seek
a protective order prior to any such disclosure. Each Party agrees that it shall
cooperate fully with the others with respect to all disclosures regarding this
Agreement or the Supply & Distribution Agreement to any governmental or
regulatory agencies or any court, including requests for confidential treatment
of proprietary information of any Party included in any such disclosure. If the
District Court dismisses the District Court Case, the Parties shall honor the
protective order and destroy or return all of the other Party’s confidential
information. [***]

 

16

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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.

 

15. GSK and Spectrum shall each bear their own costs and legal fees associated
with the District Court Case and the negotiation and preparation of this
Agreement and the Supply & Distribution Agreement.

16. This Agreement shall be governed by and construed in accordance with the
laws of the State of New York. Nothing in this Agreement shall prevent the
Parties from asserting or pursuing any claim to enforce the terms of this
Agreement. All Parties consent to the personal jurisdiction in Delaware courts
for purposes of enforcing this Agreement.

17. This Agreement may be signed by the Parties in separate counterparts, each
of which when so executed shall be deemed an original, and all of which when
taken together shall constitute the original Agreement. The Parties agree to
accept facsimile copies of the executed Agreement from one another as an
original of same.

18. None of the provisions of this Agreement shall be for the benefit of or
enforceable by any Third Party.

19. The waiver by either Party of a breach or a default of any provision of this
Agreement by the other Party shall not be construed as a waiver of any
succeeding breach of the same or any other provision, nor shall any delay or
omission on the part of the other Party to exercise or avail itself of any
right, power or privilege that it has or may have hereunder operate as a waiver
of any right, power or privilege by such Party.

 

17

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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.

 

20. Notices required or permitted under this Agreement shall be in writing and
sent by prepaid registered or certified air mail or by overnight express mail
(e.g., FedEx), or by telefacsimile confirmed by prepaid registered or certified
air mail letter or by overnight express mail (e.g., FedEx) (failure of such
confirmation shall not affect the validity of such notice by telefacsimile to
the extent the receipt of such notice is confirmed by the act of the receiving
Party (e.g., a telefacsimile of the receiving Party submitting its receipt of
such notice)), and shall be deemed to have been properly served to the addressee
upon receipt of such written communication, to the following addresses of the
Parties:

If to Spectrum:

Spectrum Pharmaceuticals, Inc.

Attn: General Counsel

157 Technology Drive

Irvine, CA 92618

Fax: (949) 788-6706

If to GSK:

SmithKline Beecham Corporation (d/b/a GlaxoSmithKline)

One Franklin Plaza (Mail Code FP 2230)

P.O. Box 7929

Philadelphia, Pennsylvania 19101, USA

Attention: [***]

Fax: [***]

 

18

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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.

 

and:

SmithKline Beecham Corporation (d/b/a GlaxoSmithKline)

One Franklin Plaza (Mail Code FP 2230)

P.O. Box 7929

Philadelphia, Pennsylvania 19101, USA

Attention: [***]

                  [***],

                  [***]

Facsimile: [***]

[Signatures Appear on the Following Page]

 

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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.

 

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
as of the Execution Date.

GLAXO GROUP LIMITED

 

By:  

/s/    Charles Dadswell

Name:  

Charles Dadswell

Title:   Vice President

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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.

 

SPECTRUM PHARMACEUTICALS, INC.

 

By:  

/S/ Rajesh C. Shrotriya, M.D.

Name:  

Rajesh C. Shrotriya, M.D.

Title:  

Chairman, CEO and President

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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.

 

APPENDIX A

Certain Definitions

As used in this Agreement, the following terms, whether used in the singular or
plural, shall have the following meanings:

“A Rated” shall mean the product in question has been assigned an “A” rating
signifying that the FDA has classified the product as “therapeutically
equivalent” to the particular product in question, applying the definition of
“therapeutically equivalent” set forth in the preface to the current edition of
the then current FDA publication “Approved Drug Products With Therapeutic
Equivalence Evaluations” (the “Orange Book”).

“Affiliate” shall mean any Person which controls, is controlled by, or is under
common control with the applicable Person. For purposes of this definition,
“control” shall mean: (a) in the case of corporate entities, direct or indirect
ownership of at least fifty percent (50%) of the stock or shares entitled to
vote for the election of directors, or otherwise having the power to control or
direct the affairs of such Person; and (b) in the case of non-corporate
entities, direct or indirect ownership of at least 50% of the equity interest or
the power to direct the management and policies of such noncorporate entities.

“Calendar Quarter” shall mean each of the three (3) month periods during a
calendar year starting on the first of January, April, July and October.

“Commercially Reasonable Efforts” shall mean with respect to a Party, efforts
and diligence in accordance with business matters in the pharmaceutical industry
that are of high importance to the Party and which are consistent with the
subject Party’s reasonable and sound business and legal judgment.

“FDA” shall mean the U.S. Food and Drug Administration, or any successor agency
thereto.

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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.

 

“Final Approval” shall mean final approval (not including any tentative
approval) required from the FDA to enable the marketing and sale of a
pharmaceutical product in the United States.

“Generic Equivalent” shall mean any prescription Sumatriptan Succinate injection
[* * *] for human use that is supplied or manufactured by or for GSK (or its
Affiliates) under a GSK owned or controlled NDA for sale in the United States as
a generic equivalent to the applicable strength and form of GSK’s Imitrex®
(Sumatriptan Succinate) injection [* * *]. For the avoidance of doubt, Generic
Equivalents shall not include any product marketed and sold under GSK’s Imitrex®
trademark.

“Launch Date” shall mean [* * *]:

[* * *]

[* * *]

[* * *].

“Net Sales” shall mean the aggregate gross sales (“Gross Sales”) amount invoiced
for Spectrum Generic Sumatriptan Products to distributors and customers (for
purposes of this definition, collectively, “customer”):

(1) less the following deductions relating to such sales to the extent such
deductions are consistent with the normal practice in the pharmaceutical
products industry and are related solely to Spectrum Generic Sumatriptan
Products:

a) [* * *];

 

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places marked “[* * *]” and has been filed separately with the Securities and
Exchange Commission pursuant to a Confidential Treatment Application filed with
the Commission.

 

b) [***];

c) [***];

d) [***];

e) [***];

f) [***];

g) [***]; and

h) [***].

The foregoing deductions from Gross Sales shall only be deducted once and only

 

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places marked “[* * *]” and has been filed separately with the Securities and
Exchange Commission pursuant to a Confidential Treatment Application filed with
the Commission.

 

to the extent not otherwise deducted from Gross Sales. Spectrum shall be
responsible for payment of rebates or other price reductions required pursuant
to applicable law to be made by Spectrum based on its sales of Spectrum Generic
Sumatriptan Products to any governmental or regulatory authority in respect of
any state or federal Medicare, Medicaid or similar programs.

In the event that Spectrum sells Spectrum Generic Sumatriptan Products as part
of a bundle or group sale with other products not covered by this Agreement, and
Spectrum provides a discount, allowance or rebate to the purchaser of such
products based on the invoiced prices for all products sold, such discount must
be allocated pro-rata based on the selling prices of such products before taking
into account the discount, allowance or rebate on Spectrum Generic Sumatriptan
Products provided as part of such bundle.

In the event that a Spectrum Generic Sumatriptan Product is sold or otherwise
commercially exploited in a manner such that the above means of calculating Net
Sales is not possible or otherwise is inappropriate, the Parties agree to
negotiate in good faith a reasonable mechanism for fairly calculating the “Net
Sales” resulting from such sales or other commercial exploitation. Net Sales
shall be determined in accordance with the accrual method of accounting in
accordance with USA generally accepted accounting principles (“GAAP”) applied in
a consistent manner.

“Person” shall mean any natural person, corporation, unincorporated
organization, partnership, association, joint stock company, joint venture,
limited liability company, trust or government, or any agency or political
subdivision of any government, or any other entity.

“Prime Rate” shall mean the rate of interest that Citibank N.A. lists as its
prime

 

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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.

 

lending rate on the last day of the applicable Calendar Quarter, or if such rate
is not available, the prime lending rate listed in the New York City, USA
version of The Wall Street Journal on the last day of the applicable Calendar
Quarter.

“Products” shall mean all injectable [* * *] prescription pharmaceutical drug
products in all dosages and presentations thereof for human use consisting of or
containing Sumatriptan. Products shall include all Spectrum Generic Sumatriptan
Products and GSK Supplied Products.

“Spectrum ANDAs” shall mean ANDA Nos. [* * *] and [* * *] (relating to a
[* * *], respectively), in the form and content in which such ANDAs exists as of
the Effective Date, (subject to amendments permitted by FDA rules and
regulations), and the subsequent ANDA owned or controlled by Spectrum covering
the [* * *].

“Spectrum Generic Sumatriptan Injection Products” shall mean the prescription
generic Sumatriptan Succinate injection product (i) in the [* * *] form
developed and manufactured by Spectrum for human use in the United States and
(ii) any [* * *]. Additionally, if by January 1, 2008 GSK has not given notice
of its commitment to so supply (on an exclusive or non-exclusive basis) Spectrum
with a Generic Equivalent of the Imitrex® [* * *] presentation, Spectrum Generic
Sumatriptan Injection Products shall also include the prescription generic
Sumatriptan Succinate injection product in the [* * *] presentation for human
use in the United States that is the generic to GSK’s Imitrex® (Sumatriptan
Succinate) injection product in the [* * *] presentation approved under GSK’s
NDA No. [* * *].

[* * *]

“Spectrum Generic Sumatriptan Products” shall mean, collectively, the [* * *]
the Spectrum Generic Sumatriptan Injection Products.

 

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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.

 

“Sumatriptan” shall mean, collectively Sumatriptan Succinate [* * *].

“Sumatriptan Succinate” shall mean sumatriptan succinate, a selective
5-hydroxytryptamine (5-HT1) receptor subtype agonist chemically designated as
“3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate
(1:1)”.

[* * *]

“Sumatriptan Pediatric Exclusivity” shall mean the marketing exclusivity rights
granted to GSK (or its Affiliate) by the FDA for Pediatric Exclusivity under
Section 505A of the Federal Food, Drug and Cosmetic Act related to Sumatriptan
as applied to the ‘845 Patent.

“Third Party” shall mean any Person other than Spectrum or GSK, or an Affiliate
of any of them.

“Third Party Generic Sumatriptan Injection Product” shall mean any Third Party’s
prescription generic Sumatriptan Succinate injection ([* * *]) product for human
use that has received Final Approval and is A Rated to the applicable GSK
Imitrex® (Sumatriptan) injection approved under GSK’s NDA [* * *]; provided that
such Third Party Generic Sumatriptan Injection Product is not licensed,
distributed or sold in the United States by (or with) Spectrum (or its
Affiliates) or made from a finished or semi-finished dosage form formulated for
use in the United States with direct or indirect support provided knowingly by
Spectrum (or its Affiliates). For the avoidance of doubt, Third Party Generic
Sumatriptan Injection Product shall not include Spectrum Generic Sumatriptan
Injection Products, GSK Supplied Product or any Sumatriptan injection product
sold under GSK’s Imitrex® trademark.

 

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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.

 

[* * *]

“Third Party Generic Sumatriptan Product” shall mean, collectively, [* * *] the
Third Party Generic Sumatriptan Injection Product.

[* * *] shall mean, [* * *], based on [* * *] under which all [* * *] for each
of the [* * *]. By way of example, if the [* * *] has occurred for the [* * *]
apply only to the [* * *] and shall not mean the [* * *].

“Trigger Date” shall mean, [* * *]

 

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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.

 

“United States” shall mean the United States of America (including the
Commonwealth of Puerto Rico) its possessions and territories, and U.S. military
or U.S. government installations that are under the purview of the FDA.

Spectrum and GSK are sometimes collectively referred to in this Agreement as the
“Parties” and separately as a “Party.”

The word “including” or any variation thereof means “including without
limitation” or any variation thereof and shall not be construed to limit any
general statement which it follows to the specific or similar items or matters
immediately following it.

 

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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.

 

APPENDIX B

Stipulation of Dismissal

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF DELAWARE

 

GLAXO GROUP LTD d/b/a GLAXOSMITHKLINE,

 

                                                                                
 Plaintiff,

 

                                                                 - against -

 

SPECTRUM PHARMACEUTICALS, INC.,

 

                                                                                
 Defendant.

   Civil Action No. 05-99 (GMS)

STIPULATIONS AND ORDER OF DISMISSAL

Plaintiff and Counterclaim-Defendant Glaxo Group Ltd d/b/a GlaxoSmithKline and
Defendant and Counterclaim-Plaintiff Spectrum Pharmaceuticals, Inc. hereby
stipulate by and through their respective attorneys that all claims,
counterclaims and defenses in the above-entitled action (“the Litigation”) are
dismissed with prejudice pursuant to Rules 41(a) and 41(c) of the Federal Rules
of Civil Procedure without costs or attorneys’ fees to either party. In support
thereof, the Parties now stipulate as follows.

1. In the above captioned action, Plaintiff alleged that Defendant infringed
U.S. Patent Number 5,037,845 (“the ‘845 Patent”) by Defendant’s submission of
Abbreviated New Drug Application No. 077332 (“Defendant’s ANDA”) to the United
States Food and Drug Administration (“FDA”).

 

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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.

 

2. Defendant’s ANDA was submitted to the FDA under 21 U.S.C. § 355(j), and
sought FDA approval for certain drug products containing as their active
ingredient sumatriptan succinate. Defendant’s ANDA has received tentative
approval from the FDA.

3. Plaintiff and Defendant have reached an agreement to settle the Litigation,
which is set forth in this Stipulation and Order of Dismissal, a separate
Settlement Agreement, and a separate Supply and Distribution Agreement, each of
which is being executed contemporaneously. As a result of this settlement there
will be early procompetitive generic competition for sumatriptan succinate
injectable products in the United States, which competition otherwise would not
have existed at least until the expiration of Plaintiff’s ‘845 patent together
with the ‘845 patent’s period of pediatric exclusivity, had Plaintiff prevailed
in the Litigation. The settlement allows generic entry of sumatriptan succinate
injectable products in advance of expiration of Plaintiff’s ‘845 patent’s period
of pediatric exclusivity.

4. This Stipulation and Order of Dismissal, the Settlement Agreement and the
Supply and Distribution Agreement are the only consideration exchanged by or on
behalf of Plaintiff, on the one side, and Defendant, on the other side, in
reaching the agreement to settle the Litigation. Neither Plaintiff nor Defendant
has received from each other any consideration for their entry into this
settlement other than that which is

 

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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.

 

described in those three documents. This settlement therefore constitutes
Defendant’s and Plaintiff’s best independent judgment as to how best settle the
Litigation and Defendant’s best independent judgment as to how most
expeditiously and competitively to sell sumatriptan succinate injectable
products in the United States in light of Defendant’s relative chances of
success in the Litigation.

5. All Claims, Counterclaims and Defenses in this Litigation should be and
hereby are dismissed with prejudice.

6. Each party to this Litigation will bear its own costs and attorneys’ fees.

SO STIPULATED:

Dated: December     , 2006

 

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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.

 

 

  

 

Jack B. Blumenfeld (#1014)    Edmund D. Johnson (# 2257) Julie Heaney (#3052)   
Peter B. Ladig (# 3513) MORRIS, NICHOLS, ARSHT & TUNNELL LLP    THE BAYARD FIRM
1201 N. Market Street    222 Delaware Avenue, Suite 900 P.O. Box 1347    P.O.
Box 25130 Wilmington, DE 19899    Wilmington, DE 19899 (302) 658-9200    (302)
655-5000    Attorneys for Plaintiff and Counterclaim-Defendant Glaxo Group   
Attorneys for Defendant and Counterclaim-Plaintiff Ltd d/b/a GlaxoSmithKline   
Spectrum Pharmaceuticals, Inc.    Of counsel:    Of counsel:    Evan R. Chesler
   Edgar H. Haug Richard J. Stark    Daniel G. Brown David Greenwald    FROMMER
LAWRENCE & HAUG LLP Andrei Harasymiak    745 Fifth Avenue CRAVATH, SWAINE &
MOORE LLP    New York, New York 10151 825 Eighth Avenue    (212) 588-0800 New
York, NY 10019       - and –    - and -    Robert M. Baechtold    Maximilian
Grant Nicholas M. Cannella    Amanda Hollis Leisa M. Smith    LATHAM & WATKINS
LLP Colleen Tracy    555 Eleventh Street, NW, Suite 1000 FITZPATRICK, CELLA,
HARPER & SCINTO    Washington, DC 20004 30 Rockefeller Plaza    (202) 637-2200
New York, New York 10112   

 

SO ORDERED:

 

United States District Judge

Dated:

 

 

 

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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.

 

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF DELAWARE

 

GLAXO GROUP LTD d/b/a GLAXOSMITHKLINE,

 

                                                                                
 Plaintiff,

 

                                                                 - against -

 

SPECTRUM PHARMACEUTICALS, INC.,

 

                                                                                
 Defendant.

   Civil Action No. 06-558 (GMS)

STIPULATIONS AND ORDER OF DISMISSAL

Plaintiff and Counterclaim-Defendant Glaxo Group Ltd d/b/a GlaxoSmithKline and
Defendant and Counterclaim-Plaintiff Spectrum Pharmaceuticals, Inc. hereby
stipulate by and through their respective attorneys that all claims,
counterclaims and defenses in the above-entitled action (“the Litigation”) are
dismissed with prejudice pursuant to Rules 41(a) and 41(c) of the Federal Rules
of Civil Procedure without costs or attorneys’ fees to either party. In support
thereof, the Parties now stipulate as follows.

1. In the above captioned action, Plaintiff alleged that Defendant infringed
U.S. Patent Number 5,037,845 (“the ‘845 Patent”) by Defendant’s submission of
Abbreviated New Drug Application No. 78-294 (“Defendant’s ANDA”) to the United
States Food and Drug Administration (“FDA”).

2. Defendant’s ANDA was submitted to the FDA under 21 U.S.C.

 

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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.

 

§ 355(j), and sought FDA approval for certain drug products containing as their
active ingredient sumatriptan succinate. Defendant’s ANDA is currently pending
with the FDA and has not yet been approved.

3. Plaintiff and Defendant have reached an agreement to settle the Litigation,
which is set forth in this Stipulation and Order of Dismissal, a separate
Settlement Agreement, and a separate Supply and Distribution Agreement, each of
which is being executed contemporaneously. As a result of this settlement there
will be early procompetitive generic competition for sumatriptan succinate
injectable products in the United States, which competition otherwise would not
have existed at least until the expiration of Plaintiff’s ‘845 patent together
with the ‘845 patent’s period of pediatric exclusivity, had Plaintiff prevailed
in the Litigation. The settlement allows generic entry of sumatriptan succinate
injectable products in advance of expiration of Plaintiff’s ‘845 patent’s period
of pediatric exclusivity.

4. This Stipulation and Order of Dismissal, the Settlement Agreement and the
Supply and Distribution Agreement are the only consideration exchanged by or on
behalf of Plaintiff, on the one side, and Defendant, on the other side, in
reaching the agreement to settle the Litigation. Neither Plaintiff nor Defendant
has received from each other any consideration for their entry into this
settlement other than that which is described in those three documents. This
settlement therefore constitutes Defendant’s

 

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and Plaintiff’s best independent judgment as to how best settle the Litigation
and Defendant’s best independent judgment as to how most expeditiously and
competitively to sell sumatriptan succinate injectable products in the United
States in light of Defendant’s relative chances of success in the Litigation.

5. All Claims, Counterclaims and Defenses in this Litigation should be and
hereby are dismissed with prejudice.

6. Each party to this Litigation will bear its own costs and attorneys’ fees.

SO STIPULATED:

Dated: December             , 2006

 

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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.

 

 

  

 

Jack B. Blumenfeld (#1014)    Edmund D. Johnson (# 2257) Julie Heaney (#3052)   
Peter B. Ladig (# 3513) MORRIS, NICHOLS, ARSHT & TUNNELL LLP    THE BAYARD FIRM
1201 N. Market Street    222 Delaware Avenue, Suite 900 P.O. Box 1347    P.O.
Box 25130 Wilmington, DE 19899    Wilmington, DE 19899 (302) 658-9200    (302)
655-5000    Attorneys for Plaintiff and Counterclaim-Defendant Glaxo Group   
Attorneys for Defendant and Counterclaim-Plaintiff Ltd d/b/a GlaxoSmithKline   
Spectrum Pharmaceuticals, Inc.    Of counsel:    Of counsel:    Evan R. Chesler
   Edgar H. Haug Richard J. Stark    Daniel G. Brown David Greenwald    FROMMER
LAWRENCE & HAUG LLP Andrei Harasymiak    745 Fifth Avenue CRAVATH, SWAINE &
MOORE LLP    New York, New York 10151 825 Eighth Avenue    (212) 588-0800 New
York, NY 10019                           - and -                        - and -
   Robert M. Baechtold    Maximilian Grant Nicholas M. Cannella    Amanda Hollis
Leisa M. Smith    LATHAM & WATKINS LLP Colleen Tracy    555 Eleventh Street, NW,
Suite 1000 FITZPATRICK, CELLA, HARPER & SCINTO    Washington, DC 20004 30
Rockefeller Plaza    (202) 637-2200 New York, New York 10112   

 

SO ORDERED:

 

United States District Judge

Dated:

 

 

 

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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.

 

APPENDIX C

Supply & Distribution Agreement

 

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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.

 

APPENDIX D

Form of FDA Notice

REQUEST FOR EXPEDITED

SELECTIVE WAIVER OF

PEDIATRIC EXCLUSIVITY

 

                                , Director                                ,
Director Office of Generic Drugs    Office of New Drugs CDER    CDER Food and
Drug Administration    Food and Drug Administration Document Control Room   
Rockville, MD 20855-2773 Metro Park North II    7500 Standish Place, Room 150   
Rockville, MD 20855-2773   

NDA No. [* * *] for IMITREX® (Sumatriptan Succinate) Injection [* * *]of GSK’s
Imitrex® (Sumatriptan) injection

ANDA Nos. [* * *] and [* * *] (relating to Sumatriptan[* * *]

REQUEST FOR EXPEDITED SELECTIVE WAIVER OF PEDIATRIC EXCLUSIVITY ASSOCIATED WITH
U.S. PATENT NO. 5,037,845 AND NDA NO. [* * *] FOR IMITREX® (SUMATRIPTAN
SUCCINATE) INJECTION IN FAVOR OF [SPECTRUM]

Dear                                 :

Reference is made to our NDA No. [* * *] for IMITREX® (Sumatriptan Succinate)
injection forms, and the pediatric exclusivity associated with U.S. Patent
No. 5,037,845 (“the ‘845 patent”), which is listed in the Orange Book in
connection with the above-referenced NDA. The period of pediatric exclusivity
associated with the ‘845 patent will expire February 6, 2009. Reference is also
made to, and only to, the above-referenced [SPECTRUM ANDAs] for [INSERT
INJECTION FORM] and no other.

The purpose of this correspondence is to notify the Agency of GlaxoSmithKline’s
(“GSK”) selective and limited waiver of its pediatric exclusivity for the ‘845
patent as of [LAUNCH DATE], solely for, and only for, the above-referenced ANDAs
            , and for no other. GSK wishes to selectively permit [SPECTRUM OR
THE SPECTRUM ASSIGNEE], holder of the above-referenced ANDAs             , and
no other party, to market the products under such ANDAs             beginning on
[LAUNCH DATE], prior to the expiration of GSK’s pediatric exclusivity for the
‘845 patent on February 6, 2009.

 

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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.

 

Please note that GSK has no objection to the immediate final approval of
[SPECTRUM] ANDAs              as of [LAUNCH DATE].

Accordingly, GSK hereby selectively waives its right to pediatric exclusivity
for the ‘845 patent as of [LAUNCH DATE], as it would otherwise apply to and
solely for [SPECTRUM] ANDA              for [INSERT INJECTION FORM], and for no
other party or ANDA.

The Agency’s prompt attention to this matter is required and appreciated. If
there are any questions regarding this correspondence, please contact the
undersigned at             .

Sincerely

 

GLAXOSMITHKLINE By:  

 

Cc:   [SPECTRUM]   FDA Office of Chief Counsel

 

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