Exhibit 10.2
 
Amendment
To
License, Development, Supply and Distribution Agreement

This Amendment to License, Development, Supply and Distribution Agreement (the
“Amendment”), effective as of June 13, 2011 (the “Amendment Effective Date”) by
and among Allergan Sales, LLC, a Delaware corporation with its principal place
of business at 2525 Dupont Drive, Irvine, California 92612 (“Allergan Sales”),
Allergan USA, Inc., a Delaware corporation with its principal place of business
at 2525 Dupont Drive, Irvine, California 92612 (“Allergan USA”), Allergan, Inc.,
a Delaware corporation with its principal place of business at 2525 Dupont
Drive, Irvine, California 92612 (“Allergan, Inc.” and, collectively with
Allergan Sales and Allergan USA, “Allergan”), and Spectrum Pharmaceuticals,
Inc., a Delaware corporation with its principal place of business at 11500 S.
Eastern Ave., Ste. 240, Henderson, Nevada 89052 (“Spectrum”).
 
RECITALS
 
WHEREAS, Allergan and Spectrum are parties to a certain License, Development,
Supply and Distribution Agreement, effective as of October 28, 2008 (the
“Agreement”); and
 
WHEREAS, Allergan and Spectrum desire to amend the Agreement.
 
AGREEMENT
 
NOW, THEREFORE, Allergan and Spectrum agree as follows:
 
1.            Any capitalized term that is not defined in this Amendment shall
have the meaning set forth in the Agreement.
 
2.            The term “BCG Refractory Study” shall be replaced with “1011 Study
and 1012 Study” throughout the Agreement; and the term “BCG Refractory
Indication” shall be replaced with “Multiple Instillation Indication” throughout
the Agreement and the term “BCG Refractory Study JDP” shall be replaced with
“1011 Study and 1012 Study JDP” throughout the Agreement.
 
3.            Section 3.2(a)(ii) of the Agreement shall be deleted and replaced
in its entirety with the following:
 
‘As of the Amendment Effective Date, the Parties have agreed upon the activities
to be performed by each Party to carry out the 1011 Study and 1012 Study, and a
budget for Development Costs relating thereto, as set forth in the JDP.  The
portions of the JDP relating to the 1011 Study and 1012 Study (including the
work plan and budget) are final and are hereinafter referred to as the “1011
Study and 1012 Study JDP”
 

**** Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 
 

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Spectrum shall perform the services necessary to successfully conduct and
complete the 1011 Study and the 1012 Study in compliance with the terms and
conditions set forth in the 1011 Study and 1012 Study JDP using diligent efforts
to meet the timetables set forth in the JDP.  Spectrum shall be named as the
sponsor of the 1011 Study and 1012 Study.’
 
4.            Section 3.2(b) of the Agreement (including Sections 3.2(b)(i) and
3.2(b)(ii)) of the Agreement shall be deleted and replaced in its entirety with
the following:
 
‘Additional Clinical Trials for Multiple Instillation Indications.  If the EMEA
requests clinical trials for the Licensed Product beyond the 611 Study and 612
Study and the 1011 Study and 1012 Study, the Party who receives notice from the
EMEA (or its equivalent) shall promptly provide such notice to the other
Party.  The following shall apply to additional Multiple Instillation Indication
studies for the EMEA: (A) Allergan may unilaterally create the development plan
for the clinical trial (including protocol, timeline and budget), consistent
with the feedback from the EMEA; (B) on completion, the JDP shall be modified to
include such development plan, whereupon Allergan shall be responsible for
conducting the clinical trial, (C) Allergan shall be the sponsor of the clinical
trial; and (D) Allergan shall pay all of the Development Costs for the clinical
trial and shall receive a credit for such payments for Spectrum’s share of total
Development Costs related to this Section 3.2(b), which, notwithstanding the
percentages set forth in Section 6.6, shall be the lesser of ****% of the
Development Costs or **** Dollars ($****), from **** royalties and/or the
milestone payment due under ****.  Notwithstanding anything within this
Agreement or otherwise, Allergan shall have full control and final say on all
issues relating to the additional Multiple Instillation Indication studies for
the EMEA, including without limitation final say on all clinical and regulatory
decisions relating to such EMEA studies.
 
5.            Section 6.2(a)(ii) of the Agreement shall be deleted and replaced
in its entirety with the following:
 
‘a one time payment of **** Dollars ($****) upon Allergan’s receipt of written
notice from Spectrum of the completion of enrollment for both of the 1011 Study
and the 1012 Study, but only if such enrollment is completed: on or before the
later of (A) ****,  or (B) **** (****) **** following: (1) receipt of agreement
to begin the study from the FDA, and (2) approval from one Institutional Review
Board (“IRB”) for each study of the 1011 Study and the 1012 Study, provided that
Spectrum submits the required protocols that meet the submission requirements to
IRBs for both the 1011 Study and the 1012 Study within **** (****) **** of FDA
agreement to begin the study;’
 

 

 
**** Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
 

 
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6.            Section 6.2(a)(vi) of the Agreement shall be deleted and replaced
in its entirety with the following:
 
‘a one time payment of **** Dollars ($****) upon Allergan’s receipt of written
notice of the first approval by the FDA of an sNDA in the Co-Promotion Region
for Licensed Product for use for the Multiple Instillation Indication;’
 
7.            Section 6.2(a)(viii) of the Agreement shall be deleted and
replaced in its entirety with the following:
 
‘a one time payment of **** Dollars ($****) upon Allergan’s receipt of written
notice of first approval by the EMEA of an MAA or an equivalent of an sNDA for
Licensed Product for use for any indication other than the Initial Indication.
 
8.            Section (l) if Schedule 1.1, the defined term “BCG Refractory” and
all uses of the defined term throughout the Agreement are hereby deleted.
 
9.            Section (m) “BCG Refractory Indication” of Schedule 1.1 of the
Agreement shall be deleted and replaced in its entirety with the following:
 
‘“Multiple Instillation Indication” means treatment of **** bladder cancer with
multiple instillations of the Licensed Product.’
 
10.            Section (n) “BCG Refractory Study” of Schedule 1.1 of the
Agreement shall be deleted and replaced in its entirety with the following:
 
 ‘“1011 Study and 1012 Study” means the clinical trials designated as clinical
study no. 1011 and clinical study no. 1012.’
 
11.            Schedule 3.1(a) “Joint Development Plan” of the Agreement shall
be deleted in its entirety and replaced with the Schedule 3.1(a) set forth in
Appendix A attached hereto.
 
12.            Except as expressly modified by this Amendment, all terms and
conditions of the Agreement shall continue in full force and effect.
 
13.            In the event of any conflict between the terms of the Agreement
and this Amendment, the terms of this Amendment shall govern.
 
14.            This Amendment may be executed in counterparts, each of which
shall be deemed an original, but both of which together shall constitute one and
the same instrument.  Signatures to this Amendment transmitted by facsimile, by
email in “portable document format” (“.pdf”), or by any other electronic means
intended to
 

 

 
**** Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
 

 
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preserve the original graphic and pictorial appearance of this Amendment shall
have the same effect as physical delivery of the paper document bearing original
signature.
 
Signature Page Follows
 

 
 

 
**** Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
 

 
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In Witness Whereof, Allergan and Spectrum have executed this Amendment by their
duly authorized representatives as of the Amendment Effective Date.

Allergan Sales,
LLC                                                                  Spectrum
Pharmaceuticals, Inc.

 
By:/s/ DAVID M.
LAWRENCE                                                                  By:/s/
RAJESH C. SHROTRIYA
 
Name:         David M.
Lawrence                                                                      Name:Rajesh
C. Shrotriya
 
Title:           Vice
President                                                                              
Title:       Chief Executive Officer and President

Allergan USA,
Inc.                                                                  

 
By:/s/ DAVID M. LAWRENCE
 
Name:         David M. Lawrence
 
Title:           Vice President

Allergan, Inc.                                                                  

 
By:/s/ SCOTT M. WHITCUP
 
Name:        Scott M. Whitcup, M.D.

Title:           Executive Vice President, Research & Development,
                  Chief Scientific Officer
 

Signature Page to
Amendment to License, Development, Supply and Distribution Agreement

**** Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
 
 
 

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Appendix A

Schedule 3.1(a)
Joint Development Plan

[See attached.]

****

**** Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.

 
 

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