Exhibit 10.37






Exhibit 10.37



CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT MARKED WITH [***] 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.




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” 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




	[***]:  	 	CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




 


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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;’



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.




	[***]:  	 	CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




 


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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 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



 


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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






 


 









 







Appendix A




Schedule 3.1(a)

Joint Development Plan




[See attached.]




[***]





	[***]:  	 	CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.