EX-10.16



 Exhibit 10.16 

CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER 

THE SECURITIES ACT OF 1933, AS AMENDED. 

[*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT 

REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL 

HAS BEEN FILED SEPARATELY WITH THE COMMISSION. 

May 7, 2010 
  

									
	 F.Hoffmann-La Roche Ltd

Grenzacherstrasse 124
 CH-4070 Basel

Switzerland
 Attn: Corporate Law

Fax: [*****]
		cc:		 Hoffmann-La Roche Inc.
 340 Kingsland
Street
 Nutley, NJ 07110
 USA

Attn: Corporate Secretary
 Fax: [*****]
		 cc:
		 Roche Palo Alto LLC
 3431 Hillview Avenue

Palo Alto, CA 94304
 USA

Attn: General Counsel
 Fax: [*****]



 

	Re:	Amended and Restated License Agreement (the “ARLA”) dated December 10, 2008, between the entities Identified above (collectively, “Roche”), and Synosia
Therapeutics, Inc. and Synosia Therapeutics AG (collectively, “Synosla”) 

 Gentlemen: 

Reference is made to the ARLA, as amended by that certain letter agreement dated February 10, 2009 (“1st Letter”) and that certain letter agreement dated October 20, 2009 (“2nd Letter” and, collectively with
the ARLA and the 1st Letter, the “Agreement”). Unless otherwise specified, capitalized terms used but not otherwise defined in this letter (“3rd Letter”) shall have the meanings provided in the Agreement. 
 Roche and Synosia have
determined that it Is not necessary or desirable that Synosia perform the POC Study of the Tier 1 Product contemplated by the Development Plan. The parties now wish to amend the Agreement to, among other things, amend and restate the Development
Plan and to reduce the payments that would be payable by Roche with respect to Tier 1 Products if It exercises the Opt-In Right and by Synosia if Roche does not exercise the Opt-In Right. 

In consideration of the foregoing and the mutual promises, terms, conditions, and covenants contained herein, Synosia and Roche, intending to be legally
bound, hereby agree as follows: 
 1. Development Plan. The Development Plan is hereby amended and restated to read in its entirety as set forth In
Appendix I to this 3rd Letter. 
 2. Roche Payment Obligations. 

(a) Roche Opt-In Fee. Section 5.1 of the ARLA is hereby amended and restated to read In Its entirety as follows: 

“5.1 Roche Opt-In Fee. If Roche timely notifies Synosia in writing pursuant to Section 3.1(e) that Roche Is
exercising its Opt-In Right, then [*****] following such notice, Roche shall pay to Synosia an opt-in fee of [*****]” 
 (b)
Development Event Payments. The development event payment for the development event [*****] under Section 5.2 of the ARLA is hereby eliminated. 

(c) Royalties. Section 5.3 of the ARLA is hereby amended and restated to read In its entirety as follows: 








 CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER 

THE SECURITIES ACT OF 1933, AS AMENDED. 

[*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT 

REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL 

HAS BEEN FILED SEPARATELY WITH THE COMMISSION. 

F.Hoffmann-La Roche Ltd 
  Page
 2
 of 4 
  

 “5.3 Royalties. If the license set forth In
Section 3.1(e) becomes effective, other than as a result of Synosia exercising its rights under Section 10.3(c), Roche shall pay to Synosia royalties on worldwide annual Net Sales of Tier 1 Products at the applicable rate(s) set forth
below: 
 [*****] 

provided, however, that if annual Net Sales exceed [*****] in a given calendar year, then the royalty rate with respect to all
annual Net Sales up to [*****] in such calendar year shall be [*****], and Roche shall make the required true-up payment to Synosia with Roche’s royally payment for the fourth
(4th) calendar quarter of such calendar year.” 
 3. Tier 2 and Tier 3 Field
Extension Option Period. The Tier 2 and Tier 3 Field Extension Option Period is hereby extended until 90 days after the dale of this 3rd Letter. 

4. Entire Agreement. The Agreement (including the Exhibits thereto), as expressly amended by this
3rd Letter (Including the Exhibit hereto), together with the Solvias Agreement, are both a final expression of the parties’ agreement and a complete and exclusive statement with respect to
the subject matter thereof. Except as specifically amended by this 3rd Letter, the Agreement shall remain in full force and effect in accordance with Its terms. 

5. Counterparts. This 3rd Letter may be executed in two or more counterparts, each of which shall
be deemed an original document, and all of which, together with this writing, shall be deemed one instrument. 
 Please indicate your acceptance of these
terms by signing in the space provided below. 
 Sincerely, 
  

									
	SYNOSIA THERAPEUTICS AG				SYNOSIA THERAPEUTICS, INC.
					
	By:		 /s/ Ian J. Massey
				By:		 /s/ Ian J. Massey

	Name:		Ian J. Massey				Name:		Ian J. Massey
	Title:		President & CEO				Title:		President & CEO
	Date:		May 7, 2010				Date:		May 7, 2010
					
	By:		 /s/ Uwe Meya
						
	Name:		Uwe Meya						
	Title:		VP Clinical Research & Development						
	Date:		May 7, 2010						









 CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER 

THE SECURITIES ACT OF 1933, AS AMENDED. 

[*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT 

REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL 

HAS BEEN FILED SEPARATELY WITH THE COMMISSION. 

F.Hoffmann-La Roche Ltd 
  Page
 3
 of 4 
  

 Agreed to and accepted as of the date set forth on the first page of this 3rd Letter: 
  

									
	F.HOFFMANN-LA ROCHE LTD				HOFFMANN-LA ROCHE INC.
					
	By:		 /s/ Stefan Arnold
				By:		 /s/ James A. Dougherty

	Name:		Stefan Arnold				Name:		James A. Dougherty
	Title:		Head Legal Pharma				Title:		Nutley Site Head Roche Partnering
	Date:		May 10, 2010				Date:		10 May 10
				
							ROCHE PALO ALTO LLC
					
	By:		 /s/ Christophe Carissimo
				By:		 /s/ Kevin A. Marks

	Name:		Christophe Carissimo				Name:		Kevin A. Marks
	Title:		Global Licensing Director				Title:		Vice President
	Date:		May 10, 2010				Date:		3/7/10









 CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER 

THE SECURITIES ACT OF 1933, AS AMENDED. 

[*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT 

REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL 

HAS BEEN FILED SEPARATELY WITH THE COMMISSION. 
  

 Appendix I 

DEVELOPMENT PLAN 

  
 1/3 









 CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER 

THE SECURITIES ACT OF 1933, AS AMENDED. 

[*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT 

REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL 

HAS BEEN FILED SEPARATELY WITH THE COMMISSION. 
  

 [*****] 

  
 2/3 









 CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER 

THE SECURITIES ACT OF 1933, AS AMENDED. 

[*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT 

REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL 

HAS BEEN FILED SEPARATELY WITH THE COMMISSION. 
  

 [*****] 

  
 3/3 









 CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER 

THE SECURITIES ACT OF 1933, AS AMENDED. 

[*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT 

REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL 

HAS BEEN FILED SEPARATELY WITH THE COMMISSION. 
  

 [*****] 








 CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER 

THE SECURITIES ACT OF 1933, AS AMENDED. 

[*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT 

REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL 

HAS BEEN FILED SEPARATELY WITH THE COMMISSION. 
  

 [*****]