Document:

EX-10.47

 Exhibit 10.47 

 
 

 
 April 26, 2013 

Sanofi 
 54, rue La Boétie, 
 75414 Paris, France 

Attn:  Philippe Goupit, Vice President, Corporate Licenses, Strategy & Development 

Dear Philippe: 
  

Amended and Restated Collaboration and License Agreement between Sanofi and Regulus Therapeutics, Inc. 

Sanofi and Regulus Therapeutics, Inc. (“Regulus”) are parties to that certain Amended and Restated
Collaboration and License Agreement, effective as of July 16, 2012 (the “Agreement”) and as amended February 25, 2013. 
 The purpose of this letter is to record the agreement of the Parties to extend the time period available to Sanofi to exercise its option to extend the Research Term (set forth in Section 3.3 of the
Agreement). Capitalized terms used but not expressly defined in this letter shall have the meanings attributed to them in the Agreement. 
 In consideration of the mutual agreements and promises contained in the Agreement, the Parties hereby agree, in accordance with Section 13.6 of the Agreement, that the first sentence of Section 3.3.3 of
the Agreement is amended to read as follows: 
 In order to exercise its option under Section 3.3.2
to extend the Research Term, Sanofi must provide Regulus a written notice exercising Sanofi’s right to extend the Research Term on or before June 7, 2013. 

Except as expressly modified by this letter, all terms and conditions set forth in the Agreement shall remain
unchanged. 

 In order to confirm Sanofi’s agreement to this letter, please return one
countersigned original by courier to our attention. 
  

			
	Sincerely, on behalf of Regulus Therapeutics Inc.	 	
		
	 /s/ Kleanthis G. Xanthopoulos
	 	
	Kleanthis G. Xanthopoulos, Ph.D.	 	
	President and CEO	 	

  
  

					
		 	Agreed on behalf of Sanofi
			
		 	By:	 	  /s/ Philippe Goupit

					
			
		 	Name:	 	 Philippe Goupit

					
			
		 	Title:	 	 Vice President, Corporate Licenses

 Cc: 
 Sanofi 
 54, rue La Boétie, 

75414 Paris, France 
 Attention: General Counsel 
 Sanofi 

9 rue du Président Allende 
 94256 Gentilly Cedex, FranceEX-10.48

 Exhibit 10.48 

 
 

 
 ***Text Omitted and Filed Separately 

with the Securities and Exchange Commission. 
 Confidential Treatment Requested 
 Under 17 C.F.R. Sections 200.80(b)(4)

 and 230.406. 

CONFIDENTIAL 
  

					
		 	 Regulus Therapeutics Inc.

3545 John Hopkins Court, Suite 210
 San
Diego, California 92121-1121
 USA
  

Attention: CEO
  
 Facsimile to: +1 (858) 202-6363
 Confirmation by courier

 
 Paris, 21 June 2013
	 	

 Dear Kleanthis, 

Exclusive Negotiation Options and microRNA Collaboration Terms. 
 This letter (“Option Letter”) sets forth: (i) Regulus’ exclusive right to negotiate with Sanofi to enter into a co-development and commercialization agreement concerning certain miR-21 programs
in Alport’s disease and oncology; and (ii) Sanofi’s exclusive right to negotiate with Regulus to enter into a co-development and commercialization agreement concerning microRNA therapies targeted to microRNA targets other than miR-21
and microRNA biomarkers. 
 Exclusive Options 
 Regulus Option: 
 Pursuant to the “Amended and Restated
Collaboration and License Agreement” between Sanofi and Regulus, having an effective date of June 21, 2010 (“Collaboration and License Agreement”), Sanofi has an exclusive license under intellectual property owned or controlled
by Regulus to research, develop and commercialize microRNA compounds targeting miR-21. Capitalized terms used but not expressly defined in this Option Letter shall have the meanings attributed to them in the Collaboration and License Agreement.

 Upon execution of this Option Letter, Regulus shall have the exclusive right (“Regulus Option”) to negotiate
with Sanofi to enter into a co-development and commercialization agreement pursuant to which Regulus would obtain the right to co-develop and commercialize with Sanofi certain miR-21 antagomirs in Alport’s disease and Oncology (“miR-21
Co-Development Agreement”). 
 The Regulus Option shall expire on December 31, 2013, or upon execution of the
miR-21 Co-Development Agreement, whichever occurs first (“Regulus Option Period”). In the 

  

 

 
  

 
event the parties are actively negotiating or drafting the miR-21 Co-Development Agreement as of December 31, 2013, but that agreement has not yet been executed, the Option Period shall be
extended for an additional thirty (30) days. 
 Regulus may exercise the Regulus Option by notifying Sanofi in
writing that it is exercising such option and the parties shall thereafter commence negotiation of the miR-21 Co-Development Agreement. Neither party shall have any obligation with respect to the proposed subject matter of the miR-21 Co-Development
Agreement unless and until the miR-21 Co-Development Agreement has been authorized by, and executed and delivered by an authorized officer of, each of the parties. Either party may terminate negotiations relating to the miR-21 Co-Development
Agreement at any time prior to execution of the miR-21 Co-Development Agreement and any such termination shall not result in any liability to either party. 
 Sanofi agrees that it will not, directly or indirectly, (i) take any action to solicit, initiate, encourage or assist the submission of any proposal, negotiation or offer from any person or entity, other than
Regulus, relating to the miR-21 Co-Development Agreement, or (ii) enter into any discussions, negotiations or execute any agreement related to any of the foregoing, and shall notify Regulus promptly of any inquiries by any third parties in
regards to the foregoing. Should the Regulus Option Period expire, Sanofi shall have no further obligations under this section and shall be free to negotiate with a third party concerning the miR-21 Co-Development Agreement. 

Sanofi Option: 
 Upon execution of this Option Letter, Sanofi shall have the exclusive right (“Sanofi Option”) to negotiate with Regulus to enter into a development and license agreement for the co-development and
commercialization of: [...***...] and other unencumbered microRNA targets; and microRNA biomarkers (“microRNA Collaboration Agreement”). 
 The Sanofi Option shall expire on December 31, 2013 or upon execution of the microRNA Collaboration Agreement, whichever occurs first (“Sanofi Option Period”). In the event the parties are actively
negotiating or drafting the microRNA Collaboration Agreement as of December 31, 2013, but that agreement has not yet been executed, the Sanofi Option Period shall be extended for an additional thirty (30) days. 

Sanofi may exercise the Sanofi Option by notifying Regulus in writing that it is exercising such option and the parties shall
thereafter commence negotiation of the microRNA Collaboration Agreement. Neither party shall have any obligation with respect to the proposed subject matter of the microRNA Collaboration Agreement unless and until the microRNA Collaboration
Agreement has been authorized by, and executed and delivered by an authorized officer of, each of the parties. Either party may terminate negotiations relating to the microRNA Collaboration Agreement at any time prior to execution of the microRNA
Collaboration Agreement and any such termination shall not result in any liability to either party. 
 Regulus agrees
that it will not, directly or indirectly, (i) take any action to solicit, initiate, encourage or assist the submission of any proposal, negotiation or offer from any person or entity, other than Sanofi, relating to the acquisition, sale, lease,
license or other disposition of the [...***...], or (ii) enter into any discussions, negotiations or execute any agreement related to any of the foregoing, and shall notify Sanofi promptly

  
 ***Confidential
Treatment Requested 

 

 
  

 
of any inquiries by any third parties in regards to the foregoing. Should the Sanofi Option Period expire, Regulus shall have no further obligations under this section and shall be free to
negotiate with a third party concerning 
[...***...] and any other target which is not a Collaboration Target under the Collaboration and License Agreement. 
 Consideration 
 In consideration for Regulus’ agreement to the
terms of this Option Letter, Sanofi would pay to Regulus the non-refundable amount of USD $2.5 million within fifteen (15) days of execution of this Option Letter. $1.25 million of such payment shall be fully creditable against any future
payments made to Regulus under either the miR-21 Co-Development Agreement or the microRNA Collaboration Agreement and the remaining $1.25 million shall be non-creditable. 

In consideration for Sanofi’s agreement to the terms of this Option Letter, Regulus hereby agrees that, until expiration of
the Regulus Option Period and notwithstanding anything to the contrary in the Collaboration and License Agreement: (i) Regulus shall continue to perform work under the Research Program pursuant to the terms of the Collaboration and License
Agreement and, in particular, Regulus shall perform those activities set forth in the 
[...***...], with Sanofi having final say on decisions concerning which party shall be responsible for each such activity; (ii) Sanofi shall have no
obligation to provide Research Program funding, fee-for-service, or any other payment to Regulus with respect to such work; and (iii) all results, data, inventions and developments generated by such work shall be deemed to have been generated
in the performance of the Research Program pursuant to the Collaboration and License Agreement and shall be governed by the terms of the Collaboration and License Agreement. Except as expressly modified by this Option Letter, all terms and
conditions set forth in the Collaboration and License Agreement shall remain unchanged. 
 In order to confirm
Regulus’s agreement to this letter, please return one countersigned original by courier to our attention. 
  

	
	Sincerely, on behalf of Sanofi,
	
	/s/ Bernard Davitian for Philippe Goupit
	  

	Philippe GOUPIT
	Vice President, Corporate Licenses
	Strategy & Business Development

  

			
	Agreed on behalf of Regulus Therapeutics Inc.,
		
	By:	 	/s/ Kleanthis G. Xanthopoulos
		
	Name:        	 	Kleanthis G. Xanthopoulos, Ph.D.
		
	Title:	 	President & CEO

  
 ***Confidential
Treatment Requested 

 

 
  

	Cc:	 Regulus Therapeutics Inc. 

 3545 John Hopkins Court, Suite 210 
 San Diego, California 92121-1121 

USA 

Attention: General Counsel 
 Facsimile: +1 (858) 202-6363

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