EX-10.5



 Exhibit 10.5 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
 First
Amendment to License Agreement 
 First Amendment to License Agreement (“Amendment”), made as of October 3, 2017
(“Amendment Effective Date”), to the License Agreement (“Original Agreement”), dated March 23, 2017 (the “Original Agreement Effective Date”), by and between Novartis International
Pharmaceutical Ltd., a for-profit corporation with its principal place of business at Lichtstrasse 35, CH-4056 Basel, Switzerland (“Novartis”) and
resTORbio, Inc., a Delaware corporation located at 501 Boylston Street, Suite 6102, Boston, Massachusetts 02116 (“resTORbio”). The Original Agreement, as amended by this Amendment, is referred to as the “Agreement”.
Novartis and resTORbio are each referred to individually as a “Party” and together as the “Parties.” 

Background 
 Pursuant to the
Section 4.2 of the Original Agreement, following the Original Agreement Effective Date, the Parties are to negotiate the terms of an amended Exhibit C to the Original Agreement, which is intended add a list of pre-clinical and clinical documents in Novartis’ possession that are material to the BEZ-235 Know How reasonably necessary for the Development of BEZ235 (each as defined
in the Original Agreement). 
 Accordingly, Novartis and resTORbio agree as follows: 

In satisfaction of Novartis’ obligations under Section 4.2 of the Original Agreement, the contents of Schedule 1 to this Amendment are, to
the best of Novartis’ knowledge, a complete list of the documents described above and are hereby added to Exhibit C. In all other respects, the Agreement is hereby ratified and confirmed. 

Schedule 1 includes a reference to certain data (the “[***]”) generated from information received from [***] (“[***]”). Pursuant to
Novartis Institutes for BioMedical Research, Inc.’s agreement with [***], the use and transfer of the [***] is subject to certain restrictions and limitations, and any subsequent recipient of the [***] must, as a condition of receipt of such
data, agree to be bound by those restrictions and limitations. Accordingly, as a condition to the transfer of the [***], resTORbio agrees that it will not file, prosecute, or maintain any patent application or patent claiming patentable inventions
created, conceived of, or reduced to practice, directly or indirectly, by it from the use of the [***], and that any such inventions will be placed in the public domain. resTORbio understands that it is entitled to refuse receipt of such
information, in which case (a) resTORbio must notify Novartis in advance of the transfer of such refusal; and (b) if Novartis is so notified, (i) the restrictions and limitations set forth in this paragraph shall
not apply, and (ii) the [***]will not be transferred. The Parties agree that this Amendment does not limit or otherwise affect the rights of resTORbio to Novartis Technology as provided in the Original Agreement, including with respect
to any data from [***] that is included in such Novartis Technology. 








 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  

 The Parties will comply with all global and local applicable laws and regulations relating to handling of
personal data in the respective country. 
 The Parties, intending to be bound, have caused this Amendment to be executed by their duly authorized
representatives. 
  

									
	 NOVARTIS INTERNATIONAL

PHARMACEUTICAL LTD.
	 		 	RESTORBIO, INC.


									
					
	By:	 	 	 		 	By:	 	/s/ Chen Schor
	Name:	 	 	 		 	Name:	 	Chen Schor
	Title:	 	 	 		 	Title:	 	President and CEO
					
	By:	 	 	 		 		 	
	Name:	 	 	 		 		 	
	Title:	 	 	 		 		 	









 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  

 Schedule 1 








 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  


			
	



	  	  
 




  
 BEZ235 Amendment

to Exhibit C
  

September 27, 2017

	  	 




  










 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  

 Contents 
  

					
	 BEZ235 Clinical Documentation
	  	 	3	 
		
	 BEZ235 Pre-clinical Documentation
	  	 	6	 
		
	 Additional documentation
	  	 	12	 
		
	 A. BEZ235 Japan Documentation
	  	 	12	 
		
	 B. CMC Additional Documentation
	  	 	12	 
		
	 C. DMPK Documentation
	  	 	12	 
		
	 D. RAD002X2202
	  	 	13	 
		
	 E. CBEZ235Y2201 Phase IIa data
	  	 	13	 
		
	 F. CRAD001X2109 BEZ235+RAD001 Oncology study
	  	 	13	 


  

			
		  	














 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  

 BEZ235 Clinical Documentation 

Source: Novartis Clinical documentum archive 
 Study: BEZ235A

  

			
	BEZ235A1101	  	
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	BEZ235A2101	  	
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	Bez23512110	  	
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 3 









 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  


			
	Study: BEZ235C	  	
	BEZ235C2102	  	
	[***]	  	
	[***]	  	[***]
		
	BEZ235C2108	  	
	[***]	  	[***]
	[***]	  	[***]
	[***]	  	[***]
		  	[***]
		  	[***]
		
	Study: BEZ235F	  	
	BEZ235F2201	  	
	[***]	  	[***]
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	Study: BEZ235Y	  	
	BEZ235Y2201	  	
	[***]	  	[***]
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	Study: BEZ235Z	  	
	BEZ235Z2401	  	
	[***]	  	[***]
	[***]	  	
	[***]	  	[***]
		  	[***]


  

			
		  	





 4 









 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  


			
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	BEZ235Z2001l	  	
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 5 









 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  

 BEZ235 Pre-clinical Documentation 

Source: Novartis Pre-clinical documentum archive 

 

			
	ADME – Animal Studies in vivo	  	
	[***]	  	[***]
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 6 









 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  


			
	ADME – In vitro, ex vivo & in-situ studies	  	
	[***]	  	[***]
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 7 









 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  


			
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	Bioanalytical Methods	  	
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 8 









 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  


			
	Human Studies	  	
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	Research Support Notes	  	
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 9 









 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  


			
	Safety Pharmacology	  	
	[***]	  	[***]
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	Toxicology – Genotoxicity	  	
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	Toxicology – Other Studies	  	
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	Toxicology – Repeated Dose Studies	  	
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 10 









 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  


			
	[***]	  	[***]
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 11 









 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  

 Additional Documentation 
  

			
	A. BEZ235 Japan Documentation
		
	Regulatory	  	
		  	[***]1
		  	[***]
		
	Clinical	  	
	[***]	  	[***]
		  	[***]
		  	[***]
		  	[***]
		  	[***]
	
	B. CMC Additional Documentation
	
	CMC Documentation for FDA
	[***]	  	[***]
	[***]	  	[***]
	[***]	  	[***]
	
	High dose manufacturing instructions
	[***]	  	[***]
	[***]	  	[***]
	[***]	  	[***]
		
	Test Methods for Genotoxic Materials	  	
	[***]	  	
	[***]	  	
	[***]	  	
	[***]	  	
	[***]	  	
	[***]	  	
		
	C. DMPK Documentation	  	
	
	Manufacturing and Synthesis for internal standard
	[***]	  	
	[***]	  	
	[***]	  	

  

	1 	[***] 


  

			
		  	





 12 









 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED 

MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE 

COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES 

ACT OF 1933, AS AMENDED 
  

 D. RAD002X2202: A multicenter, single-blind, placebo-controlled study to investigate effects of everolimus
on the immune response to vaccination in the elderly 
  

			
	Clinical Documentation
	[***]	  	[***]
		  	[***]
		  	[***]
		  	[***]
		  	[***]
	
	E. CBEZ235Y2201 Phase Ila data
	
	Additional CBEZ235Y2201 documentation
	[***]	  	[***]
	[***]	  	
	[***]	  	[***]
		  	[***]
		  	[***]
		  	[***]
		  	[***]
		  	[***]
		  	[***]
		  	[***]
	[***]2	  	[***]
	
	F. CRAD001X2109 BEZ235+RAD001 Oncology study
	
	Regulatory FDA Letter
	[***]	  	

  

	2 	[***] 


  

			
		  	





 13