Exhibit 10.10


 


Non-Federal


 


Subaward Agreement


 


	Prime Awardee	Subawardee
	Institution/Organization ("PRIME RECIPIENT")	Institution/Organization ("SUBRECIPIENT")
	 	 	 	 
	Name:	Shuttle Pharmaceutical, LLC	Name:	Rhode Island Hospital
	 	 	 	 
	Address:	1 Research Court, Suite 450	Address:	593 Eddy Street
	 	Rockville, MD 20850	 	Providence, RI 02903
	 	 	 	 
	Prime Award No.

                                                 
	Subaward No.
	 	HHSN261201400013C	 	 
	 	 	 	 
	Sponsor	  

                                     
	 	 
	 	National Cancer Institute	 	 


 


	Subaward Period of Performance	Amount Funded this Action 	Est. Total (if incrementally funded)
	 	 	 	 
	Phase I 10/27/14 - 6/18/15 Phase II 6/19/15 - 6/18/17	$65,549	$688,818
	 	 	 	 
	Project Title	 	 
	 	 	 	 
	 	Development of Radiation Modulators for Use During Radiotherapy
	Reporting Requirements [Check here if applicable: x
    See Attachment 4]


 


Terms and Conditions


 


1) Prime Recipient hereby awards a cost reimbursable
subaward, as described above, to Subrecipient. The statement of work and budget for this subaward are (check one): ___ as
specified in Subrecipient’s proposal
dated                       ;
or _X_ as shown in Attachments 3 & 4. In its performance of subaward work, Subrecipient shall be an
independent entity and not an employee or agent of Prime Recipient.


2) Prime Recipient shall reimburse Subrecipient not more often than
monthly for allowable costs. All invoices shall be submitted using Subrecipient’s standard invoice, but at a minimum shall
include current and cumulative costs (including cost sharing), subaward number, and certification as to truth and accuracy of invoice.
Invoices that do not reference Prime Recipient’s subaward number shall be returned to Subrecipient. Invoices and questions
concerning invoice receipt or payments should be directed to the appropriate party’s Financial Contact, as shown in Attachment
2.


3) A final statement of cumulative costs incurred, including cost
sharing, marked “FINAL,” must be submitted to Prime Recipient’s Administrative Contact NOT LATER THAN sixty (60)
days after subaward end date. The final statement of costs shall constitute Subrecipient’s final financial report.


4) All payments shall be considered provisional and subject to adjustment
within the total estimated cost in the event such adjustment is necessary as a result of an adverse audit finding against the Subrecipient.


5) Matters concerning the technical performance
of this subaward should be directed to the appropriate party’s Project Director, as shown in Attachment 2. Technical
reports are required as shown above, “Reporting Requirements.”


6) Matters concerning the request or negotiation of any changes
in the terms, conditions, or amounts cited in this subaward agreement should be directed to the appropriate party’s Administrative
Contact, as shown in Attachment 2. Any such changes made to this subaward agreement require the written approval of each
party’s Authorized Official, as shown in Attachment 2.


7) Each party shall be responsible for its
negligent acts or omissions and the negligent acts or omissions of its employees, officers or directors, to the extent allowed
by law.


8) Either party may terminate this agreement with thirty days written
notice to the appropriate party’s Administrative Contact, as shown in Attachment 2. Prime Recipient shall pay Subrecipient
for all allowable, noncancellable obligations in the event of termination.


9) No-cost extensions require the approval of the Prime Recipient.
Any requests for a no-cost extension should be addressed to and received by the Administrative Contact, as shown in Attachment
2, not less than thirty days prior to the desired effective date of the requested change.


10) The Subaward is subject to the terms and
conditions of the Prime Award and other special terms and conditions, as identified in Attachment 1.


 


	By an Authorized Official of PRIME RECIPIENT:	 	By an Authorized Official of SUBRECIPIENT:
	 	 	 	 	 	 	 
	/s/ Anatoly Dritschilo	 	10/22/2014	 		 	10/28/2014
	 	 	 	 	 	 	 
	Anatoly Dritschilo, MD - CEO	 	Date	 	 	 	Date


 


Lifespan 3/15/10


 




     


     


    

 


Non-Federal


 


	Attachment 2
	Subaward Agreement


 


	Prime Recipient Contacts	Subrecipient Contacts
	Administrative Contact	Administrative Contact
	 	 
	Name:	
        Peter D. Dritschilo

        President & CFO
	Name:	Kim-Marie Lawrence
	 	 	 	 
	Address:	
        Shuttle Pharmaceuticals, LLC

        One Research Court, Suite 450

        Rockville, MD 20850-6252
	Address:	
        Office of Research Administration

        1 Hoppin Street, Suite 1,300

        Providence, RI 02903-4141

	 	 	 	 
	Telephone:	240-271-0642	Telephone:	401.444.8554
	Fax:	301-519-8081	Fax:	401.444.4061
	Email:	hoya92@aol.com	Email:	klawrence@lifespan.org
	 	 
	Principal Investigator	Project Director
	 	 
	Name:	Theodore Phillips, MD	Name:	
        Timothy Kinsella, MD

        “Essential to the project.”

	 	 	 	 
	Address:	
        Shuttle Pharmaceuticals, LLC

        One Research Court, Suite 450

        Rockville, MD 20850-6252
	Address:	
        Rhode Island Hospital

        593 Eddy Street, APC 1

        Providence, RI 02903

	 	 	 	 
	Telephone:	240-403-4212	Telephone:	401.444.6203
	Fax:	301-519-8081	Fax:	401.444.5335
	Email:	farfa12@aol.com	Email:	tkinsella@lifespan.org
	 	 	 	 
	Financial Contact	Financial Contact
	 	 
	Name:	
        Peter D. Dritschilo President & CFO

        President & CFO
	Name:	
        Donald Hook

        Manager, Research Finance

	 	 	 	 
	Address:	
        Shuttle Pharmaceuticals, LLC

        One Research Court, Suite 450

        Rockville, MD 20850-6252
	Address:	
        Rhode Island Hospital

        1 Hoppin Street, Suite 1.300

        Providence, RI 02903-4141

	 	 	 	 
	Telephone:	240-271-0642	Telephone:	401-444-5112
	Fax:	301-519-8081	Fax:	401-444-4061
	Email:	hoya92@aol.com	Email:	dhook@lifespan.org
	 	 
	Authorized Official	Authorized Official
	 	 
	Name:	Anatoly Dritschilo, MD CEO	Name:	Joan M. Silva
	 	 	 	 
	Address:	Shuttle Pharmaceuticals, LLC 

One Research Court, Suite 450 

Rockville, MD 20850-6252	Address:	
        Administrative Manager

        Rhode Island Hospital

        Office of Research Administration

        1 Hoppin Street, Suite 1.300

        Providence, RI 02903-4141

	 	 	 	 
	Telephone:	202-444-4068	Telephone:	401.444.4006
	Fax:	301-519-8081	Fax:	401.444.4061
	Email:	dritscha@georgetown.edu	Email:	jsilva@lifespan.org


 


Lifespan 3/15/10


 




     


     


    

 


Proposed Budget - Attachment 3 


 


701
xxxx


 


IPdR (BrUOG 265)


 


	Tim Kinsella, MD	 	Start	 	 	10/22/14	 	 	 	 	 	6/19/15	 	 	 	 	 	6/19/16	 	 	 	 
	 	 	End	 	 	6/18/15	 	 	 	 	 	6/18/16	 	 	 	 	 	6/18/17	 	 	 	 
	Personnel	 	Salary	 	 	Cal Mos.	 	 	Effort	 	 	Yr 1	 	 	Cal Mos.	 	 	Effort	 	 	Yr 2	 	 	Cal Mos.	 	 	Effort	 	 	

                                                                                 Yr 3
	 	 	TOTAL	 
	Tim Kinsella, MD	 	$	181,500	 	 	 	1.45	 	 	 	12.1	%	 	$	16,448	 	 	 	2.76	 	 	 	23	%	 	$	41,745	 	 	 	2.76	 	 	 	23	%	 	$	41,557	 	 	$	99,750	 
	Howard Safran, MD	 	$	181,500	 	 	 	0.47	 	 	 	3.9	%	 	$	5,332	 	 	 	1.08	 	 	 	9	%	 	$	16,335	 	 	 	1.08	 	 	 	9	%	 	$	16,335	 	 	$	38,002	 
	Andrea Monckeberg,	 	$	125,000	 	 	 	 	 	 	 	0.0	%	 	$	0	 	 	 	0.36	 	 	 	3	%	 	$	3,825	 	 	 	0.36	 	 	 	3	%	 	$	3,902	 	 	$	7,727	 
	Mark LeGolvan, MD	 	$	181,500	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	0.00	 	 	 	0	%	 	 	 	 	 	 	0.23	 	 	 	2	%	 	$	3,479	 	 	$	3,479	 
	TBN, CRA	 	 	$53 500	 	 	 	1 70	 	 	 	14.2	%	 	$	5,684	 	 	 	1.70	 	 	 	14.2	%	 	$	5,798	 	 	 	1.70	 	 	 	14.2	%	 	$	5,914	 	 	 	$17 396	 
	TBN, Res Nurse	 	$	87,210	 	 	 	 	 	 	 	0.0	%	 	$	0	 	 	 	6.60	 	 	 	55	%	 	$	47,966	 	 	 	6.60	 	 	 	55	%	 	$	48,925	 	 	$	96,890	 
	Total Salaries	 	 	 	 	 	 	 	 	 	 	 	 	 	$	27,464	 	 	 	 	 	 	 	 	 	 	$	115,669	 	 	 	 	 	 	 	 	 	 	$	120,111	 	 	$	263,244	 
	Fringe:	 	 	 	 	 	 	 	 	 	 	31.9	%	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Tim Kinsella, MD	 	 	 	 	 	 	 	 	 	 	 	 	 	$	5,247	 	 	 	 	 	 	 	 	 	 	$	13,317	 	 	 	 	 	 	 	 	 	 	$	13,257	 	 	$	31,820	 
	Howard Safran, MD	 	 	 	 	 	 	 	 	 	 	 	 	 	$	1,701	 	 	 	 	 	 	 	 	 	 	$	5,211	 	 	 	 	 	 	 	 	 	 	$	5,211	 	 	$	12,122	 
	Andrea Monckeberg,	 	 	 	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	1,220	 	 	 	 	 	 	 	 	 	 	$	1,245	 	 	$	2,465	 
	Mark LeGolvan, MD	 	 	 	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	1,110	 	 	$	1,110	 
	TBN, CRA	 	 	 	 	 	 	 	 	 	 	 	 	 	$	1,813	 	 	 	 	 	 	 	 	 	 	$	1,850	 	 	 	 	 	 	 	 	 	 	$	1,887	 	 	$	5,549	 
	TBN, Res Nurse	 	 	 	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	15,301	 	 	 	 	 	 	 	 	 	 	$	15,607	 	 	$	30,908	 
	Total Fringe Benefits	 	 	 	 	 	 	 	 	 	 	 	 	 	$	8,761	 	 	 	 	 	 	 	 	 	 	$	36,898	 	 	 	 	 	 	 	 	 	 	$	38,315	 	 	$	83,975	 
	Total Sal + Fringe	 	 	 	 	 	 	 	 	 	 	 	 	 	$	36,226	 	 	 	 	 	 	 	 	 	 	$	152,567	 	 	 	 	 	 	 	 	 	 	$	158,427	 	 	$	347,219	 
	Equipment	 	 	 	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	$	0	 
	Supplies	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Animal	 	 	 	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	$	0	 
	Lab Supplies	 	 	 	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	$	0	 
	Total Supplies	 	 	 	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	$	0	 
	Travel	 	 	 	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	$	0	 
	Other	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Publications	 	 	 	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	$	0	 
	BrUOG	 	 	 	 	 	 	 	 	 	 	 	 	 	$	5,000	 	 	 	 	 	 	 	 	 	 	$	37,500	 	 	 	 	 	 	 	 	 	 	$	37,500	 	 	$	80,000	 
	Biopsy costs/ processing	 	 	 	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	6,000	 	 	$	6,000	 
	Total Other	 	 	 	 	 	 	 	 	 	 	 	 	 	$	5,000	 	 	 	 	 	 	 	 	 	 	$	37,500	 	 	 	 	 	 	 	 	 	 	$	43,500	 	 	$	86,000	 
	Total Direct	 	 	 	 	 	 	 	 	 	 	 	 	 	$	41,226	 	 	 	 	 	 	 	 	 	 	$	190,067	 	 	 	 	 	 	 	 	 	 	$	201,927	 	 	$	433,219	 
	Less: Equipment	 	 	 	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	 	 	 	 	 	 	 	 	$	0	 	 	$	0	 
	MTDC Indirect Base x Indirect Rate (59% as
    of 10/01/11)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	$41,226
 59%
	 	 	 	 	 	 	 	 	 	 	 	$190,067
 59%
	 	 	 	 	 	 	 	 	 	 	 	$201,927
 59%
	 	 	 	$433,219
 59%
	 
	Indirect Costs	 	 	 	 	 	 	 	 	 	 	 	 	 	$	24,323	 	 	 	 	 	 	 	 	 	 	$	112,139	 	 	 	 	 	 	 	 	 	 	$	119,137	 	 	$	255,599	 
	Total Costs	 	 	 	 	 	 	 	 	 	 	 	 	 	$	65,549	 	 	 	 	 	 	 	 	 	 	$	302,206	 	 	 	 	 	 	 	 	 	 	$	321,063	 	 	$	688,818	 



 




     


     


    

  


ATTACHMENT 4 

SUBAWARD AGREEMENT


 


This attachment provides a (1) a statement
of flowdown clauses from the prime contract # HHSN261201400013C, (2) precedence of the prime contract (3)statement of work and
(4) reporting requirements for Phase I and Phase II.


 


Flowdown Clauses


 


Line 10 of the subaward agreement states "The
Subaward is subject to the terms and conditions of the Prime Award and other special terms and conditions, as identified in Attachment
1.” The Items are in sections H and I of the contract # HHSN261201400013, included in Attachment 1.


 


Order of Precedence


 


This Contract, together with the enumerated
Attachments (1-4) hereto (all of which are incorporated herein by this reference) shall comprise this Contract and shall together
be referred to as the "Sub-contract Documents.” In the event of any inconsistencies between this Contract and the Prime
Contract HHSN2612014800013C, as included in Attachment 1, the prime contract will have precedence in the interpretation or resolution
of such conflict.


 


Statement of Work - Subcontract


 


I. Background Information and Objectives


 


For NIH review of the Lifespan/RIH subcontract
and the subcontract statement of work the following summary is provided. The subcontractor will work with the PI and the prime
contractor to accomplish the following tasks. The full SOW is included in the signed contract # HHSN261201400013C.


 


PHASE I SBIR


 


A. Technical Objectives


 


Objective 1. Activate the IPdR IND for the
Phase I and PK clinical trial.


 


Task 1.1. File administrative documents
to initially cross-file (IND 70,333) and obtain an IND for the IPdR and RT clinical trial.


Milestone 1.1. An IPdR IND.


 


Task 1.2. Negotiate with CTEP to transfer
sufficient clinical product IPdR for performance of the clinical trial.


Milestone 1.2. Clinical product (encapsulated) IPdR, will
be made available for the proposed Phase I and PK clinical trial at Lifespan/RIH.


 


Lifespan


 




     


     


    

 


Objective 2. Obtain approvals for the Phase I and PK clinical
protocol. Develop efficacy protocols satisfying FDA “Orphan Drug” status.


 


Task 2.1. Submit a Letter of Intent (LOI) to NCI CTEP for
the Phase I and PK clinical studies of IPdR.





Milestone 2.1. LOI approval.





Task 2.2. Submit to the IRB the Phase I and PK study protocol.





Milestone 2.2. IRB approval of the Phase I study for IPdR
+ RT.





Task 2.3. Consult with the FDA regarding "Orphan Drug”
status for IPdR


Milestone 2.3. FDA guidance on "Orphan Drug” status for IPdR for rectal cancer.


 


Objective 3. Establish the in-house (Shuttle Pharmaceuticals.
LLC Laboratories) biomarker assays.


 


Task 3.1 will be performed at NIH and Shuttle Pharmaceuticals






Task 3.2. Prepare a written report of Phase I SBIR achievements
to NIH.


Milestone 3.2.NIH accepts the report and exercises the option
for Phase II.


 


Gantt Chart 1: Phase I. Milestones, Deliverables, Timeline
& Work Distribution. between Shuttle Pharmaceuticals, LLC (SP) and Lifespan/Rhode Island Hospital (L/RIH).


 


	 	 	 	Months
	Site	 	Milestones
    and Deliverables	 	1	 	2	 	3	 	4	 	5	 	6	 	7	 	8	 	9
	SP,	 	Objective 1. Task 1.1.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	L/RIH	 	Milestone 1.1. Activation of the IPdR IND	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	Objective 1. Task 1.2.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Milestone 1.2. IPdR clinical product for use in the Phase I clinical trial	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	Objective 1. Task 1.3.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Milestone 1.3. Capsules of IPdR for Phase I.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP,	 	Objective 2. Task 2.1.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	L/RIH	 	Milestone 2.1. CTEP approval of the Phase I and PK LOI.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP,	 	Objective 2. Task 2.2.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	L/RIH	 	Milestone 5. IRB approval of the Phase I clinical trial.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	Objective 2. Task 2.3.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Milestone 6. FDA advice regarding "Orphan Drug” status for IPdR in rectal cancer treatment.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	Objective 3. Task 3.1.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Milestone 3.1. The GLP %IUdR-DNA cellular incorporation assays established in SP laboratories.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	Objective 3. Task 3.2.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Milestone 3.2. NIH approves final report and exercises the Phase II option.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 


 


Lifespan


 




     


     


    

 


PHASE II SBIR


 


A. Technical Objectives


 


Objective 1: Perform the Phase I and PK clinical trial of
IPdR-mediated radiosensitization.


 


Task 1.1. Perform the Phase I clinical
trial.


Milestone 1.1. Collect clinical data.


Milestone 1.3. Collect and transfer
clinical samples to SP Laboratories for analysis.


 


Objective 2: Perform PK analyses to determine
optimal dosing schedule.


 


Task 2.1. Determine
pharmacokinetics (PK) and %IUdR-DNA for biomarker analysis. 


Milestone 2.1. Clinical specimens are obtained and
analyzed for PK & % IUdR-DNA.


Milestone 2.2. PK analyses results.


Milestone 2.3. %IUdR-DNA incorporation
results and clinical correlation.


 


Objective 3: Use Phase I and PK results
to design the Phase IB/II clinical trial.


 


Task 3.1. Analyze the PK data to determine
optimal IPdR dosing.


Milestone 3.1. Optimum dosing schedule
of IPdR is established.


Task 3.2. Design and write the Phase IB/II protocol for efficacy
determination.


Milestone 3.2. Phase IB/II clinical protocol for IPdR and RT in rectal cancer.


 


Objective 4: Advance the business development and commercialization
plan.


 


Task 4.1. Use Phase I clinical trial
results to raise capital for efficacy clinical trials. 


Milestone 4.1. Written business development and commercialization.


Task 4.2. Prepare a final written report
for the Government Project Officer.


Milestone 4.1. Written final progress
report is accepted.


 


Gantt Chart 2: Phase II Milestones, Deliverables
and Work Distribution.


 


	 	 	 	 	Delivery Schedule (months)
	Site	 	Milestones and Deliverables	 	2	 	4	 	6	 	8	 	10	 	12	 	14	 	16	 	18	 	20	 	22	 	24
	L/RIH	 	Objective 1. Task 1.1 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Milestone 1.1. Initiation and performance of the Phase I and PK clinical trial of IUdR with RT. Milestone 1.2. Safety and MTD parameters for IPdR with RT. Milestone 1.3. Collect and transfer clinical samples to SP Labs.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	L/RIH	 	Objective 2. Task 2.1.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	Milestone 2.1. Obtain clinical specimens for PK & %IUdR-DNA Milestone 2.2. PK analyses Milestone 2.3. %IUdR-DNA incorporation is determined and correlated with clinical observations.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	Objective 3: Task 3.1.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Milestone 3.1. Dosing schedule of	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	IPdR is established, based on PK	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	Objective 3: Task 3.2.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Milestone 3.2. Written Phase IB/II clinical protocol	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	Objective 4: Task 4.1.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Milestone 4.1 Written business and commercialization plan.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP,	 	Objective 4: Task 4.2. 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	L/RIH	 	Milestone 4.2. Final report submitted to NIH.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 


 


Shuttle Pharmaceuticals, LLC (SP); Lifespan/Rhode Island Hospital
(L/RIH)


 


Lifespan


 




     


     


    

  


Reporting Requirements


 


	Phase  I	 
	1.	Kick-off presentation 10/16/14	 
	2.	Phase I, two quarterly reports	12/19/14 and 3/19/15
	3.	Draft Updated Commercialization Plan	5/18/15
	4.	Draft Final Report and Draft Summary of Salient Results	6/18/15
	5.	Final Commercialization Plan	6/18/15
	6.	Final Report	6/18/15
	7.	Final Presentation	6/18/15


 


Phase II contract activities and reporting will be contingent on
the Government’s decision to exercise the option per Article B.# of the contract # HHSN261201400013C.


 


	Phase II	 
	1.	Option exercised	(approximately) 6/19/15
	2.	Phase II, quarterly reports exercises	every 90 days after option
	3.	Draft Final Report for Phase II and Summary of Salient Clinical Trial Results	5/19/17
	4.	Draft Phase II Final Report	6/19/17
	5.	Phase II Final Report and Presentation	6/19/17
	6.	Summary of Salient Clinical Trial Results	6/19/17


 


	Additional Reporting and Certifications	 
	 	 	 
	7.	Annual technical progress report for Clinical Research Study Populations	6/19/17
	8.	Protection of Human Subjects	6/19/15
	9.	Annual Utilization	6/19/16
	10.	Final Invention Statement and Disclosure	6/19/17
	11.	Annual Report	6/19/16
	12.	Conformance Certification	6/19/15
	13.	Financial Conflict of Interest	as it arises
	14.	Life Cycle Phase I	6/18/15
	15.	Life Cycle Phase II Report 1	6/18/16
	16.	Life Cycle Phase II Report 2	6/18/17


 


Lifespan