Exhibit 10.9


 


 


 


	March 29, 2013	 
	 
	Nadav Navon, PhD, MBA
	Intec Pharma
	12 Hartom St, P.O.B 45219, Jerusalem 91450
	Israel
	 
	Re: MJFF Research Grant 2013
	 
	Project Title: “Oral Toxicity Study in Goettingen Pigs with 30-Day Recovery (GLP”
	 
	Dear Dr. Navon:
	 
	On behalf of the Board of Directors of The Michael J. Fox Foundation for Parkinson’s Research (MJFF), it is a pleasure to make this award in the amount of $704,479.25 to conduct the research described in your proposal, “Oral Toxicity Study in Goettingen Pigs with 30-Day Recovery (GLP.”
	 
	This nine-month award is offered based on your representation that you have no overlapping grants or additional funding for this work. Please contact MJFF immediately if at any time during this period additional third-party funding is sought or received, or if circumstances arise prohibiting completion of your project on schedule. The terms and conditions governing this award are detailed in the attached agreement. Please read it carefully and contact us with any questions.
	 
	To accept this award,
    please sign the enclosed agreement (including appropriate institutional sign-off). Please scan the signed agreement and send
    electronically to AHARRIS@michaeljfox.org. We ask that you return a signed agreement no later than April 5, 2013. If
    you do not wish to accept finding, please notify MJFF as soon as possible.
	 
	The Michael J. Fox Foundation for Parkinson’s Research is enthusiastic about supporting your research and wishes you utmost success with this project and all your pursuits. Congratulations!
	 
	Sincerely,
	 
	/s/ Joanne Martz
	Joanne Martz
	Chief Financial and Administrative Officer
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 




 


Grand Central Station • P.O. Box 4777 • New York, NY
10163-4777 • Tel. 212-509-0995 • Fax 212-509-2390 • www.michaeljfox.org


 




    	 



    	 



    

 


 


 


	The Michael J. Fox Foundation for Parkinson’s Research	
	Award Terms and Conditions — MJFF Research Grant 2013
	 
	Principal Investigator(s): Nadav Navon, PhD, MBA
	 
	The Michael J. Fox Foundation for Parkinson’s Research (MJFF) is pleased to make you this award (the “Award”) to support the work described in your application, “Oral Toxicity Study in Goettingen Pigs with 30-Day Recovery (GLP.” (the “Project”). In accepting this Award, you and your institution (collectively, “You” or “you”) agree to the following terms and conditions in this Agreement.
	 
	1.      Sources of Funds 
	 
	This Award is made with the understanding that your Project currently has no additional sources of funding and does not overlap with any existing grants. You agree that you will neither solicit nor accept additional funding for this Project without prior written notice to MJFF. If there is overlap between this Award and another grant made to you by another third party, MJFF will renegotiate the budget of this Award with you (a copy of the final budget is provided with this Agreement as Appendix A) and reserves the right to provide less funding than identified in this Award or obtain a refund from you, so that funding from this Award does not overlap with another grant. If you receive additional funding for your Project without MJFF’s advance written consent, MJFF reserves the rights to withhold funding and require repayment of this Award if it is not satisfied, in its reasonable discretion, that the additional funding is for incremental research activity which does not overlap with this Award or conflict with your ability to perform the Project.
	 
	2.      Use of Funds 
	 
	2.1      Funds awarded by MJFF are to be used solely for the Project and are conditioned on your meeting certain milestones and deliverables, which are attached  at Appendix B, timely delivery of expense and progress reports and participation in MJFF sponsored meetings at which your progress will be assessed. MJFF assessments are based on review of your progress at regular intervals, determination of the quality of the scientific research performed, and its continued high relevance to Parkinson’s disease (“MJFF Assessment Criteria”). In exchange, MJFF agrees to pay all direct costs for this Project, in addition to indirect costs with a limit of up to 10% of direct costs. For this Award, funds are allotted in the amount of $640,435.68 direct costs, and $64,043.57, indirect costs. Any unused funds at the end of the Award period, as detailed in a final expense report, must be returned to MJFF within one month from the submission of the expense report. You shall maintain complete and accurate books, records and accounts that, in reasonable detail, fairly reflect the use of the Award. MJFF shall have the right to review and audit such books, records and accounts at a mutually convenient time upon prior written notice to you.
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 
	 




 


Grand Central Station • P.O. Box 4777 • New York, NY
10163-4777 • Tel. 212-509-0995 • Fax 212-509-2390 • www.michaeljfox.org


 




    	 



    	 



    

 


 


 


2.2        The
Award is to be used as budgeted and reflected in the milestones. Any alterations, amendments, or changes in the specific goals
or budget of the Project will require the review and pre-approval of MJFF. Examples of such alterations or amendments include (but
are not limited to): transfer of a Principal Investigator (“PI”) from one institution to another, adding or deleting
a specific Project goal, budget reallocation, or modification of proposed workload and milestones. Please note that MJFF funds
shall not be used for travel or equipment costs not approved in the budget as awarded (see Appendix A). 


 


2.3        If
you request a change to the Award, you must submit a written request for approval detailing the requested change and
associated rationale in advance to a member of the MJFF research team. Failure to obtain prior approval for any changes in
work timeline, milestones or budget may result in revocation of funding in whole or part. You agree that funds expended by
you either not in accordance with the approved Project or prior to pre-approval of any material change to are both (i)
recoverable by, and subject to restitution by you to, MJFF and (ii) may be cause for immediate termination of funding by
MJFF.


 


		3.	Grant Timeline 



 


3.1        MJFF expects
that your Project will be completed according to the agreed timeline attached at Appendix B. Continued funding also is contingent
on demonstrated progress and satisfactory assessment by MJFF. To this end, you are required to do the following:


 


		(a)	Provide written proof of Institutional Animal Care and Use Committee (“IACUC”) approval
one month from date of award notification (March 29, 2013). Payment to begin work will not be issued without IACUC approval.



 


		(b)	Confirm in writing that all personnel (including technicians and post-doctoral fellows) have been
hired by the third month of the project, or that any delay in hiring has not postponed progress on the work described. MJFF will
contact awardees at the three-month mark of the Award for such confirmation. Failure to meet this requirement may result in withholding
of further payment.



 


		(c)	Participate in regularly scheduled assessment meetings and/or teleconferences. Failure to participate
in these assessments and to demonstrate satisfactory progress may result in withholding of future payments.



 


		(i)	The first assessment will be held at the six-month mark of your Award by teleconference to review
initial progress.



 


		(ii)	An assessment meeting will be held at the completion of your Award; The individual awardee is required
to attend assessment meetings in person, unless otherwise informed by MJFF.



 


		(d)	Complete
                                         progress and expense reports detailing your progress against milestones and your associated
                                         expenditures. These reports will be due before the assessment meeting at the completion
                                         of your award. When appropriate, additional reports may be requested before other assessment
                                         meetings and teleconferences. Templates will be provided to you to facilitate this reporting.
                                         These reports will be reviewed by MJFF against the MJFF Assessment Criteria; MJFF may
                                         thereafter provide you with suggestions, critique, and feedback.



 




    	 



    	 



    

 


 


 


		(e)	Participate openly in discussions regarding your Project with MJFF’s scientific and research
staff, and advisors.



 


3.2        Failure to meet
milestones, furnish scheduled deliverables, including any reports, satisfactorily meet MJFF Assessment Criteria or comply with
this Agreement may serve as one or more bases for termination of funding by MJFF.


 


3.3        If
at any time circumstances arise that prohibit completion of the Project on schedule, you are required to notify MJFF
immediately. MJFF will consider granting ONE no-cost extension per project on a case by case basis. To apply for a no-cost
extension, submit a letter detailing the request. The letter should include reasons for delays or changes, associated
rationale, a timeline for continuing the work, and an expense report detailing remaining funds.


 


		4.	Payment Schedule 



 


4.1        Subject to the foregoing conditions,
MJFF intends to pay your Award on the installment schedule outlined in the Milestones Appendix B document.


 


4.2        MJFF reserves the right to change
this schedule if necessary and will notify you and/or your administrator in writing in that event.


 


		5.	Confidentiality 



 


5.1        MJFF treats
all pre-proposals, applications, research projects, associated research information and underlying data (collectively, the “Confidential
Information”) as confidential, using no less than reasonable care in protecting the Confidential Information from disclosure
to third parties who do not participate in the application review and assessment processes. All Confidential Information will be
used by MJFF for the purposes of reviews and assessments, and will be shared only in accordance with its Sharing Policy (see Section
7 below). Such obligations cover any information retained in the unaided memories of persons participating in reviews and assessments
and may not be used without the permission of the disclosing party. Notwithstanding the foregoing, the obligations governing the
disclosure and use of Confidential Information do not apply with respect to Confidential Information that:


 


		(a)	was generally known to the public at the time of disclosure;



 


		(b)	becomes generally known to the public through no unlawful or unauthorized act or omission, or violation
of this Agreement, by any recipient of Confidential Information, ;



 


		(c)	was independently developed by any recipient prior to disclosure; or



 


		(d)	was disclosed to a recipient by a third party who has the right
                                                                                                        to make such disclosure. 



 




    	 



    	 



    

 


 


 


5.2        Provided that subsections
(a)-(d) above do not become applicable, if any recipient of Confidential Information is asked to produce any Confidential Information
pursuant to a legal or governmental proceeding, such recipient shall give the applicant or other owner of such Confidential Information
(the “Discloser”) as much prior notice of such request as is reasonably practicable, under the circumstances and shall
use its reasonable efforts to assist the Discloser of such Confidential Information in defending Discloser’s rights (at Discloser’s
cost), including objecting to such request, obtaining confidential treatment for Confidential Information, disclosing only that
portion of the Confidential Information responsive to a judicial or governmental order, and providing Discloser with any copies
of Confidential Information so disclosed.


 


		6.	Data Underlying Research Information to be Included with Progress Reports



 


With each progress report,
you agree to provide MJFF, in a format prescribed by it, the data underlying your research information for each milestone (the
“Data”). MJFF and its grant assessors will use the Data to assess your progress toward achieving the milestones.


 


		7.	Sharing Policy 



 


7.1        As
MJFF is a public charity, research conducted with funds from MJFF (“Research”) must be conducted in the public interest
MJFF acknowledges that discoveries and related regulatory approvals made by researchers under its sponsorship are the property
of those conducting and responsible for the Research and that unless otherwise agreed to by the parties, such researchers shall
have the first opportunity to exploit the Research commercially or otherwise.


 


		7.2	Notwithstanding the foregoing, you agree that MJFF:



 


		(a)	may retain the Data and that MJFF may, 90 or more days after expiration of the Award, make
                                                                the Data available to MJFF employees, consultants, grant recipients and others affiliated with MJFF through a secure medium
                                                                to advance scientific discovery. This subsection shall not prohibit MJFF from making the Data available before expiration of
                                                                the grant to persons executing MJFF’s Confidential Disclosure Agreement for the purpose of assessing your progress
                                                                toward achieving the milestones. If the Data ceases to be Confidential Information as described in subsections (a)-(d) of
                                                                MJFF’s Confidentiality policy, then these restrictions on dissemination shall not apply;



 


		(b)	may, after reasonable consultation which will not be unreasonably denied, conditioned or delayed
by you, publicly release a summary of findings of the research 90 or more days after expiration of the Award; and,



 


		(c)	may make all tools or reagents (i)
                                                                                                                              funded by and (ii) that result from awarded projects (collectively, the “Results”) readily available to the
                                                                                                                              community including MJFF for research purposes 90 or more days after expiration of the Award. You agree that you will
                                                                                                                              cooperate and collaborate with MJFF and other researchers and share access to Results on fair and reasonable terms and
                                                                                                                              conditions. By signing this Agreement, you and your institution are confirming that you are not aware of any requirements
                                                                                                                              that would prohibit, delay,
                                                                                                                              or restrict your ability to share your Results from this initiative, including requirements of third-party collaborators
                                                                                                                              or companies with which you are affiliated.



 




    	 



    	 



    

 


 


 


		(d)	Notwithstanding the 90-day periods set forth in subsections (a)-(c) above, MJFF will consider
                                                                  a request by you to delay the availability of Data, a summary and/or the Results in order to complete any necessary
                                                                  intellectual property filings.



 


		8.	Liability 



 


You acknowledge that MJFF
is solely a passive grantor, and you hereby agree to indemnify, defend and hold MJFF, its directors, trustees, officers, employees,
agents and consultants harmless in connection with all liability directly or indirectly arising out of the Project, including all
associated costs, damages and expenses and reasonable attorney’s fees.


 


		9.	Use of MJFF Brand



 


You agree to
abide by the following policy regarding use of MJFF’s name, logo, marks, trade dress, image, and likeness of Michael J.
Fox, its founder (collectively, the “Brand”). MJFF prohibits any use of the MJFF Brand in any publicity efforts,
notices, releases, statements or publications without its prior written approval. All use of the Brand including, without
limitation, the name/image/likeness of Michael J. Fox shall be submitted in advance to MJFF for approval. Failure of MJFF to
approve any proposed use of the Brand within five (5) business days of its receipt of any request for approval of a proposed
use shall be deemed non-approval of the proposed use. You acknowledge that these terms are reasonable precautions to protect
the MJFF Brand and its goodwill, both of which are extremely valuable assets of MJFF. Any goodwill resulting from an approved
use of the MJFF Brand by you shall inure solely and exclusively to MJFF.


 


		10.	Publication 



 


MJFF expects that information about
the Results will be published as rapidly as possible in the open scientific literature, consistent with high standards of scientific
excellence and rigor.


 


		11.	Recognition of Funder 



 


Any publications
resulting from this Award shall include acknowledgement of the funding provided by The Michael J. Fox Foundation for Parkinson’s
Research. When publications result from work funded under this Award, you are required to update MJFF, even if such publications
occur after the end of the Award.


 


		12.	Animal or Human Subjects and Compliance with Law 



 


12.1        If your
project involves the use of animals or human subjects, you must provide a letter of approval for such use from your institution’s
regulatory assurance body prior to the initiation of funding.


 




    	 



    	 



    

 


 


 


12.2        You are solely responsible for
complying with any and all applicable laws relating to the Project.


 


		13.	Miscellaneous 



 


13.1        This Agreement including appendices constitutes the entire agreement of the parties related to its subject matter and supersedes
all prior agreements, oral or written. This Agreement may not be modified, amended or waived except by written agreement of the
parties.


 


13.2        All
notices to MJFF required or permitted by this Agreement shall be sent by email to: aharris@michaeljfox.org, unless MJFF
specifies a different person to you in writing.


 


13.3        This
Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.


 


Accepted and agreed to by:


 


	/s/ Joanne Martz	3/29/13
	Joanne Martz	 
	Chief Financial and Administrative Officer, MJFF	Date
	 	 
	/s/ Nadav Navon	 
	Nadav Navon, PhD, MBA	Date 3/4/13
	 	 
	Intec Pharma Institutional Approval:	 
	Name: GIORA CARNI	 
	Title: CEO	 
	Ph: 922-2-5864657	 
	Email: GIORA@intecpharama.com	 
	Signature:
    /s/ Giora Carni	Date 3.4.2013


 




    	 



    	 



    

 


The Michael J. Fox Foundation for Parkinson’s
Research


MJFF Research Grant 2013


Appendix A - Overview


 


Name (Last, First): Navon, Nadav


Project Title: Oral Toxicity Study in
Goettingen Pigs with 30-Day Recovery (GLP


 


	Summary of Totals	 	Total Costs ($US)	 	 	Total Director Costs ($US)	 	 	Total Indirect Cost ($US)	 
	Total Administrative Costs (from Planning Phase)	 	$	3,379.20	 	 	$	3,072.00	 	 	$	307.20	 
	Total Execution Phase (Months 4-12)	 	$	701,100.05	 	 	$	637,363.68	 	 	$	63,736.37	 
	Total Execution Phase (Months 13-24)	 	 	 	 	 	 	 	 	 	 	 	 
	Total Execution Phase (Months 25-36)	 	 	 	 	 	 	 	 	 	 	 	 
	TOTAL PROJECT BUDGET	 	$	704,479.25	 	 	$	640,435.68	 	 	$	64,043.57	 



 


Note: Totals in the grey section above will pre-populate based
on the completion of additional worksheets. Your completion of this section is not required.




 


Please
specify how much each patient visit will cost (list any details factored into the costs     NA

 


	Details	 	Costs in US $	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	Cost per patient visit	 	 	0	 



 


List the number of patient visits expected throughout the duration
of the trial.       NA


 


	 	 	Year 1	 	 	Year 2	 	 	Year 3	 	 	Total	 
	Number of Patient Visits	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0	 
	Cost of Patient Visits Per Year	 	 	0	 	 	 	0	 	 	 	0	 	 	 	0	 



 




    	 



    	 



    




 


The Michael J. Fox Foundation for Parkinson’s
Research


MJFF Research Grant 2013


Appendix A - Planning Phase (Months 1-3)


 


Name (Last, First): Navon, Nadav


Project Title: Oral Toxicity Study in Goettingen
Pigs with 30-Day Recovery (GLP


 





	Total Planning Phase Costs:	 	$	3,379.20	 
	Direct Costs	 	$	3,072.00	 
	Indirect Costs:	 	$	307.20	 





 


PERSONNEL


 


	Name	 	Role	 	% Effort	 	 	Base Salary	 	 	Salary Requested	 	 	Fringe Benefits	 	 	Total Requested	 
		 	Principal Investigator	 	 	2	%	 	$	120,000.00	 	 	$	2,400.00	 	 	$	672.00	 	 	$	3,072.00	 
	 	 	 	 	 	0	%	 	$	-	 	 	$	-	 	 	$	-	 	 	$	-	 
	 	 	 	 	 	0	%	 	$	-	 	 	$	-	 	 	$	-	 	 	$	-	 
	 	 	 	 	 	0	%	 	$	-	 	 	$	-	 	 	$	-	 	 	$	-	 
	 	 	 	 	 	0	%	 	$	-	 	 	$	-	 	 	$	-	 	 	$	-	 
	 	 	 	 	 	0	%	 	$	-	 	 	$	-	 	 	$	-	 	 	$	-	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	$	3,072.00	 



 





	Other ORB submission, database set up, etc
	Description	 	Total Requested	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	$	      	 
	 	 	 	 	 
	Direct Costs:	 	$	3,072.00	 
	Indirect Costs (10%):	 	$	307.20	 
	 	 	 	 	 
	Total Expenditures:	 	$	3,379.20	 



 


 



    	 



    	 



    

 


The
Michael J. Fox Foundation for Parkinson’s Research


MJFF Research
Grant 2013


Appendix
A - Execution Phase (Months 4-12)


 


Name (Last, First): Navon, Nadav


Project Title: Oral Toxicity Study in Goettingen
Pigs with 30-Day Recovery (GLP



 


	Total Grant Amount:	 	$	701,100.04	 
	Total Direct Costs	 	$	637,363.68	 
	Total Indirect Coots:	 	$	63,736.37	 



 


	PERSONNEL	 	 
	Name	 	Role	 	%
    Effort	 	 	Base
    Salary	 	 	Salary
    Requested	 	 	Fringe
    Benefits	 	 	Total
    Requested	 	Fixed vs. Per Patient Costs
		 	Principal Investigator	 	 	8	%	 	$	120,000.00	 	 	$	9,600.00	 	 	$	2,688.00	 	 	$	12,288.00	 	 
	 	 	 	 	 	0	%	 	$	-	 	 	$	-	 	 	$	-	 	 	$	-	 	 
	 	 	 	 	 	0	%	 	$	-	 	 	$	-	 	 	$	-	 	 	$	-	 	 
	 	 	 	 	 	0	%	 	$	-	 	 	$	-	 	 	$	-	 	 	$	-	 	 
	 	 	 	 	 	0	%	 	$	-	 	 	$	-	 	 	$	-	 	 	$	-	 	 
	 	 	 	 	 	0	%	 	$	-	 	 	$	-	 	 	$	-	 	 	$	-	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	$	12,288.00	 	 


 


	SUPPLIES,
    DATA MGMT, PATTENT VISITS (please itemize)	 	 
	Item	 	Unit
    Cost	 	 	#
    Units	 	 	Total
    Requested	 	Fixed va. Per Patient Costs
	Calvert Labs	 	$	583,400.00	 	 		1	 	 	$	583,400.00	 	 
	 	 			 	 			 				 	 
	ANALYST RESEARCH LABORATORIES LTD	 	$	41,675.68	 	 		1	 	 	$	41,675.68	 	 
	 	 	 	 	 	 			 	 	$	-	 	 
	 	 			 	 			 	 	$	-	 	 
	 	 			 	 			 	 	$	-	 	 
	 	 	 	 	 	 	 	 	 	 	$	625,075.68	 	 



	Direct Costs:	 	$	637,363.68	 	 
	Indirect Costs (10%):	 	$	63,736.37	 	 
	 	 	 	 	 	 
	Total Expenditures:	 	$	701,100.04	 	 


 





	Total Fixed Costs	 	 	 	 
	Total Per Patient Costs	 	 	 	 
	Total Months 4-12 Costs	 	 	 	 


 



    	 



    	 



    

 


 


 


Nadav Navon, PhD, MBA- MJFF Award Agreement


Appendix B - Project Payment Schedule & Milestones


 


The Michael J. Fox Foundation for Parkinson’s Research


Levodapa Delivery
- MJFF Research Grant 2013


 


Principal Investigator: Nadav Navon, PhD;


Project Title: Toxicity Study in Goettingen Pigs
with 30-Day Recovery (GLP)


 


Project Deliverables:
To evaluate in Goettingen Pigs the toxicity of Accordion Pills, containing CD/LD vs. placebo control or Sinemet, when administered
orally, by capsule, two or three times daily for 180 consecutive days, followed by one month of recovery. The study will include
thorough, focused examination of the entire gastrointestinal tract at necropsy with particular attention to the presence of residual
administered product-associated material. 


 


	Description	 	Milestones 
 (required for next payment)	 	Amount	 	 	Payment Timing
	Months 0-3 Milestones	 	•   Obtain IACUC permission and send copy to MJFF

                                             •   Send final protocol to MJFF

                                             •   Purchase 48 Goettingen Pigs
	 	$	230,000	 	 	Payable within 30 days following full execution of Award
	 	 	 	 	 	 	 	 	 
	Months 4-6 Milestones	 	•   Begin experiment (4 groups of 12 pigs each, as per protocol)

                                                                             •   Participate in follow-up call and communicate progress
                                                                             report to MJFF
	 	$	230,000	 	 	Payments will be issued based on progress reports provided to MJFF by
    Awardee. Reports will indicate progress against milestones.
	 	 	 	 	 	 	 	 	 
	Months 7-9 Milestones for Execution Phase	 	•   Conclude study

                                 •   Euthanize 3 animals/sex/group to assess presence of
                                 residual administered product associated material.

                                 •   Send final report to MJFF
	 	$	244,479.25	 	 	Payments will be issued based on progress reports provided to MJFF by
    Awardee. Reports will indicate progress against milestones.
	 	 	 	 	 	 	 	 	 
	 	 	Total Project:	 	 	 	 	 	$704,479.25