Exhibit 10.3

	
	CONSULTING AGREEMENT
This Consulting Agreement ("Agreement") is made as of this 15th day of June, 20 19, by
and between Khodai Consulting, Inc., an independent consu ltant ("the Consultant") and
YisionCare, Inc. ("the Company"), in reference to the fo llowing:
RECITALS
A. The Company is in the business of manufacturing and selling medical products used
for surgical implantation in the human eye.
B. The Consultant is a clin ical and regulatory expert.
C. The Company wishes to retain the Consultant, and the Consultant wishes to be
retained by the Company, to support ongo ing clinical activities.
NOW, THEREFORE, in consideration of the prem ises stated above, and fo r other good
and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
Company and the Consultant agree as fo llows:
AGREEMENT
1. Term. The Company retains the Consultant and the Consultant accepts this appointment
with the Company for a period beginning onA:/!+?r (t~ ~~~mmencement Date").
2. Compensation. The Company shall pay to the Consultant, as compensation for the services
performed pursuant to this Agreement, the amount of $250 per hour, to be paid on the last day of each
month during the term of this agreement after the performance of the services to be performed in the prior
monthly period.
3. Termination for Cause.
3.1. Termination for Cause. The Consultant reserves the right to immediately
terminate this Agreement if the Company breaches this Agreement or habituall y neglects the duties
that is required to perform hereunder, or if Company comm its acts of dishonesty, fraud, or
misrepresentation, misuses or misappropriates Confidential Information. The Consultant reserves the
right to immediately terminate this Agreement if the Company fa ils to promptly and faithfully comply
with all laws and regulations or commits any act or becomes involved in any situation or occurrence
tending to bring the Consultant into public scandal or ridicule or which will reflect unfavorably on the
reputation of the Consultant.
3.2. Notice of Termination/No Election of Remedies. If the Consultant
terminates this Agreement pursuant to Section 3.1 above, the Consultant shall give written notice of
termination to the Company without prejudice to any other remedy under this Agreement.
3.3. Termination For Cause. Termination of this Agreement under this section
shall be considered termination " for cause."
ADDRESS CONTACT
23 Bellflower, Lake Forest, CA 92630 (949) 735-4727 omid@drkhodai.com 





	
	4. Termination by Notice. With the exception of the obligations set forth, either party may
terminate this Agreement upon thirty days' written notice to the other party.
5. Status of the Consultant. The Consultant is not an employee of the Company and that not
entitled to receive employee benefits from the Company, including, but not limited to, sick leave,
vacation, retirement, death benefits, an automobile, stock in the Company and/or participation in profits
earned by the Company. The Consultant is responsible for providing, at the Consultant's expense and in
the Consultant's name, disability, worker's compensation or other insurance as well as licenses and
permits usual or necessary for conducting the services hereunder. Fwthermore, the Consultant shall pay,
when and as due, any and all taxes incurred as a result of the Consultant's compensation hereunder,
including estimated taxes.
6. Representations by the Consultant. The Consultant represents that the Consultant has the
qualifications and ability to perform the services in a professional manner, without the advice, control, or
supervision of the Company.
7. Business Expenses. The Company shall reimburse the Consultant for all reasonable travel,
supplies, long-distance telephone and business expenses incurred by the Consultant during the course of
this Agreement.
8. Notices. Unless otherwise specifically provided in this Agreement, all notices or other
communications (collectively and severally called "Notices") required or permitted to be given under this
Agreement, shall be in writing, and shall be given by: (A) personal delivery (which form of Notice shall
be deemed to have been given upon delivery), (B) by telegraph or by private airborne/overnight delivery
service (which forms of Notice shall be deemed to have been given upon confirmed delivery by the
delivery agency), or (C) by electronic mail or facsimile or telephonic transmission, provided the receiving
paity has a compatible device or confirms receipt thereof(which forms of Notice shall be deemed
delivered upon confirmed transmission or confirmation of receipt). Notices shall be addressed to the
address set forth in the introductory section of this Agreement, or to such other address as the receiving
party shall have specified most recently by like Notice, with a copy to the other party.
9. Choice of Law and Venue. This Agreement shall be governed according to the laws of the
state of California. Venue for any legal or equitable action between the Company and the Consultant
which relates to this Agreement shall be in the courts of the State of California in the County of Orange
and the Central District of California of the United States District Court.
10. Indemnification. The Company hereby agrees to indemnify, defend and hold harmless the
Consultant, and the Consultant's officers, directors, and shareholders from and against any and all claims,
demands, losses, costs, expenses, obligations, liabilities, damages, recoveries, and deficiencies, including,
without limitation, interest, penalties, and reasonable attorney fees and costs, that the Consultant may
incur or suffer and that arise, result from, or are related to any breach or failure of the Company to
perform any of the representations, warranties and agreements contained in this Agreement.
11. Entire Agreement. This Agreement supersedes any and all other agreements, either oral or
in writing, between the parties hereto with respect to the services to be rendered by the Consultant to the
Company and contains all of the covenants and agreements between the parties with respect to the
services to be rendered by the Consultant to the Company in any manner whatsoever. Each party to this
agreement acknowledges that no representations, inducements, promises, or agreements, orally
otherwise, have been made by any party, or anyone acting on behalf of any party, that are not embodied
herein, and that no other agreement, statement, or promise not contained in this Agreement shall be
valid or binding on either party.
ADDRESS CONTACT
23 Bellflower, Lake Forest, CA 92630 (949) 735-4727 omid@drkhodai com 





	
	12. Independent Contractor. The Consultant shall at all times be an independent contractor
hereunder, and not a co-venturer, agent, employee or representative of the Company, and no act, action or
omission to act of the Consultant shall in any way be binding upon or obligate the Company. No change
in the Consultant's duties as a consultant of the Company shall result in, or be deemed to be, a
modification of the terms of this Agreement. The Company shall not be treated as an employee for
federal tax purposes. The Consultant hereby represents and warrants to the Company that the Consultant
is an independent contractor for federal, state and local tax purposes. Further, the Consultant hereby
covenants and agrees to pay any and all federal, state and local taxes required by law to be paid by an
independent contractor, including, without limitation, any taxes imposed by the Self Employment
Contribution Act.
13. Arbitration. The parties hereby agree that all controversies, claims and matters of difference
shall be resolved by binding arbitration before the American Arbitration Association (the "AAA") located
in Los Angeles County, California according to the rules and practices of the AAA from time-to-time in
force; provided however that the parties hereto reserve their rights to seek and obtain injunctive or other
equitable relief from a court of competent jurisdiction, without waiving the right to compel such
arbitration pursuant to this section. The arbitrator shall apply California law in rendering a decision.
14. Severability. If any term or provision of this Agreement or the application thereof to any
person or circumstance shall, to any extent, be determined to be invalid, illegal or unenforceable under
present or future laws effective during the term of this Agreement, then and, in that event: (A) the
performance of the offending term or provision (but only to the extent its application is invalid, illegal or
unenforceable) shall be excused as if it had never been incorporated into this Agreement, and, in lieu of
such excused provision, there shall be added a provision as similar in terms and amount to such excused
provision as may be possible and be legal, valid and enforceable, and (B) the remaining part of this
Agreement (including the application of the offending term or provision to persons or circumstances other
than those as to which it is held invalid, illegal or unenforceable) shall not be affected thereby and shall
continue in full force and effect to the fullest extent provided by law.
15. Amendment or Waiver. No amendment to this Agreement shall be valid unless in writing
and signed by both parties hereto. No waiver of any provision of this Agreement shall be valid unless the
same is in writing and signed by the party against whom such waiver is sought to be enforced; moreover,
no valid waiver of any provision of this Agreement at any time shall be deemed a waiver of any other
provision of this Agreement at such time or shall be deemed a valid waiver of such provision at any other
time.
16. Preparation of Agreement. It is acknowledged by each party that such party either had
separate and independent advice of counsel or the opportunity to avail itself or himself of same. In light
of these facts it is acknowledged that no party shall be construed to be solely responsible for the drafting
hereof, and therefore any ambiguity shall not be construed against any party as the alleged draftsman of
this Agreement.
17. Counterparts. This Agreement may be executed manually or by facsimile signature in two
or more counterparts, each of which shall be deemed an original, and all of which together shall constitute
but one and the same instrument.
ADDRESS CONTACT
23 Bellflower, lake Forest, CA 92630 (949) 735-4727 omid@drkhodai.com 





	
	IN WITNESS WHEREOF, the patties have executed this Consulting Agreement on the date first
written above.
CONSULTANT
Khodai Consulting, Inc.
Omid Khodai
COMPANY
VisionCare, Inc.
June 15, 2019
~ R,u (it4d P c1u1e~
~~
ADDRESS
23 Bellflower, Lake Forest, CA 92630
CONTACT
(949) 735-4727 omid@drkhodai.com 





	
	STATEMENT OF WORK
This statement of work (this "SOW") is entered into and made effective as of June 15, 2019 by and
between VisionCare, Inc. ("Client") and Khodai Consulting, Inc. ("Khodai Consulting") and upon execution
will be incorporated into the Consulting Agreement between Client and Khodai Consulting dated June 15,
2019 (the "Agreement"). In the event of any conflict between the terms and conditions of the Agreement
and any terms set forth in this SOW, the terms and conditions of the Agreement will control, unless this
SOW expressly states that the conflicting term in this SOW is to control, in which case the conflicting term
of the SOW will control for this SOW only.
1. Services. Khodai Consulting will render to Client the Services set forth below. Any deliverables will
be provided to Client in a mutually agreeable format and in accordance with the following project
methodology:
Khodai Consulting will provide clinical and regulatory support for VisionCare, Inc. Specifically, Khodai
Consulting will provide support for the following:
2.
 ❖ Review and prepare VisionCare's Ultra-Precision Micro-Optics Miniature Telescopes FDA annual
reports and communication related to post-approval study.
 ❖ Provide strategy and execution tactics for registry study.
 ❖ Review and prepare VisionCare·s TES \DE FDA annual reports and communication.
 ❖ Provide clinical, regulatory strategy and execution, as requested.
 ❖ Project management, data management oversight, medical writing, and training in support of
FDA Post-Approval/Registry and TES \DE clinical study. Refer to Exhibit A and 8 for additional
details.
Project Leader.
Name: Omid Khodai
Office: 949. 735.4727
Email: omid@drkhodai.com
3. Compensation and Expenses. Client will pay to Khodai Consulting $250 / hour in support of clinical,
regulatory strategy and execution activities. Exhibit A provides budget proposal for project management,
data management oversight, medical writing, and training in support of FDA Post-Approval/Registry
clinical study related responsibilities. Exhibit B provides budget proposal for project management, data
management oversight, medical writing, and training in support of TES \DE clinical study related
responsibilities. This budget is an estimate which is subject to change based on project duration, number
of site visits, number of investigator meetings, and changes in overall scope and schedules. At no point
will the budget be exceeded by greater than 10% without written notice and prior approval, at which time
revised SOW and budget amendment documents will be executed as necessary.
Khodai Consulting will document and record all time spent in the performance of the Services to the
reasonable satisfaction of Client. Travel time will be billed at 50% of the consultant's hourly rate.
Client will reimburse Khodai Consulting for all reasonable travel expenses incurred by Khodai Consulting
in rendering the Services, provided that such expenses are agreed upon in writing in advance, and are
confirmed by appropriate written expense statements and other supporting documentation.
An overview of Khodai Consulting Travel Policy is attached. The Travel Policy is deemed to be accepted by
ADDRESS CONTACT
23 Bellflower, Lake Forest, CA 92630 (949) 735--4727 ornid@drkhodai.com 





	
	Client upon signature of this SOW. Additional expenses which are: (1) not anticipated in Section 1 of this
SOW, (2) deemed necessary by Khodai Consulting and (3) incurred by Khodai Consulting in the
performance of the Services, must be submitted in writing to and approved by Client prior to Khodai
Consulting incurring said expenses from any third party or by Khodai Consulting itself. Said approval from
Client will not be unreasonably withheld, conditioned or delayed.
On or about the thirtieth (30°') of each calendar month during the perform ance of the Services hereunder,
Khodai Consulting will provide to Client an invoice for Services rendered and expenses incurred during the
preceding month. All invoices will be sent to Caro le Schreier at carole@visioncareinc.net and will contain
the detail reasonably requested by Client.
Client must indicate upon signature of this SOW if a Purchase Order is required. Client must indicate the
format of invoice they require upon signature of this SOW, if any, in order t o expedite the bill ing process.
If Client does not specify the detail required by their respective financial department, Khodai Consulting
will send invoices in Khodai Consulting format in accordance with Khodai Consulting' process.
Specified Fund for payment:
Payee Name:
Tax ID Number:
Email:
Address:
Khodai Consulting, Inc.
68-0497213
ornid@drkhodai.com
23 Bel lflower
Lake Forest, CA 92630
Khodai Consu lting will provide to Client invoices for Services rendered hereunder. Payment will be made
in accordance with t erms set forth.
4. Termination. Either party may t erminate this SOW at any time upon prior written notice to the
other party. Client will reimburse Khodai Consulting for all time spent prior to written notification.
However, t ermination of this SOW will not affect the term of the MSA unless the MSA ex pires or is
otherwise terminated pursuant to the terms of Section 4 thereof.
The parties have indica ted their acceptance of the t erms of this SOW by the signatures set forth below.
Each individual signing on behalf of a corporate entity hereby personally represents and warrants his or
her lega l authority to legally bind that entity.
EACH PARTY ACKNOWLEDGES THAT IT HAS READ THIS STATEMENT OF WORK (INCLUDING ALL
ATTACHMENTS), UNDERSTANDS IT AND AGREES TO BE BOUND BY ITS TERMS AND CONDITIONS.
Khodai Consulting, Inc.
Na me (print): = O -'-' m -'-' i= d...:.. K = h= o= d=-a i '-----­
Tit le: President
Date: June 15 2019
ADDRESS
23 Bellflower, Lake Forest, CA 92630
VisionCare, Inc.
By rk1! p ~ i' {1(loff
Name (print):£r81 ~ e:er « {1>wt:,RJ
Title: G (::' 0 9- fJ VJJ
Date: f±tt, p;f:t' Z~ £() /~
CONTACT
(949) 735-4727 ornid@drkhodai.com 





	
	Reimbursable Expenses
Attachment to Statement of Work
Travel & Expense Policy
All costs outlined below will be billed to Client as a pass-through cost with no additional mark-up. This
policy does not limit the reimbursable expenses to those outlined below. Other expenses incurred by
Khodai Consulting in the act of performing business related activities are reimbursable to Khodai
Consulting will endeavor to keep these expenses limited to reasonable and customary items and amounts.
If Client's travel policy differs from the below, all agreed upon changes must be reflected in this
Attachment.
Accommodations and Lodging
1. Accommodations must meet with industry accepted business travel standards with reference to
comfort, convenience and cost. Accommodations over $250 per night base rate (prior to
applicable taxes) require client approval. Exceptions apply to locations known to have increased
rates. These locations include but are not limited to: New York City, Boston, Washington DC, San
Francisco, Honolulu, Miami, New Orleans, Santa Barbara, Los Angeles, Chicago, Midland-Odessa,
Providence, San Diego, Abuja, Delhi, Lagos, Nairobi, Moscow, Shanghai, Bangkok, Istanbul,
Geneva, Zurich, Sydney, Hong Kong, London, Rome, Tokyo, Frankfurt, and Paris.
General Travel
2. Travel time exceeding 1 hour will be at 50% of the consultant specific rate in the SOW.
Meals and Entertainment
3. Actual, reasonable, and necessary costs for meals will be reimbursed. Reimbursement may
include a gratuity of up to twenty (20%) percent of the bill.
4. Entertainment expenses are reimbursable only with approval and only if the specific assignment
requires the entertainment of Client's customers or potential customers, or others as appropriate.
Parking
5. All Parking fees are reimbursable by Client.
Transportation: Air
6. Use of "Non-refundable" fares are recommended.
7. Khodai Consulting will fly coach class (plus) on all domestic flights. Plus provides Khodai Consulting
the ability to upgrade seat location within the coach cabin exclusively. In the event that total travel
time exceeds 6 hours, Khodai Consulting may fly business class.
8. Khodai Consulting will fly business class on international flights. If Khodai Consulting chooses to
fly coach thereby saving Client a substantial amount of money, then Client will cover all
reasonable expenses (meals and hotel) for one day prior to engagement activities and an
additional travel day following engagement activities and prior to return travel.
ADDRESS CONTACT
23 Bellflower, Lake Forest, CA 92630 (949) 735-4727 omid@drkhodai.com 





	
	9. In the event that a Khodai Consulting agent is required to change flights due to business related
circumstances, all flight change fees will be reimbursable by Client.
10. Frequent flyer plans and airport airline club memberships are the responsibility of the Khodai
Consulting.
11. Excess baggage expenses are reimbursable by Client in any of the following circumstances:
 • Khodai Consulting is transporting Client materials
 • Khodai Consulting is transporting any materials required to perform services
 • Khodai Consulting is on an extended period of travel (>5 days)
Transportation: Ground
12. When a Khodai Consulting consultant uses his/her personal car for approved client business
travel, Client will pay mileage according to established US Internal Revenue Service
reimbursement guidelines and will also reimburse all actual auto tolls.
13. All rental vehicles used for client related travel will be reimbursable by Client.
14. Taxis, ferries, shuttles and other forms of temporary transportation are reimbursable byClient.
Transportation: Rail
15. Subway and rail transportation is reimbursable by Client. Rail travel will be purchased at
reasonable and customary rates.
16. Khodai Consulting will travel coach class (plus) on all domestic rail travel. Plus provides Khodai
Consulting the ability to utilize internet access, power plugs, and other business-related amenities
within the coach cabin exclusively. In the event that total travel time exceeds 3 hours, Khodai
Consulting consultant may travel business, high speed or first class.
17. In the event that any Khodai Consulting consultant is required to change trains due to business
related circumstances, all train change fees will be reimbursable by Client.
Miscellaneous
18. Actual and reasonable laundry expenses will be reimbursed. This applies only after Khodai
Consulting consultant has been away from home for five (5) consecutive days, or if the trip has
been unexpectedly extended.
19. Business meeting expenses will be reimbursable by Client. Khodai Consulting will endeavor to
utilize all internal resources prior to incurring expenses related to meetings. Expenses include, but
are not limited to, media, printing, electronic rentals, room rentals, photocopying, postage,
internet service fees, baggage handling, and shipping.
ADDRESS CONTACT
23 Bellflower, Lake Forest, CA 92630 (949) 735-4727 omid@drkhodai.com 





	
	Exhibit A
Budget Proposal - PAS/Registry Study
Detailed Budget by Line Item
.. : Ta~KI M!iyity
..· . ~
Notes . Total Cost , , ,;_ , . .
1 Document Preparation
a Develop synopsis/ protocol Includes budget for Amendments if necessary. $0
b Develop Informed Consent Form PM I Clinical Affairs function $0
temr lates
C Develop 1B, ROPI, or draft DFU Assuming Sponsor has o current draft or prior $0 version
d Develop Study Manual PM I Clinical Affairs function $1,500
e Develop project plans (monitor, data PM/unction $6,000
management, etc.)
f Develop source documents and eCRF Based on final protocol - PM I Clinical Affairs $1,500
templates function
Sub-Total: $9,000
2 Study Start-up Notes Total Cost
Assumes PM I Clinical Affairs, Reg I Medical
a Study Kick-off meeting Affairs preparation and attendance with Sponsor - $800
2 hr mtg
b Identify potential investigators/sites KC/ to assist Sponsor with potential site $6,000 identification - PM function
Pertorm Site Qualification Interviews Assumes eventual addition of 35 sites; 2-hour $8,750 C interview and report writing · CRA function
d Final Site review, selection, and approval Assumes eventual addition of 35 sites- PM function $5,250
e EDC Build Budget - assumes <10 unique eCRFs and <20 total $24,000 per subject (6 - 8 wk max build time)
f Investigator/ Site Training & Initiation Web based Initiation & Training - PM and CRA $8,500
planning, materials, and attendance function (budget of 5 web-based meetings)
g Ongoing collection, review and tracking of 4 hours per site - CRA function $25,000 site essential regulatory documents
h IRB submissions/ interactions/ updates
Drn 2 hours per site - CRA function $12,500
i Develop study dashboards, logs, and PM function $1,500
trackers
j Set-up Trial Master File CT Assistant function $0 Maintained by VisionCare internal resource
k eTMF maintenance through study (Admin function) $54,000 Maintained by VisionCare internal resource
Sub-Total: $146,300
3 Supply Management Total Cost
ADDRESS CONTACT
23 Bellflower, lake Forest, CA 92630 (949) 735-4727 omid@drkhodai.com 





	
	20 hours+ 2 hours per site (could include study
a Obtain and distribute non-device supplies binders containing manuals, logs etc.) Admin $0 function
Maintained by VisionCare internal resources
Sub-Total: $0
4 Project Management Total Cost
Avg 20 hrs/ week X 12 weeks (start-up);
+ 2 hrs/ week X 1040 wks (enrollment period);
a Project management + 2 hrs I week X 260 weeks (5-year f/u) $426,000 Reality likely be increased involvement at start-up
and during enrollment phases and less during
follow-up phases
b Project team training PM, CRA/s), DM, and Admin (4 hrs each) $1,900
2 hours per quarter x 4 quarters/ yr· PM function
C Site payment tracking - reporting VisionCare to manage site payments based on $30,000
reports received.
Assumes one meeting quarterly with summary
d PM meetings w/Sponsor and Sites distribution/ update to all sites through $32,000 enrollment then as needed thereafter - 80
meetings
e Prepare and distribute status reports to
Sponsor Quarterly reports: 1 hours x 100 qtrs - PM function $15,000
f Manage and issue payment to vendors Avg. 1 hour I qtr for 100 qtrs $0
(TMF, EDC, etc.) Maintained by VisionCare internal resources.
Sub-Total: $504,900
5 Site Management & Monitoring Total Cost
a Off-site CRF review and query Assumes 0.50 hr per visit I avg 12 visits I subject· $192,750
management (EDC study) OM function (257 subjects)
b Routine contact with study sites Assumes 0.25 hr/ quarter I site during enrollment $112,500 and F/u (up ta 50 sites x 100 qtrs) (BUDGET)
C Perform Close-Out Assistance 2 hrs/ site· TMF / Admin assistance $0 Maintained by VisionCare internal resources.
Site Transfer and EDC / Amendment 16 site visits· Clinical PM (4 hour on•site + travel
d Training time) $40,960
Project Transfer with Amendment
e Site Initiation & Training (as needed) Add up to 35 sites - Clinical PM (4 hour on-site+ $89,600 travel time)
f Close Out Visits Up to 50 sites at study completion (4 hr on site+ $128,000 travel time)
Sub-Total: $563,810
6 Safety Monitoring Total Cost
a Protocol Review/ safety plan Budget $0
b AE / SAE assessment, narrative writing, 24/7 availability through enrollment and follow-up $150,000 and review phases
C Annual FDA report review Budget for 25 years duration (24 interim reports) $24,000
ADDRESS CONTACT
23 Bellflower, Lake Forest, CA 92630 (949) 735-4727 omid@drkhodai.com 





	
	d Final Report MM review $1,000
e Submission Correspondence w I FDA Budget $4,000
Sub-Total: $179,000
7 Data Management Total Cost
a Prepare CRF/EDC completion Incorporated into Study Manual $1,800 instructions/guidelines
EDC subscription fees; est $1000 per month; final
b EDC access and server fees based on build and paid annually in advance at "go $300,000
live" date
Includes EDC training and support needed for 50
C EDC support services (including training, study sites and £DC management. (BUDGET) $6,250 help desk support, and management) Changes to £DC system (if any) will require
additional hours
d Questionnaire ePRO $0
e Database User Acceptance Testing Performed by vendor - no charge $0 (UAT) & Validation
f Edit check specifications review Performed by vendor - no charge $0
Includes coding and preferred terms for AEs and
Adverse event and medical history coding medical history for each report. Coding system $13,200 g lees (Medra1 Wh0Drug1 etc.l to be fl.Did b~
Sponsor.
h Perform SAE reconciliation Assumes SOSAEs total $5,500
i Provide OM listings (for Clinical Review) Annualfy during study execution and final $5,500
j Database lock One soft lock per annual one hard lock per report $12,500
k Data base Interim transfers lncfudes 6 data transfers in either SAS, XML, or $25,000 Excel (annual report data archives)
I Final data base transfer Includes final transfer of all subject data in either $3,600 SAS, XML, or Excel and Study Archive
Sub-Total: $373,350
8 Biometrics Total Cost
a Prepare randomization plan/schedule No randomization planned in this project $0
b Prepare analysis plan $3,000
C Shell TFLs Up to 20 unique $6,000
d Build Analysis files derived from CRF $15,000
e Annual report analysis 24 Annual Reparts $48,000
f Prepare and deliver final analysis Up to 40 repeat tables, 20 unique listings $3,000
g Final report draft review $900
h SDTM / ADaM Datasets TBD - can price if needed or can work w/Sponsor $0 resource
Sub-Total: $75,900
9 Reporting/ Medical Writing / Reg Total Cost Oversight
a Develop Annual clinical study report shell {including review of up to 3 drafts) $1,500
b Annual clinical study report 20-hour budget for each Annual Report X 24 $72,000 (includes review of up to 2 drafts)
C Develop Final clinical study report shell (including review of up to 3 drafts) $1,500
ADDRESS CONTACT
23 Bellflower, Lake Forest, CA 92630 {949) 735-4727 omid@drkhodaLcom 





	
	d Final clinical study report (including review of up to 2 drafts) $4,500
e FDA Notification of Study Management Protocol contact information amended $1,000
Changes
Sub-Total: $80,500
10 Quality Control Total Cost
a Store/Maintain study records No additional cost for record storage. $0
b Reoonciliation and transfer of study $600
records to Sponsor
Sub-Total: $600
 ·. . .•. TRTA.LR~OFESSIONAL FEES: $1,933;360
11 Pass-Through Costs Total Cost
Investigator grants/ Subject Stipend Sponsor to pay directly $0 a Maintained b't, VisionCare internal resources.
b Advertising costs None planned at this time $0
C Translation Services Budget - 2 translations of /CF $6,000
d Sponsor IRB fees Central !RB Only - Direct bill to Sponsor $0
e Site IRB fees/ site x 25 years Use of local IRBs will increase this budget - Direct $0 bill to Sponsor
g Travel (Initial Site Visits) Average travel expenses used for cost estimate: 1- $16,000 day trip = $1000 (air, ground, hotel, food)
h Travel (Initial Site Visits - add up to 35 Average travel expenses used for cost estimate: 1- $35,000 sites) day trip= $1000 (air, ground, hotel, food)
i Travel (Close-Out Visits) Average travel expenses used for cost estimate: 1- $50,050 day trip= $1000 (air, ground, hotel, food)
j Travel Audit Visits Average travel expenses used for cost estimate: 2- $0 day trip = $1400 (no audits included in budget)
Budget estimated 2 nights I 1 fufl day/ 40 in
k Investigators Meeting costs attendance (no Investigator Mtg included in $0
budget)
I Reading Center (Endothelial Cell Count) No Reading Center Planned $0 Annual fee
Includes regulatory and correspondence binders
m Supplies, photocopies, telephone, fax and tabs and Study Manual. $0
Maintained by VisionCare internal resources.
n MaiVCouner charges Maintained by VisionCare internal resources. $0
0 Other (specify) $0
p Other (specify) $0
Total Pass-Through Costs: $107,050
',,-,'
.. TOTAL PROJECT COSTS: $2,040,410 ..
NOTE:
 • KC/ direct service budget is calculated to be up to a 25-year timeline, and is subject to injlationa,y
adjustments. Jfthere are adjustments to the timeline, there will be subsequent adjustments to the budget.
ADDRESS CONTACT
23 Bellflower, Lake forest, CA 92630 (949) 735-4727 omid@drkhodai.com 





	
	Exhibit B
Budget Proposal -TES IDE Study
Detailed Budget by Line Item .. •• t<1s~/ActMiy .· Notes Total Cost .·. ... .
1 Document Preparation
a Develop synopsis / protocol Includes budget for Amendments if necessary. $3,000
b Develop Informed Consent Form
temolates PM/ Clinical Affairs function $0
C Develop 1B, ROPI, or draft DFU Assuming Sponsor hos a current draft or prior $0 version
d Develop Study Manual PM I Clinical Affairs function - Utilize current $0 documents
e Develop project plans (monitor, data PM function - Use current. $0 management, etc.)
Develop source documents and eCRF Based on final protocol - PM/ Clinical Affairs
f function $0 templates Use current.
Sub-Total: $3,000
2 Study Start-up Notes Total Cost
Assumes PM I Clinical Affairs, Reg I Medical
a Study Kick-off meeting Affairs preparation and attendance with Sponsor - $800
2 hr mtg
b Identify potential investigators/sites KC/ to assist Sponsor with potential site $0 identification - PM function - On hold
Assumes eventual addition of 10 sites; 2-hour
C Pertorm Site Qualification Interviews interview and report writing - CRA function On $0
hold
d Final Site review, selection, and approval Assumes eventual addition of 10 sites- PM function $0 On hold
Budget - assumes <10 unique eCRFs and <20 total
e EDC Build per subject (6 wk max build time) - Use current $0
system.
Investigator/ Site Training & Initiation Web based Initiation & Training - PM and CRA
f function (budget of 5 web-based meetings) $0 planning, materials, and attendance Continue with current systems
g Initial collection, review and tracking of 4 hours per site - CRA function $0 site essential regulatory documents No additional sites to be added.
h IRB submissions/ interactions/ updates
om 2 hours per site - CRA function $5,000
i Develop study dashboards, logs, and PM/unction $1,500 trackers
j Set-up Trial Master File CT Assistant function $0 Maintained by VisionCare internal resources.
k TMF maintenance through study (Adm in function) $0 Maintained by VisionCare internal resources.
Sub-Total: $7,300
3 Supply Management Total Cost
ADDRESS CONTACT
23 Bellflower, Lake Forest, CA 92630 (949) 735-4727 omid@drkhodai.com 





	
	20 hours+ 2 hours per site (could include study
Obtain and distribute non-device supplies binders containing manuals, logs etc,) Admin $0 a function
Maintained by VisionCare internal resources.
Sub-Total: $0
4 Project Management Total Cost
Avg 5 hrs/ week
a Project management Reality likely to be increased involvement at start- $175,500 up and during enrollment phases and less during
follow-up and cfose out phases
b Project team training PM, CRA(s), OM, and Admin (4 hrs each) $1,900
Site payment management and tracking 2 hours per quarter x 4 quarters/ yr- PM function $0 C Maintained by VisionCare internal resources.
Assumes one meeting quarterly with summary
d PM meetings w/Sponsor and Sites distribution I update to all sites through $12,600 enroffment then as needed thereafter- 14
meetings
e Prepare and distribute quarterly status
reports to Sponsor
Quarterly reports: 3 hours x 18 qtrs -PM function $8,100
f Manage and issue payment to vendors Avg. 1 hour I qtr for 18 qtrs $0
(TMF, EDC, etc.) Maintained by VisionCare internal resources.
Sub-Total: $198,100
5 Site Management & Monitoring Total Cost
a Off-site CRF review and query Assumes 0.50 hr per visit/ avg 9 visits/ subject - $28,125
management (Paper study) DM function (50 subjects)
b Routine contact with study sites Assumes 0.25 hr I quarter I site during enrollment $4,860 and F/u (up to 20 sites x 18 qtrs) (BUDGET)
C Perfonn Close-Out Assistance 2 hrs/ site - TMF I Admin assistance $0 Maintained by VisionCare internal resources.
Site Transfer and EDC / Amendment 12 site visits - Clinical PM (4 hour on-site+ travel
d Training time) $0
Project Transfer with Amendment
e Site Initiation & Training (as needed) Add up to 8 sites - Clinical PM (4 hour on-site+ $24,000 travel time)
2/yr/site X current 12 sites (pending additional
sites)
f Routine Interim Monitor Visits 96 IMVs w/ 2020 close out/ 3 yr flu following $360,000
annual report
8 hr on site+ tavel time
g Close Out Visits Up to 20 sites at study completion (4 hr on site+ $24,000 travel time)
Sub-Total: $440,985
6 Safety Monitoring Total Cost
a Protocol Review/ safety plan Budget $0
ADDRESS CONTACT
23 Bellflower, Lake Forest, CA 92630 (949) 735-4727 omid@drkhodai.com 





	
	b AE / SAE assessment, narrative writing, 24/7 availability through enrollment and follow-up $27,000
and review phases
C Annual FDA report review Budget for 4.5 years duration (4 annual reports) $5,000
d Final Report MM review $1,250
e Submission Correspondence w / FDA Budget $5,000
Sub-Total: $38,250
7 Data Management Total Cost
a Prepare CRF/EDC completion Incorporated into Study Manual $0 instructions/guidelines
EDC subscription fees; est $1000 per month; final
b EDC access and server fees based on build and paid annuaffy in advance at "go $0
live" date
Includes EDC training and support needed for 50
C
EDC support services (inciuding training, study sites and EDC management. (BUDGET) $0 help desk support, and management) Changes to EDC system (if any) will req/Jire
additional hours
d Questionnaire ePRO $0
e Database User Acceptance Testing Performed by vendor -no charge $0 (UAT) & Validation
f Edit check specifications review Performed by vendor -no charge $0
g Double data entry 0.5/form - 50 x15 (9 visits and ancillary forms) X2 $93,750
Includes coding and preferred terms for A Es and
h Adverse event and medical history coding medical history for each report. Coding system $2,640 lees (Medra, WhoDru(L etc.l to be e_aid b~
Sponsor.
i Pertorrn SAE reconciliation Assumes 20 SAEs totol $2,200
j Provide DM listings (for Clinical Review) Annually during study execution, interim, and final $1,800
k Database lock One soft lock per annual one hard lock per report $3,000
I Data base Interim transfers Includes 6 data transfers (annual report data $6,000 archives)
m Final data base transfer Includes final transfer of all subject data in Excel $3,600 and Study Archive
Sub-Total: $112,990
8 Biometrics Total Cost
a Prepare randomization plan/schedule No randomization planned in this project $0
b Prepare analysis plan Use Protocol driven stats plan $0
C Shell TFLs Up to 20 unique $6,000
d Build Analysis files derived from CRF $15,000
e Annual report analysis 4 Annual Reports I 1 Interim I 1 Final $12,000
f Prepare and deliver final analysis Up to 40 repeat tables, 20 unique listings $3,000
g Final report draft review $1,200
h SDTM / ADaM Datasets TBD - can price if needed or can work w/Sponsor $0 resource - Pending requirement.
Sub-Total: $37,200
ADDRESS CONTACT
23 Bellflower, Lake Forest, CA 92630 (949) 735 .. 4727 omid@drkhodaicom 





	
	9 Reporting/ Medical Writing / Reg Total Cost Oversight
a Develop Annual clinical study report shell {including review of up to 3 drafts) $0
b Annual clinical study report 20-hour budget for each Report X 6 (includes $18,000 review of up to 2 drafts}
C Develop Final clinical study report shell (including review of up to 3 drafts) $1,500
d Final clinical study report (including review of up to 2 drafts) $4,500
e FDA Notification of Study Management Protocol contact information amended, etc. $1,000 Changes
Sub-Total: $25,000
10 Quality Control Total Cost
a Store/Maintain study records Maintained by VisionCare internal resources. $0
b Reconciliation and transfer of study Maintained by VisionCare internal resources. $0 records to Sponsor
Sub-Total: $0
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" ''
I• .; ; '; .,' ' ' ',,·•' ' ., ,' I $862,~25. "''"" ,,,,,,,,,,,,,,,,,,,,,"'",''1'"'"'''"":.C ,,, ,,,, ',
11 Pass-Through Costs Total Cost
a Investigator grants/ Subject Stipend S12onsor to ea!!'. directlv. $0
b Advertising costs None planned at this time $0
C Translation Services Budget - 2 translations of /CF $6,000
d Sponsor IRB fees Central fRB Only - Direct bill to Sponsor $0
e Site IRB fees/ site Use of local IRBs will increase this budget - Direct $0 bill to Sponsor
Travel (Initial Site Visits) Average travel expenses used for cost estimate: 1- $12,000 g day trip = $1000 (air, ground, hotel, food)
h Travel (Interim Site Visits) (see line 41) Average travel expenses used for cost estimate: 1- $96,000 day trip = $1000 (air, ground, hotel, food)
i Travel (Close-Out Visits) Average travel expenses used for cost estimate: 1- $20,000 day trip= $1000 (air, ground, hotel, food)
j Travel Audit Visits Average travel expenses used for cost estimate: 2- $0 day trip = $1400 (no audits included in budget}
Budget estimated 2 nights/ lfu/1 day I 40 in
k Investigators Meeting costs attendance (no Investigator Mtg included in $0
budget)
I Reading Center (Endothelial Cell Count) No Reading Center Planned $0 Annual fee
Includes regulatory and correspondence binders
m Supplies, photocopies, telephone, fax and tabs and Study Manual. $0
Maintained by VisianCare Internal resources.
n Mail/Couner charges Maintained by VisionCare internal resources. $0
0 Other (specify) $0
p Other (specify) $0
Total Pass-Through Costs: $134,000
ADDRESS CONTACT
23 Bellflower, Lake forest, CA 92630 (949) 735-4727 omid@drkhodai.com 





	
	TOTAL PROJECT COST$: I $!l9s,sis
Note:
 • KC! direct service budget is calculated to be spread up to a 54-month timeline. If there are adjustments to the
timeline, there will be subsequent adjustments to the budget.
ADDRESS CONTACT
23 Bellflower, Lake Forest, CA 92630 (949) 7354727 omid@drkhodai com