> **DRAFT, for attorney review before use. Not legal advice.**
> Cover memo prepared 2026-07-07. Bundles five items for a single review pass.

**To:** Clyde Mathes
**From:** Kisa Fenn, Founder and CEO, KJF Professional Services LLC d/b/a STTIL Solutions
**Date:** [DATE]
**Re:** Single-pass review of three template agreements plus two focused legal questions

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Hello Clyde,

I would like to engage you for one bundled review pass covering five items. I have grouped them deliberately so you can scope the whole thing at once rather than in pieces. An associate handling the bulk of this is completely fine with me. What I need first is a turnaround estimate and a fee estimate so I can plan around it.

Here is what is in the bundle:

1. **Pilot Letter of Intent (LOI) template (v3)**, a product-agnostic pilot LOI. Product specifics live in an Exhibit A, pre-filled for our active product, Signal.
2. **Mutual Non-Disclosure Agreement (NDA) template (v3)**, portfolio-wide.
3. **Business Associate Agreement (BAA) template (v1)**, a reusable BAA, generalized from an earlier supplier-specific draft. Please read it as a forward-looking instrument; I explain why below.
4. **U.S. Food and Drug Administration (FDA) device-status memo for Signal**, a draft I am providing for your review, not asking you to write. It argues that Signal is not an FDA-regulated medical device. It is candid about its weakest points. I need you to confirm, correct, or reject its position.
5. **Anti-Kickback Statute question** on a specific partner integration, described below. This one is time-sensitive because it gates whether we can deepen an existing partner relationship.

I have written my own focused questions under each item. Please treat these as a starting list, not a limit.

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### Overarching question (applies to all three templates)

**Q1. Confirm Florida governing law across every document.** Our entity is KJF Professional Services LLC d/b/a STTIL Solutions, a Florida limited liability company. I have confirmed the name and formation state; older drafts disagreed (Delaware, Pennsylvania), so all three templates now state Florida consistently. Please verify the registration and confirm Florida is the right governing-law and venue choice for us in each document.

**Q2. Standardize my signing title and name.** The LOI and NDA sign as "Founder and CEO" while the BAA signs as "Managing Member." Tell me which title is correct for an LLC signer and I will use it across all three. Also confirm the name format: my legal name is Arkisia Fenn (I go by Kisa), and I signed our executed letter of intent as Arkisia Fenn.

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### 1. Pilot LOI template (v3)

1. The BAA cross-reference in Section 5.3 turns on whether we are a Business Associate at all. That is the BAA question below; please keep the two consistent.
2. Section 8.3 (we retain all rights to any modification or enhancement made during a pilot, regardless of who requested it) and Section 8.4 (a narrow carve-out for a partner's pre-documented pre-existing concepts). Confirm both are enforceable and that 8.4 does not erode 8.3.
3. Section 12.3, a new mutual exclusion of consequential damages for a no-cost pilot. Confirm it is adequate and enforceable.
4. Section 14, our dispute-resolution path (30-day good-faith discussion, then arbitration, with the American Arbitration Association (AAA) as fallback, and a court carve-out for injunctive relief). I have set arbitration as our default posture, and the NDA now mirrors it in Article 10.2; the structure follows an agreement we have already signed once. Confirm both clauses as drafted.
5. Sections 6.1 and 13.3, confirming that a successful pilot does not obligate us to offer a commercial agreement. Confirm this closes any promissory-estoppel exposure.

### 2. Mutual NDA template (v3)

1. The residuals clause (Articles 1.2 and 2.3), which carves our algorithms, payer and coverage logic, and scoring formulas out of what a counterparty may reuse from memory. Confirm the carve-out is enforceable.
2. The Health Insurance Portability and Accountability Act (HIPAA) carve-out (Article 6). I softened the flat claim that the data we handle is never protected health information (PHI). Confirm the new framing is defensible.
3. The tightened third-party exclusion (Article 3.1(d)). Confirm it closes the loophole cleanly and applies equally to both sides.
4. The named-products list (Article 1.1(c)): Signal, Vitality Med Tracker, UMSIS, plus a catch-all for any current or future offering. Confirm the catch-all is sufficient to cover future products we have not named.

### 3. BAA template (v1)

1. **The single most important question in this whole bundle:** does our receipt of a supplier's internal patient_id, which is an account number and one of HIPAA's 18 identifiers, make us a Business Associate that needs this agreement, or does our architecture (we never receive names, dates of birth, or Social Security numbers, and the identity crosswalk stays with the supplier) avoid Business Associate status? Everything downstream depends on your answer.
2. Please read this as forward-looking. Real patient data is blocked today; we run on mock and de-identified data. Our current pilot vendors do not have subprocessor BAAs. Our compliant path is AWS, where we already have a signed BAA (active since 2026-05-27) with database and storage provisioned and parked until funding. I want you reviewing the instrument we would sign at the moment real data enters, and advising whether we need any interim addendum before then.
3. Whether each pilot vendor legally needs its own subprocessor BAA in the production configuration.

### 4. FDA device-status memo for Signal (for your review, not to be drafted)

The memo is at `signal/docs/compliance/fda-cds-exemption-memo-DRAFT.md`. I am not asking you to write it; I am asking you to rule on it. Its own author flagged these as the points to press on:

1. Confirm or correct the primary position: Signal is not a device under section 201(h) because its intended use is administrative and billing support, with the section 520(o)(1)(A) administrative-support exclusion as reinforcement.
2. Rule on whether a DMEPOS supplier can rely on 520(o)(1)(A) as a "health care facility," or whether the position must rest on the 201(h) intended-use analysis alone.
3. Review our live worklist status labels, reason strings, and "recommended action" strings verbatim, and tell us if any wording reads as clinical rather than documentation-focused.
4. Approve a short list of permitted marketing claim framings so our intended use stays administrative.
5. Confirm the memo's citations against FDA's Clinical Decision Support (CDS) guidance current at the time of your review (it was verified against the January 29, 2026 version).
6. Advise whether, once settled, this should be reissued as a counsel letter we can hand to supplier compliance contacts and investors.

### 5. Anti-Kickback Statute question (time-sensitive, privileged, confidential)

**Confidentiality note:** the partner named here is bound to us by a confidentiality clause that bars public mention of the relationship. I am sharing the name with you only because you are our counsel and I need the facts to get sound advice. Please keep it inside privilege.

We have an executed 180-day discovery letter of intent with Pathogens Artificial Intelligence Inc., a Delaware corporation doing business as LabABLE, a diagnostic-laboratory software platform whose team includes Dr. Mehul Patel (the LOI was signed by co-founder Daniel Rojas). During discovery we discussed a reciprocal integration concept, informally called "kit in kit": LabABLE could be made available as a component inside our Signal platform, and Signal could be made available as a component inside the LabABLE platform.

Both of our customer bases serve providers who bill federal healthcare programs (our suppliers bill Medicare for DMEPOS; laboratories bill Medicare Part B). My question:

1. Does this reciprocal embedding or cross-availability arrangement, where each party's product carries value into the other's platform and could influence orders or referrals of federally reimbursable items or services, implicate the federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)), the Eliminating Kickbacks in Recovery Act, or the Stark Law?
2. If so, what structure or safe harbor would we need before executing any definitive agreement with this partner?

This must be resolved before we execute any further agreement with them, so please tell me how heavily it weighs on your timeline.

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### What I need back

- A turnaround estimate and a fee estimate for the full bundle.
- Your answers, or corrections, to the questions above.
- A flag on anything I have framed wrong or missed.

Thank you. I am happy to get on a call to walk through any of it.

Kisa (Arkisia) Fenn
KJF Professional Services LLC d/b/a STTIL Solutions
kisasttil@gmail.com / [PHONE]

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## ATTORNEY REVIEW NOTES (for internal use, do not send)

Load-bearing facts in this memo, labeled GROUNDED (cited source) or GRAFTED (assumption to confirm):

- Recipient RESOLVED: Clyde Mathes, confirmed by Kisa 2026-07-07 (the Bittinger/Nixon names in the compliance checklist were candidate firms).
- labABLE LOI VERIFIED against the executed PDF 2026-07-07 (`signal/pitch/legal/labABLE-LOI-v3-EXECUTED-2026-06-12.pdf`): signed 6/12/2026 by Daniel Rojas (Co-Founder, Pathogens Artificial Intelligence Inc.) and Arkisia Fenn (Founder); binding sections 3 through 11; 180-day term from Effective Date; governed by Delaware law on LabABLE's paper; Section 7 publicity clause bars public mention without written consent. The kit-in-kit concept does NOT appear in the executed text; it is a discussed concept only, which is exactly how this memo frames it.
- labABLE legal entity is Pathogens Artificial Intelligence Inc. d/b/a LabABLE. GROUNDED (labABLE LOI markup 2026-06-06).
- AWS BAA signed and active 2026-05-27, RDS and S3 provisioned and parked. GROUNDED (KG Signal; Signal current-state.md).
- Real PHI blocked/mock today. GROUNDED (Signal current-state.md 2026-07-07).
- FDA memo location and its own self-identified weak points. GROUNDED (`fda-cds-exemption-memo-DRAFT.md`).
- The AKS/EKRA/Stark characterization is a lay framing of the question, not a legal conclusion. GRAFTED, for counsel to analyze.

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*Prepared for attorney review. Not legal advice.*
