Title: Letter of Intent — Free Pilot (One-Page)
Version: 0.1.0-draft
Status: Template — populate placeholders, send within 24 h of discovery call
Owner: Commercial Lead
Last Reviewed: 2026-05-07
Next Review: 2026-08-07

---

# Letter of Intent — {{COMPANY_NAME}} ⇄ {{CUSTOMER_LAB}}

**Free Pilot — GCP-native GPU-accelerated secondary analysis**

This is a **non-binding** Letter of Intent capturing the shape of a
free validation pilot. The full Pilot Agreement (`PILOT_AGREEMENT.md`)
follows once both parties sign below.

A more detailed multi-section variant lives at
[`LOI_TEMPLATE.md`](LOI_TEMPLATE.md); this one-pager is the artifact
to send within 24 hours of a successful discovery call to capture
momentum.

---

## Parties

| | Provider | Lab |
|---|---|---|
| Entity | **{{COMPANY_NAME}}** | **{{CUSTOMER_LAB}}** |
| Primary contact | {{COMPANY_CONTACT_NAME}} ({{COMPANY_CONTACT_TITLE}}) | {{CUSTOMER_CONTACT_NAME}} ({{CUSTOMER_CONTACT_TITLE}}) |
| Email | {{COMPANY_CONTACT_EMAIL}} | {{CUSTOMER_CONTACT_EMAIL}} |

---

## Pilot scope

- **Free**: up to **10 samples** at **$0** (Provider absorbs GB300 compute, GCS storage, manifest signing, audit-log retention, integration time).
- **Sample types**: {{SAMPLE_TYPES}} (e.g. "30× WGS HG002 GIAB benchmark + up to 5 pseudonymized Lab samples").
- **Pipeline version**: {{PIPELINE_VERSION}} (Parabricks DeepVariant; pinned per `technical/PIPELINE_LOCK.md`).
- **Reference**: GRCh38_no_alt_analysis_set; SHA-pinned at `9cce8b92...8702b7`.
- **PHI in scope?** {{PHI_YN}} — if **Yes**, BAA execution is a HARD GATE before any sample is processed.
- **Target start**: {{PILOT_START_DATE}}; target conclusion: {{PILOT_END_DATE}} (4–8 weeks typical).

## Per-sample deliverable

Every sample returns:

- Aligned BAM (or CRAM on request)
- VCF + (optional) gVCF — DeepVariant via Parabricks
- Annotated VCF (VEP/GENCODE)
- **Signed Ed25519 provenance manifest** + detached `signature.json` (verify offline with `genomics-verify <manifest> <signature> --public-key <pem>` — exit 0 on valid signature)
- **QC report** (PASS/WARN/FAIL with reason codes)
- Audit-log entries (Lab can pull on demand)
- Run logs sufficient to reproduce the exact Parabricks invocation
- **Side-by-side concordance report** vs the Lab's existing pipeline (the Lab keeps this report regardless of pilot outcome)

## Data handling

- **GCS-native**: data stays in {{LAB_PROJECT}} (BYOB via service-account grant) **or** in a {{COMPANY_NAME}}-managed GCS bucket isolated to the Lab's tenant.
- **Encryption**: TLS in transit; CMEK at rest.
- **Retention**: FASTQ inputs deleted 30 days post-delivery (Coldline archive optional); outputs retained 90 days online + cold archive per Lab election.
- **Deletion certificate** issued within 30 days of pilot conclusion.
- **Audit log**: append-only, hash-chained; Lab gets a copy on conclusion.

## Pilot success criteria

The pilot is **PASS** if all hold across the agreed sample set:

| Criterion | Target |
|---|---|
| In-scope SNP F1 against v4.2.1 (HG002 30×) | ≥ {{SNP_F1_TARGET}} (default 0.995) |
| In-scope Indel F1 against v4.2.1 (HG002 30×) | ≥ {{INDEL_F1_TARGET}} (default 0.99) |
| Manifest signature verification (every sample) | 100% verify=True |
| Audit chain integrity (entire pilot run) | `validate_chain` returns clean |
| Standard turnaround (≤24h target) | Hit on 100% of pilot samples |
| Lab's parallel-comparison concordance against existing pipeline | ≥ {{LAB_CONCORDANCE_TARGET}} on the in-scope complement |

The Lab is the **final arbiter** of whether the pilot meets its
internal QMS standard. We provide the evidence; the Lab signs off
on its own timeline.

## Path to paid volume pricing

Post-pilot, on Lab signoff:

- **Standard tier**: **$149 per WGS sample** (≤30×) / **$79 per WES** — all-inclusive (compute, manifest, QC, audit, annotation).
- **Priority tier**: **$249 per WGS sample** — same-day turnaround SLA + dedicated GB300 reservation.
- **Enterprise tier**: custom pricing for 200+ samples/month, multi-year, or white-label deployments. Not offered below Standard rates.

No expiration on converting a successful pilot to Standard rates.
First Standard invoice is monthly in arrears, Net 30.

## Open items to close before pilot kickoff

| Open item | Owner | Target |
|---|---|---|
| {{OPEN_ITEM_1}} (e.g. "BAA executed if PHI in scope") | {{OWNER}} | {{DATE}} |
| {{OPEN_ITEM_2}} (e.g. "Lab confirms preferred ingestion: Globus / GCS BYOB / SFTP") | Lab | {{DATE}} |
| {{OPEN_ITEM_3}} (e.g. "Lab supplies capture-kit BED if WES in scope") | Lab | {{DATE}} |
| Pilot Agreement executed | Counsel both sides | {{DATE}} |

## Non-binding statement

This LOI is **non-binding** other than as to confidentiality of
discussions and any sample data shared during scoping. Either party
may walk away before signing the formal Pilot Agreement without
liability beyond reimbursable costs already incurred at the other's
written request. The Pilot Agreement, once executed, supersedes
this LOI in full.

## Signatures

| Provider — {{COMPANY_NAME}} | Lab — {{CUSTOMER_LAB}} |
|---|---|
| _______________________________ | _______________________________ |
| {{COMPANY_SIGNATORY_NAME}}, {{COMPANY_SIGNATORY_TITLE}} | {{CUSTOMER_SIGNATORY_NAME}}, {{CUSTOMER_SIGNATORY_TITLE}} |
| Date: __________ | Date: __________ |

---

**Diligence package** (for the Lab's bioinformatics + QMS + counsel review): full clinical-readiness dossier at [`../README.md`](../README.md). Highlights: [`INTENDED_USE.md`](../intended-use/INTENDED_USE.md), [`QUALITY_METRICS.md`](../QUALITY_METRICS.md), [`PIPELINE_LOCK.md`](../technical/PIPELINE_LOCK.md), [`V5_0Q_GAP_ANALYSIS.md`](../investigations/V5_0Q_GAP_ANALYSIS.md), [`HIPAA_TECHNICAL_SAFEGUARDS.md`](../compliance/HIPAA_TECHNICAL_SAFEGUARDS.md), [`SIGNING_KEY_PUBLISHING.md`](../security/SIGNING_KEY_PUBLISHING.md), [`API_OPENAPI.json`](API_OPENAPI.json).

**Appendix A — Signing-key fingerprint (pinned at execution).**
The Lab pins the production public-key SHA-256 fingerprint here at
signature time and treats it as the trust anchor for every signed
manifest delivered under this pilot. Rotation overlap, revocation,
and historic keys are governed by [`SIGNING_KEY_PUBLISHING.md`](../security/SIGNING_KEY_PUBLISHING.md) §5.

| Key ID | Fingerprint (SHA-256 of PEM) | Status |
|---|---|---|
| {{KEY_ID}} | {{KEY_FINGERPRINT}} | Pinned for this pilot |