Section 01
Rif Valley Biomass
The sovereign raw material. Two supply channels. One terroir that cannot be replicated.
Target CBD in raw flower
8–15%
High-CBD selected lines sub-0.3% THC
Altitude — cultivation zone
1200–2000m
Ketama — Rif Mountains Morocco
Supply channels
Two
Collective contracts + founder's land
The terroir thesis. Altitude drives exceptional trichome density as a UV-stress response — the same mechanism behind the Rif's historical resin output now redirected into high-CBD lines. Intense daytime UV followed by cool nights produces an unusually complex terpene profile: elevated myrcene β-caryophyllene pinene and linalool concentrations. This is not a marketing claim. It is the agrological basis for the scientific differentiation Bob Calkin's formulation work builds on.
Supply Channel 1 — Collective contracts
ANRAC-licensed cooperative contracts. Bulk biomass supply from multiple licensed Rif Valley cultivators under Law 13-21. Specifies: CBD target THC ceiling harvest timing drying protocol delivery format (whole flower or trim). Volume security for industrial production. Spot quality audits at delivery.
Supply Channel 2 — Founder's land holdings
Founder — Mohamed El Sghiar personal family land in Ketama. Proprietary terroir. Full control over cultivation protocol: planting density irrigation harvest timing post-harvest handling. Produces the premium Grade A whole flower used for bubble hash and the highest-tier finished products. This is the storytelling biomass — the origin narrative no competitor can appropriate.
Biomass grades and downstream use
Grade A — whole flower
Bubble hash production. Premium rosin. Highest terpene retention. Le Baume and L'Élixir clinical lots. Founder's land only.
Grade B — manicured trim
Bubble hash (second wash). Quality rosin. Commercial product lots. Collective contract supply.
Grade C — machine trim
Dry sift production. B2B bulk extract. Kief for commercial derivatives.
Fan leaves + stalks
Composted. No extraction value for premium products. Return to soil.
Harvest and post-harvest protocol
Harvest timing
60–70% cloudy trichomes 20–30% amber. Jeweler's loupe or portable trichome scope (30×). Incorrect timing risks THC elevation.
Drying environment
18–20°C 55–65% RH dark continuous airflow. 10–14 days. No forced heat — preserves terpene fraction.
Curing (Grade A)
Airtight glass or food-grade vessels 62% RH packs. 21–23°C minimum 2 weeks. Degrades chlorophyll concentrates terpenes.
Moisture at processing
10–12% for dry sift. 6–8% for ice water extraction. Verified with grain moisture meter before each batch.
Cold storage
Long-term biomass: −20°C vacuum-sealed. Cold biomass = better mechanical trichome separation across all extraction methods.
Section 02
Equipment Matrix
Every machine required from harvest to finished product. Organized by production phase. Phase 1 = start now.
Phase 1 budget (essential)
$48K–75K
No HPLC 3rd-party QC core chain only
Phase 2 (add-ons)
+$30K–55K
Rotary sift homogenizer Tewameter
Phase 3 (HPLC in-house)
+$25K–60K
Agilent or Shimadzu system
| Equipment | Specification | Notes | USD low | USD high | Phase |
|---|
Section 03
Processing Chain
Rif Valley biomass → full-spectrum extract → decarboxylated active ready for Bob Calkin's formulation.
Three solventless extraction routes
Route B in full — Bubble Hash → Full-Spectrum Rosin (premium standard)
Route B is the production standard for Le Baume and L'Élixir clinical lots. Grade A whole flower from Founder — Mohamed El Sghiar personal family land in Ketama. Every step is a quality decision — cutting corners at any stage degrades the final extract that Bob Calkin formulates with.
Decarboxylation — when and how
Which products need decarboxylation
Le Baume (topical)
Partial decarb. 95°C 20 min in sealed vessel. Preserves CBDA (anti-inflammatory in skin) while activating some CBD. Bob Calkin specifies the ratio in his formulation brief.
L'Élixir (sublingual)
Full decarb required. Sublingual bioavailability requires active CBD form. 110°C 45–60 min sealed stainless vessel.
B2B crude extract
Customer specifies. Supply both decarbed and raw as separate SKUs. Different price points.
Section 04
Formulation — Bob Calkin's Domain
40 years of cannabis product development applied to Rif Valley full-spectrum rosin. The R&D cycle that converts extract into validated clinical products.
The core distinction. Bob Calkin does not work with biomass extraction or production logistics. He receives the HPLC-certified Rif Valley rosin extract and converts it into formulations that perform against a defined clinical outcome. His empirical library — 40 years of product development outcomes — is what makes formulation decisions defensible. It is the difference between a product correctly composed and a product that consistently works.
Formulation status — conceptual framework. The ingredient matrices and manufacturing protocols shown below represent the current working ideas and direction for each product. They are not locked specifications. The final formulation details — including exact ratios co-active selection processing parameters and quality criteria — will be designed and specified by Bob Calkin. These frameworks exist to map the product vision and guide initial discussions; Bob will define the definitive formulation when he receives the certified extract and begins his R&D cycle.
Le Baume Cicatrisant CBD — 50ml jar
Ingredient matrix
Full-spectrum rosin
500mg CBD / unit (10mg/ml). Partial decarb. Rif Valley HPLC certified. THC <0.03%.
Shea butter
20% w/w. Base emollient. Cold-press unrefined. Melt point 32–45°C.
Argan oil (Moroccan)
12% w/w. Sovereign sourcing — Rif region. Rich in oleic acid and tocopherols.
Beeswax
8% w/w. Structural agent. Sets balm texture at room temperature.
Calendula extract
3% w/w. Anti-inflammatory co-active. Flavonoid-rich. Wound healing support.
Allantoin
0.5% w/w. Cicatrizing co-active. Keratinocyte proliferation stimulant.
Vitamin E (tocopherol)
1% w/w. Antioxidant. Shelf life extension.
Preservation
Phenylpropanediol 1%. PET-tested per ISO 11930. No parabens.
Fragrance
None (clinical lots). Optional: lavender EO 0.1% for retail.
Manufacturing protocol
L'Élixir Phytocannabinoïde — 20ml dropper
Ingredient matrix
Full-spectrum rosin (decarbed)
500mg CBD / unit (25mg/ml). Fully decarboxylated. THC <0.03%.
MCT oil
Food grade pharmaceutical preferred. Fractionated coconut. Neutral taste high stability excellent CBD carrier. Fills to volume.
Peppermint EO (Option A)
0.3–0.5%. Sublingual palatability. Tingling aids patient compliance. Food-grade only.
Unflavored (Option B)
MCT + extract only. Clinical study lots. No taste interference with patient reporting.
Vitamin E (tocopherol)
0.5%. Antioxidant. Extends oxidative shelf life of oil base.
Preservation
None required. Anhydrous oil system — no water activity no microbial risk.
Nitrogen flush
Mandatory. Displaces oxygen in bottle before filling. Extends shelf life from ~12 to 24+ months.
Manufacturing protocol
The R&D iteration cycle
Phase 1 — Extract characterisation
Bob receives each HPLC CoA (CBD mg/g cannabinoid panel terpene profile) and calibrates formulation dosing accordingly. He tests rosin compatibility with each carrier system and maps a concentration matrix (5 / 10 / 20 mg/ml) per product type.
Phase 2 — Prototype + evaluation
Bob specifies the full formulation. L&L produces a prototype batch following his SOP exactly. Bob evaluates: texture skin feel absorption odour colour homogeneity. Third-party HPLC confirms potency at ±10% target. Iterate if outside tolerance.
Phase 3 — Stability + lock
ICH Q1A stability: 40°C/75% RH (accelerated) and 25°C/60% RH (intermediate). Test at T=0 1m 3m 6m for potency appearance odour pH viscosity microbiology. Formulation locked after T=3m accelerated data confirmed. Locked formulation filed at OMPIC.
Section 05
23-Product Portfolio
Bob Calkin's R&D scope. Two clinical anchor products first. 21 portfolio products developed sequentially as clinical data accrues.
Tier 1 — Clinical anchors
2
Locked formulations — Bob authored
Tier 2–3 — Product portfolio
17
Baume + Élixir derivatives
Tier 4 — B2B +
4
Raw materials + education tools
Section 06
Partnership Architecture
Bob Calkin is the formulation and R&D partner. The clean division of roles IP ownership and what each party does not do.
The partnership in one sentence. Leaf & Legend produces the sovereign Rif Valley extract and holds all production and market rights in Morocco. Bob Calkin designs the formulations that make that extract perform as a validated clinical product . Neither party has what the other has. Neither can produce the final product without the other.
Founder — Mohamed El Sghiar. Leaf & Legend was founded by Mohamed El Sghiar who signs the Memorandum of Understanding with Bob Calkin on behalf of the company. This MOU is the foundational document that defines the partnership structure IP ownership role boundaries and operational framework described throughout this architecture. Mohamed's signature on the MOU commits Leaf & Legend to the clean division of responsibilities that protects both parties and ensures every decision flows through the agreed structure.
Operational Sequence — How Work Begins
1
Put the plant to work
Begin with the raw material. Establish cultivation secure the Rif Valley biomass supply and set up the extraction chain. Everything starts with producing the certified extract — no formulation no clinical work no product exists without it.
2
Define the road
With the extract in hand define the product roadmap. Which products first which clinical observations which regulatory pathway. This document is the map — but it gets refined as real data replaces assumptions.
3
Founder signs the MOU with Bob Calkin
Mohamed El Sghiar signs the Memorandum of Understanding with Bob Calkin on behalf of Leaf & Legend. This is the formal commitment that activates the partnership. The MOU defines: who does what who owns what how decisions are made and what each party does not do. It is the legal and operational foundation for everything that follows.
4
Receive Bob's requirements list
Once the MOU is signed Bob Calkin provides Leaf & Legend with a detailed list of what he needs to begin his formulation work: extract specifications HPLC data quantity requirements sample sizes carrier system samples and any specific analytical data points. This list becomes Leaf & Legend's operational checklist — every item must be delivered before Bob can start designing formulations.
5
Find the best working model
With Bob's requirements in hand and the certified extract ready iterate on the most effective operational model. This means testing: which extraction parameters produce the rosin that performs best in Bob's carrier systems which licensed laboratory delivers the most consistent manufacturing which supply chain configuration gives the shortest time from harvest to HPLC-certified product. The working model is not theoretical — it is proven through prototype batches and real results.
6
Organize work around the validated model
Once the best working model is identified structure all operations around it: production scheduling quality checkpoints Bob's formulation timeline licensed laboratory coordination and CHU Marrakech clinical scheduling. Organization follows validation — not the other way around. Every process role and timeline in this architecture document is designed to be refined once real operational data confirms what works.
BC
Bob Calkin
Formulation & R&D Partner · Cannabis Career Institute · 40 years
- Designs every formulation in the 23-product portfolio — ingredient selection ratios SOP manufacturing parameters
- Specifies carrier systems co-active selection preservation per product type based on 40 years of empirical outcomes
- Defines the R&D protocol: prototype batch parameters stability schedule efficacy assessment iteration criteria
- Knows precisely how full-spectrum rosin behaves in each matrix type — anhydrous balm oil emulsion gel — without phase separation or potency loss
- Authors the formulation technical section of every AMMPS notification dossier (ingredient justification manufacturing process stability summary)
- Designs the stability programme (ICH Q1A) for every product — storage conditions test intervals degradation limits re-test triggers
- Specifies clinical lot parameters: tighter potency tolerance (±5% vs ±10%) traceability checkpoints sealed clinical packaging
- Reviews clinical outcome data from CHU and recommends formulation refinements if studies reveal performance gaps
- Signs off on all manufacturing SOPs before OMPIC filing
L&L
Leaf & Legend S.A.R.L.
Production · Clinical · IP · Market
- Produces the Rif Valley full-spectrum rosin extract to the feedstock quality standard Bob specifies
- Executes every formulation batch exactly to Bob's SOP
- Manages all AMMPS regulatory filings (Bob authors technical content L&L submits and holds registration)
- Files all jointly developed formulations at OMPIC under the agreed ownership structure — production rights exclusively Moroccan
- Manages the CHU Mohammed VI clinical programme: Belbachir relationship CERB product supply to hospital pharmacy
- Owns all production infrastructure: extraction chain formulation equipment Leaf & Legend production facility
- Controls all Moroccan market and export channels under Law 13-21 / ANRAC license
- Commissions third-party HPLC CoA for every batch and forwards to Bob for formulation calibration
- Manages investor institutional and government relationships in Morocco and internationally
IP ownership at OMPIC
Jointly owned — Bob Calkin + Leaf & Legend
The specific locked formulation of Le Baume Cicatrisant CBD. The specific locked formulation of L'Élixir Phytocannabinoïde. Each subsequent product formulation as it is locked. The R&D methodology (stability protocol iteration framework clinical lot specification). Bob's co-ownership covers R&D education and co-branding use only — not production rights.
Exclusively Leaf & Legend
The Rif Valley botanical extract (raw material). The full production process from harvest through extraction. The Leaf & Legend manufacturing facility. All ANRAC license rights. The clinical RWE data from CHU. All Moroccan market and export channels. Sub-licensing of production rights to any third party is excluded from Bob's co-ownership — this clause is explicit in the OMPIC filing and the partnership MOU.
What Bob Calkin does NOT do — clean in the MOU
Bob does not source handle or hold Moroccan biomass. Does not manage or direct the extraction process. Does not hold or exercise ANRAC license rights. Does not interface directly with CHU CERB or Prof. Belbachir — L&L manages that relationship. Does not have independent access to Leaf & Legend production records or financial data. Does not make decisions on Moroccan market pricing distribution or export strategy. Does not have authority to commit Leaf & Legend to any third-party agreement. These are not limitations on Bob's value. They are the clean delineation that protects both parties under Moroccan corporate law and ANRAC regulatory review.
Section 07
Clinical & Laboratory Roadmap
From first extract to clinical validation. The CHU Marrakech observation protocol and licensed laboratory partnerships that close the loop between production and clinical proof.
The sequencing logic. Leaf & Legend does not begin clinical work before having a finished HPLC-certified product in hand. The first priority is preparing the raw material executing the extraction chain and producing the initial formulation batch. Only after the first product exists — physically verified potency confirmed — does the observation protocol with CHU Marrakech commence. This is not a delay. It is the correct sequence: no hospital accepts a product for clinical observation that does not yet exist.
Step 1 — Current focus
Material
Prepare first extract batch + certify via HPLC
Step 2 — Licensed labs
Cosmetics
Partner with licensed labs for product manufacturing
Step 3 — Clinical
CHU Marrakech
Observation protocol after first product ready
CHU Marrakech Collaboration
Observation Protocol — when it starts
After the first product is manufactured and HPLC-certified Leaf & Legend initiates the observation protocol with CHU Marrakech (Centre Hospitalier Universitaire). This is not a pre-clinical filing — it is a structured clinical observation programme where the finished product is supplied to the hospital pharmacy under medical supervision. The protocol timing is deliberate: the hospital needs a real validated product to observe not a theoretical one. Starting the protocol before the product exists would be premature and would not survive CERB ethics review.
What CHU Marrakech provides
The collaboration with CHU Marrakech extends well beyond clinical observation alone. The CHU — and the affiliated Faculty of Medicine and Pharmacy at Cadi Ayyad University — provides Leaf & Legend with access to multiple critical capabilities: formulation support and pharmaceutical expertise HPLC analysis and analytical chemistry services pharmacology and toxicology review clinical trial infrastructure and patient recruitment and regulatory guidance for AMMPS notification dossiers. Whether the support comes from the clinical side of CHU or the academic side of the Faculty of Medicine the partnership gives Leaf & Legend scientific infrastructure that would otherwise require years and significant capital to build independently.
CHU collaboration — specific areas of support
Formulation assistance
Access to pharmaceutical formulation scientists at the Faculty of Medicine. Complementary to Bob Calkin's design work — the university team can assist with local carrier system testing Moroccan pharmacopoeia compliance and excipient sourcing specific to the Moroccan market.
HPLC analysis
The CHU's analytical chemistry laboratory can provide HPLC cannabinoid profiling and terpene analysis. This supplements third-party CoA testing and gives Leaf & Legend a local cost-effective analytical partner for routine batch verification and R&D screening.
Pharmacology & toxicology
University pharmacologists can advise on cannabinoid safety profiles drug interaction screening and dose-response characterisation — particularly valuable for the clinical observation protocol design.
Clinical infrastructure
Hospital pharmacy dispensing patient recruitment through CHU dermatology and pain clinics structured data collection under medical supervision CERB ethics filing and monitoring.
Observation protocol structure
Pre-observation
First product manufactured. HPLC CoA confirmed. Stability data initiated (T=0). AMMPS notification filed. CERB ethics submission prepared with CHU support.
Observation Phase A
Le Baume Cicatrisant CBD supplied to CHU Marrakech dermatology department. Structured observation under dermatologist supervision. TEWL wound closure time patient-reported outcomes. Minimum 30 patients.
Observation Phase B
L'Élixir Phytocannabinoïde supplied to pain management / internal medicine. Sublingual CBD dosing under physician supervision. Pain scores sleep quality anxiety indices. Minimum 30 patients.
Data synthesis
CHU and Faculty of Medicine compile Real-World Evidence (RWE) dataset. Bob Calkin reviews clinical outcomes and recommends formulation refinements if performance gaps emerge. RWE data filed at OMPIC — exclusively owned by Leaf & Legend.
Licensed Laboratory Partnerships
The manufacturing strategy. Leaf & Legend does not need to hold its own cosmetics or food supplement manufacturing licence from day one. Instead the initial production phase focuses on collaborating with existing laboratories in Morocco that already hold the required licences to create cosmetics and food supplements (compléments alimentaires). These licensed laboratories provide the regulatory cover GMP-compliant facilities and established quality systems that allow Leaf & Legend to manufacture its first products legally and to professional standards — without waiting for its own licence approval cycle.
Why licensed laboratory partners first
Building a fully licensed GMP-compliant cosmetics and supplements manufacturing facility is a 12–18 month process involving ANM (Agence Nationale du Médicament) inspections facility qualifications and dossier submissions. By partnering with laboratories that already hold these licences Leaf & Legend can bring the first product to market significantly faster. The licensed lab handles the regulatory compliance of the manufacturing act itself; Leaf & Legend controls the raw material the formulation (designed by Bob Calkin) the brand and the distribution. This is not outsourcing the core value — it is the intelligent sequencing that gets a verified product into the CHU observation protocol as quickly as possible.
What the licensed laboratory provides
Manufacturing licence
Valid ANM licence for cosmetics and/or food supplement manufacturing. Leaf & Legend products manufactured under the lab's licence until L&L's own facility licence is approved.
GMP facility
ISO 22716 (cosmetics GMP) or equivalent. Clean room qualified equipment batch recording system. Leaf & Legend provides the certified extract and Bob's SOP; the lab executes.
Quality system
Established QC protocols stability testing capability release testing batch record management. Supplements the third-party HPLC CoA process.
Regulatory filing
The licensed lab can support AMMPS notification dossier preparation with their existing regulatory templates and inspector relationships.
Transition roadmap — from partner labs to own facility
Phase 1 — Extract + partner lab
Leaf & Legend produces the Rif Valley extract in-house. Formulation manufacturing performed at a licensed partner laboratory under Bob Calkin's SOP. Focus: get the first product manufactured certified and into the CHU Marrakech observation protocol.
Phase 2 — Dual track
Continue partner lab manufacturing for volume products while building and qualifying the Leaf & Legend own facility. Apply for own manufacturing licence (cosmetics + supplements). CHU observation data accrues during this phase strengthening the licence application and market positioning.
Phase 3 — Own facility operational
Leaf & Legend manufacturing licence approved. Full in-house production. Partner laboratory relationship transitions to overflow capacity and specialist product lines. Complete vertical integration: Rif Valley biomass → extraction → formulation → packaging → market — all under Leaf & Legend control.