Digital sequence information, the Cali Fund, and what it means for IsoGentiX

What ABS was designed to cover

The Nagoya Protocol on Access and Benefit-Sharing (2010, in force 2014) was built around a physical transaction. A company travels to a biodiverse country, collects plant material, transports it home, and — years later — generates commercial value from it. The framework's three core instruments — Prior Informed Consent (PIC), Mutually Agreed Terms (MAT), and the Internationally Recognised Certificate of Compliance (IRCC) — were designed to govern exactly that sequence: consent before collection, terms agreed before use, a certificate registered publicly on the CBD ABS Clearing-House to document the chain.

Madagascar ratified the Nagoya Protocol in 2014. Decree N°2017-066 is the operative domestic ABS instrument, designating the Direction Générale de l'Environnement et des Forêts (DGEF) within the Ministry of Environment and Sustainable Development (MEDD) as the national competent authority. Every IsoGentiX collection operates under this framework: PIC granted, MAT agreed, IRCC registered — before any field team begins work.

This physical track remains the foundation. But it was designed before something important changed.

The DSI gap

Over the decade following Nagoya's entry into force, the physical specimen became commercially secondary. What pharmaceutical companies, agritech firms, and AI platform companies actually need is the data derived from specimens — the genome assembly, the transcriptomic profile, the metabolite fingerprint. Once that data is published in a global database or licensed to a customer, it exists independently of the original specimen. It can be used commercially with no traceable connection to the country of origin, and therefore no benefit-sharing obligation under the original Nagoya framework.

Digital Sequence Information (DSI) is the formal term for this digital genetic data — genome sequences, transcriptomic data, metabolomics profiles, and derived computational outputs. By 2016, DSI had become the central unresolved tension in CBD negotiations. By 2022, a structural solution was agreed in principle. By 2024, it was operational.

The Cali Fund

At CBD COP15 in Montreal (December 2022), parties agreed in principle to establish a multilateral mechanism for benefit-sharing from DSI use. At CBD COP16 in Cali, Colombia (November 2024), that mechanism was operationalised via decision 16/2. The resulting financial instrument — named the Cali Fund in honour of its birthplace — was formally launched in Rome on 25 February 2025, administered by the Multi-Partner Trust Fund Office (MPTFO) in partnership with UNDP and UNEP, with the CBD Secretariat hosting the fund secretariat.

These are indicative rates. Definitive thresholds and contribution rates will be established at COP17 (2026). The Cali Fund is explicitly designed to evolve — its governance includes an Ad Hoc Technical Expert Group on Allocation Methodology to refine contribution rates and distribution methods as the mechanism matures.

The sectors identified as in scope are precise and directly relevant to IsoGentiX's commercial targets: pharmaceuticals, cosmetics, food and health supplements, plant and animal breeding, agricultural biotechnology, industrial biotechnology, laboratory equipment associated with DSI sequencing, and — critically — information, scientific, and technical services related to DSI, including artificial intelligence. Academic institutions and entities operating public databases are explicitly exempt from monetary contributions.

Two parallel tracks, one coherent framework

The Cali Fund is not a replacement for the Nagoya Protocol's PIC/MAT/IRCC system. It is a parallel track. Both operate simultaneously and address different parts of the value chain.

The interaction between these two tracks is the genuinely novel governance question of the DSI era. No company has yet operated at scale with both tracks in play simultaneously. IsoGentiX is building the architecture to do exactly that — because our commercial offering is natively DSI.

Who must contribute to the Cali Fund

Contribution obligations apply to companies that use and benefit from DSI commercially, and that exceed at least two of the following three balance-sheet thresholds: total assets of at least USD 20 million; sales of at least USD 50 million; and profit of at least USD 5 million, averaged over the preceding three years. Definitive thresholds will be confirmed at COP17.

IsoGentiX, at its current pre-seed and seed stage, will not meet these thresholds for several years. But the commercial partners IsoGentiX targets — pharmaceutical companies, agritech groups, AI platform companies — almost certainly will, once revenues derived from DSI-containing products are attributed. The sectors explicitly listed in decision 16/2 include pharmaceuticals, plant and animal breeding, agricultural biotechnology, and AI-related scientific services — the IsoGentiX commercial target list exactly.

IsoGentiX's position in the regulatory architecture

IsoGentiX sits at the intersection of both tracks simultaneously, in a way that no conventional pharma company or agritech firm does. We are:

• A direct obligor under the Nagoya / physical track — we obtain PIC, negotiate MAT, and receive IRCCs for every collection region before any specimens are collected.
• A native DSI producer — every data layer we generate (genome assemblies, transcriptomics, LC-MS/MS metabolomics, NIR fingerprints) constitutes DSI within the meaning of CBD decision 16/2.
• A facilitator of our customers' Cali Fund obligations — because we maintain specimen-level GUID linkage from physical collection through to digital sequence, we can provide the provenance documentation that customers need to attribute their DSI use to specific species and source countries.
• A potential direct Cali Fund contributor — as IsoGentiX's revenues grow, we will monitor our approach to the applicable thresholds and build annual Cali Fund contributions into our compliance calendar.

The critical structural question — which no one has yet resolved — is how direct MAT-based benefit-sharing to Madagascar and multilateral Cali Fund disbursements to Madagascar interact. IsoGentiX's Framework MoU with MEDD must explicitly address this: defining DSI scope, establishing a Cali Fund coordination clause, and ensuring that both streams are recognised without creating double obligations or leaving Madagascar with less than it is entitled to under either system.

What IsoGentiX does — concretely

In the Framework MoU with MEDD

IsoGentiX's Framework Memorandum of Understanding with Madagascar's Ministry of Environment and Sustainable Development (MEDD) will define explicitly that the IsoGentiX dataset — genome assemblies, transcriptomics, metabolomics data, NIR fingerprints — constitutes DSI within the meaning of CBD COP16 decision 16/2. It will also include a Cali Fund coordination clause: establishing how any Cali Fund disbursements received by Madagascar attributable to IsoGentiX-origin data are accounted for alongside IsoGentiX's direct MAT-based benefit-sharing payments. This prevents genuine double-counting while protecting Madagascar's entitlement to both benefit streams.

In customer licence agreements

Every IsoGentiX commercial licence includes a DSI compliance clause. Customers represent and warrant that they will make Cali Fund contributions in respect of commercial revenues derived from IsoGentiX-origin data, once they meet the applicable thresholds under CBD decision 16/2. This removes IsoGentiX from any downstream liability for customers' Cali Fund obligations and demonstrates to MEDD and the CBD that the entire value chain is governed responsibly.

In our provenance architecture

Every specimen in the IsoGentiX dataset carries a Globally Unique Identifier (GUID) registered at the point of collection. Every derived digital sequence is traceable to that GUID, which in turn links to the PIC/MAT instrument and IRCC for that specimen's collection region. When a customer uses IsoGentiX data to develop a product and needs to document their Cali Fund exposure, IsoGentiX can generate specimen-level provenance reports showing the precise origin of every sequence used. No public database — GenBank, GBIF, the ENA — can provide this. The IsoGentiX provenance chain is the only documentation system of its kind at platform scale.

In our annual compliance calendar

Cali Fund contributions, once IsoGentiX reaches the applicable thresholds, will be included in the annual compliance calendar. Contribution receipts will be registered with the MPTFO and referenced in annual ABS Clearing-House reporting to DGEF. This creates a fully auditable benefit-sharing trail across both the physical and DSI tracks — the standard we believe should apply across the industry.

The competitive advantage

Every pharmaceutical company, agritech group, and AI platform that uses public genomic databases faces emerging Cali Fund exposure. Most have no record of which sequences they used, from which country of origin, in which product. They cannot produce the DSI provenance documentation the Cali Fund mechanism will eventually require. The compliance gap is structural and it cannot be remedied retrospectively — sequences downloaded years ago from GenBank without provenance metadata are permanently undocumented.

IsoGentiX's architecture was built before this problem fully crystallised. Specimen-level GUID linkage, digital provenance registration at the point of collection, and FAIR-formatted data outputs were designed as scientific quality requirements. They are simultaneously the compliance infrastructure the DSI era requires.

This is what it means to build a platform for the DSI era rather than the pre-Nagoya era. IsoGentiX is not retrofitting compliance onto an existing data product. Compliance is the product — and the Cali Fund has made that commercially legible to every company operating in the sectors we serve.