3.1 Criteria:

SN BioScience will consider early access to SNB-101 based on the following criteria:

• Any use of SN BioScience’s investigational products outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including SN BioScience policies and procedures.
• The patient's condition must be serious or life-threatening, with no satisfactory alternative treatments available.
• We must have a minimum level of evidence to determine appropriate dosing and safety measures, as well as evidence the investigational product is likely to be efficacious, before considering early access. Further, excessive risk to any patients who may receive the investigational product before marketing approval must be avoided.
• A benefit-risk analysis, considering both clinical data and the patient's individual circumstances, must support early access.
• Early access must not impede ongoing clinical trials or regulatory approval processes.
• Adequate supply of the investigational drug must be ensured.

3.2 Continued Treatment After Clinical Trials:

Patients participating in clinical trials may be eligible for continued treatment with SNB-101 after the trial concludes, but before regulatory approval.

Decisions will be based on the severity of the disease, available evidence of efficacy and safety, and the absence of alternative treatments.

Patients will be informed about the possibility of continued treatment before enrolling in a trial and will provide consent for ongoing data collection.

3.3 Compassionate or Emergency Use:

For patient’s ineligible for clinical trials, suffering from serious or immediately life-threatening conditions, and with no alternative treatments available,

SN BioScience may consider early access to SNB-101. Similar to post-trial treatment, patients will provide consent for ongoing data collection.

3.4 Discontinuation of Early Access:

Early access will be phased out upon regulatory approval and commercial availability of SNB-101. If evidence suggests insufficient efficacy or safety,

SN BioScience will discontinue early access and assist patients in transitioning to alternative treatments.

3.5 Treating Physician Criteria and Responsibilities:

The physician(s) attending to the patients who are receiving an investigational product through compassionate use access must be properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with:

• Any applicable country-specific legal and regulatory requirements related to providing an investigational product under Expanded Access.
• Any SN BioScience requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property.