Oneness Biotech Company Limited

Expanded Access Policy

All expanded access programs must be conducted in agreement with applicable legal and regulatory requirements related to providing an investigational product under expanded access protocols. Oneness Biotech believes that participation in one of our clinical trials is the best way to access our investigational drug product. We encourage patients to speak with their physicians regarding participating in clinical trials. In exceptional cases where patients with serious diseases are unable to participate in clinical trials and have exhausted all available options, requests for EAP will be considered, on a case-by-case basis, if it meets the following criteria listed below:

Criteria for Consideration of a Request for EAP

1. A patient has a serious, life-threatening or chronically debilitating disease;
2. There is a clear understanding that the investigational product is intended to treat diabetic foot ulcers for which use is requested by the licensed physician and the patient;
3. The investigational product is regarded by the licensed physician and the patient that the available clinical data presents evidence of efficacy such that a clinically meaningful benefit may be expected;
4. There is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the disease or condition;
5. The patients are ineligible for, or otherwise unable to participate in, a clinical trial for the product;
6. The treating physician must complete FDA Form 3926 and is willing to open a Treatment IND with the FDA, including file paperwork with FDA and IRB (for many expanded access request types), and is responsible for patient care and reporting;
7. The treating physician should provide the completed Form to Oneness Biotech for review prior to submission to FDA;
8. The treating physician and the patient (and the patient’s family or custodians) agree to waive claims for damages against Oneness Biotech;
9. There is adequate supply of the investigational product to meet all needs for patients enrolled in ongoing clinical studies, and that designating investigational product for an expanded access treatment use will not compromise supply or otherwise postpone providing the new treatment, once approved, to the broader patient population;
10. Providing expanded access to an investigational product shall not negatively jeopardize the initiation, conduct, or completion of clinical investigation(s) and the overall development program to support registration of the product.