Expanded Access and Compassionate Use Policy

Zydus Therapeutics is committed to developing transformative treatments to address the unmet medical needs of patients suffering from rare and serious diseases.

Clinical trials allow us to evaluate investigational treatments in order to generate the information needed to determine their safety and effectiveness, and to obtain regulatory approval. We believe the best way for patients to access investigational treatments is through participation in these clinical trials. However, when patients are unable to participate in clinical trials and have exhausted all available treatment options, health authorities may permit Zydus Therapeutics to consider providing your physician access to an investigational product outside of a clinical trial. We refer to this process as expanded access, and it sometimes referred to by others as compassionate use. The expanded access must be made by a physician on the patient’s behalf.

Zydus Therapeutics will consider expanded access requests outside of a clinical trial when all the following criteria are met:

• The patient has a serious or immediately life-threatening disease or condition;
• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition;
• The patient is not eligible or cannot participate in an ongoing or planned clinical trial;
• There is sufficient scientific evidence that the potential patient benefit justifies the potential risks of treatment;
• This expanded access use will not interfere with clinical trials that could support the development or marketing approval of the investigational product;

Zydus Therapeutics is committed to evaluating all requests in a fair and equitable manner. All expanded access requests must be submitted by the patient’s treating physician, and we will generally only consider requests if the investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition. Zydus Therapeutics may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient informed consent, medical monitoring, safety reporting and data collection. Each request will be given careful consideration by Zydus Therapeutics.

Physicians seeking expanded access to a Zydus Therapeutics investigational treatment should submit their requests to medinfo@zydustx.com.

Zydus Therapeutics will acknowledge a request within 5 business days after receipt of the complete request. This request should indicate the date of request, the requesting physician contact information and a medical rationale for request including an explanation for why the patient cannot qualify for a clinical trial and why no alternative can be used.

Information about Zydus Therapeutics Inc. clinical trials can be found at https://clinicaltrials.gov/

This policy does not guarantee access to any of Zydus Therapeutics investigational medicines.

Investigational treatments have not yet been approved or cleared by the Food and Drug Administration (FDA), meaning the FDA has not yet determined whether these products are safe and effective for their specific use. Furthermore, the investigational treatment may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.