Ascendis Pharma A/S

Single-Patient EA Policies/Criteria Overview Criteria for Evaluating Individual Access HCP Criteria and Responsibilities: Must be currently licensed in his/her respective jurisdiction and must not ever have been convicted of a criminal offence relating to any therapy, food, or cosmetic law. HCP must not be on the current FDA debarment list or that of any of the relevant local health authorities in the relevant jurisdiction. Provide all necessary paperwork to Sponsor for routing to an Investigational Review Board (IRB) or Ethics Committee (EC) as appropriate in their relevant health authority’s jurisdiction. The HCP must agree to oversee the patient’s treatment and supervise administration of the Investigational Therapy in accordance with Ascendis Pharma’s defined access criteria and under appropriate regulatory and ethical standards including those set by regulatory authorities and IRBs/ECs. The HCP must agree to obtain informed consent and agreement for treatment use of the Investigational Therapy, and collection, analysis, publication, and transfer of any patient data as appropriate from the patient or his/her legal guardians. The HCP must agree to maintain and release to regulatory authorities all treatment records and data as required by local regulations. The HCP must agree to report adverse events and provide patient level safety data as required by local health authorities and per the agreement with Ascendis Pharma Patient Eligibility Criteria: Request Process Requests for EAP must be made by the patient’s treating physician. Available Therapies via Single-Patient EA Palopegteriparatide (also known as TransCon PTH) for patients with hypoparathyroidism