Angioedema Field Clause Samples
The Angioedema Field clause defines the specific section or data entry area within a document or form where information related to angioedema—such as diagnosis, symptoms, or treatment details—must be recorded. In practice, this clause ensures that all relevant data about angioedema incidents are consistently captured, whether in clinical trial case report forms, electronic health records, or insurance documentation. Its core function is to standardize the collection and reporting of angioedema-related information, thereby improving data accuracy and facilitating effective monitoring or analysis.
Angioedema Field. As between the Parties, Jerini will * * * all regulatory filings and Marketing Approvals for Licensed Product developed pursuant to this Agreement for the Angioedema Field in both countries of the Territory, including all INDs and NDAs. As between the Parties, Jerini will be solely responsible for all activities in connection with maintaining such Marketing Approvals and other regulatory approvals required for the Commercialization and manufacture of Licensed Product in the Angioedema Field, including communicating and preparing and filing all reports (including adverse drug experience reports) with the applicable regulatory authorities, as described in further detail in this Section 4.
Angioedema Field. Jerini will use its Commercially Reasonable Efforts to develop and obtain Marketing Approval of one or more Licensed Products in the Angioedema Field in the Territory.
Angioedema Field. (a) Unless otherwise agreed in writing by the Parties, Jerini will be responsible for all regulatory affairs relating to Licensed Product in the Angioedema Field in both countries of the Territory, including preparing and submitting NDAs and seeking Marketing Approvals in accordance with the applicable Development Plan and preparing all reports necessary as part of any NDA. All such NDAs and Marketing Approvals will be filed and held in the name of Jerini.
(b) Subject to the provisions governing pharmacovigilance in Section 4.5 of this Agreement and the agreements contemplated in Section 4.5 of this Agreement, Jerini will consult in advance with Kos with respect to any filings to be made by Jerini in accordance with the terms of this Section 4.1.1 (including INDs and NDAs) and with respect to material and substantive correspondence with regulatory authorities (including proposed responses to inquiries received from regulatory authorities), and will consider in good faith any comments Kos may have with respect to any such filings and responses; provided, that Kos will provide such comments (if any) within 5 Business Days following receipt of the proposed correspondence from Jerini.