Clinical Development Plan. The Parties shall undertake the Development of the Products in a collaborative and efficient manner in accordance with this ARTICLE 5. The Development of the Products relating to the Territory under this Agreement shall be governed by a written clinical development plan, as revised from time to time in accordance with this Section 5.2 (the “Clinical Development Plan”). The Clinical Development Plan shall include (a) an outline of Clinical Trials to be conducted by Zai in the Territory, including the Local Studies and Joint Global Studies; and (b) the material activities to be performed by the Parties to obtain the Regulatory Approvals for the Products in the Territory and to support the Joint Global Studies. The Clinical Development Plan shall contain in reasonable detail the major Development activities and the projected timelines for conducting such activities, including activities designed to achieve Regulatory Approvals for the Products in the Territory. As of the Effective Date, the Parties have agreed to an initial Clinical Development Plan, which is attached hereto as Schedule 5.2. From time to time, […***…] Zai shall propose updates or amendments, if any, to the Clinical Development Plan in consultation with TPTX and submit such proposed updated or amended plan to the JDC for review, discussion and approval. In accordance with Section 3.3(b), the JDC shall review, discuss and approve any updates or amendments to the Clinical Development Plan; provided […***…].
Appears in 2 contracts
Samples: License Agreement (Zai Lab LTD), License Agreement (Turning Point Therapeutics, Inc.)
Clinical Development Plan. The Parties shall undertake the Development of the Products in a collaborative and efficient manner in accordance with this ARTICLE 5. The Development of the Products relating to the Territory under this Agreement shall be governed by a written clinical development plan, as revised from time to time in accordance with this Section 5.2 (the “Clinical Development Plan”). The Clinical Development Plan shall include (a) an outline of Clinical Trials to be conducted by Zai in the Territory, including the Local Studies and Joint Global Studies; and (b) the material activities to be performed by the Parties to obtain the Regulatory Approvals for the Products in the Territory and to support the Joint Global Studies. The Clinical Development Plan shall contain in reasonable detail the major Development activities and the projected timelines for conducting such activities, including activities designed to achieve Regulatory Approvals for the Products in the Territory. As of the Effective Date, the Parties have agreed to an initial Clinical Development Plan, which is attached hereto as Schedule 5.2. From time to time, […***…,] Zai shall propose updates or amendments, if any, to the Clinical Development Plan in consultation with TPTX and submit such proposed updated or amended plan to the JDC for review, discussion and approval. In accordance with Section 3.3(b), the JDC shall review, discuss and approve any updates or amendments to the Clinical Development Plan; provided […***…]. Zai may propose to [***]. For the avoidance of doubt, any proposed [***].
Appears in 1 contract
Samples: License Agreement (Zai Lab LTD)
Clinical Development Plan. The Parties shall undertake the Development of the Products in a collaborative and efficient manner in accordance with this ARTICLE 5. The Development of the Products relating to the Territory under this Agreement shall be governed by a written clinical development plan, as revised from time to time in accordance with this Section 5.2 (the “Clinical Development Plan”). The Clinical Development Plan shall include (a) an outline of Clinical Trials to be conducted by Zai in the Territory, including the Local Studies and Joint Global Studies; and (b) the material activities to be performed by the Parties to obtain the Regulatory Approvals for the Products in the Territory and to support the Joint Global Studies. The Clinical Development Plan shall contain in reasonable detail the major Development activities and the projected timelines for conducting such activities, including activities designed to achieve Regulatory Approvals for the Products in the Territory. As of the Effective Date, the Parties have agreed to an initial Clinical Development Plan, which is attached hereto as Schedule 5.2. From time to time, […***…] Zai shall propose updates or amendments, if any, to the Clinical Development Plan in consultation with TPTX and submit such proposed updated or amended plan to the JDC for review, discussion and approval. In accordance with Section 3.3(b), the JDC shall review, discuss and approve any updates or amendments to the Clinical Development Plan; provided […***…]. Zai may propose to [***]. 92975109_3 243114426 v7 For the avoidance of doubt, any proposed [***].
Appears in 1 contract
Samples: License Agreement (Turning Point Therapeutics, Inc.)