Common use of Delivery of the Phase II Report Clause in Contracts

Delivery of the Phase II Report. Following Completion of the Phase II Trial set forth in the Pre-Phase III Development Plan, PPD shall deliver to Xxxxxxx a report summarizing in reasonable detail the results of such Phase II Trial, including but not limited to all the results regarding the Option Criteria (“Phase II Report”). PPD shall provide Xxxxxxx with access to review the clinical, nonclinical, and any other data substantiating the results of such Phase II Trial. PPD shall cease all Development activities on the Licensed Product after delivery of the Phase II Report, except to the extent (i) required by applicable law, rule, or regulation, (ii) constituting the continuation of Required Option Development (to the extent not required to be performed by Xxxxxxx under the Development Plan), (iii) PPD elects in writing to Xxxxxxx to otherwise continue Development of Licensed Products, at PPD’s expense, and such Development is mutually approved by the Parties at the JAC, or (iv) otherwise agreed by the Parties in writing. In the event Xxxxxxx does not exercise the Xxxxxxx Option for such Licensed Product in writing within the Xxxxxxx Option Period, the PPD rights are those set forth in Sections 5.2(a) and, to the extent permitted thereby, 4.1 of this Agreement.

Delivery of the Phase II Report. Following Completion of the Phase II Trial set forth in the Pre-Phase III Development Plan, PPD shall deliver to Xxxxxxx a report summarizing [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. in reasonable detail the results of such Phase II Trial, including but not limited to all the results regarding the Option Criteria (“Phase II Report”). PPD shall provide Xxxxxxx with access to review the clinical, nonclinical, and any other data substantiating the results of such Phase II Trial. PPD shall cease all Development activities on the Licensed Product after delivery of the Phase II Report, except to the extent (i) required by applicable law, rule, or regulation, (ii) constituting the continuation of Required Option Development (to the extent not required to be performed by Xxxxxxx under the Development Plan), (iii) PPD elects in writing to Xxxxxxx to otherwise continue Development of Licensed Products, at PPD’s expense, and such Development is mutually approved by the Parties at the JAC, or (iv) otherwise agreed by the Parties in writing. In the event Xxxxxxx does not exercise the Xxxxxxx Option for such Licensed Product in writing within the Xxxxxxx Option Period, the PPD rights are those set forth in Sections 5.2(a) and, to the extent permitted thereby, 4.1 of this Agreement.