Common use of DSC; Development Plan; CSC Clause in Contracts

DSC; Development Plan; CSC. 4.1 B▇▇▇▇▇ ONCOLOGY and THRESHOLD shall establish the DSC and the CSC which shall exist to facilitate active communication between them during the development and commercialization of the Licensed Product, it being further agreed and understood that THRESHOLD shall be responsible for and in control of the research and development and commercialization activities of Licensed Product in the Territory. 4.2 As soon as practicable following the date hereof, B▇▇▇▇▇ ONCOLOGY and THRESHOLD shall form the DSC which shall consist of [***] representatives from THRESHOLD and [***] representatives from B▇▇▇▇▇ ONCOLOGY. 4.3 THRESHOLD shall prepare and submit a copy of the Development Plan to B▇▇▇▇▇ ONCOLOGY’s representatives on the DSC within ninety (90) days of the Execution of this Agreement. THRESHOLD shall update and/or modify the Development Plan, as well as the budget thereof, on an annual basis. 4.4 The DSC shall meet to discuss the progress of the Development Plan, the attainment of the objectives of each phase of the development and to share any information related to the development, and commercialization until the formation of the CSC, of the Licensed Product. 4.5 The DSC shall meet at least twice annually and each such meeting shall be held alternately at each of the party’s offices. The DSC shall meet on such other occasions as may be reasonably requested by either party throughout each stage of the development of the Licensed Product. THRESHOLD and B▇▇▇▇▇ ONCOLOGY shall pay their own costs in attending such meetings and may agree to conduct any such meeting by means of videoconference or teleconference. 4.6 Upon filing of an NDA for the Licensed Product, B▇▇▇▇▇ ONCOLOGY and THRESHOLD shall form the CSC which shall consist of [***] representatives from THRESHOLD and [***] representatives from B▇▇▇▇▇ ONCOLOGY. 4.7 The CSC shall meet to discuss the worldwide marketing of Licensed Product, the launch of the Licensed Product in the Territory and the supply forecast of Licensed Product requirements for sale in the Territory. 4.8 The CSC shall meet on an annual basis. THRESHOLD and B▇▇▇▇▇ ONCOLOGY shall pay their own costs in attending such meetings. 4.9 The activities of the DSC and CSC may be consolidated into one Steering Committee, at any time, upon the mutual agreement of THRESHOLD and B▇▇▇▇▇ ONCOLOGY. The DSC shall cease to exist following approval by the FDA of Licensed Product for marketing and sale; provided, however, the DSC shall continue to function thereafter until any mandatory post-marketing clinical studies, if any, have been completed and the results thereof analyzed and submitted to the FDA.

Appears in 1 contract

Sources: Licensing Agreement (Threshold Pharmaceuticals Inc)

DSC; Development Plan; CSC. 4.1 B▇▇▇▇▇ ONCOLOGY and THRESHOLD shall establish the DSC and the CSC which shall exist to facilitate active communication between them during the development and commercialization of the Licensed Product, it being further agreed and understood that THRESHOLD shall be responsible for and in control of the research and development and commercialization activities of Licensed Product in the Territory. 4.2 As soon as practicable following the date hereof, B▇▇▇▇▇ BAXTER ONCOLOGY and THRESHOLD shall form the DSC which shall consist of [***] representatives from THRESHOLD and [***] representatives from B▇▇▇▇▇ BAXTER ONCOLOGY. 4.3 THRESHOLD shall prepare and submit a copy of the Development Plan to B▇▇▇▇▇ ONCOLOGY’s representatives on the DSC within ninety (90) days of the Execution of this Agreement. THRESHOLD shall update and/or modify the Development Plan, as well as the budget thereof, on an annual basis. 4.4 The DSC shall meet to discuss the progress of the Development Plan, the attainment of the objectives of each phase of the development and to share any information related to the development, and commercialization until the formation of the CSC, of the Licensed Product. 4.5 The DSC shall meet at least twice annually and each such meeting shall be held alternately at each of the party’s offices. The DSC shall meet on such other occasions as may be reasonably requested by either party throughout each stage of the development of the Licensed Product. THRESHOLD and B▇▇▇▇▇ BAXTER ONCOLOGY shall pay their own costs in attending such meetings and may agree to conduct any such meeting by means of videoconference or teleconference. 4.6 Upon filing of an NDA for the Licensed Product, B▇▇▇▇▇ ONCOLOGY and THRESHOLD shall form the CSC which shall consist of [***] representatives from THRESHOLD and [***] representatives from B▇▇▇▇▇ ONCOLOGY. 4.7 The CSC shall meet to discuss the worldwide marketing of Licensed Product, the launch of the Licensed Product in the Territory and the supply forecast of Licensed Product requirements for sale in the Territory. 4.8 The CSC shall meet on an annual basis. THRESHOLD and B▇▇▇▇▇ ONCOLOGY shall pay their own costs in attending such meetings. 4.9 The activities of the DSC and CSC may be consolidated into one Steering Committee, at any time, upon the mutual agreement of THRESHOLD and B▇▇▇▇▇ ONCOLOGY. The DSC shall cease to exist following approval by the FDA of Licensed Product for marketing and sale; provided, however, the DSC shall continue to function thereafter until any mandatory post-marketing clinical studies, if any, have been completed and the results thereof analyzed and submitted to the FDA.

Appears in 1 contract

Sources: Licensing Agreement (Threshold Pharmaceuticals Inc)