Extension Studies definition

Extension Studies means any extension study that allows patients to continue to receive study treatment when the original Ongoing Clinical Studies into which they were enrolled have reached their designated end-dates.
View Source

Examples of Extension Studies in a sentence

  • To extent applicable and requested by KCE, BCC shall perform any activities in connection with the Long-Term Extension Studies in accordance with the terms and conditions set out in this Agreement.

  • Rigel agrees to assign to AZ, [ * ], all of its rights, title and interest in the R788 Inventory as part of the initial technology transfer under the Transition Plan, except that Rigel may retain sufficient quantities of R788 Inventory solely for its use in the conduct of the Open Label Extension Studies and to fulfill its obligations under the NCI Agreement as such agreement exists as of the Execution Date.

  • Chiesi shall provide copies of the foregoing records to Protalix on a calendar quarterly basis (and otherwise on Protalix’s reasonable request), together with a written report indicating then-current inventory levels of Drug Product (and, after [***]) intended for use in such Extension Studies.

  • Chiesi shall assume full control of and responsibility for the conduct of all Extension Studies relating to the Licensed Product in the Field as soon as reasonably practicable after the date on which the transfer contemplated in Section 3.6(c) occurs.

  • To the extent that Chiesi conducts any Extension Studies, solely in respect of any quantities of Licensed Product required for the purposes of such studies, Protalix shall Manufacture and supply, and Chiesi shall purchase from Protalix, all of Chiesi’s and its Affiliates’ requirements of the Drug Product (and, after [***]) for the sole purposes of being administered to patients enrolled in such studies.

  • Chiesi shall keep and maintain records of (x) each delivery of Drug Product (and, after [***]) it receives in respect of supply for use in Extension Studies, and (y) the administration of such Licensed Product, on a patient-by-patient and site-by-site basis, in respect of such Extension Studies.