Study Drug definition
Examples of Study Drug in a sentence
For the purposes of this Agreement, the SPONSOR is responsible for the manufacturing, packaging, labelling, QP release, import and/or supply of the Study Drug and shall obtain or shall ensure that the third party entrusted with any of these six tasks obtains from the authorities the necessary authorisation pertaining thereto.
The entire right, title and interest in and to any inventions, discoveries, know-how, copyrights or other intellectual property rights that are conceived, developed, or reduced to practice, (including all improvements or modifications), which (i) rely on, use, or incorporate the Study Drug; (ii) incorporate or are anticipated by the Protocol; or (iii) rely on, use, or incorporate any Confidential Information, shall be the exclusive property of Sponsor (collectively referred to as “Sponsor Inventions”).
The Site shall maintain complete and accurate records related to the Study, and shall retain all such records resulting from the Study in accordance with ICH GCP for at a minimum the longest of the following: (i) two (2) years following the date any marketing application is approved for the Study Drug in any indication, (ii) five (5) years after Sponsor has notified Institution that the Study has been discontinued or completed, or (iii) the time required by applicable Laws.
However, SPONSOR shall have the right, upon prior written notice to INSTITUTION, to assign this Agreement to any of its affiliates, to a contract research organization in connection with the transfer of SPONSOR’s obligations or in connection with a merger or other corporate reorganization, or otherwise in connection with a transfer of all of SPONSOR's assets that bear on the Study Drug.
During the Study, Sponsor or Sponsor’s designee shall provide to the Site, at Sponsor’s expense, the Study Drug, placebo and other compounds, or agents for the performance of the Study (collectively, the “Materials”).