Platform Study definition

Platform Study means the Clinical Study entitled “Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 5) (NCT04126200)” that is sponsored by GSK, under which the Sub-Study is being conducted. 1.91 “Platform Study IND” has the meaning set forth in Section 4.5. 1.92 “Platform Study Protocol” means the written documentation which describes the Platform Study and sets forth specific activities to be performed as part of the Platform Study conduct. 1.93 “Pricing and Reimbursement Approval” means any approval, agreement, determination, or other decision by the applicable Regulatory Authority or other governmental authority
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Platform Study means the clinical study conducted or sponsored by GSK under which one or more sub-studies (including the Sub-Study) are conducted to evaluate the combination of the GSK Compound and other compound(s) for the treatment of multiple myeloma, other plasma cell clone disorders and B-cell malignancies. For the avoidance of doubt, the Sub-Study investigating the Combination Therapy to be performed under this Agreement is for the treatment of relapsed and refractory multiple myeloma.
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Examples of Platform Study in a sentence

  • Each Party may make changes from time to time to its Compound or the Manufacturing Site in accordance with the Clinical Quality Agreement; provided that the intended changes would not require a submission, amendment or variation to the Platform Study IND or the Sub-Study, and provided further that the Party making such change provides the other Party with prior written notice of the intended changes.

  • As between the Parties, GSK shall have the sole right and authority to make and submit filings regarding the Sub-Study to the Platform Study IND.

  • In the case of proposed changes to the Compound or the Manufacturing Site which would require a submission, amendment or variation to the Platform Study IND or the Sub-Study, the Party proposing such change shall provide prior written notice to the other Party of such intended changes, providing reasonable detail, and the Party receiving such notice shall consider such request in good faith.

  • SCS uses purchased curriculum (e.g., Beyond Textbooks, Letterland, Heggerty, Math-U-See, and McGraw Hill Math), incorporating literature and software programs (e.g., iReady, Renaissance Learning Platform, Study Island, IXL, and Edulastic).

Related to Platform Study

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Research Program has the meaning set forth in Section 3.1.