Phase 2 Package definition

Phase 2 Package means, with respect to any Phase 2 Clinical Trial, (a) the final study report from such Phase 2 Clinical Trial, including completed case report forms, as and to the extent available, for all patients who participated in the Phase 2 Clinical Trial, and (b) the status of and reasonable access to available results and data of all ongoing studies (including preclinical and clinical) with respect to the Product. For purposes of this definition, the study report shall be deemed “final” at such time as such report is in the form that will be filed with the FDA.
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Examples of Phase 2 Package in a sentence

  • At any time following Advaxis’ delivery to Amgen of the Phase 2 Package as described in Section 3.1, Amgen may elect, in its sole discretion, to deliver to Advaxis written notice stating that proof-of-concept has been established (such written notice, the “POC Notice” and the date of such written notice, the “POC Date”).

  • Agreement No. CE 40/2000 10-Year Extended Landslip Preventive Measures Project, Phase 2, Package G - Outlying Islands Investigation, Design and Supervision of Landslip Preventive Works on Government Slopes and Related Studies.

Related to Phase 2 Package

  • Work package means a major sub-division of the proposed project.

  • Data Package has the meaning set forth in Section 2.9(a).

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Phase 1 means the phase of the ATP comprised of: (1) improvements to the State Street Substation; (2) construction of the Proposed Line; (3) the rebuilding of NYSEG’s existing Lines 971 and ▇▇▇ ▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇ the NYSEG ROW to allow for construction of the Proposed Line as intended; (4) improvements to the Elbridge Substation to accept the Proposed Line; and (5) National Grid’s conveyance to NYSEG of the NYSEG Acquired ROW and such other land interests as contemplated by the Purchase and Sale Agreement.

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).