STAGE O definition

STAGE O means that portion of the DEVELOPMENT program which starts with the selection of a LICENSED COMPOUND for development into a PRODUCT under Article 5 hereunder and which generally provides for toxicological and pharmacological studies as well as drug substance and drug product formulation and manufacturing development necessary to obtain the permission of regulatory authorities to begin and continue human clinical testing.
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Examples of STAGE O in a sentence

  • During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies.

  • During such DEVELOPMENT efforts, SKI will assist LICENSEE as may be mutually agreed, at LICENSEE's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies.

  • During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI’s expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies.

Related to STAGE O

  • Stage 1 means the area at Port ▇▇▇▇▇▇▇ which is the subject of this Agreement and of the ERMP and which is shown bordered in purple as “stage 1” on Department of Land Administration 4 Miscellaneous Plan No. 1743;

  • Stage 2 means the construction of the second hotel and other developments facilities and amenities referred to in the Development Proposals;

  • Completion Period means the period starting from the date of issue of "Order" and required to complete the work in all respect.

  • project completion period means the period of sixty (60) months commencing from and expiring on for the construction and obtaining of Temporary Occupation Permit or Permits for the whole of the Development as provided in clause 3.3;

  • Phase 2 means the phase of the ATP comprised of: (1) improvements to the State Street Substation to receive Rebuilt Line 972; (2) the rebuilding of NYSEG’s existing Line 972 not performed in Phase 1; (3) construction of Relocated Line 15; (4) the construction of Bused Line 5; (5) improvements to the Elbridge Substation to receive Relocated Line 15; and (6) improvements to the Elbridge Substation to receive Bused Line 5.