Independent Study Proposal definition
Examples of Independent Study Proposal in a sentence
If the JSC approves an Independent Study Proposal, then the Global Development Plan/Budget shall be deemed to be amended to include the Independent Study and associated budget upon approval of such Independent Study Proposal by the JSC.
If the non-Proposing Party notifies the Proposing Party in writing of an objection to the proposed Independent Study Proposal in accordance with this Section 5.3.2, then such dispute will be resolved in accordance with Section 16.5.3.
The non-Proposing Party may, within [...***...] after receiving an Independent Study Proposal, object to the conduct of such Clinical Study if [...***...
The Independent Study Proposal shall be prepared in a similar scope and format of the Global Development Plan/Budget.
If an Opt-In Payment is made with respect to an Independent Study that is a registration study, and the Proposing Party also conducted other non-registrational Independent Studies for the same Indication pursuant to Section 4.3.4, the Development Costs of such other studies shall be included in the calculation of the Opt-In Payment (but only to the extent that such Development Costs are within the budget included in the applicable Independent Study Proposal).
The Proposing Party shall provide the JDC with any additional Information related to the Independent Study Proposal reasonably requested by the JDC.
If the JSC does not approve the Independent Study Proposal, then the Independent Study will not be included within the Global Development Plan/Budget and shall not be deemed to be part of the Global Development Plan/Budget, and instead the provisions of Section 3.1.4(c) (Objection by the Other Party) through Section 3.1.4(e) (Opt-In for Independent Study) shall apply.