Stage Gate definition
Examples of Stage Gate in a sentence
The completion of the POC Study in accordance with the endpoints set forth on Schedule 2.3.1 shall be a condition precedent to commencing the first Stage Gate Review, at which the Parties will determine whether to proceed to the second Stage Gate.
The completion of the cGMP Manufacturing Readiness Study in accordance with the endpoints set forth therein shall be a condition precedent to commencing the second Stage Gate Review, at which the Parties will determine whether to proceed to the third Stage Gate.
Should the Parties agree to proceed to the third Stage Gate, the Parties shall conduct a Phase 1 readiness study (the “Phase I Study”) pursuant to a plan to be included within the Development Plan (the “Phase I Plan”) within thirty (30) days after agreement in writing to continue to the third Stage Gate.
Upon any termination pursuant to this Section 14.2.4, Sections 14.2.1, 14.3, 14.4, 14.5 and 14.7 shall apply mutatis mutandis, with the Party that elected to proceed to the next Stage Gate or continue the Development Activities (as applicable) to be deemed the “Continuing Party” and the Party that did not so elect to be deemed the “Opt-Out Party” and the “Non-Continuing Party”.
Unless the Parties mutually agree in writing within ninety (90) days of completion of any Stage Gate Review to proceed to the next Stage Gate or continue the Development Activities (in which case this Agreement shall remain in full force and effect), this Agreement will be automatically terminated as of the expiration of such ninety (90) day period.
The Stage Gate phase of this Agreement includes three Stage Gates as set forth in Schedule 2.3.
The Parties shall conduct a proof of concept study (the “POC Study”), which shall comprise the first Stage Gate, pursuant to a plan to be agreed upon in writing by the Parties within thirty (30) days after the Effective Date.
Should the Parties agree to proceed to the second Stage Gate, the Parties (a) shall cooperate to adopt a Development Plan pursuant to Section 2.3.5 and (b) shall conduct a cGMP manufacturing readiness study (the “cGMP Manufacturing Readiness Study”) pursuant to a plan to be included within the Development Plan (the “cGMP Manufacturing Readiness Plan”) within thirty (30) days after agreement in writing to continue to the second Stage Gate.
The completion of the Phase I Study in accordance with the endpoints set forth in the Development Plan shall be a condition precedent to commencing the third Stage Gate Review, at which the Parties will determine whether to proceed with the additional Development Activities contemplated by the Development Plan.