Phase 2 Activities definition
Examples of Phase 2 Activities in a sentence
The JSC shall also discuss whether any amendments to the Phase 2 Activities in the Clinical Development Plan should be made due to the results from the Phase 1 Activities and/or to address Material Safety Issues raised by either Party, and any such amendments shall be approved by the JSC in accordance with Section 3.2.2.
Notwithstanding the foregoing, any Third Party Subcontractor to be used by the Conducting Party to perform any Collaboration CMC Activities for the Phase 1 Activities and Phase 2 Activities must be approved in advance by the other Party, which approval shall not be unreasonably withheld.
In the event that any such facility or site is found to be non-compliant with GLP, GCP, GMP, pharmacovigilance and safety reporting, or requirements for the protection of human subjects during such an audit, and such non-compliance relates to or impacts any Phase 1 Activities or Phase 2 Activities, the audited Party shall submit to the auditing Party proposed Corrective and Preventative Actions (“CAPA”) within [ * ] after the auditing Party provides notice of such non-compliance.
The costs and expenses of the Phase 2 Activities shall be shared by the Parties in accordance with Section 7.2. ▇▇▇▇▇▇▇ shall use Diligent Efforts to conduct and complete the Phase 2 Activities in accordance with the Clinical Development Plan (including the timeline set forth therein).
If the CMC Development Plan allocates responsibility for Manufacture and supply of Compound API or Drug Product for any Phase 2 Activities to Protagonist, the Parties shall negotiate in good faith and attempt to agree within [ * ] after the Effective Date upon a supply agreement for such supplies by Protagonist to ▇▇▇▇▇▇▇ at cost with no markup (the “Clinical Supply Agreement”) and a related quality agreement.
In addition to its rights under Section 3.6.1(g), each Party shall have the right to conduct an audit of the manufacturing sites where any Collaboration CMC Activities for the Phase 1 Activities and Phase 2 Activities are conducted by the other Party (the “Manufacturing Party”) or its Third Party Subcontractors, and subject to the terms of any agreement between the Manufacturing Party and the applicable Third Party Subcontractors.
Following ▇▇▇▇▇▇▇’▇ receipt of a complete Phase 1 Data Package pursuant to Section 3.3.2, the JSC shall meet to discuss such Phase 1 Data Package and determine whether the results from the Phase 1 Activities support continuation of preparation and conduct of the CD Phase 2 Clinical Trial and related Phase 2 Activities.
We are offering fully burdened costs for Phase 1 Activities and Phase 2 Activities and separated by ▇▇▇▇ County and the KUB Extended Area.
The costs and expenses of the Phase 2 Activities shall be shared by the Parties in accordance with Section 7.2. ▇▇▇▇▇▇▇ shall use Diligent Efforts to conduct and complete the Phase 2 Activities in accordance with the applicable Development Plan (including the timeline set forth therein).
The 2nd Generation Development Plan shall include a budget for the Research ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇ Activities and Phase 2 Activities broken down by activity and by Calendar Year (the “2nd Generation Development Budget”).