Vividion PoC Program Clause Samples
Vividion PoC Program. Prior to Roche’s exercise of the Roche PoC Option, Vividion (i) shall be responsible [***] (in consultation with Roche as described below) for all regulatory affairs relating to the Vividion PoC Programs and (ii) shall lead all interactions with applicable Regulatory Authorities for the Vividion PoC Programs, each until exercise of the Roche PoC Option. During such time (a) Vividion shall file and own all INDs for a Vividion PoC Program, (b) Roche shall have the right to have one (1) representative attend (as a non-participatory observer) material regulatory meetings (including face-to-face meetings and, to the extent scheduled, phone calls) with Regulatory Authorities for the Product for a Vividion PoC Program to the extent permitted by Applicable Law; Vividion shall give notice of any such meeting within [***] Business Days after Vividion first receives notice of the scheduling of such meeting; Roche may have a reasonable number of representatives participate in any preparatory pre-meetings held prior to such a Regulatory Authority meeting, (c) Vividion will consult with Roche on its material communications with and material submissions by Vividion to any Regulatory Authority (“Regulatory Materials”) for the Vividion PoC Program, including all IND submissions, IND amendments, Regulatory Authority meeting requests and Regulatory Authority advice (including scientific advisory packages) as follows: (i) Vividion shall provide copies of draft Regulatory Authority meetings requests, Regulatory Authority advice (including scientific advisory packages) and any other material submissions and communications (including written summaries of material oral communications proposed or conducted by or on behalf of Vividion) with any Regulatory Authority pertaining to the Compound or Product sufficiently in advance, where reasonable, for Roche to comment on any such Regulatory Materials or communications with any Regulatory Authority, and (ii) Vividion shall give due consideration in good faith to any comments provided by Roche in relation to such Regulatory Materials or communications with any Regulatory Authority. Material communications include all formal communications or communications that impact the PoC Study. The following in this Section 11.1.1 shall be part of the Transfer Activities after exercise of the Roche PoC Option for a Vividion PoC Program, specifically with respect to regulatory affairs. All such Transfer Activities shall commence in accordance with t...
Vividion PoC Program. 3.2.2.1 Preparation of Preclinical Plans and Clinical Plans and exercise of the Vividion PoC Option Upon Roche’s exercise of its Option Right for a Vividion Program pursuant to Section 4.1 and in anticipation of Vividion’s exercise of the Vividion Option pursuant to Section 4.2, (other than in the case of (i) a Vividion Program Opt-Out or (ii) in the case Vividion does not have a Vividion Option or (iii) provides notice to Roche that it is not exercising the Vividion Option for such Optioned Roche Program), Vividion shall at the latest [***] Business Days after Roche’s exercise of its Option Right for a Vividion Program pursuant to Section 4.1 submit for approval (i) to the JRC a Preclinical Plan for activities up to Completion of the GLP Tox Study (“Vividion Draft Preclinical Plan”), and (ii) to the JDC a Clinical Plan for activities after the GLP Tox Study up to Completion of the PoC Study (“Vividion Draft Clinical Plan”). The JRC and JDC (as applicable) shall meet promptly after submission of the Vividion Draft Preclinical Plan and Vividion Draft Clinical Plan to discuss such draft plans and establish the Preclinical Plan for activities up to Completion of the GLP Tox Study and the Clinical Plan, as applicable. The Option Period for the Vividion Option for the respective Vividion Program shall be tolled until the final Preclinical Plan and Clinical Plan (including budgets therefor) have been established pursuant to Section 8. The Vividion Draft Clinical Plan and Clinical Plan shall include an estimated number of subjects to be dosed with the applicable Product under such plan. The Clinical Plan shall be updated and submitted for JDC approval upon Completion of the GLP Tox Study and whenever considered necessary by the JDC.
3.2.2.2 Conduct of a Vividion PoC Program Vividion shall be solely responsible for the development, manufacture and supply of Compounds under such Vividion PoC Program and shall use Commercially Reasonable Efforts to conduct its activities under the Preclinical Plan and the Clinical Plan.
Vividion PoC Program. The quarterly actuals and estimates for a Vividion PoC Program in the Territory with respect to Allowable PoC Expenses will be presented in the following format with the categories as defined in this Section 2 of this Appendix below: [***] [***] [***] [***]