Vividion PoC Program Sample Clauses

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.
Sample 1
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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...
Sample 1
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: Reporting Item [***] [***] [***] [***]
Sample 1

Related to Vividion PoC Program

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Development Plan As defined in Section 3.2(a).

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Development Schedule The schedule for design and development of the "BASE BUILDING WORK" (as defined below) and the "TENANT IMPROVEMENTS" (as defined below), including, without limitation, the time periods for preparation, delivery, review, and approval of construction documents and performance pursuant to such documents, shall be in accordance with the Development Schedule attached hereto as Schedule A, subject to adjustment as mutually agreed by the parties in writing or as provided in this Work Letter (the "DEVELOPMENT SCHEDULE").

  • Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

  • Project Plan Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s “A multi-center, randomized, double-blind, double-dummy, vehicle-controlled sequential cohort study to determine the safety of PEP005 0.025% and 0.05% topical gel in patients with actinic keratoses” (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs.

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