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...
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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.
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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: [***] [***] [***] [***]
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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) B. Estimated total development time

  • 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 document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Development Plans Customer has provided Provider with a report attached hereto as Exhibit D (the “Current Development Plan”) describing in detail, as of January 1, 2017, the planned development, drilling, production, processing, treating, marketing and other activities to take place with respect to Dedicated Production and Customer Injected NGLs for the applicable Development Period. The information contained in the Current Development Plan is, with respect to the first three Years covered by the Current Development Plan, on a Quarter-by-Quarter basis, and with respect to the remaining Years covered by the Current Development Plan, on a Year-by-Year basis. The Current Development Plan attached hereto has been approved by the Parties. (a) From time to time during each Year of the Term, the Parties shall meet to discuss the planned development, drilling, production, processing, treating, marketing and other activities that Customer expects to take place with respect to Dedicated Production and Customer Injected NGLs for the then-applicable Development Period. Customer and Provider shall each make their respective representatives available to participate in such meetings and discussions. No later than August 1 of each such Year, Customer shall provide (or cause to be provided) to Provider a proposed update of the then-currently agreed Development Plan, prepared on the same basis as the Current Development Plan and describing in detail the planned development, drilling, production, processing, treating, marketing and other activities to take place with respect to Dedicated Production and Customer Injected NGLs for the then-applicable Development Period (any such update, an “Updated Development Plan” and, together with the Current Development Plan, each, a “Development Plan”). (b) Each proposed Development Plan shall include information as to the following, in each case, broken out, with respect to the first three Years covered by such Development Plan, on a Quarter-by-Quarter basis, and, with respect to the remaining Years covered by such Development Plan, on a Year-by-Year basis: (i) forward-looking production estimates for the applicable time period covered by such Development Plan for all Customer Gas and Customer Injected NGLs (A) that Customer reasonably and in good faith believes will become owned or Controlled by Customer during the time period covered by such Development Plan, and/or (B) that will be produced from (I) in the aggregate, all ▇▇▇▇▇ then-existing and (II) in the aggregate, all ▇▇▇▇▇ that are expected to be drilled during the time period covered by such Development Plan (each such Well reflected in such Development Plan, a “Planned Well” and, such collective estimates described in subsections (A) and (B), both with respect to a particular Quarter and an entire Year, the “Dedicated Production Estimates”); TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH TWO ASTERISKS (**). (ii) (A) each new receipt point (including the location thereof) proposed by Customer with respect to the Dedicated Production Estimate reflected in such Development Plan (each such receipt point, a “Planned Receipt Point”), (B) each Receipt Point at which Customer expects to Tender Customer Gas or Customer Injected NGLs reflected in such Development Plan into the TGP System, and (C) the estimated portion of the Dedicated Production Estimate contained in such Development Plan that Customer expects to Tender at each such Receipt Point and Planned Receipt Point; (iii) (A) each new delivery point (including the location thereof) proposed by Customer with respect to the Dedication Production Estimate reflected in such Development Plan (each such delivery point, a “Planned Delivery Point”), (B) each Delivery Point at which Customer expects to Nominate Customer Residue Gas or Customer NGLs produced from the Dedicated Production Estimate reflected in such Development Plan to be redelivered to Customer, and (C) the estimated volumes of Customer Residue Gas and Customer NGLs produced from the Dedication Production Estimate contained in such Development Plan that Customer expects to Nominate to each such Delivery Point; (iv) the earliest date on which each Planned Receipt Point and Planned Delivery Point included in the Development Plan is required by Customer to be placed into service, which date shall not be earlier than three Months after the January 1st that is immediately subsequent to the date that the Development Plan that initially reflected such Planned Receipt Point or Planned Delivery Point was delivered to Provider hereunder; (v) the anticipated characteristics of the production from the ▇▇▇▇▇ and Planned ▇▇▇▇▇ reflected in such Development Plan (including liquids content and gas and liquids composition) and the projected production volumes and production pressures applicable thereto; provided that Customer may utilize the existing and historical production information from similarly situated ▇▇▇▇▇; (vi) any (A) proposed revision to the then-existing Dedicated Area and/or any then-existing Dedicated Contract and/or (B) any new contract that Customer proposes to be a Dedicated Contract; and (vii) other information reasonably requested by Provider that is relevant to the design, construction, and operation of the TGP System, including (A) any applicable Plant Expansion or Facilities Modification proposed by Customer, (B) the relevant Receipt Point and Planned Receipt Point facilities applicable to such Development Plan, and (C) the relevant Delivery Point and Planned Delivery Point facilities applicable to such Development Plan. TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH TWO ASTERISKS (**).

  • Extended Local Calling Scope Arrangement An arrangement that provides a Customer a local calling scope (Extended Area Service, “EAS”), outside of the Customer’s basic exchange serving area.