Clinical Plan Clause Samples

The Clinical Plan clause defines the framework and requirements for conducting clinical activities within an agreement, such as a clinical trial or research study. It typically outlines the objectives, methodology, timelines, and responsibilities for each party involved in the clinical process. By clearly specifying these elements, the clause ensures that all parties have a shared understanding of how the clinical work will proceed, thereby minimizing misunderstandings and supporting regulatory compliance.
Clinical Plan. 9 VIII. TIMELINES...........................................................10
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Clinical Plan. (a) Attached hereto as Exhibit A is the initial research and development plan setting forth activities, schedules, milestones, specifications, pre-clinical and clinical protocols and requirements for development of the Principal Products (the “Clinical Plan”). The Company may, from time to time, adopt or institute amendments, supplements and variations (collectively, “Plan Modifications”) to the Clinical Plan; provided, however, (i) the Company shall provide the BSC Representative Group with a copy of all such Plan Modifications and (ii) any Plan Modifications that would materially alter the then current version of the Clinical Plan may only be made in accordance with paragraphs (b) and (c) below. (b) With respect to Plan Modifications that would materially alter the then current version of the Clinical Plan, the BSC Representative Group shall have an opportunity to review and, except as provided in paragraph (c) below, approve or reject such Plan Modifications; provided, however, the BSC Representative Group shall not unreasonably withhold or delay approval of such Plan Modifications, and if the BSC Representative Group has not rejected such Plan Modifications within forty five (45) days of receiving a copy of such Plan Modifications then the BSC Representative Group will be deemed to have accepted such Plan Modifications; provided, further, the Parties acknowledge and agree that it is not unreasonable for the BSC Representative Group to reject any Plan Modifications if BSC, in its sole discretion, believes such Plan Modifications will have a material deleterious effect on BSC’s ability to market or distribute the Injection Catheter. In the event that the BSC Representative Group rejects such Plan Modifications, the Representatives shall have thirty (30) days to work together to revise such Plan Modifications. If the Representatives cannot agree on such Plan Modifications then, notwithstanding anything herein to the contrary, the Company may proceed with the Clinical Plan, as modified by the Company in its sole discretion; but BSC shall have no further obligation to supply Injection Catheters pursuant to Section 2.10 of this Agreement, and the Company shall return to BSC any and all Injection Catheters in its possession or within its control.
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Clinical Plan. Promptly following the Effective Date, [***] shall [***] a Clinical Plan on [***].
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Clinical Plan. Within ninety (90) days of the Non-Inferiority Verification Completion Date, the Parties through the Steering Committee shall develop in good faith, and agree on, a written plan for the clinical development of the Abpro Molecule through EMA or FDA BLA acceptance with the aim of commercialization of a Product throughout the Territory (the “Clinical Plan”). Celltrion shall use Commercially Reasonable Efforts to perform such Clinical Plan and to Develop the Abpro Molecule in accordance with the table below towards a Product in compliance with all Applicable Laws. These above milestone dates may be adjusted in good faith by agreement of the Parties if the delay is due to Third Party delays, for instance (but not necessarily limited to) delays caused by Celltrion’s CRO, data safety monitoring board, and/or any regulatory agencies.
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Clinical Plan. The term “
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Clinical Plan. Following the Effective Date, Tracon shall prepare and provide to Cell-Matrix a clinical development plan that sets forth Tracon’s intended research, development, manufacturing and clinical activities for the purpose of obtaining marketing approval of the Products (the “Clinical Plan”). From time to time during the term of this Agreement, as Tracon makes any significant changes to its intended development and clinical *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. activities, but not less than once per calendar year, Tracon shall provide to Cell-Matrix an updated Clinical Plan.
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Clinical Plan. Arrowhead shall, at its sole cost and expense, be responsible for the conduct and completion of the Ongoing Phase 1/2 Study. The conduct by or on behalf of Arrowhead of the Ongoing Phase 1/2 Study after the Effective Date shall be governed by the Clinical Plan. To the extent permitted by Arrowhead’s legal and regulatory obligations, the Parties, through the JSC, may amend the Clinical Plan in due course. Arrowhead shall remain responsible in all cases for all liabilities arising in connection with its performance of, or failure to perform, any activities or obligations with respect to the Ongoing Phase 1/2 Study, prior to the Effective Date and thereafter. For clarity, Section 11.5 shall apply to the Ongoing Phase 1/2 Study.
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Related to Clinical Plan

  • 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 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 (**).

  • Medical Plan ‌ Eligible employees and dependants shall be covered by the British Columbia Medical Services Plan or carrier approved by the British Columbia Medical Services Commission. The Employer shall pay one hundred percent (100%) of the premium. An eligible employee who wishes to have coverage for other than dependants may do so provided the Medical Plan is agreeable and the extra premium is paid by the employee through payroll deduction. Membership shall be a condition of employment for eligible employees who shall be enrolled for coverage following the completion of three (3) months’ employment or upon the initial date of employment for those employees with portable service as outlined in Article 14.12.

  • 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.

  • Medical Plans The Employer will maintain the current health (including vision) and dental insurance programs and practices. For Calendar Years 2022 — 2023, the Employer shall contribute 80% of the premium charge for PPO plans, 85% of premium for the EPO plan, 85% of premium for the IHM plan, 80% for the prescription drug plan and 50% for the dental plan.