Supply Plans Sample Clauses

Supply Plans. The JSC shall establish the pre-clinical, clinical and commercial supply strategy for Joint Compounds, Joint Products and Diagnostic Products for Joint Compounds or Joint Products in the United States, including Manufacturing plans with respect thereto. BII or its Affiliates, or its or their Contractors or Sublicensees. shall Manufacture (a) all pre-clinical and clinical requirements of Joint Compounds, Joint Products (including placebo or other comparators) and Diagnostic Products for Joint Compounds or Joint Products, with respect to each, for use by the Parties in connection with Development activities as contemplated in the Joint Development Plan and Budget and (b) all commercial requirements of Joint Compounds, Joint Products and Diagnostic Products for Joint Compounds or Joint Products, with respect to each, for use by the Parties in connection with Commercialization activities as contemplated in the Joint Commercialization Plan and Budget, with respect to (a)-(b), in accordance with the JSC-approved supply strategy and Manufacturing plans. If, pursuant to the Joint Development Plan and Budget, the JSC appoints Epizyme to Conduct a Clinical Trial for a Joint Product, then BII and Epizyme shall promptly enter into a (i) supply agreement for the supply and Manufacture of the Joint Compounds, Joint Products or Diagnostic Products for Joint Compounds or Joint Products that are the subject of such Clinical Trial and (ii) a quality agreement related to such Manufacture and supply, which will set forth the applicable quality, release and approval procedures.
Sample 1
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Supply Plans. By [**] of each Calendar Year during the Term, the Parties shall together prepare and submit to the JMC, for its review and discussion, a proposed supply chain management plan for the Licensed Products being Manufactured under this Agreement by the existing CMOs, such plan to be designed to provide reasonable assurance that the Parties, utilizing the existing CMOs, are able to satisfy the then-current forecast for the Licensed Products for the Clinical Trials and Joint Development Plan for the Territory, and [**] prior to the projected First Commercial Sale of the Licensed Product, the Parties will prepare and submit to the JMC, for its review and discussion and approval by the JSC, a [**] supply chain and management plan (each such plan once determined in accordance with this Section 6.5(a), a “Supply Plan”). Each Supply Plan shall include, where applicable, (i) a plan for producing sufficient quantities of the Licensed Products for each Clinical Trial set forth in the then-current Joint Development Plan and quantities of the Licensed Products for Commercialization demand as set forth in the then-current Joint Commercialization Plan, as applicable, including appropriate capacity and inventory and safety stock levels, (ii) a [**] or [**] year high-level non-binding forecast for capacity planning purposes and short-term forecasts meeting the requirements established by the JMC, (iii) life cycle planning, including capacity needs, (iv) information regarding yields and batch sizes, (v) inventory requirements (for the Licensed Products and key raw materials) in order to satisfy supply requirements and (iv) the associated budget of the Manufacturing Costs for the supply of the Licensed Products in connection with the foregoing. After the submission of the initial Supply Plan for the Licensed Products, Pfizer shall prepare and submit to the JMC for its review and discussion, an updated copy of such Supply Plan periodically as determined by the JMC. The JMC shall submit each updated Supply Plan to the JSC for review and approval on an annual basis.
Sample 1
Supply Plans. On a Product-by-Product basis, by [***], Myovant shall prepare and submit to the JMC, for its review and discussion, a proposed supply chain management plan for the Products being Manufactured under this Agreement by the Existing CMO to the extent Myovant is responsible for the supply of such Products, such plan to be designed to provide reasonable assurance that Myovant, utilizing the Existing CMO, is able to satisfy the then-current forecast for the Products in the Field in the Co-Promotion Territory (each such plan once determined in accordance with this Section 9.2, a “Supply Plan”). Each Supply Plan shall include (a) a plan for producing launch quantities for each such Product, including appropriate capacity and inventory and safety stock levels, (b) a [***] year high-level non-binding forecast for capacity planning purposes and short-term forecasts meeting the requirements established by the JMC, and (c) inventory requirements (for the Products and key raw materials) in order to satisfy supply requirements. After the submission of the initial Supply Plan for the Product, Myovant shall prepare and submit to the JMC for its review and discussion, an updated copy of such Supply Plan periodically as determined by the JMC. The JMC shall submit each updated Supply Plan to the JSC for review and approval on an annual basis. Following Option Closing (if it occurs), the Parties shall update the Supply Plan to include the Products in the Field in the Pfizer Territory, for so long as Myovant is supplying Pfizer such Products.
Sample 1

Related to Supply Plans

  • 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.

  • Marketing Plans 1. The MCO shall develop a marketing plan that meets SDOH guidelines and any local requirements as approved by the State Department of Health (SDOH).

  • 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:

  • Health and Welfare Plans (i) All Liabilities relating to, arising out of, or resulting from health and welfare coverage or claims incurred by or on behalf of each Transferred System Employee under any Time Warner Cable Benefit Plan that is a health or welfare plan within the meaning of Section 3(1) of ERISA (each a "Time Warner Cable Health or Welfare Plan") prior to the Closing shall be Liabilities of Holdco or one of its Affiliates to the extent such Liabilities are reflected in the Closing Net Liabilities Amount used in calculating the Final Adjustment Amount.

  • Work Plans Tenant shall prepare and submit to Landlord for approval schematics covering the Tenant Improvements prepared in conformity with the applicable provisions of this Work Letter (the “Draft Schematic Plans”). The Draft Schematic Plans shall contain sufficient information and detail to accurately describe the proposed design to Landlord and such other information as Landlord may reasonably request. Landlord shall notify Tenant in writing within ten (10) business days after receipt of the Draft Schematic Plans whether Landlord approves or objects to the Draft Schematic Plans and of the manner, if any, in which the Draft Schematic Plans are unacceptable. Landlord’s failure to respond within such ten (10) business day period shall be deemed approval by Landlord. If Landlord reasonably objects to the Draft Schematic Plans, then Tenant shall revise the Draft Schematic Plans and cause Landlord’s objections to be remedied in the revised Draft Schematic Plans. Tenant shall then resubmit the revised Draft Schematic Plans to Landlord for approval, such approval not to be unreasonably withheld, conditioned or delayed. Landlord’s approval of or objection to revised Draft Schematic Plans and Tenant’s correction of the same shall be in accordance with this Section until Landlord has approved the Draft Schematic Plans in writing or been deemed to have approved them. The iteration of the Draft Schematic Plans that is approved or deemed approved by Landlord without objection shall be referred to herein as the “Approved Schematic Plans.”

  • 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.

  • Research Plans The Research Plan for the [***] Designated Target is attached as Schedule 2.2.3-1. Subsequent Research Plans agreed upon in accordance with Section 2.4.2.4 will be attached as additional sequentially numbered schedules (Schedule 2.2.3-2, Schedule 2.2.3-3, etc.).

  • 401(k) Plans (a) From the Distribution Time and continuing until the 401(k) Plan Transition Date, SpinCo shall become an “adopting employer” (as defined in the Company 401(k) Plan) and the Company 401(k) Plan shall provide for the SpinCo Group to participate in the Company 401(k) Plan for the benefit of SpinCo Employees and Former SpinCo Service Providers, and the Company consents to such adoption and maintenance, in accordance with the terms of the Company 401(k) Plan.

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

  • Other Plans No amounts of income received by the Optionee pursuant to this Grant Agreement shall be considered compensation for purposes of any pension or retirement plan, insurance plan or any other employee benefit plan of the Company or its subsidiaries, unless otherwise expressly provided in such plan.

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