Updates to the Development Plans Sample Clauses

Updates to the Development Plans. As early as necessary in each year beginning with the first full calendar year after the Effective Date, the Party responsible for preparing the initial Development Plan for a Collaboration Product shall update and prepare the Development Plan for any such Collaboration Product for the following calendar year to take into account completion, commencement or cessation of Development activities not contemplated by the then-current Development Plan, and submit such proposed Development Plan to the JDC no later than September 30 of such year for review and approval.
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Updates to the Development Plans. As early as necessary in each year beginning with the first full calendar year after the Effective Date, Shire shall update and prepare the Development Plan for any such Collaboration Product for the following calendar year to take into account completion, commencement or cessation of Development activities not contemplated by the then-current Development Plan, and submit such proposed Development Plan to the JDC no later than September 30 of such year for review and approval.
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Updates to the Development Plans. (a) Updates to the Sanofi Development Plan. From time to time during the Term and at least once per calendar year, beginning with the first full calendar year after the Effective Date, Sanofi shall provide KaloBios through the JSC with annual updates to the then-current Sanofi Development Plan. Such annual updated Sanofi Development Plan shall take into account completion or cessation of Development activities or commencement of new Development activities not contemplated by the then-current Sanofi Development Plan. Once approved by the JSC, each updated or amended Development Plan shall become effective and supersede the previous Sanofi Development Plan as of the date of such approval.
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Updates to the Development Plans. No later than 30 days following Sarepta’s receipt of the Option Exercise Notice for the Exon-Skipping Products or any Gene-Editing Option Product or Gene Therapy Option Product, Roche will provide to the JDC in accordance with Section 4.4 (Roche Territory Development Plan) an update to the Roche Territory Development Plan that includes such Option Products ([**]). In addition, following such exercise of the Option for such Option Products ([**]), in accordance with Section 4.3.1 (Joint Global Development Plan), the JDC will update the Joint Global Development Plan to include such Option Products ([**]) and until the JSC approves such an update, all activities relating to such Option Products ([**]) and any corresponding Sarepta Diagnostic Products under the Option Product Development Plan will be deemed to be included in the Joint Global Development Plan as activities relating to such Option Product and Sarepta Diagnostic Products.
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Updates to the Development Plans. Unless the Co-Development Option has expired without exercise by PGx, as early as necessary in each calendar year, CRXX shall update and prepare the Development Plan for the following calendar year to take into account completion, commencement or cessation of Development activities not contemplated by the then-current Development Plan, and submit such proposed Development Plan to the JSC no later than September 30 of such year for review and approval. CRXX may, at its election, update the Development Plan between annual updates subject to review and approval by the JSC. In the event that PGx does not exercise its Co-Development Option, CRXX shall only be obligated to provide PGx with reports pursuant to Section 4.9.
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Updates to the Development Plans. Following approval by the JDC of the full Development Plan, and commencing in [***] and [***] thereafter, GNE shall update and prepare the Development Plan for each Licensed Product for the following [***] to take into account completion of Development activities, or commencement or cessation of Development activities not contemplated by the then-current Development Plan and nonetheless approved by the JDC, and submit each such proposed amended Development Plan to the JDC for review no later than [***] and for approval no later than [***] of such [***]; provided, that the Development activities in the Development Plan delegated to and agreed [***], unless [***].
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Related to Updates to the Development 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.

  • Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  • 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").

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

  • 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 Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • 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.).

  • 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.

  • 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).

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

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