Updates to the Development Plan Sample Clauses

Updates to the Development Plan. During the Term, BMS shall provide Ambrx (through the JRC if still constituted or, if the JRC is not constituted, through the Alliance Managers) with semi-annual updates to the Development Plan. Such semi-annual updated Development Plan shall take into account completion or cessation of Development activities or commencement of new Development activities. Any changes to the Research Plan shall be governed by Sections 3.3 and 3.4.
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Updates to the Development Plan. On an annual basis (no later than [*] of each Calendar Year), the Party appointed by the JDC shall prepare amendments to each then-current Development Plan and each Development Budget. Each such amended Development Plan shall cover the next Calendar Year and shall contain a corresponding Development Budget. Each such updated and amended Development Plan shall reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or additions to Development of the applicable Collaboration Product. The amended Development Plan and Development Budget shall be submitted to the JDC for review and, following such review, to the JSC for its review and approval. Once approved by the JSC, the amended Development Plan and Development Budget shall become effective on January 1 of each Calendar Year and shall be in full force throughout such Calendar Year unless further amended in accordance with this Section 3.3(c). In any event, any amended or updated Development Plan and Development Budget shall supersede the previous Development Plan and Development Budget.
Sample 1
Updates to the Development Plan. Following BMS’ submission of the Initial Development Plan, [**], BMS shall provide uniQure through the JSC with annual updates to the Development Plan. Such annual updated Development Plan shall take into account completion or cessation of Development activities or commencement of new Development activities. With regard to [**], in the event BMS makes a [**]), BMS, through its Alliance Manager, will [**]. In the event [**], the Alliance Managers will [**]. For the avoidance of doubt, any such [**]. For further avoidance of doubt, the fact that [**], shall be without any prejudice to [**] pursuant to this Agreement, [**].
Sample 1
Updates to the Development Plan. Beginning with the first full Calendar Year after the Effective Date, on an as-needed basis but not more frequently than once-per Calendar Year, Yakult shall prepare and submit for review and approval by the Committee, proposed updates and amendments to the then-existing Development Plan and prepare the Development Plan for each ThermoDox Product for the immediately subsequent Calendar Year.
Sample 1
Updates to the Development Plan. On an annual basis (no later than [ * ] of each Calendar Year), the Party appointed by the JDC shall prepare amendments to each then-current Development Plan and each Development Budget. Each such amended Development Plan shall cover the next Calendar Year and shall contain a corresponding Development Budget. Each such updated and amended Development Plan shall reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or additions [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. to Development of the applicable Collaboration Product. The amended Development Plan and Development Budget shall be submitted to the JDC for review and, following such review, to the JSC for its review and approval. Once approved by the JSC, the amended Development Plan and Development Budget shall become effective on January 1 of each Calendar Year and shall be in full force throughout such Calendar Year unless further amended in accordance with this Section 3.3(c). In any event, any amended or updated Development Plan and Development Budget shall supersede the previous Development Plan and Development Budget.
Sample 1
Updates to the Development Plan. During the Term, Exactus BioSolutions shall provide Digital Diagnostics (through the JDC if still constituted or, if the JDC is not constituted, through the Alliance Managers) with semi-annual updates to the Development Plan. Such semi-annual updated Development Plan shall take into account completion or cessation of Development activities or commencement of new Development activities. Any changes to the Development Plan shall be governed by Sections 3.3 and 3.4.
Sample 1
Updates to the Development Plan. Beginning with the first full Calendar Year after the Effective Date, on an as-needed basis but in no event less frequently than once-per Calendar Year in accordance with Pfizer’s operating plan calendar for its other pharmaceutical products (and in no event later than November 1 of each such Calendar Year), Pfizer shall prepare and submit for review by the Joint Development Committee, and approval by the JSC, proposed updates and amendments to the then-existing Development Plan and prepare the Development Plan for each Licensed Product for the immediately subsequent Calendar Year.
Sample 1
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Related to Updates to the Development Plan

  • 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 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 Plan As defined in Section 3.2(a).

  • 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").

  • 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.

  • 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:

  • 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:

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Development Funding (a) Viewray will pay 3D Line the then U.S. Dollar equivalent of €[***] within three (3) days of the Effective Date for the engineering services required to develop/ deliver the Deliverable described in Section 2.1(a)(i).

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