CMC Development Plan Sample Clauses

CMC Development Plan. All new Manufacturing Development activities to be conducted by MacroGenics under this Agreement will be set forth in the CMC Development Plan which includes an estimated budget for the costs to be incurred by MacroGenics in performing such Manufacturing Development work (the “CMC Development Budget”), including any Third Party Expenses. Updates to the CMC Development Plan will be mutually approved by the JMC prior to initiation of any activities not already mutually approved by the JMC. MacroGenics will use Commercially Reasonable Efforts to perform the Manufacturing Development activities set forth in the CMC Development Plan. MacroGenics may not exceed the CMC Development Budget [***] without the Parties agreeing to an amendment to the CMC Development Plan in accordance with Section 6.3 below. MacroGenics will not be obligated to perform any Manufacturing Development activities if the Parties cannot agree to an increase in the CMC Development Budget. In addition, MacroGenics will not be obligated to perform any Manufacturing Development activities that are not specifically set forth in the CMC Development Plan
Sample 1
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CMC Development Plan. (a) Within forty-five (45) days of the Effective Date, the Parties shall amend the CMC Development Plan to add top line operational details (which includes a detailed budget of the amount that Jxxxxxx may invoice for and the financial commitments to be made by Capricor for the CMC work (such budget, the “CMC Development Budget”)). All manufacturing Development activities for CDC Cells and CDC Products contemplated by the Parties hereunder shall be set forth and carried out pursuant to the CMC Development Plan.
Sample 1
CMC Development Plan. Subject to the oversight of the JMC and JSC, during the CMC Development Term, Xxxxxxx and MeiraGTx will each collaborate with one another to Develop the Manufacturing process used for each clinical program undertaken hereunder in connection with any Clinical IRD Product or Research IRD Product, to identify certain technical Manufacturing process improvements and efficiencies and to share data packages necessary for regulatory filings in connection therewith (“CMC Development Collaboration”). The Parties will undertake the CMC Development Collaboration in accordance with this Agreement and one or more CMC Development Plans, which plan will set forth (i) all activities that are necessary or useful to be undertaken by each Party in connection with such CMC Development Collaboration (the “CMC Development Plan Activities”), (ii) an estimated timeline for completing such activities, (iii) the respective deliverables for such activities and (iv) the allocation of responsibilities between the Parties for performance of each such activity. In addition, the CMC Development Plan Activities will comprise of: (x) those specific activities listed under “Clinical Development Manufacturing Activities” in Exhibit 8.4(a) attached hereto (“Clinical Development Manufacturing Activities”) and (y) those specific activities listed under “Process Development Activities” in Exhibit 8.4(a) attached hereto (“Process Development Activities”). In the event that any CMC Development Plan Activity does not fall under one of the specific activities listed in Exhibit 8.4(a), the JMC shall discuss and determine whether such CMC Development Plan Activity should be (1) treated as a Clinical Development Manufacturing Activity hereunder and subject to the cost provisions set forth in Section 8.4(d) or (2) treated as a Process Development Activity hereunder and subject to the cost provisions set forth in Section 8.4(e). The JMC shall develop and submit an initial CMC Development Plan to the JSC for its review and approval, [***], and upon the JSC’s approval, such initial CMC Development Plan will be automatically attached hereto and form a part of Exhibit 1.51. From time to time, and at least on an annual basis, Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by MeiraGTx Holdings plc the JMC shall propose, review and...
Sample 1

Related to CMC 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 Plan As defined in Section 3.2(a).

  • 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.

  • 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 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:

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

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • 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).

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

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