U.S. Development Plan Sample Clauses

U.S. Development Plan. The initial U.S. Development Plan for the Initial Indications has been agreed upon by the Parties and is attached hereto as Exhibit H and incorporated herein by reference. The U.S. Development Plan shall contain the following [*] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. information for the Product for each Initial Indication in the Licensed Territory, to the extent such information is available:
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U.S. Development Plan. The Development activities with respect to the Product in the Field for the United States conducted in connection with this Agreement shall occur pursuant to a Development plan proposed by Eyegate and agreed upon by the JSC (the “U.S. Development Plan”). Eyegate shall propose the initial U.S. Development Plan to the JSC within sixty (60) days after the Effective Date, and the JSC shall discuss any amendments thereto and approve the initial U.S. Development Plan within ninety (90) days after the Effective Date. Prior to submission to the JSC, Eyegate shall provide a draft of the U.S. Development Plan for Valeant’s review and comment and Eyegate shall use good faith efforts to include Valeant’s comments in such U.S. Development Plan. On at least an annual basis, Eyegate shall review, update and decide whether to amend the then-current U.S. Development Plan to reflect any changes, reprioritizations of, or additions thereto. Any changes to the U.S. Development Plan shall require approval by the JSC and once approved by the JSC, such updated or amended U.S. Development Plan shall become effective and supersede the prior U.S. Development Plan. The U.S. Development Plan shall include:
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U.S. Development Plan. The Parties shall conduct all Development of the Compound and Products in the Field in or for the U.S., and all U.S. Global Studies, in accordance with a comprehensive development plan (as amended in accordance with this Agreement, the “U.S. Development Plan”), including the timelines set forth therein, the initial version of which is attached to this Agreement as Schedule 4.1(a). For clarity, the Parties acknowledge and agree that such attachment may be subject to further discussion and updates, as agreed upon by the Parties through the JDC and approved by the JSC, following the execution of Confidential EXECUTION VERSION this Agreement. The U.S. Development Plan will include, among other things, the Indications for which the Product is to be Developed, allocation of responsibilities between the Parties, critical activities to be undertaken, certain timelines, go/no go decision points and relevant decision criteria, and feedback from the FDA, EMA and/or PMDA (which, to the extent applicable, FDA, EMA and/or PMDA feedback will be reflected in a promptly updated U.S. Development Plan, including applicable updates to U.S. Global Studies, that is reviewed and discussed by the JDC, and presented to the JSC for final approval), if applicable. The Parties may also discuss and consider the feedbacks from the other Regulatory Authorities with respect to the U.S. Development Plan. The U.S. Development Plan shall be focused on efficiently obtaining Regulatory Approval for the Product in the Field in the U.S., but may consider its impact on Regulatory Approval for the Product in EU and Japan. The U.S. Development Plan will be associated with the U.S. Development Budget. Each U.S. Development Plan shall include a three (3) Calendar Year plan for Developing the Products and shall be prepared in good faith; provided, however that the Parties acknowledge and agree that the initial U.S. Development Plan does not include a corresponding U.S. Development Budget, and that the initial U.S. Development Budget shall be deemed to equal and include any costs incurred for activities to be undertaken after the Effective Date by MEI under such initial U.S. Development Plan and any such costs shall, accordingly, be deemed to be U.S. Development Costs that are subject to Section 4.1(e)(iv) (U.S. – Development Costs) until such time as the Parties approve a U.S. Development Budget through the JSC in accordance with applicable provisions of this Agreement. In the event of any inconsiste...
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Related to U.S. 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.

  • 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 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.

  • Business Development Company Buyer is a business development company as defined in Section 202(a)(22) of the Investment Advisors Act of 1940.

  • Research and Development (i) Advice and assistance in relation to research and development of Party B;

  • 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 Plan As defined in Section 3.2(a).

  • Business Development Provide advice and assistance in business growth and development of Party B. 业务发展。对乙方的业务发展提供建议和协助。

  • 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:

  • Business Development Company Status The Company, during a period of at least 12 months from the Closing Time, will use its commercially reasonable efforts to maintain its status as a business development company; provided, however, the Company may cease to be, or withdraw its election as, a business development company, with the approval of the board of directors and a vote of stockholders as required by Section 58 of the 1940 Act or any successor provision.

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