Scope of Development Plan Sample Clauses

Scope of Development Plan. (a) The Parties acknowledge that a Summary Development Plan (including a summary development budget) dated as of the Effective Date for calendar years 2002 through NDA Approval has been approved by both Parties ("Summary Development Plan"). Pursuant to the JEC's direction under Section 2.1(b)(xiii), the PDC shall meet to approve the definitive Development Plan for the Product based on the Summary Development Plan, which shall be approved no later than the earlier of *** or the *** anniversary of the Trial Commencement Date. Such Development Plan shall include, on a calendar year-by-calendar year basis: (i) the research and development activities including clinical studies, non-clinical studies, manufacturing process validation, CMC, ICH registration batches, pre-approval inspection preparation, pharmaceutical development including quality control and stability, manufacturing qualification and regulatory tasks under this Agreement for the development of the Product through Final FDA Approval (or similar Registration elsewhere in the Territory) (in any event, excluding any and all DURECT Activities); (ii) the estimated budget for each development activity, and estimated over-all budget for performance of all development activities under the Development Plan ("Development Budget"); (iii) "go/no go" decision criteria for each stage of development of the Product; (iv) target Product profiles, which shall be created by the PDC and JCC, jointly; (v) the allocation of the respective responsibilities of DURECT and Endo regarding development activities; and (vi) timelines for scientific, medical, regulatory and other activities to be undertaken by the Parties for the purpose of obtaining Registration for the Product in the Territory. The Development Plan shall exclude any and all DURECT Activities. Once approved, the Development Plan shall be updated by and reviewed by the PDC at least once each calendar year by a date no later than *** of each year so as to cover any other amendments in accordance with the decision-making authority provided in Section 2.2(d).
Sample 1
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Scope of Development Plan. Stryker desires to partner with Microbot to collaborate in the development of NV applications that integrate the LIBERTY System of Microbot and the Devices Technology of Stryker (as such terms are defined in the Agreement) (the “Project”). Products created from the Project, if any, shall be for use in the Field in the Territory. Stryker will dedicate non-cash resources to the Project that include, but are not limited to: ● [***] ● [***] ● [***] ● [***] ● [***] ● [***] ● [***] ● [***] Microbot will dedicate non-cash resources to the Project that include, but are not limited to: ● [***] ● [***] ● [***] ● [***] This Project will be completed in phases as outlined in Table 1 below. Certain Identified Information Has Been Excluded From The Exhibit Because It Is Both (I) Not Material And (Ii) Would Be Competitively Harmful If Publicly Disclosed Table 1. Project Phases Design and Development Phase Summary of Activities Estimated Timing [***] [***] [***] [***] [***] [***] [***] [***] [***]
Sample 1
Scope of Development Plan. The Development Plan for each ThermoDox Product shall specify the composition details of such ThermoDox Product and the Named Indication of such ThermoDox Product and shall, at minimum, set forth the specific Development activities for which Yakult will be responsible, relevant timelines, and the estimated number of patients to be enrolled in each Clinical Study and the estimated duration of each Clinical Study. An English language summary of all preclinical and clinical protocols must be submitted to the Committee for review and comment, with approval required within [ * ].
Sample 1
Scope of Development Plan. Pfizer and Valneva will collaborate during the Development Term to conduct assay and diagnostic development, toxicology studies, manufacturing development and technology transfer as well as Clinical Trials in accordance with the Development Plan and the terms and conditions set forth in this Article 4. The Development Plan and Development Budget may be amended during the Development Term in accordance with Section 4.3.
Sample 1
Scope of Development Plan. The Development Plan for each Licensed Product shall specify the Named Compound contained in such Licensed Product and the Named Indication of such Licensed Product and shall, at minimum, set forth the specific Development activities for which each Party will be responsible, timelines for which each Party shall be responsible, and the estimated number of patients to be enrolled in each Clinical Study and the estimated duration of each Clinical Study.
Sample 1

Related to Scope of 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).

  • 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.

  • 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.

  • Joint Development All inventions, know-how, trade secrets, data or information which result from joint development by the Parties hereto shall be jointly owned by the Parties. The Parties hereby agree to cooperate in good faith in the filing of any and all patent applications in all jurisdictions.

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

  • Project Plan Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s “A multi-center, randomized, double-blind, double-dummy, vehicle-controlled sequential cohort study to determine the safety of PEP005 0.025% and 0.05% topical gel in patients with actinic keratoses” (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs.

  • Marketing Plan The Contractor shall have a Marketing Plan, that has been prior-approved by the SDOH and/or LDSS, that describes the Marketing activities the Contractor will undertake within the local district during the term of this Agreement. The Marketing Plan and all marketing activities must be consistent with the Marketing Guidelines which are set forth in Appendix D, which is hereby made a part of this Agreement as if set forth fully herein. The Marketing Plan shall be kept on file in the offices of the Contractor, LDSS, and the SDOH. The Marketing Plan may be modified by the Contractor subject to prior written approval by the SDOH and/or the LDSS. The LDSS or SDOH must take action on the changes submitted within sixty (60) calendar days of submission or the Contractor may deem the changes approved.

  • Development Agreement That certain Development Agreement dated of even date herewith by and between the Company and Developer providing for the development of the Project on the Property, a copy of which is attached hereto as Exhibit C and incorporated herein by reference. Development Fee. As described in Section 6.8.

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