Additional Development Work After Sample Clauses

Additional Development Work After. [***] either Party may identify New Indications that it wishes to pursue with respect to Development of Products, and shall provide the JDC with written notice specifying such New Indication and a proposal and budget for the Development of the Product in the New Indication through Proof of Concept. If the JDC approves such Development, then the JDC shall design the protocol for the Proof of Concept Clinical Trial, and shall establish Proof of Concept Criteria that must be achieved in such Proof of Concept Clinical Trial to progress Development of the Product into a Phase 3 Clinical Trial. Upon achievement of the Proof of Concept Criteria in such Proof of Concept Clinical Trial in such New Indication, progression of Development in a Phase 3 Clinical Trial in such New Indication shall be determined by the JDC. The Parties shall be responsible for Development Costs associated with Development in such New Indication through Completion of the applicable Proof of Concept Clinical Trial and any further Phase 3 Clinical Trials if SYNTA Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. does not exercise its Development Opt-Out Right with respect to such Phase 3 Clinical Trials, in accordance with Section 3.6.1. For the avoidance of doubt, if there is not a Unanimous Decision to conduct Development under this Section 3.1.3(c), then [***] shall have the final say on whether or not to conduct such Development and may either prohibit further Development in a New Indication or conduct Development in a New Indication under this Section 3.1.3(c) without SYNTA’s participation, and in the latter case, the provisions of Section 3.1.3(d) shall apply.
Sample 1
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Related to Additional Development Work After

  • 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 Work Do, or cause to be done, such development and other work as may be reasonably necessary to protect from diminution and production capacity of the Mortgaged Property and each producing well thereon.

  • 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).

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • 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.

  • Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.

  • 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 Diligence Pfizer will use its Commercially Reasonable Efforts to Develop and seek Regulatory Approval for [ * ] Product [ * ] in the Field [ * ]. Pfizer will [ * ] with respect to the Development or Regulatory Approval of Products under this Agreement.

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