Combination Therapy Development Sample Clauses

Combination Therapy Development. If either Party (a “Proposing Party” for the purposes of this Section 4.8.1 (Combination Therapy Development)) desires to conduct any Development of any Combination Product or any Product as a combination therapy with any other pharmaceutical product other than in the form of a Combination Product (e.g., where a Product is administered sequentially or co-administrated with one (1) or more other pharmaceutical products, but is not co-formulated or co-packaged with any other pharmaceutical product) in order to obtain Regulatory Approval for such Combination Product or combination therapy in any country in which such Party is the Regulatory/Reimbursement Responsible Party (any such Development, “Combination Therapy Development”), such Party shall, at least [**] prior to commencing such Combination Therapy Development, notify the other Party (the “Non-Proposing Party” for the purposes of this Section 4.8.1 (Combination Therapy Development)) via the JDC of such proposed Development (each a “Combination Therapy Development Proposal”) including in reasonable detail the proposed Combination Therapy Development activities (the “Combination Therapy Development Activities”), including, as applicable, any non-clinical studies, clinical studies, GLP Toxicology Studies, and Clinical Trials that the Proposing Party desires to conduct or have conducted as part of such Combination Therapy Development, including a synopsis of the Clinical Trials or activities, the proposed enrollment criteria, the number of patients to be included, the endpoints to be measured, and the statistical design and powering, as well as a proposed timeline and budget and an analysis of the business opportunity and revenue potential for such Combination Therapy Development Activities.
Sample 1
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Related to Combination Therapy Development

  • 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 3.1.1 Licensee agrees to and warrants that:

  • 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.

  • 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).

  • Condominiums/Planned Unit Developments If the Mortgaged Property is a condominium unit or a planned unit development (other than a de minimis planned unit development) such condominium or planned unit development project such Mortgage Loan was originated in accordance with, and the Mortgaged Property meets the guidelines set forth in the Originator's Underwriting Guidelines;

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • 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.

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

  • 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.

  • Independent Development The Disclosing Party acknowledges that the Receiving Party may currently or in the future be developing information internally, or receiving information from other parties, that is similar to the Confidential Information. Accordingly, nothing in this Agreement will be construed as a representation or agreement that the Receiving Party will not develop or have developed for it products, concepts, systems or techniques that are similar to or compete with the products, concepts, systems or techniques contemplated by or embodied in the Confidential Information, provided that the Receiving Party does not violate any of its obligations under this Agreement in connection with such development.

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