Other Studies definition

Other Studies means any Clinical Trial for a Product conducted by or on behalf of either Party in the Profit-Share Territory, other than any Additional Study, Ongoing Development Trials, New Phase III Trial, or PMR/PMC Activities. For clarity, open-label extension studies for a Product conducted by a Party in the Profit-Share Territory will constitute Other Studies.
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Other Studies means real world evidence, observational clinical and similar studies that are not Clinical Trials.
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Examples of Other Studies in a sentence

  • Other Studies have included more parameters like mean K, and axis of astigmatism as well15,16 but we in our study have limited ourselves to steep K and dioptric power of astigmatism only.

  • Any updated Joint Medical Affairs and Development Plan and Budget for a Calendar Year will be agreed to by the applicable JSC by [***] of the preceding Calendar Year, and must set out the budget for Development Costs in relation to the Clinical Trials and the Other Studies set out in the Long-Term Study Plan.

  • In addition, a scope of work and cost estimate for potential focused surveys for special-status species are provided in the Other Studies section of this proposal.

  • For purposes of this Agreement, clinical studies relating to the Product shall be categorized either (i) as "Registration Studies" which shall be studies conducted with the intention of being filed with the FDA or an Agency for the purpose of obtaining an Additional Indication or (ii) as "Other Studies".

  • Other Studies in the Primary Indication and Other Indications - [*].

  • Each such initial Joint Medical Affairs and Development Plan and Budget includes: (i) an initial budget covering anticipated Development Costs from the Effective Date through [***]; and (ii) a plan setting out a list of Clinical Trials and Other Studies to be performed covering the period from the Effective Date through [***] and the general budget of estimated costs and timelines with respect thereto (such list, the “Long-Term Study Plan”).

  • Laboratory and Other Studies E3: Addition of hepatitis C screening Hepatitis C screening on all pregnant women during each pregnancy.

  • Contractor must have qualified personnel to perform field inspections as appropriate to document on-site conditions, perform specialized studies as listed in Section 2.2.6 Other Studies, and the ability to perform desktop review using federal, Territorial, and local databases to document compliance.

Related to Other Studies

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Research Plan shall have the meaning set forth in Section 2.1.