Additional Study definition

Additional Study has the meaning set forth in Section 4.4(a).
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Additional Study means any Clinical Study (including any Phase IV Clinical Study) proposed by a Party pursuant to Section 4.4(a)(i) to be conducted during the Merck Participation Term for a given Program to Develop any Collaboration Product from such Program as a monotherapy or in combination with one or more Other Components beyond any Clinical Study(ies) contemplated by the then-current Joint Development Plan and Budget for the applicable Program.
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Additional Study has the meaning set forth in Section 1.44.
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Examples of Additional Study in a sentence

  • If no Class Year Project Developer to which the Notice of SDUs Requiring Additional Study is issued elects to proceed with such additional studies, the Class Year Study will proceed to the decision and settlement phase set forth in Section 25.8.2 of this Attachment S.

  • This notice will be referred to as the “Notice of SDUs Requiring Additional Study.” At the same time the ISO issues the Notice of SDUs Requiring Additional Study, the ISO will issue a notice to only those Class Year Project Developers for which the ISO has identified System Deliverability Upgrades requiring additional SDU studies.

  • Starting with Class Year 2019, if the ISO determines that an Additional SDU Study is required pursuant to Section 25.5.10 of this Attachment S, ISO will notify all Class Year Projects that such Additional SDU Study will be conducted, such notice to be provided as soon as practicable after the ISO receives notice from Developers in response to the Notice of SDU Requiring Additional Study.

  • Each Party shall conduct the Internal SAV Programs, POC Programs, Additional Research Programs, Joint Development Programs and Independent Additional Studies and other activities under the Internal SAV Program Plans, POC Plans, Additional Research Plans, Joint Development Plan and Budget for the applicable Program or Independent Additional Study Development Plans in compliance with all applicable Laws.

  • The JSC shall approve the form of any necessary documentation relating to any payments hereunder in connection with the Joint Development Program, Additional Study Development Plan, Global Commercialization Plan, Incremental Capacity Buildup Plan, or Commercial Capacity Buildup Plan, as applicable, so as to afford the Parties appropriate accounting treatment in relation to any of the transactions or payments contemplated hereunder.

  • If and to the extent that any Included In-License Payment becomes due with respect to activities under an Independent Additional Study Development Plan, the Party sponsoring or conducting such Independent Additional Study will pay the same, and such amount will be [***].

  • Each Party shall keep records associated with Development Costs incurred through performance of an Independent Additional Study Development Plan strictly separate from records associated with Development Costs incurred through performance of the applicable Joint Development Program.

  • The Parties shall share all Joint Development Costs incurred to conduct such Additional Study in accordance with the applicable budget and in the proportions set forth in Section 4.5. All Information resulting from such Additional Study will be available for use by each Party with respect to the Development and Commercialization of the Product in the Field in its respective territory in accordance with the licenses and rights granted or retained under Article 2 of this Agreement.

  • The Party sponsoring or conducting an Independent Additional Study under an Independent Additional Study Development Plan shall be responsible for [***], in connection with such Independent Additional Study(ies) and such costs shall be borne in accordance with this Section 4.4 and Exhibit D.

  • Each Party shall keep records associated with Development Costs incurred through performance of the Joint Development Plan and Budget for the applicable Program strictly separate from records associated with Development Costs incurred through performance of an Independent Additional Study Development Plan.


More Definitions of Additional Study

Additional Study has the meaning set forth in Section 3.5(b)(i).
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Related to Additional Study

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S).

  • Additional Indication means any indication other than the Initial Indication.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).