Supplemental Study definition

Supplemental Study is any Clinical Study (other than any Post-Marketing Study) for an additional indication or other label expansion for a Licensed Product beyond the initial Indication contemplated by the Development Plan.
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Supplemental Study means any Clinical Study (other than any Post-Marketing Study) for a Licensed Product beyond what is contemplated in the Initial Indications Development Plan.
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Supplemental Study means any clinical study (other than any Post-Marketing Study) for an additional indication or other label expansion for a Licensed Product beyond what is contemplated in the then-current Development Plan or the Global Development Plan, as applicable, or any health economic and outcomes research studies, in each case, as and to the extent approved by the JSC.
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Examples of Supplemental Study in a sentence

  • If a Party desires to conduct (i) a Supplemental Study of a Regional Licensed Product for a Regional Target for the purpose of seeking Regulatory Approval to market such Regional Licensed Product, or (ii) Regional [***] Activities, such Party (the “Proposing Party,” and such other Party, the “Non-Proposing Party”) will submit to the JDC a proposal to add such Supplemental Study or Regional [***] Activities, as applicable, to the applicable RLP Development Plan (an “Additional Development Proposal”).

  • In the event that the Proposing Party conducts a Supplemental Study or Regional [***] Activity pursuant to Section 5.2.2.4(c), the Proposing Party will provide to the Non-Proposing Party (i) [***] (the “Additional Development Data Package”).

  • If the Interconnection Provider determines the Application cannot be approved without minor modifications at minimal cost; or a Supplemental Study or other additional studies or actions; or at significant cost to address safety, reliability, or power quality problems, within the 5 day period after the determination the Interconnection Provider shall notify the Interconnection Customer and provide copies of all data and analyses underlying its conclusion.

  • The other Party shall have the right (but not the obligation) (the “Supplemental Study Opt-In Right”) to access any study reports and data of such Supplemental Study(ies) that such other Party did not co-fund for purposes of Filing for Regulatory Approval in such other Party’s Territory by paying […***…] of the Development Costs incurred by the Party conducting such Supplemental Study.

  • At the request of the Party proposing to conduct such Supplemental Study, such other Party shall explain at the JDC the basis for its determination to withhold its consent to such Supplemental Study in such other Party’s Territory.

  • If either Party desires to conduct a Supplemental Study of a Licensed Product for the purpose of seeking Regulatory Approval to market such Licensed Product in its Territory, such Party will notify the other Party of such desire and the Parties will discuss the possibility to conduct the Supplemental Study in the aTyr Territory and the Kyorin Territory in accordance with the Multi-Regional Clinical Trials Principles.

  • If Licensee desires C▇▇▇▇▇ to conduct or have conducted a Supplemental Study (other than a PMDA-Required Supplemental Study) for a Licensed Product for the purpose of seeking Regulatory Approval to market such Licensed Product in the Field in the Licensee Territory, Licensee will submit to the JDC a proposal to add such Supplemental Study to the Initial Indications Development Plan (a “Licensee Additional Development Proposal”).

  • If a Party desires to conduct a Supplemental Study of a Regional Licensed Product for a Regional Target Pair such Party (the “Proposing Party” and such other Party, the “Non-Proposing Party”) will submit to the JDC a proposal to add such Supplemental Study to the applicable RLP Development Plan (an “Additional Development Proposal”).

  • C▇▇▇▇▇ will bear one hundred percent (100%) of the Development Costs incurred in connection with the performance of any PMDA-Required Supplemental Study.

  • If either (a) the Parties decide to conduct the Supplemental Study [***] or (b) they decide not to conduct such Supplemental Study [***], then both Parties (in the case of clause (a)) or the applicable Party (in the case of clause (b)) will submit to the JSC an amendment to add such Supplemental Study to the applicable Development Plan for such Licensed Product (each “Additional Development Proposal”).


More Definitions of Supplemental Study

Supplemental Study has the meaning set forth in Section 3.5(a).
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Related to Supplemental Study

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • Pivotal Trial means (a) a Phase 2 Clinical Trial, or a combination Phase 2 Clinical Trial and Phase 3 Clinical Trial, that (taken together with any other trials completed prior to or concurrently with such trial) is intended to support Marketing Approval for a Product by the relevant Regulatory Authority in the indication under study, or (b) a Phase 3 Clinical Trial.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • 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).

  • 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).