Monotherapy Study definition

Monotherapy Study means a non-clinical study (including Manufacturing Development), preclinical study, or Clinical Study of (a) solely the Monotherapy Regimen or (b) the Monotherapy Regimen that compares the Monotherapy Regimen to an Ancillary Therapy, in each case of (a) and (b), that is performed by or on behalf of Incyte (or by MacroGenics pursuant to Section 5.9(c)). For clarity, a monotherapy arm that is included as part of a Combination Study shall not be considered a Monotherapy Study.
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Examples of Monotherapy Study in a sentence

  • Further, MacroGenics shall supply all quantities of Licensed Compound Bulk Drug Substance that are required for any particular Incyte Monotherapy Study or Incyte Combination Study from the same MacroGenics Manufacturing Facility, provided that such supply requirements do not exceed the reasonably available then-current planned capacity of the applicable Manufacturing Facility.

  • Compugen shall also provide BMS all Monotherapy Study Data produced, after the most recent JSC meeting, if requested by BMS, but for clarity, shall not be obligated to produce additional analysis if requested solely by BMS.

  • The initiation of the Phase I Monotherapy Study will occur no later than by the end of the first quarter of 2012.

  • In addition, Compugen shall provide updates with respect to the Monotherapy Arm, including: (i) reports requested by the JSC, provided that such information is relevant to the Combined Therapy or the Combined Therapy Studies, and (ii) all interim Monotherapy Study Data that is available at such time of each JSC meeting.

  • Licensed Compound and any other specific molecule or molecules (as monotherapies or combinations) other than a Monotherapy Study, Collaborator Combination Study, or a Clinical Study that includes a MacroGenics Pipeline Asset.

  • The MAT2A Program shall include preclinical activities and the Phase 1 MAT2A Monotherapy Study to generate the Option Data Package designed to allow GSK to determine whether it will exercise the Option.

  • Subject to the restrictions on disclosure of the Monotherapy Study Data to Third Parties as set forth below in this Section 8.11, BMS shall have the right to use and analyze the Monotherapy Study Data solely in connection with its independent development, commercialization or other exploitation of the BMS Compound (alone or in combination with the Compugen Compound).

  • Such use may include use of the Monotherapy Study Data during and following the Term of this Agreement to (1) submit regulatory filings and seek Regulatory Approvals for the BMS Compound as part of the Combined Therapy and (2) following the applicable Regulatory Approval of the Combined Therapy, to promote indications based on, and to disseminate, the Monotherapy Study Data for the benefit of the BMS Compound as part of the Combined Therapy, where permitted by and in accordance with Applicable Law.

  • The Monotherapy Study Data shall not be disclosed to Third Parties by BMS except as follows (and otherwise as expressly permitted under the Agreement).

Related to Monotherapy Study

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

  • Step therapy protocol means a protocol or program that establishes the specific

  • Study means the investigation to be conducted in accordance with the Protocol.

  • 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.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.