Combined Therapy Trial definition

Combined Therapy Trial or “Combined Therapy Trials” shall have the meaning set forth in Section 2.1(a) of this Agreement.
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Combined Therapy Trial has the meaning set forth in Section 2.1.
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Combined Therapy Trial. Defined Term Section Alliance Manager 2.6 Breaching Party 12.2(a) CDA 9.1 Tyrosine Kinase Inhibitor Trial 5.4(d) Co-Chair 2.3(a) Cure Period 12.2(a) Dispute 13.3(a) Exclusive Discussion Period 5.4(d) GAAP 4.1(a)
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Examples of Combined Therapy Trial in a sentence

  • In the event such officers are unable to resolve the Material Safety Issue, the applicable Combined Therapy Trial shall be discontinued.

  • Any data and intellectual property arising out of such Sample use shall be owned by the Party conducting such study using same; provided that to the extent that any such data or intellectual property relates solely to the Combined Therapy (or biomarkers solely for use with the Combined Therapy), such data or intellectual property shall be considered Combined Therapy Study Data or Combined Therapy Trial Inventions/Combined Therapy Patent Rights, as the case may be.

  • Notwithstanding the foregoing, neither Party shall be required to continue a Combined Therapy Trial if a Party reasonably deems there to be a Material Safety Issue for such Combined Therapy Trial.

  • Each Combined Therapy Trial shall be conducted under a combination IND unless a Regulatory Authority requires otherwise, for which the Conducting Party will be the sponsor of record (the “Combined Therapy IND”).

  • If, after [***] of discussions following the Clinical Hold, either Party reasonably concludes that the issue is not solvable or that unacceptable and material additional costs/delays have been and/or will continue to be incurred in the conduct of the Combined Therapy Trial, then such Party may immediately terminate this Agreement.

  • For the avoidance of doubt, each Party shall be responsible for (x) drafting and updating as necessary the investigator’s brochure for its respective Single Agent Compound, and (y) filing all necessary Regulatory Documentation to the existing IND for its respective Single Agent Compound, including the submission to such existing IND of serious adverse event and adverse drug reaction cases emerging from any Combined Therapy Trial.

  • If requested by Nektar in writing, BioXcel shall provide a reconciliation between the cumulative amounts paid and the expenses recorded by BioXcel for the Combined Therapy Trial as reported under U.S. Generally Accepted Accounting Principles.

  • To the extent any provision set forth in the Pharmacovigilance Agreement conflicts with any provision in this Agreement, the provision set forth in the Pharmacovigilance Agreement shall control as related to the exchange and reporting of safety information associated with use of the products in a Combined Therapy Trial as well as product safety surveillance.

  • Expenses incurred as described in Article 4 (regarding Manufacturing and supply up to the point where the applicable BioXcel Compound or Nektar Compound arrives at the BioXcel labeling and distribution facility for the applicable Combined Therapy Trial), and Article 6 (regarding intellectual property) shall be borne or shared by the Parties as provided in such Articles.

  • The Conducting Party will provide the Non-Conducting Party in writing with a list of all countries participating in a Combined Therapy Trial prior to study start Initiation of such Combined Therapy Trial.

Related to Combined Therapy Trial

  • Step therapy means a protocol or

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

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

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

  • 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.