Combined Therapy Clinical Trial definition

Combined Therapy Clinical Trial means the human clinical trial using the Recipient Study Drug and the BMS Study Drug, which will be conducted under the Recipient’s protocol (said, protocol, as it may be amended from time to time in accordance with this Agreement, the “Protocol”) and is incorporated herein by reference. A draft Protocol summary as of the Effective Date is attached as Appendix A hereto. The draft Protocol shall be jointly agreed by the Parties as set forth in Section 2.1(a).
Sample 1Sample 2Sample 3
Combined Therapy Clinical Trial means the human clinical trial using the Recipient Study Drug and the BMS Study Drug, which will be conducted under the Recipient’s protocol (said, protocol, as it may be amended from time to time in accordance with this Agreement, the “Protocol”) and is incorporated herein by reference. The draft Protocol as of the Effective Date is attached as Appendix A hereto.
Sample 1Sample 2Sample 3
Combined Therapy Clinical Trial means the human clinical trial(s) using the TPT Study Drug and the EQRx Study Drug, which will be conducted under the Protocol.
Sample 1

Examples of Combined Therapy Clinical Trial in a sentence

  • It shall include the responsibility for quality elements as well as exchanged GMP documents and certifications required to release the BMS Study Drug for the Combined Therapy Clinical Trial.

  • In addition, the Supply and Quality Documentation shall detail the documentation required for each shipment of BMS Study Drug supplied to the Recipient or its designee for use in the Combined Therapy Clinical Trial.

  • The Supply and Quality Documentation shall outline the additional roles and responsibilities relative to the quality of BMS Study Drug in support of the Combined Therapy Clinical Trial.

  • Experimental Operations of a Multi-cell 805 MHz Open Cavity in approximately AxialMagnetic FieldsAn ionization cooling lattice had been designed that employed liquid hydrogen absorbers inside high field solenoids separated by lower field matching solenoids surrounding 6 cell, open iris, rf cavities.

  • The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial to the extent necessary.

  • Such records shall fully and properly reflect all work done and results achieved in the performance of the Combined Therapy Clinical Trial in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes.

  • Any such wind-down activities will include the return to BMS, or destruction, of all BMS Study Drug provided to the Recipient and not consumed in the Combined Therapy Clinical Trial, except in the event that the Recipient terminates this Agreement pursuant to Section 12.2 or 12.3, in which case the Recipient shall continue to have the right to use any BMS Study Drug provided to Recipient for the conduct of the Combined Therapy Clinical Trial.

  • BMS will provide the Recipient with country-specific customs valuations initially for the BMS Study Drug prior to initiation of the Combined Therapy Clinical Trial and at the end of each Quarter during the conduct of the Combined Therapy Clinical Trial.

  • The Recipient will manage all drug safety reporting activities for the Combined Therapy Clinical Trial.

  • The SI/ESM shall test the block instrument and the Last Stop Signal control, if any, for correct operation.

Related to Combined Therapy Clinical Trial

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • 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.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.