Phase Ia Trial definition

Phase Ia Trial means the clinical trial activities contemplated under the Pre-Option Development Plan or an initial clinical trial of a Product under this Agreement that: (a) is a first-in-humans trial on subjects who are healthy volunteers or patients; (b) is for the purposes of establishing initial safety, tolerability, pharmacokinetic and pharmacodynamic Information for the Product; (c) exposes subjects to a single dose of the Product; and (d) is designed to provide the sponsor of the clinical trial with sufficient Information about the Product to initiate a Phase Ib Trial.
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Phase Ia Trial means a human clinical trial of a compound, the principal purpose of which is a preliminary determination of safety, pharmacokinetics, and pharmacodynamic parameters in healthy individuals or patients, as described in 21 C.F.R. 312.21(a), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.
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Phase Ia Trial means the second phase in the Committee Litigation at which various parties will litigate, if necessary, the solvency of each individual Debtor, and any related or appropriate remedy as a result, all as described in the Committee Litigation Management Order.
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Examples of Phase Ia Trial in a sentence

  • Licensee shall have the right (through the JDT after the JDT is formed), to review and provide comments on Development activities with respect to the Relay Phase Ia Trial and to withhold approval of any Development activities that may, in Licensee’s good faith belief, conflict with, or have a negative impact on, Licensee’s Development activities with respect to Licensed Candidates or Licensed Products (including Licensee’s activities under the Global Development Plan during an Opt-In Term).

  • Relay will also provide notice to Licensee and the opportunity to review and approve any decision for which Licensee has final decision making rights with respect to the Relay Phase Ia Trial under Section 10.7.3(b).

  • Relay will continue to conduct the Relay Phase Ia Trial in accordance with accepted pharmaceutical industry norms and ethical practices and in accordance with the Relay Phase Ia Plan as disclosed to Licensee prior to the Execution Date.

  • Such report will specify in reasonable detail (including supporting documentation, as appropriate) all amounts included in such Relay Phase Ia Trial CRO Costs during such Calendar Quarter.

  • This Section 6.3 will apply to the conduct of the Relay Phase Ia Trial.

  • Except as set forth in Sections 3.3.2 and 3.4.2, (a) Relay will be responsible for [***] up to the Relay IND Transfer Date, (b) after the Relay IND Transfer Date, [***], and (c) otherwise each Party shall bear its own costs and expenses in performing its responsibilities and activities with respect to the Relay Phase Ia Trial.

  • Anytime after the Relay IND Transfer Date, notwithstanding anything in the foregoing, if Licensee may request by written notice to Relay that the conduct of the Relay Phase Ia Trial be transferred to Licensee, in whole or in part, such that Licensee has the sole right and responsibility for the conduct of such transferred Relay Phase Ia Trial.

  • To the extent any Relay Phase Ia Trial Data is in the possession of a Third Party, Relay shall deliver any necessary instruments, including any letters of authorization and transfer of ownership, to such Third Party to grant Licensee the right to have transferred such Relay Phase Ia Trial Data from such Third Party and to document and to transfer any such Relay Phase Ia Trial Data from Relay to Licensee.

  • Concurrently with or after delivery of such report, Relay will deliver an invoice to Licensee for Licensee’s share of such Relay Phase Ia Trial CRO Costs.

  • As partial consideration for the licenses and other rights granted to Licensee hereunder, Licensee will pay to Relay, in accordance with Section 11.1.4, the non-refundable, [***] (the “Relay Phase Ia Trial Milestone”).


More Definitions of Phase Ia Trial

Phase Ia Trial means a Phase I Trial the principal purpose of which is: (a) preliminary determination of initial safety, tolerability, and pharmacokinetics in subjects; (b) exposes subjects to one or more dose(s) of the Licensed Product and (c) is designed to provide the sponsor of the clinical trial with sufficient information about the Product to initiate a subsequent trial, e.g., a dose expansion phase of the Phase I Trial (e.g., Phase Ib Trial). For clarity, [*].
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