Phase 1 Clinical Trial definition

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.

Phase 1 Clinical Trial means, as to a specific Licensed Product, a human clinical trial of a product in any country designed to satisfy the requirements of 21 C.F.R. §312.21(a) as amended from time to time, and intended to determine metabolism and pharmacologic actions of a drug in humans, the side effects associated with increasing doses and, if possible, to gain early evidence of efficacy, or any comparable trial under applicable Laws in the United States or the corresponding regulation in jurisdictions other than the United States.

Phase 1 Clinical Trial means, as to a specific Licensed Product or Licensed Service, a study as described in 21 C.F.R. §312.21(a) or a comparable clinical study in a country other than the United States.

Examples of Phase 1 Clinical Trial in a sentence

• Subject to the terms of this Agreement, and no later than three (3) months prior to the initiation of the first Phase 1 Clinical Trial, Ambrx and BMS (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall enter into a written agreement setting forth the responsibilities of the Parties to protect patients and promote their well-being in connection with the use of the Compounds and Products (the “Safety Data Exchange Agreement” or “SDEA”).

• Upon request by BMS, Ambrx will use Diligent Efforts to obtain from its Third Party manufacturers the supply of Raw Materials reasonably requested by BMS for use by BMS in the manufacture of Compound prior to the initiation of a Phase 1 Clinical Trial for Product, provided that BMS shall be responsible for reimbursing Ambrx for its Third Party Costs incurred in connection with such supply of such Raw Materials.

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• If a Phase 1 Clinical Trial is conducted for a Development Candidate in a given Program, within [***] ([***]) days after Data Lock for the applicable Clinical Trial ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the Phase 1 Data Package for such Program.

• Under the Research Program, the Parties will work collaboratively to (i) continue and complete IND-enabling pre- clinical studies for ARX618, (ii) conduct a Phase 1 Clinical Trial for ARX618 and (iii) prepare for the initiation of a Phase 2 Clinical Trial for ARX618 concurrently with the conduct of such Phase 1 Clinical Trial (the “Initial ARX618 Program”).

More Definitions of Phase 1 Clinical Trial

Phase 1 Clinical Trial means a human clinical trial of a product in any country as described in 21 C.F.R. 312.21(a), or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

Phase 1 Clinical Trial means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a).

Phase 1 Clinical Trial means the initial clinical testing of a Product in humans (first-in-humans study) with the intention of gaining a preliminary assessment of the safety of such Product.

Phase 1 Clinical Trial means a clinical development program in any country that generally provides for the first introduction into humans of a pharmaceutical product candidate with the primary purpose of which is preliminary determination of safety, metabolism and pharmacokinetic properties and clinical pharmacology of such pharmaceutical product candidate in healthy patients, or otherwise generally consistent with U.S. 21 C.F.R. §312.21(a).

Phase 1 Clinical Trial means a clinical trial as defined in 21 C.F.R. 312.21(a), as may be amended from time to time, or any foreign equivalent thereto.

Phase 1 Clinical Trial means any human clinical trial of a Product that would satisfy the requirements of 21 § CFR 312.21(a) or corresponding foreign regulations.

Phase 1 Clinical Trial means, as to a specific pharmaceutical product, a Clinical Trial in humans of the safety of such product in healthy volunteers or a limited patient population, or human clinical studies directed toward understanding the mechanisms or metabolism of the product. A Phase 1 Clinical Trial shall be deemed initiated upon the dosing of the first subject or patient.