Phase 1 Clinical Trial definition

Phase 1 Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of Licensed Product or that would otherwise satisfy the requirements of 21 C.F.R. 312.21(a) or an equivalent clinical trial in a country in the Territory 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.

Phase 1 Clinical Trial means any Clinical Trial as described in 21 C.F.R. §312.21(a), or, with respect to a jurisdiction other than the United States, a similar Clinical Trial; [***].

Examples of Phase 1 Clinical Trial in a sentence

• If Xxxxxxx decides to exercise its Celgene Phase 1 Portion Participation Right, the Parties will coordinate in good faith the conduct of the PRX019 Phase 1 Clinical Trial, which may include, at Celgene’s written request, the transition of the conduct of the PRX019 Phase 1 Clinical Trial to Celgene or wind-down of the PRX019 Phase 1 Clinical Trial (in accordance with Applicable Law and ethical standards applicable to the PRX019 Phase 1 Clinical Trial).

• Within [***] days after Data Lock for the PRX019 Phase 1 Clinical Trial (or such earlier time as reasonably requested by Celgene in writing), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the Phase 1 Data Package.

• In the event that (i) Celgene exercises its Celgene Phase 1 Portion Participation Right, and (ii) Celgene completes the PRX019 Phase 1 Clinical Trial, then Celgene shall notify Prothena of Data Lock for the PRX019 Phase 1 Clinical Trial (such date of Data Lock is the “End of Phase 1 Date” (as such term is defined hereunder) regardless of the date of Xxxxxxx’s notice to Prothena thereof).

• Until completion of the PRX019 Phase 1 Clinical Trial, upon Celgene’s request, which shall not[***], Prothena shall prepare and provide to Celgene a summary of the following data and information related to the PRX019 Phase 1 Clinical Trial: (i) the number of patients screened; (ii) the number of patients enrolled; (iii) the number of patients dosed; and (iv) serious adverse events (as defined under the PRX019 Phase 1 Clinical Trial protocol), if any.

• As soon as possible, but in all cases within [***] after Data Lock for the PRX019 Phase 1 Clinical Trial, Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the final study report for the PRX019 Phase 1 Clinical Trial (which shall be prepared in accordance with customary practice that meets the standards of ICH Topic E3 of ICH Guidelines for Structure and Content of Clinical Study Reports dated July 1996).

More Definitions of Phase 1 Clinical Trial

Phase 1 Clinical Trial means human clinical trials, the principal purpose of which is preliminary determination of safety in healthy individuals or patients (for example, as described in 21 C.F.R. §312.21, or similar clinical study in a country other than the United States).

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 trial in any country conducted in a small number of human volunteers designed or intended to establish an initial safety profile, pharmacodynamics, or pharmacokinetics of a Product. For clarity, a Phase 1 Clinical Trial may include studies conducted in oncology patients.

Phase 1 Clinical Trial means a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(a) (as amended), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country, and is intended to (a) determine the safety, pharmacokinetics and pharmacodynamic parameters in healthy individuals or patients, and (b) following the foregoing clause (a), further evaluate safety and pharmacokinetics (including exploration of trends of a biomarker-based or clinical endpoint-based efficacy relationship to dose which need not be designed to be statistically significant) of the product, whether or not in combination with concomitant treatment and which provides sufficient evidence of safety to be included in filings for a Phase 2 Clinical Trial or a Registration Enabling Clinical Trial with Regulatory Authorities.

Phase 1 Clinical Trial means a controlled human clinical trial that would satisfy the requirements of 21 C.F.R. 312.21(a) or foreign equivalents thereof; “Phase 2 Clinical Trial” means a controlled human clinical trial that would satisfy the requirements of 21 C.F.R. 312.21(b) or foreign equivalents thereof; “Pivotal Clinical Trial” means (i) a human clinical trial of a Product that is intended to be a pivotal trial for obtaining Regulatory Approval (e.g., in the United States such clinical trial is conducted after the end of phase 2 meeting with the FDA) and to otherwise establish safety and efficacy in patients with the disease or condition being studied and to provide an adequate basis for physician labeling, for purposes of filing a MAA for Product, and that would satisfy the requirements under 21 C.F.R. 312.21(c) or foreign equivalents thereof, or (ii) any other clinical trial that is intended 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 trial is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for such product in the United States 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 clinical trial.

Phase 1 Clinical Trial means, as to a particular Licensed Product, a lawful study in humans of the safety and dose ranging of such Licensed Product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase 2 Clinical Trial of such Licensed Product.

Phase 1 Clinical Trial means the first lawful study in humans, conducted in accordance with 21 C.F.R. §312.21(a) (or the equivalent LAWS and regulations in jurisdictions outside the United States). [***] indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.