Phase 2b Clinical Trial definition

Phase 2b Clinical Trial means any human clinical trial conducted in the United States on a sufficient number of patients the primary purpose of which is to make a preliminary or qualitative determination of efficacy of a Product in the patients being studied for the dosage regimes indicated in the related Phase 2a Clinical Trial as required under 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, a similar clinical trial.

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Phase 2b Clinical Trial means, as to a specific pharmaceutical product, a Clinical Trial of the feasibility, safety, dose ranging and efficacy of such product, that is prospectively designed to generate sufficient data (if successful) to commence a Phase 3 Clinical Trial (or foreign equivalent) of such product, as further defined in 21 C.F.R. 312.21(b) or the corresponding regulation in jurisdictions other than the United States. A Phase 2B Clinical Trial shall be deemed initiated upon the dosing of the first patient.

Phase 2b Clinical Trial means a study of a Licensed Product in the Field in human patients to determine initial efficacy, pharmacological effect, or dose range and/or regimen finding before embarking on Phase 3 Clinical Trial, as further defined in 21 C.F.R. 312.21(b), as amended from time to time, or the corresponding foreign regulations.

Examples of Phase 2b Clinical Trial in a sentence

• If Dermira has not completed a Phase 2b Clinical Trial for a Dermira Product, Maruho will have the right to offer Dermira the negotiation with respect to the license of such Dermira Product in the Specified Territories at any time prior to the exercise, expiration or termination of the ROFN Rights for such Dermira Product.

• For example, if Regulatory Approval for a Licensed Product is approved based on a Phase 2b Clinical Trial without a Phase 3 Clinical Trial, then upon Regulatory Approval, both the Regulatory Approval milestone and the initiation of a Phase 3 Clinical Trial milestone will be paid.

• At the time it issues the Phase 2b Completion Notice, Dermira will also physically or electronically deliver to Maruho, or provide Maruho access via secure electronic data room (any such delivery method, “make available,” and “made available” shall have a corresponding meaning) all material data related to Dermira’s development of such Dermira Product, including from such Phase 2b Clinical Trial, that Dermira then possesses (the “Phase 2b Data Package”).

• Successful completion of the first Phase 2b Clinical Trial $ 20,000,000 3.

• Purchaser hereby grants Seller an option for an exclusive, royalty-bearing license under the Purchaser 806 Patents to make, have made, use, sell, offer for sale and import, in all territories outside the United States and Canada, the first of either (i) the 806 Product or (ii) a Back-Up 806 Product successfully to complete a Phase 2b Clinical Trial for prevention or treatment of HIV infection (the “Option”).

More Definitions of Phase 2b Clinical Trial

Phase 2b Clinical Trial means a human clinical trial performed in accordance with the Applicable Laws in patients with a particular disease or condition which is designed to assess the safety, dose ranging and efficacy of a pharmaceutical product to confirm clinical efficacy of a drug and determine the therapeutic dose range and may include such a clinical trial intended to be a Pivotal Trial. Any Phase 2 Clinical Trial of a Product in an indication that is the second Phase 2 Clinical Trial of such Product in such indication shall be deemed to be a Phase 2b Clinical Trial.

Phase 2b Clinical Trial means any Phase 2 Clinical Trial of a Licensed Product that is intended to enable a Phase 3 Clinical Trial and is conducted to provide a preliminary determination of safety and efficacy of such Licensed Product in the target patient population over a range of doses and dose regimens.

Phase 2b Clinical Trial means a Phase 2 Clinical Trial that is designed in such a way as to provide efficacy and safety information about a Program Product that, alone or with other Phase 2b Clinical Trials, would be reasonably intended to lead to an End-of-Phase 2 (EOP2) meeting with the FDA, or an equivalent meeting with any Regulatory Health Authority, or a subsequent Phase 3 Clinical Trial, even if such EOP2 meeting or Phase 3 Clinical Trial does not occur.

Phase 2b Clinical Trial means any Phase 2 Clinical Trial on sufficient numbers of patients that is designed to establish dosing parameters of the Licensed Product.

Phase 2b Clinical Trial means, with respect to the United States, a clinical trial of a product, designed to support and precede the Initiation of a Phase 3 Clinical Trial program, on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such product in the target patient population over a range of doses and dose regimens, as described under 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, an equivalent clinical trial.

Phase 2b Clinical Trial means the first human clinical trial of a Royalty-Bearing Product conducted mainly to determine whether to conduct a Phase 3 Clinical Trial.

Phase 2b Clinical Trial means a clinical trial generally consistent with 21 CFR §312.21(b) that is required for receipt of clearance or marketing authorization of a Licensed Product from the applicable Regulatory Authority and which is conducted to assess the optimal manner of use of such a Licensed Product (dose and dose regimens) for a particular indication or indications in patients with the disease or condition under study.