Registration Enabling Clinical Trial definition

Registration Enabling Clinical Trial means (a) a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c), as amended, and is intended to (i) establish that the product is safe and efficacious for its intended use, (ii) define contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (iii) support Regulatory Approval for such product, or (b) a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
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Registration Enabling Clinical Trial means a human clinical trial conducted on sufficient numbers of patients for the principal purpose of definitively establishing that a drug is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed upon approval, and to provide pivotal data enabling marketing approval by the FDA of such drug or label expansion of such drug. Nothing in this Agreement shall obligate Parent or the Surviving Corporation to seek, file or take any action in respect of any Special Protocol Assessment or any NDA (or BLA, if applicable).
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Registration Enabling Clinical Trial means a human Clinical Trial that satisfies at least one of the following criteria (regardless of whether such trial is referred to as a “phase 1 clinical trial”, a “phase 2 clinical trial”, a “phase 2b clinical trial” or a “phase 3 clinical trial”):
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Examples of Registration Enabling Clinical Trial in a sentence

  • If at any time during the License Term after completion of the ongoing Phase 2 Clinical Trial of RX-3117 in combination with Abraxane® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the Lead Indication, Rexahn desires to move forward with a global Registration Enabling Clinical Trial for RX-3117 for the Lead Indication, then Rexahn shall provide Biosense with written notice thereof (the “ Lead Indication Notice”).

  • Any notice of termination pursuant to this Section 12.5 must be delivered to Rexahn within [***] days of the availability of the initial tables and listings for the relevant Registration Enabling Clinical Trial.

  • Upon completion of any Registration Enabling Clinical Trial in the Territory for an Additional Indication described in Section 4.4.4 above, Biosense shall provide Rexahn with written notice thereof, which shall include a copy of the material data arising from such Registration Enabling Clinical Trial (the “Data Notice”).

  • Notwithstanding the foregoing, Section 4.4.1 sets forth the Parties’ agreement on the allocation of costs and expenses with respect to a global Registration Enabling Clinical Trial for RX-3117 for the Lead Indication and no further written agreement with respect thereto shall be required.

  • Relative Shill Ranking: Identification Errors NotesThe histograms on the left-hand side show the score’s or, respectively, the ranking’s distribution for shill bidders and honest bidders.


More Definitions of Registration Enabling Clinical Trial

Registration Enabling Clinical Trial means (a) a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c), as amended, and is intended to (i) establish that the product is safe and efficacious for its intended use, (ii) define
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Registration Enabling Clinical Trial means (a) a human clinical trial of a product that would satisfy the requirements of
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Registration Enabling Clinical Trial means (a) a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c), as amended, and is intended to (i) establish that the product is safe and efficacious for its intended use, (ii) define [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (iii) support Regulatory Approval for such product, or (b) a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than in the United States.
Sample 1
Registration Enabling 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(c), as amended, or a similar clinical study prescribed by the EMA in the EU [**].
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Registration Enabling Clinical Trial means a Clinical Trial of a product in any country in the world that (a) satisfies the requirements of U.S. 21 C.F.R. Part 312.21(c), as amended, or its foreign counterpart as prescribed by the applicable Regulatory Authority, or (b) is intended, or otherwise acknowledged by the FDA or its foreign counterpart, to (i) provide substantial evidence, as defined at 21 U.S.C. Section 355(d), that the product is safe and efficacious for its intended use, (ii) define contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (iii) support Marketing Approval for such product without the need to conduct additional Clinical Trials.
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Registration Enabling 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(c), as amended, or a similar Clinical Trial prescribed by the EMA in the EU or the MHLW in Japan, and is intended to (a) establish that the product is safe and efficacious for its intended use; (b) define contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed; and (c) support Regulatory Approval for such product without the need to conduct additional Clinical Trials.
Sample 1
Registration Enabling 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(c), as amended, or a similar Clinical Trial prescribed by the EMA in the EU or the MHLW in Japan, and is intended to (a) establish that the product is safe and efficacious for its intended use; (b) define contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed; and (c) support Regulatory Approval for such product without the need to conduct additional Clinical Trials.
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