MAD Study definition

MAD Study means a first clinical study involving multiple ascending doses in patients, assessing the pharmacokinetics and pharmacodynamics of the Compound as a single agent including safety and tolerability.
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MAD Study means the [* * *]
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MAD Study means the Phase I Clinical Trial [***] originally designed by [***] and subject to modification by the JDCC to evaluate the safety, pharmacokinetics, [***] and [***] of [***] of ITMN-191 in patients with [***].
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Examples of MAD Study in a sentence

  • Notwithstanding anything herein to the contrary, any costs of the first Phase 1 MAD Study for which Agios is paid the Phase I Amount shall not be included in the Development Costs under this Section 9.4(a).

  • Subsequent to the earlier of the MTD Determination or the Option Exercise Date, Celgene shall be responsible for bearing one hundred percent (100%) of the Development Costs for remaining phase(s) of such Phase I MAD Study that (A) are incurred for any such Phase I MAD Study and (B) are within [****] percent ([****]%) of the approved Development Budget under the Development Plan for such Phase I MAD Study.

  • Section 4.1(h) is hereby amended to append the following phrase at the end of the sentence: except to the extent such Manufacturing Costs are included in Development Costs payable by Celgene pursuant to Section 9.4(a)(ii) in connection with a Phase I MAD Study or additional activities performed by Agios pursuant to Section 3.6(b)(iii)(A)(2)”.

  • Section 2.4(a) is hereby amended to add the following to the end of such section: In addition, if Celgene requests that Agios perform any Phase I MAD Study and additional activities pursuant to Section 3.6(b)(iii)(A)(2) with respect to a Development Candidate, the JDC shall have oversight over such Phase I MAD Study and such additional activities for such Development Candidate (and the related Discovery Program).

  • For clarity, Celgene shall not be responsible for the Phase I Amount or the Development Costs of any Phase I MAD Study conducted by Agios, pursuant to Section 3.6(b)(iii)(A)(2)), with respect to any Split Program.

  • Notwithstanding anything herein to the contrary, any costs of the first Phase I MAD Study conducted by Agios, pursuant to Section 3.6(b)(iii)(A)(2)), shall not be included in the Development Costs under this Section 9.4(a)(i) but shall be addressed by Section 9.4(a)(ii).