ARRY-403 Sample Clauses

ARRY-403. It is understood that, prior to the Effective Date, Array has been proceeding with development activities with respect to ARRY-403, including the filing of an IND (the “Initial IND”), the completion of a Phase I single-rising dose clinical trial (the “403 SAD”), the initiation of a Phase I multiple-rising-dose clinical trial (the “403 MAD”) and the initiation of a bioequivalence trial (the “403 Bioequivalence Trial”). Array shall use Commercially Reasonable Efforts to complete, and be responsible, at its own cost, for completion of, the 403 MAD and the 403 Bioequivalence Trial in compliance with the Global Development Plan, Law and common standards of pharmaceutical practice. Array shall comply with each of the following: (i) during each of the 403 MAD and the ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ shall provide Amgen with all safety data arising from such trial as soon as reasonably practicable (but in no event later than 24 hours for reportable safety data and 3 business days for other safety data, in each case after first becoming aware of such safety data); and (ii) during each of the 403 MAD and the ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ shall provide Amgen with all pharmacokinetic and pharmacodynamic data, and any other data requested by Amgen, arising from or related to such trial as soon as reasonably practicable (but in no event later than 5 business days after first receiving such data, or after receiving such request, as applicable).