Certain Minimum Payments Clause Samples

Certain Minimum Payments. In the event that within three --------------------------------------- (3) years after the date first above written ▇▇▇▇▇▇▇ fails to submit to the FDA a completed NDA for the Licensed Product, ▇▇▇▇▇▇▇ shall be obligated to pay to Hydro Med, as non-refundable advances against the percentage royalties, the sum of $41,666.66 (the AAdvance Amount@) on the first day of each calendar month beginning after the expiration of such three (3) year period (such three (3) year period as the same may be extended pursuant to this Section 4.03 is the ANDA Submission Period@) and continuing until such NDA is submitted to the FDA, after which submission this obligation shall cease. All amounts paid to Hydro Med under this Section 4.03 shall be credited against the amounts due under Section 4.01 above. If the FDA requires two or more phase III clinical studies, or two or more treatment cycles of one or more phase III studies, with respect to the Licensed Product the NDA Submission Period shall be extended from three (3) years to four (4) years and ▇▇▇▇▇▇▇ shall not be obligated to pay any Advance Amount to Hydro Med until the first day of each calendar month beginning after the expiration of such four (4) year period. Any payment to be made by ▇▇▇▇▇▇▇ to Hydro Med pursuant to this Section 4.03 shall be conditioned upon Hydro Med having supplied ▇▇▇▇▇▇▇ with a completed Chemistry, Pharmacy and Controls Section of the NDA which can be submitted to the FDA as part of the aforesaid completed NDA. Notwithstanding any provision to the contrary contained herein, if the FDA requires substantial additional studies to be conducted with respect to the Licensed Product prior to authorizing the commencement of a phase III clinical study for the Licensed Product, the NDA Submission Period shall not be deemed to commence for the purposes of this Section 4.03 until the date on which the FDA authorizes the commencement of such phase III clinical study.