Insys definition
Examples of Insys in a sentence
Insys has developed the ANDA for the Product, as defined below, which it will have manufactured under a separate contract by Catalent Pharma Solutions, Inc.
Insys shall own and maintain at its own cost all ANDAs and associated regulatory filings made in the Territory for the Product, or for any alternate version of the Product that Insys may develop and have approved during the term hereof.
Insys shall pay to Mylan a Distribution and Storage Fee in the amount of […***…].
However, Insys shall not be responsible for failure to supply the Product(s) at the agreed timeline if the same is due to the existence of Force Majeure conditions.
During the Term of this Agreement, if at any time Insys desires to market the Product in any other territory in addition to the Territory as defined herein, Mylan shall have the right of first refusal to market the Product in the new territory or territories.
The decision when and whether to launch the Product in the Territory shall be made jointly by Insys and Mylan, acting through the JSC.
Insys agrees that it shall provide Mylan’s inspectors with unfettered access to all of the facilities and information related to all of the facilities, in order that the inspectors may carry out the inspections or inquiries referred to in the provisions of this Article.
In the event that a cure period relevant to a breach by Insys is extended beyond the forty-five (45) calendar day period as set forth in the previous sentence, then Mylan shall have the right to use alternative site(s) for the manufacture of the Product subject to the provisions of Section 4.4 of this Agreement.
For any such failure to supply, Insys shall be liable for: (a) […***…]; (b) the cost of delivery to Mylan by air freight, if required to meet Mylan’s commitments to its customers; and (c) any third party customer penalties levied against Mylan arising from its failure to supply Product(s) in accordance with binding purchase orders, subject to receipt by Insys of appropriate evidence thereof.
If Mylan determines that the Product does not conform to the Specifications, it shall immediately notify Insys.