Supplied Item definition
Examples of Supplied Item in a sentence
Cardiome shall have the sole responsibility for processing Supplied Item returns in the Territory.
In addition, the Initial Forecast shall separately specify: (i) Cardiome’s good faith estimate of the Launch Quantity; and (ii) Cardiome’s good faith estimate of the number of Non-Commercial Units of each Supplied Item required for delivery during the Launch Period, provided that the aggregate number of Non-Commercial Units of a Supplied Item for the Launch Period shall not exceed the JSC-approved quantity of such Supplied Item.
In no event shall Cardiome or any of its Affiliates, directly or indirectly, make or cause to be made any admission or acknowledgment, whether orally, in writing or otherwise, that the manufacture, use, sale, offer for sale or import of any Supplied Item in the Territory infringes or may infringe, or otherwise is or may be within the scope of, such Third Party’s Patent.
The Parties shall, to the extent practicable, endeavor to discuss and agree upon whether to recall or withdraw such Supplied Item in the Territory; provided that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then such recall or withdrawal shall be undertaken.
SteadyMed shall notify, or shall cause the applicable Contract Manufacturer to notify, Cardiome immediately in writing in the event any action is taken or threatened by FDA or any Regulatory Authority in a Major Market relating to the Manufacture of a Supplied Item or to the applicable Manufacturing Facility that, in each case, would reasonably be expected to impair the ability of SteadyMed to Manufacture, or have Manufactured, and supply such Supplied Item in accordance with this Agreement.
To the extent that it is necessary or appropriate to communicate with any person in the Territory, including any Regulatory Authority, the media or any customer, concerning any recall, withdrawal, other remedial action, event, incidence or circumstance concerning a Supplied Item in the Territory, as between the Parties, Cardiome shall be responsible for such communication.
Notwithstanding the above, Cardiome may export, reexport, or transfer any Supplied Items as permitted by Applicable Law or based upon specific or general licenses allowed by Applicable Law at the export, reexport or transfer of the Supplied Item.
If any Regulatory Authority issues or requests a recall or takes similar action in connection with a Supplied Item in the Territory, or a Party decides that a recall or withdrawal of a Supplied Item in the Territory is necessary, Cardiome shall be responsible for conducting such recall or withdrawal in the Territory in accordance with Applicable Law, the requirements of the applicable Regulatory Authority, and SteadyMed’s instructions.
Any change to the Specifications for a Supplied Item will require the mutual written agreement of the Parties.
Each such Forecast shall otherwise be non-binding, except as provided below, but shall reflect Cardiome’s good faith expectation (at the time of submitting the Forecast) of the orders of Supplied Item to be delivered during the Forecast period.