Celera Product definition
Examples of Celera Product in a sentence
AB will provide Celera access to documentation under AB’s control reasonably required for Celera Product regulatory registration (subject to AB’s reasonable confidentiality requirements), provided that any such registration will not impose any duties or requirements on AB or require AB to take any action except to permit regulatory inspections as and to the extent expressly set forth in Section 11.3 of this Agreement.
AB will maintain all material records documenting the manufacture, testing and shipment of the Products supplied to Celera (“Celera Product Documents”) for a period of five years following the shipment of the Celera Products to Celera or its designee; provided, however, that AB will notify Celera prior to destruction of any Celera Product Documents and send them to Celera, at Celera’s cost, if so requested.
Intermediates and Raw Materials will be deemed to be and will be components for further manufacturing, and Celera will be deemed to be and will be the finished device manufacturer, or the manufacturer of any Celera Product that is a diagnostic product, within the meaning of the U.S. Food and Drug Administration (“FDA”) laws, rules and regulations and foreign laws, rules and regulations governing the manufacture, sale and distribution of diagnostic and other medical devices.
AB will allow Celera to review such Celera Product Documents during any site inspection conducted under the terms of this Agreement and at other reasonable times at the request of Celera, in all cases subject to AB’s reasonable health and safety, security, and confidentiality requirements.
In conjunction with the marketing and promotion of Celera Products, AMI may distribute a limited amount of Specific Celera Products to customers or prospective customers at no charge (“Free Products”) as an introduction to a New Celera Product that has been accepted by AMI pursuant to Section 2.13(a) or an introduction of a new customer to Celera Products, consistent with the overall free product policy of AMI in connection with the sale of its other Molecular Diagnostic Products.
If AMI accepts the offer to distribute the Celera Pipeline Product, such product will be a Celera Product hereunder.
Upon AMI’s reasonable request, Celera representatives will meet with AMI representatives at mutually agreed times and places regarding the completion of the international Celera Product master file data generation and submission.
Celera will make a good faith effort to notify AMI promptly after Celera determines that the average Estimated Purchase Price for a Celera Product Group is within five percent (5%) of Celera’s Fully Loaded Product Cost plus the applicable percentage rate as determined in Section 3.2(c).
If Celera reasonably believes it requires more than sixty (60) days to deliver such replacement Specific Celera Product, Celera will request AMI’s prior written approval for a reasonable extension of the replacement date, which will not be unreasonably withheld.
In the event of such claim or shortage that is verified by Celera, AMI’s sole and exclusive remedy will be replacement of the Specific Celera Product or make up of the shortage within sixty (60) days after receiving such notice, at no additional cost to AMI.