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.
Celera, at its expense at AMI’s direction and to AMI’s satisfaction, will prepare Material Safety Data Sheets (“MSDSs”) and generate any other information and documentation related to Celera Product safety, including but not limited to physical, chemical, and biological characteristics of each of the Celera Products that AMI reasonably requests as needed for addressing safety issues related to each Celera Product.
Celera will immediately notify AMI and follow-up with a written notification of any lot failure, manufacturing problems or similar issues of which Celera is actually aware, that may impact AMI’s ability to distribute Celera Product to its customers.
AMI for itself and its Affiliates will initially pay to Celera the Estimated Purchase Price for each Specific Celera Product, calculated as set forth in this Section 3.2. AMI will determine the difference, if any, between the Actual Purchase Price and the Estimated Purchase Price of each Specific Celera Product pursuant to the procedures set forth in this Section 3.2 and Section 3.9. Any over payment or under payment by AMI will be reconciled pursuant to Section 3.11.
Celera will maintain a safety stock of the following Specific Celera Product components: rare reagents, such as nucleic acid primers and probes (collectively, the “Components”) in a quantity equivalent to AMI’s forecasted purchases for Specific Celera Products for the immediately succeeding [*] ([*]) month forecast period.
AMI will notify Celera in writing of the results of an inspection or audit to the extent involving any Celera Product promptly after such inspection or audit has occurred.
In the event any customer of AMI rejects or returns a Specific Celera Product to AMI as a result of performance problems or other deficiencies that are the result of noncompliance of any Celera Product with the Specifications or the failure by Celera to satisfy any of its responsibilities under this Agreement, the Parties will handle the matter in accordance with Section 4.8.