Common use of Marketed Product Stability Samples Clause in Contracts

Marketed Product Stability Samples. Hospira shall, in accordance with SOPs, pull stability samples of Product and either (a) retain, store and test such stability samples in accordance with the Specifications, or (b) ship such stability samples to Omeros or a third party designated by Omeros in accordance with the Specifications. Hospira shall provide Omeros at least sixty (60) days advance written notice prior to disposition of any stability samples after specified storage times have elapsed, and Omeros shall provide instructions on disposal, continued storage or shipment of such samples at Omeros’ reasonable expense. Upon Omeros’ written request, Hospira shall provide stability testing of the Product in accordance with ICH guidance at a total cost of [†] (the “Stability Lot Price”) put up on stability testing in accordance with a time point matrix to be mutually agreed in writing and, upon such agreement, appended and incorporated into this Agreement as Exhibit C.. The Stability Lot Price shall be invoiced on a pro-rata basis for each stability time point completed. The Stability Lot Price is based on an assumed shelf life of [†], and should the shelf life increase or decrease the Stability Lot Price shall be adjusted proportionately.

Appears in 3 contracts

Samples: Commercial Supply Agreement (Omeros Corp), Commercial Supply Agreement (Omeros Corp), Commercial Supply Agreement (Omeros Corp)

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Marketed Product Stability Samples. Hospira shall, in accordance with SOPs, pull stability samples of Product and either (a) retain, store and test such stability samples in accordance with the Specifications, or (b) ship such stability samples to Omeros or a third party designated by Omeros in accordance with the Specifications. Hospira shall provide Omeros at least sixty (60) days advance written notice prior to disposition of any stability samples after specified storage times have elapsed, and Omeros shall provide instructions on disposal, continued storage or shipment of such samples at Omeros’ reasonable expense. Upon Omeros’ written request, Hospira shall provide stability testing of the Product in accordance with ICH guidance at a total cost of [†] (the “Stability Lot Price”) put up on stability testing in accordance with a time point matrix to be mutually agreed in writing and, upon such agreement, appended and incorporated into Exhibit C of this Agreement as Exhibit C.. The Agreement. Stability Lot Price shall be invoiced on a pro-rata basis for each stability time point completed. The Stability Lot Price testing is based on an assumed Product shelf life of [†], and should the Product shelf life increase or decrease the Stability Lot Price stability testing shall be adjusted proportionately.

Appears in 1 contract

Samples: Commercial Supply Agreement (Omeros Corp)

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