Filled Product definition
Examples of Filled Product in a sentence
Savient QA will be responsible for the review of the manufacturing batch record for Filled Product, review of the Certificate of Analysis and Release of the Filled Product.
Savient will use its best efforts to effectuate the Technology Transfer of Product Technology to enable such Filled Product release testing to be performed by Savient’s Third Party Fill/Finisher or its alternate Product supplier as expeditiously as commercially practicable, and upon the approval of such amendments to this Agreement, and, if still in effect at such time, the Development Agreement shall be entered into relieving BTG of its obligation to perform release testing on Filled Product.
The Parties acknowledge that BTG is performing the Filled Product release testing for Savient under the terms of this Agreement and the Development Agreement until such time as the Filled Product release testing and methods can be transferred to Savient’s new third party fill/finisher of Product (hereinafter “Third Party Fill/Finisher”) or alternate Bulk Product or Product supplier.
If the parties disagree, samples of both the Filled Product in question and the corresponding retention sample shall be submitted to a mutually acceptable independent laboratory for resolution of the disagreement in accordance with the provisions of Section 5.4(d).
If such independent laboratory determines that such Filled Product is not stable during its Remaining Shelf-life, and such instability is not a result of Chiron's mishandling of such Filled Product (including improper storage thereof or any other actions taken by Chiron described in Section 9.1(b)), then such Filled Product shall be considered Defective Manufactured Product for purposes of Article 5 of this Supply Agreement.
Notwithstanding anything to the contrary set forth in this Section 8.1, in no event shall Cubist be required to supply Chiron with units of Filled Product for the [*] following Commercial Launch of Licensed Product in the first country in the Territory in an amount greater than [*] of the quantity of all units of such Filled Product available to Cubist for allocation to all parties under this Section 8.1 at such time.
The Parties shall mutually agree in writing (such agreement not to be unreasonably delayed or withheld), on a timely basis, on applicable API Specifications, Filled Product Specifications and Packaging Specifications that meet the requirements of the Regulatory Authorities and the Applicable Laws of each country in which Finished Products are to be sold.
Chiron may reject any Non-Conforming Product by delivering written notice thereof to Cubist within [*] of Chiron's receipt of (a) pre-shipment samples and the related Lot Documentation Package, in cases in which Chiron has requested and received pre-shipment samples pursuant to Section 5.1, or (b) ordered Filled Product and related Lot Documentation Package, in cases in which Chiron has not requested and received pre-shipment samples of ordered Filled Product.
Cubist or the Cubist Supplier shall retain a sample of Filled Product for each Lot included in each shipment.
At Kiniksa’s request, to the extent Product is supplied in Filled Product form, Regeneron shall request that its Third Party Fill/Finish Provider package and label such Filled Product in accordance with Kiniksa’s instructions and shall use reasonable efforts to facilitate the transfer of Kiniksa’s packaging and labeling instructions to such Third Party Fill/Finish Provider.