Product Approval. Notwithstanding the terms set forth above, Client shall use its best efforts to expedite and obtain all regulatory approvals necessary for Catalent to commence production at the Facility (“Regulatory Approvals”).
Product Approval. Notwithstanding the terms set forth above, Indivior shall use its best efforts to expedite and obtain all regulatory approvals necessary for Curia to commence production at a Facility, as applicable ("Regulatory Approvals").
Product Approval. If any Regulatory Approvals in the United States necessary for Catalent to commence Processing at the Facility have not been obtained by Client by the Regulatory Approval Target Date, then Client shall pay to Catalent the monthly fee as provided in Attachment D (“Delayed Approval Fee”) until the earlier of (A) the date this Agreement is terminated by a party pursuant to this Section 7.3 or (B) the date such Regulatory Approval has been obtained. If such Regulatory Approval has not been obtained within [**] following the Regulatory Approval Target Date, then Client and Catalent shall each have the right to terminate this Agreement pursuant to Section 16.2(C).
Product Approval. .1 Bidders are required to provide submittals indicating compliance with this specification. Submit test reports from approved independent testing laboratories, certifying compliance with reference standards.
Product Approval. University shall have the right to review any and all products of the associated with the Permitted Uses and reserves the right to reject and disallow Facility User’s use or distribution of any and all content that denigrates the quality or reputation of the university, faculty, staff, students or degrees in anyway.
Product Approval. If any Regulatory Approval necessary for Catalent to commence Processing at the Facility has not been obtained by Client within 12 months following the Effective Date, then Client shall pay to Catalent a fee as provided in Attachment C (“Delayed Approval Fee”) until such Regulatory Approval has been obtained and Catalent is able to commence Processing.
Product Approval. Within the Territory, Abbott shall exercise its Reasonable Best Efforts to maintain Product Approval of Norvir and to file, obtain and maintain Product Approval of ABT-378, and shall bear the full cost and expense thereof. Abbott shall keep Triangle generally apprised with respect to its regulatory activities in the Territory. Abbott shall control all decisions regarding its regulatory activities in the United States.
Product Approval. “Product Approval” shall mean final FDA approval of Discovery Labs New Drug Application (“NDA” or “ANDA”) or other Regulatory Documentation.
Product Approval. “Product Approval” shall mean final approval by FDA of OMEROS’ NDA or ANDA for marketing of Product or analogous approval(s) from other Regulatory Authorities, as applicable.
Product Approval. Valneva shall ensure all Regulatory Filings and obtain and maintain, at its own cost and risk, all Regulatory Approvals needed for the Product, the Services which are particular to the Product and/or required in accordance with the Legal Requirements. Valneva shall not distribute or otherwise use the Product without first securing such Regulatory Approvals. Xxxxxx shall cooperate and make every commercially reasonable effort, at the cost and/or expense of Valneva, to provide such information and other Assistance as Valneva may reasonably request in connection with such Regulatory Filings and Regulatory Approvals, all in accordance with and subject to the terms of the Quality Agreement. If approvals by regulatory authorities are needed for the Manufacture (other than set forth in Section 7(2)), all risks, costs and/or expenses thereof shall be borne by Valneva and neither Xxxxxx nor any of its Affiliates shall pay for or warrant such approvals.
