Product NDAs definition
Examples of Product NDAs in a sentence
Following the Date of Agreement, USL shall oversee, monitor, control and coordinate all regulatory actions, communications and filings with and submissions, including filings and submissions to INDs and Product NDAs for Product, and any supplements and amendments thereto, to the FDA and other Regulatory Authorities in the Territory with respect to all Product.
USL shall be responsible for diligently compiling and preparing all Product NDAs for the Territory and seeking, obtaining and maintaining Regulatory Approval for the Product in the Territory in accordance with the terms and conditions of this Agreement.
The costs incurred by USL in compiling and preparing Product NDAs and any and all other regulatory documents for the Product in the Territory shall be considered part of USL’s Development Costs.
Without limiting the generality of the foregoing, USL will act as the Sponsor upon whom service of all processes, notices, orders, decisions, requirements, and other FDA communications shall be made with regard to all INDs and Product NDAs for the Product in the Territory.
Such authorization shall include the right of reference to such DMFs by all of the INDs and Product NDAs submitted under this Section 8.
Services will be scheduled and performed during regular business hours, Monday through Friday, 8:00 AM to 4:30 PM, excluding holidays.
Indevus hereby assigns to Esprit all right, title and interest in the Product NDAs, effective as of the NDA Transfer Date.
Seller has maintained the Product NDAs in accordance in all material respects with Laws and its normal business practices.
Abbott shall test Product lots (in any -------------------- strength) kept on stability for compliance with the applicable Product stability protocols contained in the Product NDAs. Abbott shall submit the data and records of any applicable investigations for review and approval by Anesta prior to incorporating such information into any internal or external reports.
Depomed shall have the right to request review and approve, with reasonable notice, any and all Regulatory Communications, Regulatory Approvals, and related regulatory documents that pertain to the Product NDAs before they are submitted to FDA or other Regulatory Authorities by Collegium or Newco.