Regulatory Liaison. USL shall be responsible for interfacing, corresponding and meeting with the FDA and other Regulatory Authorities in the Territory with respect to the Product. 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. Orion shall have the right to participate and cooperate in such meetings (and planning therefor), as may be appropriate and reasonable.
Appears in 4 contracts
Samples: Quality Assurance Agreement (Osmotica Pharmaceuticals PLC), Quality Assurance Agreement (Osmotica Pharmaceuticals LTD), Quality Assurance Agreement (Osmotica Pharmaceuticals LTD)
