Common use of TKT Responsibilities Clause in Contracts

TKT Responsibilities. TKT will be responsible for obtaining and maintaining all necessary regulatory approvals for the distribution and sale of Product. Additionally, TKT will be responsible for all other regulatory requirements which are not specifically assigned to CBL in this Agreement, including the payment of any FDA user fees or other fees associated with the review and approval to market the Product imposed by any regulatory agency. TKT will be responsible for maintaining claim files and for submitting appropriate reports to the FDA and other similar foreign regulatory agencies. TKT will be further responsible for promptly notifying CBL of all communications from the FDA or other regulatory agencies, which may impact or change the production and/or testing of the Product as performed by CBL. TKT will notify CBL of any consumer complaints concerning Product, which might reasonably be attributed to CBL’s obligations and warrants, within seven (7) days of receipt by TKT of any such complaints. All such information disclosed to CBL shall be considered confidential information under Section 9 below.

Appears in 2 contracts

Sources: Commercial Supply Agreement (Transkaryotic Therapies Inc), Commercial Supply Agreement (Transkaryotic Therapies Inc)