Common use of FDA Filings Clause in Contracts

FDA Filings. The Client shall have the sole responsibility for filing all documents with the FDA and taking any other actions that may be required for the receipt of FDA Approval for the commercial manufacture of the Drug Product. Patheon shall assist the Client, to the extent consistent with Patheon’s obligations under this Agreement, to obtain FDA Approval for the commercial manufacture of the Drug Product as quickly as reasonably possible.

FDA Filings. The Client shall have the sole responsibility for filing all documents with the FDA and taking any other actions that may be required for the receipt of to maintain FDA Approval for the commercial manufacture of all of the Drug ProductProducts. Patheon shall assist the Client, to the extent consistent with Patheon’s 's obligations under this Agreement. Client shall provide Patheon with copies of all FDA filings at the time of submission which contain chemistry, to obtain FDA Approval for manufacturing and controls (CMC) information regarding the commercial manufacture of the Drug Product as quickly as reasonably possibleProduct.

FDA Filings. The Client shall have the sole responsibility for filing all documents with the FDA and taking any other actions that may be required for the receipt of to maintain FDA Approval for the commercial manufacture of all of the Drug ProductProducts. Patheon shall assist the Client, to the extent consistent with Patheon’s 's obligations under this Agreement. Client shall provide Patheon with -21- <PAGE> copies of all FDA filings at the time of submission which contain chemistry, to obtain FDA Approval for manufacturing and controls (CMC) information regarding the commercial manufacture of the Drug Product as quickly as reasonably possible.Product. (b)

FDA Filings. The Client shall have the sole responsibility for filing all documents with with, the FDA and taking any other actions that may be required for the receipt of FDA Approval for the commercial manufacture of all of the Drug ProductProducts. Patheon shall assist the Client, to the extent consistent with Patheon’s obligations under this Agreement, to obtain FDA Approval for the commercial manufacture of the Drug Product all Products as quickly as reasonably possible.