Common use of DMF Clause in Contracts

DMF. Supplier shall provide Kala the appropriate documentation allowing Kala to reference Supplier’s DMF in its regulatory filings. Supplier shall also provide Kala and/or the applicable regulatory authority with the appropriate technical documentation for those regulatory filings where a reference to Supplier’s DMF is not sufficient or allowed; provided, however, if Supplier is not permitted to share such information with Kala directly, the information provided to Kala may be redacted. Upon request Supplier shall provide Kala yearly confirmation that it has filed with the FDA the required annual progress report to Supplier’s DMF for the year then ended. Supplier shall provide Kala with written notification of an anticipated amendment to the DMF and any equivalent regulatory filing required by any other Ministry of Health authority as soon as practical with sufficient advance notice, if possible, in order to allow Kala to make necessary changes to its own regulatory filings. The Parties agree to work together in good faith regarding any DMF or similar Filing for other countries. Where applicable, Supplier will provide Kala with a reference letter to Supplier’s Certificate of Suitability for the Product. Kala, on a yearly basis, will inform Supplier on the registration status of the Product up to its approval.