Changes by DPT. DPT agrees that any changes developed by DPT, which may be incorporated into the Product shall require the written approval of COMPANY via a CCR prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications. It is also agreed that any regulatory filings incident to any such change shall be the sole responsibility of COMPANY.
Appears in 5 contracts
Samples: Manufacturing Agreement (Anacor Pharmaceuticals, Inc.), Manufacturing Agreement (Insys Therapeutics, Inc.), Manufacturing Agreement (Insys Therapeutics, Inc.)
Changes by DPT. DPT agrees that any changes to the Product developed by DPT, which may be incorporated into the Product shall require the written approval of COMPANY via a CCR prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications. It is also agreed that any regulatory filings incident to with any Regulatory Authority necessitated by any such change shall be the sole responsibility of COMPANY.
Appears in 2 contracts
Samples: Supply and Manufacturing Agreement (Arcutis Biotherapeutics, Inc.), Supply and Manufacturing Agreement (Evofem Biosciences, Inc.)
Changes by DPT. DPT agrees that any changes developed by DPT, which may be incorporated into the Product shall require the written approval of COMPANY via a CCR PCR prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications. It is also agreed that any regulatory filings incident to any such change shall be the sole responsibility of COMPANY.
Appears in 1 contract
Samples: Agreement (Barrier Therapeutics Inc)
