Dosage Forms definition
Examples of Dosage Forms in a sentence
SCANDIPHARM shall notify EURAND of the Launch Date of the Finished Dosage Forms no later than two (2) weeks after said date.
ELAN is beneficially entitled to the use of French Patent No. 7836084 (filing date 22nd December 1978) and various other patents have been granted or are pending under the International Convention in relation to the development and production of Drug Specific Dosage Forms for pharmaceutical products.
This Agreement, the Quality Agreement, and other exhibits hereto shall serve as a supply agreement governing the Manufacture, purchase and supply of Packaged Dosage Forms and/or Packaged Devices between the Parties.
MRD, inspection, analyses and packaging of the Dosage Forms and/or Device changes must be Approved by both Parties in writing using the mutually agreed upon change control procedures.
SCANDIPHARM will exert “commercially reasonable efforts” towards submission of any additional documentation on the Finished Dosage Forms required under Applicable Laws.
Upon written request of EURAND, SCANDIPHARM undertakes to provide EURAND with the US Free Sale Certificate of the Finished Dosage Forms; for such Certificate EURAND shall pay to SCANDIPHARM the documented expenses borne by SCANDIPHARM to get such Certificate from the FDA in the United States of America.
In the event that any API and Other Excipients contain Defects, Aradigm shall promptly replace such API and Other Excipients and Novo Nordisk Delivery Technologies, Inc.’s obligations to manufacture and supply Packaged Dosage Forms will be extended for an amount of time provided that, the capacity limitations set forth in Section 3.1(a) are not exceeded.
Aradigm will be responsible for all regulatory communication as pertains to Packaged Dosage Forms and/or Packaged Device.
For the avoidance of doubt it is expressly stated that nothing herein shall be deemed as to grant Licensee any negotiation or other rights in respect of any Dexmedetomidine Product in formulation(s) other than Licensed Dosage Forms, or to any Dexmedetomidine Product in a Licensed Dosage Form outside Recro Territory.
The Parties have the responsibility to notify each other within twenty-four (24) hours of a situation which could be reasonably expected to result in a recall and/or withdrawal of Packaged Dosage Forms and/or Packaged Device.