Examples of Dosage Forms in a sentence
The sole decision to recall the Packaged Dosage Forms and/or the Packaged Device shall reside with Aradigm, pursuant to Aradigm’s written policy.
Subject to the terms and conditions of this Agreement, EURAND hereby grants to SCANDIPHARM an exclusive royalty-bearing license within the Territory to use the Product to register, package, market and sell the Finished Dosage Forms.
Upon written request, SCANDIPHARM will inform EURAND about any useful marketing literature concerning the sales of the Finished Dosage Forms in the Territory.
Notwithstanding any provision in this Agreement to the contrary, SCANDIPHARM shall have no obligation to apply for or obtain Applicable Permits in any country in the Territory if such registration or approval is reasonably deemed to be unnecessary to market the Finished Dosage Forms in such country.
Additionally, each Party shall immediately notify the Authorized Quality Representative of the other Party of any information it receives relating to the quality of the Packaged Dosage Forms and/or Packaged Device in human clinical trials, which in the notifying Party’s judgment, relates to the Manufacturing process of the Packaged Dosage Forms and/or Packaged Device.
Aradigm will be responsible for all regulatory communication as pertains to Packaged Dosage Forms and/or Packaged Device.
Packaged Dosage Forms containing controlled substances shall be shipped as soon as practicable.
For clarity, Aradigm will be responsible for developing and conducting analytical testing for all non-iDMS identical materials and components and cleaning agents including API and Other Excipients and testing to verify cleaning of Novo Nordisk Delivery Technologies, Inc.’s facilities after manufacture of Dosage Forms.
No Batch of Packaged Dosage Forms or Packaged Devices shall be deemed to have been accepted until the quality control sample and associated documentation related to such Batch have been accepted by Aradigm pursuant to Section 5.4, such acceptance not to be unreasonably withheld or delayed.
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.