Examples of labelling in a sentence
Both Parties recognize that extenuating circumstances may arise that warrant a delay in launching the Product, including but not limited to, unfavorable pricing, pricing reimbursement or Labelling.
Unless prohibited by applicable law, if Schering elects to use the ICN Trademark, the Labelling shall indicate that the Product is under license from ICN.
Subject to the terms and conditions of Section 3.4 hereof, ICN may terminate Schering's rights with respect to a particular country within the Territory, effective upon sixty (60) days' written notice to Schering if Schering has failed to make any commercial sale of the Product in such country within six (6) months following Regulatory Approval with the Minimum Labelling with respect to the Product in such country.
The Parties agree that if ICN makes a commercial launch of the Product in any country of the EU prior to Schering making such a launch in such country, and Schering has not made such launch because of unfavorable pricing, pricing reimbursement or Labelling, then Schering shall be relieved of its obligation to pay minimum royalties (as described in Section 6.2) in all of the countries of the EU.
The Regulatory Approval of the Product in the European Union (including, as applicable, the CPMP or the European Agency for the Evaluation of Medicinal Products) with Minimum Labelling (as defined in the License Agreement) in at least [REDACTED] of the [REDACTED], shall have occurred.